Form 8-K

8-K — Azora Therapeutics, Inc. (DE)

Accession: 0001213900-26-118922

Filed: 2026-11-12

Period: 2026-11-12

CIK: 0001513525

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0311952-8k_azora.htm (Primary)

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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):

November 12, 2026

AZORA THERAPEUTICS, 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.)

16501 Ventura Blvd, Suite 400

Encino, CA 91436

(Address of principal executive offices and zip

code)

(818) 253-9118

(Registrant’s telephone number including

area code)

N/A

(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

AZR

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 2.02. Results of Operations and Financial

Condition

On November 12, 2026, Azora Therapeutics, Inc.

(the “Company”) announced its financial results for the quarter ended September 30, 2026 and provided recent business

highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report

on Form 8-K.

The information contained in Item 2.02 of this

Current Report on Form 8-K (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

provided by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d)   Exhibits.

Ex. No.

Description

99.1

Press Release issued by Azora Therapeutics, Inc. dated November 12, 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.

Date: November 12, 2026

AZORA THERAPEUTICS, INC.

By:

/s/ Matthew G. Davidson

Name:

Matthew G. Davidson

Title:

President and Chief Executive Officer

EX-99.1 — PRESS RELEASE ISSUED BY AZORA THERAPEUTICS, INC. DATED NOVEMBER 12, 2026

EX-99.1

Filename: ea031195201ex99-1.htm · Sequence: 2

Exhibit 99.1

Azora Therapeutics Reports 2026 Third Quarter

Financial Results

and Provides Business Update

Azora Therapeutics commenced trading on Nasdaq

as “AZR”

New executive team and Board of Directors appointed

AT177 IND submission and Phase 1a initiation

on track for the first half of 2027

Los Angeles, CA, November 12, 2026 (GLOBE NEWSWIRE)

-- Azora Therapeutics, Inc. (Nasdaq: AZR) (“Azora” or the “Company”), a biopharmaceutical company developing

locally acting treatments for serious immune-mediated and inflammatory diseases, today provided a business update and reported its financial

results for the third quarter ended September 30, 2026.

During the quarter, Azora continued to advance

AT177 through IND-enabling studies and expanded its scientific and operating team. AT177 is a proprietary, oral, colon-targeted aryl-hydrocarbon

receptor (AhR) agonist designed to restore mucosal immune homeostasis at the site of disease with minimal systemic exposure.

“With our transition to Nasdaq, Azora is

well positioned for success to bring AhR biology to people living with ulcerative colitis,” said Matt Davidson, Ph.D., President,

Co-Founder and Chief Executive Officer. “We are pleased to have recently strengthened our leadership team, appointing Celia Economides

as CFO and David Rubenstein, M.D., Ph.D., as Chief Scientist. Dr. Rubenstein led the development and FDA approval of the first AhR agonist.

We have further added to our depth of experience through the appointment of new Board members who bring inflammatory disease, clinical

development and company building expertise to Azora. Our focus now is execution excellence, and we remain on track to submit an IND for

AT177 and initiate our Phase 1a trial in the first half of 2027.”

Corporate Highlights

● New name and Nasdaq ticker. Effective October 29, 2026, the Company changed its name from Adial

Pharmaceuticals, Inc. to Azora Therapeutics, Inc., and its common stock began trading on The Nasdaq Capital Market under the symbol “AZR.”

● Stockholder approvals. On October 28, 2026, the Company’s stockholders approved all remaining

transaction matters, including the conversion of the Series A preferred stock and the exercise of the pre-funded and milestone warrants.

On November 2, 2026, 9,924.260 shares of Series A preferred stock converted into 9,924,260 shares of common stock. The remaining 3,006.341

shares of Series A preferred stock remain outstanding and convertible into 3,006,341 shares of common stock, subject to beneficial ownership

limitations.

New executive team

The following were appointed to executive roles

at Azora effective October 28, 2026:

● Matt Davidson, Ph.D., Azora co-founder, was appointed President and Chief Executive Officer. He

previously founded Verrica Pharmaceuticals and led development of the first FDA-approved treatment for molluscum contagiosum.

● Celia Economides was appointed Chief Financial Officer based on her more than 20 years of biopharma

finance leadership across public and private companies.

● Julie Saiki, Ph.D., Azora co-founder, was appointed Chief Strategy Officer. Her research at Stanford

helped establish AhR activation as a potential therapeutic approach for ulcerative colitis and provided the scientific foundation for

AT177.

● David Rubenstein, M.D., Ph.D., joined as Chief Scientist. As Chief Scientific Officer of Dermavant

Sciences, he led tapinarof (VTAMA® cream 1%), the first FDA-approved AhR agonist, through development and approval.

New Board of Directors

On November 3, 2026, the Board appointed three

independent directors, joining Dr. Davidson, who serves as Chair, and Wendy Young, Ph.D., former Senior Vice President of Small Molecule

Drug Discovery at Genentech:

● Aida Habtezion, M.D., former Chief Medical Officer of Pfizer and former Stanford gastroenterologist

whose research included the role of AhR in intestinal immunity.

● Paul Hastings, Chief Executive Officer of Nkarta and former Chair of the Biotechnology Innovation

Organization (BIO).

● Thomas Soloway, Chief Executive Officer of T-knife Therapeutics and former Chief Financial Officer

of Audentes Therapeutics and Ascendis Pharma, chairs the Audit Committee.

Milestone financing

On September 16 and September 30, 2026, the Company

amended its securities purchase agreement and note exchange agreements to remove a provision that reduced investors’ milestone warrant

purchase rights by the percentage of their initial closing pre-funded warrants exercised. Up to approximately $32.4 million in gross proceeds

could be received if investors elect to purchase the milestone warrants.

AT177 Program Update and Milestones

● IND-enabling studies continued, building on completed GLP toxicology studies and pre-IND feedback from

the FDA.

● GMP manufacturing initiated to support clinical development of AT177.

● First half of 2027: Planned IND submission and initiation of a Phase 1a single- and multiple-ascending-dose

(SAD/MAD) trial, subject to regulatory clearance.

Third Quarter 2026 Financial Results

Cash position

Cash and cash equivalents were $22.0 million as

of September 30, 2026, compared to $28.7 million as of June 30, 2026. Existing cash and cash equivalents are anticipated to fund the Company’s

current operating plan, including completion of IND-enabling studies and the Phase 1a trial. This does not assume any proceeds from the

issuance and sale of milestone warrants.

Research and development (R&D) expenses

increased by approximately $1.3 million to $1.8 million for the three months ended September 30, 2026, compared to $0.5 million for

the same period in 2025. The increase reflects preclinical and toxicology work for AT177.

General and administrative (G&A) expenses

increased by approximately $4.5 million to $5.8 million for the three months ended September 30, 2026, compared to $1.2 million for

the same period in 2025. The increase reflects merger and integration costs, as well as stock-based compensation and severance expenses.

Net loss was $64.6 million, or $4.52 per

basic and diluted share, for the three months ended September 30, 2026, compared to $1.8 million, or $2.02 per share, for the same period

in 2025. The third quarter net loss includes a non-cash charge of $57.1 million for the change in fair value of the milestone warrant

rights liability, recorded before those rights were reclassified to equity.

Stockholders’ equity

As of September 30, 2026, the Company had a stockholders’

deficit of $21.1 million, primarily because $38.5 million of Series A convertible preferred stock was classified as temporary equity pending

conversion. Following the September amendments, the $80.9 million milestone warrant rights liability was reclassified to equity, and it

no longer requires remeasurement. On October 28, 2026, the stockholders approved the conversion of the Series A convertible preferred

stock, and as a result the Company expects to reclassify the $38.5 million carrying value of the Series A convertible preferred stock

into stockholders’ equity in the fourth quarter of 2026. On November 2, 2026, 9,924.260 shares of Series A preferred stock converted

into 9,924,260 shares of common stock.

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 is designed to deliver 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 an IND submission and Phase 1a clinical trial planned for

the first half of 2027.

About Azora Therapeutics

Azora Therapeutics is a biopharmaceutical company

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

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

of 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 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 submit an IND

in the first half of 2027; existing cash and cash equivalents funding the Company’s current operating plan; the potential purchase

of milestone warrants by investors; and the initiation of a Phase 1a SAD/MAD clinical trial planned to commence in the first half of 2027,

followed by a Phase 1b proof-of-concept study in UC patients. 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 continue as a

going concern and to raise additional capital when needed on acceptable terms or at all; the Company’s identified material weakness

in internal control over financial reporting; the Company’s ability to submit an IND and initiate a Phase 1a SAD/MAD clinical trial

in the first 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. 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 (including Amendment No. 1 to the Quarterly Report on Form 10-Q for the quarter ended June 30,

2026) 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.

Investor Contact:

Mike Moyer

Managing Director

LifeSci Advisors, LLC

Phone: (617) 328-4326

Email: mmoyer@lifesciadvisors.com

Media Contact:

Ashley Biladeau

Inizio Evoke Comms

Ashley.Biladeau@inizioevoke.com

AZORA THERAPEUTICS, INC.

Condensed Statement of Operations and Comprehensive

Loss

(Unaudited)

(in thousands, except share and per share data)

For the Three Months Ended

For the Nine Months Ended

September 30,

2026

2025

2026

2025

Operating Expenses:

Research and development expenses(1)

$ 1,775

$ 521

$ 2,648

$ 2,000

General and administrative expenses(1)

5,756

1,243

12,725

3,914

Acquired in-process research and development

—

46,185

—

Total Operating Expenses

7,531

1,764

61,558

5,914

Loss From Operations

(7,531 )

(1,764 )

(61,558 )

(5,914 )

Other Income (Expense)

Interest income

170

275

107

Change in fair value of milestone warrant rights liability

(57,108 )

—

(48,828 )

—

Financing expense allocated to milestone warrant rights liability

—

(2,067 )

—

Loss on extinguishment of Azora Therapeutics convertible promissory notes

—

(6,054 )

—

Loss on equity method investment

(93 )

(77 )

(342 )

(339 )

Other income (expenses)

—

(1 )

—

165

Total other income (expense)

(57,031 )

(30 )

(57,016 )

(67 )

Net Loss

$ (64,562 )

$ (1,794 )

$ (118,574 )

$ (5,981 )

Loss per share, basic and diluted

$ (4.52 )

$ (2.02 )

$ (17.41 )

$ (11.35 )

Weighted average shares, basic and diluted

14,296,323

886,852

6,810,071

526,829

(1) Includes stock-based compensation as follows (non-cash operating

expenses):

Three Months Ended

Nine Months Ended

September 30,

2026

2025

2026

2025

Research and development

$ 213

220

General and administrative

745

143

1,023

498

Total stock-based compensation expense

$ 958

$ 147

$ 1,243

$ 508

AZORA THERAPEUTICS, INC.

Condensed Balance Sheet Data

(Unaudited)

(in thousands)

September 30,

December 31,

2026

2025

Cash and cash equivalents

$ 22,044

$ 5,881

Working capital

17,321

4,784

Total assets

22,528

6,674

Stockholders’ (deficit) equity

$ (21,061 )

$ 5,277

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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 written communications pursuant to Rule 425 under the Securities Act.

+ References

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

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration