Telomir Pharmaceuticals Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 13, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-13.
0001493152-24-018909
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001493152-24-031606
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 40 previous paragraphs and 41 current paragraphs.
17 unchanged; 16 reworded; 5 added; 7 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule being developed to lengthen the DNA’s protective telomere caps, potentially promoting longevity in humans and canine animals by treating age-related conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and proteins, naturally shorten as humans age. This shortening is accelerated by metal reactivity, which increases the risk of degenerative and age-related diseases
Current report
For the six months ended June 30***, 2024 compared to the six months ended June 30, 2023***
Current report
Interest income (expense). We earned $0.025 million in interest income during the three months ended June 30, 2024, and incurred $0.1 million in interest expense during the three months ended June 30, 2023. The interest income received in the three months ended June 30, 2024 is primarily related to income earned from money market accounts.
Current report
Net Cash Flows from Operating Activities
Current report
Net Cash Flows from Financing Activities
Removed paragraphs (7)
Previous report
We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule being developed to function as an oral in situ therapeutic treatment for human stem cells. Our initial focus will be on treatments to inhibit the production of pro-inflammatory cytokines, such as IL-17, by oral administration of TELOMIR-1 as a therapeutic treatment for stem cells in situ. In situ stem cell therapy uses the body’s natural resources to regenerate damaged tissue and replace cells with new, functional cells.
Previous report
Reverse Stock Split
Previous report
Effective December 11, 2023, we completed a reverse stock split of our outstanding common stock upon the filing of our Second Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were or will be issued in connection with the reverse stock split, and all such fractional shares resulting from the reverse stock split were and will be rounded up to the nearest whole number. The shares issuable upon the exercise of our outstanding warrants, and the exercise prices of such warrants, have been adjusted to reflect the reverse stock split. Unless otherwise noted, the share and per share information in this report reflects the reverse stock split.
Previous report
Since inception, we have not earned any revenue, nor do we anticipate doing so until we successfully conclude preclinical and clinical development and obtain regulatory approval. The timing and certainty of this event remain unknown.
Previous report
We did not have any material non-cancellable contractual obligations as of March 31, 2024.
Previous report
Net Cash from Operating Activities
Previous report
Net Cash from Financing Activities
Reworded paragraphs (16)
Previous wording
Our goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions such as osteoarthritis and hemochromatosis, as well as in post-chemotherapy recovery, with our initial targeted indications being osteoarthritis, hemochromatosis, and post-chemotherapy recovery.
Current wording
Our goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions and commercialize Telomir-1, proposed to be dosed orally, with the broader aim of promoting longevity and enhancing overall quality of life.
Previous wording
We had net losses of $6.3 million and $0.5 million for the three months ended March 31, 2024 and 2023, respectively.
Current wording
We had net losses of $7.6 million and $2.0 million for the six months ended June 30, 2024 and 2023, respectively.
Previous wording
Interest expense. We incurred $4.3 million in interest expense during the three months ended March 31, 2024. There was no such expense incurred during the same period ended March 31, 2023. The 2024 interest expense consists of the amortization of the deferred financing costs on warrants issued on the related party line of credit as disclosed in Note 5 to the financial statements.
Current wording
Interest expense. We incurred $4.3 million and $0.1 million in interest expenses during the six months ended June 30, 2024 and June 30, 2023, respectively. The 2024 interest expense consists of the amortization of the deferred financing costs on warrants issued in connection with the related party line of credit as disclosed in Note 5 to the condensed financial statements.
Previous wording
For the three months endedMarch 31, 2024 compared to the three months ended March 31, 2023
Current wording
For the three months ended June 30***, 2024 compared to the three months ended June 30, 2023***
Previous wording
Research and Development Expenses. During the three months ended March 31, 2024, we incurred $0.8 million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research projects. We incurred $0.4 million in research and development expenses during the three months ended March 31, 2023, relating to initial payments for toxicology studies and consulting arrangements. Research and development expenses represent costs incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities
Current wording
Research and Development Expenses. During the three months ended June 30, 2024, we incurred $0.6 million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research projects. We incurred $0.7 million in research and development expenses during the three months ended June 30, 2023, relating to initial payments for toxicology studies and consulting arrangements. Going forward, we expect our research and development expenses to generally remain at consistent levels as incurred in 2024. Research and development expenses represent costs incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities.
Previous wording
General and Administrative Expenses. We incurred $0.7 million and $0.04 million in general and administrative expenses during the three months ended March 31, 2024 and March 31, 2023, respectively. The increase is primarily due to an increase in insurance costs of $0.06 million, professional fees of $0.14 million and compensation costs of $0.47 million. General and administrative expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.
Current wording
General and Administrative Expenses. We incurred $0.9 million and $0.06 million in general and administrative expenses during the three months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due to payroll costs for management and consultants that began upon the IPO and were not incurred during the three months ended June 30, 2023. Going forward, we expect our general and administrative expenses to generally remain at consistent levels as incurred in 2024. General and administrative expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.
Previous wording
Related Party Travel Costs. We incurred $0.4 million in related party travel costs during the three months ended March 31, 2024. There was no such expense incurred during the same period ended March 31, 2023. Related party travel costs consisted of a lease and use of an airplane with an entity under common control. The Company will not participate in the use of the airplane after March of 2024 and, pursuant to the terms of the agreement, constitutes no further obligation under the agreement.
Current wording
Related Party Travel Costs. We incurred $0.7 million in related party travel costs during the three months ended June 30, 2023. There was no such expense incurred during the same period ended June 30, 2024. Related party travel costs consisted of a lease and use of an airplane with an entity under common control. The Company will not participate in the use of the airplane after March of 2024 and, pursuant to the terms of the Shared Agreement, will not have any further obligation under the agreement.
Previous wording
Since the Company’s inception in August 2021, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company and through a $1.0 million private placement of shares of our common stock that occurred during the first quarter 2023 at $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023). We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, including the proceeds from our initial public offering that occurred in February of 2024.
Current wording
Since the Company’s inception in August 2021, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company and through a $1.0 million private placement of shares of our common stock that occurred during the first quarter 2023 at $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023). We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, including the proceeds from our initial public offering that occurred in February of 2024. Further, the Company plans to conduct a raise of capital in the near future to assist in financing working capital needs.
Previous wording
On June 15, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, Jonnie R. Williams, Sr., and under which various of his family members are beneficiaries. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public offering (“IPO”). Future advances are no longer available due to the terms of the agreement, specifically the closing of the Company’s IPO, which was made effective on February 13, 2024. Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will accrue interest at a rate equal to 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. As of November 30, 2023, the total amount outstanding under the Bay Shore Note was $1.4 million. The total amount outstanding was converted into 674,637 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) pursuant to a conversion agreement. As of February 9, 2024, the agreement has been terminated.
Current wording
On June 15, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, which was established by a significant shareholder of the Company. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), we had the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public offering (“IPO”). Future advances are no longer available due to the terms of the agreement, specifically the closing of the Company’s IPO, which was made effective on February 13, 2024. Our right to borrow funds under the Bay Shore Note was subject to the absence of a material adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest, was to become due and payable on the second anniversary of the issuance of the note, provided that prepayment at any time without penalty. The Bay Shore Note accrued interest at a rate equal to 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note was unsecured. As of February 9, 2024, the agreement has been terminated.
Previous wording
Since January 1, 2023, MIRALOGX, an intellectual property development and holding company owned by Bay Shore Trust, and The Starwood Trust, a separate trust established by our founder, have advanced funds on behalf of Bay Shore Trust to our company in order to fund operating activities. The total amount advanced and outstanding as of November 30, 2023, was $1.7 million. These advances were converted into 837,841 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) pursuant to a conversion agreement. As of the three months ended March 31, 2024, the total amount outstanding was $0.008 million.
Current wording
Since January 1, 2023, MIRALOGX, an intellectual property development and holding company owned by Bay Shore Trust, established by a significant shareholder of the Company, have advanced funds on behalf of Bay Shore Trust to our company in order to fund operating activities. The total amount advanced and outstanding as of November 30, 2023, was $1.7 million. These advances were converted into 837,841 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share pursuant to a conversion agreement. As of the six months ended June 30, 2024, the total amount outstanding was $0.04 million.
Previous wording
We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit, which we do not expect to occur in the near future. We had negative cash flow from operations of approximately $1.9 million for the three months ended March 31, 2024. As of March 31, 2024, we had cash and cash equivalents of approximately $3.3 million and an accumulated deficit of approximately $20.3 million.
Current wording
We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit, which we do not expect to occur in the near future. We had negative cash flow from operations of approximately $3.5 million for the six months ended June 30, 2024. As of June 30, 2024, we had cash and cash equivalents of approximately $1.9 million and an accumulated deficit of approximately $21.7 million.
Previous wording
We currently expect that our cash and cash equivalents, when taking into account the net proceeds of $5.8 million from our initial public offering which closed on February 13, 2024, will be sufficient to fund our operations, development plans, and capital expenditures through the beginning of the fourth quarter of 2024. As such, there is substantial doubt about the Company’s ability to continue as a going concern.
Current wording
We currently expect that our cash and cash equivalents, when taking into account the net proceeds of $5.8 million from our initial public offering, will not be sufficient to fund our operations, development plans, and capital expenditures through Q1 2025 without additional financing. As such, there is substantial doubt about the Company’s ability to continue as a going concern.
Previous wording
For the three months ended March 31, 2024, operating activities used $1.9 million of cash, primarily due to a net loss of $6.3 million, debt issuance costs of $4.3 million and a $0.002 million change in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs, legal and accounting expenses.
Current wording
For the six months ended June 30, 2024, operating activities used $3.4 million of cash, primarily due to a net loss of $7.6 million, offset by amortization of debt issuance costs of $4.3 million and a $0.16 million change in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs, legal and accounting expenses.
Previous wording
For the three months ended March 31, 2023, operating activities used $0.7 million of cash, primarily due to a net loss of $0.5 million, a $0.3 million change in accounts payable and accrued expenses. Accounts payable and accrued expenses was primarily composed of research and development expenses and consultant costs.
Current wording
For the six months ended June 30, 2023, operating activities used $0.9 million of cash, primarily due to a net loss of $2.0 million, offset by a $1 million increase in accounts payable and accrued expenses. Accounts payable and accrued expenses was primarily composed of research and development expenses and consultant costs.
Previous wording
For the three months ended March 31, 2024, financing activities provided $5.2 million of cash, resulting primarily from $5.8 million in proceeds from sale of common stock, less offering costs, offset by $0.5 million payments to related parties, and $0.1 million of repayments under related party line of credit.
Current wording
For the six months ended June 30, 2024, financing activities provided $5.3 million of cash, resulting primarily from $5.8 million in proceeds from sale of common stock, less offering costs, offset by $0.4 million payments to related parties, and $0.1 million of repayments under related party line of credit.
Previous wording
For the three months ended March 31, 2023, financing activities provided $0.7 million of cash, resulting primarily from $1 million in proceeds from sale of common stock, offset by $0.3 million of payments to related parties.
Current wording
For the six months ended June 30, 2023, financing activities provided $0.9 million of cash, resulting primarily from $1 million in proceeds from sale of common stock, offset by $0.1 million net in related party borrowing and payments
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Research and Development Expenses. During the six months ended June 30, 2024, we incurred $1.4 million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research projects. We incurred $1.1 million in research and development expenses during the six months ended June 30, 2023, relating to initial payments for toxicology studies and consulting arrangements. Going forward, we expect our research and development expenses to generally remain consistent as incurred in 2024. Research and development expenses represent costs incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities.
Current report — wording carried from elsewhere
General and Administrative Expenses. We incurred $1.6 million and $0.1 million in general and administrative expenses during the six months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due to payroll costs for management and consultants that began after the IPO and were not incurred during the six months ended June 30, 2023. Going forward, we expect our general and administrative expenses to generally remain consistent with amounts incurred in 2024. General and administrative expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.
Current report — wording carried from elsewhere
Related Party Travel Costs. We incurred $0.4 and $0.7 million in related party travel costs during the six months ended June 30, 2024 and June 30, 2023, respectively. Related party travel costs consisted of a lease and use of an airplane with an entity under common control. The Company will not participate in the use of the airplane after March of 2024 and, pursuant to the terms of the Shared Agreement, will not have any further obligation under the agreement.