Business Overview and History

Telomir Pharmaceuticals, a pre-clinical stage biopharmaceutical company, is poised to revolutionize the treatment of age-related conditions through its innovative lead candidate, Telomir-1. Established in 2021, the company has rapidly advanced its research and development efforts, positioning itself at the forefront of the rapidly evolving longevity science landscape.

Telomir Pharmaceuticals was founded in August 2021 with the ambitious goal of developing novel therapies to promote longevity and enhance overall quality of life. The company's core focus is centered around Telomir-1, a first-of-its-kind small molecule designed to lengthen the DNA's protective telomere caps, which play a crucial role in the aging process.

Telomir began substantive operations in late 2022 and filed its initial patent on the TELOMIR-1 compound. The company has been primarily engaged in developing TELOMIR-1 through pre-clinical research and studies. During this time, Telomir has sustained significant losses as it has invested in the development of its lead product candidate.

To fund its operations, Telomir has relied on financing from related parties, including an unsecured line of credit from Bay Shore Trust, which was established by a significant shareholder. In 2023, Telomir also completed a $1 million private placement of its common stock. These funding sources have been critical in allowing Telomir to advance its pre-clinical work on TELOMIR-1.

The company's journey began with an exclusive licensing agreement established in August 2023 with MIRALOGX, LLC, a significant shareholder-owned intellectual property development and holding company. This agreement granted Telomir the exclusive perpetual rights to develop, manufacture, and commercialize Telomir-1 for human and veterinary applications in the United States.

Telomir's Investigational New Drug (IND) application is anticipated to be filed with the U.S. Food and Drug Administration (FDA) in the first half of 2025. National phase filings are expected to be made during the first quarter of 2025.

Financials and Liquidity

Telomir Pharmaceuticals has primarily financed its operations through related party financings and an initial public offering (IPO) completed in February 2024. The IPO raised approximately $5.8 million in net proceeds, which the company intends to use primarily to fund its clinical development programs, including preclinical toxicology studies, chemistry, manufacturing, and controls (CMC) activities, and the initial IND application.

As of June 30, 2024, the company had cash and cash equivalents of approximately $1.9 million. During the six months ended June 30, 2024, the company reported a net loss of $7.7 million and used $3.5 million in net cash from operating activities. The company's accumulated deficit as of June 30, 2024, stood at $21.8 million.

Telomir's financial statements raise substantial doubt about the company's ability to continue as a going concern, as its current cash and cash equivalents may not be sufficient to fund its operations, development plans, and capital expenditures through the first quarter of 2025 without additional financing. The company plans to conduct a capital raise in the near future to address its working capital needs.

For the fiscal year ended December 31, 2023, Telomir reported no revenue, a net loss of $13,071,864, operating cash flow (OCF) of -$3,859,796, and free cash flow (FCF) of -$3,859,796. In the most recent quarter ended June 30, 2024, the company again reported no revenue, with a net loss of $1,449,003, OCF of -$1,522,843, and FCF of -$1,522,843. The decreases in net income, OCF, and FCF were primarily due to increased research and development expenses as the company advanced its pre-clinical activities and increased general and administrative costs related to becoming a public company.

As of June 30, 2024, Telomir's debt-to-equity ratio was 0, as the company had no outstanding debt. The current ratio and quick ratio both stood at 3.93, indicating a strong short-term liquidity position. The company previously had a $5 million line of credit with Bay Shore Trust, which was paid off in full during Q1 2024, with no further borrowings available under this facility.

Operational Highlights and Challenges

In June 2023, Telomir entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a significant shareholder, which provided the company with the right to borrow up to $5 million. However, future advances under this agreement are no longer available due to the terms of the agreement, specifically the closing of the company's IPO in February 2024.

The company has incurred significant losses and negative cash flows from operations since its inception, primarily due to the costs associated with its initial investment in pre-clinical research and development activities. Research and development expenses have been the largest component of the company's operating expenses, totaling $1.4 million and $1.1 million for the six months ended June 30, 2024, and 2023, respectively.

Telomir's general and administrative expenses have also increased significantly, from $0.1 million in the six months ended June 30, 2023, to $1.6 million in the six months ended June 30, 2024, primarily due to the addition of management and consulting personnel after the IPO.

The company has also incurred significant related party travel costs, which totaled $0.4 million and $0.7 million for the six months ended June 30, 2024, and 2023, respectively. These costs were associated with the lease and use of an airplane with an entity under common control. Telomir will not participate in the use of the airplane after March 2024 and, pursuant to the terms of the shared agreement, will not have any further obligation under the agreement.

Leadership Changes and Outlook

On August 8, 2024, the company announced the passing of its Chairman and Chief Executive Officer, Dr. Christopher Chapman. In the wake of this unfortunate event, the remaining members of the Board of Directors appointed Erez Aminov as the new Chief Executive Officer and Chairman of the Board.

Aminov, who previously served as the Chief Executive Officer and Chairman of MIRA Pharmaceuticals, Inc., brings extensive experience in the biotech consulting sector and a track record of guiding early-stage companies towards growth and prosperity. The company also appointed Dr. Matthew P. Del Giudice, Matthew Pratt Whalen, and Ned MacPherson to the Board of Directors to fill the vacancies created by the resignations and Dr. Chapman's passing.

Looking ahead, Telomir Pharmaceuticals remains focused on advancing the clinical development of Telomir-1 and navigating the regulatory landscape to bring this novel therapy to market. The company's success will hinge on its ability to secure additional financing, successfully execute its clinical trials, and overcome the challenges inherent in the development of new pharmaceutical products.

Risks and Uncertainties

Telomir Pharmaceuticals faces several risks and uncertainties that could impact its future performance. The company's ability to continue as a going concern is dependent on its ability to obtain significant additional external funding in the near term. There can be no assurance that the company will be able to secure such funding on commercially reasonable terms, if at all.

The success of Telomir-1 is also subject to significant regulatory and clinical development risks. The company may never succeed in timely development and achieving regulatory approval for its product candidate, and the probability of success may be affected by numerous factors, including clinical data, competition, manufacturing capability, and commercial viability.

Additionally, the company's reliance on related party financing and the loss of key personnel, such as the recent passing of Dr. Chapman, pose potential risks to the company's operations and future growth.

Conclusion

Telomir Pharmaceuticals is at a pivotal juncture in its journey as a pioneer in the longevity science field. With the development of Telomir-1, the company is poised to potentially revolutionize the treatment of age-related conditions, offering the promise of improved quality of life and longevity. However, the company's path forward is not without challenges, as it must navigate the complex regulatory landscape, secure additional financing, and overcome the inherent risks associated with drug development.

As Telomir Pharmaceuticals continues to advance its research and clinical trials, the market will closely monitor the company's progress and its ability to translate its innovative science into tangible outcomes. The appointment of Erez Aminov as the new CEO and the addition of seasoned industry veterans to the Board of Directors suggest that the company is well-positioned to navigate these challenges and capitalize on the significant opportunities that lie ahead.

The company's financial position remains precarious, with no revenue generated to date and significant ongoing losses. However, the successful completion of its IPO in February 2024 has provided some financial runway. Telomir's research and development expenses are expected to remain consistent with 2024 levels as it continues to advance TELOMIR-1 through the development process. Similarly, general and administrative expenses are anticipated to remain in line with 2024 figures.

As Telomir Pharmaceuticals progresses towards its goal of filing an IND application in the first half of 2025, investors and industry observers will be keenly watching for signs of scientific progress, successful capital raises, and the company's ability to navigate the complex landscape of biotech development. The potential of TELOMIR-1 to address age-related conditions in both humans and canines represents a significant market opportunity, but realizing this potential will require careful management, successful clinical trials, and continued financial support.