MIRA PHARMACEUTICALS, INC.
For the period ended Dec 31, 2024. Filed Mar 28, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 28, 2025
MIRA$0.57+5.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-04-01.
0001493152-24-012141
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-28.
0001641172-25-001183
Item 7. 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 70 previous paragraphs and 61 current paragraphs.
41 unchanged; 17 reworded; 3 added; 12 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 5 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 (3)
Current report
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical development company advancing two neuroscience programs targeting neurologic and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55, two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function.
Current report
General and Administrative Expenses. We incurred $4.7 million and $6.5 million in general and administrative expenses during the year ended December 31, 2024 and December 31, 2023, respectively. General and administrative expenses in 2024 consisted of stock compensation expense of $1.9 million, payroll expense of $0.9 million, accounting and legal expenses of $0.4 million, marketing, investor relations, advertising, and general corporate expenses of $1.0 million and insurance expenses of $0.5 million. The decrease in general and administrative expenses during 2024 relate primarily to a decrease in personnel in 2024 compared to 2023 and a concerted effort to conserve cash until the shelf registration statement and at-the-market offering was put into place in August 2024.
Current report
On August 12, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to completion of any such offering
Removed paragraphs (12)
Previous report
We are a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We have an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI) and potentially post-traumatic stress disorder (PTSD).
Previous report
Additionally, our novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.
Previous report
Recent Developments
Previous report
In early February 2024, we made a significant discovery during the manufacturing and scale-up process of our patented molecule known as “MIRA1a,” which we had been utilizing with a contract manufacturer. Through this process, we identified a novel and improved version of the molecule, MIRA-55. MIRA-55 exhibits enhanced potency and holds promise for improved efficacy compared to MIRA1a.
Previous report
As part of our due diligence and subsequent testing, we discovered that the pre-clinical studies we conducted, previously attributed to MIRA1a, were in fact performed on MIRA-55. Following this revelation, we promptly filed a provisional patent for MIRA-55, which encompasses all pre-clinical studies disclosed in our two registration statements on Form S-1, declared effective on August 2, 2023 and December 27, 2023 (File Nos. 333-273024 and 333-276118, respectively).
Previous report
Moreover, based on our pre-clinical analyses to date, we believe that MIRA-55 is an improvement over MIRA1a in that it displays enhanced potency and potential for efficacy. In early March 2024, we filed a provisional patent application for MIRA-55, aiming for global patent protection. If such patent is issued, we would own the patent rights to both MIRA1a and MIRA-55.
Previous report
Based on our discoveries to date, we have decided to advance MIRA-55 as our lead compound for our oral pharmaceutical marijuana drug candidate while still retaining our rights to MIRA1a.
Previous report
General and Administrative Expenses. We incurred $6.5 million and $2.9 million in general and administrative expenses during the year ended December 31, 2023 and December 31, 2022, respectively. General and administrative expenses are composed primarily of compensation, insurance, professional fees, stock-based compensation, administration and other related costs. The increase is primarily due to an increase in stock-based compensation, debt issuance costs, and compensation related to the IPO efforts of the executive team.
Previous report
Income taxes
Previous report
We are a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets are recognized for temporary differences that will result in deductible amounts in future years and for loss carryovers. A valuation allowance is recognized regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred tax asset will not be realized.
Previous report
Use of estimates
Previous report
The preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires our company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from such estimates and such differences could be material.
Reworded paragraphs (17)
Previous wording
The U.S. Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations. Additionally, we have filed the required paperwork for MIRA-55 to be evaluated by the U.S. DEA.
Current wording
The U.S. Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 and MIRA-55 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.
Previous wording
We had net losses of $12 million and $7.1 million for the year ended December 31, 2023 and December 31, 2022, respectively.
Current wording
We had net losses of $7.9 million and $12.0 million for the year ended December 31, 2024 and December 31, 2023, respectively.
Previous wording
General and administrative expenses consist of employee-related expenses, including salaries, benefits, and travel, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expense. Legal costs include general corporate legal fees and patent 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 consist of employee-related expenses, including salaries, benefits, and travel, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expense. Legal costs include general corporate legal fees. 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 and $1.7 million in related party travel costs during the year ended December 31, 2023 and December 31, 2022 respectively. Related party travel costs consisted of a lease and use of an airplane with an entity under common control. The decrease in related party travel costs in 2023 is due to the termination of the lease in March 2023.
Current wording
Related Party Travel Costs. We incurred $0.5 million in related party travel costs during the year ended December 31, 2023. There were no related party travel costs incurred during the year ended December 31, 2024. Related party travel costs consisted of a lease and use of an airplane with an entity under common control. The airplane lease was terminated in March 2023, and hence, we ceased use of the airplane and there were no further costs incurred.
Previous wording
Interest expense. We incurred $3.5 million, net in interest expense and interest income during the year ended December 31, 2023, and $0.01 million interest expense during the year ended December 31, 2022, respectively. Interest expense during 2023 included $2.8 million of write-off of unamortized deferred financing costs, $0.44 million of debt issuance costs and $0.02 million of interest income. The remaining 2023 and 2022 interest expense consists of accrued interest on a related party line of credit.
Current wording
Interest income (expense). We earned $0.2 million, in interest income (expense) net, during the year ended December 31, 2024, which consisted of income earned from funds in a money market account. We incurred $3.5 million, in interest income (expense) net, during the year ended December 31, 2023, which consisted of $2.8 million of write-off of unamortized deferred financing costs, $0.7 million of debt issuance costs, offset by $0.02 million of interest income.
Previous wording
Research and Development Expenses. During the year ended December 31, 2023, we incurred $1.6 million in research and development expenses, which were primarily related to initial payments for toxicology studies, consultants and stock compensation. We incurred $2.4 million in research and development expenses during the three months ended December 31, 2022, relating to initial payment for toxicology study costs. Research and development expenses include pre-clinical, toxicology and consultant expenses. Major components of research and development expenses during the year ended December 31, 2023 are as follows:
Current wording
Research and Development Expenses. During the year ended December 31, 2024, we incurred $3.3 million in research and development expenses, which were primarily related to pre-IND submission work, consultants and stock compensation. During the year ended December 31, 2023, we incurred $1.6 million in research and development expenses, which were primarily related to initial payments for toxicology studies, consultants and stock compensation. The increase in research and development expenses during 2024 are related to the IND enabling studies and submission. Major components of research and development expenses during the year ended December 31, 2024 are as follows:
Previous wording
Since our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company and through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022. 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 completed IPO in August 2023. We may enter into new licensing and commercial partnership agreements.
Current wording
Since our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company and through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022. 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 completed IPO in August 2023, and through proceeds of an ATM offering. We may also enter into new licensing and commercial partnership agreements.
Previous wording
On April 28, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, and under which various of his family members are beneficiaries (the “Bay Shore Trust”). Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5,000,000 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. Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in our 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 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 December 31, 2023, the Bay Shore Note was paid in full except for an unpaid interest balance of $.01 million. In consideration of the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on April 28, 2023, giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of $5.00 per share, which warrant will expire five years after the date of grant.
Current wording
On April 28, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, and under which various of his family members are beneficiaries (the “Bay Shore Trust”). Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5,000,000 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. Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in our 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 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 December 31, 2024, the Bay Shore Note was paid in full. In consideration of the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on April 28, 2023, giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of $5.00 per share, which warrant will expire five years after the date of grant.
Previous wording
We used $3.4 million in operating activities during the year ended December 31, 2023, compared to $5.6 million in operating activities during the year ended December 31, 2022.
Current wording
We used $5.6 million in operating activities during the year ended December 31, 2024, compared to $4.5 million in operating activities during the year ended December 31, 2023.
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. We had negative cash flow from operations of approximately $3.4 million for the year ended December 31, 2023 and an accumulated deficit of approximately $21.2 million as of December 31, 2023. As of December 31, 2023, we had cash and cash equivalents of approximately $4.6 million and working capital of $4.4 million. We currently expect that our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures through at least the fourth quarter of 2024.
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. We had negative cash flow from operations of approximately $5.6 million for the year ended December 31, 2024 and an accumulated deficit of approximately $29.1 million as of December 31, 2024. As of December 31, 2024, we had cash and cash equivalents of approximately $2.8 million. We currently expect that our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures through at least the third quarter of 2025.
Previous wording
The cash used in operating activities resulted primarily from our net losses, stock-based compensation expense, amortization of debt issuance costs and changes in components of accounts payable and accrued liabilities.
Current wording
The cash used in operating activities resulted primarily from our net losses, stock-based compensation expense and changes in components of accounts payable and accrued liabilities.
Previous wording
For the year ended December 31, 2022, operating activities used $5.6 million of cash, primarily due to a net loss of $7.1 million, a $0.06 million change in accounts payable, accrued and prepaid expenses, offset by $1.3 million in stock-based compensation expense. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.
Current wording
For the year ended December 31, 2024, operating activities used $5.6 million of cash, primarily due to a net loss of $7.9 million, offset by $1.9 million in stock-based compensation expense, and a $0.4 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 and investor relations expenses.
Previous wording
For the year ended December 31, 2023, operating activities used $4.5 million of cash, primarily due to a net loss of $12 million, a $0.6 million change in accounts payable, accrued and prepaid expenses, offset by $2.5 million in stock-based compensation expense, $0.7 million in amortization of debt issuance costs, $3.5 million of interest expense, and $1.1 million of repayments under related party line of credit. Interest expense, net was primarily composed of warrant expense and line of credit expense, offset by interest income. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.
Current wording
For the year ended December 31, 2023, operating activities used $4.5 million of cash, primarily due to a net loss of $12 million, a $0.6 million change in accounts payable, accrued and prepaid expenses, offset by $2.5 million in stock-based compensation expense, $0.7 million in amortization of debt issuance costs, $3.5 million of interest expense, and $1.1 million of repayments under related party line of credit. Interest income (expense), net was primarily composed of debt issuance costs, offset by interest income. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.
Previous wording
For the year ended December 31, 2022, financing activities provided $3.1 million of cash, resulting primarily from $2.9 million in proceeds from sale of common stock, less offering costs, offset by $0.16 million of repayments under related party line of credit.
Current wording
For the year ended December 31, 2024, financing activities provided $3.8 million of cash, resulting primarily from $3.6 million in proceeds from sale of common stock, less offering costs, $0.1 million from the Bay Shore Trust short-swing disgorgement, and $0.03 million in advances from related party.
Previous wording
We currently anticipate that we will seek to monetize our product candidates, Ketamir-2 and MIRA-55, at the end of our planned Phase 2 studies. Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development. Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all.
Current wording
We currently anticipate that we will seek to monetize our product candidates, Ketamir-2 and MIRA-55, at the end of our planned Phase II studies. Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development. Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all.
Previous wording
We believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they become due into the fourth quarter of 2024. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date that the financial statements are issued.
Current wording
We believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they become due into the third quarter of 2025. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date that the financial statements are issued.
Previous wording
Summary of Critical Accounting Policies
Current wording
Summary of Critical Accounting Policies and Estimates