Atossa Therapeutics Inc Stock Price, News & Analysis

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.

Atossa Therapeutics announced the completion of patient dosing in its Phase 2 Karisma-Endoxifen clinical trial. This study, which enrolled 240 premenopausal women with mammographic breast density (MBD), aims to reduce MBD, a risk factor for breast cancer. The trial, fully enrolled in November 2023, tested daily doses of 1 mg and 2 mg (Z)-endoxifen versus placebo over six months. Results will be important for potential Phase 3 trials. MBD reduction is linked to a 50%-63% decrease in breast cancer risk over 3-15 years. Atossa is focusing on breast cancer treatments, with five ongoing Phase 2 studies.

Atossa Therapeutics announced its first-quarter 2024 financial results, showcasing positive data from the EVANGELINE study with a 100% disease control rate. They also initiated a study combining (Z)-endoxifen with abemaciclib, ended Q1 2024 with $84.0 million in cash, and appointed Dr. Tessa Cigler to the Board of Directors. The company is focused on developing innovative oncology medicines, particularly for breast cancer. Despite having no revenue, the operating expenses were $7.0 million, with a decrease from the previous year. R&D expenses increased slightly, primarily due to higher spending on clinical trials for (Z)-endoxifen. G&A expenses decreased, with a lower compensation cost driven by reduced non-cash stock-based compensation. Interest income also saw a slight increase due to a better rate of return.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) supports new breast cancer screening guidelines recommended by the U.S. Preventive Services Task Force (USPSTF), advising women to start biennial mammography screening at age 40. These guidelines aim to address rising breast cancer rates in younger women and racial disparities in diagnosis and mortality. The company is currently evaluating (Z)-endoxifen in Phase 2 trials to reduce breast density, a significant risk factor for breast cancer development.