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Item 1. Business

2026-03-31 compared with 2025-03-31 · 259 added, 336 removed, 32 unchanged (95% of the section changed)

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

Key findings from two separate DIO studies (non-GLP) are summarized below (nominal reported p-values are unadjusted for multiple comparisons):

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.

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.

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

Relative to DIO controls, mean percent change in body weight for ALN1003-treated mice peaked at -12.9% (p<0.0001) on Day 34 and was

-10.3% (p<0.0001) after 48 days of treatment.

Peak reductions in absolute weight loss were observed by Day 13 and remained lower than DIO controls through Day 48 (p<0.0001 at selected timepoints).

Food and water consumption:

ALN1003 reduced cumulative food consumption versus DIO control (347.5 g/cage vs 425.0 g/cage;

nominal p<0.05).

ALN1003 reduced water consumption (445.8 mL/cage vs 494.5 mL/cage;

not statistically significant).

Liver and Fat Tissue:

In this study, ALN1003 reduced liver weight compared to untreated mice by 43% (p<0.0001) and by 39% when expressed as a percentage of body weight (p<0.0001).

Long-term administration of ALN1003 was associated with lower ALT (alanine aminotransferase;

p<0.0001), AST (aspartate aminotransferase;

nominal p<0.0001) and ALP (alkaline phosphatase;

p<0.0001), with a trend toward lower total bilirubin (nominal p=0.058) compared to untreated mice.

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.

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.

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.

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.

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.

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).

Food and water consumption:

ALN1003 reduced cumulative food intake in a dose-dependent manner over the 14-day treatment period.

Cumulative food consumption in grams per cage was 84.5g, 80.8g, 76.7g and 56.7g (nominal p<0.05) for the DIO control, low, medium and high doses, respectively.

Cumulative food consumption when normalized to body weight per cage was 87.9g, 85.6g, 86.7g and 73.6g for the DIO control, low, medium and high doses, respectively.

ALN1003 reduced water intake significantly over the 14-day treatment period.

Cumulative water consumption in milliliters per cage was 112.8 mL, 80.1 mL (nominal p<0.05), 71.1 mL (p<0.0001) and 63.5 mL (p<0.0001) for the DIO control, low, medium and high doses, respectively.

Cumulative water consumption when normalized to body weight per cage was 116.9 mL, 84.9 mL, 80.5 mL and 80.3 mL for the DIO control, low, medium and high doses, respectively.

Actual dose consumed is dependent on how much water mice drink.

Actual doses consumed during the 14-day treatment period were consistent with planned doses, with variances to planned doses of +7.3%, -0.3% and -6.9% in the low, medium and high dose groups, respectively.

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.

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:

D17 Fat% of BW

D17 Lean% of BW

D17 Fluid% of BW

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:

nominal p<0.05;

nominal p<0.001;

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<0.01) in the low, medium and high dose groups, respectively.

Reductions in liver weights expressed as a percentage of body weight relative to DIO control were -2.6%, -12.0% and -32.6% (nominal p<0.05).

Liver enzymes showed no statistically significant change after 18 days;

gross liver appearance suggested reduced fat accumulation.

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.

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.

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<0.0001) and lower total cholesterol (162 mg/dL in high dose vs 209 mg/dL in DIO control;

nominal p<0.05).

HDL-C (high-density lipoprotein cholesterol), the dominant lipoprotein in DIO mice, also decreased to 130 mg/dL in high dose vs 165 mg/dL in DIO control;

nominal p<0.05.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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

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.

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.

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.

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.

As obesity increasingly affects younger populations and becomes a true lifelong condition, there is growing recognition that additional therapeutic modalities will be required to complement or substitute hormone‑based approaches.

Within this evolving landscape, there is strong interest in non‑hormonal alternatives that offer differentiated safety profiles and easier chronic use.

Programs positioned in this space are essential for expanding the treatable population and supporting the next phase of sustainable, long-term disease management.

Legacy Cell Therapy Programs

We were historically involved in developing adoptive T-cell receptor (TCR) engineered T-cell therapies (TCR-T) targeting solid tumors using our proprietary non-viral Sleeping Beauty gene transfer platform and hunTR TCR discovery engine.

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.

Efforts to consummate a sale or out-license transaction of this intellectual property portfolio have been unsuccessful to date.

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.

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.

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.

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.

Manufacturing

We have no internal manufacturing capability and outsource the production of active pharmaceutical ingredient (API) and drug product for our preclinical small-molecule obesity program to third-party contract development and manufacturing organizations (CDMOs) with experience in small-molecule synthesis and production.

We currently rely on a limited number of CDMOs for API supply, and we may depend on single or limited sources for certain raw materials or specialized services.

We are engaged in chemistry, manufacturing, and controls (CMC) activities to support formulation optimization, small-scale production, and future IND-enabling studies.

Reliance on third-party manufacturers involves risks, including potential delays in supply, quality or purity issues, regulatory compliance challenges, and increased costs.

Intellectual Property

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Our policy is to actively seek the strongest possible intellectual property protection for our technology and product candidates through a combination of license agreements and owned patents, both in the United States and abroad.

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.

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.

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.

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.

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.

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.

The United States Patent

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.

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.

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.

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.

Please read Item Ia.

Risk Factors— “ Risks Related to Our Intellectual Property ” section for further information about certain risks and uncertainties that may affect our patent position and proprietary rights.

Obesity and Metabolic Disorders Program

For our small-molecule obesity program (including lead candidate ALN1003), we are pursuing intellectual property protection through pending and planned patent applications directed to compositions of matter, methods of use, formulations, and related technologies.

We have initiated a computational chemistry effort to conceive, manufacture and evaluate analogs of our product candidates to expand and strengthen our patent portfolio.

As with our legacy assets, we currently have no issued patents protecting the obesity and metabolic disorders program, and protection is limited to pending applications and trade secret safeguards.

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.

General IP Strategy & Risks

Patent terms vary by jurisdiction and depend on filing or grant dates, claim scope, and legal remedies available.

Under the Hatch-Waxman Act, certain patents may qualify for up to five years of term extension (not exceeding 14 years from approval) to offset development and regulatory delays, subject to USPTO/FDA review.

We intend to pursue such extensions where applicable, but there is no assurance of success.

We also rely on trade secrets and confidentiality agreements to protect unpatentable know-how, proprietary methods, and other confidential information.

Employees, consultants, and contractors are generally required to assign inventions to us and enter into confidentiality obligations.

Our IP position is subject to significant risks, including challenges to patentability, enforceability, or validity;

third-party infringement claims;

and dependence on licensed rights (see License Agreements below).

Please refer to Item 1A, “Risk Factors — Risks Related to Our Intellectual Property” for a detailed discussion of these and other risks that could materially impair our ability to protect or commercialize our technologies and candidates.

License 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.

On August 17, 2015, we, Precigen, and MD Anderson executed the 2015 R&D Agreement, establishing the scope and terms for transferring existing and future research programs and technologies.

Precigen's rights were later assigned to us effective October 5, 2018.

A joint steering committee, including two members from our company and one from MD Anderson, oversees activities under this agreement.

Under the MD Anderson License, we funded R&D activities for three years at $15-20 million annually.

Amendments to the 2015 R&D Agreement extended its term first to April 15, 2021, then to December 31, 2026, and allowed existing funds to support costs under the 2019 R&D Agreement, initiated on October 22, 2019, focusing on the TCR program.

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.

MD Anderson may convert the license to non-exclusive after ten years if we fail commercial diligence, or terminate specific technologies after five years if diligence requirements tied to funding or third-party contracts aren't met, subject to specified cure periods.

MD Anderson can terminate upon uncured material breach or certain insolvency events and through mutual agreement

2019 Research and Development Agreement-The University of Texas MD Anderson Cancer Center

Under the 2019 R&D Agreement, we were to, along with MD Anderson, among other things, collaborate on programs to expand our TCR library and conduct clinical trials of the same.

The activities under the 2019 R&D Agreement are directed by a joint steering committee comprised of two members from the Company and one member from MD Anderson.

The Company will own all inventions and intellectual property developed under the 2019 R&D Agreement and the Company will retain all rights to all intellectual property, patentable or not, for oncology products manufactured using non-viral gene transfer technologies under the 2019 R&D Agreement, including the Sleeping Beauty technology.

We granted MD Anderson an exclusive license for such intellectual property to develop and commercialize autologous TCR products manufactured using viral gene transfer technologies and any products outside the field of oncology and a non-exclusive license for allogenic TCR products manufactured using viral-based technologies.

Under the 2019 R&D Agreement, we agreed, beginning on January 1, 2021, to reimburse MD Anderson up to a total of $20.0 million for development costs under the 2019 R&D Agreement, after the funds from the 2015 R&D Agreement are exhausted.

In addition, we will pay MD Anderson royalties on net sales of its TCR products, if any.

We are required to make performance-based payments upon the successful completion of clinical and regulatory benchmarks relating to our TCR products.

The aggregate potential benchmark payments are $36.5 million, of which only $3.0 million will be due prior to the first marketing approval of our TCR products.

The royalty rates and benchmark payments owed to MD Anderson may be reduced upon the occurrence of certain events.

We also agreed to sell our TCR products to MD Anderson at preferential prices and will sell our TCR products in Texas exclusively to MD Anderson for a limited period of time following the first commercial sale of our TCR products.

The 2019 R&D Agreement will terminate on December 31, 2026 and either party may terminate the 2019 R&D Agreement following written notice of a material breach.

The 2019 R&D Agreement also contains customary provisions related to indemnification obligations, confidentiality and other matters.

In connection with the execution of the 2019 R&D Agreement, on October 22, 2019, we issued MD Anderson a warrant to purchase 22,222 shares of the Company's common stock, which is referred to as the MD Anderson Warrant.

The MD Anderson Warrant has an initial exercise price of $0.15 per share, expires on December 31, 2026, and vests upon the occurrence of certain clinical milestones.

As of December 31, 2024, the milestones have not been met.

We have historically relied on license and research agreements to access key technologies for our former TCR-T cell therapy programs.

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.

MD 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 August 2015, we, together with Precigen (formerly Intrexon), entered into a research and development agreement (the “2015 R&D Agreement”) to facilitate the transfer and development of these technologies.

Precigen’s rights were later assigned to us.

The MD Anderson License and related agreements were amended several times to extend terms and adjust funding obligations.

In October 2019, we entered into a separate 2019 R&D Agreement focused on TCR library expansion and clinical development.

Under these arrangements, we funded specified research and development activities and agreed to pay royalties on net sales of resulting TCR products (if any), as well as

potential milestone payments tied to clinical and regulatory progress (aggregate potential milestones up to $36.5 million, with only $3.0 million due prior to first marketing approval).

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).

Either party may terminate for uncured material breach or certain insolvency events.

Current Status

Following our August 2023 strategic reprioritization and wind-down of the TCR-T Library Phase 1/2 Trial, we are no longer conducting clinical development under these agreements.

Efforts to consummate a sale or out-license transaction of this intellectual property portfolio have been unsuccessful to date.

In December 2025, we entered into a Settlement and Release Agreement with MD Anderson to fully resolve outstanding invoices and payment disputes arising from historical activities under the 2015 and 2019 R&D Agreements.

Under the terms of the settlement, we agreed to make payments totaling $285,000 in six installments through May 30, 2026, in full satisfaction of all amounts due.

The agreement includes mutual general releases (subject to customary exceptions) and does not affect our retained intellectual property rights under the MD Anderson License.

Our ability to realize value from these legacy agreements and related IP is subject to significant risks, including termination rights, diligence requirements, and third-party claims.

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

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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.

Product Development Process

In the United States, the FDA regulates pharmaceutical products under the Public Health Service Act, or PHSA, and the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations.

Products are also subject to other federal, state and local statutes and regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

Failure to comply with the applicable United States requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.

FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters and similar public notice of alleged non-compliance with laws, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal penalties.

Any agency or judicial enforcement action could have a material adverse effect on us.

The process required by the FDA before a pharmaceutical product may be approved for marketing in the United States generally involves the following:

• completion of preclinical laboratory tests and animal studies according to Good Laboratory Practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations;

• submission to the FDA of an IND, which must become effective before human clinical trials may begin;

• performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as Good Clinical Practices, or GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

• preparation and submission to the FDA of an NDA or biologics license application or BLA for marketing approval that includes substantive evidence of safety, purity and potency from results of nonclinical testing and clinical trials;

• satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities where the biological product is produced to assess compliance with cGMP to assure that the facilities, methods and controls used in product manufacture are adequate to preserve the biological product’s identity, strength, quality and purity and, if applicable, the FDA’s current Good Tissue Practices, or GTPs, for the use of human cellular and tissue products;

• potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the NDA or BLA;

• payment of user fees for FDA review of the NDA or BLA;

• FDA acceptance, review and approval, or licensure, of the NDA or BLA, which might include review by an advisory committee, a panel typically consisting of independent clinicians and other experts who provide recommendations as to whether the application should be approved and under what conditions.

Before testing any biological product candidate, including our product candidates, in humans, the product candidate must undergo rigorous preclinical testing.

Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations as well as in vitro and animal studies to assess the potential safety and efficacy of the product candidate.

The clinical trial sponsor must submit an IND to the FDA before clinical testing can begin in the United States.

An IND must contain the results of the preclinical tests, manufacturing information, analytical data, any available clinical data or literature, a proposed clinical protocol, an investigator’s brochure, a sample informed consent form and other materials.

Clinical trial protocols detail, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur.

Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.

Some preclinical testing, such as toxicity studies, may continue even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials or places the trial on a clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

The FDA may also impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA.

Further, each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution at which the clinical trial will be conducted.

An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

Clinical trials involving recombinant or synthetic nucleic acid molecules also must be reviewed by an institutional biosafety committee, or IBC, a local institutional committee that reviews and oversees basic and clinical research conducted at that institution.

The IBC assesses the safety of the research and identifies any potential risk to public health or the environment.

Clinical trials involve the administration of the biological product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control.

Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising the GCP requirements.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

The biological product is initially introduced into healthy human subjects and tested for safety.

In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the target disease or condition.

The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population, generally at geographically dispersed clinical trial sites.

These clinical trials are intended to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk to benefit profile of the product and to provide an adequate basis for product labeling.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators.

Annual progress reports detailing the results of the clinical trials must be submitted to the FDA.

Written IND safety reports must be promptly submitted to the FDA, the NIH and the investigators for serious and unexpected adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human patients, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

The FDA or the sponsor or its data safety monitoring board, an independent group of experts that evaluates study data for safety and makes recommendations concerning continuation, modification, or termination of clinical trials, may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients.

Concurrently with clinical trials, companies usually complete additional nonclinical studies and must also develop additional information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.

The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product.

Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

The FDA has a fast track designation program that is intended to expedite or facilitate the process for reviewing new drug or biologic products that meet certain criteria.

Specifically, new drugs or biologics are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Unique to a fast track product, the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

After the completion of clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the biological product.

The BLA must include results of product development, laboratory and animal studies, human trials, information on the manufacture and composition of the product, proposed labeling and other relevant information.

Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a significant user fee.

The FDA adjusts the PDUFA user fees on an annual basis.

PDUFA also imposes an annual program fee for approved biological products.

Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business.

Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the agency accepts it for filing.

The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.

In this event, the BLA must be resubmitted with the additional information.

The resubmitted application also is subject to review before the FDA accepts it for filing.

Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA.

The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.

The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

During the biological product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to ensure that the benefits of the product outweigh its risks and to assure the safe use of the biological product, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

FDA determines the requirement for a REMS, as well as the specific REMS provisions, on a case-by-case basis.

If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS.

The FDA will not approve a BLA without a REMS, if required.

Before approving a BLA, the FDA will inspect the facilities at which the product is manufactured.

The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

For immunotherapy products, the FDA also will not approve the product if the manufacturer is not in compliance with the GTPs, to the extent applicable.

These are FDA regulations and guidance documents that govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissues and cellular and tissue-based products, or HCT/Ps, which are human cells or tissue intended for implantation, transplant, infusion, or transfer into a human recipient.

The primary intent of the GTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease.

FDA GTP regulations also require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing.

Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements.

Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval.

If the agency decides not to approve the BLA in its present form, the FDA will issue a Complete Response Letter, which generally outlines the specific deficiencies in the BLA identified by the FDA and may require additional clinical or other data or impose other conditions that must be met in order to secure final approval of the application.

The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials.

Even with the submission of additional information, the FDA may ultimately decide that the application does not satisfy the regulatory criteria for approval.

If a Complete Response Letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

The FDA may require that certain contraindications, warnings or precautions be included in the product labeling, or otherwise limit the scope of any approval.

In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biological product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.

In addition, under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

The FDA may grant deferrals for submission of data or full or partial waivers.

Post-Approval Requirements

Any products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements and complying with FDA promotion and advertising requirements.

In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability of the product.

We relied on third parties for the production of clinical and commercial quantities of our products in accordance with cGMP regulations.

cGMP regulations require, among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.

Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

Discovery of problems with a product after approval may result in restrictions on a product, manufacturer or holder of an approved BLA, including, among other things, recall or withdrawal of the product from the market.

The FDA also may require post-marketing testing, known as Phase 4 testing, and surveillance to monitor the effects of an approved product.

Discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, with manufacturing processes, or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, complete withdrawal from the market, product recalls, warning letters from the FDA, mandated corrective advertising or communications with doctors, product seizure or detention, injunctions and civil or criminal penalties, among others.

Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures.

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.

Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, in the practice of medicine, may prescribe approved drugs for unapproved indications.

However, companies may share truthful and not misleading information that is otherwise consistent with the labeling.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Regulatory Process

In the United States, the FDA regulates small-molecule drugs under the Federal Food, Drug, and Cosmetic Act and implementing regulations.

Before human testing can begin, we must submit an Investigational New Drug application (IND) to the FDA containing preclinical data, manufacturing information, and a proposed clinical protocol.

The IND becomes effective 30 days after submission unless the FDA places a clinical hold.

We have not yet filed an IND for any product candidate and are currently in the preclinical stage.

Clinical development typically occurs in three phases:

Phase 1 (safety in healthy volunteers or patients), Phase 2 (preliminary efficacy and dosing), and Phase 3 (confirmatory efficacy and safety in larger populations).

Clinical trials must comply with Good Clinical Practices (GCP) and be overseen by institutional review boards (IRBs).

Before marketing approval, we would submit a New Drug Application (NDA) demonstrating safety and efficacy, followed by FDA review, potential advisory committee input, and facility inspections for compliance with current Good Manufacturing Practices (cGMP).

Approval may be subject to restrictions, post-marketing studies (Phase 4), or Risk Evaluation and Mitigation Strategies (REMS).

Even if approved, marketed products remain subject to ongoing FDA regulation, including adverse event reporting, labeling changes, and manufacturing inspections.

Failure to comply with regulatory requirements can result in warning letters, product recalls, clinical holds, approval withdrawal, or civil/criminal penalties.

Coverage, Pricing, and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval.

In the United States and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in significant part, on the extent to which third-party payors provide coverage, and establish adequate reimbursement levels for such products.

In the United States, third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations.

The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product.

Third-party payors may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the FDA-approved products for a particular indication.

In addition, in the United States, no uniform policy of coverage and reimbursement for drug products exists among third-party payors.

Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor.

Third-party payors are increasingly challenging the price, examining the medical necessity of and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy.

Reimbursement may impact the demand for, and/or the price of, any product candidate that obtains marketing approval.

Even if coverage and reimbursement is obtained for a given product candidate by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with those medications.

Patients are unlikely to use a product, and physicians may be less likely to prescribe a product, unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the cost of the product.

Therefore, coverage and adequate reimbursement is critical to new drug product acceptance.

The downward pressure on health care costs in general, particularly prescription drugs and biologics, has become very intense.

Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products.

As a result, increasingly high barriers are being erected to the entry of new products.

The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide favorable coverage and adequate reimbursement.

In addition, emphasis on managed care in the United States has increased, and we expect will continue to increase, the pressure on healthcare pricing.

Coverage policies and third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Health Care Laws Governing Interactions with Healthcare Providers

Healthcare providers and third-party payors in the United States play a primary role in the recommendation and prescription of drug products.

Arrangements with healthcare providers, third-party payors and customers can expose pharmaceutical manufactures to broadly applicable fraud and abuse and other healthcare laws, including false claims, privacy and security, price reporting and physician sunshine laws or regulations.

Some of our pre-commercial activities are subject to some of these laws.

The applicable federal, state and foreign healthcare laws and regulations laws that may affect a pharmaceutical manufacture’s ability to operate include, but are not limited to:

• The federal Anti-Kickback Statute, which regulates our business activities, including our marketing practices, educational programs, pricing policies and relationships with healthcare providers or other entities, by prohibiting, among other things, soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;

• Federal civil and criminal false claims laws, including the False Claims Act which permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the False Claims Act, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

• The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal civil and criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information on entities and individuals subject to the law including certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities, as well as individuals and entities that perform services for them which involve the use, or disclosure of, individually identifiable health information, known as business associates as well as their covered subcontractors;

• Requirements to report annually to the Centers for Medicare & Medicaid Services, or CMS, certain financial arrangements with physicians and teaching hospitals, as defined in the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, and its implementing regulations, including reporting any “transfer of value” made or distributed to prescribers and teaching hospitals, and reporting any ownership and investment interests held by physicians and their immediate family members during the preceding calendar year;

• State and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers;

state laws that require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government that otherwise restricts certain payments that may be made to healthcare providers and entities;

state laws that require drug manufacturers to report information related to payments and other transfer of value to physicians and other healthcare providers and entities;

state laws that require the reporting of information related to drug pricing;

state and local laws that require the registration of pharmaceutical sales representatives;

and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that business arrangements comply with applicable healthcare laws involve substantial costs.

It is possible that governmental and enforcement authorities will conclude that a pharmaceutical manufacturer’s business practices do not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.

If any such actions are instituted against a pharmaceutical manufacturer, and it is not successful in defending itself or asserting its rights, it may be subject to the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of operations, as well as additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.

In addition, the approval and commercialization of drug products outside the United States may also subject a pharmaceutical manufacturer to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

Healthcare Reform Efforts

A primary trend in the United States healthcare industry and elsewhere is cost containment.

Over the last several years, there have been federal and state proposals and legislation enacted regarding the pricing of pharmaceutical and biopharmaceutical products, limiting coverage and reimbursement for drugs and other medical products and making changes to healthcare financing and the delivery of care in the United States.

In March 2010, President Obama signed into law the ACA, which included measures that have significantly changed the way healthcare is financed by both governmental and private insurers.

The ACA, among other things, imposed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program, extended the rebate program to individuals enrolled in Medicaid managed care organizations, added a provision to increase the Medicaid rebate for line extensions or

reformulated drugs, established annual fees on manufacturers and importers of certain branded prescription drugs and biologic agents, promoted a new Medicare Part D coverage gap discount program, expanded the entities eligible for discounts under the Public Health Service Act pharmaceutical pricing program and imposed a number of substantial new compliance provisions related to pharmaceutical companies’ interactions with healthcare practitioners.

The ACA also expanded eligibility for Medicaid programs and introduced a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research and a new Center for Medicare & Medicaid Innovation at CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

There have been executive, legal and political challenges to certain aspects of the ACA.

For example, President Trump signed several executive orders and other directives designed to delay, circumvent or loosen certain requirements mandated by the ACA.

Concurrently, Congress considered legislation to repeal or repeal and replace all or part of the ACA.

While Congress has not passed legislation that would repeal the ACA in total, several bills affecting the implementation of certain taxes under the ACA have been signed into law.

The Tax Cuts and Jobs Act of 2017, or Tax Act, included a provision which repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Further, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the ACA-mandated “Cadillac” tax on high-cost employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminated the health insurer tax.

The Bipartisan Budget Act of 2018, or the BBA, among other things, amended the ACA, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” Further, President Biden had issued an executive order that instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA, though this and similar Biden-era policies are currently being revisited by the current Trump administration.

There had been a number of health reform initiatives by the Biden administration that have impacted the ACA, including adoption of the Inflation Reduction Act, or IRA, into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

The IRA also eliminated the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and implementing a newly established manufacturer discount program.

It is possible that the ACA will be subject to judicial or Congressional challenges in the future, particularly in light of the Trump administration's interest in reducing federal expenditures to include those under federal healthcare programs..

It is unclear how any such challenges and the cost reduction measures of the Trump administration will impact ACA and our business.

The ultimate content, timing or effect of any healthcare reform measures on the U.S.

healthcare industry is unclear.

In addition, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted.

For example, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year, which went into effect on April 1, 2013.

This 2% reduction was temporarily suspended during the COVID-19 pandemic, but has since been reinstated and, unless Congress and/or the Executive Branch take additional action will extend to 2032.

Further, the American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments from providers from three to five years.

The Medicare Access and CHIP Reauthorization Act of 2015 also introduced a quality payment program under which certain individual Medicare providers will be subject to certain incentives or penalties based on new program quality standards.

In November 2019, CMS issued a final rule finalizing the changes to the Medicare Quality Payment Program.

Further, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics.

Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for products.

At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives.

For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that attempt to implement several of the administration’s proposals.

The FDA also released a final rule, effective November 30, 2020, implementing a portion of the importation executive order providing guidance for states to build and submit importation plans for drugs from Canada.

On November 30, 2020, the U.S.

Department of Health and Human Services, or HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The IRA delayed the implementation of the rule to January 1, 2032.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers;

the implementation of these provisions has also been delayed by the IRA until January 1, 2032.

In addition, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate price cap, which was set at 100% of a drug’s average manufacturer price for single source and innovator multiple source products, beginning on January 1, 2024.

The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

These provisions began to take effect progressively starting

in fiscal year 2023, although they may be subject to legal challenges.

It is currently unclear how the IRA will be effectuated but is likely to have a significant impact on the pharmaceutical industry.

At the state level, legislatures have increasingly enacted legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

Foreign Corrupt Practices Act, U.K.

Bribery Act and Other Laws

The Foreign Corrupt Practices Act, or the FCPA, prohibits any United States individual or business from paying, offering or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.

The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the government of the United States, including applicable export control regulations, economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements and currency exchange regulations, collectively referred to as trade control laws.

Failure to comply with the Bribery Act, the FCPA and other anti-corruption laws and trade control laws could subject us to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses.

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 goal of this program is to develop a drug 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 other obesity treatments.

These treatments are currently being developed or marketed by many pharmaceutical or biotech companies at various stages.

While our small molecule product candidates are different from these competitors' product offerings, our goals are the same, to treat obesity, and therefore, we are competitors in the same market.

These competitors include 35 Pharma, Aardvark Tx, Altimmune, Amgen, Amplifier, Aphaia Pharma, Ascletis, AstraZeneca, Astrizi, BioAge Labs, Biomea Fusion, Biomed Industries, Boehringer Ingelheim, Clearmind, Corbus Pharma, Corxel, Currax Pharma, Eli Lilly, Empros Pharma, EndevicaBio, Entera/Opko, Epitomee, ERX Pharma, Gan & Lee Pharmaceuticals, Gilead, Glaceum, Glyscend, Halia Therapeutics, Hansoh Pharmaceutical, Huadong Medicine, Kailera/Hengrui, Kallyope, Lexicon, Merck, Metsera, Mindrank AI, Neurogastrx, NodThera, Novo Nordisk, OrsoBio, Pelagos, Pep2Tango Therapeutics, Pfizer, ProGen/Rani Therapeutics, Regeneron, Regor, Response Pharmaceuticals, Roche, Scilex, Scohia Pharma, Shionogi, Structure Tx, Syntis Bio, Terns Pharma, Verdiva Bio/Sciwind, Verge Genomics, Veru, and Viking Therapeutics.

We also believe our novel hunTR discovery engine demonstrated the ability to identify proprietary TCRs, allowing us to further expand and advance our pipeline with multiple solid tumor programs under development.

In addition, our non-viral transposon method of expressing TCRs, Sleeping Beauty, was less complex relative to many of our competitors’ viral approaches.

Finally, our TCR-T Phase 1/2 Library Trial was designed to allow us to treat patients quickly and efficiently in many different indications with a tumor mutation and HLA matching one or more of the several TCRs in our library, which we believe gives us a distinct competitive advantage.

However, the development and commercialization for new products to treat cancer, including the indications we pursued, is highly competitive and considerable competition exists from major pharmaceutical, biotechnology and specialty cancer companies.

Many of these companies have more experience in preclinical and clinical development, manufacturing, regulatory, and global commercialization.

These competitors include 2Seventy Bio, Achilles Therapeutics, Adaptimmune Therapeutics, Affini-T Therapeutics, Annoca, ArsenalBio, BioNTech, Bristol-Myers Squibb, Immatics, Iovance Biotherapeutics, Kite (a Gilead company), Lion TCR, Lyell Immunopharma, Medigene, Nurix Therapeutics, Neogene Therapeutics (a member of the AstraZeneca group), NexImmune, PACT Pharma, Precigen, Tactiva Therapeutics, Takara Bio, TCR 2 Therapeutics, T-Cure BioScience, T-knife Therapeutics, Triumvira Immunologics, TScan Therapeutics, Turnstone Biologics, Zelluna Immunotherapy and others.

Moreover, if our competitors develop and market a drug that is safer, more effective with fewer side effects, easier to administer, or less expensive, we could see a less favorable market opportunity for our TCR-T therapy candidates.

Our competition may also receive FDA or other regulatory approval for their products more quickly than we do, which could give them a first mover advantage and a strong market position before we are able to commercialize our products.

If approved, key competitive factors that may affect the success of our TCR-T candidates are likely their efficacy, safety, ease of administering, price and reimbursement from insurance or government.

Significant uncertainty exists regarding third-party payor coverage and reimbursement for any product candidates that may receive marketing approval.

In the United States, third-party payors (government programs, private insurers) increasingly challenge pricing, medical necessity, and cost-effectiveness.

Inadequate reimbursement could limit market acceptance and our ability to generate revenue.

We are subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act), as well as foreign equivalents, which restrict certain business practices and relationships with healthcare providers and payors.

Compliance with these laws involves significant costs and risks.

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

For a more detailed discussion of these and other regulatory risks, see Item 1A, “Risk Factors — Risks Related to Our Ability to Commercialize Our Product Candidates.”

The obesity treatment market is highly competitive and rapidly evolving.

We are developing an oral, small-molecule candidate (ALN1003) with a differentiated, non-hormonal, non-incretin approach.

However, numerous pharmaceutical and biotechnology companies are actively developing or marketing competing obesity treatments, including GLP-1 receptor agonists, dual/triple agonists, and other mechanisms.

Many of these competitors have significantly greater financial resources, clinical development experience, manufacturing capabilities, regulatory expertise, and commercial infrastructure than we do.

Key competitors in the obesity space include (but are not limited to) companies such as Novo Nordisk, Eli Lilly, Amgen, Pfizer, Viking Therapeutics, Structure Therapeutics, and others.

If competitors develop and commercialize products that are more effective, safer, better tolerated, easier to administer, or less expensive than our candidates, or if they obtain regulatory approval more quickly, our potential market opportunity could be significantly reduced.

Competitive factors that may affect any future product include efficacy, safety, tolerability, ease of administration, price, reimbursement, and market access.

Employees and Human Capital Resources

As of March 1, 2025, we had 1 full-time employee who is engaged in administration and no part-time employees.

As of March 31, 2026, we had one full-time employee and no part-time employees.

Our employee is not subject to a collective bargaining agreement.

In addition, we have engaged various consultants with our material consulting agreement being described below.

Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees.

We endeavor to recruit the best people for the position regardless of gender, ethnicity or other protected traits and it is our policy to fully comply with all laws applicable to discrimination in the workplace.

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.

The Boyle Consulting Agreement

On January 1, 2024, we also entered into a consulting agreement (the “Boyle Consulting Agreement”) with Mr.

our former Chief Executive Officer and Director, pursuant to which he provided strategic and advisory services to us.

The Boyle Consulting Agreement had a six months term.

The Boyle Consulting Agreement provided for compensation at a fixed rate of $15,000 per month and reimbursement for any usual and customary expenses incurred by Mr.

Boyle in connection with performing services pursuant to the Boyle Consulting Agreement.

The Lackey Consulting Agreement

Lackey, our former Senior Vice President, Legal & Administration, continues to be engaged by us under her consulting agreement , effective November 16, 2023, (the “Lackey Consulting Agreement”) pursuant to which Ms.

Lackey continues to provide legal and administrative services to us.

The Lackey Consulting Agreement will continue indefinitely until terminated by the Company or Ms.

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.

Groenewald's Engagement

On February 22, 2024, the Company and Ferdinand Groenewald entered into a consulting agreement (the “Groenewald Consulting Agreement”), effective February 22, 2024, pursuant to which Mr.

Groenewald will lead accounting and financial reporting activities of the Company.

Groenewald will serve as the Company’s Vice President, Finance taking over from Mr.

Wong our former Vice President of Finance.

The Groenewald Consulting Agreement will continue indefinitely until terminated by either party upon 30 days’ advance notice.

The Groenewald Consulting Agreement provides for compensation at a fixed rate of $15,000 per month and reimbursement by the Company for any usual and customary business expenses incurred by Mr.

Groenewald in connection with performing services pursuant to the Groenewald Consulting Agreement.

In addition, the Groenewald Consulting Agreement provides for the Company to indemnify Mr.

Groenewald on terms customary for officers.

Given our current size and strategic focus, we rely heavily on consultants and external advisors to perform key functions, including finance, legal, regulatory, and preclinical development activities.

Several material consulting agreements remain in place to support business continuity and execution of our obesity program and strategic alternatives review.

Our human capital strategy emphasizes retaining and incentivizing our limited internal team while effectively managing consultant relationships to advance our objectives with constrained resources.

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.

Departure of Dale Curtis Hogue, Jr.

as Chief Executive Officer and Director

On July 1, 2025, Dale Curtis Hogue, Jr.

notified the Company of his resignation from the board of directors (the “Board”) of Alaunos Company and his position as Chief Executive Officer, effective immediately.

His departure was not due to any disagreement with the Company.

On the same day, Mr.

Hogue entered into a Consulting Agreement with the Company, effective July 1, 2025 (the “Consulting Agreement”), pursuant to which Mr.

Hogue will continue providing strategic and advisory services to the Company.

The Consulting Agreement will continue until terminated by either party.

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.

Weis Engagement

Effective July 2, 2025, the Company entered into an employment agreement with Mr.

Weis in connection with his appointment as Chief Executive Officer.

Pursuant to the employment agreement, Mr.

Weis is entitled to an annual base salary of $275,000.

In addition, Mr.

Weis was granted an option to purchase 130,000 shares of the Company’s common stock at an exercise price of $5.06 per share.

One-fourth of the option vested and became exercisable on the grant date, and the remaining three-fourths vest in equal installments over three years on each quarterly anniversary of the grant date, beginning October 2, 2025, subject to Mr.

Weis’s continued employment with the Company through each applicable vesting date.

Any unvested portion of the option will be forfeited upon the termination of Mr.

Weis’s employment with the Company.

The option grant is

governed by the Company’s 2020 Equity Incentive Plan and the applicable stock option agreement thereunder.

Appointment of Michael A.

On July 15, 2025, the board of directors of the Company appointed Mr.

Jerman, as a director of the Company.

Jerman filled the vacancy created by Mr.

Dale Curtis Hogue’s resignation.

Jerman was also appointed to the Audit Committee and the Compensation Committee of the Board, replacing Mr.

Holger Weis, who was appointed Chief Executive Officer of the Company.

Jerman serves as the chair of the Audit Committee.

The Board has determined that Mr.

Jerman meets the requirements for independence under the applicable listing standards of the Nasdaq Stock Market LLC and the Securities and Exchange Act of 1934, as amended.

Departure of Melinda Lackey as Legal & Administration, Corporate Secretary

On July 16, 2025, Melinda Lackey notified the Company that, pursuant to Section 1 of the November 11, 2023 Consulting Agreement (the “Agreement”) between the parties, she was terminating the agreement, effective 30 days from the date of the notice, or August 15, 2025 (the “Effective Date”).

Concurrent with this notice, Ms.

Lackey resigned as Legal and Administrative Officer and as the Company’s corporate secretary as of the Effective Date.

Lackey's departure is not the result of any disagreement with the Company on any matter related to the Company's operations, policies or procedures.

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.

Corporate Information

9 unchanged sentences

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.

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.

Available Information

5 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business