false
--12-31
0001513525
0001513525
2026-10-28
2026-10-28
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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 |
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
