BRANFORD, Conn. - Azitra Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1/2 clinical study of ATR-04, a potential treatment for moderate to severe skin rash associated with the use of epidermal growth factor receptor inhibitors (EGFRis), commonly prescribed for certain types of cancer.
The company's CEO, Francisco Salva, emphasized the unmet medical need for patients who develop skin toxicity as a side effect of EGFRi cancer therapies. He expressed confidence in ATR-04's potential to address this issue, which currently affects an estimated 150,000 patients in the United States and represents a market opportunity exceeding $1 billion globally.
ATR-04 is a live biotherapeutic product candidate that includes a genetically modified strain of Staphylococcus epidermidis. This engineered strain is designed to be safer by lacking an antibiotic resistance gene and having controlled growth. Preclinical studies have shown ATR-04 to significantly reduce levels of IL-36γ and methicillin-resistant Staphylococcus aureus (MRSA), both implicated in the development of EGFRi-associated skin rash.
Earlier this year, Azitra presented preclinical data at scientific meetings, which highlighted the therapeutic potential of ATR-04. Following the FDA's IND clearance, the company plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial by the end of 2024.
Azitra's approach to precision dermatology involves the use of engineered proteins and topical live biotherapeutic products. The company has developed a proprietary platform with a microbial library of approximately 1,500 bacterial strains, supplemented by artificial intelligence and machine learning technologies to identify promising therapeutic candidates.
This article is based on a press release statement. Azitra has cautioned that forward-looking statements in the press release are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These include potential failures in clinical trials, regulatory delays or changes, inaccurate market estimations, funding issues, emergence of superior competing treatments, intellectual property disputes, and dependency on third-party manufacturing and testing.
In other recent news, Azitra, Inc., a clinical-stage biopharmaceutical company, has made significant strides in the development of treatments for skin diseases. The company has secured patents in the U.S., Canada, and China for its filaggrin-secreting strain of Staphylococcus epidermidis, a breakthrough aimed at treating atopic dermatitis and other skin conditions. This expands Azitra's global intellectual property portfolio, strengthening its position in key markets.
The company also reported significant advances in its product candidates ATR-04 and ATR-12. Preclinical data revealed ATR-04's potential in reducing methicillin-resistant Staphylococcus aureus (MRSA) on skin models, while ATR-12 demonstrated efficacy in delivering the LEKTI protein to human skin, a crucial development for treating Netherton syndrome. Azitra plans to submit an Investigational New Drug (IND) application to the FDA for a Phase 1b clinical trial for ATR-04, and has outlined the design for an upcoming Phase 1b clinical trial for ATR-12.
In a recent restructuring move, Azitra executed a 1-for-30 reverse stock split of its common stock following approval from its stockholders. This strategic decision is expected to reduce the number of Azitra's shares in circulation. The company's common stock will continue trading on the NYSE American under the ticker symbol AZTR. These are the latest developments in Azitra's ongoing efforts to advance precision dermatology therapies.
InvestingPro Insights
As Azitra Inc. (NYSE American: AZTR) gears up for its Phase 1/2 clinical study of ATR-04, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Azitra has a market capitalization of $5.13 million, reflecting the size of the company in the biopharmaceutical landscape. The revenue for the last twelve months as of Q2 2024 stood at $0.41 million with a notable gross profit margin of 100%. Despite these figures, the company's operating income margin was reported at -2511.47%, indicating significant operational costs relative to its revenue.
InvestingPro Tips highlight some challenges and considerations for potential investors. Azitra's stock is known to trade with high price volatility, which could be a concern for risk-averse shareholders. Additionally, the company has been flagged for quickly burning through cash, a critical factor as it advances its clinical programs. It's also worth mentioning that analysts do not anticipate Azitra will be profitable this year, a sentiment echoed by the company's recent performance with a year-to-date price total return of -97.56%.
For investors seeking a deeper dive into Azitra's financials and stock performance, InvestingPro offers additional tips. There are 13 more InvestingPro Tips available, providing a comprehensive analysis that could guide investment decisions. These tips can be accessed by visiting the InvestingPro platform for Azitra at https://www.investing.com/pro/AZTR.
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