The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Alpha Cognition Inc. (ACOG) 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? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Alpha Cognition Inc. is a member of the Medical sector. This group inc ...

Core Insights - The targeted radiotherapy cancer market is experiencing significant growth, particularly in the radioligand therapy (RLT) segment, driven by technological advancements and increased investment [4][5] - Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) is focusing on developing next-generation targeted radiotherapies, with a strong emphasis on its lead program, ATNM-400, which targets multiple cancers [6][7] Company Overview - Actinium Pharmaceuticals is a pioneer in differentiated, targeted radiotherapies, holding approximately 250 issued and pending patents globally [1] - The company is developing ATNM-400, a first-in-class alpha-emitter targeted radiotherapy candidate, with preclinical data showing promise in prostate cancer, non-small cell lung cancer, and breast cancer [6][7] Market Dynamics - Novartis, a key player in the RLT market, is expanding its portfolio and has projected the RLT market could be valued between $25 billion and $30 billion [5] - Novartis's Pluvicto, approved for prostate cancer, generated sales of approximately $1.39 billion in 2024 and is expected to reach around $4.3 billion by 2030 [6] Competitive Landscape - Actinium's ATNM-400 is positioned to address unmet needs in the metastatic prostate cancer treatment landscape, particularly for patients who do not respond to existing therapies like Pluvicto [9][10] - The company believes that ATNM-400 can target a significant subset of the mCRPC patient population, especially those who have progressed on second-generation ARPIs or have not responded to PSMA-targeted therapies [11] Research and Development - Actinium is evaluating the potential of Actimab-A, which targets CD33 in acute myeloid leukemia and myelodysplastic syndromes, and Iomab-ACT, aimed at improving access to cellular therapies [7][8] - The company has reported superior tumor control and improved overall survival in preclinical studies for ATNM-400 compared to existing therapies [8][10] Collaborations and Innovations - Lila Biologics has announced a collaboration with Eli Lilly to develop novel radioligand therapies for solid tumors, showcasing the trend of partnerships in the biotech sector [12][13] - AdvanCell is expanding its collaboration with Eli Lilly to develop targeted alpha therapies, indicating a growing interest in innovative cancer treatments [14][15][16]

Drug Development and Clinical Trials - Actinium Pharmaceuticals is advancing its lead program ATNM-400, a first-in-class targeted radiotherapy candidate, with preclinical data showing potential efficacy in prostate cancer, non-small cell lung cancer (NSCLC), and breast cancer[81]. - The Iomab-ACT trial for sickle cell disease (SCD) is progressing with increased patient recruitment, expected to yield initial proof of concept data in the first half of 2026[87]. - Actinium Pharmaceuticals is actively seeking strategic partners for Iomab-B, Actimab-A, and Iomab-ACT to enhance development efforts in hematology and cellular therapies[83]. - The combination of ATNM-400 and osimertinib resulted in complete tumor regression in all tumor-bearing animals, suggesting synergistic activity and a potential new treatment approach for NSCLC[103]. - Actimab-A is being developed as a mutation-agnostic therapy for acute myeloid leukemia (AML), with potential as a backbone therapy in combination with various treatments[135]. - A Phase 2/3 trial comparing Actimab-A + CLAG-M to CLAG-M alone in relapsed/refractory AML has been aligned with the FDA, with favorable Phase 1 results showing improved overall response rates and survival outcomes[137]. - The SIERRA trial for Iomab-B demonstrated a durable complete remission (dCR) rate of 22% compared to 0% in the control arm, achieving statistical significance (p-value < 0.0001)[152]. - Actinium expects initial clinical data from the Iomab-ACT trials in the first half of 2026, focusing on targeted conditioning for improved patient access to cell and gene therapies[150]. Financial Performance - Total revenue for the three months ended September 30, 2025, was $90, with no commercial revenue recorded for the same period in 2024[180]. - The company recognized $0.1 million in other revenue during the three months ended September 30, 2025, from a grant awarded by the National Institutes of Health[181]. - Long-term license revenue deferred was $35 million at September 30, 2025, resulting from a license agreement with Immedica for Iomab-B[183]. - Total revenue for the nine months ended September 30, 2025, was $0.1 million, compared to no revenue for the same period in 2024[191]. - Net loss for the three months ended September 30, 2025, was $5.1 million, a decrease of 44.5% from $11.6 million for the same period in 2024[188]. - Net loss for the nine months ended September 30, 2025, was $27.9 million, a decrease of 11.7% from $31.6 million for the same period in 2024[197]. - Cash used in operating activities for the nine months ended September 30, 2025, was $19.3 million, a decrease of 29.3% from $27.3 million in the prior-year period[198]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $4.2 million, down 57.1% from $9.8 million for the same period in 2024[185]. - Research and development expenses for the nine months ended September 30, 2025, were $16.8 million, a decrease of 33.3% from $25.2 million for the same period in 2024[193]. - The company has conducted 2 Phase 2/3 trials and 4 Phase 1 trials supported by NCI CRADA, with data from over 500 patients treated with Iomab-B and Actimab-A[158]. Strategic Partnerships and Collaborations - Actinium has entered a Cooperative Research and Development Agreement (CRADA) with the NCI to develop Actimab-A, which may accelerate clinical trials and reduce costs[144]. - The myeloMATCH program, part of the CRADA, aims to enroll over 5,000 patients in trials testing precision medicine treatments for AML and MDS across the U.S. and Canada[145]. - The company is seeking a strategic partner for Iomab-B in the U.S. and may consider partnering, divesting, or out-licensing Iomab-B, Actimab-A, or Iomab-ACT for all non-solid tumor indications[156]. Market Opportunities - The company is focusing on expanding ATNM-400's application across multiple solid tumors, with a market potential exceeding $20 billion, addressing over 800,000 new cases annually in the U.S.[88]. - Approximately 226,650 new lung cancer cases are expected in 2025, with 85% being NSCLC, indicating a significant market opportunity for ATNM-400[119]. - Hormone receptor-positive, HER2-negative breast cancer accounts for 70-75% of breast cancer cases, with sales of tamoxifen and trastuzumab reaching approximately $4.0 billion in 2024[123]. - The market for PD-1 inhibitors exceeded $40 billion in global sales in 2024, highlighting the competitive landscape for oncology therapies[124]. - The unmet need for effective therapies in mCRPC and NSCLC presents a significant opportunity for ATNM-400 to address critical gaps in treatment[117]. Manufacturing and Supply Chain - The company has established significant manufacturing and supply chain expertise, delivering over 500 doses for 18 clinical trials without missing a dose[167]. - The proprietary Ac-225 cyclotron manufacturing technology is expected to produce Ac-225 at a cost 10 to 20 times lower than currently available material[166]. Regulatory and Compliance Risks - The Company faces risks common in the biopharmaceutical industry, including regulatory approval delays and competition, which could adversely impact operations[211]. - Ongoing geopolitical conflicts and rising global inflation may contribute to increased market volatility affecting the Company's business[211]. - The recent U.S. federal government shutdown may disrupt the Company's ability to advance clinical trials and secure regulatory approvals[211]. Employee and Operational Insights - As of November 13, 2025, the company had 25 full-time employees, with 20 engaged in research and development and clinical development activities[176]. - Non-cash stock-based compensation expense for the three months ended September 30, 2025, was $0.1 million, a decrease of 92.3% from $1.3 million for the same period in 2024[184]. - General and administrative expenses for the three months ended September 30, 2025, decreased to $1.5 million, a reduction of 46.4% from $2.8 million for the same period in 2024[186].

Core Insights - Actinium Pharmaceuticals, Inc. has presented promising preclinical data for ATNM-400, a first-in-class antibody radioconjugate targeting a novel, non-PSMA antigen, demonstrating superior efficacy in prostate cancer treatment compared to existing therapies [1][2][3] Prostate Cancer Treatment Insights - ATNM-400 shows robust tumor control and extended survival in enzalutamide-resistant prostate cancer models, achieving complete tumor regression in 40% of treated animals [4][5] - The therapy demonstrated five times more durable anti-tumor efficacy compared to enzalutamide alone, extending tumor control to 100 days versus approximately 20 days with enzalutamide [4][11] - In models resistant to 177Lu-PSMA-617, ATNM-400 exhibited approximately two times longer overall survival and maintained potent therapeutic activity independent of PSMA expression levels [6][11] Mechanism and Differentiation - ATNM-400 targets a distinct, non-PSMA antigen associated with treatment resistance, providing a mechanistically differentiated approach to alpha-radiotherapy [8][13] - The combination of ATNM-400 with enzalutamide resulted in synergistic effects, enhancing treatment responses and overcoming resistance [9][16] Market Context and Unmet Needs - Prostate cancer remains a significant health issue, with approximately 1.5 million new cases globally and over 313,000 expected in the U.S. in 2025, highlighting the need for effective treatments [14] - A substantial portion of metastatic castration-resistant prostate cancer (mCRPC) patients do not respond to PSMA-targeted therapies, with 25%-30% having low or no detectable PSMA [7][14] Future Directions - Actinium Pharmaceuticals is advancing ATNM-400 into non-small cell lung cancer (NSCLC) treatment, where it has shown potential to overcome resistance to osimertinib [9][13] - The company envisions multiple clinical applications for ATNM-400, including monotherapy, combination therapy with ARPI, and sequential therapy for patients relapsing after standard treatments [12][15]

Core Insights - Actinium Pharmaceuticals, Inc. announced the acceptance of preclinical data for its ATNM-400 program in non-small cell lung cancer (NSCLC) for presentation at the AACR-NCI-EORTC conference in October 2025, highlighting its innovative approach in targeted radiotherapies [1][5] Summary by Sections ATNM-400 in NSCLC - NSCLC accounts for about 85% of lung cancer cases and is the leading cause of cancer mortality globally [2] - EGFR tyrosine kinase inhibitors (TKIs) like osimertinib have improved outcomes for patients, but resistance develops in nearly all patients within 2 to 3 years, leading to disease progression [2] Preclinical Data - Preclinical data indicates that ATNM-400 shows strong anti-tumor activity in EGFR-mutant NSCLC models and can overcome resistance to osimertinib, demonstrating potential as a combination therapy [3][8] - The data suggests ATNM-400 could address a significant unmet need in oncology for patients with relapsed or refractory EGFR-mutant NSCLC [3] Clinical Trial Insights - A Phase 2 trial reported a median progression-free survival (PFS) of 32.3 months for patients receiving osimertinib plus consolidative radiotherapy, a notable improvement over the 20.0-month PFS with osimertinib alone [4] Multi-Indication Potential - Initially developed for prostate cancer, ATNM-400 targets a distinct receptor involved in tumor progression and treatment resistance, maintaining efficacy in PSMA-low or PSMA-resistant cases [6][10] - In preclinical models, ATNM-400 has shown synergy with enzalutamide, leading to significant tumor control and improved overall survival [6][10] Mechanism of Action - ATNM-400 utilizes Actinium-225 to induce irreparable double-strand DNA breaks, which is expected to overcome conventional resistance pathways and provide durable tumor control [7][10] Market Context - Prostate cancer is the most commonly diagnosed cancer in men, with approximately 1.5 million new cases globally and over 313,000 expected in the U.S. in 2025 [11] - Lung cancer, particularly NSCLC, is projected to have over 200,000 new cases in the U.S. in 2025, emphasizing the significant market potential for ATNM-400 [11] Company Overview - Actinium Pharmaceuticals is focused on developing targeted radiotherapies to improve patient outcomes, with ATNM-400 being a key candidate for both prostate cancer and NSCLC [12]

Core Insights - Actinium Pharmaceuticals, Inc. announced compelling preclinical data for ATNM-400, a first-in-class antibody radioconjugate targeting a non-PSMA antigen associated with prostate cancer progression, demonstrating potent therapeutic activity independent of PSMA expression levels [1][4][5] Group 1: Product Overview - ATNM-400 utilizes Actinium-225 (Ac-225) as a potent alpha-emitter, showing superior efficacy compared to existing therapies like enzalutamide and 177Lu-PSMA-617 [1][4] - The product is designed to maintain efficacy in PSMA-low or PSMA-resistant prostate cancer, addressing a significant unmet clinical need [5][8] - Preclinical models indicate that ATNM-400 can overcome resistance to enzalutamide and enhance overall survival when used in combination with ARPI therapies [4][6] Group 2: Market Context - Prostate cancer is the most diagnosed cancer in men, with approximately 1.5 million new cases globally and over 313,000 expected in the U.S. in 2025 [7] - Up to 20% of prostate cancer cases progress to metastatic castration-resistant prostate cancer (mCRPC), a stage with limited treatment options [7] - The ARPI class, including enzalutamide, generated over $10 billion in sales in 2024, highlighting the significant market potential for new therapies like ATNM-400 [7] Group 3: Future Developments - Actinium plans to present ATNM-400 at the 32nd Annual Prostate Cancer Foundation Scientific Retreat on October 23-25, 2025 [2] - The company aims to evaluate ATNM-400 in other solid tumor indications beyond prostate cancer, indicating a broader application of the technology [7][8]

[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)

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.

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].

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].