Atossa Therapeutics(US:ATOS)2025-11-12 13:45Drug Development - The company is developing (Z)-endoxifen for both the prevention and treatment of breast cancer, with a focus on metastatic breast cancer and mammographic breast density reduction [84][89]. - In a Phase 2 study, the 1 mg dose of (Z)-endoxifen reduced mammographic breast density (MBD) by 17.3% (p<0.01), while the 2 mg dose achieved a reduction of 23.5% (p<0.01), compared to a minimal change of 0.27% in the placebo group [96]. - The company has completed four Phase 1 clinical studies and two Phase 2 clinical studies for (Z)-endoxifen, demonstrating significant progress in clinical development [92]. - The FDA has provided positive feedback regarding the proposed global Phase 2 dose optimization trial for (Z)-endoxifen in patients with ER+/HER2- metastatic breast cancer, paving the way for a potential IND submission targeted for Q4 2025 [89]. - The company is pursuing a Type C meeting with the FDA to discuss an accelerated regulatory strategy for low-dose (Z)-endoxifen for breast cancer risk reduction, with a meeting scheduled for November 17, 2025 [87]. - The company has received authorization from the FDA for its IND application for oral (Z)-endoxifen, with a Phase 2 study assessing its use as neoadjuvant therapy in premenopausal women with primary ER+, HER2- breast cancer [101]. - Approximately 240 patients are expected to be treated in the ongoing Phase 2 DCIS study, which investigates (Z)-endoxifen as a neoadjuvant treatment for ductal carcinoma in situ [99]. - The company has patent protection for (Z)-endoxifen through at least November 17, 2038, ensuring intellectual property rights for its proprietary drug [85]. Financial Performance - Total operating expenses increased to $9.3 million for the three months and $25.7 million for the nine months ended September 30, 2025, compared to $6.4 million and $20.5 million for the same periods in 2024, representing increases of 45% and 25% respectively [114]. - Research and Development (R&D) expenses totaled $5.4 million for the three months and $15.0 million for the nine months ended September 30, 2025, up 57% and 40% from $3.4 million and $10.7 million in 2024 [115]. - Clinical and non-clinical trial expenses rose by $1.8 million and $3.3 million for the three and nine months ended September 30, 2025, primarily due to increased spending on (Z)-endoxifen trials [121]. - Interest income decreased to $0.6 million and $1.9 million for the three and nine months ended September 30, 2025, down from $1.0 million and $3.2 million in 2024, reflecting lower average balances in the money market account [117]. - Net cash used in operating activities was $19.2 million for the nine months ended September 30, 2025, compared to $14.0 million in 2024, indicating an increase of $5.2 million [123]. - As of September 30, 2025, the company had $51.8 million in cash and cash equivalents, with working capital of $47.5 million, sufficient to fund projected operating requirements for at least the next 12 months [123]. - The company reported a net loss of $23.8 million for the nine months ended September 30, 2025 [123]. Clinical Trials and Studies - The Phase 2 EVANGELINE study was amended to reduce the patient total from 214 to 40-65, focusing on objective, short-interval endpoints [104]. - In the ongoing I-SPY 2 EOP trial, 95% of participants completed at least 75% of planned dosing, with median Ki-67 falling from 10.5% at baseline to 5% by Week 3 [106]. Operational Strategy - The company aims to shorten clinical development timelines and reduce costs through an accelerated path to filing a New Drug Application (NDA) with the FDA [82]. - The company is exploring the potential of artificial intelligence (AI) in its product candidates, which may enhance development efficiency and outcomes [88]. - The company entered into an operating lease for additional office space at $3 thousand per month for 13 months starting November 1, 2025 [110]. - The company expects ongoing operating losses as it continues to develop therapeutic programs, impacting future funding requirements [126]. - An increase of $2.7 million in cash used for clinical and non-clinical trials, including drug development costs [128]. - Estimated non-cancellable commitments as of September 30, 2025, amount to $7.8 million, to be paid over the term of clinical trials [132]. Funding and Market Conditions - The company may face challenges in raising additional funding due to uncertain market conditions, including inflation and high interest rates [127]. - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share [131]. - A decrease of $1.3 million in cash provided by interest income due to lower amounts invested in the money market account [128]. - The company may need to modify or delay development programs if adequate funds are not available [127]. - The company has no off-balance sheet arrangements or relationships with unconsolidated entities [133]. - The company may elect to raise additional funds even before they are needed if capital raising conditions are favorable [130]. - The company is subject to potential adverse effects on stockholder rights if additional funds are raised through equity offerings [127].