Financial Performance - The Company reported a net income of $1,927,839 for the three months ended September 30, 2025, primarily from interest earned on marketable securities of $2,508,797, offset by operating costs of $1,638,082[143]. - For the nine months ended September 30, 2025, the Company had a net income of $3,218,865, with interest income of $7,449,387 and total operating costs of $4,230,522[144]. - The Company incurred cash used in operating activities of $1,055,702 for the nine months ended September 30, 2025, influenced by changes in operating assets and liabilities[151]. Marketable Securities and Trust Account - As of September 30, 2025, the Company held marketable securities in the trust account amounting to $242,642,972, which will be used to complete the Business Combination[153]. - As of September 30, 2025, the fair value of the forward purchase derivative liability was $0[158]. - The company has no off-balance sheet arrangements or obligations as of September 30, 2025[159]. Business Combination - The Business Combination Agreement with Terrestrial Energy Inc. was entered into on March 26, 2025, with an aggregate consideration of $925,000,000 for the merger[137]. - The Business Combination is expected to close in the fourth quarter of 2025, pending shareholder approvals and customary closing conditions[138]. - The Company has until August 19, 2026, to complete the initial Business Combination, or it will trigger an automatic winding up and liquidation[155]. Initial Public Offering - The Company completed its Initial Public Offering on August 19, 2024, raising gross proceeds of $230,000,000 from the sale of 23,000,000 Units[148]. - The underwriter is entitled to a deferred underwriting discount of 4.40% of gross proceeds from the Initial Public Offering, totaling $10,720,000, payable upon completion of the initial Business Combination[162]. Capital and Financing - The Company plans to issue 5,000,000 shares of Domesticated Common Stock at $10.00 per share through PIPE Financing, raising an additional $50,000,000[141]. - As of September 30, 2025, the Company had cash held outside the trust account of $350,389 available for working capital needs[154]. Accounting and Reporting - Management does not have any critical accounting estimates to disclose as of September 30, 2025[163]. - Recent accounting standards are not expected to materially affect the company's financial statements[164]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[166]. Liabilities - The company has no long-term debt or significant liabilities, except for a monthly payment of $15,000 to the Sponsor for office-related services[161].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR o 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 001-40760 ATLANTIC INTERNATIONAL CORP. (Exact name of registrant as specified in its charter) Delaware 46-5319744 (State or ...

Company Overview - Proficient Auto Logistics operates one of the largest auto transportation fleets in North America with over 800 owned assets and 804 dedicated employees as of September 30, 2025[116]. - The company has strategically located 57 facilities across the United States, focusing on transporting finished vehicles from production facilities to dealerships[116]. Revenue Generation - Revenue is generated through OEM contract and spot arrangements, secondary market auto moves, and long-term contract services[120]. - The Company Drivers segment generates revenue through transporting autos under fixed contracts, focusing on high-service and high-priority freight[134]. Acquisitions and Growth - The company completed multiple acquisitions, including Delta, Deluxe, Sierra, Proficient Transport, and Tribeca, enhancing its geographic presence and service offerings[117]. Financial Performance - Total operating revenue for the three months ended September 30, 2025, was $114,294,804, compared to $91,505,501 for the same period in 2024, representing a 25% increase[147]. - The Company reported a net loss of $3,019,686 for the three months ended September 30, 2025, compared to a net loss of $1,365,476 for the same period in 2024[147]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $31,003,907, with an adjusted EBITDA margin of 9.5%[145]. - The operating ratio for the three months ended September 30, 2025, was 100.1%, compared to 102.4% for the same period in 2024, indicating improved operational efficiency[146]. - Total operating revenue for the nine months ended September 30, 2025, was $325.0 million, compared to $147.4 million for the same period last year[171]. Segment Performance - Company Drivers segment revenue for the three months ended September 30, 2025, was $41,717,289, up from $33,329,336 in 2024, reflecting a 25% increase[148]. - Subhaulers segment revenue for the three months ended September 30, 2025, was $66,492,924, compared to $53,384,131 in 2024, marking a 24.5% increase[148]. - Operating revenues in the Company Driver segment increased by $8.4 million, or 25.2%, to $41.7 million for the three months ended September 30, 2025, compared to $33.3 million for the same period last year[150]. - In the Subhaulers segment, operating revenues increased by $14.4 million, or 24.8%, to $42.6 million for the three months ended September 30, 2025, compared to $58.2 million for the same period last year[151]. - Operating revenues in the Subhaulers segment increased by $113.5 million, or 118.5%, to $209.2 million for the nine months ended September 30, 2025, compared to $95.7 million for the same period last year[173]. Expenses and Costs - Operating expenses are significantly influenced by fuel costs, driver-related expenses, and maintenance of the fleet[123]. - Total operating expenses for the three months ended September 30, 2025, were $114,395,552, compared to $93,691,006 in 2024, representing a 22% increase[147]. - Salaries, wages, and benefits increased by $5.0 million, or 28.6%, to $22.3 million for the three months ended September 30, 2025, compared to $17.4 million for the same period last year[153]. - Purchased transportation expenses increased by $11.9 million, or 26.3%, to $56.9 million for the three months ended September 30, 2025, compared to $45.0 million for the same period last year[157]. - Fuel and fuel taxes increased by $9.9 million, or 104.8%, to $19.3 million for the nine months ended September 30, 2025, compared to $9.4 million for the same period last year[179]. - Purchased transportation expenses increased by $89.9 million, or 123.0%, to $163.0 million for the nine months ended September 30, 2025, compared to $73.1 million for the same period last year[180]. EBITDA and Adjusted EBITDA - EBITDA decreased by $308,000, or 3.6%, to $8.2 million for the three months ended September 30, 2025, compared to $8.5 million for the same period last year[169]. - Adjusted EBITDA increased by $2.4 million, or 25%, to $12.0 million for the three months ended September 30, 2025, compared to $9.6 million for the same period last year[170]. - EBITDA increased by $14.6 million, or 142.4%, to $24.8 million for the nine months ended September 30, 2025, compared to $10.2 million for the same period last year[191]. - Adjusted EBITDA increased by $13.0 million, or 72.3%, to $31.0 million for the nine months ended September 30, 2025, compared to $18.0 million for the same period last year[192]. Cash Flow - Cash flows from operating activities were $25.7 million, representing a $17.9 million increase compared to the same period in 2024[202]. - Cash flows used in investing activities decreased significantly by $190.6 million to $11.2 million for the nine months ended September 30, 2025, compared to $201.8 million for the same period in 2024[203]. Interest and Expenses - Interest expense increased by $275,000, or 19.6%, to $1.7 million for the three months ended September 30, 2025, compared to $1.4 million for the same period last year[166]. - Interest expense, net increased by $3.1 million, or 148.7%, to $5.1 million for the nine months ended September 30, 2025, compared to $2.0 million for the same period last year[187]. Risks and Accounting - The company is subject to risks related to economic conditions, market dynamics, and geopolitical developments that may affect its operations[114]. - Proficient Auto Logistics has identified itself as the accounting acquirer in its business combinations, impacting financial reporting and comparability[118]. - The company may take advantage of exemptions for up to five years as an emerging growth company[206]. - The company will cease to be an emerging growth company if total annual gross revenues exceed $1.235 billion[206]. - The company has elected to delay the adoption of certain accounting standards while classified as an emerging growth company[206]. - Financial statements may not be comparable to those of other public companies due to the election to avail of exemptions[206]. - No quantitative or qualitative disclosures about market risk were provided[207].

Revenue Performance - Revenues for the three months ended September 30, 2025, were $3,545,412, an increase of $987,827 or 38.6% from $2,557,585 in the same period of 2024[122] - Revenues for the nine months ended September 30, 2025, were $8,689,360, a decrease of $2,352,649 or 21.3% from $11,042,009 in 2024, attributed to reduced customer demand[131] Cost and Expenses - Cost of revenues increased to $4,986,401 for the three months ended September 30, 2025, compared to $929,002 for the same period in 2024, with tariffs paid rising from $57,613 to $251,728[123] - Cost of revenues for the nine months ended September 30, 2025, was $10,653,499, compared to $6,968,809 in 2024, with tariffs increasing from $197,060 to $572,649[132] - Selling expenses surged to $6,362,313 for the three months ended September 30, 2025, up from $159,368 in 2024, primarily due to a $5,929,200 increase in share-based compensation[125] - Selling expenses for the nine months ended September 30, 2025, rose to $7,901,900 from $564,805 in 2024, largely due to a $6,745,950 increase in share-based compensation[134] - General and administrative expenses increased by $127,965 to $2,649,905 for the nine months ended September 30, 2025, primarily due to a $573,715 increase in service fees and a $415,183 increase in share-based compensation[136] - Research and development expenses decreased to $1,007,783 for the nine months ended September 30, 2025, down from $1,272,257 for the same period in 2024[137] - The company’s operating lease expenses were $327,142 for the nine months ended September 30, 2025, compared to $59,617 for the same period in 2024[151] Profitability - Gross profit for the three months ended September 30, 2025, was -$1,440,989, a significant decline from a gross profit of $1,628,583 in 2024, resulting in a gross margin decrease from 63.7% to -40.6%[124] - Gross profit for the nine months ended September 30, 2025, was -$1,964,139, down from $4,073,200 in 2024, leading to a gross margin decline from 36.9% to -22.6%[133] - Net loss for the three months ended September 30, 2025, was $8,799,313, compared to a net income of $496,565 for the same period in 2024, driven by decreased gross profit and increased operating expenses[128] - For the nine months ended September 30, 2025, the company reported a net loss of $13,691,600, compared to a net loss of $440,897 for the same period in 2024, indicating a significant increase in losses[138] Cash Flow - Net cash used in operating activities was $3,845,524 for the nine months ended September 30, 2025, primarily due to the net loss adjusted for non-cash items[144] - The company had cash of $40,883 as of September 30, 2025, down from $245,164 as of December 31, 2024[139] - Net cash provided by financing activities was $3,777,759 for the nine months ended September 30, 2025, mainly from the issuance of 120,000,000 common stock[148] - The increase in cash used in operating activities was attributed to a net increase of $2,726,683 in operating assets and liabilities[144] Future Outlook - The company may need additional cash resources in the future for investments, acquisitions, or strategic cooperation[140]

Financial Performance - For the three months ended September 30, 2025, research and development expenses increased to $816,697, a rise of 789% compared to $91,911 in the same period of 2024[140] - General and administrative expenses for the same period rose to $1,480,356, reflecting a 269% increase from $401,636 in the prior year[141] - Total operating expenses for the three months ended September 30, 2025, were $2,297,053, up 365% from $493,547 in the same period of 2024[139] - The net loss for the three months ended September 30, 2025, was $2,288,034, compared to a net loss of $591,021 for the same period in 2024, representing an increase of 287%[139] - For the nine months ended September 30, 2025, research and development expenses were $2,042,890, a 600% increase from $291,655 in the same period of 2024[148] - General and administrative expenses for the nine months ended September 30, 2025, totaled $4,057,046, up 202% from $1,341,271 in the prior year[149] - The net loss for the nine months ended September 30, 2025, was $6,069,866, compared to a net loss of $911,998 for the same period in 2024, indicating a 566% increase[147] Cash Flow and Financing - Net cash used in operating activities during the nine months ended September 30, 2025 was $3,045,713, a substantial increase from $215,225 used in the same period in 2024[161] - Net cash provided by financing activities was $0 for the nine months ended September 30, 2025, compared to $187,000 in the same period in 2024[162] - The company has an accumulated deficit of $32,091,995 since inception, raising substantial doubt about its ability to continue as a going concern for at least twelve months[155] - The company generated no revenues from product sales since inception, highlighting its reliance on external financing[155] - The company is dependent on raising additional funds to sustain operations and may need to delay or terminate development programs if unable to secure financing[156] Interest Income and Expenses - Interest income for the three months ended September 30, 2025, was $10,212, a significant increase from $23 in the same period of 2024, reflecting a 44,300% rise[142] - Interest expense for the three months ended September 30, 2025, decreased to $1,193 from $107,382 in the prior year, representing a 99% reduction[143] Business Development and Strategy - The company has initiated business development activities in the Asian region, aiming to accelerate drug development and commercialization efforts[165] - The company has entered into service agreements that include equity investments in exchange for services, which are expected to facilitate potential out-licensing deals[166] - The CEO has loaned the company $146,432 as of September 30, 2025, with an interest rate of 3% per year[167] - The company has no off-balance sheet financing arrangements that could materially affect its financial condition[163] - The Company plans to finance future operations through equity securities, grant awards, and strategic collaborations, although there is no assurance of success in these efforts[133]

Financial Performance - The company reported a net loss of $60,837 for the three months ended September 30, 2025, primarily due to general and administrative costs of $84,688, offset by interest income of $23,851 from marketable securities held in the Trust Account[111]. - For the period from inception (June 9, 2025) through September 30, 2025, the total net loss was $77,978, with general and administrative costs amounting to $101,829[111]. - The company has incurred $105,991 in net cash used in operating activities from inception through September 30, 2025[116]. Initial Public Offering (IPO) - The company completed its Initial Public Offering on September 29, 2025, raising gross proceeds of $287,500,000 from the sale of 28,750,000 Units, including an over-allotment option[114]. - Following the IPO, $287,500,000 was placed in the Trust Account, with total offering costs incurred amounting to $17,861,874[115]. Business Combination Plans - The company intends to use substantially all funds in the Trust Account to complete its Business Combination, with remaining proceeds allocated for working capital to finance operations of the target business[117]. - The company may seek to extend the Combination Period by amending its Articles, which would require approval from Public Shareholders[109]. - The SEC's 2024 SPAC Rules may materially affect the company's ability to negotiate and complete its initial Business Combination, potentially increasing costs and time[108]. - The company does not anticipate needing to raise additional funds for operating expenditures but may require additional financing to complete its Business Combination[120]. Debt and Financial Position - As of September 30, 2025, the company had no long-term debt or off-balance sheet arrangements[121][122].

Company Overview - HCW Biologics Inc. is focused on developing proprietary immunotherapies targeting chronic inflammation and age-related diseases, with a particular emphasis on cancer and conditions that impact quality of life [149]. - The company has a clinical development pipeline that includes lead product candidates targeting life-threatening diseases such as pancreatic and ovarian cancer, as well as quality-of-life conditions like alopecia areata [154]. - The company’s TRBC platform is designed to create novel immunotherapeutics, including multi-specific cytokines and immune checkpoint inhibitors, aimed at treating cancer and age-related diseases [157]. - The company is focused on diseases with no curative FDA-approved treatments, particularly those driven by chronic inflammation and senescence [154]. - HCW Biologics aims to establish control over its clinical supply of materials and licensed molecules, responding to industry trends favoring domestic manufacturing [164]. Financial Performance - The Company recognized revenues of $426,423 and $15,606 for the three months ended September 30, 2024 and 2025, respectively, with revenues derived exclusively from the sale of licensed molecules to Wugen and related ancillary services [210]. - The Company has recognized $16.2 million of revenues derived from the Wugen License since inception, including upfront license fees and payments for materials [190]. - Revenues increased from $2.2 million for the nine months ended September 30, 2024, to $27,222 for the nine months ended September 30, 2025, primarily from the sale of licensed molecules to Wugen [231]. - The Company reported a net loss of $26,650,541 for the nine months ended September 30, 2025, compared to a net loss of $8,678,941 for the same period in 2024 [209]. - The company reported a net loss of $8.7 million for the nine months ended September 30, 2025, compared to a net loss of $26.7 million for the same period in 2024 [275]. Research and Development - Research and development expenses increased by $217,334, or 18%, from $1.2 million for the three months ended September 30, 2024 to $1.4 million for the three months ended September 30, 2025 [212]. - The Company expects research and development expenses to increase substantially for the foreseeable future as it continues the development of its product candidates [195]. - The Company has identified over 50 proprietary compounds for clinical development, with a focus on a select few for internal programs and clinical trials [168]. - HCW9302, the lead product candidate for autoimmune disorders, is expected to begin a Phase 1 clinical trial in Q4 2025, targeting alopecia areata [169]. - The Company presented a novel multi-functional bispecific T-cell engager molecule at the SITC meeting, highlighting its broad coverage and favorable pharmacokinetics [174]. Expenses and Cost Management - Total operating expenses for the nine months ended September 30, 2025, were $27,189,472, compared to $8,706,133 for the same period in 2024 [209]. - Salaries, benefits, and related expenses within research and development rose by 23% from $652,867 in Q3 2024 to $801,504 in Q3 2025 [211]. - General and administrative expenses increased by $251,537, or 15%, from $1.6 million for the three months ended September 30, 2024, to $1.9 million for the three months ended September 30, 2025 [219]. - Manufacturing and materials expense increased by $2,511, or 5%, from $47,748 for the three months ended September 30, 2024, to $50,259 for the three months ended September 30, 2025 [214]. - Clinical activities expenses decreased by $83,781, or 51%, from $164,139 for the three months ended September 30, 2024, to $80,358 for the three months ended September 30, 2025 [216]. Financing and Capital Structure - The company has raised $2.2 million through the issuance of 475,000 shares of Common Stock under its Standby Equity Purchase Agreement as of September 30, 2025 [160]. - The Company raised $7.0 million in the nine months ended September 30, 2025 through issuance of equity securities [254]. - The Company closed on a $5.0 million follow-on public offering with an offering priced at the market under Nasdaq rules in the nine months ended September 30, 2025 [257]. - The company is actively seeking financing to complete the renovation of a biologics manufacturing facility [266]. - The company believes there is substantial doubt regarding its ability to continue as a going concern for at least 12 months from the date of the financial statements without additional funding [269]. Legal and Compliance Issues - The Company entered a forbearance agreement with BE&K Building Group due to unpaid invoices related to construction, which terminated on March 31, 2025, leading to legal proceedings [165]. - The Company has a loan agreement with Cogent Bank for $6.5 million, which is currently in default due to mechanics liens, and negotiations for a forbearance agreement are ongoing [166]. - The Company reported a balance of $12.1 million for legal fees incurred in connection to the Arbitration but not yet paid as of September 30, 2025 [247]. - The company is negotiating terms for a forbearance agreement with Cogent Bank to address mechanics liens related to construction [268]. - The company was granted an extension until December 31, 2025 to regain compliance with the Nasdaq Listing Rules related to the minimum requirements to maintain a $2.5 million balance in stockholders' equity [258]. Market and Investment Risks - The company has a primary exposure to market risk related to interest rate sensitivity, affected by changes in U.S. interest rates [295]. - The fair value of the Wugen investment declined from $3.3 million as of June 30, 2025, to $1.3 million as of September 30, 2025 [287]. - The fair value of the related contingent liability for rights to proceeds from the sale or liquidation of Wugen shares decreased from $1.7 million to $692,531 during the same period [287]. - The company recognized an unrealized loss of $966,284 in the three months ended September 30, 2025, and an unrealized net gain of $782,404 in the nine months ended September 30, 2025 [287]. - The company has limited access to liquidity for Wugen common stock until these shares become publicly traded [295].

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 September 30, 2025 ☐ 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 001-33135 Regional Health Properties, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of i ...

Merger and Corporate Structure - The Company completed a merger with Vyome Therapeutics, Inc. on August 15, 2025, resulting in the renaming to Vyome Holdings, Inc.[157] - A private placement raised approximately $5.735 million from the sale of 520,514 shares at $11.02 per share immediately after the merger[175]. - A 1-for-4 reverse stock split was executed on August 15, 2025, reclassifying every four shares into one new share of common stock[176][177]. Product Development and Licensing - The lead program, VT-1953, is a topical gel for treating malignant fungating wounds, with discussions planned with the FDA for a pivotal trial protocol in the first half of 2026[158]. - The Company has commercialized two topical anti-fungal products in India and amended its agreement with Sun Pharma to receive a net service fee for sales instead of handling inventory[160]. - The Company has entered into a licensing agreement with Sun Pharma for the development of Luliconazole topical cream for skin fungal diseases in India[160]. - The Company has not generated any revenue from product sales in the biotechnology segment, focusing instead on development and clinical studies[161]. Financial Performance - Revenue for the nine months ended September 30, 2025, was $283,163, an increase of 44.8% compared to $195,516 for the same period in 2024[197]. - For the three months ended September 30, 2025, revenue was $34,627, a decrease of 58.7% from $84,526 in 2024[205]. - Ingredient sales under the Luliconazole Agreement for the three months ended September 30, 2025, were $26,973, down from $84,129 in 2024, a decline of 67.9%[207]. Expenses and Losses - General and administrative expenses rose significantly to $1,369,365 for the nine months ended September 30, 2025, compared to $651,196 in 2024, reflecting an increase of 110.8%[201]. - The company incurred transactional and financial advisory fees of approximately $7.7 million for the nine months ended September 30, 2025, related to the Merger[204]. - The net loss for the nine months ended September 30, 2025, was $9,198,033, compared to a net loss of $1,140,904 for the same period in 2024, representing an increase in loss of 707.5%[197]. - Research and development expenses decreased to $210,006 for the nine months ended September 30, 2025, from $217,864 in 2024, a reduction of 3.5%[200]. - Research and development expenses decreased to $39,677 in Q3 2025 from $66,815 in Q3 2024, primarily due to resource allocation towards the Merger[208]. - General and administrative expenses increased significantly to $844,344 in Q3 2025 from $246,821 in Q3 2024, driven by legal and professional fees related to the Merger and stock-based compensation of $574,109[209]. Cash Flow and Financing - Net cash used in operating activities was $(2,270,655) for the nine months ended September 30, 2025, compared to $(611,168) in the same period of 2024, indicating a significant increase in operational losses[213][214]. - Cash provided by financing activities rose to $7,890,956 in the nine months ended September 30, 2025, compared to $644,485 in the same period of 2024, primarily from a Private Placement offering[216]. - As of September 30, 2025, the company had a cash balance of approximately $5,707,000 and expects to incur significant expenses as it advances product candidates through development[217]. - Future capital requirements will depend on various factors, including clinical trial costs and commercialization activities, with substantial additional funding needed to support operations[221]. - The company anticipates financing operations through equity offerings and debt financings until it can generate significant product revenues[222]. Research and Clinical Trials - The company has entered into agreements for research and clinical trials, which are generally cancellable upon notice, indicating flexibility in managing commitments[224]. - The company expects research and development costs to increase significantly in the foreseeable future as it commences clinical trials and continues product development[189]. Interest and Fair Value Adjustments - Interest expense decreased to $136,697 for the nine months ended September 30, 2025, from $153,229 in 2024, a reduction of 10.8%[202]. - Interest expense decreased to $25,604 in Q3 2025 from $45,742 in Q3 2024, attributed to the conversion of Convertible Debt in August 2025[210]. - The fair value adjustment for convertible notes improved to $0 in Q3 2025 from $(221,690) in Q3 2024, reflecting changes in Merger completion probabilities[211]. - The company recorded a fair value adjustment of $30,511 for the nine months ended September 30, 2025, compared to a negative adjustment of $(239,686) in 2024[203].

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].