BRANFORD, Conn. - Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company, has announced the issuance of a U.S. patent and the allowance of additional patents in the U.S., Canada, and China for its filaggrin-secreting strain of Staphylococcus epidermidis, aimed at treating atopic dermatitis and other skin diseases.
On July 16, 2024, the U.S. Patent and Trademark Office granted U.S. patent No. 12,036,248, which covers potential pipeline candidates for conditions including atopic dermatitis. Atopic dermatitis is a significant concern, affecting an estimated 16.5 million people in the U.S., with no FDA-approved treatment options currently available.
The newly allowed patents in the U.S., Canada, and China protect the composition and use of the filaggrin-secreting strains of Staphylococcus epidermidis, expanding Azitra's global intellectual property portfolio.
Travis Whitfill, COO, co-founder, and inventor of the patents, expressed satisfaction with the company's strengthened IP position in key markets. Azitra's innovation involves the development of live biotherapeutic product candidates designed to address skin diseases by delivering essential proteins directly to the skin.
The company's approach involves a functional unit of the human filagrin protein combined with a cell penetrating peptide, which is expected to facilitate stable delivery and deeper skin penetration when applied topically.
Azitra’s ATR-12 product candidate, which delivers LEKTI for Netherton syndrome, is a similar biotherapeutic approach. A first-in-human study for ATR-12 is currently recruiting adult Netherton syndrome patients.
With the addition of the recent patent issuances, Azitra now holds a total of 4 granted U.S. patents, 14 international patents, 9 pending U.S. patent applications, and 44 pending international patent applications.
Azitra is focused on the development of genetically engineered strains of Staphylococcus epidermidis for precision dermatology, leveraging a proprietary platform that includes a microbial library and artificial intelligence technologies.
This announcement is based on a press release statement from Azitra, Inc., which also included forward-looking statements about the anticipated benefits of the patents and the development of its live biotherapeutic product candidates.
In other recent news, Azitra, Inc., a clinical-stage biopharmaceutical company, has announced significant advances in its product candidates ATR-04 and ATR-12. The company recently presented promising preclinical data for ATR-04, a treatment for skin toxicity caused by epidermal growth factor receptor inhibitors (EGFRi).
The data revealed that ATR-04 significantly reduces methicillin-resistant Staphylococcus aureus (MRSA) on skin models. Azitra also reported notable preclinical data on ATR-12, a treatment candidate for Netherton syndrome, demonstrating its efficacy in delivering the LEKTI protein to human skin.
In addition to these developments, Azitra plans to submit an Investigational New Drug (IND) application to the FDA for a Phase 1b clinical trial for ATR-04. The company also outlined the design of an upcoming Phase 1b clinical trial for ATR-12. These recent developments, presented at the Society of Investigative Dermatology and the American Society of Gene and Cell Therapy, respectively, demonstrate Azitra's ongoing commitment to advancing precision dermatology therapies.
Still, the company has cautioned that further preclinical trial data may not align with initial results and that its IND application for ATR-04 may not be approved by the FDA. Furthermore, Azitra's forward-looking statements regarding ATR-12 are subject to risks and uncertainties, and actual outcomes may differ.
InvestingPro Insights
Amid the recent achievements in its patent portfolio, Azitra, Inc. (NYSE American: AZTR) is navigating a challenging financial landscape. According to InvestingPro data, the company's market capitalization currently stands at a modest 1.56 million USD, reflecting the small size of this clinical-stage entity.
Despite an impressive revenue growth of 106.53% in the last twelve months as of Q1 2024, the company's financial performance indicators highlight significant hurdles. The operating income margin for the same period was deeply negative at -1574.85%, pointing to substantial costs outweighing revenues.
In terms of stock performance, Azitra's price has declined steeply, with a 1-month price total return of -60.35% as of a recent 2024 date. This trend aligns with InvestingPro Tips that indicate the stock has taken a big hit over the last week and has fared poorly over the last month. Moreover, the company's valuation implies a poor free cash flow yield, and analysts do not anticipate Azitra will be profitable this year.
Investors and potential stakeholders considering Azitra should note that the company holds more cash than debt on its balance sheet, which could be a cushion against financial strain. Moreover, liquid assets exceed short-term obligations, suggesting a degree of short-term financial stability. Still, the company is quickly burning through cash, and the stock generally trades with high price volatility, which could be a concern for risk-averse investors.
For those seeking a more in-depth analysis, there are over 13 additional InvestingPro Tips available, which could provide further guidance on Azitra's financial health and stock performance. Interested parties can access these tips by visiting InvestingPro at: https://www.investing.com/pro/AZTR. Additionally, to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, use the coupon code PRONEWS24.
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