Financial Performance - For the three months ended March 31, 2024, the company incurred a net loss of $6.3 million, compared to a net loss of $0.5 million for the same period in 2023, representing a significant increase in losses [73]. - The company incurred negative cash flow from operations of approximately $1.9 million for the three months ended March 31, 2024, compared to $0.7 million for the same period in 2023 [87]. Expenses - Research and development expenses for the three months ended March 31, 2024, were $0.8 million, up from $0.4 million in the same period in 2023, indicating a 100% increase as the company advances its product candidate TELOMIR-1 [79]. - General and administrative expenses rose to $0.7 million for the three months ended March 31, 2024, from $0.04 million in the same period in 2023, reflecting a substantial increase of 1,650% [81]. - The company reported $4.3 million in interest expense for the three months ended March 31, 2024, with no such expense recorded in the same period in 2023 [83]. Cash and Financing - As of March 31, 2024, the company had cash and cash equivalents of approximately $3.3 million and an accumulated deficit of approximately $20.3 million [87]. - The company expects that its cash and cash equivalents, along with net proceeds of $5.8 million from its initial public offering, will be sufficient to fund operations through the beginning of the fourth quarter of 2024 [88]. - The company has financed operations primarily through an unsecured line of credit and a $1.0 million private placement of shares at $3.73 per share [84]. - The total amount outstanding under the Bay Shore Note was $1.4 million as of November 30, 2023, which was converted into 674,637 shares of common stock at a conversion rate of $2.05 per share [85]. - Financing activities provided $5.2 million of cash for the three months ended March 31, 2024, primarily from proceeds of $5.8 million from the sale of common stock [95].

Product Development and Clinical Trials - TELOMIR-1 is under pre-clinical investigation as a potential oral therapeutic treatment for age-related inflammatory conditions, with a focus on osteoarthritis as the lead indication[19] - The company plans to submit an Investigational New Drug Application (IND) for TELOMIR-1 to the FDA in Q1 2025, aiming to initiate a Phase I trial with 40-60 healthy subjects[37] - Pre-clinical studies indicate that TELOMIR-1 may act as a metal enzyme inhibitor, potentially reducing overload of essential metals like iron, zinc, and copper associated with age-related conditions[18] - The maximum tolerated dose (MTD) of TELOMIR-1 in rats was determined to be ≥ 750 mg/kg/day, with no significant toxicity observed in Beagle dogs at doses up to 7.5 mg/kg/day[34] - The company has completed several IND-enabling studies demonstrating that TELOMIR-1 is non-toxic and has good biological and metal binding capabilities[33] - TELOMIR-1 has shown potential to elongate telomeres, which may delay or reverse age-related conditions, as indicated by studies using 50mM of TELOMIR-1[27] - The company is exploring TELOMIR-1's potential for post-chemotherapy recovery, aiming to mitigate side effects of chemotherapy treatments[32] - The second IND application will focus on TELOMIR-1 for treating hemochromatosis, with potential future applications for post-chemotherapy recovery[38] - Clinical trials for product candidates are expensive, time-consuming, and uncertain, with potential delays or terminations due to various factors[131] - Regulatory agencies may impose significant restrictions on a product's indicated uses or marketing, even after FDA approval[135] - Serious adverse events or safety risks could lead to the abandonment of product development or market withdrawal[148] - The regulatory approval process is lengthy and unpredictable, with potential delays in obtaining necessary approvals[139] Market Potential and Competition - Approximately 32.5 million adults in the U.S. have osteoarthritis, projected to rise to 78.4 million by 2040, with the osteoarthritis treatment market valued at approximately $19.5 to $26 billion annually[42] - There are about 13 million U.S. patients carrying mutations for hemochromatosis, with approximately 750,000 expressing iron overload symptoms[44] - Annually, 650,000 patients receive chemotherapy in the U.S., with 45% experiencing severe side effects, translating to around 158,000 patients diagnosed with adverse effects[45] - TELOMIR-1 aims to compete in the osteoarthritis market, where current treatments include NSAIDs and corticosteroids, with no known cure available[46] - The standard treatment for hemochromatosis is phlebotomy, costing between $80 and $300 per visit, while iron chelators like Exjade and Jadenu are significantly more expensive[48] - Current post-chemotherapy recovery treatments can cost between $4,000 and $6,400 per dose, limiting access to high-risk patients[50] - The commercial success of the company's product candidates will depend on various factors, including physician prescription rates and payer reimbursement willingness[111] - The company expects to face intense competition from larger pharmaceutical companies and specialized biotechnology firms, which may impact its ability to develop and commercialize its drug candidates[115] Financial Overview and Funding - The company has an accumulated deficit of $14.1 million as of December 31, 2023, compared to $1.0 million as of December 31, 2022[89] - The company has generated no revenue to date and operates at a loss, indicating a significant reliance on external financing for continued operations[93] - The company expects to require additional funding to support business operations and initial clinical development programs by the fourth quarter of 2024[94] - The company is obligated to pay an 8% royalty on net sales or revenue from the commercialization of TELOMIR-1[86] - The company reported net losses of $13.1 million for the year ended December 31, 2023, compared to a loss of $0.85 million in 2022[210] - Research and development expenses increased to $1.57 million in 2023 from $0.83 million in 2022, reflecting the company's focus on advancing its product candidate TELOMIR-1[215] - Total operating costs for 2023 were $3.94 million, significantly higher than $0.85 million in 2022[215] - The company plans to rely on equity offerings to finance its current and future projects, which may dilute existing shareholders' interests[192] Intellectual Property and Legal Risks - The company has licensed U.S. patent rights for TELOMIR-1 from MIRALOGX, with protection extending through at least August 29, 2043[51] - The company does not own the intellectual property rights to TELOMIR-1, which is in-licensed from another company, and any loss of rights could prevent product sales[79] - The company anticipates significant financial and managerial resources will be expended in the defense of its intellectual property rights in the future[72] - There is a risk of litigation related to intellectual property rights, which could adversely affect operating profits and divert management's attention[87] - The company has not been granted rights to TELOMIR-1 patents in foreign jurisdictions, limiting its market potential outside the U.S.[88] Operational Challenges - The company is in discussions with Anthem Biosciences and Frontage Laboratories for the manufacturing and formulation of TELOMIR-1 for clinical trials[40] - The company does not own manufacturing facilities and relies on third-party manufacturers, which may lead to supply issues and impact development timelines[155] - The company lacks long-term supply agreements with manufacturers, increasing the risk of not obtaining sufficient quantities of TELOMIR-1[159] - The company is dependent on a limited number of suppliers for critical materials, which could cause delays and negatively impact operations[164] - Reliance on third parties for conducting clinical trials poses risks if they fail to meet contractual or regulatory obligations[150] Management and Corporate Structure - The company was organized in August 2021 and changed its name to "Telomir Pharmaceuticals, Inc." in October 2022[73] - As of March 15, 2024, the company had 1 full-time employee and 8 part-time employees, with 1 part-time employee engaged in research and development[70] - The company expects to continue building its team to effectively execute its development plans[70] - The company relies heavily on key personnel and may face challenges in attracting and retaining qualified employees, which could adversely affect its business[122] - Founding stockholders control over 30% of the company's common stock, potentially influencing significant corporate decisions[166] Regulatory Environment - The FDA imposes substantial requirements on clinical development, which can significantly impact timelines and costs[53] - The FDA review process for a New Drug Application (NDA) typically takes twelve months from submission, with a goal to review and act within ten months for standard NDAs[63] - Compliance with extensive regulations is necessary, including FDA's Good Laboratory Practice and Good Manufacturing Practices, to avoid sanctions[135] - The company may face penalties or suspension from federal health care programs if found in violation of fraud and abuse laws[144] Cybersecurity and Risk Management - The company recognizes the importance of managing cybersecurity risks and has implemented a multi-faceted approach to address these threats[198] - Business interruptions could disrupt product development and sales, as the company currently lacks insurance coverage for such events[117] - The company may face legal claims and regulatory penalties due to potential data security breaches, which could adversely affect its operations and reputation[130] Emerging Growth Company Status - The company is classified as an "emerging growth company," which allows it to take advantage of reduced reporting requirements, potentially making its shares less attractive to investors[175] - The company may remain an emerging growth company until the fifth anniversary of its initial public offering, which took place on February 9, 2024, unless it exceeds $1.235 billion in annual revenue or $700 million in market value[177] - The company is also classified as a "smaller reporting company," which allows it to provide only two years of audited financial statements, remaining so until its market value exceeds $250 million or annual revenues exceed $100 million[179] Shareholder Considerations - If the company fails to maintain compliance with Nasdaq Listing Rules, its shares may be delisted, resulting in a limited trading market and difficulties in obtaining future financing[180] - Delisting from Nasdaq could subject the company's securities to SEC's "penny stock" rules, making transactions more difficult for shareholders[181] - The company has anti-takeover provisions in its bylaws that may discourage acquisitions, even if beneficial to shareholders[182] - The control share acquisition statute in Florida requires majority approval for voting rights restoration if a person acquires more than 20% of the company's voting shares[183] - The affiliated transaction statute in Florida restricts certain transactions with "interested shareholders" for three years unless specific conditions are met[184] - The company's bylaws designate Florida state courts as the exclusive forum for most disputes, potentially limiting shareholders' ability to obtain a favorable judicial forum[189] - The choice of forum provisions in the company's bylaws may be challenged in legal proceedings, potentially incurring additional costs for the company[190]