What changed in Alaunos Therapeutics, Inc.'s 2025 10-K compared to 2024?

Across the narrative sections we track, Alaunos Therapeutics, Inc. (TCRT) added 369 paragraphs, removed 658, and edited 117 between the 2024 and 2025 10-K filings. The biggest movers are Item 1A. Risk Factors (+182/−374), Item 1. Business (+85/−194), Item 7. Management's Discussion & Analysis (+89/−77).

Did Alaunos Therapeutics, Inc. add new Risk Factors in the 2025 10-K?

Yes — Item 1A Risk Factors shows 182 new/edited paragraphs and 374 removed paragraphs versus the 2024 10-K.

What changed in Alaunos Therapeutics, Inc.'s MD&A (Item 7) in 2025?

Item 7 Management's Discussion & Analysis shows 89 new/edited paragraphs and 77 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Did Alaunos Therapeutics, Inc. update its Cybersecurity disclosure (Item 1C) in 2025?

Item 1C Cybersecurity has 9 paragraph-level changes between the 2024 and 2025 filings.

Did Alaunos Therapeutics, Inc.'s Legal Proceedings (Item 3) change in 2025?

Item 3 shows 1 added/edited paragraphs and 1 removed paragraphs — usually indicating new litigation disclosed or settled cases removed.

Where does this TCRT 10-K diff come from?

The source filings are Alaunos Therapeutics, Inc.'s official 2024 and 2025 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

What changed in Alaunos Therapeutics, Inc.'s 10-K — 2024 vs 2025

Paragraph-level year-over-year comparison of Alaunos Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+369 added−658 removedSource: 10-K (2026-03-31) vs 10-K (2024-12-31)

Top changes in Alaunos Therapeutics, Inc.'s 2025 10-K

369 paragraphs added · 658 removed · 117 edited across 6 sections

Item 1A. Risk Factors+182 / −374 · 65 edited
Item 1. Business+85 / −194 · 16 edited
Item 7. Management's Discussion & Analysis+89 / −77 · 23 edited
Item 1C. Cybersecurity+9 / −9 · 9 edited
Item 5. Market for Registrant's Common Equity+3 / −3 · 3 edited

Item 1. Business

Business — how the company describes what it does

16 edited+69 added−178 removed6 unchanged

2024 filing

2025 filing

Biggest changeLicense Agreements License Agreement and 2015 Research and Development Agreement-The University of Texas MD Anderson Cancer Center On January 13, 2015, we and Precigen (later assigned to PGEN) entered into the MD Anderson License, granting us an exclusive global license to technologies from MD Anderson, primarily related to CAR T-cell therapies, non-viral gene transfer, genetic modification of immune cells, NK cells, and TCRs, developed by Laurence Cooper, M.D., Ph.D., our CEO from May 2015 to February 2021.

Biggest changeMD Anderson License and Research Agreements In January 2015, we entered into an exclusive worldwide license agreement (the “MD Anderson License”) with The University of Texas MD Anderson Cancer Center (“MD Anderson”) for certain technologies related to non-viral gene transfer, genetic modification of immune cells, TCRs, and other cellular therapy approaches.

In addition, the SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers, like us, that file electronically with the SEC. 17

On September 13, 2005, we completed a “reverse” acquisition of privately held Ziopharm, Inc., a Delaware corporation. To effect this transaction, we caused ZIO Acquisition Corp., our wholly-owned subsidiary, to merge with and into Ziopharm, Inc., with Ziopharm, Inc. surviving as our wholly owned subsidiary.

We re-incorporated in Delaware on May 16, 2005 under the same name. On September 13, 2005, we completed a “reverse” acquisition of privately held Ziopharm, Inc., a Delaware corporation. To effect this transaction, we caused ZIO Acquisition Corp., our wholly-owned subsidiary, to merge with and into Ziopharm, Inc., with Ziopharm, Inc. surviving as our wholly owned subsidiary.

Governmental Regulation and Product Approval Government authorities in the United States (at the federal, state and local level) and in other countries and jurisdictions extensively regulate, among other things, the research, development, preclinical and clinical testing, manufacturing, quality control, labeling, packaging, storage, record-keeping, promotion, advertising, sale, distribution, post-approval monitoring and reporting, marketing and export and import of pharmaceutical products such as those we are developing.

For a full discussion, see Item 1A, “Risk Factors — Risks Related to Our Intellectual Property” and “Risks Related to Our Strategic Reprioritization.” Governmental Regulation and Product Approval Government authorities in the United States (at the federal, state and local level) and in other countries and jurisdictions extensively regulate, among other things, the research, development, preclinical and clinical testing, manufacturing, quality control, labeling, packaging, storage, record-keeping, promotion, advertising, sale, distribution, post-approval monitoring and reporting, marketing and export and import of pharmaceutical products such as those we are developing.

On January 25, 2022, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to change our name to Alaunos Therapeutics, Inc. Our principal executive offices are located at 2617 Bissonnet Street, Suite 233, Houston, Texas 77005, and our telephone number is (346) 355-4099.

On January 25, 2022, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to change our name to Alaunos Therapeutics, Inc. Our principal executive offices are located at 501 E. Las Olas Blvd., Suite 300, Fort Lauderdale, Florida 33301, and our telephone number is (346) 355-4099.

The process for obtaining regulatory marketing approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. U.S. Regulatory Process In the United States, the FDA regulates small-molecule drugs under the Federal Food, Drug, and Cosmetic Act and implementing regulations.

Lackey upon 30 days prior written notice. The Lackey Consulting Agreement provides for compensation at a fixed rate of $400 per hour and reimbursement by the Company for any usual and customary expenses incurred by Ms. Lackey in connection with performing services pursuant to the Lackey Consulting Agreement. Mr.

The Consulting Agreement provides for compensation at a fixed rate of $250 per hour and reimbursement by the Company for any usual and customary expenses incurred by Mr. Hogue in connection with performing services pursuant to the Consulting Agreement. Mr. Weis Engagement Effective July 2, 2025, the Company entered into an employment agreement with Mr.

In addition, the Groenewald Consulting Agreement provides for the Company to indemnify Mr. Groenewald on terms customary for officers. Corporate Information We originally incorporated in Colorado in September 1998 (under the name Net Escapes, Inc.) and later changed our name to “EasyWeb, Inc.” in February 1999. We re-incorporated in Delaware on May 16, 2005 under the same name.

Appointment of Ferdinand Groenewald as Corporate Secretary On August 14, 2025, the Board of Directors of the Company appointed Mr. Ferdinand Groenewald as Corporate Secretary effective upon the resignation of Ms. Lackey. Corporate Information We originally incorporated in Colorado in September 1998 (under the name Net Escapes, Inc.) and later changed our name to “EasyWeb, Inc.” in February 1999.

Manufacturing of our Obesity Product Candidates We currently outsource the manufacturing of our active pharmaceutical ingredient or API to a third party vendor with extensive experience in manufacturing small molecule drug products. Intellectual Property Our goal is to obtain, maintain and enforce patent and trade secret protection for our product candidates, formulations, processes, methods and other proprietary technologies.

Reliance on third-party manufacturers involves risks, including potential delays in supply, quality or purity issues, regulatory compliance challenges, and increased costs. Intellectual Property Our goal is to obtain, maintain and enforce patent and trade secret protection for our product candidates, formulations, processes, methods and other proprietary technologies.

Alaunos Patents & Patent Applications As of December 31, 2024, we have six families of pending patent applications that cover our TCR-T library, products and processes. We do not currently own any granted patents.

Legacy TCR-T Programs As of December 31, 2025, we have six families of pending patent applications covering aspects of our historical TCR-T library, products, and processes (including Sleeping Beauty gene transfer and hunTR TCR discovery technologies). We currently hold no issued patents in this area.

The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus awards. We continue to have in place several material consulting agreements to ensure business continuity.

We maintain equity incentive plans (including the 2020 Equity Incentive Plan) to attract, retain, and motivate employees, consultants, and directors through stock-based compensation awards and, where applicable, cash-based performance bonuses. The small size of our workforce and dependence on consultants increase execution risk for our remaining programs and strategic initiatives.

Our ability to execute on this plan is dependent on study results and our ability to raise additional capital or partner these assets with other companies or research institutions. Obesity Market Obesity remains one of the most pressing public health challenges globally, with rates continuing to rise across many regions, particularly in the United States, Europe, and parts of Asia.

Obesity Market Obesity remains one of the most critical and rapidly escalating global health challenges. Prevalence continues to rise across nearly all regions, with particularly high and still increasing rates in the United States, Europe, the Middle East, and parts of Asia.

More information regarding our TCR-T clinical trial, strategy and approved is detailed on our 2023 Form 10-K. Despite the encouraging TCR-T Library Phase 1/2 Trial data, based on the substantial cost to continue development and the current financing environment, we announced in August 2023 that we would not pursue any further development of our TCR-T clinical programs.

These programs were being developed in collaboration with The University of Texas MD Anderson Cancer Center in a Phase 1/2 TCR-T Library Trial. In August 2023, due to substantial development costs and the challenging financing environment, we announced a strategic reprioritization and discontinued further clinical development of our TCR-T programs.

Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development. Moreover, the FDA strictly regulates marketing, labeling, advertising and promotion of products.

The regulatory process is subject to change, including through new legislation or FDA policies, which could delay or prevent approval of our product candidates.

On August 14, 2023, the Company announced a strategic reprioritization of its business and wind down of its TCR-T Library Phase 1/2 Trial. We are currently working to close the TCR-T clinical trial internally and externally with the Federal Drug Administration or FDA.

The most material of these agreements are summarized below. We no longer have active clinical development under these arrangements following our August 2023 strategic reprioritization and wind-down of the TCR-T Library Phase 1/2 Trial.

The MD Anderson License term ends upon the later of the expiration of all licensed patents or the twentieth anniversary of the agreement. Post-expiration, we retain a perpetual, royalty-free, sublicensable license.

The MD Anderson License term continues until the later of the expiration of all licensed patents or 20 years from the agreement date, after which we retain a perpetual, royalty-free license. MD Anderson retains certain rights to terminate or convert licenses to non-exclusive under specified conditions (e.g., failure to meet diligence requirements or commercial efforts).

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Item 1. Business Overview We are a preclinical stage obesity and metabolic health drug development company that is aiming to develop a small molecule-based drug to treat obesity and other metabolic disorders that have a differentiated profile relative to currently marketed and in development oral and injectable products.

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Item 1. Business Overview We are a preclinical-stage biopharmaceutical company focused on the development of novel, orally administered small-molecule therapeutics for obesity and related metabolic disorders, such as metabolic dysfunction-associated steatotic liver disease (MASLD, a type of fatty liver disease). The program aims to develop a differentiated, non-hormonal, non-incretin approach, unlike hormone-based treatments like GLP-1 drugs.

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We believe ALN1001 and related small molecule product candidates are distinct in that they do not rely on hormonal manipulation, which is common with many obesity treatments. We aim to develop an oral obesity compound that addresses many of the shortcomings of injectable GLP-1 receptor agonists including preserving lean muscle mass.

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On March 2, 2026, we announced positive preclinical proof-of-concept data for ALN1003 from two separate studies using a standard diet-induced obesity (DIO) mouse model in male C57BL/6 mice maintained on a high-fat diet (60% of calories from fat).

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We engaged a contract development and manufacturing organization or CMDO to manufacture active pharmaceutical ingredients for our small molecule product candidates and initiated in vitro testing of our candidates in the fourth quarter 2024. The ongoing in vitro study aims to evaluate the impact of ALN1001 and its derivatives on lipid deposition and gene expression.

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Highlights from these studies include dose-dependent body weight loss with favorable body composition changes, reductions in liver weight, improvement in liver function biomarkers, and improvement in metabolic biomarkers. Collectively, these findings suggest encouraging metabolic effects of ALN1003 in the DIO model. We were previously a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapies.

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This study evaluates if genes related to thermogenic activity, lipid metabolism, and energy regulation are activated or deactivated by treatment, to determine if these compounds positively affect fat and energy metabolism.

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We have not generated any product revenue and have incurred significant net losses in each year since our inception. For the year ended December 31, 2025, we reported a net loss of $4.2 million and an accumulated deficit of $924.6 million as of that date.

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The results of this study, which are expected early second quarter of 2025, will provide critical insights into the development strategy for ALN1001 and its derivatives for obesity, metabolic disorders, and inflammation. Drug development candidates most effective in increasing metabolic activity and reducing fat accumulation may be advanced to evaluation of the compounds in rodent models of obesity.

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We expect to continue incurring substantial operating losses and will require significant additional capital to fund operations and advance our programs. Small Molecule Oral Obesity and Metabolic Disorders Program We are advancing our internally developed, preclinical small molecule program for the treatment of obesity and related metabolic disorders through a non-hormonal mechanism.

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As is standard in the industry, if the aforementioned in vitro study is successful, we plan to conduct a proof-of-concept diet-induced obesity or DIO mouse study to validate our mechanism of action by the third quarter of 2025 before proceeding to Investigational New Drug or IND Application enabling studies.

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This program focuses on discovering and developing novel, orally administered therapeutics with the potential for a differentiated and complementary profile compared to currently available therapies. While other pipeline therapies for obesity explore alternative hormonal pathways such as amylin or dual GIP/GLP-1 receptor agonism, our approach is focused on a non-hormonal mechanism of action.

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It is closely linked to a range of comorbid conditions, including type 2 diabetes, cardiovascular diseases, and certain cancers, which exacerbates the overall healthcare burden. The obesity market is seeing increased attention, driven by growing awareness, better treatment options, and emerging scientific breakthroughs. The global obesity market is experiencing rapid growth.

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Key findings from two separate DIO studies (non-GLP) are summarized below (nominal reported p-values are unadjusted for multiple comparisons): DIO Study 1 The purpose of the first study was to evaluate the pharmacokinetics (PK) and tolerability of ALN1003 and to assess early proof-of-concept anti-obesity efficacy including changes in weight, metabolic biomarkers, and adipose remodeling.

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Globally, the market size for branded obesity drugs was $6 billion in 2023 and is estimated that it will reach $105.0 billion by 2030. This growth is fueled by the rising obesity prevalence, evolving patient demographics, and increasing demand for effective weight-management solutions.

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Mice received low, controlled oral doses of ALN1003, split into two doses each day. Measurements included daily body weight, food and water consumption at the cage level, and metabolic markers (blood collection after a 4-6 hour fast at end of study). All animals were observed prior to and after each dose administration.

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The shift toward more personalized treatments and the need for long-term weight management are key drivers of this growth. The current treatment landscape for obesity consists of a combination of lifestyle interventions, pharmaceuticals, and surgical options.

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There were 12 mice in each group, with mice housed 3 per cage.

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Lifestyle interventions—dietary changes and physical activity—are the first-line treatment for most individuals, but many struggle to achieve and maintain significant weight loss through these methods alone. Traditional weight-loss medications (e.g., OrlistatTM) are still used, though their side effects and modest results have limited their appeal.

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Relative to DIO controls, mean percent change in body weight for ALN1003-treated mice peaked at -12.9% (p Food and water consumption: ALN1003 reduced cumulative food consumption versus DIO control (347.5 g/cage vs 425.0 g/cage; nominal p Liver and Fat Tissue: In this study, ALN1003 reduced liver weight compared to untreated mice by 43% (p An unblinded macroscopic visual review of organ morphology was conducted comparing the liver and adipose tissues of the DIO control to the ALN1003 treatment group.

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Newer drugs, like GLP-1 receptor agonists (e.g., OzempicTM, WegovyTM), are quickly becoming the gold standard in the market. These drugs, which mimic the action of gut hormones to promote satiety and reduce appetite, have shown remarkable efficacy in clinical trials and are significantly improving patient outcomes.

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Relative to DIO controls, ALN1003-treated animals exhibited smaller, deep reddish-brown livers; reduced epididymal white adipose tissue (eWAT) and inguinal white adipose tissue (iWAT) depots consistent with decreased adiposity; and darker interscapular BAT with appearance consistent with reduced “whitening” of BAT. Tolerability: ALN1003 was generally well tolerated throughout the study.

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The success of GLP-1s has led to a surge in interest from both pharmaceutical companies and patients. However, issues such as high cost, insurance reimbursement, and potential long-term side effects remain areas of concern. The future of the obesity market is promising, with new therapies, enhanced patient targeting, and continued scientific breakthroughs on the horizon.

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Mild, short-term, reversible hypolocomotion was observed after dosing in approximately one-half of dose administrations. There were no similar observations in DIO control animals. 7 DIO Study 2 The second study conducted was a pilot study to evaluate palatability, tolerability, anti-obesity effects, body composition and PK of ALN1003 administered orally in drinking water at three dose levels in DIO mice.

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As the global obesity epidemic continues to grow, demand for more effective and affordable treatments will likely continue to rise. However, success will depend on overcoming challenges related to cost, access, and patient adherence. Advancements in personalized medicine, non-invasive treatments, and innovative drug mechanisms will shape the next phase of the obesity treatment landscape.

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The study comprised a treatment period of 14 days and a PK period of 4 days. ALN1003 was administered at three dose levels: low, medium and high. The middle and highest planned doses were 3 and 9 times higher than the low dose, respectively.

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The obesity market today is vibrant and expanding, but still in need of accessible, scalable, and sustainable solutions to effectively manage this complex and widespread health issue.

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Measurements included daily body weight, food and water consumption at the cage level, and metabolic parameters (blood collection after a 4-6 hour fast at end of study). All animals were observed each day. There were 6 mice in each group (2 mice per cage).

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Cell Therapy 7 We were historically involved in developing adoptive T-cell receptor, or TCR, engineered T-cell therapies, or TCR-T, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs.

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Food and water consumption: ALN1003 reduced cumulative food intake in a dose-dependent manner over the 14-day treatment period.

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We leveraged our cancer hotspot mutation TCR library and our proprietary, non-viral Sleeping Beauty gene transfer platform to design and manufacture patient-specific cell therapies that target neoantigens arising from common tumor-related mutations in key oncogenic genes, including KRAS, TP53 and EGFR.

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Cumulative food consumption in grams per cage was 84.5g, 80.8g, 76.7g and 56.7g (nominal p Body composition was assessed using a Bruker Minispec TM LF90II Body Composition Analyzer (Bruker BioSpin, Billerica, MA, USA) and demonstrated dose-related changes that were driven primarily by fat loss but also included the loss of lean and fluid mass.

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In collaboration with The University of Texas MD Anderson Cancer Center, or MD Anderson, we were enrolling and treating patients for a Phase 1/2 clinical trial evaluating 12 TCRs reactive to mutated KRAS, TP53 and EGFR from our TCR library for the investigational treatment of non-small cell lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers, which we refer to as our TCR-T Library Phase 1/2 Trial.

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The table below summarizes the mean percentage change from baseline through Day 17 in fat, lean and fluid as a % of body weight (BW) and mass in grams: Mean % Change: Control Low Medium High D17 Fat% of BW +2.4% -1.5% -5.4% -21.9% c D17 Lean% of BW -1.3% +2.4% +4.6% +17.2% c D17 Fluid% of BW +0.4% -9.3% -12.0% -25.7% b D17 Fat in grams +4.7% (+0.9g) -1.8% (-0.4g) -12.3% (-2.5g) b -44.6% (-8.9g) c D17 Lean grams +1.9% (+0.5g) +2.2% (+0.6g) -4.1% (-1.1g) a -18.8% (-5.0g) c D17 Fluid grams +2.7% (+0.1g) -9.6% (-0.4g) -18.8% (-0.7g) a -47.3% (-1.8g) c Significance of comparison to Control group: a: nominal p Liver and Fat Tissue: At end of study Day 18, including the 14-day treatment period plus the PK period, dose-related reductions in liver weights compared to DIO control were -6.8%, -20.5% and -55.0% (nominal p An unblinded macroscopic visual review of organ morphology was conducted comparing the liver and adipose tissues of the DIO control to the high dose group.

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The Company continues to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.

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This analysis showed reductions in white fat depots (such as epididymal white adipose tissue, or eWAT, and inguinal white adipose tissue, or iWAT) and an interscapular BAT appearance consistent with reduced “whitening” in the ALN1003 tissues vs DIO control. Review of liver images suggested less visible fat accumulation and smaller, deep red-brown livers compared to DIO control.

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Preclinical and Clinical Development Preclinical Development of our Obesity Product Candidates We aim to develop an oral obesity compound that addresses many of the shortcomings of injectable GLP-1 receptor agonists including preserving lean muscle mass. The ongoing in vitro study aims to evaluate the impact of ALN1001 and its derivatives on lipid deposition and gene expression.

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Metabolic parameters: In this study, the highest-dose group showed lower blood sugar (glucose; 197 mg/dL in high dose vs 320 mg/dL in DIO control; p Tolerability: ALN1003 was generally well tolerated throughout the study; however, on Day 16 (during the PK portion of the study), two mice in the high-dose group were noted to be slightly dehydrated for the remainder of the study, although they otherwise appeared normal.

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Despite actual doses consumed approximating planned doses in this study, reductions in drinking may confound attribution of weight loss solely to drug exposure in this model. 8 Development Roadmap The findings from these two studies support the Company’s strategy to focus on additional preclinical studies and CMC activities to optimize formulations while maintaining effective overall drug levels.

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We are also planning to conduct studies to better understand mechanisms of ALN1003, including measuring liver fat levels and scoring MASLD severity of the liver in a blinded manner. We are planning to further refine manufacturing processes and to run a small-scale production run based on these improvements. Thereafter, a larger scale production run is planned.

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Our ability to execute on this plan is dependent on study results and our ability to raise additional capital or partner these assets with other companies or research institutions.

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In parallel, the Company has initiated a computational chemistry program to design, make, and test ALN1003 variations to strengthen the Company’s intellectual property and assess next-generation compounds. These initiatives, including large animal pharmacokinetic studies, will inform plans to conduct IND enabling studies. The advancement of this program is subject to numerous risks and uncertainties inherent in early-stage drug development.

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Patent terms extend for varying periods according to the date of patent filing or grant and the legal patent terms in the various countries where patent protection is obtained.

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Subject to favorable data from these preclinical studies and our ability to secure additional capital, we plan to advance a selected development candidate into formal investigational new drug (IND)-enabling studies. We intend to actively explore strategic financing and collaboration opportunities to fund the continued development of this program.

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The actual protection offered by a patent, which can vary from country to country, depends on the type of patent, the scope of its coverage, the issued claims and the availability of legal remedies in the country.

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Importantly, obesity is no longer viewed solely as a lifestyle issue but as a chronic, relapsing, multisystem disease that drives long‑term morbidity, mortality, and healthcare costs.

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Pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments, some of our patents, under certain conditions, may be eligible for limited patent term extension for a period of up to five years as compensation for patent term lost during drug development and the FDA regulatory review process.

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The burden of obesity is amplified by its strong causal links to a wide spectrum of comorbidities, including type 2 diabetes, cardiovascular disease, chronic kidney disease, and liver disorders—most notably Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD)—as well as several cancers.

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However, this extension period cannot be extended beyond 14 years from the drug’s approval date. The patent term restoration period is generally one-half the period of time elapsed between the effective date of an IND application or the issue date of the patent, whichever is later.

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Increasing evidence also links obesity to neurological and neurodegenerative conditions, including vascular dementia and Alzheimer’s disease, further expanding its societal and economic impact. As a result, obesity sits at the center of converging metabolic, inflammatory, cardiovascular, and oncologic disease pathways, making it a major focus for health systems and biopharma innovation. The global obesity therapeutics market is undergoing unprecedented expansion.

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The submission date of a New Drug Application, or NDA, plus the period of time between the submission date of the NDA or the issue date of the patent, whichever is later, and FDA approval.

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In 2026, analyst revisions now project the market reaching $150 billion by 2030, reflecting one of the fastest growth trajectories in pharmaceutical history.

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The United States Patent 8 and Trademark Office, or USPTO, in consultation with the FDA, reviews and approves applications for any patent term extension or restoration. We intend to seek the benefits of this statute, but there can be no assurance that we will be able to obtain any such benefits.

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This acceleration is driven by rising prevalence across all age groups, earlier diagnosis, increased recognition of obesity as a treatable disease, and a historic shift in reimbursement policies, including expanded coverage under Medicare for patients with established cardiovascular risk.

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We also depended upon the skills, knowledge and experience of our scientific and technical employees, as well as those of our advisors, consultants, and other contractors, none of which may be patentable.

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Key additional growth drivers include the expansion of obesity treatment beyond simple weight loss into the prevention of downstream cardiometabolic and liver disease. There is also a notable shift toward long‑term, chronic management paradigms and the emergence of "oral revolutions," where highly effective pill-based formulations are broadening adoption among younger and needle-hesitant populations.

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To help protect unpatentable proprietary know-how, and for inventions for which patents may be difficult to enforce, we currently rely, and in the future, will continue to rely, on trade secret protection and confidentiality agreements to protect our interests.

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The market has been fundamentally reshaped by the rapid adoption of incretin‑based therapies, particularly GLP‑1 receptor agonists and multi-receptor agonists (e.g., Ozempic, Wegovy, Zepbound). These agents have demonstrated unprecedented weight‑loss efficacy and emerging benefits across cardiovascular and renal outcomes. Despite transforming obesity care, hormone‑based therapies have important limitations, including high cost, gastrointestinal tolerability issues, and uncertainty around lifelong use.

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To this end, we generally require employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business. Our patent position and proprietary rights are subject to certain risks and uncertainties.

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Critically, data reveals a clinically meaningful rate of non‑response, affecting approximately 10–30% of patients who fail to achieve ≥5% weight loss despite adequate dosing. This highlights the biological heterogeneity of obesity and underscores the urgent need for complementary or non‑hormonal approaches, particularly for patients who hit metabolic plateaus or cannot tolerate hormonal side effects.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

65 edited+117 added−309 removed121 unchanged

2024 filing

2025 filing

Biggest changeThere can be no assurance that the market price of our common stock will remain above the minimum bid price requirements even if we conduct another reverse stock split, and there can be no assurance of a positive outcome from an appeal of any delisting determination. *We have identified a material weakness and may identify more in the future or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our financial statements or could have a material adverse effect on our business and trading price of our securities. 22 We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and the rules and regulations of the Nasdaq Capital Market.

Biggest changeThese requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market. *We have identified a material weakness and may identify more in the future or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our financial statements or could have a material adverse effect on our business and trading price of our securities.

In addition, the federal, state and local laws and regulations 25 governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require our contractors to incur substantial compliance costs that could materially adversely affect our business, financial condition, results of operations, cash flows and prospects.

In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require our contractors to incur substantial compliance costs that could materially adversely affect our business, financial condition, results of operations, cash flows and prospects.

Noncompliance events 41 that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to submit documents with the necessary formal requirements, such as notarization and legalization.

Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to submit documents with the necessary formal requirements, such as notarization and legalization.

While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

While an inadvertent lapse can in many cases be cured by payment 24 of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

In addition, while it is our policy to require our employee and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own.

In addition, while it is our policy to require our sole employee and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own.

To date, we have maintained our TCR-T related patent portfolio including those exclusive rights in the field of cancer treatment to certain U.S. and foreign intellectual property with respect to certain cell therapy and related technologies licensed from MD Anderson.

To date, we have maintained our legacy TCR-T related patent portfolio including those exclusive rights in the field of cancer treatment to certain U.S. and foreign intellectual property with respect to certain cell therapy and related technologies licensed from MD Anderson.

If any of our trade secrets or other confidential information were to be lawfully obtained or independently developed by competitors, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us.

If any of our trade secrets or other confidential information were to be lawfully obtained or independently developed by competitors, we would have no right to prevent them, or those to whom they communicate, from using that technology or information to compete with us.

To this end, it is our general policy to require our employee, consultants, advisors and contractors to enter into agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

To this end, it is our general policy to require our sole employee, consultants, advisors and contractors to enter into agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, we could lose visibility 27 in the financial markets, which in turn could cause our stock price or trading volume to decline.

If we are unable to successfully remediate any future material weakness and maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results in future periods, or report them within the timeframes required by the requirements of the SEC, Nasdaq or the Sarbanes-Oxley Act.

If we are unable to successfully remediate any future material weakness and maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results in future periods, or report them within the timeframe required by the requirements of the SEC, Nasdaq or the Sarbanes-Oxley Act.

If we do not successfully defend any infringement actions to which we become a party or if we are unable to have any asserted third-party patents declared invalid or unenforceable, we may have to pay substantial monetary damages, which can be tripled if the infringement is deemed willful, and/or we may be required to discontinue or significantly delay commercialization and development of the affected products.

If we do not successfully defend any infringement actions to which we become a party or if we are unable to have any asserted third-party patents declared invalid or unenforceable, we may have to pay substantial monetary damages, which can be tripled if the infringement is deemed willful, and/or we may be required to discontinue or significantly delay development or monetization of the affected products.

The market price for our common stock is volatile and may fluctuate significantly in response to a number of factors, most of which we cannot control, including: • Price and volume fluctuations in the overall stock market; • Changes in operating results and performance and stock market valuations of other biopharmaceutical companies generally, or those that develop and commercialize cancer drugs in particular; • Market conditions or trends in our industry or the economy as a whole; • Preclinical studies or clinical trial results, should we resume clinical development; • The commencement, enrollment or results of clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates; 42 • Public statements by third parties like trial participants and clinical investigators regarding clinical trials; • Public concern as to the safety of drugs developed by us or others; • The financial or operational projections we may provide to the public, any changes in these projections or our failure to meet these projections; • Comments by securities analysts or changes in financial estimates or ratings by any securities analysts who follow our common stock, our failure to meet these estimates or failure of those analysts to initiate or maintain coverage of our common stock; • The public’s response to press releases or other public announcements by us or third parties, including our filings with the SEC, as well as announcements of the status of development of our products, announcements of technological innovations or new therapeutic products by us or our competitors, announcements regarding collaborative agreements and other announcements relating to product development, litigation and intellectual property impacting us or our business; • Government regulation; • FDA determinations on the approval of a product candidate NDA or BLA submission; • The sustainability of an active trading market for our common stock; • Future sales of our common stock by us, our executive officers, directors and significant stockholders; • Announcements of mergers or acquisition transactions; • Our inclusion or removal from certain stock indices; • Our delisting from Nasdaq; • Developments in patent or other proprietary rights; • Changes in reimbursement policies; • Announcements of medical innovations or new products by our competitors; • Announcements of changes in our senior management or directors; • General economic, industry, political and market conditions, including, but not limited to, the ongoing impact of global economic conditions; • Other events or factors, including those resulting from war, incidents of terrorism, natural disasters, pandemics or responses to these events; and • Changes in accounting principles.

The market price for our common stock is volatile and may fluctuate significantly in response to a number of factors, most of which we cannot control, including: • Price and volume fluctuations in the overall stock market; • Changes in operating results and performance and stock market valuations of other biopharmaceutical companies generally, or those that develop and commercialize obesity or metabolic disorder drugs in particular; • Market conditions or trends in our industry or the economy as a whole; • Preclinical studies or clinical trial results, if we initiate clinical development; • The commencement, enrollment or results of clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates; 25 • Public statements by third parties like trial participants and clinical investigators regarding clinical trials; • Public concern as to the safety of drugs developed by us or others; • The financial or operational projections we may provide to the public, any changes in these projections or our failure to meet these projections; • Comments by securities analysts or changes in financial estimates or ratings by any securities analysts who follow our common stock, our failure to meet these estimates or failure of those analysts to initiate or maintain coverage of our common stock; • The public’s response to press releases or other public announcements by us or third parties, including our filings with the SEC, as well as announcements of the status of development of our products, announcements of technological innovations or new therapeutic products by us or our competitors, announcements regarding collaborative agreements and other announcements relating to product development, litigation and intellectual property impacting us or our business; • Government regulation; • FDA determinations on the approval of a product candidate NDA or BLA submission; • The sustainability of an active trading market for our common stock; • Future sales of our common stock by us, our executive officers, directors and significant stockholders; • Announcements of mergers or acquisition transactions; • Our inclusion or removal from certain stock indices; • Our delisting from Nasdaq; • Developments in patent or other proprietary rights; • Changes in reimbursement policies; • Announcements of medical innovations or new products by our competitors; • Announcements of changes in our senior management or directors; • General economic, industry, political and market conditions, including, but not limited to, the ongoing impact of global economic conditions; • Other events or factors, including those resulting from war, incidents of terrorism, natural disasters, pandemics or responses to these events; and • Changes in accounting principles.

These agreements may not provide adequate protection for our trade secrets, know-how, confidential information or other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of such information. 40 Moreover, we may not be able to obtain adequate remedies for any breaches of these agreements.

These agreements may not provide adequate protection for our trade secrets, know-how, confidential information or 23 other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of such information. Moreover, we may not be able to obtain adequate remedies for any breaches of these agreements.

These provisions authorize the issuance of “blank check” preferred stock that could be issued by our Board of Directors to increase the number of outstanding shares and hinder a takeover attempt, and 43 limit who may call a special meeting of stockholders.

These provisions authorize the issuance of “blank check” preferred stock that could be issued by our Board of Directors to increase the number of outstanding shares and hinder a takeover attempt, and 26 limit who may call a special meeting of stockholders.

We may be subject to claims by third parties asserting that our employee or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property. Many of our former employees were previously employed at universities or at other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

We may be subject to claims by third parties asserting that our employee or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property. Many of our current and former employees and consultants were previously employed at universities or at other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

We have limited experience in biopharmaceutical manufacturing. We currently lack the internal resources and expertise to formulate or manufacture our own small molecule product candidates and, therefore, contract the manufacture of these with third parties for use in in vitro and in vivo studies.

If a claim for patent infringement is asserted, there can be no assurance that the resolution of the claim would permit us to continue marketing the relevant product on commercially reasonable terms, if at all. We may not have sufficient resources to bring these actions to a successful conclusion.

If a claim for patent infringement is asserted, there can be no assurance that the resolution of the claim would permit us to continue developing or monetizing relevant product on commercially reasonable terms, if at all. We may not have sufficient resources to bring these actions to a successful conclusion.

If we are approached by a third-party in connection with such process, and our Board of Directors does not believe that a transaction with such party is in the best interest of our stockholders, we may rely on the provisions described above to prevent an acquisition by such party in order to maximize stockholder value.

If we are approached by a third-party in connection with an acquisition, merger or reverse merger, and our Board of Directors does not believe that a transaction with such party is in the best interest of our stockholders, we may rely on the provisions described above to prevent an acquisition by such party in order to maximize stockholder value.

On August 14, 2023, we announced a strategic reprioritization of our business and wind down of our TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, we have reduced our workforce by approximately 95% to date and we continue working to reduce costs in order to extend our cash runway.

On August 14, 2023, we announced a strategic reprioritization of our business and wind-down of our TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, we reduced our workforce by approximately 95% and continue to reduce costs to extend our cash runway.

In addition, this significant concentration of stock ownership may adversely affect the trading price of our common stock should investors perceive disadvantages in owning shares of common stock in a company that has such concentrated ownership.

In addition, this significant concentration of stock ownership and preferred stock rights may adversely affect the trading price of our common stock should investors perceive disadvantages in owning shares of common stock in a company that has such concentrated ownership.

OTHER RISKS RELATED TO OUR COMPANY Our stock price has been, and may continue to be, volatile.

RISKS RELATED TO STOCK OWNERSHIP IN OUR COMPANY AND OTHER RISKS Our stock price has been, and may continue to be, volatile.

We have not generated significant revenue and have incurred significant net losses in each year since our inception. For the year ended December 31, 2024, we had a net loss of $4.6 million, and, as of December 31, 2024, our accumulated deficit since inception in 2003 was $920.4 million.

We have not generated significant revenue and have incurred significant net losses in each year since our inception. For the year ended December 31, 2025, we had a net loss of $4.2 million, and, as of December 31, 2025, our accumulated deficit since inception in 2003 was $924.6 million.

Our operations have been limited to organizing and staffing our company, acquiring, developing and securing our proprietary product candidates and undertaking preclinical and clinical trials of our product candidates. These operations provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing in our securities.

Our operations have been limited to organizing and staffing our company, acquiring, developing and securing our proprietary product candidates, and undertaking pre-clinical animal studies of our product candidates. These operations provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing in our securities.

Delisting could also cause a loss of confidence of our customers, collaborators, vendors, suppliers and employee, which could harm our business and future prospects.

Delisting could also cause a loss of confidence of our collaborators, vendors, suppliers and employees, which could harm our business and future prospects.

If our preclinical obesity program is successful or we resume development of our TCR-T product candidates, successful commercialization of any product candidates will require us to perform a variety of functions, including: • Continuing to undertake preclinical development and clinical trials; • Participating in regulatory approval processes; • Formulating and manufacturing products; and • Conducting sales and marketing activities.

If our preclinical Obesity and Metabolic Disorders Program is successful, successful commercialization of any product candidates will require us to perform a variety of functions, including: • Continuing to undertake preclinical development and clinical trials; • Participating in regulatory approval processes; • Formulating and manufacturing products; and • Conducting sales and marketing activities.

Although we sought and, should we resume development activities, will seek to avoid pursuing the development of products that may infringe any third-party patent claims that we believe to be valid and enforceable, we may fail to do so.

Although we seek to avoid pursuing the development of products that may infringe any third-party patent claims that we believe to be valid and enforceable, we may fail to do so.

If our common stock is delisted by Nasdaq, it could lead to a number of negative implications, including an adverse effect on the price of our common stock, deterring broker-dealers from making a market in or otherwise seeking or generating interest in our common stock, increased volatility in our common stock, reduced liquidity in our common stock, the loss of federal preemption of state securities laws and greater difficulty in obtaining financing.

If our common stock is delisted by Nasdaq (whether due to stockholders’ equity, minimum bid price, or any other rule), it could lead to a number of negative implications, including an adverse effect on the price of our common stock, deterring broker-dealers from making a market in or 16 otherwise seeking or generating interest in our common stock, increased volatility in our common stock, reduced liquidity in our common stock, the loss of federal preemption of state securities laws and greater difficulty in obtaining financing.

Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, creating liens, making capital expenditures or declaring dividends, which may further constrain our ability to execute on strategic alternatives.

We also believe that the potential value of our obesity program for patients and our stockholders is high but that expectation may not be recognized by potential strategic alternative partners or by the market.

We believe that the potential value of our Obesity and Metabolic Disorders Program for patients and our stockholders is high, but that expectation may not be recognized by potential partners, investors, or the market.

Global political and economic events, including the war in Ukraine and increased inflation, have already resulted in a significant disruption of global financial markets. If the disruption persists and deepens, we could experience an inability to access additional capital or make the terms of any available financing less attractive, which could in the future negatively affect our operations.

Global political and economic events, including the wars in Ukraine and Iran, may increase inflation and result in a significant disruption of global financial markets. If the disruption persists and deepens, we could experience an inability to access additional capital or make the terms of any available financing less attractive, which could in the future negatively affect our operations.

Certain statements below are forward-looking statements. See “Special Note Regarding Forward-Looking Statements” in this Annual Report. RISKS RELATED TO OUR STRATEGIC REPRIORITIZATION *Our strategic reprioritization may not be successful, may not yield the desired results and we may be unsuccessful in identifying and implementing any strategic transaction.

Certain statements below are forward-looking statements. See “Special Note Regarding Forward-Looking Statements” in this Annual Report. RISKS RELATED TO OUR REPRIORITIZATION, FINANCIAL POSITION AND CAPITAL REQUIREMENTS *Our strategic reprioritization to progress our Obesity and Metabolic Program may not be successful, may not yield the desired results and we may be unsuccessful in identifying and implementing any alternate strategic transaction.

However, we cannot predict or guarantee for either our in-licensed patent portfolios or for Alaunos’ proprietary patent portfolio: • When, if at all, any patents will be granted on such applications; • The scope of protection that any patents, if obtained, will afford us against competitors; • That third parties will not find ways to invalidate and/or circumvent our patents, if obtained; • That others will not obtain patents claiming subject matter related to or relevant to our product candidates; or • That we will not need to initiate litigation and/or administrative proceedings that may be costly whether we win or lose.

In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such decision and, with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations and exploration of strategic alternatives.

In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such decision and, with the passage of time, the amount of cash available for distribution will be reduced as we continue to fund our operations and advance our Obesity and Metabolic Disorders Program.

Furthermore, if our common stock is delisted, we would expect it to have an adverse impact on our ability to consummate certain strategic alternatives. Further, if our common stock is delisted, we would incur additional costs under state blue sky laws in connection with any sales of our securities.

Furthermore, if our common stock is delisted, we would expect it to have an adverse impact on our ability to raise capital or advance our obesity program. Further, if our common stock is delisted, we would incur additional costs under state blue sky laws in connection with any sales of our securities.

We also intend to contract with one or more manufacturers to manufacture, supply, store, and distribute supplies for our clinical trials. In addition, we plan to use CDMOs, under our supervision, to perform our in vitro studies of the small molecules.

We also intend to contract with one or more manufacturers to manufacture, supply, store, and distribute material for additional animal studies and IND-enabling work. In addition, we plan to use CDMOs, under our supervision, to perform our in vitro and in vivo preclinical studies of the small molecules.

The forecast of cash resources is forward-looking information that involves risks and uncertainties, and our actual cash requirements may vary materially from our current expectations for a number of other factors that may include, but are not limited to, the progress of our strategic review and the pursuit of and progress on one or more options identified in such review.

Accordingly, this concentration of ownership may harm the market price of our common stock by: • Delaying, deferring or preventing a change in control; • Impeding a merger, consolidation, takeover or other business combination involving us; or • Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

These rights, preferences, and privileges senior to common stock could adversely affect the voting power, economic interests, and market price of our common stock. 28 Accordingly, this concentration of ownership and the rights associated with our Series A Preferred Stock may harm the market price of our common stock by: • Delaying, deferring or preventing a change in control; • Impeding a merger, consolidation, takeover or other business combination involving us; or • Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

Furthermore, if we cannot provide reliable financial reports or prevent fraud, our business, financial condition, results of operations, cash flows and prospects could be materially harmed and investors could lose confidence in our reported financial information.

Our principal stockholders, executive officers and directors have substantial control over the Company, which may prevent you and other stockholders from influencing significant corporate decisions and may significantly harm the market price of our common stock. Our executive officers and directors beneficially owned, in the aggregate, approximately 25.71% of our outstanding common stock (including options exercisable within 60 days).

In the ordinary course of our business, we, our CROs and other third parties on which we rely have and will collect and store sensitive data, including legally protected patient health information, personally identifiable information about our employee and certain consultants, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing cloud-based systems.

In the ordinary course of our business, we, our CROs, consultants, and other third parties collect and store sensitive data, including intellectual property, proprietary business information, financial data, and personally identifiable information. We rely on cloud-based systems to manage and maintain this information.

The patent landscape in the field of immuno-oncology is particularly complex. We are aware of numerous United States and foreign patents and pending patent applications of third parties directed to compositions, methods of use and methods of manufacture of immuno-oncology products. In addition, there may be patents and patent applications in the field of which we are not aware.

The patent landscape in the fields of obesity and legacy immuno-oncology is particularly complex. We are aware of numerous United States and foreign patents and pending patent applications of third parties directed to compositions, methods of use and methods of manufacture relevant to our programs.

Our future financial performance and our ability to develop our product candidates or additional assets will depend, in part, on our ability to effectively manage any future growth or restructuring, as the case may be.

For example, further workforce constraints could negatively impact our ability to advance our Obesity and Metabolic Disorders Program. Our future financial performance and our ability to develop our product candidates will depend, in part, on our ability to effectively manage any future growth or restructuring, as the case may be.

Any future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees.

If we are unable to successfully retain our personnel, we are at risk of a disruption to our business operations. Any future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees.

We anticipate that we will file additional patent applications both in the United States and in other jurisdictions on all of our product candidates.

We anticipate that we will file additional patent applications both in the United States and in other jurisdictions for our Obesity and Metabolic Disorders Program and related technologies.

If a strategic transaction is not completed, our Board of Directors may decide to pursue a dissolution and liquidation.

If we are unable to do so, our Board of Directors may decide to pursue a dissolution and liquidation.

Our failure to achieve or maintain profitability could negatively impact the trading price of our common stock. Our operating history makes it difficult to evaluate our business and prospects. We have not previously completed any pivotal clinical trials, submitted a BLA or demonstrated an ability to perform the functions necessary for the successful commercialization of any product candidates.

We have not previously completed any pivotal clinical trials, submitted a BLA or demonstrated an ability to perform the functions necessary for the successful commercialization of any product candidates.

We will remain a smaller reporting company until our public float exceeds $250 million as of the last business day of our most recently completed second quarter if our annual revenues are $100 million or more as of our most recently completed fiscal year, or until our public float exceeds $700 million as of the last business day of our most recently completed second quarter if our annual revenues are less than $100 million as of our most recently completed fiscal year. *Artificial intelligence used by us and our partners and vendors may have negative effects on our company. 45 Artificial intelligence or AI use in many industries has rapidly expanded.

We will remain a smaller reporting company until our public float exceeds $250 million as of the last business day of our most recently completed second quarter if our annual revenues are $100 million or more as of our most recently completed fiscal year, or until our public float exceeds $700 million as of the last business day of our most recently completed second quarter if our annual revenues are less than $100 million as of our most recently completed fiscal year. *We have issued preferred stock, and future issuances of preferred stock could adversely affect the rights of holders of our common stock.

Section 203 could have the effect of delaying, deferring or preventing a change in control that our stockholders might consider to be in their best interests. We have begun exploring strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.

Section 203 could have the effect of delaying, deferring or preventing a change in control that our stockholders might consider to be in their best interests.

As a result, our NOLs and business credits (including R&D credits) may be subject to limitations, and we may be required to pay taxes earlier and in larger amounts than would be the case if our NOLs or R&D credits were freely usable. 44 If securities' and/or industry analysts' recommendations change adversely or if our business, financial condition, results of operations, cash flows or prospects do not meet their expectations, our stock price and trading volume could significantly decline.

Accordingly, we could exhaust our current cash resources prior to the identification or consummation of a suitable strategic alternative, requiring the Company to raise additional capital. We anticipate that our exploration of strategic alternatives and advancing our obesity program will make it more difficult to raise additional capital.

Accordingly, we could exhaust our current cash resources before we are able to meaningfully advance our Obesity and Metabolic Disorders Program, requiring the Company to raise additional capital on uncertain terms or at all. We anticipate that advancing our Obesity and Metabolic Disorders Program will make it more difficult to raise additional capital on favorable terms.

Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to damage from cyber-attacks, computer viruses, breaches, unauthorized access, interruptions due to employee error or malfeasance or other disruptions, or damage from natural disasters, terrorism, war and telecommunication and electrical failures.

The secure processing, storage, and transmission of this data is critical to our operations and our ability to pursue strategic alternatives. Despite security measures, our systems and those of third parties are vulnerable to cyber-attacks, breaches, viruses, unauthorized access, employee error, malfeasance, or disruptions from natural disasters, terrorism, war, or telecommunications failures.

Moreover, in some circumstances, we do not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. We may also require the cooperation of our licensors in order to enforce the licensed patent rights, and such cooperation may not be provided.

It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we do not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties.

Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of other jurisdictions may not protect our rights to the same extent as the laws of the United States.

We may be forced to execute a transaction that undervalues or eliminates the obesity program entirely despite our best efforts to continue work on the assets if that transaction is in the best interest of the stockholders. 18 If we are not successful in setting forth a new strategic path for the Company, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and the value of our securities may be adversely impacted.

If we are not successful in advancing our Obesity and Metabolic Disorders Program, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and the value of our securities may be adversely impacted.

Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, government enforcement actions and regulatory penalties.

Any such event could result in unauthorized access, public disclosure, theft, or loss of sensitive data. This could lead to legal claims, liability under privacy laws, government enforcement actions, regulatory penalties, reputational harm, and substantial remediation costs.

In addition, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties related to the future of the Company could cause our stock price to fluctuate significantly. *We will require substantial additional financial resources to continue as a going concern and to advance our Obesity and Metabolic Program, and if we raise additional funds, this may materially and negatively affect the value of your investment in our common stock.

An inability to renew our policies or to obtain sufficient insurance at an acceptable cost could prevent or inhibit the commercialization of pharmaceutical products that we develop, alone or with collaborators. *Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

An inability to renew our policies or to obtain sufficient insurance at an acceptable cost could prevent or inhibit the commercialization of pharmaceutical products that we develop, alone or with collaborators. Our legacy TCR-T cell therapy programs and related intellectual property are no longer in active development and may not generate any meaningful value.

We are also susceptible to any future limited availability and supply chain disruptions of needed, critical raw materials which could affect our ability to manufacture sufficient materials needed for our testing and therefore delay clinical trials and commercialization. *Our reliance on third parties to formulate, manufacture and perform preclinical assays on our product candidates exposes us to a number of risks that may delay the development, regulatory approval and commercialization of our products or result in higher product costs.

As a result, we cannot be sure that we will be able to submit an IND or similar applications for our current or future preclinical programs, including without limitation, on the timelines we expect, if at all, and we cannot be sure that submission of an IND or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin. *Our reliance on third parties to formulate, manufacture and perform preclinical assays on our product candidates exposes us to a number of risks that may delay the development, regulatory approval and commercialization of our products or result in higher product costs.

Even if we should in the future resume development of our TCR-T product candidates and obtain regulatory approval for one or more of our TCR-T product candidates, if we are unable to successfully commercialize our TCR-T products, we may not be able to generate sufficient revenues to achieve or maintain profitability or to continue our business without raising significant additional capital, which may not be available.

If we are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our current or any future product candidates, we may not be able to generate sufficient revenue to continue our business. Preclinical development is uncertain.

We may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.

Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction. * Artificial intelligence and other advanced technologies used by us, our employees, consultants, or business partners may expose us to significant risks, including the loss or unauthorized disclosure of confidential information, intellectual property, or clinical and preclinical data, while the rapidly evolving regulatory and legal landscape surrounding artificial intelligence could materially and adversely affect our business.

During that process, we also internally developed an obesity program whereby we are now performing pre-clinical studies on our obesity assets. As of December 31, 2024, we have approximately $1.1 million of cash and cash equivalents. Following implementation of the Plan, we anticipate our cash resources will be sufficient to fund our operations into the second quarter of 2025.

Following the closure and wind down of our TCR-T Library Phase 1/2 Trial and a reduction in force to reduce operating expenditures and net losses, we also internally developed an Obesity and Metabolic Disorders Program whereby we are now performing preclinical studies. As of December 31, 2025, we have approximately $1.4 million of cash and cash equivalents.

Our ability to consummate a strategic transaction depends on our ability to retain our remaining employee and consultants. Our ability to consummate a strategic transaction depends upon our ability to retain our remaining employee and consultants, the loss of whose services may adversely impact our ability to consummate such transaction.

Our ability to advance our Obesity and Metabolic Disorders Program depends upon our ability to retain our remaining employee and consultants, the loss of whose services may adversely impact our progress. We are highly dependent on our sole full-time employee, who serves as our Chief Executive Officer and performs multiple executive, operational, and oversight roles.

There is no guarantee that the shareholders would approve another reserve stock split. *Shareholders may not approve another reverse stock split. Even if we are able to convene a shareholders meeting within the time required by a future delisting notice, if received, there is no guarantee that the shareholders would approve a reverse stock split.

In the past, we effected a reverse stock split to address a bid price deficiency, and shareholders may not approve another reverse stock split if required in the future. Even if approved and effected, there can be no assurance that a reverse stock split would increase or sustain the trading price above $1.00 or maintain compliance.

We have not set a timetable for completion of the strategic review process and the timing of consummating a strategic transaction, if any, is not entirely within our control. We have no committed sources of additional capital at this time.

We are not actively pursuing broad strategic alternatives. Our primary focus is advancing our Obesity and Metabolic Disorders Program. We have no committed sources of additional capital at this time.

Any anticipated benefits will depend on a number of factors, including our ability to integrate with any future business partner, the success of any future business we may engage in following the transaction and our ability to obtain value for our product candidates or technologies, if divested.

The success of our business, including our ability to finance our company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of our current and any future product candidates, which may never occur.

Removed

We continue to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. We engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process.

Added

We had previously engaged Cantor Fitzgerald & Co. to act as strategic advisor for this process; the engagement was terminated effective January 8, 2026. Efforts to consummate a sale or out-license transaction of this legacy intellectual property portfolio have been unsuccessful to date. We are not actively pursuing broad strategic alternatives such as acquisitions, mergers, or sales of the Company.

Removed

In addition, while we are evaluating several potential in-licensing opportunities in obesity, oncology and virology, there is no assurance that any of these potential opportunities will come to fruition. We believe there is value in our hunTR® TCR discovery platform. However, the platform is experimental.

Added

Our primary focus is advancing our internally developed small-molecule Obesity and Metabolic Disorders Program. We devote substantial time and resources to the advancement of our Obesity and Metabolic Disorders Program.

Removed

There can be no assurances that we can succeed in improving the platform’s appeal and increasing its value. We may be unable to successfully monetize the platform or any TCRs we discovered, either through partnerships or out-licensing. We expect to devote substantial time and resources to exploring strategic alternatives that our Board of Directors believes will maximize stockholder value.

Added

There can be no assurance that this program will succeed, that we will be able to advance it through IND-enabling studies, or that we will secure the additional capital required to do so. The process of advancing our Obesity and Metabolic Disorders Program is costly and resource-intensive.

Removed

Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all.

Added

We have incurred, and will continue to incur, significant costs related to preclinical studies, formulation development, manufacturing, and regulatory activities. Any strategic transaction or financing would likely depend primarily on the perceived value and progress of our Obesity and Metabolic Disorders Program.

Removed

We have not set a timetable for completion of this strategic review process, and our Board of Directors has not approved a definitive course of action.

Added

We may be forced to accept terms in any future financing or transaction that undervalue or limit the Obesity and Metabolic Disorders Program if such transaction is determined to be in the best interest of the stockholders.

Removed

Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value or that we will make any additional cash distributions to our stockholders.

Added

Following implementation of the Plan, we anticipate our cash resources will be sufficient to fund our operations into the second quarter of 2026. We have terminated our engagement with Cantor Fitzgerald & Co. as strategic advisor effective January 8, 2026. Efforts to consummate a sale or out-license transaction of this legacy intellectual 14 property portfolio have been unsuccessful to date.

Removed

The process of continuing to evaluate these strategic options may be very costly, time-consuming and complex and we have incurred, and may in the future incur, significant costs related to this continued evaluation, such as legal and accounting fees and expenses and other related charges. We may also incur additional unanticipated expenses in connection with this process.

Added

We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.

Removed

A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed. Any such expenses will decrease the remaining cash available for use in our business.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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2024 filing

2025 filing

Biggest changeWhile we have implemented a cybersecurity program, the techniques used to infiltrate information technology systems continue to evolve. Accordingly, we may not be able to timely detect threats or anticipate and implement adequate security measures. For additional information regarding risks relating to privacy and cybersecurity, see "Item IA—Risk Factors—Risks Related to Our Business." Item 2.

Biggest changeAccordingly, we may not be able to timely detect threats or anticipate and implement adequate security measures. For additional information regarding risks relating to privacy and cybersecurity, see "Item IA—Risk Factors—Risks Related to Our Business." Item 2. Properties Our corporate office is located at 501 E. Las Olas Blvd., Suite 300 Fort Lauderdale, FL 33301.

As part of that risk management 46 process, our management team identifies, assesses and evaluates risks impacting our operations, including those risks related to cybersecurity, and raise them for internal discussion, and where it is determined to be appropriate, issues are also raised to our Board of Directors for consideration.

As part of that risk management process, our management team identifies, assesses and evaluates risks impacting our operations, including those risks related to cybersecurity, and raises them for internal discussion, and where it is determined to be appropriate, issues are also raised to our Board of Directors for consideration.

Item 1C. Cyber security Cybersecurity Program We have implemented a cybersecurity program to support both the effectiveness of our systems and our preparedness for information security risks. This program includes a number of safeguards, such as: password protection; multi-factor authentication; monitoring and alerting systems for internal and external threats; and regular evaluations of our cybersecurity program.

Item 1C. Cyber security Cybersecurity Program 29 We have implemented a cybersecurity program designed to support the effectiveness of our systems and our preparedness for information security risks. This program includes safeguards, such as: password protection; multi-factor authentication; monitoring and alerting systems for internal and external threats; and regular evaluations of our cybersecurity program.

On a regular basis, the head of administration reports to our Board of Directors on cybersecurity matters, including key risks, the potential impact of those exposures on our business, financial condition, results of operations, cash flows and prospects, and the programs and steps implemented by our management team to monitor and mitigate risks.

On a regular basis, the VP of Finance reports to our Board of Directors on cybersecurity matters, including key risks, the potential impact of those exposures on our business, financial condition, results of operations, cash flows and prospects, and the programs and steps implemented by our management team to monitor and mitigate risks.

Our head of administration is responsible for the day-to-day management of the cybersecurity program, including the prevention, detection, investigation, response to, and recovery from cybersecurity threats and incidents, and is regularly engaged to help ensure the cybersecurity program functions effectively in the face of evolving cybersecurity threats.

Our VP of Finance is responsible for the day-to-day management of the cybersecurity program, including the prevention, detection, investigation, response to, and recovery from cybersecurity threats and incidents, and is regularly engaged to help ensure the cybersecurity program functions effectively in the face of evolving cybersecurity threats.

Our head of administration oversees the Incident Response Plan and briefs our board of directors on cybersecurity matters, including the nature and design of our cybersecurity program, and threats, events, and program enhancements.

Our VP of Finance oversees the Incident Response Plan and briefs our board of directors on cybersecurity matters, including the nature and design of our cybersecurity program, and threats, events, and program enhancements.

Governance Management Oversight The controls and processes employed to assess, identify and manage material risks from cybersecurity threats are implemented and overseen by head of administration and our managed service provider. Our head of administration has over four years of experience addressing cybersecurity risks.

As of the date of this Annual Report on Form 10-K, we are not aware of any previous cybersecurity incidents that have materially affected our business, financial condition, results of operations, cash flows and prospects or that are reasonably likely to have such a material effect.

As of the date of this Annual Report on Form 10-K, we are not aware of any previous cybersecurity incidents that have materially affected or are reasonably likely to materially affect our business, financial condition, results of operations, cash flows and prospects. While we have implemented a cybersecurity program, the techniques used to infiltrate information technology systems continue to evolve.

Properties Our corporate office is located at 2617 Bissonnet Street, Suite 233, Houston, Texas 77005. We believe that our existing facilities are adequate to meet our current needs.

We believe that our existing facilities are adequate to meet our current needs.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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2024 filing

2025 filing

Biggest changeWe do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, be reasonably likely to have a material adverse effect on our business, financial condition, results of operations, cash flows or prospects. Item 4. Mine Safety Disclosures Not applicable. 47 PART II

Biggest changeWe do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, be reasonably likely to have a material adverse effect on our business, financial condition, results of operations, cash flows or prospects. 30 Item 4. Mine Safety Disclosures Not applicable. 31 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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2025 filing

Biggest changeMarket for Registrant’s Common Equity, Related Stockholders Matters and Issuer Purchases of Equity Securities Market for Common Stock Our common stock trades on the Nasdaq Capital Market under the symbol “TCRT.” Record Holders As of March 31, 2024, we had approximately 129 holders of record of our common stock, one of which was Cede & Co., a nominee for Depository Trust Company, or DTC.

Biggest changeMarket for Registrant’s Common Equity, Related Stockholders Matters and Issuer Purchases of Equity Securities Market for Common Stock Our common stock trades on the Nasdaq Capital Market under the symbol “TCRT.” Record Holders As of March 31, 2026, we had approximately 131 holders of record of our common stock, one of which was Cede & Co., a nominee for Depository Trust Company, or DTC.

Dividends We have never declared or paid a cash dividend on our common stock and do not anticipate paying any cash dividends in the foreseeable future. Unregistered Sales of Securities We did not sell or issue any equity securities during the three months ended December 31, 2024 that were not registered under the Securities Act.

Dividends We have never declared or paid a cash dividend on our common stock and do not anticipate paying any cash dividends in the foreseeable future. Unregistered Sales of Securities We did not sell or issue any equity securities during the three months ended December 31, 2025 that were not registered under the Securities Act.

Repurchases There were no repurchases of our common stock by the Company during the fiscal quarter ended December 31, 2024. Item 6. [Reserved] 48

Repurchases There were no repurchases of our common stock by the Company during the fiscal quarter ended December 31, 2025. Item 6. [Reserved] 32

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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2024 filing

2025 filing

Biggest changeResearch and Development Expenses Our research and development expenses have historically consisted primarily of salaries and related expenses for personnel, costs of contract manufacturing services, costs of facilities, reagents, and equipment, fees paid to professional service providers in conjunction with our clinical trials, fees paid to contract research organizations, or CROs, in conjunction with clinical trials, fees paid to CROs in conjunction with costs of materials used in research and development, consulting, license and milestone payments, sponsored research fees paid to third parties and impairment charges to prepaid expenses and other current assets.

Biggest changeRevenue during the years ended December 31, 2025 and 2024 were as follows: For the years ended December 31, 2025 2024 Change ($ in thousands) Revenue $ 5 $ 10 $ (5 ) (50 )% Research and Development Expenses Research and development expenses have historically consisted primarily of salaries and related personnel costs, contract manufacturing and research organization fees, costs of facilities, reagents and equipment, consulting and license fees, and impairment charges.

Operating cash flow is derived by adjusting our net loss for: • Non-cash operating items such as depreciation, amortization, impairment charges, stock-based compensation and reduction in right-of-use assets; and • Changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations.

Operating cash flow is derived by adjusting our net loss for: • Non-cash operating items such as depreciation, amortization, and stock-based compensation; and • Changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations.

Actual results may differ materially from these estimates under different assumptions or conditions. We believe the following are our more significant estimates and judgments used in the preparation of our financial statements: • Clinical trial expenses and other research and development expenses; • Collaboration agreements; • Fair value measurements of stock-based compensation; and • Income taxes.

General and Administrative Expenses General and administrative expenses consist primarily of salaries, benefits and stock-based compensation, consulting and professional fees, including patent related costs, general corporate costs and facility costs not otherwise included in research and development expenses or cost of product revenue.

General and Administrative Expenses General and administrative expenses consist primarily of salaries, benefits and stock-based compensation, consulting and professional fees (including patent-related costs), general corporate costs, and facility costs not otherwise included in research and development.

Based on the current cash forecast, management has determined that our present capital resources will not be sufficient to fund our planned operations for at least one year from the issuance date of the financial statements, which raises substantial doubt as to our ability to continue as a going concern.

Based on our current cash forecast, management has determined that our present capital resources will not be sufficient to fund our planned operations for at least one year after the date these financial statements are issued. This raises substantial doubt about our ability to continue as a going concern.

K., or Solasia, announced that darinaparsin had been approved from relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the year ended December 31, 2024, the Company did not earn collaboration revenue and earned $10 thousand in royalty revenues on net sales under the Solasia License and Collaboration Agreement.

K., or Solasia, announced that darinaparsin had been approved for relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the years ended December 31, 2025 and 2024, the Company earned $5 and $10, respectively, in royalty revenues on net sales under the Solasia License and Collaboration Agreement.

Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, we are not required to provide the information under this Item 7A. Item 8. Financial Statements and Supplementary Data None. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures None.

Cash Flows The following table summarizes our net increase (decrease) in cash and cash equivalents for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 ($ in thousands) Net cash flows in: Operating activities $ (4,971 ) $ (30,142 ) Investing activities — 1,346 Financing activities — (18,138 ) Net decrease in cash and cash equivalents $ (4,971 ) $ (46,934 ) Cash flows from operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities.

Cash Flows The following table summarizes our net increase (decrease) in cash and cash equivalents for the years ended December 31, 2025 and 2024: 38 For the years ended December 31, 2025 2024 ($ in thousands) Net cash flows from: Operating activities $ (2,869 ) $ (4,971 ) Investing activities (98 ) — Financing activities 3,261 — Net increase (decrease) in cash and cash equivalents $ 294 $ (4,971 ) Cash flows from operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities.

For the year ended December 31, 2024, we had a net loss of $4.6 million, and as of December 31, 2024, we have incurred approximately $920.4 million of accumulated deficit since our inception in 2003.

Overview We have not generated any product revenue and have incurred significant net losses in each year since our inception. For the year ended December 31, 2025, we had a net loss of $4.1 million, and as of December 31, 2025, we have incurred approximately $924.6 million of accumulated deficit since our inception in 2003.

Consistent with prior years, the Company uses the Black-Scholes option pricing model, which requires estimates of the expected term option holders will retain their options before exercising them and the estimated volatility of the Company’s common stock price over the expected term. 39 We review our valuation assumptions periodically and, as a result, we may change our valuation assumptions used to value share-based awards granted in future periods.

We expect to continue to incur significant operating expenditures and net losses for the foreseeable future. 2024 Developments Obesity Program On October 10, 2024, we announced our continued progress and evaluation of our internally developed small molecule oral obesity program.

We expect to continue to incur significant operating expenditures and net losses for the foreseeable future as we advance our internally developed preclinical small-molecule oral Obesity and Metabolic Disorders Program.

Net cash used in operating activities for the year ended December 31, 2024 was $5.0 million, as compared to $30.1 million for the year ended December 31, 2023.

Net cash flows used in operating activities for the year December 31, 2025 was $2.87 million, as compared to net cash used in operating activities of $4.97 million for the year ended December 31, 2024.

On August 14, 2023, we announced a strategic reprioritization of our business and wind down of our TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, we have reduced our workforce, and we continue working to reduce costs in order to extend our cash runway.

On August 14, 2023, we announced a strategic reprioritization that included the wind-down of our TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, we reduced our workforce during the third and fourth quarters of 2023 (approximately 95% overall) and continued to implement cost-saving measures to extend our cash runway.

Stock-based compensation expense is based on the number of awards ultimately expected to vest and is reduced for forfeitures as they occur.

Accounting for Stock-Based Compensation Stock-based compensation cost is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense over the employee’s requisite service period. Stock-based compensation expense is based on the number of awards ultimately expected to vest and is reduced for forfeitures as they occur.

We review our valuation assumptions periodically and, as a result, we may change our valuation assumptions used to value share-based awards granted in future periods. Such changes may lead to a significant change in the expense we recognize in connection with share-based payments.

Such changes may lead to a significant change in the expense we recognize in connection with share-based payments.

Our actual cash requirements may vary materially from those planned because of a number of factors, including changes in the focus, direction and pace of our development programs, including those resulting from the recently announced exploration of strategic alternatives and related workforce reduction. 53 As of December 31, 2024, we had approximately $1.1 million of cash and cash equivalents.

Our actual cash requirements may vary materially from those planned because of a number of factors, including changes in the focus, direction and pace of our development programs.

Overview On October 10, 2024, we announced our continued progress and evaluation of our internally developed small molecule oral obesity program. The aim of this program is to develop a drug for obesity with a differentiated profile relative to currently marketed and in development oral and injectable products.

On October 10, 2024, we announced continued progress on this program, which is focused on developing an oral small-molecule therapeutic with a differentiated, non-hormonal profile relative to currently marketed and in-development GLP-1-based and other hormonal treatments.

The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. We have based our estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate.

We have based our runway estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate.

Other Income (Expense) Other income (expense) during the years ended December 31, 2024 and 2023 was as follows: Year Ended December 31, 2024 2023 Change ($ in thousands) Interest expense $ — $ (1,921 ) $ 1,921 (100 )% Other income, net 133 1,048 (915 ) (87 )% Total $ 133 $ (873 ) $ 1,006 (115 )% Total other income (expense), net for the year ended December 31, 2024 increased by $1.00 million as compared to the year ended December 31, 2023 primarily due to no interest expense associated with our former amended Loan and Security Agreement.

Other income (expense) during the years ended December 31, 2025 and 2024 was as follows: For the years ended December 31, 2025 2024 Change ($ in thousands) Other income, net 80 133 (53 ) (40 )% Total other income (expense), net for the year ended December 31, 2025 decreased $53 as compared to the year ended December 31, 2024.

Restructuring costs Restructuring costs during the years ended December 31, 2024 and 2023 were as follows: Year Ended December 31, 2024 2023 Change ($ in thousands) Restructuring costs $ — $ 1,269 $ (1,269 ) (100 )% Restructuring costs during the year ended December 31, 2024 were $0 million as compared to $1.3 during the year ended December 31, 2023, due to severance expenses for terminated employees related to our strategic reprioritization announced in August 2023.

Research and development expenses during the years ended December 31, 2025 and 2024 were as follows: For the years ended December 31, 2025 2024 Change ($ in thousands) Research and development expenses $ 1,363 $ 362 $ 1,001 277 % Research and development expenses for the year ended December 31, 2025 increased by $1.0 million when compared to the year ended December 31, 2024 due to the expansion of the obesity and metabolic disorders program.

Net cash provided by investing activities was $0 million for the year ended December 31, 2024 as compared to net cash provided in investing activities of $1.3 million for the year ended December 31, 2023. The decrease is related to no investing activities during the current period as compared to the prior period.

The decrease in net cash used in operating activities was primarily related to reductions in our net loss, offset by an increase in timing of accounts payable and accrued expenses. The net cash flows used in investing activities for the year December 31, 2025 was $98 as compared to $0 for the year ended December 31, 2024.

Liquidity and Capital Resources Sources of Liquidity We have not generated any revenue from product sales. Since inception, we have incurred net losses and negative cash flows from our operations. 52 To date, we have financed our operations primarily through public offerings of our common stock, private placements of our convertible equity securities, term debt and collaborations.

Liquidity and Capital Resources Sources of Liquidity We have not generated any revenue from product sales. Since inception, we have incurred net losses and negative cash flows from our operations. We have operated at a loss since inception in 2003 and have no significant recurring revenue from operations. We anticipate that losses will continue for the foreseeable future.

In order to continue our operations beyond our forecasted runway, including, if necessary, to continue to explore strategic alternatives, we will need to raise additional capital, and we have no committed sources of additional capital at this time.

We have no committed sources of additional capital. To continue operations beyond our current forecasted runway and to advance our preclinical Obesity and Metabolic Disorders Program through additional animal studies, formulation optimization, manufacturing scale-up, and IND-enabling work, we will need to raise substantial additional capital through equity or debt financings, collaborations, or other strategic transactions.

Removed

We have also operated as a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. On August 14, 2023, we announced a strategic reprioritization of our business and wind down of our TCR-T Library Phase 1/2 Trial.

Added

Our primary focus is advancing this preclinical program through additional animal studies, formulation optimization, manufacturing scale-up, and IND-enabling work, subject to favorable data and the availability of additional capital. Historically, we operated as a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy.

Removed

In connection with the reprioritization, we have reduced our workforce during the third and fourth quarters of 2023, and we continue working to reduce costs in order to extend our cash runway. We continue to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.

Added

We terminated our engagement with Cantor Fitzgerald & Co. as strategic advisor effective January 8, 2026. Efforts to consummate a sale or out-license transaction of this intellectual property portfolio have been unsuccessful to date.

Removed

We engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process. We have not generated any product revenue and have incurred significant net losses in each year since our inception.

Added

We are no longer actively pursuing broad strategic alternatives such as acquisitions, mergers, reverse mergers, or sales of the Company. 2025 Developments Small Molecule Oral Obesity and Metabolic Disorders Program The Company is advancing an internally developed, preclinical small molecule program for the treatment of obesity and related metabolic disorders.

Removed

The aim of this program is to develop an oral drug for obesity and other metabolic disorders with a differentiated profile relative to currently marketed and in development oral and injectable products. We believe our small molecule product candidates are distinct in that they do not rely on hormonal manipulation, which is common with many obesity treatments.

Added

This program is focused on the discovery and development of novel, orally administered therapeutics with the potential to provide a differentiated and complementary profile relative to currently available therapies. While other pipeline therapies for obesity are exploring alternative hormonal pathways, including amylin and dual GIP/GLP-1 receptor agonism, the Company’s approach is focused on a non-hormonal mechanism of action.

Removed

We aim to develop an oral obesity compound that addresses many of the shortcomings of injectable GLP-1 receptor agonists including preserving lean muscle mass. We engaged a contract development and manufacturing organization or CMDO to manufacture active pharmaceutical ingredients for our small molecule product candidates and initiated in vitro testing of our candidates in the fourth quarter 2024.

Added

The program is intended to identify an oral therapeutic candidate that may address certain limitations associated with existing hormonal therapies, including improved tolerability.

Removed

The ongoing in vitro study aims to evaluate the impact of ALN1001 and its derivatives on lipid deposition and gene expression. This study evaluates if genes related to thermogenic activity, lipid metabolism, and energy regulation are activated or deactivated by treatment, to determine if these compounds positively affect fat and energy metabolism.

Added

In the second half of 2025, the Company conducted two separate non-GLP (Good Laboratory Practice) pharmacology studies using a standard diet-induced obesity (DIO) mouse model in male C57BL/6 mice maintained on a high-fat diet (60% of calories from fat).

Removed

Added

On January 8, 2026, the Company announced it had identified a lead compound for continued preclinical evaluation and had established proof-of-concept in the diet induced obesity (DIO) mouse model from these two studies, noting observations from the studies conducted were encouraging and consistent with statistically significant dose-related reductions in body weight, statistically significant improvements in body composition, specifically percentage fat and relative preservation of percentage lean, alongside favorable changes in metabolic parameters.

Removed

Added

On March 2, 2026, we announced additional details regarding this positive preclinical proof-of-concept data for ALN1003 from the two separate DIO studies conducted. Highlights from these studies include dose-dependent body weight loss with favorable body composition changes, reductions in liver weight, improvement in liver function biomarkers, and improvement in metabolic biomarkers.

Removed

Our ability to execute on this plan is dependent on study results and our ability to raise additional capital or partner these assets with other companies or research institutions. TCR-T Library Phase 1/2 Trial Eight patients were treated and evaluated in our TCR-T Library Phase 1/2 Trial from 2022-2023.

Added

Collectively, these findings suggest encouraging metabolic effects of ALN1003 in the DIO model.

Removed

Patients with pancreatic (3), colorectal (4) and non-small cell lung cancer (1) were treated, with certain pancreatic and colorectal patients also having lung metastases. Overall, the trial showed our T-cells were generally well-tolerated in all evaluable participants with no dose-limiting toxicities (DLTs) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

Added

Removed

All cytokine release syndrome (CRS) events were within grades 1-3 and were self-limiting or resolved with standard clinical management and, in some cases, a single dose of tocilizumab. One patient with non-small cell lung cancer (NSCLC) achieved an objective partial response with six months progression-free survival. Six other patients achieved a best overall response of stable disease.

Added

Mice received low, controlled oral doses of ALN1003, split into two doses each day. Measurements included daily body weight, food and water consumption at the cage level, and metabolic 33 markers (blood collection after a 4-6 hour fast at end of study). All animals were observed prior to and after each dose administration.

Removed

The total overall response rate was 13% and disease control rate was 87% in evaluable patients with advanced, metastatic, refractory solid tumors (see Figure A). This trial established proof-of-concept that Sleeping Beauty TCR-T cells can result in objective clinical responses and recognize established tumors in vivo .

Added

There were 12 mice in each group, with mice housed 3 per cage.

Removed

Despite the encouraging TCR-T Library Phase 1/2 Trial data, based on the substantial 49 cost to continue development and the current financing environment, we announced in August 2023 that we would not pursue any further development of our clinical programs. hunTR® Platform We have discovered multiple proprietary TCRs targeting driver mutations through our hunTR TCR discovery platform.

Added

Removed

In addition to TCRs that recognize KRAS and TP53 mutations similar to those licensed from the NCI, we identified additional TCRs that bind to other driver mutations and TCRs that are restricted to additional HLAs. We believe that the hunTR library has the potential to allow for the treatment of a large patient population.

Added

Removed

Strategic Alternatives We continue to explore strategic alternatives, which may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.

Added

Mild, short-term, reversible hypolocomotion was observed after dosing in approximately one-half of dose administrations. There were no similar observations in DIO control animals. DIO Study 2 The second study conducted was a pilot study to evaluate palatability, tolerability, anti-obesity effects, body composition and PK of ALN1003 administered orally in drinking water at three dose levels in DIO mice.

Removed

Nasdaq Delisting Determination As previously disclosed on January 4, 2023, we were notified by the Listing Qualifications Department, or the Staff, of The Nasdaq Stock Market LLC, or Nasdaq, that we were in breach of Listing Rule 5450(a)(1), or the Minimum Bid Price Rule, for continued listing on the Nasdaq Global Select Market because the minimum bid price of our listed securities for 30 consecutive business days had been less than $1 per share.

Added

Removed

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), or the Compliance Period Rule, we were provided a period of 180 calendar days, or until July 3, 2023, or the Compliance Date, to regain compliance with the Bid Price Requirement.

Added

Removed

On June 22, 2023, we applied to transfer our listing from the Nasdaq Global Select Market to the Nasdaq Capital Market, or the Transfer.

Added

Food and water consumption: ALN1003 reduced cumulative food intake in a dose-dependent manner over the 14-day treatment period.

Removed

On July 5, 2023, Nasdaq notified us that the Transfer was approved, and that, in connection with the Transfer, we were eligible for an additional 180 calendar day period, or until January 2, 2024, or the Extended Compliance Date, to regain compliance with the Minimum Bid Price Rule.

Added

Removed

On November 8, 2023, we received a Staff Delisting Determination letter, or the Delisting Determination, from the Staff notifying us that, because the closing bid price for our common stock was below $0.10 per share for 10 consecutive trading days during the Extended Compliance Period, the Staff has determined to suspend trading of our common stock on Nasdaq pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii), effective November 17, 2023, and file a Form 25-NSE with the SEC to remove our common stock from listing and registration under the Securities Exchange Act of 1934, as amended, unless we timely request an appeal of the Delisting Determination to a Nasdaq Hearings Panel, or the Panel.

Added

The table below summarizes the mean percentage change from baseline through Day 17 in fat, lean and fluid as a % of body weight (BW) and mass in grams: Mean % Change: Control Low Medium High D17 Fat% of BW +2.4% -1.5% -5.4% -21.9% c D17 Lean% of BW -1.3% +2.4% +4.6% +17.2% c D17 Fluid% of BW +0.4% -9.3% -12.0% -25.7% b D17 Fat in grams +4.7% (+0.9g) -1.8% (-0.4g) -12.3% (-2.5g) b -44.6% (-8.9g) c D17 Lean grams +1.9% (+0.5g) +2.2% (+0.6g) -4.1% (-1.1g) a -18.8% (-5.0g) c D17 Fluid grams +2.7% (+0.1g) -9.6% (-0.4g) -18.8% (-0.7g) a -47.3% (-1.8g) c Significance of comparison to Control group: a: nominal p Liver and Fat Tissue: At end of study Day 18, including the 14-day treatment period plus the PK period, dose-related reductions in liver weights compared to DIO control were -6.8%, -20.5% and -55.0% (nominal p 34 enzymes showed no statistically significant change after 18 days; gross liver appearance suggested reduced fat accumulation.

Removed

We timely requested a hearing before the Panel to appeal the Delisting Determination and were granted a hearing before the Panel on January 25, 2024.

Added

Histological analyses of liver and adipose tissues are planned. An unblinded macroscopic visual review of organ morphology was conducted comparing the liver and adipose tissues of the DIO control to the high dose group.

Removed

This timely request for a hearing stayed the suspension or delisting of our common stock so our common stock continued to trade on the Nasdaq Capital Market under the symbol “TCRT” while the appeal process was pending.

Added

Removed

By letter dated February 16, 2024, we were notified by the Nasdaq Stock Market LLC that we regained compliance with the minimum $1.00 bid price requirement, and otherwise satisfied all applicable criteria for continued listing on the Nasdaq Capital Market. As such, the listing matter was closed.

Added

Removed

Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we were subject to a mandatory panel monitor for the one-year period which was completed on February 16, 2025.We are no longer subject to monitoring by the panel. Financial Overview Collaboration Revenue We recognize research and development funding revenue over the estimated period of performance. To date we have not generated product revenue.

Added

Important Context and Model Limitations Behavior-coupled dosing in unrestricted (ad libitum) drinking-water studies: In this paradigm, ALN1003 caused dose-related loss of appetite and thirst (anorexia/hypodipsia), leading to avoidance of medicated water. Despite actual doses consumed approximating planned doses in this study, reductions in drinking may confound attribution of weight loss solely to drug exposure in this model.

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Unless and until we receive approval from the FDA and/or other regulatory authorities for our product candidates, we cannot sell our products and will not have product revenue.

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Development Roadmap The findings from these two studies support the Company’s strategy to focus on additional preclinical studies and CMC activities to optimize formulations while maintaining effective overall drug levels. We are also planning to conduct studies to better understand mechanisms of ALN1003, including measuring liver fat levels and scoring MASLD severity of the liver in a blinded manner.

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Restructuring Costs Restructuring costs consists of severance provided to terminated employees. 50 Other Income (Expense) Other income (expense) consists primarily of interest expense associated with our amended Loan and Security Agreement, interest income on our cash balances and sublease income.

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We are planning to further refine manufacturing processes and to run a small-scale production run based on these improvements. Thereafter, a larger scale production run is planned. In parallel, the Company has initiated a computational chemistry program to design, make, and test ALN1003 variations to strengthen the Company’s intellectual property and assess next-generation compounds.

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Results of Operations for the Fiscal Years ended December 31, 2024 and 2023 Year Ended December 31, ($ in thousands) 2024 2023 Revenue $ 10 $ 5 Operating expenses: Research and development 362 16,279 General and administrative 4,460 12,219 Gain on lease modification and termination - (298 ) Restructuring costs - 1,269 Property and equipment and right-of-use assets impairment - 4,803 Total operating expenses 4,822 34,272 Loss from operations (4,812 ) (34,267 ) Other income (expense): Interest expense - (1,921 ) Other income (expense), net 133 1,048 Other income (expense), net 133 (873 ) Net loss $ (4,679 ) $ (35,140 ) Revenue Revenue during the years ended December 31, 2024 and 2023 were as follows: Year Ended December 31, 2024 2023 Change ($ in thousands) Revenue $ 10 $ 5 $ 5 100 % Revenue during the year ended December 31, 2024 was $10 thousand compared to $5 thousand during the year ended December 31, 2023.

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These initiatives, including large animal pharmacokinetic studies, will inform plans to conduct IND enabling studies. The advancement of this program is subject to numerous risks and uncertainties inherent in early-stage drug development.

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Research and Development Expenses Research and development expenses during the years ended December 31, 2024 and 2023 were as follows: Year Ended December 31, 2024 2023 Change ($ in thousands) Research and development expenses $ 362 $ 16,279 $ (15,917 ) (98 )% Research and development expenses for the year ended December 31, 2024 decreased by $15.9 million when compared to the year ended December 31, 2023 primarily due to lower program expenses of $8.5 million as a result of the wind down of our clinical activities, a $4.5 million decrease in employee-related expenses due to our reduced headcount, an accrual adjustment related to our de-prioritized clinical programs of $0.2 million, a $2.5 million decrease in facilities costs following the termination of our leases.

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Removed

Our clinical stage projects included our TCR-T Library Phase 1/2 Trial evaluating TCRs from our library for the investigational treatment of non-small cell lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers, which we are still in the process of winding down due to various closing processes and follow up studies that are required before the project can be shut down permanently.

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Top changes in Alaunos Therapeutics, Inc.'s 2025 10-K

Item 1. Business

Item 1A. Risk Factors

Item 1C. Cybersecurity

Item 3. Legal Proceedings

Item 5. Market for Registrant's Common Equity

Item 7. Management's Discussion & Analysis

Other TCRT 10-K year-over-year comparisons