Telomir Pharmaceuticals Inc

Overview

We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization ofTELOMIR-1, a novel small molecule being developed to function as an oralin situ therapeutic treatment for human stem cells. In situ stem cell therapy uses the body’s natural resources to regenerate damaged tissue and replace cells with new, functional cells.

Specifically, pluripotent stem cells are a type of stem cells that have the ability to undergo self-renewal and to give rise to various cell types of the tissues of the body. If demonstrated by future clinical trials and approved by the U.S. Food and Drug Administration, or FDA, we believe TELOMIR-1 may also protect the stem cells by elongating and stimulating the telomeres to sustain self-renewal of stem cells. 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.

Based on our pre-clinical studies to date, and if ultimately approved by the FDA, we believe that TELOMIR-1 may potentially serve as a metal enzyme inhibitor of essential metals such as iron, zinc and copper. These essential metals play a role in a host of age-related inflammatory conditions such as osteoarthritis and hemochromatosis (a condition that causes the body to absorb too much iron, which can damage organs and tissues), as well as in post-chemotherapy health problems. Based on pre-clinical studies, we believe that TELOMIR-1 may have the potential to protect stem cells in situ by reducing the overload of metals such as iron, zinc and copper that accompany age-related inflammatory conditions and certain cancers by modulating pro-inflammatory cytokines such as Interleukin-17 (or IL-17).

Our goal is to advance the clinical development of TELOMIR-1 in the United States as a potential therapeutic intervention for age-related inflammatory conditions. Our initial development plan was to research TELOMIR-1 as a potential treatment for hemochromatosis followed by the post-chemotherapy recovery indication. Due to the inability to define the preclinical mouse model for hemochromatosis and register the investigator site, in March 2024 we shifted our research focus to make osteoarthritis our lead indication for TELOMIR-1. Our research plan now includes hemochromatosis as the second indication followed by post-chemotherapy recovery. As our research progresses, we may explore different indications or shift our indication focus as we deem necessary or as circumstances require.

TELOMIR-1 is currently under pre-clinical investigation, with the goal of submitting an Investigational New Drug Application (or IND) for Telomor-1 to the FDA which, if accepted, would allow us to move in human clinical trials. In particular, we are studying TELOMIR-1’s potential to interrupt and prevent the IL-17 induced inflammatory pathways that create the systemic imbalance of cellular metals. Our studies suggest that TELOMIR-1 may achieve this outcome by selectively binding to metal ions in a dose dependent manner, slowing enzyme reactivity, and protecting and lengthening telomeres in the human chromosome. If demonstrated in clinical trials and approved by the FDA and comparable foreign regulators, we believe that TELOMIR-1 has potential as a non-toxic oral enzyme inhibitor that may regulate the overactivity of the enzymes caused by excessive metal reactivity.

To date, we have completed several pre-clinical studies with respect to TELOMIR-1. Some of these studies were designed to demonstrate that TELOMIR-1 is not mutagenic and has good biological and metal binding capabilities (Graphic 1). Using “in silico modeling”, which deploys artificial intelligence-driven computational models to predict a compound’s therapeutic potential, biological activities and toxicity, we are continuing to find evidence that the mechanism of action of TELOMIR-1 has the potential to reverse age-related conditions such as osteoarthritis by lengthening DNA’s protective telomere caps.

Graphic 1. TELOMIR-1 Molecule

We have collaborations with third parties who conduct our research for us. One of these is InSilicoTrials, a company founded by life science, cybersecurity, and digital innovation experts, which utilizes in silico digital simulations. Through such collaborations, we specialize in leveraging artificial intelligence and simulations to enhance drug development. Using in silico techniques, we analyze data to predict safety and efficacy of potential compounds, which we believe is an efficient and cost-effective research and development advancement with the potential to minimize the extensiveness of later clinical trials.

In Situ Therapeutic Treatment of Stem Cells

Stem cells have the potential to renew themselves. They can develop into many different cell types in the body during early and adult life. Pluripotent stem cells have the ability to differentiate into all of the cells of the adult body. Since pluripotent stem cells are undifferentiated, they do not have any tissue-specific characteristics that allow them to perform specialized functions. Given the regenerative abilities and limited quantities of stem cells in the adult human body,in situ treatment and protection of stem cells may provide an important therapeutic mechanism for treatment of disease.

The graph below describes telomere elongation secondary to TELOMIR-1 stimulation and subsequent stem cell self-renewal. As noted, telomeres shorten during the natural aging process. Based on our initial studies, we believe that TELOMIR-1may be able to delay or reverse age-related conditions through telomere elongation.

Invitro Human Stem Cell Therapy with Frontage Laboratories: Telomir Length Determination

Through research studies with Frontage Laboratories, we are investigating in vitro human stem cell in human cell lines. Specifically, we are engaged in the following in conjunction with Frontage Laboratories:

Cell line selection. Based on the literature highlighting their appropriateness for telomere and aging research, Frontage acquires three vials for each stem cell line: primary human umbilical vein endothelial cell, non-immortalized human fibroblast, and the human BM-derived mesenchymal stem cell line. The cells then undergo an evaluation to determine telomere length and their capacity for cell renewal and proliferation and assess cell death, as described below.

Telomere length determination. A commercially available qPCR kit is employed to treat and assess the absolute telomere length of the cells. Cells undergo treatment with different concentrations of TELOMIR-1, followed by harvesting at distinct time intervals, and subsequently subjected to telomere length analysis.

Results of our research with Frontage Laboratories is provided in the graph below. The graph shows that 50mM of TELOMIR-1 elongated telomeres compared to untreated and vehicle cells.

Our Strategy

Our goal is to develop, gain US regulatory approval for and commercialize TELOMIR-1 as a new treatment option targeting the elongation of telomeres for treatment of age-related inflammatory conditions, with osteoarthritis as our initial clinical focus followed by hemochromatosis. Thereafter, we plan to expand the development of TELOMIR-1 to post-chemotherapy recovery therapeutic. The key elements of our strategy to achieve this goal include:

Osteoarthritis Background

According to the CDC, osteoarthritis is the most common form of arthritis. Some people call it degenerative joint disease or “wear and tear” arthritis. It occurs most frequently in the hands, hips, and knees. With osteoarthritis, the cartilage within a joint begins to break down and the underlying bone begins to change. These changes usually develop slowly and get worse over time. Osteoarthritis can cause pain, stiffness, and swelling. In some cases, it also causes reduced function and disability. Key impacted joints include hands, knees, hips, and neck. Most patients with osteoarthritis often present with pain and stiffness in their joints as soft tissue damage progresses, restricting their ability to participate in normal life activities. IL-17 promotes osteoarthritis disease progression byregulating chondrocyte autophagy, senescence, and cartilage matrix degradation.

There is no cure for osteoarthritis, so doctors usually treat osteoarthritis symptoms with various therapies, which may include: increasing physical activity, physical therapy with muscle strengthening exercises, weight loss, medications, including over-the-counter pain relievers, supportive devices such as crutches or canes and surgery (typically joint replacement, if other treatment options have not been effective).

Hemochromatosis Background

According to the CDC, hemochromatosis is a disorder in which the body builds up too much iron in the skin, heart, liver, pancreas, pituitary glands, and joints. This overload of iron is toxic to the body, and over time, the high levels of iron can damage tissues and organs and lead to conditions such as liver damage, liver cancer, heart problems, arthritis, and diabetes. Other conditions associated with high iron levels include inflammatory conditions, chronic kidney disease, and autoimmune disorders. Hemochromatosis is a life-long condition requiring regular treatment to avoid long-term serious effects with poor pharmacologic options. The most used treatment for hemochromatosis is phlebotomy, a procedure to remove some of the patient’s blood. Phlebotomy is relatively inexpensive, well accepted, and well tolerated, but it requires regular visits to health care professionals and blood draws and may not be appropriate for all patients.

Post-Chemotherapy Recovery Background

Post-chemotherapy recovery from adverse effects of antineoplastic treatments is often important for cancer therapy success. While chemotherapy treatment can be highly effective for cancer, it can also come with many side effects, as chemotherapy drugs destroy both cancerous and healthy cells. We plan to investigate the use of TELOMIR-1 as a potential complementary treatment for patients receiving chemotherapy in the form of a twice daily, oral regimen to inhibit pro-inflammatory cytokines and to reduce blood iron levels, enabling potentially more effective adherence and improved outcomes.

Pre-Clinical IND-Enabling Studies

To date, as shown in the table below, we have completed several IND-enabling studies with respect to TELOMIR-1 that were designed to demonstrate that TELOMIR-1 is non-toxic. Our research studies with Frontage Laboratories have also helped us establish the metabolism and maximum tolerated dose (or MTD) of TELOMIR-1.

We are planning pre-clinical proof-of-concept studies for TELOMIR-1, including canine and rat osteoarthritis studies.

All pre-clinical studies described in this Annual Report were conducted with the assistance of third parties, including Frontage Laboratories of Exton Pennsylvania and InSilico Trials Technologies of Trieste, Italy, each of whom utilize artificial intelligence-driven computer in-silico testing models.

Our Clinical Development Plan

Following completion of the toxicology studies and preclinical proof-of-concept studies pre-clinical development program, we plan to submit to the FDA an IND, focused on investigating TELOMIR-1 for the treatment of osteoarthritis. We will consider a second IND for hemochromatosis with FDA guidance.

Our first IND application submission investigating TELOMIR-1 for the treatment of osteoarthritis is currently planned for the first quarter of 2025. If allowed to proceed by the FDA, a Phase I double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of TELOMIR-1 in 40-60 healthy male and female adult subjects will be initiated approximately 30 days post-IND submission.

Our second IND application will likely focus on investigating TELOMIR-1 for the treatment of hemochromatosis and is planned for submission with guidance from the FDA. Additionally, post-chemotherapy recovery may be considered as a future contender with additional guidance from the FDA.

Our clinical development plans will depend on FDA acceptance of our IND applications. As appropriate and pursuant to discussions with the FDA, we may periodically adjust the timeline for certain filings and associated clinical trials. It is important to note that the process for conducting clinical trials is uncertain and there is no assurance that our clinical development activities will meet the planned timelines set forth above.

Manufacture of Product for Clinical Development Activities

Anthem Biosciences, a leading contract development and manufacturing organization located in India, has been developing a large-scale synthesis protocol for us and will be supplying quantities of TELOMIR-1 needed for our pre-clinical and clinical development activities. We are currently in discussions with Frontage Laboratories to have TELOMIR-1 formulated into solid oral dosage forms for clinical trials. DAVOS Pharm is a US intermediary between Anthem in India and Telomir in the US.

Market Opportunity

TELOMIR-1, if approved, is expected to initially compete in the osteoarthritis market followed by hemochromatosis. TELOMIR-1, if approved, may have the potential to secondarily compete in the post-chemotherapy recovery market.

Potential Market for Osteoarthritis

As of 2022, according to the CDC, approximately 32.5 million adults in the United States have osteoarthritis or on average 10% of the population. The patient count will rise to 78.4 million by 2040. As the U.S. population ages, it is anticipated that the burden of osteoarthritis will grow, accounting for 5%-6% of all hospitalization related costs. Most patients manage their symptoms using a variety of pharmacologic and non-pharmacologic tools depending on the severity of pain felt. For the approximately 25% of patients considered severe cases (i.e. a pain score of 7 and above out of 10), a mix of pharmaceutical options exist, usually starting with corticosteroids, hyaluronic acid, and prescription strength non-steroidal anti-inflammatory drugs (or NSAIDs). The market for medications to treat osteoarthritis is worth $600 - $800/patient/annum or approximately $19.5 to $26 billion in annual costs spread across multiple medications from NSAIDs to steroids. We are seeking to have TELOMIR-1 become a novel, first line treatment for osteoarthritis, and compete for a material share of the estimated medical costs market.

Potential Market in Hemochromatosis

Patients with two mutated copies of theHFE gene (C282Y and H63D) are at the greatest risk for developing hemochromatosis, alongside patients with a family history of hemochromatosis. As a result, approximately 13 million U.S. patients carry mutations for hemochromatosis but only a fraction of them has symptoms, and not every symptomatic patient develops hemochromatosis. On average, about 750,000 U.S. patients express one or more iron overload symptoms. There are 2 types of hemochromatosis, with the following patient mix: 150,000 primary hemochromatosis, and 65,000 secondary hemochromatosis confirmed diagnoses in the United States. Today, we estimate that over 150,000 patients have sought treatment since 2018, with most receiving phlebotomy, which is the withdrawal of blood to bring iron to normal levels.

Potential Market in Post-Chemotherapy

Patients undergoing chemotherapy irrespective of the type of cancer are at risk. That said, older patients aged 65+ and above, have a higher risk of developing post-chemotherapy side effects such as digestive issues, sleep and memory issues, fatigue, and body aches. Other risk factors include the presence of metabolic conditions, dose levels of chemotherapy medication, blood count, and BMI.US CDC health data estimates that 650,000 patients receive chemotherapy annually in the US, with 45% experiencing severe side effects and 40% having more moderate side effects. Thus, approximately 158,000 patients were diagnosed with the adverse effects of chemotherapy (antineoplastic and immunosuppressive drugs. Today, Neulasta is given to patients undergoing chemotherapy as a “catch-all” therapeutic to help manage side effects. Neulasta is typically given to patients after chemotherapy for recovery.

Competition

We are subject to competition from pharmaceutical and biotechnology companies and academic and research institutions. Nearly all of our competitors have significantly more resources and experience than we do.

TELOMIR-1 will face competition in its initial target indication, osteoarthritis, as well as in its potential second target indication hemochromatosis followed by post-chemotherapy recovery.

In osteoarthritis, TELOMIR-1 would compete as a treatment with a variety of pharmacologic compounds, including NSAIDs, corticosteroids, hyaluronic acid, opioids, stem cell injections, platelet injects, and nutritional supplements. Since there is presently no known cure, the front line treatment for osteoarthritis is pain management, although some treatment options seek to reverse osteoarthritis, which is what we are targeting for TELOMIR-1.

In hemochromatosis, as noted above, the current standard of care is phlebotomy, which typically costs $80 - $300 per visit in community health facilities or offered for free at blood banks. Based on historical treatment data, phlebotomy serves more than 95% of hemochromatosis patients, as there are no FDA-approved therapeutics for this indication. Patients who use phlebotomy continue to embrace it given the lack of clinical options, its broad accessibility and low treatment cost. However, this option is not available to patients with hemophilia and other blood disorders. About 5% of patients are treated with iron chelators such as Exjade and Jadenu (and associated generics). These options are more expensive with pricing for Exjade at $532 per day and Jadenu at $517 per day. The last treatment option, deferasirox / deferoxamine was used with only 7,000 patients (2018-2022) based on IQVIA claims and scripts data. Future clinical options for treating hemochromatosis exist and remain limited. For example, 2 molecules are pre-clinical, 2 in Phase 1, 1 in Phase 2, and 1 is in Phase 3 clinicial trials.

In post-chemo recovery, the current standard of care involves prescribing a small set of compounds designed to reduce patient discomfort from side effects. Filgrastim, pegfilgrastim, sargramostim are some examples of prescribed medication. These medications stimulate the growth of healthy white blood cells and granulocytes by subcutaneous injection. However, prices are high and can cost around $4,000 to $6,400 per dose of injection. Jakafi, a tyrosine kinase inhibitor, is used in polycythemia vera and graft-versus-host disease. Pricing for Jakafi is $16,200 per bottle, with a $270 wholesale acquisition cost (WAC) unit price. Thus, given the cost, only a portion of the high-risk patients are given the script; these are usually patients who are older than 65, and with a weakened immune system and low white blood cell count. Patients who use the class of medication do so to reduce post-treatment infection risk, even if they suffer from fevers and aches because of usage. The development pipeline of competing assets is robust but targeted at specific side effects such as iron deficiency or thrombotic constraints.

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 our company 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.

U.S. Government Regulation

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, among other things, 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 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 to assure 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 March 15, 2024, we had 1 full-time employee, our chief financial officer, and 8 part-time employees, of which one of our part-time employees is engaged in research and development. 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 our Company or any of our subsidiaries or has a material interest adverse to our Company 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 located at 855 N Wolfe Street, Suite 601, Baltimore, Maryland 21205. Our telephone number is (737) 289-0835.

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.