Telomir Pharmaceuticals, Inc 10-K for FY2023

Telomir Pharmaceuticals, Inc. (TELO)

10-K 2024-03-29 For: 2023-12-31

Added on April 11, 2026

About this 10-K

Telomir Pharmaceuticals, Inc filed this 10-K on March 29, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $13.07M; compared with a net loss of $854.15K a year earlier
Diluted EPS: -$0.45; compared with -$0.03 a year earlier

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855 N Wolfe Street, Suite 601, Baltimore, Maryland		21205
(Address of principal executive offices)		(Zip Code)

Title of each class		Trading Symbol(s)		Name of exchange on which registered
Common stock, no par value		TELO		The Nasdaq Capital Market

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

	TABLE OF CONTENTS

Cautionary Note on Forward-Looking Statements		3

PART I		5
Item 1.	Description of Business	5
Item 1A.	Risk Factors	17
Item 1B.	Unresolved Staff Comments	42
Item 1C.	Cybersecurity	42
Item 2.	Description of Property	42
Item 3.	Legal Proceedings	42
Item 4.	Mine Safety Disclosure	42
PART II		43
Item 5.	Market for Common Equity and Related Stockholder Matters	43
Item 6.	Selected Financial Data	43
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	44
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	50
Item 8.	Financial Statements	50
Item 9.	Changes In and Disagreements with Accountants on Accounting and Financial Disclosure	50
Item 9A.	Controls and Procedures	50
Item 9B.	Other Information	51
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	51
PART III		52
Item 10.	Directors, Executive Officers and Corporate Governance	52
Item 11.	Executive Compensation	58
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	65
Item 13.	Certain Relationships and Related Transactions, and Director Independence	66
Item 14.	Principal Accountant Fees and Services	68
PART IV		69
Item 15.	Exhibits, Financial Statement Schedules	69
Signatures		70

	●	our ability to obtain and maintain regulatory approval of our product candidates;

	●	our ability to successfully commercialize and market our product candidates, if approved by the FDA;

	●	our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;

	●	the potential market size, opportunity, and growth potential for our product candidates, if approved by the FDA;

	●	our ability to obtain additional funding for our operations and development activities;

	●	the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

	●	the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;

	●	the timing of anticipated regulatory filings;

	●	our future expenses, capital requirements and need for additional financing;

	●	our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

	●	our ability to advance product candidates into, and successfully complete, clinical trials;

	●	our ability to recruit and enroll suitable patients in our clinical trials;

	●	the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;

	●	the pricing and reimbursement of our product candidates, if approved by the FDA;

	●	the rate and degree of market acceptance of our product candidates, if approved by the FDA;

	●	the implementation of our business model and strategic plans for our business, product candidates, and technology;

	●	the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

	●	developments relating to our competitors and our industry;

	●	the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the future impact of such events on our business operations and funding requirements; and

	●	other risks and factors listed under “Risk Factors” and elsewhere in this Annual Report.

	●	*Advancing TELOMIR-1 through clinical development and approval for osteoarthritis.* Osteoarthritis is the most common cause of disability. There is no treatment for osteoarthritis. Pain is mitigated through medication, therapy, and surgical procedures. We believe TELOMIR-1 may represent an opportunity for a treatment for osteoarthritis.
	●	*Advancing TELOMIR-1 through clinical development and approval for hemochromatosis.* Our product candidate, TELOMIR-1, is in pre-clinical studies. Existing treatment options for hemochromatosis have significant limitations, and, if approved, we believe TELOMIR-1 may represent a major therapeutic advancement for patients.

	●	*Explore the potential of TELOMIR-1 for Post-Chemotherapy Recovery.* We believe TELOMIR-1 may represent a major therapeutic advancement for post-chemotherapy patients. Our product candidate, TELOMIR-1 may have the potential in post-chemotherapy recovery.

	●	*Continuing pre-clinical development of TELOMIR-1 across a range of inflammatory diseases associated with cellular aging*. Given the impact of telomere cap regrowth on a variety of age-related inflammatory diseases, we intend to explore TELOMIR-1’s broader potential, as we believe TELOMIR-1 may have potential in several inflammatory diseases, associated with a range of metabolic and geriatric related conditions.

	●	*Exploring strategic collaborations to maximize the value of TELOMIR-1.* We plan to explore collaborations opportunistically to maximize the value of TELOMIR-1. We intend to retain significant economic and commercial rights to our programs.

Type of Study	Species *(in vitro* studies)**	Purpose	Results
Metabolite Identification	CD-1 mouse, SD-rat, Beagle dog, Cynomolgus monkey and human	To determine the metabolic pathways of TELOMIR-1 across species	TELOMIR-1 showed little/no metabolism by CYP enzymes.
TELOMIR-1 Reaction Phenotyping Using Liver S9	Mouse, rat, monkey and human liver	Identification of the Enzymes Involved in the Metabolism of TELOMIR-1 Using Hepatic S9 Fraction	The compound does not appear to be a substrate of cytochrome P450 enzymes. There was little/no metabolism of TELOMIR-1 in dog S9, consistent with the fact that the dog lacks aldehyde oxidase activity.
Cytochrome P450 (CYP) reaction phenotyping	Human	To evaluate the potential of TELOMIR-1 to be a victim of drug-drug interactions	TELOMIR-1 was extensively metabolized in mouse, rat, monkey, dog, and human hepatocytes.
Cytochrome P450 (CYP) inhibition	Human	To evaluate the potential of TELOMIR-1 to cause drug-drug interactions as a perpetrator	TELOMIR-1 (up to 100 µM) did not inhibit any of the tested CYP enzymes.
Plasma protein binding	CD-1 mouse, SD rat, Beagle dog, Cynomolgus monkey and human	To know the unbound fraction of TELOMIR-1 in plasma	Not highly Protein Bound
Maximum Tolerated Dose and 7 Day Repeat-Dose Toxicity/Toxicokinetic Study in Rats	Sprague Dawley Rats	To evaluate and characterize the toxicokinetic and toxicity of TELOMIR-1 and to estimate the MTD of TELOMIR-1 following	The MTD following 7 days of repeated administration of TELOMIR-1 at dose levels of 50, 200, and 750 mg/kg/day in rats was determined to be ≥ 750 mg/kg/day
Maximum Tolerated Dose and 7 Day Repeat-Dose Toxicity/Toxicokinetic Study in Dogs	Beagle Dogs	To evaluate and characterize the toxicokinetic and toxicity of TELOMIR-1 and to estimate the MTD of TELOMIR-	There were no treatment-related clinical observations, body weights, clinical pathology and anatomic gross pathology findings up to 7.5 mg/kg/day.
SafetyScreen44 ^TM	N/A	To evaluate, in Enzyme, and Radioligand Binding assays, the activity of TELOMIR-1	No significant results noted

	●	completion of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice (“GLP”) regulations;

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

	●	approval by an independent Institutional Review Board (“IRB”), at each clinical site before each trial may be initiated;

	●	performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCP”) requirements to establish the safety and efficacy of the proposed drug product for each indication;

	●	demonstration that the API and finished product are manufactured under cGMP conditions and meet all applicable standards of identity, strength, quality, and purity;

	●	submission to the FDA of an NDA;

	●	satisfactory completion of an FDA advisory committee review, if applicable;

	●	satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the drug’s identity, strength, quality, and purity;

	●	FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to commercial marketing or sale of the drug in the United States; and

	●	compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”) or to conduct a post-approval study.

	●	Phase II clinical trials involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted.

	●	Phase III clinical trials generally involve a larger number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.

	●	our use of the net proceeds from this offering;

	●	our ability to obtain and maintain regulatory approval of our product candidates;

	●	our ability to successfully commercialize and market our product candidates, if approved by the FDA;

	●	our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;

	●	the potential market size, opportunity, and growth potential for our product candidates, if approved by the FDA;

	●	general economic conditions in the geographies and industries where we sell our services and conduct operations; legislative policies where we sell our services and conduct operations;

	●	the budgetary constraints of our customers;

	●	success of our strategic growth initiatives;

	●	costs associated with the launching or integration of new or acquired businesses; timing of new product introductions by us, our suppliers and our competitors; product and service mix, availability, utilization and pricing;

	●	the mix, by state and country, of our revenues, personnel, and assets; movements in interest rates or tax rates;

	●	changes in, and application of, accounting rules; changes in the regulations applicable to us; and litigation matters.

	●	complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our studies;

	●	receive IND acceptance and regulatory approvals from the FDA;

	●	produce, through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently large quantities of product candidates to permit successful commercialization;

	●	obtain reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels of pricing;

	●	secure acceptance of our product candidates from physicians, health care payers, patients, and the medical community;

	●	create positive publicity surrounding our product candidates;

	●	manage our spending as costs and expenses increase due to clinical trials and commercialization; and

	●	obtain and enforce sufficient intellectual property for our product candidates.

	●	continue to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

	●	attract and retain enough talented employees;

	●	manage our clinical trials effectively;

	●	manage our external manufacturing operations with contract research organizations effectively and in a cost-effective manner;

	●	manage our development efforts effectively while carrying out our contractual obligations to contractors and other third parties; and

	●	the timing of FDA approval, if any, and approvals in international markets of our product candidates, if at all;

	●	the timing and amount of revenue from sales of our products, or revenue from grants or other sources;

	●	The rate of progress and cost of our clinical trials and other product development programs;

	●	costs of establishing or outsourcing sales, marketing, and distribution capabilities;

	●	costs and timing of completion of expanded in-house manufacturing facilities as well as any outsourced commercial manufacturing supply arrangements for our product candidates;

	●	costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights associated with our product candidates;

	●	the effect of competing technological and market developments;

	●	personnel, facilities, and equipment requirements; and

	●	the terms and timing of any additional collaborative, licensing, co-promotion, or other arrangements that we may establish.

	●	commercial sales of our products;

	●	our achievement of product development objectives and milestones;

	●	clinical trial enrollment and expenses;

	●	research and development expenses; and

	●	the timing and nature of contract manufacturing and contract research payments.

	●	lack of effectiveness of any product candidate during clinical trials;

	●	discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions, including those which cause confounding changes to the levels of other concomitant medications;

	●	slower than expected rates of subject recruitment and enrollment rates in clinical trials;

	●	difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

	●	delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints;

	●	delays in obtaining regulatory authorization to commence a trial, including “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced;

	●	changes in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature, or timing of studies;

	●	delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

	●	uncertainty regarding proper dosing;

	●	delay or failure to supply product for use in clinical trials which conforms to regulatory specification;

	●	unfavorable results from ongoing pre-clinical studies and clinical trials;

	●	failure of our contract research organizations, or CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner;

	●	failure by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security, and recordkeeping;

	●	scheduling conflicts with participating clinicians and clinical institutions;

	●	failure to design appropriate clinical trial protocols;

	●	insufficient data to support regulatory approval;

	●	inability or unwillingness of medical investigators to follow our clinical protocols; or

	●	difficulty in maintaining contact with patients during or after treatment, which may result in incomplete data.

	●	issue untitled or warning letters;

	●	seek to enjoin our activities;

	●	impose civil or criminal penalties;

	●	suspend regulatory approval;

	●	suspend any of our ongoing clinical trials;

	●	refuse to approve pending applications or supplements to approved applications submitted by us;

	●	impose restrictions on our operations, including by requiring us to enter into a Corporate Integrity Agreement or closing our contract manufacturers’ facilities, if any; or

	●	seize or detain products or require a product recall.

	●	an inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA;

	●	results of clinical trials that may not meet the level of statistical or clinical significance required by the FDA;

	●	disagreements with the FDA with respect to the number, design, size, conduct or implementation of clinical trials;

	●	requirements by the FDA to conduct additional clinical trials;

	●	disapproval by the FDA of certain formulations, labeling or specifications of product candidates;

	●	findings by the FDA that the data from pre-clinical studies and clinical trials are insufficient;

	●	findings by the FDA that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity;

	●	the FDA may disagree with the interpretation of data from pre-clinical studies and clinical trials; and

	●	the FDA may change their approval policies or adopt new regulations.

	●	regulatory authorities may deny regulatory approval of our product candidates;

	●	regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”) in connection with approval or post-approval;

	●	regulatory authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive REMS, or require us to recall any product that is approved;

	●	we may be required to change the way the product is administered or conduct additional clinical trials;

	●	our relationships with our collaboration partners may suffer;

	●	we could be sued and held liable for harm caused to patients; or

	●	our reputation may suffer. The reputational risk is heightened with respect to those of our product candidates that are being developed for pediatric indications.

●	directors will only be able to be removed for cause;

●	our amended and restated articles of incorporation authorizes undesignated preferred stock, the terms of which may be established and shares of which may be issued, without the approval of the holders of our capital stock; and

	●	contracted research and manufacturing;

	●	consulting arrangements; and

	●	other expenses incurred to advance the Company’s research and development activities.

	Year Ended December 31,
	2023			2022
Revenues	$	-		$	-

Operating costs:
General and administrative expenses		600,192			20,941
Related party travel costs		1,767,550			-
Research and development expenses		1,574,306			833,206
Total operating costs		3,942,048			854,147

Interest expense		(1,643,049	)		-
Loss on extinguishment of debt		(7,486,767	)		-
Net loss attributable to common stockholders	$	(13,071,864	)	$	(854,147	)

R&D Category	Expense
Toxicology	$	0.6 million
Pre-clinical research	$	0.5 million
R&D consultants	$	0.4 million

	Year Ended December 31, 2023			Year Ended December 31, 2022
Net cash provided by (used in):
Operating activities	$	(3,859,796	)	$	(468,661	)
Financing activities		3,859,608			470,080
Net change in cash	$	(188	)	$	1,419

	●	the rate of progress in the development of our TELOMIR-1 program and other development programs;

	●	the scope, progress, results and costs of pre-clinical studies and clinical trials for any other current and future programs;

	●	the number and characteristics of programs and technologies that we develop or may in-license;

	●	the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our programs for which we receive marketing approval;

	●	the costs necessary to obtain regulatory approvals, if any, for any approved products in the United States and other jurisdictions, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where approval is obtained;

	●	the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

	●	the continuation of our existing licensing arrangements and entry into new collaborations and licensing arrangements;

	●	the costs we incur in maintaining business operations;

	●	the costs of hiring additional clinical, quality control, manufacturing and other scientific personnel;

	●	the costs adding operational, financial and management information systems and personnel;

	●	the costs associated with being a public company;

	●	the revenue, if any, received from commercial sales of our programs for which we receive marketing approval;

	●	the effect of competing technological and market developments; and

	●	the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for programs.

Name	Age	Position
Christopher Chapman, Jr., MD	71	Chief Executive Officer and Chairman
Nathen Fuentes, CPA	41	Chief Financial Officer, Treasurer, and Secretary
Christos Nicholoudis, Esq.	34	General Counsel and Director
Michael Jerman, CPA	40	Director
Brad Kroenig	44	Director
Craig Eagle, MD	56	Director
Talhia Tuck	45	Director
Hugh McColl III	63	Director
Dr. Michael Roizen	77	Key Advisor on Age Reversal

	●	selecting a qualified firm to serve as the independent registered public accounting firm to audit our financial statements;

	●	helping to ensure the independence and performance of the independent registered public accounting firm;

	●	discussing the scope and results of the audit with the independent registered public accounting firm, and reviewing, with management and the independent registered public accounting firm, our interim and year-end results of operations;

	●	developing procedures for employees to submit concerns anonymously about questionable accounting or audit matters;

	●	reviewing our policies on risk assessment and risk management;

	●	reviewing related party transactions;

	●	reviewing and pre-approving, as required, all audit and all permissible non-audit services to be performed by the independent registered public accounting firm; and

	●	assisting our board of directors in monitoring the performance of our internal audit function.