Azora Therapeutics, Inc. (DE)

S-11 ea0244873-s1_adialpharma.htm REGISTRATION STATEMENT

As filed with the Securities and Exchange Commission on June 6, 2025.

Registration No. 333-

**UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

**FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

ADIAL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Adial Pharmaceuticals, Inc.

**4870 Sadler Road, Ste 300

Glen Allen, Virginia 23060

(804) 487-8196

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

Cary Claiborne

President and Chief Executive Officer

Adial Pharmaceuticals, Inc.

**4870 Sadler Road, Ste 300

Glen Allen, Virgina 23060

(804) 487-8196

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

Copies to:

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

If any of the Securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box:☒

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

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

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act Registration Statement number of the earlier effective Registration Statement for the same offering:☐

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

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

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

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities, and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

ADIAL PHARMACEUTICALS, INC.

Up to 7,593,014 Shares of Common Stock

Pre-Funded Warrants to Purchase up to 7,593,014 Shares of Common Stock

Series D Warrants to Purchase up to 7,593,014 Shares of Common Stock

Series E Warrants to Purchase up to 7,593,014 Shares of Common Stock

Up to 22,779,042 Shares of Common Stock Issuable Upon Exercise of the Series D Warrants, Series E Warrants and the Pre-Funded Warrants

Adial Pharmaceuticals, Inc. (the “Company”, “we”, “us”, or “our”) is offering up to 7,593,014 shares of its common stock, par value $0.001 per share (the “Common Stock”), together with Series D warrants (the “Series D Warrants”) to purchase up to 7,593,014 shares of Common Stock and Series E warrants (the “Series E Warrants” and, together with the Series D Warrants, the “Common Warrants”) to purchase up to 7,593,014 shares of Common Stock pursuant to this prospectus. The assumed combined public offering price for each share of Common Stock and accompanying Common Warrants is $0.6585, which is equal to the last reported sale price of our Common Stock on the Nasdaq Capital Market (“Nasdaq” or the “Nasdaq Capital Market”) on June 3, 2025. Each share of our Common Stock is being sold together with one Series D Warrant and one Series E Warrant. The shares of Common Stock and Common Warrants are immediately separable and will be issued separately in this offering, but must be purchased together in this offering.

The Common Warrants will have an exercise price of $ per share of Common Stock (100% of the combined public offering price per share of Common Stock and accompanying Common Warrants) and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Common Warrants (“Warrant Stockholder Approval”); provided however, if (i) the offering is deemed a public offering, or (ii) the Pricing Conditions (as defined below) are met, the Warrant Stockholder Approval will not be required and the Common Warrants will be exercisable immediately upon issuance (the “Initial Exercise Date”). As used herein “Pricing Conditions” means that the combined public offering price per share of Common Stock and accompanying Common Warrants is such that the Warrant Stockholder Approval is not required under the rules of The Nasdaq Stock Market LLC (the “Nasdaq Stock Market”) because either (i) the offering is priced at-the-market under the rules of the Nasdaq Stock Market and such price equals or exceeds the sum of (a) the applicable “Minimum Price” per share under Nasdaq Stock Market Rule 5635(d) plus (b) $0.125 per whole share of Common Stock underlying each Common Warrant, or (ii) the offering is a discounted offering where the pricing and discount (including attributing a value of $0.125 per whole share underlying each Common Warrant) meet the pricing requirements under the rules of the Nasdaq Stock Market. The Series D Warrants will expire on the 5-year anniversary of the Initial Exercise Date and the Series E Warrants will expire on the 18-month anniversary of the Initial Exercise Date.

We are also offering to those purchasers, if any, whose purchase of shares of Common Stock in this offering would result in such purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding Common Stock following the consummation of this offering, the opportunity to purchase, in lieu of the shares of our Common Stock that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%), pre-funded warrants (the “Pre-Funded Warrants”) each to purchase one share of Common Stock at an exercise price of $0.001 per share of Common Stock. Each Pre-Funded Warrant is being issued together with one Series D Warrant and one Series E Warrant. The assumed combined public offering price for each Pre-Funded Warrant and accompanying Common Warrants will be equal to the public offering price per share of Common Stock and accompanying Common Warrants in this offering, minus $0.001. Each Pre-Funded Warrant will be exercisable upon issuance and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full.

This prospectus also relates to the offering of the shares of Common Stock issuable upon exercise of the Common Warrants and the Pre-Funded Warrants. We sometimes collectively refer to the shares of Common Stock, the Common Warrants and the Pre-Funded Warrants offered hereby and the shares of Common Stock underlying the Common Warrants and the Pre-Funded Warrants as the “Securities.”

For each Pre-Funded Warrant sold, the number of shares of Common Stock sold will be reduced on a one-for-one basis. The shares of Common Stock and/or Pre-Funded Warrants and the accompanying Common Warrants can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.

The securities will be offered at a fixed price and are expected to be issued in a single closing. The offering will terminate on June 30, 2025 unless completed sooner or unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date; however, our shares of Common Stock underlying the Common Warrants and the Pre-Funded Warrants will be offered on a continuous basis pursuant to Rule 415 under the Securities Act. We expect to enter into a securities purchase agreement (the “Securities Purchase Agreement”), relating to the offering with those investors that choose to enter into such an agreement on the day that the registration statement of which this prospectus forms a part is declared effective and that the closing of the offering will end one trading day after we first enter into such Securities Purchase Agreement relating to the offering. The offering will settle delivery versus payment /receipt versus payment (on the closing date we will issue the shares of Common Stock directly to the account(s) at the Placement Agent identified by each purchaser; upon receipt of such shares, the Placement Agent shall promptly electronically deliver such shares to the applicable purchaser, and payment therefor shall be made by the Placement Agent (or its clearing firm) by wire transfer to us.

We have engaged A.G.P./Alliance Global Partners (“A.G.P.” or the “Placement Agent”), as our sole Placement Agent, to use its best efforts to solicit offers to purchase our securities in this offering. The Placement Agent has no obligation to purchase any securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. Because there is no minimum offering amount required as a condition to closing in this offering the actual public offering amount, Placement Agent’s fee, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth in this prospectus. We have agreed to pay the Placement Agent the Placement Agent fees set forth in the table below. Since we will deliver the securities to be issued in this offering upon our receipt of investor funds, there is no arrangement for funds to be received in escrow, trust or similar arrangement. There is no minimum offering requirement as a condition of closing of this offering. Because there is no minimum offering amount required as a condition to closing in this offering, we may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue our business goals described in this prospectus. In addition, because there is no escrow account, trust or similar arrangement and no minimum offering amount, investors could be in a position where they have invested in our company, but we are unable to fulfill all of our contemplated objectives due to a lack of interest in this offering. Further, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. We will bear all costs associated with the offering. See the “Plan of Distribution” section of this prospectus for more information.

Our Common Stock is listed on the Nasdaq Capital Market under the symbol “ADIL.” On June 5, 2025, the last reported sale price on Nasdaq of our Common Stock was $0.6582 per share. There is no established public trading market for the Common Warrants or the Pre-Funded Warrants, and we do not expect a market to develop. We do not intend to apply for listing of the Common Warrants or the Pre-Funded Warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Common Warrants and the Pre-Funded Warrants will be limited.

We have assumed a public offering price of $0.6585 per share of Common Stock, the last reported sale price on the Nasdaq Capital Market of our Common Stock on June 3, 2025. The actual offering price per share of Common Stock and accompanying Common Warrants or Pre-Funded Warrant and accompanying Common Warrants will be negotiated between us and the investors, in consultation with the Placement Agent based on, among other things, the trading price of our Common Stock prior to the offering and may be at a discount to the current market price. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final offering price.

We are a “smaller reporting company” as defined under federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and may elect to comply with reduced public company reporting requirements in future filings. See “Prospectus Summary––Implications of Being a Smaller Reporting Company.”

Investing in our securities involves a high degree of risk. See the section entitled “Risk Factors”beginning on page 5 of this prospectus and in the documents incorporated by reference into this prospectus for a discussion of risks that should be considered in connection with an investment in our securities.

The delivery of the securities offered hereby is expected to be made on or about , 2025, subject to satisfaction of certain customary closing conditions.

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

Sole Placement Agent

A.G.P.

The date of this prospectus is , 2025

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