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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (date of earliest event reported):
September 16, 2026
Adial Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
Delaware
(State or other jurisdiction of incorporation)
| 001-38323 |
|
82-3074668 |
| (Commission File Number) |
|
(IRS Employer Identification No.) |
4870 Sadler Road, Ste 300
Glen Allen, VA 23060
(Address of principal executive offices and
zip code)
(804) 487-8196
(Registrant’s telephone number including
area code)
(Former Name and Former Address)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbols |
|
Name of each exchange on which registered |
| Common Stock |
|
ADIL |
|
The
Nasdaq Stock Market LLC
(Nasdaq Capital Market) |
Indicate by check mark whether the registrant
is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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 13(a) of the Exchange Act. ☐
INTRODUCTORY NOTE
As previously disclosed in that Current Report
on Form 8-K (the “Prior 8-K”) filed by Adial Pharmaceuticals, Inc. (the “Company”) with the Securities and Exchange
Commission (the “SEC”) on June 11, 2026, the Company acquired Azora Therapeutics, Inc. (“Azora”), in accordance
with the terms of the Agreement and Plan of Merger, dated June 11, 2026 (the “Merger Agreement”), by and among the Company,
Adial Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of the Company, Adial Second Merger Sub, LLC, a Delaware
limited liability company and wholly owned subsidiary of the Company, and Azora. Under the terms of the Merger Agreement, upon the consummation
of the Merger, in exchange for the outstanding shares of capital stock of Azora immediately prior to the effective time of the Merger,
the Company issued to the stockholders of Azora an aggregate of (i) 437,474 shares of its common stock, par value $0.001 per share (the
“Common Stock”), and (ii) 12,930.617 shares of its Series A Non-Voting Convertible Preferred Stock, par value $0.001 per share
(the “Series A Preferred Stock”), each share of which is convertible into 1,000 shares of Common Stock.
In connection with the Merger, the Company entered
into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “PIPE Investors”)
on June 11, 2026, pursuant to which the Company sold and issued to the PIPE Investors, in a private placement transaction (the “PIPE”),
pre-funded warrants (the “Initial Closing PIPE Pre-Funded Warrants”) to purchase an aggregate of 9,749,345 shares of Common
Stock. As further disclosed in the Prior 8-K, on June 11, 2026, the Company also entered into exchange agreements (the “Exchange
Agreements”), with the former holders of Azora promissory notes (the “Former Azora Noteholders”), pursuant to which
the Company issued pre-funded warrants (the “Initial Closing Noteholder Pre-Funded Warrants” and, together with the Initial
Closing PIPE Pre-Funded Warrants, the “Initial Closing Pre-Funded Warrants”) to purchase an aggregate of 2,031,603 shares
of Common Stock to the Former Azora Noteholders in exchange for the extinguishment of the Company’s guarantee of the payment of
notes issued by Azora to the Former Azora Noteholders in the principal amount of $5,500,000 (the “Azora Notes”) and the retirement
of the Azora Notes (the “Note Exchange”).
Pursuant to the Purchase Agreement and the Exchange
Agreements, the PIPE Investors and the Former Azora Noteholders have the right to participate in one or more additional closings, at which
they will have the right, but not the obligation, to purchase additional pre-funded warrants (the “Milestone Pre-Funded Warrants”)
to purchase up to an aggregate of 11,780,946 shares of Common Stock together with common warrants (the “Milestone Common Warrants”
and, together with the Milestone Pre-Funded Warrants, the “Milestone Warrants”), to purchase up to an aggregate of 11,780,946
shares of Common Stock at a combined purchase price of $2.7489 per set of Milestone Warrants; provided, however, that to the extent that
a PIPE Investor or a Former Azora Noteholder were to exercise any of their respective Initial Closing Pre-Funded Warrants prior to any
such additional closing, such PIPE Investor’s or Former Azora Noteholder’s right to purchase Milestone Warrants would be decreased
by the percentage of their Initial Closing Pre-Funded Warrants that they exercised (the “Penalty Provision”).
For additional information regarding the terms
and conditions of the Purchase Agreement and the Note Exchange Agreements, as well as the other transactions and agreements entered into
by the Company in connection therewith, please refer to the Prior 8-K, including the copies of the Purchase Agreement, Exchange Agreement
and other agreements filed as exhibits thereto.
Item 1.01 Entry into a Material
Definitive Agreement.
After the closing of the PIPE and the Note Exchange,
it was determined that, for accounting purposes, the Penalty Provision in the Purchase Agreement and Exchange Agreements caused the entire
value of the Milestone Warrants that the PIPE Investors and Former Azora Noteholders have a right to purchase to be classified as a liability
in the Company’s financial statements, as reflected in the Company’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2026, which the Company filed with the SEC on August 14, 2026, which in turn caused the Company’s stockholders’ equity
to fall below the minimum stockholders’ equity required for continued listing of the Company’s Common Stock on the Nasdaq
Capital Market as of June 30, 2026, as well as below the minimum stockholders’ equity amount required for Nasdaq for approval of
the Company’s Initial Listing Application in connection with the anticipated change in control that will be triggered by approval
by the Company’s stockholders of certain of the proposals being presented for approval at the Company’s 2026 Annual Meeting
of Stockholders (the “Annual Meeting”).
On September 16, 2026, the Company entered into
an Amendment No. 2 to Securities Purchase Agreement (the “Purchase Agreement Amendment”) with certain PIPE Investors, constituting
holders of the Majority of Interest (as defined in the Purchase Agreement), pursuant to which the Purchase Agreement was amended to (i)
remove the Penalty Provision and to (ii) add a provision prohibiting the PIPE Investor from offering for sale, selling, assigning, transferring,
pledging or otherwise disposing of certain of the shares of Common Stock issuable upon exercise of the Initial Closing PIPE Pre-Funded
Warrants for the Lock-Up Period specified in the Purchase Agreement Amendment, subject to certain exceptions.
On September 16, 2026, the Company also entered
into an Amendment No. 1 to Note Exchange Agreement (the “Note Agreement Amendment” and together with the Purchase Agreement
Amendment, the “Amendments”) with certain Former Azora Noteholders who received Initial Closing Noteholder Pre-Funded Warrants
to purchase an aggregate of 1,504,098 shares of Common Stock in the Note Exchange, pursuant to which the Note Exchange Agreements were
amended to (i) remove the Penalty Provision and to (ii) add a provision prohibiting such Former Azora Noteholders from offering for sale,
selling, assigning, transferring, pledging or otherwise disposing of certain of the shares of Common Stock issuable upon exercise of the
Initial Closing Noteholder Pre-Funded Warrants for the Lock-Up Period specified in the Note Agreement Amendment, subject to certain exceptions.
The Company intends to enter into a similar amendment with additional Former Azora Noteholders in the near term.
The purpose of the Amendments is to change the
accounting treatment of the Milestone Warrant rights so that the value of the Milestone Warrants is no longer treated as a liability on
the Company’s financial statements, and to ensure that the Company regains compliance with the continued listing requirements and
satisfies the initial listing standards of the Nasdaq Capital Market.
The foregoing description of the Amendments does
not purport to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement Amendment and Note
Exchange Agreement Amendment, the forms of which are filed as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K and are incorporated
herein by reference.
Item 8.01 Other Events.
As previously announced, the Company plans
to hold its Annual Meeting on September 17, 2026, at 8:30 a.m. Eastern Daylight Time, unless postponed or adjourned to a later
date. At the Annual Meeting, stockholders will be asked to approve, among other things, the issuance of shares of Common Stock upon
conversion of Series A Preferred Stock, which (i) will represent more than 19.99% of the shares of Common Stock outstanding
immediately prior to execution of the Merger Agreement, and (ii) result in the change of control of the Company pursuant to
Nasdaq Listing Rules 5635(a) and 5635(b), respectively. In connection with the Annual Meeting, the Company is filing, as an exhibit
to this Current Report on Form 8-K, unaudited pro forma condensed consolidated balance sheet of the Company for the quarter ended
June 30, 2026, presenting the historical consolidated financial position of the Company for the quarter ended June 30, 2026, as
adjusted to give effect to the conversion of the shares of Series A Preferred Stock into shares of Common Stock and to reflect the
change in accounting treatment of the Milestone Warrants as a result of the Amendments, as discussed in Item 1.01 above.
The unaudited pro forma condensed balance
sheet, including the notes thereto, should be read in conjunction with the financial statements of the Company and the Company’s
management’s discussion and analysis of financial condition and results of operations included in the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 14, 2026. Such unaudited pro forma
condensed financial information is presented for illustrative purposes only and may not be an indication of the Company’s financial
condition following the conversion of the Series A Preferred Stock and execution of the Amendments for several reasons. The unaudited
pro forma condensed balance sheet has been derived from the historical unaudited financial statements of the Company for the quarter ended
June 30, 2026, and certain adjustments and assumptions have been made regarding the Company after giving effect to the conversion of the
Series A Preferred Stock and execution of the Amendments. The unaudited pro forma condensed balance sheet does not reflect all costs that
are expected to be incurred by the Company in connection with the conversion of the Series A Preferred Stock and execution of the Amendments.
As a result, the actual financial condition of the Company following the conversion of the Series A Preferred Stock and execution of the
Amendments may not be consistent with, or evident from, the unaudited pro forma condensed balance sheet. Certain assumptions used in preparing
the unaudited pro forma condensed balance sheet may not prove to be accurate, and other factors may affect the Company’s financial
condition following the conversion of the Series A Preferred Stock and execution of the Amendments. For more information, please see Exhibit
99.1 attached hereto and incorporated herein by reference.
For additional information regarding the Annual
Meeting, please refer to the Company’s Definitive Proxy Statement, filed with the SEC on August 24, 2026.
Item 9.01 Financial Statements and
Exhibits.
(d) Exhibits
Exhibit
Number |
|
Exhibit Description |
| 10.1 |
|
Form of Amendment No. 2 to Securities Purchase Agreement, dated September 16, 2026, by and between Adial Pharmaceuticals, Inc. and the investor signatories thereto. |
| 10.2 |
|
Form of Amendment No. 1 to Note Exchange Agreement, dated September 16, 2026, by and between Adial Pharmaceuticals, Inc. and the investor signatories thereto. |
| 99.1 |
|
Unaudited Pro Forma Condensed Balance Sheet of Adial Pharmaceuticals, Inc. for the quarter ended June 30, 2026. |
| 104 |
|
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: September 16, 2026 |
ADIAL PHARMACEUTICALS, INC. |
| |
|
| |
By: |
/s/ Cary J. Claiborne |
| |
Name: |
Cary J. Claiborne |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
ADIAL PHARMACEUTICALS, INC.
UNAUDITED PRO FORMA CONDENSED FINANCIAL INFORMATION
The following unaudited pro forma condensed
financial information presents the historical unaudited consolidated balance sheet as of June 30, 2026 of Adial Pharmaceuticals, Inc.
(“Adial” or the “Company”), adjusted to give effect to (i) an amendment to the Securities Purchase Agreement (the
“Purchase Agreement”), dated June 11, 2026, entered into by the Company with certain accredited investors (the “PIPE
Investors”) and certain Note Exchange Agreements (the “Exchange Agreements”), dated June 11, 2026, entered into by the
Company with certain former holders (the “Azora Noteholders”) of promissory notes of Azora Therapeutics, Inc., resulting in
the reclassification of the liability attributable to pre-funded warrants and common stock purchase warrants (collectively, the “Milestone
Warrants”) that the PIPE Investors and Former Azora Noteholders have a right to purchase in one or more future closings pursuant
to the Purchase Agreement from liability to equity classification and (ii) the conversion of the outstanding shares of the Company’s
Series A Non-Voting Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred Stock”) into shares of Company
common stock, par value $0.001 per share (“Common Stock”), each as described below.
Pursuant to the Purchase Agreement and the Exchange
Agreements, the PIPE Investors and the Former Azora Noteholders have the right to participate in one or more additional closings, at which
they will have the right, but not the obligation, to purchase Milestone Warrants at a combined purchase price of $2.7489 per set of Milestone
Warrants; provided, however, that to the extent that a PIPE Investor or a Former Azora Noteholder were to exercise any of their respective
pre-funded warrants (the “Initial Closing Pre-Funded Warrants”) issued to them at the initial closing of the private placement
(the “PIPE”) under the Purchase Agreement or upon closing of the note exchange pursuant to the Note Exchange Agreement, as
applicable, prior to any such additional closing, such PIPE Investor’s or Former Azora Noteholder’s right to purchase Milestone
Warrants would be decreased by the percentage of their Initial Closing Pre-Funded Warrants that they exercised (the “Penalty Provision”).
On September 16, 2026, the Company entered into
an Amendment No. 2 to the Purchase Agreement (the “Purchase Agreement Amendment”) with certain PIPE Investors, constituting
holders of the Majority of Interest (as defined in the Purchase Agreement), pursuant to which the Purchase Agreement was amended to (i)
remove the Penalty Provision and to (ii) add a provision prohibiting the PIPE Investors from offering for sale, selling, assigning, transferring,
pledging or otherwise disposing of certain of the shares of Common Stock issuable upon exercise of the Initial Closing Pre-Funded Warrants
issued in the PIPE for the Lock-Up Period specified in the Purchase Agreement Amendment, subject to certain exceptions. Execution of the
Purchase Agreement Amendment resulted in the reclassification of the Milestone Warrant rights held by PIPE Investors from liability to
equity classification. The unaudited pro forma condensed consolidated balance sheet gives effect to the reclassification as if it had
been consummated on June 30, 2026.
On September 16, 2026, the Company also entered
into an Amendment No. 1 to the Note Exchange Agreement (the “Note Agreement Amendment” and together with the Purchase Agreement
Amendment, the “Amendments”) with certain Former Azora Noteholders who received Initial Closing Pre-Funded Warrants upon closing
of the Note Exchange, pursuant to which the Note Exchange Agreements previously entered into with such Former Azora Noteholders were amended
to (i) remove the Penalty Provision and to (ii) add a provision prohibiting such Former Azora Noteholders from offering for sale, selling,
assigning, transferring, pledging or otherwise disposing of certain of the shares of Common Stock issuable upon exercise of the Initial
Closing Pre-Funded Warrants issued in the Note Exchange for the Lock-Up Period specified in the Note Agreement Amendment, subject to certain
exceptions. Execution of the Note Exchange Agreement Amendments resulted in the reclassification of the Milestone Warrant rights held
the Former Azora Noteholders who entered into the Note Exchange Agreement Amendments from liability to equity classification. The unaudited
pro forma condensed consolidated balance sheet gives effect to the reclassification as if it had been consummated on June 30, 2026.
The Company intends to enter into a similar amendment
with additional Former Azora Noteholders who hold Milestone Warrant rights pursuant to the Note Exchange Agreement; however, such amendments
are yet to be executed. The unaudited pro forma condensed consolidated balance sheet gives no effect to the anticipated execution of the
additional Note Exchange Agreement Amendments.
The Company’s outstanding shares of Series
A Preferred Stock will automatically convert into shares of Common Stock (the “Conversion”) three business days after the
anticipated affirmative stockholder vote approving the Conversion and certain other related matters, which vote is expected to be obtained
at the Company’s 2026 Annual Meeting of Stockholders, which is currently scheduled to be held on September 17, 2026, subject to
adjournment or postponement thereof. The unaudited pro forma condensed consolidated balance sheet gives effect to the Conversion as if
it had been consummated on June 30, 2026.
The unaudited pro forma condensed consolidated
balance sheet is based on the assumptions and adjustments described in the accompanying notes. The pro forma adjustments are preliminary
and have been prepared solely for purposes of this presentation; they remain subject to revision as additional information becomes available
and further analysis is performed. The unaudited pro forma condensed consolidated balance sheet is presented for illustrative purposes
only and does not purport to represent what the Company’s actual financial position would have been had the Purchase Agreement Amendment,
Note Exchange Agreement Amendment and the Conversion been completed as of the date indicated, nor is it necessarily indicative of the
Company’s future financial position.
The unaudited pro forma condensed consolidated
balance sheet, including the notes thereto, should be read in conjunction with the consolidated financial statements of the Company and
the Company’s management’s discussion and analysis of financial condition and results of operations included in the Company’s
Quarterly Report on Form 10-Q as of June 30, 2026, filed with the Securities and Exchange Commission (“SEC”) on August 14,
2026.
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED BALANCE
SHEET
AS OF JUNE 30, 2026
(in thousands)
| | |
June 30,
2026 | | |
Transaction Accounting Adjustments | | |
Pro Forma As Adjusted | |
| Assets | |
| | |
| | |
| |
| Current assets: | |
| | |
| | |
| |
| Cash and cash equivalents | |
$ | 28,712 | | |
$ | — | | |
$ | 28,712 | |
| Prepaid expenses and other current assets | |
| 133 | | |
| — | | |
| 133 | |
| Total current assets | |
| 28,845 | | |
| — | | |
| 28,845 | |
| Intangible assets, net | |
| 3 | | |
| — | | |
| 3 | |
| Equity method investments | |
| 241 | | |
| — | | |
| 241 | |
| Total assets | |
$ | 29,089 | | |
$ | — | | |
$ | 29,089 | |
| Liabilities, temporary equity and stockholders’ (deficit) equity | |
| | | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | | |
| | |
| Accounts payable | |
$ | 2,624 | | |
$ | — | | |
$ | 2,624 | |
| Accrued expenses | |
| 2,497 | | |
| — | | |
| 2,497 | |
| Total current liabilities | |
| 5,121 | | |
| — | | |
| 5,121 | |
| Milestone warrant rights liability | |
| 23,812 | | |
| (22,746 | )(a) | |
| 1,066 | |
| Total liabilities | |
| 28,933 | | |
| (22,746 | ) | |
| 6,187 | |
| Commitments and contingencies | |
| | | |
| | | |
| | |
| Series A convertible preferred stock, $0.001 par value; 13,000 shares designated and 12,930.617 shares issued and outstanding as of June 30, 2026, actual; 13,000 shares designated and 0 shares issued and outstanding as of June 30, 2026, pro forma. | |
| 38,533 | | |
| (38,533 | )(b) | |
| — | |
| Stockholders’ (deficit) equity: | |
| | | |
| | | |
| | |
| Preferred Stock, $0.001 par value; 5,000,000 shares authorized as of June 30, 2026, actual and pro forma. | |
| — | | |
| — | | |
| — | |
| Common Stock, $0.001 par value; 100,000,000 shares authorized, 2,625,890 shares issued and outstanding at June 30, 2026, actual; 100,000,000 shares authorized, 15,556,507 shares issued and outstanding at June 30, 2026, pro forma. | |
| 3 | | |
| 13 | (b) | |
| 16 | |
| Additional paid-in capital | |
| 105,604 | | |
| 22,746 | (a) | |
| 166,870 | |
| | |
| | | |
| 38,520 | (b) | |
| | |
| Accumulated deficit | |
| (143,984 | ) | |
| — | | |
| (143,984 | ) |
| Total stockholders’ (deficit) equity | |
| (38,377 | ) | |
| 61,279 | | |
| 22,902 | |
| Total liabilities, temporary equity and stockholders’ (deficit) equity | |
$ | 29,089 | | |
$ | — | | |
$ | 29,089 | |
ADIAL PHARMACEUTICALS, INC.
NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED
BALANCE SHEET
| a. | Reflects the reclassification of $19.7 million and $3.0 million of the Milestone Warrant rights liability
to additional paid-in capital following amendments to the Purchase Agreement and the Note Exchange Agreements, respectively, that resulted
in equity classification. As a result of the Amendments, the conditions requiring liability classification of the Milestone Warrant rights
are no longer present, and equity classification is appropriate. The portion of the Milestone Warrant rights liability related to Milestone
Warrants held by Former Azora Noteholders that have not executed the Note Exchange Agreement Amendment was not impacted by the Purchase
Agreement Amendment or the Note Exchange Agreement Amendments that have been executed and remains liability classified. |
| b. | Reflects the expected conversion of 12,930.617 shares of Series A Preferred Stock into 12,930,617 shares
of Common Stock, with the carrying amount reclassified between Common Stock and additional paid-in capital based on par value. The transaction
accounting adjustments reflecting the Conversion assumes the full conversion of all of the shares of Series A Preferred Stock and do not
reflect the conversion of shares that are not expected to convert due to certain beneficial ownership limitations established by each
holder based solely on the shares of Series A Preferred Stock beneficially owned by the holders thereof. The number of shares of Series
A Preferred Stock that ultimately convert into shares of Common Stock may be more or less than the Company’s expectations. |
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