Accessibility StatementSkip Navigation Studies highlight findings in the use of (Z)-endoxifen to advance breast cancer treatment and prevention SEATTLE, Nov. 6, 2025 /PRNewswire/ --Â Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, announces that four abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), being held on Decembe ...

Group 1 - Atossa Therapeutics, Inc. (ATOS) is a clinical-stage biopharmaceutical company with a 4% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Bridgeline Digital, Inc. (BLIN) is a marketing technology company that has seen a 12% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Cantaloupe, Inc. (CTLP) is a digital payment and software services company with a 6.7% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2]

Core Insights - Atossa Therapeutics is actively engaging with investors by participating in the Maxim Growth Summit on October 22–23, 2025, where the CEO will be available for one-on-one meetings [1][3] - The company focuses on developing innovative therapies for breast cancer, emphasizing disciplined capital allocation to support future regulatory submissions and commercialization [4][6] Company Overview - Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker ATOS, dedicated to addressing significant unmet needs in breast cancer treatment and prevention [4] - The company's strategy includes concentrating resources on programs that can lead to regulatory submissions and potential market entry [6] Investor Engagement - Prospective and existing investors are encouraged to visit Atossa's website for the latest presentations, SEC filings, and to sign up for email alerts [3] - The company believes that its disciplined capital allocation and clear clinical objectives create an attractive investment opportunity for long-term value creation [6]

Core Insights - Atossa Therapeutics has appointed Mark Daniel as Chief Financial Officer to support its transition to commercial operations with (Z)-endoxifen [1][3] - Daniel brings over 25 years of experience in life sciences finance, including revenue forecasting, public company controls, and capital markets expertise [1][2] - The company aims to focus on revenue-ready systems, disciplined spending, and milestone-aligned financing as it prepares for commercialization [3] Financial Management - Daniel has managed operating expense budgets exceeding $200 million and has implemented Sarbanes-Oxley (SOX) controls [1] - He has overseen a cash and investments portfolio of $400 million and executed nearly $1 billion in various financing transactions [2] - The company emphasizes disciplined capital allocation and aims to align spending with value-creating milestones [5] Operational Strategy - Atossa plans to operationalize commercial readiness through improved financial planning and analysis (FP&A), revenue forecasting, and capital planning [3] - The company is focused on enhancing systems that support scale and pursuing a balanced financing strategy for efficient market entry [3] - Daniel's experience includes leading international subsidiaries and managing supply agreements to ensure operational scale and margin discipline [7]

Core Insights - Three stocks have been added to the Zacks Rank 5 (Strong Sell) List, indicating a negative outlook for these companies [1][2] Company Summaries - **Antero Resources (AR)**: This independent explorer is primarily engaged in the acquisition and development of natural gas, natural gas liquids, and oil resources in the Appalachian Basin. The Zacks Consensus Estimate for its current year earnings has been revised downward by approximately 25.4% over the last 60 days [1] - **BTCS Inc. (BTCS)**: Focused on blockchain infrastructure and technology, BTCS has seen its Zacks Consensus Estimate for current year earnings revised downward by nearly 23.5% over the last 60 days [2] - **Atossa Genetics (ATOS)**: A healthcare company that develops and markets cellular and molecular diagnostic risk assessment products for breast cancer. The Zacks Consensus Estimate for its current year earnings has been revised downward by 8.3% over the last 60 days [2]

Core Insights - Atossa Therapeutics has made significant progress in its global intellectual property strategy for Z-endoxifen, including the issuance of a new patent in Israel, which reinforces protection for its lead program across major jurisdictions [1][4]. Intellectual Property Developments - The Israeli patent (No. 304863) was granted on July 2, 2025, and covers oral, delayed-release dosage forms with at least 90% by weight Z-endoxifen, along with specific impurity limits and defined release characteristics [2][4]. - The patent also includes claims related to manufacturing methods that enhance the Z-isomer through stepwise crystallization and solvent control, aligning with Atossa's quality-by-design approach [2][4]. Patent Renewal and Management - Atossa received a Certificate of Patent Renewal from the Israel Patent Office, confirming the renewal status for Patent No. 304863, which supports the life-cycle management of Z-endoxifen intellectual property in Israel [3][8]. - The granted patent encompasses various aspects such as stability, delayed-release attributes, dose ranges (1–4 mg and 8 mg), and pharmacokinetic performance targets [4][8]. Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet needs in breast cancer, emphasizing disciplined capital allocation and resource focus on regulatory submissions and potential commercialization [5].

Core Insights - Atossa Therapeutics has appointed CORE IR to enhance investor awareness and strengthen shareholder engagement [1][2] - The collaboration aims to broaden the company's reach to both institutional and retail audiences [1] - CORE IR will provide a comprehensive suite of investor relations services, including strategic messaging and investor outreach [2] Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on innovative approaches to breast cancer treatment and prevention [3] - The company's lead product candidate, (Z)-endoxifen, is designed for use across the breast cancer spectrum, including risk-reduction and treatment in various settings [3] - Atossa is committed to advancing clinical research programs to improve patient outcomes and create sustainable value for shareholders [3]

Atossa Therapeutics FY Conference Summary Company Overview - **Company**: Atossa Therapeutics (NasdaqCM: ATOS) - **Lead Asset**: Zinhoxifen, a novel drug for breast cancer treatment Key Points Product Differentiation - Zinhoxifen is a pure form of (Z)-endoxifen, which is derived from tamoxifen, offering efficacy with fewer side effects [2][5] - It has unique properties: it blocks estrogen receptor interaction and stimulates receptor degradation, unlike other drugs that only block [2][3] - Higher doses of Zinhoxifen activate a different apoptotic pathway (PKC beta), enhancing its cancer-fighting capabilities [3] Clinical Trial Insights - Clinical trials involving approximately 700 women showed a reduced incidence of vasomotor symptoms (e.g., hot flashes) compared to tamoxifen [5][6] - Higher levels of (Z)-endoxifen correlated with fewer hot flashes, indicating a potentially better safety profile [6] - Zinhoxifen is being explored for both prevention (1-4 mg) and treatment of metastatic breast cancer (20-80 mg) [7][8] Metastatic Breast Cancer - Initial data from trials at the National Cancer Institute and Mayo Clinic indicated a 25% clinical response rate and 50% partial response rate in patients resistant to current therapies [9] - The iSpy 2 trial is underway, combining Zinhoxifen with the CDK4/6 inhibitor abemaciclib, showing promising recruitment [11][12] Regulatory and Development Plans - Atossa is preparing for an IND filing under the FDA's Project Optimus, focusing on optimal dosing strategies [14][20] - The iSpy 2 trial aims to assess biological activity and tumor shrinkage in high-risk breast cancer patients [21] Market Opportunity - Approximately 1.7 million women currently take tamoxifen, indicating a significant market for Zinhoxifen, especially due to its better tolerance [27] - Pricing strategies suggest that Zinhoxifen could be positioned between $6,000 to $20,000 per year for prevention, contrasting with higher costs for metastatic treatments [28] Upcoming Milestones - Key upcoming events include data from the low-dose program in December and the initiation of the high-dose Project Optimus trial [29] Additional Insights - The FDA's recent requirement for mammogram results to include breast density information may increase awareness and demand for preventive treatments like Zinhoxifen [24][25] - The potential for Zinhoxifen to reduce side effects associated with current therapies could enhance patient compliance and market acceptance [26] This summary encapsulates the critical aspects of Atossa Therapeutics' conference, highlighting the innovative approach of Zinhoxifen in breast cancer treatment and the company's strategic direction in clinical development and market positioning.

Core Viewpoint - Atossa Therapeutics is actively engaging with investors and the biotech community to discuss its clinical advancements and future milestones, particularly focusing on its lead product candidate, (Z)-endoxifen, which aims to innovate breast cancer treatment and prevention [1][3]. Group 1: Company Overview - Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment and prevention through innovative science and patient-focused solutions [6]. - The company's lead product candidate, (Z)-endoxifen, is being developed as a therapy across the breast cancer spectrum, including both prevention and treatment settings [6]. Group 2: Upcoming Events - Dr. Steven Quay, Chairman and CEO of Atossa, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 3:00 p.m. ET [1][3]. - The live presentation will be webcast, with a replay available for approximately 90 days on the company's investor website [4]. Group 3: Clinical Progress - Dr. Quay will provide updates on the clinical progress of (Z)-endoxifen, highlighting its dual mechanisms of action as a Selective Estrogen Receptor Modulator (SERM) that may offer a differentiated solution for breast cancer prevention and treatment [3]. - Recent feedback from regulatory advisors has been encouraging, which could potentially accelerate the company's development path [3].

Core Insights - Atossa Therapeutics is advancing (Z)-endoxifen into a pivotal Phase 2 dose-ranging study for metastatic breast cancer, with regulatory input from the FDA and an IND filing expected in Q4 2025, aiming for topline results in 2026 [1][3][4] Study Design and Execution - The global Phase 2 study will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of (Z)-endoxifen monotherapy [3][4] - PSI has been selected as the contract research organization to manage the study, recognized for its efficiency in oncology trials, with 93% of its studies enrolling on time in 2024 [4][5][6] Market Opportunity - Approximately 5.6% of newly diagnosed invasive breast cancers in the U.S. are metastatic, equating to about 13,000 women annually, with an estimated 170,000 women currently living with metastatic breast cancer [7] - Current therapies often fail due to resistance, creating a significant market opportunity for (Z)-endoxifen as a potential first-in-class therapy in this multi-billion-dollar market [7] Pipeline Development - In addition to the metastatic trial, Atossa is advancing other Phase 2 studies, including (Z)-endoxifen monotherapy in early-stage breast cancer and combination therapy with abemaciclib [8] Product Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with dual mechanisms of action, showing potential for superior bone protection and a favorable safety profile compared to tamoxifen [9][10] - The proprietary formulation of (Z)-endoxifen is designed to enhance bioavailability and overcome limitations of previous formulations [10]