Atossa Therapeutics Inc Stock Price, News & Analysis

Atossa Therapeutics (Nasdaq: ATOS) reported Q3 2025 results and corporate updates on Nov 12, 2025. Key items: operating expenses of $9.3M for Q3 2025 (vs $6.4M Q3 2024); prioritized IND-targeted programs for (Z)-endoxifen with a planned IND filing in Q4 2025 and an FDA Type C meeting scheduled for Nov 17, 2025. The company selected PSI as CRO for a global Phase 2 dose-ranging mBC study with enrollment post-IND and topline data expected in 2026. Hires include a new SVP R&D and a CFO to support regulatory and commercial readiness. The Israeli patent No. 304863 issued July 2, 2025; two U.S. patents face post-grant challenges.

Atossa Therapeutics (Nasdaq: ATOS) announced four abstracts featuring (Z)-endoxifen research were accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), Dec 9-12, 2025 in San Antonio, TX. The company will present four posters on Dec 11-12 covering DCIS management, a low-dose I-SPY2 endocrine pilot, ESR1 mutant activity, and a Phase 2 neoadjuvant EVANGELINE trial.

Presentations include scheduled poster sessions on Dec 11 (12:30pm–2:00pm CT) and Dec 12 (7:00am–8:30am CT and 12:30pm–2:00pm CT).

Atossa Therapeutics (Nasdaq: ATOS) highlighted enrollment progress and biomarker strategy for the RECAST™ Phase 2 DCIS platform trial ahead of an Early Detection Research Conference presentation on October 21, 2025.

RECAST is a multi-arm, randomized neoadjuvant trial testing standard endocrine therapy and novel agents—(Z)-Endoxifen, elacestrant, Hav-088—with imaging, biomarker discovery, and quality-of-life endpoints. Enrollment began January 2024 with 50 of 400 patients enrolled across 17 active U.S. sites. The trial aims to identify patients suitable for long-term active surveillance and generate interim imaging and biomarker readouts to de-risk later-stage development.

Atossa Therapeutics (Nasdaq: ATOS) announced that Chairman & CEO Steven Quay, M.D., Ph.D. will present at the Maxim Growth Summit on October 22–23, 2025 at the Hard Rock Hotel, New York City.

The company invited new and existing investors to attend or request one-on-one meetings to discuss Atossa's clinical programs, development plans, and capital-allocation strategy focused on preparing data packages for potential regulatory submissions and commercialization.

Investors are directed to the Atossa investor website for presentations, SEC filings, FAQs, and meeting requests.

Atossa (NASDAQ: ATOS) appointed Mark Daniel, CPA, as Chief Financial Officer effective Oct 14, 2025 to lead finance, systems, and capital strategy as the company prepares for commercial launch of (Z)-endoxifen.

Mr. Daniel brings >25 years of life‑sciences finance experience, including weekly revenue forecasting with commercial teams, management of operating budgets >$200M, implementation and certification of SOX controls, programs delivering >$50M in cost savings, stewardship of a $400M cash and investments portfolio, and participation in nearly $1B of equity, convertible debt, and credit transactions.

Atossa Therapeutics (NASDAQ: ATOS) announced expansion of its global intellectual-property strategy for Z-endoxifen, including issuance of an Israeli patent (No. 304863) granted on July 2, 2025 and a Certificate of Patent Renewal confirming fee payment and active status.

The Israeli claims cover oral delayed-release enteric dosage forms with at least 90% Z-endoxifen, optional impurity limits (<2%), defined gastric/intestinal release characteristics, dose strengths (e.g., 1–4 mg and 8 mg), pharmacokinetic targets, and manufacturing methods that enrich the Z-isomer via crystallization and solvent control.

Atossa Therapeutics (NASDAQ: ATOS) amended its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal ER+/HER2– early breast cancer to a single-arm, open-label, non-registrational design. The amendment reduces planned enrollment from 214 to 40–65 patients, implements a Cohort A two-stage futility rule using Week-4 Ki-67 ≤10% for earlier go/no-go decisions, and retains unchanged patient-safety data collection and DSMC oversight. Run-in data showed a Week-4 Ki-67 ≤10% rate of 86%. The company says the change aims to cut future study costs, accelerate objective readouts, and prioritize NDA-enabling activities in 2026.

Atossa Therapeutics (NASDAQ:ATOS) has appointed Janet R. Rea, MSPH as Senior Vice President, R&D. This strategic hire brings over 20 years of clinical development and regulatory expertise to accelerate the development of (Z)-endoxifen, the company's lead product candidate for breast cancer treatment and prevention.

Ms. Rea, who previously served at Atossa, returns with significant experience in securing regulatory approvals, including her role in the approval of FluBlok® at Protein Sciences. Her prior work at Atossa involved securing regulatory clearance for (Z)-endoxifen clinical studies in Australia, the US, and Sweden.

In her new role, Ms. Rea will focus on upcoming FDA submissions and defining the pathway to commercialization for (Z)-endoxifen across multiple indications.

Atossa Therapeutics (NASDAQ:ATOS), a clinical-stage biopharmaceutical company focused on breast cancer treatment and prevention, has appointed CORE IR as its strategic investor relations and communications partner. The collaboration aims to enhance investor awareness and strengthen shareholder engagement through comprehensive IR services.

Under the agreement, CORE IR will provide strategic messaging, non-deal roadshow support, investor targeting and outreach, and communication program support. The partnership reflects Atossa's commitment to improving market visibility and communicating its progress to both institutional and retail investors.