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180 LIFE SCIENCES CORP.

Date Filed : Jul 19, 2024

S-11ea0209604-s1_180life.htmREGISTRATION STATEMENT

As filed with the U.S. Securities and Exchange Commission on July 19, 2024

Registration No. 333-         

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM S-1

REGISTRATION STATEMENT

 

UNDER

THE SECURITIES ACT OF 1933

 

180 Life Sciences Corp.

(Exact name of registrant as specified in itscharter)

 

Delaware   2834   90-1890354
(State or other jurisdiction of   (Primary Standard Industrial   (I.R.S. Employer
incorporation or organization)   Classification Code Number)   Identification Number)

 

3000 El Camino Real, Bldg. 4, Suite 200
Palo Alto, CA 94306
(650) 507-0669

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

 

Blair Jordan
Interim Chief Executive Officer
180 Life Sciences Corp.
3000 El Camino Real, Bldg. 4, Suite 200
Palo Alto, CA 94306
(650) 507-0669

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

 

Copies to:

 

David M. Loev, Esq.
John S. Gillies, Esq.
The Loev Law Firm, PC
6300 West Loop South, Suite 280
Bellaire, Texas 77401
Telephone: (713) 524-4110
 

 

Approximate date of commencementof proposed sale to the public: From time to time after this registration statement becomes effective.

 

If any of the securities beingregistered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, checkthe following box:  

 

If this Form is filed to registeradditional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the SecuritiesAct registration statement number of the earlier effective registration statement for the same offering.  

 

If this Form is a post-effectiveamendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering.  

 

If this Form is a post-effectiveamendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering.  

 

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

 

Large accelerated filer   Accelerated filer
Non-accelerated filer   Smaller reporting company
      Emerging growth company

 

If an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  

 

The registrant hereby amends this registrationstatement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment whichspecifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the SecuritiesAct of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, actingpursuant to said Section 8(a), may determine.

 

 

 

 

 

 

The information containedin this prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with theSecurities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offerto buy these securities in any state where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION,DATED JULY 19, 2024

 

PRELIMINARY PROSPECTUS

 

Up to _____ Shares of Common Stock

Pre-Funded Warrants to Purchase up to _____Shares of Common Stock

Common Warrants to Purchase up to _____ Sharesof Common Stock

Up to _____ Shares of Common Stock Underlyingthe Pre-Funded Warrants

Up to _____ Shares of Common Stock Underlyingthe Common Warrants

 

 

We are offering up to $____million of shares of common stock, par value $0.0001 per share (the “Common Stock”), together with common warrants(the “Common Warrants”) to purchase up to _____ shares of Common Stock. Each share of our Common Stock, or pre-fundedwarrant (the “Pre-Funded Warrant”) in lieu thereof, is being sold together with a Common Warrant to purchase up to_____ shares of our Common Stock. The shares of Common Stock and Common Warrants are immediately separable and will be issued separatelyin this offering, but must be purchased together in this offering.

 

We have assumed a public offeringprice of $_____ per share, the last reported sales price of our Common Stock on The Nasdaq Capital Market (“Nasdaq”)on July __, 2024. The Common Warrants have an assumed initial exercise price of $_____ per share (assuming an exercise price equal tothe reported sales price of our Common Stock on Nasdaq on July __, 2024, which was $_____ per share) and will have a five-year term. Theactual public offering price will be determined between us, _____________ (whom we refer to herein as the “Placement Agent”)and the investors in the offering and may be at a discount to the current market price of our Common Stock. Therefore, the assumed publicoffering price used throughout this prospectus may not be indicative of the final offering price.

 

We are also offering Pre-FundedWarrants to purchase up to _____ shares of Common Stock to those purchasers whose purchase of shares of Common Stock in this offeringwould result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at theelection of the purchaser, 9.99%) of our outstanding Common Stock immediately following the consummation of this offering, in lieu ofshares of Common Stock that would result in beneficial ownership in excess of 4.99% (or, at the election of the purchaser, 9.99%) of ouroutstanding Common Stock. Each Pre-Funded Warrant is exercisable for one share of our Common Stock and has an exercise price of $0.0001per share. Each Pre-Funded Warrant is being offered together with the Common Warrants. The Pre-Funded Warrants and Common Warrants areimmediately separable and will be issued separately in this offering but must be purchased together in this offering. For each Pre-FundedWarrant that we sell, the number of shares of Common Stock we are offering will be reduced on a one-for-one basis.

 

Pursuant to this prospectus,we are also offering the shares of Common Stock issuable upon the exercise of Pre-Funded Warrants and Common Warrants offered hereby.These securities are being sold in this offering to certain purchasers under a securities purchase agreement dated          ,2024 between us and the purchasers.

 

The shares of our Common Stock,Pre-Funded Warrants and Common Warrants being offered will be sold in a single closing. The shares issuable upon exercise of the Pre-FundedWarrants or Common Warrants will be issued upon the exercise thereof. Because there is no minimum number of securities or minimum aggregateamount of proceeds for this offering to close, we may sell fewer than all of the securities offered hereby, and investors in this offeringwill not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined inthis prospectus. Because there is no escrow account and there is no minimum offering amount, investors could be in a position where theyhave invested in our company, but we are unable to fulfill our objectives due to a lack of interest in this offering. Also, any proceedsfrom the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be ableto use such funds to effectively implement our business plan. The offering of the shares of our Common Stock, Pre-Funded Warrants andCommon Warrants will terminate no later than _____, 2024; however, the shares of our Common Stock underlying the Pre-Funded Warrants andthe Common Warrants will be offered on a continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “SecuritiesAct”).

 

 

 

 

Our Common Stock is listedon Nasdaq under the symbol “ATNF”. On July 18, 2024, the closing sale price of our Common Stock was $2.39 per share. Thereis no established public trading market for the Pre-Funded Warrants and the Common Warrants, and we do not expect a market to develop.Without an active trading market, the liquidity of the Pre-Funded Warrants and the Common Warrants will be limited. In addition, we donot intend to apply for a listing of the Pre-Funded Warrants or the Common Warrants on any national securities exchange or other nationallyrecognized trading system.

 

INVESTING IN OUR SECURITIESINVOLVES SUBSTANTIAL RISKS. SEE THE SECTION TITLED “RISK FACTORS” BEGINNING ON PAGE 9 OF THIS PROSPECTUS TO READABOUT FACTORS YOU SHOULD CONSIDER BEFORE BUYING OUR SECURITIES.

 

NEITHER THE SECURITIESAND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACYOR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

 

We have engaged the PlacementAgent in connection with the securities offered by this prospectus. The Placement Agent has no obligation to buy any of the securitiesfrom us or to arrange for the purchase or sale of any specific number or dollar amount of securities but has agreed to use its reasonablebest efforts to sell the securities offered by this prospectus. We have agreed to pay the Placement Agent a fee based on the aggregateproceeds raised in this offering as set forth in the table below:

 

   Per Share
and
Common Warrant
   Per Pre- Funded
Warrant and
Common Warrant
   Total 
Public offering price  $        $    $  
Placement Agent fees(1)  $    $    $  
Proceeds, before expenses, to us(2)  $    $       $    

 

(1) We have agreed to pay the Placement Agent a cash placement commission equal to __% of the aggregate proceeds from this offering. We have also agreed to reimburse the Placement Agent for certain expenses incurred in connection with this offering. See “Plan of Distribution” beginning on page 30 for additional information regarding the compensation to be paid to the Placement Agent.
   
(2) The amount of the offering proceeds to us presented in this table does not give effect to any exercise of the Pre-Funded Warrants or Common Warrants being issued in this offering.

 

Delivery of the securitiesbeing offered pursuant to this prospectus is expected to be made on or about ,                     2024,subject to the satisfaction of certain closing conditions.

 

The date of this prospectus is     , 2024.

 

 

 

 

TABLE OF CONTENTS

 

About This Prospectus iii
Cautionary Note Regarding Forward-Looking Statements iv
Prospectus Summary 1
Risk Factors 9
Incorporation by Reference 24
Use of Proceeds 25
Capitalization 26
Dilution 27
Dividend Policy 29
Plan of Distribution 30
Description of Capital Stock 32
Description of Securities We Are Offering 35
Legal Matters 38
Experts 38
Where You Can Find More Information 38

 

i

 

 

Our logo and some of our trademarksand tradenames are used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the propertyof others. Solely for convenience, trademarks, tradenames and service marks referred to in this prospectus may appear without the ®,™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate in any way that we willnot assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if any, nor that respectiveowners to other intellectual property rights will not assert, to the fullest extent under applicable law, their rights thereto. We donot intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorshipof us by, any other companies.

 

The market data and certainother statistical information used throughout this prospectus are based on independent industry publications, reports by market researchfirms or other independent sources that we believe to be reliable sources; however, we have not commissioned any of the market or surveydata that is presented in this prospectus. Industry publications and third-party research, surveys and studies generally indicate thattheir information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completenessof such information. We are responsible for all of the disclosures contained in this prospectus, and we believe these industry publicationsand third-party research, surveys and studies are reliable, provided that we have not commissioned any such information. While we arenot aware of any misstatements regarding any third-party information presented in this prospectus, their estimates, in particular, asthey relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on variousfactors, including those discussed under the section entitled “Risk Factors” of this prospectus. These and other factorscould cause our future performance to differ materially from our assumptions and estimates. Some market and other data included herein,as well as the data of competitors as they relate to 180 Life Sciences Corp., is also based on our good faith estimates.

 

Unless the context requiresotherwise, references to the “Company,” “we,” “us,” “our,”“180 Life”, “180LS” and “180 Life Sciences Corp.” refer specifically to 180 LifeSciences Corp. and its consolidated subsidiaries. References to “KBL” refer to the Company prior to the November 6,2020 Business Combination.

 

In addition, unless the contextotherwise requires and for the purposes of this prospectus only:

 

  CAD” refers to Canadian dollars;

 

  Exchange Act” refers to the Securities Exchange Act of 1934, as amended;

 

  £” or “GBP” refers to British pounds sterling;

 

  SEC” or the “Commission” refers to the United States Securities and Exchange Commission; and

 

  Securities Act” refers to the Securities Act of 1933, as amended.

 

Effective on December 19,2022 at 12:01 a.m. Eastern Time, we affected a 1-for-20 reverse stock split of our then outstanding Common Stock, with any fractionalshares rounded up to the nearest whole share. Effective on February 28, 2024 at 12:01 a.m. Eastern Time, we affected a 1-for 19 reversestock split of our then outstanding Common Stock with any fractional shares rounded up to the nearest whole share.

 

In connection with the reversesplits discussed above (the “Reverse Stock Split”), all outstanding options, warrants, and other securities entitlingtheir holders to purchase or otherwise receive shares of Common Stock were adjusted, as required by the terms of each security. The numberof shares available to be awarded under the Company’s equity incentive plans were also appropriately adjusted. Following the ReverseStock Splits, the par value of the Common Stock remained unchanged at $0.0001 par value per share. The reverse stock splits did not changethe authorized number of shares of Common Stock or preferred stock.

 

The effects of the ReverseStock Splits have been retroactively reflected throughout this prospectus.

 

ii

 

 

About This Prospectus

 

This prospectus is part ofa registration statement on Form S-1 that we filed with the SEC to register the securities offered hereby under the Securities Act.We may also file a prospectus supplement or post-effective amendment to the registration statement of which this prospectus forms a partthat may contain material information relating to these offerings. The prospectus supplement or post-effective amendment may also add,update or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the informationin this prospectus and the applicable prospectus supplement or post-effective amendment, you should rely on the prospectus supplementor post-effective amendment, as applicable. Before purchasing any securities, you should carefully read this prospectus, any post-effectiveamendment, and any applicable prospectus supplement, together with the additional information described under the heading “WhereYou Can Find More Information” and the information incorporated by reference herein, as discussed under the heading “Incorporationby Reference”.

 

Neither we, nor the PlacementAgent, have authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus,any post-effective amendment, or any applicable prospectus supplement prepared by or on behalf of us or to which we have referred you.We and the Placement Agent take no responsibility for, and can provide no assurance as to the reliability of, any other information thatothers may give you. We and the Placement Agent will not make an offer to sell these securities in any jurisdiction where the offer orsale is not permitted. You should assume that the information appearing in this prospectus, any post-effective amendment and any applicableprospectus supplement to this prospectus is accurate only as of the date on its respective cover. Our business, financial condition, resultsof operations and prospects may have changed since those dates. This prospectus contains, and any post-effective amendment or any prospectussupplement may contain, market data and industry statistics and forecasts that are based on independent industry publications and otherpublicly available information. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of thisinformation and we have not independently verified this information. In addition, the market and industry data and forecasts that maybe included in this prospectus, any post-effective amendment or any prospectus supplement may involve estimates, assumptions and otherrisks and uncertainties and are subject to change based on various factors, including those discussed under the heading “RiskFactors” contained in this prospectus, any post-effective amendment and the applicable prospectus supplement. Accordingly, investorsshould not place undue reliance on this information.

 

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

 

iii

 

 

Cautionary NoteRegarding Forward-Looking Statements

 

This prospectus contains forward-lookingstatements under federal securities laws, including within the meaning of the Private Securities Litigation Reform Act of 1995.In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,”“continue,” “could,” “estimate,” “expect,” “intend,”“may,” “ongoing,” “plan,” “potential,” “predict,”“project,” “should,” or the negative of these terms or other comparable terminology, although notall forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, andwill not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-lookingstatements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties andother factors that may cause our results, levels of activity, performance or achievements to be materially different from the informationexpressed or implied by the forward-looking statements in this prospectus.

 

In particular, forward-lookingstatements include, but are not limited to, any statements that are not statements of current or historical facts, such as statementsrelating to our expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization ofour product candidates, the accuracy of our estimates regarding expenses, future revenues and capital requirements, our ability to executeour plans to develop and market new drug products and the timing and costs of these development programs, and estimates of the sufficiencyof our existing capital resources combined with future anticipated cash flows to finance our operating requirements.

 

Such statements are basedon management’s current expectations, but actual results may differ materially due to various factors, including, but not limitedto:

 

  The need for additional funding, our ability to raise funding in the future, the terms of such funding, and dilution caused thereby;

 

  expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of our product candidates;

 

  the uncertainties associated with the clinical development and regulatory approval of the Company’s drug candidates, including potential delays in the enrollment and completion of clinical trials, issues raised by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA);

 

  regulatory developments in the United States and foreign countries;

 

  our success in retaining or recruiting, or changes required in, our officers, key employees or directors;

 

  current negative operating cash flows and our potential ability to obtain additional financing to advance our business and the terms of any further financing, which may be highly dilutive and may include onerous terms;

 

  the continued impact of the COVID-19 pandemic on our business operations and our research and development initiatives;

 

iv

 

 

  the accuracy of our estimates regarding expenses, future revenues and capital requirements;

  

  the Company’s reliance on third parties to conduct its clinical trials, enroll patients, and manufacture its preclinical and clinical drug supplies;

 

  the ability to come to mutually agreeable terms with such third parties and partners, and the terms of such agreements, the terms of the Company’s current licensing agreements, and the termination rights associated therewith;

 

  estimates of patient populations for the Company’s planned products;

 

  unexpected adverse side effects or inadequate therapeutic efficacy of drug candidates that could limit approval and/or commercialization, or that could result in recalls or product liability claims;

 

  the Company’s ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities;

 

  challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; and uncertainty of commercial success;

 

  the ability of the Company to execute its plans to develop and market new drug products and the timing and costs of these development programs;

 

  changing rates of inflation and interest rates, and economic downturns, including potential recessions, as well as macroeconomic, geopolitical, health and industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian conflict, and Israel/Hamas conflict) and other large-scale crises;

 

estimates of the sufficiencyof our existing capital resources combined with future anticipated cash flows to finance our operating requirements;

 

  the review and evaluation of strategic transactions and their impact on shareholder value; the process by which the Company engages in evaluation of strategic transactions; the outcome of potential future strategic transactions and the terms thereof;
     
  our ability to maintain our listing of our Common Stock and public warrants on the Nasdaq Capital Market, including our current non-compliance with Nasdaq’s continued listing rules; and

 

  other risks and uncertainties, including those described under “Risk Factors”, below.

 

Any forward-looking statementsin this prospectus reflect our current views with respect to future events or to our future financial performance and involve known andunknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially differentfrom any future results, performance or achievements expressed or implied by these forward-looking statements. Given these uncertainties,you should not place undue reliance on these forward-looking statements. All forward-looking statements included herein speak only asof the date of this prospectus. All subsequent written and oral forward-looking statements attributable to us, or persons acting on ourbehalf, are expressly qualified in their entirety by the cautionary statements above. Except as required by law, we assume no obligationto update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

 

v

 

 

Prospectus Summary

 

The following summary highlightsselected information contained elsewhere in this prospectus and/or incorporated by reference herein, and does not contain all of the informationthat you should consider in making your investment decision. Before investing in our securities, you should carefully read this entireprospectus and the information incorporated by reference herein.

 

Our Company

 

We are a clinical stage biotechnologycompany headquartered in Palo Alto, California, focused on the development of therapeutics for unmet medical needs in chronic pain, inflammationand fibrosis by employing innovative research, and, where appropriate, combination therapy.

 

We have three different productdevelopment platforms that are focused on different diseases or medical conditions, and that target different factors, molecules or proteins,as follows:

 

  fibrosis and anti-tumor necrosis factor (“TNF”);

 

  drugs which are derivatives of cannabidiol (“CBD”) or cannabigerol (“CBG”) analogues (“SCAs”); and

 

  alpha 7 nicotinic acetylcholine receptor (“α7nAChR”).

 

Due to restrictions in theCompany’s resources, the Company has slowed down research and development activities significantly in the SCA platform and the anti-TNFplatform, and the Company has not made progress in the α7nAChR platform and has suspended further research and development activityin this program the meantime.

 

The Company is currently evaluatingall options to monetize its existing assets, in addition to exploring other strategic alternatives to maximize value for its stockholders.Potential strategic alternatives that may be explored or evaluated by the Company as part of this process include, but are not limitedto, an acquisition, merger, reverse merger, other business combination, sale of assets, licensing or other strategic transactions involvingthe Company.

 

Recent Developments

 

Declaratory Relief Action Against the Companyby AmTrust International

 

On June 29, 2022, AmTrustInternational Underwriters DAC (“AmTrust”), which was the premerger directors’ and officers’ insurancepolicy underwriter for KBL, filed a declaratory relief action against the Company in the U.S. District Court for the NorthernDistrict of California (the “Declaratory Relief Action”) seeking declaration of AmTrust’s obligations under thedirectors’ and officers’ insurance policy.  In the Declaratory Relief Action, AmTrust is claiming that as a result ofthe merger the Company is no longer the insured under the subject insurance policy, notwithstanding the fact that the fees whichthe Company seeks to recover from AmTrust relate to matters occurring prior to the merger. 

 

On September 20, 2022, theCompany filed its Answer and Counterclaims against AmTrust for bad faith breach of AmTrust’s insurance coverage obligations to theCompany under the subject directors’ and officers’ insurance policy, and seeking damages of at least $2 million in compensatorydamages, together with applicable punitive damages. In addition, the Company brought a Third-Party Complaint against its excess insurancecarrier, Freedom Specialty Insurance Company (“Freedom”) seeking declaratory relief that Freedom will also be requiredto honor its policy coverage as soon as the amount of AmTrust’s insurance coverage obligations to the Company have been exhausted.On October 25, 2022, AmTrust filed its Answer to the Company’s Counterclaims and, on October 27, 2022, Freedom filed its Answerto the Third-Party Complaint.

 

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On November 22, 2022,the Company filed a Motion for Summary Adjudication against both AmTrust and Freedom.  The Motion was fully briefed and a hearingwas held on March 9, 2023. The standard to prevail on a Motion for Summary Adjudication in the Court is high to prevail and requiresa judge to find that there are no disputed issues of fact so that they can rule on the issues as a matter of law. In this instance thejudge found three major issues could be decided as a matter of law in the Company’s favor and that one issue, the Change in Controlexclusion, requires further discovery.

 

On April 21, 2023, the Courtissued an Order Granting in Part and Denying in Part the Company’s Motion for Partial Summary Judgment.

 

Specifically, the Court grantedsummary adjudication in favor of the Company on the following issues: (a) that the Company is, in fact, an insured under both the AmTrustand Freedom insurance policies; (b) that certain SEC subpoena related expenses for defendants Dr. Marlene Krauss, the Company’sformer Chief Executive Officer and Director, and George Hornig, the former Chairman of the Board, are within the basic scope of coverageunder both the AmTrust and Freedom insurance policies; and (c) that the Insured vs. Insured exclusion relied upon by AmTrust and Freedomis not applicable to bar any such coverage.

 

The Court also found thatthere were issues of disputed facts as to the Change in Control exclusion contained within the policies, which therefore precluded theCourt from granting the remainder of the Company’s requests for summary adjudication as a matter of law. Accordingly, the Court,at that time, denied the Company’s further requests for summary adjudication and deemed that for the time being, the Change in Controlissue is to be determined at the time of trial, in order to find that the policies (i) provide coverage for the fees which the Companyhas advanced and will advance to Dr. Marlene Krauss and George Hornig; (ii) that AmTrust has breached the policy; (iii) that AmTrust mustpay such expenses of the Company; and that, once the AmTrust policy has been exhausted, (iv) Freedom will be obligated to pay such expensesof the Company pursuant to its policy.

 

On August 4, 2023, the Courtgranted the Company’s request to file a second motion for partial summary judgment in the case, this one being on the issue of whetherAmTrust should be required to advance to the Company the defense costs being incurred by Dr. Marlene Krauss and George Hornig during thependency of the case. The Motion for Partial Summary Judgment was fully briefed by the parties, and a hearing for such Motion was heldon January 11, 2024. After the matter was taken under submission, on February 12, 2024, the Court granted the Company’s Motion forPartial Summary Judgment against both AmTrust and Freedom, and ordered as follows: (a) AmTrust is obligated under its insurance policywith the Company to advance to the Company all defense costs in excess of the deductible that the Company has advanced, or will advance,to Dr. Krauss and Mr. Hornig in connection with certain SEC Subpoenas, and (b) upon exhaustion of the AmTrust insurance policy, Freedomis obligated to do the same pursuant to its excess liability insurance policy with the Company. This Order applies throughout the interimof the case, but does not constitute a final judgment, and both the Company and the two insurers retain their rights to contest all applicableissues at trial, which is scheduled for May 12, 2025. A final judgment following trial could potentially confirm these obligations ofthe insurers or, alternatively, reverse and require the Company to repay all or portions of such advance payments. There is no assuranceat this time as to what the final judgment may entail.

 

On April 16, 2024, AmTrustpaid the Company $2.27 million in reimbursement of fees which the Company has advanced to Dr. Marlene Krauss and George Hornig, ofwhich the Company received $1.5 million after the payment of attorney’s fees. On May 9, 2024, AmTrust paid the Company $300,140 inreimbursement of fees which the Company had advanced to Dr. Marlene Krauss and George Hornig, and the Company has received $200,093 afterthe payment of attorney’s fees.

 

The Company and Amtrust havea mediation conference scheduled for August 21, 2024, during which, the parties could agree on a settlement agreement.

 

The parties have commencedwritten discovery proceedings against each other and anticipate that depositions will also occur. The Company intends to continue to vigorouslypursue this matter in order to establish the Company’s entitlement to full and final payment by both AmTrust and Freedom of thesubject advancement expenses of the Company. While the Company continues to believe it has a strong case against both AmTrust and Freedom,there can be no assurance that the Company will prevail in this action. The final outcome of the litigation is unknown at this time andsuch final outcome could be materially adverse to the Company.

 

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Nasdaq Non-Compliance Issues

 

As previously disclosed, onNovember 15, 2023, the Listing Qualifications department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”)notified us that we did not comply with the minimum $2,500,000 stockholders’ equity requirement for continued listing set forthin Nasdaq Listing Rule 5550(b) (the “Rule”).

 

Nasdaq provided the Companyuntil January 2, 2024, to submit to Nasdaq a plan to regain compliance. We submitted the plan to regain compliance in a timely manner,and on January 11, 2024, Nasdaq advised the Company that it has determined to grant the Company an extension to regain compliance withthe Rule.

 

The terms of the extensionwere as follows: on or before May 13, 2024, the Company must have completed certain transactions described in greater detail in the complianceplan, contemplated to result in the Company increasing its stockholders’ equity to more than $2.5 million, and opt for one of thetwo following alternatives to evidence compliance with the Rule: Alternative 1: The Company must have furnished to the SEC and Nasdaqa publicly available report (e.g., a Form 8-K) including: 1. A disclosure of the Staff’s deficiency letter and the specific deficiency(ies)cited; 2. A description of the completed transaction or event that enabled the Company to satisfy the stockholders’ equity requirementfor continued listing; and 3. An affirmative statement that, as of the date of the report, the Company believed it had regained compliancewith the stockholders’ equity requirement based upon the specific transaction or event referenced in Step 2; or Alternative 2: theCompany must furnish to the SEC and Nasdaq a publicly available report including: 1. Steps 1 & 2 set forth above; 2. a balance sheetno older than 60 days with pro forma adjustments for any significant transactions or event occurring on or before the report date; and3. that the Company believes it satisfies the stockholders’ equity requirement as of the report date. The pro forma balance sheetmust have evidenced compliance with the stockholders’ equity requirement.

 

Additionally, in either casethe Company was required to disclose that Nasdaq will continue to monitor the Company’s ongoing compliance with the stockholders’equity requirement and, if at the time of its next periodic report the Company does not evidence compliance, that it may be subject todelisting.

 

While the Company was ableto undertake some of the transactions described in the compliance plan, it was unable to regain compliance with the Rule prior to theend of the plan period (May 13, 2024). As a result, on May 14, 2024, the Company received a delist determination letter from the Staffadvising the Company that the Staff had determined that the Company did not meet the terms of the extension. Specifically, the Companydid not complete its proposed transactions and was unable to file a Current Report Form 8-K by the May 13, 2024 deadline previously requiredby the Staff, evidencing compliance with the Rule. As a result, unless the Company requests an appeal of the Staff’s determination,trading of the Company’s Common Stock will be suspended at the opening of business on May 23, 2024, and a Form 25-NSE will be filedwith the SEC, which will remove the Company’s Common Stock and public warrants from listing and registration on The Nasdaq StockMarket.

 

On May 17, 2024, the Companyrequested an appeal of the Staff’s delisting determination, and on May 20, 2024, the Staff advised the Company that the delistingaction referenced in the Staff’s determination letter was stayed, pending the final written decision by the Hearings Panel.

 

The Company subsequently receivednotice that the Hearings Panel determined to grant the Company’s request to continue its listing on Nasdaq, subject to the Companymeeting certain conditions, including filing on or before July 31, 2024, a public disclosure describing the transactions undertaken bythe Company to achieve compliance with Nasdaq’s continued listing rules and demonstrate long-term compliance with the Rule and providingan indication of its equity following those transactions.

 

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There can be no assurancethat the Company will be able to regain compliance with the applicable Nasdaq listing requirements or meet the requirements of the HearingPanel. If the Company’s Common Stock and public warrants are delisted, it could be more difficult to buy or sell the Company’sCommon Stock and public warrants or to obtain accurate quotations, and the price of the Company’s Common Stock and public warrantscould suffer a material decline. Delisting could also impair the Company’s ability to raise capital and/or trigger defaults andpenalties under outstanding agreements or securities of the Company.

 

The Company is continuingto work towards completing the necessary transactions in an effort to achieve compliance with the Rule and is currently evaluating variouscourses of action to regain compliance with the Rule. However, there can be no assurance that the Company will be able to complete thetransactions necessary to regain compliance with the Rule.

 

Separately, on May 14, 2024,the Staff provided us notice of our non-compliance with the audit committee requirements for continued listing on Nasdaq set forth inListing Rule 5605(c)(2), which requires that listed companies maintain an audit committee of at least three independent directors. Nasdaqprovided the Company a cure period in order to regain compliance as follows: until the earlier of the Company’s next annual shareholders’meeting or May 7, 2025; or if the next annual shareholders’ meeting is held before November 4, 2024, then the Company must evidencecompliance no later than November 4, 2024. In the event the Company does not regain compliance by the applicable date above, Nasdaq rulesrequire the Staff to provide written notification to the Company that its securities will be delisted. At that time, the Company may appealthe delisting determination to a Hearings Panel. The Company is currently seeking out qualified independent directors to serve on theCompany’s audit committee and expects to regain compliance with Listing Rule 5605(c)(2) in the near future.

 

Strategic Transactions

 

The Company is currently evaluatingall options to monetize its existing assets, in addition to exploring other strategic alternatives to maximize value for its stockholders.Potential strategic alternatives that may be explored or evaluated by the Company as part of this process include, but are not limitedto, an acquisition, merger, reverse merger, other business combination, sale of assets, licensing or other strategic transactions involvingthe Company.

 

Summary Risk Factors

 

The following is a summaryof select risks and uncertainties that could materially adversely affect us and our business, financial condition and results of operations.Before you invest in our Common Stock, you should carefully consider all the information in this prospectus, including matters set forthunder the heading “Risk Factors,” immediately following this prospectus summary. These risks include the following,among others:

 

Risks Related to This Offering

 

  You will experience immediate and substantial dilution in the net tangible book value per share of the Common Stock you purchase.

 

  You may also experience future dilution as a result of future equity offerings.

 

  Resales of our Common Stock in the public market during this offering by our stockholders may cause the market price of our Common Stock to fall.

 

  We will have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

 

  This offering may cause the trading price of our Common Stock to decrease.

 

  There is no public market for the Pre-Funded Warrants and Common Warrants being offered in this offering.

 

  Holders of our Pre-Funded Warrants and Common Warrants will have no rights as common stockholders until they acquire our Common Stock.

 

  If we do not maintain a current and effective prospectus relating to the Common Stock issuable upon exercise of the Pre-Funded Warrants and Common Warrants, holders will only be able to exercise such Pre-Funded Warrants and Common Warrants on a “cashless basis.”

 

  The Pre-Funded Warrants and the Common Warrants are speculative in nature.

 

  The Common Warrants may not have any value.

 

  This is a reasonable best efforts offering, in which no minimum number or dollar amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans.

 

  Certain provisions of the Pre-Funded Warrants and Common Warrants could discourage an acquisition of us by a third party.

 

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Risks Relating to the Company and our CommonStock

 

We face risks and uncertaintiesrelated to our business, many of which are beyond our control. In particular, risks associated with our business include:

 

  we are a clinical stage biotechnology company that had no revenue for the three months ended March 31, 2024, and for the years ended December 31, 2023 and 2022, and do not anticipate generating revenue for the near future;

 

  our need for additional financing, both near term and long term, to support our operations, our ability to raise such financing as needed, the terms of such financing, if available, potential significant dilution associated therewith, and covenants and restrictions we may need to comply with in connection with such funding;

 

  our dependence on the success of our future product candidates, some of which may not receive regulatory approval or be successfully commercialized; problems in our manufacturing process for our new products and/or our failure to comply with manufacturing regulations, or unexpected increases in our manufacturing costs; problems with distribution of our products; and failure to adequately market our products;

 

  risks associated with the growth of our business, our ability to maintain such growth, difficulties in managing our growth, and executing our growth strategy;

 

  liability for previously restated financial statements and associated with ineffective controls and procedures, as well as costs and expenses related to the indemnification of current and former officers and directors;

 

  our dependence on our key personnel and our ability to attract and retain employees and consultants;

 

  risks from intense competition from companies with greater resources and experience than we have;

 

  our ability to receive regulatory approvals for our product candidates, and the timeline and costs associated therewith, including the uncertainties associated with the clinical development and regulatory approval of our drug candidates, including potential delays in the enrollment and completion of clinical trials, issues raised by the U.S. The Food and Drug Administration (FDA) and The Medicines and Healthcare products Regulatory Agency (MHRA);

 

  risks that our future product candidates, if approved by regulatory authorities, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products;

 

  the outcome of currently pending and future claims and litigation, future government investigations, and other proceedings may adversely affect our business and results of operations;

 

  the fact that the majority of our license agreements provide the licensors and/or counter-parties the right to use, own and/or exploit such licensed intellectual property;

 

  preclinical studies and earlier clinical trials may not necessarily be predictive of future results and may not have favorable results; we have limited marketing experience, and our future ability to successfully commercialize any of our product candidates, even if they are approved in the future is unknown; and business interruptions could delay us in the process of developing our future product candidates and could disrupt our product sales;

 

  liability from lawsuits (including product liability lawsuits, stockholder lawsuits and regulatory matters), including judgments, damages, fines and penalties and including the outcome of currently pending litigation, potential future government investigations, and other proceedings that may adversely affect our business and results of operations;

 

  security breaches, loss of data and other disruptions which could prevent us from accessing critical information or expose us to liabilities or damages;

 

  risks associated with clinical trials that are expensive, time-consuming, uncertain and susceptible to change, delay or termination and which are open to differing interpretations, delays in the trials, testing, application, or approval process for drug candidates and/or our ability to obtain approval for promising drug candidates, and the costs associated therewith;

 

  our ability to comply with existing and future rules and regulations, including federal, state and foreign healthcare laws and regulations and implementation of, or changes to, such healthcare laws and regulations;

 

  our ability to adequately protect our future product candidates or our proprietary technology in the marketplace, claims and liability from third parties regarding our alleged infringement of their intellectual property;

 

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  differences in laws and regulations between countries and other jurisdictions and changes in laws or regulations, including, but not limited to tax laws and controlled substance laws, or a failure to comply with any laws and regulations;

 

  dilution caused by future fund raising, the conversion/exercise of outstanding convertible securities, and downward pressure on the value of our securities caused by such future issuances/sales;

 

  the extremely volatile nature of our securities and potential lack of liquidity thereof;

 

  the fact that our Certificate of Incorporation provides for indemnification of officers and directors, limits the liability of officers and directors, allows for the authorization of preferred stock without stockholder approval, and includes certain other anti-takeover provisions and exclusive forum provisions;

 

  our ability to maintain the listing of our Common Stock and warrants on Nasdaq and the costs of compliance with SEC and Nasdaq rules and requirements;

 

  failure of our information technology systems, including cybersecurity attacks or other data security incidents, that could significantly disrupt the operation of our business;

 

  the fact that we may acquire other companies which could divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results and if we make any acquisitions, they may disrupt or have a negative impact on our business;

 

  the effect of changes in inflation and interest rates, and economic downturns, including potential recessions, as well as macroeconomic, geopolitical, health and industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian and Hamas/Israel conflict) and other large-scale crises, as well as the potential implications of a Congressional impasse over the U.S. debt limit or possible future U.S. governmental shutdowns over budget disagreements;

 

  the fact that we do not currently have $2.5 million or more of stockholders’ equity, and as a result, we are not in compliance with the continued listing requirements of the Nasdaq Capital Market and our Common Stock and public warrants are subject to delisting;

 

  the fact that we may apply working capital and future funding to uses that ultimately do not improve our operating results or increase the value of our securities; and
     
  potential future strategic alternatives, including, but not limited to a potential acquisition, merger, reverse merger, other business combination, sale of assets, licensing or other strategic transactions involving the Company, the effects thereof on the value of our securities, dilution caused thereby, and potential changes in our operations, management and Board of Directors in connection therewith; and

 

  our growth depends in part on the success of our strategic relationships with third parties.

 

Corporate Information

 

We were originally formedas KBL Merger Corp. IV, a blank check company organized under the laws of the State of Delaware on September 7, 2016, which consummatedits initial public offering on June 7, 2017. On November 6, 2020, we consummated the Business Combination and, in connection therewith,changed our name to 180 Life Sciences Corp.

 

Our principal executive officesare located at 3000 El Camino Real, Bldg. 4, Suite 200, Palo Alto, California 94306, and our telephone number is (650) 507-0669. Wemaintain a website at www.180lifesciences.com. We have not incorporated by reference into this prospectus the information in, or thatcan be accessed through, our website, and you should not consider it to be a part of this prospectus.

 

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THE OFFERING

 

Shares of Common Stock outstanding prior to this offering   969,602 shares of Common Stock as of July __, 2024
     
Securities offered by us   Up to _____ shares of Common Stock in the aggregate represented by _____ shares of Common Stock, or Pre-Funded Warrants to purchase up to _____ shares of Common Stock, and Common Warrants to purchase up to _____ shares of Common Stock. Each share of Common Stock and Pre-Funded Warrant will be sold together with one Common Warrant.
     
Pre-Funded Warrants offered by us   We are offering to certain purchasers whose purchase of shares of Common Stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of our outstanding shares of Common Stock immediately following the closing of this offering, the opportunity to purchase, if such purchasers so choose, Pre-Funded Warrants, in lieu of shares of Common Stock that would otherwise result in any such purchaser’s beneficial ownership, together with its affiliates and certain related parties, exceeding 4.99% (or, at the election of such purchaser, 9.99%) of our outstanding shares of Common Stock immediately following the consummation of this offering. The purchase price of each Pre-Funded Warrant is equal to the purchase price of the shares of Common Stock in this offering minus $0.0001, the exercise price of each Pre-Funded Warrant. Each Pre-Funded Warrant is immediately exercisable and may be exercised at any time until it has been exercised in full. For each Pre-Funded Warrant we sell, the number of shares of Common Stock we are offering will be decreased on a one-for-one basis. This offering also relates to the shares of Common Stock issuable upon exercise of any Pre-Funded Warrants sold in this offering.
     
Common Stock to be outstanding immediately after this offering   Up to _____ shares of Common Stock, assuming no sales of Pre-Funded Warrants which, if sold, would reduce the number of shares of Common Stock that we are offering on a one-for-one basis.
     
Common Warrants   Each share of Common Stock will be sold together with one Common Warrant. Each Common Warrant has an exercise price per share equal to 100% of the public offering price of shares in this offering and expires on the fifth anniversary of the original issuance date. Because we will issue a Common Warrant for each share of Common Stock and for each Pre-Funded Warrant sold in this offering, the number of Common Warrants sold in this offering will not change as a result of a change in the mix of shares of Common Stock and Pre-Funded Warrants sold. This offering also relates to the shares of Common Warrants sold in this offering, and the shares of Common Stock issuable upon exercise of any Common Warrants sold in this offering.
     
Reasonable Best Efforts   We have agreed to issue and sell the securities offered hereby to the purchasers through the Placement Agent. The Placement Agent is not required to buy or sell any specific number or dollar amount of the securities offered hereby, but they will use their reasonable best efforts to solicit offers to purchase the securities offered by this prospectus. See the section entitled “Plan of Distribution” on page 30 of this prospectus.
     
Use of Proceeds   We estimate that the net proceeds from this offering will be approximately $_____ million, at an assumed public offering price of $_____ per share (assuming a public offering price equal to the last sale price of our Common Stock as reported by Nasdaq on July __, 2024, which was $_____ per share), after deducting the placement agent fees and estimated offering expenses payable by us. We currently intend to use the net proceeds from the sale of our securities under this prospectus for research and development expenses and general corporate purposes, transaction costs to complete a reverse-merger and legal expenses. See the section entitled “Use of Proceeds” on page 25 of this prospectus.

 

Risk Factors   The purchase of our securities involves a high degree of risk. See “Risk Factors” beginning on page 9 and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in our securities.
     
Nasdaq symbol   Our Common Stock is listed on Nasdaq under the symbol “ATNF”. We do not intend to apply for a listing of the Pre-Funded Warrants or the Common Warrants on any national securities exchange or other nationally recognized trading system.

 

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The number of shares of ourCommon Stock to be outstanding upon completion of this offering is based on 969,602 shares outstanding as of July __, 2024, does not giveeffect to the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and Common Warrants issued in this offering, andexcludes, as of such date: 

 

  12,954  shares of Common Stock issuable upon the exercise of outstanding stock options;

 

  1,924 additional shares of our Common Stock reserved for future issuance under our 2020 Omnibus Incentive Plan;

 

  87,855  additional shares of our Common Stock reserved for future issuance under our 2022 Omnibus Incentive Plan; and

 

  (a) 15,132 shares of Common Stock issuable upon the exercise of outstanding public warrants exercisable at an exercise price of $4,370.00 per share, (b) 662 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants exercisable at an exercise price of $4,370.00 per share, (c) 6,748 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $1,900.00 per share, (d) 66 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,686.60 per share, (e) 168 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,006.40 per share, (f) 6,579 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,850.00 per share, and (g) 954,118 shares of Common Stock issuable upon the exercise of warrants to purchase 954,118 shares of Common Stock with an exercise price of $3.23 per share.

 

Unless otherwise indicated, all share numbers in this prospectus, includingshares of Common Stock and all securities convertible into, or exercisable for, shares of Common Stock, give effect to the Reverse StockSplits.

 

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RiskFactors

 

Investingin shares of our Common Stock involves a high degree of risk. Before making an investment decision, you should carefully consider andevaluate the risks described below and in the “Risk Factors” section in our most recent Annual Report on Form 10-K, as wellas any updates to those risk factors in our subsequent Quarterly Reports on Form 10-Q, together with all of the other information appearingin or incorporated by reference into this prospectus, before deciding whether to purchase any of the Common Stock being offered. Therisks described in these documents are not the only ones we face, but those that we consider to be material. There may be other unknownor unpredictable economic, business, competitive, regulatory or other factors that could have material adverse effects on our futureresults. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. Thetrading price of shares of our Common Stock could decline due to any of these risks, and you may lose all or part of your investment.Please also read carefully the section entitled “Cautionary Note Regarding Forward-Looking Statements.” The riskfactors described below and incorporated by reference herein are not necessarily exhaustive and you are encouraged to perform your owninvestigation with respect to us and our business.

 

RisksRelated to This Offering

 

You willexperience immediate and substantial dilution in the net tangible book value per share of the Common Stock you purchase. You may alsoexperience future dilution as a result of future equity offerings.

 

The priceper share, together with the number of shares of our Common Stock we propose to issue and ultimately will issue if this offering is completed,may result in an immediate decrease in the market price of our Common Stock. Our historical net tangible book value as of March 31, 2024was $(2,541,258), or approximately $(2.98) per share of our Common Stock. After giving effect to the _____ shares of our Common Stockto be sold in this offering at a public offering price of $_____ per share (assuming a public offering price equal to the last saleprice of our Common Stock as reported by Nasdaq on July __, 2024, which was $_____ per share) and assuming exercise of the Pre-FundedWarrants in this offering for _____ shares of Common Stock, our as adjusted net tangible book value as of March 31, 2024 would have been$_____, or approximately $_____ per share of our Common Stock. This represents an immediate increase in the net tangible book value of$_____ per share of our Common Stock to our existing stockholders and an immediate dilution in net tangible book value of approximately$_____ per share of our Common Stock to new investors, representing the difference between the public offering price and our as adjustednet tangible book value as of March 31, 2024, after giving effect to this offering, and the public offering price per share. Furthermore,if outstanding options or warrants are exercised, you could experience further dilution.

 

In addition,we have a number of stock options and warrants outstanding, and, in order to raise additional capital, we may in the future offer additionalshares of our Common Stock or other securities convertible into or exchangeable for our Common Stock at prices that may not be the sameas the price per share in this offering. In the event that the outstanding options or warrants are exercised or settled, or that we makeadditional issuances of Common Stock or other convertible or exchangeable securities, you could experience additional dilution. We cannotassure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greaterthan the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future couldhave rights superior to existing stockholders, including investors who purchase shares of Common Stock in this offering. The price pershare at which we sell additional shares of our Common Stock or securities convertible into Common Stock in future transactions, maybe higher or lower than the price per share in this offering. As a result, purchasers of the shares we sell, as well as our existingstockholders, will experience significant dilution if we sell at prices significantly below the price at which they invested. See thesection entitled “Dilution” below for a more detailed illustration of the dilution you would incur if you participatedin this offering.

 

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Resalesof our Common Stock in the public market during this offering by our stockholders may cause the market price of our Common Stock to fall.

 

Sales ofa substantial number of shares of our Common Stock could occur at any time. The issuance of new shares of our Common Stock could resultin resales of our Common Stock by our current stockholders concerned about the potential ownership dilution of their holdings. In turn,these resales could have the effect of depressing the market price for our Common Stock.

 

Wewill have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

 

We currentlyintend to use the net proceeds from the offering of securities under this prospectus for research and development expenses, and generalcorporate purposes, transaction costs to complete a reverse-merger and legal expenses, as described in the section of this prospectusentitled “Use of Proceeds.” We will have broad discretion in the application of the net proceeds in the category ofgeneral corporate purposes and investors will be relying on the judgment of our management regarding the application of the proceedsof this offering.

 

Theprecise amount and timing of the application of these proceeds, if any, will depend upon a number of factors, such as the timing andprogress of efforts to complete a strategic transaction, our research and development efforts, our funding requirements and the availabilityand costs of other funds. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the netproceeds to us from this offering. Depending on the outcome of our efforts and other unforeseen events, our plans and priorities maychange and we may apply the net proceeds of this offering in different manners than we currently anticipate.

 

Thefailure by our management to apply these funds effectively could harm our business, financial condition and results of operations. Pendingtheir use, we may invest the net proceeds from this offering in short-term, interest-bearing instruments. These investments may not yielda favorable return to our stockholders.

 

Thisoffering may cause the trading price of our Common Stock to decrease.

 

Theprice per share, together with the number of shares of Common Stock we propose to issue and ultimately will issue if this offering iscompleted, may result in an immediate decrease in the market price of our Common Stock. This decrease may continue after the completionof this offering.

 

Thereis no public market for the Pre-Funded Warrants and Common Warrants being offered in this offering.

 

Thereis no established public trading market for the Pre-Funded Warrants and Common Warrants being offered in this offering, and we do notexpect a market to develop. In addition, we do not intend to apply to list the Pre-Funded Warrants and Common Warrants on any securitiesexchange or nationally recognized trading system. Without an active market, the liquidity of the Pre-Funded Warrants and Common Warrantswill be limited.

 

Holdersof our Pre-Funded Warrants and Common Warrants will have no rights as common stockholders until they acquire our Common Stock.

 

Untilyou acquire shares of Common Stock upon exercise of your Pre-Funded Warrants or the Common Warrants, you will have no rights with respectto the shares of Common Stock issuable upon exercise of your Common Warrants. Upon exercise of your Pre-Funded Warrants or the CommonWarrants, you will be entitled to exercise the rights of a holder of shares only as to matters for which the record date occurs afterthe exercise date.

 

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Ifwe do not maintain a current and effective prospectus relating to the Common Stock issuable upon exercise of the Pre-Funded Warrantsand Common Warrants, holders will only be able to exercise such Pre-Funded Warrants and Common Warrants on a “cashless basis.”

 

Ifwe do not maintain a current and effective prospectus relating to the shares of Common Stock issuable upon exercise of the Pre-FundedWarrants or the Common Warrants at the time that holders wish to exercise such warrants, they will only be able to exercise them on a“cashless basis,” and under no circumstances would we be required to make any cash payments or net cash settle such warrantsto the holders. As a result, the number of shares of Common Stock that holders will receive upon exercise of the Pre-Funded Warrantsor the Common Warrants will be fewer than it would have been had such holders exercised their Pre-Funded Warrants or the Common Warrantsfor cash. Under the terms of the Pre-Funded Warrants or the Common Warrants, we have agreed to use our reasonable best efforts to maintaina current and effective prospectus relating to the shares of Common Stock issuable upon exercise of such warrants until the expirationof such warrants. However, we cannot assure you that we will be able to do so. If we are unable to do so, the potential “upside”of the holder’s investment in our company may be reduced.

 

ThePre-Funded Warrants and the Common Warrants are speculative in nature.

 

ThePre-Funded Warrants and Common Warrants offered hereby do not confer any rights of Common Stock ownership on their holders, such as votingrights or the right to receive dividends, but rather merely represent the right to acquire shares of Common Stock at a fixed price. Specifically,commencing on the date of issuance, holders of the Pre-Funded Warrants may acquire the Common Stock issuable upon exercise of such warrantsat an exercise price of $0.0001 per share and holders of the Common Warrants may acquire the Common Stock issuable upon exercise of suchwarrants at an exercise price per share equal to the public offering price of shares of Common Stock in this offering. Moreover, followingthis offering, the market value of the Pre-Funded Warrants and the Common Warrants is uncertain, and there can be no assurance that themarket value of the Pre-Funded Warrants or the Common Warrants will equal or exceed their public offering price.

 

TheCommon Warrants may not have any value.

 

EachCommon Warrant has an exercise price per share equal to the public offering price of shares of Common Stock in this offering and expireson the fifth anniversary of its original issuance date. In the event the market price per share of Common Stock does not exceed the exerciseprice of the Common Warrants during the period when the Common Warrants are exercisable, the Common Warrants may not have any value.

 

Thisis a reasonable best efforts offering, in which no minimum number or dollar amount of securities is required to be sold, and we may notraise the amount of capital we believe is required for our 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 ouroperations. Thus, we may not raise the amount of capital we believe is required for our operations in the short-term and may need toraise additional funds to complete such short-term operations. Such additional fundraises may not be available or available on termsacceptable to us.

 

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ThePlacement Agent is offering the shares on a “reasonable best efforts” basis, and the Placement Agent is under no obligationto purchase any shares for its own account. The Placement Agent is not required to sell any specific number or dollar amount of sharesof Common Stock in this offering but will use its reasonable best efforts to sell the securities offered in this prospectus. As a “reasonablebest efforts” offering, there can be no assurance that the offering contemplated hereby will ultimately be consummated.

 

RisksRelated to Our Business Operations

 

Ourbusiness, financial condition and results of operations are subject to various risks and uncertainties, including those described below.This section discusses factors that, individually or in the aggregate, could cause our actual results to differ materially from expectedand historical results. Our business, financial condition or results of operations could be materially adversely affected by any of theserisks. It is not possible to predict or identify all such factors. Consequently, the following description of Risk Factors is not a completediscussion of all potential risks or uncertainties applicable to our business.

 

Ourcurrent cash balance is only expected to be sufficient to fund our planned business operations through approximately October 2024. Ifadditional capital is not available, we may not be able to pursue our planned business operations, may be forced to change our plannedbusiness operations, or may take other actions that could adversely impact our stockholders, including seeking bankruptcy protection.

 

Weare a clinical stage biotechnology company that currently has no revenue. Thus, our business does not generate the cash necessary tofinance our planned business operations. We will require significant additional capital to: (i) develop FDA and/or MHRA-approvedproducts and commercialize such products; (ii) fund research and development activities relating to, and obtain regulatory approvalfor, our product candidates; (iii) protect our intellectual property; (iv) attract and retain highly-qualified personnel; (v) respondeffectively to competitive pressures; and (vi) acquire complementary businesses or technologies.

 

Ourfuture capital needs depend on many factors, including: (i) the scope, duration and expenditures associated with our research, developmentand commercialization efforts; (ii) continued scientific progress in our programs; (iii) the outcome of potential partneringor licensing transactions, if any; (iv) competing technological developments; (v) our proprietary patent position; and (vi) theregulatory approval process for our products.

 

Wewill need to raise substantial additional funds through public or private equity offerings, debt financings or strategic alliances andlicensing arrangements to finance our planned business operations. We may not be able to obtain additional financing on terms favorableto us, if at all. General market conditions, rising interest rates and inflation, as well as global conflicts such as the ongoing conflictbetween Ukraine and Russia, and Israel and Hamas, may make it difficult for us to seek financing from the capital markets, and the termsof any financing may adversely affect the holdings or the rights of our stockholders. For example, if we raise additional funds by issuingequity securities, further dilution to our stockholders will result, which may substantially dilute the value of their investment. Anyequity financing may also have the effect of reducing the conversion or exercise price of our outstanding convertible or exercisablesecurities, which could result in the issuance (or potential issuance) of a significant number of additional shares of our CommonStock. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superiorto those of existing stockholders. Debt financing, if available, may involve restrictive covenants that could limit our flexibility toconduct future business activities and, in the event of insolvency, could be paid before holders of equity securities received any distributionof our assets. We may be required to relinquish rights to our technologies or product candidates, or grant licenses through alliance,joint venture or agreements on terms that are not favorable to us, in order to raise additional funds. If adequate funds are not available,we may have to delay, reduce or eliminate one or more of our planned activities with respect to our business, or terminate our operations,or may be forced to seek bankruptcy protection. These actions would likely reduce the market price of our Common Stock.

 

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Wewill need additional capital which may not be available on commercially acceptable terms, if at all, which raises questions about ourability to continue as a going concern.

 

Asof March 31, 2024, we had an accumulated deficit of $128,413,401 and a working capital deficit of $2,225,359, and for the three monthsended March 31, 2024, we had a net loss of $1,069,744. As of December 31, 2023, we had an accumulated deficit of $127,343,657 and a workingcapital deficit of $1,422,710, and for the year ended December 31, 2023, a net loss of $19,935,112 and cash used in operating activitiesfor the year ended December 31, 2023, of $10,922,223. As of July 15, 2024, we had cash on hand of approximately $0.8 million. The ConsolidatedFinancial Statements incorporated by reference herein have been prepared assuming we will continue as a going concern. As we are notgenerating revenues, we need to raise a significant amount of capital in order to pay our debts and cover our operating costs. Whilewe recently raised funds through the sale of equity in July 2022 (approximately $6.5 million of gross proceeds), December 2022 (approximately$6.0 million of gross proceeds), April 2023 (approximately $3.0 million of gross proceeds), August 2023 (approximately $3.0 million)and November 2023 (approximately $0.8 million), there is no assurance that we will be able to raise additional needed capital or thatsuch capital will be available under favorable terms.

 

Weare subject to all the substantial risks inherent in the development of a new business enterprise within an extremely competitive industry.Due to the absence of a long-standing operating history and the emerging nature of the markets in which we compete, we anticipate operatinglosses until we can successfully implement our business strategy, which includes all associated revenue streams. We may never achieveprofitable operations or generate significant revenues.

 

Wecurrently have a monthly cash requirement spend of approximately $250,000. We believe that in the aggregate, we will require significantadditional capital funding to support and expand the research and development and marketing of our products, fund future clinical trials,repay debt obligations, provide capital expenditures for additional equipment and development costs, payment obligations, office spaceand systems for managing the business, and cover other operating costs until our planned revenue streams from products are fully-implementedand begin to offset our operating costs, if ever.

 

Sinceour inception, we have funded our operations with the proceeds from equity and debt financing. We have experienced liquidity issues dueto, among other reasons, our limited ability to raise adequate capital on acceptable terms. We have historically relied upon the saleof equity and debt funding that is convertible into shares of our Common Stock to fund our operations and have devoted significant effortsto reduce that exposure. We anticipate that we will need to issue equity to fund our operations and fund our operating expenses for theforeseeable future. If we are unable to achieve operational profitability or we are not successful in securing other forms of financing,we will have to evaluate alternative actions to reduce our operating expenses and conserve cash.

 

Theseconditions raise substantial doubt about our ability to continue as a going concern. The Consolidated Financial Statements included hereinhave been prepared in accordance with accounting principles generally accepted in the United States on a going concern basis, which contemplatesthe realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, the Consolidated FinancialStatements included herein do not include any adjustments relating to the recoverability of assets and classification of liabilitiesthat might be necessary should we be unable to continue as a going concern. The Consolidated Financial Statements included herein alsoinclude a going concern footnote.

 

Additionally,wherever possible, our board of directors (“Board of Directors” or “Board”) will attempt touse non-cash consideration to satisfy obligations. In many instances, we believe that the non-cash consideration will consist of restrictedshares of our Common Stock, preferred stock or warrants to purchase shares of our Common Stock. Our Board has authority, without actionor vote of the stockholders, but subject to Nasdaq rules and regulations (which generally require stockholder approval for any transactionswhich would result in the issuance of more than 20% of our then outstanding shares of Common Stock or voting rights representing over20% of our then outstanding shares of stock, subject to certain exceptions), to issue all or part of the authorized but unissued sharesof Common Stock, preferred stock or warrants to purchase such shares of Common Stock. In addition, we may attempt to raise capital byselling shares of our Common Stock, possibly at a discount to market in the future. These actions will result in dilution of the ownershipinterests of existing stockholders, may further dilute Common Stock book value, and that dilution may be material. Such issuances mayalso serve to enhance existing management’s ability to maintain control of us, because the shares may be issued to parties or entitiescommitted to supporting existing management.

 

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Wewill need to raise additional capital, which may not be available on favorable terms, if at all, causing dilution to our stockholders,restricting our operations or adversely affecting our ability to operate our business.

 

Wemay not be able to obtain additional financing on terms favorable to us, if at all, including as a result of macroeconomic conditionssuch as a severe or prolonged economic downturn. Disruption, uncertainty or volatility in the capital markets could increase our costof capital or limit our ability to raise funds needed to operate our business. Disruptions could be caused by Federal Reserve policiesand actions, currency concerns, inflation, economic downturn or uncertainty, monetary policies, failures of financial institutions, U.S.debt management concerns, and U.S. debt limit and budget disputes, including government shutdowns, European and worldwide sovereign debtconcerns, other global or geopolitical events, or other factors. Current macroeconomic conditions have negatively impacted the U.S. bankingsector, including for example, the recent closures and FDIC receiverships of Silicon Valley Bank and Signature Bank. Although we do nothave any accounts at or business relationships with these banks, we may be negatively impacted by other disruptions to the U.S. bankingsystem caused by these or similar developments.

 

Wehave significant and increasing liquidity needs and require additional funding.

 

Researchand development, management and administrative expenses, including legal expenses, and cash used for operations will continue to be significantand may increase substantially in the future in connection with new research and development initiatives, clinical trials, continuedproduct commercialization efforts and the launch of our future product candidates. We will need to raise additional capital to fund ouroperations, continue to conduct clinical trials to support potential regulatory approval of marketing applications, and to fund commercializationof our future product candidates.

 

Theamount and timing of our future funding requirements will depend on many factors, including, but not limited to:

 

  the timing of FDA and/or MHRA approval, if any, and approvals in other international markets of our future product candidates, if at all;

 

  the timing and amount of revenue from sales of our products, or revenue from grants or other sources;

 

  the rate of progress and cost of our clinical trials and other product development programs;

 

  costs of establishing or outsourcing sales, marketing and distribution capabilities;

 

  costs and timing of any outsourced growing and commercial manufacturing supply arrangements for our future product candidates;

 

  costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our future product candidates;

 

  the effect of competing technological and market developments;

 

  personnel, facilities and equipment requirements; and

 

  the terms and timing of any additional collaborative, licensing, co-promotion or other arrangements that we may establish.

 

Whilewe expect to fund our future capital requirements from a number of sources, including the proceeds from further public and/or privateofferings, we cannot assure you that any of these funding sources will be available to us on favorable terms, or at all. Further, evenif we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet our future capital requirements.

 

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OurLicense Agreements with the University of Oxford and other licensors may be terminated in certain circumstances without our consent.

 

Allof our License Agreements with the University of Oxford and other licensors remain subject to various conditions and covenants, and providefor certain termination rights to the licensors. Those agreements typically allow termination by the licensor for our failure to payamounts due timely, our failure to cure a material breach under the terms of the applicable license agreement, and our insolvency. Asa result, if we are deemed insolvent, or in the event we seek bankruptcy protection, the licensors of our license agreements may terminatetheir license agreements with us. In the event such license agreements are terminated, we could lose the right to develop all of ourplatforms and technologies, may lose any investments made towards developing such platforms and technologies, and may be left withoutany intellectual property, product pathways, or development opportunities. Such terminations may result in the value of our securitiesdeclining in value or becoming worthless, the need for us to change our business plan, and may result in the Company seeking bankruptcyprotection.

 

Weowe a significant amount of money to the University of Oxford, which funds we do not have. The university may take action against usto enforce their rights to payment in the future, which could have a material adverse effect on us and our operations.

 

Dueto recent financial constraints, the Company has been unable to timely pay amounts due to the University of Oxford (“Oxford”),the licensor of the majority of the Company’s licenses and patents and the Company’s research partner. Oxford alleges thatan aggregate of approximately $1.3 million is owed from the Company and one of its subsidiaries to Oxford under the terms of licensesand agreements with Oxford and related parties. The Company is currently in ongoing discussions with Oxford to reduce that amount andenter into a payment plan with regards to the amounts owed; however, no definitive terms or extensions have been agreed to date. Oxfordhas also notified the Company that it is not willing to discuss any new projects or arrangements until all outstanding invoices havebeen paid or a payment plan has been agreed to; has engaged a law firm to seek the collection of the amounts owed, together with interest;and has threatened legal proceedings against us. While we are hopeful that we can come to mutually agreeable terms regarding a settlement,payment plan, and/or extension, with Oxford, we may not have sufficient funds to pay amounts due to Oxford in the near term, if at all,and Oxford may take action against us, including filing legal proceedings against us seeking amounts due and interest, attempting toterminate their relationship with us, and/or filing a wind-up petition against one of the Company’s subsidiaries in the U.K. IfOxford were to take legal action against us or terminate their relationship with us, we may be forced to scale back our business planand/or seek bankruptcy protection. We may be subject to litigation and damages for our failure to pay amounts due to Oxford, and maybe forced to pay interest and penalties, which funds we do not currently have. We plan to seek to raise funding in the future to supportour operations, and to pay amounts due to Oxford, through a combination of equity offerings, debt financing or other capital sources,including potentially collaborations, licenses and other similar arrangements, which may not be available on favorable terms, if at all.The sale of additional equity or debt securities, if accomplished, may result in dilution to our then stockholders. Additionally, inDecember 2023, we engaged A.G.P./Alliance Global Partners as financial advisor to explore and evaluate strategic alternatives to enhanceshareholder value. Potential strategic alternatives that may be explored or evaluated by the Company as part of this process include,but are not limited to, an acquisition, merger, reverse merger, other business combination, sale of assets, licensing or other strategictransactions involving the Company. The Company does not intend to discuss or disclose further developments during this process unlessand until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate. Thereis no assurance that the strategic review process will result in the approval or completion of any specific transaction or outcome.

 

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Wemay enter into strategic transactions in the future which may result in a material change in our operations and/or a change of control.

 

InDecember 2023, we engaged A.G.P./Alliance Global Partners as financial advisor to explore and evaluate strategic alternatives to enhanceshareholder value. Potential strategic alternatives that may be explored or evaluated by the Company as part of this process include,but are not limited to, an acquisition, merger, reverse merger, other business combination, sale of assets, licensing or other strategictransactions involving the Company. The Company does not intend to discuss or disclose further developments during this process unlessand until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate. Thereis no assurance that the strategic review process will result in the approval or completion of any specific transaction or outcome.

 

TheBoard of Directors and management team are committed to acting in the best interests of the Company, its stockholders and its stakeholders.There is no deadline or definitive timetable set for completion of the strategic alternatives review process and there can be no assurancethat this process will result in the Company pursuing a transaction or any other strategic outcome.

 

Asa result of the above, in the future, we may enter into transactions with parties seeking to merge and/or acquire us and/or our operations.While we have not entered into any agreements or understandings with any such parties to date, in the event that we do enter into sucha transaction or transactions in the future, new shares of Common Stock or preferred stock could be issued resulting in substantial dilutionto our then current stockholders and/or a change of control. As a result, our new majority stockholders may change the composition ofour Board of Directors and may replace our current management. Any future transaction may also result in a change in our business focus.We have not entered into any agreements relating to any strategic transaction involving the Company as of the date of this Report andmay not enter into such agreements in the future. Any future strategic transaction involving the Company or its operations may have amaterial effect on our operations, cash flows, results of operations, prospects, plan of operations, the listing of our Common Stockon Nasdaq, our officers, directors and majority stockholder(s), and the value of our securities.

 

Wemay not receive any further amount under our pre-merger directors’ and officers’ insurance policy in connection with certainlitigation matters.

 

OnJune 29, 2022, AmTrust International Underwriters DAC (“AmTrust”), which was the premerger directors’ and officers’insurance policy underwriter for KBL, filed a declaratory relief action against us in the U.S. District Court for the Northern Districtof California (the “Declaratory Relief Action”) seeking declaration of AmTrust’s obligations under thedirectors’ and officers’ insurance policy. In the Declaratory Relief Action, AmTrust is claiming that as a result of themerger, we are no longer the insured under the subject insurance policy, notwithstanding the fact that the fees which we seek to recoverfrom AmTrust relate to matters occurring prior to the merger.

 

OnApril 21, 2023, the Court issued an Order Granting in Part and Denying in Part the Company’s Motion for Partial Summary Judgment.Specifically, the Court granted summary adjudication in favor of the Company on the following issues: (a) that the Company is, infact, an insured under both the AmTrust and Freedom insurance policies; (b) that certain SEC subpoena related expenses for defendantsDr. Marlene Krauss, the Company’s former Chief Executive Officer and Director, and George Hornig, the former Chairman of the Board,are within the basic scope of coverage under both the AmTrust and Freedom insurance policies; and (c) that the Insured vs. Insuredexclusion relied upon by AmTrust and Freedom is not applicable to bar any such coverage.

 

TheCourt also found that there were issues of disputed facts as to the Change in Control exclusion contained within the policies, whichtherefore precluded the Court from granting the remainder of the Company’s requests for summary adjudication as a matter of law.Accordingly, the Court, at this time, denied the Company’s further requests for summary adjudication and deemed that for the timebeing, the Change in Control issue is to be determined at the time of trial, in order to find that the policies provide (i) coveragefor the fees which the Company has advanced and will advance to Dr. Marlene Krauss and George Hornig; (ii) that AmTrust has breachedthe policy; (iii) that AmTrust must pay such expenses of the Company; and that, once the AmTrust policy has been exhausted, (iv) thatFreedom will be obligated to pay such expenses of the Company pursuant to its policy.

 

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OnAugust 4, 2023, the Court granted the Company’s request to file a second motion for partial summary judgment in this case, thisone being on the issue of whether AmTrust should be required to advance to the Company the defense costs being incurred by Dr. MarleneKrauss and George Hornig during the pendency of the case. The Company filed such Motion for Partial Summary Judgment, and it has nowbeen fully briefed by the parties. The hearing for such motion was held on January 11, 2024, After the matter was taken under submission,on February 12, 2024, the Court granted the Company’s Motion for Partial Summary Judgment against both AmTrust and Freedom, andordered as follows: (a) AmTrust is obligated under its insurance policy with the Company to advance to the Company all defense costsin excess of the deductible that the Company has advanced, or will advance, to Dr. Krauss and Mr. Hornig in connection with certain SECSubpoenas, and (b) upon exhaustion of the AmTrust insurance policy, Freedom is obligated to do the same pursuant to its excess liabilityinsurance policy with the Company. This Order applies throughout the interim of the case, but does not constitute a final judgment, andboth the Company and the two insurers retain their rights to contest all applicable issues at trial, which is scheduled for May 12, 2025.A final judgment following trial could potentially confirm these obligations of the insurers or, alternatively, reverse and require theCompany to repay all or portions of such advance payments. There is no assurance at this time as to what the final judgment may entail.

 

OnApril 16, 2024, AmTrust paid the Company $2.27 million in reimbursement of fees which the Company has advanced to Dr. Marlene Kraussand George Hornig, of which the Company received $1.5 million after the payment of attorney’s fees. On May 9, 2024, AmTrustpaid the Company $300,140 in reimbursement of fees which the Company had advanced to Dr. Marlene Krauss and George Hornig, of whichthe Company has received $200,093 after the payment of attorney’s fees.

 

Whilethe Company continues to believe it has a strong case against both AmTrust and Freedom and believes the Court ruling in its favor inregards to the matters discussed above is a significant positive outcome for the Company, there can be no assurance that the Companywill prevail in this action or whether the Company will receive the reimbursement of any fees or other amounts.

 

Ifwe make any acquisitions, they may disrupt or have a negative impact on our business.

 

Ifwe make acquisitions in the future, funding permitting, which may not be available on favorable terms, if at all, we could have difficultyintegrating the acquired company’s assets, personnel and operations with our own. We do not anticipate that any acquisitions ormergers we may enter into in the future would result in a change of control of the Company. In addition, the key personnel of the acquiredbusiness may not be willing to work for us. We cannot predict the effect expansion may have on our core business. Regardless of whetherwe are successful in making an acquisition, the negotiations could disrupt our ongoing business, distract our management and employeesand increase our expenses. In addition to the risks described above, acquisitions are accompanied by a number of inherent risks, including,without limitation, the following:

 

  the difficulty of integrating acquired products, services or operations;

 

  the potential disruption of the ongoing businesses and distraction of our management and the management of acquired companies;

 

  difficulties in maintaining uniform standards, controls, procedures and policies;

 

  the potential impairment of relationships with employees and customers as a result of any integration of new management personnel;

 

  the potential inability or failure to achieve additional sales and enhance our customer base through cross-marketing of the products to new and existing customers;

 

  the effect of any government regulations which relate to the business acquired;

 

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  potential unknown liabilities associated with acquired businesses or product lines, or the need to spend significant amounts to retool, reposition or modify the marketing and sales of acquired products or operations, or the defense of any litigation, whether or not successful, resulting from actions of the acquired company prior to our acquisition; and

 

  potential expenses under the labor, environmental and other laws of various jurisdictions.

 

Ourbusiness could be severely impaired if and to the extent that we are unable to succeed in addressing any of these risks or other problemsencountered in connection with an acquisition, many of which cannot be presently identified. These risks and problems could disrupt ourongoing business, distract our management and employees, increase our expenses and adversely affect our results of operations.

 

Claims,litigation, government investigations, and other proceedings may adversely affect our business and results of operations.

 

Weare currently subject to, and expect to continue to be regularly subject to, actual and threatened claims, litigation, reviews, investigations,and other proceedings. In addition, we have filed lawsuits against certain parties for matters we discovered which related to KBL, priorto the November 6, 2020, business combination. Any of these types of proceedings may have an adverse effect on us because of legal costs,disruption of our operations, diversion of management resources, negative publicity, and other factors. The outcomes of these mattersare inherently unpredictable and subject to significant uncertainties. Determining legal reserves and possible losses from such mattersinvolves judgment and may not reflect the full range of uncertainties and unpredictable outcomes. Until the final resolution of suchmatters, we may be exposed to losses in excess of the amount recorded, and such amounts could be material. Should any of our estimatesand assumptions change or prove to have been incorrect, it could have a material effect on our business, consolidated financial position,results of operations, or cash flows. In addition, it is possible that a resolution of one or more such proceedings, including as a resultof a settlement, could require us to make substantial future payments, prevent us from offering certain products or services, requireus to change our business practices in a manner materially adverse to our business, requiring development of non-infringing or otherwisealtered products or technologies, damaging our reputation, or otherwise having a material effect on our operations.

 

RisksRelating to our Common Stock

 

Themarket price of our Common Stock has been extremely volatile and may continue to be volatile due to numerous circumstances beyond ourcontrol.

 

Themarket price of our Common Stock has fluctuated, and may continue to fluctuate, widely, due to many factors, some of which may be beyondour control. These factors include, without limitation:

 

  “short squeezes”;

 

  comments by securities analysts or other third parties, including blogs, articles, message boards and social and other media;

 

  large stockholders exiting their position in our securities or an increase or decrease in the short interest in our securities;

 

  actual or anticipated fluctuations in our financial and operating results;

 

  changes in foreign currency exchange rates;

 

  the commencement, enrollment or results of our planned or future clinical trials of our product candidates or those of our competitors;

 

  the success of competitive drugs or therapies;

 

  regulatory or legal developments in the U.S. and other countries;

 

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  the success of competitive products or technologies;

 

  developments or disputes concerning patent applications, issued patents or other proprietary rights;

 

  the recruitment or departure of key personnel;

 

  the level of expenses related to our product candidates or clinical development programs;

 

  litigation matters, including amounts which may or may not be recoverable pursuant to our officer and director insurance policies, regulatory actions affecting the Company and the outcome thereof;

 

  the results of our efforts to discover, develop, acquire or in-license additional product candidates;

 

  actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

 

  our inability to obtain or delays in obtaining adequate drug supply for any approved drug or inability to do so at acceptable prices;

 

  disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

 

  significant lawsuits, including patent or stockholder litigation;

 

  variations in our financial results or those of companies that are perceived to be similar to us;

 

  changes in the structure of healthcare payment systems, including coverage and adequate reimbursement for any approved drug;

 

  market conditions in the pharmaceutical and biotechnology sectors;

 

  general economic, political, and market conditions and overall fluctuations in the financial markets in the U.S. and abroad; and

 

  investors’ general perception of us and our business.

 

Stockmarkets in general and our stock price in particular have recently experienced extreme price and volume fluctuations that have oftenbeen unrelated or disproportionate to the operating performance of those companies and our company. For example, during 2022, the closingsales prices of our Common Stock ranged from a post-split adjusted high of $1,482.04 per share to a low of $23.56 per share and duringfiscal 2023, the closing sales prices of our Common Stock ranged from a high of $100.70 per share to a low of $3.21 per share. Duringthis time, we do not believe that we have experienced any material changes in our financial condition or results of operations that wouldexplain such price volatility or trading volume; however, we have sold equity which was dilutive to existing stockholders. These broadmarket fluctuations may adversely affect the trading price of our securities. Additionally, these and other external factors have causedand may continue to cause the market price and demand for our Common Stock to fluctuate substantially, which may limit or prevent ourstockholders from readily selling their shares of our Common Stock and may otherwise negatively affect the liquidity of our Common Stock.

 

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Informationavailable in public media that is published by third parties, including blogs, articles, message boards and social and other media mayinclude statements not attributable to us and may not be reliable or accurate.

 

Weare aware of a large volume of information being disseminated by third parties relating to our operations, including in blogs, messageboards and social and other media. Such information as reported by third parties may not be accurate, may lead to significant volatilityin our securities and may ultimately result in our Common Stock or other securities declining in value.

 

Theexercise of our outstanding options and warrants, and the sale of Common Stock upon exercise thereof, may adversely affect the tradingprice of our securities.

 

Asof July [   ], 2024, we had (i) outstanding stock options to purchase an aggregate of 12,954 shares of Common Stock ata weighted average exercise price of $708.29 per share; and (ii) outstanding warrants to purchase 983,473 shares of Common Stockat a weighted average exercise price of $105.93 per share. For the life of the options and warrants, the holders have the opportunityto profit from a rise in the market price of our Common Stock without assuming the risk of ownership. The issuance of shares upon theexercise of outstanding securities will also dilute the ownership interests of our existing stockholders.

 

Theavailability of these shares for public resale, as well as any actual resales of these shares, could adversely affect the trading priceof our Common Stock. We cannot predict the size of future issuances of our Common Stock pursuant to the exercise of outstanding optionsor warrants or conversion of other securities, or the effect, if any, that future issuances and sales of shares of our Common Stock mayhave on the market price of our Common Stock. Sales or distributions of substantial amounts of our Common Stock (including shares issuedin connection with an acquisition), or the perception that such sales could occur, may cause the market price of our Common Stock todecline.

 

Inaddition, the Common Stock issuable upon exercise/conversion of outstanding convertible securities may represent overhang that may alsoadversely affect the market price of our Common Stock. Overhang occurs when there is a greater supply of a company’s stock in themarket than there is demand for that stock. When this happens the price of our stock will decrease, and any additional shares which stockholdersattempt to sell in the market will only further decrease the share price. If the share volume of our Common Stock cannot absorb sharessold by holders of our outstanding convertible securities, then the value of our Common Stock will likely decrease.

 

Ouroutstanding public warrants are significantly out of the money.

 

EachPublic Warrant entitles the holder to purchase one-seven hundred sixtieth of one share of Common Stock at an exercise price of $5.75per 1/760th of one share ($4,370.00 per whole share), subject to adjustment. No fractional shares will be issued uponexercise of the Public Warrants. The Public Warrants became exercisable 12 months from the closing of the IPO and expire five years afterthe completion of the Business Combination (November 6, 2025). The Public Warrants are significantly out of the money and because nofractional shares will be issued upon exercise of the Public Warrants, the Public Warrants are only exercisable in multiples of 760.As a result, the Public Warrants may not have any significant value. Additionally, warrant holders not holding at least 760 Public Warrantsor who hold Public Warrants which would be exercisable for a fractional share of Common Stock, must sell any warrants to obtain valuefrom the fractional interest. As a result, the trading of the Public Warrants may be limited or sporadic, and such Public Warrants maynot have any significant value. Any holder of Public Warrants holding less than 760 Public Warrants or a number of Public Warrants notevenly divisible by 760 will not receive any Common Stock upon the exercise of Public Warrants, as no fractional shares of Common Stockare issuable upon exercise thereof.

 

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Asignificant number of our shares are eligible for sale and their sale or potential sale may depress the market price of our Common Stockand cause significant dilution to existing stockholders.

 

Salesof a significant number of shares of our Common Stock in the public market could harm the market price of our Common Stock. Most of ourCommon Stock is available for immediate resale in the public market, including (a) options to purchase 12,954 shares of Common Stockwith a weighted average exercise price of $708.29 per share; and (b) warrants to purchase 987,473 shares of Common Stock with aweighted average exercise price of $105.93 per share. If a significant number of shares were sold, such sales would increase the supplyof our Common Stock, thereby potentially causing a decrease in its price. The exercise of outstanding convertible securities will alsocause significant dilution to existing stockholders and will likely cause the per-share value of our Common Stock to decline, possiblysignificantly. Some or all of our shares of Common Stock may be offered from time to time in the open market pursuant to effective registrationstatements and/or compliance with Rule 144, which sales could have a depressive effect on the market for our shares of Common Stock.Subject to certain restrictions, a person who has held restricted shares for a period of six months may generally sell Common Stock intothe market. The sale of a significant portion of such shares when such shares are eligible for public sale may cause the value of ourCommon Stock to decline in value.

 

Theremay not be sufficient liquidity in the market for our securities in order for investors to sell their shares. The market price of ourCommon Stock may continue to be volatile.

 

Themarket price of our Common Stock will likely continue to be highly volatile. Some of the factors that may materially affect the marketprice of our Common Stock are beyond our control, such as conditions or trends in the industry in which we operate or sales of our CommonStock. This situation is attributable to a number of factors, including the fact that we are a small company which is relatively unknownto stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume,and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven companysuch as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable.

 

Asa consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as comparedto a mature issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverseeffect on share price. It is possible that a broader or more active public trading market for our Common Stock will not develop or besustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our Common Stock,regardless of our performance. In addition, the public stock markets have experienced extreme price and trading volume volatility. Thisvolatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operatingperformance of the specific companies. These broad market fluctuations may adversely affect the market price of our Common Stock.

 

Weface significant penalties and damages in the event registration statements we have previously filed to register certain securities soldin our prior offerings are subsequently suspended or terminated.

 

Pursuantto certain prior private offerings of securities, we entered into registration rights agreements which required us to file certain registrationstatements to register the resale of the privately sold shares and certain securities issuable upon exercise/conversion thereof, andto maintain the effectiveness of such registration statements for certain periods of time. To date, all such required registration statementshave been declared effective by the SEC. However, in the event the registration statements are subsequently suspended or terminated,or we otherwise fail to meet certain requirements set forth in the registration rights agreements, we could be required to pay significantpenalties which could adversely affect our cash flow and cause the value of our securities to decline in value.

 

Weare not in compliance with the continued listing standards of Nasdaq and Nasdaq has provided a delisting determination letter; we maynot be able to comply with Nasdaq’s continued listing standards in the future, and as a result our Common Stock and Public Warrantsmay be delisted from Nasdaq.

 

OurCommon Stock and Public Warrants trade on Nasdaq under the symbols “ATNF” and “ATNFW,” respectively. Notwithstandingsuch listing, there can be no assurance any broker will be interested in trading our securities. Therefore, it may be difficult to sellour securities publicly. There is also no guarantee that we will be able to maintain our listings on Nasdaq for any period of time byperpetually satisfying Nasdaq’s continued listing requirements.

 

Wehave previously been out of compliance with Nasdaq’s continued listing requirements due to our failure to maintain a minimum bidprice of at least $1.00 per share for our Common Stock, which failure was remedied in March 2024.

 

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Also,on October 11, 2023, the Company received written notice from Nasdaq notifying the Company that it was not in compliance with the shareholderapproval requirements set forth in Nasdaq Listing Rule 5635(d), which require prior shareholder approval for transactions, other thanpublic offerings, involving the issuance of 20% or more of the pre-transaction shares outstanding at less than the applicable MinimumPrice (as defined in Listing Rule 5635(d)(1)(A)), which non-compliance we remedied in December 2023.

 

Additionally,on November 15, 2023, the Company received a letter from Nasdaq notifying the Company that it was not in compliance with the minimumstockholders’ equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) (the “Rule”)requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000. In the Company’sQuarterly Report on Form 10-Q for the quarter ended September 30, 2023, the Company reported a stockholders’ deficit of ($149,327),which is below the minimum stockholders’ equity required for continued listing pursuant to the Rule. Additionally, the Companydoes not meet the alternative Nasdaq continued listing standards under Nasdaq Listing Rules and did not meet the minimum stockholders’equity requirement as of December 31, 2023 or March 31, 2024.

 

Nasdaqprovided the Company until January 2, 2024 to submit to Nasdaq a plan to regain compliance. We submitted the plan to regain compliancein a timely manner, and on January 11, 2024, Nasdaq advised the Company that it has determined to grant the Company an extension to regaincompliance with the Rule.

 

Theterms of the extension were as follows: on or before May 13, 2024, the Company must have completed certain transactions described ingreater detail in the compliance plan, contemplated to result in the Company increasing its stockholders’ equity to more than $2.5million, and opt for one of the two following alternatives to evidence compliance with the Rule: Alternative 1: The Company must havefurnished to the SEC and Nasdaq a publicly available report (e.g., a Form 8-K) including: 1. A disclosure of the Staff’s deficiencyletter and the specific deficiency(ies) cited; 2. A description of the completed transaction or event that enabled the Company to satisfythe stockholders’ equity requirement for continued listing; and 3. An affirmative statement that, as of the date of the report,the Company believed it had regained compliance with the stockholders’ equity requirement based upon the specific transaction orevent referenced in Step 2; or Alternative 2: The Company must furnish to the SEC and Nasdaq a publicly available report including: 1.Steps 1 & 2 set forth above; 2. A balance sheet no older than 60 days with pro forma adjustments for any significant transactionsor event occurring on or before the report date; and 3. That the Company believes it satisfies the stockholders’ equity requirementas of the report date. The pro forma balance sheet must have evidenced compliance with the stockholders’ equity requirement.

 

Additionally,in either case the Company was required to disclose that Nasdaq will continue to monitor the Company’s ongoing compliance withthe stockholders’ equity requirement and, if at the time of its next periodic report the Company does not evidence compliance,that it may be subject to delisting.

 

Whilethe Company was able to undertake some of the transactions described in the compliance plan, it was unable to regain compliance withthe Rule prior to the end of the plan period (May 13, 2024). As a result, on May 14, 2024, the Company received a delist determinationletter from the Staff advising the Company that the Staff had determined that the Company did not meet the terms of the extension. Specifically,the Company did not complete its proposed transactions and was unable to file a Current Report Form 8-K by the May 13, 2024 deadlinepreviously required by the Staff, evidencing compliance with the Rule. As a result, unless the Company requests an appeal of the Staff’sdetermination, trading of the Company’s Common Stock will be suspended at the opening of business on May 23, 2024, and a Form 25-NSEwill be filed with the SEC, which will remove the Company’s Common Stock and public warrants from listing and registration on TheNasdaq Stock Market.

 

OnMay 17, 2024, the Company requested an appeal of the Staff’s delisting determination, and on May 20, 2024, the Staff advised theCompany that the delisting action referenced in the Staff’s determination letter was stayed, pending the final written decisionby the Hearings Panel.

 

TheCompany subsequently received notice that the Hearings Panel determined to grant the Company’s request to continue its listingon Nasdaq, subject to the Company meeting certain conditions, including filing on or before July 31, 2024, a public disclosure describingthe transactions undertaken by the Company to achieve compliance with Nasdaq’s continued listing rules and demonstrate long-termcompliance with the Rule and providing an indication of its equity following those transactions.

 

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Therecan be no assurance that the Company will be able to regain compliance with the applicable Nasdaq listing requirements or meet the requirementsof the Hearing Panel. If the Company’s Common Stock and public warrants are delisted, it could be more difficult to buy or sellthe Company’s Common Stock and public warrants or to obtain accurate quotations, and the price of the Company’s Common Stockand public warrants could suffer a material decline. Delisting could also impair the Company’s ability to raise capital and/ortrigger defaults and penalties under outstanding agreements or securities of the Company.

 

TheCompany is continuing to work towards completing the necessary transactions in an effort to achieve compliance with the Rule and is currentlyevaluating various courses of action to regain compliance with the Rule. However, there can be no assurance that the Company will beable to complete the transactions necessary to regain compliance with the Rule.

 

Separately,on May 14, 2024, the Staff provided us notice of our non-compliance with the audit committee requirements for continued listing on Nasdaqset forth in Listing Rule 5605(c)(2), which requires that listed companies maintain an audit committee of at least three independentdirectors. Nasdaq provided the Company a cure period in order to regain compliance as follows: until the earlier of the Company’snext annual shareholders’ meeting or May 7, 2025; or if the next annual shareholders’ meeting is held before November 4,2024, then the Company must evidence compliance no later than November 4, 2024. In the event the Company does not regain compliance bythe applicable date above, Nasdaq rules require the Staff to provide written notification to the Company that its securities will bedelisted. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company is currently seeking outqualified independent directors to serve on the Company’s audit committee and expects to regain compliance with Listing Rule 5605(c)(2)in the near future.

 

Evenif we demonstrate compliance with the requirements of Nasdaq, we will have to continue to meet other objective and subjective listingrequirements to continue to be listed on The Nasdaq Capital Market. Delisting from The Nasdaq Capital Market could make trading our CommonStock and Public Warrants more difficult for investors, potentially leading to declines in our share price and liquidity. Without a NasdaqCapital Market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our Common Stock and PublicWarrants, the sale or purchase of our Common Stock and Public Warrants would likely be made more difficult, and the trading volume andliquidity of our Common Stock and Public Warrants could decline. Delisting from The Nasdaq Capital Market could also result in negativepublicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affectthe acceptance of our Common Stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incuradditional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit themarket liquidity of our Common Stock and Public Warrants and the ability of our stockholders and warrant holders to sell our Common Stockand Public Warrants in the secondary market. If our Common Stock and Public Warrants are delisted by Nasdaq, our Common Stock and PublicWarrants may be eligible to trade on an over-the-counter quotation system, such as the OTCQB Market or the OTC Pink market, where aninvestor may find it more difficult to sell our Common Stock and Public Warrants or obtain accurate quotations as to the market valueof our Common Stock and Public Warrants. In the event our Common Stock and Public Warrants are delisted from The Nasdaq Capital Market,we may not be able to list our Common Stock on another national securities exchange or obtain quotation on an over-the counter quotationsystem.

 

Stockholdersmay be diluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of additional sharesof our Common Stock.

 

Whereverpossible, our Board will attempt to use non-cash consideration to satisfy obligations. In many instances, we believe that the non-cashconsideration will consist of restricted shares of our Common Stock or where shares are to be issued to our officers, directors and applicableconsultants. Our Board of Directors has authority, without action or vote of the stockholders, but subject to Nasdaq rules and regulations(which generally require stockholder approval for any transactions which would result in the issuance of more than 20% of our then outstandingshares of Common Stock or voting rights representing over 20% of our then outstanding shares of stock, subject to certain exceptions),to issue all or part of the authorized but unissued shares of Common Stock. In addition, we may attempt to raise capital by selling sharesof our Common Stock, possibly at a discount to market. These actions will result in dilution of the ownership interests of existing stockholders,which may further dilute Common Stock book value, and that dilution may be material. Such issuances may also serve to enhance existingmanagement’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supportingexisting management.

 

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Incorporationby Reference

 

TheSEC allows us to “incorporate by reference” into this prospectus the information in other documents that we file with it.This means that we can disclose important information to you by referring you to those documents. The information incorporated by referenceis considered to be a part of this prospectus, and information in documents that we file later with the SEC will automatically updateand supersede information contained in documents filed earlier with the SEC or contained in this prospectus. We incorporate by referencein this prospectus the documents listed below and any future filings that we may make with the SEC under Sections 13(a), 13(c), 14, or15(d) of the Exchange Act prior to the termination of the offering under this prospectus; provided, however, that we are not incorporating,in each case, any documents or information deemed to have been furnished and not filed in accordance with SEC rules:

 

  (a) The Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 25, 2024, as amended by Amendment No. 1 thereto filed with the SEC on April 29, 2024 (File No. 001-38105) (as amended, the “Annual Report”);

 

  (b) The Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 15, 2024 (File No. 001-38105);
     
  (c) The Company’s Current Reports on Form 8-K (other than information furnished rather than filed) filed with the SEC on January 16, 2024January 17, 2024January 29, 2024February 16, 2024February 20, 2024February 26, 2024February 28, 2024February 29, 2024March 1, 2024March 8, 2024March 11, 2024March 14, 2024April 19, 2024, May 9, 2024, May 15, 2024, May 21, 2024 and July 2, 2024 (File No. 001-38105); and

 

  (d) The description of the Company’s Common Stock contained in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, as Exhibit 4.6 (File No. 001-38105), including any amendment or report filed for the purpose of updating such description.

 

Additionally,all documents filed by us with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after (i) the date of the initialfiling of this registration statement and prior to effectiveness of the registration statement, and (ii) the date of this prospectusand before the termination or completion of any offering hereunder, shall be deemed to be incorporated by reference into this prospectusfrom the respective dates of filing of such documents, except that we do not incorporate any document or portion of a document that is“furnished” to the SEC, but not deemed “filed.”

 

Wewill provide, without charge, to each person to whom a copy of this prospectus is delivered, including any beneficial owner, upon thewritten or oral request of such person, a copy of any or all of the documents incorporated by reference herein, including exhibits. Requestsshould be directed to: Attention: Corporate Secretary, 3000 El Camino Real, Bldg. 4, Suite 200, Palo Alto, California 94306, telephone(650) 507-0669 . The documents incorporated by reference may be accessed on the “Investors”—“SEC Filings”—“AllSEC Filings” page of our website at www.180lifesciences.com. We do not incorporate the information on our website into this prospectusor any supplement to this prospectus and you should not consider any information on, or that can be accessed through, our website aspart of this prospectus or any supplement to this prospectus (other than those filings with the SEC that we specifically incorporateby reference into this prospectus or any supplement to this prospectus).

 

Anystatement contained in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed modified,superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus modifies, supersedesor replaces such statement.

 

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Useof Proceeds

 

Weestimate the net proceeds to us from this offering will be approximately $        million, after deductingthe placement agent fees and estimated offering expenses payable to us. We intend to use the net proceeds from the offering of securitiesunder this prospectus for research and development expenses, and general corporate purposes, transaction costs to complete a reverse-merger,and legal expenses.

 

Theseexpected uses represent our intentions based upon our current plans and business conditions, which could change in the future as ourplans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerousfactors, including the progress of our development, the status of and results from clinical trials, and any unforeseen cash needs. Asa result, our management will have broad discretion in the application of the net proceeds from this offering, and investors will berelying on the judgment of our management regarding the application of the net proceeds from this offering. The timing and amount ofour actual expenditures will be based on many factors, including cash flows from operations and the anticipated growth of our business. 

 

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Capitalization

 

Thefollowing table sets forth our capitalization as of March 31, 2024 on:

 

an actual basis; and

 

  on an as adjusted basis to reflect the issuance and sale of Common Stock in this offering, after deducting placement agent fees and estimated offering expenses payable by us. The as-adjusted basis assumes no Pre-Funded Warrants are sold in this offering and excludes the proceeds, if any, from the exercise of any Common Warrants issued in this offering.

 

Youshould read this table in conjunction with the section of this prospectus entitled “Use of Proceeds” and “Management’sDiscussion and Analysis of Financial Condition and Results of Operations” and our Consolidated Financial Statements and therelated notes thereto incorporated by reference into this prospectus.

 

   As of March 31, 2024 
   Actual   As-adjusted 
Cash  $675,977   $                 
Total debt   788,878      
Stockholders’ Equity          
Class C Preferred Stock; 1 share authorized, issued and outstanding         
Class K Preferred Stock; 1 share authorized, issued and outstanding         
Common Stock, $0.0001 par value; 100,000,000 shares authorized; 852,772, and [______________] shares issued and outstanding at March 31, 2024, on an actual, and an as adjusted basis, respectively   86      
Additional paid-in capital   130,353,728      
Accumulated other comprehensive (loss) income   (2,894,879)     
Accumulated deficit   (128,413,401)     
Total stockholders’ deficit   (954,466)     
Total capitalization  $(165,588)  $  

 

Theabove discussion and table are based on 852,772 shares of our Common Stock outstanding as of March 31, 2024 and assumes the exerciseof the Pre-Funded Warrants. The number of shares outstanding as of March 31, 2024 excludes, as of such date:

 

 

12,954 shares of Common Stock issuable upon the exercise of outstanding stock options;

 

  1,924 additional shares of our Common Stock reserved for future issuance under our 2020 Omnibus Incentive Plan;

 

  204,685  additional shares of our Common Stock reserved for future issuance under our 2022 Omnibus Incentive Plan; and

 

  (a) 15,132 shares of Common Stock issuable upon the exercise of outstanding public warrants exercisable at an exercise price of $4,370.00 per share, (b) 662 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants exercisable at an exercise price of $4,370.00 per share, (c) 6,748 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $1,900.00 per share, (d) 66 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,686.60 per share, (e) 168 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,006.40 per share, (f) 6,579 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,850.00 per share, and (g) 954,118 shares of Common Stock issuable upon the exercise of warrants to purchase 954,118 shares of Common Stock with an exercise price of $3.23 per share.

 

26

 

 

Dilution

 

Ifyou purchase our Common Stock (or equivalent) in this offering, your interest will be diluted to the extent of the difference betweenthe public offering price per share and the net tangible book value per share of our Common Stock after this offering. We calculate nettangible book value per share by dividing our net tangible assets (tangible assets less total liabilities) by the number of shares ofour Common Stock issued and outstanding as of March 31, 2024.

 

Ournet tangible book value as of March 31, 2024 was $(2,541,258), or approximately $(2.98) per share. After giving effect to the sale ofour Common Stock in this offering at a public offering price of $      per share and assuming exercise of thePre-Funded Warrants in this offering for        shares of Common Stock, our as adjusted net tangiblebook value as of March 31, 2024 would have been $       , or approximately $        per share of our Common Stock. This represents an immediate increase in the net tangible book value of $         per share of our Common Stock to our existing stockholders and an immediate dilution in net tangible book value of approximately $         per share of our Common Stock to new investors. The following table illustrates this per share dilution: 

 

Public offering price per share of our Common Stock         $    
Net tangible book value per share as of March 31, 2024   $ (2.98 )      
Increase in net tangible book value per share of our Common Stock attributable to this offering   $          
As adjusted net tangible book value per share of our Common Stock as of March 31, 2024, after giving effect to this offering         $    
Dilution per share to new investors purchasing shares of our Common Stock in this offering         $    

 

27

 

 

The above discussion and table are based on 852,772 shares of our CommonStock outstanding as of March 31, 2024, and assumes the exercise of the Pre-Funded Warrants. The number of shares outstanding as of March31, 2024, excludes, as of such date:

 

 

12,954 shares of Common Stock issuable upon the exercise of outstanding stock options;

 

  1,924 additional shares of our Common Stock reserved for future issuance under our 2020 Omnibus Incentive Plan;

 

  204,685 additional shares of our Common Stock reserved for future issuance under our 2022 Omnibus Incentive Plan; and

 

  (a) 15,132 shares of Common Stock issuable upon the exercise of outstanding public warrants exercisable at an exercise price of $4,370.00 per share, (b) 662 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants exercisable at an exercise price of $4,370.00 per share, (c) 6,748 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $1,900.00 per share, (d) 66 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,686.60 per share, (e) 168 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,006.40 per share, (f) 6,579 shares of Common Stock issuable upon the exercise of certain outstanding private placement warrants at an exercise price of $2,850.00 per share, and (g) 954,118 shares of Common Stock issuable upon the exercise of warrants to purchase 954,118 shares of Common Stock with an exercise price of $3.23 per share.

 

Exceptas otherwise indicated, all information in this prospectus assumes no exercise or forfeiture of the outstanding options or warrants afterMarch 31, 2024, including, for the avoidance of doubt, any Common Warrants but not the Pre-Funded Warrants, which are assumed will beexercised for purposes of the above dilution calculation. 

 

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DividendPolicy

 

Wehave never paid or declared any cash dividends on our Common Stock and do not anticipate paying cash dividends in the foreseeable future.We anticipate that we will retain all of our future earnings for use in the operation of our business and for general corporate purposes.Any determination to pay dividends in the future will be at the discretion of our Board. Accordingly, investors must rely on sales oftheir Common Stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments.

 

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Planof Distribution

 

________has agreed to act as our exclusive placement agent in connection with this offering subject to the terms and conditions of the placementagent agreement dated                 , 2024. ThePlacement Agent is not purchasing or selling any of the securities offered by this prospectus, nor is it required to arrange the purchaseor sale of any specific number or dollar amount of securities, but has agreed to use its reasonable best efforts to arrangefor the sale of all of the securities offered hereby. Therefore, we may not sell the entire amount of securities offered pursuant tothis prospectus. We will enter into a securities purchase agreement directly with certain investors, at the investor’s option,who purchase our securities in this offering. Investors who do not enter into a securities purchase agreement shall rely solely on thisprospectus in connection with the purchase of our securities in this offering.

 

Wewill deliver the securities being issued to the investors upon receipt of such investor funds for the purchase of the securities offeredpursuant to this prospectus. We expect to deliver the securities being offered pursuant to this prospectus on or about              ,2024.

 

Wehave agreed to indemnify the Placement Agent against specified liabilities, including liabilities under the Securities Act, and to contributeto payments the Placement Agent may be required to make in respect thereof.

 

Feesand Expenses

 

Wehave engaged ________ as our exclusive placement agent in connection with this offering. This offering is being conducted on a “reasonable bestefforts” basis and the Placement Agent has no obligation to buy any of the securities from us or to arrange for the purchase orsale of any specific number or dollar amount of securities. We have agreed to pay the Placement Agent a fee based on the aggregate proceedsas set forth in the table below:

 

    Per Share
and
Common
Warrant
    Per Pre-
Funded
Warrant and
Common
Warrant
    Total  
Public offering price   $              $             $        
Placement agent fees(1)   $       $       $    
Proceeds, before expenses, to us(2)   $       $       $    

 

(1) We have agreed to pay the Placement Agent a cash placement commission equal to __% of the aggregate proceeds from this offering. We have also agreed to reimburse the Placement Agent for certain expenses incurred in connection with this offering.
 
(2) The amount of the offering proceeds to us presented in this table does not give effect to any exercise of the Pre-Funded Warrants or Common Warrants being issued in this offering.

 

Wehave also agreed to reimburse the Placement Agent at closing for legal and other out-of-pocket expenses incurred by them in connectionwith this offering in an aggregate amount up to $_____________, as well as non-accountable expenses which shall not exceed $______, including,but not limited to, IPREO software related expenses, background check(s), tombstones, marketing related expenses (i.e., roadshow, travel,clearing expenses, et al.) and any other expenses incurred by the Placement Agent in connection with this offering. We estimate the totalexpenses payable by us for this offering, excluding the placement agent fees and expenses, will be approximately $500,000.

 

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ThePlacement Agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissionsreceived by it and any profit realized on the resale of the shares sold by it while acting as principal might be deemed to be underwritingdiscounts or commissions under the Securities Act. As an underwriter, the Placement Agent would be required to comply with the requirementsof the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 andRegulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares by the PlacementAgent acting as principal. Under these rules and regulations, the Placement Agent:

 

  may not engage in any stabilization activity in connection with our securities; and
 
  may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation in the distribution.

 

Listing

 

OurCommon Stock is listed on Nasdaq under the trading symbol “ATNF.” We do not intend to list the Pre-Funded Warrants or theCommon Warrants on any securities exchange or nationally recognized trading system.

 

Lock-UpAgreements

 

Ourdirectors and executive officers have agreed to enter into lock-up agreements. Under these agreements, these individuals have agreed,subject to specified exceptions, not to sell or transfer any shares of Common Stock or securities convertible into, or exchangeable orexercisable for, our shares of Common Stock during a period ending 90 days after the completion of this offering, without first obtainingthe written consent of the investors. Specifically, these individuals have agreed, in part, not to:

 

  sell, offer, contract or grant any option to sell (including any short sale), pledge, transfer, establish an open “put equivalent position” within the meaning of Rule 16a-l(h) under the Securities Exchange Act of 1934, as amended;
     
  enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of our securities, whether any such transaction is to be settled by delivery of our shares of Common Stock, in cash or otherwise;
     
  make any demand for or exercise any right with respect to the registration of any of our securities;
     
  publicly disclose the intention to make any offer, sale, pledge or disposition, or to enter into any transaction, swap, hedge; or
     
  other arrangement relating to any of our securities.

 

Notwithstandingthese limitations, these shares of Common Stock may be transferred under limited circumstances, including, without limitation, by gift,will or intestate succession.

 

Inaddition, we have agreed that, subject to certain exceptions, (i) we will not conduct any issuances of our Common Stock for a periodof 90 days following closing of this offering and that (ii) we will not enter into a variable rate transaction for a period of 6 monthsfollowing the closing of this offering.

 

DiscretionaryAccounts

 

ThePlacement Agent does not intend to confirm sales of the securities offered hereby to any accounts over which it has discretionary authority.

 

OtherActivities and Relationships

 

ThePlacement Agent and certain of its affiliates are full service financial institutions engaged in various activities, which may includesecurities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment,hedging, financing and brokerage activities. The Placement Agent and certain of its affiliates have, from time to time, performed, andmay in the future perform, various commercial and investment banking and financial advisory services for us and our affiliates, for whichthey received or will receive customary fees and expenses.

 

Inthe ordinary course of their various business activities, the Placement Agent and certain of its affiliates may make or hold a broadarray of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (includingbank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involvesecurities and/or instruments issued by us and our affiliates. If the Placement Agent or its affiliates have a lending relationship withus, they routinely hedge their credit exposure to us consistent with their customary risk management policies. The Placement Agent andits affiliates may hedge such exposure by entering into transactions that consist of either the purchase of credit default swaps or thecreation of short positions in our securities or the securities of our affiliates, including potentially the Common Stock offered hereby.Any such short positions could adversely affect future trading prices of the Common Stock offered hereby. The Placement Agent and certainof its affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or expressindependent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire,long and/or short positions in such securities and instruments.

 

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Descriptionof Capital Stock

 

AuthorizedCapital Stock

 

Thefollowing summary of the material terms of our capital stock is not intended to be a complete summary of the rights and preferences ofsuch securities. We urge you to read our Certificate of Incorporation, as amended in its entirety for a complete description of the rightsand preferences of our securities.

 

Asof the date of this prospectus, we have 100,000,000 authorized shares of Common Stock, $0.0001 par value per share and 5,000,000 sharesof preferred stock, $0.0001 par value per share, of which 1,000,000 shares have been designated as Series A Convertible Preferred Stock(of which none are outstanding), of which one share of preferred stock has been designated as a Class C Special Voting Share, of whichnone are outstanding, and one share of preferred stock has been designated as a Class K Special Voting Share, of which none are outstanding.

 

Asthe date of this prospectus, there were 969,602 shares of Common Stock outstanding held by 122 holders of record, and no shares of preferredstock issued or outstanding.

 

CommonStock

 

Exceptas otherwise required by law or as otherwise provided in any certificate of designation for any series of preferred stock, the holdersof our Common Stock possess all voting power for the election of our directors and all other matters requiring stockholder action andwill at all times vote together as one class on all matters submitted to a vote of our stockholders. Holders of Common Stock are entitledto one vote per share on matters to be voted on by stockholders and do not have the right to cumulate votes in the election of directors.

 

Holdersof Common Stock will be entitled to receive dividends and other distributions, if any, in amounts declared from time to time by our Boardof Directors in its discretion out of funds legally available therefor and shall share equally on a per share basis in these dividendsand distributions.

 

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In the event of our voluntaryor involuntary liquidation, dissolution, distribution of assets or winding-up, the holders of the Common Stock will be entitled to receivean equal amount per share of all of our assets of whatever kind available for distribution to stockholders, after the rights of the holdersof the preferred stock, if any, have been satisfied.

 

Our stockholders have no preemptiveor other subscription rights and there are no sinking fund or redemption provisions applicable to our Common Stock.

 

Our Board of Directors isdivided into two classes, with only one class of directors being elected in each year and each class generally serving a two-year term.

 

Preferred Stock

 

Our Certificate of Incorporationprovides that shares of preferred stock may be issued from time to time in one or more series. Our Board of Directors will be authorizedto fix the voting rights, if any, designations, powers, preferences, the relative, participating, optional or other special rights andany qualifications, limitations and restrictions thereof, applicable to the shares of each series. Our Board of Directors will be ableto, without stockholder approval, issue preferred stock with voting and other rights that could adversely affect the voting power andother rights of the holders of the Common Stock and could have anti-takeover effects. The ability of our Board of Directors to issue preferredstock without stockholder approval could have the effect of delaying, deferring or preventing a change of control of the Company or theremoval of existing management.

 

Stock Exchange Listing

 

Our Common Stock is currentlylisted on Nasdaq under the symbol “ATNF”.

 

Stock Exchange Listing

 

The transfer agent and registrarfor our Common Stock is Continental Stock Transfer & Trust Company.

 

Certain Anti-Takeover Provisions of DelawareLaw and our Certificate of Incorporation and Bylaws

 

We are subject to the provisionsof Section 203 of the Delaware General Corporation Law (the “DGCL”) regulating corporate takeovers. This statute preventscertain Delaware corporations, under certain circumstances, from engaging in a “business combination” with:

 

  a stockholder who owns 15% or more of our outstanding voting stock (otherwise known as an “interested stockholder”);

 

  an affiliate of an interested stockholder; or

 

  an associate of an interested stockholder, for three years following the date that the stockholder became an interested stockholder.

 

A“business combination” includes a merger or sale of more than 10% of our assets. However, the above provisions of Section203 do not apply if:

 

  our Board of Directors approves the transaction that made the stockholder an “interested stockholder,” prior to the date of the transaction;

 

  after the completion of the transaction that resulted in the stockholder becoming an interested stockholder, that stockholder owned at least 85% of our voting stock outstanding at the time the transaction commenced, other than statutorily excluded shares of Common Stock; or

  

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  on or subsequent to the date of the transaction, the business combination is approved by our Board of Directors and authorized at a meeting of our stockholders, and not by written consent, by an affirmative vote of at least two-thirds of the outstanding voting stock not owned by the interested stockholder.

 

Our Certificate of Incorporationprovides that our Board of Directors be classified into two classes of directors. As a result, in most circumstances, a person can gaincontrol of our Board of Directors only by successfully engaging in a proxy contest at two or more annual meetings.

 

Our authorized but unissuedCommon Stock and preferred stock are available for future issuances without stockholder approval and could be utilized for a variety ofcorporate purposes, including future offerings to raise additional capital, acquisitions and employee benefit plans. The existence ofauthorized but unissued and unreserved Common Stock and preferred stock could render more difficult or discourage an attempt to obtaincontrol of us by means of a proxy contest, tender offer, merger or otherwise.

 

Securities Eligible for Future Sale

 

Rule 144

 

Pursuant to Rule 144, a personwho has beneficially owned restricted shares of our Common Stock or warrants for at least six months would be entitled to sell their securitiesprovided that (i) such person is not deemed to have been one of our affiliates at the time of, or at any time during the three monthspreceding, a sale and (ii) we are subject to the Exchange Act periodic reporting requirements for at least three months before the saleand have filed all required reports under Section 13 or 15(d) of the Exchange Act during the 12 months (or such shorter period as we wererequired to file reports) preceding the sale.

 

Persons who have beneficiallyowned restricted shares of our Common Stock or warrants for at least six months but who are our affiliates at the time of, or at any timeduring the three months preceding, a sale, would be subject to additional restrictions, by which such person would be entitled to sellwithin any three-month period only a number of securities that does not exceed the greater of:

 

  1% of the total number of shares of Common Stock then outstanding; or

 

  the average weekly reported trading volume of the Common Stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

 

Sales by our affiliates underRule 144 are also limited by manner of sale provisions and notice requirements and to the availability of current public information aboutus.

 

Restrictions on theUse of Rule 144 by Shell Companies or Former Shell Companies

 

Rule 144 is not availablefor the resale of securities initially issued by shell companies (other than business combination related shell companies) or issuersthat have been at any time previously a shell company. However, Rule 144 also includes an important exception to this prohibition if thefollowing conditions are met:

 

  the issuer of the securities that was formerly a shell company has ceased to be a shell company;

 

  the issuer of the securities is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act;

 

  the issuer of the securities has filed all Exchange Act reports and material required to be filed, as applicable, during the preceding 12 months (or such shorter period that the issuer was required to file such reports and materials), other than Form 8-K reports; and

 

  at least one year has elapsed from the time that the issuer filed current Form 10 type information with the SEC reflecting its status as an entity that is not a shell company.

 

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Description ofSecurities We Are Offering

 

Common Stock

 

The material terms and provisionsof our Common Stock are described in the section titled, “Description of Capital Stock” in this prospectus.

 

Pre-Funded Warrants

 

The following summary ofcertain terms and provisions of Pre-Funded Warrants that are being offered hereby is not complete and is subject to, and qualified inits entirety by, the provisions of the Pre-Funded Warrant, the form of which is filed as an exhibit to the registration statement of whichthis prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of Pre-Funded Warrantfor a complete description of the terms and conditions of the Pre-Funded Warrants.

 

Duration and ExercisePrice

 

Each Pre-Funded Warrant offeredhereby will have an assumed initial exercise price of $0.0001 per share. The Pre-Funded Warrants will be immediately exercisable and maybe exercised at any time until the Pre-Funded Warrants are exercised in full. The exercise price and number of shares of Common Stockissuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similarevents affecting our Common Stock and the exercise price, as described in the Pre-Funded Warrant.

 

Exercisability

 

The Pre-Funded Warrants willbe exercisable, at the option of each holder, in whole or in part, by delivering a duly executed exercise notice accompanied by paymentin full for the number of purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (togetherwith its affiliates) may not exercise any portion of the Pre-Funded Warrant to the extent that the holder would own more than 4.99% ofthe outstanding Common Stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us,the holder may increase the amount of ownership of outstanding stock after exercising the holder’s Pre-Funded Warrants up to 9.99%of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determinedin accordance with the terms of the Pre-Funded Warrants. No fractional shares of Common Stock will be issued in connection with the exerciseof a Pre-Funded Warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multipliedby the exercise price.

 

Cashless Exercise

 

In lieu of making the cashpayment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect insteadto receive upon such exercise (either in whole or in part) the net number of shares of Common Stock determined according to a formulaset forth in the Pre-Funded Warrants.

 

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Fundamental Transactions

 

In the event of a fundamentaltransaction, as described in the Pre-Funded Warrants and generally including any reorganization, recapitalization or reclassificationof our Common Stock pursuant to which the shares of Common Stock are converted or exchanged for other securities, cash, or property, thesale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or intoanother person pursuant to which we are not the surviving entity, the acquisition of more than 50% of our outstanding voting securities,the holders of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind and amount of securities,cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamentaltransaction. In addition, the holders of the Pre-Funded Warrants have the right to require us or a successor entity to redeem the Pre-FundedWarrant for the cash paid in the fundamental transaction in the amount of the Black Scholes value of the unexercised portion of the Pre-FundedWarrant on the date of the consummation of the fundamental transaction.

 

Transferability

 

Subject to applicable laws,a Pre-Funded Warrant may be transferred at the option of the holder upon surrender of the Pre-Funded Warrant together with the appropriateinstruments of transfer.

 

Exchange Listing

 

We do not intend to list thePre-Funded Warrants on any securities exchange or nationally recognized trading system.

 

Rights as a Stockholder

 

Except as otherwise providedin the Pre-Funded Warrants or by virtue of such holder’s ownership of, the holders of the Pre-Funded Warrants do not have the rightsor privileges of holders of our Common Stock, including any voting rights, until they exercise their Pre-Funded Warrants.

 

Warrant Agent

 

The Pre-Funded Warrants willbe issued in registered form under a warrant agent agreement between Continental Stock Transfer & Trust Company, as warrant agent,and us. The Pre-Funded Warrants shall initially be represented only by one or more global warrants deposited with the warrant agent, ascustodian on behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwisedirected by DTC.

 

Common Warrants

 

The following summary ofcertain terms and provisions of the Common Warrants that are being offered hereby is not complete and is subject to, and qualified inits entirety by, the provisions of the Common Warrants, the form of which is filed as an exhibit to the registration statement of whichthis prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of Common Warrant fora complete description of the terms and conditions of the Common Warrants.

 

Duration and ExercisePrice

 

Each Common Warrant offeredhas an assumed initial exercise price of $____ per share (assuming an exercise price equal to the reported sales price of our CommonStock on Nasdaq on July __, 2024, which was $____ per share). The Common Warrants will be exercisable six months after their issuanceand will expire on the fifth anniversary of the date on which the Common Warrants become exercisable. The exercise price and number ofshares of Common Stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizationsor similar events affecting our Common Stock and the exercise price, as described in the Common Warrant. Common Warrants will be issuedseparately from the Common Stock and Pre-Funded Warrants and may be transferred separately immediately thereafter. For each share of CommonStock (or Pre-Funded Warrant, as applicable) purchased in this offering, one Common Warrant will be issued. Each whole Common Warrantis exercisable for one share of Common Stock.

 

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Exercisability

 

The Common Warrants will beexercisable, at the option of each holder, in whole or in part, by delivering a duly executed exercise notice accompanied by payment infull for the number of purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (togetherwith its affiliates) may not exercise any portion of the Common Warrant to the extent that the holder would own more than 4.99% of theoutstanding Common Stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, theholder may increase the amount of ownership of outstanding stock after exercising the holder’s Common Warrants up to 9.99% of thenumber of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determinedin accordance with the terms of the Common Warrants. No fractional shares of Common Stock will be issued in connection with the exerciseof a Common Warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multipliedby the exercise price.

 

Cashless Exercise

 

If, at the time a holder exercisesits Common Warrants, a registration statement registering the issuance of the shares of Common Stock underlying the Common Warrants underthe Securities Act is not then effective or available, then in lieu of making the cash payment otherwise contemplated to be made to usupon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in wholeor in part) the net number of shares of Common Stock determined according to a formula set forth in the Common Warrants.

 

Fundamental Transaction

 

In the event of a fundamentaltransaction, as described in the Common Warrants and generally including any reorganization, recapitalization or reclassification of ourCommon Stock pursuant to which the shares of Common Stock are converted or exchanged for other securities, cash, or property, the sale,transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into anotherperson pursuant to which we are not the surviving entity, the acquisition of more than 50% of our outstanding voting securities, the holdersof the Common Warrants will be entitled to receive upon exercise of the Common Warrants the kind and amount of securities, cash or otherproperty that the holders would have received had they exercised the Common Warrants immediately prior to such fundamental transaction.In addition, the holders of the Common Warrants have the right to require us or a successor entity to redeem the Common Warrant for thecash paid in the fundamental transaction in the amount of the Black Scholes value of the unexercised portion of the Common Warrant onthe date of the consummation of the fundamental transaction.

 

Transferability

 

Subject to applicable laws,a Common Warrant may be transferred at the option of the holder upon surrender of the Common Warrant together with the appropriate instrumentsof transfer.

 

Exchange Listing

 

We do not intend to list theCommon Warrants on any securities exchange or nationally recognized trading system.

 

Right as a Stockholder

 

Except as otherwise providedin the Common Warrants or by virtue of such holder’s ownership of, the holders of the Common Warrants do not have the rights orprivileges of holders of our Common Stock, including any voting rights, until they exercise their Common Warrants.

 

Warrant Agent

 

The Common Warrants will beissued in registered form under a warrant agent agreement between Continental Stock Transfer & Trust Company, as warrant agent, andus. The Common Warrants shall initially be represented only by one or more global warrants deposited with the warrant agent, as custodianon behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directedby DTC.

 

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Legal Matters

 

Certain legal matters relatingto the validity of the shares of Common Stock offered by this prospectus will be passed upon for us by The Loev Law Firm, PC, Bellaire,Texas. David M. Loev, the President and sole owner of The Loev Law Firm, PC, beneficially owns less than 1% of the outstanding sharesof our Common Stock.

 

The Placement Agent is beingrepresented in connection with this offering by _____________________.

 

Experts

 

The consolidated financialstatements of 180 Life Sciences Corp. and its subsidiaries as of December 31, 2023 and 2022 and for each of the two years in the periodended December 31, 2023, incorporated by reference in this prospectus, have been so incorporated by reference in reliance on the report,which includes an explanatory paragraph as to 180 Life Sciences Corp.’s ability to continue as a going concern, of Marcum LLP, anindependent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.

 

Where You Can FindMore Information

 

We file annual, quarterlyand current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internetat the SEC’s website at http://www.sec.gov. Copies of certain information filed by us with the SEC are also available, free of charge,on our website at www.180lifesciences.com. Our website is not a part of this prospectus and is not incorporated by reference in this prospectus.

 

This prospectus is part ofa registration statement that we filed with the SEC. This prospectus omits some information contained in the registration statement inaccordance with SEC rules and regulations. You should review the information and exhibits in the registration statement for further informationabout us and our subsidiaries and the securities we are offering. Statements in this prospectus concerning any document we filed as anexhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive and are qualified byreference to these filings. You should review the complete document to evaluate these statements.

 

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Up to _____ Shares of Common Stock

Pre-Funded Warrants to Purchase up to _____Shares of Common Stock

Common Warrants to Purchase up to _____ Sharesof Common Stock

Up to _____ Shares of Common Stock Underlyingthe Pre-Funded Warrants

Up to _____ Shares of Common Stock Underlyingthe Common Warrants

 

 

PROSPECTUS

 

Sole Placement Agent

 

              , 2024

 

 

 

 

PART II
INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 13. Other Expenses of Issuance and Distribution.

 

The following table sets forthall expenses, other than the underwriting discounts and commissions, payable by the registrant in connection with the sale of the CommonStock being registered. All the amounts shown are estimates except the SEC registration fee and the Financial Industry Regulatory Authority,or FINRA, filing fee.

 

SEC registration fee   $ [__]  
FINRA filing fee     *  
Legal fees and expenses     *  
Accounting fees and expenses     *  
Miscellaneous fees and expenses     *  
Total   $ *  

 

*To be provided by amendment.

 

Item 14. Indemnification of Directors and Officers.

 

Section 145 of the DGCL authorizesa court to award, or a corporation’s board of directors to grant, indemnity to directors and officers in terms sufficiently broadto permit such indemnification under certain circumstances for liabilities, including reimbursement for expenses incurred, arising underthe Securities Act.

 

Our Certificate of Incorporationprovides for indemnification of our directors, officers, employees and other agents to the maximum extent permitted by the DGCL, and ourbylaws provide for indemnification of our directors, officers, employees and other agents to the maximum extent permitted by the DGCL.

 

In addition, we have enteredinto indemnification agreements with directors, officers and some employees containing provisions that are in some respects broader thanthe specific indemnification provisions contained in the DGCL. The indemnification agreements will require us, among other things, toindemnify our directors against certain liabilities that may arise by reason of their status or service as directors and to advance theirexpenses incurred as a result of any proceeding against them as to which they could be indemnified.

 

Item 15. Recent Sales of Unregistered Securities.

 

In April 2021, we issued 100shares of our Common Stock to Dr. Jagdeep Nanchahal, a consultant, pursuant to the terms of his consulting agreement, as partial considerationfor a bonus owed to Dr. Nanchahal. We issued such securities without registration under the Securities Act, based on the exemption fromregistration afforded by Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder.

 

On July 30, 2021, we enteredinto a Mutual Release and Settlement Agreement with Alpha Capital Anstalt pursuant to which we issued 395 shares of our Common Stock,and three-year warrants to purchase up to 66 shares of our Common Stock (exercisable at an exercise price of $2,686.60 per share), toAlpha Capital Anstalt. We issued such securities without registration under the Securities Act, based on the exemption from registrationafforded by Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder.

 

In August 2021, we issued14 shares of our Common Stock for director fees due to Donald A. McGovern, Jr., our former lead independent director, in considerationfor services rendered, and 13 shares of our Common Stock for director fees due to Larry Gold, a former independent director, in considerationfor services rendered. We issued such securities without registration under the Securities Act, based on the exemption from registrationafforded by Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder.

 

II-1

 

 

On August 19, 2021, we enteredinto a securities purchase agreement with the purchasers identified on the signature pages thereto pursuant to which we sold to the purchasersan aggregate of 6,579 shares of our Common Stock and warrants to purchase up to an aggregate of 6,579 shares of our Common Stock at acombined purchase price of $2,280.00 per share and accompanying warrant. The offering closed on August 23, 2021. We issued such securitieswithout registration under the Securities Act, based on the exemption from registration afforded by Section 4(a)(2) thereof and/orRule 506(b) of Regulation D promulgated thereunder.

 

On August 23, 2021, at therequest of Prof. Jagdeep Nanchahal, we agreed to issue Prof. Nanchahal 162 shares of our Common Stock in consideration for the remainingportion of a bonus payable based on a $1,140.00 per share price. The shares were issued under our 2020 Omnibus Incentive Plan. We claiman exemption from registration pursuant to Section 4(a)(2) and/or Rule 506 of Regulation D of the Securities Act for such issuance.

 

On April 5, 2023, we enteredinto a placement agent agreement with A.G.P. On April 5, 2023, in connection with the placement agent agreement, we also entered intoa securities purchase agreement pursuant to which we issued and sold, in a private placement, warrants to purchase up to 82,668 sharesof our Common Stock at a purchase price per share (and accompanying warrant) of $36.29 in the concurrent private placement (togetherwith a registered direct offering)(the “April 2023 Offering”). The April 2023 Offering closed on April 10, 2023. Thenet proceeds to us from the offering was approximately $2.7 million, after deducting placement agent fees and expenses and estimated offeringexpenses payable by us. We issued the warrants to purchase up to 82,668 shares of our Common Stock without registration under the SecuritiesAct, based on the exemption from registration afforded by Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgatedthereunder.

 

On November 28, 2023, theCompany entered into Amendment No. 1 to a securities purchase agreement, dated as of August 9, 2023 (the “August 2023 SPA”)with a certain institutional investor (the “Purchaser”)(the “December 2023 SPA Amendment”), pursuantto which (i) the Purchaser agreed to pay an additional $830,769.30 in connection with the repricing of 351,102 shares of Common Stockand pre-funded warrants to purchase up to 207,814 shares of Common Stock, (ii) the Company agreed to issue to the Purchaser (x) pre-fundedwarrants to purchase up to 257,205 shares of Common Stock, with an exercise price of $0.0001 per share (the “December 2023 Pre-FundedWarrants”), and (y) warrants to purchase up to 477,058 shares of Common Stock, with an exercise price of $3.23 per share (the“December 2023 Common Warrants” and, together with the December 2023 Pre-Funded Warrants, the “December 2023Warrants”), and (iii) the Company and the Purchaser agreed to enter into a warrant amendment agreement with the Purchaser, datedNovember 28, 2023 (the “Warrant Amendment Agreement”), whereby the Company agreed to amend the following outstandingwarrants held by the Purchaser: (i) common stock warrants to purchase up to an aggregate of 135,339 shares of common stock (the “December2022 Common Warrants”), previously amended in January 2023, April 2023 and August 2023; (ii) common stock warrants to purchaseup to an aggregate of 16,138 shares of common stock (the “July 2022 Common Warrants”), previously amended in April2023 and August 2023; (iii) common stock warrants to purchase up to an aggregate of 242,915 shares of common stock (the “August2023 Common Warrants”), previously issued on August 14, 2023; and (iv) common stock warrants to purchase up to an aggregate of 82,668shares of common stock (the “April 2023 Common Warrants”) (collectively (i) through (iv), the “Existing CommonWarrants”). Pursuant to the Warrant Amendment Agreement, the Existing Common Warrants were amended (the “Warrant Amendment”),to not be exercisable until the Company obtained stockholder approval for the issuance of certain shares of common stock (“StockholderApproval”), which was received on February 16, 2024, and to be exercisable until the fifth (5th) anniversary of the StockholderApproval on February 16, 2029, and so that they will have an exercise price of $3.23 per share.

 

The warrants and the warrantshares have not been registered under the Securities Act, and were instead offered pursuant to the exemption provided in Section 4(a)(2)under the Securities Act.

 

II-2

 

 

On February 21, 2024, February28, 2024, March 6, 2024 and March 7, 2024, the holder of pre-funded warrants to purchase shares of Common Stock of the Company (i.e.,the December 2023 Pre-Funded Warrants) at an exercise price of $0.0019 per share, exercised warrants to purchase 58,520, 64,684, 72,000and 62,000 shares of Common Stock, respectively, for $111.19, $122.90, $136.80 and $117.80 of cash, respectively, and was issued 58,520,64,684, 72,000 and 62,000 shares of Common Stock upon exercise thereof, respectively. The exercise of the warrants was exempt from registrationpursuant to Section 4(a)(2) of the Securities Act.

 

On March 12, 2024, a holderof Class K Special Voting Shares converted such shares into 14 shares of Common Stock of the Company in a transaction exempt from registrationpursuant to Section 3(a)(9) of the Securities Act. As a result of such conversion, there are no longer any Class K Special Voting Shares.

 

Item 16. Exhibits.

 

No.   Description
1.1   Placement Agent Agreement, dated April 5, 2023, between 180 Life Sciences Corp. and A.G.P./Alliance Global Partners (filed as Exhibit 1.1 to the registrant’s Current Report on Form 8-K filed on April 10, 2023 and incorporated by reference herein).
1.2   Placement Agency Agreement, dated August 9, 2023, by and between 180 Life Sciences Corp. and A.G.P./Alliance Global Partners. (filed as Exhibit 1.1 to the registrant’s Current Report on Form 8-K filed on August 15, 2023 and incorporated by reference herein).
1.3**   Form of Placement Agency Agreement
3.1   Second Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on November 12, 2020 and incorporated by reference herein).
3.2   Certificate of Amendment of Second Amended and Restated Certificate of Incorporation, filed with the Secretary of State of Delaware on December 15, 2022 (filed as Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on December 16, 2022 and incorporated by reference herein).
3.3   Certificate of Amendment of Second Amended and Restated Certificate of Incorporation of 180 Life Sciences Corp., filed with the Secretary of State of Delaware on February 26, 2024 (Filed as Exhibit 3.1 To the Current Report on Form 8-K filed by the registrant on February 28, 2024, and incorporated by reference herein).
3.4   Second Amended and Restated Bylaws of 180 Life Sciences Corp., effective as of September 4, 2023 (filed as Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on September 7, 2023 and incorporated by reference herein).
4.1   Specimen Common Stock Certificate (filed as Exhibit 4.2 to the registrant’s Registration Statement Form S-1 filed on April 26, 2017 and incorporated herein by reference).
4.2   Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934, as amended (filed as Exhibit 4.6 to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Commission on March 31, 2023 and incorporated herein by reference).
4.3   Form of July Common Warrant (filed as Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on July 19, 2022 and incorporated by reference herein).
4.4   Form of December Common Warrant (filed as Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on December 22, 2022 and incorporated by reference herein).
4.5   Amendment No. 1 to the December 2022 Common Warrants, dated January 12, 2023, by and between 180 Life Sciences Corp. and the Selling Stockholder (filed as Exhibit 4.1 to the registrant’s Current Report on Form 8-K filed on January 12, 2023 and incorporated by reference herein).
4.6   Amendment No. 1 to the Warrants, dated April 5, 2023, by and between 180 Life Sciences Corp. and the Selling Stockholder. (filed as Exhibit 10.11 to the registrant’s Quarterly Report on Form 10-Q filed on May 15, 2023 and incorporated by reference herein).
4.7   Form of April Common Warrant (filed as Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on April 10, 2023 and incorporated by reference herein).
4.8   Warrant Agent Agreement for Pre-Funded Warrants and Common Warrants, dated August 14, 2023, by and between 180 Life Sciences Corp. and Continental Stock Transfer & Trust Company. (filed as Exhibit 4.1 to the registrant’s Current Report on Form 8-K filed on August 15, 2023 and incorporated by reference herein).

 

II-3

 

 

4.9   Warrant Amendment Agreement, dated August 9, 2023, by and between the Company and Armistice Capital Master Fund Ltd. (filed as Exhibit 4.4 to the registrant’s Current Report on Form 8-K filed on August 15, 2023 and incorporated by reference herein).
4.10   Form of Warrant Agent Agreement for December 2023 Pre-Funded Warrants and Common Warrants (filed as Exhibit 4.1 to the registrant’s Current Report on Form 8-K filed on November 29, 2023 and incorporated by reference herein).
4.11  

Form of December 2023 Pre-Funded Warrant (included as Annex A to Exhibit 4.10) (filed as Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on November 29, 2023 and incorporated by reference herein).

4.12  

Form of December 2023 Common Warrant (included as Annex B to Exhibit 4.10) (filed as Exhibit 4.3 to the registrant’s Current Report on Form 8-K filed on November 29, 2023 and incorporated by reference herein).

4.13   Warrant Amendment Agreement, dated November 28, 2023, by and between the Company and the Purchaser (filed as Exhibit 4.4 to the registrant’s Current Report on Form 8-K filed on November 29, 2023 and incorporated by reference herein).
4.14**   Form of Pre-Funded Warrant
4.15**   Form of Common Warrant
5.1**   Opinion of The Loev Law Firm, PC
10.1   Registration Rights Agreement among the registrant and certain securityholders (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on June 7, 2017 and incorporated by reference herein).
10.2   Form of Indemnity Agreement (filed as Exhibit 10.8 to the registrant’s Registration Statement Form S-1 filed on April 26, 2017 and incorporated by reference herein).
10.3   Form of Guarantee and Commitment Agreement (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on July 26, 2019 and incorporated herein by reference).
10.4#   180 Life Sciences Corp. 2020 Omnibus Incentive Plan (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on November 12, 2020 and incorporated by reference herein).
10.5#   Form of Stock Option Agreement (Independent Directors August 2021 Grants) (filed as Exhibit 10.9 to the registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2021 filed on August 16, 2021 and incorporated herein by reference).
10.6#   Form of Stock Option Agreement 180 Life Sciences Corp. 2020 Omnibus Incentive Plan (filed as Exhibit 4.2 to the registrant’s Form S-8 filed on September 30, 2021 and incorporated by reference herein).
10.7#   Form of Restricted Stock Grant Agreement and Stock Option Agreement 180 Life Sciences Corp. 2020 Omnibus Incentive Plan (filed as Exhibit 4.3 to the registrant’s Form S-8 filed on September 30, 2021 and incorporated by reference herein).
10.8   Promissory Note, dated March 15, 2019 issued to KBL IV Sponsor LLC (filed as Exhibit 10.13 to the registrant’s Registration Statement Form S-4 filed on November 12, 2019 and incorporated by reference herein).
10.9   Registration Rights Agreement, dated June 12, 2020, by and among the Company and the parties signatory thereto (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on July 2, 2020 and incorporated herein by reference).
10.10   Registration Rights Agreement, dated September 8, 2020, by and among the Company and the parties signatory thereto (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on September 14, 2020 and incorporated herein by reference).
10.11   Amended and Restated Promissory Note, dated September 8, 2020, issued to KBL IV Sponsor LLC (filed as Exhibit 10.24 to the registrant’s Registration Statement on Form S-1 filed on October 19, 2020 and incorporated by reference herein).
10.12#   Employment Agreement, dated July 1, 2020, by and between 180 Life Corp. (f/k/a 180 Life Sciences Corp.) and James N. Woody, M.D., Ph.D. (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on November 12, 2020 and incorporated by reference herein). 

 

II-4

 

 

10.13#   First Amendment to Employment Agreement by and between 180 Life Corp. (f/k/a 180 Life Sciences Corp.) and James N. Woody, M.D., Ph.D. (filed as Exhibit 10.5 to the registrant’s Current Report on Form 8-K filed on November 12, 2020 and incorporated herein by reference). 
10.14   Amendment Agreement dated November 25, 2020 (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on November 27, 2020 and incorporated herein by reference). 
10.15   Registration Rights Agreement dated as of February 23, 2021 by and between 180 Life Sciences Corp. and the purchasers signatory thereto (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on February 24, 2021 and incorporated herein by reference). 
10.16#   Form of Lock-Up Agreement between 180 Life Sciences Corp. and its directors and executive officers (filed as Exhibit 10.5 to the registrant’s Current Report on Form 8-K filed on February 24, 2021 and incorporated herein by reference). 
10.17#   Consultancy Agreement dated February 22, 2021, by and between 180 Life Sciences Corp. and Prof. Jagdeep Nanchahal (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on March 3, 2021 and incorporated herein by reference). 
10.18#   Amended and Restated Employment Agreement dated February 25, 2021 and effective November 6, 2020, by and between 180 Life Sciences Corp. and James N. Woody (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on March 3, 2021 and incorporated herein by reference). 
10.19#   James N. Woody — Stock Option Agreement effective February 26, 2021 (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on March 3, 2021 and incorporated herein by reference). 
10.20#   Employment Agreement dated February 24, 2021, and effective November 6, 2020, by and between 180 Life Sciences Corp. and Ozan Pamir and Amendment and Correction Thereto dated March 1, 2021 (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on March 3, 2021 and incorporated herein by reference). 
10.21#   Ozan Pamir — Stock Option Agreement effective February 26, 2021 (filed as Exhibit 10.5 to the registrant’s Current Report on Form 8-K filed on March 3, 2021 and incorporated herein by reference). 
10.22#   First Amendment to Consultancy Agreement dated March 31, 2021, by and between 180 Life Sciences Corp. and Prof. Jagdeep Nanchahal (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on April 2, 2021 and incorporated herein by reference). 
10.23   Settlement and Mutual Release Agreement dated May 4, 2021 by and between 180 Life Sciences Corp. and EarlyBirdCapital, Inc. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on May 7, 2021 and incorporated herein by reference). 
10.24#   Second Amendment to Employment Agreement dated May 27, 2021, and effective November 6, 2020, by and between 180 Life Sciences Corp. Katexco Pharmaceuticals Corp. and Ozan Pamir (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on May 27, 2021 and incorporated herein by reference). 
10.25#   Form of Director Nominee Offer Letter (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on May 27, 2021 and incorporated herein by reference). 
10.26#   Employment Agreement dated August 21, 2019 between the registrant and Jonathan Rothbard (filed as Exhibit 10.44 to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed on July 9, 2021 and incorporated herein by reference). 
10.27   Mutual Release and Settlement Agreement dated as of July 31, 2021 among Alpha Capital Anstalt and the registrant (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on August 2, 2021 and incorporated herein by reference). 
10.28   Registration Rights Agreement dated as of August 23, 2021 by and between 180 Life Sciences Corp. and the purchasers signatory thereto (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on August 24, 2021 and incorporated herein by reference). 
10.29   Form of Lock-Up Agreement between the 180 Life Sciences Corp. and its directors and executive officers (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on August 24, 2021 and incorporated herein by reference). 
10.30£   Settlement and Mutual Release Agreement dated September 17, 2021, by and between 180 Life Sciences Corp. and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on September 20, 2021 and incorporated herein by reference). 

 

II-5

 

 

10.31   Debt Conversion Agreement dated September 30, 2021, by and between 180 Life Sciences Corp. and Dr. Lawrence Steinman and Sir Marc Feldmann (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on October 5, 2021 and incorporated by reference herein).
10.32#   Consulting Agreement dated November 17, 2021, by and between 180 Life Sciences Corp. and Lawrence Steinman, M.D. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on November 18, 2021 and incorporated by reference herein).
10.33#   First Amendment to Amended and Restated Employment Agreement dated April 27, 2022, between 180 Life Sciences Corp. and James N. Woody, M.D., Ph.D. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on April 28, 2022 and incorporated by reference herein).
10.34#   First Amendment to Employment Agreement dated April 27, 2022, between 180 Life Sciences Corp. and Jonathan Rothbard, Ph.D. (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on April 28, 2022 and incorporated by reference herein).
10.35#   First Amendment to Employment Agreement dated April 27, 2022, between Cannbiorex Pharma Ltd. and Sir Marc Feldmann, Ph.D. (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on April 28, 2022 and incorporated by reference herein).
10.36#   First Amendment to Consulting Agreement dated April 27, 2022, between 180 Life Sciences Corp. and Lawrence Steinman, M.D. (filed as Exhibit 10.5 to the registrant’s Current Report on Form 8-K filed on April 28, 2022 and incorporated by reference herein).
10.37#   Second Amendment to Consulting Agreement dated April 27, 2022, between Cannbiorex Pharma Ltd. and Prof. Jagdeep Nanchahal (filed as Exhibit 10.6 to the registrant’s Current Report on Form 8-K filed on April 28, 2022 and incorporated by reference herein).
10.38#   Second Amendment to Employment Agreement dated May 26, 2022 and effective as of June 1, 2022, between 180 Life Sciences Corp. and James N. Woody, M.D., Ph.D. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on May 26, 2022 and incorporated by reference herein).
10.39#   Second Amendment to Employment Agreement dated May 26, 2022 and effective as of June 1, 2022, between 180 Life Sciences Corp. and Jonathan Rothbard, Ph.D. (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on May 26, 2022 and incorporated by reference herein).
10.40#   Second Amendment to Consulting Agreement dated May 26, 2022 and effective as of June 1, 2022, between 180 Life Sciences Corp. and Lawrence Steinman, M.D (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on May 26, 2022 and incorporated by reference herein).
10.41#   180 Life Sciences Corp. 2022 Omnibus Incentive Plan (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on June 14, 2022 and incorporated by reference herein).
10.42£   Securities Purchase Agreement dated July 17, 2022, by and between 180 Life Sciences Corp. and the Purchaser (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on July 19, 2022 and incorporated by reference herein).
10.43   Warrant Agent Agreement for the July 2022 Common Warrants, dated July 29, 2022, by and between 180 Life Sciences Corp. and Continental Stock Transfer & Trust Company (filed as Exhibit 10.43 to the registrant’s Registration Statement on Form S-1 filed on May 5, 2023 and incorporated by reference herein).
10.44   Form of Lock-Up Agreement (July 2022 Offering) (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on July 19, 2022 and incorporated by reference herein).
10.45£   Securities Purchase Agreement dated December 20, 2022, by and between 180 Life Sciences Corp. and the Purchaser (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on December 22, 2022 and incorporated by reference herein).
10.46   Warrant Agent Agreement for the December 2022 Common Warrants, dated December 22, 2022, by and between 180 Life Sciences Corp. and Continental Stock Transfer & Trust Company (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on December 22, 2022 and incorporated by reference herein).
10.47   Form of Lock-Up Agreement (December 2022 Offering) (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on December 22, 2022 and incorporated by reference herein).

 

II-6

 

 

10.48#   Third Amendment to Consulting Agreement dated December 28, 2022, between 180 Life Sciences Corp., Cannbiorex Pharma Ltd. and Prof. Jagdeep Nanchahal (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on December 29, 2022 and incorporated by reference herein).
10.49#   Amendment to the Warrant Agent Agreement, dated January 13, 2023, by and between 180 Life Sciences Corp. and Continental Stock Transfer & Trust Company (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on January 18, 2023 and incorporated by reference herein).
10.50#   Separation and Release Agreement, dated January 18, 2023, by and between 180 Life Sciences Corp. and Quan Vu (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on January 20, 2023 and incorporated by reference herein).
10.51#   First Amendment to Separation and Release Agreement, dated March 29, 2023, by and between 180 Life Sciences Corp. and Quan Vu (filed as Exhibit 10.59 to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Commission on March 31, 2023 and incorporated herein by reference).
10.52£   Securities Purchase Agreement dated April 10, 2023, by and between 180 Life Sciences Corp. and the Purchaser (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on April 10, 2023 and incorporated by reference herein).
10.53   Warrant Agent Agreement for the April 2023 Common Warrants, dated April 10, 2023 by and between 180 Life Sciences Corp. and Continental Stock Transfer & Trust Company (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on April 10, 2023 and incorporated by reference herein).
10.54   Form of Lock-Up Agreement (April 2023 Offering) (filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on April 10, 2023 and incorporated by reference herein).
10.55#   Third Amendment to Employment Agreement dated April 27, 2023 and effective as of January 1, 2023, between 180 Life Sciences Corp. and James N. Woody, M.D., Ph.D. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on April 28, 2023 and incorporated by reference herein).
10.56#   Third Amendment to Employment Agreement dated April 27, 2023 and effective as of January 1, 2023, between 180 Life Sciences Corp. and Ozan Pamir (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on April 28, 2023 and incorporated by reference herein).
10.57#   Third Amendment to Employment Agreement dated April 27, 2023 and effective as of January 1, 2023, between 180 Life Sciences Corp. and Jonathan Rothbard, Ph.D. (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on April 28, 2023 and incorporated by reference herein).
10.58#   Amended and Corrected Third Amendment to Employment Agreement dated May 9, 2023, between 180 Life Sciences Corp. and Ozan Pamir (filed as Exhibit 10.12 to the registrant’s Current Report on Form 8-K filed on May 15, 2023 and incorporated by reference herein).
10.59#   First Amended and Restated 180 Life Sciences Corp. 2022 Omnibus Incentive Plan (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on July 10, 2023 and incorporated by reference herein).
10.60£   Securities Purchase Agreement dated August 9, 2023, by and between 180 Life Sciences Corp. and the Institutional Investor. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on August 15, 2023 and incorporated by reference herein).
10.61   Form of Lock-Up Agreement (incorporated by reference to Exhibit 10.56 to the Company’s Registration Statement on Form S-1 (File No. 333-272749) filed on June 16, 2023).
10.62#   Form of Stock Option Agreement (First Amended and Restated 2022 Omnibus Incentive Plan) (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on September 7, 2023 and incorporated by reference herein).
10.63   Termination Letter (Oxford License) September 22, 2023 (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on September 28, 2023 and incorporated by reference herein).
10.64£   Amendment No. 1 to the Securities Purchase Agreement, dated November 28, 2023, by and between 180 Life Sciences Corp. and the Purchaser (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on November 29, 2023 and incorporated by reference herein).

 

II-7

 

 

10.65#   Fourth Amendment to Employment Agreement dated January 10, 2024 and effective as of January 1, 2024, between 180 Life Sciences Corp. and James N. Woody, M.D., Ph.D. (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on January 17, 2024 and incorporated by reference herein).
10.66#   Fourth Amendment to Employment Agreement dated January 10, 2024 and effective as of January 1, 2024, between 180 Life Sciences Corp. and Jonathan Rothbard, Ph.D. (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on January 17, 2024 and incorporated by reference herein).
10.67#   Third Amendment to Consulting Agreement dated January 10, 2024 and effective as of January 1, 2024, between 180 Life Sciences Corp. and Lawrence Steinman, M.D. (filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed on January 17, 2024 and incorporated by reference herein).
10.68#   Second Amendment to Consulting Agreement dated January 10, 2024 and effective as of January 1, 2024, between Cannbiorex Pharma Ltd. and Sir Marc Feldmann(filed as Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed on January 17, 2024 and incorporated by reference herein).
10.69#   Offer Letter between 180 Life Science Corp. and Blair Jordan (director) dated February 24, 2024 and effective February 28, 2024 (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on February 29, 2024 and incorporated by reference herein).
10.70#   Offer Letter between 180 Life Science Corp. and Omar Jimenez (director) dated March 4, 2024 and effective March 7, 2024 (filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on March 11, 2024 and incorporated by reference herein).
10.71#   Offer Letter between 180 Life Science Corp. and Ryan L. Smith (director) dated March 5, 2024 and effective March 7, 2024 (filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on March 11, 2024 and incorporated by reference herein).
10.72#   Second Amended and Restated 180 Life Sciences Corp. 2022 Omnibus Incentive Plan (filed as Exhibit 10.2 to the Current Report on Form 8-K filed on February 16, 2024, and incorporated herein by reference)
10.73#   Separation and Release Agreement dated May 7, 2024, by and between 180 Life Sciences Corp. and Dr. James N. Woody (filed as Exhibit 10.1 to the Current Report on Form 8-K filed on May 6, 2024, and incorporated herein by reference)
10.74#   Separation and Release Agreement dated May 7, 2024, by and between 180 Life Sciences Corp. and Dr. Jonathan Rothbard (filed as Exhibit 10.2 to the Current Report on Form 8-K filed on May 6, 2024, and incorporated herein by reference)
10.75#   Consulting Agreement dated May 7, 2024, by and between 180 Life Sciences Corp. and Dr. Jonathan Rothbard (filed as Exhibit 10.3 to the Current Report on Form 8-K filed on May 6, 2024, and incorporated herein by reference)
10.76#   Fourth Amendment to Consulting Agreement dated May 7, 2024, by and between 180 Life Sciences Corp. and Dr. Lawrence Steinman (filed as Exhibit 10.4 to the Current Report on Form 8-K filed on May 6, 2024, and incorporated herein by reference)
10.77#   Executive Consulting Agreement dated May 7, 2024, by and between 180 Life Sciences Corp. , Blair Jordan and Blair Jordan Strategy and Finance Consulting Inc. (filed as Exhibit 10.5 to the Current Report on Form 8-K filed on May 6, 2024, and incorporated herein by reference)
10.78**   Form of Securities Purchase Agreement
10.79**   Form of Lock-Up Agreement
10.80**   Form of Warrant Agent Agreement for Pre-Funded Warrants
10.81**   Form of Warrant Agent Agreement for Common Warrants
21.1   List of Subsidiaries (filed as Exhibit 21.1 to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Commission on March 31, 2023 and incorporated herein by reference).
23.1*   Consent of Marcum LLP, independent registered public accounting firm.
23.2**   Consent of The Loev Law Firm, PC (included in Exhibit 5.1).
24*   Power of Attorney (included on signature page of this Registration Statement).
107*   Filing Fee Table.

 

*Filed herewith.

 

**To be filed by amendment.

 

#Management contract or compensatoryplans or arrangements.

 

£Certain schedules and exhibitshave been omitted pursuant to Item 601(a)(5) of Regulation S-K.

 

II-8

 

 

(b) Financial Statement Schedules

 

Schedules not listed abovehave been omitted because the information required to be set forth therein is not applicable or is shown in the Consolidated FinancialStatements or notes thereto.

 

Item 17. Undertakings.

 

(a) The undersigned registrant hereby undertakes:

 

(1) To file, during any periodin which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i) To include any prospectusrequired by Section 10(a)(3) of the Securities Act;

 

(ii) To reflect in the prospectusany facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof)which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstandingthe foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceedthat which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in theform of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent nomore than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee”table in the effective registration statement;

 

(iii) To include any materialinformation with respect to the plan of distribution not previously disclosed in the registration statement or any material change tosuch information in the registration statement;

 

providedhowever, that paragraphs(a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information required to be included in a post-effective amendment by thoseparagraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d)of the Securities Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectusfiled pursuant to Rule 424(b) that is part of the registration statement.

 

(2) That, for the purpose ofdetermining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statementrelating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fideoffering thereof.

 

(3) To remove from registrationby means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

(4) That, for the purpose ofdetermining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registrationstatement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in relianceon Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Providedhowever,that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporatedor deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, asto a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registrationstatement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of firstuse; and

 

II-9

 

 

(5) That, for the purpose ofdetermining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersignedregistrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement,regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaserby means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered tooffer or sell such securities to such purchaser:

 

(i) Any preliminary prospectusor prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

(ii) Any free writing prospectusrelating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

(iii) The portion of any otherfree writing prospectus relating to the offering containing material information about the undersigned registrant or its securities providedby or on behalf of an undersigned registrant; and

 

(iv) Any other communicationthat is an offer in the offering made by the undersigned registrant to the purchaser.

 

(b) The undersigned registrant hereby undertakesthat, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuantto section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’sannual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registrationstatement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securitiesat that time shall be deemed to be the initial bona fide offering thereof.

 

(c) Insofar as indemnification for liabilitiesarising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoingprovisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policyas expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (otherthan the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in thesuccessful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with thesecurities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent,submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed inthe Securities Act and will be governed by the final adjudication of such issue.

 

(d) The undersigned registrant hereby undertakesthat:

 

(1) For purposes of determiningany liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statementin reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h)under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

 

(2) For the purpose of determiningany liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registrationstatement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initialbona fide offering thereof.

 

II-10

 

 

SIGNATURES

 

Pursuant to the requirementsof the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned,thereunto duly authorized in the City of Palo Alto, State of California, on July 19, 2024.

 

  180 LIFE SCIENCES CORP.
   
  By: /s/ Blair Jordan
  Name:  Blair Jordan
  Title: Interim Chief Executive Officer

 

POWER OF ATTORNEY

 

KNOW ALL PERSONS BY THESEPRESENTS, that the persons whose signature appears below constitute and appoint Blair Jordan and Ozan Pamir, and each of them, as trueand lawful attorneys-in-fact and agents, with full powers of substitution and resubstitution, for them and in their name, place and stead,in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement (or anyregistration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933),and to file the same, with all exhibits thereto, and other documents in connection therewith, with the SEC, and generally to do all suchthings in their names and behalf in their capacities as officers and directors to enable 180 Life Sciences Corp. to comply with the provisionsof the Securities Act of 1933 and all requirements of the SEC, granting unto said attorneys-in-fact and agents, and each of them, fullpower and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fullyto all intents and purposes as he might or could do in person, ratifying and confirming all that said attorneys-in-fact and agents, orany of them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.

 

Pursuant to the requirementsof the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities indicated.

 

Signature   Title   Date
         
/s/ Blair Jordan   Interim Chief Executive Officer and Director   July 19, 2024
Blair Jordan   (Principal Executive Officer)    
         
/s/ Ozan Pamir   Chief Financial Officer   July 19, 2024
Ozan Pamir   (Principal Financial and Accounting Officer)    
         
/s/ Lawrence Steinman   Director   July 19, 2024
Lawrence Steinman        
         
/s/ Omar Jimenez   Director   July 19, 2024
Omar Jimenez        
         
/s/ Ryan Smith   Director   July 19, 2024
Ryan Smith        

 

 

II-11

 

Stock View