Actinium Pharmaceuticals
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May 27, 2025 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against ATNM
Prnewswire· 2025-04-28 09:45
Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Actinium Pharmaceuticals, Inc. regarding a class action lawsuit related to misleading statements and omissions concerning the company's Iomab-B BLA application to the FDA [1][2]. Group 1: Allegations - The complaint alleges that during the class period from October 31, 2022, to August 2, 2024, the defendants made materially false and misleading statements regarding the company's Phase 3 Sierra trial data [2]. - It is claimed that the data from the Sierra trial was unlikely to meet FDA guidelines for the acceptance and approval of the Iomab-B BLA [2]. - The additional analyses provided to the FDA, which suggested improved Overall Survival, were also unlikely to satisfy FDA requirements [2]. - As a result of these issues, the FDA was expected to refuse to review the Iomab-B BLA or find it unlikely to approve the application in its current form [2]. - The defendants' positive statements about the company's business and prospects were deemed materially misleading and lacked a reasonable basis [2]. Group 2: Next Steps for Shareholders - Shareholders who purchased shares of ATNM during the specified class period are encouraged to register for the class action by May 27, 2025 [3]. - Upon registration, shareholders will be enrolled in a portfolio monitoring system to receive updates on the case [3]. - There is no cost or obligation for shareholders to participate in this class action [3]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by deceit and illegal business practices [4]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [4].
Class Action Filed Against Actinium Pharmaceuticals, Inc. (ATNM) Seeking Recovery for Investors - Contact Levi & Korsinsky
Prnewswire· 2025-04-25 09:45
NEW YORK, April 25, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Actinium Pharmaceuticals, Inc. ("Actinium" or the "Company") (NYSE: ATNM) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Actinium investors who were adversely affected by alleged securities fraud between October 31, 2022 and August 2, 2024. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/actinium-lawsuit-s ...
Actinium Pharmaceuticals(ATNM) - 2024 Q4 - Annual Report
2025-03-31 21:00
☒ Annual Report Pursuant To Section 13 or 15(d) Of The Securities Exchange Act Of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (Exact name of registrant as specified in its charter) | Delaware | 74-2963609 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 100 Park Ave., 23 Floor For the fiscal year ended December 31, 2024 New York, NY 10017 or ☐ Transition Report Pursuant To Sec ...
ATNM INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Actinium Pharmaceuticals, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
GlobeNewswire News Room· 2025-03-30 20:00
Core Viewpoint - A class action lawsuit has been filed against Actinium Pharmaceuticals, Inc. for alleged violations of federal securities laws during the Class Period from March 31, 2022, to August 2, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Actinium and its officers made materially false and misleading statements regarding the likelihood of FDA approval for Actinium's Biologics License Application (BLA) for Iomab-B [3]. - Defendants allegedly emphasized positive data from the Phase 3 Sierra trial while downplaying the lack of statistically significant Overall Survival data, misleading investors about the trial's implications for FDA approval [3]. Group 2: Class Action Participation - Investors who purchased Actinium securities during the Class Period are encouraged to join the lawsuit, with a deadline of May 26, 2025, to request lead plaintiff status [4]. - Participation in any recovery does not require serving as lead plaintiff [4]. Group 3: Legal Representation - The law firm Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only collect fees if the lawsuit is successful [5]. - The firm has a history of recovering hundreds of millions of dollars for investors in securities fraud cases [6].
SHAREHOLDER ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Actinium
GlobeNewswire News Room· 2025-03-30 12:16
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Actinium Pharmaceuticals, Inc. due to allegations of violations of federal securities laws related to misleading statements and the approval process of the Iomab-B BLA [3][5]. Group 1: Legal Investigation and Claims - The law firm is encouraging investors who suffered losses exceeding $75,000 in Actinium between October 31, 2022, and August 2, 2024, to discuss their legal rights [1]. - A federal securities class action has been filed against Actinium, with a deadline of May 26, 2025, for investors to seek the role of lead plaintiff [3]. - The complaint alleges that Actinium and its executives made false or misleading statements regarding the likelihood of FDA approval for the Iomab-B BLA [5]. Group 2: Stock Performance and Market Reaction - Following the revelation of the need for an additional clinical trial to support the BLA filing, Actinium's stock price dropped significantly, plummeting $3.69, or nearly 60%, to close at $2.48 on August 5, 2024 [6][7]. - The decline in stock price occurred on unusually high trading volume, indicating a strong market reaction to the news [7]. Group 3: Class Action Participation - The lead plaintiff in a class action is defined as the investor with the largest financial interest who is typical of class members and oversees the litigation [8]. - Any member of the putative class can move the court to serve as lead plaintiff or choose to remain an absent class member without affecting their ability to share in any recovery [8]. Group 4: Additional Information and Contact - Faruqi & Faruqi encourages anyone with information regarding Actinium's conduct, including whistleblowers and former employees, to contact the firm [9].
INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in Actinium Pharmaceuticals, Inc. of Class Action Lawsuit and Upcoming Deadlines - ATNM
GlobeNewswire News Room· 2025-03-30 12:00
Core Points - A class action lawsuit has been filed against Actinium Pharmaceuticals, Inc. for alleged securities fraud and unlawful business practices [2][4] - Investors who purchased Actinium securities during the Class Period have until May 26, 2025, to apply as Lead Plaintiff [2] - Actinium's stock price experienced a significant decline of nearly 60% following a regulatory update regarding its Biologics License Application for Iomab-B [4] Company Overview - Actinium Pharmaceuticals, Inc. is involved in the development of therapies for patients with cancer, specifically focusing on acute myeloid leukemia [4] - The company faced a setback when the FDA deemed the Phase 3 SIERRA trial inadequate for supporting a BLA filing for Iomab-B [4] Legal Context - Pomerantz LLP, a law firm specializing in corporate and securities class litigation, is leading the class action against Actinium [5] - The firm has a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [5]
ATNM Investors Have Opportunity to Lead ROSEN, NATIONALLY REGARDED INVESTOR COUNSEL, Encourages Actinium Pharmaceuticals, Inc. Securities Fraud Lawsuit
Prnewswire· 2025-03-29 17:15
Core Viewpoint - A class action lawsuit has been filed against Actinium Pharmaceuticals, Inc. for alleged misleading statements regarding its Iomab-B Biologics License Application during the Class Period from October 31, 2022, to August 2, 2024 [1][5]. Group 1: Lawsuit Details - The lawsuit claims that Actinium made false and/or misleading statements about the likelihood of FDA approval for its Iomab-B BLA, particularly regarding data from the Sierra Trial [5]. - It is alleged that the additional analyses provided to the FDA were unlikely to meet the necessary guidelines for approval, leading to potential refusal or rejection of the BLA [5]. - The lawsuit asserts that the misleading statements caused investors to suffer damages when the true situation became known [5]. Group 2: Participation Information - Investors who purchased Actinium securities during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - To join the class action, interested parties can visit the provided link or contact the law firm directly for more information [3][6]. - A lead plaintiff must file a motion with the Court by May 26, 2025, to represent other class members in the litigation [1][3]. Group 3: Law Firm Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements and recognition in the field [4]. - The firm has recovered hundreds of millions of dollars for investors, with notable achievements in past years, including over $438 million secured in 2019 [4].
Actinium Pharmaceuticals(ATNM) - 2024 Q3 - Quarterly Report
2024-11-14 21:57
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]
Actinium Pharmaceuticals(ATNM) - 2024 Q2 - Quarterly Report
2024-08-05 21:15
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]
Actinium Pharmaceuticals(ATNM) - 2024 Q1 - Quarterly Report
2024-04-26 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-36374 ACTINIUM PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) | --- | --- | ...