Item 1A. Risk Factors 19
Item 1B. Unresolved Staff Comments 46
Item 1C. Cybersecurity 46
Item 2. Description of Property 46
Item 3. Legal Proceedings 46
Item 4. Mine Safety Disclosure 46
Item 5. Market for Common Equity and Related Stockholder Matters 47
Item 6. [Reserved] 47
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 54
Item 8. Financial Statements 54
Item 9A. Controls and Procedures 55
Item 9B. Other Information 55
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 55
PART III 55
Item 10. Directors, Executive Officers and Corporate Governance 55
Item 11. Executive Compensation 61
Item 14. Principal Accountant Fees and Services 72
Item 15. Exhibits, Financial Statement Schedules 73
Signatures 75
Unless
we have indicated otherwise, or the context otherwise requires, references in this Report to “TELO,” the “Company,”
“we,” “us” and “our” or similar terms refer to Telomir Pharmaceuticals, Inc., a Florida corporation.
From
time to time, we may use our website, our Facebook page at https://www.facebook.com/people/Telomir-Pharmaceuticals-Inc/100087267737318/#,
our Twitter at https://x.com/TelomirPharma, and on our LinkedIn account at https://www.linkedin.com/company/telomir-pharmaceuticals-inc/posts/?feedView=all
to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors
section of our website, available at www.telomirpharma.com. Investors are encouraged to review the Investors section of our website
because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and
can be accessed through our website, our Facebook page, our Twitter posts and our LinkedIn posts are not incorporated into, and does
not form a part of, this Annual Report.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Annual Report on Form 10-K contains forward-looking statements (as defined in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act) that
reflect our current expectations and views of future events. In some cases, you can identify forward-looking statements by terms
such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other
similar expressions. In particular, statements about the markets in which we operate, including expectations regarding our studies, growth
of our various markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance
contained in this Annual Report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and “Business” are forward-looking statements.
We
have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these
expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve
known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed
in this Annual Report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and “Business,” may cause our actual results, performance, or achievements to differ materially
from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share
price. Important factors that could cause actual results or events to differ materially and adversely from those expressed in forward-looking
statements include, but are not limited to, the following:
● the timing of anticipated regulatory filings;
● our future expenses, capital requirements and need for additional financing;
● our ability to recruit and enroll suitable patients in our clinical trials;
● developments relating to our competitors and our industry;
Given
the risks and uncertainties set forth in this Annual Report, you are cautioned not to place undue reliance on such forward-looking statements.
The forward-looking statements contained in this Annual Report are not guarantees of future performance and our actual results of operations,
financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking
statements contained in this Annual Report. In addition, even if our results of operations, financial condition and liquidity, and events
in the industry in which we operate are consistent with the forward-looking statements contained in this Annual Report, they may not
be predictive of results or developments in future periods.
Any
forward-looking statement that we make in this Annual Report speaks only as of the date of such statement. Except as required by federal
securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the
forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Annual Report.
PART
I
ITEM
1. Description of Business
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 in wrn-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:
● Cancer Research: Exploring anti-cancer applications using xenograft studies.
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.
Type of Study Species Purpose Results
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:
● submission to the FDA of an NDA;
● satisfactory completion of an FDA advisory committee review, if applicable;
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
to ensure 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.
Legal
Proceedings
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 2nd 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
ITEM
1A. Risk Factors
RISK
FACTORS
Investing
in shares of our common stock is very speculative and involves a high degree of risk. You should carefully consider the risks
and uncertainties described below, the section of this Annual Report entitled “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and our financial statements and related notes included elsewhere in this Annual Report. The
risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or
that we currently believe are not material, may also become important factors that affect us. If any of the following risks occur, our
business, operating results and prospects could be materially harmed. In that event, the price of our common stock could decline, and
you could lose part or all of your investment.
Summary
Risk Factors
Our
business is subject to numerous risks and uncertainties that you should consider before investing in our company. You should carefully
consider all of the risks described more fully in the section titled “Risk Factors” in this Annual Report on page 19,
before deciding to invest in our common stock. If any of these risks actually occurs, our business, financial condition and results of
operations would likely be materially adversely affected.
Important
factors that could cause actual results or events to differ materially, but are not limited to, the following:
Risks
Related to Our Intellectual Property
We
depend on rights to Telomir-1 that are or will be licensed to us.
We
may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.
If
third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual
property, our operating profits could be adversely affected.
We
have been granted a license to the right to develop Telomir-1 in the United States in human and pet application, but we have not been
granted a license to the rights to patents covering Telomir-1 in foreign jurisdictions.
Risks
Related to Our Operations and Financial Condition
We
are an early development-stage company with no revenues and our financial condition raises substantial
doubt as to our ability to continue as a going concern.
Because
we have a limited operating history, you may not be able to accurately evaluate our operations.
We
will need to raise additional financing for the continuation of our operations.
Our
operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues
and succeed overall.
We
have yet to achieve a profit and will not achieve a profit in the near future, if at all.
Certain
of our executive officers are not be employed by us on a full-time basis.
Conflicts
of interest may arise between us and MIRALOGX.
Risks
Relating to Our Business and Our Industry
Our
future success will largely depend on the success of Telomir-1 and any future product candidates, which development will require significant
capital resources and years of clinical development effort.
We
are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
Results
of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.
We
have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement
capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.
We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
our growth and executing our growth strategy.
We