Azitra Inc Stock Price, News & Analysis

Azitra (NYSE American: AZTR) has initiated dosing in a Phase 1/2 clinical trial for ATR04-484, a topical live biotherapeutic treatment targeting EGFR inhibitor (EGFRi)-associated rash. The condition affects approximately 150,000 people annually in the U.S. and has received FDA Fast Track designation.

The multicenter, randomized, double-blind, vehicle-controlled study (NCT06830863) will evaluate ATR04-484's safety and tolerability in adult patients. The treatment addresses a critical medical need, as EGFRi-associated rash affects 50-80% of cancer patients receiving EGFR inhibitor treatments, often leading to cancer treatment interruption or discontinuation.

ATR04-484 is derived from a specially engineered Staphylococcus epidermidis strain, designed to reduce IL-36γ and S. aureus levels, which are elevated in affected patients.

Azitra (NYSE American: AZTR), a clinical-stage biopharmaceutical company, reported Q2 2025 financial results and business updates. The company achieved 50% enrollment in Phase 1b trial of ATR-12 for Netherton syndrome, showing promising safety data in the first five patients. Additionally, Azitra secured a $20 million equity line of credit from Alumni Capital LP.

The company's pipeline includes ATR-04, targeting EGFRi-associated rash affecting approximately 150,000 US patients annually. Key upcoming milestones include first patient dosing in ATR-04's Phase 1/2 trial in Q3 2025 and ATR-12's Phase 1b topline data in Q1 2026. Financial results show R&D expenses of $1.4 million, G&A expenses of $1.5 million, and a net loss of $2.9 million, with cash position at $1.0 million.

Azitra (NYSE American: AZTR), a clinical-stage biopharmaceutical company specializing in precision dermatology, has announced a 1-for-6.66 reverse stock split effective August 21, 2025. The company's common stock will continue trading under the symbol "AZTR" on the NYSE American with a new CUSIP number 05479L302.

The reverse split will reduce Azitra's outstanding shares from 23,476,354 to approximately 3,524,978. Stockholders will receive cash in lieu of fractional shares, calculated based on the average closing prices for the five trading days before the split. The split will proportionally adjust equity awards and warrants, including their exercise prices.

["Will help maintain NYSE American listing requirements", "No change to stockholder's percentage ownership in the company", "Stockholders automatically receive cash for fractional shares"]

Azitra (NYSE: AZTR) reported positive initial safety data from its Phase 1b trial of ATR12-351, a live biotherapeutic candidate for Netherton syndrome, a rare genetic skin disorder affecting 1 in 200,000 people. The trial, now 50% enrolled with six patients dosed, shows ATR12-351 has been generally safe and well-tolerated when applied topically. The treatment aims to deliver engineered S. epidermidis bacteria to replace deficient LEKTI protein in the skin. While some mild to moderate application site reactions were observed, these were transient and occurred bilaterally, suggesting they were not drug-related. No severe or serious adverse events have been reported. The trial remains blinded, and efficacy data is not yet available. ATR12-351 represents a potential breakthrough for Netherton syndrome, which currently has no cure and limited treatment options.

Azitra (NYSE American: AZTR), a clinical stage biopharmaceutical company specializing in precision dermatology, will present at the 2025 BIO International Convention in Boston from June 16-19. The company's COO and Cofounder, Travis Whitfill PhD MPH, will present on June 17 at 12:00 PM ET, focusing on pipeline updates including ATR-12 (in Phase 1b trials for Netherton syndrome) and ATR-04 (in development for EGFRi-associated dermal toxicity). Dr. Whitfill will also conduct one-on-one meetings with investors and potential partners to discuss business strategy, corporate achievements, and upcoming milestones.

Azitra (NYSE: AZTR) announced it will present a poster at ASCO 2025 detailing its Phase 1/2 clinical trial of ATR04-484, a treatment for EGFR inhibitor-associated rash. The presentation will take place at McCormick Place, Chicago, from May 30-June 3, 2025.

ATR04-484 is a live biotherapeutic product using an engineered Staphylococcus epidermidis strain, designed to treat dermal toxicity in patients using EGFRi cancer therapies. The FDA has granted Fast Track designation for this indication. The treatment addresses a significant side effect of EGFRi therapies, commonly used in non-small cell lung cancer and colorectal cancer treatment, where patients often reduce or discontinue treatment due to severe skin reactions.

Azitra (NYSE: AZTR) announced its upcoming presentation at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) regarding their Phase 1/2 clinical trial of ATR04-484. The presentation, scheduled for May 15, 2025, will focus on this novel compound designed to treat EGFR inhibitor-associated rash. The company plans to begin dosing its first patient in the Phase 1/2 trial in the first half of 2025. Chief Medical Officer Mary Spellman, MD, will present details about the topical treatment's development and clinical study design at the conference in New Orleans.

Azitra (NYSE: AZTR) reported its Q1 2025 financial results and provided business updates. The company secured up to $20 million in funding through a partnership with Alumni Capital LP and raised an additional $2.2 million through public offerings. Key developments include acceptance of a poster presentation at ASCO 2025 for their ATR-04 program targeting EGFR inhibitor-associated rash.

The company expects initial safety data from their ATR-12 Phase 1b trial for Netherton syndrome in 1H 2025, with topline results by year-end. They also plan to begin dosing patients in a Phase 1/2 trial for ATR-04 by mid-2025. Financial results show R&D expenses of $1.3 million, G&A expenses of $1.9 million, and a net loss of $3.1 million for Q1 2025. Cash position stands at $3.2 million as of March 31, 2025.

Azitra (NYSE American: AZTR) announced that its ATR04-484 program for treating EGFR inhibitor-associated rash will be presented at the 2025 ASCO Annual Meeting in Chicago (May 30-June 3, 2025). The company plans to dose the first patient in their Phase 1/2 clinical trial during the first half of 2025.

ATR04-484 is a live biotherapeutic product using an engineered Staphylococcus epidermidis strain, developed to treat skin rashes caused by EGFR inhibitor cancer treatments. The product has received Fast Track designation from the FDA for this indication. These rashes occur due to suppressed skin immunity and inflammation, often showing elevated IL-36γ and S. aureus levels.

EGFR inhibitors are cancer drugs targeting the EGFR protein, commonly used in treating non-small cell lung cancer and colorectal cancer. The complete ASCO abstract will be available on May 22, 2025.