Actinium Pharmaceuticals(ATNM) - 2024 Q2 - Quarterly Report

Product Development and Clinical Trials - Actinium Pharmaceuticals is developing Iomab-B and Actimab-A to improve outcomes for patients with relapsed or refractory acute myeloid leukemia (r/r AML) [74] - The Phase 3 SIERRA trial for Iomab-B enrolled 153 patients, achieving a durable Complete Remission (dCR) rate of 22% compared to 0% in the control arm, with a p-value of <0.0001 [82] - Actinium has received positive feedback from the FDA regarding the Chemistry, Manufacturing and Controls (CMC) package for Iomab-B, but requires an additional clinical study to demonstrate overall survival benefit [81] - Actimab-A has been studied in approximately 150 patients across six clinical trials, showing potential as a backbone therapy in AML due to its mutation-agnostic ability [86] - Actinium has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to accelerate the development of Actimab-A [87] - Actinium plans to seek a strategic partner for Iomab-B in the U.S. following further discussions with the FDA regarding the additional clinical trial [84] - Iomab-ACT is being studied for conditioning prior to CAR-T therapy, with a Phase 1 trial showing no patients developed ICANS, compared to a 25% incidence in typical cases [90] - The company has received FDA clearance for an IND to study Iomab-ACT as targeted conditioning prior to commercial CAR-T therapy, marking a significant advancement in clinical trials [91] Market Opportunities - The EUMENA market opportunity for Iomab-B is estimated at approximately 7,200 bone marrow transplants (BMTs) performed in AML patients, which is about twice the number of BMTs performed in the U.S. [84] - The CAR-T market is projected to grow at a CAGR of approximately 11% over the next five years, with total sales exceeding $3.5 billion in 2023 [93] - The addressable patient population for CAR-T and gene therapies is expected to nearly double to approximately 93,000 patients in the U.S. by 2030 [93] Financial Performance - The company reported a net loss of$11.353 million for the three months ended June 30, 2024, compared to a net loss of $15.181 million for the same period in 2023, indicating a reduction in losses [111] - Research and development expenses decreased to$8.825 million in Q2 2024 from $11.081 million in Q2 2023, reflecting a 20.3$12.418 million in Q2 2024 from $15.642 million in Q2 2023, a decline of 20.8$3.6 million, down from $4.6 million in the same period of 2023, a decrease of$1.0 million [119] - Net loss for the three months ended June 30, 2024, was $11.4 million, a decrease of$3.8 million from $15.2 million for the same period in 2023 [121] - Research and development expenses for the six months ended June 30, 2024, were$15.5 million, a decrease of $3.4 million from$18.9 million in the same period of 2023 [125] - General and administrative expenses for the six months ended June 30, 2024, were $6.6 million, down from$8.3 million in the same period of 2023, a decrease of $1.7 million [126] - Net loss for the six months ended June 30, 2024, was$20.0 million, a decrease of $6.2 million from$26.2 million for the same period in 2023 [128] - Cash used in operating activities for the six months ended June 30, 2024, was $15.3 million, a decrease of$13.4 million from $28.7 million in the prior-year period [132] - Cash provided by financing activities for the six months ended June 30, 2024, was$24.7 million, compared to $10.8 million for the same period in 2023 [132] - No commercial revenue was recorded for the three months ended June 30, 2024, and June 30, 2023 [113] Intellectual Property and Technology - Actinium's technology platform is supported by over 235 issued and pending patents worldwide, indicating a strong intellectual property position [72] - The patent portfolio includes over 235 issued patents and pending applications worldwide, providing a strong foundation for the company's intellectual property strategy [107] - The proprietary technology for producing Ac-225 is expected to reduce costs to between$650 and $1,000 per mCi, which is 10 to 20 times less expensive than current methods [100] Operational Outlook - As of the date of filing, the company expects existing resources to be sufficient to fund planned operations for more than 12 months [134] - As of June 30, 2024, the company's cash equivalents primarily consisted of short-term money market funds, indicating a low-risk profile [142] - The company is not currently exposed to significant market risk related to changes in interest rates, with an immediate 10% change in interest rates not materially affecting its financial position [142] - There is no significant exposure to foreign currency exchange rate fluctuations at present, although future operations may be subject to such risks [142] - Inflation has generally increased labor and clinical trial costs, but it did not have a material effect on the company's business or financial results during the six months ended June 30, 2024 and 2023 [143]