UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 001-37566 SYNLOGIC, INC. (Exact name of Registrant as specified in its Charter) FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or organiza ...

Financial Performance and Condition - For the year ended December 31, 2025, the company incurred net losses of $22.4 million and net cash used in operating activities was $20.8 million, with an accumulated deficit of $515.9 million[179]. - The company expects to continue incurring net losses and negative cash flow from operating activities for at least the next twelve months, primarily due to increased expenses associated with research and development and clinical trial-related activities[179]. - As of December 31, 2025, the company had approximately $13.1 million in cash and cash equivalents, restricted cash, and short-term investments, raising substantial doubt about its ability to continue as a going concern[182]. - The company has a history of generating losses and negative cash flows from operations, and its financial statements have been prepared under the assumption of continuing as a going concern for the next twelve months[183]. - The company requires additional funding to develop its product candidates and conduct future operations, and it may pursue various financing options, including debt and equity offerings[197]. Compliance and Regulatory Issues - The company is subject to compliance with Nasdaq's Minimum Stockholders' Equity Requirement of at least $2.5 million, and it received additional time until March 4, 2025, to regain compliance[188]. - The company was notified on May 16, 2025, that it no longer complied with the Minimum Bid Requirement, with an initial compliance period until November 12, 2025, to regain compliance[189]. - If the company fails to regain compliance with Nasdaq's listing requirements, it could face significant material adverse consequences, including a decline in the market price of its common stock[192]. - The company is subject to the Sarbanes-Oxley Act and must maintain effective internal controls over financial reporting, with potential implications for timely and accurate financial statements[206]. - The company faces ongoing regulatory obligations that may result in significant expenses and could harm business if compliance is not maintained[275]. Product Development and Market Strategy - The company has established a scalable testing laboratory in Houston, TX, and has obtained state licensure for 49 of 50 US states by January 2026, with plans for New York by 2027[217]. - The company acquired the CNSide Portfolio in 2024 and is executing a commercial market access strategy, including agreements with UnitedHealthcare and Humana[217]. - The company is focused on developing its nanomedicine platform, specifically rhenium (186Re) obisbemeda and 188RNL-BAM, but faces significant regulatory and development risks[210]. - The company has limited product candidates in development, and its business heavily relies on their successful commercialization and regulatory approval[225]. - The company emphasizes the importance of strategic partnerships for commercialization, as it lacks the resources to independently develop and market its therapeutic offerings[223]. Clinical Trials and Regulatory Approval - Clinical trials for product candidates are lengthy and expensive, with uncertain outcomes that may lead to delays or failures in development[246]. - The company relies on third-party service providers for clinical trials, and any failure by these providers could adversely affect trial outcomes[251]. - Regulatory authorities may suspend clinical trials for various reasons, which could delay the commercialization of product candidates[252]. - The company may incur additional costs or experience delays in clinical trials due to unforeseen circumstances, impacting its ability to generate revenues[253]. - Any significant adverse events during clinical trials could lead to challenges in obtaining regulatory approval and market acceptance, adversely affecting financial position[266]. Intellectual Property and Competition - The company relies on the protection of its intellectual property, including patents and trade secrets, for its platform technology and product candidates[343]. - The future protection of proprietary rights is uncertain due to recent changes in patent laws and interpretations, which may affect the ability to obtain and maintain patents[345]. - The company may face challenges in obtaining patent term extensions for product candidates, which could materially harm its business[348]. - The company faces competition in acquiring product candidates or technologies, which may hinder growth if suitable opportunities are not identified[320]. - The company faces significant competition from established drugs and therapies, which may impact the commercial viability of its product candidates[239]. Financial Risks and Market Conditions - The market price of the company's common stock may be volatile, influenced by operating results, clinical trial outcomes, and changes in market conditions[365]. - The company has the authority to issue up to 2 billion shares of common stock and 5 million shares of preferred stock, which could lead to substantial dilution for existing shareholders[362]. - Significant additional capital will be needed for operations, including product development and clinical trials, which may require selling equity securities[363]. - The company may face claims regarding the wrongful use of trade secrets by employees who previously worked for competitors, potentially leading to costly litigation[353]. - The company may experience extreme price and volume fluctuations in its common stock due to loss of investor confidence[367].

Acquisition and Investment Activities - As of December 31, 2025, the company owned, managed, or invested in 96 senior housing communities with an aggregate capacity of approximately 10,150 residents[216]. - The company completed the acquisition of CHP for approximately $1.8 billion, with 68% paid in stock and 32% in cash[217]. - In 2025, the company acquired a senior living community in Mansfield, Texas for $15.6 million and recorded $14.2 million in property and equipment[220]. - The company acquired a community in Alpharetta, Georgia for $11.0 million, recording $9.2 million in property and equipment[221]. - The company recorded $27.5 million in property and equipment for four senior living communities acquired through a joint venture with Palatine Capital Partners[230]. - The company expects its 2026 results to be materially impacted by the CHP merger, acquiring 69 additional senior housing communities[219]. - The company recorded $102.9 million for the acquisition of eight senior living communities in 2024, with $89.2 million recorded in property and equipment[227]. Financial Performance - Resident revenue increased by 23.9% to $331.96 million in 2025 from $267.85 million in 2024, primarily driven by the acquisition of 19 additional operating communities[267][271]. - Community operating expenses rose by 24.7% to $248.47 million in 2025 from $199.18 million in 2024, largely due to increased expenses related to the newly acquired communities[267][272]. - Adjusted EBITDA increased by 24.3% to $53.76 million in 2025 compared to $43.24 million in 2024, reflecting higher resident revenue despite increased operating expenses[267][274]. - The Company experienced a net loss of $72.5 million in 2025, compared to a net loss of $3.3 million in 2024, with general and administrative expenses increasing to $39.9 million[291]. - Adjusted EBITDA for 2025 was $53.8 million, up from $43.2 million in 2024, reflecting improved operational performance despite increased costs[293]. - The Company’s same-store community net operating income margin improved to 27.9% in 2025 from 27.4% in 2024, indicating better efficiency in revenue generation[291]. Debt and Financing Activities - The company entered into a senior secured revolving credit facility with an initial borrowing capacity of $75.0 million, which was increased to $150.0 million in October 2024[234]. - The company borrowed $49.6 million under the revolving credit facility in 2025 at a weighted average interest rate of 6.6%[234]. - The Company amended its revolving credit facility to $405.0 million, extending maturity to March 10, 2030, and reducing the leverage-based pricing matrix to SOFR plus 1.35% to 2.00%[235]. - A $525.0 million Term Loan Facility was established in two equal tranches to fund the CHP Merger, with maturities of March 10, 2029, and March 10, 2031, and a pricing matrix of SOFR plus 1.30% to 1.95%[235]. - The Company secured a $900.0 million Bridge Facility, reduced to $270.0 million, to fund the CHP Merger, maturing on March 9, 2027, with a pricing matrix of SOFR plus 1.35% to 2.00%[236]. - The 2025 Ally Term Loan of $137.0 million has a variable interest rate of one-month SOFR plus a 2.65% margin, with a maturity date of August 2028[237]. - The Company recognized a gain on debt extinguishment of $10.4 million from a discounted payoff of $18.3 million on a Texas loan, representing a 36% discount[243]. - The Company is expected to refinance its $270 million Bridge Facility by 2026, with no assurance of favorable terms[284]. - The Company was in compliance with all financial covenants of its outstanding indebtedness as of December 31, 2025[295]. Operational Metrics - The number of communities owned increased by 3 to 80 as of December 31, 2025, compared to 77 at the end of 2024[270]. - RevPAR (average monthly revenue per available unit) increased by 7.9% to $3,952 in 2025 from $3,664 in 2024, indicating improved revenue performance[270]. - Weighted average occupancy decreased slightly to 84.7% in 2025 from 85.3% in 2024, reflecting a 0.6% decline[270]. - General and administrative expenses increased by 16.8% to $39.85 million in 2025 from $34.12 million in 2024, primarily due to higher labor and employee-related costs[275][276]. - Transaction, transition, and restructuring costs surged to $16.23 million in 2025 from $5.87 million in 2024, reflecting costs associated with recent acquisitions and debt restructuring[275][277]. - Non-labor operating expenses increased by 3.5% in 2025 compared to the previous year, influenced by inflationary pressures[297]. - Labor costs, which historically account for approximately two-thirds of total operating expenses, continued to rise due to competitive labor market conditions and increased use of premium labor[298]. Cash Flow and Liquidity - The Company had an unrestricted cash balance of approximately $11.0 million as of December 31, 2025, with future liquidity dependent on operating performance and other financial factors[281][282]. - The Company reported net cash provided by operating activities of $24.4 million for the year ended December 31, 2025, a significant increase of $26.1 million compared to a net cash used of $1.8 million in 2024[286]. - Net cash used in investing activities for 2025 was $70.7 million, primarily due to $38.2 million for acquisitions of new communities and $33.3 million for ongoing capital improvements[287]. - The net cash provided by financing activities for 2025 was $37.5 million, mainly from proceeds of $49.6 million from the Revolving Credit Facility and $18.1 million from notes payable[288].

Revenue Performance - Fourth quarter 2025 revenue was $43.1 million, a decrease from $47.7 million in the prior year period, attributed to ongoing pricing pressure in core markets[6] - Full year 2025 revenue was $174.7 million, down from $184.5 million in the prior year, driven by headwinds in core markets[13] - Total revenues for the year ended December 31, 2025, were $174.704 million, a decrease of 5.3% from $184.514 million in 2024[27] Client Metrics - Average monthly paying clients decreased to 5,120 from 5,225 in the prior year, primarily due to churn in established markets[6] - Average monthly paying clients for the full year increased to 5,190 from 5,077, mainly due to new client acquisitions in developing markets[13] Revenue per Client - Average monthly revenues per paying client fell to $2,804 from $3,041 in the prior year, reflecting spending declines in established markets[6] - Average monthly revenues per paying client for the full year decreased to $2,805 from $3,029, impacted by price deflation and consolidation in the industry[13] Profitability - The company reported a net loss of $5.0 million for the fourth quarter, compared to a net income of $3.7 million in the prior year[6] - Operating income for the year ended December 31, 2025, was $766 thousand, down from $14.765 million in 2024, reflecting a significant decline in profitability[27] - Net loss attributable to WM Technology, Inc. for the year ended December 31, 2025, was $1.962 million, compared to a net income of $7.639 million in 2024[27] - Adjusted EBITDA decreased to $10.4 million from $11.9 million in the prior year[6] - Adjusted EBITDA for the year ended December 31, 2025, was $39.847 million, down from $42.919 million in 2024, reflecting a decline of 7.2%[30] Cash and Assets - Cash increased to $62.4 million as of December 31, 2025, compared to $52.0 million as of December 31, 2024[13] - Cash and cash equivalents at the end of 2025 increased to $62.401 million from $51.966 million at the end of 2024, representing a 20% increase[29] - Total assets as of December 31, 2025, were $190.667 million, up from $181.866 million in 2024, indicating a growth of 4.4%[25] Liabilities and Equity - Total liabilities decreased to $58.867 million in 2025 from $61.799 million in 2024, a reduction of 4.7%[25] - The company’s stockholders' equity increased to $131.800 million in 2025 from $120.067 million in 2024, reflecting an increase of 9.1%[25] Future Outlook - The company expects first quarter 2026 revenue to decline by mid- to high-single digit percentages sequentially from the fourth quarter[10] Asset Impairment - The company reported a significant asset impairment charge of $7.777 million for the year ended December 31, 2025[27] Cash Flow - Cash flows from operating activities for the year ended December 31, 2025, were $26.188 million, compared to $36.676 million in 2024, a decrease of 28.6%[29]

Regulatory Capital Requirements - The Parent Company and the Bank's regulatory capital ratios were above minimum requirements and exceeded the Capital Conservation Buffer requirement as of December 31, 2025[69]. - The Bank must maintain a Capital Conservation Buffer of 2.5% over the minimum risk-based capital ratio requirements to avoid restrictions on capital distributions[68]. - The Company is subject to risk-based capital and leverage ratio requirements under the U.S. Basel III capital rules, which may require higher capital levels based on size, complexity, or risk profile[63]. - The CET1 Risk-Based Capital Ratio is calculated as the ratio of CET1 capital to risk-weighted assets, with CET1 capital primarily including common shareholders' equity[64]. - The Total Risk-Based Capital Ratio includes CET1 capital, Tier 1 capital, and Tier 2 capital, calculated against risk-weighted assets[65]. Compliance and Ratings - The Bank received a "Satisfactory" CRA rating in its most recent examination conducted by the FRB on January 22, 2024[79]. - The Bank is required to maintain an effective, risk-based anti-money laundering program, including ongoing employee training and independent testing[84]. - The Company is listed on the Nasdaq Capital Market under the trading symbol "ORRF" and is subject to Nasdaq's rules for listed companies[88]. - The Company files annual, quarterly, and current reports with the SEC, which are available on its website[89]. - The FRB established a new reserve requirement exemption amount effective January 1, 2025, but did not elevate the current reserve percentage from zero for depository institutions[87]. Financial Performance - Net income for 2025 reached $80.9 million, significantly higher than $22.1 million in 2024[364]. - Adjusted net income (non-GAAP) for 2025 was $82.9 million, compared to $56.1 million in 2024, indicating a 47.6% increase[364]. - The diluted earnings per share (GAAP) for 2025 was $4.18, compared to $1.48 in 2024, showing a substantial increase[364]. - Tangible book value per share (non-GAAP) increased to $25.21 in 2025 from $21.19 in 2024, reflecting a growth of 9.5%[363]. - Shareholders' equity increased to $591,535 in 2025 from $516,682 in 2024, representing a growth of 14.5%[363]. Obligations and Expenses - Total contractual obligations amount to $1,264,314, with $1,047,876 due within one year[354]. - Commitments to fund home equity lines of credit total $539,336, while commercial, industrial, and other loans amount to $597,023[356]. - The company incurred merger-related expenses of $2.6 million for the year ended December 31, 2025, down from $22.7 million in 2024[359]. - The company reported total intangible assets of $107.7 million as of December 31, 2025, up from $21.1 million in 2023[358]. Off-Balance Sheet Arrangements - The company’s off-balance sheet arrangements include standby letters of credit totaling $37,241[355].

Financial Performance - The company has incurred net losses since its inception, with a recorded net loss of $116.8 million for the year ended December 31, 2025, and an accumulated deficit of $614.7 million as of the same date[215]. - The company raised approximately $19.3 million from common stock sales in January 2024, $91.7 million from an underwritten public offering in January 2024, and $74.8 million from a registered direct offering in October 2025[215]. - The company has $158.5 million in cash and equivalents as of December 31, 2025, which is expected to last into the second half of 2027[282]. - The company anticipates needing substantial additional financing to develop product candidates and implement operating plans, particularly for clinical trials and commercial production[281]. - A workforce reduction plan was implemented in July 2025, with expected costs of approximately $2.3 million primarily for one-time severance benefits[291]. - As of December 31, 2025, the company had federal net operating loss carryforwards of approximately $472.7 million, which may be limited by potential ownership changes[357]. Research and Development - The company is focused on developing its gamma delta T cell platform, with ongoing clinical trials for its lead product candidate, prula-cel, which began dosing patients in November 2024[219]. - Enrollment for prula-cel's Phase 1 clinical trial has expanded to include patients with systemic lupus erythematosus (SLE) and systemic sclerosis (SSc), with preliminary data reported in October 2025[219]. - The company anticipates significant expenditures for research and development, which are expected to increase as it seeks regulatory approvals for its product candidates[216]. - The success of the company's business is highly dependent on the regulatory approval and commercialization of prula-cel, as well as the efficacy and safety profile of its product candidates[223]. - The company faces challenges related to the novel nature of its gamma delta T cell therapies, including potential delays in clinical trials and manufacturing processes[222]. - The regulatory approval process for the company's product candidates may be more complex and costly due to their novel nature, with no allogeneic T cell therapies currently licensed in the U.S. or EU[225]. - The company must address potential adverse side effects associated with its product candidates, which could impact clinical development and regulatory approval[229]. - The company is in the early stages of developing its manufacturing capabilities, which are critical for the successful commercialization of its product candidates[224]. - The company has received clearance for INDs to evaluate prula-cel in clinical trials for multiple indications, with plans to submit a regulatory filing for ADI-212 targeting metastatic castration-resistant prostate cancer (mCRPC) in Q3 2026[240]. - The company aims to submit a new regulatory submission, such as an IND application, every 12-18 months, but may face delays in these filings[240]. - Clinical trials are expensive and time-consuming, with costs expected to be significantly higher than conventional therapeutic technologies due to the novel nature of the product candidates[251]. - The company may encounter substantial delays in clinical trials due to various factors, including patient enrollment challenges and regulatory requirements[241]. - The company has deprioritized enrollment of large B cell lymphoma patients in its Phase 1 clinical trial of prula-cel to focus on autoimmune indications[252]. - The company discontinued the development of ADI-270 for metastatic/advanced clear renal cell carcinoma to prioritize resources on prula-cel and ADI-212[252]. - The company plans to submit one new IND to the FDA every 12-18 months, including a regulatory filing for ADI-212 in Q3 2026[261]. Regulatory Challenges - The FDA may require approval of companion diagnostics for product candidates, which could materially impair the company's ability to generate revenue if not obtained[232]. - The company faces a high rate of attrition in clinical trials, with many product candidates failing to demonstrate the desired safety and efficacy profiles[236]. - Monitoring patient safety during clinical trials is challenging, which could adversely affect the ability to obtain regulatory approval[245]. - The company may experience difficulties in developing and obtaining approval for companion diagnostics, which could delay or prevent the marketing of relevant products[234]. - The company must demonstrate the safety and efficacy of product candidates through lengthy and complex clinical trials, with uncertain outcomes[235]. - Delays in patient enrollment could increase costs and affect the timing or outcome of ongoing and planned clinical trials[250]. - The company faces significant competition in the biopharmaceutical industry, which may affect its operating results[266]. - The company’s product candidates may only be approved for patients who are ineligible for existing therapies, limiting market opportunities[259]. - The company’s estimates of the addressable patient population may prove to be incorrect, potentially affecting profitability[260]. - The company’s manufacturing processes may encounter difficulties, impacting the availability of products for clinical trials and commercial sale[272]. - The company relies on third-party suppliers for manufacturing, which increases the risk of delays and impacts on development and commercialization efforts[268]. - The company has commenced manufacturing operations at its Redwood City facility but still depends significantly on third parties for clinical development[269]. - The company is subject to ongoing risks related to compliance with securities laws and internal controls, which could affect investor confidence and stock price[356]. Compliance and Regulatory Environment - The pharmaceutical industry in China is highly regulated, and changes in regulations could affect the development and commercialization of product candidates[292]. - The 2024 Negative List in China prohibits foreign investment in certain technologies, which may impact the company's research and development activities[294]. - The company faces uncertainties regarding the interpretation and application of PRC laws, which may impact its business operations and compliance[300]. - Compliance with China's Data Security Law and Cyber Security Law may significantly increase operational costs and affect service offerings[310]. - The Personal Information Protection Law imposes fines of up to RMB 50 million or 5% of annual revenues for serious violations, affecting data processing activities[307]. - The regulatory framework for the pharmaceutical industry in China is extensive, covering all aspects from product development to post-approval requirements, which may impact business operations[311]. - Changes in U.S. and Chinese regulations could adversely affect the company's financial condition and results of operations[301]. - The company may be restricted from transferring scientific data abroad, which could hinder research and development efforts[304]. - The implementation of the Regulations on the Administration of Human Genetic Resources may expose the company to compliance risks regarding the use of human genetic resources[309]. - The company must navigate extensive regulatory approvals, which are uncertain and may impose additional burdens on operations in China[311]. - The company is subject to anti-corruption laws, which could limit competitiveness in foreign markets and result in significant penalties if violated[313]. - Compliance with U.S. and foreign export controls and trade sanctions could adversely affect international sales and revenue[314]. - Failure to comply with Chinese regulations regarding employee equity incentive plans may lead to fines and impact financial results[315]. - Regulatory uncertainties in China could limit the ability to adopt additional employee incentive plans[316]. Strategic Partnerships and Collaborations - The collaboration with Regeneron includes a non-refundable upfront payment of $25 million and an additional $20 million for research funding as of December 31, 2025[361]. - Regeneron has the option to obtain development and commercial rights for certain product candidates, with a payment of $20 million received for the exclusive rights to ADI-002[361]. - The company faces risks related to collaborations, including potential termination or changes in strategic focus by partners like Regeneron, which could impact revenue and development timelines[361][362]. - The exclusivity obligations under the Regeneron Agreement may limit the company's ability to pursue other collaborations for immune cell products[369]. - The company may need to seek additional funding or collaborations if existing partnerships do not perform as expected, which could delay product development and commercialization efforts[367]. Operational Risks - The company faces significant competition in the biopharmaceutical industry, which may affect its operating results[266]. - Business disruptions from natural disasters or conflicts could significantly harm future revenue and increase costs[317]. - Global conflicts may hinder the ability to source materials for product candidates and conduct clinical trials[319]. - Changes in U.S.-China relations could negatively impact business operations and financial condition[320]. - Inadequate funding for regulatory agencies like the FDA could delay product approvals and impact business operations[322]. - Political and trade developments may have a material adverse effect on financial condition and results of operations[326]. - Increased scrutiny of healthcare regulations could lead to substantial penalties for non-compliance[327]. - Evolving data protection laws may require significant resources for compliance and could adversely affect business operations[331]. - The financial services industry faces risks from liquidity issues, as evidenced by the closure of Silicon Valley Bank and others in March 2023, which could impact access to funds[344]. - Inflation and rising interest rates have decreased the trading value of government securities, leading to potential liquidity challenges for financial institutions[345]. Internal Controls and Reporting - The company must maintain effective internal control over financial reporting to avoid material weaknesses, which could negatively impact stock value[347]. - The company is required to assess and document internal controls, which is a costly and challenging process, with potential for undetected weaknesses[349]. - Future material weaknesses in internal control could adversely affect the accuracy and timing of financial reporting, leading to compliance issues[350]. - The company identified a material weakness in internal control over financial reporting related to cash disbursements during Q4 2024, which has been remediated as of the Annual Report for the year ended December 31, 2024[354]. - The company is focused on improving internal controls to enhance the accuracy and timeliness of financial reporting, consulting with experts on technical accounting matters[355]. Regulatory Approval and Market Access - The regulatory approval pathway for the company's product candidates may be uncertain, complex, expensive, and lengthy due to the novel nature of the therapies[391]. - The company expects its product candidates to be regulated as biological products, which may expose them to competition from biosimilar products after a 12-year exclusivity period[396][397]. - The regulatory landscape for the company's allogeneic cell immunotherapy product candidates is unclear, with evolving requirements that could lead to delays or increased costs[399][401]. - The FDA may require post-marketing studies for accelerated approval, and failure to conduct these studies in a timely manner could result in withdrawal of approval[404]. - The company may seek orphan drug designation for its product candidates, which could provide market exclusivity but is subject to various conditions and risks[406][407]. - Fast track designation by the FDA does not guarantee a faster development or approval process for the company's product candidates[409]. - The company may encounter delays in clinical trials due to unresolved ethical issues or regulatory compliance failures[394][405]. - The potential for regulatory changes could impact the company's ability to generate sufficient product revenue and maintain its business[402]. - The company has received fast track designation for prula-cel for the treatment of relapsed/refractory Class III or IV LN, refractory SLE with extrarenal involvement, and SSc[411]. - Fast track designation does not guarantee faster development or ultimate marketing approval by the FDA[411]. - The company may seek RMAT designation for its product candidates, which could provide benefits such as more frequent meetings with the FDA and eligibility for rolling review[412]. - RMAT designation does not change the FDA's standards for product approval and may be revoked if eligibility criteria are not met[412]. - The approval policies or regulations of the FDA may change, potentially rendering clinical data insufficient for approval[410]. - The company may not be able to demonstrate that product candidates' clinical benefits outweigh safety risks[410]. - Data from clinical trials may not satisfy the FDA or comparable foreign regulatory authorities for BLA submission[410]. - The FDA may inspect the manufacturing facility and may not find it acceptable[410]. - There is no assurance that the FDA will grant fast track designation for any of the company's product candidates[411]. - The company may experience no faster development process even with fast track designation[411].

Revenue Performance - Total revenues increased by $44.2 million or 5.2% year-over-year, reaching $896.5 million in 2025, with a $2.3 million positive impact from favorable foreign exchange rates [136]. - IHT segment revenues rose by $32.2 million or 7.5%, primarily due to a $24.3 million increase in U.S. operations driven by higher call-out and turnaround activity [137]. - MS segment revenues increased by $12.1 million or 2.8%, attributed to a $14.6 million rise in U.S. operations, offset by a $9.9 million decline in international operations [137]. Operating Income and Expenses - Operating income increased by $3.9 million to $14.1 million in 2025, with IHT's operating income up by 18.5% to $43.9 million [138]. - Total operating income excluding non-core expenses increased by $10.2 million to $25.9 million, reflecting a 64.7% year-over-year growth [140]. - Interest expense decreased by $3.1 million to $44.7 million, primarily due to lower interest rates from refinancing activities [141]. Debt and Financing Activities - The company completed a $225.0 million senior secured first lien term loan refinancing on March 12, 2025, maturing in 2030 [129]. - On September 11, 2025, the company issued 75,000 shares of Series B Preferred Stock and warrants for total consideration of $75.0 million to repay outstanding loans and cover transaction expenses [132]. - The company incurred a loss on debt extinguishment of $11.9 million related to refinancing transactions completed on March 12, 2025 [142]. Tax and Net Loss - The provision for income tax was $2.6 million on a pre-tax loss of $46.6 million for the year ended December 31, 2025, compared to a provision of $3.3 million on a pre-tax loss of $35.0 million for 2024, resulting in effective tax rates of 5.5% and 9.4% respectively [144]. - Adjusted net loss for the twelve months ended December 31, 2025, was $24.5 million, improving from an adjusted net loss of $32.9 million in 2024, with adjusted net loss per share of $6.20 compared to $7.43 [152]. - The company reported a net loss of $49.2 million for the twelve months ended December 31, 2025, compared to a net loss of $38.3 million in 2024 [152]. Cash Flow and Liquidity - Free cash flow for the year ended December 31, 2025, was negative $20.6 million, a decline from positive $13.3 million in 2024, reflecting challenges in cash generation [152]. - Cash and cash equivalents totaled $18.1 million as of December 31, 2025, down from $35.5 million in 2024, indicating a significant reduction in liquidity [166]. - Operating activities generated a cash outflow of $11.3 million in 2025, a decline of $34.1 million compared to a cash inflow of $22.8 million in 2024 [166]. Working Capital and Investments - Changes in working capital items used $31.3 million in cash flows during the twelve months ended December 31, 2025, a $36.0 million increase compared to $4.7 million in 2024 [171]. - For the year ended December 31, 2025, net cash used in investing activities was $9.1 million, consisting of $9.3 million in capital expenditures [172]. Financing Activities - For the year ended December 31, 2025, net cash provided by financing activities totaled $2.8 million, primarily from $175.0 million borrowing under the new First Lien Term Loan [173]. - The company incurred $11.3 million in debt issuance costs related to refinancing transactions completed as of March 12, 2025 [173]. - For the year ended December 31, 2024, net cash used in financing activities was $12.7 million, primarily due to $8.5 million in debt issuance costs [174]. Foreign Exchange and Tax Positions - The effect of foreign exchange rate changes on cash was a positive impact of $0.2 million for the year ended December 31, 2025, compared to a negative impact of $0.6 million in 2024 [175]. - The company recognizes deferred tax assets to the extent that they are more likely than not to be realized, considering various factors [179]. - The company establishes reserves for uncertain tax positions when it is not more likely than not that the position will be sustained upon challenge [180]. Compliance and Off-Balance Sheet Arrangements - The company remains in compliance with its debt covenants as of December 31, 2025, but future compliance is dependent on operational performance [163]. - The company engages in off-balance sheet arrangements that may give rise to material obligations [176].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________ FORM 10-K _____________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-39990 (Exact name of registrant as ...

Cancer Immunotherapy Development - The company is advancing ELI-002 7P, a cancer immunotherapy targeting seven KRAS mutations found in approximately 88% of pancreatic ductal adenocarcinoma (PDAC) patients and 25% of all solid tumors[23]. - The ongoing Phase 2 trial for ELI-002 7P has completed enrollment, with a final disease-free survival analysis anticipated in the first half of 2026[25]. - The company plans to expand ELI-002 7P to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers[23]. - ELI-007 and ELI-008 are preclinical candidates targeting BRAF and TP53 mutations, respectively, with grants received to fund their development[31]. - ELI-002 is designed as an "off-the-shelf" treatment, providing cost and time-to-treatment advantages compared to personalized therapies[48]. - The Phase 1A trial of ELI-002 7P was well tolerated, with no dose-limiting toxicities or serious adverse events reported[53]. - The IDMC confirmed the favorable safety profile of ELI-002 7P, allowing the trial to continue to final analysis without modifications[55]. - ELI-007 targets 95% of BRAF gene mutations found in solid tumors, with BRAF mutations present in 40% of melanoma cases, 9% in colorectal cancer (CRC), and 2% in lung cancer[68]. - ELI-008 targets approximately 30% of TP53 hotspot mutations in solid tumors, with funding received for its initial development through three grants[70]. Clinical Trial Results - The AMPLIFY-201 Phase 1 trial data showed a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months for the full study population[23]. - In the Phase 1A trial of ELI-002 7P, 84% of patients generated mKRAS-specific T cell responses with an average fold-change of 58x compared to baseline, and 100% of the above-median T cell response group achieved tumor biomarker responses[53]. - The Phase 2 AMPLIFY-7P trial reported robust mKRAS-specific T cell responses in 99% of evaluable patients, with an average increase of 145.3x over baseline[56]. - The median relapse-free survival (RFS) for the full 25 patient cohort in the ELI-002 2P study was 16.3 months, while the above median T cell responders had not reached median RFS compared to 4.01 months for below median responders[53]. - The Phase 2 AMPLIFY-7P trial utilized disease-free survival (DFS) as the primary endpoint, with patients randomized in a 2:1 ratio to receive ELI-002 7P or standard observation[54]. - In the ongoing Phase 2 AMPLIFY-7P study, fewer disease progressions and deaths than projected were observed, suggesting a favorable impact on DFS[62]. - Antigen spreading was observed in 87% of evaluated patients, indicating the potential for ELI-002 7P to generate broader immune responses beyond mKRAS[63]. AMP Technology and Applications - The AMP technology aims to enhance T cell responses by localizing immunotherapeutic payloads to lymph nodes, potentially improving therapeutic efficacy[33]. - The AMP technology has shown potential in improving immune responses in various therapeutic modalities, including CAR-T and TCR-T cell therapies[31]. - The company aims to realize the full value of its AMP technology through collaborations and further research into its applications[31]. - The AMP platform has potential applications for CAR T cell therapeutics and TCR T cell therapeutics, with plans for out-licensing and co-development[72]. - Preclinical studies indicated that AMP immunotherapy combined with TCR-T cell therapy led to complete tumor eradication in murine models[73]. Regulatory and Compliance Considerations - The FDA requires substantial time and financial resources for the approval process of biopharmaceutical products, which can take many years depending on the product's complexity and novelty[118]. - Human clinical trials are conducted in three phases, with Phase 3 requiring sufficient data from larger populations to establish clinical efficacy and safety, typically needing two well-controlled trials for approval[131]. - The FDA may impose clinical holds on trials due to safety concerns or non-compliance, which can delay the initiation of clinical trials[121]. - A Biologics License Application (BLA) must demonstrate the product's safety, purity, potency, and efficacy, and must include all relevant clinical trial results, including negative findings[134]. - The Prescription Drug User Fee Act (PDUFA) mandates substantial application user fees for each BLA submission, which are adjusted annually by the FDA[135]. - The FDA may require additional post-approval Phase 4 trials to gather further safety and efficacy data after a product is approved[130]. - Compliance with current good manufacturing practice (cGMP) regulations is essential for the manufacturing of investigational biologics[127]. Market and Competitive Landscape - The biotechnology industry is characterized by rapid technological evolution and strong competition, with many competitors having greater financial resources[111]. - The company faces competition from various established pharmaceutical and biotechnology firms, as well as smaller companies with collaborative arrangements[114]. - Key competitive factors for the company's success include product safety, efficacy, convenience, and treatment cost[115]. - The commercial success of product candidates will depend on governmental payor programs and private health insurers providing adequate coverage and reimbursement levels[194]. - Government authorities and third-party payors are increasingly limiting or regulating the price of medical products, often resulting in average selling prices lower than expected[198]. Intellectual Property and Patent Considerations - The company has two issued U.S. patents and pending U.S. and Canadian patent applications related to ALK polypeptides for tumor indications[97]. - The company holds a patent family for mutant KRAS sequences with granted patents in multiple countries, including the U.S., and pending applications in various regions[98]. - The company has a patent family for CpG amphiphiles with granted patents in the U.S. and other countries, focusing on tumor indications driven by human papillomavirus proteins[99]. - The company has pending applications for compositions inducing immune responses against coronavirus, utilizing its AMP technology[100]. - The company anticipates patent expirations for its patents between 2037 and 2046, excluding potential adjustments or extensions[105]. Legislative and Policy Impacts - The Inflation Reduction Act of 2022 mandates that manufacturers pay rebates to the federal government if drug prices increase faster than inflation, impacting revenue from Medicare-covered drugs[210]. - CMS will negotiate prices for select single-source Part D drugs starting in 2026, which is expected to decrease revenue for those products[210]. - Legislative changes may limit the amounts that federal and state governments will pay for health care products, potentially impacting future drug pricing[215]. - The federal Anti-Kickback Statute prohibits remuneration to induce referrals for federally reimbursed services, with broad interpretations affecting biopharmaceutical industry practices[181]. - The federal civil False Claims Act imposes liability for presenting false claims to the government, with potential penalties including treble damages and significant fines[183].

Financial Performance - Generated fourth quarter 2025 revenues of $224.8 million, an increase of 5.4% over the 2024 period[6] - Reported a net loss of $3.8 million in Q4 2025, an improvement of 47.4% from the prior year[11] - Increased consolidated Adjusted EBITDA to $16.4 million, representing 7.3% of consolidated revenue, up 12.1% from the 2024 period[6] - Full year 2025 revenues reached $896.5 million, a 5.2% increase compared to 2024[12] - Reported a net loss of $49.2 million for 2025, including a $13.1 million loss on debt extinguishment[14] - Consolidated Adjusted EBITDA for 2025 improved by 11.9% to $60.7 million, or 6.8% of revenue[14] - Revenues for Q4 2025 were $224.826 million, an increase of 5.7% from $213.296 million in Q4 2024[32] - Operating income for Q4 2025 was $6.629 million, compared to $2.205 million in Q4 2024, reflecting a significant improvement[32] - Net loss for Q4 2025 was $3.779 million, a reduction from a net loss of $7.182 million in Q4 2024[32] - Adjusted net loss for Q4 2025 was $2.641 million, compared to $3.654 million in Q4 2024, while the adjusted net loss for the full year 2025 was $24.453 million, down from $32.918 million in 2024[46] - Consolidated Adjusted EBITDA for Q4 2025 was $16.404 million, an increase from $14.631 million in Q4 2024, and for the full year 2025, it reached $60.725 million, compared to $54.262 million in 2024[46] - Consolidated Adjusted EBIT for Q4 2025 was $7.868 million, up from $5.741 million in Q4 2024, and for the full year 2025, it was $25.848 million, compared to $15.694 million in 2024[46] - The company reported a net loss of $3.779 million for Q4 2025, an improvement from a net loss of $7.182 million in Q4 2024, with a full year net loss of $49.210 million compared to $38.266 million in 2024[46] Cash Flow and Assets - Cash flow from operations for Q4 2025 was $16.8 million, with Free Cash Flow of $14.6 million[6] - Cash provided by operating activities for Q4 2025 was $16.774 million, a decrease from $21.624 million in Q4 2024, while the full year 2025 showed a cash outflow of $11.348 million compared to an inflow of $22.767 million in 2024[46] - Total assets decreased to $485.453 million as of December 31, 2025, down from $528.365 million a year earlier[34] - Cash and cash equivalents dropped to $18.145 million from $35.545 million year-over-year[34] Segment Performance - The Industrial Heat Treatment (IHT) segment generated revenues of $108.490 million in Q4 2025, up from $106.436 million in Q4 2024[38] - The Maintenance Services (MS) segment saw revenues increase to $116.336 million in Q4 2025 from $106.860 million in Q4 2024[38] - The company reported segment Adjusted EBITDA for the IHT segment of $11.068 million in Q4 2025, down from $12.567 million in Q4 2024, while the MS segment reported $16.086 million in Q4 2025, up from $12.564 million in Q4 2024[50] Expenses - The company’s total operating expenses for Q4 2025 were $166.517 million, compared to $155.955 million in Q4 2024[32] - Selling, General and Administrative Expenses for Q4 2025 were $51.68 million, a decrease from $55.14 million in Q4 2024, representing a reduction of approximately 8.3%[53] - Adjusted Selling, General and Administrative Expenses for the full year 2025 were $183.72 million, slightly up from $182.70 million in 2024, indicating a marginal increase of about 0.6%[53] - Total non-cash/non-recurring items in SG&A for Q4 2025 amounted to $6.69 million, down from $9.18 million in Q4 2024, reflecting a decrease of approximately 27.2%[53] - The company incurred $1.7 million related to debt financing in the full year 2025, compared to $3.8 million in 2024, showing a reduction of about 55.3%[53] - Legal costs and litigation reserves for the full year 2025 were $2.12 million, significantly higher than $0.12 million in 2024, marking an increase of over 1,600%[53] - Severance charges included in SG&A expenses for Q4 2025 were $0.40 million, slightly up from $0.33 million in Q4 2024, representing an increase of approximately 21.0%[53] - Depreciation and amortization in SG&A expenses for the full year 2025 was $21.59 million, down from $22.57 million in 2024, indicating a decrease of about 4.3%[53] - Non-cash share-based compensation costs for Q4 2025 were $0.13 million, significantly lower than $0.53 million in Q4 2024, reflecting a decrease of approximately 75.5%[53] - Professional fees and other expenses for the full year 2025 were $8.19 million, up from $4.11 million in 2024, indicating an increase of approximately 99.5%[53] Future Outlook - The Company plans to accelerate expansion into aerospace and power markets in 2026[8] - The Company is not providing full-year guidance for 2026 at this time due to a change in leadership[25]