UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO ________ COMMISSION FILE NUMBER 001-40796 WINVEST ACQUISITION CORP. (Exact name of registrant as specified in its charter) | Delaware | 86-2451181 | | --- | --- ...

Financial Performance - The company recognized $0.7 million in revenue for the year ended December 31, 2025, related to the provision of fire safety and protection equipment following the acquisition of Fitters Sdn. Bhd.[264] - Total revenue for the year ended December 31, 2025, was $747,000, a significant increase of 1,637% compared to $43,000 in 2024[294]. - The gross margin across all revenue streams was approximately 19% of gross revenues, with 80% generated from low-margin product sales[297]. - The company expects modest growth in fire safety revenues, particularly due to the expansion of data centers in Southern Malaysia[296]. Cash and Liquidity - As of December 31, 2025, the company had cash and cash equivalents of $3.5 million and an accumulated deficit of $454.4 million[266]. - The company anticipates that its current cash resources will allow it to meet liquidity requirements into the third quarter of 2026, but there is substantial doubt about its ability to continue as a going concern beyond that[270]. - Cash and cash equivalents increased to $3.5 million in 2025 from $3.1 million in 2024[310]. - Net cash used in operating activities decreased by $3.1 million, from $7.99 million in 2024 to $4.77 million in 2025[312]. - Net cash provided by financing activities was $5.3 million in 2025, compared to $7.8 million in 2024[314]. - Current assets increased to $6.3 million in 2025 from $3.7 million in 2024, while current liabilities decreased from $6.3 million to $1.3 million[310]. - Total working capital improved to a surplus of $4.9 million in 2025 from a deficit of $2.6 million in 2024[310]. Operational Changes - Following the creditors' voluntary liquidation of Cyclacel Limited, the company lost operational control over it, resulting in an increase in stockholders' equity by approximately $4.9 million[258]. - The company has shifted its focus to the development of the plogosertib clinical program only after the liquidation of Cyclacel Limited[259]. - The company does not anticipate incurring further material research and development expenditures following the liquidation of Cyclacel Limited and the sale of plogosertib[301]. Expenses - Research and development expenses decreased by $5.8 million from $6.7 million in 2024 to $848,000 in 2025, representing a reduction of 87%[300]. - General and administrative expenses increased by $2.3 million from $5.4 million in 2024 to $7.7 million in 2025, a rise of 43%[303]. - General and administrative expenditures for 2026 are expected to reduce significantly compared to 2025 due to the elimination of nonrecurring costs[304]. Financing Activities - The company issued 3,000,000 shares of Series F Convertible Preferred Stock for aggregate gross proceeds of $3 million, with all shares converted into 654,000 shares of common stock during 2025[274][276]. - The company issued 1,000,000 shares of Series E Convertible Preferred Stock at $1.00 per share, raising $1 million for general corporate purposes[278]. - An additional 119,136 shares of Common Stock were issued to Helena as Make-Whole Shares in February 2026[281]. Other Income and Tax - Total other income, net increased by $5.4 million from $10,000 in 2024 to $5.4 million in 2025, primarily due to a $4.9 million gain on deconsolidation of Cyclacel Limited[305]. - Income tax benefit decreased significantly by approximately $0.8 million, from a benefit of $782,000 in 2024 to a charge of $7,000 in 2025[308]. Foreign Exchange and Investments - The company recorded a foreign exchange gain of $73,000 in 2025, compared to a loss of $54,000 in 2024, an increase of $127,000[306]. - The company has no net cash used in investing activities for both 2025 and 2024[313]. - The company is no longer eligible to receive UK research and development tax credits following the liquidation of its UK subsidiary[309].

Financial Performance - Total revenue for the year ended December 31, 2025, was $747,000, a significant increase from $43,000 in 2024, representing a growth of 1,637%[294]. - The company recognized $0.7 million in revenue for the year ended December 31, 2025, related to the provision of fire safety and protection equipment following the acquisition of Fitters Sdn. Bhd.[264]. - The gross margin across all revenue streams was approximately 19% of gross revenues, with 80% generated from low-margin product sales[297]. - The company expects modest growth in fire safety revenues, particularly due to the expansion of data centers in Southern Malaysia[296]. Cash and Liquidity - As of December 31, 2025, the company had cash and cash equivalents of $3.5 million and an accumulated deficit of $454.4 million[266]. - Cash and cash equivalents increased to $3.5 million in 2025 from $3.1 million in 2024[310]. - Net cash used in operating activities decreased by $3.1 million, from $7.99 million in 2024 to $4.77 million in 2025[312]. - Net cash provided by financing activities was $5.3 million in 2025, compared to $7.8 million in 2024[314]. - Current assets increased to $6.3 million in 2025 from $3.7 million in 2024, while current liabilities decreased from $6.3 million to $1.3 million[310]. Operating Expenses - Research and development expenses decreased by $5.8 million from $6.7 million in 2024 to $848,000 in 2025, a reduction of 87%[300]. - General and administrative expenses increased by $2.3 million from $5.4 million in 2024 to $7.7 million in 2025, representing a 43% increase[303]. - General and administrative expenditures for 2026 are expected to reduce significantly compared to 2025 due to the elimination of nonrecurring costs[304]. Strategic Actions - The company plans to focus on the development of the plogosertib clinical program and has repurchased related assets for approximately $0.3 million[259]. - The company aims to position itself as a key player in Malaysia's fire safety market, focusing on trading and distribution of fire safety products[262]. - The company has no plans to repurchase rights to or assets of the fadraciclib program, which continues to be marketed for sale by the joint liquidator[260]. Stock and Equity Transactions - The company entered into a securities purchase agreement with investors for the purchase of 3,000,000 shares of Series F Convertible Preferred Stock at a price of $1.00 per share, generating gross proceeds of $3 million[274]. - The company issued 1,402,605 shares of common stock in exchange for existing warrants, recording a deemed dividend of approximately $9.5 million[271]. - The company issued 1,000,000 shares of Series E Convertible Preferred Stock at $1.00 per share, raising $1 million for general corporate purposes[278]. - An additional 119,136 shares of Common Stock were issued as Make-Whole Shares to Helena in February 2026[281]. - The company completed a one-for-sixteen reverse stock split and a subsequent one-for-fifteen reverse stock split of its common stock in 2025[253]. Other Income and Tax - Total other income, net increased by $5.4 million from $10,000 in 2024 to $5.4 million in 2025, primarily due to a $4.9 million gain on deconsolidation of Cyclacel Limited[305]. - Income tax benefit decreased significantly by approximately $0.8 million, from a benefit of $782,000 in 2024 to a charge of $7,000 in 2025[308]. Liquidation and Control Changes - Following the creditors' voluntary liquidation of Cyclacel Limited, the company lost operational control over it, resulting in an increase in stockholders' equity by approximately $4.9 million[258]. - The company is no longer eligible to receive UK research and development tax credits following the liquidation of its UK subsidiary[309]. Foreign Exchange Impact - Favorable foreign exchange movements resulted in a gain of $73,000 in 2025, compared to a loss of $54,000 in 2024, an increase of $127,000[306].

Revenue Performance - VerifyMe reported Q4 2025 revenue of $2.4 million, a decrease of 68% from $7.7 million in Q4 2024, primarily due to the termination of the agreement with the previous shipping partner[6]. - The annual revenue for 2025 was $16.4 million, down from $24.2 million in 2024, with a net loss of $4.9 million compared to a net loss of $3.8 million in 2024[4]. - Total net revenue for the year ended December 31, 2025, was $16,398,000, a decrease of 32.2% compared to $24,207,000 for the year ended December 31, 2024[27]. Profitability Metrics - Gross profit for Q4 2025 was $1.2 million, representing a gross margin of 49%, compared to $2.4 million and a 32% margin in Q4 2024[7]. - Gross profit for the year ended December 31, 2025, was $6,321,000, down 27.0% from $8,662,000 in 2024[27]. - Adjusted EBITDA for 2025 was $1.0 million, an increase from $0.9 million in 2024, while Q4 2025 adjusted EBITDA was ($0.1) million compared to $0.5 million in Q4 2024[10]. - Adjusted EBITDA for the year ended December 31, 2025, was $1,033,000, an increase of 8.7% from $950,000 in 2024[29]. Operating Loss and Expenses - The operating loss for Q4 2025 was ($0.7) million, compared to an operating loss of ($0.3) million in Q4 2024, reflecting the impact of reduced revenue[8]. - Operating expenses for the year ended December 31, 2025, totaled $11,391,000, down 12.7% from $13,052,000 in 2024[27]. Cash and Assets - As of December 31, 2025, VerifyMe had cash of $4.4 million and a short-term note receivable of $2.0 million[4]. - Cash and cash equivalents rose to $4,353,000 as of December 31, 2025, compared to $2,823,000 as of December 31, 2024, marking a 54.3% increase[24]. - Total current assets increased to $7,727,000 as of December 31, 2025, from $6,362,000 as of December 31, 2024, representing a growth of 21.4%[24]. Liabilities and Shareholder Equity - Total liabilities decreased significantly to $2,025,000 as of December 31, 2025, from $5,853,000 as of December 31, 2024, a reduction of 65.5%[25]. - The weighted average common shares outstanding increased to 12,846,593 for the year ended December 31, 2025, from 10,402,508 in 2024, reflecting a growth of 23.5%[27]. Strategic Moves - The company is in the process of transitioning clients to a new shipping partner, which is expected to enhance service offerings[3]. - VerifyMe entered into an Agreement and Plan of Merger to combine with Open World, Ltd., indicating a strategic move for market expansion[11]. - The company terminated its ATM Sales Agreement with Roth Capital Partners, LLC, as part of its strategic adjustments[11]. Inventory and Other Metrics - The company’s inventory decreased slightly to $37,000 as of December 31, 2025, from $39,000 as of December 31, 2024[24]. - The net loss per diluted share in Q4 2025 was ($0.05), consistent with the loss per diluted share in Q4 2024[9]. - The company reported a net loss of $4,905,000 for the year ended December 31, 2025, compared to a net loss of $3,824,000 in 2024, indicating a worsening of 28.3%[27].

Financial Performance - Total net revenue increased by $219 million to $5.547 billion in Fiscal 2025 compared to $5.329 billion in Fiscal 2024, representing a 4% increase [226]. - Total comparable sales increased by 3%, with Aerie's comparable sales rising by 9% while American Eagle's remained flat year-over-year [226]. - Gross profit decreased by 3% to $2.025 billion, with gross margin declining by 270 basis points to 36.5% as a percentage of revenue [226]. - Operating income fell by 47% to $226.2 million, with a decrease of 390 basis points to 4.1% as a percentage of total revenue [226]. - Net income attributable to AEO decreased by 42% to $192.0 million, with diluted earnings per share dropping to $1.09 from $1.68 in Fiscal 2024 [226]. - Digital revenue increased by 7%, driven by higher transaction volume and increased traffic, while store revenue remained flat compared to Fiscal 2024 [228]. Costs and Expenses - Buying, occupancy, and warehousing costs increased by $34 million year-over-year, primarily due to new store openings and digital sales volume [232]. - The decrease in gross profit was attributed to a $30 million decline in merchandise margin due to increased promotional activity and $70 million in incremental tariffs [231]. - Selling, general and administrative (SG&A) expenses increased by $53.7 million year-over-year, reaching $1,485.5 million, representing 26.8% of net revenue [234]. - Interest expense increased by 153% to $4.1 million, primarily due to a reduction in interest income and increased borrowings [243]. - Depreciation and amortization expense totaled $212.0 million, slightly down by 0.1% from the previous year, accounting for 3.8% of net revenue [238]. Impairment and Restructuring - Total impairment and restructuring charges for Fiscal 2025 amounted to $101.6 million, which is 1.8% of net revenue, primarily due to the closure of the Quiet Platforms business [235]. - The company recorded an impairment charge of $17.6 million, which was added back in the non-GAAP reconciliation [254]. Cash Flow and Capital Expenditures - Cash flow and liquidity are expected to be sufficient to fund anticipated capital expenditures and working capital requirements for the next 12 months and beyond [219]. - Total cash provided by operating activities decreased by $20.6 million from Fiscal 2024 to Fiscal 2025, totaling $456.2 million [259]. - Capital expenditures for Fiscal 2025 amounted to $260.8 million, a 17% increase from $222.5 million in Fiscal 2024 [264]. - Cash returned to shareholders through dividends and share repurchases was $344.0 million in Fiscal 2025, up from $287.4 million in Fiscal 2024 [263]. - The company expects capital expenditures for Fiscal 2026 to be in the range of $250 to $260 million to support expansion and technology upgrades [264]. Tax and Other Income - The effective tax rate for Fiscal 2025 was 25.6%, a slight decrease from 25.7% in Fiscal 2024 [245]. - Other income increased significantly by 482% to $(27.3) million, primarily due to a $26 million gain on equity method investments [244]. - Net income per diluted share for Fiscal 2025 was $1.09, which included $97.9 million of pre-tax impairment and restructuring charges [249]. Shareholder Actions - During Fiscal 2025, the company repurchased 3.0 million shares under its share repurchase program, with a total of 49.0 million shares remaining authorized for repurchase [270]. - The company has a revolving credit facility of up to $700 million, expiring in June 2027, with $12 million outstanding in stand-by letters of credit as of January 31, 2026 [268][269]. Market Risks - The company has market risk exposure related to interest rates and foreign currency exchange rates, with a hypothetical 10% adverse change in rates estimated to impact earnings and cash flows [292]. - A hypothetical 10% movement in the Canadian dollar and Mexican peso exchange rate could result in a foreign currency translation fluctuation of $30 million to $35 million [295]. - An unrealized gain of $40.8 million is included in accumulated other comprehensive loss, primarily related to fluctuations in the U.S. dollar to Mexican peso and Canadian dollar exchange rates [295].

Financial Performance - Total revenue for FY 2025 reached $11.4 million, a 442% increase from $2.1 million in FY 2024[13] - Digital Asset Treasury revenue was $9.2 million, with a net loss of $73.8 million primarily due to unrealized losses on digital assets[14] - The Annualized Organic Yield (AOY) for Q4 was 8.3%, below the 10% guidance target due to a crypto-wide liquidation event[15] - Solana's Q4'25 metrics showed a 52% year-over-year decline in Daily Active Users (DAUs) to 2.9M, and revenue decreased by 89% to $90.5M[42] - DFDV was recognized as the top-performing crypto stock of 2025, delivering a +633% return, outperforming all listed DAT peers[60] User Engagement and Market Growth - Daily active users on Solana surpassed 4.2 million, representing a 56% year-over-year growth[4] - Total Value Locked (TVL) in stablecoins on Solana increased to over $16 billion, up more than 5x from late 2021[4] - Real-world asset (RWA) TVL on Solana grew over 400% year-over-year, reaching approximately $1.7 billion, which is 6% of the total RWA TVL of $27 billion[6] - Five Solana ETFs launched in Q4'25, with total flows reaching approximately $1.0 billion[44] Strategic Investments and Initiatives - The company closed $164 million in convertible debt and $149 million in equity PIPEs while deploying a $5 billion Equity Line of Credit (ELOC)[12] - The company monetized its stake in ZeroStack for approximately $3M, validating its ability to identify asymmetric investment opportunities[38] - A strategic investment in Apyx, a DeFi protocol for dividend-backed stablecoins, was made in Q1'26, reflecting the company's commitment to bridging TradFi and DeFi[39] - Japan and Korea are identified as attractive markets for the Treasury Accelerator, with strong retail and institutional demand for crypto, and ongoing evaluations for market launch[37] Future Outlook and Guidance - The company aims to maintain a long-term target of 1.0 SPS by December 2028, assuming a more favorable crypto environment[25] - The revised June 2026 SPS guidance was lowered from 0.165 to 0.085 due to broad-based mNAV compression across the Digital Asset Treasury space[21] - The company plans to publish additional research in Q2 2026 to quantify demand vectors feeding into its DFDV Model, reinforcing the view that SOL remains undervalued[53] - The company aims to grow SPS and deepen participation in the Solana ecosystem as it enters 2026, focusing on transparency and disciplined capital allocation[61] Risks and Uncertainties - The company anticipates fluctuations in the market price of SOL, which may lead to associated losses[74] - There is uncertainty regarding the demand for SOL and the growth of activity on the SOL network as predicted in the DFDV Model[74] - The company faces volatility in its stock price, which may be influenced by future issuances of common stock[74] - The ongoing volatility in interest rates presents uncertainties that could impact the company's financial condition[74] - Regulatory environment complexities and compliance issues may affect the company's business operations[74] - Changes in accounting treatment related to the company's SOL holdings could impact financial reporting[74] - The company must effectively manage its growth and expectations regarding business development and expansion[74] - Access to capital sources, including debt financing, is crucial for financing operations and growth[74] - The company acknowledges various risks and uncertainties that could affect its actual results compared to forward-looking statements[75]

or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 Commission file number 001-43073 KRAKacquisition Corp (Exact name of registrant as specified in its charter) Cayman Islands 98-1875195 (State or other jurisdict ...

Economic Conditions - The Brazilian economy has shown moderate GDP growth alongside rising inflation and tighter monetary policy, which may adversely affect the company's results of operations and cash flows [195]. - Inflation increased during 2024 and remained above the official target for part of 2025, prompting the Central Bank to raise interest rates, which could lead to reduced consumer spending on telecommunications services [196]. - Higher inflation and interest rates may lead to increased debt service burdens for consumers, potentially resulting in downgrades to lower-priced plans and increased churn rates [196]. - Geopolitical risks, including conflicts in Europe and the Middle East, may contribute to volatility in commodity prices and affect inflation, interest rates, and global growth, impacting the company's financial stability [201]. Financial Market Exposure - The company is exposed to global financial market volatility, which can affect the market price and liquidity of its securities, as well as access to international capital markets [199]. - Any deterioration in global financial conditions could lead to capital outflows from Brazil, exchange rate depreciation, and tighter funding conditions, adversely affecting the company's operations [207]. Shareholder Influence - The controlling shareholder, Telecom Italia, has significant influence over the company's strategic decisions, which may conflict with the interests of other shareholders [208]. Currency and Tax Implications - Cash dividends and other distributions are payable only in Brazilian reais, meaning exchange rate fluctuations can affect the dollar amounts received by holders of American Depositary Shares (ADSs) [212]. - Non-Brazilian holders of ADSs may be subject to Brazilian income tax on capital gains from sales, with rates varying between 15% and 22.5%, and potentially up to 25% for those in Low or Nil Tax Jurisdictions [213]. - Gains realized through transactions on Brazilian stock exchanges are exempt from Brazilian income tax if conducted according to CMN regulations and the investor is not in a Low or Nil Tax Jurisdiction [213]. - Resolution CMN 4,373 was replaced by Resolution No. 13 in December 2024, which is expected to maintain the current tax treatment for non-Brazilian holders [214]. - Holders of ADSs who exchange them for common shares risk losing certain foreign currency remittance and Brazilian tax advantages [215]. - If holders of ADSs do not qualify under Resolution No. 13, they will face less favorable tax treatment on distributions related to common shares [217]. Regulatory Risks - Brazilian law allows the government to impose temporary restrictions on remittances to foreign investors during significant balance of payments imbalances [218]. - Future restrictions could adversely affect the market price of shares and ADSs, hindering the ability to remit dividends abroad [219]. - A more restrictive policy could increase the cost of servicing foreign currency-denominated debt obligations, potentially leading to default [220].

Financial Performance - The company reported a loss from operations of $17.3 million for the year ended December 31, 2025, a 20% decrease from a loss of $21.6 million in 2024[378]. - Net loss applicable to common shareholders was $17.3 million in 2025, compared to $19.8 million in 2024, reflecting a reduction in losses[406]. - Cash balance at December 31, 2025, was $5.2 million, with an accumulated deficit of $264.5 million[407]. - The company expects existing cash to fund operations into April 2026 but will need to raise additional capital to continue operations[433]. - The Company has substantial doubt regarding its ability to continue as a going concern within one year due to recurring losses and the need for additional capital[438]. Research and Development - Research and development expenses decreased by 60% to $2.8 million in 2025, down from $7.0 million in 2024[378]. - The company aims to establish AKTX-101 as a best-in-class Trop-2-targeting ADC for treating various solid tumors[361]. - The company is focused on advancing its lead program, AKTX-101, through IND-enabling activities, with a projected timeline to enter clinical trials by Q1 2027[367]. - Total research and development expenses decreased by approximately $4.2 million, or 60%, from $6.983 million in 2024 to $2.815 million in 2025[381]. - ADC preclinical development expenses increased by $1.238 million, or 100%, from $47,000 in 2024 to $1.285 million in 2025[381]. - HSCT-TMA clinical development expenses decreased by $1.817 million, or 96%, from $1.896 million in 2024 to $79,000 in 2025 due to the suspension of the AK901 clinical program[383]. - Chemistry, manufacturing and control expenses decreased by $3.281 million, or 94%, from $3.497 million in 2024 to $216,000 in 2025, also due to the suspension of the AK901 program[384]. - The company plans to invest in additional ADC-related discovery and pre-clinical development activities following the strategic prioritization of its ADC technology[382]. Financing Activities - In December 2025, the company completed equity-related transactions totaling approximately $8.7 million in gross cash proceeds[376]. - The Company closed its 2025 Registered Direct Offering on October 16, 2025, issuing 3,125,000 ADSs with gross proceeds of $2.5 million[416]. - The company entered into a securities purchase agreement on December 16, 2025, for the issuance of 10,043,774 ADSs, raising approximately $5 million in gross proceeds[413]. - The Placement Agent received a cash commission of 8.0% and a management fee of 0.5% from the December 2025 Offerings[415]. - The Company issued August 2025 Notes with an aggregate purchase price of $3,011,000 and a principal amount of $3,763,750[428]. - The company recognized $14.2 million in net proceeds from debt and equity securities issuance in 2025, compared to $11.8 million in 2024[446]. Management Changes - The company appointed a new President and CEO, Mr. Abizer Gaslightwala, in April 2025, and an Interim CFO, Mr. Kameel Farag, in October 2025[374][375]. Impairment and Valuation - An impairment charge of $5.18 million was recorded for the PHP 303 IPR&D asset due to resource reprioritization and lack of further development plans[460]. - As of December 31, 2025, the company performed its annual impairment test and concluded that the fair values of the AKTX 101 IPR&D asset and reporting unit exceeded their carrying values[461]. - The estimated fair value of Adjusted Warrants at the acquisition closing date was $1.8 million, calculated using the Black Scholes Option Pricing Model[450]. Currency and Interest Rate Risks - The company's operations are subject to currency transactional risk, particularly with fluctuations in the U.S. dollar against the British Pound, Euro, Swiss Franc, and Korean Won, which may impact profitability and shareholders' equity[466]. - The functional currency is the U.S. dollar, with activities predominantly executed in U.S. dollars, Euros, and British Pounds, and no significant operational exposures to currency fluctuations have been identified[467]. - The company has short-term promissory notes and a short-term insurance premium financing arrangement initiated in January 2026, with no current plans to hedge against interest rate risks[468]. - A hypothetical ten percent adverse movement in interest rates would result in immaterial potential losses in future earnings and cash flows, although actual effects may differ[469].

Oncology Product Development - The company is focused on developing targeted radiotherapies for oncology, with a pipeline including two novel solid tumor product candidates, ATNM-400 and Actimab-A, and two targeted conditioning agents, Iomab-B and Iomab-ACT[16]. - ATNM-400 has demonstrated pre-clinical efficacy across multiple solid tumors, with a combined patient population exceeding 800,000 in the U.S., outperforming leading therapies by 3-5 fold in tumor growth inhibition[23]. - Actimab-A targets myeloid-derived suppressor cells (MDSCs) and is positioned to expand the $40+ billion PD-1 inhibitor market by addressing resistance mechanisms in solid tumors[24]. - The hematology franchise, including Iomab-B, has been validated in over 500 patients and is aligned with FDA for a Phase 2/3 trial, targeting approximately 150,000 patients in relapsed/refractory AML[25]. - Actimab-A is set to undergo a basket trial in combination with PD-1 inhibitors across four solid tumor types, with initial data expected in 2H:2026[35]. - Actimab-A aims to address a combined patient population in AML and MDS estimated at over $2 billion, with potential for mutation-agnostic therapy[91]. - Iomab-ACT is being developed as a universal conditioning agent for cell and gene therapies, improving access and outcomes while reducing toxicities associated with traditional conditioning methods[92]. - Actimab-A is being evaluated as a backbone therapy in combination with venetoclax and a hypomethylating agent for newly diagnosed AML patients, potentially benefiting a broad patient population[93]. - Iomab-B has been evaluated in over 500 patients, demonstrating successful donor cell engraftment in elderly R/R AML patients who are ineligible for conventional conditioning[99]. - The Phase 3 SIERRA trial met its primary endpoint of durable complete remission (dCR) but did not meet the secondary endpoint of overall survival (OS) due to patient crossover[99]. - Iomab-B has composition of matter patents extending to 2038 and has potential market expansion beyond R/R AML, addressing approximately 150,000 patients across multiple disease indications[101]. Clinical Trials and Regulatory Strategy - The company has established a comprehensive end-to-end supply chain for clinical trials, successfully executing multiple Phase 1-3 trials across its programs[28]. - The company is actively seeking strategic partnerships to advance its late-stage hematology programs, leveraging existing relationships to support cost-effective clinical development[38]. - The FDA has a standard goal to review applications within 10 months of filing, or 6 months for priority review drugs[150]. - The FDA requires a randomized head-to-head trial to demonstrate overall survival (OS) benefit for Iomab-B, which is necessary for a Biologics License Application (BLA) filing[200]. - The FDA requires a Biologics License Application (BLA) to include results from product development, laboratory and animal studies, and human trials before commercial marketing can begin[213]. - The FDA may grant deferrals for submission of data or full/partial waivers, but there is no assurance that the BLA will be accepted or approved in a timely manner[213]. - The FDA may ultimately deny approval of a BLA if it does not meet regulatory criteria, regardless of submitted data[214]. - The clinical trial process is lengthy and requires substantial resources, making it difficult to predict the timing of BLA submissions[214]. Manufacturing and Supply Chain - The company is investing in a radiopharmaceutical manufacturing facility expected to be operational by 2H:2026, enhancing its clinical supply capabilities[29]. - The internal cGMP radiopharmaceutical manufacturing facility is expected to be operational in 2H:2026, designed to manufacture Ac-225 based radioconjugates for clinical trials[39]. - The company has developed proprietary technology for commercial-scale production of Ac-225, which may represent a significant competitive advantage in radiopharmaceutical development[106]. - A radiopharmaceutical manufacturing facility is expected to be operational in the second half of 2026, designed for Ac-225-based final drug products[107]. - The company maintains a comprehensive supply chain for isotope production and patient administration, ensuring reliable service to approximately 50 leading cancer centers[108]. - The company’s manufacturing strategy combines internal capabilities with external partnerships to create a flexible and cost-effective supply chain[139]. Intellectual Property and Competitive Landscape - The intellectual property portfolio includes approximately 250 patents, providing extensive protection for product candidates and creating barriers to entry for competitors[30]. - The company’s intellectual property portfolio includes patents that provide market exclusivity in major territories such as the U.S., Europe, and Japan[136]. - The competitive landscape includes large pharmaceutical companies and clinical-stage radiopharmaceutical companies, with a focus on novel, first-in-class targets to differentiate from competitors[115]. Financial Performance and Risks - The company has incurred net losses every year since inception and anticipates continuing to incur net losses in the future[170]. - The company has generated no revenue from commercial sales to date, highlighting its status as a clinical-stage biopharmaceutical company[171]. - The company is highly dependent on the clinical, regulatory, and commercial success of its pipeline candidates, including ATNM-400, Actimab-A, and Iomab-ACT[170]. - The company has incurred net losses every year since inception, with an accumulated deficit of $409.7 million as of December 31, 2025, and a net loss of $33.9 million for the year ended December 31, 2025[173]. - The company expects to continue operating at a net loss due to ongoing research and development efforts, clinical trials, and the development of manufacturing and marketing capabilities[173]. - The company has limited access to capital markets, making it difficult to secure funding on favorable terms, which could adversely affect its business and operations[179]. - The company is highly dependent on the clinical, regulatory, and commercial success of its drug candidates, including ATNM-400, Actimab-A, and Iomab-ACT, none of which have received regulatory approval yet[180]. Workforce and Operational Challenges - The company employs 25 full-time employees, with 12 holding Ph.D. or M.D. degrees, focusing on research and development activities[144]. - The company has reduced its workforce by approximately 20% in the third quarter of 2024, primarily from clinical and CMC groups, but does not expect this to materially impact operations[186]. - Future health epidemics could adversely affect clinical trial operations, including recruitment and retention of patients and investigators[192]. - The company may need to establish commercial sales and marketing capabilities if its product candidates are approved, which would be expensive and time-consuming[191]. Cybersecurity and Regulatory Compliance - The company faces risks related to cybersecurity, which could adversely affect its business operations[170]. - The company has cybersecurity insurance, but it may not be sufficient to cover losses from cyberattacks[197]. - The company must comply with various regulatory requirements, including the Drug Supply Chain Security Act (DSCSA), which affects product distribution and tracing[157]. - The company is subject to foreign regulations governing clinical trials and commercial sales, which can vary significantly from U.S. regulations[160]. - Regulatory disruptions, such as government shutdowns, could delay clinical development and regulatory approvals, impacting business strategy[205]. - The FDA's evolving regulatory policies and potential changes in leadership could create challenges for the company's development efforts[205].