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BRANFORD, Conn. - Azitra, Inc. (NYSE American:AZTR), a micro-cap biotech company currently valued at $3.74 million, announced Wednesday it has dosed the first patient in its Phase 1/2 clinical trial of ATR04-484, a topical live biotherapeutic product candidate designed to treat rashes associated with EGFR inhibitor cancer treatments. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn.
The company’s candidate has received Fast Track designation from the FDA for this condition, which affects approximately 150,000 people annually in the United States. Despite the significant market opportunity, InvestingPro analysis indicates the stock is currently trading below its Fair Value, with analyst price targets ranging from $5.00 to $13.32.
The multicenter, randomized, double-blind, vehicle-controlled study will evaluate the safety and tolerability of topical ATR04-484 for treating EGFR inhibitor-associated dermal toxicity on the face of adult patients. The trial will also assess efficacy signals including disease severity, itching, and pain.
EGFR inhibitors are targeted cancer therapies used to treat various tumors including non-small cell lung cancer and colorectal cancer. However, they frequently cause skin rashes in 50-80% of patients, which can be severe enough to interrupt or halt cancer treatment.
"Dosing the first patient is an important milestone in the advancement of ATR04-484 as a potential treatment for EGFRi associated rash," said Francisco Salva, CEO of Azitra, in a press release statement.
ATR04-484 is derived from a naturally occurring Staphylococcus epidermidis strain selected for its ability to reduce IL-36γ and S. aureus levels, both of which are elevated in patients with this condition. The strain has been engineered with safety modifications, including deletion of an antibiotic resistance gene.
The trial is registered under identifier NCT06830863. With the stock down over 83% in the past year and trading at $0.76, InvestingPro subscribers have access to 15+ additional exclusive insights about Azitra’s financial health and market performance metrics that could be crucial for investment decisions.
In other recent news, Azitra, Inc. has reported encouraging safety data from its Phase 1b clinical trial for ATR12-351, a treatment targeting Netherton syndrome. The trial has reached 50% enrollment and has not shown any severe or serious adverse events, with only mild to moderate symptoms observed at application sites. Additionally, Azitra announced a 1-for-6.66 reverse stock split effective August 21, 2025. This adjustment will see the company’s common stock trading on a split-adjusted basis on the NYSE American. In another development, Azitra’s shareholders have approved an amendment to increase the authorized number of common shares from 100,000,000 to 200,000,000. The decision was made at the reconvened annual meeting following a previous adjournment to allow more time for voting. The amendment was adopted with 1,090,701 shares in favor, and 278,960 shares against, with 2,607 shares abstaining. These are the latest updates concerning Azitra, Inc.
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