GRI BIO 424B5 Prospectus supplement for primary offering

Filed pursuant to Rule 424(b)(5)

Registration File No. 333-264488

PROSPECTUS SUPPLEMENT

(To Prospectus, dated May 2, 2022)

Vallon Pharmaceuticals, Inc.

3,700,000 Shares of Common Stock

We are offering 3,700,000 shares of our common stock, par value $0.0001 per share, pursuant to this prospectus supplement and the accompanying base prospectus.

In a concurrent private placement, we are also selling to the purchasers in this offering warrants to purchase 3,700,000 shares of our common stock at an exercise price of $0.9382 per share, the closing bid price of our common stock on May 12, 2022. The warrants will be immediately exercisable following the date of issuance and expire five (5) years from the date of issuance. The shares of common stock issuable from time to time pursuant to the exercise of the warrants are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act of 1933, as amended (the Securities Act), and Rule 506(b) promulgated thereunder and are not being registered under the Securities Act at this time or offered pursuant to this prospectus supplement and the accompanying prospectus.

We have retained Ladenburg Thalmann & Co. Inc. (Ladenburg) as the placement agent (the Placement Agent) with respect to this offering. The Placement Agent is not purchasing or selling any securities offered hereby, nor is it required to arrange for the purchase or sale of any specific number or dollar amount of securities. However, the Placement Agent has agreed to use its reasonable best efforts to arrange for the sale of all of the securities being offered pursuant to this prospectus supplement. See “Plan of Distribution” beginning on page S-17 of this prospectus supplement for more information regarding these arrangements.


	Per Share		Total
Offering Price	$	1.0632	$	3,933,840
Placement agent’s fees	$	0.085	$	314,707
Proceeds, before expenses, to us(1)	$	0.9782	$	3,619,133

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(1)The amount of the offering proceeds to us presented in this table does not take into account the exercise of any of the purchase warrants being issued in the concurrent private placement.

Our common stock is listed on The Nasdaq Capital Market under the symbol “VLON.” On May 12, 2022, the last reported sale price of our common stock on The Nasdaq Capital Market was $0.9382. As of May 12, 2022, there were 6,812,836 shares of our common stock outstanding.

The aggregate market value of our common stock held by non-affiliates as of May 12, 2022, pursuant to General Instruction I.B.6 of Form S-3 is $33,801,251, which was calculated based on 4,412,696 shares of our common stock outstanding held by non-affiliates and at a price of $7.66 per share, the closing price of our common stock on March 15, 2022. As of the date hereof, we have not offered or sold any securities pursuant to General Instruction I.B.6 of Form S-3 during the prior 12 calendar month period that ends on, and includes, the date hereof.

The Placement Agent will receive from us in the aggregate a cash fee equal to 8.0% of the gross proceeds from this offering. We have also agreed to reimburse the Placement Agent for certain out-of-pocket expenses in connection with this offering.

Investing in our securities involves risks. See the “Risk Factors” on page S-9 of this prospectus supplement and any similar section contained in the applicable prospectus and in the documents incorporated by reference into this prospectus supplement.

Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.

Ladenburg Thalmann

The date of this prospectus supplement is May 13, 2022

TABLE OF CONTENTS


Prospectus Supplement

ABOUT THIS PROSPECTUS SUPPLEMENT			S-2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS			S-3
PROSPECTUS SUPPLEMENT SUMMARY			S-5
RISK FACTORS			S-9
USE OF PROCEEDS			S-12
DIVIDEND POLICY			S-13
DILUTION			S-14
PRIVATE PLACEMENT TRANSACTIONS			S-15
PLAN OF DISTRIBUTION			S-17
LEGAL MATTERS			S-19
EXPERTS			S-19
WHERE YOU CAN FIND MORE INFORMATION			S-19
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE			S-19

Prospectus

ABOUT THIS PROSPECTUS			3
FORWARD-LOOKING STATEMENTS			4
THE COMPANY			5
RISK FACTORS			8
USE OF PROCEEDS			9
PLAN OF DISTRIBUTION			9
THE SECURITIES WE MAY OFFER			11
DESCRIPTION OF COMMON STOCK			11
DESCRIPTION OF PREFERRED STOCK			16
DESCRIPTION OF STOCK WARRANTS			17
DESCRIPTION OF DEBT SECURITIES			19
DESCRIPTION OF PURCHASE CONTRACTS			21
DESCRIPTION OF UNITS			21
LEGAL OWNERSHIP OF SECURITIES			22
LEGAL MATTERS			25
EXPERTS			25
WHERE YOU CAN FIND MORE INFORMATION			25
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE			25

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ABOUT THIS PROSPECTUS SUPPLEMENT

This prospectus supplement is part of a registration statement on Form S-3 that we have filed with the U.S. Securities and Exchange Commission, or the SEC, utilizing a “shelf” registration process.

We provide information to you about this offering of shares of our common stock in two separate documents that are bound together: (1) this prospectus supplement, which describes the specific details regarding this offering; and (2) the accompanying prospectus, which provides general information, some of which may not apply to this offering. Generally, when we refer to this “prospectus,” we are referring to both documents combined. If information in this prospectus supplement is inconsistent with the accompanying prospectus, you should rely on this prospectus supplement. However, if any statement in one of these documents is inconsistent with a statement in another document having a later date – for example, a document incorporated by reference in this prospectus supplement – the statement in the document having the later date modifies or supersedes the earlier statement as our business, financial condition, results of operations and prospects may have changed since the earlier dates.

We have not, and Ladenburg has not, authorized anyone to provide any information other than that contained in or incorporated by reference in this prospectus supplement, the accompanying prospectus and any free writing prospectus prepared by or on behalf of us or to which we have referred you. We and Ladenburg take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We are not, and Ladenburg is not, making an offer to sell or soliciting an offer to buy our securities in any jurisdiction where an offer or solicitation is not authorized or in which the person making that offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make an offer or solicitation. You should assume that the information appearing in this prospectus supplement, the accompanying prospectus, the documents incorporated by reference into this prospectus supplement, and in any free writing prospectus that we may authorize for use in connection with this offering, is accurate only as of the date of those respective documents. Our business, financial condition, results of operations and prospects may have changed since those dates. You should read this prospectus supplement, the accompanying prospectus, the documents incorporated by reference into this prospectus supplement, and any free writing prospectus that we may authorize for use in connection with this offering, in their entirety before making an investment decision. You should also read and consider the information in the documents to which we have referred you in the sections of this prospectus supplement entitled “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”

We are offering to sell shares of common stock only in jurisdictions where offers and sales are permitted. The distribution of this prospectus supplement and the accompanying prospectus and the offering of the common stock in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus supplement must inform themselves about, and observe any restrictions relating to, the offering of the common stock and the distribution of this prospectus supplement outside the United States. This prospectus supplement does not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.

When we refer to “Vallon,” “we,” “our,” “us” and the “Company” in this prospectus supplement, we mean Vallon Pharmaceuticals, Inc., unless otherwise specified.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein contain forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions described under the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the 2021 Annual Report), as revised or supplemented by our Quarterly Reports on Form 10-Q and other documents we file with the SEC, regarding, among other things:

•the likelihood of our clinical trials and non-clinical studies demonstrating safety and efficacy of our product candidates, and other positive results;

•the timing of initiation of our future clinical trials, and the reporting of data from our completed, current and future preclinical and clinical trials;

•the size of the market opportunity for our product candidates;

•our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;

•the success of competing therapies that are or may become available;

•our estimates of the number of patients in the United States who suffer from ADHD or narcolepsy and the number of patients that will enroll in our clinical trials;

•the beneficial characteristics, safety and efficacy of our product candidates;

•the timing or likelihood of regulatory filings and approval for our product candidates;

•our ability to obtain and maintain regulatory approval of our product candidates;

•our plans relating to the further development and manufacturing of our product candidates, including ADMIR;

•the expected potential benefits of strategic collaborations with third parties, including MEDICE Arzneimittel GmbH & Co. KG, who is affiliated with one of our principal stockholders, SALMON Pharma GmbH (Salmon Pharma), and represented by one member of our board of directors, and our ability to attract collaborators with development, regulatory and commercialization expertise;

•existing regulations and regulatory developments in the United States, the European Union, and other geographic territories;

•our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;

•our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;

•the need to hire additional personnel, and our ability to attract and retain such personnel;

•the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

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•our financial performance;

•the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements;

•the impacts of the COVID-19 pandemic on our operations;

•our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act;

•our anticipated use of our existing resources and the proceeds from this offering;

•our ability to maintain the listing of our common stock on The Nasdaq Capital Market; and

•our ability to identify, evaluate, and complete any strategic alternative that yields value for our stockholders.

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 the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act do not protect any forward-looking statements that we make in connection with this offering. Any forward-looking statements that we make in this prospectus supplement speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this prospectus supplement or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

You should read this prospectus supplement, the accompanying base prospectus, and the documents incorporated by reference herein and therein, with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus supplement, the accompanying base prospectus, and the documents incorporated by reference herein and therein by these cautionary statements.

Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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PROSPECTUS SUPPLEMENT SUMMARY

This summary provides a general overview of selected information and does not contain all of the information you should consider before buying our common stock. Therefore, you should read the entire prospectus supplement, accompanying base prospectus and any free writing prospectus that we have authorized for use in connection with this offering carefully, including the information incorporated by reference, before deciding to invest in our common stock. Investors should carefully consider the information set forth under “Risk Factors” beginning on page S-9 and incorporated by reference to our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q.

Our Company

We are a clinical-stage biopharmaceutical company primarily focused on the development and commercialization of proprietary biopharmaceutical products. We are developing novel medications for central nervous system (CNS) disorders with a focus on abuse-deterrent medications. Our lead investigational product candidate, ADAIR, is a proprietary, abuse-deterrent oral formulation of immediate-release dextroamphetamine (the main active ingredient in Adderall®) for the treatment of attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. However, as described below, our SEAL study for ADAIR did not reach its primary endpoint, and there is no assurance that ADAIR will receive approval by the U.S. Food and Drug Administration (the FDA). In addition to ADAIR, we completed formulation development work and selected the final formulation of our second product candidate, ADMIR, an abuse deterrent formulation of methylphenidate (Ritalin®), for the treatment of ADHD.

In the future, we plan to use our abuse deterrent platform technology to develop other products that have potential for abuse in their current forms and will continue business development activities and seek partnering, licensing, merger and acquisition opportunities or other transactions to further develop our pipeline and drug-development capabilities.

Recent Developments

The SEAL study (Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation), was our pivotal intranasal human abuse liability study assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of snorting professional laboratory-manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo in recreational drug users. ADAIR was prepared for snorting by a pharmacist using a multi-step technique that had been developed by a professional laboratory and agreed upon by the FDA. The SEAL study enrolled 55 subjects, of whom 53 completed the study and 52 were included in the final analysis. The study involved a four-way crossover design to evaluate professionally manipulated, intranasal ADAIR 30 mg, crushed intranasal dextroamphetamine, ADAIR 30 mg taken orally, and placebo. All subjects were non-dependent recreational stimulant users with an additional history of recreational intranasal drug use.

The SEAL study did not meet its primary endpoint, which was Emax Drug Liking. ADAIR scored similarly to what was observed in an earlier proof-of-concept study, however, reference dextroamphetamine did not score as high as expected and as seen in the previous study, thus driving the lack of statistical significance.

We are continuing to assess the best path forward for the ADAIR and ADMIR development programs. In addition, we have engaged Ladenburg Thalmann & Co. Inc. (Ladenburg) to evaluate our strategic alternatives with the goal of maximizing shareholder value. Ladenburg has been engaged to advise us on the strategic review process, which could include, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets. In the meantime, and in conjunction with the exploration of strategic alternatives, we are streamlining our operations in order to preserve our capital and cash resources.

Summary of Risks Associated with Our Business

Our ability to execute on our business strategy is subject to a number of risks, which are discussed more fully in the “Risk Factors” section of this prospectus supplement, and in the documents incorporated by reference into this

S-5

prospectus supplement. You should carefully consider these risks before making an investment in our common stock. These risks include, among others, the following:

•we are a clinical-stage company with no approved products and a lack of operating history, which makes it difficult to assess our future viability;

•we do not currently have any drug products for sale, and only two products currently under development, ADAIR and ADMIR, neither of which has completed clinical trials or received regulatory approval;

•we may not receive regulatory approval for ADAIR or any future product, such as ADMIR, or its or their approvals may be further delayed, which would have a material adverse effect on our business and financial condition;

•our SEAL study for ADAIR, which is our pivotal intranasal human abuse liability study assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of snorting professional laboratory-manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo in recreational drug users, failed to reach its primary endpoint;

•our prospects currently depend significantly on the success of ADAIR, which is still in clinical development, and we may not be able to generate revenues from ADAIR;

•if serious adverse or unacceptable side effects are identified during the development of ADAIR or any potential future products, including ADMIR, we may need to abandon or limit our development of some of such product;

•if ADAIR, or any other future product, such as ADMIR, does receive regulatory approval but we do not achieve broad market acceptance, the revenues that we generate from sales will be limited;

•we have not generated any significant revenue, and will likely incur future losses and negative cash flow, and it is uncertain if or when we will become profitable;

•we will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations;

•if we are unable to establish sales, marketing, and distribution capabilities or to enter into agreements with third parties to market and sell ADAIR or any future product we may develop, such as ADMIR, we may not be successful in commercializing such products if and when they are approved;

•we will continue to incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives;

•even if ADAIR or any future product we may develop, such as ADMIR, receives marketing approval, we will continue to face extensive regulatory requirements and such products may still face future development and regulatory difficulties; and

•the potential effects of COVID-19 on our manufacturing activities, preclinical and clinical programs and business.

Emerging Growth Company

We are an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, as amended (the Securities Act), as modified by the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). We will remain an emerging growth company until the earliest of the end of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds $700 million as of the end of the second fiscal quarter, (ii) the end of the fiscal year in which we have total annual gross revenues of $1.07 billion or more during such fiscal year, (iii) the date on which we issue more than $1 billion in non-convertible debt in a three-year period, or (iv) the end of

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the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement filed under the Securities Act.

For as long as we continue to be an emerging growth company, we also intend to take advantage of certain other exemptions from various reporting requirements that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory stockholder vote on executive compensation and any golden parachute payments not previously approved, exemption from the requirement of auditor attestation in the assessment of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis).

Corporate Information

We were incorporated in Delaware in January 2018, and completed our organization, formation and initial capitalization activities effective as of June 7, 2018. Our executive offices are located at 100 N. 18th Street, Suite 300, Philadelphia, PA 19103. Our telephone number is (267) 607-8255, and our email address is info@vallon-pharma.com. Our website address is https://www.vallon-pharma.com. The information contained on, or that can be accessed through, our website is not part of this prospectus supplement and is not incorporated by reference. We have included our website address herein solely as an inactive textual reference.

S-7

The Offering


Common stock offered by us			3,700,000 shares of our common stock.
Offering price per share			$1.0632
Concurrent private placement of purchase warrants to purchasers in this offering			In a concurrent private placement, we are also selling to the purchasers in this offering warrants to purchase 3,700,000 shares of our common stock at an exercise price of $0.9382 per share, the closing bid price of our common stock on May 12, 2022. The warrants will be immediately exercisable following the date of issuance. The warrants and the shares of common stock issuable upon exercise thereof are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act of 1933, as amended, or the Securities Act, and Rule 506(b) promulgated thereunder and are not being registered under the Securities Act at this time or offered pursuant to this prospectus supplement and the accompanying prospectus. Pursuant to the securities purchase agreement, dated May 13, 2022, by and among us and the purchaser signatories thereto, within 15 days following the closing of this offering, we will file a registration statement providing for the resale by holders of shares of our common stock issuable upon the exercise of the purchase warrants and will use commercially reasonable efforts to cause such registration statement to become effective as soon as practicable following the filing thereof and to keep such registration statement effective at all times until such date that no purchaser owns any purchase warrants or shares of common stock issuable upon exercise thereof.
Common stock to be outstanding after this offering			10,512,836 shares (assuming no exercise of the warrants being issued in the concurrent private placement to purchasers in this offering).
Use of proceeds			We currently intend to use the net proceeds from this offering for general corporate and working capital purposes and expenses associated with the exploration of strategic alternatives. See the section entitled “Use of Proceeds” on page S-12.
Risk factors			Investment in our securities involves a high degree of risk. You should read the section entitled “Risk Factors” beginning on page S-9 of this prospectus supplement and in the documents incorporated by reference into this prospectus supplement for a discussion of factors to consider before deciding to purchase shares of our common stock.
Nasdaq Capital Market symbol			“VLON”

The number of shares of common stock to be outstanding after this offering is based on 6,812,836 shares of common stock outstanding as of May 12, 2022, and excludes:

•787,262 shares issuable upon the exercise of outstanding stock options with a weighted-average exercise price of $4.12 per share;

•112,500 shares issuable upon the exercise of outstanding warrants with a weighted-average exercise price of $10.00 per share;

•124,398 shares reserved for future issuance under our 2018 Equity Incentive Plan; and

•3,700,000 shares of common stock issuable upon the exercise of the warrants issued in a concurrent private placement to this offering.

Except as otherwise indicated herein, all information in this prospectus supplement, including the number of shares that will be outstanding after this offering, assumes no further exercise of outstanding options or warrants.

S-8

RISK FACTORS

Investing in our common stock involves a high degree of risk. You should consider carefully the risks described below and discussed under the section captioned “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent filings under the Securities Exchange Act of 1934, as amended, or the Exchange Act, each of which is incorporated by reference in this prospectus supplement in their entirety, together with other information in this prospectus supplement, and the information and documents incorporated by reference in this prospectus supplement, and any free writing prospectus that we have authorized for use in connection with this offering before you make a decision to invest in our common stock. If any of the risks described therein or below actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. The risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business operations.

Risks Related to the Offering

If you purchase shares in this offering, you will suffer immediate dilution of your investment.

You will suffer immediate and substantial dilution of your investment in this offering because the public offering price per share of our common stock is higher than the net tangible book value per share of our common stock. Investors purchasing shares of common stock in this offering will incur immediate dilution of approximately $0.42 per share. In addition, we have outstanding stock options and warrants that are convertible into, or exercisable for, shares of our common stock. To the extent that such outstanding securities are exercised or converted into shares of our common stock, investors purchasing our securities in this offering may experience further dilution. See the section entitled “Dilution” on page S -14 for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering.

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

To raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by investors in this offering.

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

We may issue common stock from time to time in connection with this offering. This issuance from time to time of these new shares of our common stock, or our ability to issue these shares of common stock in this offering, could result in resales of our common stock by our current stockholders concerned about the potential dilution of their holdings. In turn, these resales could have the effect of depressing the market price for our common stock.

There is a limited trading market for our common stock, which could make it difficult to liquidate an investment in our common stock in a timely manner.

Our common stock is currently traded on The Nasdaq Capital Market. Because there is a limited public market for our common stock, investors may not be able to liquidate their investment whenever desired. We cannot assure that there will be an active trading market for our common stock and the lack of an active public trading market could mean that investors may be exposed to increased risk. In addition, if we failed to meet the criteria set forth in SEC regulations, various requirements would be imposed by law on broker-dealers who sell our securities to persons other than established customers and accredited investors. Consequently, such regulations may deter broker-dealers from recommending or selling our common stock, which may further affect its liquidity.

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There is no public market for the warrants being offered in this offering.

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

The holders of warrants purchased in this offering will have no rights as a common stockholder until such holder exercises its warrants and acquires shares of our common stock, except as may be set forth in such Warrants.

Until a holder of warrants acquires the shares of common stock upon exercise of the warrants, as applicable, a holder of warrants will have no rights with respect to the shares of common stock underlying such warrants, except as may be set forth in the warrants. Upon exercise of the warrants, the holder will be entitled to exercise the rights of a common shareholder only as to matters for which the record date occurs after the exercise date.

We do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.

We have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future. Our current policy is to retain all funds and any earnings for use in the operation and expansion of our business. If we do not pay dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.

The market price for our securities may be volatile, which could result in substantial losses to investors.

The market prices for securities of biotechnology and biopharmaceutical companies have historically been highly volatile, and the market has from time-to-time experienced significant price and volume fluctuations that are related to the operating performance of particular companies. In particular, the trading prices for pharmaceutical, biopharmaceutical and biotechnology companies have been highly volatile as a result of the COVID-19 pandemic.

The market price of our common stock is likely to be highly volatile and may fluctuate substantially due to many factors, including:

•results from, and any delays in, our clinical trials for our product candidates, including ADAIR and ADMIR, or any other future clinical development programs, including any delays related to the COVID-19 pandemic;

•announcements concerning the progress of our efforts to obtain regulatory approval for and commercialize ADAIR or any future product, including ADMIR, including any requests we receive from the FDA for additional studies or data that result in delays in obtaining regulatory approval or launching such proposed product, if approved;

•market conditions in the biopharmaceutical and biotechnology sectors or the economy as a whole;

•price and volume fluctuations in the overall stock market;

•the failure of ADAIR or any future product, such as ADMIR, if approved, to achieve commercial success;

•announcements of the introduction of new products by us or our competitors;

•developments concerning product development results or intellectual property rights of others;

•litigation or public concern about the safety of our potential products;

•actual fluctuations in our quarterly operating results, and concerns by investors that such fluctuations may occur in the future;

•deviations in our operating results from the estimates of securities analysts or other analyst comments;

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•additions or departures of key personnel;

•health care reform legislation, including measures directed at controlling the pricing of biopharmaceutical products, and third-party coverage and reimbursement policies;

•developments concerning current or future strategic collaborations; and

•discussion of us or our stock price by the financial and scientific press and in online investor communities.

In addition, the securities markets have from time to time experienced significant price and volume fluctuations that are not related to the operating performance of particular companies. As a result, to the extent shareholders sell our securities in negative market fluctuation, they may not receive a price per share that is based solely upon our business performance. We cannot guarantee that shareholders will not lose some of their entire investment in our securities.

Our management will have broad discretion in how we use the net proceeds of this offering and might not use them effectively.

Our management will have considerable discretion over the use of proceeds from this offering. You will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used in a manner which you may consider most appropriate. Our management might spend a portion or all of the net proceeds from this offering in ways that our stockholders do not desire or that might not yield a favorable return. The failure by our management to apply these funds effectively could harm our business. Furthermore, you will have no direct say on how our management allocates the net proceeds of this offering. Until the net proceeds are used, they may be placed in investments that do not produce significant income or that may lose value.

Risks Related to the Company

Our prospects were highly dependent on a single product candidate, ADAIR, and while we are assessing the best path forward for ADAIR, we may not complete the development or commercialization of ADAIR.

Our long-term prospects were highly dependent on future acceptance and revenues from our lead product candidate, ADAIR. In March 2022, we announced that topline data from our SEAL study of ADAIR for the treatment of ADHD failed to meet statistical significance for the primary endpoint of Emax Drug Liking and that, given that result, we are currently assessing the best path forward for ADAIR. Any further development of ADAIR would require substantial capital and time to complete, and there is no guarantee that any future clinical trial, if pursued, would be timely or successful, or that ADAIR would be approved or, if approved, that commercialization would be successful. Concurrently, we have been evaluating strategic alternatives to maximize stockholder value, which could involve, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets. However, there is no assurance that we will be successful in our pursuit of a strategic alternative, failure of which may have a material adverse impact on our business, financial condition, and results of operations.

S-11

USE OF PROCEEDS

We estimate that the net proceeds from this offering, after deducting placement agent fees and estimated offering expenses payable by us, will be approximately $3.5 million.

We will retain broad discretion over the use of the net proceeds from the sale of the securities offered hereby. We currently intend to use the net proceeds from this offering for general corporate and working capital purposes and expenses associated with the exploration of strategic alternatives.

The amounts and timing of our actual expenditures will depend on numerous factors, including the factors described under “Risk Factors” in this prospectus supplement and in the documents incorporated by reference herein, as well as the amount of cash used in our operations. We may find it necessary or advisable to use the net proceeds for other purposes, and we will have broad discretion in the application of the net proceeds.

Pending the uses described above, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

S-12

DIVIDEND POLICY

We have never declared or paid dividends on shares of our common stock. We anticipate that we will retain all available funds and any future earnings, if any, for use in the operation of our business and do not anticipate paying cash dividends in the foreseeable future. In addition, future debt instruments may materially restrict our ability to pay dividends on our common stock. Payment of future cash dividends, if any, will be at the discretion of the board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of then-existing debt instruments and other factors that the board of directors deems relevant. Because we do not intent to declare cash dividends on our common stock in the foreseeable future, stockholders must rely on appreciation of the value of our common stock for any return on their investment.

S-13

DILUTION

If you purchase shares in this offering, your interest will be diluted to the extent of the difference between the public offering price per share of common stock and the as adjusted net tangible book value per share of our common stock after this offering.

Our net tangible book value as of March 31, 2022 was approximately $3.4 million, or $0.49 per share. Net tangible book value per share is determined by dividing our total tangible assets, less total liabilities, by the number of shares of our common stock outstanding as of March 31, 2022. Dilution in net tangible book value per share represents the difference between the amount per share paid by purchasers of shares of common stock in this offering and the as adjusted net tangible book value per share of our common stock immediately after giving effect to this offering.

The last reported sale price of our common stock on The Nasdaq Capital Market on May 12, 2022 was $0.9382. After giving effect to the sale of 3,700,000 shares of our common stock in this offering at an offering price of $1.0632, and after deducting commissions and estimated aggregate offering expenses payable by us, our as adjusted net tangible book value as of March 31, 2022, would have been approximately $6.8 million, or $0.64 per share. This represents an immediate increase in net tangible book value of $0.15 per share to existing stockholders and immediate dilution in net tangible book value of $0.42 per share to new investors purchasing our common stock in this offering. The following table illustrates this dilution on a per share basis:


Offering price per share		$1.0632
Net tangible book value per share as of March 31, 2022	$0.49
Increase per share attributable to new investors	$0.15
As adjusted net tangible book value per share after this offering		$0.64
Dilution per share to new investors participating in this offering		$0.42

The above discussion and table are based on 6,812,836 shares of common stock outstanding as of March 31, 2022, and excludes, in each case as of March 31, 2022:

•890,490 shares issuable upon the exercise of outstanding stock options with a weighted average exercise price of $4.05 per share;

•112,500 shares of our common stock issuable upon the exercise of warrants to purchase common stock outstanding as of March 31, 2022, with an exercise price of $10.00 per share;

•21,170 shares reserved for future issuance under our 2018 Equity Incentive Plan; and

•3,700,000 shares of common stock issuable upon the exercise of the warrants issued in a concurrent private placement to this offering.

S-14

PRIVATE PLACEMENT TRANSACTIONS

The warrants and the shares of common stock issuable upon exercise thereof are being offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder and are not being registered under the Securities Act at this time or offered pursuant to this prospectus supplement and the accompanying prospectus. Accordingly, the purchasers in this offering may only sell the warrants and the shares of our common stock issued upon exercise of the warrants pursuant to an effective registration statement under the Securities Act covering the resale of those shares, an exemption under Rule 144 under the Securities Act or another applicable exemption under the Securities Act. Pursuant to the securities purchase agreement, dated May 13, 2022, by and among us and the purchaser signatories thereto, within 15 days following the closing of this offering, we will file a registration statement on Form S-3 providing for the resale by holders of shares of our common stock issuable upon the exercise of the warrants and will use commercially reasonable efforts to cause such registration statement to become effective as soon as practicable following the filing thereof and to keep such registration statement effective at all times until such date that no purchaser owns any warrants or shares of common stock issuable upon exercise thereof.

Purchase Warrants

Exercisability. The warrants will be immediately exercisable following the date of issuance, and at any time thereafter up to five (5) years from the initial issuance date. The warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and by payment in full in immediately available funds for the number of shares of our common stock purchased upon such exercise. If at the time of exercise there is no effective registration statement registering, or the prospectus contained therein is not available for the issuance of the shares of our common stock underlying the warrants, then the warrants may also be exercised, in whole or in part, at such time by means of a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of our common stock determined according to the formula set forth in the warrants.

Exercise Limitation. A holder will not have the right to exercise any portion of the warrant if the holder would beneficially own in excess of 4.99% of the outstanding common stock immediately after exercise, except that upon notice from the holder to us, the holder may increase or decrease the beneficial ownership limitation up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrants, provided that any increase in such beneficial ownership limitation shall not be effective until 61 days following notice from the holder to us.

Exercise Price; Adjustments. The warrants have an exercise price of $0.9382 per share. The exercise price and the number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting shares of our common stock. In addition, if we grant, issue or sell certain securities pro rata to the record holders of our common stock, other than certain exempt issuances, or if we declare or make any dividend or other distribution of our assets, including cash, stock or other property to the holders of our common stock, then the holders of the warrants will be entitled to participate in such transactions to the same extent such holder would have participated in such transaction if it held the number of shares of common stock issuable upon exercise of the warrants without regard to any limits on exercise contained in the warrants.

Transferability. Subject to applicable laws, the warrants may be offered for sale, sold, transferred or assigned without our consent.

Exchange Listing. There is no established trading market for the warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the warrants will be limited.

S-15

Fundamental Transactions. If a fundamental transaction (as defined in the warrants) occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of our obligations under the purchase warrants with the same effect as if such successor entity had been named in the warrant itself. Following such fundamental transaction, the holders of the warrants will be entitled to receive upon exercise of the warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the warrants immediately prior to such fundamental transaction without regard to any limits on exercise contained in the warrants. If holders of shares of our common stock are given a choice as to the securities, cash or property to be received in a fundamental transaction, then the holder shall be given the same choice as to the consideration it receives upon any exercise of the warrant following such fundamental transaction. In addition, upon a fundamental transaction in which we are not the successor entity, the holder will have (i) the right to require us to cause any successor entity to assume in writing all of our obligations under the warrants and (ii) the option to receive, prior to such fundamental transaction and in exchange for the warrants, a security of the successor entity that is exercisable for a corresponding number of shares of capital stock of such successor entity equivalent to the shares of common stock receivable upon exercise of the warrants.

Alternate Cashless Exercise. Subject to Stockholder Approval (as defined in that certain Securities Purchase Agreement) if required by Nasdaq, in the event that Company (and all of its Subsidiaries, taken as a whole) directly or indirectly, in one or more related transactions consummates any Extraordinary Transaction (as defined in the Warrant, the Holder shall have the right, at the Holder’s sole option and as elected by the Holder on the applicable Exercise Notice, to effect a cashless exercise hereunder, in whole or in part, but in lieu of receiving such aggregate number of Warrant Shares as described in the formula set forth in Section 2(c)(i) of the Warrant, the Holder shall receive one (1) share of Common Stock for each Warrant Share being exercised hereunder in such cashless exercise.

Rights as a Stockholder. Except as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holder of a warrant does not have the rights or privileges of a holder of shares of our common stock, including any voting rights, until the holder exercises the warrant.

S-16

PLAN OF DISTRIBUTION

Pursuant to a placement agency agreement, dated as of May 13, 2022, we have retained Ladenburg, or the Placement Agent, to act as our exclusive placement agent in connection with this offering. Under the terms of the placement agency agreement, the Placement Agent is not purchasing the securities offered by us in this offering and is not required to sell any specific number or dollar amount of securities but will assist us in this offering on a reasonable best efforts basis. The terms of this offering were subject to market conditions and negotiations between us, the Placement Agent and prospective investors. The Placement Agent will have no authority to bind us by virtue of the agreement. We may not sell the entire amount of the shares of our common stock offered pursuant to this prospectus supplement.

The Placement Agent proposes to arrange for the sale of the shares we are offering pursuant to this prospectus supplement and accompanying prospectus to certain institutional and accredited investors through a securities purchase agreement directly between each investor and us. We will only sell to such investors who have entered into the securities purchase agreement with us.

Fees and Expenses

We will pay the Placement Agent a commission equal to 8.0% of the aggregate gross proceeds we receive from this offering. We have also agreed to reimburse the Placement Agent for the fees and disbursements of its counsel and other out-of-pocket expenses in connection with this offering, including a pre-closing expense allowance of up to $15,000 and an additional closing expense allowance of up to $60,000. We estimate the total offering expenses of this offering that will be payable by us, excluding the Placement Agent’s fees and expenses, will be approximately $150,000.

Pursuant to an investment banking agreement, dated as of April 26, 2022, we also agreed to pay the Placement Agent a cash fee equal to 8.0% of the aggregate gross proceeds to us from the sale of securities by us during the term of the investment banking agreement, or within 12 months after the date of termination or expiration of the investment banking agreement, to investors contacted by the Placement Agent and with whom the Placement Agent had significant discussions regarding participation in a transaction with us. Under the terms of the placement agency agreement, fees paid to the Placement Agent will supersede any fees payable by us to the Placement Agent under the investment banking agreement. The following table shows the per share and total cash placement agent fee we will pay to the Placement Agent in connection with this offering, assuming the purchase of all of the shares offered hereby.


	Per Share		Total
Offering Price	$	1.0632	$	3,933,840
Placement agent’s fees	$	0.085	$	314,707
Proceeds, before expenses, to us(1)	$	0.9782	$	3,619,133

__________________

(1)The amount of the offering proceeds to us presented in this table does not take into account the exercise of any of the purchase warrants being issued in the concurrent private placement.

Right of First Refusal

In addition, pursuant to the investment banking agreement, if at any time during the 12 months following the closing of this offering we propose to effect a further financing, we must offer the Placement Agent the opportunity to participate as a sole bookrunner or exclusive placement agent or exclusive sales agent with respect to such financing. However, such right of first refusal will terminate and be of no further force and effect if we consummate a change in control transaction, as defined by Nasdaq Listing Rule 5635(b).

Indemnification

We have agreed to indemnify the Placement Agent and specified other persons against certain liabilities relating to or arising out of the Placement Agent’s activities under the placement agency agreement and to contribute to payments that the Placement Agent may be required to make in respect of such liabilities.

S-17

Lock-up Agreements

Our officers, directors and each of their respective affiliates and associated partners have agreed with the Placement Agent to be subject to a lock-up period of 90 days following the date of this prospectus supplement. 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 or indirectly, any shares of our common stock or any securities convertible into, or exercisable or exchangeable for, shares of our common stock. Certain limited transfers are permitted during the lock-up period if the transferee agrees to these lock-up restrictions.

Regulation M

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

•may not engage in any stabilization activity in connection with our securities; and

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

This summary of the material provisions of the securities purchase agreement does not purport to be a complete statement of its terms and conditions. A copy of the securities purchase agreement has been included as an exhibit to our Current Report on Form 8-K that we filed with the SEC on May 13, 2022, and is incorporated by reference into the registration statement of which this prospectus supplement forms a part.

Other Relationships

From time to time, the Placement Agent may provide in the future various advisory, investment and commercial banking and other services to us in the ordinary course of business, for which they have received and may continue to receive customary fees and commissions.

Transfer Agent and Registrar

The transfer agent for our common stock is Broadridge Corporate Issuer Solutions, Inc.

Common Stock Listing

Our shares of common stock are listed on The Nasdaq Capital Market under the symbol “VLON.”

S-18

LEGAL MATTERS

Unless otherwise specified in the applicable prospectus supplement, the validity of the securities covered by this prospectus supplement will be passed upon for us by Thompson Hine LLP, New York, New York. Ladenburg is being represented in connection with this offering by Sheppard, Mullin, Richter & Hampton LLP.

EXPERTS

The balance sheets of Vallon Pharmaceuticals, Inc. as of December 31, 2021 and 2020, and the related statements of operations and comprehensive loss, changes in stockholders’ equity (deficit), and cash flows for each of the years then ended, have been audited by EisnerAmper LLP, independent registered public accounting firm, as stated in their report which is incorporated herein by reference, which report includes an explanatory paragraph disclosing substantial doubt about the Company’s ability to continue as a going concern. Such financial statements have been incorporated herein by reference in reliance on the report of such firm given upon their authority as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-3 under the Securities Act, with respect to the securities being offered by this prospectus supplement. This prospectus supplement does not contain all of the information in the registration statement and its exhibits. For further information with respect to us and the securities offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus supplement as to the contents of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference. The SEC maintains an internet website that contains reports, proxy statements, and other information about registrants, like us, that file electronically with the SEC. The address of that website is www.sec.gov. The information contained in, or that can be accessed through, the SEC’s website is not incorporated by reference in, and is not part of, this prospectus supplement.

We are subject to the information and periodic reporting requirements of the Exchange Act, and we file periodic reports, proxy statements and other information with the SEC. We maintain a website at https://www.vallon-pharma.com. You may access our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not incorporated by reference in, and is not part of, this prospectus supplement.

S-19

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

The SEC allows us to “incorporate by reference” the information that we file with the SEC, which means that we can disclose important information to you by referring you to those documents filed separately with the SEC. The information incorporated by reference is considered to be part of this prospectus supplement. Information in this prospectus supplement supersedes information incorporated by reference that we filed with the SEC prior to the date of this prospectus supplement. We incorporate by reference into this prospectus supplement and the registration statement of which this prospectus supplement is a part the information or documents listed below that we have filed with the SEC:

•our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 14, 2022;

•our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 9, 2022;

•our Current Reports on Form 8-K filed with the SEC on February 14, 2022, February 28, 2022, March 21, 2022, March 30, 2022, April 22, 2022, May 12, 2022 and May 13, 2022;

•the portions of our Definitive Proxy Statement on Schedule 14A that are deemed to have been “filed” with the SEC on April 27, 2022; and

•the description of our common stock contained in our Registration Statement on Form S-1, filed with the SEC on October 23, 2020, including any amendments or reports filed for the purpose of updating such description.

In addition, all documents (other than Current Reports furnished under Items 2.02 or 7.01 of Form 8-K and exhibits filed on such form that are related to such items) that are filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of the initial registration statement of which this prospectus supplement is a part and prior to the effectiveness of such registration statement and all documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of the offering (excluding any information furnished rather than filed) shall be deemed to be incorporated by reference into this prospectus supplement.

Notwithstanding the statements in the preceding paragraphs, no document, report or exhibit (or portion of any of the foregoing) or any other information deemed to be “furnished” and not filed in accordance with SEC rules shall be incorporated by reference into this prospectus supplement.

We will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference in this prospectus supplement, including exhibits to these documents. You should direct any requests for documents to Vallon Pharmaceuticals, Inc., 100 N. 18th Street, Suite 300, Philadelphia, PA 19103.

You also may access these filings on our website at www.vallon-pharma.com. Other than the SEC filings listed above, no documents or other information on our website is incorporated by reference into this prospectus supplement, and you should not consider any information on, or that can be accessed through, our website as part of this prospectus supplement.

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

S-14

Filed Pursuant to Rule 424(b)(3)

File No. 333-264488


PROSPECTUS

Vallon Pharmaceuticals, Inc.

$75,000,000

Common Stock

Preferred Stock

Warrants

Debt Securities

Purchase Contracts

Units

We may offer, issue and sell from time to time together or separately, in one or more offerings, any combination of (i) our common stock, (ii) our preferred stock, which we may issue in one or more series, (iii) warrants, (iv) senior or subordinated debt securities, (v) purchase contracts and (vi) units. The debt securities may consist of debentures, notes, or other types of debt. The debt securities, preferred stock and warrants may be convertible into, or exercisable or exchangeable for, common or preferred stock or other securities of ours. The units may consist of any combination of the securities listed above.

The aggregate public offering price of the securities that we are offering will not exceed $75,000,000. We will offer the securities in an amount and on terms that market conditions will determine at the time of the offering. Our common stock is listed on The Nasdaq Capital Market under the symbol “VLON”. The last reported sale price for our common stock on April 22, 2022 as quoted on the Nasdaq Capital Market, was $2.27 per share. You are urged to obtain current market quotations of our common stock. We have no preferred stock, warrants, debt securities, purchase contracts or units listed on any market and have made no application for such listing. Each prospectus supplement will indicate if the securities offered thereby will be listed on any securities exchange.

As of April 22, 2022, the aggregate market value of our outstanding common stock held by non-affiliates, or the public float, was approximately $10.0 million, which was calculated based on 4,412,696 shares of our outstanding common stock held by non-affiliates at a price of $2.27 per share, the closing price of our common stock on April 22, 2022. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell shares pursuant to this prospectus with a value of more than one-third of the aggregate market value of our common stock held by non-affiliates in any twelve-month period, so long as the aggregate market value of our common stock held by non-affiliates is less than $75,000,000. During the twelve calendar months prior to, and including, the date of this prospectus, we have not sold any securities pursuant to General Instruction I.B.6 of Form S-3.

Investing in our securities involves risk. You should carefully consider the risks that we refer you to under the section captioned “Risk Factors” in this prospectus on page 8 and in the documents incorporated by reference into this prospectus before buying our securities.

Should we offer any of the securities described in this prospectus, we will provide you with the specific terms of the particular securities being offered in one or more supplements to this prospectus. You should read this prospectus and any supplement, together with additional information described under the headings “Additional Information” and “Incorporation of Certain Information by Reference” carefully before you invest. This prospectus may not be used to offer or sell securities unless accompanied by a prospectus supplement.

We may sell these securities directly to our stockholders or to other purchasers or through agents on our behalf or through underwriters or dealers as designated from time to time. If any agents or underwriters are involved in the sale of any of these securities, the applicable prospectus supplement will provide the names of the agents or underwriters and any applicable fees, commissions or discounts.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is May 2, 2022

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS

This prospectus is a part of a registration statement that we filed with the U.S. Securities and Exchange Commission (the SEC or the Commission) using a “shelf” registration process. Under this shelf registration process, we may offer to sell any of the securities, or any combination of the securities, described in this prospectus, in each case in one or more offerings, up to a total dollar amount of $75,000,000.

This prospectus provides you only with a general description of the securities that we may offer. Each time securities are sold under the shelf registration statement, we will provide a prospectus supplement that will contain specific information about the terms of those securities and the terms of that offering. The prospectus supplement may also add, update or change information contained in this prospectus. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information in the prospectus supplement. You should read both this prospectus and any prospectus supplement, including all documents incorporated herein by reference herein and therein, together with the additional information described under “Where You Can Find More Information” or “Incorporation of Certain Information by Reference” below.

The information contained in this prospectus is not complete and may be changed. You should rely only on the information provided in or incorporated by reference in this prospectus or in any prospectus supplement, or documents to which we otherwise refer you. We have not authorized anyone else to provide you with different information.

We have not authorized any dealer, agent or other person to give any information or to make any representation other than those contained or incorporated by reference in this prospectus and any accompanying prospectus supplement. You must not rely upon any information or representation not contained or incorporated by reference in this prospectus or an accompanying prospectus supplement. This prospectus and the accompanying prospectus supplement, if any, do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus and the accompanying prospectus supplement, if any, constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus and the accompanying prospectus supplement, if any, is accurate on any date subsequent to the date set forth on the front of such document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus and any accompanying prospectus supplement is delivered or securities are sold on a later date.

___________________

References in this prospectus to the terms “Company,” “Vallon” “we,” “our” and “us” or other similar terms mean Vallon Pharmaceuticals, Inc. , unless stated otherwise or the context indicates otherwise.

FORWARD-LOOKING STATEMENTS

This prospectus and the documents incorporated by reference herein contain, and any prospectus supplement and the documents incorporated therein, may contain forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions described under the section titled “Risk Factors” in this prospectus, our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the 2021 Annual Report), as revised or supplemented by our Quarterly Reports on Form 10-Q and other documents we file with the SEC, regarding, among other things: