SEATTLE - Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company with a market capitalization of $157 million, announced results from its Phase 2 KARISMA-Endoxifen trial indicating that a 1 mg dose of (Z)-endoxifen could serve as a well-tolerated, preventative therapy for premenopausal women at risk of developing breast cancer. The company's stock has shown remarkable strength, delivering a 72% return over the past year. According to InvestingPro analysis, the company maintains a strong financial position with more cash than debt on its balance sheet. The study, conducted at the Karolinska Institute in Stockholm, Sweden, showed that this dosage significantly reduced mammographic breast density (MBD), a key risk factor for the disease, while maintaining a favorable safety profile.
The double-blind, placebo-controlled trial enrolled 240 premenopausal women between the ages of 40 and 55, who were randomized to receive either a placebo, 1 mg, or 2 mg of daily oral (Z)-endoxifen for six months. The primary goal was to evaluate reductions in MBD and assess safety and tolerability. The findings revealed that the 1 mg dose of (Z)-endoxifen reduced MBD by 17.3 percentage points (p
Plasma concentrations of (Z)-endoxifen were reported at 4.8 ng/mL for the 1 mg dose and 9.7 ng/mL for the 2 mg dose, highlighting the effectiveness of the lower dose in achieving significant reductions. Notably, the study reported no significant differences in adverse events between the 1 mg dose and placebo. However, the 2 mg dose was associated with higher rates of hot flashes, night sweats, and vaginal discharge.
Steven Quay, M.D., Ph.D., President and CEO of Atossa, emphasized the potential of (Z)-endoxifen as a preventative therapy, particularly for premenopausal women, due to its ability to significantly reduce MBD and avoid toxicity issues commonly associated with tamoxifen. While the company is not yet profitable, with an EBITDA of -$29.46 million in the last twelve months, InvestingPro data shows analysts have set price targets ranging from $4 to $7, suggesting significant upside potential. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial analysis to make informed investment decisions.
The results of the KARISMA-Endoxifen trial, which align with outcomes observed in prior studies using tamoxifen, suggest that (Z)-endoxifen could be a safer and more targeted alternative. The data will be presented in a Poster Spotlight Session at the 2024 San Antonio Breast Cancer Symposium.
(Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM), has shown efficacy in patients with tumor resistance to other hormonal treatments and targets oncogenic proteins at clinically attainable blood concentrations. Atossa is developing a proprietary oral formulation of (Z)-endoxifen and is currently studying it in five Phase 2 trials for various breast cancer conditions.
This report is based on a press release statement from Atossa Therapeutics, Inc. The company maintains a healthy financial position with a current ratio of 13.3, indicating strong liquidity to fund its ongoing clinical trials. InvestingPro subscribers can access detailed financial health metrics, comprehensive analyst coverage, and real-time updates on Atossa's development progress.
In other recent news, Atossa Genetics (NASDAQ:ATOS) has reported promising results from its Phase 2 KARISMA-Endoxifen study. The trial focused on assessing the efficacy of Z-endoxifen in reducing mammographic breast density (MBD) among premenopausal women. H.C. Wainwright, in response to these findings, increased the stock price target for Atossa Genetics to $7.00, up from the previous $6.00, while maintaining a Buy rating on the stock.
In addition, Atossa Genetics has secured a new patent from the United States Patent and Trademark Office (USPTO) for compositions including the active ingredient endoxifen. This expands the company's intellectual property portfolio.
The company has also 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. The outcomes of this trial are expected in 2026. These are recent developments at Atossa Genetics.
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