Telomir Pharmaceuticals Inc

Overview

Telomir-1 is a novel oral small molecule metal ion regulator designed to extend telomere caps, maintain cellular balance, and combat oxidative stress, a key driver of aging and disease progression. By modulating essential metal ions such as iron, and copper, Telomir-1 may help protect against age-related conditions, including Progeria (a rare genetic disorder that causes rapid aging in children), Wilson’s disease (a genetic disorder leading to toxic copper buildup in the body), and Age-related Macular Degeneration (AMD), as well as Type 2 Diabetes, cancer, and Alzheimer’s disease.

Oxidative stress also plays a critical role in the propagation and severity of viral infections like bird flu, where the virus triggers an imbalance between increased production of reactive oxygen species (ROS) and reduced antioxidant host responses that leads to increased redox stress, a process which ultimately excessive weakens immune defenses, increases inflammation, and enables enhanced viral replication. By reversing oxidative stress, Telomir-1 may help strengthen immune resilience and reduce disease severity, offering broad therapeutic potential across both age-related and infectious diseases.

Telomeres are repetitive DNA sequences at the end of chromosomes that protect the chromosomes from becoming frayed or tangled. Each time a cell divides, the telomeres become slightly shorter, and eventually they become so short that the cell can no longer divide, with the result being that the cell dies. Effectively, telomeres protect the ends of our chromosomes by forming a cap, much like the plastic tip on shoelaces, thereby allowing the chromosome to be replaced properly during cell division. If demonstrated by future clinical trials and approved by the U.S. Food and Drug Administration, or FDA, we believe Telomir-1 may protect variable cells by elongating and stimulating the telomeres to sustain self-renewal and longevity.

Based on our preclinical studies, we have gathered experimental evidence suggesting that Telomir-1 may act as a regulator of essential metal ions such as iron, zinc, and copper. While these trace elements are critical for various physiological functions, imbalances—whether due to excess or deficiency—can drive oxidative stress, leading to cellular damage, telomere shortening, and accelerated aging. This oxidative burden is also linked to age-related conditions and certain cancers.

We believe Telomir-1 has the potential to protect cells in situ by mitigating metal overload, particularly of iron and copper, which are known to accelerate oxidative stress and contribute to telomere attrition. By modulating ion levels and reducing oxidative damage, Telomir-1 may help preserve telomere integrity, restore cellular homeostasis, and enhance overall cell resilience, potentially slowing down age-related degeneration. Additionally, by reversing oxidative stress, Telomir-1 may help mitigate the severity of viral infections such as bird flu by strengthening cellular defense mechanisms and improving immune system function, potentially reducing disease progression and severity.

Our focus is on addressing the effects of iron and copper overload while emphasizing the protective role of zinc. Excess iron can cause serious health problems, such as liver fibrosis, liver failure, heart issues, and endocrine dysfunction. It is also linked to type 2 diabetes mellitus (T2DM), as it disrupts insulin secretion, increases insulin resistance, and affects glucose production in the liver. In the retina, iron buildup leads to oxidative stress and damage, contributing to Age-related Macular Degeneration (AMD).

Copper, while essential for many physiological processes, becomes harmful when present in excess. High levels of copper increase oxidative stress, damage retinal cells, and disrupt mitochondrial energy production, which can result in cell death and tissue degeneration. Copper overload is particularly significant in Wilson’s disease, a rare genetic disorder that causes toxic copper accumulation in vital organs like the liver and brain, leading to severe health complications.

In contrast, zinc plays a protective role by reducing oxidative stress, regulating iron and copper levels, and restoring balance in cases of imbalance or deficiency. This highlights zinc’s critical role in maintaining physiological health and equilibrium.

Our objective is to investigate the molecular mechanisms of action of Telomir-1 through various biochemical methods. Additionally, we utilize a range of animal models to evaluate the drug’s therapeutic potential and activity. As our research advances and our understanding deepens, we may consider exploring alternative indications or adjusting our focus based on emerging insights or evolving circumstances.

Telomir-1 is currently undergoing preclinical investigation, with the goal of submitting an Investigational New Drug (IND) application and an Investigational New Animal Drug (INAD) application to the FDA. If accepted, these submissions would enable progression to human and animal clinical trials. Our research focuses on Telomir-1’s potential to interrupt, regulate, and prevent inflammatory pathways and enzymatic intracellular processes responsible for cellular metal imbalances. Preliminary studies suggest that Telomir-1 may achieve these outcomes by selectively binding to and exchanging between metal ions in a form- and dose-dependent manner, slowing enzyme reactivity, and preserving cellular functions. If clinical trials demonstrate its efficacy and it gains FDA and other regulatory approvals, we believe Telomir-1 could serve as a non-toxic, orally administered ion-overload regulator with the potential to balance enzyme and pathway overactivity caused by excessive metal reactivity.

To date, we have completed multiple preclinical studies on Telomir-1, including those demonstrating that Telomir-1 is non-mutagenic and possesses strong biological and metal-binding properties (Graphic 1). Using advanced “in silico modeling,” driven by artificial intelligence to predict a compound’s therapeutic potential, chemical and biological activity, and toxicity, we continue to uncover evidence supporting Telomir-1’s potential to address metal-overload conditions. Additionally, recent independent in vitro studies have confirmed that Telomir-1 exhibits strong binding affinities for copper and iron, with reduced binding affinity for zinc.

Graphic 1: Telomir-1 is capable binding to several metal ions

We collaborate with third-party organizations to conduct research and advance development efforts. One such partner, InSilico Trials, utilizes in silico digital simulations to support drug development through computational modeling. These techniques allow us to efficiently predict the safety and efficacy of potential compounds, reducing the need for extensive clinical trials. Additionally, we work with Recipharm and Smart Assays to assess Telomir-1’s binding properties and investigate ion competition and exchange under varying conditions, further refining its therapeutic potential.

An example of these findings is illustrated in the Graphic 2 below, created in collaboration with Smart Assays Biotechnologies Ltd. The figure depicts the concentration of free iron (Fe²⁺) in the presence of Telomir-1 (T1) and various ions. When Telomir-1 is introduced, the concentration of free iron decreases (indicated by the shift from the blue point to the orange point). This is direct evidence for the binding of iron to T1, reducing its free ion concertation in the solution. However, the addition of copper (Cu²⁺) at varying concentrations leads to an exchange between bound iron and copper, resulting in the release of previously bound iron and restoration of free iron levels in solution. This is evidenced by an increase in free iron concentration, corresponding to the amount of copper added. In contrast, zinc does not induce an exchange effect on the binding of iron to Telomir-1, indicating a lower affinity of Zinc to Telomir-1.

Graphic 2: Ionic exchange between iron and copper or zinc

Wilson’s disease

Wilson’s disease is a rare genetic disorder affecting approximately 1 in 30,000 individuals worldwide. It is caused by mutations in the ATP7B gene, which disrupt the body’s ability to regulate copper metabolism. This results in toxic copper accumulation, particularly in the liver and brain, leading to severe complications such as liver failure, neurological damage, and psychiatric disorders. Without treatment, Wilson’s disease is fatal.

Current treatments, including chelating agents (e.g., penicillamine and trientine) and zinc therapy, focus on reducing copper levels but have notable limitations:

These challenges highlight the urgent need for novel therapies that address the root cause of Wilson’s disease while minimizing adverse effects. Telomir-1, with its targeted copper-binding properties, has the potential to provide a safer, more effective treatment by directly addressing the underlying mechanisms of the disease. Furthermore, Wilson’s disease qualifies as a candidate for orphan drug designation due to its rarity and life-threatening nature, offering opportunities for accelerated development and additional regulatory and financial incentives.

We are actively investigating Telomir-1’s potential in treating Wilson’s disease by studying its effects on copper toxicity through in vitro experiments and a mouse model of the disease. These studies are currently ongoing.

Type 2 Diabetic (NIDDM)

In collaboration with the India-based research organization Pentagrit, in 2024 Telomir conducted preclinical studies evaluating two forms of Telomir-1, administered orally at three different doses, in zebrafish models of Type 2 diabetes mellitus induced by a high-calorie diet. The study assessed key metabolic indicators, including fasting glucose levels, Oral Glucose Tolerance Test (OGTT) results, insulin concentrations, and HOMA-IR. The findings revealed:

A Novel Mechanism of Action

Telomir-1 introduces a novel mechanism of action by addressing the cellular role of iron metabolism in chronic diseases such as Type 2 diabetes. Excess iron contributes to oxidative stress, beta-cell damage, and insulin resistance. Telomir-1 is designed to normalize iron homeostasis, reducing oxidative stress and enhancing insulin sensitivity. This differentiates it from current diabetes drugs that primarily treat symptoms without targeting the underlying causes.

The study demonstrated significant reductions in fasting plasma glucose to basal levels, improvements in glucose tolerance, and a reversal of insulin resistance to near pre-diabetic levels. These results were accompanied by improved HOMA-IR values, a standard measure of insulin sensitivity and resistance, and increased survival rates in treated models.

Global Impact of Type 2 Diabetes

According to the International Diabetes Federation, over 800 million adults worldwide are affected by Type 2 diabetes (both diagnosed and undiagnosed), with annual healthcare costs exceeding $966 billion as of 2021. Existing treatments primarily manage blood glucose and symptoms but fail to address the root causes of the disease. These therapies are often associated with significant limitations, including minimal impact on insulin resistance, gastrointestinal issues, risk of hypoglycemia, cardiovascular risks, and weight gain.

The findings from this zebrafish diabetes model suggest that Telomir-1 could offer a transformative approach to managing Type 2 diabetes. By targeting the underlying mechanisms of insulin resistance and oxidative stress through iron metabolism normalization, Telomir-1 represents a potential breakthrough in diabetes treatment. A key indicator of its success was the significant reduction in HOMA-IR values, highlighting its ability to improve insulin sensitivity and glucose regulation. The reversal of insulin resistance to near pre-diabetic levels underscores Telomir-1’s potential as a groundbreaking therapy (Graphic).

Graphic 3: Effects of two forms of Telomir-1 on HOMA-IR, a measure of insulin resistance in Zebrafish

We are currently evaluating the potential in NIDDM by studying the effect of Telomir-1 on several metabolic parameters in a rat model of NIDDM. These studies are ongoing.

Age reversal

We have carried out a preclinical study, conducted in collaboration with Nagi Bioscience SA, utilized a sophisticated in vivo microfluidic-based assay to assess the effects of Telomir-1 on the nematode Caenorhabditis elegans, a well-established model for aging studies. The microfluidic platform allowed precise, automated tracking of lifespan, health span, and age-related mobility decline in real-time, enabling the research team to accurately measure the effects of Telomir-1 on these critical metrics.

Two forms of Telomir-1 were administered in two concentrations, allowing the study to examine dose-dependent responses in treated subjects. The study found that Telomir-1 significantly enhanced lifespan and health span parameters in aged microorganism populations. Key findings included:

Graphic 4: Effect of Telomir-1 on c.elegans life span

Graphic 5: Effect of two forms of Telomir-1 on several motility parameters

Progeria Study: Telomir-1 Shows Promising Age-Reversal Effects

We recently completed a study evaluating the effects of Telomir-1 in a nematode model of Progeria (Caenorhabditis elegans). The study focused on nematodes with a mutation in the wrn-1 gene, the equivalent of the human WRN gene, which is implicated in Werner Syndrome, a form of Progeria. In C. elegans, wrn-1 depletion is associated with a significantly reduced mean and median lifespan compared to normal (wild-type) organisms.

The study demonstrated significant age-reversal effects inwrn-1-mutated nematodes treated with Telomir-1. Treatment effectively restored longevity levels to those comparable to wild-type organisms. Additional benefits included an extended healthy lifespan and normalization of physiological parameters such as movement velocity and tail amplitude.

Further studies in a Progeria human cell line are planned in collaboration with Smart Assays to build on these promising findings.

Oxidative Stress Study: Telomir-1 Shows potential to Fully Reverse Oxidative Stress and Provide Robust Cellular Protection

Oxidative stress is a key driver of aging and disease progression, contributing to conditions such as Alzheimer’s, Age-related Macular Degeneration (AMD), cardiovascular diseases, cancer, and diabetes. It also plays a critical role in the severity of viral infections, including avian influenza (bird flu), by increasing inflammation, cellular damage, and impairing immune responses. Addressing oxidative stress is essential for mitigating these effects and improving patient outcomes.

Telomir Pharmaceuticals recently conducted preclinical studies in collaboration with Smart Assays Biotechnologies Ltd. to evaluate Telomir-1’s ability to combat copper-induced oxidative stress. The study, performed in human cell lines, demonstrated:

These findings suggest Telomir-1’s potential to preserve cellular integrity, combat oxidative damage, and regulate metal ion balance—critical factors in aging-related diseases and viral infections. This breakthrough supports further clinical development to assess its full potential in disease intervention.

Graphic 6: Effect of Telomir-1 on Oxidative Stress

Graphic 7: Effect of Telomir-1 on Copper Toxicity

Expanding Telomir-1’s Therapeutic Potential

Building on these results, Telomir is planning and advancing studies to expand the therapeutic potential of Telomir-1. Key ongoing initiatives include:

Future Plans and Milestones

Telomir-1 has demonstrated significant potential in reversing age-related and metabolic conditions while targeting underlying disease mechanisms. As the company continues to refine the molecular understanding of Telomir-1, efforts are underway to identify the most impactful indication for its initial IND application.

The company is optimizing manufacturing processes to produce GMP-grade Telomir-1 for IND-enabling studies and future clinical trials. Safety studies are scheduled for Q2 2025, with IND submission targeted for Q4 2025 and first-in-human trials anticipated in early 2026. Concurrently, the company aims to secure an INAD to enable veterinary applications, highlighting Telomir-1’s dual potential for both human and animal health.

Through these initiatives, Telomir is committed to revolutionizing treatments for age-related and chronic diseases by addressing their root causes and paving the way for transformative healthcare solutions.

Market Potential

The market potential for Telomir-1 is substantial, given its focus on addressing the root causes of age-related diseases and promoting longevity. Chronic diseases such as diabetes, cancer, Alzheimer’s, and cardiovascular disorders, which are closely tied to aging, account for over 75% of healthcare spending in the United States, exceeding $4 trillion annually, according to the CDC. As the global population ages, the demand for innovative therapies targeting the underlying mechanisms of these conditions is expected to grow significantly. Furthermore, Verified Market Research reports that the anti-aging drug market was valued at approximately $91.05 billion in 2024 and is projected to reach $160.24 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.32%. With its novel mechanism of action that regulates cellular metal imbalances and reduces oxidative stress, Telomir-1 is uniquely positioned to capitalize on these expanding markets, offering transformative potential to enhance health span, slow disease progression, and redefine longevity treatments.

Pre-Clinical IND-Enabling Studies

As outlined in the table below, we have successfully completed several IND-enabling studies for Telomir-1, demonstrating its non-toxic profile. In collaboration with Frontage Laboratories, our research has also established the metabolism and maximum tolerated dose (MTD) of Telomir-1, providing critical data to support its development.

All preclinical studies referenced in this Annual Report were conducted in collaboration with third-party organizations, including Frontage Laboratories, InSilico Trials, Pharmaseed Ltd, Smart Assay Biotechnologies Ltd., Recipharm, Naji Biosciences, and Pantagrit. These partners played a key role in supporting the execution and analysis of the research.

Our Clinical Development Plan

Upon completing toxicology studies and preclinical proof-of-concept studies, we plan to submit an Investigational New Drug (IND) application to the FDA for Telomir-1. While the specific indication is still being evaluated, we intend to explore additional indications with FDA guidance as the development program evolves. Our first IND submission for Telomir-1 is targeted for the fourth quarter of 2025. If approved by the FDA, we plan to initiate a Phase I double-blind, randomized, placebo-controlled trial approximately 30 days post-submission. This trial will assess the safety, tolerability, and pharmacokinetics of Telomir-1 in 40–60 healthy adult male and female participants.

The progress of our clinical development program will depend on FDA acceptance of our IND submissions. As discussions with the FDA progress, we may adjust timelines for filings and associated clinical trials when necessary. It is important to acknowledge that conducting clinical trials is inherently uncertain, and there can be no assurance that our clinical development activities will proceed according to the planned timelines outlined above.

Manufacture of Product for Clinical Development Activities

Anthem Biosciences, a leading contract development and manufacturing organization, initially developed the large-scale synthesis protocol for Telomir-1, enabling the production of material required for preclinical studies. The manufacturing and synthesis processes have since been successfully transferred to Recipharm, a globally recognized CDMO known for its expertise in advanced chemistry, operational excellence, and commitment to delivering high-quality manufacturing solutions.

Market Opportunity

Telomir-1 is under investigation for its therapeutic potential across multiple areas, including Progeria, Type 2 Diabetes, Wilson’s disease, Age-related Macular Degeneration (AMD), Alzheimer’s disease, cancer, and other age-related conditions. Additionally, Telomir-1 is being explored for its potential in mitigating the severity of viral infections such as avian influenza (bird flu) by addressing oxidative stress and immune dysfunction. These indications are being carefully evaluated to identify the most impactful opportunities for clinical development and market entry.

The market potential for these conditions is substantial across the United States, Canada, and Mexico. The Type 2 Diabetes market in the U.S. alone was valued at approximately $30.47 billion in 2022, according to Fortune Business Insights, driven by rising prevalence and demand for advanced therapies. The global AMD market is projected to reach $18 billion by 2030, growing at a CAGR of 8.2% from 2024 to 2030. Alzheimer’s disease, one of the most pressing age-related conditions, is projected to grow significantly, with the global market expected to reach $13 billion by 2031, according to Allied Market Research, fueled by increasing diagnoses and advancements in treatments targeting cognitive decline.

The U.S oncology market, covering a broad range of cancers, was valued at $74.1 billion in 2023, and is projected to reach $180.12 billion by 2033, growing at a CAGR of 9.2% from 2024 to 2033, as per Precedence Research. Meanwhile, the anti-aging and age-reversal market was valued at $91.05 billion in 2024 globally and is projected to grow to $160.24 billion globally by 2031, with a CAGR of 7.32%, according to Verified Market Research.

Rare diseases such as Progeria and Wilson’s disease, despite having smaller patient populations, represent highly lucrative opportunities due to significant unmet medical needs and strong pricing potential. For instance, the annual treatment cost for Progeria exceeds $1 million, based on the price of Zokinvy (lonafarnib), the FDA-approved drug for the condition. Similarly, treatments for Wilson’s disease, like Syprine (trientine hydrochloride), can cost approximately $300,000 per year.

The global antiviral drugs market is experiencing significant growth, driven by the increasing prevalence of viral infections and advancements in treatment options. In 2022, the market was valued at approximately $49.8 billion and is projected to reach around $71.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 3.73% during this period.

Specifically focusing on avian influenza (bird flu), the treatment market was estimated at $22.06 billion in 2023 and is expected to grow at a CAGR of 8.18%, reaching approximately $38.27 billion by 2030.

These figures highlight the substantial market opportunity for innovative treatments addressing chronic, age-related, and viral diseases. With increasing demand for therapies targeting oxidative stress, cellular degeneration, and immune resilience, Telomir-1 is well-positioned to address these critical unmet medical needs. Its broad therapeutic potential, spanning rare diseases, metabolic disorders, neurodegeneration, and viral infections, represents a significant market opportunity across North America and beyond, reinforcing its potential as a transformative solution in modern medicine.

Intellectual Property

We license the U.S. patent rights for the use of Telomir-1 in human applications from MIRALOGX, LLC (“MIRALOGX”), an intellectual property development and holding company. MIRALOGX has filed a Patent Cooperation Treaty (PCT) application, PCT/US2023/073106 on August 29, 2023. The application designated the U.S. and will enter U.S. national phase. The application, if granted and subject to payment of patent maintenance fees, would offer protection extending through at least August 29, 2043 in the U.S. The patent rights for Telomir-1 outside of the United States are not included in our current patent rights.

Our license from MIRALOGX is set forth in an Amended and Restated Exclusive License Agreement, dated August 11, 2023, between us and MIRALOGX, pursuant to which we obtained the exclusive perpetual right and license under the above-described patent rights to make, have made, use, and sell “Licensed Products” in the U.S. for human uses and pre-clinical studies and activities of any kind conducted in furtherance of obtaining regulatory approval or commercialization for human uses (the “Initial MIRALOGX License Agreement”). On November 10, 2023, we and MIRALOGX entered into the Amendment No. 1 to the Amended and Restated License Agreement, pursuant to which the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined in the agreement as a drug product containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl) pyridine or a pharmaceutically acceptable salt, ester, or solvate thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales of Licensed Products by us or our sublicensees and on non-royalty bearing milestone revenue. There are no up-front, execution, or milestone payments in the license agreement. Further, no payments have been made to date under the agreement.

Government Regulation

The FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling and export and import of our drug candidates.

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (NDAs), withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

Pre-clinical studies

Before testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events (“AEs”) and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

An IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to proceed by the FDA before human clinical trials may begin. Some long-term pre-clinical testing, such as animal tests of reproductive AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

Clinical trials

The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with GCPs, which include the requirement that all research patients provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, 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 and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined.

Post-approval trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics License Application (“BLA”).

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if significant adverse events (“SAEs”) occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can refuse, 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 drug has been associated with unexpected serious harm to patients.

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

Marketing Approval

Assuming successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee.

The review process typically takes twelve months from the date the NDA is submitted to the FDA. The FDA conducts a preliminary review of all NDAs within the first 60 days after submission to determine whether they are sufficiently complete to permit substantive review before accepting them for “filing.” The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information and may be subject to an additional application user fee. The resubmitted application is also 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. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets standards designed to assure the product’s continued safety, quality and purity. Under the current guidelines in effect in the Prescription Drug User Fee Act (PDUFA), the FDA has a goal to review and act on the submission within ten months from the completion of the preliminary review of a standard NDA for a new molecular entity.

The FDA also may require submission of a REMS plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk minimization tools.

The FDA may refer to an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides 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.

Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate toensure the consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP requirements.

After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical trials or pre-clinical studies in order for FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

Post-approval requirements

Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.

Employees and Human Capital Resources

As of February 4th, 2025, we had 5 part-time employees None of our employees is represented by a labor union or are covered by a collective bargaining agreement. We consider our relationship with our employees to be satisfactory. In addition, we utilize the services of contractors and part-time outside consultants to support our organization’s needs. We expect to continue to build our team to ensure we can effectively execute our development plans.

There are no material proceedings to which any director or officer, or any associate of any such director or officer, is a party that is adverse to us or any of our subsidiaries or has a material interest adverse to us or any of our subsidiaries. No director or executive officer has been a director or executive officer of any business which has filed a bankruptcy petition or had a bankruptcy petition filed against it during the past ten years. No current director or executive officer has been convicted of a criminal offense or is the subject of a pending criminal proceeding during the past ten years. No current director or executive officer has been the subject of any order, judgment or decree of any court permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities during the past ten years. No current director or officer has been found by a court to have violated a federal or state securities or commodities law during the past ten years. From time to time, we may be named in claims arising in the ordinary course of business.

We anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.

Corporation Information

We were organized as a Florida corporation in August 2021 for the purpose of pursuing the development and commercialization of Telomir-1 in the United States in human applications. We were originally incorporated under the name “Metallo Therapies Inc.” and changed our name to “Telomir Pharmaceuticals, Inc.” in October 2022.

Our corporate headquarters is a virtual office and is located at 100 SE 2 nd St., Suite 2000 #1009 Miami, Florida 33131. Our telephone number is (786) 396-6723.

Our website address is www.telomirpharma.com. The information contained on, or that can be accessed through, our website is deemed not to be incorporated in this Annual Report or to be part of this Annual Report. You should not consider the information contained on our website to be part of this Annual Report