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 ...

- Sickle cell disease affects approximately 100,000 patients in the U.S. annually and is a debilitating and lifethreatening condition with high unmet need - Current conditioning with non-targeted chemotherapies provides limited access to potentially curative bone marrow transplant and recently approved gene therapies for sickle cell disease patients - Initial trial focused on conditioning for bone marrow transplant intended to inform subsequent gene therapy conditioning study and provide broader access to c ...

Presentation to highlight positive outcomes of Iomab-B led bone marrow transplant in difficult to treat TP53 patients and the mutation-agnostic mechanism of Actimab-A for patients with relapsed or refractory acute myeloid leukemiaIomab-B and Actimab-A represent the only clinical stage antibody radiation conjugates in development for patients with acute myeloid leukemiaNEW YORK, July 25, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the devel ...

Low-cap biotech companies are a high-risk but high-reward investment choice. If their clinical trials are successful, that can often mean an explosion in value as investors anticipate a buyout. However, if they fail, that may mean the end of the road for these companies. Here is a list of promising biotechs priced under $10 that could offer a huge return on investment in the coming months.Actinium Pharmaceuticals (ATNM)Source: ShutterstockActinium Pharmaceuticals (NYSEMKT:ATNM) is a biotech working on targe ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Actinium Pharmaceuticals (ATNM) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Actinium Pharmaceuticals is a member of our Medical group, which includes 1042 different companies and currently sits at #6 in the ...

PALM BEACH, Fla., June 17, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - According to a report from Mordor Intelligence the Acute Myeloid Leukemia Market size is estimated at USD 1.83 billion in 2024, and is expected to reach USD 2.97 billion by 2029, growing at a CAGR of 10.15% during the forecast period (2024-2029). The report said: "Key factors propelling the growth of this market are the high incidence and prevalence of acute myeloid leukemia, advancements in pharmacology and molecular biolo ...

PALM BEACH, Fla., June 17, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal myeloid cells, which are immature blood cells that normally develop into red blood cells, white blood cells, and platelets. In AML, these abnormal cells accumulate in the bone marrow and interfere with the production of normal blood cells. According to Global Market Insights the Acute ...

Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - June 17, 2024) - Investorideas.com, a go-to investing platform, releases the first of a two-part series looking at developments for the treatment of blood cancers. Today's snapshot focuses in on acute myeloid leukemia (AML) and the companies developing innovative solutions, featuring Actinium Pharmaceuticals, Inc. (NYSE American: ATNM). Actinium is a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiot ...