Company Overview - Actinium Pharmaceuticals, Inc. is a pioneer in the development of targeted radiotherapies aimed at improving patient outcomes [3] - The company is advancing its lead product candidate, Actimab-A, which targets CD33 and is being developed as a potential backbone therapy for acute myeloid leukemia (AML) and other myeloid malignancies [3] - Actinium holds 230 patents and patent applications, including several related to the manufacture of the isotope Ac-225 in a cyclotron [3] Product Development - Actimab-A has shown potential activity in relapsed and refractory AML patients when combined with the chemotherapy CLAG-M, achieving high rates of Complete Remissions (CR) and improved survival outcomes [3] - The company is advancing Actimab-A to a Phase 2/3 trial and is collaborating with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) [3] - The first clinical trial under the CRADA will evaluate a triplet combination of Actimab-A, Venetoclax, and ASTX-727 in frontline AML patients [3] Future Initiatives - Iomab-ACT, a next-generation conditioning candidate, is being developed to enhance patient access and outcomes for cell and gene therapies [3] - Iomab-B is an induction and conditioning agent for bone marrow transplant in patients with relapsed/refractory AML, for which Actinium is seeking a strategic partner in the U.S. [3] - The company's R&D efforts are also focused on advancing several preclinical programs for solid tumor indications [3] Conference Participation - Actinium will participate in the 37th Annual Roth Conference from March 16th to 18th, 2025, with management available for one-on-one meetings on March 17th and 18th [1][2]

Core Viewpoint - Actinium Pharmaceuticals has initiated the first clinical trial for Actimab-A under a Cooperative Research and Development Agreement with the National Cancer Institute, focusing on a triplet combination therapy for acute myeloid leukemia (AML) patients [1][2][3] Group 1: Clinical Trial Details - The trial (NCT06802523) will evaluate the combination of Actimab-A, Venetoclax, and ASTX-727 in frontline AML patients, aiming to assess the rate and duration of Complete Remission (CR) and safety [1][2] - Actimab-A is a humanized anti-CD33 antibody conjugated to Actinium-225, targeting CD33, which is expressed on myeloid blasts in AML patients [1][4] - The triplet regimen is designed for outpatient administration, as both Venetoclax and ASTX-727 are oral agents, and Actimab-A does not require patient isolation [2][3] Group 2: Mechanism and Efficacy - Actimab-A's mechanism is mutation agnostic, potentially improving outcomes for patients with high-risk features, such as TP53 mutations, where current therapies have limited success [2][3] - Previous studies indicated that Actimab-A in combination with Venetoclax was well tolerated, with manageable adverse events, and preclinical studies suggested a synergistic effect by depleting MCL-1, which mediates resistance to Venetoclax [2][5] Group 3: Strategic Vision and Market Potential - The company aims to establish Actimab-A as a backbone therapy for AML and other myeloid malignancies, leveraging the broad expression of CD33 and the mutation agnostic nature of Ac-225 [3][4] - Actinium anticipates generating preclinical data and initiating additional clinical trials throughout 2025 to further differentiate Actimab-A and demonstrate its potential as a first-in-class radiotherapy for over 100,000 AML patients in the U.S. and other major markets [3][4]

Core Insights - Actinium Pharmaceuticals is advancing its clinical programs for Actimab-A, Iomab-ACT, and Iomab-B, with significant regulatory updates and financial results reported for Q3 2024 [1][2][6] Regulatory and Development Updates - Actinium has aligned with the FDA on a seamless Phase 2/3 trial for Actimab-A combined with CLAG-M for relapsed/refractory acute myeloid leukemia (r/r AML) [1][3] - Actimab-A has been selected for the National Cancer Institute's myeloMATCH precision medicine program targeting AML and myelodysplastic syndromes [1][4] - The FDA has cleared two IND applications for Iomab-ACT, including a commercial CAR-T trial and a sickle cell transplant trial, with proof-of-concept data expected in 2025 [1][4] - Actinium is seeking a U.S. strategic partner for Iomab-B to conduct a Phase 3 trial based on FDA guidance [1][5] Financial Performance - As of September 30, 2024, Actinium reported cash and cash equivalents of approximately $78.6 million, expected to fund operations into 2027 [1][6] - Research and development expenses decreased to $9.8 million in Q3 2024 from $11.6 million in Q3 2023, primarily due to lower CMC expenses [7] - General and administrative expenses increased slightly to $2.8 million in Q3 2024, attributed to higher non-cash stock compensation [8] - The net loss for Q3 2024 was $11.6 million, a decrease from $13.3 million in Q3 2023, due to lower R&D expenses [11]

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% from $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% from $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% over the next five years [89] - Actinium has delivered over 500 doses for 18 clinical trials at 45 large cancer hospitals without missing a dose, showcasing its manufacturing and supply chain expertise [99] Intellectual Property and Technology - Actinium's technology platform is supported by over 230 issued and pending patents worldwide [64] - The patent portfolio includes over 230 issued patents and pending applications worldwide, with effective lives ranging from expirations between 2025 and 2045 [103] - Iomab-B has four issued patents in the U.S. and additional patents in Canada, Europe, and Japan, with basic patent terms expiring in 2036 and 2037 [104] - The company has treated approximately 150 patients with alpha-emitter-based therapies and holds five issued patents in the U.S. and 41 internationally related to the manufacturing of Ac-225 [105] Cost and Economic Factors - The estimated cost of goods sold for Ac-225 production is between $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]

Core Viewpoint - Actinium Pharmaceuticals (ATNM) has received a Zacks Rank 1 (Strong Buy) upgrade, indicating a positive outlook on its earnings potential, which is expected to drive buying pressure and increase its stock price [1][2]. Earnings Outlook - The Zacks Consensus Estimate for Actinium indicates an expected loss of -$1.38 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 24.6% [5]. - Over the past three months, the Zacks Consensus Estimate for Actinium has increased by 12%, showcasing a positive trend in earnings estimates [5]. Impact of Earnings Estimates - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [3]. - Institutional investors utilize earnings estimates to assess the fair value of a company's shares, leading to significant buying or selling activity that influences stock prices [3]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [4]. - The upgrade of Actinium to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [7].

Core Insights - Actinium Pharmaceuticals has developed Iomab-B, the first CD45 targeted radiotherapy aimed at enabling potentially curative bone marrow transplants, representing an alternative to traditional chemotherapy approaches [1][6] - The Phase 3 SIERRA trial demonstrated significant efficacy, achieving durable Complete Remission and Event-Free Survival with high statistical significance [1][3] - Actinium plans to seek a strategic partner for further development of Iomab-B in the U.S. after completing FDA interactions for an additional clinical trial [1][6] Study Details - The SIERRA trial was a randomized, multicenter, controlled study involving 153 patients aged 55 and above with active relapsed or refractory Acute Myeloid Leukemia [2] - Patients receiving Iomab-B showed a 22% rate of durable Complete Remission compared to 0% in the control group, with a p-value of <0.0001 [3] - The trial also achieved a significant improvement in Event-Free Survival with a Hazard Ratio of 0.22 and a p-value of <0.0001 [3] Future Development - Despite positive results, the SIERRA trial did not meet the overall survival endpoint due to a high crossover rate, with nearly 60% of control patients receiving Iomab-B [3][5] - Actinium is focused on finalizing the specifics of an additional Phase 3 randomized trial to demonstrate overall survival benefits as required by the FDA for a Biologics License Application [6] - The company aims to accelerate the availability of Iomab-B for patients with high unmet needs in the context of bone marrow transplants [6][7]

Core Viewpoint - Actinium Pharmaceuticals, Inc. is under investigation for potential claims following a significant stock drop after the FDA's decision regarding its Biologics License Application for Iomab-B [2][3]. Investigation Details - On August 5, 2024, Actinium announced that the FDA deemed the Phase 3 SIERRA trial insufficient to support a BLA filing for Iomab-B, despite achieving a statistically significant primary endpoint [2]. - Following this announcement, Actinium's stock plummeted nearly 60% on the same day [2]. Next Steps - Investors who have information related to the investigation or who purchased Actinium securities are encouraged to assist by visiting the firm's website or contacting the firm's representatives [3]. Legal Representation - Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if successful in the case [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a recognized firm specializing in representing investors in securities fraud class actions and has recovered hundreds of millions of dollars for investors across the nation [5].

Core Viewpoint - The Schall Law Firm is investigating Actinium Pharmaceuticals, Inc. for potential violations of securities laws related to misleading statements and failure to disclose important information to investors [1] Group 1: Company Overview - Actinium Pharmaceuticals, Inc. is focused on developing treatments for acute myeloid leukemia, specifically through its product Iomab-B [1] - The company announced a regulatory update regarding its Biologics License Application (BLA) filing for Iomab-B on August 5, 2024 [1] Group 2: Regulatory and Market Impact - The FDA has determined that the Phase 3 SIERRA trial is insufficient to support a BLA filing for Iomab-B, despite the trial meeting its statistically significant primary endpoint [1] - Following this announcement, Actinium's shares experienced a significant decline, falling by almost 60% on the same day [1]

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% reduction [111] - Total operating expenses decreased to $12.418 million in Q2 2024 from $15.642 million in Q2 2023, a decline of 20.8% [111] - General and administrative expenses for the three months ended June 30, 2024, were $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]

FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B despite its statistically significant primary endpointAdditional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by FDA to support a BLA filingActinium to request a meeting with the FDA to further discuss specifics of additional trialActinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development ef ...