Bullish indicating open at $55-$60, IPO prices at $37
SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company with a market capitalization of $93 million, announced today its strategic decision to focus on metastatic breast cancer indication for its lead product candidate, (Z)-endoxifen. The company’s stock has declined over 50% in the past six months, though InvestingPro analysis suggests the current price is near its Fair Value. The company believes this move will provide a more efficient regulatory pathway for delivering the drug to patients in critical need.
Metastatic breast cancer, which is cancer that has spread beyond the breast to other parts of the body, represents a significant area of unmet medical need. Current treatments often have limited effectiveness and considerable side effects. (Z)-endoxifen, a selective estrogen receptor modulator (SERM), has demonstrated promise in early clinical trials, suggesting it could address this gap.
The company’s decision is supported by data from Phase 1 and Phase 2 trials. These trials have shown that (Z)-endoxifen can more than double the median progression-free survival (PFS) in patients who have not previously received CDK4/6 inhibitors, compared to tamoxifen. Additionally, patients who progressed on tamoxifen and then switched to (Z)-endoxifen saw clinical benefits, including partial responses and prolonged stable disease, in some cases exceeding two to three years. The drug has also been generally well-tolerated, with a safety profile comparable to tamoxifen. According to InvestingPro data, Atossa maintains a strong liquidity position with a current ratio of 13.3, and holds more cash than debt on its balance sheet, though the company is currently burning through cash rapidly.
Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics, stated, "Our decision to advance (Z)-endoxifen into a metastatic breast cancer indication underscores our unwavering commitment to developing a best-in-class therapy for women facing this devastating disease." He added that the clinical data generated to date supports the potential of (Z)-endoxifen to benefit patients who have exhausted other treatment options.
Atossa’s strategy to prioritize a metastatic indication could potentially allow for a more rapid introduction of (Z)-endoxifen to the market. This approach may also lay the groundwork for the expansion of the drug’s use into earlier stages of the disease, where it has shown potential in reducing tumor proliferation and preventing recurrence.
Beyond metastatic disease, Atossa remains committed to exploring (Z)-endoxifen’s utility in breast cancer prevention and as a neoadjuvant therapy. The company is actively engaging with the FDA to define regulatory paths forward for these additional indications.
Atossa Therapeutics focuses on transforming breast cancer treatment and is dedicated to advancing its clinical research programs to improve patient outcomes. The information presented in this article is based on a press release statement from Atossa Therapeutics.
In other recent news, Atossa Therapeutics, Inc. has reported progress in its clinical programs for breast cancer treatment, particularly with its drug, (Z)-endoxifen. The company completed the KARISMA-Endoxifen Phase 2 Study, showing significant reductions in mammographic breast density with both 1 mg and 2 mg doses, which were well tolerated. Additionally, Atossa is advancing its EVANGELINE trial, which has shown promising initial results in tumor suppression for premenopausal women with ER+/HER2- breast cancer. Despite a setback with the Patent Trial and Appeal Board deeming all claims in Atossa’s ’334 patent unpatentable, the company has secured a new patent for sustained release compositions of endoxifen. Atossa plans to file a new Continuation Patent Application and continues to innovate in the oncology space. The company has also been notified by Nasdaq regarding non-compliance with the minimum bid price requirement but is evaluating options to regain compliance. These developments reflect Atossa’s ongoing efforts to advance its breast cancer treatments while navigating regulatory and market challenges.
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