Atossa Therapeutics Inc Stock Price, News & Analysis

Atossa Therapeutics (Nasdaq: ATOS) and Quantum Leap Healthcare Collaborative have dosed the first patient in their clinical trial evaluating Atossa's (Z)-endoxifen combined with abemaciclib (VERZENIO®) for ER+/HER2- breast cancer. The study, part of the I-SPY 2 Endocrine Optimization Pilot Protocol, aims to enroll 80 participants across two cohorts, focusing on patients with newly diagnosed ER+ invasive breast cancer. Participants will receive 80 mg (Z)-endoxifen daily and 150 mg abemaciclib twice daily for 24 weeks before surgery. The second cohort will also include ovarian function suppression for premenopausal women. Results are expected in 2026, potentially validating (Z)-endoxifen's safety and efficacy in both pre- and postmenopausal breast cancer patients.

Atossa Therapeutics (Nasdaq: ATOS) has appointed Michael Parks as Vice President of Investor and Public Relations. With nearly 30 years of experience in the biopharmaceutical and healthcare industries, Parks will oversee corporate communications, investor relations, and branding for the company. Atossa, a clinical-stage biopharmaceutical company, focuses on developing innovative medicines for breast cancer and other areas of unmet medical need in oncology.

Parks' extensive background includes roles at PAVmed, Lucid Diagnostics, Liquidia , and his own consulting firm, Pitch360. He also held positions at Johnson & Johnson's Centocor, Pfizer, Pharmacia, and Searle Pharmaceuticals. Dr. Steven Quay, Atossa's CEO, expressed excitement about Parks joining the team, highlighting his seasoned experience and multidisciplined approach to communications.

Atossa Therapeutics (NASDAQ: ATOS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

• Completed enrollment in 80mg PK Run-in Cohort for EVANGELINE trial
• Presented data showing 100% disease control rate after 24-week treatment with (Z)-Endoxifen in 40mg cohort of Phase 2 EVANGELINE study
• Completed Phase 2 Karisma-Endoxifen clinical trial dosing
• Ended Q2 with $79.5 million in cash and no debt

Financial results: Total operating expenses decreased to $7.1 million for Q2 2024, down from $7.8 million in Q2 2023. R&D expenses slightly decreased, while G&A expenses saw a significant reduction in compensation costs. Interest income increased to $1.1 million for Q2 2024.

Atossa Therapeutics (Nasdaq: ATOS) has completed enrollment for the 80mg pharmacokinetic run-in cohort in its Phase 2 EVANGELINE clinical trial. This study evaluates (Z)-endoxifen as a neoadjuvant treatment for ER+ / HER2- breast cancer. The cohort includes 12 pre-menopausal women who will receive 80mg/day of (Z)-endoxifen for four weeks. Key points:

• The full study aims to enroll 175 patients across 25 U.S. sites
• Previous 40mg cohort showed 92% average reduction in Ki-67 and 37% average target lesion decrease
• 80mg dose is expected to optimize PKCβ1 inhibition and enhance antitumor efficacy
• EVANGELINE compares (Z)-endoxifen to exemestane plus goserelin in pre-menopausal women with Grade 1 or 2 ER+ / HER2- breast cancer

Atossa Therapeutics has appointed Heather Rees as its new Chief Financial Officer (CFO). Rees, who has been with Atossa for seven years and previously served as Senior Vice President of Finance and Principal Accounting Officer, brings nearly 30 years of experience in accounting, business, and finance to this role. She first joined Atossa as Controller in 2017. Prior to Atossa, Rees led a consulting practice providing services to companies like Getty Images and Avalara, and served as Controller of the Americas for Irdeto Inc. Atossa's CEO, Steven Quay, praised Rees for her contributions, which have been key to the company's success. With multiple data milestones expected this year and sufficient working capital for approximately three years, Atossa is well-positioned to enhance shareholder value.

Atossa Therapeutics has updated the protocol for its study on (Z)-endoxifen combined with abemaciclib (VERZENIO®) for ER+/HER2- breast cancer. Based on Phase 2 EVANGELINE study data, the study dose of (Z)-endoxifen has been increased from 40 mg to 80 mg daily due to positive safety and efficacy results. Participants showed a 92% average reduction in Ki-67 and a 37% decrease in tumor size. The updated protocol now includes 80 participants split into two cohorts, with premenopausal women in one cohort also receiving ovarian function suppression (OFS). This expanded protocol aims to validate the efficacy and safety of (Z)-endoxifen without OFS in premenopausal women.

Atossa Therapeutics (Nasdaq: ATOS) announced its upcoming inclusion in the Russell 3000® Index, effective after market close on June 28, 2024. This marks a significant milestone for the clinical-stage biopharmaceutical company, which focuses on developing innovative oncology medicines, particularly for breast cancer. The inclusion reflects the progress of Atossa's (Z)-endoxifen development program. In 2024, the company presented promising monotherapy data at the AACR Annual Meeting and initiated a Phase 2 study combining (Z)-endoxifen with Eli Lilly's abemaciclib. With $10.5 trillion in assets benchmarked against Russell US indexes, this inclusion is expected to increase Atossa's visibility and expand its shareholder base.

Atossa Therapeutics (Nasdaq: ATOS) will present at the Sidoti Small-Cap Investor Conference on June 12-13, 2024. Dr. Steven Quay, CEO, will deliver the presentation on June 13 at 9:15 am ET. Atossa, a clinical-stage biopharma company, focuses on developing innovative oncology treatments, particularly for breast cancer. Interested parties can register to view the live webcast through the event's website. A recording will be available afterward on Atossa's investor relations page.

Atossa Therapeutics has announced its support for a Phase 2 study aiming to validate an AI-driven breast cancer risk assessment model. The Stockholm Mammography Risk stratified Trial (SMART) will enroll 70,000 women post-mammogram to assess their risk of developing breast cancer over the next two years. The Profound AI Model will analyze mammogram data and other personal risk factors to identify high-risk individuals. Those at highest risk will undergo a contrast-enhanced mammogram (CEM). The study aims to determine the predictive power of the AI model, potentially paving the way for a Phase 3 trial focusing on (Z)-endoxifen for breast cancer prevention.