Atossa Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update

Core Insights - Atossa Therapeutics announced positive topline results from the KARISMA-Endoxifen Phase 2 study, showing that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), a key risk factor for breast cancer [1][2] - The company reported a preliminary analysis from the I-SPY 2 Endocrine Optimization Pilot trial, indicating that 95% of patients completed over 75% of the planned treatment, with significant reductions in breast cancer biomarkers [2][3] - Atossa initiated a clinical trial in collaboration with Quantum Leap Healthcare Collaborative to evaluate (Z)-endoxifen in combination with abemaciclib for high-risk women with ER+/HER2- breast cancer [1][2] - The company received a new patent for (Z)-endoxifen compositions, enhancing its intellectual property portfolio [1][2] Financial Performance - For Q3 2024, Atossa reported total operating expenses of $6.4 million, a decrease from $7.5 million in Q3 2023 [4][15] - Research and Development (R&D) expenses for Q3 2024 were $3.4 million, down from $4.5 million in Q3 2023, primarily due to reduced spending on (Z)-endoxifen trials [5][14] - General and Administrative (G&A) expenses for Q3 2024 were $3.0 million, slightly decreased from $3.0 million in Q3 2023, with notable reductions in compensation expenses [6][15] - The company ended Q3 2024 with $74.8 million in cash and cash equivalents, maintaining a debt-free status [1][2] Research and Development Updates - The KARISMA-Endoxifen Phase 2 study showed a 19.3% reduction in MBD for the 1 mg treatment group and a 26.5% reduction for the 2 mg group compared to placebo over six months [2] - The I-SPY 2 EOP trial demonstrated a 69% reduction in Ki-67 and a 30.4% reduction in functional tumor volume after three weeks of treatment [2] - Atossa's (Z)-endoxifen is currently being studied in five Phase 2 trials, targeting various breast cancer patient populations [10] Management Changes - Atossa appointed Michael Parks as Vice President of Investor and Public Relations, bringing nearly 30 years of experience in the field [2] - Claudia Lopez, DVM, MSc, was appointed as Vice President of Clinical Product Development, contributing over 20 years of clinical development experience [2]