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BRANFORD, Conn. - Azitra, Inc. (NYSE American: AZTR), a clinical-stage biotech company currently valued at $4.64 million, announced Tuesday that its Phase 1b clinical trial for ATR12-351, a live biotherapeutic candidate targeting Netherton syndrome, has reached 50% enrollment with encouraging safety data. According to InvestingPro analysis, the company maintains a strong liquidity position with a current ratio of 3.02, indicating solid short-term financial stability.
The trial, which has dosed six patients so far, has shown no severe or serious adverse events, according to the company. Patients experienced only occasional, transient mild to moderate symptoms at application sites, including localized itch, redness, and burning sensations. These reactions occurred bilaterally, suggesting they may not be drug-related.
ATR12-351 is designed to deliver an engineered strain of S. epidermidis into the skin to replace deficient LEKTI protein in patients with Netherton syndrome, a rare genetic skin disorder affecting approximately one in 200,000 people.
"Dosing the sixth patient marks an important milestone for our Phase 1b trial of our ATR-12 program," said Francisco Salva, CEO of Azitra, in the press release statement. The company’s shares have faced significant pressure, declining over 96% in the past year, with the stock currently trading at $0.27. InvestingPro data reveals 14 additional key insights about the company’s financial position and market performance.
In the ongoing blinded trial, patients with genetically confirmed Netherton syndrome receive applications of ATR12-351 on affected areas on one side of the body and a vehicle without the active ingredient on the opposite side.
Netherton syndrome causes severe skin inflammation and dehydration throughout life, with no known cure and limited treatment options. The condition can be fatal in infancy, with approximately 10% of affected infants reportedly dying in their first year.
The company is also conducting a Phase 1/2 trial for ATR04-484, targeting EGFR inhibitor-associated rash. While Azitra holds more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash utilization, with a negative free cash flow yield of -221%. The company is presenting information about both clinical programs at the 2025 BIO International Convention in Boston on Tuesday.
The information in this article is based on a press release from Azitra, Inc.
In other recent news, Azitra, Inc. has secured a significant funding agreement with Alumni Capital LP, allowing the company to raise up to $20 million. This funding is intended to advance Azitra’s therapies for rare and severe skin conditions, including ATR-12 for Netherton Syndrome and ATR-04 for EGFRi associated rash. The agreement gives Azitra the flexibility to sell shares and warrants over a 20-month period, with the aim of minimizing shareholder dilution. Both ATR-12 and ATR-04 are in clinical trial stages, with ATR-12 in Phase 1b and ATR-04 having an open Investigational New Drug application. The funding arrangement requires certain conditions, such as shareholder approval for warrant exercises and registration of Alumni’s resale of Azitra’s common stock. Azitra’s approach involves engineered proteins and live biotherapeutic products, supported by artificial intelligence and machine learning. The share issuance is conducted under exemptions from federal and state securities laws. The company’s press release includes forward-looking statements, noting potential risks and uncertainties in meeting agreement conditions and completing clinical trials.
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