As filed with the Securities and Exchange Commission on September18, 2019

RegistrationNo. 333-___

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

AppliedDNA Sciences, Inc.
(Exact name of registrant as specified in its charter)

50 Health Sciences Drive
Stony Brook, New York 11790
631-240-8800
(Address, including zip code, and telephone number, including
area code, of registrant’s principal executive offices)

James A. Hayward, Ph.D., Sc.D.
Chairman, Chief Executive Officer and President
Applied DNA Sciences, Inc.
50 Health Sciences Drive
Stony Brook, New York 11790
631-240-8801

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

Copies to:

Approximate date of commencement of proposedsale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registeredon this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check thefollowing box. x

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

If this Form is a post-effective amendmentfiled 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-effective amendmentfiled 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 whether the registrantis a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

If an emerging growth company, indicateby 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 and Section 13(a) of the Exchange Act. ¨

The Registrant hereby amends thisregistration statement on such date or dates as may be necessary to delay its effective date until the registrant shall filea further amendment which specifically states that this registration statement shall thereafter become effective inaccordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on suchdate as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The informationin this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filedwith the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and the Companyis not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARYPROSPECTUS, SUBJECT TO COMPLETION, DATED September 18, 2019

Applied DNA Sciences, Inc.

Shares of Common Stock

Pre-Funded Warrants to Purchase Up to            Shares of Common Stock

Common Warrants to Purchase Up to             Sharesof Common Stock

We are offering            shares of our common stock together with            common warrants to purchase shares of our commonstock (and the shares of common stock that are issuable from time to time upon exercise of the common warrants) in a firmcommitment underwritten public offering by Maxim Group LLC, the underwriter (the “Underwriter”). The commonwarrants will be issued separately but must be purchased together with the common stock and/or the pre-funded warrants (asdescribed below). The combined purchase price for each share of common stock and accompanying common warrant is$            . The common warrants will be exercisable beginningon the date of issuance (the “Initial Exercise Date”), at an exercise price of$            per share and will expire on the five-yearanniversary of the Initial Exercise Date. The common warrants include an adjustment provision that, subject to certainexceptions, reduces their exercise price if the Company issues common stock or common stock equivalents at a price lower thanthe then current exercise price of the common warrants, subject to a minimum exercise price of$            per share.

We have also granted the underwriter a periodof 45 days to purchase up to an additional shares of common stock and/or common warrants, which the underwriter may only exerciseto cover over-allotments made in connection with this offering.

We are also offering to those purchasers,if any, whose purchase of our common stock in this offering would otherwise result in such purchaser, together with its affiliatesand certain related parties, beneficially owning more than 4.99% (or, at the election of the holder, 9.99%) of our outstandingcommon stock immediately following the consummation of this offering, the opportunity, in lieu of purchasing common stock, to purchasepre-funded warrants to purchase shares of our common stock. The purchase price of each pre-funded warrant will equal the priceper share at which shares of our common stock are being sold to the public in this offering, minus $0.01, and the exercise priceof each pre-funded warrant will equal $0.01 per share of common stock. For each pre-funded warrant purchased in this offering inlieu of common stock, we will reduce the number of shares of common stock being sold in the offering by one. Pursuant to this prospectus,we are also offering the shares of common stock issuable upon the exercise of the common warrants and the pre-funded warrants.

Each pre-funded warrant is exercisable forone share of our common stock (subject to adjustment as provided for therein) at any time at the option of the holder until suchpre-funded warrant is exercised in full, provided that the holder will be prohibited from exercising pre-funded warrants for sharesof our common stock if, as a result of such exercise, the holder, together with its affiliates, would own more than 4.99% of thetotal number of shares of our common stock then issued and outstanding. However, any holder may increase such percentage to anyother percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days aftersuch notice to us.

Our common stock is listed on The NasdaqCapital Market under the symbol “APDN.” Our publicly traded warrants are listed on The Nasdaq Capital Market underthe symbol “APDNW.” The closing price of our common stock on September 16, 2019, as reported by The Nasdaq CapitalMarket, was $0.34 per share. The closing price of our publicly traded warrants on September 16, 2019, as reported by The NasdaqCapital Market, was $0.004 per share.

The public offering price per share ofcommon stock and/or any pre-funded warrant, together with the common warrant that accompanies common stock or a pre-fundedwarrant will be determined between us and the Underwriter at the time of pricing, and may be at a discount to the currentmarket price. Therefore, the recent market price used throughout this prospectus may not be indicative of the actual publicoffering price for our common stock, our pre-funded warrants and the common warrants. There is no established public tradingmarket for the pre-funded warrants or common warrants, and we do not expect a market to develop. In addition, we do notintend to apply for the listing of the pre-funded warrants or common warrants on any national securities exchange. Without anactive trading market, the liquidity of the common warrants and the pre-funded warrants will be limited.

Maxim Group LLC has agreed to act asthe Underwriter in connection with this offering. The offering is being underwritten on a firm commitment basis. We havegranted the Underwriter an option for a period of 45 days from the date of this prospectus to purchase up to an additional            shares of our common stock at a price of $            per share,and/or common warrants to purchase up to an aggregate of             shares of common stock at a price of $            per common warrant, to coverover-allotments, if any.

Investing in our securities involvesa high degree of risk. See “Risk Factors” beginning on page 15 of this prospectus and elsewhere in this prospectusfor a discussion of information that should be considered in connection with an investment in our securities.

Neither the Securities and Exchange Commissionnor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy ofthis prospectus. Any representation to the contrary is a criminal offense. The securities are not being offered in any jurisdictionwhere the offer is not permitted.

The Underwriter expects to deliver the sharesof common stock, any pre-funded warrants, and common warrants to purchasers on or about             , 2019.

Maxim Group LLC

The date of this Prospectus is             , 2019.

Table of Contents

About thisProspectus

The registration statement of which thisprospectus forms a part that we have filed with the Securities and Exchange Commission (the “SEC”) includes exhibitsthat provide more detail of the matters discussed in this prospectus. You should read this prospectus and the related exhibitsfiled with the SEC, together with the additional information described under the headings “Where You Can Find More Information”and “Incorporation by Reference” before making your investment decision.

You should rely only on the informationcontained or incorporated by reference in this prospectus. We have not, and the Underwriter and its affiliates have not, authorizedanyone to provide you with any information or to make any representation not contained or incorporated by reference in this prospectus.We do not, and the Underwriter and its affiliates do not, take any responsibility for, and can provide no assurance as to the reliabilityof, any information that others may provide to you. You must not rely upon any information or representation other than those containedor incorporated by reference into this prospectus. This prospectus is not an offer to sell or an offer to buy securities in anyjurisdiction where offers and sales are not permitted. The information in this prospectus is accurate only as of its date, regardlessof the time of delivery of this prospectus or any sale of securities. You should also read and consider the information in thedocuments to which we have referred you under the caption “Where You Can Find More Information” in the prospectus.In addition, this prospectus contains summaries of certain provisions contained in some of the documents described herein, butreference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by theactual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated byreference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documentsas described below under the heading “Where You Can Find More Information.”

You should assume that the information inthis prospectus is accurate only as of the date hereof, or in the case of documents incorporated by reference, the original dateof any such documents, based on information available to us as of such date, regardless of the time of delivery of this prospectus,or any sale of a security registered under the registration statement of which this prospectus is a part.

Neither we nor the Underwriter have doneanything that would permit a public offering of the securities or possession or distribution of this prospectus in any jurisdictionwhere action for that purpose is required, other than in the United States. Persons outside the United States who come into possessionof this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and thedistribution of this prospectus outside of the United States.

We further note that the representations,warranties and covenants made by us in any agreement that is filed as an exhibit to the registration statement of which this prospectusforms a part or any document that is incorporated by reference in this prospectus were made solely for the benefit of the partiesto such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and shouldnot be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants wereaccurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on asaccurately representing the current state of our affairs.

Unless the context otherwise requires, referencesin this prospectus to “Applied DNA,” the “Company,” “we,” “us” and “our”refer to Applied DNA Sciences, Inc., a Delaware corporation, and our subsidiaries. Our trademarks in the United States includeApplied DNA Sciences®, SigNature® molecular tags, SigNature® T molecular tags, fiberTyping®, DNAnet®, digitalDNA®,SigNify®, BackTrac®, Beacon® and CertainT®. Solely for convenience, trademarks and tradenames referred to in thisprospectus may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that wewill not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights,to these trademarks and tradenames. We do not intend our use or display of other companies’ trade names or trademarks toimply a relationship with, or endorsement or sponsorship of us by, any other companies.

This prospectus contains and incorporatesby reference market data and industry statistics and forecasts that are based on our own internal estimates as well as independentindustry publications and other publicly-available information. Although we believe these sources are reliable, we do not guaranteethe accuracy or completeness of this information and we have not independently verified this information. Although we are not awareof any misstatements regarding the market and industry data presented in this prospectus or the documents incorporated herein byreference, these estimates involve risks and uncertainties and are subject to change based on various factors, including thosediscussed under the headings “Risk Factors” in this prospectus, and under similar headings in the other documents thatare incorporated herein by reference. Accordingly, investors should not place undue reliance on this information.

Forward-LookingStatements

This prospectus and the documents incorporatedby reference herein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “ExchangeAct”), that are intended to qualify for the “safe harbor” created by those sections. In addition, we may makeforward-looking statements in other documents filed with or furnished to the Securities and Exchange Commission (the “SEC”),and our management and other representatives may make forward-looking statements orally or in writing to analysts, investors, representativesof the media and others.

Forward-looking statements can generallybe identified by the fact that they do not relate strictly to historical or current facts and include, but are not limited to,statements using terminology such as “can”, “may”, “could”, “should”, “assume”,“forecasts”, “believe”, “designated to”, “will”, “expect”, “plan”,“anticipate”, “estimate”, “potential”, “position”, “predicts”, “strategy”,“guidance”, “intend”, “seek”, “budget”, “project” or “continue”,or the negative thereof or other comparable terminology regarding beliefs, plans, expectations or intentions regarding the future.You should read statements that contain these words carefully because they:

We believe it is important to communicateour expectations. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectusand incorporated by reference into this prospectus, we caution you that these statements are based on our projections of the futurethat are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity,performance or achievements expressed or implied by these forward-looking statements, to differ. Forward-looking statements involverisks and uncertainties and our actual results and the timing of certain events could differ materially from those discussed inforward-looking statements as a result of certain factors, including those set forth under “Risk Factors” and “ProspectusSummary – Our Company” set forth in this prospectus and the documents incorporated herein by reference.

Accordingly, our actual results and thetiming of certain events may differ materially from those expressed or implied in such forward-looking statements due to a varietyof factors and risks, including, but not limited to, those set forth under “Risk Factors,” those set forth from timeto time in our other filings with the SEC, and the following factors and risks:

All forward-looking statements and riskfactors included in this prospectus are made as of the date hereof, or in the case of documents incorporated by reference, theoriginal date of any such documents, based on information available to us as of such date, and we assume no obligations to updateany forward-looking statement or risk factor, unless we are required to do so by law. If we do update one or more forward-lookingstatements, no inference should be drawn that we will make updates with respect to other forward-looking statements or that wewill make any further updates to those forward-looking statements at any future time. All forward-looking statements are qualifiedin their entirety by this cautionary statement. Our forward-looking statements do not reflect the potential impact of any futureacquisitions, mergers, dispositions, joint ventures or investments we may make. You should read this prospectus and the documentsthat we have filed as exhibits to this prospectus and incorporated by reference herein completely and with the understanding thatour actual future results may be materially different from the plans, intentions and expectations disclosed in the forward-lookingstatements we make.

Forward-looking statements may include ourplans and objectives for future operations, including plans and objectives relating to our products and our future economic performance,projections, business strategy and timing and likelihood of success. Assumptions relating to the foregoing involve judgments withrespect to, among other things, future economic, competitive and market conditions, future business decisions, and the time andmoney required to successfully complete development and commercialization of our technologies, all of which are difficult or impossibleto predict accurately and many of which are beyond our control. We may not actually achieve the plans, intentions or expectationsdisclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Forward-lookingstatements should be regarded solely as our current plans, estimates and beliefs. We have included important factors in the cautionarystatements included in this document, particularly in the section entitled “Risk Factors” beginning on page 15of this prospectus that we believe could cause actual results or events to differ materially from the forward-looking statementsthat we make. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time.It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or theextent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in anyforward-looking statements we may make.

Any of the assumptions underlying the forward-lookingstatements contained in this prospectus could prove inaccurate and, therefore, we cannot assure you that the results or eventscontemplated in any of such forward-looking statements will be realized. Based on the significant uncertainties inherent in theseforward-looking statements, the inclusion of any such statement should not be regarded as a representation or as a guarantee byus that our objectives or plans will be achieved, and we caution you against relying on any of the forward-looking statements containedherein.

Risk Factors

Investment in our securities,including our common stock , common warrants, and pre-funded warrants, involves a high degree of risk. In addition to therisks and investment considerations discussed elsewhere in this prospectus or any document incorporated by reference herein,the following factors should be carefully considered by anyone purchasing the securities offered by this prospectus. Therisks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently knownto us or that we currently deem immaterial also may impair our business operations. We also update risk factors from time totime in our periodic reports on Forms10-K, 10-Qand 8-Kwhich will be incorporated by reference in this prospectus. If any of the following risks actually occur, our business couldbe harmed. In such case, the trading price of our common stock could decline and investors could lose all or a part oftheir investment. All of these risks could adversely affect our business, business prospects, results of operations,financial condition and cash flows.

See also the statements contained underthe heading “Forward-Looking Statements.”

Risks Related to Our Business:

There is substantial doubt relating to our abilityto continue as a going concern.

We have recurring net losses, which haveresulted in an accumulated deficit of $255,271,848 as of June 30, 2019 and $248,366,083 as of September 30, 2018. We haveincurred a net loss of $11,692,928 for the fiscal year ended September 30, 2018 and $7,398,988 for the nine-month period endedJune 30, 2019. At September 30, 2018, we had cash and cash equivalents of $1,659,564, and $507,146 as of June 30, 2019. We haveconcluded that these factors raise substantial doubt about our ability to continue as a going concern for one year from the issuanceof the financial statements.

In addition, the report from our independentregistered public accounting firm for the year ended September 30, 2018 includes an explanatory paragraph stating that our significantlosses and need to raise additional funds to meet our obligations and sustain operations raise substantial doubt about our abilityto continue as a going concern. We will continue to seek to raise additional working capital through public equity, private equityor debt financings. If we fail to raise additional working capital, or do so on commercially unfavorable terms, it would materiallyand adversely affect our business, prospects, financial condition and results of operations, and we may be unable to continue asa going concern. Future reports from our independent registered public accounting firm may also contain statements expressing substantialdoubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in thefuture and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sourcesmay be unwilling to provide additional funding to us on commercially reasonable terms, if at all.

If we are unsuccessful in our pending hearing beforethe Nasdaq Hearings Panel, and a final decision is made by Nasdaq to delist our securities, our securities will be delisted fromNasdaq and we may incur adverse consequences.

Our common stock and publicly traded warrantsare listed on The Nasdaq Capital Market under the symbols “APDN” and “APDNW,” respectively. For our commonstock and publicly traded warrants to continue to be listed on The Nasdaq Capital Market, we must meet the current continued listingrequirements, including the requirements that (1) our stock must maintain a minimum closing bid price of $1.00 pursuant to NasdaqListing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”); and (2) we must maintain net income from continuingoperations (in the latest fiscal year or two of the three last fiscal years) of at least $500,000, a market value of listed securitiesof at least $35 million (the “Minimum Value of Listed Securities Requirement”), or stockholders’ equity of atleast $2.5 million, pursuant to Nasdaq Listing Rule 5550(b).

On January 29, 2019 andJanuary 30, 2019, we received written notices from the Listing Qualifications Department of Nasdaq notifying us that we are notin compliance with the Minimum Bid Price Requirement as well as the market value of listed securities requirement, or the alternativestandards of Nasdaq Listing Rule 5550(b)(1) or 5550(b)(3) which require a company to have minimum stockholders equity of $2.5million or for it to have had net income from continuing operations of at least $500,000 in the latest fiscal year or in two ofthe last three fiscal years.

OnJuly 30, 2019, we received written notice from Nasdaq indicating that, based upon our continued non-compliance with the MinimumBid Price Requirement and Minimum Value of Listed Securities Requirement, as set forthin Nasdaq Listing Rules 5550(a)(2) and 5550(b)(2), respectively, as of July 29, 2019, the staff of Nasdaq (the “Staff”)had determined to delist our securities (including our common stock and publicly traded warrants) from The Nasdaq Capital Marketunless we timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). We have requested a hearing beforethe Panel, which will stay any further action by the Staff at least pending the ultimate conclusion of the hearing process. Duringthe pendency of the requested hearing before the Panel, our listed securities will remain listed on The Nasdaq Capital Market.Our hearing date is scheduled for September 19, 2019.

Weare diligently working to evidence compliance with all applicable requirements for continued listing on The Nasdaq Capital Marketand have submitted a plan to that effect to the Panel as part of the hearing process; however, there can be no assurance that thePanel will grant our request for continued listing on The Nasdaq Capital Market orthat we will be able to regain compliance with the applicable listing criteria within the period of time that may be granted bythe Panel.

Ifour common stock is delisted by Nasdaq, it could lead to a number of negative implications, including an adverse effect on theprice of our common stock, increased volatility in our common stock, reduced liquidity in our common stock, the loss of federalpreemption of state securities laws and greater difficulty in obtaining financing. In addition, delisting of our common stock coulddeter broker-dealers from making a market in or otherwise seeking or generating interest in our common stock, could result in aloss of current or future coverage by certain sell-side analysts and might deter certain institutions and persons from investingin our securities at all. Delisting could also cause a loss of confidence of our customers, collaborators, vendors, suppliers andemployees, which could harm our business and future prospects.

Ifour common stock is delisted by Nasdaq, our common stock may be eligible to trade on the OTC Bulletin Board, OTC-QB or anotherover-the-counter market. Any such alternative would likely result in it being more difficult for us to raise additional capitalthrough the public or private sale of equity securities and for investors to dispose of or obtain accurate quotations as to themarket value of, our common stock. In addition, there can be no assurance that our common stock would be eligible for trading onany such alternative exchange or markets. Moreover, if our common stock is delisted, it may come within the definition of “pennystock” under the Exchange Act, which imposes additional sales practice requirements on broker-dealers who sell securitiesto persons other than established customers and accredited investors. For example, we and/or broker-dealers are required to makea special suitability determination for purchases of such securities and must receive a purchaser’s written consent to thetransaction prior to any purchase. Additionally, unless exempt, prior to a transaction involving a penny stock, the penny stockrules require the delivery of a disclosure schedule prescribed by the SEC relating to the penny stock market. The broker-dealermust also disclose the commissions payable to the broker-dealer, current quotations for the securities and, if the broker-dealeris the sole market-maker for the security, the fact that they are the sole market-maker and their presumed control over the market.Finally, monthly statements disclosing recent price information on the limited market in penny stocks must be sent to holders ofsuch penny stocks. These requirements may reduce trading activity in the secondary market for our common stock and may impact theability or willingness of broker-dealers to sell our securities which could limit the ability of stockholders to sell their securitiesin the public market and limit our ability to attract and retain qualified employees or raise additional capital in the future.

We may conduct a reverse stock split to maintain Nasdaq’sMinimum Bid Price Requirement which may adversely impact the market price and liquidity of our common stock.

In order to maintain listing on The NasdaqCapital Market, our common stock must meet the Minimum Bid Price Requirement. In the future, we may decide to effect a reversestock split in order to satisfy this Minimum Bid Price Requirement. Any such reverse stock split may adversely affect the liquidityof the shares of our common stock and there is no assurance that our common stock will trade at a price consistent with such reversestock split. As a result, if we effect a reverse stock split after the closing of this offering, those purchasers of securitiesin this offering may suffer a loss of their investment. Moreover, even if the reverse stock split achieves the requisite increasein the market price of our common stock to be in compliance with the requirements of the Nasdaq Listing Rules, there is no assurancethat the market price of our common stock following the reverse stock split will remain at the level required to maintain compliance.

We have not produced significant revenues. Thismakes it difficult to evaluate our future prospects and increases the risk that we will not be successful.

Our operations since inception have producedlimited revenues, and may not produce significant revenues in the near term, or at all, which may harm our ability to obtain additionalfinancing and may require us to reduce or discontinue our operations. If we create significant revenues in the future, we expectto derive most of such revenues from the sale of supply chain security and product authentication solutions. You must considerour business and prospects in light of the risks and difficulties we will encounter as a company operating in a rapidly evolvingindustry. We may not be able to successfully address these risks and difficulties, which could significantly harm our business,operating results, and financial condition.

We have a history of net losses which may continue,and which may harm our ability to obtain financing and continue our operations.

We incurred net losses of $11.7 millionand $12.9 million for the fiscal years ended September 30, 2018 and 2017, respectively, and $7,398,988 and $8,217,645 for the nine-monthperiods ended June 30, 2019 and 2018, respectively. These net losses have principally been the result of the various costs associatedwith our selling, general and administrative and research and development expenses as we expanded operations, acquired, developedand validated technologies and expanded marketing activities. Our operations are subject to the risks and competition inherentin a company that moved from the development stage to an operating company. We may not generate sufficient revenues from operationsto achieve or sustain profitability on a quarterly, annual or any other basis in the future. Our revenues and profits, if any,will depend upon various factors, including whether our existing products and services or any new products and services we developwill achieve market acceptance. If we continue to incur losses, then our accumulated deficit will continue to increase which maysignificantly impair our ability to obtain additional financing. As a result, our business, results of operations and financialcondition would be significantly harmed, and we may be required to reduce or terminate our operations.

If we are unable to obtain additional financingour business operations may be harmed or discontinued.

Our continuation as a going concern is dependentupon our future revenues and our ability to commercialize more products, obtain additional capital and attain profitable operations.We will require additional funds to complete the continued development and commercialization of our products, product manufacturing,and to fund expected additional losses from operations, until revenues are sufficient to cover our operating expenses. If we areunsuccessful in obtaining any necessary additional financing, we will most likely be forced to reduce or terminate our operations.

Our opportunities in pharmaceuticals and biologicswill require substantial additional funding. We may not be successful in our efforts to create a pipeline of product candidatesor to develop commercially successful products. If we fail to successfully identify, finance and develop product candidates, ourcommercial opportunities in pharmaceuticals and biologics may be limited.

We have no pharmaceutical or biologic productsapproved for commercial sale and have not generated any revenue from pharmaceutical or biologic product sales. Identifying, developing,obtaining regulatory approval and commercializing pharmaceutical and biologic product candidates will require substantial additionalfunding beyond our current available resources and is prone to the risks of failure inherent in drug or biologic development. Developingproduct candidates is expensive, and we expect to spend substantial amounts as we fund our early-stage research projects, engagein preclinical development of early-stage programs and, in particular, advance program candidates through preclinical developmentand clinical trials.

Even if we receive regulatory approval tomarket any of our product candidates, we cannot assure you that any such product candidate will be successfully commercialized,widely accepted in the marketplace or more effective than other commercially available alternatives.

Investment in pharmaceutical and biologicproduct development involves significant risk that any product candidate will fail to demonstrate adequate efficacy or an acceptablesafety profile, gain regulatory approval, and become commercially viable. We cannot provide any assurance that we will be ableto successfully advance any product candidates through the development process or, if approved, successfully commercialize anyproduct candidates.

Even if we are able to generate revenuefrom the sale of any approved pharmaceutical and biologic products, we may not become profitable and may need to obtain additionalfunding to continue operations. Our failure to become and remain profitable would decrease the value of our Company and could impairour ability to raise capital, expand our business, maintain our research and development efforts, diversify our pipeline of productcandidates or continue our operations, and cause a decline in the value of our common stock, all or any of which may adverselyaffect our viability.

Our operating results could be adversely affectedby a reduction in business with our significant customers.

Our revenue earned from the sale of productsand services for the nine month period ended June 30, 2019 and the fiscal year ended September 30, 2018 included an aggregate of68%, from three customers, and 65% of our total revenues, from four customers, respectively. At June 30, 2019, three customersaccounted for 52% of the Company’s accounts receivable, and one customer accounted for 82% of the Company’s accountsreceivable at September 30, 2018. Our revenues earned from sale of products and services for the nine month period ended June 30,2018 included an aggregate of 59% from three customers of our total revenues. Our revenues earned from sale of products and servicesfor the fiscal year ended September 30, 2017 included an aggregate of 78% from four customers of our total revenues. At September30, 2017, one customer accounted for 80% of our total accounts receivable. Generally, our customers do not have an obligation tomake purchases from us and may stop ordering our products and services or may terminate existing orders or contracts at any timewith little or no financial penalty. The loss of any of our significant customers, any substantial decline in sales to these customers,or any significant change in the timing or volume of purchases by our customers could result in lower revenues and could harm ourbusiness, financial condition or results of operations.

If our existing products and services are not acceptedby potential customers or if we fail to introduce new products and services, our business, results of operations and financialcondition will be harmed.

There has been limited market acceptanceof our DNA based technology, encapsulation, embedment and authentication products and services to date. Some of the factors thatwill affect whether we achieve market acceptance of our solutions include:

Our dependence on channel partners exposes us tocertain risks that could harm our business, results of operations and financial condition.

Our future growth will depend to a materialextent on the successful advocacy of our technology by channel partners to their members and customers, and implementation of ourtechnology in solutions propagated by channel partners and provided by third parties. Our business has relied on the success ofbusiness partners. Our continuing success is largely dependent on a new generation of business partners involved in our taggingtechnology.

If our channel partners are not successfulin advocating and deploying our technology, we may not be able to achieve and sustain profitable operations. If other businesspartners who include our technology in their products or otherwise license our intellectual property for use in their productscease to do so, or we fail to obtain other partners who will incorporate, embed, integrate or bundle our technology, or these partnersare unsuccessful in their efforts, expanding deployment of our technology and increasing revenues will be adversely affected. Consequently,our ability to increase revenue could be adversely affected and we may suffer other adverse effects to our business. In addition,if our technology does not perform according to market expectations, our future sales would suffer as customers seek and employalternative technologies.

Many of our business endeavors can be impededor frustrated by larger, more influential companies or by standard-setting bodies or institutions downplaying, minimizing or rejectingthe value or use of our technology. A negative position by such companies, bodies or institutions, could result in obstacles forus that we would be incapable of overcoming and may block or impede the adoption of our technology. In addition, potential customersmay delay or reject initiatives that relate to deployment of our technology. Such a development would make the achievement of ourbusiness objectives in this market difficult or impossible.

The expenses or losses associated with lack of widespreadmarket acceptance of our solutions may harm our business, operating results and financial condition.

Rapid technological changes and frequentnew product introductions are typical in the markets we serve. Our future success may depend in part on continuous, timely developmentand introduction of new products that address evolving market requirements. We believe successful new product introductions mayprovide a significant competitive advantage because customers invest their time in selecting and learning to use new products,and once invested in the new technology, are often reluctant to switch products. To the extent we fail to introduce new and innovativeproducts, we may lose any market share we then have to our competitors, which will be difficult or impossible to regain. Any inability,for technological or other reasons, to successfully develop and introduce new products could reduce our growth rate or damage ourbusiness. We may experience delays in the development and introduction of products. We may not keep pace with the rapid rate ofchange in anti-counterfeiting and security products’ research, and any new products acquired or developed by us may not meetthe requirements of the marketplace or achieve market acceptance.

We need to expand our sales, marketing and supportorganizations and our distribution arrangements to increase market acceptance of our products and services.

We currently have a limited number of sales,marketing, customer service and support personnel and may need to increase our staff to generate a greater volume of sales andto support any new customers or the expanding needs of existing customers. The employment market for sales, marketing, customerservice and support personnel in our industry is very competitive, and we may not be able to hire the kind and number of sales,marketing, customer service and support personnel we are targeting. Our inability to hire qualified sales, marketing, customerservice and support personnel may harm our business, operating results and financial condition. While we have entered into a limitednumber of agreements with distributors, we may not be able to sufficiently build out a distribution network or enter into arrangementswith qualified distributors on acceptable terms or at all. If we are not able to develop greater distribution capacity, we maynot be able to generate sufficient revenue to support our operations.

If we are unable to continue to retain the servicesof Dr. James A. Hayward, we may not be able to continue our operations.

Our success depends to a significant extentupon the continued service of Dr. James A. Hayward, our Chairman, Chief Executive Officer and President. On July 28, 2016, we enteredinto an employment agreement with Dr. Hayward. The initial term was from July 1, 2016 through June 30, 2017, with automatic one-yearrenewal periods. As of June 30, 2019, the employment contract automatically renewed for an additional year. Loss of the servicesof Dr. Hayward could significantly harm our business, results of operations and financial condition. We do not maintain key-personinsurance on the life of Dr. Hayward.

We may have conflicts of interest with our affiliatesand related parties, and in the past we have engaged in transactions and entered into agreements with affiliates that were notnegotiated at arms’ length.

We have engaged, and may in the future engage,in transactions with affiliates and other related parties. These transactions may not have been, and may not be, on terms as favorableto us as they could have been if obtained from non-affiliated persons. While an effort has been made, and will continue to be made,to enter into transactions with affiliated persons and other related parties at rates and on terms as favorable as would be chargedby others, there will always be an inherent conflict of interest between our interests and those of our affiliates and relatedparties. In August 2018 and November 2018, we issued an aggregate of $2.2 million in principal amount of secured convertible notes,a majority of which were owned by Dr. James A. Hayward, our Chairman, Chief Executive Officer and President. Dr. Hayward and otherdirectors, officers, and affiliates of the Company converted substantial portions of such August 2018 Notes and November 2018 Notesinto common stock of the Company in September 2019. Upon conversion by Dr. Hayward and by our other officers, directors, and affiliates,such individuals gained an increased amount of control over the Company. The Company may be adversely impacted if any related partyagreement or transaction is made on unfavorable terms.

The markets for our supply chain security and productauthentication solutions are very competitive, and we may be unable to continue to compete effectively in these industries in thefuture.

The principal markets for our offeringsare intensely competitive. We compete with many existing suppliers and new competitors continue to enter the market. Many of ourcompetitors, both in the United States and elsewhere, are major pharmaceutical, chemical and biotechnology companies, or have strategicalliances with such companies, and many of them have substantially greater capital resources, marketing experience, research anddevelopment staff, and facilities than we do. Any of these companies could succeed in developing products that are more effectivethan the products that we have or may develop and may be more successful than us in producing and marketing their existing products.Some of our competitors that operate in the anti-counterfeiting and fraud prevention markets include: 3DTL Inc., AlpVision Sa,Authentix Inc., Brandwatch Technologies, Chromologic LLC, Collectors Universe Inc., DataDot Technology, De La Rue Plc., DigimarcCorp., DNA Technologies, Inc., FractureCode Corporation, Haelixa, ICA Bremen GmbH, Ipsidy Inc., IEHCorporationInformium AG, EastmanKodak Company, IDEMIA, opSec Security Group plc., MicroTag Temed Ltd., Nanotech Security Corp., Nokomis, Inc., Oritain Global Limited,Prooftag SAS, SafeTraces Inc., Selectamark Security Systems plc, Spectra Systems Corp., SmartWater Technology, Inc., Sun ChemicalCorp, TraceTag International, TruTag Technologies Inc., Tailorlux gmbH and YottaMark Inc.

We expect this competition to continue andintensify in the future. Competition in our markets is primarily driven by:

If a competitor develops superior technologyor cost-effective alternatives to our products, our business, financial condition and results of operations could be significantlyharmed.

Revenues from our customer contracts with respectto cotton will be seasonal and may also be subject to weather conditions and other factors beyond our control, which may causeour operating results to fluctuate significantly quarterly and annually.

A significant proportion of our revenuesis expected to be derived from customer contracts for tagging, authentications and other services related to cotton. The cottonginning season in the United States takes place between September and March each year. Therefore, revenues from our customer contractsrelating to cotton may be seasonal and recognized primarily during our first and fourth fiscal quarters, which may cause our operatingresults to fluctuate significantly quarterly and annually. Additionally, weather and climatic conditions, natural disasters andother factors beyond our control also affect the production and sale of cotton and other agricultural commodities to which ourcustomer contracts may relate, as well as our customers’ or prospective customers’ decisions regarding purchases ofour products and services, and may cause our operating results to fluctuate significantly quarterly and annually. The seasonalfluctuations in operating results described above may cause a decline in the price of our common stock.

Fluctuations in quarterly results may cause a declinein the price of our common stock.

Our revenues and profitability are difficultto predict due to the nature of the markets in which we compete, fluctuating user demand, the uncertainty of current and futureglobal economic conditions, and for many other reasons, including that our operating results are highly dependent on the volumeand timing of orders received during a quarter, which are difficult to forecast. Customers generally order on an as-needed basisand we typically do not obtain firm, long-term purchase commitments from our customers. The quarterly fluctuations in operatingresults described above may cause a decline in the price of our common stock.

Shifting enforcement priorities of U.S. federallaws relating to cannabis may create uncertainties for our business.

The Company is currently developing supplychain solutions for the cannabis industry. These solutions are intended to verify the authenticity, origin and provenance of cannabis.Cannabis is a Schedule I substance as defined under U.S. federal law, and its possession and use is generally not permitted underU.S. federal law, although a number of individual states have enacted state laws to authorize possession, sale and use of cannabisfor medical purposes, and in some states for recreational purposes. Our solutions will be utilized in those U.S. states wherecannabis possession, sale and/or use is legal under state law. While our cannabis supply chain solutions are distinct fromcannabis itself, our cannabis supply chain business and related revenue may nevertheless be adversely impacted by such laws atthe federal and/or state level in the United States, or potentially in foreign jurisdictions. It is possible that such laws mayresult in our cannabis supply chain business having no revenues or may subject the Company to increased risk of litigation.

Pharmaceutical and biologic-related revenue is generallydependent on regulatory approval, oversight and compliance.

All of our pharmaceutical and biologic productcandidates will require significant preclinical and clinical development before we can seek regulatory approval for them and launcha product commercially. The sale and use of our products and services in the pharmaceutical and biologic markets will generallybe subject to regulatory approval and oversight, potentially including approval and/or oversight in various foreign jurisdictions.In addition, our pharmaceutical and biologic products and services may be incorporated into products that cannot be marketed inthe United States or in many other jurisdictions without approval by the Food and Drug Administration (“FDA”) or comparableagencies of other countries or regions. Obtaining such regulatory approvals is costly, time-consuming, uncertain, and subject tounanticipated delays. When, if ever, such approvals will be obtained is unknown. Our revenue in the pharmaceutical and biologicmarkets is highly dependent upon obtaining such approval.

Federal agencies, including the FDA andFederal Trade Commission (“FTC”), as well as state, local, and foreign authorities, also exercise ongoing review andcontrol of the manufacturing, packaging, labeling, advertising, sale, distribution, and monitoring of pharmaceutical and biologicproducts. If our pharmaceutical or biologic product candidates or pharmaceutical or biologic products incorporating our productsare ever approved, failure to comply with any of these regulations or other requirements could also have an adverse effect on ourrevenue in the pharmaceutical and biologic markets.

Pharmaceutical and biologic-related revenue willbe highly dependent on our collaborators’ and customers’ success in obtaining regulatory approval and commercializingtheir products.

Some of our products in the pharmaceuticaland biologic market will be incorporated into products that are subject to comprehensive regulation by the FDA and other regulatoryagencies in the United States and by comparable authorities in other countries. In the United States, to obtain approval from theFDA to market any future pharmaceutical or biologic product that incorporates our technology, our collaborators or customers willbe required to submit a New Drug Application (“NDA”) or Biologics Licensing Application (“BLA”). Ordinarily,the FDA requires a company to support an NDA or BLA with substantial evidence of the product candidate’s safety and efficacyin treating the targeted indication based on data derived from adequate and well-controlled clinical trials, including Phase IIIsafety and efficacy trials conducted in patients with the disease or condition being targeted. The process of obtaining such regulatoryapprovals is expensive, often takes many years if approval is obtained at all, and can vary substantially based upon the type,complexity and novelty of the product candidate involved. Changes in the regulatory approval process during the development period,changes in or the enactment of additional statutes or regulations, or changes in the regulatory review process may cause delaysin the approval or rejection of an application. There is no guarantee that our collaborators and customers will ever be successfulin obtaining regulatory approval for any product that incorporates our products or technology. Even if regulatory approval is received,the manufacturing processes, post approval clinical data, labeling, advertising and promotional activities for any such productwill be subject to continual requirements of and review by the FDA and other regulatory bodies. Our business may be materiallyharmed by our collaborators’ and customers’ inability to obtain or maintain regulatory approvals for their products.

In addition, we will be dependent on, andhave no control over, consumer demand for the products into which our products are incorporated. Consumer demand for our collaborators’and customers’ products could be adversely affected by, among other things, delays in health regulatory approval, the lossof patent and other intellectual property rights protection, the emergence of competing products, including generic drugs or biosimilars,the degree to which private and government drug plans subsidize payment for a particular product and changes in the marketing strategiesfor such products. The healthcare industry has changed significantly over time, and we expect the industry to continue to evolve.Some of these changes may have a material adverse effect on our collaborators and customers and thus may have a material adverseeffect on our business. If the products into which our products are incorporated do not gain market acceptance, our revenues andprofitability may be adversely affected.

Pharmaceutical and biologic products are highlycomplex, and if we or our collaborators and customers are unable to provide quality and timely offerings to our respective customers,our business could suffer.

The process of manufacturing pharmaceuticaland biologics and their components is complex, highly-regulated and subject to multiple risks.

Manufacturing biologics is highly susceptibleto product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error,inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minordeviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions.

Our ability to generate revenue in the pharmaceuticaland biologic market depends on our ability to manufacture products that meet exacting quality and safety standards. If we are unableto manufacture these products to the required levels, it could have an adverse effect on our business, financial condition, andresults of operations and may subject us to regulatory actions, including product recalls, product seizures, injunctions to haltmanufacture or distribution, restrictions on our operations, or civil sanctions, including monetary sanctions and criminal actions.In addition, we could be subject to costly litigation, including claims from our collaborators and customers for reimbursementfor the cost of our products or other related losses, the cost of which could be significant.

Our business also depends on the abilityof our collaborators and customers to manufacture the pharmaceutical or biologic products that incorporate our products. If theFDA determines that our collaborators and customers are not in compliance with FDA laws and regulations, including those governingCurrent Good Manufacturing Practice (“cGMP”) regulations, the FDA may deny NDA or BLA approval until the deficienciesare corrected. Even if our collaborators or customers obtain regulatory approval for any of their product candidates, there isno assurance that they will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatoryauthorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product or to meetpotential future demand. If our collaborators or customers are unable to produce sufficient quantities for clinical trials or forcommercialization, commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition,results of operations and growth prospects.

Pharmaceutical and biologic-related revenue willbe dependent on our collaborators’ and customers’ demand for our manufacturing services.

The amount of customer spending on biologicdevelopment and manufacturing will have an impact on our sales and profitability in the pharmaceutical and biologic market. Ourcollaborators and customers determine the amounts that they will spend based upon, among other things, available resources, accessto capital, and their need to develop new products, which, in turn, are dependent upon a number of factors, including their competitors’research, development and product initiatives and the anticipated market uptake, and clinical and reimbursement scenarios for specificproducts and therapeutic areas. Consolidation in the pharmaceutical and biologic industry may impact such spending as customersintegrate acquired operations, including R&D departments and manufacturing operations. Any reduction in spending on pharmaceuticaland biotechnology development and related services as a result of these and other factors could have a material adverse effecton our business, results of operations and financial condition.

The markets for our drug and biologic candidatesand linear DNA are very competitive, and we may be unable to continue to compete effectively in these industries in the future.

The principal markets for our drug and biologiccandidates and linear DNA are intensely competitive. We compete with many existing suppliers and new competitors continue to enterthe market. Many of our competitors, both in the United States and elsewhere, are major pharmaceutical, chemical and biotechnologycompanies, or have strategic alliances with such companies, and many of them have substantially greater capital resources, marketingexperience, research and development staff, and facilities than we do. Any of these companies could succeed in developing productsthat are more effective than the product candidates that we have or may develop and may be more successful than us in producingand marketing their existing products. Some of our competitors that operate in the drugs, biologics and DNA manufacturing marketsinclude: Intrexon Corp., Aldervron, LLC, Cobra Biologics, Limited, Integrated DNA Technologies, Inc., Ziopharm Oncology, Inc.,MaxCyte Inc., Touchlight Genetics Ltd., Novartis AG, Kite Pharma, Inc. and Juno Therapeutics, Inc.

We expect this competition to continue andintensify in the future. Our competitors also compete with us in recruiting and retaining qualified scientific and management personnel,as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunities could be reducedor eliminated if our competitors develop and commercialize drug and biologic candidates or linear DNA that are safer, more effective,have fewer or less severe side effects, are more convenient, or are less expensive than any drug and biologic candidates and linearDNA that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly thanwe may obtain approval for ours, which could result in our competitors establishing a strong market position before we are ableto enter the market. Additionally, drug and biologic candidates and linear DNA developed by our competitors may render our potentialdrug and biologic candidates and linear DNA uneconomical or obsolete, and we may not be successful in marketing any drug and biologiccandidates and linear DNA we may develop against competitors.

If any of these risks occur, our business,financial condition and results of operations could be significantly harmed.

Our research and development efforts for new productsmay be unsuccessful.

We incur research and development expensesto develop new products and technologies in an effort to maintain our competitive position in a market characterized by rapid ratesof technological advancement. Our research and development efforts are subject to unanticipated delays, expenses and technicalproblems. There can be no assurance that any of these products or technologies will be successfully developed or that, if developed,will be commercially successful. In the event that we are unable to develop commercialized products from our research and developmentefforts or we are unable or unwilling to allocate amounts beyond our currently anticipated research and development investment,we could lose our entire investment in these new products and technologies. Any failure to translate research and development expendituresinto successful new product introduction could have an adverse effect on our business.

In addition, research, development, andcommercialization of pharmaceutical and biologic products is inherently risky. We cannot give any assurance that any of our pharmaceuticaland biologic product candidates will receive regulatory approval, which is necessary before they can be commercialized.

Other risks include:

Failure to license new technologies could impairsales of our existing products or any new product development we undertake in the future.

To generate broad product lines, it is advantageousto sometimes license technologies from third parties rather than depend exclusively on the development efforts of our own employees.As a result, we believe our ability to license new technologies from third parties may be important to our ability to offer newproducts. In addition, from time to time we are notified of, or become aware of patents held by third parties that are relatedto technologies we are selling or may sell in the future. After a review of these patents, we may decide to seek a license forthese technologies from these third parties. There can be no assurance that we will be able to successfully identify new technologiesdeveloped by others. Even if we are able to identify new technologies of interest, we may not be able to negotiate a license onfavorable terms, or at all.

Our failure to manage our growth in operations andacquisitions of new product lines and new businesses could harm our business.

The recent growth in our operations couldplace a significant strain on our current management resources. To manage such growth, we may need to improve our:

Our future growth, if any, may be attributableto acquisitions of new product lines and new businesses. Future acquisitions, if successfully consummated, would likely createincreased working capital requirements, which would likely precede by several months any material contribution of an acquisitionto our net income. Our failure to manage growth or future acquisitions successfully could seriously harm our operating results.Also, acquisition costs could cause our operating results to vary significantly from quarter to quarter. Furthermore, our stockholderswould be diluted if we financed the acquisitions by incurring convertible debt or issuing securities.

If we explore or engage in future business combinationsor other transactions, we may be subject to various uncertainties and risks.

From time-to-time, unrelated third-partiesmay approach the Company about potential transactions, including business combinations. As such, to date, we have not entered intoany agreements related to any business combination. While we may explore such opportunities when they arise, we could not pursueany proposed business combination or other transaction unless our board of directors first has determined that doing so would bein our and our stockholders’ interest. There can be no assurance that we will negotiate acceptable terms, enter into bindingagreements or successfully consummate any business combination or other transaction with this private company or any other thirdparties.

We cannot currently predict the effectsa future, potential business combination or other transaction would have on holders of our common stock, the pre-funded warrants,or common warrants, or any of our other securities. There are various uncertainties and risks relating to our evaluation and negotiationof possible business combination or other transactions, our ability to consummate such transactions and the consummation of suchtransactions, including:

A percentage of our sales occur outside of the U.S.As a result, we are subject to the economic, political, regulatory, legal, operational and other risks of international operations,which could adversely impact our businesses in many ways.

For the three and nine months ended June30, 2019, 72% and 60%, respectively, of our revenue was from customers located outside of the U.S. For fiscal 2018 and 2017, 45%and 27%, respectively, of our revenue was from customers located outside of the U.S. We believe that the revenue from the saleof our products and services outside the U.S. will continue to grow in the near future. We intend to expand our international operationsto the extent that suitable opportunities become available. Our foreign operations and sales could be adversely affected as a resultof:

In addition, as a U.S. company, we are requiredto comply with the economic sanctions and embargo programs administered by Office of Foreign Assets Control and similar multi-nationalbodies and governmental agencies worldwide, and the Foreign Corrupt Practices Act (“FCPA”). A violation of a sanctionor embargo program or of the FCPA or similar laws prohibiting certain payments to governmental officials, such as the U.K. BriberyAct, could subject us, and individual employees, to a regulatory enforcement action as well as significant civil and criminal penaltieswhich could adversely impact our business and operations.

Failure to attract and retain qualified scientific,production and managerial personnel could harm our business.

Recruiting and retaining qualified scientificand production personnel to perform and manage prototype, sample, and product manufacturing and business development personnelto conduct business development are critical to our success. In addition, our desired growth and expansion into areas and activitiesrequiring additional expertise, such as clinical testing, government approvals, production, sales and marketing will require theaddition of new management personnel and the development of additional expertise by existing management personnel. Because ourindustry is very competitive, we face significant challenges in attracting and retaining a qualified personnel base. Although webelieve we have been, and will continue to be, able to attract and retain these personnel, we cannot assure you that we will continueto be able to successfully attract qualified personnel in the future. The failure to attract and retain these personnel or, alternatively,to develop this expertise internally would harm our business since our ability to conduct business development and manufacturingwould be reduced or eliminated, resulting in lower revenues. We generally do not enter into employment agreements requiring ouremployees to continue in our employment for any period of time, with the exception of Dr. James A. Hayward, our Chairman, ChiefExecutive Officer and President. See “If we are unable to continue to retain the services of Dr. James A. Hayward, we maynot be able to continue our operations” above.

Our intellectual property rights are valuable, andany inability to protect them could reduce the value of our products, services and brand.

Our patents, trademarks, trade secrets,copyrights and all of our other intellectual property rights are important assets for us. There are events that are outside ofour control that pose a threat to our intellectual property rights as well as to our products and services. For example, effectiveintellectual property protection may not be available in every country in which our products and services are distributed. Theefforts we have taken to protect our proprietary rights may not be sufficient or effective. Any significant impairment of our intellectualproperty rights could harm our business or our ability to compete. Protecting our intellectual property rights is costly and timeconsuming. Any increase in the unauthorized use of our intellectual property could make it more expensive to do business and harmour operating results. Although we seek to obtain patent protection for our innovations, it is possible we may not be able to protectsome of these innovations. Given the costs of obtaining patent protection, we may choose not to protect certain innovations thatlater turn out to be important. There is always the possibility that the scope of the protection gained from one of our issuedpatents will be insufficient or deemed invalid or unenforceable. We also seek to maintain certain intellectual property as tradesecrets. The secrecy could be compromised by third parties, or intentionally or accidentally by our employees, which would causeus to lose the competitive advantage resulting from these trade secrets.

Intellectual property litigation could harm ourbusiness, financial condition and results of operations.

Litigation regarding patents and other intellectualproperty rights is extensive in the drug and biotechnology industry. In the event of an intellectual property dispute, we may beforced to litigate. This litigation could involve proceedings instituted by the U.S. Patent and Trademark Office or the InternationalTrade Commission, as well as proceedings brought directly by affected third parties. Intellectual property litigation can be extremelyexpensive, and these expenses, as well as the consequences should we not prevail, could seriously harm our business.

If a third party claims an intellectualproperty right to technology we use, we might need to discontinue an important product or product line, alter our products andprocesses, pay license fees or cease our affected business activities. Although we might under these circumstances attempt to obtaina license to this intellectual property, we may not be able to do so on favorable terms, or at all. Furthermore, a third partymay claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engagingin our normal operations and activities, including making or selling our products. These lawsuits are costly and could affect ourresults of operations and divert the attention of managerial and technical personnel. A court may decide that we are infringingthe third party’s patents and would order us to stop the activities covered by the patents. In addition, a court may orderus to pay the other party damages for having violated the other party’s patents. The drug and biotechnology industry hasproduced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover varioustypes of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretationis not always uniform. If we are sued for patent infringement, we would need to demonstrate that our products or methods of useeither do not infringe the patent claims of the relevant patent and/or that the patent claims are invalid, and we may not be ableto do this. Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcomethe presumption of validity enjoyed by issued patents.

Because some patent applications in theUnited States may be maintained in secrecy until the patents are issued, because patent applications in the United States and manyforeign jurisdictions are typically not published until eighteen months after filing, and because publications in the scientificliterature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technologycovered by our or our licensor’s issued patents or pending applications or that we or our licensors were the first to inventthe technology. During the ordinary course of our business, we do not conduct “prior art” searches before filing apatent application. Our competitors may have filed, and may in the future file, patent applications covering technology similarto ours. Any such patent application may have priority over our or our licensors’ patent applications and could further requireus to obtain rights to issued patents covering such technologies. If another party has filed a United States patent applicationon inventions similar to ours, we may have to participate in an interference proceeding declared by the U.S. Patent and TrademarkOffice to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it ispossible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respect to suchinventions.

Some of our competitors may be able to sustainthe costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition,any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on ourability to raise the funds necessary to continue our operations.

Accidents related to hazardous materials could adverselyaffect our business.

Some of our operations require the controlleduse of hazardous materials for chemical reactions and synthesis. These materials are common to molecular/biological/chemical laboratoriesand require no special handling or regulation. Although we believe our safety procedures comply with the standards prescribed byfederal, state, local and foreign regulations, the risk of accidental contamination of property or injury to individuals from thesematerials cannot be completely eliminated. In the event of an accident, we could be liable for any damages that result, which couldseriously damage our business and results of operations.

Potential product liability claims could affectour earnings and financial condition.

We face a potential risk of liability claimsbased on our products and services. Though we have product liability insurance coverage which we believe is adequate, we may notbe able to maintain this insurance at reasonable cost and on reasonable terms. We also cannot assure that this insurance will beadequate to protect us against a product liability claim, should one arise. In the event that a product liability claim is successfullybrought against us, it could result in a significant decrease in our liquidity or assets, which could result in the reduction ortermination of our business. A successful product liability claim or series of claims brought against us could cause our stockprice to decline, and, if judgments exceed our insurance coverage, could adversely affect our results of operations, prospects,and business. Product liability claims may result in impairment of our business reputation and other losses.

Litigation generally could affect our financialcondition and results of operations.

We generally may be subject to claims madeby and required to respond to litigation brought by customers, former employees, former officers and directors, former distributorsand sales representatives, former consultants and vendors and service providers. We have faced such claims and litigation in thepast and we cannot assure you that we will not be subject to claims in the future. In the event that a claim is successfully broughtagainst us, considering our lack of material revenue and the losses our business has incurred for the period from our inceptionto June 30, 2019, this could result in a significant decrease in our liquidity or assets, which could result in the reduction ortermination of our business.

Business disruptions could seriously harm our futurerevenue and financial condition and increase our costs and expenses.

Our operations could be subject to earthquakes,power shortages, telecommunications failures, cyber-attacks or other vulnerabilities in our computer systems, terrorism, watershortages, tsunamis, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, political or economicinstability, and other natural or manmade disasters or business interruptions. The occurrence of any of these business disruptionscould seriously harm our revenue and financial condition and increase our costs and expenses.

General economic conditions may adversely affectour business, operating results and financial condition.

A general weakening or decline in the globaleconomy or a period of economic slowdown may have serious negative consequences for our business and operating results. Since ourcustomers incorporate our products into a variety of consumer goods, the demand for our products is subject to worldwide economicconditions and their impact on levels of consumer spending. Some of the factors affecting consumer spending include general economicconditions, unemployment, consumer debt, reductions in net worth, residential real estate and mortgage markets, taxation, energyprices, interest rates, consumer confidence and other macroeconomic factors. During periods of economic weakness or uncertainty,demand for consumer goods incorporating our products may weaken, and current or potential customers may defer purchases of ourproducts.

A cybersecurity incident and other technology disruptionscould negatively affect our business and our relationships with customers.

We use technology in substantially all aspectsof our business operations. The widespread use of technology, including mobile devices, cloud computing, and the internet, giverise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information.Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectualproperty, including information relating to customers and suppliers, private information about employees, and financial and strategicinformation about us and our business partners. If we fail to effectively assess and identify cybersecurity risks associated withthe use of technology in our business operations, we may become increasingly vulnerable to such risks. Additionally, while we haveimplemented measures to prevent security breaches and cyber incidents, our preventative measures and incident response effortsmay not be entirely effective. The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential informationor intellectual property, or interference with our information technology systems or the technology systems of third parties onwhich we rely, could result in business disruption, negative publicity, brand damage, violation of privacy laws, loss of customers,potential liability and competitive disadvantage.

Risks Related to Regulatory Approval of Our Pharmaceuticaland Biotherapeutic Product Candidates and Other Legal Compliance Matters:

The regulatory approval processes of the FDA andcomparable foreign regulatory authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unableto obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will besubstantially harmed.

The time required to obtain approval bythe FDA and comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement ofclinical trials, and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved.In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change duringthe course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in theapproval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval processand may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical,clinical or other studies. We have not submitted for, or obtained regulatory approval for any product candidate, and it is possiblethat none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatoryapproval. Applications for our product candidates could fail to receive regulatory approval for a variety of reasons. This lengthyapproval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatoryapproval to market any of our product candidates, which would significantly harm our business, results of operations, and prospects.

Our product candidates may cause undesirable sideeffects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercialpotential, or result in significant negative consequences.

Adverse events or other undesirable sideeffects caused by our product candidates could cause us or regulatory authorities to interrupt, delay, or halt clinical trialsand could result in a more restrictive label or the delay or denial of regulatory approval by regulatory authorities. Side effectsrelated to a drug or biologic could affect patient recruitment, the ability of enrolled patients to complete the study, and/orresult in potential product liability claims.

Additionally, if one or more of our productcandidates receives marketing approval, and we or others later identify undesirable side effects or adverse events caused by suchproducts, a number of potentially significant negative consequences could result. Regulatory authorities may withdraw approvalsof such product or impose restrictions on distribution. They may require additional warnings or contraindications on the productlabel that could diminish the usage or otherwise limit the commercial success of the product. We may be required to change theway the product is administered, conduct additional clinical trials or post-approval studies. We may be forced to suspend marketingof the product or required to create a Risk Evaluation and Mitigation Strategy (“REMS”). In addition, our reputationmay suffer. Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate,if approved, and could significantly harm our business, results of operations, and prospects.

Obtaining and maintaining regulatory approval ofour product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our productcandidates in other jurisdictions.

Obtaining and maintaining regulatory approvalof our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approvalin any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effecton the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrativereview periods different from those in the United States, including additional preclinical studies or clinical trials as clinicaltrials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictionsoutside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.In some cases, the price that we intend to charge for our products is also subject to approval. There could be significant delays,difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. Failure to complywith the regulatory requirements in international markets or failure to receive applicable marketing approvals could reduce ourtarget market and harm our ability to realize the full market potential of our product candidates.

Even if we obtain regulatory approval for a productcandidate, our products will remain subject to extensive regulatory scrutiny.

If any of our product candidates areapproved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage,advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, andother post-market information, including both federal and state requirements in the United States and requirements ofcomparable foreign regulatory authorities. Ongoing regulatory requirements include ensuring that quality control andmanufacturing and production procedures conform to cGMP regulations, and we will be subject to continual review andinspections to assess compliance with cGMP regulations and adherence to commitments made in any regulatory filings.Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatorycompliance.

Any regulatory approvals that we receivefor our product candidates will be subject to limitations on the approved indicated uses for which the product may be marketedand promoted or to the conditions of approval (including the requirement to implement a REMS), or contain requirements for potentiallycostly post-marketing testing. We will be required to report certain adverse reactions and production problems, if any, to theFDA and comparable foreign regulatory authorities. Any new legislation addressing drug or biologic safety issues could result indelays in product development or commercialization, or increased costs to assure compliance. The FDA and other agencies, includingthe Department of Justice, closely regulate and monitor the post-approval marketing and promotion of products to ensure that theyare manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approvedlabeling. We will have to comply with requirements concerning advertising and promotion for our products. Promotional communicationswith respect to prescription drugs and biologics are subject to a variety of legal and regulatory restrictions and must be consistentwith the information in the product’s approved label. As such, we may not promote our products for indications or uses forwhich they do not have approval. The holder of an approved NDA must submit new or supplemental applications and obtain approvalfor certain changes to the approved product, product labeling, or manufacturing process. We could also be asked to conduct post-marketingclinical trials to verify the safety and efficacy of our products in general or in specific patient subsets. If original marketingapproval was obtained via the accelerated approval pathway, we could be required to conduct a successful post-marketing clinicaltrial to confirm clinical benefit for our products. An unsuccessful post-marketing study or failure to complete such a study couldresult in the withdrawal of marketing approval.

If a regulatory agency discovers previouslyunknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility wherethe product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may imposerestrictions on that product or us, including, but not limited to, requiring withdrawal or recall of the product from the market,imposing civil or criminal penalties, and imposing restrictions on our operations. Any government investigation of alleged violationsof law could require us to expend significant time and resources in response, and could generate negative publicity. Any failureto comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generaterevenue from our products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our Companyand our operating results will be adversely affected.

In addition, the FDA’s regulations,policies or guidance may change and new or additional statutes or government regulations in the United States and other jurisdictionsmay be enacted that could further restrict or regulate post-approval activities. We cannot predict the likelihood, nature or extentof adverse government regulation that may arise from pending or future legislation or administrative action. If we are not ableto achieve and maintain regulatory compliance, we may not be permitted to market our products and/or product candidates, whichwould adversely affect our ability to generate revenue and achieve or maintain profitability.

Healthcare legislative measures aimed at reducinghealthcare costs may have a material adverse effect on our business and results of operations.

Third party payors are developing increasinglysophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there havebeen a number of legislative and regulatory changes to the health care system that could impact our ability to sell our productsprofitably. In particular, in the United States in 2010, the Affordable Care Act, or ACA, was enacted. In addition, other legislativechanges have been proposed and adopted in the United States since the ACA was enacted. The repeal of or changes in some or allof the ACA and complying with any new legislation or reversing changes implemented under the ACA could be time-intensive and expensive,resulting in a material adverse effect on our business. Until the ACA is fully implemented or there is more certainty concerningthe future of the ACA, it will be difficult to predict its full impact and influence on our business.

There have been, and likely will continueto be, legislative and regulatory proposals at the foreign, federal and state levels directed at containing or lowering the costof healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurancecompanies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or imposeprice controls may adversely affect the demand for our product candidates, if we obtain regulatory approval, including: our abilityto receive or set a price that we believe is fair for our products; our ability to generate revenue and achieve or maintain profitability;the level of taxes that we are required to pay; and the availability of capital. We expect that the ACA, as well as other healthcarereform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding,more rigorous coverage criteria, lower reimbursement, and new payment methodologies. This could lower the price that we receivefor any approved product. Any denial in coverage or reduction in reimbursement from Medicare or other government-funded programsmay result in a similar denial or reduction in payments from private payors, which may prevent us from being able to generate sufficientrevenue, attain profitability or commercialize our product candidates, if approved.

Our employees, independent contractors, consultants,commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatorystandards and requirements.

We are exposed to the risk of fraud, misconductor other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct bythese parties could include intentional, reckless and negligent conduct that fails to: comply with the laws of the FDA and othercomparable foreign regulatory authorities; provide true, complete and accurate information to the FDA and other comparable foreignregulatory authorities; comply with manufacturing standards we have established; comply with healthcare fraud and abuse laws inthe United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to discloseunauthorized activities to us.

If we obtain FDA approval of any of ourproduct candidates and begin commercializing those products in the United States, our potential exposure under such laws will increasesignificantly, and our costs associated with compliance with such laws are also likely to increase. In particular, research, sales,marketing, education and other business arrangements in the healthcare industry are subject to extensive laws designed to preventfraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range ofpricing, discounting, educating, marketing and promotion, sales and commission, certain customer incentive programs and other businessarrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course ofpatient recruitment for clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. Wehave adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct by employeesand third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknownor unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from afailure to be in compliance with such laws. If any such actions are instituted against us, and we are not successful in defendingourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significantfines or other sanctions.

If we fail to comply with healthcare laws, we couldface substantial penalties and our business, operations and financial conditions could be adversely affected.

Healthcare providers, physicians and payorsplay a primary role in the recommendation and prescription of any product candidates for which we may obtain marketing approval.Our future arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare lawsand regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distributeany product candidates for which we may obtain marketing approval. Even though we do not and will not control referrals of healthcareservices or bill directly to Medicare, Medicaid or other third party payors, federal and state healthcare laws and regulationspertaining to fraud and abuse and patients’ rights are and will be applicable to our business. Restrictions under applicablefederal, state and foreign healthcare laws and regulations which may affect our ability to operate and expose us to areas of riskinclude: federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act; the federalHealth Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economicand Clinical Health Act of 2009; the federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations;federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentiallyharm consumers; and analogous state and foreign laws and regulations.

Because of the breadth of these laws andthe narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could,despite our efforts to comply, be subject to challenge under one or more of such laws. Efforts to ensure that our business arrangementswill comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authoritieswill conclude that our business practices may not comply with current or future statutes, regulations or case law interpretingapplicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we arenot successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, includingthe imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion fromparticipation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profitsand future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our businessand our results of operations. In addition, the approval and commercialization of any of our product candidates outside the UnitedStates will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

If we or any suppliers we engage fail to complywith environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs thatcould have a material adverse effect on the success of our business.

We and any suppliers we currently or mayin the future engage are subject to numerous federal, state, and local environmental, health, and safety laws, regulations, andpermitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment, anddisposal of hazardous and regulated materials and wastes; the emission and discharge of hazardous materials into the ground, air,and water; and employee health and safety. Under certain environmental laws, we could be held responsible for costs relating toany contamination at our current or past facilities and at third party facilities. We also could incur significant costs associatedwith civil or criminal fines and penalties. Compliance with applicable environmental laws and regulations may be expensive, andcurrent or future environmental laws and regulations may impair our research, product development and manufacturing efforts. Inaddition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. Althoughwe maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employeesresulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty, and general liability insurancepolicies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination.Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amountexceeding our resources, and our preclinical trials, future clinical trials or regulatory approvals could be suspended, which couldhave a material adverse effect on our business, prospects, financial condition, results of operations, and prospects.

Risks Related to Our Common Stock and Other Securities:

There are a large number of shares of common stockunderlying our outstanding options and warrants and the sale of these shares may depress the market price of our common stock andcause immediate and substantial dilution to our existing stockholders. The holders of our publicly traded warrants may requiretheir repurchase in certain circumstances.

As of September 16, 2019, we had 47,153,616shares of common stock issued and outstanding, outstanding options to purchase 7,972,504 shares of common stock, outstanding warrantsto purchase 11,213,527 shares of common stock, 3,391,916 shares of common stock issuable upon conversion of secured convertiblenotes and 5,563,759 shares available for grant under our 2005 Incentive Stock Plan. The issuance of shares upon exercise of ouroutstanding options and warrants will cause immediate and substantial dilution to our stockholders. Under our publicly traded warrants(including additional warrants sold privately that have registration rights), in the event of a “Fundamental Transaction”(as defined in the related warrant agreement, which generally includes any merger with another entity, the sale, transfer or otherdisposition of all or substantially all of our assets to another entity, or the acquisition by a person of more than 50% of ourcommon stock), each warrant holder will have the right at any time prior to the consummation of the Fundamental Transaction torequire us to repurchase the warrant for a purchase price in cash equal to the Black Scholes value (as calculated under the warrantagreement) of the then remaining unexercised portion of such warrant on the date of such Fundamental Transaction, which may materiallyadversely affect our financial condition and/or results of operations and may prevent or deter a third party from acquiring us.

We may require additional financing which may inturn require the issuance of additional shares of common stock, preferred stock or other debt or equity securities (including convertiblesecurities) and which would dilute the ownership held by our stockholders.

We may need to raise funds through eitherdebt or the sale of our shares of our common stock in order to achieve our business goals. Any additional shares issued would furtherdilute the percentage ownership held by the stockholders. Furthermore, if we raise funds in equity transactions through the issuanceof convertible securities which are convertible at the time of conversion at a discount to the prevailing market price, substantialdilution is likely to occur resulting in a material decline in the price of your shares. Our public offerings completed in November2014, April 2015, and December 2018, our registered direct public offering and concurrent private placement during November 2015,our private placements completed in November 2016, June 2017, and August 2019, and our registered direct offering in December 2017resulted in dilution to investors and future offerings of securities could result in further dilution to investors. Our privateplacements of secured convertible notes in August 2018, November 2018 and July 2019 could result in dilution to investors if theholders convert their notes into shares of our common stock. In particular, holders of such secured convertible notes, includingDr. Hayward and other directors, officers, and affiliates of the Company, converted substantial portions of such August 2018 Notesand November 2018 Notes into common stock of the Company in September 2019.

Conversion of our convertible notes into commonstock will result in additional dilution to our stockholders.

Upon satisfaction of certain conversionconditions (including conditions outside of our control, such as market price or trading price) and proper conversion of the CompanyNotes by a holder, we may be required to deliver shares of our common stock to a converting holder. If additional shares of ourcommon stock are issued due to conversion of some or all of the outstanding Company Notes, the ownership interests of existingstockholders will be diluted. Further, any sales in the public market of any shares of common stock issued upon conversion or hedgingor arbitrage trading activity that develops due to the potential conversion of the Company Notes could adversely affect prevailingmarket prices of our common stock.

Substantially all of our assets are encumbered.If we should fail to make timely payments on our secured convertible notes, holders of the notes may choose to enforce their remediesand ultimately realize on the collateral securing the notes, which includes substantially all of our intellectual property.

The Company issued and sold an aggregateof $1.65 million in principal amount of August 2018 Notes, of which $159,296 remain outstanding and $550,000 in principal amountof November 2018 Notes of which $52,334 remain outstanding. The Company issued and sold $1.5million in principal amount of July 2019 Notes, bearing interest at a rate of 6% per annum, in a non-brokered private placementwith Dillon Hill and simultaneously amended the terms of the Existing Notes. The outstanding Company Notes are due and payablein full on November 28, 2021 and are convertible, in whole or in part, at any time, at the option of the purchasers, into sharesof our common stock in an amount determined by dividing the principal amount of each Company Note, together with any and all accruedand unpaid interest, by the Conversion Price. A majority of the Existing Notes were owned by Dr. James A. Hayward, our Chairman,Chief Executive Officer and President. Dr. Hayward and other directors, officers, and affiliates of the Company converted the outstandingprincipal and unpaid interest of their Existing Notes, which represented more than 80% of the Existing Notes, into common stockof the Company in September 2019.

Until the principal and accrued but unpaidinterest under the Company Notes outstanding is paid in full, or the Company Notes are converted into shares of common stock, ourobligations under the Company Notes are secured by a lien on substantially all of our assets (excluding certain cash accounts)and the assets of APDN (B.V.I.) Inc., our wholly-owned subsidiary, in favor of Delaware Trust Company, as collateral agent forthe purchasers of the Company Notes. The secured assets also include substantially all of our intellectual property. In addition,on July 19, 2019, the Company also amended the security agreements dated as of October 19, 2018, to among other amendments, exclude20% of the Company’s equity interest in LRx from the assets securing the Company Notes. The existence of such lien may substantiallylimit our ability to obtain additional secured financing and force us to attempt to incur additional unsecured indebtedness, whichmay be unavailable to us. If we should fail to make timely payments on the Company Notes, holders of the Company Notes may chooseto enforce their remedies and ultimately realize on the collateral securing the Company Notes, which may have a material adverseeffect on our business, including the inability for us to continue our operations.

We may require additional financing in the future,which may not be available or, if available, may be on terms that cause a decline in the value of the shares of our common stockheld by stockholders.

If we raise capital in the future by issuingadditional securities, our stockholders may experience a decline in the value of the shares of our common stock they currentlyhold or may acquire prior to any such financing. In addition, such securities may have rights senior to the rights of holders ofour shares of common stock.

Any material weaknesses in our internal controlover financing reporting in the future could adversely affect investor confidence, impair the value of our common stock and increaseour cost of raising capital.

Any failure to remedy deficiencies in ourinternal control over financial reporting that may be discovered or our failure to implement new or improved controls, or difficultiesencountered in the implementation of such controls, could harm our operating results, cause us to fail to meet our reporting obligationsor result in material misstatements in our financial statements. Any such failure could, in turn, affect the future ability ofour management to certify that internal control over our financial reporting is effective. Inferior internal control over financialreporting could also subject us to the scrutiny of the SEC and other regulatory bodies which could cause investors to lose confidencein our reported financial information and could subject us to civil or criminal penalties or stockholder litigation, which couldhave an adverse effect on our results of operations and the market price of our common stock.

In addition, if we or our independent registeredpublic accounting firm identify deficiencies in our internal control over financial reporting, the disclosure of that fact, evenif quickly remedied, could reduce the market’s confidence in our financial statements and harm our share price. Furthermore,deficiencies could result in future non-compliance with Section 404 of the Sarbanes-Oxley Act of 2002. Such non-compliance couldsubject us to a variety of administrative sanctions, including review by the SEC or other regulatory authorities.

Short sellers of our stock may be manipulative andmay drive down the market price of our common stock.

Short selling is the practice of sellingsecurities that the seller does not own but rather has borrowed or intends to borrow from a third party with the intention of buyingidentical securities at a later date to return to the lender. A short seller hopes to profit from a decline in the value of thesecurities between the sale of the borrowed securities and the purchase of the replacement shares, as the short seller expectsto pay less in that purchase than it received in the sale. As it is therefore in the short seller’s interest for the priceof the stock to decline, some short sellers publish, or arrange for the publication of, opinions or characterizations regardingthe relevant issuer, its business prospects and similar matters calculated to or which may create negative market momentum, whichmay permit them to obtain profits for themselves as a result of selling the stock short. Issuers whose securities have historicallyhad limited trading volumes and/or have been susceptible to relatively high volatility levels can be particularly vulnerable tosuch short seller attacks. The publication of any such commentary regarding us in the future may bring about a temporary, or possiblylong term, decline in the market price of our common stock. In the past, the publication of commentary regarding us by a disclosedshort seller has been associated with the selling of shares of our common stock in the market on a large scale, resulting in aprecipitous decline in the market price per share of our common stock. No assurances can be made that similar declines in the marketprice of our common stock will not occur in the future, in connection with such commentary by short sellers or otherwise.

The price of our common stock may be volatile ormay decline, and the trading volume of our common stock may fluctuate, which may make it more difficult to realize a profit onyour investment in our shares of common stock.

Our common stock is listed on The NasdaqCapital Market. The trading price of our common stock has been and may continue to be volatile. In addition, the trading volumeof our common stock may fluctuate and cause significant price variations to occur. Volatility in the market price of our commonstock may prevent you from being able to sell your shares of common stock at or above the price you paid for your shares of commonstock, which may make it more difficult to realize a profit on your investment. A number of factors may affect the market priceof our common stock, including, but not limited to, the following:

In addition, Nasdaq and other securitiesmarkets have, from time to time, experienced extreme price and trading volume fluctuations. The market prices of securities ofbiotechnology and other life sciences companies in a comparable stage to ours historically have been particularly volatile, andtrading volume in such securities and our common stock has often been relatively low. Moreover, the securities and financial marketsin general have experienced substantial volatility that has often been unrelated or disproportionate to the operating results ofany individual company. During certain periods, specific industry sectors, such as the biotechnology segment, may experience greatervolatility than other sectors or the securities markets as a whole. These broad market fluctuations, during which our industryand companies at our stage may experience a stronger degree of market sensitivity, will adversely affect the market price of ourcommon stock.

In the past, following periods of volatilityin the market price of a company’s securities, stockholders have often instituted class action securities litigation againstthose companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources,which could significantly harm our reputation and materially adversely affect our business, financial condition and results ofoperations.

Risks Related to this Offering:

Management will have broad discretion as to theuse of proceeds from this offering and we may use the net proceeds in ways with which you may disagree.

We intend to use the net proceeds of thisoffering for general corporate purposes, which may include research and development expenses, capital expenditures, working capitaland general and administrative expenses, and potential acquisitions of or investments in businesses, products and technologiesthat complement our business, although we have no present commitments or agreements to make any such acquisitions or investmentsas of the date of this prospectus. Our management will have broad discretion in the application of the net proceeds from this offeringand could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. Accordingly,you will be relying on the judgment of our management on the use of net proceeds, and you will not have the opportunity, as partof your investment decision, to assess whether the proceeds are being used appropriately. Our failure to apply these funds effectivelycould have a material adverse effect on our business and cause the price of our common stock to decline.

Pending these uses, we intend to investthe funds in short-term, investment grade, interest-bearing securities. It is possible that, pending their use, we may invest thenet proceeds in a way that does not yield a favorable, or any, return for us.

The offering price will be set by our board of directorsand does not necessarily indicate the actual or market value of our common stock.

Our board of directors will approve theoffering price and other terms of this offering after considering, among other things: the number of shares authorized in our certificateof incorporation, as amended (the “Certificate of Incorporation”); the current market price of our common stock; tradingprices of our common stock over time; the volatility of our common stock; our current financial condition and the prospects forour future cash flows; the availability of and likely cost of capital of other potential sources of capital; the characteristicsof interested investors and market and economic conditions at the time of the offering. The offering price is not intended to bearany relationship to the book value of our assets or our past operations, cash flows, losses, financial condition, net worth orany other established criteria used to value securities. The offering price may not be indicative of the fair value of the commonstock.

If you purchase the common stock or pre-funded warrantssold in this offering, you will experience immediate dilution as a result of this offering and future equity issuances.

Because the price per share of our commonstock and pre-funded warrants being offered is higher than the book value per share of our common stock, you will suffer immediatesubstantial dilution in the net tangible book value of the common stock you purchase in this offering. See the section entitled“Dilution” of this prospectus for a more detailed discussion of the dilution you will incur if you purchase commonstock and pre-funded warrants in this offering. The issuance of additional shares of our common stock in future offerings couldbe dilutive to stockholders if they do not invest in future offerings. Moreover, to the extent that we issue options or warrantsto purchase, or securities convertible into or exchangeable for, shares of our common stock in the future and those options, warrantsor other securities are exercised, converted or exchanged, stockholders may experience further dilution.

There is no public market for thepre-funded warrants or common warrants being offered in this offering.

There is no establishedpublic trading market for the pre-funded warrants or common warrants being offered in this offering, and we do not expect a marketto develop. In addition, we do not intend to apply to list the pre-funded warrants or common warrants on any securities exchangeor nationally recognized trading system, including The Nasdaq Capital Market. Without an active market, the liquidity of the pre-fundedwarrants or common warrants will be limited.

Holders of pre-funded warrants orcommon warrants purchased in this offering will have no rights as common stockholders until such holders exercise their pre-fundedwarrants or common warrants and acquire our common stock.

Until holders of pre-fundedwarrants or common warrants acquire shares of our common stock upon exercise of the pre-funded warrants or common warrants, asapplicable, holders of pre-funded warrants or common warrants will have no rights with respect to the shares of our common stockunderlying such pre-funded warrants or common warrants. Upon exercise of the pre-funded warrants or common warrants, the holderswill be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercisedate.

Provisions of the common warrantsand pre-funded warrants offered by this prospectus could discourage an acquisition of us by a third party.

In addition to thediscussion of the provisions of our Certificate of Incorporation, certain provisions of the common warrants and pre-funded warrantsoffered by this prospectus could make it more difficult or expensive for a third party to acquire us. Such common warrants andpre-funded warrants prohibit us from engaging in certain transactions constituting “fundamental transactions” unless,among other things, the surviving entity assumes our obligations under the common warrants and pre-funded warrants. Further, thecommon warrants and pre-funded warrants provide that, in the event of certain transactions constituting “fundamental transactions,”with some exception, holders of such the common warrants and pre-funded warrants will have the right, at their option, to requireus to repurchase such the common warrants and pre-funded warrants at a price described in the common warrants and pre-funded warrants.These and other provisions of the common warrants and pre-funded warrants offered by this prospectus could prevent or deter a thirdparty from acquiring us even where the acquisition could be beneficial to you.

The exercise price of the commonwarrants and pre-funded warrants offered by this prospectus will be adjusted for certain dilutive events.

The exercise priceof the common warrants and pre-funded warrants offered by this prospectus is subject to adjustment for certain events, including,but not limited to, certain issuances and/or distributions of capital stock, options, convertible securities and other securities.However, the exercise prices will not be adjusted for dilutive issuances of securities considered “excluded securities”and there may be transactions or occurrences that may adversely affect the market price of our common stock or the market valueof such warrants without resulting in an adjustment of the exercise prices of such warrants.

The sale of our common stock and the common warrants inthis offering could result in the reset of the exercise price of certain outstanding warrants.

We have outstanding warrants to purchase1,005,000 shares of our common stock with an initial exercise price of $0.50 per share that is subject to adjustment. Subject tocertain exceptions, the terms of these warrants provide that (i) if we sell common stock at a price per share less than the then-currentexercise price, or securities which are convertible or exercisable into shares of common stock at an effective per share priceless than the then current exercise price, then we are required to reduce the exercise price of the warrants to be the lower priceof such subsequent sale, or (ii) if we sell securities which are convertible or exercisable into shares of common stock at a pricewhich varies or may vary with the market price of the shares of our common stock, including by way of one or more reset(s) to afixed price, the holders of such securities have the right to substitute the variable price for the exercise price.

In connection with the August2019 private placement offering of our common stock, the exercise price of these warrants was reduced to $0.30 per share.Should the market price of our common stock fall below the current exercise price of $0.30 or if we sell our common stockbelow $0.30 per share, and the common warrants are exercisable into shares of common stock at a price which varies or mayvary with the market price of the shares of our common stock, the sale of shares of our common stock and common warrants inthis offering may result in a reduction of the exercise price of those outstanding warrants to a price not less than $0.14per share, which will reduce the proceeds we might receive from their possible exercise.

Use of Proceeds

We estimate that the net proceeds from thisoffering will be approximately $             million, after deducting the underwriting discounts and commissions and estimated offering expensespayable by us and assuming no exercise of the common warrants. If the Underwriter exercises their over-allotment option in full,we estimate that our net proceeds will be approximately $             million, after deducting the underwriting discounts and commissions andestimated offering expenses payable by us. We will only receive additional proceeds from the exercise of the common warrants issuablein connection with this offering if such warrants are exercised at their exercise price of $             and the holders of such warrants paythe exercise price in cash upon such exercise. Such proceeds with respect to the common warrants could not exceed $             .

The foregoing discussion assumes (i) noexercise of the underwriter’s option to purchase up to an additional             shares of common stock and/or common warrants to purchaseup to an aggregate of             shares of common stock and (ii) no sale of pre-funded warrants.

We intend to use the net proceeds from thisoffering for general corporate purposes, which may include research and development expenses, capital expenditures, working capitaland general and administrative expenses, and potential acquisitions of or investments in businesses, products and technologiesthat complement our business, although we have no present commitments or agreements to make any such acquisitions or investmentsas of the date of this prospectus. Pending these uses, we intend to invest the funds in short-term, investment grade, interest-bearingsecurities. It is possible that, pending their use, we may invest the net proceeds in a way that does not yield a favorable, orany, return for us.

Our expected use of net proceeds from thisoffering represents our current intentions based upon our present plans and business condition. As of the date of this prospectus,we cannot currently allocate specific percentages of the net proceeds that we may use for the purposes specified above, and wecannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering,or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual use of the net proceedswill vary depending on numerous factors, including our ability to obtain additional financing. We may find it necessary or advisableto use the net proceeds for other purposes, and our management will have broad discretion in the application of the net proceeds,and investors will be relying on our judgment regarding the application of the net proceeds from this offering. See “RiskFactors” for a discussion of certain risks that may affect our intended use of the net proceeds from this offering.

Market Priceof our Common Stock and Related Stockholder Matters

Market Information

Our common stock is listed on TheNasdaq Capital Market under the symbol “APDN.” Our publicly traded warrants are listed on The Nasdaq CapitalMarket under the symbol “APDNW.” A description of the common stock that we are issuing in this offering is setforth under the heading “Description of Securities” beginning on page 49 of this prospectus. We do not intend toapply for the listing of the pre-funded warrants or common warrants that are part of this offering on any nationalsecurities exchange.

The last reported sale price for our commonstock on September 16, 2019 was $0.34 per share. The last reported sale price for our publicly traded warrants on September 16,2019 was $ 0.004 per share.

Holders

As of September 16, 2019, we had 457 recordholders of our common stock, 3 holders of record of our publicly traded warrants, and no preferred stock issued and outstanding.The number of record holders was determined from the records of our transfer agent and does not include beneficial owners of commonstock whose shares are held in the names of various security brokers, dealers, and registered clearing agencies. The transfer agentof our common stock and publicly traded warrants is American Stock Transfer & Trust Company, 6201 15th Avenue, Brooklyn, NewYork 11219.

Dividend Policy

We have never declared or paid any cashdividends on our common stock. We do not anticipate paying any cash dividends to stockholders in the foreseeable future. In addition,any future determination to pay cash dividends will be at the discretion of the board of directors and will be dependent upon ourfinancial condition, results of operations, capital requirements, and such other factors as the board of directors deem relevant.

Capitalization

The following table sets forth our capitalizationas of June 30, 2019:

The information set forth in the followingtable should be read in conjunction with and is qualified in its entirety by “Use of Proceeds” above, as well as our“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statementsand the notes to those financial statements incorporated by reference in this prospectus. See “The Offering” in thisprospectus for information relating to the expected number of shares of our common stock to be outstanding after this offering.Our capitalization following the closing of this offering will be adjusted based on the actual public offering price and otherterms of this offering determined at pricing.

*Assumes a $10,000,000 capital raise with net cash proceedsof $9,379,385; number of shares derived by dividing closing stock price on September 16, 2019 of $0.34. Each $0.05 increase (decrease)in the assumed public offering price per share would increase (decrease) the amount of cash and cash equivalents, working capital,total assets, and total stockholders’ equity by approximately $1,367,647, assuming the number of securities offered by us,as set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissionsand estimated offering expenses payable by us. We may also increase or decrease the number of securities to be issued in this offering.Each increase (decrease) of 1.0 million shares offered by us would increase (decrease) the as adjusted amount of cash and cashequivalents, working capital, total assets and total stockholders’ equity by approximately $316,200, assuming the assumedpublic offering price remains the same, and after deducting underwriting discounts and commissions and estimated offering expensespayable by us.

Transactions involvingwarrants are summarized as follows:

The discussion and tables above are basedon 38,327,057 shares of our common stock outstanding as of June 30, 2019, which excludes             shares of our common stock that may beissued upon exercise of pre-funded warrants and common warrants issued in this offering and any additional shares and/or commonwarrants that may be sold to cover over-allotments, if any, 7,929,446 shares of common stock issuable upon exercise of outstandingoptions, 16,293,527 shares of common stock issuable upon exercise of outstanding warrants, 5,606,817 shares available for grantunder our 2005 Incentive Stock Plan as of such date, and             shares of common stock initially issuable upon the common exercise ofthe common warrants to be issued pursuant to this prospectus.

Dilution

If you invest in our common stock and/orpre-funded warrants in this offering, your ownership interest will be diluted immediately to the extent of the difference betweenthe public offering price per share of our common stock and the as adjusted net tangible book value per share of our common stockafter this offering. Our net tangible book value as of June 30, 2019 was approximately ($2.8 million), or $(0.07) per share ofour common stock (based upon 38,327,057 shares of our common stock outstanding). Net tangible book value per share is equal toour total tangible assets less our total liabilities, divided by the number of shares of our outstanding common stock.

After giving effect to the sale of sharesof our common stock and accompanying common warrants in this offering at the assumed public offering price of $ 0.34 per share(the last reported sale price of our common stock on The Nasdaq Capital Market on September 16, 2019), and after deducting theestimated underwriting discount and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any,from the exercise of the common warrants and pre-funded warrants, if any, issued in this offering, our as adjusted net tangiblebook value as of June 30, 2019 would have been approximately $6,738,822 million, or $0.10 per share of common stock. This representsan immediate increase in as adjusted net tangible book value of $0.17 per share to our existing stockholders, and an immediatedilution of $ per share to new investors purchasing securities in this offering at the assumed public offering price.

The following table illustrates this dilutionon a per share basis:

A $0.05 increase in the assumedpublic offering price of $0.34 per share, which is the last reported sale price of our common stock on The Nasdaq CapitalMarket on September 16, 2019, would result in an increase in our as adjusted net tangible book value per share after thisoffering by approximately $0.01 and the dilution per share to new investors purchasing shares in this offering by $0.28assuming the number of securities offered by us as set forth on the cover page of this prospectus remains the same, and afterdeducting underwriting discounts and commissions and estimated offering expenses payable by us. A $0.05 decrease in theassumed public offering price of $0.34 per share, which is the last reported sale price of our common stock on The NasdaqCapital Market on September 16, 2019, would result in a decrease in our as adjusted net tangible book value pershare after this offering by approximately $0.01 and the dilution per share to new investors purchasing shares in thisoffering by $0.22 assuming the number of securities offered by us as set forth on the cover page of this prospectus remainsthe same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We mayalso increase or decrease the number of securities to be issued in this offering. Each increase (decrease) of 1.0 millionshares offered by us would increase (decrease) our as adjusted net tangible book value per share and the dilution per shareto new investors purchasing securities in this offering by $    assuming that the assumed public offering price remains thesame, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Theinformation discussed above is illustrative only and will be adjusted based on the actual public offering price and otherterms of this offering as determined between us and the Underwriter at pricing.

The foregoing discussion and table do nottake into account further dilution to investors in this offering that could occur upon the exercise of outstanding options andwarrants, including the pre-funded warrants and common warrants offered in this offering, having a per share exercise price lessthan the public offering price per share in this offering.

The discussion and tables above are basedon 38,327,057 shares of our common stock outstanding as of June 30, 2019, which excludes             shares of our common stock that may beissued upon exercise of pre-funded warrants and common warrants issued in this offering, 7,929,446 shares of common stock issuableupon exercise of outstanding options and 16,293,527 shares of common stock issuable upon exercise of outstanding warrants, 5,606,817shares available for grant under our 2005 Incentive Stock Plan as of such date, and             shares of common stock initially issuable uponthe common exercise of the common warrants to be issued pursuant to this prospectus.

The discussion and table above assume (i)no sale of pre-funded warrants, which, if sold, would reduce the number of shares of common stock that we are offering on a one-for-onebasis and (ii) no exercise of the underwriter’s option to purchase up to             additional shares of common stock and/or commonwarrants to purchase up to             shares of common stock. If the Underwriter exercises their over-allotment option in full, the as adjustednet tangible book value will increase to $             per share, representing an immediate increase to existing stockholders of $             per shareand an immediate dilution of $             per share to new investors.

To the extent that outstanding options orwarrants, new options are issued under our equity incentive plan, or we issue additional shares of common stock in the future,there may be further dilution to investors participating in this offering. In addition, we may choose to raise additional capitalbecause of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or futureoperating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of thesesecurities could result in further dilution to our stockholders.

SECURITYOWNERSHIP OF CERTAIN BENEFICIAL OWNERS
AND MANAGEMENT

The following table sets forth certain informationregarding the shares of our common stock beneficially owned as of September 16, 2019, (i) by each person who is known to us tobeneficially own 5% or more of the outstanding common stock, (ii) by each of our principal executive officer, our principal financialofficer and our other executive officers and by each of our directors and (iii) by all executive officers and directors as a group.

Unless otherwise indicated below, each personor entity has an address in care of our principal executive offices at 50 Health Sciences Drive, Stony Brook, New York 11790.

* indicates less than one percent

(1) Beneficial ownership is determined in accordance withthe rules of the SEC and generally includes voting or investment power with respect to the shares shown. Except as indicated byfootnote and subject to community property laws where applicable, to our knowledge, the stockholders named in the table have solevoting and investment power with respect to all shares of common stock shown as beneficially owned by them. A person is deemedto be the beneficial owner of securities that can be acquired by such person within 60 days upon the exercise of options, warrantsor convertible securities (in any case, the “Currently Exercisable Options”).

(2) Does not include the remaining unvested shares subjectto options granted on December 21, 2015 pursuant to the 2005 Incentive Stock Plan, which vest 25% of the underlying shares ratablyon each anniversary date thereafter until fully vested on the fourth anniversary date of grant, including 12,500 for each of Dr.Hayward, Ms. Jantzen and Ms. Murrah.

(3) Based upon 47,153,616 shares of common stock outstandingas of September 16, 2019. Each beneficial owner’s percentage ownership is determined by assuming that the Currently ExercisableOptions that are beneficially held by such person (but not those held by any other person) have been exercised and converted.

(4) Includes 2,671,262 shares underlying currently exercisableoptions and warrants.

(5) Includes 257,767 shares underlying currently exercisableoptions and warrants.

(6) Includes 213,177 shares underlying currently exercisableoptions for Messrs. Bitzer and Ryan.

(7) Includes 1,185,855 shares of common stock, 76,923 currentlyexercisable warrants to purchase our common stock and 193,563 shares of common stock issuable upon the conversion of secured convertiblenotes payable owned by Delabarta, Inc. (“Delabarta”), a wholly-owned subsidiary of ABARTA, Inc. (“ABARTA”).Mr. Bitzer is President and a member of the board of directors of each of Delabarta and ABARTA. Mr. Bitzer disclaims beneficialownership of the shares held by Delabarta except to the extent of his pecuniary interest therein.

(8) Includes 187,924 shares underlying currently exercisableoptions.

(9) Includes 209,308 shares underlying currently exercisableoptions.

(10) Includes 4,734,228 shares underlying currently exercisableoptions and warrants and 193,563 shares of common stock issuable upon conversion of secured convertible notes payable.

(11) Includes 152,830 shares underlying currently exercisableoptions.

(12) Includes 280,001 shares underlying currently exercisableoptions.

(13) Includes 360,001 shares underlying currently exercisableoptions.

(14) Includes 111,858 shares underlying currently exercisableoptions.

(15) This information is based on a Form 4 filed with theSEC on September 16, 2019 by William W. Montgomery. William W. Montgomery reported sole voting and sole dispositive power of 6,030,900shares of common stock. The address of William W. Montgomery is 34211 Seavey Loop Road, Eugene, Oregon 97405.

(16) This information is based on a Schedule 13G filedwith the SEC on July 24, 2019 by Bruce Grossman, the sole member of Dillon Hill. Bruce Grossman reported indirect beneficial ownership,and sole voting and sole dispositive power, of 2,777,777 shares of common stock, issuable upon conversion of secured convertiblenotes payable. Until October 13, 2019, Dillon Hill has the right to purchase up to an additional$500,000 principal amount of such July 2019 Notes, which would be convertible into an additional 925,925 shares of common stockof the Company.  The July 2019 Notes include a provision limiting conversion of such notes to the extent that conversionwould result in the holder beneficially owning more than 9.99% of the Company’s common stock. The address of BruceGrossman is c/o Dillon Hill Capital LLC, 200 Business Park Drive, Suite 306, Armonk, NY 10504.

CERTAINRELATIONSHIPS AND RELATED TRANSACTIONS

Delabarta /John Bitzer, III

John Bitzer, III, one of our directors, isPresident and Chief Executive Officer of ABARTA, a private, third- and fourth-generation family holding-company, which owns Delabarta.On June 23, 2014, Delabarta purchased 7,275 shares of our common stock at a purchase price of  $6.87 per share for grossproceeds of $50,000 in a private placement transaction. Delabarta also received 7,275 warrants to purchase shares of our commonstock as part of this private placement transaction. In connection with the investment in the Company by Delabarta during July2011, we agreed to use best efforts to nominate its designee, Mr. Bitzer, to the board of directors and elect Mr. Bitzer as a directorwithin 30 days of the closing and to nominate and include Mr. Bitzer on the slate of nominees for the board of directors for electionby stockholders at the annual meetings of stockholders for so long as Delabarta owns at least 2% of the outstanding shares of commonstock.

Other Relationships

June 2017 Private Placement

On June 28, 2017, our officers and directorspurchased approximately $545,000 of our common stock as part of a private placement in the dollar amounts listed below:

The Company Notes

On August 31, 2018, we entered intoa securities purchase agreement with certain investors, including Delabarta and William Montgomery, who subsequently becamea 5% or greater stockholder, and certain of our officers and directors, pursuant to which we issued and sold anaggregate of  $1.65 million in principal amount of August 2018 Notes. As of September 16, 2019, $159,296 remainsoutstanding on the August 2018 Notes. As of September 16, 2019, we have paid $102,251 of in-kind interest with respect to theAugust 2018 Notes, which increased the outstanding balance of our Company Notes.

On November 29, 2018, we entered intoa securities purchase agreement, pursuant to which we issued and sold an aggregate of  $550,000 in principal amount ofNovember 2018 Notes. Dr. Hayward, our chairman, president and chief executive officer, purchased $500,000 in principal amountof the November 2018 Notes. As of September 16, 2019, $52,334 remains outstanding on the November 2018 Notes. As of September16, 2019, we have paid $25,676 of in-kind interest with respect to the November 2018 Notes, which increased the outstanding balance of ourCompany Notes.

During September2019, certain holders of Company Notes, including our chief executive officer, president and chairman of the board of directors,the chief information officer, certain board members and William Montgomery, a 5% or greater stockholder, converted an aggregateof $1,887,974 of Company Notes into 3,496,247 shares of the Company’s common stock, which represented more than 80% of theExisting Notes.

On July 16, 2019, we entered into a securitiespurchase agreement, pursuant to which we issued and sold an aggregate of $1.5 million in principal amount of July 2019 Notes, ina non-brokered private placement with Dillon Hill, who subsequently became a 5% or greater stockholder. The sole member of DillonHill and indirect beneficial owner of the July 2019 Notes is Bruce Grossman. As of September 16, 2019, $1.5 million remains outstandingon the July 2019 Notes and no interest has been paid.

Under the terms of the July 2019 Notes, untilOctober 13, 2019, Dillon Hill has the right to purchase on the same terms as the July 16, 2019 sale up to an additional $500,000in principal amount of the July 2019 Notes, and up to an additional $1 million in principal amount of the July 2019 Notes if approvedby the Company. In addition, Dillon Hill was granted a right to participate in certain Subsequent Financings until July 16, 2020equal to the amount required for Dillon Hill to maintain its pro rata ownership of the Company as if the July 2019 Notes had beenfully converted into the Company’s common stock. Until October 13, 2019, Dillon Hill shall have the right to participatein full, including in this offering, for the first $1 million of such Subsequent Financing.

In connection with the issuance and saleof the July 2019 Notes, the Company simultaneously amended the terms of the Existing Notes to, among other amendments, (i) reducethe conversion price of the Existing Notes to $0.54 to facilitate their conversion into equity and (ii) change the maturity dateof the August 2018 Notes to be November 28, 2021. The Company Notes are convertible, in whole or in part, at any time, at the optionof the purchasers, into shares of our common stock, in an amount determined by dividing the principal amount of each Company Note,together with any and all accrued and unpaid interest, by the Conversion Price. We have the right to require the purchasers toconvert all or any part of their Company Notes into shares of our common stock at the Conversion Price if the price of our commonstock remains at a closing price of  $3.50 or more for a period of twenty consecutive trading days. The Company Notes aredue and payable in full on November 28, 2021.

After giving effect to the amendments tothe Existing Notes, the July 2019 Notes are substantially similar to the Existing Notes. The Company Notes bear interest at a rateof 6% per annum. Until the principal and accrued but unpaid interest under the Company Notes is paid in full, or converted intoshares of common stock pursuant to their terms, our obligations under the Company Notes will be secured by a lien on substantiallyall assets of the Company and the assets of APDN (B.V.I.) Inc., our wholly-owned subsidiary, in favor of Delaware Trust Company,as collateral agent for the purchasers pursuant to related security agreements. In addition, on July 19, 2019, the Company alsoamended the security agreements dated as of October 19, 2018, to among other amendments, exclude 20% of the Company’s equityinterest in LRx from the assets securing the Company Notes.

Upon any Change in Control (as defined inthe Company Notes), the purchasers have the right to require us to redeem the Company Notes, in whole or in part, at a redemptionprice equal to such Company Notes’ outstanding principal balance plus accrued interest. The Company Notes contain certainnegative covenants that restrict the Company, including prohibitions or limitations, among other things, on the incurrence of additionalindebtedness, subsidiary asset sales, intercompany loans, liens, amendments to the Company’s organization documents, dividends,and redemptions without consent of the Required Holders (as defined in the Company Notes).

The Company Notes contain certain eventsof default that are customarily included in financings of this nature. If an event of default occurs, the holders of the CompanyNotes (by an affirmative vote of the holders of the Company Notes representing at least 30% of the aggregate principal amount ofthe Company Notes then outstanding) may require the Company to redeem the Company Notes, in whole or in part, at a redemption priceequal to the greater of (i) their outstanding principal balance, plus all accrued and unpaid interest, divided by the ConversionPrice, multiplied by the VWAP on the date the redemption price is either (x) demanded or otherwise due or (y) paid in full, whicheverhas a higher VWAP, or (ii) 130% of the outstanding principal, plus all accrued and unpaid interest.

We also entered into related registrationrights agreements with the purchasers of the Company Notes, pursuant to which the Company has agreed to prepare and file a registrationstatement with the SEC to register under the Securities Act resales from time to time of the common stock issued or issuable uponconversion or redemption of the Notes. We are required to file a registration statement within 60 days of receiving a demandregistration request from holders of a majority of the outstanding principal balance of the Company Notes, and to cause the registrationstatement to be declared effective within 45 days (or 90 days if the registration statement is reviewed by the SEC).

August 2019 Private Placement

On August 22, 2019, we issued and sold 1,548,151shares of common stock at a price of $0.27 per share for total gross proceeds of $418,000 to a group of accredited investors, includingour chief executive officer, president and chairman of the board of directors, our chief information officer, and William Montgomery,a 5% or greater stockholder.

Director Independence

The board of directors has determined thatcurrently and at all times since the fiscal year ended September 30, 2018, each of our directors other than Dr. Hayward—consistingof John Bitzer, III, Robert B. Catell, Joseph D. Ceccoli, Charles S. Ryan, Yacov A. Shamash, Sanford R. Simon, and Elizabeth M.Schmalz Ferguson —are and were “independent” as defined by the listing standards of Nasdaq, constituting a majorityof independent directors on our board of directors as required by the rules of Nasdaq. The board of directors considers in itsevaluation of independence whether any director has a relationship with us that would interfere with the exercise of independentjudgment in carrying out his or her responsibilities of a director.

Descriptionof Securities

The following description of our commonstock, pre-funded warrants, and accompanying common warrants summarizes the material terms and provisions of the common stock thatwe may issue in connection with this offering. It may not contain all the information that is important to you. For the completeterms of our common stock, please refer to our Certificate of Incorporation and our by-laws (“By-Laws”), which arefiled as exhibits to the registration statement which includes this prospectus. See “Where You Can Find More Information”and “Incorporation by Reference.” The Delaware General Corporation Law (“DGCL”) may also affect the termsof these securities. The summary below is qualified in its entirety by reference to our Certificate of Incorporation and By-Laws,each as in effect at the time of any offering of securities under this prospectus.

As of September 16, 2019, ourauthorized capital stock consists of 500,000,000 shares of common stock, par value $0.001 per share, of which 47,153,616shares were issued and outstanding, and 10,000,000 shares of preferred stock, par value $0.001 per share, of which no shareswere issued and outstanding. In addition, as of September 16, 2019, there were issued and outstanding options to purchase7,972,504 shares of common stock, warrants to purchase 11,213,527 shares of our common stock and 5,563,759 shares availablefor grant under our 2005 Incentive Stock Plan. The authorized and unissued shares of common stock and preferred stock areavailable for issuance without further action by our stockholders.

Common Stock

Each stockholder of our common stock isentitled to one vote for each share issued and outstanding held on all matters to be voted upon by the stockholders. Our sharesof common stock have no preemptive, conversion, or redemption rights. The rights, preferences, and privileges of the holders ofcommon stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock.Upon the sale of substantially all of our stock or assets or dissolution, liquidation or winding up, and after all liquidationpreferences payable to any series of preferred stock entitled thereto have been satisfied, our remaining assets shall be distributedto all holders of common stock and any similarly situated stockholders who are not entitled to any liquidation preference or, ifthere be an insufficient amount to pay all such stockholders, then ratably among such holders. All of our issued and outstandingshares of common stock are fully paid and non-assessable. The holders of shares of our common stock will be entitled to such cashdividends as may be declared from time to time by our board of directors from funds available therefor.

The shares of common stock offered by thisprospectus, when issued and paid for, will also be, fully paid and non-assessable.

Our common stock is listed on The NasdaqCapital Market under the symbol “APDN.” American Stock Transfer & Trust Company, located in Brooklyn, New York,is the transfer agent and registrar for our common stock.

Preferred Stock

Our Certificateof Incorporation provides that our board of directors may, by resolution, designate classes of preferred stock in the future. Thedesignated series of preferred stock shall have such powers, designations, preferences and relative, participation or optionalor other special rights and qualifications, limitations or restrictions as shall be expressed in the resolution adopted by theboard of directors. Once designated by our board of directors, each series of preferred stock will have specific financial andother terms described in the documents that govern the preferred stock, which include our Certificate of Incorporation and anycertificates of designation that our board of directors may adopt. Prior to the issuance of shares of each series of preferredstock, the board of directors is required by the DGCL and our Certificate of Incorporation to adopt resolutions and file a certificateof designations with the Secretary of State of the State of Delaware. The certificate of designations fixes for each class or seriesthe designations, powers, preferences, rights, qualifications, limitations and restrictions, including, but not limited to, someor all of the following:

Althoughour board of directors has no intention at the present time of doing so, it could authorize the issuance of a series of preferredstock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt.

Warrants

The followingdescription summarizes the material terms and provisions of our publicly traded warrants and any related warrant agreement andwarrant certificate. While the terms summarized below will apply generally to any warrants that we may offer, we will describethe specific terms of any series of warrants in more detail in the documents that govern the warrants. Specific warrant agreementswill contain additional important terms and provisions.

We mayissue warrants for the purchase of common stock, preferred stock and/or debt securities in one or more series. We may issue warrantsindependently or together with common stock, preferred stock and/or debt securities, and the warrants may be attached to or separatefrom these securities. We will evidence each series of warrants by warrant certificates that we may issue under a separate agreement.The designations, powers, preferences, rights, qualifications, limitations and restrictions of a series of warrants may include,but may not be limited to, some or all of the following:

Common Warrants

The following summary of certain termsand provisions of common warrants that are being offered hereby is not complete and is subject to, and qualified in its entiretyby, the provisions of the common warrant, the form of which is filed as an exhibit to the registration statement of which thisprospectus 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.

We are selling to investors in this offeringshares of our common stock with accompanying common warrants to purchase             shares of our common stock and/or pre-funded warrantswith accompanying common warrants to purchase             shares of our common stock at a combined purchase price of $             for shares and accompanyingcommon warrants and $             for pre-funded warrants and accompanying common warrants.

Each common warrant will be exercisablebeginning on the Initial Exercise Date, which is the date of closing, at an exercise price of $             per share, subject to adjustment.The common warrants will be exercisable for five years from the Initial Exercise Date, but not thereafter. No fractional sharesof common stock will be issued in connection with the exercise of a common warrant. In lieu of fractional shares, we will roundup to the next whole share. The common warrants include an adjustment provision that, subject to certain exceptions, reduces theirexercise price if the Company issues common stock or common stock equivalents at a price lower than the then-current exercise priceof the common warrants, subject to a minimum exercise price of $             per share.

The common warrants are subject to a callprovision whereby we may, subject to certain provisions including that the VWAP of the Company’s common stock has exceeded            % of the exercise price for consecutive trading days, call for cancellation of all or any portion of the common warrant not yetexercised.

Subject to limited exceptions, aholder of common warrants will not have the right to exercise any portion of its common warrants if the holder, together withits affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, 9.99%) of the number of sharesof our common stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”);provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the BeneficialOwnership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%.

The common warrants contain a “cashlessexercise” feature that allows holders to exercise the common warrants without a cash payment to the Company upon the termsset forth in the common warrants, if, at the time of exercise there is no effective registration statement registering, or theprospectus contained therein is not available for the issuance of the shares to the exercising common warrant holder.

In the case of certain fundamental transactionsaffecting the Company, a holder of common warrants, upon exercise of such common warrants after such fundamental transaction, willhave the right to receive, in lieu of shares of the Company’s common stock, the same amount and kind of securities, cashor property that such holder would have been entitled to receive upon the occurrence of the fundamental transaction, had the commonwarrants been exercised immediately prior to such fundamental transaction. In lieu of such consideration, a holder of common warrantsmay instead elect to receive a cash payment based upon the Black-Scholes value of their common warrants.

The exercise price and number of the sharesof our common stock issuable upon the exercise of the common warrants will be subject to adjustment in the event of any stock dividendsand splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the common warrants.

Pre-Funded Warrants

The following summary of certain termsand provisions of pre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in its entiretyby, the provisions of the pre-funded warrant, the form of which is filed as an exhibit to the registration statement of which thisprospectus 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.

Each pre-funded warrantoffered hereby will have an initial exercise price per share equal to $0.01. The pre-funded warrants will be immediately exercisableand may be exercised at any time until the pre-funded warrants are exercised in full. The exercise price and number of shares ofcommon 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. The pre-funded warrants will be issued separately from theaccompanying common warrants, and may be transferred separately immediately thereafter.

The pre-funded warrantswill be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompaniedby payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashlessexercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the pre-funded warrant tothe extent that the holder would own more than 4.99 % of the outstanding common stock immediately after exercise, except that uponat least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stockafter exercising the holder’s pre-funded warrants up to 9.9 % of the number of shares of our common stock outstanding immediatelyafter giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-fundedwarrants. Purchasers of pre-funded warrants in this offering may also elect prior to the issuance of the pre-funded warrants tohave the initial exercise limitation set at 9.9% of our outstanding common stock. No fractional shares of common stock will beissued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares, we will either pay the holder anamount in cash equal to the fractional amount multiplied by the exercise price or round up to the next whole share.

If, at the timea holder exercises its pre-funded warrants, a registration statement registering the issuance of the shares of common stock underlyingthe pre-funded warrants under the Securities Act is not then effective or available and an exemption from registration under theSecurities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplatedto be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon suchexercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth inthe pre-funded warrants.

Subject to applicablelaws, a pre-funded warrant may be transferred at the option of the holder upon surrender of the pre-funded warrant to us togetherwith the appropriate instruments of transfer.

We do not intend tolist the pre-funded warrants on any securities exchange or nationally recognized trading system. Except as otherwise provided inthe pre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the pre-fundedwarrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercisetheir pre-funded warrants.

Possible Anti-Takeover Effects of Delaware Law and ourCertificate of Incorporation and By-Laws

Our Certificate of Incorporation containsprovisions that could make it more difficult to acquire control of our company by means of a tender offer, open market purchases,a proxy contest or otherwise. A description of these provisions is set forth below.

Anti-Takeover Effects of Delaware Law

Companies incorporated in Delaware are subjectto the provisions of Section 203 of the DGCL, or Section 203, unless the corporation has “opted out” of these provisionswith an express provision in its original certificate of incorporation or an express provision in its certificate of incorporationor by-laws resulting from a stockholders’ amendment approved by at least a majority of the outstanding voting shares. Wehave opted out of Section 203 with an express provision in our Certificate of Incorporation. Therefore, the anti-takeover effectsof Section 203 do not apply to us.

In general, Section 203 prohibits a publicly-heldDelaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-yearperiod following the time that this stockholder becomes an interested stockholder, unless the business combination is approvedin a prescribed manner. A “business combination” includes, among other things, a merger, asset or stock sale or othertransaction resulting in a financial benefit to the interested stockholder. An “interested stockholder” is a personwho, together with affiliates and associates, owns, or did own within three years prior to the determination of interested stockholderstatus, 15% or more of the corporation’s voting stock.

Under Section 203, a business combinationbetween a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions: before thestockholder became interested, the board of directors approved either the business combination or the transaction which resultedin the stockholder becoming an interested stockholder; upon consummation of the transaction which resulted in the stockholder becomingan interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding atthe time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by personswho are directors and also officers, and employee stock plans, in some instances; or at or after the time the stockholder becameinterested, the business combination was approved by the board of directors of the corporation and authorized at an annual or specialmeeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned bythe interested stockholder.

Election and Removal of Directors

Directors will be elected by a pluralityof the voting power of the shares present in person or represented by proxy at the meeting and entitled to vote on the electionof directors. Our Certificate of Incorporation does not provide for a classified board of directors or for cumulative voting inthe election of directors. Under Article VIII of the Certificate of Incorporation and Section 3.13 of the By-Laws, directors maybe removed by the stockholders of the Company only for cause, and in such case only by the affirmative vote of the holders of atleast a majority of the voting power of the issued and outstanding shares of capital stock of the Company then entitled to votein the election of directors. On December 21, 2015, the Court of Chancery of the State of Delaware invalidated as a matter of lawprovisions of the certificate of incorporation and bylaws of VAALCO Energy, Inc. (“VAALCO”), a Delaware corporation,that permitted the removal of VAALCO’s directors by its stockholders only for cause. In In re VAALCO Energy, Inc. StockholderLitigation, Consol. C.A. No. 11775-VCL (Del. Ch. Dec. 21, 2015), the Court ruled from the bench to hold that, in the absenceof a classified board or cumulative voting, VAALCO’s “only for-cause” director removal provisions conflict withSection 141(k) of the DGCL and are therefore invalid. Because the Company’s Certificate of Incorporation and By-Laws containsimilar “only for-cause” director removal provisions and the Company does not have a classified board of directorsor cumulative voting, the Company will not attempt to enforce the foregoing “only for-cause” director removal provisionin light of the recent VAALCO decision.

Size of Board and Vacancies

Theauthorized number of directors may be determined by the board of directors, provided the board shall consist of at least one (1)member. No decrease in the number of directors constituting the board shall shorten the term of any incumbent director.

Vacanciesoccurring on our board of directors for any reason and newly created directorships resulting from an increase in the authorizednumber of directors may be filled only by a vote of a majority of the remaining members of the board of directors, although lessthan a quorum, or by a sole remaining director, at any meeting of the board of directors.

Amendment

TheCertificate of Incorporation may be amended in the manner prescribed by the DGCL. The board of directors is authorized to adopt,amend, alter or repeal the By-Laws by the affirmative vote of at least a majority of the board of directors then in office. Noamendment to the Certificate of Incorporation or the By-Laws may adversely affect any indemnification right or protection of anydirector, officer, employee or other agent existing at the time of such amendment, repeal or adoption of an inconsistent provisionfor or in respect of any act, omission or other matter occurring, or any action or proceeding accruing or arising prior to suchamendment, repeal or adoption of an inconsistent provision.

Authorized but Unissued Shares of Common Stock and ofPreferred Stock

We believe that the availability of the“Blank Check” preferred stock under our Certificate of Incorporation provides us with flexibility in addressing corporateissues that may arise. The board of directors has the power, subject to applicable law, to issue series of preferred stock thatcould, depending on the terms of the series, impede the completion of a merger, tender offer or other takeover attempt that some,or a majority, of the stockholders might believe to be in their best interests or in which stockholders might receive a premiumfor their stock over the then prevailing market price of the stock. Our board of directors may issue preferred stock with votingrights or conversion rights that, if exercised, could adversely affect the voting power of the holders of common stock.

The authorized shares of preferred stock,as well as shares of common stock, will be available for issuance without further action by our stockholders, unless action isrequired by applicable law or the rules of any stock exchange on which our securities may be listed. Having these authorized sharesavailable for issuance allows us to issue shares without the expense and delay of a special stockholders’ meeting. We mayuse additional shares for a variety of purposes, including future public offerings to raise additional capital, to fund acquisitionsand as employee compensation. The existence of authorized but unissued shares of common stock and preferred stock could rendermore difficult or discourage an attempt to obtain control of our company by means of a proxy contest, tender offer, merger or otherwise.The above provisions may deter a hostile takeover or delay a change in control or management of our company.

Advance Notice Procedure

Our By-Laws provide an advance notice procedurefor stockholders to nominate director candidates for election or to bring business before an annual meeting of stockholders. Onlypersons nominated by, or at the direction of, our board of directors or by a stockholder of record who has given proper and timelynotice to our secretary prior to the meeting at which such stockholder is entitled to vote and appears, will be eligible for electionas a director. In addition, any proposed business other than the nomination of persons for election to our board of directors mustconstitute a proper matter for stockholder action pursuant to a proper notice of meeting delivered to us. For notice to be timely,it must generally be delivered to our secretary not less than 90 nor more than 120 calendar days prior to the first anniversaryof the previous year’s annual meeting (or if the date of the annual meeting is more than 30 calendar days before or morethan 60 calendar days after the anniversary date of the previous year’s annual meeting, not earlier than the 120th calendarday prior to such meeting and not later than either the 90th calendar day prior to such meeting or the 10th calendar day afterpublic disclosure of the date of such meeting is first made by us). These advance notice provisions may have the effect of precludingthe conduct of certain business at a meeting if the proper procedures are not followed or may discourage or deter a potential acquirerfrom conducting a solicitation of proxies to elect its own slate of directors or otherwise attempt to obtain control of us.

Special Meetings of Stockholders

Our By-Laws provide that special meetingsof stockholders may be called only by the Chairman of the Board, the Chief Executive Officer, or the board of directors pursuantto a resolution adopted by a majority of the board.

UNDERWRITING

Listing

We are offering up to       shares of ourcommon stock and accompanying common warrants, and pre-funded warrants. Our common stock is listed on The Nasdaq CapitalMarket under the symbol “APDN.” Our publicly traded warrants are listed on The Nasdaq Capital Market under thesymbol “APDNW.” There is no certainty that the common stock or the publicly traded warrants will continue to belisted. We do not intend to apply for the listing of the pre-funded warrants or common warrants that are part of thisoffering on any national securities exchange.

Underwriter and Underwriting Obligation

We have entered into an underwriting agreementdated             , 2019 with the Underwriter acting as the sole underwriter and book-running manager for this offering. Subject to the termsand conditions of the underwriting agreement, the Underwriter has agreed to purchase, and we have agreed to sell to it, the numberof our securities set forth on the cover page of this prospectus.

The underwriting agreement provides thatthe obligations of the Underwriter to pay for and accept delivery of the shares of our common stock and accompanying common warrantsand/or pre-funded warrants and accompanying common warrants is subject to the approval of certain legal matters by its counseland to certain other conditions. The Underwriter is obligated to take and pay for all of the shares of common stock and/or pre-fundedwarrants and common warrants offered hereby if any of such securities are purchased. We have granted the Underwriter an over-allotmentoption. This option, which is exercisable for up to 45 days after the date of this prospectus, permits the Underwriter to purchaseup to             shares of common stock and/or common warrants at a price of $             per share exercisable for up to             shares of common stock fromus to cover over-allotments, if any.

The Underwriter has advised us that it doesnot intend to confirm sales to any account over which it exercises discretionary authority.

Underwriting Commissions and Discount and Expenses

We have agreed to pay the Underwriter acash fee equal to 7% of the gross proceeds raised in this offering The Underwriter proposes to offer the shares of commonstock, the pre-funded warrants, and accompanying common warrants directly to the public at the public offering price set forthon the cover page of this prospectus. After the offering to the public, the offering price and other selling terms may be changedby the Underwriter without changing the proceeds we will receive from the Underwriter.

The following table summarizes the publicoffering price, underwriting commissions and proceeds before expenses to us assuming no exercise of the Underwriter’s optionto purchase up to an additional             shares of common stock and/or common warrants to purchase             shares of common stock at the publicoffering price, less the underwriting discount. The underwriting commissions are equal to the public offering price per share lessthe amount per share the Underwriter pays us for the shares of common stock, the pre-funded warrants and/or common warrants.

We estimate the total expenses payable byus for this offering to be approximately $             which amount includes (i) the underwriting discount of $             ($             if the Underwriter’sover-allotment option is exercised in full) and (ii) reimbursement of the accountable expenses of the Underwriter up to a maximumof $75,000 including the legal fees of the Underwriter being paid by us, regardless of whether the offering is consummated, and(iii) other estimated company expenses of approximately $             which includes legal, accounting, printing costs and various fees associatedwith the registration and listing of our shares. The securities we are offering are being offered by the Underwriter subject tocertain conditions specified in the underwriting agreement.

Over-allotment Option

We have grantedto the Underwriter an option exercisable not later than 45 days after the date of this prospectus to purchase up to            additional shares of common stock and/or commonwarrants to purchase             shares of common stock at thepublic offering price per share of common stock and/or common warrant set forth on the cover page hereto less theunderwriting discounts and commissions. The Underwriter may exercise the option solely to cover over-allotments, if any,made in connection with this offering. If any additional shares of common stock and/or common warrants are purchased pursuantto the over-allotment option, the Underwriter will offer these shares of common stock and/or common warrants on the sameterms as those on which the other securities are being offered.

Determination of Offering Price

Our common stock is currently traded onThe Nasdaq Capital Market under the symbol “APDN.” On September 16, 2019 the closing price of our common stock was$0.34 per share.

There is a material disparity between theoffering price of the shares of our common stock being offered under this prospectus and pre-funded warrants and the market priceof the common stock at the date of this prospectus. We believe that the market price of our common stock at the date of this prospectusis not the appropriate offering price for the shares of our common stock because the market price is affected by a number of factors.The public offering price was determined by negotiation by us and the Underwriter. The principal factors considered by us and theUnderwriter in determining the public offering price included:

The offering price stated on the cover pageof this prospectus should not be considered an indication of the actual value of the shares of common stock and accompanying commonwarrants and/or pre-funded warrants and accompanying common warrants sold in this offering. That price is subject to change asa result of market conditions and other factors and we cannot assure you that the shares of common stock and accompanying commonwarrants and/or pre-funded warrants and accompanying common warrants sold in this offering can be resold at or above the publicoffering price.

Lock-up Agreements

Our officers, directors, and 5% orgreater stockholders, representing 27.42% of our outstanding shares of common stock, areexpected to agree with the Underwriter to be subject to a lock-up period of 180 days following the closing of this offering.This means that, during the applicable lock-up period, such persons may not offer for sale, contract to sell, sell,distribute, grant any option, right or warrant to purchase, pledge, hypothecate or otherwise dispose of, directly orindirectly, any shares of our common stock or any securities convertible into, or exercisable or exchangeable for, shares ofour common stock. Certain limited transfers are permitted during the lock-up period if the transferee agrees to these lock-uprestrictions. We have also agreed, in the underwriting agreement, to similar lock-up restrictions on the issuance and sale ofour securities for 180 days following the closing of this offering, although we will be permitted to issue stock options orstock awards to directors, officers and employees under our existing plans. The lock-up period is subject to an additionalextension to accommodate for our reports of financial results or material news releases. The Underwriter may, in its solediscretion and without notice, waive the terms of any of these lock-up agreements.

Transfer Agent and Registrar

The transfer agent and registrar for ourcommon stock is American Stock Transfer & Trust Company, LLC.

Price Stabilization, Short Positions and Penalty Bids

In connection with this offering, the Underwritermay engage in transactions that stabilize, maintain or otherwise affect the price of our common stock. Specifically, the Underwritermay over-allot in connection with this offering by selling more shares of common stock than are set forth on the cover page ofthis prospectus. This creates a short position in our common stock for the Underwriter’s own account. The short positionmay be either a covered short position or a naked short position. In a covered short position, the number of shares of common stockover-allotted by the Underwriter is not greater than the number of shares of common stock that they may purchase in the over-allotmentoption. In a naked short position, the number of shares of common stock involved is greater than the number of shares of commonstock in the over-allotment option. To close out a short position, the Underwriter may elect to exercise all or part of the over-allotmentoption. The Underwriter may also elect to stabilize the price of our common stock or reduce any short position by bidding for,and purchasing, common stock in the open market.

The Underwriter may also impose a penaltybid. This occurs when a particular underwriter or dealer repays selling concessions allowed to it for distributing a security inthis offering because the Underwriter repurchases that security in stabilizing or short covering transactions.

Finally, the Underwriter may bid for, andpurchase, shares of our common stock in market making transactions, including “passive” market making transactionsas described below.

These activities may stabilize or maintainthe market price of our common stock at a price that is higher than the price that might otherwise exist in the absence of theseactivities. The Underwriter is not required to engage in these activities, and may discontinue any of these activities at any timewithout notice. These transactions may be effected on The Nasdaq Capital Market, in the over-the-counter market, or otherwise.

In connection with this offering, the Underwriterand selling group members, if any, or their affiliates may engage in passive market making transactions in our common stock immediatelyprior to the commencement of sales in this offering, in accordance with Rule 103 of Regulation M under the Exchange Act. Rule 103generally provides that:

Our Relationship with the Underwriter

The Underwriter and its affiliates haveengaged, and may in the future engage, in investment banking transactions and other commercial dealings in the ordinary courseof business with us or our affiliates. The Underwriter has received, or may in the future receive, customary fees and commissionsfor these transactions. As of the date hereof, an affiliate of the Underwriter holds warrants to purchase 128,800, 163,720, 51,137,and 50,000 shares of our common stock with an exercise prices of $3.73, $3.44, $2.53, and $4.01 per share, respectively.

In addition, in the ordinary course of theirbusiness activities, the Underwriter and its affiliates may make or hold a broad array of investments and actively trade debt andequity securities (or related derivative securities) for their own account and for the accounts of their customers. Such investmentsand securities activities may involve securities and/or instruments of ours or our affiliates. The Underwriter and its affiliatesmay also make investment recommendations and/or publish or express independent research views in respect of such securities orfinancial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such securities andinstruments.

Indemnification

We have agreed to indemnify the Underwriteragainst liabilities relating to the offering arising under the Securities Act and the Exchange Act, liabilities arising from breachesof some or all of the representations and warranties contained in the underwriting agreement, and to contribute to payments thatthe Underwriter may be required to make for these liabilities.

The underwriting agreement will be filedas an exhibit to our Current Report on Form 8-K to be filed with the SEC in connection with this offering.

Electronic Distribution

A prospectus in electronic format may bemade available on a website maintained by the Underwriter. The Underwriter may agree to allocate a number of shares to underwritersfor sale to their online brokerage account holders. Internet distributions will be allocated by the representatives of the Underwriterto underwriters that may make Internet distributions on the same basis as other allocations. In connection with the offering, theUnderwriter may distribute prospectuses electronically. No forms of electronic prospectus other than prospectuses that are printableas Adobe® PDF will be used in connection with this offering.

Other than the prospectus in electronicformat, the information on the Underwriter’s website and any information contained in any other website maintained by theUnderwriter is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approvedand/or endorsed by us or the Underwriter in its capacity as underwriter and should not be relied upon by investors.

Foreign Regulatory Restrictions on Purchase of SecuritiesOffered Hereby Generally

No action has been or will be taken in anyjurisdiction (except in the United States) that would permit a public offering of the securities offered by this prospectus, orthe possession, circulation or distribution of this prospectus or any other material relating to us or the securities offered herebyin any jurisdiction where action for that purpose is required. Accordingly, the securities offered hereby may not be offered orsold, directly or indirectly, and neither of this prospectus nor any other offering material or advertisements in connection withthe securities offered hereby may be distributed or published, in or from any country or jurisdiction except in compliance withany applicable rules and regulations of any such country or jurisdiction.

The Underwriter may arrange to sell securitiesoffered by this prospectus in certain jurisdictions outside the United States, either directly or through affiliates, where theyare permitted to do so. The foregoing does not purport to be a complete statement of the terms and conditions of the underwritingagreement. A copy of the underwriting agreement will be included as an exhibit to our Current Report on Form 8-K to be filed withthe SEC in connection with this offering. See “Where You Can Find More Information.”

Experts

Marcum LLP, independent registered publicaccounting firm, has audited our consolidated financial statements included in our Annual Report on Form 10-K for the years ended September 30, 2018 and 2017, as set forth in their report, which is incorporated by reference in this prospectus and elsewherein this registration statement. Marcum LLP’s report includes an explanatory paragraph relating to our ability to continueas a going concern. Our consolidated financial statements are incorporated by reference in reliance on Marcum LLP’s report,given on their authority as experts in accounting and auditing.

Legal Matters

Certain legal matters relating to the issuanceof the securities offered by this prospectus will be passed upon for us by Pepper Hamilton LLP, New York, New York. Certain legalmatters in connection with this offering will be passed upon for the Underwriter by Harter Secrest & Emery LLP, Rochester,New York.

Where youcan find more information

This prospectus is a part of the registrationstatement on Form S-1 we filed with the SEC under the Securities Act and does not contain all the information set forth in theregistration statement. Whenever a reference is made in this prospectus to any of our contracts, agreements or other documents,the reference may not be complete and you should refer to the exhibits that are a part of the registration statement or the exhibitsto the reports or other documents incorporated herein by reference for a copy of such contract, agreement or other document. Becausewe are subject to the information and reporting requirements of the Exchange Act, we file or furnish, as applicable, annual, quarterlyand current reports, proxy statements and other information with the SEC. The SEC also maintains a web site that contains reports,proxy and information statements and other information regarding companies, such as ours, that file documents electronically withthe SEC. The website address is www.sec.gov. The information on the SEC’s website is not part of this prospectus, and anyreferences to this website or any other website are inactive textual references only. Our Internet address is www.adnas.com. Theinformation found on our website is not part of this prospectus and investors should not rely on any such information in decidingwhether to invest.

Incorporationby Reference

We have elected to incorporate certain informationby reference into this prospectus. By incorporating by reference, we can disclose important information to you by referring youto other documents we have filed or will file with the SEC. The information incorporated by reference is deemed to be part of thisprospectus, except for information incorporated by reference that is superseded by information contained in this prospectus. Thismeans that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in the prospectusor any document previously incorporated by reference have been modified or superseded. This prospectus incorporates by referencethe documents set forth below that we have previously filed with the SEC, except in each case the information contained in suchdocument to the extent “furnished” and not “filed” (Commission File No. 001-36745):

Information in such future filings updatesand supplements the information provided in this prospectus. Any statements in any such future filings will automatically be deemedto modify and supersede any information in any document we previously filed with the SEC that is incorporated or deemed to be incorporatedherein by reference to the extent that statements in the later filed document modify or replace such earlier statements. Any statementso modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

All reports and other documents subsequentlyfiled by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of this offering, includingall such documents we may file with the SEC after the date of the initial registration statement and prior to the effectivenessof the registration statement but excluding any information furnished and not filed with the SEC, shall be deemed to be incorporatedby reference in this prospectus and to be a part hereof from the date of filing such reports and other documents.

You may obtain copies of these documentson the website maintained by the SEC at http://www.sec.gov. We will furnish to you, upon written or oral request, a copyof any or all of the documents that have been incorporated by reference, including exhibits to these documents. You may requesta copy of those filings at no cost by writing or telephoning us at Corporate Secretary, Applied DNA Sciences, Inc., 50 Health SciencesDrive, Stony Brook, New York 11790, (631) 240-8800 or visiting our website at http://www.adnas.com. No information contained onour website is intended to be included as part of, or incorporated by reference into, this prospectus.

Shares of Common Stock

Pre-Funded Warrants to Purchase Up to            Shares of Common Stock

Warrants to Purchase Up to             Shares ofCommon Stock

PROSPECTUS

Maxim Group LLC

     , 2019

PART II

INFORMATIONNOT REQUIRED IN PROSPECTUS

The following table sets forth the feesand expenses, other than placement agent fees and expenses, payable in connection with the registration of the common stock hereunder.All amounts are estimates except the SEC registration fee and the FINRA filing fee.

* Tobe completed by amendment.

Section 145 of the Delaware General CorporationLaw provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses(including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connectionwith any threatened, pending or completed actions, suits or proceedings in which such person is made a party by reason of suchperson being or having been a director, officer, employee or agent to the corporation. The Delaware General Corporation Law providesthat Section 145 is not exclusive of other rights to which those seeking indemnification may be entitled under any by-law, agreement,vote of stockholders or disinterested directors or otherwise.

Section 102(b)(7) of the Delaware GeneralCorporation Law provides that a corporation may adopt a provision in its certificate of incorporation eliminating or limiting thepersonal liability of a director of the corporation to the corporation or its stockholders for monetary damages for breaches offiduciary duty as a director, except for liability for any: (i) breach of the director’s duty of loyalty to the corporationor its stockholders; (ii) acts or omissions not in good faith or which involve intentional misconduct or a knowing violation oflaw; (iii) unlawful payment of dividends or unlawful stock purchases or redemptions; or (iv) transaction from which the directorderives an improper personal benefit.

Our Certificate of Incorporation providesto the fullest extent permitted by Delaware law that our directors or officers shall not be personally liable to us or our stockholdersfor damages for breach of such director’s or officer’s fiduciary duty. The effect of this provision of our Certificateof Incorporation is to eliminate our rights and the rights of our stockholders (through stockholders’ derivative suits onbehalf of our company) to recover damages against a director or officer for breach of the fiduciary duty of care as a directoror officer (including breaches resulting from negligent or grossly negligent behavior), except under certain situations definedby statute. We believe that the indemnification provisions in our Certificate of Incorporation are necessary to attract and retainqualified persons as directors and officers.

Our Certificate of Incorporation also providesthat we shall have the power to indemnify, to the extent permitted by the DGCL, as it presently exists or may hereafter be amendedfrom time to time, any employee or agent of ours who was or is a party or is threatened to be made a party to any proceeding byreason of the fact that he or she is or was a director, officer, employee or agent of ours or is or was serving at our requestas a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, includingservice with respect to employee benefit plans, against expenses (including attorneys’ fees), judgments, fines and amountspaid in settlement actually and reasonably incurred by such person in connection with any such proceeding.

Section 9.3 of our By-Laws provides forthe indemnification of our directors, officers and employees to the fullest extent permitted by the DGCL.

We have entered into an indemnificationagreement (each, an “Indemnification Agreement”) with each of our directors and executive officers. In general, theIndemnification Agreement obligates us to indemnify a director or executive officer, to the fullest extent permitted by applicablelaw, for certain expenses, including attorneys’ fees, judgments, penalties, fines and settlement amounts actually and reasonablyincurred by them in any action or proceeding arising out of their services as one of our directors or executive officers, or anyof our subsidiaries or any other company or enterprise to which the person provides services at our request. In addition, the IndemnificationAgreement provides for the advancement of expenses incurred by the indemnitee in connection with any covered proceeding to thefullest extent permitted by applicable law. The rights provided by the Indemnification Agreement are in addition to any other rightsto indemnification or advancement of expenses to which the indemnitee may be entitled under applicable law, our Certificate ofIncorporation or By-Laws, or otherwise.

Insofar as indemnification for liabilitiesarising under the Securities Act, may be permitted to directors, officers and controlling persons of ours pursuant to the foregoingprovisions, or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy asexpressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities(other than the payment by us of expenses incurred or paid by a director, officer or controlling person of ours in the successfuldefense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securitiesbeing registered, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit toa court of appropriate jurisdiction the question whether such indemnification by us is against public policy as expressed in theSecurities Act and will be governed by the final adjudication of such issue.

We maintain a director and officer insurancepolicy that covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in theircapacities as directors or officers.

Since January 1, 2016, we made salesof the unregistered securities discussed below. None of these transactions involved any underwriters, underwriting discounts orcommissions, except as specified below, or any public offering, and the registrant believes that, except as set forth below, eachtransaction was exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof and/or RegulationD.

On August 22, 2019, we issued and sold 1,548,151shares of common stock at a price of $0.27 per share for total gross proceeds of $418,000 to a group of accredited investors, includingour chief executive officer, president and chairman of the board of directors and the chief information officer. The foregoingissuance of common stock was exempt from registration under the Securities Act by virtue of Section 4(a)(2) thereof and RegulationD thereunder. Each investor gave representations that he, she or it was an “accredited investor” (as defined underRule 501 of Regulation D) and that he, she or it was purchasing such securities without a present view toward a distribution ofthe securities.

On July 16, 2019, November 29, 2018 andAugust 31, 2018, we sold an aggregate of $1.5 million, $550,0000 and $1.65 million, respectively, in principal amount of CompanyNotes to certain investors, including Dr. James A. Hayward, our Chairman, Chief Executive Officer and President, certain membersof the board of directors and management team, and certain other accredited investors. The Company Notes are convertible, in wholeor in part, at any time, at the option of the purchasers, into shares of our common stock in an amount determined by dividing theprincipal amount of each Company Note, together with any and all accrued and unpaid interest, by the Conversion Price if the priceof the common stock remains at a closing price of $3.50 or more for a period of twenty consecutive trading days. The foregoingissuances of the Company Notes were exempt from registration under the Securities Act by virtue of Section 4(a)(2) thereofand Regulation D thereunder. Each of the purchasers represented to the Company that it is an “accredited investor”as that term is defined in Rule 501 of Regulation D. Holders of such secured convertible notes, including Dr. Hayward and otherdirectors, officers, and affiliates of the Company, converted substantial portions of such August 2018 Notes and November 2018Notes into common stock of the Company in September 2019.

On June 28, 2017, we issued and sold 1,025,574shares of common stock at a price of $1.76 per share for total gross proceeds of $1,805,000 to a group of investors, includinga strategic investor which is also a key customer and intellectual property licensee of the Company as well as all of the Company’sexecutive officers and all members of the board of directors. The foregoing issuance of common stock was exempt from registrationunder the Securities Act by virtue of Section 4(a)(2) thereof and Regulation D thereunder. Each investor gave representationsthat he, she or it was an “accredited investor” (as defined under Rule 501 of Regulation D) and that he, she or itwas purchasing such securities without a present view toward a distribution of the securities.

On November 2, 2016, we issued and sold2,272,727 shares of common stock and warrants to purchase 2,272,727 shares of common stock to certain investors. The aggregategross proceeds were $5.0 million before deducting the placement agents’ fee and other placement expenses. The Underwriterin this offering acted as the lead placement agent for the November 2, 2016 issuance described in this paragraph and Imperial Capital,LLC acted as the co-placement agent. The foregoing issuance of common stock and warrants was exempt from registration under theSecurities Act by virtue of Section 4(a)(2) thereof and Regulation D thereunder.

On June 30, 2016, we issued 3,000 sharesof our common stock to a consultant for services provided, pursuant to our 2005 Incentive Stock Plan. The foregoing issuance ofcommon stock was exempt from registration under the Securities Act by virtue of Section 4(a)(2) of the Securities Act and RegulationD thereunder.

On March 31, 2016, we issued 3,000 sharesof our common stock to a consultant for services provided, pursuant to our 2005 Incentive Stock Plan. The foregoing issuance ofcommon stock was exempt from registration under the Securities Act by virtue of Section 4(a)(2) of the Securities Act and RegulationD thereunder.

(a) Exhibits

The following exhibits are being filed withthis Registration Statement:

† Indicates a management contract or any compensatoryplan, contract or arrangement.

+ Indicates to be filed by amendment.

* A request for confidentiality has been granted for certainportions of the indicated document. Confidential portions have been omitted and filed separately with the SEC as required by Rule24b-2 promulgated under the Exchange Act.

** Portions of the indicated document have been omittedbecause the information is both not material and would likely cause competitive harm to the registrant if publicly disclosed. Theomissions have been indicated by bracketed asterisks (“[***]”).

(b) Financial Statement Schedules

All schedules have been omitted becauseeither they are not required, are not applicable or the information is otherwise set forth in the financial statements and relatednotes thereto.

The undersigned registrant hereby undertakes:

(1)       Tofile, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(i)       Toinclude any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

(ii)       Toreflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recentpost-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information setforth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (ifthe total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or highend of the estimated maximum offering range may be reflected in the form of prospectus filed with the U.S. Securities and ExchangeCommission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table inthe effective registration statement; and

(iii)       Toinclude any material information with respect to the plan of distribution not previously disclosed in the registration statementor any material change to such information in the registration statement; provided, however, that paragraphs (1)(i), (1)(ii) and(1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is containedin reports filed with or furnished to the Securities and Exchange Commission by the registrant pursuant to Section 13 or Section15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement.

(2)       That,for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemedto be a new registration statement relating to the securities offered therein, and the offering of such securities at that timeshall be deemed to be the initial bona fide offering thereof.

(3)       Toremove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at thetermination of the offering.

(4)       That,for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each prospectus filed pursuant to Rule424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B orother than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statementas of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectusthat is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registrationstatement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale priorto such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part ofthe registration statement or made in any such document immediately prior to such date of first use.

(5)       Thatfor the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distributionof securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuantto this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securitiesare offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a sellerto the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)       Anypreliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule424;

(ii)       Anyfree writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred toby the undersigned registrant;

(iii)       Theportion of any other free writing prospectus relating to the offering containing material information about the undersigned registrantor its securities provided by or on behalf of the undersigned registrant; and

(iv)       Anyother communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(6)       Theundersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, eachfiling of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and,where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities ExchangeAct of 1934) that is incorporated by reference in the registration statement 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 initialbona fide offering thereof.

(7)       Insofaras indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controllingpersons of the registrant pursuant to any charter provision, by law or otherwise, the registrant has been advised that in the opinionof the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than payment bythe registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defenseof any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securitiesbeing 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 expressedin the Securities Act and will be governed by the final adjudication of such issue.

(8)       Theundersigned registrant hereby undertakes that:

(i)       Forpurposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filedas part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrantpursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statementas of the time it was declared effective; and

(ii)       Forthe purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form ofprospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of suchsecurities at that time shall be deemed to be the initial bona fide offering thereof.

SIGNATURES

Pursuant to the requirements of the SecuritiesAct of 1933, the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereuntoduly authorized, in the Town of Stony Brook, State of New York, on September 18, 2019.

POWER OF ATTORNEY

Each person whose signature appears belowconstitutes and appoints Dr. James A. Hayward and Ms. Beth Jantzen, and each of them, any of whom may act without the joinder ofthe other, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, forhim or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments (including post-effectiveamendments) to this Registration Statement and any Registration Statement (including any amendment thereto) for this offering thatis to be effective upon filing pursuant to Rule 462 under the Securities Act and to file the same, with all exhibits thereto, andall other documents in connection therewith, with the U.S. Securities and Exchange Commission, granting unto said attorneys-in-factand agents full power and authority to do and perform each and every act and thing requisite and necessary to be done, as fullyto all intents and purposes as he or she might or would do in person, hereby ratifying and confirming all that said attorneys-in-factand agents or any of them of their or his or her substitute and substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the SecuritiesAct of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.