Form 8-K

8-K — ADIAL PHARMACEUTICALS, INC.

Accession: 0001213900-26-113337

Filed: 2026-10-28

Period: 2026-10-28

CIK: 0001513525

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year

Item: Submission of Matters to a Vote of Security Holders

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0309977-8k_adial.htm (Primary)

EX-3.1 — CERTIFICATE OF AMENDMENT TO AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF THE COMPANY, EFFECTIVE OCTOBER 28, 2026 (ea030997701ex3-1.htm)

EX-99.1 — PRESS RELEASE, DATED OCTOBER 28, 2026 (ea030997701ex99-1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — CURRENT REPORT

8-K (Primary)

Filename: ea0309977-8k_adial.htm · Sequence: 1

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2026-10-28

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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): October 28, 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,

Suite 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 or

former address, if changed since last report)

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 (see General Instruction A.2. below):

☐

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, par value $0.001 per share

ADIL

The Nasdaq Stock Market LLC

(Nasdaq Capital Market)

Indicate by check

mark whether the registrant is an emerging growth company as defined 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

Appointment

of Chief Executive Officer

The Board of Directors (the “Board”) of Azora

Therapeutics, Inc., formerly known as Adial Pharmaceuticals, Inc. (the “Company”), appointed Matthew Davidson,

Ph.D. as President and Chief Executive Officer of the Company, on October 28, 2026 (the “Effective Date”). Dr.

Davidson will also remain a member of the Board.

Matthew Davidson,

Ph.D. (age 42) has served as the Company’s Chief Development Officer and a member of the Board since June 2026. Dr. Davidson previously

served as the Chief Executive Officer, Co-Founder and Chairman of the Board of Directors of Azora Therapeutics, Inc. (“Legacy

Azora”) since its inception in March 2019. From August 2013 until December 2017, he served as the Chief Executive Officer,

Founder and Chairman of the Board of Directors of Verrica Pharmaceuticals, Inc., a Nasdaq-listed company, where he invented and developed

the first FDA-approved drug for the skin disease molluscum contagiosum. Dr. Davidson holds a Ph.D. in Immunology from Stanford University

School of Medicine and a B.A. in Molecular and Cell Biology from the University of California, Berkeley.

Dr. Davidson’s

existing compensation arrangements with the Company remain unchanged following his appointment. There are no family relationships between

Dr. Davidson and any director or executive officer of the Company and Dr. Davidson does not have any direct or indirect material interest

in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K under the Securities Act of 1933, as amended.

In connection with

Dr. Davidson’s appointment as President and Chief Executive Officer, Dr. Davidson will succeed Cary J. Claiborne, whose employment

was terminated effective as of the Effective Date. Subject to the execution of a release, Mr. Claiborne will be entitled to receive the

severance payments and benefits provided for by his amended and restated employment agreement, as amended by the first amendment thereto.

Appointment

of Chief Financial Officer

Effective as of

the Effective Date, the Board appointed Celia Economides as the Company’s Chief Financial Officer.

Celia

Economides (age 47) has served as the Company’s Executive Vice President of Finance since August 2026. Prior to joining the

Company, Ms. Economides was the founder and managing partner of Vecon Advisory from January 2026 to August 2026. From May 2025 to

November 2025, she was Chief Financial Business Officer of CellCentric. During the period from June 2021 through April 2025, she served as Chief Financial Officer of Gritstone bio, Inc. and as Interim Chief Executive Officer during the

company’s restructuring. Earlier in her career she held senior roles at Kezar Life Sciences, Aurinia

Pharmaceuticals, BioMarin Pharmaceutical, the Biotechnology Innovation Organization (BIO), and a healthcare-focused hedge fund

covering the biotech sector. Celia is also the founder of the Biotech CFO Sisterhood, a nonprofit organization and network for women

finance leaders in life sciences, and serves on the board of Scientific Adventures for Girls, a nonprofit focused on STEM education.

Celia received her B.A. from McGill University and her M.P.H. in Health Policy and Management from Columbia University.

Ms. Economides’

existing compensation arrangements with the Company remain unchanged following her appointment. There are no family relationships between

Ms. Economides and any director or executive officer of the Company and Ms. Economides does not have any direct or indirect material

interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K under the Securities Act of 1933, as amended.

In connection with

Ms. Economides’ appointment as Chief Financial Officer, Ms. Economides will succeed Vinay Shah, whose employment was terminated

effective as of the Effective Date. Subject to the execution of a release, Mr. Shah will be entitled to receive the severance payments

and benefits provided for by his amended and restated employment agreement, as amended by the first amendment thereto.

Appointment

of Chief Strategy Officer

Effective as of

the Effective Date, the Board appointed Julie Saiki, Ph.D. as the Company’s Chief Strategy Officer.

Julie Saiki, Ph.D. (age

41) has served as the Company’s Executive Vice President of Strategy since June 2026. Dr. Saiki is an experienced biotechnology

executive with expertise bringing novel therapeutics from early-stage research into clinical development. She previously served as Co-founder

and Chief Operating Officer at Legacy Azora, where she advanced multiple preclinical assets into clinical-stage development. Prior to

her role at Legacy Azora, she worked as a management consultant at McKinsey and Company where she advised biopharmaceutical companies

on strategy and operations. She holds an M.S. in Medicine and a Ph.D. in Chemical and Systems Biology from Stanford University.

Dr. Saiki’s

existing compensation arrangements with the Company remain unchanged following her appointment. There are no family relationships between

Dr. Saiki and any director or executive officer of the Company and Dr. Saiki does not have any direct or indirect material interest in

any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K under the Securities Act of 1933, as amended.

Indemnification

Agreements

As previously disclosed, Dr. Davidson and the

Company entered into a standard form of indemnification agreement, a copy of which was filed as Exhibit 10.7 to the Company’s Annual

Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”)

on March 5, 2026 (the “Indemnification Agreement”) and is incorporated by reference herein. Additionally, Ms.

Economides and Dr. Saiki have each entered into Indemnification Agreements, in substantially the same form, with the Company.

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

At the Company’s reconvened 2026 Annual

Meeting of Stockholders held on October 28, 2026 (the “Reconvened Annual Meeting”), the Company’s stockholders

approved an amendment to the Company’s Certificate of Incorporation, as amended (the “Amendment”), to increase

the authorized number of shares of common stock from 100,000,000 to 500,000,000 (the “Authorized Shares Amendment”)

and to change the name of the Company from “Adial Pharmaceuticals, Inc.” to “Azora Therapeutics, Inc.” (the “Name

Change Amendment,” and together with the Authorized Shares Amendment, the “Amendment”). The Amendment

was filed with the Secretary of State of the State of Delaware on October 28, 2026 and will become effective as of 12:01 AM Eastern on

October 29, 2026.

The Board approved

the Name Change Amendment pursuant to Section 242 of the General Corporation Law of the State of Delaware. Pursuant to Section 242

of the Delaware General Corporation Law, stockholder approval was not required to approve or effect the Name Change Amendment. The Name

Change Amendment will not in any way affect the voting or other rights that accompany the Company’s common stock, par value $0.001

per share (“Common Stock”), or the validity or transferability of the shares of Common Stock currently outstanding.

The Common Stock

will continue to be quoted on The Nasdaq Capital Market, but beginning with the opening of trading on October 29, 2026, trading is expected

to be under the new symbol “AZR” (the “Symbol Change”) and will trade under a new CUSIP of 054800107.

The foregoing description is qualified

in its entirety by the Amendment, a copy of which is attached as Exhibit 3.1 to this Current Report on Form 8-K and incorporated herein

by reference.

Item 5.07 Submission of Matters to a Vote of Security Holders.

As previously disclosed

in that Current Report on Form 8-K filed by the Company with the SEC on September 18, 2026, on September 17, 2026, the Company convened

its 2026 Annual Meeting of Stockholders (the “2026 Annual Meeting”). However, because the Company had not yet

received Nasdaq’s conditional approval of the Initial Listing Application that the Company submitted to Nasdaq in connection with

certain of the proposals presented to the Company’s stockholders for approval at the 2026 Annual Meeting, the Company determined

to only move forward with the vote on Proposals 1, 2, 7, 8, 9, 10, 11 and 12 and to exercise its authority to adjourn the 2026 Annual

Meeting, in part, with respect to the vote on Proposals 3, 4, 5 and 6, until October 1, 2026.

The Company reconvened

the 2026 Annual Meeting with respect to Proposals 3, 4, 5 and 6 on October 1, 2026, further reconvened the 2026 Annual Meeting with respect

to the foregoing proposals on October 26, 2026, and further reconvened the 2026 Annual Meeting with respect to the foregoing proposals

on October 27, 2026, each time electing to exercise its authority to further adjourn the 2026 Annual Meeting with respect to the foregoing

proposals. On October 28, 2026, the Company reconvened the 2026 Annual Meeting with respect to Proposals 3, 4, 5 and 6, as scheduled.

At the Reconvened Annual Meeting, the stockholders

voted on four proposals, each of which is described in more detail in the Company’s Definitive Proxy Statement on Schedule 14A,

filed with the SEC on August 24, 2026. Of the 2,625,890 shares outstanding as of the record date, 1,291,091 shares, or 49.17%, were present

or represented by proxy at the Reconvened Annual Meeting. Set forth below are the results of the matters submitted for a vote of stockholders

at the Reconvened Annual Meeting.

Proposal No.

3: Approval of, for purposes of complying with Nasdaq Listing Rule 5635(a) and 5635(b), the issuance of 12,930,601 shares of

the Company’s Common Stock in connection with the conversion of the Company’s Series A Non-Voting Preferred Stock, that were

issued pursuant to the terms of that certain Agreement and Plan of Merger, dated June 11, 2026 (the “Merger Agreement”),

by and among the Company, Adial Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company, Adial Merger

Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of Adial, and Legacy Azora. The votes were cast as follows:

Votes For

Votes Against

Abstained

Broker Non-Votes

652,227

7,655

1,067

442,840

Proposal No. 3 was approved.

Proposal No.

4: Approval of, for purposes of complying with Nasdaq Listing Rule 5635(a) and 5635(b), the issuance of up to an aggregate of 1,177,782 shares

of the Company’s Common Stock in connection with the exercise of Legacy Azora options assumed by the Company pursuant to the terms

of the Merger Agreement. The votes were cast as follows:

Votes For

Votes Against

Abstained

Broker Non-Votes

652,607

7,310

1,032

442,840

Proposal No. 4 was approved.

Proposal No. 5: Approval of, for purposes

of complying with Nasdaq Listing Rule 5635(a) and 5635(d), the issuance of up to an aggregate of 11,780,948 shares of the Company’s

Common Stock upon the exercise of the pre-funded warrants that were issued to investors in a private placement and to prior noteholders

of Legacy Azora. The votes were cast as follows:

Votes For

Votes Against

Abstained

Broker Non-Votes

652,545

7,337

1,067

442,840

Proposal No. 5 was approved.

Proposal No. 6: Approval of, for purposes

of complying with Nasdaq Listing Rule 5635(a)and 5635(d), the issuance of 23,561,896 shares of our Common Stock upon the exercise

of the milestone pre-funded warrants and the milestone incentive warrants that we agreed to issue to investors in a private placement

and to prior noteholders of Legacy Azora. The votes were cast as follows:

Votes For

Votes Against

Abstained

Broker Non-Votes

652,534

7,343

1,072

442,840

Proposal No. 6 was approved.

Item 7.01 Regulation FD Disclosure.

On October 28, 2026, the Company issued a press

release announcing the Name Change Amendment and the Symbol Change, a copy of which is furnished herewith as Exhibit 99.1 and is

incorporated by reference herein. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to

the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended,

or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit

Number

Exhibit Description

3.1

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Company, effective October 28, 2026

99.1

Press Release, dated October 28, 2026

104

Cover Page Interactive Data File

(embedded with 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.

Adial Pharmaceuticals, Inc.

Date: October 28, 2026

/s/ Matthew G. Davidson

Matthew G. Davidson

President and Chief Executive Officer

EX-3.1 — CERTIFICATE OF AMENDMENT TO AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF THE COMPANY, EFFECTIVE OCTOBER 28, 2026

EX-3.1

Filename: ea030997701ex3-1.htm · Sequence: 2

Exhibit 3.1

CERTIFICATE OF AMENDMENT

CERTIFICATE OF INCORPORATION OF

ADIAL PHARMACEUTICALS, INC.

Adial

Pharmaceuticals, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General

Corporation Law of the State of Delaware, does hereby certify that:

The name of the Corporation is Adial Pharmaceuticals, Inc.

The Board of Directors of the Corporation has duly adopted a resolution pursuant to Section 242 of the General Corporation Law of

the State of Delaware setting forth a proposed amendments to the Certificate of Incorporation of the Corporation and declaring said amendment

to be advisable. The requisite stockholders of the Corporation have duly approved said proposed amendments, to the extent required, in

accordance with Section 242 of the General Corporation Law of the State of Delaware. This Certificate of Amendment amends the Certificate

of Incorporation of the Corporation as follows:

ARTICLE I of the Certificate of Incorporation is hereby amended and restated in its entirety to read as follows:

The

name of this Corporation is Azora Therapeutics, Inc. (the “Corporation”).

Paragraph A to ARTICLE IV of the Certificate of Incorporation is hereby amended and restated in its entirety to read as follows:

“A. This

Corporation is authorized to issue two classes of stock to be designated, respectively, “Common Stock” and “Preferred

Stock.” The total number of shares which the Corporation is authorized to issue is Five Hundred and Five Million (505,000,000)

shares. Five Hundred Million (500,000,000) shares shall be Common Stock, each having a par value of one-tenth of one cent ($0.001). Five

Million (5,000,000) shares shall be Preferred Stock, each having a par value of one-tenth of one cent ($0.001).”

5. The

foregoing amendments were duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State

of Delaware.

6. This

Certificate of Amendment shall be effective as of October 29, 2026 at 12:01 a.m. Eastern Time.

[SIGNATURE PAGE TO CERTIFICATE

OF AMENDMENT]

WITNESS WHEREOF, Adial Pharmaceuticals, Inc. has caused this Certificate to be duly executed by the undersigned duly authorized officer

as of this 28th day of October, 2026.

ADIAL PHARMACEUTICALS, INC.

By:

/s/ Matthew G. Davidson

Name:

Matthew G. Davidson

Title:

President and Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED OCTOBER 28, 2026

EX-99.1

Filename: ea030997701ex99-1.htm · Sequence: 3

Exhibit 99.1

Adial Pharmaceuticals Announces Name Change

to Azora Therapeutics and New Executive Team, Focused on Advancing AT177, an Oral, Colon-Targeted AhR Agonist for Ulcerative Colitis

Stockholders approved the conversion of the

preferred stock issued in the June 2026 acquisition of Azora Therapeutics

Azora’s common stock to begin trading

on Nasdaq under the ticker symbol “AZR”

New executive leadership team with deep experience

spanning drug development and clinical expertise in AhR biology and inflammatory bowel disease

Phase 1 clinical trial initiation of AT177 expected

in the first half of 2027

LOS ANGELES, October 28, 2026 (GLOBE NEWSWIRE)

-- Adial Pharmaceuticals, Inc., a biopharmaceutical company developing treatments for serious inflammatory diseases, today announced that

it has changed its corporate name to Azora Therapeutics, Inc. The company’s common stock is expected to commence trading on The

Nasdaq Capital Market under the new ticker symbol “AZR” on October 29, 2026. Azora has also launched a new corporate website

at www.AzoraTherapeutics.com.

On October 28, 2026, stockholders approved the

conversion of the Company’s Series A preferred stock issued in connection with the June 2026 acquisition of Azora Therapeutics.

As a result, outstanding shares of the Company’s Series A preferred stock will automatically convert into common stock, subject

to certain beneficial ownership limitations set by each holder.

“This milestone marks a new phase of growth

and value creation for Azora as we rapidly advance our oral, colon-targeted AhR agonist candidate into the clinic for ulcerative colitis,”

said Matt Davidson, Ph.D., co-founder and newly appointed President and Chief Executive Officer of Azora Therapeutics. “Founded

on discoveries from direct patient experience, Azora is pioneering an innovative approach to restoring intestinal health for people living

with ulcerative colitis. Through precise activation of the AhR pathway, AT177 targets a mechanism recognized as an important regulator

of immune function and intestinal barrier integrity in inflammatory bowel disease. With the capital, team and infrastructure in place,

we believe to be well positioned to advance AT177 into the clinic in 2027 with the goal of unlocking the therapeutic potential of AhR

agonism.”

Azora’s lead asset is AT177, an oral, proprietary,

colon-targeted aryl hydrocarbon receptor (AhR) agonist designed to deliver localized therapeutic activity in the colon while mitigating

systemic exposure through a highly selective and differentiated approach. AT177 is in development for the treatment of ulcerative colitis

(UC), a chronic inflammatory disease that occurs when the intestinal barrier and immune regulation break down. Azora expects to advance

AT177 into a Phase 1 clinical trial in the first half of 2027.

“Azora exists because people living with

ulcerative colitis deserve to have better therapeutic options than those available today,” said Julie Saiki, Ph.D., co-founder and

newly appointed Chief Strategy Officer of Azora Therapeutics. “Current treatments have an efficacy ceiling, fail to achieve remission

in many patients, and have safety tradeoffs that can lead to inadequate care and long-term complications. AT177 was engineered to precisely

activate the AhR, a key regulator of gut homeostasis, while maintaining limited systemic exposure. We believe our approach offers the

potential to combine deep biological insights with a targeted drug design strategy to close the gaps that current therapies cannot address.”

Concurrent with the closing of the merger in June,

the Company completed the initial closing of a private placement financing, which provided approximately $32 million of gross proceeds,

including the conversion and retirement of certain outstanding Azora notes. The financing was led by Coastlands Capital with participation

from Boxer Capital Management, Stonepine Capital Management, AuGC BioFund, Kern Capital, and other biotech specialists and institutional

investors, as well as insiders and management. Stockholders also approved the exercise of the prefunded warrants sold in the concurrent

private placement. Following these transactions, Azora’s current cash and cash equivalents are expected to fund current operational

plans into 2028, including IND-enabling studies and the initiation of the Phase 1 clinical trial in UC. Under the terms of the financing,

Azora has the potential to receive an additional $32 million in gross proceeds in connection with the initiation of the Phase 1 clinical

study.

Executive Leadership Team

Azora Therapeutics was co-founded by Julie Saiki,

Ph.D., an ulcerative colitis patient herself who found relief through AhR activation with the uncontrolled botanical indigo naturalis,

and Matt Davidson, Ph.D., who invented a treatment for a viral skin condition he had himself and developed it into a controlled-drug leading

to FDA approval. Joining the executive team are biotech veterans, physician-scientists and seasoned drug developers.

Effective today, the Company has appointed a new

executive leadership team as follows:

● Matt Davidson, Ph.D., President and Chief Executive Officer, co-founded Azora Therapeutics

out of Stanford University’s SPARK translational medicine program. Previously, he was founder and Chief Executive Officer of Verrica

Pharmaceuticals, where he developed the core technology and led the company into Phase 3 trials resulting in the FDA approval of YCANTH®

(cantharidin), the first approved treatment for molluscum contagiosum.

● Julie Saiki, Ph.D., Chief Strategy Officer, co-founded Azora Therapeutics after leading

the Stanford Phase 1b study that established clinical evidence that AhR activation could treat ulcerative colitis, providing the scientific

foundation for AT177. Prior to launching Azora, she advised pharmaceutical and biotechnology companies on strategy and operations as a

consultant at McKinsey & Company.

● Celia Economides, Chief Financial Officer, has more than 20 years of biopharmaceutical finance

leadership across public and private companies. She most recently served as Chief Financial and Business Officer of CellCentric, Chief

Financial Officer of Gritstone bio and previously held senior roles at Kezar Life Sciences, Aurinia Pharmaceuticals, and BioMarin Pharmaceutical,

following BioMarin’s acquisition of Prosensa.

● David Rubenstein, M.D., Ph.D., Chief Scientist, is a physician-scientist who led the development

of the first FDA-approved AhR agonist, tapinarof, as Chief Scientific Officer of Dermavant Sciences. He has previously held senior roles

focused on preclinical development at Stiefel and GSK.

● Ajay Duggal, MBChB, MRCP, DPM, Consulting Chief Medical Officer, leads clinical strategy

for AT177. He has previously held senior roles at Bristol Myers Squibb, Pfizer, Genzyme and Takeda, where as Vice President and Global

Therapeutic Area Head for General Medicine, he led the mid- and late-stage development pipeline across a range of inflammatory and immunological

indications, including IBD.

About AT177

AT177 is a fully synthetic, patented, oral AhR

agonist designed to restore mucosal immune homeostasis at the site of disease with minimal systemic exposure. AT177 is a prodrug of the

active ingredient, indirubin, a potent AhR agonist derived from indigo naturalis, a botanical extract that has been evaluated in clinical

studies in patients with ulcerative colitis but has not been approved by the U.S. Food and Drug Administration. AT177’s colon-targeted

formulation delivers therapeutic AhR engagement directly to the colonic mucosa with the goal of minimizing the systemic AhR exposure associated

with adverse effects. In preclinical studies, AT177 demonstrated robust local colonic AhR activation with markedly limited systemic exposure.

AT177 is currently in IND-enabling studies, with a Phase 1 clinical trial planned for the first half of 2027.

About Azora Therapeutics

Azora Therapeutics Inc. is a biopharmaceutical

company focused on developing treatments for serious inflammatory diseases. The company was spun out of Stanford University after being

incubated in the translational medicine SPARK program. Azora owns the worldwide royalty-free rights to its technology, which is based

on the development of potential best-in-class oral agonists of the aryl hydrocarbon receptor. Azora’s lead program is AT177, a proprietary

colon-targeted aryl hydrocarbon receptor (AhR) agonist designed to enable localized activation with limited systemic exposure in development

for ulcerative colitis. More information on Azora can be found on the company’s website at www.AzoraTherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements

within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are

not historical facts and may be identified by words such as “anticipate,” “believe,” “expect,” “intend,”

“plan,” “may,” “will,” “would,” “could,” “should,” “estimate,”

“potential,” “target,” “goal,” “on track” and similar expressions, although not all forward-looking

statements contain these words. These statements include, but are not limited to, statements regarding: the change of the Company’s

corporate name to Azora Therapeutics, Inc.; the anticipated commencement of trading of Azora’s common stock on The Nasdaq Capital

Market under the ticker symbol “AZR” and its timing; the Company’s expectations regarding its pipeline and development

plans, including submitting an investigational new drug application; rapidly advancing AT177 into the clinic and the expected timing and

initiation of the Phase 1 clinical trial of AT177 in ulcerative colitis; the potential to receive an additional $32 million; and the potential

of Azora’s approach to address gaps that current therapies cannot address.

Forward-looking statements are based on management’s

current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s

control, that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include,

among others, risks related to clinical development and the conduct, timing and results of clinical trials; the Company’s need for

additional financing; its limited operating history and history of operating losses; risks related to the integration of Azora; the Company’s

ability to satisfy applicable Nasdaq listing requirements and to maintain the listing of its common stock; and the other risks and uncertainties

described under the headings “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December

31, 2025 and subsequent Quarterly Reports on Form 10-Q and amendments thereto, and its definitive proxy statement filed with the SEC on

August 24, 2026, as well as in the Company’s subsequent filings. Forward-looking statements speak only as of the date of this press

release, and the Company undertakes no obligation to update any forward-looking statement, except as required by law.

Media Contact:

Ashley Biladeau

Inizio Evoke Comms

Ashley.Biladeau@inizioevoke.com

Investor Contact:

Mike Moyer

LifeSci Advisors, LLC

mmoyer@lifesciadvisors.com

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End date of current fiscal year in the format --MM-DD.

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For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

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- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

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No definition available.

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Name:

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- Definition

Address Line 1 such as Attn, Building Name, Street Name

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- Definition

Address Line 2 such as Street or Suite number

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Name of the City or Town

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Code for the postal or zip code

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- Definition

Name of the state or province.

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- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Indicate if registrant meets the emerging growth company criteria.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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No definition available.

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- Definition

Two-character EDGAR code representing the state or country of incorporation.

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- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Local phone number for entity.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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- Definition

Title of a 12(b) registered security.

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-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Name:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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