SEATTLE - Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company, announced today that a breast cancer patient has completed a five-year treatment with (Z)-endoxifen and remains cancer-free. The patient was part of an FDA-approved expanded access program for individuals with Estrogen Receptor positive (ER+) and Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer who are pre-menopausal.
The patient, diagnosed in late 2018 with a common subtype of breast cancer, was not a suitable candidate for standard treatments such as tamoxifen due to a genetic predisposition that reduced its efficacy. Instead, she received 4 mg/day of oral (Z)-endoxifen both before surgery (neoadjuvant therapy) and as a follow-up (adjuvant therapy). Her treatment led to a significant reduction in tumor markers and, following surgery, she has experienced no cancer recurrence or significant side effects.
Atossa's CEO, Steven Quay, M.D., Ph.D., highlighted the potential of (Z)-endoxifen to change the treatment paradigm for the approximately 250,000 women diagnosed annually with this type of breast cancer in the U.S. He noted that the standard of care often involves drugs that can cause side effects impacting patient adherence.
(Z)-endoxifen is an active metabolite of tamoxifen, a commonly used drug in breast cancer treatment. Atossa is developing a proprietary oral formulation of (Z)-endoxifen, which has shown tolerability in Phase 1 and Phase 2 studies. The company is conducting four Phase 2 trials to further investigate its efficacy.
The FDA's expanded access program, also known as compassionate use, allows patients with serious or life-threatening conditions to access investigational medical products outside of clinical trials when no satisfactory alternatives are available.
The information in this article is based on a press release.
InvestingPro Insights
In light of Atossa Therapeutics' recent announcement regarding the successful long-term treatment with (Z)-endoxifen, investors may be keen to understand the financial health and market performance of the company. InvestingPro data shows that Atossa Therapeutics, Inc. (NASDAQ: ATOS) holds a market capitalization of approximately $178.56 million. Despite the company's promising clinical outcomes, analysts are not expecting profitability this year, as reflected in the negative P/E ratio of -5.81. The company's financials also indicate challenges with an operating income of around -$30.5 million for the last twelve months as of Q3 2023.
However, it's not all challenging news on the financial front. An InvestingPro Tip reveals that Atossa Therapeutics maintains a stronger liquidity position, holding more cash than debt on its balance sheet, which is a positive sign for the company's financial resilience. Additionally, the firm's liquid assets exceed short-term obligations, indicating a solid short-term financial footing. This financial stability may provide the company with a buffer to continue its clinical developments and potentially bring new treatments to market.
From a market performance perspective, Atossa Therapeutics has seen a notable price uptick over the last six months, with a 62.53% total return, and an impressive 86.96% return over the last year. These figures suggest a growing investor confidence in the company's potential, particularly in light of its recent clinical successes. However, investors should note that Atossa does not pay a dividend, which may influence investment decisions for those seeking regular income streams from their holdings.
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