Debt Management - The company reduced its total outstanding indebtedness from $1.8 billion at December 31, 2024, to $1.4 billion at December 31, 2025[330] - The company anticipates that the reduction of indebtedness will remain a key priority for the foreseeable future[330] - The Company's debt structure included borrowings of $1.4 billion as of December 31, 2025, primarily from Senior Notes and Senior Secured Second Lien Notes[419] Investment Performance - Total securities and other investments owned increased from $282.3 million in 2024 to $446.8 million in 2025, representing a growth of 58.2%[344] - The carrying value of Babcock & Wilcox Enterprises, Inc. common stock rose to $174.0 million in 2025, accounting for 38.9% of total securities and other investments owned[344] - The carrying value of investments in other private equities increased from $107.6 million in 2024 to $135.6 million in 2025, reflecting a growth of 26.0%[347] - The carrying value of partnership interests and other securities increased from $15.9 million in 2024 to $41.9 million in 2025, a growth of 163.5%[348] - The company’s investment approach is value-oriented, emphasizing complex transactions consistent with its investment philosophy[334] Revenue and Income - Total revenues increased by approximately $221.2 million to $967.6 million for the year ended December 31, 2025, compared to $746.4 million for the year ended December 31, 2024, representing a 29.6% increase[362] - Revenue from trading gains increased by $182.5 million, while revenue from fair value adjustments on loans increased by $325.1 million[362] - Services and fees revenue decreased by $149.5 million, with notable declines in the Wealth Management segment ($39.4 million) and the Capital Markets segment ($32.3 million)[363] - Operating income improved to $75.6 million for the year ended December 31, 2025, compared to a loss of $497.5 million in the previous year[357] - Net income for the year ended December 31, 2025, was $310.3 million, a significant recovery from a net loss of $774.9 million in 2024[357] Compliance and Regulatory Matters - The company filed its 2024 10-K on September 19, 2025, after receiving multiple Staff Determination Letters from Nasdaq for non-compliance[349] - The Company regained compliance with Nasdaq's Periodic Filing Rule on January 27, 2026, after timely filing its Q1, Q2, and Q3 reports[353] - Nasdaq imposed a "Mandatory Panel Monitor" for one year, requiring the Company to meet periodic filing requirements to avoid delisting[353] - The Company is subject to conditions outlined in the Decision Letter from the Nasdaq Hearings Panel to maintain its listing[352] - Future compliance with Nasdaq's continued listing requirements is uncertain, as there is no assurance the Company will file reports timely[354] Cash Flow and Expenditures - Net cash used in operating activities was $59.7 million for the year ended December 31, 2025, a decrease of $323.3 million compared to $263.6 million provided in 2024[423] - Cash provided by investing activities was $311.5 million for the year ended December 31, 2025, down from $440.5 million in 2024, primarily due to reduced proceeds from business sales[424] - Cash used in financing activities was $279.4 million for the year ended December 31, 2025, compared to $671.9 million in 2024, reflecting a net increase in debt-related proceeds[425] - The Company had $226.6 million of unrestricted cash and cash equivalents as of December 31, 2025[416] - The Company expects capital expenditures to be less than $7.0 million for the next twelve months[415] Segment Performance - The company operates in seven reportable business segments, including Capital Markets, Wealth Management, and Consumer Products[331] - Capital Markets segment revenues decreased by approximately $32.3 million to $154.4 million in 2025 from $186.8 million in 2024, driven by declines in corporate finance, consulting, and investment banking fees[364] - Wealth Management segment total revenues fell by $25.2 million to $175.6 million in 2025, a decrease of 12.5%, with brokerage revenues down 24.3% and advisory revenues down 34.7%[365] - Lingo segment revenues decreased by $31.7 million to $164.1 million in 2025, primarily due to a $24.8 million drop in subscription revenue following the divestiture of its wholesale carrier business[366] - magicJack segment revenues decreased by $4.5 million to $36.7 million in 2025, attributed to a decline in active subscription customers and APP users[368] Expenses and Cost Management - Total selling, general and administrative expenses decreased by $89.7 million to $599.7 million for the year ended December 31, 2025, down from $689.4 million in 2024, representing a 13.0% decline[383] - Direct cost of services decreased by $74.5 million to $139.4 million in 2025, primarily due to reductions in the Lingo segment and the sale of Atlantic Coast Recycling[380] - Cost of goods sold decreased by $22.3 million to $145.4 million in 2025, mainly due to lower sales across all products in the Consumer Products segment[381] - The Capital Markets segment's expenses decreased by $0.4 million to $170.1 million, primarily due to a $3.2 million reduction in employee compensation and benefits[384] - Wealth Management segment expenses decreased by $34.0 million to $160.3 million, largely due to a $30.4 million reduction in employee compensation following the sale of part of the business[385] Taxation and Impairment - The effective income tax benefit rate was (4.3%) for the year ended December 31, 2025, compared to 2.4% for the year ended December 31, 2024[406] - Income from discontinued operations for GlassRatner and Farber was $70.8 million for the year ended December 31, 2025, compared to $21.6 million for the year ended December 31, 2024[409] - The Company recorded non-cash impairment charges of $105.4 million during the year ended December 31, 2024, including $84.3 million related to goodwill and $5.0 million related to tradenames[441] - An impairment charge of $1.5 million was recognized for the Targus tradename in the Consumer Products segment at June 30, 2025, based on a 3.5% growth rate and a discount rate of 22.2%[440] - As of December 31, 2025, a valuation allowance for deferred tax assets was recorded, indicating that it is more likely than not that these assets will not be realized[447] Fair Value and Tax Legislation - The Company has a fair value measurement hierarchy, with Level 1 inputs being the highest priority, including unadjusted quoted prices in active markets[433] - The Company performed a quantitative assessment for goodwill and other intangible assets at December 31, 2025, concluding no goodwill impairment was necessary[439] - Deferred tax assets are recognized if their realizability is determined to be more likely than not, and management regularly reviews these assets[446] - The Company’s provision for income taxes includes current and deferred taxes, which are based on estimates that may differ from actual results[449] - The Company continues to monitor evolving tax legislation, including the Pillar Two directive establishing a 15% minimum effective tax rate for multinational enterprises[445]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________ FORM 10-K _____________________________________ (Mark One) x 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 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 001-37503 _________________________________ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): March 31, 2026 VolitionRx Limited (Exact name of registrant as specified in its charter) (State or other jurisdiction (Commission File Number) (IRS Employer Delaware 001-36833 91-1949078 (Address of principal executive offices and Zip Code) +1 (512) 774-8930 (Registrant's telephone number, incl ...

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 January 31, 2026 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 001-38026 J.Jill, Inc. (Exact name of Registrant as specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 45-1459825 (State or other jurisdiction of incorp ...

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 LeonaBio, Inc. 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 001-39503 (Exact name of registrant as specified in its charter) | Delaware | 45-3368487 | | --- | --- | | (State or other ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 ____________________ FORM 20-F ____________________ (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ 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 ____ ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K 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 COMMISSION FILE NUMBER: 001-36279 TVARDI THERAPEUTICS, INC. (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report For the transition period from to OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

Drug Development and Clinical Trials - Connect Biopharma is advancing rademikibart, a next-generation antibody targeting IL-4Rα for asthma and COPD treatment[21]. - The Phase 2 trials for rademikibart initiated in May 2025 aim to evaluate treatment failure over 28 days post-randomization[25]. - In January 2026, new data indicated rademikibart's rapid improvement in FEV, with many patients showing improvements of ≥200 mL as early as 15 minutes post-dosing[27]. - Rademikibart demonstrated mean FEV improvements of approximately 200-400 mL maintained through Day 29 in asthma and COPD patients[27]. - The global Phase 2b trial of rademikibart demonstrated significant improvement in lung function, with a 140 ml (p = 0.005) increase in FEV for the 150 mg group and a 189 ml (p < 0.001) increase for the 300 mg group at Week 12 compared to placebo[36]. - Improvements in asthma control were noted, with absolute placebo-adjusted changes in ACQ-6 score at Week 24 of -0.33 (p < 0.01) for the 300 mg group and -0.44 (p < 0.001) for the 150 mg group[36]. - In patients with baseline eosinophils >150 cells/µL, the 150 mg group showed a statistically significant reduction in exacerbations (p = 0.023)[36]. - Rademikibart was well-tolerated, with low incidences of adverse events such as injection site reactions (1.8%) and conjunctivitis (3.5%) reported[44]. - The company has only one Product Candidate, rademikibart, currently in clinical development, and has invested substantially all efforts and financial resources into its development[195]. - The company may need to conduct additional clinical trials if it fails to obtain accelerated approval, increasing development costs and delaying commercialization[194]. - The ability to recruit competent clinical trial investigators and maintain patient consents is crucial for the success of clinical trials[182]. - Regulatory authorities may suspend or terminate clinical trials due to various factors, including failure to comply with regulatory requirements[170]. - The company has engaged CROs to conduct clinical trials outside the U.S., including in Ukraine, but the ongoing Russia-Ukraine war has impacted trial progress[172]. - The company may experience delays in patient enrollment for clinical trials, which could adversely affect research and development efforts[176]. - Serious adverse events associated with Product Candidates could lead to interruptions or halts in clinical trials and regulatory approval[179]. - The company must comply with evolving regulatory requirements, such as the EU Clinical Trials Regulation, which may impact development plans[175]. - Delays in clinical trials could shorten the exclusive commercialization period for Product Candidates, allowing competitors to enter the market sooner[174]. - The company has never submitted an NDA or BLA and may face challenges in obtaining regulatory approvals for its Product Candidates[203]. - The regulatory approval processes by the FDA and NMPA are lengthy and unpredictable, typically taking many years after the commencement of clinical trials[204]. - The company has not obtained regulatory approval for any Product Candidates in the U.S. or other jurisdictions, which may hinder future development[205]. - Approval policies and regulations may change during clinical development, potentially affecting the approval process for Product Candidates[206]. - The FDA and NMPA can delay or deny approval for various reasons, including disagreements on clinical trial design and unexpected side effects[207]. Market Opportunities and Financials - Asthma affects approximately 23 million adults and 5 million children in the U.S., with 50% of patients failing to improve on first-line treatments[22]. - COPD impacts around 14.2 million adults in the U.S., with 85% of patients not improving on initial therapies[23]. - The AD market in China represents a significant opportunity, with an estimated 70 million patients affected[30]. - Rademikibart's development plan focuses on addressing unmet needs in acute asthma and COPD, targeting approximately 1 million and 1.3 million patients visiting emergency departments annually[28]. - The company incurred net losses of $55.5 million and $15.6 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated loss of $400.8 million as of December 31, 2025[153]. - The company expects to continue incurring significant losses for the foreseeable future as it conducts ongoing and planned preclinical studies and clinical trials[153]. - The company anticipates that additional capital will be required to fund product development and commercialization efforts[155]. - The company has an effective shelf registration statement covering the offering of up to $300 million in securities, including up to $150 million of ordinary shares[164]. - The company’s ability to raise additional capital may cause substantial dilution to shareholders and restrict operations[164]. - The company’s future financing requirements will depend on various factors, including the progress and results of clinical trials and regulatory reviews[160]. Regulatory Environment - The FDA requires extensive regulatory compliance for drug approval, including the submission of an Investigational New Drug (IND) application[66]. - Clinical trials are divided into three phases, with Phase 1 focusing on safety and dosage, Phase 2 on preliminary efficacy, and Phase 3 on larger population testing[76]. - The NDA or BLA submission requires comprehensive data from clinical trials and payment of a substantial application user fee to the FDA[75]. - The FDA requires an initial pediatric study plan to be submitted within 60 days after an end-of-Phase 2 meeting for any NDA or BLA that includes a new active ingredient or indication[77]. - The FDA aims to review standard applications within 10 months and priority reviews within 6 months after filing, with possible extensions for major amendments[78]. - Approval of an NDA or BLA is contingent upon compliance with cGMP requirements and successful inspections of manufacturing facilities[79]. - The FDA may issue a Complete Response Letter (CRL) detailing deficiencies in the NDA or BLA, which could require additional clinical trials or labeling changes[80]. - Orphan drug designation can be granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S., providing potential exclusivity benefits[88]. - Products with orphan drug designation may receive exclusivity for 7 years if they are the first to be approved for the designated condition[89]. - The FDA offers expedited programs like fast track and breakthrough therapy designations to accelerate the development and review of qualifying product candidates[82][84]. - Pediatric exclusivity can provide an additional 6 months of exclusivity if clinical trials in children are conducted in response to an FDA request[99]. - The FDA imposes ongoing regulatory requirements post-approval, including record-keeping and reporting of adverse experiences[92]. - Non-compliance with FDA regulations can lead to severe consequences, including product recalls and withdrawal of approval[93]. - The Biologics Price Competition and Innovation Act (BPCIA) allows biosimilar applications to be submitted to the FDA four years after the reference product's first licensing, with a 12-year exclusivity period for the reference product[101]. - The ACA increased Medicaid rebates for brand-name drugs from 15.1% to 23.1%, impacting pricing strategies for pharmaceutical manufacturers[119]. - The Inflation Reduction Act of 2022 implements significant changes to the Medicare program, including drug pricing reforms[123]. - The EU's HTA Regulation, effective from January 2025, aims to provide a transparent framework for health technology assessments, influencing pricing and reimbursement decisions[118]. - Third-party payors are increasingly reducing reimbursements for pharmaceutical products, which may limit sales and affect physician usage[114]. - The U.S. government and state legislatures are implementing cost-containment programs, including price controls and restrictions on coverage, impacting market dynamics[114]. - The approval process for pharmaceutical products varies significantly across countries, with no assurance that FDA approval will lead to foreign approvals[103]. - The federal Anti-Kickback Statute imposes strict regulations on remuneration practices, with potential criminal and civil penalties for violations[105]. - The Physician Payments Sunshine Act requires annual reporting of certain payments to healthcare providers, adding compliance complexity for manufacturers[110]. - The BPCIA allows biosimilars to rely on previous FDA determinations of safety and effectiveness, potentially reducing approval costs and time[100]. - The IRA imposes inflation rebates on drug manufacturers if prices increase faster than inflation, starting in 2023, and caps Medicare Part D out-of-pocket spending at $2,000 beginning in 2025[124]. - The OBBBA enacted in July 2025 is expected to decrease Medicaid enrollment and services, potentially impacting sales of commercialized products[125]. - The Trump administration's proposed Globe and Guard regulations could require drug manufacturers to pay rebates based on most favored nation pricing, significantly affecting the pharmaceutical sector[126]. - States in the U.S. are implementing regulations for pharmaceutical pricing transparency, which may include price limits on certain drugs[127]. - Future healthcare reforms may lead to stricter coverage criteria and downward pressure on prices received for approved products[128]. Intellectual Property and Patents - As of December 31, 2025, the company holds over 93 issued patents and has more than 50 pending patent applications globally[54]. - The patent family for rademikibart includes two granted U.S. patents and over 28 foreign patents, with expected expiration in 2037 and 2040 for different formulations[55]. - The company intends to pursue patent protection for composition, method of use, process, dosing, and formulation for its Product Candidates[57]. - Patent terms typically last 20 years from the earliest filing date, with potential extensions under the Hatch-Waxman Act for FDA-approved drugs of up to five years[56]. - The company may submit provisional patent applications to the USPTO, which must be followed by non-provisional applications within 12 months[58]. - The Patent Cooperation Treaty (PCT) allows for a single application to be filed within 12 months of the original priority date, enabling protection in multiple member states[59]. - The company continuously reassesses its patent portfolio to ensure maximum coverage and value for its processes and compositions[61]. - There is no assurance that the company will be able to obtain or maintain all necessary patents and intellectual property rights[62]. - The company may rely on trade secrets to protect proprietary information that is not suitable for patent protection[63]. Company Operations and Workforce - The company has 64 full-time employees as of December 31, 2025, with 38 in research and development and 26 in general administration[141]. - The equity incentive plan aims to attract and retain employees through share-based compensation awards[142]. - The company offers competitive compensation and benefits, including a 401(k) plan, health insurance, and an employee stock purchase plan[143]. - The company does not own manufacturing facilities and relies on third-party contract manufacturers for production[50]. - The Foreign Investment Law of the PRC governs investment activities by non-PRC investors, impacting the company's operations in China[136]. - The company is subject to various financial disclosure and securities trading regulations as a public entity, including SEC oversight[140]. - The company has incurred significant costs associated with operating as a public company and expects these costs to continue[157]. - The company maintains most of its cash and cash equivalents in accounts with major financial institutions, which may exceed insured limits[163]. - The company faces risks related to the lengthy and expensive clinical drug development process, which may incur unforeseen costs or delays[168]. - The company relies on third parties for conducting preclinical studies and clinical trials, which may impact the ability to obtain regulatory approval if not managed properly[217]. - Compliance with GCP and cGMP regulations is critical; failure to do so may require repeating clinical trials and delay the approval process[218]. - Clinical sites and CROs have the right to terminate agreements under certain conditions, which could adversely affect the company's clinical trials[220].

Drug Development Pipeline - The company has a pipeline of seven drug candidates, including ENV 105 and ENV 205, targeting significant unmet needs in prostate and lung cancer markets, with the global prostate cancer therapeutics market valued at USD 7.9 billion and EGFR mutant non-small cell lung cancer at USD 1.7 billion[25]. - ENV 105 has shown a clinical benefit rate of 62% in a Phase 2 trial involving heavily pre-treated prostate cancer patients, indicating disease stabilization or regression[25]. - The Phase 2 trial for ENV 105 is being conducted at multiple centers, including Cedars-Sinai, University of Utah, and City of Hope, focusing on patients resistant to standard hormone therapies[31]. - The company initiated three clinical trials in the fall of 2023 for KROS 201 and ENV 105, with ENV 105 targeting both cancer cells and their supportive non-cancer environment to address resistance mechanisms[24]. - KROS 101, a small molecule targeting the GITR ligand, is in pre-IND studies and aims to enhance the antitumor immune response by depleting regulatory T cells[39]. - ENV 205 is designed to target elevated mitochondrial DNA in circulation, which is associated with chemotherapy resistance and aims to restore chemotherapy sensitivity while reducing side effects[33]. - The company is developing KROS 102, KROS 301, and KROS 401, which target various mechanisms of immune suppression at the tumor site[32]. - KROS 201 is an activated T cell therapy targeting glioblastoma, with the market for T cell therapy expected to grow from $4.9 billion in 2021 to $20.8 billion by 2030, reflecting a CAGR of 20.4%[62]. - ENV 105 is in a Phase 2 clinical trial for prostate cancer patients resistant to androgen-targeted therapy, with a potential market of $9 billion for a six-month dose in the U.S. alone[58]. - ENV 205 has shown promise in preclinical studies for limiting chemotherapy-resistant prostate cancer, with the chemotherapy market for docetaxel projected to grow from $137 billion in 2024 to $329 billion by 2033[55]. - KROS 301 is in active preclinical development, targeting the NF-kB pathway, with the global small-molecule cancer therapies market valued at $175.3 billion in 2021[63]. - KROS 401 is a cyclic peptide in preclinical development, with the global peptide therapeutics market size estimated at $117.3 billion in 2024, expected to grow at a CAGR of 10.77%[64]. - The global immune checkpoint inhibitor market size was $47.4 billion in 2023 and is anticipated to reach $189.1 billion by 2032, with a CAGR of 16.7% from 2024 to 2032[61]. - ENV 205 is positioned to address cachexia, a condition affecting 50% of cancer patients, with the specific cancer cachexia therapeutics market projected to grow from over $2 billion in 2022 to over $4 billion by 2032[65]. Clinical Trials and Regulatory Challenges - The company aims to develop innovative therapeutics targeting drug resistance and immune suppression in cancer treatment, with a focus on advancing its clinical pipeline[67]. - The company plans to complete enrollment in a Phase 2 trial of ENV 105 for prostate cancer and a Phase 1 trial for non-small cell lung cancer patients on Tagrisso[67]. - The time required to obtain regulatory approval is unpredictable and typically takes many years, influenced by various factors including the discretion of regulatory authorities and government funding levels[130]. - The company has not submitted a marketing application for any product candidates in any country or region, which is a lengthy and uncertain process requiring extensive data to establish safety and efficacy[133]. - Only a small percentage of drugs in development successfully complete the FDA approval process and are commercialized, posing a significant risk to the company's business and financial condition[134]. - Even if regulatory approval is obtained, it may be contingent on the performance of additional costly clinical trials, which could limit the approved indications or patient populations[145]. - The company relies on third-party contract research organizations for regulatory application support, which may introduce additional risks due to limited experience in this area[129]. - Regulatory approval processes may change during clinical development, impacting the ability to commercialize products in a timely manner[131]. - The company must demonstrate that its product candidates are safe and effective, which requires extensive preclinical and clinical studies that can be costly and time-consuming[139]. - Delays in clinical trials can occur due to various factors, including regulatory requirements, patient recruitment challenges, and unforeseen safety issues[141]. - The company faces significant risks related to the potential for negative clinical trial results, which could prevent obtaining regulatory approval or achieving market acceptance[138]. - Delays in clinical trials could harm the commercial prospects of product candidates and increase costs, potentially allowing competitors to market their products first[147]. - Future regulations from authorities like the FDA may increase the time and cost required for clinical trials, impacting the ability to obtain marketing approvals[148]. - The company has limited experience in designing and implementing clinical trials, which could lead to increased costs and delays in obtaining regulatory approvals[156]. - Serious adverse events (SAEs) or undesirable side effects identified during development could lead to the discontinuation of clinical programs or limitations on product use, affecting commercial potential[150]. - Positive results from early clinical trials may not predict future outcomes, and there is a high failure rate for drugs in clinical development[154]. Financial and Operational Considerations - The company has incurred significant losses since inception and expects to continue incurring losses over the next several years, with no products approved for commercial sale[118]. - The company requires substantial additional funding to meet financial needs and pursue business objectives, with future capital requirements dependent on various factors[119]. - The company has limited operating history, making it difficult to evaluate its prospects for achieving business objectives and commercial success[123]. - The company may face dilution of stockholder ownership if additional capital is raised through equity offerings or debt financings[121]. - The company is committed to employee development, offering competitive compensation and benefits to attract and retain skilled personnel[112]. - The company lacks a sales or marketing infrastructure and limited experience in the sale, marketing, or distribution of pharmaceutical products[200]. - Establishing sales, marketing, and distribution capabilities will require substantial resources and could delay product launches[200]. - Market acceptance of approved product candidates will depend on various factors, including the size of the target market[199]. - Coverage and adequate reimbursement from third-party payors are critical for the commercial success of any product candidates[203]. Patent and Intellectual Property - The company holds multiple patents related to cancer treatment, including compositions and methods for treating cancer and autoimmune diseases, with expiration dates ranging from 2037 to 2040[91][92][93]. - The patent for "Sensitization of Tumors to Therapies through Endoglin Antagonism" is currently in application status in Australia and Canada, with a protection date until June 14, 2037[91][92]. - The company holds a patent for "Method of Generating Activated T Cells for Cancer Therapy," which is set to expire on August 10, 2040 in Canada[91]. - The patent portfolio includes compositions for treating diseases by depletion of mitochondrial or genomic DNA from circulation, with a protection date until November 25, 2040 in Canada[91]. - The company has secured patents in multiple jurisdictions, including China, Europe, and Japan, for various cancer treatment methods and compositions[92][93]. - The patent for "Antibody Formulations and Uses Thereof" is granted in India and Japan, with an expiration date of September 5, 2033[93]. - The company has a granted patent for treating fibrosis, which is applicable in France, Germany, Switzerland, and the United Kingdom, expiring on September 18, 2035[93]. - The patent for "Compositions and Methods for Treating Cancer and Autoimmune Diseases" is granted in Japan, with a protection date until August 8, 2039[93]. - The company is actively pursuing new technologies and methods for cancer treatment, as evidenced by its extensive patent applications and granted patents[91][92][93]. - The company’s patent strategy indicates a strong focus on innovative cancer therapies, positioning it well for future market opportunities[91][92][93]. Acquisitions and Corporate Structure - The company acquired Enviro Therapeutics, Inc. in June 2021, enhancing its pipeline with advanced drug candidates in Phase 1 and Phase 2 trials[21]. - Kairos Pharma conducted a 1-for-2.5 reverse stock split on May 10, 2023, resulting in 10,334,357 shares of common stock outstanding[98]. - The company acquired AcTcell Biopharma, issuing 5,045,000 shares for all outstanding shares of AcTcell[99]. - The acquisition of AcTcell was treated as a transaction under common control, recognizing the historical cost basis of AcTcell's assets and liabilities[100]. - Kairos acquired Enviro in a share exchange, issuing 6,000,000 shares of restricted common stock, representing approximately 20% of the outstanding shares on a fully diluted basis[102]. - Following the Enviro-Kairos share exchange, Kairos had approximately 19,825,957 shares of common stock issued and outstanding on a fully diluted basis[103]. - Effective April 17, 2025, Kairos assumed all responsibilities and liabilities of Enviro under existing agreements, leading to Enviro's dissolution[104]. Market and Economic Factors - The global cancer drug spending was valued at approximately $232 billion in 2024 and is expected to reach $532 billion by 2031, driven by targeted therapies and immuno-oncology[56]. - The healthcare industry's trend towards cost containment may impact the demand and pricing of drugs, affecting commercialization efforts[205]. - The company faces risks associated with international marketing, including differing regulatory requirements and potential economic instability in foreign markets[212]. - The company is exposed to product liability claims that could result in substantial liabilities and limit commercialization of its products[208]. - The company may not be able to obtain adequate product liability insurance coverage, which could adversely affect its operations and share price[209]. - The reliance on single-sourced third parties for clinical trials and manufacturing may lead to delays if those parties fail to perform satisfactorily[215]. - The company must navigate various risks related to compliance with healthcare laws and regulations, which could result in significant penalties and reputational harm[214].