SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company, announced positive preliminary results from a phase 2 trial of its breast cancer drug, (Z)-endoxifen. The study, part of the I-SPY 2 Endocrine Optimization Pilot (EOP), showed that the low dose of the drug met its primary endpoint, with 95% of patients receiving more than 75% of the planned treatment.
The trial, which enrolled 20 women with ER+/HER2- breast cancer between March 2023 and May 2024, revealed that 10 mg of (Z)-endoxifen taken orally once daily significantly reduced key biomarkers for the disease. After three weeks of treatment, the protein Ki-67, which indicates cancer cell proliferation, dropped by 69% from baseline, and functional tumor volume (FTV) shrank by 30.4%. These early results suggest that (Z)-endoxifen could potentially slow the progression of ER+ breast cancer in a neoadjuvant setting.
Patients in the trial experienced mild side effects, such as hot flushes, insomnia, and fatigue, but no dose reductions or treatment discontinuations due to adverse events were reported. Further analysis, including surgical Ki-67 values and 24-week imaging, will be conducted in the future.
Dr. Steven Quay, CEO of Atossa Therapeutics, expressed optimism about the rapid reduction in Ki-67 and FTV, indicating progress in the development of (Z)-endoxifen as an effective and tolerable treatment. The company is also exploring higher doses of (Z)-endoxifen in combination with other drugs to enhance treatment efficacy.
The I-SPY 2 EOP trial targets patients with newly diagnosed estrogen receptor-positive invasive breast cancer who are unlikely to benefit from chemotherapy. The findings from this study will be presented at the upcoming RISE UP Breast Cancer Conference in San Francisco.
(Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM), not only inhibits estrogen receptors but also targets the oncogenic protein PKCβ1. It has shown efficacy in patients resistant to other hormonal treatments and has demonstrated bone agonistic effects with minimal endometrial proliferative impact compared to treatments like tamoxifen.
Atossa's proprietary oral formulation of (Z)-endoxifen aims to improve drug stability and efficacy by bypassing acidic conditions in the stomach. The drug is currently being evaluated in five phase 2 trials for various breast cancer conditions.
This announcement is based on a press release statement from Atossa Therapeutics, Inc.
In other recent news, Atossa Therapeutics has been actively advancing its breast cancer treatments. The biopharmaceutical company recently expressed support for the FDA's updated mammography regulations, which now require facilities to inform patients of their breast density, a significant factor in breast cancer risk. Atossa's ongoing projects include the development of (Z)-endoxifen, a Selective Estrogen Receptor Modulator (SERM), in multiple phase 2 clinical trials, and the support of the SMART study, a phase 2 trial using artificial intelligence to assess breast cancer risk.
Atossa has also secured a new patent from the USPTO for compositions that include the active ingredient endoxifen. This expands Atossa's intellectual property portfolio and provides broader protection for its endoxifen-based compositions and their methods of administration. Analyst firm H.C. Wainwright has maintained a Buy rating on Atossa, indicating positive expectations for the company's performance.
In collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, Atossa has initiated several clinical trials for breast cancer treatments. One such trial involves a combination of Atossa's proprietary (Z)-endoxifen and Eli Lilly (NYSE:LLY)'s abemaciclib, intended for high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. The outcomes of these trials, expected in 2026, could further validate (Z)-endoxifen's safety and efficacy. These are the recent developments at Atossa Therapeutics.
InvestingPro Insights
As Atossa Therapeutics (NASDAQ:ATOS) reports positive preliminary results from its phase 2 trial of (Z)-endoxifen, investors may find additional context from InvestingPro's financial metrics and tips valuable.
According to InvestingPro data, Atossa's market capitalization stands at $177.32 million, reflecting the market's current valuation of the company's potential. This relatively modest market cap suggests that the market is still assessing the full impact of Atossa's drug development pipeline, including the promising (Z)-endoxifen results.
An InvestingPro Tip highlights that Atossa holds more cash than debt on its balance sheet. This strong liquidity position is crucial for a clinical-stage biopharmaceutical company, as it provides the financial runway needed to continue drug development and clinical trials without immediate funding concerns.
Another relevant InvestingPro Tip notes that Atossa is not profitable over the last twelve months, with an adjusted operating income of -$30.57 million. This is not unusual for a company in the clinical trial phase, as significant investments in research and development often precede revenue generation in the pharmaceutical industry.
Interestingly, despite the lack of profitability, Atossa has seen a high return over the last year, with a one-year price total return of 110.32%. This suggests that investors are optimistic about the company's future prospects, likely influenced by positive clinical trial results such as those recently announced for (Z)-endoxifen.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into Atossa's financial health and market position. There are 7 more InvestingPro Tips available for Atossa Therapeutics, which could offer valuable perspective for those considering an investment in this emerging biopharmaceutical company.
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