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SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a biopharmaceutical company focusing on breast cancer treatment with a market capitalization of $107 million, has encountered a challenge in its intellectual property strategy. The Patent Trial and Appeal Board (PTAB) has deemed all claims in the company’s ’334 patent unpatentable. With its stock trading near 52-week lows at $0.85, down 63% from its high of $2.31, the company has announced that it will not appeal the decision due to the associated costs and time.
Atossa’s current clinical formulations remain unaffected by this ruling, and the company plans to file a new Continuation Patent Application with the U.S. Patent Office. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt and a healthy current ratio of 13.3. Additionally, Atossa has recently secured a new patent, U.S. Patent No. 12,201,591, which covers sustained release compositions of endoxifen, a key compound in the company’s drug development pipeline.
Endoxifen, a Selective Estrogen Receptor Modulator (SERM), is known for its strong inhibition of estrogen receptors and potential efficacy in patients resistant to other hormonal treatments. Atossa is developing an oral formulation of endoxifen designed to bypass the stomach, improving its bioavailability. The drug has demonstrated tolerability in Phase 1 studies and is currently undergoing five Phase 2 trials for various conditions related to breast cancer.
The company’s CEO, Dr. Steven Quay, expressed disappointment with the PTAB’s decision but reaffirmed the company’s dedication to advancing treatment options for patients and securing further patent protection for their formulations.
Atossa’s patent estate includes several other U.S. patents with claims directed to its formulations in clinical development. This comprehensive patent estate is crucial for the company as it continues to innovate in the oncology space, particularly in the prevention and treatment of breast cancer.
This news is based on a press release statement and reflects the company’s ongoing efforts to navigate the complex landscape of patent law while advancing its clinical programs. InvestingPro analysis reveals the company maintains a FAIR financial health score, though it is currently burning through cash reserves. Despite the recent patent decision, Atossa Therapeutics remains committed to its mission of improving treatments for breast cancer patients. For deeper insights into Atossa’s financial health and 8 additional exclusive ProTips, visit InvestingPro.
In other recent news, Atossa Therapeutics has made significant advancements in breast cancer treatment and prevention. The biopharmaceutical company has successfully completed the KARISMA-Endoxifen Phase 2 Study, revealing significant reductions in mammographic breast density, a risk factor for breast cancer. Further progress was made with the EVANGELINE trial, a phase 2 non-inferiority study, and two I-SPY 2 studies, all showing promising preliminary data.
Atossa Therapeutics has also secured two new U.S. patents for (Z)-endoxifen, expanding its intellectual property portfolio. In response to these developments, H.C. Wainwright upgraded the stock price target for Atossa from $6.00 to $7.00, maintaining a Buy rating.
Additionally, Atossa has launched a clinical trial in collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, testing a combination of (Z)-endoxifen and Eli Lilly (NYSE:LLY)’s abemaciclib. The outcomes of this trial are expected in 2026. These are the recent developments at Atossa Therapeutics.
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