Core Insights - Telomir Pharmaceuticals, Inc. has been added to the Russell 3000® and Russell Microcap® Indexes, effective July 1, 2024, indicating significant progress as a publicly-traded company since its IPO in February 2024 [1][6][11] Company Overview - Telomir Pharmaceuticals is a pre-clinical-stage pharmaceutical company focused on developing and commercializing Telomir-1, a novel small molecule aimed at lengthening DNA's protective telomere caps to potentially treat age-related conditions [1][13] - The company aims to address a range of age-related inflammatory conditions, including osteoarthritis, through the oral administration of Telomir-1 [13] Industry Context - The Russell indexes are widely utilized by investment managers and institutional investors, with approximately $10.5 trillion in assets benchmarked against these indexes as of December 2023 [2][11] - Membership in the Russell 3000® and Russell Microcap® Indexes provides automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index, enhancing visibility and credibility in the market [11]

Company Overview - Telomir Pharmaceuticals, Inc. is a pre-clinical-stage pharmaceutical company focused on developing and commercializing Telomir-1, a novel small molecule aimed at lengthening DNA's protective telomere caps to potentially reverse age-related conditions [12]. Recent Developments - Telomir has been added to the Russell 3000® and Russell Microcap® Indexes, effective July 1, 2024, as part of the 2024 Russell indexes reconstitution, indicating progress as a publicly-traded company since its IPO in February [9][8]. - The company aims to achieve corporate and clinical objectives in the second half of 2024 and beyond, particularly for its lead product candidate, Telomir-1 [8]. Market Context - The Russell indexes are widely utilized by investment managers and institutional investors for index funds and as benchmarks for active investment strategies, with approximately $10.5 trillion in assets benchmarked against these indexes as of December 2023 [10].

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]

As filed with the Securities and Exchange Commission on January 3, 2024 Registration No. 333-275534 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 Amendment No. 3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TELOMIR PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Florida 2834 87-2606031 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificatio ...

As filed with the Securities and Exchange Commission on December 19, 2023 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Florida 2834 87-2606031 (I.R.S. Employer Identification No.) Registration No. 333-275534 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 Amendment No. 2 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TELOMIR PHARMACEUTICA ...

As filed with the Securities and Exchange Commission on December 14, 2023 Registration No. 333-275534 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 Amendment No. 1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TELOMIR PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Florida 2834 87-2606031 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificat ...

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 As filed with the Securities and Exchange Commission on November 14, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 TELOMIR PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Florida 2834 87-2606031 (I.R.S. Employer Identification No.) 855 N Wolfe S ...