Revenue Performance - Revenue for Q4 2025 was $20.9 million, an 18% increase compared to Q4 2024, driven by new customers and the U.S. launch of the larger OviTex PRS product configuration[5] - Full year 2025 revenue reached $80.3 million, a 16% increase from 2024, attributed to new customers and growing international sales[11] - TELA Bio expects at least 8% revenue growth in 2026 compared to 2025, with projected Q1 2026 revenue of approximately $18.5 million[16] Profitability - Gross profit for Q4 2025 was $13.8 million, representing 65.9% of revenue, up from 63.6% in Q4 2024, due to lower excess inventory costs[6] - The net loss for Q4 2025 was $9.0 million, a slight improvement from a net loss of $9.2 million in Q4 2024[10] Operating Expenses - Operating expenses in Q4 2025 were $20.4 million, slightly higher than $19.6 million in Q4 2024, primarily due to increased compensation costs[8] Financial Position - Cash and cash equivalents as of December 31, 2025, totaled $50.8 million[14] - The total liabilities increased to $75.1 million in 2025 from $58.1 million in 2024, primarily due to an increase in long-term debt[21] Strategic Initiatives - The company expanded its sales force to 88 representatives, enhancing market penetration capabilities[7] - TELA Bio closed a credit facility for up to $70 million, including an initial loan of $60 million received at closing[7]

Revenue Performance - Fourth quarter revenue for 2025 was approximately $1.5 million, a decrease of 12% year-over-year due to delayed U.S. government contract awards[5] - Full year revenue for 2025 was $7.1 million, an increase of $1.3 million or 23% compared to 2024[8] Profitability Metrics - Gross profit margin for the fourth quarter of 2025 was 74%, slightly down from the prior year, while the full year gross profit margin was 76% compared to 77% in 2024[6][9] - The net loss for the fourth quarter of 2025 was $2.8 million, or $(0.14) per share, which is a decrease of $0.9 million compared to the prior year[7] - The net loss for the full year ended December 31, 2025, was ($9.1) million, or $(0.46) per share, compared to a loss of ($7.8) million, or $(1.63) per share, in 2024[10] Operating Expenses - Operating expenses for the fourth quarter of 2025 were $4.0 million, an increase of $0.8 million compared to the fourth quarter of 2024[7] Cash Position - Cash and cash equivalents as of December 31, 2025, were $3.6 million, down from $4.9 million in 2024[11] Strategic Initiatives - The company launched the P.O.S.S.E Program in partnership with PortNexus to enhance cybersecurity for law enforcement[4] - Intrusion Shield Cloud was released on Microsoft Azure, expanding access to new customers[4] - The company is seeking small debt financing to improve its cash position and support growth initiatives[11]

Financial Performance - The company has incurred a net loss of approximately $141.0 million and $68.7 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of approximately $556.3 million as of December 31, 2025[393]. - The company has not generated any significant revenue from product sales to date and has financed operations primarily through equity and debt financing[393]. - The company expects to continue incurring significant losses for the foreseeable future, with the potential for these losses to increase substantially as it develops and commercializes product candidates[396]. - As of December 31, 2025, the company had approximately $81.5 million in cash and cash equivalents, which is expected to fund operations into early 2027[401]. - The company has identified substantial doubt about its ability to continue as a going concern for at least one year after the issuance of its financial statements[402]. - Future funding requirements will depend on various factors, including the progress and costs of clinical studies and the potential expansion of development programs[404]. - The company may need to seek additional funding through public or private offerings, which could dilute stockholders or restrict operational activities[406]. - The company’s ability to raise additional capital may be limited, potentially leading to dilution of existing stockholders' interests[410]. Regulatory and Compliance Challenges - The regulatory approval processes for medical devices and biopharmaceutical products are lengthy and unpredictable, impacting the timeline for obtaining marketing authorization[417]. - The company must comply with the EU's Medical Devices Regulation to market its products in the EU, which includes extensive safety and performance requirements[423]. - The company is currently working on obtaining MDR certification for its devices, which may impact its ability to sell products in the EU and EEA if non-compliance occurs[425]. - The company may face challenges in obtaining regulatory approval for its product candidates due to the lengthy and unpredictable approval process, which could significantly harm its business[429]. - Changes in regulatory policies or requirements could impact the approval process and the company's ability to bring products to market[431]. - The company is subject to ongoing consultations and potential changes in EU pharmaceutical legislation, which may significantly affect the biopharmaceutical industry in the long term[433]. - Regulatory authorities may require additional studies or impose restrictions on marketing approval, affecting the commercialization of the company's product candidates[441]. - Compliance with ongoing regulatory obligations post-approval may result in significant expenses and could restrict the company's operations[471]. Clinical Development and Trials - The ongoing REMAIN-1 pivotal clinical study of the lead product candidate Revita is currently underway, with additional investment in Revita programs for T2D paused[394][405]. - Clinical studies are expensive and time-consuming, and delays in these studies could harm the commercial prospects of the company's product candidates[434]. - The acceptance of clinical study data from outside the U.S. by the FDA or comparable foreign regulatory authorities may be subject to strict conditions, potentially delaying marketing authorization[440]. - Adverse events in clinical studies could lead to suspension or termination of studies, affecting the approval process for product candidates[454]. - The company must demonstrate that its product candidates are safe and effective through complex clinical studies, which may not yield favorable results[434]. - The company plans to submit IDEs for Revita but may face delays in obtaining necessary approvals, impacting clinical study timelines[444]. - There is uncertainty regarding the approval of IDE applications, which could lead to significant delays or prohibitions on conducting clinical investigations[445]. Market and Competitive Landscape - The company faces significant competition from established medical device and biopharmaceutical companies, which may have advantages in resources and market presence[521]. - The biotechnology and biopharmaceutical industries are characterized by rapid technological advancements and intense competition, impacting the company's product candidates[523]. - Competitors may develop safer, more effective products that could reduce the company's market opportunity, potentially leading to a loss of competitive edge[528]. - The anticipated sales cycle for the company's products could take up to 12 months or longer, leading to fluctuations in product sales[533]. - Acceptance of the company's product candidates by the medical community and third-party payors is critical for success, and any negative perception could adversely affect business[534]. Supply Chain and Manufacturing Risks - The company relies on third-party manufacturers for the production of product candidates, which increases risks related to supply and compliance with regulatory standards[552][557]. - The company does not have long-term supply agreements, making it vulnerable to unexpected supply disruptions that could delay clinical studies[553]. - The company relies on third-party sole-source suppliers for certain sub-assembly components of its Revita product, which poses a risk of supply interruptions if relationships with these suppliers are disrupted[565]. - Any contamination or shortage of raw materials could adversely impact the commercial manufacturing of Rejuva gene therapy candidates, affecting development timelines[569]. Legal and Compliance Risks - The company faces potential product liability claims that could divert management's attention and harm its reputation, with significant costs associated with litigation and claims[572]. - Compliance with healthcare laws and regulations is critical, as violations could lead to substantial penalties and affect the company's ability to commercialize its products[575]. - The company is subject to increased scrutiny from enforcement bodies regarding interactions with healthcare providers, which could lead to investigations and additional compliance requirements[581]. - The company may incur significant legal expenses and management distraction due to potential violations of federal, state, and foreign laws, including the federal False Claims Act, which could lead to treble damages and penalties[582]. Healthcare Policy and Economic Factors - The Affordable Care Act (ACA) has implemented substantial changes in healthcare financing, including payment system reforms and expanded Medicaid eligibility, which could impact the company's revenue from product sales[584]. - The One Big Beautiful Bill Act (OBBBA) is expected to reduce the number of insured Americans and Medicaid spending, potentially leading to decreased demand for the company's products[585]. - The Budget Control Act of 2011 mandates an average reduction of 2% in Medicare payments per fiscal year, effective through 2032, which could adversely affect the company's financial condition[587]. - Legislative changes, including the Medicare Access and CHIP Reauthorization Act of 2015, may result in additional reductions in Medicare funding, impacting the company's customers and financial operations[588].

Financial Performance - The company reported a net loss of $8.2 million for the year ended December 31, 2025, with an accumulated deficit of $168.3 million[163]. - Cash and cash equivalents were approximately $2.5 million as of December 31, 2025, which may not be sufficient to fund operations beyond May 2026[167]. - Future financial performance is highly uncertain due to the speculative nature of biopharmaceutical product development and potential regulatory challenges[164]. - The company has never declared or paid cash dividends on its common stock and anticipates retaining future earnings for business development, limiting returns to stockholders to stock appreciation[323]. - The company’s operating results are expected to fluctuate significantly, which may cause stock price volatility if results fall below investor or analyst expectations[316]. Revenue Generation - The company has not generated any revenue from its cell therapy systems and does not anticipate doing so in the next few years[165]. - Market acceptance of therapeutic candidates is crucial for revenue generation, with potential challenges in gaining acceptance among physicians, patients, and payors[203]. - The reimbursement landscape is complex, with third-party payors scrutinizing coverage and pricing, which could adversely affect sales and profitability[216]. - Legislative changes in the U.S. healthcare system may lead to lower reimbursement rates, impacting the financial viability of approved therapies[218]. Regulatory Approval and Compliance - The ongoing Phase III pivotal trial for the CardiAMP Cell Therapy System is critical for regulatory approval, but there are no guarantees of success[176]. - The approval process for the CardiAMP Cell Therapy System is uncertain, as it is the first cardiac cell-based therapy regulated by the FDA via the premarket approval pathway[178]. - Regulatory requirements for cell-based therapies are frequently changing, which may increase development costs and delay approval processes[182]. - The company must ensure compliance with Good Clinical Practices (GCPs) during clinical trials, as failure to do so could result in unreliable data and additional trials being required[196]. - Non-compliance with regulatory requirements could lead to significant penalties, including product recalls and operational restrictions[234]. - The regulatory approval process is costly and time-consuming, with no guarantee of success for therapeutic candidates[247]. - The FDA and other regulatory authorities have broad enforcement powers, and failure to comply could result in severe sanctions[238]. - The company must conduct extensive testing to demonstrate safety and efficacy before obtaining regulatory approval, which is a lengthy and expensive process[233]. Clinical Trials and Development - The company expects to incur significant research and development expenses as it continues its clinical trials and seeks regulatory approvals[166]. - The company faced a clinical hold in 2020 for its allogeneic cell therapy product candidate due to FDA concerns regarding chemistry, manufacturing, and controls[179]. - The company has encountered substantial delays in clinical studies, which could adversely affect its ability to complete trials and obtain regulatory approval[183]. - Patient enrollment in clinical trials is critical, and negative publicity or competition may hinder recruitment efforts, leading to further delays[185]. - Serious adverse events during clinical trials could negatively impact the approval process and market acceptance of therapeutic candidates[239]. Manufacturing and Supply Chain - The company is seeking to expand its manufacturing capabilities and develop a sales and marketing infrastructure for future product commercialization[172]. - The company relies on third-party vendors for manufacturing components, which exposes it to risks such as supply shortages and price fluctuations[200]. - The company plans to expand manufacturing capacity, but faces challenges such as reliance on a limited number of suppliers and compliance with FDA regulations[219]. - Supply chain interruptions or inventory loss may adversely affect the company's operating results and financial condition, potentially leading to production delays and lost sales[284]. Competition and Market Risks - The company faces substantial competition from major players like AstraZeneca and Bristol-Myers Squibb, which have greater resources and experience in the market[208]. - The company is at risk of securities class action litigation due to significant stock price volatility in the biotechnology sector[326]. - Competing technological and market developments may impact the company's operations[403]. Intellectual Property and Legal Risks - The company may face challenges in protecting its intellectual property, which could adversely impact its competitive position and business operations[288]. - Patent protection for biotherapeutics is complex and uncertain, with potential implications for the company's future therapeutic candidates and products[290]. - The company may incur significant costs in enforcing its intellectual property rights, which could distract from its core business activities[297]. - The company has not conducted a freedom-to-operate search for its therapeutic candidates, which may expose it to infringement claims from third parties[301]. Management and Operational Risks - The company is highly dependent on its executive team and key scientific personnel, and losing these individuals could adversely impact its objectives[274]. - Recruiting and retaining qualified personnel in scientific, clinical, and marketing roles is critical, but competition for such talent is intense within the industry[275]. - The company anticipates expanding its workforce and may face challenges in managing this growth, which could disrupt operations and divert management's attention[277]. - The effectiveness of the company's financial controls may be limited, potentially impacting investor confidence and the value of its common stock[286]. Security and Data Privacy Risks - Security incidents or breaches could result in significant liabilities, reputational harm, and delays in the development and commercialization of product candidates[280]. - The company may incur substantial costs in efforts to detect and respond to security incidents, which could divert resources and impact financial performance[282]. - The General Data Protection Regulation (GDPR) imposes strict requirements on the processing of personal data, with potential fines of up to €20 million or 4% of annual global revenues for serious violations[259]. - The California Consumer Privacy Act (CCPA) requires companies to disclose data collection practices and allows consumers to opt-out, impacting operational costs and compliance[263]. Environmental and Compliance Risks - The company is subject to numerous environmental, health, and safety laws, which could result in substantial fines or penalties if not complied with, potentially impacting business operations[324]. - The company’s disaster recovery and business continuity plans are currently limited, which could lead to substantial expenses in the event of a serious disaster[285].

Financial Overview - The company has raised approximately $552.1 million in aggregate net proceeds since its inception, with net losses of $90.4 million and $75.1 million for the years ended December 31, 2025 and 2024, respectively[29]. - As of December 31, 2025, the company had an accumulated deficit of $352.6 million and cash, cash equivalents, and short-term investments totaling $269.0 million[29]. - The company has not generated any commercial revenue from product sales and expects to incur significant development and marketing costs prior to achieving profitability[31]. Clinical Trials and Development - The ongoing registrational trial of NGN-401 for Rett syndrome has enrolled 100% of participants, with over 50% dosed, and is expected to complete dosing in Q2 2026[27]. - NGN-401 is designed to be administered via a one-time intracerebroventricular (ICV) procedure, targeting key areas of the brain for optimal biodistribution[27]. - The company has completed a Phase 1/2 clinical trial of NGN-401, with ten participants receiving the 1E15 vg dose, demonstrating its commitment to advancing clinical development[27]. - All pediatric participants in the trial gained an aggregate of 35 developmental milestones across core clinical domains of Rett syndrome[53]. - As of October 30, 2025, 80% of participants with at least 12 months of follow-up met the primary endpoint responder definition in the Embolden trial[54]. - NGN-401 has been generally well-tolerated at the 1E15 vg dose, with all treatment-related adverse events being Grade 1 or Grade 2 in severity[55]. - The Embolden Phase 3 trial has enrolled 100% of participants, with over 50% already dosed, and is expected to complete dosing by Q2 2026[59]. - The Phase 1/2 trial showed no cases of hemophagocytic lymphohistiocytosis (HLH) at the 1E15 vg dose, with enhanced monitoring protocols in place[57]. - The primary endpoint of the Embolden trial requires a minimum response rate of 35% (7 out of 20 patients) to reject the null hypothesis[58]. Research Collaborations - The Master Research Collaboration with the University of Edinburgh has been extended to December 2026, supporting research and pipeline development activities[31]. - The company has entered into a Master Collaboration Agreement with the University of Edinburgh, which was extended for an additional 33 months in November 2023[90]. - Under the March 2022 Edinburgh License Agreement, the company obtained an exclusive worldwide license to certain patents, with royalties payable on a product-by-product basis[91]. Regulatory and Compliance - The FDA and other regulatory authorities extensively regulate the research, development, and approval processes for biologics products[95]. - The company must submit an IND to the FDA before beginning any clinical trial, which must become effective within 30 days unless safety concerns arise[98]. - The FDA began accepting applications for the START pilot program in 2024 to accelerate the development of novel drugs for rare diseases, with NGN-401 for Rett syndrome selected for this program[114]. - NGN-401 has received fast track designation for the treatment of Rett syndrome, allowing for more frequent interactions with the FDA during product development[116]. - The FDA aims to review standard BLA applications within ten months and priority reviews within six months after filing, with potential extensions for additional information requests[109]. - A BLA must include all relevant data from preclinical studies and clinical trials, including both positive and negative results, along with detailed product information[107]. - The FDA may require post-marketing studies to verify clinical benefits for products granted accelerated approval, with potential expedited withdrawal procedures if conditions are not met[117]. - The FDA requires that a BLA or supplement must contain pediatric data to assess safety and effectiveness for all relevant pediatric subpopulations under the Pediatric Research Equity Act[108]. - The FDA may refuse to file a BLA deemed incomplete, requiring resubmission with additional information[109]. - The manufacturing process for a product must comply with cGMP requirements to ensure consistent quality and safety before BLA approval[110]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with regulatory standards before approving a BLA[110]. - The FDA's priority review aims to take action on marketing applications within six months, compared to ten months under standard review, although the company has not sought this designation for any product candidates to date[120]. - The company has received orphan drug designation for NGN-401, which is intended for a rare disease affecting fewer than 200,000 individuals in the U.S.[122]. - Orphan drug exclusivity grants seven years of exclusive approval for the product if it is the first to receive FDA approval for the designated condition[123]. - The FDA may withdraw approval if regulatory compliance is not maintained, which could lead to significant consequences including product recalls and fines[127]. - The BPCIA allows for a 12-year exclusivity period for reference biologics, during which biosimilars cannot be approved[133]. - Patent term extensions of up to five years may be applied for after BLA approval, compensating for time lost during the FDA regulatory process[138]. Market and Pricing Regulations - The company faces significant uncertainty regarding coverage and reimbursement for its pharmaceutical products, which is essential for successful commercialization[156][157]. - Third-party payors are increasingly challenging the prices of medical products, which could limit sales of approved products[157]. - Obtaining coverage and adequate reimbursement for products administered under physician supervision may be particularly difficult due to higher associated prices[158]. - The company must provide scientific and clinical support for the use of its product candidates to each payor separately, with no assurance of consistent coverage and reimbursement[157]. - The company is also subject to federal price reporting laws, which require complex pricing metrics to be reported to government programs[146]. - The U.S. government is increasing scrutiny on drug pricing practices, leading to potential Congressional inquiries and new regulations aimed at reducing prescription drug costs[167]. - Individual states are implementing regulations to control pharmaceutical pricing, which may negatively impact the company's financial condition and operations[169]. International Regulations - Clinical trials for marketing authorization in the EU must comply with EU regulations, including the new Clinical Trials Regulation that took effect on January 31, 2022[180]. - The centralized authorization procedure allows for a single marketing authorization (MA) valid across all EU Member States, with a typical evaluation timeframe of 210 days, which can be reduced to 150 days for accelerated assessments[189][190]. - Innovative medicinal products, classified as New Chemical Entities (NCE), are eligible for eight years of data exclusivity and ten years of marketing exclusivity in the EU[199]. - A conditional marketing authorization can be granted in exceptional circumstances, valid for one year and renewable annually, provided specific obligations are met[198]. - The European Commission's proposal for pharmaceutical legislation reform includes shortening data exclusivity from eight years to six years and extending market exclusivity for orphan medicines under certain conditions[205]. - The Medicines and Healthcare Products Regulatory Agency (MHRA) aims to reach a decision on MA applications within 210 "clock-on" days, excluding any "clock-stops" for applicant responses[185]. - The IRP, effective January 1, 2024, allows for fast-tracked reviews of medicinal products approved in other jurisdictions, replacing existing EU reliance procedures[186]. - The UK government has adopted the Medicines and Medical Devices Act 2021 to update regulatory frameworks post-Brexit, impacting human medicines and clinical trials[226]. - Pediatric Investigation Plans (PIPs) are mandatory for new medicinal products in the EU, with compliance required for marketing authorization applications[209]. - The EMA's pharmacovigilance rules impose obligations on marketing authorization holders to monitor and report on the safety of medicinal products[215]. - Non-compliance with pharmacovigilance obligations can lead to the variation, suspension, or withdrawal of marketing authorizations[216]. - The advertising and promotion of medicinal products must comply with the approved Summary of Product Characteristics (SmPC) to avoid off-label promotion[219]. - The company must ensure compliance with EU laws governing clinical trials and marketing authorizations to avoid penalties[213].

Financial Overview - The company has raised approximately $552.1 million in aggregate net proceeds since its inception, primarily through the sale of preferred stock, common stock, and pre-funded warrants[29]. - The net loss for the year ended December 31, 2025, was $90.4 million, with an accumulated deficit of $352.6 million as of the same date[29]. - The company plans to finance operations through private or public equity or debt financings until it achieves profitability[31]. Clinical Trials and Development - The ongoing registrational trial of NGN-401 for Rett syndrome has enrolled 100% of participants, with over 50% already dosed, and is expected to complete dosing in Q2 2026[27]. - NGN-401 is designed to be administered via a one-time intracerebroventricular (ICV) procedure, targeting key areas of the brain for optimal biodistribution[27]. - The company has completed a Phase 1/2 trial of NGN-401, with ten participants receiving the 1E15 vg dose, and has reported positive interim clinical data from the pediatric cohort[51]. - All pediatric participants in the trial gained an aggregate of 35 developmental milestones across core clinical domains of Rett syndrome[53]. - As of October 30, 2025, 80% of participants with at least 12 months of follow-up met the primary endpoint responder definition in the Embolden trial[54]. - NGN-401 has been generally well-tolerated at the 1E15 vg dose, with all treatment-related adverse events being Grade 1 or Grade 2 in severity[55]. - The Embolden Phase 3 trial has enrolled 100% of participants, with over 50% already dosed, and is expected to complete dosing by Q2 2026[59]. - The primary endpoint of the Embolden trial is a responder-based composite endpoint, with a minimum success threshold of 35% response rate[58]. - The Phase 1/2 trial showed no cases of hemophagocytic lymphohistiocytosis (HLH) at the 1E15 vg dose, with enhanced monitoring protocols in place[57][59]. - The company completed enrollment in a Phase 1/2 clinical trial for NGN-101 but does not expect to advance the program due to alignment issues with the FDA[65]. Manufacturing and Facilities - The company has established a fully operational current good manufacturing practices (cGMP) facility in Houston, Texas, to ensure product quality and development timelines[27]. - The manufacturing facility in Houston, Texas, spans approximately 42,000 square feet, with 6,000 square feet dedicated to cGMP production of clinical products[82]. - The company has successfully manufactured clinical-grade product for the ongoing Phase 3 Embolden clinical trial for NGN-401, targeting Rett syndrome[83]. - The cGMP platform processes are executed at a 200L scale, which is expected to support anticipated commercial demand[84]. - The company plans to initiate its Process Performance Qualification campaign in mid-2026, confirming commercial scale aligns with clinical scale[60]. Regulatory Designations and Approvals - NGN-401 received Breakthrough Therapy designation from the FDA based on interim efficacy and safety data as of October 30, 2025[61]. - NGN-401 has received fast track designation for the treatment of Rett syndrome, allowing for more frequent interactions with the FDA during product development[116]. - The FDA may grant accelerated approval for products that show effects on surrogate endpoints likely to predict clinical benefit, with NGN-401 potentially qualifying under this provision[117]. - Breakthrough Therapy designation has been granted to NGN-401 based on preliminary clinical evidence indicating substantial improvement over existing therapies[118]. - The FDA's goal is to review standard BLA applications within ten months and priority reviews within six months after filing[109]. - The FDA may refuse to file any BLA deemed incomplete, requiring resubmission with additional information[109]. - Before approving a BLA, the FDA inspects manufacturing facilities to ensure compliance with cGMP requirements[110]. - The FDA may require post-marketing studies to monitor the safety and efficacy of approved products[112]. - The START Pilot Program aims to address clinical development issues that could delay promising novel drugs from progressing to pivotal clinical trials[115]. - NGN-401 received RMAT designation for the treatment of Rett syndrome in August 2024, indicating potential for accelerated development and approval[119]. - The FDA's priority review aims for action on marketing applications within six months, compared to ten months under standard review; no priority review has been sought for product candidates to date[120]. - Orphan drug designation has been granted for NGN-401, which may lead to seven years of exclusivity upon first FDA approval for the indicated condition[122][123]. Competition and Market Challenges - The company faces competition from other biotechnology firms and must navigate clinical trials and regulatory approvals to successfully market its products[85]. - The FDA's interpretation of orphan drug exclusivity may impact the approval of competing products for the same condition[125]. - The company has not yet sought priority review for NGN-401 but may consider it in the future[120]. - The Inflation Reduction Act of 2022 aims to foster competition in the biosimilar market and reduce drug costs[137]. - The U.S. government continues to implement cost-containment programs, including price controls and mandatory discounts, impacting drug pricing and reimbursement[161]. Compliance and Regulatory Environment - The FDA and other regulatory authorities extensively regulate the research, development, and marketing of biologics, requiring substantial time and financial resources[95]. - The company must submit an IND to the FDA before beginning any clinical trial, which must become effective within 30 days unless safety concerns arise[98]. - Pharmaceutical companies are subject to various healthcare regulations, including the federal Anti-Kickback Statute and the False Claims Act, which can lead to significant penalties for non-compliance[140][142]. - The U.S. federal Physician Payments Sunshine Act requires manufacturers to report payments to healthcare professionals, with California's Assembly Bill 1278 mandating notifications about the Open Payments database starting January 1, 2023[145]. - Coverage and reimbursement from third-party payors, including Medicare and Medicaid, are critical for the acceptance of new products, with significant uncertainty regarding reimbursement levels for approved products[156][157]. - The coverage determination process is often time-consuming and costly, requiring scientific and clinical support for each payor separately, with no assurance of consistent reimbursement[157]. - Third-party payors increasingly challenge the prices of medical products, examining medical necessity and cost-effectiveness, which could limit sales of approved products[157]. - Obtaining coverage and adequate reimbursement for products administered under physician supervision may be particularly difficult due to higher associated prices[158]. - The California Consumer Privacy Act imposes additional obligations on businesses regarding personal information, complicating compliance efforts and increasing legal risks[153]. - Failure to comply with privacy and security laws can result in significant civil and criminal penalties, complicating compliance efforts due to constantly evolving regulations[155]. International Regulations and Market Entry - The company must comply with varying regulations across countries regarding clinical trials and drug pricing, which can affect market entry and profitability[172]. - Legislative changes in individual U.S. states are increasingly controlling pharmaceutical pricing, which could negatively impact the company's financial condition[169]. - The new Clinical Trials Regulation (CTR) mandates the submission of initial clinical trial applications via the Clinical Trials Information System (CTIS) starting January 31, 2023, with compliance required for ongoing trials by January 31, 2025[181]. - The centralized authorization procedure allows for a single marketing authorization (MA) valid across all EU Member States, with a typical evaluation timeframe of 210 days, which can be reduced to 150 days for accelerated assessments[189][190]. - Innovative medicinal products, classified as New Chemical Entities (NCE), are eligible for eight years of data exclusivity and ten years of marketing exclusivity in the EU[199]. - A conditional marketing authorization can be granted in exceptional circumstances, valid for one year and renewable annually, provided specific obligations are met[198]. - The European Commission's proposal for pharmaceutical legislation reform includes shortening data exclusivity from eight years to six years and extending market exclusivity for orphan medicines under certain conditions[205]. - The Medicines and Healthcare Products Regulatory Agency (MHRA) aims to reach a decision on MA applications within 210 "clock-on" days, excluding any "clock-stops" for applicant responses[185]. - The IRP, effective January 1, 2024, allows for fast-tracked reviews of medicinal products approved in other jurisdictions, replacing existing EU reliance procedures[186]. - The MHRA will review applications for orphan designation and provide incentives such as market exclusivity and fee refunds to encourage development of rare disease medicines[208]. Pharmacovigilance and Marketing Compliance - Non-compliance with pharmacovigilance obligations can lead to the variation, suspension, or withdrawal of marketing authorizations, along with financial penalties[216]. - The company must comply with EU pharmacovigilance legislation, which includes ongoing assessments of the safety and effectiveness of medicinal products[214]. - The advertising and promotion of medicinal products must comply with the approved Summary of Product Characteristics (SmPC) to avoid off-label promotion[219]. - The UK and EU have agreed on a trade and cooperation agreement that includes mutual recognition of GMP and inspections for medicinal products[225]. - The 10-year market exclusivity for orphan medicinal products may be reduced to six years if the product no longer meets orphan designation criteria[207]. - The MHRA is considering updating its licensing framework for orphan medicines, with a draft expected by spring 2026[208].

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 January 31, 2026 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 1-32637 GameStop Corp. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of incorporation or organization) 625 Westport Parkway Grapevine, Texas 76051 ( ...

Financial Position - As of December 31, 2025, the company's preliminary unaudited cash and cash equivalents were approximately $81.5 million, which increased to $85.6 million after receiving an additional $4.1 million from Tranche A warrants[9]. - The company anticipates that its current cash position will fund operations through early 2027, supporting planned clinical and regulatory milestones for 2026[9]. - The company had 153,372,044 shares of common stock outstanding as of December 31, 2025, with no Tranche A warrants remaining[10]. - The company’s financial information is preliminary and unaudited, subject to completion of financial closing procedures for the fiscal year ended December 31, 2025[17]. Clinical and Regulatory Milestones - The company plans to advance its Revita program through key clinical and regulatory milestones in 2026, focusing on validation in post-GLP-1 weight maintenance[11]. - The anticipated milestones for the Revita program include 6-month randomized data from the REMAIN-1 Midpoint Cohort in late January 2026 and a potential PMA filing in H2 2026[14]. - The Rejuva gene therapy platform is expected to progress toward clinical validation in 2026, with first-in-human dosing of RJVA-001 anticipated in H2 2026, subject to regulatory authorization[12]. - The company is aligning its clinical development with regulatory strategy and real-world implementation considerations for Revita as it moves through a registrational year[11]. - The company has completed Clinical Trial Applications for RJVA-001 in the EU and Australia, setting the stage for expected dosing of first patients in 2026[12]. - The company’s strategic outlook for 2026 includes anticipated clinical and regulatory milestones across its Revita and Rejuva programs[8].

Exhibit 99.1 GameStop Reports Fourth Quarter and Fiscal Year 2025 Results GRAPEVINE, Texas--(BUSINESS WIRE)--March 24, 2026--GameStop Corp. (NYSE: GME) ("GameStop" or the "Company") today released financial results for the fourth quarter and fiscal year ended January 31, 2026. The Company's consolidated financial statements, including GAAP and non-GAAP results, are below. The Company's Form 10-K and supplemental information can be found at https://investor.gamestop.com. FOURTH QUARTER OVERVIEW FULL YEAR OVE ...

Company Strategy and Product Focus - The company focuses on developing and commercializing transformative technologies aimed at improving clinical outcomes and reducing healthcare expenditures in the surgical market[19]. - The company has shifted its strategy to focus exclusively on surgical products, discontinuing the Tissue Health Plus (THP) segment due to persistent losses and lack of investor interest[24]. - The company's strategy emphasizes market penetration and geographic expansion, leveraging its comprehensive product portfolio to drive sales growth[37]. - The company has established a strong pipeline of innovative products, with ongoing research validating the clinical and economic value of its offerings[44]. - The company plans to advance multicenter studies to validate the real-world performance of its technologies, aligning with its mission to improve surgical outcomes and reduce healthcare costs[56]. Key Products and Innovations - Key products include CellerateRX Surgical, a hydrolyzed collagen for managing surgical wounds, and BIASURGE, an advanced surgical solution for wound irrigation[20]. - CellerateRX Surgical has shown efficacy in improving wound healing and reducing complications, particularly in patients with comorbidities[28]. - BIASURGE demonstrated significant antimicrobial efficacy in preventing biofilm formation on orthopedic implants, supporting its use as a preferred irrigation solution[46]. - ALLOCYTEPlus achieved universal radiographic fusion in a study of lumbar spinal fusions, with a high cell viability of approximately 92% and no reported complications[53]. - The company has partnered with Biomimetic Innovations Limited to commercialize OsStic BioAdhesive, expected to launch in Q1 2027, enhancing its product portfolio[39]. Financial Performance and Growth - The company has incurred net losses in most years since operations began in 2004, indicating a need for continued revenue growth to achieve profitability[103]. - Revenue growth is difficult to predict, and shortfalls in forecasted revenues may harm operating results, as fixed expenses may not be quickly reducible[104]. - The company is required to maintain annual minimum revenue of at least $60.0 million for 2024, increasing to $105.0 million for each twelve-month period beginning in 2028[122]. - The company may require additional capital to support growth, which could lead to dilution for existing shareholders if raised through equity financing[180]. Regulatory Compliance and Risks - The FDA's PMA process requires extensive data, including preclinical studies and clinical trials, to demonstrate device safety and effectiveness[76]. - Regulatory approvals and market entry timing are critical for product acceptance, and delays could hinder commercialization efforts[110]. - Compliance with federal and state healthcare fraud and abuse laws is critical, as violations can lead to substantial penalties and damage to reputation[160]. - Non-compliance with regulatory requirements can result in severe consequences, including product recalls, civil and criminal penalties, and suspension of marketing approvals[152]. - The company must comply with FDA regulations and good manufacturing practices, and any failure to do so could delay product commercialization[121]. Intellectual Property and Competition - The company has a robust intellectual property portfolio, including 11 issued U.S. patents and over 200 foreign patents, following acquisitions from Rochal and Hymed[58]. - The company relies on patents and trade secrets for competitive advantage, but the effectiveness of these protections is uncertain and may not prevent competitors from introducing similar products[134]. - The competitive landscape may be affected by the ability of competitors to design around existing patents, which could undermine the company's market position[135]. - The company faces significant competition in the medical device market, which may affect market acceptance and financial condition[109]. Employee and Operational Structure - The company had a staff of 108 full-time employees as of December 31, 2025[98]. - As of December 31, 2025, the company employed 40 U.S.-based field sales representatives to enhance its sales efforts in the surgical market[61]. - The company relies on research and development partners for product design and supply, and any failure in performance could incur significant costs[102]. Cybersecurity and Data Privacy - The company has not experienced any material adverse effects from cybersecurity threats to date, but recognizes the importance of cybersecurity in safeguarding sensitive information[203]. - The company has invested in growing its internal technology team and enhancing partnerships for cybersecurity, including carrying cybersecurity insurance for additional protection[201]. - The company is subject to numerous federal and state laws, including HIPAA, which govern the privacy and security of PII, including protected health information (PHI)[166]. Market Conditions and Stock Performance - The trading price of the company's common stock is highly volatile, influenced by various factors including technological innovations and market conditions[181]. - The company has never declared or paid cash dividends on its common stock and does not intend to do so in the foreseeable future, which may limit the current return on investment for shareholders[214]. - The company has a significant concentration of control, with directors and their affiliates owning approximately 42% of the outstanding common stock as of March 20, 2026[188].