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SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company with a market capitalization of $96 million, has announced plans for a Phase 3 clinical study, SMART 2.0, to evaluate the efficacy of (Z)-endoxifen in reducing interval breast cancer in high-risk women. The study framework was unveiled at the American Association for Cancer Research Annual Meeting. According to InvestingPro analysis, the company maintains a strong liquidity position with more cash than debt, though it’s currently experiencing rapid cash burn as it advances its clinical programs.
Interval breast cancers, which occur between regular mammography screenings, tend to be more aggressive. Mammographic density, a modifiable risk factor, can hinder early detection. Atossa’s (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM), has been shown to reduce mammographic density and may increase the sensitivity of mammograms. The Phase 2 KARISMA trial reported nearly a 20% reduction in mammographic density over six months, with side effects comparable to a placebo. With a robust current ratio of 14.99, InvestingPro data shows the company is well-positioned to fund its clinical development programs, though analysts don’t expect profitability this year.
The upcoming SMART 2.0 trial aims to randomize participants using an AI Risk model into treatment and placebo groups. Over two years, the study will assess the relative reduction in interval breast cancer incidence and tolerability of (Z)-endoxifen compared to placebo.
Steven C. Quay, CEO of Atossa Therapeutics, stated, "The SMART 2.0 study proposal represents a significant step forward for the advancement of breast cancer prevention." The company hopes that this trial will provide the pivotal data needed for regulatory approval of (Z)-endoxifen as a preventative treatment option. Despite recent market volatility, with the stock showing an 11.97% gain over the last week but a 48% decline over six months, analyst price targets remain optimistic, ranging from $4 to $7.25 per share. Investors can access detailed financial analysis and 8 additional key insights through InvestingPro’s comprehensive research report.
(Z)-endoxifen is not only a highly potent SERM for estrogen receptor inhibition but also targets PKCβ1, an oncogenic protein, and may have bone agonistic effects with minimal endometrial proliferative effects compared to tamoxifen. Atossa has developed an oral formulation of (Z)-endoxifen designed to bypass the stomach, thus maintaining its efficacy.
Atossa Therapeutics is dedicated to developing solutions for the full spectrum of breast cancer treatment, including prevention and metastatic settings. The company’s commitment to clinical research aims to improve patient outcomes and provide value for shareholders. This press release statement is based on information from Atossa Therapeutics and contains forward-looking statements subject to risks and uncertainties.
In other recent news, Atossa Therapeutics reported its fourth-quarter 2024 earnings, revealing an earnings per share (EPS) of -0.04, which exceeded the forecasted -0.065. This performance marks an improvement for the company, which also reduced its net loss to $25.5 million from $30.1 million in the previous year. Operating expenses were cut significantly, reflecting a disciplined approach to spending. Concurrently, Atossa secured a new patent for its (Z)-endoxifen formulations, which are being developed as a treatment for hormone receptor-positive breast cancer. This patent strengthens Atossa’s intellectual property portfolio and supports its ongoing clinical programs. H.C. Wainwright recently maintained its Buy rating for Atossa, setting a price target of $7.00, citing the strategic focus on (Z)-endoxifen for metastatic breast cancer. The company plans to initiate a new clinical trial in 2025, with consultations underway with key opinion leaders to navigate the complexities of the metastatic breast cancer treatment landscape. Atossa’s commitment to advancing its lead program, (Z)-endoxifen, highlights its strategic direction in addressing unmet needs in breast cancer treatment.
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