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Actinium Pharmaceuticals(ATNM) - 2025 Q2 - Quarterly Report
2025-08-08 21:00
[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show a decrease in cash and cash equivalents to **$59.9 million** from **$72.9 million** at year-end 2024, with no revenue and a net loss of **$22.8 million** for the first six months of 2025, primarily due to an **$8.8 million** non-cash stock-based compensation expense [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to **$63.0 million** from **$76.9 million** at December 31, 2024, mainly due to reduced cash, while total stockholders' equity significantly decreased to **$19.0 million** from **$32.8 million** Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,928 | $72,904 | | Total Current Assets | $61,029 | $74,506 | | **Total Assets** | **$63,017** | **$76,899** | | **Liabilities and Stockholders' Equity** | | | | Total Current Liabilities | $8,314 | $8,148 | | Long-term license revenue deferred | $35,000 | $35,000 | | **Total Liabilities** | **$44,004** | **$44,141** | | **Total Stockholders' Equity** | **$19,013** | **$32,758** | | **Total Liabilities and Stockholders' Equity** | **$63,017** | **$76,899** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no revenue for the periods, with a net loss of **$6.9 million** for Q2 2025 and an increased net loss of **$22.8 million** for the six months ended June 30, 2025, primarily due to higher general and administrative expenses including a significant stock-based compensation charge Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Total revenue | $ - | $ - | $ - | $ - | | Research and development, net | $4,879 | $8,825 | $12,579 | $15,460 | | General and administrative | $2,624 | $3,593 | $11,562 | $6,555 | | Loss from operations | $(7,503) | $(12,418) | $(24,141) | $(22,015) | | **Net loss** | **$(6,878)** | **$(11,353)** | **$(22,816)** | **$(20,023)** | | Net loss per common share | $(0.22) | $(0.38) | $(0.73) | $(0.69) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for the first six months of 2025 was **$13.0 million**, with no investing or financing activities, resulting in a net decrease in cash of **$13.0 million** compared to a net increase in the prior year due to stock sales Cash Flow Summary for Six Months Ended June 30 (in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,966) | $(15,346) | | Net cash used in investing activities | $ - | $(11) | | Net cash used in/provided by financing activities | $(5) | $24,722 | | **Net change in cash, cash equivalents, and restricted cash** | **$(12,971)** | **$9,365** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a developer of targeted radiotherapies, disclose commitments including a potential **$1 million** milestone payment and ongoing securities litigation, and highlight an **$8.8 million** stock compensation expense from option cancellations - The company is a clinical-stage firm focused on developing targeted radiotherapies for advanced cancers, with a pipeline of clinical and preclinical candidates[24](index=24&type=chunk) - A milestone payment of **$1 million** is due to Fred Hutchinson Cancer Research Center (FHCRC) upon FDA approval of the first drug using the licensed apamistamab antibody[52](index=52&type=chunk) - The company is facing a putative class action securities complaint and derivative shareholder complaints related to disclosures about the Iomab-B Phase 3 SIERRA Trial[53](index=53&type=chunk)[54](index=54&type=chunk) - In March 2025, the company cancelled 4.9 million stock options, resulting in an **$8.8 million** stock option compensation expense for the six months ended June 30, 2025[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a strategic pipeline prioritization towards solid tumor programs, notably ATNM-400 for prostate cancer, while seeking partners for its hematology assets, and reports sufficient cash to fund operations for more than 12 months despite an increased six-month net loss due to a one-time **$8.8 million** stock compensation charge [Business Overview and Strategy](index=20&type=section&id=Business%20Overview%20and%20Strategy) Actinium is a clinical-stage company developing targeted radiotherapies for advanced cancers, strategically prioritizing resources towards solid tumor pipeline candidates like ATNM-400 for prostate cancer, and actively seeking strategic partners for its hematology programs - The company is prioritizing development and resources for its targeted radiotherapy solid tumor pipeline, including the ATNM-400 program for prostate cancer[77](index=77&type=chunk) - Actinium is actively seeking strategic partners for its hematology programs, including Iomab-B, Actimab-A, and Iomab-ACT, potentially through partnerships, divestitures, or out-licensing[77](index=77&type=chunk) [Targeted Radiotherapy Candidate Pipeline](index=20&type=section&id=Targeted%20Radiotherapy%20Candidate%20Pipeline) The pipeline is led by Actimab-A, ATNM-400, and Iomab-ACT, with recent positive preclinical data for ATNM-400, an FDA agreement on a new Phase 2/3 trial protocol for Iomab-B, and ongoing clinical trials for Iomab-ACT - Presented preclinical data for ATNM-400, a novel non-PSMA Ac-225 radiotherapy for prostate cancer, showing it was more efficacious than the active agent in Pluvicto and can overcome resistance[78](index=78&type=chunk)[81](index=81&type=chunk) - The FDA provided definitive feedback that the SIERRA trial alone is not adequate to support a BLA filing for Iomab-B and that an additional trial demonstrating an overall survival benefit is necessary[131](index=131&type=chunk) - The company has reached an agreement with the FDA on a new Phase 2/3 clinical trial protocol for Iomab-B and is authorized to initiate the Phase 2 portion, while actively seeking a strategic partner to execute the trial[132](index=132&type=chunk) - The first patient was enrolled in the Iomab-ACT investigator-sponsored trial with a commercial CAR-T therapy at the University of Texas Southwestern Medical Center[81](index=81&type=chunk)[84](index=84&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) For the three months ended June 30, 2025, the net loss decreased to **$6.9 million** from **$11.4 million** in Q2 2024, while the six-month net loss increased to **$22.8 million** from **$20.0 million** in the prior-year period, primarily due to a **$9.1 million** non-cash stock-based compensation expense Comparison of Operations for the Three Months Ended June 30 (in thousands) | | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $4,879 | $8,825 | $(3,946) | | General and administrative | $2,624 | $3,593 | $(969) | | **Net loss** | **$(6,878)** | **$(11,353)** | **$4,475** | Comparison of Operations for the Six Months Ended June 30 (in thousands) | | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $12,579 | $15,460 | $(2,881) | | General and administrative | $11,562 | $6,555 | $5,007 | | **Net loss** | **$(22,816)** | **$(20,023)** | **$(2,793)** | - The cancellation of stock options in March 2025 resulted in a significant increase in non-cash stock-based compensation expense to **$9.1 million** for the six months ended June 30, 2025, compared to **$2.8 million** in the prior-year period[170](index=170&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) Net cash used in operating activities for the first six months of 2025 was **$13.0 million**, with no common stock sales during this period, and management expects existing resources to fund planned operations for more than 12 months Selected Cash Flow Information for the Six Months Ended June 30 (in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Cash used in operating activities | $(12,966) | $(15,346) | | Cash used in/provided by financing activities | $(5) | $24,722 | | **Net change in cash, cash equivalents and restricted cash** | **$(12,971)** | **$9,365** | - The company did not sell any shares of common stock during the six months ended June 30, 2025. In the same period of 2024, it sold 2.9 million shares for net proceeds of **$24.7 million**[67](index=67&type=chunk)[177](index=177&type=chunk) - The company expects its existing resources will be sufficient to fund planned operations for more than 12 months from the date of this report[179](index=179&type=chunk)[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Actinium Pharmaceuticals, Inc. is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[185](index=185&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective[186](index=186&type=chunk) - No changes in internal controls over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[187](index=187&type=chunk) [PART II – OTHER INFORMATION](index=44&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is facing a putative class action securities complaint and two consolidated derivative shareholder complaints filed in March and May 2025, alleging material misrepresentations and omissions concerning the Iomab-B Phase 3 SIERRA trial, which the company intends to vigorously defend - A putative class action complaint was filed on March 27, 2025, alleging material misrepresentations and omissions concerning the Iomab-B Phase 3 SIERRA Trial[190](index=190&type=chunk) - Two derivative shareholder complaints were filed in May 2025, also alleging derivative liability for the allegations made in the securities complaint. These have been consolidated into a single Derivative Action[191](index=191&type=chunk) - The company intends to defend vigorously against these claims, but the outcome cannot be assured[192](index=192&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company identifies significant risks including its clinical-stage status with no commercial revenue and a history of net losses, dependency on pipeline success and additional financing, the FDA's requirement for an additional trial for Iomab-B, reliance on third-party manufacturers, intellectual property uncertainty, and key personnel dependence - The company is a clinical-stage entity with no revenue from commercial sales and a history of net losses, anticipating continued losses in the future[194](index=194&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk) - The FDA has determined the SIERRA trial alone is inadequate for a BLA filing for Iomab-B and requires an additional randomized trial to demonstrate an overall survival benefit, making the U.S. commercial opportunity highly uncertain[207](index=207&type=chunk) - The company depends on single third-party manufacturers for preclinical and clinical drug supplies, and any disruption could adversely affect business and results[195](index=195&type=chunk)[302](index=302&type=chunk) - The company's ability to utilize its net operating loss carryforwards of approximately **$398.6 million** may be limited by Section 382 ownership change rules[198](index=198&type=chunk)[362](index=362&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[369](index=369&type=chunk) [Defaults Upon Senior Securities](index=84&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[370](index=370&type=chunk) [Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[371](index=371&type=chunk) [Other Information](index=85&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[372](index=372&type=chunk) [Exhibits](index=86&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including certifications from the CEO and CFO as required by the Sarbanes-Oxley Act of 2002 and Inline XBRL documents - The report includes required certifications from the Chief Executive Officer and Principal Financial and Accounting Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[374](index=374&type=chunk)
Actinium Pharmaceuticals (ATNM) Conference Transcript
2025-06-12 16:00
Summary of Actinium Pharmaceuticals Conference Call Company Overview - **Company**: Actinium Pharmaceuticals - **Industry**: Biotechnology, specifically focused on targeted radiotherapy for cancer treatment - **Stock Symbol**: ATNM on NYSE American Key Points and Arguments 1. **Targeted Radiotherapy**: Actinium Pharmaceuticals specializes in linking radiation to targeting agents aimed at various cancer targets, utilizing both beta and alpha emitters for treatment across blood cancers and solid tumors [3][4] 2. **Pipeline Overview**: The company has a robust pipeline with over 230 patents, focusing on three key disease areas: hematology (blood cancers), solid tumors, and targeted conditioning for cell and gene therapy [5] 3. **Lead Program - Actemab A**: Actemab A is advancing towards a Phase 2/3 trial, targeting CD33 in blood cancers, particularly acute myeloid leukemia (AML). The drug has shown promising results in combination with chemotherapy [10][12] 4. **Clinical Trials**: Actemab A has been studied in approximately 150 patients across six clinical trials, demonstrating a high overall response rate of over 50% in high-risk patient groups [15][16] 5. **Market Opportunities**: The potential market for Actemab A exceeds 100,000 patients in the US and top five countries, with mutation-agnostic properties making it a versatile treatment option [19][20] 6. **Solid Tumor Expansion**: The company is exploring Actemab A's application in solid tumors, particularly in combination with PD-1 checkpoint inhibitors for head and neck and non-small cell lung cancer [21][24] 7. **New Program - ATNM-400**: A next-generation prostate cancer therapeutic candidate, ATNM-400, is being developed to address a large patient population, showing more potency than existing therapies like Pluvicto [7][25] 8. **Manufacturing Capabilities**: Actinium is focused on establishing in-house manufacturing capabilities for radioisotopes, particularly Actinium-225, to support future clinical trials [9][34] 9. **IMMab ACT Program**: This program targets CD45 for CAR T therapy and sickle cell disease, with promising preclinical data indicating low toxicity and effective outcomes in heavily pretreated patients [28][30] 10. **Financial Outlook**: The company has a cash runway extending into mid-2027, allowing for the advancement of multiple pipeline assets and potential partnerships [34][36] Additional Important Content - **Collaboration with NCI**: Actinium has entered a cooperative research and development agreement with the National Cancer Institute (NCI) to co-develop Actemab A, enhancing its clinical research capabilities [6][18] - **Survival Outcomes**: The trial results indicated a median overall survival of 18 months for patients treated with Actemab A, significantly higher than typical outcomes for similar patient groups [17] - **Regulatory Alignment**: The company has aligned with the FDA on the Phase 2/3 study design for Actemab A, indicating a structured approach to clinical development [18][36] - **Market Growth**: The CAR T therapy market has grown to over $4 billion in annual sales, with significant growth expected in the cell and gene therapy market [32] This summary encapsulates the critical insights from the conference call, highlighting Actinium Pharmaceuticals' strategic focus on targeted radiotherapy and its promising pipeline in the oncology space.
ATNM DEADLINE NOTICE: ROSEN, A HIGHLY RECOGNIZED LAW FIRM, Encourages Actinium Pharmaceuticals, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important May 27 Deadline in Securities Class Action – ATNM
GlobeNewswire News Room· 2025-05-25 22:07
Core Viewpoint - Rosen Law Firm is reminding investors who purchased Actinium Pharmaceuticals, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline on May 27, 2025 [1]. Group 1: Class Action Details - Investors who purchased Actinium securities between October 31, 2022, and August 2, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by contacting Rosen Law Firm [3][6]. - The lawsuit alleges that during the Class Period, Actinium made false or misleading statements regarding its Iomab-B Biologics License Application, which may not meet FDA guidelines [5]. Group 2: Legal Representation - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in this area [4]. - The firm has achieved significant settlements for investors, including over $438 million in 2019 alone, and has been recognized as a leader in securities class action settlements [4].
Class Action Filed Against Actinium Pharmaceuticals, Inc. (ATNM) - May 27, 2025 Deadline to Join - Contact Levi & Korsinsky
Prnewswire· 2025-05-23 09:45
Core Viewpoint - A class action securities lawsuit has been filed against Actinium Pharmaceuticals, alleging securities fraud that negatively impacted investors between October 31, 2022, and August 2, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that the defendants made false statements regarding the Phase 3 Sierra trial data, which was unlikely to meet FDA guidelines for the approval of the targeted radiotherapy, Iomab-B BLA [2]. - It is alleged that additional analyses provided to the FDA, which suggested improved Overall Survival, were also unlikely to satisfy FDA requirements, leading to a probable refusal to review the Iomab-B BLA [2]. - The lawsuit contends that the defendants' positive statements about the company's business and prospects were materially misleading and lacked a reasonable basis [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until May 27, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, indicating no financial obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4]. - The firm has over 70 employees dedicated to serving clients in complex securities litigation [4].
Shareholders that lost money on Actinium Pharmaceuticals, Inc. (ATNM) Urged to Join Class Action – Contact Levi & Korsinsky to Learn More
GlobeNewswire News Room· 2025-05-22 17:29
Core Viewpoint - Actinium Pharmaceuticals, Inc. is facing a class action securities lawsuit due to alleged securities fraud that affected investors between October 31, 2022, and August 2, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that the defendants made false statements regarding the Phase 3 Sierra trial data, which was unlikely to meet FDA guidelines for the approval of the targeted radiotherapy, Iomab-B BLA [2]. - Additional analyses provided to the FDA, which were intended to show improved Overall Survival, were also unlikely to satisfy FDA requirements for the Iomab-B BLA [2]. - The lawsuit suggests that the FDA would likely refuse to review the Iomab-B BLA or that the application, in its current form, was unlikely to be approved [2]. - Defendants' positive statements about the Company's business and prospects were materially misleading and lacked a reasonable basis [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until May 27, 2025, to request to be appointed as lead plaintiff [3]. - Participation in the lawsuit does not require serving as a lead plaintiff, and there are no out-of-pocket costs for class members [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4].
The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 27, 2025 in Actinium Lawsuit - ATNM
Prnewswire· 2025-05-22 09:45
Core Viewpoint - The Gross Law Firm is notifying shareholders of Actinium Pharmaceuticals, Inc. regarding a class action lawsuit due to alleged misleading statements related to the company's drug approval process [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 Phase 3 Sierra trial data [2]. - It is claimed that the data from the Sierra trial was unlikely to meet FDA guidelines for the approval of the targeted radiotherapy, Iomab-B BLA [2]. - The additional analyses provided to the FDA to support the Sierra trial's poor overall survival data 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: Class Action Details - The deadline for shareholders to register for the class action is May 27, 2025, and they are encouraged to register promptly [3]. - Registered shareholders will be enrolled in a portfolio monitoring system to receive updates on the case's progress [3]. - There is no cost or obligation for shareholders to participate in the case [3]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [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].
ATNM Deadline: ATNM Investors with Losses in Excess of $100K Have Opportunity to Lead Actinium Pharmaceuticals, Inc. Securities Fraud Lawsuit
Prnewswire· 2025-05-21 21:59
Core Viewpoint - Rosen Law Firm is reminding investors who purchased Actinium Pharmaceuticals, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline on May 26, 2025 [1] Group 1: Class Action Details - Investors who purchased Actinium securities between October 31, 2022, and August 2, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties can join by contacting Rosen Law Firm [3][6] - To serve as lead plaintiff, individuals must file a motion with the Court by May 26, 2025 [3] Group 2: Law Firm Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [4] - The firm was ranked No. 1 by ISS Securities Class Action Services for the number of securities class action settlements in 2017 and has consistently ranked in the top 4 since 2013 [4] - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering significant amounts for clients [4] Group 3: Case Allegations - The lawsuit alleges that during the Class Period, Actinium made false or misleading statements regarding its Iomab-B Biologics License Application (BLA) and the likelihood of FDA approval [5] - Specific claims include that data from the Sierra Trial was unlikely to meet FDA guidelines, and as a result, the FDA might refuse to review the BLA or deny approval [5] - The lawsuit asserts that the defendants' positive statements about Actinium's business and prospects were materially misleading [5]
ATNM INVESTOR ALERT: Kirby McInerney LLP Reminds Actinium Pharmaceuticals, Inc. Investors of Looming Lead Plaintiff Deadline in Class Action Lawsuit
GlobeNewswire News Room· 2025-05-21 00:00
Core Viewpoint - A federal securities class action has been filed against Actinium Pharmaceuticals, with a deadline for investors to seek lead plaintiff status by May 27, 2025, related to securities acquired between October 31, 2022, and August 2, 2024 [1]. Group 1: Company Developments - On August 5, 2024, Actinium announced a regulatory update regarding its Biologics License Application (BLA) for lomab-B, revealing that the FDA required an additional clinical study to support the BLA filing [3]. - Following the announcement, Actinium's share price fell by $3.69, or approximately 59%, from $6.17 on August 2, 2024, to $2.48 on August 5, 2024 [3]. Group 2: Legal Allegations - The complaint alleges that during the Class Period, Actinium misled the market regarding the likelihood of its BLA data meeting FDA guidelines for acceptance and approval [4].
Investors in Actinium Pharmaceuticals, Inc. Should Contact Levi & Korsinsky Before May 27, 2025 to Discuss Your Rights - ATNM
Prnewswire· 2025-05-20 09:45
Core Viewpoint - Actinium Pharmaceuticals, Inc. is facing a class action securities lawsuit due to alleged securities fraud that affected investors between October 31, 2022, and August 2, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that the defendants made false statements regarding the Phase 3 Sierra trial data, which was unlikely to meet FDA guidelines for the approval of the targeted radiotherapy, Iomab-B BLA [2]. - Additional analyses provided to the FDA, which suggested improved Overall Survival, were also claimed to be insufficient to satisfy FDA requirements for Iomab-B BLA approval [2]. - The lawsuit indicates that the FDA would likely refuse to review the Iomab-B BLA or that the application, in its current form, was unlikely to be approved [2]. - Defendants' positive statements about the Company's business and prospects were alleged to be materially misleading [2]. Group 2: Next Steps for Investors - Investors who suffered losses in Actinium during the specified timeframe have until May 27, 2025, to request to be appointed as lead plaintiff [3]. - Participation in the lawsuit does not require serving as a lead plaintiff, and class members may be entitled to compensation without any out-of-pocket costs [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4].
ROSEN, A TOP RANKED LAW FIRM, Encourages Actinium Pharmaceuticals, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – ATNM
GlobeNewswire News Room· 2025-05-19 23:40
Core Viewpoint - Rosen Law Firm is reminding investors who purchased Actinium Pharmaceuticals, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline on May 26, 2025, for a class action lawsuit [1] Group 1: Class Action Details - Investors who purchased Actinium securities between October 31, 2022, and August 2, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties can join by submitting a form or contacting the law firm [3][6] - The deadline to move the Court to serve as lead plaintiff is May 26, 2025, with the lead plaintiff acting on behalf of other class members [3] Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting their own achievements in this area [4] - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone, and has been ranked highly for securities class action settlements [4] Group 3: Case Allegations - The lawsuit alleges that during the Class Period, Actinium made false or misleading statements regarding the likelihood of FDA approval for its Iomab-B Biologics License Application [5] - Specific claims include that data from the Sierra Trial was unlikely to meet FDA guidelines, and that positive statements made by Actinium were materially misleading [5]