SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company, in collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, has announced the initiation of a clinical trial where the first patient has been dosed with a combination of (Z)-endoxifen and abemaciclib as a neoadjuvant treatment for high-risk breast cancer.
The trial focuses on women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer, a condition with a substantial risk for recurrence. The study aims to offer a more effective and tolerable treatment compared to the current standard of care.
Approximately 80 participants will be enrolled across two cohorts, with both pre-and-post menopausal women receiving 80 mg of (Z)-endoxifen daily and 150 mg of abemaciclib twice daily for 24 weeks before surgery. Premenopausal women in the second cohort will also undergo ovarian function suppression (OFS) to assess the impact of this addition to the treatment regimen.
(Z)-endoxifen, Atossa's proprietary drug, is recognized for its potent anti-estrogen effects and for targeting PKCβ1, an oncogenic protein. It is designed to bypass liver metabolism and stomach acidification, which may convert it to an inactive form. The drug has been well-tolerated in early-phase trials and is currently under investigation in several Phase 2 studies.
Dr. Steven Quay, President and CEO of Atossa, expressed optimism about the potential of the drug combination to improve patient outcomes and quality of life. Dr. Jo Chien, a Professor of Medicine at UCSF and the study's principal investigator, highlighted the need for better treatment options for patients with HR+ tumors that do not respond well to chemotherapy and immunotherapy.
Atossa and Eli Lilly and Company (NYSE:LLY), the marketer of abemaciclib, are responsible for supplying their respective drugs for the study. Results from the trial are expected in 2026 and could validate the efficacy of (Z)-endoxifen in both premenopausal and postmenopausal patients.
This news is based on a press release statement from Atossa Therapeutics, Inc. and does not include any promotional content. The company is dedicated to developing innovative medicines for oncology, with a particular emphasis on breast cancer prevention and treatment.
In other recent news, Atossa Therapeutics has undergone notable developments. The company announced the appointment of Heather Rees as the new Chief Financial Officer, and the expansion of its stock incentive plan by 12 million shares. Atossa also increased the total number of authorized shares to 360 million. Atossa's shareholders ratified the selection of Ernst & Young LLP as the company's independent auditor for the fiscal year ending December 31, 2024.
On the research front, Atossa expanded its research agreement with Weill Cornell Medicine to investigate the combination of antibody-drug conjugates and (Z)-endoxifen in treating advanced breast cancer. The company, in collaboration with Quantum Leap Healthcare Collaborative, launched a new study to assess the efficacy of Atossa's proprietary (Z)-endoxifen in combination with Eli Lilly's abemaciclib in treating ER+/HER2- breast cancer.
The company also reported positive results from its Phase 2 EVANGELINE clinical trial, assessing (Z)-endoxifen as a neoadjuvant treatment for pre-menopausal women with certain types of breast cancer. H.C. Wainwright maintained a Buy rating on Atossa Genetics (NASDAQ:ATOS), raising the price target to $6.00. These are some of the recent developments at Atossa Therapeutics.
InvestingPro Insights
Atossa Therapeutics, Inc. (NASDAQ:ATOS) has recently initiated a promising clinical trial for breast cancer treatment, and this development has sparked interest among investors. Reflecting on the company's financial health and stock performance, InvestingPro provides valuable insights.
An InvestingPro Tip highlights that Atossa holds more cash than debt on its balance sheet, which could provide the company with financial flexibility to fund ongoing research and trials without the immediate need for external financing. Additionally, Atossa's liquid assets exceed its short-term obligations, indicating a strong liquidity position that can support its operations in the near term.
From a stock performance perspective, Atossa has seen a significant return over the last week, with a price total return of 8.06%. This uptick could reflect investor optimism following the announcement of the clinical trial. However, it's worth noting that analysts do not anticipate the company will be profitable this year, and Atossa has not been profitable over the last twelve months.
InvestingPro Data further provides key metrics that investors may consider. Atossa's market capitalization stands at $168.51 million, and the company's P/E ratio is currently negative at -6.55, reflecting its lack of profitability. The price to book ratio is 2.1, suggesting that the stock may be valued reasonably in relation to its net assets.
For those interested in deeper analysis, InvestingPro offers additional tips on Atossa Therapeutics, Inc. on their platform, which can provide a more comprehensive view of the company's financial status and stock performance.
Investors and stakeholders can stay informed about Atossa's financial health and stock performance by visiting https://www.investing.com/pro/ATOS, which features a total of 9 InvestingPro Tips for a more detailed understanding of the company's prospects.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.