Azitra Inc. filings document the regulatory record of a clinical-stage biopharmaceutical company focused on precision dermatology. Recent disclosures cover proxy materials for annual and special stockholder meetings, shareholder voting procedures, board and governance matters, and meeting-status updates filed on Form 8-K.
Azitra's SEC reports also describe material agreements and capital-structure changes, including private placement securities, Series A preferred stock and Series B and Series C warrants. Other filings address furnished financial results, pipeline business updates, use of financing proceeds for research and development and working capital, and NYSE American continued-listing compliance matters tied to stockholders' equity standards.
Azitra, Inc. said Cofounder and Chief Operating Officer Travis Whitfill, Ph.D., MPH, will present pipeline updates at BIO-Europe in Cologne, Germany, on November 10, 2026. The presentation includes results from ATR-COSF, a recombinant filaggrin protein designed for topical use.
Azitra reported a 56% wrinkle reduction from baseline in an ex vivo human torso-skin model. In a second model, a 4% formulation improved elasticity; ex vivo models also showed improved elasticity and wrinkle depth compared with vehicle at 48 hours. Initial results from an ATR-COSF first-in-human study are anticipated by year-end. The ongoing Phase 1/2 trial of ATR-04 was expanded in October 2026 to include patients with rashes associated with KRAS and MEK inhibitors, and patients with neurofibromatosis type 1 and MEK-inhibitor-associated rash, in addition to patients with EGFR-inhibitor-associated rash. Azitra cited approximately 85,000 U.S. patients treated with KRAS or MEK inhibitors annually and approximately 220,000 treated with EGFR inhibitors annually.
Azitra, Inc. amended the protocol for its ongoing Phase 1/2 trial of topical ATR04-484 to include patients with rashes associated with KRAS and MEK inhibitors, including patients with NF1 who have MEK inhibitor-associated rash. The amendments also shorten required washout periods for antibiotics and steroids, broadening eligibility beyond the trial’s initial focus on EGFR inhibitor-associated rash.
The study evaluates safety, tolerability, bioavailability, pharmacodynamics and preliminary efficacy. After reviewing available Cohort 1 safety data, the safety review committee recommended proceeding to Cohort 2, which is expected to enroll approximately 24 patients for once-daily treatment over 28 days. The release cites approximately 85,000 U.S. patients treated with KRAS or MEK inhibitors annually and approximately 220,000 treated with EGFR inhibitors annually.
Azitra, Inc. (AZTR) reported ex vivo results for ATR-COSF, its cosmetic product candidate, and said it will not sell shares through its at-the-market program for the foreseeable future, effective October 26, 2026. It may resume sales or pursue other financing at any time in its discretion. From September 28, 2026 through October 26, 2026, Azitra sold 1,000 common shares through the program for aggregate gross proceeds of approximately $126.
In dorsal skin explants, one 2% dose was associated with approximately 15% reduction in fine-line and wrinkle appearance at 3 hours, approximately 20% at 24 hours and approximately 50% overall at 48 hours. In face-lift skin explants, the 4% formulation outperformed 2% ATR-COSF and hydrogel alone across measured elasticity parameters at 6 hours. Azitra anticipates a first-in-human study of 4% ATR-COSF in approximately 30 subjects, with initial data expected by year end.
Azitra, Inc. will implement a 1-for-10 reverse stock split effective October 26, 2026, at 12:01 a.m. Eastern Time. The company filed the certificate amendment on October 22, 2026; its common stock is expected to begin trading on a reverse-split-adjusted basis on NYSE American at market open that day. Each 10 issued and outstanding shares will be combined into one, while the common stock’s par value and other terms remain unchanged.
No fractional shares will be issued. Stockholders of record otherwise entitled to fractions will receive cash calculated using the average closing price for the five trading days immediately before October 26, 2026, multiplied by the number of pre-split shares reclassified into the fractional share.
Azitra, Inc. said the safety review committee recommended that its ATR-04 Phase 1/2 trial may proceed to Cohort 2 after reviewing Cohort 1 data. Seven patients received Cohort 1 treatment; the safety review was based on six patients. Cohort 2 is expected to enroll approximately 24 patients, who will receive a 4g application once daily for 28 days.
The randomized, double-blind, vehicle-controlled study compares ATR04-484 with its vehicle in a 3:1 randomization and evaluates safety, tolerability, bioavailability, pharmacodynamics and preliminary efficacy. The FDA has granted ATR04-484 Fast Track designation for EGFR inhibitor-associated rash.
Azitra, Inc. (AZTR) entered into a sales agreement under which it may issue and sell common stock with an aggregate offering price of up to $3,503,232 through A.G.P./Alliance Global Partners as sales agent. Sales may be made from time to time through an at-the-market offering, and Azitra has no obligation to sell shares; it may suspend offers or terminate the agreement.
Azitra will pay A.G.P. a cash fee equal to 3.0% of gross proceeds from sales and reimburse certain specified expenses. Azitra intends to use net proceeds, if any, for working capital and general corporate purposes.
Azitra, Inc. may offer and sell common stock with an aggregate offering price of up to $3,503,232 under an at-the-market sales agreement with A.G.P./Alliance Global Partners, acting as agent or principal. Sales may occur from time to time, subject to the agreement’s conditions. A.G.P. is entitled to a cash fee equal to 3.0% of gross proceeds, and Azitra intends to use net proceeds for working capital and general corporate purposes.
Azitra’s public float was approximately $10,509,696 as of September 25, 2026. While it remains below $75 million, Form S-3 limits public primary sales to no more than one-third of public float in any 12-month period. As of June 30, 2026, total assets were $8.9 million and working capital was $5.9 million; Azitra said cash on hand plus offering proceeds would not cover its proposed operations for at least the next 12 months. The incorporated audit report describes conditions that raise substantial doubt about Azitra’s ability to continue as a going concern.
Azitra paused ATR-12 trial enrollment in June 2026 for capital preservation. It continues IND-enabling studies for ATR-01 and plans to announce initial ATR-04 Cohort 1 data around Q4 2026.
Azitra, Inc. (AZTR) announced that Co-founder and Chief Operating Officer Dr. Travis Whitfill will deliver a virtual presentation at the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026 in New York City.
He will provide an update on recent progress and key pipeline activities, including initial data from the ATR-COSF cosmetic protein program, which leverages Azitra’s microbial genetic engineering platform for applications such as fine lines and wrinkles. The presentation will also cover continued enrollment in the first cohort of the Phase 1/2 clinical trial of ATR-04, an investigational live biotherapeutic for EGFR inhibitor-associated rash, a condition impacting approximately 150,000 people in the U.S. During the conference, Dr. Whitfill plans one-on-one meetings with investors and potential partners to discuss business strategy, recent achievements, and anticipated milestones.
Azitra, Inc. (AZTR) announced that NYSE Regulation has confirmed the company has regained compliance with all NYSE American continued listing standards set forth in Part 10 of the NYSE American Company Guide, resolving earlier deficiencies under Sections 1003(a)(ii) and 1003(a)(iii). The “below compliance” (.BC) indicator will be removed from Azitra’s trading symbol and the company will come off NYSE American’s list of noncompliant issuers. Azitra will remain subject to NYSE American’s continued listing monitoring procedures, and under Section 1009(h), any new noncompliance within 12 months could lead NYSE American to truncate normal compliance procedures or immediately initiate delisting proceedings.
Nantahala Capital Management, LLC and related reporting persons report beneficial ownership of 6,480,584 shares of Azitra, Inc. common stock as of June 30, 2026. This represents 9.99% of the outstanding common stock. The position includes 4,266,971 shares that may be acquired within sixty days through the exercise of convertible securities.
All reported shares are held with shared voting and dispositive power by Nantahala and its principals, Wilmot B. Harkey and Daniel Mack, and none are held with sole voting or dispositive power. Certain funds advised by Nantahala, including Blackwell Partners LLC – Series A and Nantahala Capital Partners Limited Partnership, have the right to receive dividends or sale proceeds from more than five percent of the outstanding common stock attributed to this beneficial ownership.