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Atossa Therapeutics Advances (Z)-endoxifen in Rare Diseases
"During the quarter, we executed well across the business," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and Chief Executive Officer. "We continued to advance the scientific rationale for (Z)-endoxifen's potential in rare pediatric diseases, such as Duchenne Muscular Dystrophy and McCune-Albright Syndrome, while also strengthening its clinical and scientific foundation in breast cancer, all through new data presented at important industry conferences, including ASCO and AACR, as well as publications in well-regarded peer-reviewed journals, Degenerative Neurological and Neuromuscular Disease and npj Breast Cancer."
Atossa Therapeutics CFO Discusses Endoxifen Development Strategy
In an exclusive interview, Atossa Therapeutics'CFO Mark Daniel spoke with The Fly about the company's development strategy, the evolving clinical narrative around-endoxifen, and how the biotech is positioning itself for its next phase of growth.THE COMPANY:Atossa Therapeutics positions itself as a clinical stage biopharmaceutical company focused on developing innovative medicines for breast cancer and selected rare diseases with significant unmet medical needs. The company's lead program,-endoxifen, is being advanced across multiple stages of breast cancer while also being evaluated in rare diseases where the scientific rationale is strong.The mission, CFO Mark Daniel explained to The Fly, is straightforward, namely to "develop therapies that can make a meaningful difference for patients while creating long-term value for shareholders through disciplined clinical development."LONG-TERM VISION FOR-ENDOXIFEN:While breast cancer remains the foundation of Atossa's strategy, Daniel explains that the company has identified additional opportunities where-endoxifen's biology suggests broader therapeutic potential. Rather than expanding indications for the sake of pipeline breadth, Atossa is targeting diseases with significant unmet need and a realistic regulatory path — including Duchenne muscular dystrophy and McCune Albright syndrome.Long term, the executive says they "see-endoxifen as a platform molecule with the potential to address multiple diseases, while remaining disciplined about where we invest our resources."CLINICAL NARRATIVE:Recent clinical milestones have strengthened confidence in the program. Daniel points to the KARISMA trial publication, which offered encouraging evidence supporting-endoxifen's potential in breast cancer risk reduction. At ASCO 2026, Atossa presented data spanning earlier stage breast cancer to endocrine resistant disease, reinforcing the breadth of the development program."Together, these milestones give us greater confidence that we're building a program with multiple opportunities, while continuing to generate the clinical evidence needed for future development," the CFO added.The executive also noted that the company is looking at partnering strategies.INFLECTION POINTS AHEAD:For Daniel, the next 12–24 months are defined by execution. With a strong scientific and clinical foundation in place, Atossa is focused on advancing its clinical programs, engaging regulators, and generating the data needed to chart the most efficient path toward late stage development."As a management team, we're committed to balancing scientific ambition with financial discipline so we can continue creating value for both patients and shareholders," the executive noted.CORRECTING MISCONCEPTIONS:Discussing any potential misconceptions associated with the company, the CFO told The Fly there are two he believes deserve correction. The first is the idea that-endoxifen is simply another version of tamoxifen. He stresses that it is a differentiated therapy with its own intellectual property, clinical strategy, and expanding evidence base.The second misconception is that Atossa is a single program company. While breast cancer remains the anchor, the company has built a promising rare disease pipeline supported by extensive clinical history and ongoing preclinical work. Daniel says this foundation puts Atossa in a strong position to complete rare disease program development and move into the clinic in the near future.Meet the Company is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
Atossa Therapeutics Sees Opportunities for (Z)-endoxifen Beyond Breast Cancer
Atossa Therapeutics sees opportunities for (Z)-endoxifen beyond breast cancer
Atossa Therapeutics Publishes Breast Cancer Study Results
Atossa Therapeutics announced the publication of a peer-reviewed preclinical study in npj Breast Cancer evaluating five novel chemical entities structurally related to (Z)-endoxifen. The study reported anti-estrogenic and anti-cancer activity across multiple estrogen receptor-positive breast cancer models, including models harboring clinically relevant activating mutations in ESR1. The investigators evaluated five previously uncharacterized compounds generated during the synthesis of (Z)-endoxifen alongside (Z)-endoxifen in a broad panel of laboratory assays. Several compounds demonstrated potent anti-estrogenic effects, and affected multiple anti-cancer processes including apoptosis, cell-cycle progression, migration, invasion and estrogen receptor-driven transcription. The compounds also showed activity in models containing activating ESR1 mutations, associated with endocrine resistance and recurrent or metastatic estrogen receptor-positive breast cancer. The authors concluded that select compounds warrant further in vivo safety evaluation, as well as efficacy studies, including as potential second- or third-line approaches for recurrent disease. These findings are preclinical and do not establish safety or efficacy in patients.
Atossa Therapeutics Enters Securities Purchase Agreement, Expected to Raise $4.5M
Atossa Therapeutics announced that it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 1,363,638 shares of its common stock, par value 18c per share, Series A warrants to purchase up to 1,363,638 shares of Common Stock and short-term Series B warrants to purchase up to 1,363,638 shares of Common Stock and accompanying Series Warrants in a registered direct offering. The Series Warrants will be exercisable six months following the date of issuance. The Series A warrants will expire on the five one-half year anniversary of the date of issuance. The short-term Series B warrants will expire on the two year anniversary of the date of issuance. The closing of the offering is expected to occur on or about June 12. The aggregate gross proceeds to the company from the offering are expected to be approximately $4.5M before deducting the placement agent's fees and other estimated offering expenses payable by the company. The potential additional gross proceeds to the company from the Series Warrants, if fully exercised on a cash basis, will be approximately $12M. Rodman & Renshaw is acting as the exclusive placement agent for the offering.
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