Actinium Pharmaceuticals(ATNM) - 2024 Q3 - Quarterly Report

Product Development and Clinical Trials - Actinium Pharmaceuticals has developed Iomab-B and Actimab-A to improve outcomes for patients with relapsed or refractory acute myeloid leukemia (r/r AML) [66] - In the Phase 3 SIERRA trial, 22% of patients (13/76) on the Iomab-B arm achieved durable Complete Remission (dCR) compared to 0% (0/77) on the control arm, with a p-value of <0.0001 [73] - Actinium is actively seeking a strategic partner for Iomab-B to advance a required head-to-head clinical trial as mandated by the FDA [76] - Actimab-A has been studied in over 150 patients across six clinical trials, demonstrating its potential as a backbone therapy in AML [77] - The NCI's myeloMATCH program aims to enroll over 5,000 patients in clinical trials for AML and myelodysplastic syndrome (MDS), with Actimab-A included in future studies [79] - Actinium has entered into a Cooperative Research and Development Agreement (CRADA) with the NCI to accelerate the development of Actimab-A [78] - The FDA has aligned with Actinium on a seamless randomized Phase 2/3 clinical trial design for Actimab-A in combination with CLAG-M for r/r AML [80] - Iomab-ACT is being studied for conditioning prior to CAR-T therapy, with no patients (0/4) developing ICANS, a major safety measure, compared to a 25% incidence in typical CAR-T treatments [85] - The FDA cleared an IND for a new clinical trial studying Iomab-ACT as targeted conditioning prior to commercial CAR-T therapy, with patient enrollment expected to commence in Q1 2025 [86] Financial Performance - Total operating expenses for Q3 2024 were $12.6 million, a decrease of 12.2$14.4 million in Q3 2023 [107] - Research and development expenses for Q3 2024 were $9.8 million, down from$11.6 million in Q3 2023, primarily due to a decline in CMC expenses [111] - The net loss for Q3 2024 was $11.6 million, a decrease of 12.8$13.3 million in Q3 2023 [114] - For the nine months ended September 30, 2024, total operating expenses were $34.6 million, down from$41.6 million in the same period of 2023 [115] - The company recorded no commercial revenue for both the three and nine months ended September 30, 2024 and 2023 [108][116] - Cash used in operating activities for the nine months ended September 30, 2024 was $27.3 million, a decrease of$13.5 million from $39.8 million in the prior-year period [120] - The company sold 3.5 million shares of common stock for gross proceeds of$29.9 million in the nine months ended September 30, 2024 [122] - Long-term license revenue deferred was $35 million as of September 30, 2024, resulting from the receipt from Immedica [110] Market and Industry Insights - The addressable patient population for CAR-T and gene therapies is projected to nearly double to approximately 93,000 patients in the U.S. by 2030, with CAR-T market revenue expected to grow at a CAGR of approximately 11$650 and $1,000 per mCi, which is 10 to 20 times less expensive than currently available Ac-225 material [96] - Inflation has increased labor and clinical trial costs, but it did not have a material effect on the company's financial condition during the nine months ended September 30, 2024, and 2023 [129] Regulatory and Accounting Updates - FASB issued ASU 2023-07, effective January 1, 2024, requiring enhanced disclosures on segment expenses and performance measures [126] - ASU 2021-08, effective January 1, 2023, provides guidance on accounting for contract assets and liabilities in business combinations [127] Risk Management - As of September 30, 2024, the company’s cash equivalents primarily consist of short-term money market funds, with no significant exposure to interest rate risk [128] - An immediate 10% change in interest rates would not materially affect the fair market value of the company's financial position or results of operations [128] - The company is not currently exposed to significant market risk related to foreign currency exchange rates, although future fluctuations may occur [129]