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SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company with a market capitalization of $120 million and an impressive 13% gain over the past week, has announced significant advancements in their clinical programs for breast cancer treatment and prevention. InvestingPro analysis shows two analysts have recently revised their earnings estimates upward for the upcoming period, suggesting growing confidence in the company's prospects. The company's Chairman and CEO, Steven Quay, M.D., Ph.D., provided a shareholder update highlighting the progress made in 2024, particularly with their proprietary drug, (Z)-endoxifen.
The company completed the KARISMA-Endoxifen Phase 2 Study, which focused on the drug's ability to reduce mammographic breast density (MBD), a risk factor for breast cancer. The results showed significant reductions in MBD, with the study arms receiving 1 mg and 2 mg doses of (Z)-endoxifen exhibiting decreases of 17.3 and 23.5 percentage points, respectively, compared to minimal change in the placebo group. Both doses were well tolerated, with the 1 mg dose showing a safety profile similar to placebo.
Further progress was made with the EVANGELINE trial, a phase 2 non-inferiority study evaluating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with estrogen receptor-positive (ER+)/ Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Initial results from the pharmacokinetic run-in phase were promising, with significant tumor suppression observed across all dosing levels.
Additionally, Atossa has two I-SPY 2 studies underway. Preliminary data from the monotherapy arm, where patients received (Z)-endoxifen, met the primary endpoint with a 95 percent treatment adherence rate. The drug also demonstrated activity in reducing key biomarkers and functional tumor volume, while being well tolerated with mild side effects.
The company has also strengthened its intellectual property portfolio with two new U.S. patents for (Z)-endoxifen, and maintains a strong cash position to fund research and development efforts. According to InvestingPro data, Atossa holds more cash than debt on its balance sheet, with a healthy current ratio of 13.3x, though investors should note the company is currently burning through cash at a significant rate.
Looking ahead to 2025, Atossa Therapeutics aims to advance (Z)-endoxifen into registrational clinical trials and continue its business development efforts to make the therapy globally available. The company emphasizes its commitment to providing safer and more tolerable treatment options for breast cancer patients. With analyst price targets ranging from $4 to $7 per share and an overall Financial Health score rated as 'FAIR' by InvestingPro, investors seeking deeper insights into Atossa's potential can access over 30 additional financial metrics and analysis tools through the platform.
This information is based on a press release statement from Atossa Therapeutics, Inc.
In other recent news, Atossa Therapeutics has reported promising results from various Phase 2 trials. The KARISMA-Endoxifen study showed that a 1 mg dose of (Z)-endoxifen significantly reduced mammographic breast density (MBD), a key risk factor for breast cancer. The company has also secured a new patent for compositions including the active ingredient endoxifen, expanding its intellectual property portfolio. In response to these developments, H.C. Wainwright increased the stock price target for Atossa Genetics to $7.00, maintaining a Buy rating on the stock.
In addition, Atossa Therapeutics has initiated a clinical trial in collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative. The trial will test a combination of Atossa's proprietary drug, (Z)-endoxifen, and Eli Lilly (NYSE:LLY)'s abemaciclib, aimed at high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer, with outcomes expected in 2026.
The company also announced positive preliminary results from a phase 2 trial of its breast cancer drug, (Z)-endoxifen. The study showed that the low dose of the drug significantly reduced key biomarkers for the disease. These are the recent developments at Atossa Therapeutics.
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