Clinical Trials and Efficacy - Annamycin has shown no evidence of cardiotoxicity in 62 subjects treated across four clinical trials, with 50 of 66 subjects treated above the FDA's lifetime maximum anthracycline limit of 550 mg/m2[81]. - The Phase 1B portion of the clinical trial using Annamycin in combination with Cytarabine for AML has reported a total of 33% complete responses (CRs) among treated subjects[87]. - The combination trial for AML (MB-106) has shown a 68% improvement in activity with Annamycin combined with Cytarabine compared to Annamycin alone[78]. - The company has completed recruitment and treatment in one Phase 1B/2 trial and is actively monitoring progression-free survival and overall survival[76]. - The median age of subjects in the Phase 1B portion of the AML trial was 66 years, with a median of five prior therapies for the first cohort[85]. - Annamycin is being developed for the treatment of soft tissue sarcoma lung metastases and in combination with Cytarabine for acute myeloid leukemia[73]. - In the Phase 2 trial of Annamycin, 3 subjects were treated, with a complete response (CR) rate of 38% (n=8) across both phases[90]. - The median age of subjects in the Phase 2 trial is 69 years, with a median of 3 prior therapies[89]. - The median progression-free survival (PFS) for the MB-107 trial is 2.2 months, with a notable improvement to 3.4 months for subjects receiving lower doses of Annamycin (≤330 mg/m2)[101]. - The overall survival (OS) for subjects in the Phase 1B portion of the MB-107 trial is currently at 11 months[101]. - The company plans to complete recruitment for the Phase 2 trial by early 2024, potentially treating up to 21 subjects[89]. - A total of 32 subjects were treated in the MB-107 trial, with 27 receiving at least two cycles of treatment[96]. - The company presented preliminary efficacy findings from the MB-107 trial at the 2023 CTOS Annual Meeting in Dublin, Ireland[102]. Financial Performance - Research and development (R&D) expenses decreased to $3.3 million in Q3 2023 from $6.0 million in Q3 2022, a reduction of $2.7 million primarily due to timing of clinical trial costs[110]. - General and administrative expenses fell to $2.6 million in Q3 2023 from $3.1 million in Q3 2022, a decrease of $0.5 million attributed to lower regulatory and legal services[111]. - Net loss for Q3 2023 was $5.6 million compared to a net loss of $8.6 million in Q3 2022, reflecting an improvement in financial performance[109]. - Interest income increased by approximately $0.3 million in Q3 2023 due to rising interest rates, totaling $0.3 million compared to $0.03 million in Q3 2022[113]. - For the nine months ended September 30, 2023, R&D expenses were $12.9 million, down from $14.8 million in the same period of 2022, a decrease of $1.9 million[114]. - General and administrative expenses for the nine months ended September 30, 2023 were $7.8 million, down from $8.7 million in 2022, a decrease of $0.9 million[115]. - Net cash used in operating activities was $18.7 million for the nine months ended September 30, 2023, a decrease of $1.7 million from $20.4 million in the prior year[120]. - The company issued 225,568 shares of common stock at an average price of $0.94 per share, resulting in gross proceeds of $0.2 million during the nine months ended September 30, 2023[121]. - As of September 30, 2023, the company had $0.3 million in cash on hand in Australia, with no known limitations impacting liquidity[119]. - The company anticipates that existing cash and cash equivalents will fund planned operations into Q3 2024 without the need for additional equity issuance[122]. Future Plans and Developments - The company anticipates up to two externally funded Phase 1B/2 clinical trials for WP1066 in the treatment of GBM and other brain tumors in the first half of 2024[77]. - The company has established a Recommended Phase 2 Dose (RP2D) for WP1122 to enable future oncology and virology trials[74]. - The company has received approval for eleven clinical trials for four drug candidates, all in Phase 1 or 2 stages[75]. - The company expects to finalize agreements for externally funded trials for WP1066 in the second half of 2023[98]. - The company has submitted a final clinical study report for WP1122 in late October 2023, exploring further development avenues[100]. Licensing and Agreements - The termination of the WPD licensing agreement resulted in a payment of $700,000 in cash and $800,000 in common stock, along with acquiring rights to certain intellectual property[107].
Moleculin(MBRX) - 2023 Q3 - Quarterly Report