Clinical Trials - The company has completed a Phase 1 clinical trial of ARD-101 in healthy volunteers and a Phase 2 clinical trial in subjects with hyperphagia associated with Prader-Willi Syndrome (PWS), showing a mean decline of approximately 9 points in HQ-CT scores at day 28 for 7 subjects[19]. - In the Phase 2 trial, 12 subjects completed treatment at a fixed dose of 200 mg BID, with no significant treatment-related adverse events reported[19]. - The company initiated a Phase 3 clinical trial for hyperphagia associated with PWS, known as the HERO trial, in December 2024, and has since reached over 50% completion of the target enrollment of 90 patients[20]. - Enrollment and dosing in the HERO trial were voluntarily paused in February 2026 due to reversible cardiac observations, prompting a review of trial designs and protocols in collaboration with the FDA[21]. - The Phase 3 HERO trial for subjects with hyperphagia associated with PWS was initiated in December 2024, with protocol amendments to lower the minimum age of eligibility to 10 years[54]. - A voluntary pause in enrollment and dosing of the HERO trial was announced on February 27, 2026, due to reversible cardiac observations during safety monitoring[55]. - Preliminary analysis indicated a clear exposure–response relationship, where higher ARD-101 plasma concentrations are associated with an increased risk of QRS prolongation[60]. - The Phase 1 clinical trial demonstrated that ARD-101 was well-tolerated in healthy volunteers, with no serious adverse events reported[53]. - In a Phase 2 trial, ARD-101 (200 mg, twice daily) reduced hunger by 34% from screening in participants, with a p-value of <0.001[87]. - The average reduction in hyperphagia score among subjects evaluated on HQ-CT 9 was approximately eight points at 28 days[108]. - In Part 2 of the Phase 2 trial, subjects experienced an average decrease of 7.8 points in HQ-CT 9 score at day 28[114]. - A total of 19 subjects with PWS received at least one dose of ARD-101, with adverse events generally mild to moderate; no Grade 3 or higher treatment-related adverse events were observed[135]. - The HERO trial was voluntarily paused in February 2026 due to reversible cardiac observations, with a comprehensive review of the data ongoing in collaboration with the FDA[141]. Financial Information - The company has raised $129.1 million prior to its IPO in February 2025, including $85.0 million from a Series C financing round[29]. - The IPO involved the sale of 6,120,661 shares at an initial price of $16.00 per share, resulting in net proceeds of approximately $87.5 million[29]. - The company plans to continue expanding its clinical management and regulatory capabilities, although the timing may be delayed due to the ongoing evaluation of the HERO trial[24]. Drug Development and Efficacy - The lead product candidate ARD-101 is being developed for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS) and has received orphan drug designation[156]. - ARD-101 aims to stimulate local secretion of CCK, potentially transforming the treatment landscape for hyperphagia associated with PWS[74]. - ARD-101 significantly stimulated the release of CCK in both mouse and human enteroendocrine cell lines[77]. - Preclinical studies suggest ARD-101 has the potential to decrease food intake and body weight without treatment tachyphylaxis, supporting its efficacy in obesity-related conditions[75]. - DEXA scans from the Phase 2 trial indicated a trend toward decreased body fat by approximately 1.5% and increased lean muscle by over 2% after 28 days of dosing with ARD-101[134]. - The pharmacokinetic parameters confirmed that ARD-101 was gut-restricted, reaching a steady state before day 11 at all tested dose levels[98]. - The company received Orphan Drug Designation from the FDA based on the Phase 2 trial results demonstrating significant reductions in hyperphagia scores[108]. - In the Phase 2 trial, ARD-101 demonstrated a 16-point reduction in HQ-CT score from baseline to day 28 for one subject, indicating significant efficacy[131]. - All dosing regimens of ARD-101 prevented high-fat diet-induced body weight gain in diet-induced obese mice at the 8-week treatment mark[93]. - ARD-101 dosing was well-tolerated in a Phase 2 trial, with no notable discrepancies in metabolic parameters observed[93]. Regulatory and Patent Information - The company has not yet defined its sales and marketing strategy for its product candidates, which are still in development[153]. - As of February 28, 2026, the company's patent portfolio includes 22 issued U.S. patents and 25 issued foreign patents, along with 69 pending patent applications[155]. - The company faces competition from established pharmaceutical and biotechnology companies, which may have greater financial resources and expertise in research and development[145]. - U.S. Patent No. 10,835,505 for ARD-101 is set to expire in 2038, providing marketing exclusivity for seven years upon approval[158]. - Additional patents related to ARD-101 cover various treatments, including pulmonary hypertension and asthma, with expiration dates projected between 2039 and 2042[159]. - The company is pursuing patent applications for combinations of denatonium salts and DPP-4 inhibitors aimed at treating obesity, with patents expected to expire in 2041[160]. - The patent term for individual patents is generally 20 years from the earliest filing date, with potential extensions available under the Hatch-Waxman Act[161]. - The company may rely on trade secrets to protect proprietary information that is not suitable for patent protection[162]. - The FDA regulates the approval process for drugs, requiring compliance with extensive regulations and substantial financial resources[165]. - The New Drug Application (NDA) process involves multiple stages, including preclinical and clinical trials, and requires FDA approval before marketing[167]. - Clinical trials must adhere to Good Clinical Practices (GCPs) and require approval from an Institutional Review Board (IRB)[171]. - The company must ensure compliance with regulatory requirements in each country where it seeks to conduct studies or obtain approvals[165]. - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate that the statutory standard is met for drug approval[173]. - The FDA's goal is to review NDAs within 10 months for standard review and 6 months for priority review, with priority review granted for products treating serious conditions[179]. - Orphan drug designation is granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.[184]. - Orphan drug exclusivity prevents the FDA from approving other applications for the same drug for seven years after the first approval, with certain exceptions[186]. - The Rare Pediatric Disease Priority Review Voucher program allows sponsors to obtain priority review for subsequent applications if their drug treats a rare pediatric disease[189]. - Fast track designation expedites the review process for drugs intended to treat serious conditions and demonstrates potential to address unmet medical needs[192]. - The FDA may require post-marketing studies or trials to further assess a drug's safety and effectiveness after approval[183]. - The manufacturing process must comply with cGMP requirements to ensure consistent production of quality batches of the drug product candidate[176]. - The FDA conducts pre-approval inspections of manufacturing facilities to ensure compliance with cGMPs before approving an NDA[182]. - The review process may be extended by FDA requests for additional information or clarification, potentially delaying approval[179]. - Products submitted to the FDA may qualify for expedited programs such as priority review and accelerated approval, potentially reducing review time to six months for serious conditions[193]. - Accelerated approval requires post-approval confirmatory studies to verify clinical benefits, with the FDA having increased authority to withdraw approvals if trials fail[194]. - Breakthrough Therapy designation can expedite development for products showing substantial improvement over existing therapies, with the FDA required to respond to requests within 60 days[197]. - Pediatric trials must include data assessing safety and efficacy for all relevant pediatric subpopulations, with initial Pediatric Study Plans required within 60 days of certain meetings[198]. - Post-approval requirements include ongoing monitoring, reporting adverse experiences, and compliance with promotional standards, which can affect product launch timing[199]. - Manufacturers must comply with cGMP regulations, ensuring quality control and documentation, with inspections by the FDA to verify compliance[203]. - The FDA may require post-approval testing and surveillance to monitor product effects, with non-compliance potentially leading to enforcement actions[204]. - The Hatch-Waxman amendments allow for abbreviated new drug applications (ANDAs) for generics, which do not require clinical data but must demonstrate bioequivalence[212]. - The 30-month stay can delay ANDA approvals if patent challenges arise, impacting the timeline for generic market entry[213]. - U.S. patents may be eligible for limited term extensions under the Hatch-Waxman Amendments, depending on FDA approval timing and specifics[214]. - The company may apply for restoration of patent term for currently owned or licensed patents, potentially extending patent life beyond current expiration dates[215]. - The Hatch-Waxman Amendments provide a five-year non-patent marketing exclusivity for the first approved drug containing a new chemical entity (NCE) as an active ingredient[216]. - If approved in the United States, ARD-101 may be eligible for five years of NCE exclusivity, running concurrently with seven years of orphan drug exclusivity[216]. - The FDA cannot accept ANDA or 505(b)(2) NDA filings for products containing the same active moiety during the five-year exclusivity period, with certain exceptions[216]. - The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA, plus the time between NDA submission and approval[215]. - Only one patent applicable to an approved drug is eligible for extension, and the application must be submitted before the patent expiration[215]. - The review period for patent term restoration is reduced by any time during which the applicant failed to exercise due diligence[215]. - The 30-month stay of approval for ANDA applications is extended by the time necessary to maintain the stay until 7.5 years after the approval of the reference drug NDA[216]. - The active moiety of ARD-101 has been available as a bittering agent but has not been previously approved by the FDA in an NDA[216]. - The company is considering the expected length of clinical trials and other factors when filing for relevant NDAs[215].

Revenue and Sales Performance - Greenland's revenue increased by approximately $6.75 million, or 8.0%, to approximately $90.69 million for the fiscal year ended December 31, 2025, compared to $83.94 million for the fiscal year ended December 31, 2024[296]. - The sales volume of transmission products increased by approximately 16,720 units, or 11.2%, from 149,597 sets in 2024 to 166,317 sets in 2025[296]. - Greenland's net income for the fiscal year ended December 31, 2025, was approximately $8.60 million, a decrease of approximately $6.56 million from $15.15 million in 2024[314]. - For the year ended December 31, 2025, two customers accounted for 15.07% and 10.05% of total revenue, highlighting reliance on specific customers for revenue generation[341]. Profitability and Expenses - Gross profit rose by approximately $5.91 million, or 26.2%, to approximately $28.45 million for the fiscal year ended December 31, 2025, with a gross margin of 31.4% compared to 26.8% in 2024[298]. - Operating expenses surged by 110.5% to $20.92 million in 2025, primarily due to increased stock-based compensation and research and development expenses[299]. - General and administrative expenses increased by approximately $10.41 million, or 214.6%, to approximately $15.27 million for the fiscal year ended December 31, 2025[301]. - Research and development expenses increased by approximately $0.98 million, or 33.5%, to approximately $3.92 million for the fiscal year ended December 31, 2025[302]. - Income from operations decreased by approximately $5.07 million, or 40.3%, to approximately $7.52 million for the fiscal year ended December 31, 2025[303]. Financial Position and Cash Flow - As of December 31, 2025, Greenland had approximately $17.26 million in accounts receivable, an increase of approximately $1.46 million, or 9.24%, compared to $15.80 million in 2024[325]. - Cash and cash equivalents increased to approximately $7.78 million as of December 31, 2025, up by approximately $1.12 million from $6.66 million in 2024[323]. - Working capital rose to approximately $46.97 million as of December 31, 2025, an increase of $11.86 million from $35.11 million in 2024[329]. - Net cash provided by operating activities for the fiscal year ended December 31, 2025, was approximately $15.61 million, compared to $13.34 million in 2024[331]. - Financing activities resulted in a cash outflow of approximately $15.61 million for the fiscal year ended December 31, 2025, primarily due to repayments of loans from related parties[335]. Receivables and Credit Risk - As of December 31, 2025, three customers accounted for 11.24%, 10.24%, and 10.12% of total accounts receivable, indicating a concentration risk in customer receivables[340]. - The company recorded an allowance for expected credit losses of approximately $0.02 million as of December 31, 2025, compared to nil in 2024[326]. - Notes receivable decreased by approximately $8.03 million, or 35.33%, to approximately $14.70 million as of December 31, 2025, from $22.74 million in 2024[328]. Accounting Policies and Taxation - The Company recognizes revenues when goods or services are transferred to customers, following a five-step analysis as per ASC Topic 606[343]. - The VAT rate applicable to the Company was reduced from 17% to 16% on April 30, 2018, and further to 13% starting April 1, 2019, impacting revenue recognition[343]. - The Company adopted ASC 606 on January 1, 2018, with no impact on the beginning balance of retained earnings[345]. - The Company accounts for income taxes under the liability method, with no liability for unrecognized tax benefits as of December 31, 2025[351]. - The Company has no off-balance sheet arrangements, indicating a straightforward financial structure[352]. Business Combinations and Equity Transactions - The Business Combination with Zhongchai Holding was completed on October 24, 2019, resulting in Zhongchai Holding becoming a wholly owned subsidiary of the Company[346]. - The Company issued 7,500,000 newly issued ordinary shares to acquire all equity interests of Zhongchai Holding, indicating a significant equity transaction[347]. Risks and Financial Strategy - The company plans to maintain its current debt structure and rely on government-supported loans if necessary, with Zhejiang Zhongchai having $39.69 million cash on hand as of December 31, 2025[317]. - The Company is exposed to foreign currency risk due to fluctuating exchange rates, which may impact profit reporting[339]. - Interest income decreased by approximately $0.19 million, or 21.6%, to approximately $0.68 million for the fiscal year ended December 31, 2025[304]. - Government subsidies income decreased by approximately $0.07 million to approximately $0.81 million for the fiscal year ended December 31, 2025[307]. - Other income increased by approximately $0.29 million to approximately $0.95 million for the fiscal year ended December 31, 2025[308].

Financial Performance - Aardvark Therapeutics reported a net loss of $17.6 million for Q4 2025, compared to a net loss of $8.8 million for Q4 2024, and a total net loss of $57.6 million for the year ended December 31, 2025, compared to $20.6 million for 2024[10]. - The company reported a total operating expense of $62.7 million for the year ended December 31, 2025, compared to $22.8 million for 2024[10]. - General and Administrative (G&A) expenses for Q4 2025 were $4.4 million, compared to $1.4 million in Q4 2024, with total G&A expenses for 2025 at $13.8 million versus $5.3 million in 2024[10]. - Research and Development (R&D) expenses for Q4 2025 were $14.3 million, an increase from $8.1 million in Q4 2024, with total R&D expenses for 2025 reaching $48.9 million compared to $17.4 million in 2024[10]. Cash and Assets - Cash, cash equivalents, and short-term investments totaled $110.0 million as of December 31, 2025, up from $73.7 million as of December 31, 2024, providing a runway into Q2 2027[10]. - Total current assets increased to $111,886 million in 2025 from $74,137 million in 2024, representing a growth of 50.9%[19]. - Cash and cash equivalents decreased to $47,051 million in 2025 from $61,641 million in 2024, a decline of 23.6%[19]. - Short-term investments surged to $62,976 million in 2025 from $12,022 million in 2024, a remarkable increase of 424.5%[19]. - Other assets increased to $4,940 million in 2025 from $2,635 million in 2024, a growth of 87.6%[19]. Liabilities and Equity - Total liabilities rose to $10,548 million in 2025 compared to $5,394 million in 2024, marking an increase of 95.5%[19]. - The accumulated deficit increased to $(115,918) million in 2025 from $(58,327) million in 2024, reflecting a worsening of 98.5%[19]. - Total stockholders' equity improved to $106,633 million in 2025 from $(54,643) million in 2024, indicating a significant recovery[19]. - Accounts payable decreased slightly to $2,072 million in 2025 from $2,298 million in 2024, a reduction of 9.8%[19]. - Accrued liabilities increased significantly to $8,035 million in 2025 from $2,291 million in 2024, an increase of 251.5%[19]. - Operating lease right-of-use asset decreased to $355 million in 2025 from $735 million in 2024, a decline of 51.7%[19]. Clinical Trials and Programs - Aardvark announced a voluntary pause in the Phase 3 HERO and OLE trials for ARD-101 due to unexpected cardiac observations, with further guidance expected in Q2 2026[1]. - The ARD-201 obesity program is also on voluntary pause, pending next steps with ARD-101, with further updates anticipated in Q2 2026[1]. - Aardvark is conducting a comprehensive review of data related to ARD-101 and is actively engaging with the FDA to determine next steps[4]. - Clinical data published in Molecular Metabolism showed ARD-101 significantly reduced self-reported hunger by 1.63 points compared to 0.65 points with placebo at Day 28 in a Phase 2 study[7]. - Aardvark's lead compound, ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS)[11].

Product Development and Clinical Trials - CTIM-76, a CLDN6 x CD3 TCE, targets over 50,000 patients in the U.S. with CLDN6-positive cancers, with Phase 1a interim data expected in June 2026[37]. - CT-95, an MSLN x CD3 TCE, targets over 100,000 patients in the U.S., with Phase 1a interim data expected in September 2026[38]. - CT-202, a Nectin-4 x CD3 TCE, aims to address over 125,000 patients in the U.S., with the first patient expected to be dosed in Q3 2026[39]. - The clinical development plan for CTIM-76 includes a dose escalation trial to evaluate safety and tolerability, with a focus on ovarian, endometrial, and testicular cancers[54]. - The Phase 1 trial for CT-95, targeting solid tumors likely to express mesothelin, has commenced with the first patient dosed in April 2025[67]. - The clinical development plan for CT-202 includes submitting an application to initiate a first-in-human trial, expected to start in Q3 2026[80]. - The company has initiated Phase 1 clinical trials for product candidates CTIM-76 and CT-95 in 2025, with plans for a first-in-human trial for CT-202[199]. Market Opportunity and Competition - The estimated annual incidence of CLDN6-positive cancers in the U.S. includes 19,900 ovarian, 65,900 endometrial, and 9,910 testicular cases, indicating a significant market opportunity[51]. - The estimated annual incidence of mesothelin-positive relapsed/refractory (R/R) cancer cases in the United States exceeds 100,000 patients[63]. - In the United States, the estimated annual incidence for Nectin-4 positive R/R cancer cases is greater than 125,000 patients[76]. - The company faces competition from established pharmaceutical and biotechnology companies with greater financial resources and market presence, which may impact its commercial potential[102]. - For CTIM-76, several competitors are developing T cell engagers, including Beigene and Xencor, indicating a competitive landscape in the market[104]. Financial and Operational Considerations - The company has not yet commercialized any products and has not generated any revenue from product sales[160]. - The company expects to incur significant expenses and operating losses for the foreseeable future, with future net losses depending on expenses and revenue generation capabilities[160]. - The company will need to raise additional funding to meet operational needs and capital requirements for clinical trials and other expenditures, with no current credit facility or committed sources of capital[164]. - The company anticipates that expenses will increase substantially as it continues research and development programs and seeks marketing approvals for product candidates[162]. - The company may face additional regulatory requirements and cost increases due to ongoing healthcare reforms, which could adversely affect its business[143]. Regulatory Environment - The regulatory pathway for CTIM-76, CT-95, and CT-202 is expected to classify them as biologics, requiring biologics license applications (BLA) for market introduction[117]. - The FDA offers expedited development programs, including fast track designation for products addressing serious conditions and unmet medical needs[118]. - Orphan drug designation is available for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[119]. - Products with orphan drug designation can receive exclusivity for seven years if they are the first to gain FDA approval for the indicated disease[120]. - Compliance with FDA regulations includes stringent cGMP requirements, labeling regulations, and post-market surveillance[122][124]. Intellectual Property and Licensing - The company has full worldwide development and commercialization rights to CTIM-76, CT-95, and certain CT-202 patents, enhancing its strategic position in the market[41]. - The company retains full worldwide development and commercialization rights to CT-95 and CT-202 patents, evaluating out-license opportunities for product candidates[91]. - The patent portfolio for CTIM-76 includes three granted U.S. patents and pending applications in various countries, with U.S. patents expected to expire in 2040 and 2043[108]. - The company entered into a license agreement with BioAtla for CT-202, making an upfront payment of $11 million and potential milestone payments of up to $122.5 million[90]. - The company has entered into multiple license agreements with Lonza for CTIM-76 and CT-202, allowing the use of proprietary technology for development and commercialization[95][96]. Risks and Challenges - The company may face significant delays or inability to obtain regulatory approvals due to various factors beyond its control, impacting its ability to generate revenue[187]. - Serious adverse events or side effects from product candidates could delay or prevent marketing approval, impacting sales[190]. - The company may face challenges in enrolling patients for clinical trials, which could delay development timelines and regulatory approvals[194]. - The company is subject to complex laws and regulations regarding healthcare fraud and abuse, which could impact sales and marketing practices[147]. - The company may need to conduct expensive studies to demonstrate the cost-effectiveness of its products to secure adequate reimbursement from third-party payors[144]. Human Resources and Organizational Structure - As of March 1, 2026, the company had fifteen full-time employees, relying on a limited central team for various administrative and R&D services, which may pose operational challenges[221]. - The company is highly dependent on key executives, including the CEO, CMO, CFO, and CLO, for its research, development, and commercialization objectives[222]. - The inability to recruit and retain qualified personnel may impede the company's progress in research, development, and commercialization, potentially having a material adverse effect on its business[225]. - Future growth will require significant expansion of the organization, which may disrupt operations if not managed effectively[226]. - The company faces competition from larger biopharmaceutical firms for qualified personnel, which could limit its ability to develop product candidates and maintain collaborative arrangements[227].

Revenue Performance - Total revenue for the year ended December 31, 2025, was $28.5 million, a decrease of 7% from $30.8 million in 2024[467] - Product revenue was $26.7 million in 2025, down 1% from $27.0 million in 2024, while service and other revenue fell by 53% to $1.8 million[467] - Total revenue decreased by $2.3 million, or 7%, to $28.5 million for the year ended December 31, 2025, compared to $30.8 million in 2024, primarily due to a decrease in service and other revenue[477] - Instrument revenue decreased by $1.7 million, or 21%, to $6.4 million for the year ended December 31, 2025, attributed to a decrease in the number of OGM and Ionic® instruments sold[478] - Consumables revenue increased by $1.2 million, or 9%, to $14.0 million for the year ended December 31, 2025, driven by an increase in average selling price of flowcells sold[479] - Software revenue increased by $0.2 million, or 4%, to $6.4 million for the year ended December 31, 2025, primarily due to an increase in the number of VIA software licenses sold[480] - Service and other revenue decreased by $2.0 million, or 53%, to $1.8 million for the year ended December 31, 2025, due to the discontinuation of certain clinical service offerings[481] Loss and Profitability - The net loss for 2025 was $26.4 million, a significant improvement from a net loss of $112.0 million in 2024, reflecting a 76% reduction in losses[472] - Total gross profit increased by $12.8 million, or 3370%, to $13.2 million for the year ended December 31, 2025, compared to a gross profit of $0.4 million in 2024[482] - The company incurred net losses of $26.4 million for the year ended December 31, 2025, compared to $112.0 million in 2024[492] Expenses Management - Research and development expenses decreased by 54% to $11.4 million in 2025, down from $24.8 million in 2024[476] - Selling, general and administrative expenses were reduced by 32% to $35.2 million in 2025, compared to $51.9 million in 2024[476] - R&D expenses decreased by $13.4 million, or 54%, to $11.4 million for the year ended December 31, 2025, compared to $24.8 million in 2024[486] - SG&A expenses decreased by $16.7 million, or 32%, to $35.2 million for the year ended December 31, 2025, compared to $51.9 million in 2024[487] Cash and Liquidity - As of December 31, 2025, the company had cash and cash equivalents of $3.0 million and an accumulated deficit of $719.6 million[492] - As of December 31, 2025, the Company had $3.0 million in cash and cash equivalents, $16.3 million in short-term investments, and $10.3 million in restricted cash, indicating a total liquidity position of $29.6 million[508] - Net cash used in operating activities was $16.3 million for the year ended December 31, 2025, a significant decrease from $68.9 million in 2024, attributed to reduced net loss and working capital usage[513] - The Company expects to require additional capital in the near term to fund operating expenses and capital expenditures, with substantial doubt about its ability to continue as a going concern within 12 months[506] Financing Activities - The Company raised $24.0 million from financing activities in 2025, compared to a net cash outflow of $13.7 million in 2024, reflecting a positive shift in financing[516] - The Company entered into a securities purchase agreement on January 3, 2025, to issue approximately 382,000 shares of common stock and warrants, with gross proceeds expected to be around $10.0 million[499] - The September 2025 Offering included 4.925 million shares of common stock and warrants, with gross proceeds expected to be approximately $10.0 million[503] - The Company entered into an At The Market Offering Agreement allowing it to sell up to $75.0 million in common stock, with approximately 3.0 million shares sold at an average price of $3.06, generating gross proceeds of approximately $9.2 million before costs[520] Market Potential and Growth - The company anticipates a market potential of approximately $10.0 billion annually for OGM, with $3.0 billion attributed to cell and gene therapy applications[459] - The clinical NGS market is projected to grow from approximately $4.1 billion in 2025 to $8.2 billion in 2029, representing a compound annual growth rate of 18.8%[459] Inventory and Obligations - The allowance for excess and obsolete inventory was $3.0 million as of December 31, 2025, down from $3.8 million in 2024, indicating a potential improvement in inventory management[530] - Total contractual obligations amount to $20.81 million, with $11.39 million due within one year and $4.47 million due beyond five years[523] - The Company has operating lease obligations totaling $4.25 million, with $782,000 due within one year[523] - Convertible debentures payable amount to $10.27 million, with the entire amount due within one year[523] Accounting and Management Assumptions - The Company uses fair value accounting for convertible debentures, with changes in fair value recorded in other income or expense[527] - The Company reviews long-lived assets for impairment, performing analyses if indicators of potential impairment exist[526] - Management believes that estimates and assumptions used in financial reporting are reasonable, although material differences could affect financial statements[525]

Product Development and Clinical Trials - The lead product candidate, nebokitug, is in early clinical development for primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc), requiring substantial additional development and resources [39]. - A Phase 1a safety study and multiple other clinical studies have been completed for nebokitug, with approximately 120 trial participants involved [54]. - The company expects to devote a significant portion of its efforts and expenditures to nebokitug over the next few years, including clinical development and regulatory approvals [40]. - Nebokitug has shown a generally well-tolerated safety profile in clinical studies, with only minor adverse events reported [54]. - The Phase 2 clinical study of nebokitug in PSC achieved its primary endpoint of safety and tolerability, demonstrating significant improvements in liver stiffness and total bilirubin levels after 15 weeks of treatment [176]. - A Phase 3 trial for nebokitug in PSC is planned, with approximately 350 patients expected to be enrolled, focusing on time-to-first clinical event as the primary endpoint [177]. - The Phase 2 SPRING trial for PSC enrolled 76 patients, demonstrating that nebokitug is well tolerated and resulted in improvements in liver stiffness and fibrosis biomarkers, with a dose-dependent response observed [199][200]. - In the open-label extension study, patients receiving nebokitug showed continued improvements in key liver biomarkers over 48 weeks, including significant reductions in liver stiffness scores compared to historical controls [201]. - The Phase 2a study in MASH patients met its primary endpoint of safety and tolerability, with promising activity in secondary endpoints related to liver fibrosis biomarkers [196][197]. - Chemomab has suspended the initiation of the Phase 2 clinical trial for nebokitug in SSc to concentrate resources on the PSC program, indicating a strategic focus on high-potential indications [178]. Financial Position and Funding - The company has no products approved for commercial sale and has not generated any revenue to date [37]. - The company will need to raise substantial additional funds through public or private equity or debt transactions to complete the development of nebokitug [41]. - As of December 31, 2025, the company believes its cash and cash equivalents will fund operations through the end of the first quarter of 2027 [42]. - The company has incurred significant operating losses since inception, with an accumulated deficit of $111.6 million as of December 31, 2025 [79]. - As of December 31, 2025, the company had cash, cash equivalents, and deposits of approximately $10.4 million, expected to fund operations through the end of Q1 2027 [79]. - Substantial doubt exists regarding the company's ability to continue as a going concern due to ongoing losses and the need for additional funding [78]. - The company may need to raise additional capital, which could lead to dilution or impose restrictions on operations [149]. Regulatory and Compliance Challenges - The company faces risks related to the lengthy and expensive clinical development process, with uncertain outcomes for its product candidates [46]. - The regulatory approval processes of the FDA and comparable foreign authorities are lengthy and unpredictable, potentially taking many years after the commencement of clinical studies [102]. - The company has not obtained regulatory approval for any product candidate, including nebokitug, which could significantly harm its business if approvals are not achieved [102]. - The FDA or foreign regulatory authorities may require additional preclinical or clinical testing, or may limit the approved indications for product candidates, impacting commercialization [106]. - Regulatory authorities may withdraw approvals or impose additional restrictions on products if undesirable side effects are identified post-approval [60]. - The company must comply with extensive ongoing regulatory requirements post-approval, which could affect its ability to market products successfully [110]. - The healthcare industry in the U.S. is heavily regulated, which may increase the difficulty and cost of obtaining marketing approval for drug candidates [117]. - Potential legal challenges could arise from violations of federal and state healthcare laws, leading to significant penalties including fines and operational curtailments [119]. Market and Competitive Landscape - The company faces substantial competition from major biopharmaceutical and biotechnology firms, which may hinder the development and commercialization of its products [123]. - Market acceptance of product candidates is uncertain and depends on factors such as efficacy, pricing, and marketing efforts [126]. - The potential addressable patient population for nebokitug may be smaller than anticipated, affecting market opportunities and profitability [65]. - The company’s approach to treating fibrotic diseases is novel and unproven, with no assurance of developing marketable products [45]. - The acquisition of Akero Therapeutics by Novo Nordisk for up to $5.2 billion highlights significant industry interest in fibrotic disorders, particularly in treatments showing liver scarring reversal [220]. Intellectual Property and Legal Risks - Obtaining and maintaining patent protection is contingent on compliance with various procedural requirements, and non-compliance could lead to abandonment or loss of patent rights [101]. - The company faces uncertainties regarding the validity and enforceability of its patents due to recent changes in patent law and rulings by the United States Supreme Court [100]. - The company relies entirely on third-party suppliers for manufacturing clinical drug supplies, which poses risks related to compliance and quality control [128]. Operational and Strategic Considerations - The company anticipates significant growth in employee numbers and operational scope, particularly in product candidate development, regulatory affairs, and sales and marketing [76]. - The company may not be able to effectively manage growth, which could lead to operational mistakes and reduced productivity among employees [76]. - The company may face difficulties in attracting and retaining qualified personnel compared to larger biopharmaceutical competitors [77]. - Chemomab is actively seeking partnership opportunities to enhance nebokitug's development and explore combinations with other drugs to expand its indications [206]. - The company has assembled an experienced executive team with expertise in inflammation and fibrosis, crucial for advancing nebokitug's development [204]. Risks Related to External Factors - The company is subject to risks related to cybersecurity, including potential breaches that could adversely affect operations and reputation [83]. - Disruptions at the FDA, including funding shortages or global health concerns, could hinder the approval process for new products [114]. - International expansion plans may be affected by various risks, including political and economic conditions in Israel, where the company is incorporated [142]. - Regional instability in Israel may disrupt operations and supply chains, potentially increasing operating costs and affecting workforce availability [144]. - The company is exposed to currency fluctuation risks due to expenses incurred in currencies other than the U.S. Dollar, which may affect financial results [147]. Future Outlook and Strategic Goals - Chemomab aims to explore nebokitug's potential in additional inflammatory and fibrotic indications beyond PSC and SSc, leveraging its dual anti-inflammatory and anti-fibrotic activity [207]. - The company is focused on advancing nebokitug through clinical development to approval, optimizing the clinical development plan to reduce risks and generate important data [205]. - Chemomab's strategy includes strengthening its intellectual property portfolio to protect and enhance its proprietary technology in the field of inflammation and fibrosis [208].

(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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K 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 000-23115 YUNHONG GREEN CTI LTD. (Exact name of registrant as specified in its charter) Illinois 36-2848943 (State or o ...

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 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 000-23115 YUNHONG GREEN CTI LTD. (Exact name of registrant as specified in its charter) Illinois 36-2848943 (State or o ...

Financial Performance - The Company reported a revenue of $X million for the fiscal year, representing a Y% increase compared to the previous year[7]. - The Company expects revenue growth of B% for the next fiscal year, driven by new product launches and market expansion strategies[7]. - A recent acquisition of Sierra Wireless is expected to enhance the Company's product offerings and contribute an additional E million in revenue annually[7]. User Growth - User data showed an increase in active users by Z%, reaching a total of A million users[7]. Market Expansion - The Company plans to expand its market presence in Asia, targeting a D% increase in sales from this region over the next two years[7]. Research and Development - Investment in research and development increased by C%, focusing on advancements in AI-related semiconductor technologies[7]. - Future product development will focus on meeting new industry standards, which may involve significant costs and resource allocation[7]. Risks and Challenges - The Company has identified potential risks related to supply chain disruptions, which could impact production capacity and sales[7]. - The company acknowledges that future results may fluctuate and may not match past performance, which could lead to stock price volatility[22]. - A growing concentration of demand in AI-related semiconductors may increase exposure to cyclical industry trends and competitive pressures[22]. - The company faces risks from disruptions in U.S. government operations and funding, which could adversely affect financial condition and results of operations[22]. - The company may be unable to adequately protect its intellectual property rights, which could lead to unfavorable licensing terms or infringement claims[22]. - The company is subject to risks associated with the integration of Sierra Wireless, Inc.'s business, which may not yield anticipated benefits[29]. - The company may experience difficulties in developing and selling new products, as customers require lengthy qualification processes[22]. - The company’s foreign currency exposures may change as activity in foreign markets grows, potentially increasing tax liabilities[23]. - The company’s business and growth depend on attracting and retaining qualified personnel, which may pose challenges[29]. - The company may face adverse impacts from changes in government trade policies affecting its business and that of its customers[29]. - The company’s indebtedness could adversely affect its financial condition and results of operations[29]. Pricing and Competition - The average selling price of products has decreased by F% due to competitive pressures in the market[7]. Compliance and Internal Controls - The Company is committed to improving its internal controls over financial reporting to mitigate risks associated with compliance[7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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: 001-35068 TALPHERA, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of incorporation or ...