Atossa reports positive Phase 2 breast cancer trial results

SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company, today shared positive outcomes from its Phase 2 EVANGELINE clinical trial, assessing (Z)-endoxifen as a neoadjuvant treatment for pre-menopausal women with certain types of breast cancer.

The study focused on patients with Grade 1 or 2 Estrogen Receptor positive (ER+) and Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.

The trial's preliminary data, presented at the American Association for Cancer Research (AACR) Annual Meeting, came from a 40mg pharmacokinetic cohort involving seven women treated daily for 28 days.

Six out of seven participants showed a significant reduction in Ki-67 levels—a marker for tumor growth—after the treatment period, with one patient achieving a complete response as per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. The average target lesion reduction was 32% at 12 weeks and 37% at 24 weeks.

Dr. Nusayba A. Bagegni, an investigator in the study, noted the treatment's potential to address an unmet need in this patient population without the need for ovarian function suppression. Dr. Steven Quay, President and CEO of Atossa, expressed optimism about the trial's next phase, which involves an increased daily dose of 80mg of (Z)-endoxifen.

The company highlighted the drug's potency as a Selective Estrogen Receptor Modulator (SERM), its efficacy in patients resistant to other hormonal treatments, and its minimal proliferative effects on the endometrium compared to standard treatments like tamoxifen.

Breast cancer is the most common cancer in pre-menopausal women globally, with the majority being ER+. The current standard of care combines ovarian function suppression with either tamoxifen or an aromatase inhibitor, which can be associated with significant morbidity.

The EVANGELINE trial aims to enroll approximately 175 patients across the United States, comparing the effects of (Z)-endoxifen to the current standard of care on tumor cell growth. An earlier Phase 2 study of the treatment resulted in a 65.1% reduction in Ki-67 levels, suggesting a correlation with improved long-term survival.

Atossa Therapeutics is focused on developing (Z)-endoxifen to prevent and treat breast cancer, with four Phase 2 trials currently underway. The company's approach is protected by three issued U.S. patents and numerous pending patent applications.

This article is based on a press release statement from Atossa Therapeutics, Inc. and contains forward-looking statements subject to risks and uncertainties.

As Atossa Therapeutics (NASDAQ:ATOS) continues to make strides in the clinical development of (Z)-endoxifen for the treatment of breast cancer, the company's financial health and market performance provide additional context for investors. According to InvestingPro data, Atossa Therapeutics holds a market capitalization of approximately $228.68 million.

Get The App

Join the millions of people who stay on top of global financial markets with Investing.com.

Download Now

Despite the company's ambitious clinical programs, analysts have expressed concerns regarding Atossa's profitability, with the company not expected to be profitable this year and having reported a negative operating income of roughly $31.38 million over the last twelve months as of Q4 2023.

InvestingPro Tips highlight a mixed financial picture for Atossa. The company holds more cash than debt, suggesting a solid financial footing, and liquid assets exceed its short-term obligations, indicating good liquidity.

Still, weak gross profit margins and the lack of profitability over the last twelve months are points of caution for potential investors. On the performance front, Atossa has experienced a strong return over the last month, three months, and six months, with a significant 153.62% price uptick over the last six months, reflecting investor optimism following recent developments.

For those seeking to delve deeper into Atossa's financials and performance metrics, InvestingPro offers a comprehensive set of additional tips—totaling 10 for ATOS. These insights could prove invaluable in making informed investment decisions, especially in the volatile biopharmaceutical sector. Interested readers can enhance their market analysis with these insights and can benefit from an exclusive offer: use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.