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Atossa Therapeutics(ATOS) - 2025 Q1 - Quarterly Report
ATOSAtossa Therapeutics(ATOS)2025-05-13 12:15

Drug Development - The company is developing (Z)-endoxifen for breast cancer treatment, with a focus on metastatic breast cancer, aiming for a streamlined regulatory pathway[85] - The FDA has authorized the Investigational New Drug (IND) application for (Z)-endoxifen, with a Phase 2 study enrolling approximately 190 patients planned[98] - The ongoing Phase 2 DCIS study aims to evaluate (Z)-endoxifen's suitability for long-term active surveillance in women with ductal carcinoma in situ, with approximately 100 patients expected to be treated[96] - The treatment cohort for the neoadjuvant study of (Z)-endoxifen was initiated in April 2025, comparing it to exemestane plus OFS[100] - The company plans to conduct additional studies to assess (Z)-endoxifen's correlation with breast cancer risk reduction, as advised by the FDA[94] - (Z)-endoxifen achieved a primary endpoint with 95% of patients receiving over 75% of planned treatment, showing a 69% reduction in Ki-67 and a 30.4% reduction in functional tumor volume after three weeks[102] - The company has completed four Phase 1 and two Phase 2 clinical studies for (Z)-endoxifen, demonstrating its potential in treating breast cancer and reducing breast density[89] Financial Performance - Total operating expenses increased to 7.4millionforthethreemonthsendedMarch31,2025,upfrom7.4 million for the three months ended March 31, 2025, up from 7.0 million in the same period in 2024, reflecting a 0.4 million increase[110] - Research and Development (R&D) expenses totaled 4.2 million for the three months ended March 31, 2025, an 11% increase from 3.7 million in 2024[111] - Compensation expenses within R&D rose by 41% to 0.9 million, while professional fees increased by 123% to 0.5millionforthesameperiod[111]−Interestincomedecreasedto0.5 million for the same period[111] - Interest income decreased to 0.7 million for the three months ended March 31, 2025, down from 1.1millionin2024,duetoalowerbalanceinthemoneymarketaccount[112]−Netcashusedinoperatingactivitieswas1.1 million in 2024, due to a lower balance in the money market account[112] - Net cash used in operating activities was 5.96 million for the three months ended March 31, 2025, compared to 4.70millionin2024,reflectinga4.70 million in 2024, reflecting a 1.3 million increase[115] - As of March 31, 2025, the company had 65.1millionincashandcashequivalents,sufficienttofundprojectedoperatingrequirementsforatleastthenext12months[115]−Thecompanyhasanestimatednon−cancellablecommitmentof65.1 million in cash and cash equivalents, sufficient to fund projected operating requirements for at least the next 12 months[115] - The company has an estimated non-cancellable commitment of 9.4 million for clinical trial service providers as of March 31, 2025[122] - The company is not currently generating revenue and does not anticipate doing so until pharmaceutical programs are developed and launched[104] Intellectual Property - The company has been granted six U.S. and ten international patents for (Z)-endoxifen, with protection extending through at least November 17, 2038[83] Corporate Strategy - The company aims to opportunistically add programs in areas of high unmet medical need through acquisition or collaboration[84] - The company is focused on advancing its clinical studies and successfully commercializing new therapeutics[82] Compliance and Regulatory Issues - The company received a letter from Nasdaq regarding non-compliance with the minimum bid price requirement, with a deadline to regain compliance by August 20, 2025[121]