Asfiled with the Securities and Exchange Commission on April 25, 2024.

RegistrationNo. 333-

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORMS-1

REGISTRATIONSTATEMENT

UNDER

THESECURITIES ACT OF 1933

FibroBiologics,Inc.

(Exactname of registrant as specified in its charter)

455E. Medical Center Blvd.

Suite300

Houston,Texas 77598

(281)671-5150

(Address,including zip code, and telephone number, including area code, of registrant’s principal executive offices)

PeteO’Heeron

ChiefExecutive Officer

FibroBiologics,Inc.

455E. Medical Center Blvd.

Suite300

Houston,Texas 77598

(281)671-5150

(Name,address, including zip code, and telephone number, including area code, of agent for service)

Copiesto:

Approximatedate of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

Ifany of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under theSecurities Act of 1933 check the following box. ☒

Ifthis Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check thefollowing box and list the Securities Act registration statement number of the earlier effective registration statement for the sameoffering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

Theregistrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until theregistrant shall file a further amendment which specifically states that this registration statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effectiveon such date as the Securities and Exchange Commission acting pursuant to said Section 8(a), may determine.

Theinformation in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registrationstatement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securitiesand it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

FibroBiologics,Inc.

Upto 1,801,801 Units, each consisting of

OneShare of Common Stock and

OneWarrant to purchase One Share of Common Stock

Upto 1,801,801 Shares of Common Stock Underlying the Warrants

Weare offering on a best efforts basis up to 1,801,801 units (the “Units”), of FibroBiologics, Inc., each Unit consistingof one share of our common stock, par value $0.00001 per share (the “common stock”), and one warrant to purchase one shareof common stock (“Warrant”). We have assumed a public offering price of $11.10 per Unit, which was the last reportedsale price of our common stock on The Nasdaq Global Market on April 23, 2024.

Ourcommon stock is listed on The Nasdaq Global Market (“Nasdaq”) under the symbol “FBLG”. There is no establishedpublic trading market for the Warrants. We do not intend to apply for listing of the Warrants on any securities exchange or recognizedtrading system.

TheUnits have no stand-alone rights and will not be certificated or issued as stand-alone securities. The Warrants will have an exerciseprice of $11.10 (100% of the public offering price per Unit) and will be exercisable for a period of five years commencing uponissuance. The shares of common stock and the Warrants included in the Units can only be purchased together in this offering, but areimmediately separable and will be issued separately. The Warrants will be exercisable, at the option of the holder, in whole or in part.Each Warrant will entitle the holder thereof to purchase one share of common stock, and the Warrants are not exercisable for a fractionalshare. A holder of a Warrant may not exercise any portion of a Warrant to the extent that the holder, together with its affiliates andany other person or entity acting as a group, would own more than 4.99% (or, at the election of the investor, 9.99%) of our outstandingshares of common stock after exercise, as such ownership percentage is determined in accordance with the terms of the Warrants, exceptthat upon notice from the holder to us, the holder may waive such limitation up to a percentage, not in excess of 9.99%. To better understandthe terms of the Warrants, you should carefully read the “Description of Our Securities” section on page 83 of this prospectus.

Ourfounder and Chief Executive Officer, Pete O’Heeron, beneficially owns approximately 60% of the voting power of our outstandingvoting securities, and we are a “controlled company” within the meaning of the listing rules of The Nasdaq Stock Market LLC.We do not intend to rely on any exemptions from the corporate governance requirements that are available to controlled companies.

Thepublic offering price per Unit will be determined at the time of pricing and may be at a discount to the then current market price. Theassumed public offering price used throughout this prospectus may not be indicative of the final offering price. The final public offeringprice will be determined through negotiation between us and investors based upon a number of factors, including our history and our prospects,the industry in which we operate, our past and present operating results, the previous experience of our executive officers and the generalcondition of the securities markets at the time of this offering.

TheUnits will be offered at a fixed price and are expected to be issued in a single closing. We expect this offering to be completedno later than two business days following the commencement of this offering. This offering willterminate on May 31, 2024, unless the offering is fully subscribed before that date or we decide to terminate the offering (which wemay do at any time in our discretion) prior to that date. We will deliver all securities to be issued in connection with this offeringdelivery versus payment/receipt versus payment upon receipt of investor funds received by us. Accordingly, neither we northe placement agent have made any arrangements to place investor funds in an escrow account or trust account since the placement agentwill not receive investor funds in connection with the sale of the securities offered hereunder.

Wehave engaged Maxim Group LLC as our exclusive placement agent (“Maxim” or the “placement agent”) to use its reasonablebest efforts to solicit offers to purchase our securities in this offering. The placement agent is not purchasing or selling any of thesecurities we are offering and is not required to arrange for the purchase or sale of any specific number or dollar amount of the securities.Because there is no minimum offering amount required as a condition to closing in this offering the actual public offering amount, placementagent’s fee, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offeringamounts set forth above and throughout this prospectus. We have agreed to pay the placement agent the placement agent fees set forthin the table below. See “Plan of Distribution” in this prospectus for more information.

Weare an “emerging growth company” and a “smaller reporting company” as defined under the federal securities lawsand, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and may elect todo so in future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company and a Smaller ReportingCompany.”

Investingin our common stock involves a high degree of risk. See the “Risk Factors” section beginning on page 10 of this prospectusfor the risks and uncertainties you should consider before investing in our common stock.

Neitherthe Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determinedif this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Deliveryof the securities offered hereby is expected to be made on or about April , 2024, subject to satisfaction of certain customary closingconditions.

SolePlacement Agent

MaximGroup LLC

Thedate of this prospectus is             , 2024

TABLEOF CONTENTS

Youshould rely only on the information contained in this prospectus or contained in any free writing prospectus filed with the Securitiesand Exchange Commission. Neither we nor the placement agent have authorized anyone to provide any information different from, or in additionto, the information contained in this prospectus and in any free writing prospectuses we have prepared or that have been prepared onour behalf or to which we have referred you. Neither we nor the placement agent take responsibility for, and can provide no assuranceas to the reliability of, any other information that others may give you. We are offering to sell, and seeking offers to buy, the securitiesonly under the circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is currentonly as of its date, regardless of the time of delivery of this prospectus or of any sale of our securities. Our business, financialcondition, results of operations and prospects may have changed since such date.

Forinvestors outside the United States: Neither we nor the placement agent have done anything that would permit the use of or possessionor distribution of this prospectus or any related free writing prospectus in any jurisdiction where action for that purpose is required,other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselvesabout, and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside the UnitedStates.

ABOUTTHIS PROSPECTUS

Thisprospectus is a part of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission, or the SEC. Wemay provide a prospectus supplement to add information to, or update or change information contained in, this prospectus, including thesection titled “Plan of Distribution”. You may obtain this information without charge by following the instructionsunder the “Where You Can Find Additional Information” section of this prospectus. You should read this prospectusand any prospectus supplement before deciding to invest in our securities.

Thisprospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to theactual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of someof the documents referred to herein have been filed or will be filed as exhibits to the registration statement of which this prospectusis a part, and you may obtain copies of those documents as described under “Where You Can Find Additional Information.”

PROSPECTUSSUMMARY

Thissummary highlights select information contained elsewhere in this prospectus and does not contain all the information you should considerbefore making an investment decision. You should read the entire prospectus carefully, including the sections entitled “Risk Factors,”“Cautionary Note Regarding Forward-Looking Statements,” “Management’s Discussion and Analysis of Financial Conditionand Results of Operations” and our financial statements and the accompanying notes included elsewhere in, or incorporated by referenceinto, this prospectus before making an investment decision. Unless otherwise indicated or the context otherwise requires, all referencesin this prospectus to “we,” “us,” “our,” the “Company,” “FibroBiologics”and similar terms refer to FibroBiologics, Inc.

Overview

Weare a clinical-stage cell therapy company focused on developing and commercializing fibroblast-based therapies for patients sufferingfrom chronic diseases with significant unmet medical needs, including degenerative disc disease, multiple sclerosis, wound healing, andcertain cancers, and for potential extension of life applications including thymic and splenic involution reversal.

Wewere formed in April 2021 as a Texas limited liability company under the name FibroBiologics, LLC, and converted to a Delaware corporationin December 2021 under the name Fibrobiologics, Inc. On April 12, 2023, we changed our name to FibroBiologics, Inc. In connection withour formation, we issued shares of our Series A Preferred Stock, or the Series A Preferred Stock, to our then parent, SpinalCyte LLC(doing business as FibroGenesis), or FibroGenesis, in return for rights to certain intellectual property through a patent assignmentagreement and an intellectual property cross-licensing agreement. Developing the intellectual property obtained from FibroGenesis wasthe basis for our formation. Prior to our inception, preclinical research and development related to the transferred intellectual propertytook place under FibroGenesis.

FibroblastsTechnology Platform

Fibroblastsand stem cells are the only two cell types in the human body that can regenerate tissue and organs. Studies have indicated that mesenchymalstem cells and fibroblasts share many surface markers in common, and can differentiate into many cells including adipocytes, chondrocytes,osteoblasts, hepatocytes, and cardiomyocytes, and can regulate the immune system. However, transcriptomic and epigenetic studies haveindicated a clear difference between the two cell types.

Fibroblastscomprise the main cell type of connective tissue, possessing a spindle-shaped morphology, whose classical function has historically beenbelieved to produce an extracellular matrix responsible for maintaining the structural integrity of the tissue. Fibroblasts also playan important role in maintaining stem cell niches in organs and are involved in every stage of wound healing.

Fibroblastsare favorable to stem cells as a cell therapy treatment platform because fibroblasts:

Studieshave demonstrated that allogeneic fibroblasts, much like mesenchymal stem cells, are immune-privileged and do not provoke an immune responsein vitro and in vivo. If autologous fibroblasts were required instead, it would mean that cells would have to be harvestedfrom each patient, processed and cultured, and then administered to the same patient, which would be more costly and inefficient. Becauseallogeneic fibroblasts do not cause an immune response, we are planning to build our own current Good Manufacturing Practices, or cGMP,manufacturing facility to source allogeneic fibroblast cells for clinical testing of our product candidates and for commercial salesif our product candidates receive marketing approval.

Todate, however, no fibroblast therapy products have been approved and there have only been a few clinical trials involving fibroblasts.The costs to develop, manufacture, and commercialize product candidates utilizing our fibroblasts technology platform may exceed ourestimates. Furthermore, the biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intensecompetition and a strong emphasis on proprietary and novel products and product candidates so any product candidates that we successfullydevelop and commercialize will compete with existing therapies and new therapies that may become available in the future. Additionalinformation regarding risks and uncertainties relating to our product candidates technology and business are set forth in the sectionstitled “—Summary of Risk Factors” and “Risk Factors” in this prospectus.

OurManagement Team and Oversight

Wehave assembled an executive leadership team comprised of our founder, chief executive officer and chairperson of our board of directors,our chief scientific officer, our chief financial officer, and our general counsel, with combined successful track records in startupentrepreneurial companies and in the life sciences industry. Our executive leadership team works under the oversight of our board ofdirectors who are recognized leaders with hands-on industry experience. We also have a team of world-renowned scientists with relevantexpertise on our scientific advisory board to help guide our research and development efforts.

OurCurrent Pipeline

Wehave a pipeline of product candidates at various stages of development, including the following:

CYWC628for Wound Healing: We are in the late pre-clinical stages of developing CYWC628 as an allogeneic fibroblast cell-based therapy forwound healing. Our studies are presently focused on utilizing fibroblasts and fibroblast-derived cells to treat wounds in diabetic mice.Our data to date is compiled from four separate animal model studies (manuscript for publication in progress). Each study utilized 16wild type as well as leptin mutated NONcNZO10LTJ mouse that develops type 2 diabetes when fed a high fat diet. Wound size and area forall our experiments were measured using an eKare inSight™ device which is FDA approved for measuring and monitoring wound size,area and depth. Phase 1 of our pre-clinical study studied the subcutaneous and topically administered single cell mouse dermal fibroblasts(both treatments administered every two days), as well as mouse dermal fibroblast derived exosomes. The results of this study indicatedsignificant improvement in wound healing (p <0.0005) for topically administered mouse fibroblasts and mouse fibroblast exosomes ascompared to untreated control, and significant improvement in wound healing with subcutaneous inject of fibroblast in the wound periphery(p < .005). Our Phase 2 pre-clinical study studied the impact of using frozen and thawed single cell mouse fibroblasts administeredevery two days, as well as mouse spheroid fibroblasts, one-time topical administration, measuring 250 um and each containing approximately10,000 mouse dermal fibroblasts. In total 100 spheroids were topically administered on to an 8 millimeter diameter wound on the backof the wild type and leptin mutated mice. The results of the study indicated significant improvement in wound healing with the frozenthawed single cell mouse fibroblasts (p < 0.005), as well as 4°C stored mouse fibroblast spheroids (p <0.0005) with both mousetypes. Our objective was to test the feasibility of using spheroid fibroblasts as an extended-release mechanism on wound surfaces. The results indicated that spheroid fibroblasts are easier to use and more viable than single cell fibroblasts, and generate more significantresults. Our Phase 3 pre-clinical study tested the effect of using a single topical administration ofhuman dermal fibroblast (CYWC628) spheroids compared to a single administration of mouse dermal spheroids, in addition to comparing witha commercially available and FDA approved diabetic foot ulcer treatment called Grafix™. The results of our study indicated thatCYWC628 significantly improved wound healing rate (p < 0.0005) as compared to untreated control as well as significant improvement(p < 0.05) over mouse fibroblast spheroids and Grafix™. For our Phase 4 pre-clinical study we studied the impact of a singletopical treatment of CYWC628 spheroids and Grafix™ on a chemically induced chronic wound model often used to mimic diabetic footulcers in animal models. The results of our study indicated a 58.5% reduction in wound area three days after a single topical administrationof CYWC628 as compared to 34.5% for Grafix™ (p < 0.005). The untreated saline control group had an 11% improvement in woundhealing which was not statistically significant (p < 0.06). Our results also indicated that with multiple topical administration ofCYWC628, the rate of wound closure will likely be more rapid.

The following graph and chart summarize the resultsof our Phase 4 pre-clinical study.

CYMS101 for Multiple Sclerosis: We aredeveloping CYMS101 as an allogeneic fibroblast cell-based therapy to treat multiple sclerosis, or MS. After completing animal studiesusing CYMS101 (allogeneic fibroblast cells), we received approval from Mexico to conduct clinical investigations using the fibroblastcell composition for patients with MS and have completed a Phase 1 clinical trial called “Feasibility Study of Tolerogenic Fibroblastsin Patients with Refractory Multiple Sclerosis.” The study was conducted in five participants. The primary objective of the studywas to assess safety, and the secondary objective was to assess efficacy. The results of the study for safety were no adverse effectsduring intravenous injection of the tolerogenic fibroblasts, no short or long-impact in complete blood count test during the 16-weekmonitoring period, and no short or long impact in electrocardiogram results during the 16-week monitoring period. In addition, the resultsof the study for efficacy included general improvement of Paced Auditory Serial Addition Test, or PASAT, score for all patients duringthe 16-week monitoring period, general improvement of 9-hole Peg test completion time for all patients during the 16-week testing period,no general improvement or deterioration noted with the Timed 25-Foot walk test, no general improvement or deterioration noted with ExpandedDisability Status Scale, or EDSS, test, and no patient exhibited further deterioration during the trial. We are currently conductingfurther research to determine the mode of action of fibroblasts in oligodendrocyte expansion and expect to file an IND application fora Phase 2 clinical trial in MS. We will likely seek a strategic partner to collaborate with us on the development of CYMS101 either beforeinitiating the Phase 2 clinical trial, or after its completion, if successful, and prior to commencing with a Phase 3 clinical trial.

CybroCell™for Degenerative Disc Disease: CybroCell™ is an allogeneic fibroblast cell-based therapy for degenerative disc disease Thisnew technology is being designed as an alternative method for repairing the cartilage of the intervertebral disc (or any other articularcartilage). The method is based on using human dermal fibroblasts, or HDFs, which are forced to differentiate into chondrocyte-like cellsin vivo using the mechanical force and intermittent hydrostatic pressure found in the spine, for chondrogenic differentiationof fibroblasts. We believe our solution will prove superior to existing treatments because we expect it will be less invasive, and willregenerate the disc, restore function and reduce pain without debilitating long-term effects. We have completed two rounds of animalstudies. The results from the studies were positive and resulted in “first in human” trial approval in our investigationalnew drug, or IND, submission to the U.S. Food and Drug Administration, or FDA. We have received IND clearance from the FDA, conditionalupon approval of our master cell bank, to run a Phase 1/2 clinical trial for patients suffering from degenerative disc disease. We willbe conducting this trial within the United States. A timeline will be determined through discussions with the FDA.

Business Update and Recent Developments

CYWC628for Wound Healing: For our Phase 5 pre-clinical study, using a diabetic mouse model (BKS.Cg-Dock7m), we studied the impact of multipleadministrations of CYWC628 spheroids and Grafix™ on a chemically induced chronic wound often used to mimic diabetic foot ulcersin animal models. The CYWC628 spheroids were administered on Day 0, Day 4, Day 8 and Day 12. The results of our study with this mousemodel of a chronic wound indicated (i) a 34.8% reduction in wound area four days after the first administration (day 4) of CYWC628 ascompared to 28.6 % for Grafix™ (p > 0.05), which was not statistically significant, and 10.2% for the untreated saline controlgroup (p < 0.05); (ii) a 43.4% reduction in wound area four days after the second administration (day 8) of CYWC628 as compared to37.6 % for Grafix™ (p > 0.05), which was not statistically significant, and 21.7% for the untreated saline control group (p< 0.05); (iii) a 69.3% reduction in wound area four days after the third administration (day 12) of CYWC628 as compared to 47.13%for Grafix™ (p < 0.05), which was statistically significant, and 36.4% for the untreated saline control group (p < 0.05),which was also statistically significant.; and (iv) an 83.8% reduction in wound area four days after the fourth administration (Day 19)of CYWC628 as compared to 66% for Grafix™ (p< 0.05), which was statistically significant, and 55.2% for the untreated salinecontrol group (p<0.01), which was also statistically significant. Grafix™ results as compared to saline control were not statisticallysignificant at any of the measured timepoints, whereas CYWC628 as compared to saline control was statistically significant at all measuredtimepoints.

The following graph and chart summarize the resultsof our Phase 5 pre-clinical study.

Effectivewound healing is not only determined by the efficiency of wound closure, but also by the quality of the healed wound. For our multipleCYWC628 administration study, we also looked at several metrics essential to the quality of wound healing. These metrics are re-epithelialization,granulation, cell proliferation, neo-vascularization, and fibroblast recruitment. The results of the study indicated that at day 19 afterthe final treatment, CYWC628 had a significantly improved epithelization, granulation, cell proliferation (as measured using Ki67), neo-vascularization(as measured by CD31 and VEGF), and fibroblast recruitment (as measured by αSMA and IL-6) compared to control and Grafix™.

Forour remaining pre-clinical studies, we will investigate multiple administrations of CYWC628 on a chemically induced chronic woundNONcNZO10/LtJ mouse model, complete a dose titration study to provide information on effective dose range of CYWC628, andcomplete an acute and chronic toxicity study. We expect to complete these studies in the 3rd quarter of 2024. Based upon our resultsachieved to date and the expected timing of these additional pre-clinical studies, we are planning to initiate a Phase 1/2 clinicaltrial in Australia for treatment of diabetic foot ulcers in 2025 with results expected in the third quarter of 2025.

Manufacturing:We are planning to complete a technology transfer of our cell manufacturing processes to a contract development and manufacturingorganization, or CDMO, and conduct feasibility studies for our fibroblast spheroid-based drug product, with the intent to enterinto a master services agreement with that CDMO to supply drug product for clinical trials. We expect to produce a master cell bank,working cell bank, and drug product for use in clinical trials by year end 2024.

OurCompetitive Strengths

Ourstrengths lie in our technology platform centered around the power of fibroblasts and in our experienced leadership team. Fibroblastsare the most common cell found in the human body and we believe they are more robust and potent than stem cells. Our intellectual propertyportfolio includes 48 issued patents and 108 pending patents for the use of fibroblasts in diverse therapeutic areas. We also have anexperienced leadership team with successful track records in entrepreneurial startup companies and the life sciences industry, a boardof directors with life sciences operational leadership experience, and a world-renowned scientific advisory board with relevant expertise.

OurStrategy

Weare leveraging fibroblast cells as a technology platform to research and develop innovative treatments for chronic diseases with significantunmet treatment needs. Our vision is to become a world leader in regenerative medicine through a rigorous scientific process and commitmentto serving patients’ needs. To achieve our vision, we will focus our efforts on the following strategy:

Summaryof Risk Factors

Ourbusiness is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including thosehighlighted in the section entitled “Risk Factors” in this prospectus. These risks include, but are not limited to,the following:

ReverseStock Split

OnOctober 6, 2023, our board of directors and our stockholders each approved a 1-for-4 reverse stock split of all classes of our issuedand outstanding capital stock (the “Reverse Stock Split”), and on October 31, 2023, we filed an amended and restated certificateof incorporation with the State of Delaware to immediately effect the Reverse Stock Split. All share and per share information in thisprospectus have been adjusted to reflect the Reverse Stock Split, unless otherwise stated.

Implicationsof being a Controlled Company

Ourfounder and Chief Executive Officer, Pete O’Heeron, collectively beneficially owns approximately 60% of the voting power of ouroutstanding voting securities and we are a “controlled company” within the meaning of the listing rules of The Nasdaq StockMarket LLC.

Aslong as our principal shareholder owns at least 50% of the voting power of our Company, we will continue to be a “controlled company”as defined under Nasdaq Listing Rules. As a controlled company, we are permitted to rely on certain exemptions from Nasdaq’s corporategovernance rules, including:

Althoughwe currently do not intend to rely on the “controlled company” exemption under the Nasdaq listing rules, we could elect torely on this exemption in the future. As a result, you may not in the future have the same protection afforded to shareholders of companiesthat are subject to these corporate governance requirements.

Implicationsof being an emerging growth company and a smaller reporting company

Weare an “emerging growth company” as defined in the Securities Act of 1933, or the Securities Act, as modified by the JumpstartOur Business Startups Act of 2012, or the JOBS Act. As such, we are eligible to take, and intend to take, advantage of certain exemptionsfrom various reporting requirements applicable to other public companies that are not emerging growth companies for as long as we continueto be an emerging growth company, including (i) the exemption from the auditor attestation requirements with respect to internal controlover financial reporting under Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, (ii) the exemptions fromsay-on-pay, say-on-frequency and say-on-golden parachute voting requirements and (iii) reduced disclosure obligations regarding executivecompensation in our periodic reports and proxy statements.

Wewill remain an emerging growth company until the earliest of (i) December 31, 2028, (ii) the last day of the fiscal year in which wehave total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “largeaccelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act, which wouldoccur if the market value of our common stock held by non-affiliates was $700.0 million or more as of the last business day of the secondfiscal quarter of such year or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities duringthe prior three-year period.

Inaddition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying withnew or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards untilthose standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period and,as a result, we may adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required fornon-public companies instead of the dates required for other public companies.

Weare also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting companyeven after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smallerreporting companies until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliatesis $250 million or more measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 millionduring the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is $700 million or moremeasured on the last business day of our second fiscal quarter.

CorporateInformation

Wewere formed in April 2021 as a Texas limited liability company under the name FibroBiologics, LLC, and converted to a Delaware corporationin December 2021 under the name Fibrobiologics, Inc. On April 12, 2023, we changed our name to FibroBiologics, Inc. Our principal executiveoffices are located at 455 E. Medical Center Blvd., Suite 300, Houston, Texas 77598. Our telephone number is (281) 671-5150, and ourwebsite address is www.fibrobiologics.com. Information contained on or that can be accessed through our website is neither a part ofnor incorporated by reference into this prospectus, and you should not consider information on our website to be part of this prospectus.Our website address is included in this prospectus as an inactive textual reference only.

THEOFFERING

Thesummary below describes the principal terms of this offering.

Unlessotherwise indicated, all information in this prospectus assumes no exercise of the Warrants being offered in this offering.

SUMMARYFINANCIAL AND OTHER DATA

Thesummary financial and other data set forth below should be read together with our financial statements and the related notes to thosestatements, as well as the “Management’s Discussion and Analysis of Financial Condition and Results of Operations”section incorporated by reference into this prospectus. The statements of operations and cash flows data for the years ended December31, 2023 and 2022, have been derived from our audited financial statements incorporate by reference into this prospectus. Our historicalresults are not necessarily indicative of the results that may be expected in any future period.

Allshare numbers and per share amounts in the tables below have been adjusted to reflect the Reverse Stock Split.

¹We define working capital as current assets less current liabilities.

RISKFACTORS

Aninvestment in our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, togetherwith all of the other information contained in this prospectus, including our financial statements and related notes appearing elsewherein this prospectus, before deciding whether to invest in our securities. The occurrence of one or more of the events or circumstancesdescribed in these risk factors, alone or in combination with other events or circumstances, may have a material adverse effect on ourbusiness, reputation, revenue, financial condition, results of operations and future prospects, in which event you could lose all orpart of your investment. The risks and uncertainties described below are not intended to be exhaustive and are not the only ones we face.Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations.This prospectus also contains forward-looking statements that involve risks and uncertainties. See “Cautionary Note Regarding Forward-LookingStatements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statementsas a result of certain factors, including those described below.

RisksRelated to this Offering

Thisis a best-efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believeis required for our business plans, including our near-term business plans.

Theplacement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The placementagent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollaramount of the securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering.Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placementagent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth herein.We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, andinvestors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support ourcontinued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe is requiredfor our operations in the short-term and may need to raise additional funds to complete such short-term operations. Such additional fundraisesmay not be available or available on terms acceptable to us.

Youwill experience immediate dilution as a result of this offering and may experience additional dilution in the future.

Thepublic offering price for the Units offered hereby will be substantially higher than the net tangible book value per share of our commonstock immediately after this offering. If you purchase Units in this offering, you will incur substantial and immediate dilution in thenet tangible book value of your investment. Net tangible book value per share represents the amount of total tangible assets less totalliabilities, divided by the number of shares of our common stock then outstanding. After giving effect to the sale by us of 1,801,801Units in this offering at an assumed public offering price of $11.10 per Unit, and after deducting placement agent fees andestimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $10.37 per share. To the extentthat options and warrants that are currently outstanding are exercised, there will be further dilution to your investment. We may alsoissue additional common stock, options, warrants and other securities in the future that may result in further dilution of your sharesof our common stock.

Futuresales of our common stock, or the perception that such sales may occur, could depress the trading price of our common stock.

Afterthe completion of this offering, we expect to have up to 34,537,007 shares of our common stock outstanding. We and each of our officersand directors have signed lock-up agreements for a period of 90 days following the date of closing of this offering, subject tospecified exceptions. See “Plan of Distribution.”

Theplacement agent may, in its sole discretion and without notice, release all or any portion of the shares of our common stock subjectto lock-up agreements. As restrictions on resale end, the market price of our common stock could drop significantly if the holders ofthese shares of our common stock sell them or are perceived by the market as intending to sell them. These factors could also make itmore difficult for us to raise additional funds through future offerings of our common stock or other securities.

Wehave broad discretion in the use of the net proceeds we receive from this offering and may not use them effectively.

Ourmanagement will have broad discretion in the application of the net proceeds we receive in this offering, including for any of the purposesdescribed in the section entitled “Use of Proceeds,” and you will not have the opportunity as part of your investment decisionto assess whether our management is using the net proceeds appropriately. Because of the number and variability of factors that willdetermine our use of our net proceeds from this offering, their ultimate use may vary substantially from their currently intended use.The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effecton our business and cause the price of our common stock to decline. Pending their use, we may invest our net proceeds from this offeringin short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders.

TheWarrants are speculative in nature.

TheWarrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends,but rather merely represent the right to acquire shares of our common stock at a fixed price for a limited period of time. Specifically,holders of the Warrants may exercise their right to acquire the common stock and pay an exercise price of $11.10 per share, priorto five years from the date of issuance, after which date any unexercised Warrants will expire and have no further value.

Holdersof Warrants will have no rights as a common stockholder unless such holders exercise their Warrants and acquire our common stock.

Untilholders of Warrants acquire shares of our common stock upon exercise of the Warrants, holders of Warrants will have no rights with respectto the shares of our common stock underlying such Warrants. Upon exercise of the Warrants, the holders thereof will be entitled to exercisethe rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

Thereis no public market for the Warrants in this offering, which may limit your ability to resell the Warrants.

Thereis no established public trading market for the Warrants, and we do not expect a market to develop. In addition, we do not intend toapply for listing of the Warrants on any securities exchange or recognized trading system. As a result, the Warrants may not be widelydistributed and purchasers of the Warrants may be unable to resell them or sell them only at an unfavorable price for an extended periodof time, if at all.

Themarket price of our common stock may never exceed the exercise price of the Warrants issued in connection with this offering.

TheWarrants being issued in connection with this offering become exercisable upon issuance and will expire five years from the date of issuance.The market price of our common stock may never exceed the exercise price of the Warrants prior to their date of expiration. Any warrantsnot exercised by their date of expiration will expire worthless and we will be under no further obligation to the warrant holder.

RisksRelated to Our Financial Condition and Capital Requirements

Thesuccessful development of biopharmaceutical products is highly uncertain.

Successfuldevelopment of biopharmaceutical products is highly uncertain and is dependent on numerous factors, many of which are beyond our control.Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:

Thelength of time necessary to complete clinical trials and submit an application for marketing approval for a final decision by a regulatoryauthority varies significantly from one product candidate to the next and from one country or jurisdiction to the next and may be difficultto predict.

Evenif we are successful in obtaining marketing approval, commercial success of approved products may also depend in large part on the availabilityof coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programsand managed care organizations in the United States or country-specific governmental organizations in foreign countries, which may beaffected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could requireus to conduct additional studies, including post-marketing studies related to the cost effectiveness of an approved product, to qualifyfor reimbursement, which could be costly and divert our resources. If government and other healthcare payors were to not provide coverageand adequate reimbursement for our products once approved, market acceptance and commercial success may be reduced.

Inaddition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regardingthe submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensurethat any third-party providers comply) with cGMPs and good clinical practices, or GCPs, for any clinical trials that we conduct post-approval.In addition, there is always the risk that we, a regulatory authority or a third party might identify previously unknown problems witha product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly,and any failure to comply or other issues with our product candidates post-approval could adversely affect our business, financial conditionand results of operations.

Wehave a limited operating history and none of our current product candidates have been approved for commercial sale, which may make itdifficult for you to evaluate our current business and predict our future success and viability.

Biopharmaceuticalproduct development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage cell therapycompany with a limited operating history upon which you can evaluate our business and prospects. None of our current product candidatesare approved for commercial sale and we have not generated any revenue from such product candidates. To date, we have devoted substantiallyall of our resources and efforts to organizing and staffing our company, business planning, executing partnerships, raising capital,discovering, identifying and developing potential product candidates, securing related intellectual property rights and conducting andplanning preclinical studies and clinical trials of our product candidates. In relation to our current product candidates, we have notyet demonstrated our ability to successfully complete any Phase 3 clinical trials, obtain marketing approvals, manufacture a commercial-scaleproduct or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful productcommercialization. As a result, it may be more difficult for you to accurately predict our future success or viability than it couldbe if we had a longer operating history or a history of successfully developing and commercializing biopharmaceutical products.

Inaddition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequentlyexperienced by clinical-stage biopharmaceutical companies in rapidly evolving fields. We also may need to transition from a company witha research focus to a company capable of supporting commercial activities. If we do not adequately address these risks and difficultiesor successfully make such a transition, our business will suffer.

Wehave incurred significant net losses since inception, expect to continue to incur significant net losses for the foreseeable future,and may never achieve or maintain profitability.

Wehave incurred significant net losses since our inception, have not generated any revenue from product sales to date and have financedour operations principally through private financings. For the years ended December 31, 2023 and 2022, we incurred net losses of $16.5million and $5.1 million, respectively. As of December 31, 2023, we had an accumulated deficit of $24.4 million. Our losses have resultedprincipally from expenses incurred in research and development of our product candidates, from management and administrative costs andother expenses that we have incurred while building our business infrastructure, and from a loss due to the change in fair value of liabilityinstrument. We expect that it will be several years, if ever, before we have a commercialized product and generate revenue from productsales. Even if we succeed in receiving marketing approval for, and commercializing, one or more of our product candidates, we expectthat we will continue to incur substantial research and development and other expenses as we discover, develop and market additionalpotential product candidates.

Weexpect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase substantially if andas we:

Thenet losses we incur may fluctuate significantly from period to period, such that a period-to-period comparison of our results of operationsmay not be a good indication of our future performance. The size of our future net losses will depend, in part, on the rate of futuregrowth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue tohave an adverse effect on our working capital and our ability to achieve and maintain profitability.

Ourability to become and remain profitable depends on our ability to generate revenue or execute other business development arrangements.We do not expect to generate significant revenue, if any, unless and until we are able to obtain regulatory approval for, and successfullycommercialize, one or more product candidates we are developing or may develop. Successful commercialization will require achievementof many key milestones, including demonstrating safety and efficacy in clinical trials, obtaining regulatory approval for these productcandidates, manufacturing, marketing and selling those products for which we may obtain regulatory approval, satisfying any post-marketingrequirements and obtaining reimbursement for our products from private insurance or government payors. Because of the uncertainties andrisks associated with these activities, we are unable to accurately and precisely predict the timing and amount of revenues, the extentof any further losses or if or when we might achieve profitability.

Wemay never succeed in these activities and, even if we do, we may never generate revenues that are significant enough for us to achieveprofitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annualbasis. Our failure to become and remain profitable could impair our ability to raise capital, expand our business, diversify our productofferings or continue our operations. If we continue to incur losses as we have since our inception, investors may not receive any returnon their investment and may lose their entire investment.

Wewill require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptableterms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercializationefforts.

Developingbiopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertainprocess that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expensesto increase in connection with our ongoing activities, particularly as we initiate and conduct clinical trials of, and seek marketingapproval for our current product candidates and any future product candidates. Even if one or more of the product candidates that wedevelop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved productcandidate. Our expenses could increase beyond expectations if we are required by the FDA, the EMA or other comparable regulatory authoritiesto perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may alsoarise. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercializationexpenses related to drug sales, marketing, manufacturing and distribution. Because the design and outcome of our anticipated clinicaltrials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development andcommercialization of any product candidate we develop. Accordingly, we will need to obtain substantial additional funding in order tomaintain our continuing operations.

Asof December 31, 2023, we had approximately $9.2 million in cash and cash equivalents. Based on our current business plans, we believethat our existing capital will enable us to fund our operations through at least February 28, 2025. Our estimate as to how long we expectour existing capital to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could useour available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, couldcause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

Ourfuture funding requirements will depend on many factors, including, but not limited to:

Advancingthe development of our product candidates will require a significant amount of capital. In order to fund all of the activities that arenecessary to complete the development of our product candidates, we will be required to obtain further funding through equity offerings,debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operatingactivities. Adequate additional funding may not be available to us on acceptable terms, or at all.

Ourfailure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our abilityto pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research-stageprograms, clinical trials or future commercialization efforts, grant rights to develop and market product candidates that we would otherwiseprefer to develop and market ourselves, obtain funds through arrangement with collaborators on terms unfavorable to us or pursue mergeror acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders.

Raisingadditional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to ourproduct candidates on unfavorable terms to us.

Wemay seek additional capital through a variety of means, including through equity, debt financings, or other sources, including up-frontpayments and milestone payments from strategic collaborations. We may seek additional capital due to favorable market conditions or strategicconsiderations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additionalcapital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may includeliquidation or other preferences and anti-dilution protections that adversely affect your rights as a stockholder.

Suchfinancing may also result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may adverselyaffect our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances or marketing, distributionor licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams,research programs or product candidates, or grant licenses on terms that are not favorable to us.

Weare party to a share purchase agreement, dated November 12, 2021, with certain investors (the “GEM SPA”), pursuant to whichwe may elect to issue and sell to such investors, and if so elected, such investors will be obligated to purchase, for a period commencingon the first day on which our common stock trade on a principal U.S. securities exchange and ending 60 months from such date, up to $100,000,000worth of shares of our common stock, or the Aggregate Limit, subject to a 10% discount for the investors for shares acquired pursuantto the GEM SPA. The GEM SPA was contingent upon our achieving a public listing of our common stock, which was satisfied by the directlisting of our common stock on Nasdaq (the “Direct Listing”). However, it is possible that we may not be able to obtainaccess to the full amount potentially available to us under the GEM SPA due to a variety of factors outside of our control.

TheGEM SPA prohibits the investors and their affiliates from:

(1)selling any of our securities during its term except for the shares that it owns or has the right to purchase pursuant to the provisionsof a Draw Down Notice or the Warrant (as defined in the GEM SPA);

(2)entering into a short position, engaging in any short sales or equivalent transactions, establishing or increasing a put equivalent positionor liquidating or decreasing any call equivalent position with respect to our shares, or taking, directly or indirectly, any action designedor intended to cause the manipulation of the price of our shares to facilitate the sale or resale of any of the shares; and

(3)granting any option to purchase or acquiring any right to dispose or otherwise dispose for value of any of our shares, or any securitiesconvertible into, or exchangeable for, or warrants to purchase, any of our shares, respectively, or entering into any swap, hedge orother agreement that transfers, in whole or in part, the economic risk of ownership of our shares (except for shares that it has theright to purchase pursuant to the provisions of a Draw Down Notice or the Warrant).

Theinvestors under the GEM SPA have further agreed to comply in all material respects with all applicable laws, rules, regulations and orders,including, without limitation, the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4)under the Securities Act and Regulation M and Rule 10b-5 under the Exchange Act, where applicable. GEM and GYBL have informed us thatthey did not engage in any short selling of our securities or other hedging activities prior to entering into the GEM SPA.

OnJanuary 31, 2024, in conjunction with the Direct Listing, we issued a draw-down notice under the GEM SPA to have GEM purchase up to 900,000shares of our common stock at a draw-down threshold price of no less than $15.00 per share. GEM submitted two closing notices after 65,447shares and 76,851 shares of our common stock were purchased at $13.50 per share. The net proceeds from these two closing notices underthis draw-down were approximately $1.8 million. We then authorized a reduction of the draw-down threshold price to no less than $13.50per share, and GEM submitted one additional closing notice after 84,759 shares of our common stock were purchased pursuant to the GEMSPA at $12.15 per share for net cash proceeds of approximately $1.0 million. Pursuant to the GEM SPA, we are required to pay the investorsa commitment fee equal to 2% of the Aggregate Limit, payable in cash or shares of our common stock. The commitment fee is payable evenif we do not utilize any drawdowns.

Inaddition, the GEM SPA required us to issue to GYBL, on our public listing date, a warrant to purchase up to the number of shares of ourcommon stock that is equal to 4% of our total equity interests outstanding immediately after the completion of our public listing, ata price per share equal to the lesser of (i) the public offering price per share (in the case of an initial public offering) or the closingbid price per share on the public listing date (in the case of a public listing other than an initial public offering) or (ii) the quotientobtained by dividing $700,000,000 by the total number of equity interests. With approval from our Board of Directors, we issued 1,299,783warrants with an initial exercise price of $21.54 per share to GYBL.

Ourelection to issue and sell to the investors, shares of our common stock pursuant to the GEM SPA, or the exercise of the warrant we wereobligated to issue upon consummation of the Direct Listing, will result in further dilution to our existing stockholders and investorswho purchase shares of our common stock in this offering.

RisksRelated to Development, Regulatory Approval and Commercialization

Theregulatory approval processes of the FDA, the EMA and other comparable foreign regulatory authorities are lengthy, time consuming andinherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable togenerate product revenue and our business will be substantially harmed.

Weare not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approvalfrom the FDA. Foreign regulatory authorities, such as the EMA, impose similar requirements. The time required to obtain approval by theFDA, the EMA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencementof clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved.In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during thecourse of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval orthe decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuseto accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or otherdata. Even if we eventually complete clinical testing and receive approval of any regulatory filing for our product candidates, the FDA,the EMA and other comparable foreign regulatory authorities may approve our product candidates for a more limited indication or a narrowerpatient population than we originally requested. We have not submitted for, or obtained, regulatory approval for any product candidate,and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will everobtain regulatory approval.

Further,development of our product candidates and/or regulatory approval may be delayed for reasons beyond our control.

Applicationsfor our product candidates could fail to receive regulatory approval for many reasons, including the following:

Thislengthy, uncertain approval process, as well as the unpredictability of the results of clinical trials, may result in our failing toobtain regulatory approval to market any of our product candidates, which would significantly harm our business, results of operationsand prospects. In addition, the FDA, the EMA or comparable foreign regulatory authorities may change their policies, adopt additionalregulations or revise existing regulations or take other actions, which may prevent or delay approval of our future product candidatesunder development on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delayour ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations wemay have obtained.

Wemay encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our productcandidates.

Beforeobtaining marketing approval from the FDA, the EMA or other comparable foreign regulatory authorities for the sale of our product candidates,we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates.Clinical testing is expensive, difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain.A failure of one or more clinical trials can occur at any stage of the process. The outcome of preclinical studies and early-stage clinicaltrials may not be predictive of the success of later clinical trials.

Wedo not know whether our future clinical trials will begin on time or enroll patients on time, or whether our ongoing and/or future clinicaltrials will be completed on schedule or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

Conductingclinical trials in foreign countries, as we may do for our product candidates, presents additional risks that may delay completion ofour clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a resultof differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatoryschemes, as well as political and economic risks relevant to such foreign countries.

Additionally,if the results of our clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with ourproduct candidates, we may:

Ourdevelopment costs will also increase if we experience delays in testing or obtaining marketing approvals. We do not know whether anyof our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all.Any delay in, or termination of, our clinical trials will delay the submission of a BLA to the FDA or similar applications with comparableforeign regulatory authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate productrevenue. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our claims for differentiationor the effectiveness or safety of our product candidate. The FDA has substantial discretion in the review and approval process and maydisagree that our data support the claims we propose.

Moreover,principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensationin connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA, theEMA or other comparable foreign regulatory authorities. The FDA, the EMA or other comparable foreign regulatory authorities may concludethat a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretationof the study. The FDA, the EMA or other comparable foreign regulatory authorities may therefore question the integrity of the data generatedat the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay inapproval, or rejection, of our marketing applications by the FDA, the EMA or other comparable foreign regulatory authorities, as thecase may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.

Ifwe experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospectsof our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed.Moreover, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approvalprocess and jeopardize our ability to commence product sales and generate revenues.

Inaddition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of,clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any delays to our clinical trialsthat occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidatesand our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates couldbe significantly reduced. Any of these occurrences may harm our business, financial condition and prospects significantly.

Theoutcome of preclinical studies or early clinical trials may not be predictive of the success of later clinical trials, and the resultsof our clinical trials may not satisfy the requirements of the FDA, the EMA or other comparable foreign regulatory authorities.

Positiveresults from preclinical studies and early clinical trials do not mean that future clinical trials will be successful. Failure can occurat any time during the clinical trial process. We do not know whether any of our product candidates will perform in current or futureclinical trials as they have performed in preclinical studies and early clinical trials. Product candidates in later-stage clinical trialsmay fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, the EMA and other comparable foreign regulatoryauthorities despite having progressed through preclinical studies and early-stage clinical trials.

Insome instances, there can be significant variability in safety and efficacy results between different clinical trials of the same productcandidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differencesin and adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. Patientstreated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments and may be using other approvedproducts or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product candidate. Asa result, assessments of efficacy can vary widely for a particular patient, and from patient to patient and site to site within a clinicaltrial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes. We do not know whether anyclinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval tomarket our product candidates. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

Additionally,some of our planned clinical trials may utilize an “open-label” trial design. An “open-label” clinical trialis one where both the patient and investigator know whether the patient is receiving either the investigational product candidate oran existing approved pharmaceutical or placebo. Most typically, open-label clinical trials test only the investigational product candidateand sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate anytherapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trialsmay be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awarenessof receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias”where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatmentand may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial maynot be predictive of future clinical trial results with any of our product candidates for which we include an open-label clinical trialwhen studied in a controlled environment with a placebo or active control.

Moreover,preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their productcandidates performed satisfactorily in preclinical studies or clinical trials nonetheless failed to obtain FDA, EMA or comparable foreignregulatory authority approval. We cannot guarantee that the FDA, the EMA or comparable foreign regulatory authorities will interprettrial results as we do, and more trials could be required before we are able to submit applications seeking approval of our product candidates.This is particularly true for clinical trials in rare diseases, where the very small patient population makes it difficult to conducttwo traditional, adequate and well-controlled studies, and therefore the FDA, the EMA or comparable foreign regulatory authorities areoften required to exercise flexibility in approving therapies for such diseases. To the extent that the results of the trials are notsatisfactory to the FDA, the EMA or comparable foreign regulatory authorities for support of a marketing application, we may be requiredto expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of ourproduct candidates. Even if regulatory approval is secured for any of our product candidates, the terms of such approval may limit thescope and use of our product candidate, which may also limit its commercial potential. Furthermore, the approval policies or regulationsof the FDA, the EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficientfor approval, which may lead to the FDA, the EMA or comparable foreign regulatory authorities delaying, limiting or denying approvalof our product candidates.

Interim,topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomeavailable and are subject to audit and verification procedures that could result in material changes in the final data.

Fromtime to time, we may publicly disclose interim, preliminary or topline data from our preclinical studies or clinical trials, which isbased on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change followinga more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculationsand conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluateall data. As a result, the interim, topline or preliminary results that we report may differ from future results of the same studies,or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Interim,preliminary and topline data also remain subject to audit and verification procedures that may result in the final data being materiallydifferent from the preliminary data we previously published. As a result, interim, topline and preliminary data should be viewed withcaution until the final data are available. Adverse differences between preliminary, topline or interim data and final data could significantlyharm our business prospects.

Further,others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analysesor may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvabilityor commercialization of the particular product candidate and our company in general. In addition, the information we choose to publiclydisclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may notagree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, topline orpreliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusionsreached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business,operating results, prospects or financial condition.

Ourcurrent or future product candidates may cause adverse events, toxicities or other undesirable side effects when used alone or in combinationwith other approved products or investigational new drugs that may result in a safety profile that could inhibit regulatory approval,prevent market acceptance, limit their commercial potential or result in significant negative consequences.

Asis the case with biopharmaceuticals generally, it is likely that there may be side effects and adverse events associated with our productcandidates’ use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects orunexpected characteristics. Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt,delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA,the EMA or comparable foreign regulatory authorities. The drug-related side effects could affect patient recruitment or the ability ofenrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business,financial condition and prospects significantly.

Ifour product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinicaltrials when used alone or in combination with other approved products or investigational new drugs we may need to interrupt, delay orabandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristicsare less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related side effects could also affectpatient recruitment or the ability of enrolled subjects to complete the trial, or result in potential product liability claims. Any ofthese occurrences may prevent us from achieving or maintaining market acceptance of the affected product candidate and may harm our business,financial condition and prospects significantly.

Patientsin our ongoing and planned clinical trials in the future may suffer significant adverse events or other side effects not observed inour preclinical studies or previous clinical trials. Some of our product candidates may be used as chronic therapies or be used in pediatricpopulations, for which safety concerns may be particularly scrutinized by regulatory agencies. In addition, if our product candidatesare used in combination with other therapies, our product candidates may exacerbate adverse events associated with the therapy. Patientstreated with our product candidates may also be undergoing surgical, radiation or chemotherapy treatments, which can cause side effectsor adverse events that are unrelated to our product candidate but may still impact the success of our clinical trials. The inclusionof critically ill patients in our clinical trials may result in deaths or other adverse medical events due to other therapies or medicationsthat such patients may be using or due to the gravity of such patients’ illnesses.

Ifsignificant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficultyrecruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our developmentefforts of that product candidate altogether. We, the FDA, the EMA, other comparable regulatory authorities or an IRB may suspend clinicaltrials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptablehealth risks or adverse side effects.

Additionally,if any of our product candidates receives regulatory approval and becomes a product, and we or others later identify undesirable sideeffects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could requireus to adopt a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that the benefits of treatment with such product outweigh therisks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education,extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than whatis typical for the industry. We or our collaborators may also be required to adopt a REMS or engage in similar actions, such as patienteducation, certification of health care professionals or specific monitoring, if we or others later identify undesirable side effectscaused by any product that we develop alone or with collaborators. Other potentially significant negative consequences include that:

Anyof these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achievingor maintaining market acceptance of the affected product candidate, if approved by applicable regulatory authorities.

Evenif approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and othersin the medical community necessary for commercial success.

Evenif our product candidates receive regulatory approval and become a product, they may not gain adequate market acceptance among physicians,patients, healthcare payors and others in the medical community. The degree of market acceptance of any of our approved product candidateswill depend on a number of factors, including:

Ifany of our product candidates is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payorsand patients, we may not generate or derive sufficient revenue from that product candidate and our financial results could be negativelyimpacted.

Ourrefrigerated product candidates require specific storage, handling and administration at the clinical sites.

Ourrefrigerated drug product candidates must be stored at low temperatures in specialized refrigerated containers until immediately priorto use. For administration, the drug product container must be carefully removed from storage, warmed to room temperature and invertedto place cells into suspension prior to drawing the product into syringes. The handling, warming and administration of the cell therapyproduct must be performed according to specific instructions. Failure to correctly handle the product, follow the instructions for warmingand administration and/or failure to administer the product within the specified period post-warming could negatively impact the efficacyand or safety of the product.

Becausecell therapy is novel and the regulatory landscape that governs any cell therapy product candidates we may develop is rigorous, complex,uncertain and subject to change, we cannot predict the time and cost of obtaining regulatory approval, if we receive it at all, for anyproduct candidates we may develop. At the moment, only a small number of cell therapy products have been approved in the United Statesand the European Union.

Theregulatory requirements that will govern any novel cell therapy product candidates we develop are not entirely clear and are subjectto change. Within the broader genetic medicine field, very few therapeutic products have received marketing authorization from the FDAor the EMA. Even with respect to more established products that fit into the categories of gene therapies or cell therapies, the regulatorylandscape is still developing. Regulatory requirements governing cell therapy products have changed frequently and will likely continueto change in the future. Moreover, there is substantial overlap in those responsible for regulation of existing cell therapy products.For example, in the United States, the FDA has established the Office of Tissues and Advanced Therapies within its Center for BiologicsEvaluation and Research to consolidate the review of cell therapy and related products. Although the FDA has approved other cell-basedtherapies, there is no assurance that these previous approvals will affect the FDA’s review of our product candidates.

Ourcell therapy product candidates will need to meet safety and efficacy standards applicable to any new biologic under the regulatory frameworkadministered by the FDA. In addition to FDA oversight and oversight by IRBs, under the National Institutes of Health Guidelines for ResearchInvolving Recombinant or Synthetic Nucleic Acid Molecules, or NIH Guidelines, cell therapy clinical trials are also subject to reviewand oversight by an Institutional Biosafety Committee, or IBC, a local institutional committee that reviews and oversees research utilizingrecombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potentialrisk to public health or the environment. While the NIH Guidelines are not mandatory unless the research in question is being conductedat or sponsored by institutions receiving National Institutes of Health, or NIH, funding of recombinant or synthetic nucleic acid moleculeresearch, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them. Although the FDAdecides whether individual cell therapy protocols may proceed, the review process and determinations of other reviewing bodies can impedeor delay the initiation of a clinical trial, even if the FDA has reviewed the trial and approved its initiation.

Thesame applies in the European Union. The EMA’s Committee for Advanced Therapies, or CAT, is responsible for assessing the quality,safety, and efficacy of advanced-therapy medicinal products. Advanced-therapy medicinal products include cell therapy medicines, somatic-celltherapy medicines and tissue-engineered medicines. The role of the CAT is to prepare a draft opinion on an application for marketingauthorization for a cell therapy medicinal candidate that is submitted to the EMA. In the European Union, the development and evaluationof a cell therapy product must be considered in the context of the relevant EU guidelines. The EMA may issue new guidelines concerningthe development and marketing authorization for cell therapy products and require that we comply with these new guidelines. As a result,the procedures and standards applied to cell therapy products may be applied to any cell therapy product candidate we may develop, butthat remains uncertain at this point.

Adversedevelopments in preclinical studies or clinical trials conducted by others in the field of cell therapy and cell regulation productsmay cause the FDA, the EMA and other regulatory bodies to revise the requirements for approval of any product candidates we may developor limit the use of products utilizing cell therapy technologies, either of which could harm our business. In addition, the clinicaltrial requirements of the FDA, the EMA and other regulatory authorities and the criteria these regulators use to determine the safetyand efficacy of a product candidate vary substantially according to the type, complexity, novelty, and intended use and market of thepotential products. The regulatory approval process for product candidates such as ours can be more expensive and take longer than forother, better known, or more extensively studied pharmaceutical or other product candidates. Further, as we are developing novel potentialtreatments for diseases in which, in some cases, there is little clinical experience with potential new endpoints and methodologies,there is heightened risk that the FDA, the EMA or other regulatory bodies may not consider the clinical trial endpoints to provide clinicallymeaningful results, and the resulting clinical data and results may be more difficult to analyze. In addition, we may not be able toidentify or develop appropriate animal disease models to enable or support planned clinical development. Any natural history studiesthat we may conduct or rely upon in our clinical development may not be accepted by the FDA, the EMA or other regulatory authorities.Regulatory agencies administering existing or future regulations or legislation may not allow production and marketing of products utilizingcell therapy technology in a timely manner or under technically or commercially feasible conditions. In addition, regulatory action orprivate litigation could result in expenses, delays or other impediments to our research programs or the commercialization of resultingproducts. Further, approvals by one regulatory agency may not be indicative of what other regulatory agencies may require for approval.

Theregulatory review committees and advisory groups described above and the new guidelines they promulgate may lengthen the regulatory reviewprocess, require us to perform additional preclinical studies or clinical trials, increase our development costs, lead to changes inregulatory positions and interpretations, delay or prevent approval and commercialization of these product candidates, or lead to significantpost-approval limitations or restrictions. As we advance our research programs and develop future product candidates, we will be requiredto consult with these regulatory and advisory groups and to comply with applicable guidelines. If we fail to do so, we may be requiredto delay or discontinue development of any product candidates we identify and develop. These additional processes may result in a reviewand approval process that is longer than we otherwise would have expected. Delays as a result of an increased or lengthier regulatoryapproval process or further restrictions on the development of our product candidates can be costly and could negatively impact our abilityto complete clinical trials and commercialize our current and future product candidates in a timely manner, if at all.

Wemay be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our product candidates.

Ourproduct candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development,manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing,marketing and distribution of drugs. Rigorous preclinical studies and clinical trials and an extensive regulatory approval process mustbe successfully completed in the United States and in many foreign jurisdictions before a new drug can be marketed. Satisfaction of theseand other regulatory requirements is costly, time-consuming, uncertain and subject to unanticipated delays. We cannot provide any assurancethat any product candidate we may develop will progress through required clinical testing and obtain the regulatory approvals necessaryfor us to begin selling them.

Wehave not conducted, managed or completed large-scale or pivotal clinical trials nor managed the regulatory approval process with theFDA, the EMA or any other regulatory authority with respect to our current product candidates. The time required to obtain approvalsfrom the FDA and other regulatory authorities is unpredictable and requires successful completion of extensive clinical trials whichtypically takes many years, depending upon the type, complexity and novelty of the product candidate. The standards that the FDA andits foreign counterparts use when evaluating clinical trial data can and often change during drug development, which makes it difficultto predict with any certainty how they will be applied. We may also encounter unexpected delays or increased costs due to new governmentregulations, including future legislation or administrative action, or changes in FDA policy during the period of drug development, clinicaltrials and FDA regulatory review.

Anydelay or failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenuefrom the particular product candidate for which we are developing and seeking approval. Furthermore, any regulatory approval to marketa product candidate may be subject to significant limitations on the approved uses or indications for which we may market the productcandidate or the labeling or other restrictions. In addition, the FDA has the authority to require a REMS as part of approving an NDAor BLA, or after approval, which may impose further requirements or restrictions on the distribution or use of an approved product candidate.These requirements or restrictions might include limiting prescribing to certain physicians or medical centers that have undergone specializedtraining, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry. Theselimitations and restrictions may significantly limit the size of the market for the product candidate and affect reimbursement by third-partypayors.

Weare also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturingand marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries, andgenerally includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction oflocal regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDAapproval.

Wemay develop our current and future product candidates in combination with other therapies, which exposes us to additional risks, andcertain of our product candidates are regulated as combination products.

Wemay develop our current and future product candidates in combination with one or more other approved or unapproved therapies to treatskin and connective tissue diseases or other diseases. We may also develop certain product candidates as biologic/drug combination products.Additional time may be required to obtain regulatory approval for our product candidates because they are combination products. Our productcandidates that are biologic/drug combination products require coordination within the FDA and similar foreign regulatory agencies forreview of their biologic and drug components. Although the FDA and similar foreign regulatory agencies have systems in place for thereview and approval of combination products such as ours, we may experience delays in the development and commercialization of our productcandidates due to regulatory timing constraints and uncertainties in the product development and approval process.

Inaddition, even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination withother existing therapies, we would continue to be subject to the risks that the FDA, the EMA or comparable foreign regulatory authoritiescould revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues couldarise with any of those existing therapies. If the therapies we use in combination with our product candidates are replaced as the standardof care for the indications we choose for any of our product candidates, the FDA, the EMA or comparable foreign regulatory authoritiesmay require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own product candidates,if approved, being removed from the market or being less successful commercially.

Wealso may choose to evaluate our current product candidates or any future product candidates in combination with one or more therapiesthat have not yet been approved for marketing by the FDA, the EMA or comparable foreign regulatory authorities. We will not be able tomarket and sell our product candidates we develop in combination with an unapproved therapy for a combination indication if that unapprovedtherapy does not ultimately obtain marketing approval either alone or in combination with our product candidate. In addition, unapprovedtherapies face the same risks described with respect to our product candidates currently in development and clinical trials, includingthe potential for serious adverse effects, delay in their clinical trials and lack of FDA approval.

Ifthe FDA, the EMA or comparable foreign regulatory authorities do not approve these other products or revoke their approval of, or ifsafety, efficacy, quality, manufacturing or supply issues arise with, the products we choose to evaluate in combination with our productcandidates we develop, we may be unable to obtain approval of or market such combination therapy.

Anyproduct candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.

ThePatient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, each as amended, or collectively,the ACA, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviatedapproval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that thereference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDAuntil 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another companymay still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing thesponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity andpotency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact,implementation and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement BPCIA may be fullyadopted by the FDA, any such processes could have an adverse effect on the future commercial prospects for our biological products.

Thereis a risk that any of our product candidates approved as a biological product under a BLA would not qualify for the 12-year period ofexclusivity or that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider ourproduct candidates to be reference products for competing products, potentially creating the opportunity for generic competition soonerthan anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject oflitigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in away that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number ofmarketplace and regulatory factors that are still developing. If competitors are able to obtain marketing approval for biosimilars referencingour candidates, if approved, our products may become subject to competition from such biosimilars, with the attendant competitive pressureand potential adverse consequences.

Wemay expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidatesor indications that may be more profitable or for which there is a greater likelihood of success.

Becausewe have limited financial and managerial resources, we focus on research programs, therapeutic platforms and product candidates thatwe identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other therapeutic platforms orproduct candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success.Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.Our spending on current and future research and development programs, therapeutic platforms and product candidates for specific indicationsmay not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particularproduct candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangementsin cases in which it would have been more advantageous for us to retain sole development and commercialization rights.

RisksRelated to Our Business

Ourcompany has limited experience in designing clinical trials and may experience delays or unexpected difficulties in obtaining regulatoryapproval for our current and future product candidates.

Wehave limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval.We cannot be certain that our planned clinical trials or any future clinical trials will be successful. It is possible that the FDA mayrefuse to accept any or all of our planned BLAs for substantive review or may conclude after review of our data that our applicationis insufficient to obtain regulatory approval for any product candidates. If the FDA does not approve any of our planned BLAs, it mayrequire that we conduct additional costly clinical trials, preclinical studies or manufacturing validation studies before it will reconsiderour applications. Depending on the extent of these or any other FDA-required studies, approval of any BLA or other application that wesubmit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Anyfailure or delay in obtaining regulatory approvals would prevent us from commercializing our product candidates, generating revenuesand achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be consideredsufficient by the FDA to approve any BLA or other application that we submit. If any of these outcomes occur, we may be forced to abandonthe development of our product candidates, which would materially adversely affect our business and could potentially cause us to ceaseoperations. We face similar risks for our applications in foreign jurisdictions.

Weintend to identify and develop novel cell therapy product candidates, which makes it difficult to predict the time, cost and potentialsuccess of product candidate development.

Ourstrategy is to identify, develop and commercialize cell therapy product candidates using our proprietary fibroblast technology, whichinvolves collecting skin biopsies from donor patients, isolating cells and expanding them in culture. Our future success depends on thesuccessful development of these novel therapeutic approaches. To date, no fibroblast therapy products have been approved. In addition,there have been a few number of clinical trials involving fibroblasts as compared to other, more conventional forms of therapy.

Thesizes of the markets for our product candidates are estimates, and these markets may be smaller than estimated.

Theestimates in this prospectus of the annual addressable markets for our product candidates are based on a number of third-party estimates.While we believe the assumptions and the data underlying the estimates are reasonable, these assumptions and estimates may not be correctand the conditions supporting the assumptions or estimates may change at any time, thereby reducing the predictive accuracy of theseunderlying factors. As a result, the estimates of the annual addressable market for our product candidates may prove to be incorrect.

Ourlong-term prospects depend in part upon discovering, developing and commercializing additional product candidates, which may fail indevelopment or suffer delays that adversely affect their commercial viability.

Ourfuture operating results are dependent on our ability to successfully discover, develop, obtain regulatory approval for and commercializeproduct candidates beyond those we currently have in clinical development. A product candidate can unexpectedly fail at any stage ofpreclinical or clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy,clinical execution, changing standards of medical care and other unpredictable variables. The results from preclinical studies or earlyclinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of theproduct candidate.

Thesuccess of other product candidates we may develop will depend on many factors, including the following:

Evenif we successfully advance any other product candidates into clinical development, their success will be subject to all of the clinical,regulatory and commercial risks described elsewhere in this “Risk Factors” section. Accordingly, we cannot assureyou that we will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue fromour product candidates.

Wehave never commercialized a fibroblast cell-based therapy product candidate before and may lack the necessary expertise, personnel andresources to successfully commercialize any product candidates, if approved, on our own or together with suitable collaborators.

Wehave never commercialized a fibroblast cell-based therapy product candidate, and we currently have no sales force, marketing or distributioncapabilities. To achieve commercial success for our current product candidates, which we may license to others, we will rely on the assistanceand guidance of those collaborators. For any approved product candidates for which we retain commercialization rights, we will have todevelop our own sales, marketing and supply organization or outsource these activities to a third party.

Factorsthat may affect our ability to commercialize our product candidates on our own include recruiting and retaining adequate numbers of effectivesales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our product candidates andother unforeseen costs associated with creating an independent sales and marketing organization. Developing a sales and marketing organizationwill be expensive and time-consuming and could delay the launch of our product candidates, if approved. We may not be able to build aneffective sales and marketing organization. If we are unable to build our own distribution and marketing capabilities or to find suitablepartners for the commercialization of our product candidates, we may not generate revenues from them or be able to reach or sustain profitability.

Weface significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that aremore effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted.

Thebiotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasison proprietary and novel products and product candidates. Our competitors have developed, are developing or may develop products, productcandidates and processes competitive with our product candidates. Any product candidates that we successfully develop and commercializewill compete with existing therapies and new therapies that may become available in the future. We believe that a significant numberof products are currently under development, and may become commercially available in the future, for the treatment of conditions forwhich we may attempt to develop product candidates. See “Business—Competition” for additional details. In addition,our products may need to compete with off-label drugs used by physicians to treat the indications for which we seek approval. This maymake it difficult for us to replace existing therapies with our products.

Manycurrent and potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and humanresources and commercial expertise than we do. Large pharmaceutical and biotechnology companies, in particular, have extensive experiencein clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing biotechnology products. These companies alsohave significantly greater research and marketing capabilities than we do and may also have products that have been approved or are inlate stages of development, and collaborative arrangements in our target markets with leading companies and research institutions. Establishedpharmaceutical and biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-licensenovel compounds that could make the product candidates that we develop obsolete. Smaller or early-stage companies may also prove to besignificant competitors, particularly through collaborative arrangements with large and established companies, as well as in acquiringtechnologies complementary to, or necessary for, our programs. As a result, our competitors may succeed in obtaining approval from theFDA, the EMA or other comparable foreign regulatory authorities or in discovering, developing and commercializing products in our fieldbefore we do.

Ourcommercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,have fewer or less severe effects, are more convenient, have a broader label, are marketed more effectively, are reimbursed or are lessexpensive than any product candidates that we may develop. Our competitors also may obtain marketing approval from the FDA, the EMA orother comparable foreign regulatory authorities for their products more rapidly than we may obtain approval for ours, which could resultin our competitors establishing a strong market position before we are able to enter the market. Even if the product candidates we developachieve marketing approval, they may be priced at a significant premium over competitive products if any have been approved by then,resulting in reduced competitiveness. Technological advances or products developed by our competitors may render our technologies orproduct candidates obsolete, less competitive or uneconomical. If we are unable to compete effectively, our opportunity to generate revenuefrom the sale of any products we may develop, if approved, could be adversely affected.

Wewill incur increased costs as a result of operating as a public company, and our management will be required to devote substantial timeto new compliance initiatives. We will be subject to financial reporting and other requirements for which our accounting and other managementsystems and resources may not be adequately prepared.

Asa public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting andother expenses that we did not incur as a private company. In addition, the federal securities laws, including the Sarbanes-Oxley Act,the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and rules and regulations subsequently implemented by the SECand Nasdaq have imposed various requirements on public companies, including requirements to file annual, quarterly, and event drivenreports with respect to their business and financial condition, and to establish and maintain effective disclosure and financial controlsand corporate governance practices. These rules and regulations will increase our legal and financial compliance costs, make certainactivities more time-consuming and costly, and require our management and other personnel to devote a substantial amount of time to complianceinitiatives.

Despiteour best efforts, we may not be able to produce reliable financial statements or file such financial statements as part of a periodicreport in a timely manner with the SEC or comply with Nasdaq listing requirements. We also expect that these rules and regulations maymake it more difficult and more expensive for us to obtain director and officer liability insurance.

Pursuantto Section 404 of the Sarbanes-Oxley Act, we will be required to furnish a report by our management on our internal control over financialreporting, including an attestation report on internal control over financial reporting issued by our independent registered public accountingfirm, beginning with the first full year after we become a public company. However, while we remain an emerging growth company, we willnot be required to include an attestation report on internal control over financial reporting issued by our independent registered publicaccounting firm. To achieve compliance with Section 404 of the Sarbanes-Oxley Act, we will be engaged in a process to document and evaluateour internal control over financial reporting, which is both costly and challenging. We will need to continue to dedicate internal resources,potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financialreporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documentedand implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, thereis a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframethat our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act. This could resultin an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. We couldalso become subject to investigations by the SEC or other regulatory authorities, which could require additional financial and managementresources. See the risk factor below captioned “We have identified a material weakness in our internal control over financialreporting due to lack of segregation of duties. Failure to maintain effective internal control over financial reporting could cause ourinvestors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls over financialreporting are not effective, we may not be able to accurately report our financial results or prevent fraud.”

Asa public company, we are required to maintain disclosure controls and procedures. Disclosure controls and procedures means our controlsand other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submitunder the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of theSEC. We do not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detectall errors and all fraud. We believe a control system, no matter how well-designed and operated, can provide only reasonable, not absolute,assurance that the control system’s objectives will be met. Due to the inherent limitations in all control systems, no evaluationof controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instancesof fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihoodof future events, and any design may not succeed in achieving its stated goals under all potential future conditions. Over time, controlsmay become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Accordingly,because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

Wehave identified a material weakness in our internal control over financial reporting due to lack of segregation of duties. Failure tomaintain effective internal control over financial reporting could cause our investors to lose confidence in us and adversely affectthe market price of our common stock. If our internal controls over financial reporting are not effective, we may not be able to accuratelyreport our financial results or prevent fraud.

Duringthe preparation of our financial statements for the fiscal year ended December 31, 2023 and 2022, our management identified a materialweakness in our internal control over financial reporting due to a lack of segregation of duties. A material weakness is defined as adeficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibilitythat a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

Specifically,our management identified a deficiency in our internal controls within the financial reporting function that resulted from an ineffectivedesign and implementation of controls over proper segregation of duties for the period of time covered by our financial statements priorto our Chief Financial Officer joining us in June 2022 when all financial functions were handled by a single individual, and afterward,through December 31, 2023, due to a limited number of individuals. Based upon such evaluation, and due to the material weakness identified,our principal executive officer and principal financial and accounting officer have concluded that our disclosure controls and procedureswere not effective.

Withthe addition of our Chief Financial Officer and the changes made to our accounting and financial reporting processes and internal controlsduring the last half of fiscal year 2022 and through December 31, 2023, we have strengthened our internal controls and will continueto add staff, evaluate segregation of duties, and implement initiatives to improve our internal controls over financial reporting aswe grow. However, the implementation of these initiatives may not fully address the material weakness in our internal control over financialreporting and we cannot assure you that we will not identify other material weaknesses or deficiencies, which could negatively impactour results of operations in future periods.

RisksRelating to Our Dependence on Third Parties

Werely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct certain aspectsof our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, complywith applicable regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercializeour product candidates and our business could be adversely harmed.

Wehave relied upon and plan to continue to rely upon third parties, including independent clinical investigators and third-party CROs,to conduct certain aspects of our preclinical studies and clinical trials and to monitor and manage data for our ongoing preclinicaland clinical programs. We rely on these parties for execution of our preclinical studies and clinical trials, and control only certainaspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordancewith the applicable protocol, legal, regulatory and scientific standards, and our reliance on these third parties does not relieve usof our regulatory responsibilities. We, our third-party contractors and CROs are required to comply with GCP requirements, which areregulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for all of our product candidates in clinicaldevelopment. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trialsites. If we or any of these third parties or our CROs fail to comply with applicable GCPs, the clinical data generated in our clinicaltrials may be deemed unreliable and the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additionalclinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority,such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trialsmust be conducted with products manufactured under cGMP regulations. Our failure to comply with these regulations may require us to repeatclinical trials, which would delay the regulatory approval process. Moreover, our business may be adversely affected if any of thesethird parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Further,there is no guarantee that any such CROs, investigators or other third parties on which we rely will devote adequate time and resourcesto our development activities or perform as contractually required. These third parties may also have relationships with other commercialentities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, whichcould affect their performance on our behalf. If independent investigators or CROs fail to devote sufficient resources to the developmentof our product candidates, or if CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines,if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhereto our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated andwe may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Consequently, our resultsof operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generaterevenues could be delayed or halted entirely.

OurCROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our CROs havean ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participatingin our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors or if we are liquidated.

Ifany of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs orto do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management timeand focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materiallyimpact our ability to meet our desired clinical development timelines. Additionally, CROs may lack the capacity to absorb higher workloadsor take on additional capacity to support our needs. Though we carefully manage our relationships with our CROs, there can be no assurancethat we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverseimpact on our business, financial condition and prospects.

Ifwe decide to establish additional collaborations but are not able to establish those collaborations on commercially reasonable terms,we may have to alter our development and commercialization plans.

Ourproduct candidate development programs and the potential commercialization of our product candidates will require substantial additionalcash to fund expenses. We may continue to seek to selectively form collaborations to expand our capabilities, potentially accelerateresearch and development activities and provide for commercialization activities by third parties. Any of these relationships may requireus to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existingstockholders, or disrupt our management and business.

Wewould face significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex. Whetherwe reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’sresources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of anumber of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, the EMAor comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturingand delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect toour ownership of intellectual property and industry and market conditions generally. The potential collaborator may also consider alternativeproduct candidates or technologies for similar indications that may be available to collaborate on and whether such collaboration couldbe more attractive than the one with us for our product candidate. Further, we may not be successful in our efforts to establish a collaborationor other alternative arrangements for future product candidates because they may be deemed to be at too early of a stage of developmentfor collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

Inaddition, mergers among large biopharmaceutical companies may result in a reduced number of potential future collaborators. Even if weare successful in entering into a collaboration, the terms and conditions of that collaboration may restrict us from entering into futureagreements on certain terms with potential collaborators.

Ifand when we seek to enter into collaborations, we may not be able to negotiate collaborations on a timely basis, on acceptable terms,or at all. If we are unable to do so, we may have to curtail the development of a product candidate, reduce or delay its developmentprogram or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketingactivities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect toincrease our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, whichmay not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop ourproduct candidates or bring them to market and generate product revenue.

Inthe future we may enter into collaborations with third parties for the development and commercialization of product candidates. If thosecollaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.

Wemay in the future seek third-party collaborators for the development and commercialization of one or more of our product candidates.Our likely collaborators for any future collaboration arrangements include large and mid-size biopharmaceutical companies, regional andnational biopharmaceutical companies and biotechnology companies. We have and will likely have limited control over the amount and timingof resources that our collaborators dedicate to the development or commercialization of our product candidates. Our ability to generaterevenues from these arrangements will depend on our collaborators’ abilities and efforts to successfully perform the functionsassigned to them in these arrangements. Collaborations involving our product candidates could pose numerous risks to us, including thefollowing:

Ouremployees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engagein misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverseeffect on our results of operations.

Weare exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators,CROs, suppliers and vendors may engage in misconduct or other improper activities. Misconduct by these parties could include failuresto comply with FDA regulations, provide accurate information to the FDA, comply with federal and state health care fraud and abuse lawsand regulations, accurately report financial information or data or disclose unauthorized activities to us. In particular, sales, marketingand business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct,kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by these parties couldalso involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions andserious harm to our reputation. It is not always possible to identify and deter misconduct by these parties, and the precautions we taketo detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us fromgovernmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any suchactions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could havea significant impact on our business, including the imposition of significant penalties, including civil, criminal and administrativepenalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare programs,such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profitsand future earnings and the curtailment or restructuring of our operations.

RisksRelated to Manufacturing

Manufacturingcell therapy products is complex and subject to both human and systemic risks. Our third-party manufacturers or we may encounter difficultiesin production and sourcing and may be subject to variations and supply constraints of critical components. If we or any of our third-partymanufacturers encounter such difficulties, our ability to supply our product candidates for clinical trials or our products for patients,if approved, could be delayed or prevented.

Themanufacture of biologic cell therapy product candidates, and products, if approved, is complex and requires significant expertise andcapital investment, including developing advanced manufacturing techniques and process controls. Manufacturers of biologic products oftenencounter difficulties in production and sourcing, particularly in scaling up or out, validating the production process, and assuringhigh reliability of the manufacturing processes (including the absence of contamination), in light of variations and supply constraintsof critical components. These problems include logistics and shipping, difficulties with production costs and yields, quality control,including consistency, stability, purity, and efficacy of the product, product testing, operator error, and availability of qualifiedpersonnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discoveredin our supply of our product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for anextended period of time to investigate and remedy the contamination. We cannot assure you that any stability, purity, and efficacy failures,deficiencies, or other issues relating to manufacturing our product candidates will not occur in the future.

Additionally,our product candidates are derived from cells collected from humans. Such cells may vary in type and quality as the donors may vary inage, medical history and many other factors. We have strict specifications for donor cell material and our product candidates. The donorcell material variability may exceed our manufacturing process capability or deviate from the specified ranges and result in failurein the production of the cell therapy product, lower quality batches, or even require adjustments to the specifications approved by authorities.The donor cell material may also be variable in factors that we currently may not be able to detect with the analytical methods usedor may not know how to measure. We may also discover failures with the material after production. As a result, we may not be able todeliver the quality and consistency of our cell therapy products that we need or may need to re-collect cell material which can increasecosts and/or cause delay, adversely impact patient outcomes and otherwise harm our clinical trials, reputation, business and prospects.

Wemay fail to manage the logistics of collecting and shipping patient material to the manufacturing site, shipping the product candidateback to the relevant parties, and experiencing delays or shortages of certain clinical or commercial-grade supplies and components. Logisticaland shipment delays and problems caused by us, our vendors, or other factors not in our control, including business interruptions, globalsupply chain issues, and weather, could prevent or delay the delivery of product candidates to patients. Additionally, we have to maintaina complex chain of identity and chain of custody with respect to donor material as it moves to the manufacturing facility, through themanufacturing processes, and ultimately to a patient. Failure to maintain a chain of identity and chain of custody could result in patientdeath, loss of product, or regulatory action.

Thetransfer or production of our cell banks to a contract development manufacturing organization may fail and result in delays, additionalcosts, or technical failure.

Wecurrently purchase our cell therapy product candidates from a contract development and manufacturing organization, or CDMO. We are inthe process of contracting with a CDMO, for the transfer of our experimental cell bank to produce our master cell bank, working cellbank and our fibroblast cell-based product candidates to enable clinical trials. If the transfer of our experimental cell bank to theCDMO is not successful, we may encounter delays, additional costs, or technical failure of one or more of our product candidates. Similarly,if the CDMO is unable to produce from the experimental cell bank our master cell bank, working cell bank and our fibroblast cell-basedproduct candidates to enable clinical trials, we may encounter delays, additional costs, or technical failure of one or more of our productcandidates.

Changesin the methods of product candidate manufacturing or formulation may result in additional costs or delay.

Asproduct candidates proceed through preclinical studies to late-stage clinical trials towards potential marketing approval and commercialization,it is common that various aspects of the development program, such as manufacturing methods, formulation, materials and processes, arealtered along the way in an effort to optimize processes and product characteristics. Such alterations can also occur due to changesin manufacturers. Such changes carry the risk that they will not achieve their intended objectives. Any such changes could cause ourproduct candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conductedwith product candidates produced using the modified manufacturing methods, materials and processes. Such changes may also require additionaltesting, FDA notification or FDA approval. This could delay the completion of clinical trials, require the conduct of bridging clinicaltrials or the repetition of one or more clinical trials beyond those we currently anticipate, increase clinical trial costs, delay approvalof our product candidates and jeopardize our ability to commercialize our product candidates if approved. In addition, we may be requiredto make significant changes to our upstream and downstream processes across our pipeline, which could delay the development of futureproduct candidates.

Ifwe or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law,we may be liable for damages.

Researchand development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials,by us and our third-party manufacturers. We currently outsource all manufacturing to third parties. Still, we and our manufacturers aresubject to federal, state and local laws and regulations in the United States governing the use, manufacture, storage, handling and disposalof medical and hazardous materials. Although we believe that our manufacturers’ procedures for using, handling, storing and disposingof these materials comply with legally prescribed standards, we cannot completely eliminate the risk of contamination or injury resultingfrom medical or hazardous materials. As a result of any such contamination or injury, we may incur liability, or local, city, state orfederal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we couldbe held liable for damages or penalized with fines, and the liability could exceed our resources. We do not currently have any insurancefor liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive,and current or future environmental regulations may impair our research, development and production efforts, which could harm our business,prospects, financial condition or results of operations.

Werely on third parties for our manufacturing process and may, in the future, depend on third-party manufacturers for our product candidates,and this increases the risk related to the timely and sufficient production of our product candidates.

Wedo not have complete control over all aspects of the manufacturing process of, and are dependent on, our contract manufacturing partnersfor compliance with cGMP regulations for manufacturing our cell therapy product candidates. Third-party manufacturers may be unable tocomply with cGMP regulations or similar regulatory requirements outside the United States. If our contract manufacturers cannot successfullymanufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, the EMA or others, they willnot be able to secure and/or maintain marketing approval for their manufacturing facilities. In addition, we do not have control overthe ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA,the EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidatesor if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantlyimpact our ability to develop, obtain marketing approval for or market our product candidates, if approved. Our failure, or the failureof our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines,injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates,operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidatesand harm our business and results of operations. Furthermore, the raw materials for our product candidates may be sourced, in some cases,from a single-source supplier. If we were to experience an unexpected loss of supply of any of our product candidates or any of our futureproduct candidates for any reason, whether as a result of manufacturing, supply, or storage issues or otherwise, we could experiencedelays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.

Wecurrently rely on third-party manufacturers to produce our product candidates for use in development and commercialization under theguidance of members of our organization. In the event that we or any of our third-party manufacturers fail to comply with such requirementsor to perform with certain requirements in relation to quality, timing, or otherwise, or if our supply of components or other materialsbecomes limited or interrupted for other reasons, we may be forced to enter into an agreement with another third party, which we maynot be able to do on commercially reasonable terms, if at all. In particular, any replacement of our third-party manufacturers couldrequire significant effort and expertise because there may be a limited number of qualified replacements. In some cases, the technicalskills or technology required to manufacture our product candidates may be unique or proprietary to us or the third-party manufacturer.We may have difficulty transferring such skills or technology to another third party, and a feasible alternative may not exist. In addition,certain of our product candidates and our own proprietary methods have never been produced or implemented outside of our company. Therefore,we may experience delays in our development programs if we attempt to establish new third-party manufacturing arrangements for theseproduct candidates or methods. These factors would increase our reliance on such manufacturers or require us to obtain a license fromsuch manufacturers in order to have another third party manufacture our product candidates. If we are required to or voluntarily stopmanufacturing our product candidates for any reason, we will be required to verify that the new manufacturer maintains facilities andprocedures that comply with quality standards and with all applicable regulations and guidelines and that the product produced is equivalentto that produced in our facility. The delays associated with the verification of a new manufacturer and equivalent product could negativelyaffect our ability to develop product candidates in a timely manner or within budget.

Ouror a third party’s failure to execute our manufacturing requirements, do so on commercially reasonable terms and timelines, andcomply with cGMP requirements could adversely affect our business in a number of ways, including:

Anycontamination or interruption in our manufacturing processes, shortages of raw materials, or failure of our suppliers to deliver necessarycomponents could result in delays in our clinical development or marketing schedules.

Giventhe nature of cell therapy manufacturing, there is a risk of contamination. Any contamination could adversely affect our ability to produceproduct candidates on schedule and could, therefore, harm our results of operations and cause reputational damage. Additionally, althoughour cell therapies are tested for contamination prior to release, if a contaminated product candidate was administered to a patient,it could result in harm to the patient. Some of the raw materials required in our manufacturing process are derived from biological sources.Such raw materials are difficult to procure and may be subject to contamination or recall. A material shortage, contamination, recall,or restriction on the use of biologically derived substances in the manufacture of our product candidates could adversely impact or disruptthe commercial manufacturing or the production of clinical material, which could adversely affect our development timelines and our business,financial condition, results of operations and prospects.

RisksRelated to Legal and Regulatory Compliance Matters

Ourrelationships with healthcare professionals, clinical investigators, CROs and third-party payors in connection with our current and futurebusiness activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, governmentprice reporting, and health information privacy and security laws, which could expose us to, among other things, criminal sanctions,civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens anddiminished profits and future earnings.

Healthcareproviders and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we obtainmarketing approval. Our current and future arrangements with healthcare professionals, clinical investigators, CROs, third-party payorsand customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the businessor financial arrangements and relationships through which we market, sell and distribute our product candidates for which we obtain marketingapproval. Restrictions under applicable federal and state healthcare laws and regulations include the following:

Additionally,we are subject to state and foreign equivalents of each of the healthcare laws and regulations described above, among others, some ofwhich may be broader in scope and may apply regardless of the payor. Many U.S. states have adopted laws similar to the federal Anti-KickbackStatute and False Claims Act, and may apply to our business practices, including, but not limited to, research, distribution, sales ormarketing arrangements and claims involving healthcare items or services reimbursed by non-governmental payors, including private insurers.In addition, some states have passed laws that require biopharmaceutical companies to comply with the April 2003 Office of InspectorGeneral Compliance Program Guidance for Pharmaceutical Manufacturers and/or the Pharmaceutical Research and Manufacturers of America’sCode on Interactions with Healthcare Professionals. Several states also impose other marketing restrictions or require biopharmaceuticalcompanies to make marketing or price disclosures to the state and require the registration of biopharmaceutical sales representatives.Privacy and data protection laws from outside of the United States, including, for example, the European Union General Data ProtectionRegulation and the UK Data Protection Act 2018, or, collectively, the GDPR, also govern the privacy and security of personal information,including health information in some circumstances, and many of these laws differ from each other in significant ways, thus complicatingcompliance efforts. In addition, in the United States, there are a number of states that have enacted laws that govern the privacy andsecurity of personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thuscomplicating compliance efforts. There are ambiguities as to what is required to comply with these state requirements and if we failto comply with an applicable state law requirement we could be subject to penalties.

Thescope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform,especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increasedtheir scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions,convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare and privacylaws, as well as responding to possible investigations by government authorities, can be time and resource-consuming and can divert acompany’s attention from the business.

Ensuringthat our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulationswill involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not complywith current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare lawsand regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws andregulations that may apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties,damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment, reputationalharm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subjectto a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, defending againstany such actions can be costly and time consuming, and may require significant financial and personnel resources. Therefore, even ifwe are successful in defending against any such actions that may be brought against us, our business may be impaired. If any of the physiciansor other providers or entities with whom we do, or expect to do, business is found to not be in compliance with applicable laws, theymay be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment.If any of the above occur, our ability to operate our business and our results of operations could be adversely affected.

Wemay be or become subject to evolving global data protection laws and regulations, which may require us to incur substantial compliancecosts, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.

Theglobal data protection landscape is rapidly evolving, and we may be or become subject to or affected by numerous federal, state and foreignlaws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, transfer, security and processing ofpersonal data, such as information that we collect about participants and healthcare providers in connection with clinical trials. Implementationstandards and enforcement practices are likely to remain uncertain for the foreseeable future, which may create uncertainty in our business,affect our ability to operate in certain jurisdictions or to collect, store, transfer use and share personal data, result in liabilityor impose additional compliance or other costs on us. Any failure or perceived failure by us to comply with federal, state, or foreignlaws or self-regulatory standards could result in negative publicity, diversion of management time and effort and proceedings againstus by governmental entities or others. For example, states, such as California, Virginia, Colorado, Utah and Connecticut have recentlyenacted consumer privacy laws that grant rights to data subjects and places privacy and security obligations on entities handling personaldata of consumers or households. Some observers note that the CCPA and similar legislation could mark the beginning of a trend towardmore stringent privacy legislation in the United States, which could increase our potential liability and adversely affect our business.

Inaddition to our operations in the United States, which may be subject to healthcare and other laws relating to the privacy and securityof health information and other personal information, we may seek to conduct clinical trials in the United Kingdom or the European EconomicArea, or the EEA, and may become subject to additional European data privacy laws, regulations and guidelines. We will be subject tothe data protection laws of the European Union and United Kingdom in relation to personal data we collect from these territories. Theselaws impose additional obligations and risk upon our business, including substantial expenses and changes to business operations thatare required to comply with these laws. The withdrawal of the United Kingdom from the European Union, or Brexit, and the subsequent separationof the data protection regimes of these territories mean we are required to comply with separate data protection laws in the EuropeanUnion and United Kingdom, which may lead to additional compliance costs and could increase our overall risk.

TheGDPR, which deals with the processing of personal data and on the free movement of such data, imposes a broad range of strict requirements,including requirements relating to having lawful bases for processing personal data and transferring such information outside the EEA/UK,including to the United States, providing details to those individuals regarding the processing of their personal data, keeping personaldata secure, having data processing agreements with third parties who process personal data, responding to individuals’ requeststo exercise their rights in respect of their personal data, reporting security breaches involving personal data to the competent nationaldata protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessmentsand record-keeping.

TheGDPR imposes strict rules on the transfer of personal data out of the EEA/UK to countries not regarded by European Commission and theUnited Kingdom government as providing adequate protection, or the third countries, including the United States. These transfers areprohibited unless an appropriate safeguard specified by data protection laws is implemented, such as the Standard Contractual Clauses,or the SCCs, approved by the European Commission, or a derogation applies. The UK has published its own transfer mechanism, the InternationalData Transfer Agreement and International Data Transfer Addendum, which enables transfers from the UK and has implemented a similar TransferEquivalence Test. The international transfer obligations under the EU and UK data protection regimes require effort and cost and mayresult in us needing to make strategic considerations around where EEA/UK personal data is located and which service providers we utilizefor the processing of EEA/UK personal data, particularly as the enforcement around GDPR international transfer compliance obligationsis currently unclear. The UK Government has also now introduced a Data Protection and Digital Information Bill, or the UK Bill, intothe UK legislative process with the intention for this bill to reform the UK’s data protection regime. If passed, the final versionof the UK Bill may have the effect of further altering the similarities between the UK and EU data protection regime. This may lead toadditional compliance costs and could increase our overall risk.

Wecannot assure you that any efforts to comply with any obligations under European privacy laws will be sufficient. If we are investigatedby a European data protection authority, we may face fines and other penalties. Any such investigation or charges by European data protectionauthorities could have a negative effect on our reputation and materially harm our business.

Ourbusiness entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inabilitycould have an adverse effect on our business and financial condition.

Ourbusiness exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutictreatments. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing productcandidates, such claims could result in an FDA, EMA or other regulatory authority investigation of the safety and effectiveness of ourproduct candidates, our manufacturing processes and facilities or our marketing programs. FDA, EMA or other regulatory authority investigationscould potentially lead to a recall of our product candidates or more serious enforcement action, limitations on the approved indicationsfor which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims mayalso result in decreased demand for our product candidates, if approved, injury to our reputation, costs to defend the related litigation,a diversion of management’s time and our resources and substantial monetary awards to trial participants or patients. We currentlyhave product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels priorto marketing any of our product candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage againstpotential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, wemay be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims thatcould have an adverse effect on our business and financial condition.

Anyproduct candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricingregulations.

Theavailability and extent of coverage and adequate reimbursement by third-party payors, including government health administration authorities,private health coverage insurers, managed care organizations and other third-party payors is essential for most patients to be able toafford expensive treatments. Sales of any of our product candidates that receive marketing approval will depend substantially, both inthe United States and internationally, on the extent to which the costs of our product candidates will be covered and reimbursed by third-partypayors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize ourproduct candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish ormaintain pricing sufficient to realize an adequate return on our investment. Coverage and reimbursement may impact the demand for, orthe price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursementis available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval.For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficultbecause of the higher prices often associated with such drugs.

Thereis significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States,no uniform policy of coverage and reimbursement for products exists among third-party payors and coverage and reimbursement levels forproducts can differ significantly from payor to payor. The Medicare and Medicaid programs increasingly are used as models for how privatepayors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. However, one third-partypayor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coveragefor the product candidate. As a result, the coverage determination process is often time-consuming and costly. This process will requireus to provide scientific and clinical support for the use of our product candidates to each third-party payor separately, with no assurancethat coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Factors payors consider in determiningreimbursement are based on whether the product is: (i) a covered benefit under its health plan; (ii) safe, effective and medically necessary;(iii) appropriate for the specific patient; (iv) cost-effective; and (v) neither experimental nor investigational.

Increasingly,third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging theprices charged for medical products. Further, such payors are increasingly challenging the price, examining the medical necessity andreviewing the cost effectiveness of medical product candidates. There may be especially significant delays in obtaining coverage andreimbursement for newly approved drugs. Third-party payors may limit coverage to specific product candidates on an approved list, knownas a formulary, which might not include all FDA-approved drugs for a particular indication. We may need to conduct expensive pharmacoeconomicstudies to demonstrate the medical necessity and cost effectiveness of our product candidates. Nonetheless, our product candidates maynot be considered medically necessary or cost effective. We cannot be sure that coverage and reimbursement will be available for anyproduct candidate that we commercialize and, if reimbursement is available, what the level of reimbursement will be.

Outsidethe United States, international operations are generally subject to extensive governmental price controls and other market regulations,and we believe the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will continue toput pressure on the pricing and usage of therapeutics such as our product candidates. In many countries, particularly the countries ofthe European Union, medical product prices are subject to varying price control mechanisms as part of national health systems. In thesecountries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing approval.To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectivenessof our product candidate to other available therapies. In general, product prices under such systems are substantially lower than inthe United States. Other countries allow companies to fix their own prices for products, but monitor and control company profits. Additionalforeign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates.Accordingly, in markets outside the United States, the reimbursement for our product candidates may be reduced compared with the UnitedStates and may be insufficient to generate commercially reasonable revenue and profits.

Ifwe are unable to establish or sustain coverage and adequate reimbursement for any future product candidates from third-party payors,the adoption of those product candidates and sales revenue will be adversely affected, which, in turn, could adversely affect the abilityto market or sell those product candidates, if approved. Coverage policies and third-party payor reimbursement rates may change at anytime. Even if favorable coverage and reimbursement status is attained for one or more product candidates for which we receive regulatoryapproval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Weface potential liability related to the privacy of health information we obtain from clinical trials sponsored by us.

Mosthealthcare providers, including research institutions from which we obtain patient health information, are subject to privacy and securityregulations promulgated under HIPAA, as amended by the HITECH. We are not currently classified as a covered entity or business associateunder HIPAA and thus are not directly subject to its requirements or penalties. However, any person may be prosecuted under HIPAA’scriminal provisions either directly or under aiding-and-abetting or conspiracy principles. Consequently, depending on the facts and circumstances,we could face substantial criminal penalties if we knowingly receive individually identifiable health information from a HIPAA-coveredhealthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of individually identifiablehealth information. In addition, we may maintain sensitive personally identifiable information, including health information, that wereceive throughout the clinical trial process, in the course of our research collaborations, and directly from individuals (or theirhealthcare providers) who enroll in our patient assistance programs. As such, we may be subject to state laws requiring notificationof affected individuals and state regulators in the event of a breach of personal information, which is a broader class of informationthan the health information protected by HIPAA.

Furthermore,certain health privacy laws, data breach notification laws, consumer protection laws and genetic testing laws may apply directly to ouroperations and/or those of our collaborators and may impose restrictions on our collection, use and dissemination of individuals’health information. Patients about whom we or our collaborators obtain health information, as well as the providers who share this informationwith us, may have statutory or contractual rights that limit our ability to use and disclose the information. We may be required to expendsignificant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws. Claims that we haveviolated individuals’ privacy rights or breached our contractual obligations, even if we are not found liable, could be expensiveand time consuming to defend and could result in adverse publicity that could harm our business.

Ifwe or third-party contract manufacturing organizations, CROs or other contractors or consultants fail to comply with applicable federal,state or local regulatory requirements, we could be subject to a range of regulatory actions that could affect our or our contractors’ability to develop and commercialize our product candidates and could harm or prevent sales of any affected product candidates that weare able to commercialize, or could substantially increase the costs and expenses of developing, commercializing and marketing our productcandidates. Any threatened or actual government enforcement action could also generate adverse publicity and require that we devote substantialresources that could otherwise be used in other aspects of our business. Increasing use of social media could give rise to liability,breaches of data security or reputational damage.

Ifwe fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incurcosts that could have a material adverse effect on our business.

Weare subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and thehandling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammablematerials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contractwith third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from thesematerials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resultingdamages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal finesand penalties.

Althoughwe maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resultingfrom the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintaininsurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposalof hazardous and flammable materials, including chemicals and biological materials.

Inaddition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.These current or future laws and regulations may impair our research, development or commercialization efforts. Failure to comply withthese laws and regulations also may result in substantial fines, penalties or other sanctions.

TheFDA, the EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of theirjurisdiction.

Wemay choose to conduct international clinical trials in the future. The acceptance of study data by the FDA, the EMA or other comparableforeign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions.In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, theFDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United Statespopulation and United States medical practice; (ii) the trials are performed by clinical investigators of recognized competence and pursuantto current GCP requirements; and (iii) the FDA is able to validate the data through an on-site inspection or other appropriate mean.Additionally, the FDA’s clinical trial requirements, including the adequacy of the patient population studied and statistical powering,must be met. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trialsare conducted. There can be no assurance that the FDA, the EMA or any applicable foreign regulatory authority will accept data from trialsconducted outside of its applicable jurisdiction. If the FDA, the EMA or any applicable foreign regulatory authority does not acceptsuch data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our businessplan, and which may result in our product candidates not receiving approval for commercialization in the applicable jurisdiction.

Obtainingand maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtainingregulatory approval of our product candidates in other jurisdictions.

Obtainingand maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain ormaintain regulatory approval in any other jurisdiction. For example, even if the FDA or the EMA grants marketing approval of a productcandidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion andreimbursement of the product candidate in those countries. However, a failure or delay in obtaining regulatory approval in one jurisdictionmay have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involverequirements and administrative review periods different from those in the United States, including additional preclinical studies orclinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved forsale in that jurisdiction. In some cases, the price that we intend to charge for our product candidates is also subject to approval.

Obtainingforeign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significantdelays, difficulties and costs for us and could delay or prevent the introduction of our product candidates in certain countries. Ifwe or any future collaborator fail to comply with the regulatory requirements in international markets or fail to receive applicablemarketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidateswill be harmed.

Evenif our product candidates receive regulatory approval and become products, they will be subject to significant post-marketing regulatoryrequirements and oversight.

Anyregulatory approvals that we may receive for our product candidates will require the submission of reports to regulatory authoritiesand surveillance to monitor the safety and efficacy of the products, may contain significant limitations related to use restrictionsfor specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk managementrequirements. For example, the FDA may require a REMS in order to approve our product candidates, which could entail requirements fora medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distributionmethods, patient registries and other risk minimization tools. In addition, if the FDA, the EMA or foreign regulatory authorities approveour product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising,promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements.These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-goingcompliance with cGMPs and GCP for any clinical trials that we conduct post-approval. In addition, manufacturers of drug products andtheir facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities forcompliance with cGMP regulations and standards. If we or a regulatory agency discover previously unknown problems with a product, suchas adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatoryagency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the productfrom the market or suspension of manufacturing. In addition, failure to comply with FDA, the EMA or other comparable foreign regulatoryrequirements may subject our company to administrative or judicially imposed sanctions, including:

Theoccurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenueand could require us to expend significant time and resources in response and could generate negative publicity.

TheFDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that couldprevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirementsor the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approvalthat we may have obtained, and we may not achieve or sustain profitability.

Wealso cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrativeor executive action, either in the United States or abroad. For example, certain policies of the current U.S. administration may impactour business and industry. Namely, the previous U.S. administration took several executive actions, including the issuance of a numberof Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routineregulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval ofmarketing applications. It is difficult to predict whether or how these executive actions, including the Executive Orders, will be implemented,or whether they will be rescinded or replaced under the new U.S. administration. If these executive actions impose constraints on FDA’sability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

TheFDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

Ifany of our product candidates are approved and we are found to have improperly promoted off-label uses of those products, we may becomesubject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made aboutprescription products. In particular, a product may not be promoted for uses that are not approved by the FDA, the EMA or such otherregulatory agencies as reflected in the product’s approved labeling. If we receive marketing approval for a product candidate,physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are foundto have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civiland criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engagingin off-label promotion. The government has also required companies to enter into consent decrees or imposed permanent injunctions underwhich specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our product candidates,if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

Wemay face difficulties from changes to current regulations and future legislation.

Existingregulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approvalof our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislationor administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirementsor the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approvalthat we may have obtained and we may not achieve or sustain profitability.

Forexample, the ACA substantially changed the way healthcare is financed by both the government and private insurers, and significantlyimpacts the U.S. biopharmaceutical industry. Other legislative changes have been proposed and adopted in the United States since theACA was enacted. These changes include aggregate reductions to Medicare payments and may result in additional reductions in Medicareand other healthcare funding, all of which could have a material adverse effect on customers for our product candidates, if approved,and accordingly, our financial operations.

Therehave also been several changes and challenges to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturerscan charge for medications sold to certain health care facilities. It is unclear how these developments could affect covered hospitalswho might purchase our future product candidate and affect the rates we may charge such facilities for our approved product candidatesin the future, if any.

Moreover,there has been heightened governmental scrutiny in recent years over the manner in which drug manufacturers set prices for their marketedproducts, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designedto, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patientprograms, and reform government program reimbursement methodologies for pharmaceutical products. The U.S. Congress has indicated thatit will continue to seek new legislative measures to control drug costs.

Further,on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patientsto access certain investigational new product candidates that have completed a Phase 1 clinical trial and that are undergoing investigationfor FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and withoutobtaining FDA permission under the FDA expanded access program. There is no obligation for a drug manufacturer to make its products availableto eligible patients as a result of the Right to Try Act.

Weexpect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coveragecriteria and in additional downward pressure on the price that we receive for any approved product candidates. Any reduction in reimbursementfrom Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of costcontainment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercializeour product candidates.

Legislativeand regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for biotechnologyproducts. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretationswill be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition,increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well assubject us to more stringent product labeling and post-marketing testing and other requirements.

RisksRelated to Our Intellectual Property

Oursuccess depends on our ability to protect our intellectual property and our proprietary technologies.

Ourcommercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for our productcandidates, proprietary technologies and their uses to operate without infringing the proprietary rights of others. If we or our licensorsare unable to protect our intellectual property rights or if our intellectual property rights are inadequate for our technology or ourproduct candidates, our competitive position could be harmed. We and our licensors generally seek to protect our proprietary positionby filing patent applications in the United States and abroad related to our product candidates, proprietary technologies and their usesthat are important to our business. Our in-licensed patent applications cannot be enforced against third parties practicing the technologyclaimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims coverthe technology. There can be no assurance that our in-licensed patent applications will result in patents being issued or that issuedpatents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patentsif issued will not be infringed, designed around, invalidated or rendered unenforceable by third parties. Even issued patents may laterbe found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent officesor in courts. The degree of future protection for our and our licensors’ proprietary rights is uncertain. Only limited protectionmay be available and may not adequately protect our or our licensors’ rights or permit us or our licensors to gain or keep anycompetitive advantage. These uncertainties and/or limitations in our and our licensors’ ability to properly protect the intellectualproperty rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.

Althoughwe may in-license issued patents in the United States and foreign countries, we cannot be certain that the claims in our other in-licensedU.S. pending patent applications, corresponding international patent applications and patent applications in certain foreign countrieswill be considered patentable by the United States Patent and Trademark Office, or USPTO, courts in the United States or by the patentoffices and courts in foreign countries, nor can we be certain that the claims in our in-licensed issued patents will not be found invalidor unenforceable if challenged.

Thepatent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or our licensors orany of our potential future collaborators will be successful in protecting our product candidates by obtaining and defending patents.These risks and uncertainties include the following:

Thepatent prosecution process is also expensive and time-consuming, and we or our licensors may not be able to file and prosecute all necessaryor desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commerciallyadvantageous. It is also possible that we or our licensors may not identify patentable aspects of our research and development outputbefore it is too late to obtain patent protection. Moreover, in some circumstances, we do not have the right to control the preparation,filing and prosecution of patent applications, or to maintain the patents, directed to technology that we license, including those fromour licensors and from third parties. We also may require the cooperation of our licensors in order to enforce the licensed patent rights,and such cooperation may not be provided. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistentwith the best interests of our business. We cannot be certain that patent prosecution and maintenance activities by our licensors havebeen or will be conducted in compliance with applicable laws and regulations, which may affect the validity and enforceability of suchpatents or any patents that may issue from such applications. If they fail to do so, this could cause us to lose rights in any applicableintellectual property that we in-license, and as a result our ability to develop and commercialize products or product candidates maybe adversely affected and we may be unable to prevent competitors from making, using and selling competing products.

Compositionof matter patents for biological and pharmaceutical products such as cell therapy product candidates often provide a strong form of intellectualproperty protection for those types of products, as such patents provide protection without regard to any method of use. We cannot becertain, however, that the claims in our pending patent applications covering the composition of matter of our product candidates willbe considered patentable by the USPTO, or by patent offices in foreign countries, or that the claims in any of our issued patents willbe considered valid and enforceable by courts in the United States or foreign countries. Method of use patents protect the use of a productfor the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical toour product for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promotetheir product for our targeted indications, physicians may prescribe these products “off-label” for those uses that are coveredby our method of use patents. Although off-label prescriptions may infringe or contribute to the infringement of method of use patents,the practice is common and such infringement is difficult to prevent or prosecute.

Inaddition, although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects ofour research and development output, such as our employees, outside scientific collaborators, CROs, third-party manufacturers, consultants,advisors, licensors and other third parties, any of these parties may breach such agreements and disclose such output before a patentapplication is filed, thereby jeopardizing our ability to seek patent protection.

Ifthe scope of any patent protection our licensors obtain is not sufficiently broad, or if our licensors lose any of the patent protectionwe license, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.

Thepatent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has beenthe subject of much litigation in recent years. As a result, the existence, issuance, scope, validity, enforceability and commercialvalue of our in-licensed patent rights are highly uncertain. Our pending and future in-licensed patent applications may not result inpatents being issued that protect our product candidates or that effectively prevent others from commercializing competitive productcandidates.

Moreover,the scope of claims in a patent application can be significantly reduced before any claims in a patent is issued, and claim scope canbe reinterpreted after issuance. Even if patent applications we license currently or in the future issue as patents, they may not issuein a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, orotherwise provide us with any competitive advantage. Any patents that we license may be challenged or circumvented by third parties ormay be narrowed or invalidated as a result of challenges by third parties. Consequently, we do not know whether our product candidateswill be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumventour patents by developing similar or alternative technologies or products in a non-infringing manner, which could materially adverselyaffect our business, financial condition, results of operations and prospects.

Theissuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed-in patents may notcover our product candidates or may be challenged in the courts or patent offices in the United States and abroad. We may be subjectto a third party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination,post-grant review, or PGR, and inter partes review, or IPR, or other similar proceedings in the USPTO or foreign patent officeschallenging our patent rights. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respectto validity of our in-licensed patents, for example, we cannot be certain that there is no invalidating prior art, of which we or ourlicensors and the patent examiner were unaware during prosecution. There is no assurance that all potentially relevant prior art relatingto our in-licensed patents and patent applications or those of our licensors has been found. There is also no assurance that there isnot prior art of which we or licensors are aware, but which we do not believe affects the validity or enforceability of a claim in ourpatents and patent applications or those of our licensors, which may, nonetheless, ultimately be found to affect the validity or enforceabilityof a claim. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or renderunenforceable, our in-licensed patent rights, allow third parties to commercialize our product candidates and compete directly with us,without payment to us. Such loss of licensed patent rights, loss of exclusivity or in patent claims being narrowed, invalidated or heldunenforceable could limit our ability to stop others from using or commercializing similar or identical technology and products, or limitthe duration of the patent protection of our product candidates. Such proceedings also may result in substantial cost and require significanttime from our scientists and management, even if the eventual outcome is favorable to us. In addition, if the breadth or strength ofprotection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies fromcollaborating with us to license, develop or commercialize current or future product candidates.

Wemay not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent,which might adversely affect our ability to develop and market our product candidates.

Wecannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claimsor the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-partypatent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our productcandidates in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure ina patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending applicationmay be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products arenot covered by a third-party patent or may incorrectly predict whether a third-party’s pending application will issue with claimsof relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant maybe incorrect, which may negatively impact our ability to develop and market our product candidates. Our failure to identify and correctlyinterpret relevant patents may negatively impact our ability to develop and market our product candidates.

Oneaspect of the determination of patentability of our inventions depends on the scope and content of the “prior art,” informationthat was or is deemed available to a person of skill in the relevant art prior to the priority date of the claimed invention. There maybe prior art of which we are not aware that may affect the patentability of our patent claims or, if issued, affect the validity or enforceabilityof a patent claim. Further, we may not be aware of all third-party intellectual property rights potentially relating to our product candidatesor their intended uses, and as a result the impact of such third-party intellectual property rights upon the patentability of our ownpatents and patent applications, as well as the impact of such third-party intellectual property upon our freedom to operate, is highlyuncertain. Because patent applications in the United States and most other countries are confidential for typically a period of 18 monthsafter filing, or may not be published at all, we cannot be certain that we were the first to file any patent application related to ourproduct candidates. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.Furthermore, for U.S. applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceedingcan be provoked by a third party or instituted by the USPTO to determine who was the first to invent any of the subject matter coveredby the patent claims of our applications. For U.S. applications containing a claim not entitled to priority before March 16, 2013, thereis a greater level of uncertainty in the patent law in view of the passage of the America Invents Act, which brought into effect significantchanges to the U.S. patent laws, including new procedures for challenging pending patent applications and issued patents.

Ourpatents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad. For example,we may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in PGR procedures, oppositions,derivations, reexaminations or IPR proceedings, in the United States or elsewhere, challenging our patent rights or the patent rightsof others. An adverse determination in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated,or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identicaltechnology and products, or limit the duration of the patent protection of our technology and products. In addition, given the amountof time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates mightexpire before or shortly after such candidates are commercialized. Any failure to obtain or maintain patent protection with respect toour product candidates could have a material adverse effect on our business, financial condition, results of operations and prospects.

Inthe future, some of our intellectual property may be discovered through government-funded programs and thus may be subject to federalregulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliancewith such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

Someof the intellectual property rights we may acquire or license in the future may be generated through the use of U.S. government fundingand may therefore be subject to certain federal regulations. These U.S. government rights may include retained rights in the intellectualproperty, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.In addition, the U.S. government may have the right, under certain limited circumstances, to require us to grant exclusive, partiallyexclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not beentaken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) governmentaction is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”).The U.S. government may also have the right to take title to these inventions if the grant recipient fails to disclose the inventionto the government or fails to file an application to register the intellectual property within specified time limits. Intellectual propertygenerated under a government funded program is also subject to certain reporting requirements, compliance with which may require us toexpend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or producedthrough the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry maybe waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonablebut unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacturesubstantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preferencefor U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property.To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions ofthe Bayh-Dole Act may similarly apply.

Intellectualproperty rights do not necessarily address all potential threats to our competitive advantage.

Thedegree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations,and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Shouldany of these events occur, they could significantly harm our business, results of operations and prospects.

Ourcommercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of thirdparties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay ourdevelopmental and commercialization efforts.

Ourcommercial success depends in part on avoiding infringement of the patents and proprietary rights of third parties. However, our research,development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectualproperty rights owned or controlled by third parties. Other entities may have or obtain patents or proprietary rights that could limitour ability to make, use, sell, offer for sale or import our product candidates and products that may be approved in the future, or impairour competitive position. There is a substantial amount of litigation, both within and outside the United States, involving patent andother intellectual property rights in the biopharmaceutical industry, including patent infringement lawsuits, oppositions, reexaminations,IPR proceedings and PGR proceedings before the USPTO and/or foreign patent offices. Numerous third-party U.S. and foreign issued patentsand pending patent applications exist in the fields in which we are developing product candidates. There may be third-party patents orpatent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufactureof our product candidates.

Asthe biopharmaceutical industry expands and more patents are issued, the risk increases that our product candidates may be subject toclaims of infringement of the patent rights of third parties. We cannot provide any assurances that third-party patents do not existwhich might be enforced against our current product candidates or future products, resulting in either an injunction prohibiting oursales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties.Because patent applications are maintained as confidential for a certain period of time, until the relevant application is published,we may be unaware of third-party patents that may be infringed by commercialization of any of our product candidates, and we cannot becertain that we were the first to file a patent application related to a product candidate or technology. Moreover, because patent applicationscan take many years to issue, there may be currently pending patent applications that may later result in issued patents that our productcandidates may infringe. In addition, identification of third-party patent rights that may be relevant to our technology is difficultbecause patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessingthe meaning of patent claims. It is also possible that patents owned by third parties of which we are aware, but which we do not believeare relevant to our product candidates and other proprietary technologies we may develop, could be found to be infringed by our productcandidate. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.Any claims of patent infringement asserted by third parties would be time consuming and could:

Although,to our knowledge, no third party has asserted a claim of patent infringement against us as of the date of this prospectus, others mayhold proprietary rights that could prevent our product candidates from being marketed. Any patent-related legal action against us claimingdamages and seeking to enjoin activities relating to our product candidates or processes could subject us to potential liability fordamages, including treble damages if we were determined to willfully infringe, and require us to obtain a license to manufacture or developour product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would bea substantial diversion of management and employee resources from our business. We cannot predict whether we would prevail in any suchactions or that any license required under any of these patents would be made available on commercially acceptable terms, if at all.Moreover, even if we or our future strategic partners were able to obtain a license, the rights may be nonexclusive, which could resultin our competitors gaining access to the same intellectual property. In addition, we cannot be certain that we could redesign our productcandidates or processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding,or the failure to obtain necessary licenses, could prevent us from developing and commercializing our product candidates, which couldharm our business, financial condition and operating results.

Partiesmaking claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they havesubstantially greater resources or more mature and developed intellectual property portfolios, or both. Furthermore, because of the substantialamount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk thatsome of our confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiationand continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have amaterial adverse effect on our business, our ability to compete in the marketplace, results of operations, financial condition and prospects.

Wemay be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consumingand unsuccessful. Further, our in-licensed issued patents could be found invalid or unenforceable if challenged in court.

Competitorsmay infringe our patents or other intellectual property rights or the intellectual property rights of our licensors. To cease such infringementor unauthorized use, we and/or our licensors may be required to file infringement claims, which can be expensive and time-consuming.Further, our licensors may need to file infringement claims, and our licensors may elect not to file such claims. Our pending patentapplications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patentissues from such applications. In addition, in a patent infringement proceeding, a court may decide that a patent we own or license isnot valid, is unenforceable and/or is not infringed. If we or any of our licensors or potential future collaborators were to initiatelegal proceedings against a third party to enforce a patent directed at one of our product candidates, the defendant could counterclaimthat our patent is invalid and/or unenforceable in whole or in part. In patent litigation, defendant counterclaims alleging invalidityand/or unenforceability are commonplace. Grounds for a validity challenge include an alleged failure to meet any of several statutoryrequirements, including lack of novelty or written description, obviousness, written description, or non-enablement. Grounds for an unenforceabilityassertion could include an allegation that someone connected with prosecution of the patent intentionally withheld material informationfrom the USPTO or made a misleading statement during prosecution.

Ifa defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all,of the patent protection on such product candidate. There is also a risk that, even if the validity of such patents is upheld, the courtwill construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the inventionat issue on the grounds that our patent claims do not cover the invention, or decide that the other party’s use of our patentedtechnology falls under the safe harbor to patent infringement under 35 U.S.C. §271(e)(1). In addition, if the breadth or strengthof protection provided by our patents and patent applications or those of our licensors is threatened, it could dissuade companies fromcollaborating with us to license, develop or commercialize current or future product candidates. Such a loss of patent protection wouldhave a material adverse impact on our business. Similarly, if we assert trademark infringement claims, a court may determine that themarks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superiorrights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Evenif resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significantexpenses and could distract our technical and management personnel from their normal responsibilities. Such litigation or proceedingscould substantially increase our operating losses and reduce the resources available for development activities or any future sales,marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedingsadequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can becauseof their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedingscould compromise our ability to compete in the marketplace.

Evenif we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award onlymonetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required inconnection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is arisk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.

Intellectualproperty litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.

Duringthe course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well asresults of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regardthese announcements as negative, the perceived value of our existing product candidates, programs or intellectual property could be diminished.Such announcements could also harm our reputation or the market for our future product candidates, which could have a material adverseeffect on our business.

Derivationor interference proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to ceaseusing the related technology or to attempt to license rights from the prevailing party.

Derivationor interference proceedings provoked by third parties or brought by us or our licensors, or declared by the USPTO or similar proceedingsin foreign patent offices may be necessary to determine the priority of inventions with respect to, or correct the inventorship of, ouror our licensors’ patents or patent applications. An unfavorable outcome could result in a loss of our current patent rights andrequire us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business couldbe harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our or our licensors’ defense ofsuch proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. Inaddition, the uncertainties associated with such proceedings could have a material adverse effect on our ability to raise the funds necessaryto continue our clinical trials, continue our research programs, license necessary technology from third parties or enter into developmentor manufacturing partnerships that would help us bring our product candidates to market.

Patentreform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcementor defense of our issued patents.

InSeptember 2011, the Leahy-Smith America Invents Act, or Leahy-Smith Act, was signed into law. The Leahy-Smith Act could increase uncertaintiesand costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-SmithAct includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications areprosecuted, redefine prior art, and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents.In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first inventor to file” systemin which, assuming that other requirements of patentability are met, the first inventor to file a patent application will be entitledto the patent regardless of whether a third party was first to invent the claimed invention. A third party that files a patent applicationin the USPTO after March 2013 but before we file an application covering the same invention, could therefore be awarded a patent coveringan invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant goingforward of the time from invention to filing of a patent application. Furthermore, our ability to obtain and maintain valid and enforceablepatents depends on whether the differences between our technology and the prior art allow our technology to be patentable over the priorart. Since patent applications in the United States and most other countries are confidential for a period of time after filing or untilissuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our productcandidates and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our or our licensors’patents or patent applications. Even where we have a valid and enforceable patent, we may not be able to exclude others from practicingthe claimed invention where the other party can show that they used the invention in commerce before our filing date or the other partybenefits from a compulsory license.

TheLeahy-Smith Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also mayaffect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additionalprocedures to attack the validity of a patent by USPTO administered post-grant proceedings, including PGR, IPR, and derivation proceedings.An adverse determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, our patentrights, which could adversely affect our competitive position.

Becauseof a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary toinvalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold aclaim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidatedif first challenged by the third party as a defendant in a district court action. Thus, the Leahy-Smith Act and its implementation couldincrease the uncertainties and costs surrounding the prosecution of our or licensors’ patent applications and the enforcement ordefense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operationsand prospects.

Changesin U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protectour product candidates.

Asis the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.Obtaining and enforcing patents in the biopharmaceutical industry involves a high degree of technological and legal complexity. Therefore,obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain. Changes in either the patent lawsor in the interpretations of patent laws in the United States and other countries may diminish our ability to protect our inventions,obtain, maintain, and enforce our intellectual property rights, and, more generally, could affect the value of our intellectual propertyand may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issuedpatents. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition,Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us or narrows the scope of ourowned and licensed patents.

Forexample, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection availablein certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regardto our or our licensors’ ability to obtain patents in the future, this combination of events has created uncertainty with respectto the value of patents, once obtained. Depending on decisions by the U.S. Congress, the U.S. federal courts, the USPTO, or similar authoritiesin foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our or ourlicensors’ ability to obtain new patents or to enforce our existing patents and patents we might obtain in the future. We cannotpredict how future decisions by Congress, the federal courts or the USPTO may impact the value of our patents.

Weor our licensors may be subject to claims challenging the inventorship or ownership of our or our in-licensed patents and other intellectualproperty.

Wemay also be subject to claims that former employees, collaborators, or other third parties have an ownership interest in our in-licensedpatents or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent applicationcan result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributionsof different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of thesubject matter of the patent, conflicting obligations of third parties involved in developing our product candidates or as a result ofquestions regarding co-ownership of potential joint inventions. For example, we may have inventorship disputes arise from conflictingobligations of consultants or others who are involved in developing our product candidates. Alternatively, or additionally, we may enterinto agreements to clarify the scope of our rights in such intellectual property. Litigation may be necessary to defend against theseand other claims challenging inventorship or ownership. If we or our licensors fail in defending any such claims, in addition to payingmonetary damages, we may lose valuable intellectual property rights, such as exclusive ownership or a right to use. Such an outcome couldhave a material adverse effect on our business. Even if we or our licensors are successful in defending against such claims, litigationcould result in substantial costs and be a distraction to management and other employees.

Inaddition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectualproperty to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement witheach party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual propertyrights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties,or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claimscould have a material adverse effect on our business, financial condition, results of operations, and prospects.

Patentterms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

Patentshave a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally20 years after its first effective filing date. Various extensions may be available, but the term of a patent, and the protection itaffords, is limited. Even if patents directed to our product candidates are obtained, once the patent term has expired, we may be opento competition from competitive products. Given the amount of time required for the development, testing and regulatory review of productcandidates, patents directed to our product candidates might expire before or shortly after such candidates are commercialized. As aresult, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identicalto ours. In addition, although upon issuance in the United States a patent’s life can be increased based on certain delays causedby the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution.

Ifwe or our licensors do not obtain patent term extension for our product candidates, our business may be materially harmed.

Dependingupon the timing, duration and specifics of FDA marketing approval, if any, of our product candidates, one or more of our U.S. patentsmay be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, or theHatch-Waxman Amendments. The Hatch- Waxman Amendments permit a patent restoration term of up to five years as compensation for patentterm lost during product development and the FDA regulatory review process. A maximum of one patent may be extended per FDA-approvedproduct as compensation for the patent term lost during the FDA regulatory review process. A patent term extension cannot extend theremaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approveddrug product, a method for using it or a method for manufacturing it may be extended. Patent term extension may also be available incertain foreign countries upon regulatory approval of our product candidates. However, we or our licensors may not be granted an extensionbecause of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwisefailing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could beless than we request. If we or our licensors are unable to obtain patent term extension or restoration or the term of any such extensionis less than we request, our competitors may obtain approval of competing products following our patent expiration, and our revenue couldbe reduced, possibly materially. Further, if this occurs, our competitors may take advantage of our investment in development and clinicaltrials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. If we do nothave sufficient patent life to protect our products, our business and results of operations will be adversely affected.

Wemay not be able to protect our intellectual property rights throughout the world.

Althoughwe have in-licensed pending patent applications in the United States and certain other countries, filing, prosecuting and defending patentsin all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outsidethe United States can be less extensive than those in the United States. In addition, the laws of some foreign countries, particularlycertain developing countries, do not protect intellectual property rights to the same extent as federal and state laws in the UnitedStates. Consequently, we may not be able to prevent third parties from practicing our in-licensed inventions in all countries outsidethe United States or from selling or importing products made using our in-licensed inventions in and into the United States or otherjurisdictions. Competitors may use our in-licensed technologies in jurisdictions where we have not obtained patent protection to developtheir own products and, further, may export otherwise infringing products to territories where we or our licensors have patent protection,but enforcement is not as strong as that in the United States. These products may compete with our product candidates, and our or ourlicensors patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Manycompanies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. Thelegal systems of many foreign countries do not favor the enforcement of patents, trade secrets, and other intellectual property protection,which could make it difficult in those jurisdictions for us to stop the infringement or misappropriation of our or our licensors’patents or other intellectual property rights, or marketing of competing products in violation of our proprietary rights. Proceedingsto enforce our or our licensors’ patent rights in foreign jurisdictions could result in substantial costs and divert our effortsand attention from other aspects of our business, could put our or our licensors’ patents at risk of being invalidated, held unenforceable,or interpreted narrowly and our or our licensors’ patent applications at risk of not issuing and could provoke third parties toassert claims against us. We or our licensors may not prevail in any lawsuits that we or our licensors initiate, and the damages or otherremedies awarded, if any, may not be commercially meaningful. Similarly, if our trade secrets are disclosed in a foreign jurisdiction,competitors worldwide could have access to our proprietary information and we may be without satisfactory recourse. Such disclosure couldhave a material adverse effect on our business. Accordingly, our or our licensors’ efforts to enforce our intellectual propertyrights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we developor license.

Inaddition, certain countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled togrant licenses to third parties. In those countries, we and our licensors may have limited remedies if patents are infringed or if weor our licensors are compelled to grant a license to a third-party, which could materially diminish the value of those patents. In addition,many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patentowner may have limited remedies, which could materially diminish the value of such patent. If we or our licensors are forced to granta license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business,financial condition, results of operations and prospects may be adversely affected.

Becauseof the expense and uncertainty of litigation in certain foreign jurisdictions, we may conclude that even if a third-party is infringingour issued patents, any patents that may be issued as a result of our pending or future patent applications or other intellectual propertyrights, the risk-adjusted cost of bringing and enforcing such a claim or action, which typically last for years before they are concluded,may be too high or not in the best interest of our company or our stockholders, or it may be otherwise impractical or undesirable toenforce our intellectual property against some third parties. Our competitors or other third parties may be able to sustain the costsof complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more matureand developed intellectual property portfolios. In such cases, we may decide that the monetary cost of such litigation and the diversionof the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings andthat the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution.In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinicaltrials, continue our internal research programs, in-license needed technology or other product candidates, or enter into developmentpartnerships that would help us bring our product candidates to market.

Obtainingand maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirementsimposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliancewith these requirements.

Periodicmaintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the USPTOand various foreign patent offices at various points over the lifetime of our patents and/or applications. We have systems in place toremind us to pay these fees, and we rely on third parties to pay these fees when due. Additionally, the USPTO and various foreign patentoffices require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent applicationprocess. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be curedby payment of a late fee or by other means in accordance with rules applicable to the particular jurisdiction. However, there are situationsin which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete lossof patent rights in the relevant jurisdiction. If such an event were to occur, it could have a material adverse effect on our business.

Ifwe are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

Inaddition to the protection afforded by other types of intellectual property, we rely on the protection of our trade secrets, includingunpatented know-how, technology and other proprietary information to maintain our competitive position. Although we have taken stepsto protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties (including,but not limited to, contractors, collaborators, and outside scientific advisors), and confidential information and inventions agreementswith employees, consultants, licensors and advisors, we cannot provide any assurances that all such agreements have been duly executed,and any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we maynot be able to obtain adequate remedies for such breaches. We require our employees to enter into written confidentiality agreementsthat assign to us any inventions, developments, creative works and useful ideas of any description that are conceived of, reduced topractice or developed in the course of their employment. In addition, we require our third-party contractors to enter into a writtennon-disclosure agreement that requires the third party to not disclose certain of our confidential information in any manner or for anypurpose other than as necessary and/or appropriate in connection with their obligations for a defined period of time, subject to certainexclusions. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming,and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protecttrade secrets. We may need to share our proprietary information, including trade secrets, with our current and future business partners,collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusionby private parties or foreign actors, and those affiliated with or controlled by state actors.

Moreover,third parties may still obtain this information or may come upon this or similar information independently, and we would have no rightto prevent them from using that technology or information to compete with us. If any of these events occurs or if we otherwise lose protectionfor our trade secrets, the value of this information may be greatly reduced and our competitive position would be harmed. If we or ourlicensors do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of ourproprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secretinformation may be jeopardized.

Wemay be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully usedor disclosed alleged confidential information or trade secrets of their former employers.

Wemay be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential informationof third parties.

Asis common in the biopharmaceutical industry, in addition to our employees, we engage the services of consultants to assist us in thedevelopment of our product candidates. Many of these consultants, and many of our employees, were previously employed at, or may havepreviously provided or may be currently providing consulting services to, other biopharmaceutical companies including our competitorsor potential competitors. We may become subject to claims that we, our employees, independent contractors, or consultants inadvertentlyor otherwise used or disclosed trade secrets or other information proprietary to their former employers or their former or current clients.Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages,we may lose valuable intellectual property rights or personnel, which could adversely affect our business. Even if we are successfulin defending against these claims, litigation could result in substantial costs and be a distraction to our management team and otheremployees.

Ifour trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interestand our business may be adversely affected.

Ourcurrent or future trademarks or trade names may be challenged, infringed, circumvented, or declared generic or descriptive or determinedto be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stopusing these names, which we need for name recognition by potential partners or customers in our markets of interest. During trademarkregistration proceedings, we may receive rejections of our applications by the USPTO or in other foreign jurisdictions. Although we wouldbe given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and incomparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications andto seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarksmay not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may notbe able to compete effectively and our business may be adversely affected. We may license our trademarks and trade names to third parties,such as distributors. Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breachof these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwillassociated with our trademarks and trade names.

Moreover,any name we have proposed to use with product candidates in the United States may need FDA approval, regardless of whether we have registeredit, or applied to register it, as a trademark. Similar requirements exist in Europe. The FDA typically conducts a review of proposedproduct names, including an evaluation of potential for confusion with other product names. If the FDA (or an equivalent administrativebody in a foreign jurisdiction) objects to any of our proposed proprietary product names, we may be required to expend significant additionalresources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existingrights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registrationmay not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. At times, competitorsor other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity andpossibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by ownersof other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.If we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or thatthe party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimatelybe forced to cease use of such trademarks.

RisksRelated to Employee Matters and Managing our Growth

Ifwe are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our productcandidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.

Wecurrently do not have and have never had a marketing or sales team. In order to commercialize any product candidates, if approved, wemust build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties toperform these services for each of the territories in which we may have approval to sell or market our product candidates. We may notbe successful in accomplishing these required tasks.

Establishingan internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidateswill be expensive and time-consuming, and will require significant attention of our executive officers to manage. Any failure or delayin the development of our internal sales, marketing and distribution capabilities could adversely impact the commercialization of anyof our product candidates that we obtain approval to market, if we do not have arrangements in place with third parties to provide suchservices on our behalf. Alternatively, if we choose to collaborate, either globally or on a territory-by-territory basis, with thirdparties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systemsor in lieu of our own sales force and distribution systems, we will be required to negotiate and enter into arrangements with such thirdparties relating to the proposed collaboration. If we are unable to enter into such arrangements when needed, on acceptable terms, orat all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval, or any suchcommercialization may experience delays or limitations. If we are unable to successfully commercialize our approved product candidates,either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significantadditional losses.

Oursuccess is highly dependent on our ability to attract and retain highly skilled executive officers and employees.

Tosucceed, we must recruit, retain, manage and motivate qualified clinical, scientific, technical and management personnel, and we facesignificant competition for experienced personnel. We are highly dependent on the principal members of our management and scientificand medical staff. If we do not succeed in attracting and retaining qualified personnel, particularly at the management level, it couldadversely affect our ability to execute our business plan and harm our operating results. In particular, the loss of one or more of ourexecutive officers could be detrimental to us if we cannot recruit suitable replacements in a timely manner. The competition for qualifiedpersonnel in the biotechnology field is intense and as a result, we may be unable to continue to attract and retain qualified personnelnecessary for the future success of our business. We could in the future have difficulty attracting experienced personnel to our companyand may be required to expend significant financial resources in our employee recruitment and retention efforts.

Manyof the other biotechnology companies that we compete against for qualified personnel have greater financial and other resources, differentrisk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better prospectsfor career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. Ifwe are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover, develop and commercializeour product candidates will be limited and the potential for successfully growing our business will be harmed.

Inorder to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficultiesin managing this growth.

Asof December 31, 2023, we had ten full-time employees. In order to successfully implement our development and commercialization plansand strategies, we expect to need additional managerial, operational, sales, marketing, financial and other personnel. Future growthwould impose significant added responsibilities on members of management, including:

Ourfuture financial performance and our ability to successfully develop and, if approved, commercialize any of our current product candidatesand any other product candidate we may develop will depend, in part, on our ability to effectively manage any future growth, and ourmanagement may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantialamount of time to managing these growth activities.

Wecurrently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisorsand consultants to provide certain services, including key aspects of clinical development and manufacturing. We cannot assure you thatthe services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed,or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the qualityor accuracy of the services provided by third party service providers is compromised for any reason, our clinical trials may be extended,delayed or terminated, and we may not be able to obtain marketing approval of any current or future product candidates or otherwise advanceour business. We cannot assure you that we will be able to manage our existing third party service providers or find other competentoutside contractors and consultants on economically reasonable terms, or at all.

Ifwe are not able to effectively expand our organization by hiring new employees and/or engaging additional third party service providers,we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and anyfuture product candidates and, accordingly, may not achieve our research, development and commercialization goals.

RisksRelated to This Offering and Ownership of Our Common Stock

Wemay not be able to maintain compliance with Nasdaq’s listing standards, which could limit stockholders’ ability to tradeour common stock.

OnJanuary 31, 2024, we completed the Direct Listing, pursuant to which we registered 4,806,226 shares of our common stock held bycertain stockholders, or their permitted transferees (the “Registered Stockholders”). As a listed company on the Nasdaq,we are required to meet certain financial, public float, bid price and liquidity standards on an ongoing basis in order to continue thelisting of our common stock. If we fail to meet these continued listing requirements, our common stock may be subject to delisting, whichcould materially impact the liquidity of our common stock making it more challenging to buy and sell shares of our common stock.

Ourcommon stock have a very short trading history on Nasdaq. An active trading market may not develop or continue to be liquid and the marketprice of shares of our common stock may be volatile.

Ourcommon stock is listed and traded on Nasdaq. Prior to the listing on Nasdaq, there was not a public market for any of our securities,and an active market for our common stock may not develop or be sustained, which could depress the market price of shares of our commonstock and could affect the ability of our stockholders to sell our common stock. In the absence of an active public trading market, investorsmay not be able to liquidate their investments in our common stock. An inactive market may also impair our ability to raise capital byselling shares of our common stock, our ability to motivate our employees through equity incentive awards and our ability to acquireother companies, products or technologies by using shares of our common stock as consideration.

Inaddition, we cannot predict the prices at which our common stock may trade on Nasdaq, and the market price of our common stock may fluctuatesignificantly in response to various factors, some of which are beyond our control.

Thepublic price of our common stock could be subject to wide fluctuations in response to the risk factors described in this prospectus andothers beyond our control, including:

Inaddition, securities exchanges have experienced price and volume fluctuations that have affected and continue to affect the market pricesof equity securities of many companies. Stock prices of many companies have fluctuated in a manner often unrelated to the operating performanceof those companies. These fluctuations may be even more pronounced in the trading market for our common stock shortly following the listingof our common stock on Nasdaq as a result of the supply and demand forces described above. In the past, stockholders have institutedsecurities class action litigation following periods of market volatility. If we were to become involved in securities litigation, itcould subject us to substantial costs, divert resources and the attention of management from our business and harm our business, resultsof operations and financial condition.

Futuresales of common stock by our Registered Stockholders and other stockholders could cause our share price to decline.

Ourcommon stock is listed and traded on Nasdaq. Prior to listing on Nasdaq, there was no public market for our common stock and there hasnot been a sustained history of trading in our common stock in “over-the-counter” markets. While our common stock may besold by the Registered Stockholders pursuant to this prospectus or by our stockholders pursuant to other current or future effectiveregistration statements or in accordance with Rule 144 under the Securities Act or other exemption from registration, there can be noassurance that any Registered Stockholders or other existing stockholders will sell any of their shares of common stock and there mayinitially be a lack of supply of, or demand for, our common stock on Nasdaq. As described herein, certain shares of our common stockoutstanding as of the date hereof will be registered under this registration statement. There can be no assurance that the RegisteredStockholders and other stockholders will not sell all of their shares of common stock (including, upon exercise by GYBL, the shares ofcommon stock underlying the warrants we issued to GYBL), resulting in an oversupply of our common stock on Nasdaq. In the case of a lackof supply of our common stock, the trading price of our common stock may rise to an unsustainable level. Further, institutional investorsmay be discouraged from purchasing our common stock if they are unable to purchase a block of our common stock in the open market dueto a potential unwillingness of our existing stockholders to sell a sufficient amount of common stock at the price offered by such institutionalinvestors and the greater influence individual investors have in setting the trading price. If institutional investors are unable topurchase our common stock, the market for our common stock may be more volatile without the influence of long-term institutional investorsholding significant amounts of our common stock. In the case of a lack of market demand for our common stock, the trading price of ourcommon stock could decline significantly and rapidly after our listing. Therefore, an active, liquid and orderly trading market for ourcommon stock may not initially develop or be sustained, which could significantly depress the public price of our common stock and/orresult in significant volatility, which could affect your ability to sell your shares of common stock.

Wehave 2,500 shares of Series C Preferred Stock with super voting rights.

Ourboard of directors and stockholders have each approved the creation and issuance of an aggregate of 2,500 (after giving effect to theReverse Stock Split) Series C Preferred Stock, all of which Series C Preferred Stock were issued to Pete O’Heeron, our founderand Chief Executive Officer, in conjunction with the Direct Listing.

TheSeries C Preferred Stock (i) have no dividend rights, (ii) convert into common stock upon any transfer from the initial holder, (iii)have a liquidation preference of $18.00 per share (subject to appropriate adjustment in the event of any stock split, combination, orother similar recapitalization) upon our liquidation, dissolution or winding up and (iv) are entitled to 13,000 votes for each shareof Series C Preferred Stock.

TheSeries C Preferred Stock are subject to an irrevocable proxy issued by Pete O’Heeron, the holder of all of the Series C PreferredStock, in favor and for the benefit of, our board of directors, granting our board of directors the irrevocable proxy, for as long asthe Series C Preferred Stock remain outstanding, to vote all of the Series C Preferred Stock on all matters on which the Series C PreferredStock are entitled to vote, in any manner that our board of directors may determine in its sole and absolute discretion; provided, however,that such irrevocable proxy shall not, without the written consent of Pete O’Heeron, permit our board of directors to vote theSeries C Preferred Stock with respect to any proposal to amend, delete or waive any rights of Pete O’Heeron with respect to theSeries C Preferred Stock as set forth in our amended and restated certificate of incorporation. In light of the superior voting rightsassociated with the Series C Preferred Stock, the irrevocable proxy is intended to ensure that such superior voting rights are utilizedin our best interest and to avoid or mitigate conflicts that may arise in the future for Pete O’Heeron as an individual stockholderemployee.

See“Description of Capital Stock—Series C Preferred Stock” for additional information regarding our Series C PreferredStock.

Inaddition to the dilutive effect on the voting power and value of our common stock, the foregoing structure of our capital stock may renderour common stock ineligible for inclusion in certain securities market indices, and thus adversely affect the price and liquidity of,and public sentiment regarding, our common stock or other securities. The existence of, and voting rights associated with, our SeriesC Preferred Stock, either alone or in conjunction with certain of the other provisions of our amended and restated certificate of incorporation,such as the requirement to have a staggered board, could also have the effect of delaying, deterring or preventing a change in our controlor make the removal of our management more difficult.

Weare a “controlled company” within the meaning of The Nasdaq Stock Market Rules because our insiders beneficially own morethan 50% of the voting power of our outstanding voting securities.

Ourfounder and Chief Executive Officer, Pete O’Heeron, collectively beneficially owns approximately 60% of the voting power of ouroutstanding voting securities and we are a “controlled company” within the meaning of the listing rules of The Nasdaq StockMarket LLC. We may rely on certain exemptions from corporate governance rules, including an exemption from the rule that a majority ofour board of directors must be independent directors. Although we currently do not intend to rely on the “controlled company”exemption under the Nasdaq listing rules, we could elect to rely on this exemption in the future. In the event that we elected to relyon the “controlled company” exemption, a majority of the members of our board of directors might not be independent directors,and our governance and nominating and compensation committees might not consist entirely of independent directors. Our status as a controlledcompany could cause our shares of common stock to be less attractive to certain investors or otherwise harm our trading price. As a result,you would not have the same protection afforded to shareholders of companies that are subject to these corporate governance requirements.

Youmay be diluted by future issuances of preferred stock or additional common stock in connection with our incentive plans, acquisitionsor otherwise; future sales of such shares in the public market, or the expectations that such sales may occur, could lower our stockprice.

Ouramended and restated certificate of incorporation authorizes us to issue shares of common stock and options, rights, warrants and appreciationrights relating to our common stock for the consideration and on the terms and conditions established by our board of directors in itssole discretion. We could issue a significant number of shares of common stock in the future in connection with investments or acquisitions.Any of these issuances could dilute our existing stockholders, and such dilution could be significant. Moreover, such dilution couldhave a material adverse effect on the market price for the shares of our common stock.

Thefuture issuance of shares of preferred stock with voting rights may adversely affect the voting power of the holders of shares of ourcommon stock, either by diluting the voting power of our common stock if the preferred stock votes together with the common stock asa single class, or by giving the holders of any such preferred stock the right to block an action on which they have a separate classvote, even if the action were approved by the holders of our shares of our common stock.

Thefuture issuance of shares of preferred stock with dividend or conversion rights, liquidation preferences or other economic terms favorableto the holders of preferred stock could adversely affect the market price for our common stock by making an investment in the commonstock less attractive. For example, investors in the common stock may not wish to purchase common stock at a price above the conversionprice of a series of convertible preferred stock because the holders of the preferred stock would effectively be entitled to purchasecommon stock at the lower conversion price, causing economic dilution to the holders of common stock.

Becausewe have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell yourcommon stock for a price greater than that which you paid for it.

Wecurrently intend to retain all available funds and any future earnings to fund the development, commercialization and growth of our business,and therefore we do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determinationto declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results,capital requirements, general business conditions and other factors that our board of directors may deem relevant. Our future abilityto pay cash dividends on our common stock may also be limited by the terms of any future debt securities or credit facility. Asa result, capital appreciation, if any, of the common stock you purchase in this offering will be your sole source of gain for the foreseeablefuture.

Weare an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors.

Weare an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company,we may take advantage of certain exemptions and relief from various reporting requirements that are applicable to other public companiesthat are not emerging growth companies, including (i) not being required to comply with the auditor attestation requirements of Section404 of the Sarbanes-Oxley Act, (ii) having the option of delaying the adoption of certain new or revised financial accounting standards,(iii) reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statementsand (iv) exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval ofany golden parachute payments not previously approved. We may take advantage of these exemptions until such time that we are no longeran emerging growth company. Accordingly, the information contained herein may be different than the information you receive from otherpublic companies in which you hold stock. Further, pursuant to Section 107 of the JOBS Act, we have elected to take advantage of theextended transition period for complying with new or revised accounting standards until those standards would otherwise apply to privatecompanies. As a result, our operating results and financial statements may not be comparable to the operating results and financial statementsof other companies who have adopted the new or revised accounting standards.

Wewill remain an emerging growth company until the earliest of (i) December 31, 2028, (ii) the last day of the fiscal year in which wehave total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “largeaccelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock heldby non-affiliates was $700.0 million or more as of the last business day of the second fiscal quarter of such year or (iv) the date onwhich we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

Weare also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting companyeven after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smallerreporting companies until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliatesis $250 million or more measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 millionduring the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is $700 million or moremeasured on the last business day of our second fiscal quarter.

Itis possible that some investors will find our common stock less attractive as a result of the foregoing, which may result in a less activetrading market for our common stock and higher volatility in our stock price.

Ourmanagement and principal stockholders own a significant percentage of our stock and will be able to exert significant control over matterssubject to stockholder approval.

Asof December 31, 2023, our executive officers, directors and five percent or greater stockholders and their respective affiliates, beneficiallyown, in the aggregate, approximately 19% of our outstanding common stock on an as converted basis. To the extent that the same groupcontinue to own a significant percentage of our common stock following this offering, these stockholders, if they act together, willbe able to control the management and affairs of our company and most matters requiring stockholder approval, including the electionof directors, amendments of our organizational documents and approval of any merger, sale of substantially all our assets or other significantcorporate transactions. This concentration of ownership may prevent or discourage unsolicited acquisition proposals or offers for ourcommon stock that you or other stockholders may feel are in your or their best interest as one of our stockholders.

Provisionsof our amended and restated certificate of incorporation and bylaws may delay or prevent a take-over that may not be in the best interestsof our stockholders.

Provisionsof our amended and restated certificate of incorporation and bylaws may be deemed to have anti-takeover effects, which include, amongothers, (i) the existence of our Series C Preferred Stock entitled to 13,000 votes per share of Series C Preferred Stock, as more particularlydescribed elsewhere in this prospectus, (ii) a classified board of directors serving staggered three-year terms, (iii) who can fill vacanciesof our board of directors, (iv) supermajority voting thresholds for the removal of members of our board, and (v) when and by whom specialmeetings of our stockholders may be called, and may delay, defer or prevent a takeover attempt.

Inaddition, our amended and restated certificate of incorporation authorize the issuance of shares of preferred stock which will have suchrights and preferences determined from time to time by our board of directors. Our board of directors may, without stockholder approval(except as may be required under Nasdaq rules), issue additional preferred shares with dividends, liquidation, conversion, voting orother rights that could adversely affect the voting power or other rights of the holders of our common stock. Further, our amended andrestated certificate of incorporation authorizes the issuance of “blank check” preferred stock that our board of directorscould use to implement a stockholder rights plan (also known as a “poison pill”).

Ouramended and restated certificate of incorporation provides for an exclusive forum in the Court of Chancery of the State of Delaware forcertain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forumfor disputes with us or our directors, officers or employees.

Ouramended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum,(i) the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal district courtfor the District of Delaware) shall, to the fullest extent permitted by law, be the sole and exclusive forum for (a) any derivative actionor proceeding brought on our behalf, (b) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officersor other employees to us or our stockholders, (c) any action arising pursuant to any provision of the General Corporation Law of theState of Delaware, or the DGCL, our certificate of incorporation or our bylaws or (d) any action asserting a claim governed by the internalaffairs doctrine and (ii) to the fullest extent permitted by law, the federal district courts of the United States of America shall bethe exclusive forum for the resolution of any complaint asserting a cause or causes of action arising under the Securities Act, includingall causes of action asserted against any defendant to such complaint. Pursuant to our planned amended and restated certificate of incorporation,any person or entity purchasing or otherwise acquiring or holding any interest in shares of our common stock will be deemed to have hadnotice of and consented to the forum selection clause in our planned amended and restated certificate of incorporation described in thisparagraph.

Theforegoing provision would not preclude stockholders that assert claims under the Exchange Act from bringing such claims in federal court,to the extent that the Exchange Act confers exclusive federal jurisdiction over such claims, subject to applicable law.

Webelieve our choice of forum provision may benefit us by providing increased consistency in the application of Delaware law by chancellorsand judges particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relativeto other forums and protection against the burdens of multi-forum litigation. However, our choice of forum provision may impose additionallitigation costs on stockholders in pursuing claims and may limit a stockholder’s ability to bring a claim in a judicial forumthat it believes to be favorable for disputes with us or any of our directors, officers or other employees, which may discourage lawsuitswith respect to such claims. In addition, while the Delaware courts have determined that such choice of forum provisions are faciallyvalid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the choice of forum provision,and there can be no assurance that such provision will be enforced by a court in those other jurisdictions. If a court were to find thechoice of forum provision in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additionalcosts associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

GeneralRisks

Reportspublished by analysts, including projections in those reports that differ from our actual results, could adversely affect the price andtrading volume of our common stock.

Securitiesresearch analysts may establish and publish their own periodic projections for our Company. These projections may vary widely and maynot accurately predict the results we actually achieve. The price of our common stock may decline if our actual results do not matchthe projections of these securities research analysts. Similarly, if one or more of the analysts who write reports on us downgrades ourstock or publishes inaccurate or unfavorable research about our business, our stock price could decline. If one or more of these analystsceases coverage of us or fails to publish reports on us regularly, our stock price or trading volume could decline.

Ourinternal computer systems, or those of any of our CROs, manufacturers, other contractors, consultants, collaborators or potential futurecollaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destructionof our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significantliabilities, harm to our brand and material disruption of our operations.

Despitethe implementation of security measures, our internal computer systems and those of our current and any future CROs and other contractors,consultants, collaborators and third-party service providers, are vulnerable to damage from computer viruses, cybersecurity threats,unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failure. Because the techniques used to obtainunauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we maybe unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that mayremain undetected for an extended period. If such an event were to occur and cause interruptions in our operations or result in the unauthorizedacquisition of or access to personally identifiable information or individually identifiable health information (violating certain privacylaws such as HIPAA and GDPR), it could result in a material disruption of our drug discovery and development programs and our businessoperations, whether due to a loss of our trade secrets or other similar disruptions. Some of the federal, state and foreign governmentrequirements include obligations of companies to notify individuals of security breaches involving particular personally identifiableinformation, which could result from breaches experienced by us or by our vendors, contractors or organizations with which we have formedstrategic relationships. Notifications and follow-up actions related to a security breach could impact our reputation, cause us to incursignificant costs, including legal expenses and remediation costs. For example, the loss of clinical trial data from completed or futureclinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproducethe lost data. We also rely on third parties for certain portions of our manufacturing process, and similar events relating to theircomputer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach wereto result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposedto litigation and governmental investigations, the further development and commercialization of our product candidates could be delayed,and we could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or international privacyand security laws.

Ourinsurance policies may not be adequate to compensate us for the potential losses arising from any such disruption, failure or securitybreach. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, ourinsurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless ofits merit, could be costly and divert management attention.

Ouroperations are vulnerable to interruption by fire, severe weather conditions, power loss, telecommunications failure, terrorist activityand other events beyond our control, which could harm our business.

Ourfacility is located in a region which experiences severe weather from time to time. We have not undertaken a systematic analysis of thepotential consequences to our business and financial results from a major tornado, flood, fire, earthquake, power loss, terrorist activityor other disasters and do not have a recovery plan for such disasters. In addition, we do not carry sufficient insurance to compensateus for actual losses from interruption of our business that may occur, and any losses or damages incurred by us could harm our business.The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costsand expenses.

CAUTIONARYNOTE REGARDING FORWARD-LOOKING STATEMENTS

Thisprospectus contains forward-looking statements that can involve substantial risks and uncertainties. All statements other than statementsof historical facts contained in this prospectus, including statements regarding our future results of operations and financial position,business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood ofsuccess, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectivesof management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factorsthat may cause our actual results, performance or achievements to be materially different from any future results, performance or achievementsexpressed or implied by the forward-looking statements.

Insome cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,”“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”“potential,” “predict,” “project,” “should,” “target,” “will,”or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements containthese words. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

Wehave based these forward-looking statements largely on our current expectations and projections about our business, the industry in whichwe operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, andthese forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak onlyas of the date of this prospectus and are subject to a number of risks, uncertainties and assumptions described in the section titled“Risk Factors” and elsewhere in this prospectus. Because forward-looking statements are inherently subject to risksand uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictionsof future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual resultscould differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not planto publicly update or revise any forward-looking statements contained herein until after we distribute this prospectus, whether as aresult of any new information, future events or otherwise.

Inaddition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. Thesestatements are based upon information available to us as of the date of this prospectus, and while we believe such information formsa reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicatethat we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements areinherently uncertain and you are cautioned not to unduly rely upon these statements.

MARKETAND INDUSTRY DATA

Thisprospectus includes estimates regarding market and industry data. Unless otherwise indicated, information concerning our industry andthe markets in which we operate, including our general expectations, market position, market opportunity, and market size, are basedon our management’s knowledge and experience in the markets in which we operate, together with currently available informationobtained from various sources, including publicly available information, industry reports and publications, surveys, our customers, tradeand business organizations, and other contacts in the markets in which we operate. Certain information is based on management estimates,which have been derived from third-party sources, as well as data from our internal research.

Inpresenting this information, we have made certain assumptions that we believe to be reasonable based on such data and other similar sourcesand on our knowledge of, and our experience to date in, the markets in which we operate. While we believe the estimated market and industrydata included in this prospectus is generally reliable, such information is inherently uncertain and imprecise. Market and industry datais subject to change and may be limited by the availability of raw data, the voluntary nature of the data gathering process, and otherlimitations inherent in any statistical survey of such data. In addition, projections, assumptions, and estimates of the future performanceof the markets in which we operate are necessarily subject to uncertainty and risk due to a variety of factors, including those describedin “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” These and other factorscould cause results to differ materially from those expressed in the estimates made by third parties and by us. Accordingly, you arecautioned not to place undue reliance on such market and industry data or any other such estimates.

Thesource of certain statistical data, estimates, and forecasts contained in this prospectus are the following independent industry publicationsor reports:

Thecontent of the above sources, except to the extent specifically set forth in this prospectus, does not constitute a portion of this prospectusand is not incorporated herein.

TRADEMARKS,SERVICE MARKS AND TRADENAMES

Weown or otherwise have rights to the trademarks, including those mentioned in this prospectus, used in conjunction with the operationof our business. This prospectus includes our own trademarks, which are protected under applicable intellectual property laws, as wellas trademarks, service marks and tradenames of other entities, which are the property of their respective owners. Solely for convenience,trademarks, trade names and service marks referred to in this prospectus may appear without the ^®, ^TM or ^SMsymbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullestextent under applicable law, its rights to these trademarks, service marks and tradenames. We do not intend our use or display of otherentities’ trademarks, service marks or tradenames to imply a relationship with, or endorsement or sponsorship of us by, any otherentities.

USEOF PROCEEDS

Weestimate that the net proceeds of this offering, after deducting placement agent fees and estimated expenses payable by us, will be approximately$18.4 million, assuming the sale of all Units offered hereby at an assumed offering price of $11.10 per Unit, which representsthe closing sale price of our common stock on The Nasdaq Global Market on April 23, 2024, and further assuming no exercise ofthe Warrants issued in connection with this offering.

Wecurrently intend to use the net proceeds received from this offering for general corporate purposes, including to hire key personnel,conduct research and development, and for working capital.

Changingcircumstances may cause us to consume capital significantly faster than we currently anticipate. The amounts and timing of our actualexpenditures will depend upon numerous factors, including the development efforts and the overall economic environment. Therefore, ourmanagement will retain broad discretion over the use of the proceeds from this offering. We may ultimately use the proceeds for differentpurposes than what we currently intend. Pending any ultimate use of any portion of the proceeds from this offering, if the anticipatedproceeds will not be sufficient to fund all the proposed purposes, our management will determine the order of priority for using theproceeds, as well as the amount and sources of other funds needed.

Pendingour use of the net proceeds from this offering, we may invest the net proceeds in a variety of capital preservation investments, includingshort-term, investment grade, interest bearing instruments and U.S. government securities.

DIVIDENDPOLICY

Wehave never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earningsto fund the development, commercialization and growth of our business, and therefore we do not anticipate declaring or paying any cashdividends on our common stock in the foreseeable future. Any future determination as to the declaration and payment of dividends, ifany, will be at the discretion of our board of directors. Any such determination will also depend upon our business prospects, operatingresults, financial condition, capital requirements, general business conditions and other factors that our board of directors may deemrelevant. Our future ability to pay cash dividends on our common stock may also be limited by the terms of any future debt securitiesor credit facility.

DILUTION

Ifyou invest in our Units in this offering, your interest will be diluted to the extent of the difference between $11.10, the assumedoffering price per share of our common stock included as part of the Units (without assigning any value to the Warrants), and the proforma as adjusted net tangible book value per share of our common stock immediately after this offering.

Ournet tangible book value as of December 31, 2023, was approximately $1.3 million, and at such time we had no shares of common stockoutstanding.

Ourpro forma net tangible book value as of December 31, 2023, was approximately $4.1 million, or $0.12 per share of common stock, aftergiving effect to (i) the conversion of all outstanding shares of non-voting common stock, Series B Preferred Stock, and SeriesB-1 Preferred Stock into shares of voting common stock upon completion of our Direct Listing on January 31, 2024, and (ii) the sale of227,057 shares of common stock to GEM for net proceeds of approximately $2.8 million (collectively, (i) and (ii), the “Pro FormaAdjustments”). Net tangible book value per share represents our total tangible assets less our total liabilities, divided by thenumber of outstanding shares of common stock.

Aftergiving further effect to our sale of 1,801,801 Units in this offering at an assumed offering price of $11.10 per Unit,and after deducting estimated placement agent discounts and commissions and estimated offering expenses payable by us, and assuming noexercise of the Warrants, our pro forma as adjusted net tangible book value as of December 31, 2023, would have been $22.4 million or$0.65 per share. This represents an immediate dilution in net tangible book value of $10.37 per share to purchasers of common stock includedin the Units sold in this offering, as illustrated in the following table:

Theabove discussion and tables are based on no shares of common stock outstanding as of December 31, 2023. As of December 31, 2023, priorto giving effect to the Pro-Forma Adjustments, we had 32,492,068 shares of common stock issuable upon the conversion of all outstandingshares of Non-voting Common Stock, Series B Preferred Stock, and Series B-1 Preferred Stock into shares of common stock upon completionof our Direct Listing on January 31, 2024.

A$1.00 increase or decrease in the assumed public offering price of $11.10 per Unit would increase or decrease our pro forma asadjusted net tangible book value of common stock after this offering by $1.7 million and the dilution per share of common stock to newinvestors by $0.95, assuming the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same,after deducting the estimated placement agent discounts and commissions and estimated offering expenses payable by us. We may also increaseor decrease the number of Units we are offering. An increase or decrease of 100,000 in the number of Units offered by us would increaseor decrease our pro forma as adjusted net tangible book value after this offering by approximately $1.0 million and increase or decreasepro forma as adjusted net tangible book value per share of common stock after this offering by $0.03 per share of common stock and wouldincrease or decrease the dilution per share of common stock to new investors by $0.03, assuming the assumed public offering price remainsthe same, and after deducting estimated placement agent discounts and commissions and estimated offering expenses payable by us.

Tothe extent that shares are issued upon the exercise of outstanding options and warrants or shares are issued under our equity incentiveplan, you will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategicconsiderations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capitalis raised through the sale of equity or convertible debt securities, the issuance of these securities may result in further dilutionto our stockholders.

CAPITALIZATION

Thefollowing table sets forth our cash and cash equivalents and capitalization as of December 31, 2023, as follows.

Theshare numbers in the table below have been adjusted to reflect the Reverse Stock Split and the related adjustments to our authorizedcapital stock.

Thistable should be read in conjunction with, and is qualified in its entirety by reference to, our financial statements and related notesappearing elsewhere in this prospectus.

Thenumber of shares of our voting common stock reflected in our actual, pro forma, and pro forma as adjusted information set forth in thetable above excludes:

MANAGEMENT

ExecutiveOfficers

Thefollowing table sets forth certain information, as of the date of this prospectus, concerning our executive officers:

Thefollowing is a biographical summary of the experience of our executive officers.

PeteO’Heeron, MSHA. Pete O’Heeron founded our company and has served as our Chief Executive Officer, and the Chairpersonand member of our board of directors since our inception in April 2021. Mr. O’Heeron is also the founder of FibroGenesis, our affiliate,and has served as the Chief Executive Officer of FibroGenesis since January 2006. Mr. O’Heeron is a preeminent biopharma inventor,with over 300 patents issued and pending in the areas of biologics, cell therapy and medical devices. Mr. O’Heeron is a seasonedleader in his field, with over 25 years of experience in medical technology and biotech development. As Chief Executive Officer, he aimsto position us to become a global leader in fibroblast-based cell therapies with the development and commercialization of therapies thatcan cure and treat patients suffering from chronic diseases. Mr. O’Heeron brings together multi-disciplinary teams and resourcesnecessary to commercialize unique technologies. Prior to founding our company and FibroGenesis, he founded an operational investmentgroup, Advanced Medical Technologies, LLC, that identified early-stage opportunities in the medical field with strong intellectual propertypotential in 2006. He also founded in 1998 NeoSurg Technologies, which developed the T2000 Minimally Invasive Access System. NeoSurgTechnologies was sold to Cooper Surgical in 2006. Mr. O’Heeron also previously served in a variety of executive-level positionsat Christus Health Care Corporation from 1988 until 1995 and has provided strategic advisory services to healthcare companies in theareas of biologics, advanced surgical instrumentation and telemedicine. Mr. O’Heeron received his Bachelor’s Degree in HealthcareAdministration from Texas State University, his Masters in Healthcare Administration from the University of Houston Clear Lake, and hisExecutive Management Certification in Mergers and Acquisition from the University of Chicago. We believe Mr. O’Heeron is qualifiedto serve as a member of our board of directors based on our review of his experience, qualifications, attributes and skills, includingco-founding our company and his executive leadership experience in the biotechnology industry.

MarkAndersen, CPA CFA. Mark Andersen has served as our Chief Financial Officer since June 2022. Prior to joining us, Mr. Andersenmost recently served as Chief Financial Officer and Vice President of Administration for the Indiana Biosciences Research Institute inIndianapolis, Indiana, from May 2016 until May 2022. In that role, he was responsible for finance, human resources, legal, and informationtechnology for the institute. Mr. Andersen helped create the operating infrastructure for the institute, assisted with fundraising andprovided oversight for the endowment investment portfolio, which grew to nearly $150.0 million. Prior to that, from August 2015 untilFebruary 2016, Mr. Andersen served as Vice President Finance and Corporate Controller for MiMedx with responsibility for SEC reportingand finance functions. Previously, from January 2004 to August 2015, Mr. Andersen held multiple financial leadership roles at Eli Lillyand Company, including Investments Director for the company’s pension plan, Finance Director for Mergers and Acquisitions, andController for Lilly USA. Mr. Andersen received his Bachelor of Science degree in accounting and Master of Science in accountancy fromSouthern Utah University, and his MBA from the University of Michigan Ross School of Business.

HamidKhoja, Ph.D. Hamid Khoja has served as our Chief Scientific Officer since August 2021. Dr. Khoja has more than 25 years of experienceas a leader of scientific teams, development of cell-based genomic, proteomic, epigenetics assays, and tools, protocols and technologiesfor use in drug discovery and development and clinical diagnostics. Prior to joining us, Dr. Khoja most recently served from March 2009to August 2021 as the Principal Scientist as Covaris, LLC, a privately-held scientific tools company with emphasis in genomics, epigenetics,and proteomics, where he provided long-term strategic applications proposals to the Chief Executive Officer, managed external collaborationsfor product and applications development, assessed new technologies for acquisition and OEM opportunities, and presented posters andpresentations at numerous scientific conferences. Dr. Khoja led the effort in successfully incorporating Covaris technology into theIllumina Next Generation Sequencing technology protocols leading to over 15,000 citations. Dr. Khoja also developed the Covaris chromatinimmunoprecipitation methodology with over 3,000 citations in peer-reviewed publications, as well as leading the effort in using Covaristechnology for simplifying epigenetics assay workflows for use in drug development and discovery, and clinical use. Dr. Khoja also ledcollaborations with the U.S. National Cancer Institute for successful development of microbiome DNA extraction using acoustics, and completionof FDA EUA SARA-CoC-2 bridge study design for approval of new sample collection and viral ribonucleic acid (RNA) extraction using Covaristechnology. Dr. Khoja also developed a patented workflow for the manufacturing of synthetic cell-free DNA for use as reference standardin sequencing based liquid biopsy clinical oncology-based assays. Prior to Covaris, Dr. Khoja was a Senior Applications Scientist atGenomic Solutions, a startup scientific tools company later acquired by Harvard Apparatus, from March 2022 to March 2009, where he ledthe development of a high throughput protein crystallization platform used in pharmaceutical industry for drug development, managed thescientific applications group, presented company resources at scientific meetings and assessed new technologies for acquisition and OEMopportunities. During the startup phase of Sequenom, Inc., from January 2000 to March 2003, Dr. Khoja established the methodology forhighly multiplexed polymerase chain reaction, or PCR, used in the development of Sequenom’s massEXTEND technology for MALDI-TOFMS-based analysis of single nucleotide polymorphisms and genetic disease. Dr. Khoja led the effort in developing diagnostic MS-basedassays for hemochromatosis, cystic fibrosis and ten predominantly Jewish genetic diseases using Sequenom’s massEXTEND technologywhich were then transferred to a large clinical diagnostic company. Dr. Khoja also previously worked at Eli Lilly and Company from November1998 to September 1999 and Chiron Corporation from October 1995 to October 1998. During his career at Eli Lilly, Dr. Khoja establisheda high throughput PCR and sequencing strategy using a variety of sequencing strategies and bioinformatic tools available in 1999 forobtaining high coverage genome sequencing which led to the finalizing of the first ever complete sequence of the S. pneumoniae genome.At Chiron Corporation, which was subsequently acquired by Novartis, Dr. Khoja helped in the design, development and optimization of HTPbinding assays for FGFR, VEGF, PDGF, and EPO receptors, identification of novel g-protein coupled seven transmembrane receptors, andidentification of novel proteins involved in the TNF signaling pathway, and development of branched-DNA based HTP screening for ligand-inducedoncogene quantification.

Dr.Khoja received his Bachelor of Science in Molecular Biology from the University of Southern California and his Ph.D. in Molecular Biologyfrom Boston University.

RubenGarcia. Ruben Garcia has served as our General Counsel since March 1, 2024. Prior to FibroBiologics, Mr. Garcia most recentlyserved as Senior Vice President, General Counsel and Corporate Secretary at AcelRx Pharmaceuticals, Inc. (n/k/a Talphera, Inc.), a pharmaceuticalcompany, from April 2019 to February 2022. In that role, he was responsible for all legal and compliance matters. Prior to AcelRx, Mr.Garcia was Senior Corporate Counsel and Assistant Secretary at Ultragenyx Pharmaceutical Inc., a biopharmaceutical company, from November2016 to April 2019, with responsibility for SEC and governance matters. Prior to Ultragenyx, Mr. Garcia was an attorney at Vinson &Elkins LLP and Jones Day, where he practiced in the areas of capital markets, securities offerings, corporate governance and mergersand acquisitions. Mr. Garcia holds a B.A. in Government and Economics from Georgetown University and a J.D. from Stanford Law School.

Non-EmployeeDirectors

Thefollowing table sets forth certain information, as of the date of this prospectus, concerning our non-employees who serve on our boardof directors:

Thefollowing is a biographical summary of the experience of our non-employee directors.

RobertHoffman. Robert Hoffman has served on our board of directors since April 2021. Mr. Hoffman currently serves asPresident, Chief Executive Officer and Chairperson of the board of directors of Kintara Therapeutics, Inc. (Nasdaq: KTRA), a clinicalstage, biopharmaceutical company focused on the development and commercialization of new cancer therapies, a member of the board of directorsof ASLAN Pharmaceuticals Limited (Nasdaq: ASLN), an oncology-focused biotechnology company developing a portfolio of immuno-oncologyagents and targeted therapies, and Chairperson, and a member, of the board of directors of Antibe Therapeutics Inc., a Toronto, Canada-basedpharmaceutical company listed on the Toronto Stock Exchange. Mr. Hoffman previously served as Senior Vice President and Chief FinancialOfficer of Heron Therapeutics, Inc., (Nasdaq: HRTX), a commercial-stage biotechnology company, from April 2017 to October 2020, and asChief Financial Officer of AnaptysBio, Inc. (Nasdaq: ANAB), a specialty pharmaceutical company, from July 2015 to September 2016. FromJune 2012 to July 2015, Mr. Hoffman served as the Senior Vice President, Finance and Chief Financial Officer of Arena Pharmaceuticals,Inc., or Arena, a biopharmaceutical company, prior to its acquisition by Pfizer Inc. in March 2022. From August 2011 to June 2012 andpreviously from December 2005 to March 2011, Mr. Hoffman served as Arena’s Vice President, Finance and Chief Financial Officerand in a number of various roles of increasing responsibility from 1997 to December 2005. Mr. Hoffman formerly served as a member ofthe board of directors of Saniona AB, a biopharmaceutical company, from September 2021 to May 2022, and as a member of the board of directorsof Kura Oncology, Inc. (Nasdaq: KURA), a cancer research company, from March 2015 to August 2021. He also previously served as a memberof the board of directors of CombiMatrix Corporation, a molecular diagnostics company, MabVax Therapeutics Holdings, Inc., a biopharmaceuticalcompany, and Aravive, Inc. (Nasdaq: ARAV), a clinical stage biotechnology company. Mr. Hoffman serves as a member of the steering committeeof the Association of Bioscience Financial Officers. Mr. Hoffman formerly served as a director and President of the San Diego Chapterof Financial Executives International and was an advisor to the Financial Accounting Standard Board, or FASB, from 2010 to 2020, advisingthe U.S. accounting rulemaking organization on emerging issues and new financial guidance. Mr. Hoffman holds a B.B.A. from St. BonaventureUniversity. We believe Mr. Hoffman’s financial and executive business experience qualifies him to serve on our board of directors.

VictoriaNiklas, M.D. Victoria Niklas has served on our board of directors since April 2021. Dr. Niklas has a distinguished career spanningmore than two decades in translational research, clinical care and teaching at academic health centers, and is currently the Chief MedicalOfficer of Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, a position she has held since 2022. Priorto joining Oak Hill Bio, Dr. Niklas served in Global Medical Affairs and as Global Program Leader of the OHB-607 program in Rare Diseaseand Hematology at Takeda Pharmaceuticals. Before Takeda, she was Chief Medical and Scientific Officer at Prolacta Bioscience, a neonatalnutritional product development company based on human donor milk. Dr. Niklas has over 20 years of experience as an academic neonatologistwith expertise in developmental and acquired inflammatory disorders of the gut, the lung and the mucosal immune system with relevanceto diseases across the lifespan. She has held positions as Chief, Division of Newborn Medicine at Nemours Children’s Hospital,Chief of Neonatology at UCLA Olive View Medical Center, and Visiting Professor of Clinical Pediatrics at the David Geffen School of Medicineat UCLA. Dr. Niklas is board certified in Perinatal and Neonatal Medicine and holds a California medical license. In addition to beinga co-author on numerous scientific and clinical publications, she has helped lead the development of patented products and has servedas a board member for multiple biotech and early-stage companies in functional foods. Dr. Niklas received her MD from Harvard MedicalSchool, her MA in Biochemistry and Molecular Biology from Harvard University, and her bachelor’s in Biological Sciences from GoucherCollege. We believe Dr. Niklas’ extensive experience and knowledge in the biotechnology sector qualifies her to serve on our boardof directors.

RichardCilento, Jr., MBA. Richard Cilento has served on our board of directors since April 2021. Mr. Cilento is the founder, Chairpersonof the board of directors and Chief Executive Officer of GlycosBio Inc., a life sciences research and development company. Mr. Cilentowas the founder, President and Chief Executive Officer of FuelQuest, Inc., a provider of information technology, supply chain managementand tax automation technologies, which was acquired by Saracen Energy Advisors LP in May 2007. Mr. Cilento has held senior-managementpositions with several technology firms, including Xerox Corporation, where he served as Vice President of Strategic Services of XeroxConnect. Prior to that, he was the Vice President of Corporate Services for XLConnect Solutions, where he served as the lead technologistfor advanced systems and supported the organization through its initial public offering and its eventual merger with Xerox. An aeronauticaland astronomical engineer, Mr. Cilento began his career at the U.S. National Aeronautics and Space Administration (NASA), where he andhis team built space shuttle flight plans for the U.S. Department of Defense Star Wars program and a diverse set of government-fundedtechnology and life science experimentation. Mr. Cilento was a lead engineer who designed and planned the space station assembly sequencesfor the construction of the International Space Station. Mr. Cilento holds a BS degree in Aeronautical and Astronomical Engineering fromthe University of Illinois and an MBA at the University of Houston, Clear Lake. We believe Mr. Cilento’s business experienceacross a broad set of technical industries and executive-level knowledge of capital markets, including venture capital, private equityand public markets, qualifies him to serve on our board of directors.

StacyCoen, MBA. Stacy Coen has served as a member of our board of directors since July 2021. Ms. Coen has over 25 years of businessand corporate development experience from leading oncology and rare disease companies. She most recently served as the Chief BusinessOfficer for ImmunoGen, Inc., a company that is developing the next generation of antibody-drug conjugates to improve outcomes for cancerpatients. Prior to ImmunoGen, Ms. Coen worked at Editas Medicine, Inc., a biotechnology company developing therapies for rare diseases,where she served as Vice President, Business Development and was responsible for business development, strategy, transactions and alliancemanagement. Prior to joining Editas, Ms. Coen served in multiple roles of increasing responsibility at Genzyme Corporation (now knownas Sanofi Genzyme), including as Vice President, Head of Rare Disease Business Development and Licensing, and as Vice President, GlobalHead of Strategy and Business Development, Multiple Sclerosis, among others. Ms. Coen currently serves on the Huntington’s DiseaseSociety of America’s Center Programs & Education Advisory Committee. Ms. Coen received a BS in Finance and Economics from the University of Massachusetts and an MBA from the Darden Graduate Schoolof Business at the University of Virginia. We believe Ms. Coen’s extensive executive-level experience in the biotechnology industryqualifies her to serve on our board of directors.

MatthewLink. Matthew Link has served on our board of directors since April 2021. Mr. Link has more than 20 years of experience in thehealthcare and medical technology industries and currently serves as Chief Commercial Officer for Sight Sciences (SGHT). From 2021 to2023 he served as managing partner at Orion Healthcare Advisors, LLC, a consulting services provider. From 2006 to 2021 Mr. Link servedin regional and executive leadership positions at NuVasive Inc., a global leader in surgical implants and enabling technology for spinesurgery and orthopedics. As President of NuVasive, Inc., his responsibilities included oversight of global business units in spine, neurophysiology,and orthopedics. Prior to NuVasive, Inc., Mr. Link held commercial leadership roles at Depuy Orthopedics and Depuy Spine. He also currentlyserves as chairman of the board of directors at Galen Robotics and as a member of the board of directors of Springbok Analytics and DinamicOR,and the Coulter Translational Research Endowment at the University of Virginia. Mr. Link received a BSEd in Physical Education and SportsMedicine from the University of Virginia. We believe Mr. Link’s extensive medical technology industry and executive experiencequalifies him to serve on our board of directors.

FamilyRelationships

Thereare no family relationships among any of our directors or executive officers.

ScientificAdvisory Board

Wehave a scientific advisory board, comprised of the following world-renowned scientists with relevant expertise, which helps guide ourresearch and development efforts.

Boardof Directors

Ourboard of directors currently consists of six directors. Our amended and restated certificate of incorporation provides that, subjectto the rights of holders of any series of our preferred stock to elect directors, the number of directors on our board of directors shallbe fixed from time to time solely by resolution of the majority of the total number of authorized directors, whether or not there existany vacancies in previously authorized directorships.

Pursuantto our amended and restated certificate of incorporation, subject to the preferential rights of holders of any series of our preferredstock, any newly created directorship that results from an increase in the number of directors or any vacancy on our board of directorscan only be filled by the affirmative vote of a majority of the total number of directors then in office, even if less than a quorum,or by a sole remaining director and cannot be filled by the stockholders. Further, any member of our board of directors or our entireboard of directors may only be removed for cause, and then only by the affirmative vote of the holders of at least 66^2/3%in voting power of our stock.

Whenconsidering whether directors have the experience, qualifications, attributes or skills, taken as a whole, to enable our board of directorsto satisfy its oversight responsibilities effectively in light of our business and structure, the board of directors focuses primarilyon each person’s background and experience as reflected in the information discussed in each of the directors’ individualbiographies set forth above. We believe that our directors provide an appropriate mix of experience and skills relevant to the size andnature of our business.

DirectorIndependence

Ourboard of directors has determined that all members of our board of directors, except Pete O’Heeron, are independent directors forpurposes of the rules of Nasdaq and the SEC. In making this determination, our board of directors considered the relationships that eachnon-employee director has with us and all other facts and circumstances that our board of directors deemed relevant, including the beneficialownership of our common stock by each non-employee director.

Thecomposition and functioning of our board of directors and each of our committees complies with all applicable requirements of Nasdaqand the rules and regulations of the SEC.

StaggeredBoard

Inaccordance with the terms of our amended and restated certificate of incorporation, our board of directors is divided into three staggeredclasses of directors and each is assigned to one of the three classes. At each annual meeting of our stockholders, a class of directorswill be elected for a three-year term to succeed the directors of the same class whose terms are then expiring. The terms of the directorswill expire upon the election and qualification of successor directors at the annual meeting of shareholders to be held during the years2024 for Class I directors, 2025 for Class II directors and 2026 for Class III directors and will be subject to their earlier death,disqualification, resignation or removal.

Thedivision of our board of directors into three classes with staggered three-year terms may delay or prevent stockholder efforts to effecta change of our management or a change in our control.

BoardLeadership Structure

Ourboard of directors is currently chaired by our founder, Pete O’Heeron. Our board of directors can modify our leadership structurein the future as it deems appropriate.

Committeesof our Board of Directors

Ourboard of directors has established an audit committee, a compensation committee and a governance and nominating committee, each of whichoperates pursuant to a charter adopted by our board of directors. Our board of directors may also establish other committees from timeto time to assist the board of directors. The composition and functioning of all of our committees complies with all applicable requirementsof the Sarbanes-Oxley Act, Nasdaq and SEC rules and regulations. Each committee’s charter is available on our website at www.fibrobiologics.com.

AuditCommittee

Themembers of our audit committee are Mr. Hoffman, Dr. Niklas, and Mr. Cilento. Mr. Hoffman serves as the chairperson of the committee.Our board of directors has determined that each member of the audit committee is “independent” as that term is defined inNasdaq rules and has sufficient knowledge in financial and auditing matters to serve on the audit committee. In addition, our board ofdirectors has determined that each member of the audit committee meets the heightened independence requirements for audit committeesrequired under Section 10A of the Exchange Act and related SEC and Nasdaq rules. Our board of directors has determined that Mr. Hoffmanis an “audit committee financial expert,” as defined under the applicable rules of the SEC. The audit committee’s responsibilitiesinclude:

CompensationCommittee

Themembers of our compensation committee are Mr. Hoffman, Ms. Coen and Mr. Link. Mr. Hoffman serves as the chairperson of the committee.Our board of directors has determined that each member of the compensation committee is “independent” as that term is definedin Nasdaq rules and is a “non-employee director” under Rule 16b-3 under the Exchange Act. In addition, our board of directorshas determined that each member of the compensation committee meets the heightened independence requirements for compensation committeepurposes under Section 10C of the Exchange Act and related SEC and Nasdaq rules. The compensation committee’s responsibilitiesinclude:

Governanceand Nominating Committee

Themembers of our governance and nominating committee are Ms. Coen, Dr. Niklas and Mr. Link. Ms. Coen serves as the chairperson of the committee.Our board of directors has determined that each member of the governance and nominating committee is “independent” as definedin Nasdaq rules. The governance and nominating committee’s responsibilities include:

Codeof Conduct

Wehave adopted a written code of ethics and business conduct that applies to our directors, officers and employees, including our principalexecutive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions.A current copy of the code is posted on our website at www.fibrobiologics.com. If we make any substantive amendments to, or grant anywaivers from, the code of ethics and business conduct for any officer or director, we will disclose the nature of such amendment or waiveron our website or in a current report on Form 8-K.

EXECUTIVEAND DIRECTOR COMPENSATION

ExecutiveCompensation

Thissection discusses the material components of the executive compensation program for our executive officers who are named in the “—2023Summary Compensation Table” below. For the fiscal year ended December 31, 2023, our “named executive officers”and their positions were as follows: