Atossa Therapeutics(US:ATOS)2024-11-12 13:35Drug Development and Clinical Trials - The company is developing oral (Z)-endoxifen for the prevention and treatment of breast cancer, with patent protection extending through at least November 17, 2038[79]. - A Phase 2 study of oral (Z)-endoxifen for women with mammographic breast density (MBD) fully enrolled 240 participants in November 2023, showing reductions of 19.3% and 26.5% in breast density for 1 mg and 2 mg doses, respectively, compared to placebo[80]. - The study on (Z)-endoxifen for MBD demonstrated that it was generally well tolerated, with only 4, 5, and 11 women discontinuing due to side effects in the placebo, 1 mg, and 2 mg arms, respectively[80]. - The company plans to conduct additional studies to assess the correlation between (Z)-endoxifen and the risk of breast cancer, as reduction in MBD may not be an approvable indication without demonstrating a decrease in breast cancer incidence[80]. - The company has completed four Phase 1 and two Phase 2 clinical studies of (Z)-endoxifen, including studies in men and various formulations[80]. - The Phase 2 RECAST study for (Z)-endoxifen is ongoing, with approximately 100 patients being treated to evaluate suitability for long-term active surveillance[1]. - The EVANGELINE study is expected to enroll approximately 180 patients, with the Treatment Cohort initiation anticipated in Q4 2024[1]. - A preliminary analysis from the I-SPY 2 trial showed that 95% of patients received over 75% of planned treatment, with a 69% reduction in Ki-67 after three weeks of (Z)-endoxifen treatment[1]. Financial Performance - Total operating expenses decreased to $6.4 million for the three months ended September 30, 2024, down from $7.5 million in the same period of 2023, representing a decrease of approximately 14.7%[85]. - Research and Development (R&D) expenses totaled $3.4 million for the three months ended September 30, 2024, a decrease of $1.1 million or 24% compared to $4.5 million in the same period of 2023[86]. - Clinical and non-clinical trial expenses decreased by $0.9 million for the three months ended September 30, 2024, primarily due to reduced spending on (Z)-endoxifen trials[87]. - General and Administrative (G&A) expenses totaled $2.973 million for the three months ended September 30, 2024, a slight decrease of 1% from $3.001 million in the same period of 2023[90]. - G&A professional fees increased by $0.3 million for the three months ended September 30, 2024, primarily due to higher legal fees related to patent activity[91]. - The company has no revenue sources and does not anticipate generating revenue until pharmaceutical programs are developed and launched[82]. - For the nine months ended September 30, 2024, the net loss was $19.2 million, with cash used in operating activities amounting to $14.0 million, a decrease of $1.4 million from the same period in 2023[94]. - As of September 30, 2024, the company had $74.8 million in cash and cash equivalents, indicating sufficient funds to cover projected operating requirements for at least the next 12 months[94]. - The estimated non-cancellable commitment for clinical trials as of September 30, 2024, was $10.5 million[96]. - The company recorded an impairment charge on investment in equity securities of $1.7 million for the nine months ended September 30, 2024, compared to $3.0 million for the same period in 2023[93]. - Net cash used in investing activities was $19 thousand for the nine months ended September 30, 2024, primarily related to purchases of computers[94]. - The company expects to incur ongoing operating losses as it continues to develop its therapeutic programs, with future funding requirements dependent on various factors including clinical trial costs[95]. - The company may need to raise additional funds even before they are required if market conditions are favorable[95]. Operational and Strategic Focus - The company aims to advance its programs through clinical studies and opportunistically add programs in areas of high unmet medical need through acquisitions or collaborations[79]. - The company is focused on addressing significant unmet medical needs in oncology, particularly in women's breast cancer and related conditions[79]. - The company is developing clinical manufacturing capabilities through qualified third parties to support its drug development[80]. - The company is subject to various risks, including regulatory approvals and the ability to attract and retain key personnel, which could impact its future performance[77]. - The company has not engaged in off-balance sheet arrangements or trading activities involving non-exchange traded contracts[98]. - The company entered into a new operating lease for office space at $1,000 per month starting June 1, 2024, after terminating a previous lease[82]. - No shares were repurchased under the Share Repurchase Program during the three and nine months ended September 30, 2024, despite the program authorizing up to $10.0 million[97].