Actinium Pharmaceuticals(ATNM) - 2025 Q2 - Quarterly Report

PART I – FINANCIAL INFORMATION Financial Statements 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 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 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 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 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] - 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] - 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][54] - 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] Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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] - 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] Targeted Radiotherapy Candidate Pipeline 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][81] - 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] - 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] - 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][84] Results of Operations 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] Liquidity and Capital Resources 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][177] - 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][199] Quantitative and Qualitative Disclosures About Market Risk 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] Controls and Procedures 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] - 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] PART II – OTHER INFORMATION Legal Proceedings 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] - 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] - The company intends to defend vigorously against these claims, but the outcome cannot be assured[192] Risk Factors 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][196][197] - 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] - The company depends on single third-party manufacturers for preclinical and clinical drug supplies, and any disruption could adversely affect business and results[195][302] - 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][362] Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None[369] Defaults Upon Senior Securities There were no defaults upon senior securities during the period - None[370] Mine Safety Disclosures This item is not applicable to the company - None[371] Other Information There is no other information to report for the period - None[372] Exhibits 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]