Form 8-K

8-K — ADIAL PHARMACEUTICALS, INC.

Accession: 0001213900-26-090482

Filed: 2026-08-17

Period: 2026-08-17

CIK: 0001513525

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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):

August 17, 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. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 17, 2026, Adial Pharmaceuticals, Inc.,

a Delaware corporation (the “Company”), issued a press release that included financial information for its quarter ended June

30, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 and in the press

release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section

18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2)

of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1

to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission

made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release, dated August 17, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: August 17, 2026

ADIAL PHARMACEUTICALS, INC.

By:

/s/ Cary J. Claiborne

Name:

Cary J. Claiborne

Title:

President and Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED AUGUST 17, 2026

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Exhibit 99.1

Adiel Pharmaceuticals Reports 2026 Second Quarter

Financial Results and Provides Business Update

Completed acquisition of Azora Therapeutics,

adding AT177, a fully synthetic, oral, colon-targeted aryl hydrocarbon receptor (“Ahr”) agonist in development for ulcerative

colitis, to its pipeline

Closed initial $32 million tranche, including

the conversion of notes, of an up to $64 million private placement from biotech specialist investors

Glen Allen, VA – August 17, 2026 –

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”) today provided a business update and

reported its financial results for the 2026 second quarter ended June 30, 2026.

“The acquisition of Azora Therapeutics and

the concurrent financing mark an important inflection point for Adial,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals.

“AT177 establishes a new strategic focus for the Company around a differentiated approach to treating ulcerative colitis, an area

where many patients continue to experience inadequate outcomes despite a growing number of therapies. AT177 is built on a mechanism with

demonstrated clinical benefit, delivered in a form designed to concentrate activity in the colon, where it matters. Our focus is now on

advancing AT177 into the clinic in 2027 and building long-term value for patients and shareholders.”

During the quarter, the Company strengthened its

financial position by closing the first $32 million tranche, including the conversion of $5.5 million of notes, of an up to $64 million

private financing led by biotechnology-focused institutional investors. This financing provides the capital needed to advance AT177 through

key clinical development milestones. In parallel, the Company enhanced its board and executive leadership team with experienced pharmaceutical

industry veterans with expertise in small molecule drug development.

“AhR signaling is a clinically validated

pathway with the potential to restore immune homeostasis and epithelial barrier function in ulcerative colitis,” said Matt Davidson,

Ph.D., Chief Development Officer and Director of Adial Pharmaceuticals. “AT177 is differentiated by design, a fully synthetic, oral

prodrug engineered to release the active AhR agonist in the colon, where disease occurs, while minimizing systemic exposure. We believe

this targeted delivery strategy addresses an important limitation of earlier AhR agonists and positions AT177 to capture the promise of

localized AhR activation with a potentially better safety profile. With strong progress across our preclinical and CMC programs, we remain

on track to file an IND in the first half of 2027.”

Second Quarter 2026 Financial Results

● Cash and cash equivalents were $28.7 million as of June 30, 2026, compared to $4.6 million as of March

31, 2026. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2027.

This does not assume receipt of the additional $32 million available under the milestone tranche of the private placement.

● Research and development expenses decreased by approximately $292 thousand to $440 thousand during the

three months ended June 30, 2026, compared to $732 thousand for the three months ended June 30, 2025. This was mainly due to decreased

research and development activity as the Company was engaged in merger discussions during the three months ended June 30, 2026 as compared

to the same period in 2025.

● General and administrative expenses increased by approximately $4.3 million to $5.4 million during the

three months ended June 30, 2026 compared to $1.2 million for the three months ended June 30, 2025. The increase was mainly due to merger

related costs associated with the acquisition of Azora and severance expenses incurred during the three months ended June 30, 2026 as

compared to the same period in 2025.

● Acquired in-process research and development expense was $46.2 million for the three months ended June

30, 2026. This is a non-cash charge representing the fair value of the in-process research and development acquired in the Azora Therapeutics

transaction, which was expensed at closing because the acquired in-process research and development has no alternative future use as of

the acquisition date. The charge has no effect on the Company’s cash position or on the cash runway described above.

● Net loss was $52.0 million for the three months ended June 30, 2026, or $(11.25) per basic and diluted

share, compared to a net loss of $2.0 million, or $(4.61) per basic and diluted share, for the three months ended June 30, 2025. The increase

in net loss was primarily driven by acquired in-process research and development expense of $46.2 million, together with increased general

and administrative expenses in the three months ended June 30, 2026 as compared to the same period in 2025. Net loss per share is calculated

on 4,621,735 weighted-average shares outstanding and does not give effect to the conversion of the Series A convertible preferred stock,

which remains subject to stockholder approval and which would result in 12,930,617 additional shares on an as-converted basis.

● At June 30, 2026, the Company had a Stockholders’ Deficit of ($38.4) million resulting primarily

from the addition of a $23.8 million milestone warrant liability and the classification as mezzanine equity of $38.5 million resulting

from the issuance of Series A convertible preferred stock in the merger. The $38.5 million attributable to the Series A convertible preferred

stock is expected to be reclassified as equity upon obtaining stockholder approval of its conversion to common stock. The milestone warrant

liability resulting from the potential issuance of milestone warrants is a non-cash liability that does not require any cash payment and

results from the fact that the number of shares underlying the milestone warrants are not fixed and vary based on investors election of

their rights to purchase milestone warrants. Upon the issuance of the milestone warrants, the liability is expected to be converted into

equity.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals, a clinical-stage biopharmaceutical

company, has historically focused on the development of treatments for addictions and related disorders. In June 2026, the Company acquired

Azora Therapeutics, a biopharmaceutical company focused on treating autoimmune diseases, including ulcerative colitis (“UC”).

Following the acquisition of Azora, the Company’s focus has shifted to the treatment of serious inflammatory diseases, and its lead

program is AT177, which is being studied for the treatment of UC. AT177 is a fully synthetic, patented, oral AhR agonist designed to restore

mucosal immune homeostasis at the site of disease with minimal systemic exposure. Its active ingredient is a prodrug of indirubin, the

most potent AhR agonist within indigo naturalis, a botanical extract with best-in-category clinical efficacy in UC. In preclinical studies,

AT177 demonstrated robust local colonic AhR activation with markedly limited systemic exposure and superior colon-to-systemic selectivity

compared to other AhR agonists in development. AT177 is currently in IND-enabling studies, with an investigational new drug (“IND”)

filing planned for the first half of 2027, initiation of a Phase 1a single- and multiple-ascending-dose (“SAD/MAD”) clinical

trial planned to commence in the second half of 2027, followed by a Phase 1b proof-of-concept study in UC patients. Additional information

is available at www.adial.com.

Forward-Looking Statements

This communication contains certain “forward-looking

statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing

numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results,

performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such

forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,”

“anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions

or future or conditional verbs such as “will,” “should,” “would,” “may” and “could”

are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The

forward-looking statements include, but are not limited to, statements regarding advancing AT177 into the clinic in 2027; building long-term

value for patients and shareholders; the aryl hydrocarbon receptor’s (“AhR”) potential to restore immune homeostasis

and epithelial barrier function in UC; the targeted delivery strategy addressing an important limitation of earlier AhR agonists and positioning

AT177 to capture the promise of localized AhR activation with a potentially better safety profile; remaining on track to file an IND in

the first half of 2027; existing cash and cash equivalents funding operating expenses into the second half of 2027; and initiation of

a Phase 1a SAD/MAD clinical trial planned to commence in the second half of 2027, followed by a Phase 1b proof-of-concept study in UC

patients; and the reclassification of the Series A convertible preferred stock as equity upon receipt of stockholder approval and the

conversion of the warrant liability into equity upon issuance of the milestone warrants. Any forward-looking statements included herein

reflect the Company’s current views, and they involve certain risks and uncertainties, including, among others, the Company’s

ability to file an IND in the first half of 2027, and to initiate a Phase 1a SAD/MAD clinical trial planned to commence in the second

half of 2027, followed by a Phase 1b proof-of-concept study in UC patients; the Company’s ability to pursue its regulatory strategy;

the ability to reproduce favorable results in clinical trials; the Company’s ability to obtain regulatory approvals for commercialization

of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to develop strategic partnership

opportunities and maintain collaborations; the Company’s ability to obtain or maintain the capital or grants necessary to fund its

research and development activities; the Company’s ability to complete clinical trials on time and achieve desired results and benefits

as expected; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for specific

indications; acceptance of the Company’s product candidates in the marketplace and the successful development, marketing or sale

of its products; the Company’s ability to maintain its license agreements; the continued maintenance and growth of the Company’s

patent estate and its ability to retain its key employees or maintain the Company’s Nasdaq listing, including to obtain Nasdaq’s

conditional approval of an initial listing application that the Company intends to file with Nasdaq in the near term prior to the Company’s

2026 Annual Meeting of stockholders. These risks should not be construed as exhaustive and should be read together with the other cautionary

statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports

on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only

as of the date on which it was initially made. The Company undertakes no obligation to publicly update or revise any forward-looking statement,

whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:

Mike Moyer

Managing Director

LifeSci Advisors, LLC

Phone: (617) 328-4326

Email: mmoyer@lifesciadvisors.com

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