MIRA PHARMACEUTICALS, INC.

Previous wording

The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.

Current wording

The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” above.

Previous wording

We are a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico forKetamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling NP, TRD, MDSI and potentially PTSD.

Current wording

We are a clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada, and Mexico for Ketamir-2, a novel, patent-pending oral ketamine analog currently under clinical investigation. Ketamir-2 is being developed for the treatment of neuropathic pain, with a Phase 1 clinical trial currently underway in healthy subjects. Preclinical studies have been conducted and are ongoing as part of the oral development program to further evaluate its potential in treating depression and post-traumatic stress disorder (PTSD). In addition, we have successfully formulated a topical cream version of Ketamir-2 and will be initiating preclinical studies to evaluate its efficacy in treating inflammatory pain.

Previous wording

Additionally, our novel oral pharmaceutical marijuana molecule,MIRA-55, is being studied for its potential to alleviate neuropathic pain, as well as anxiety and cognitive decline, symptoms commonly 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.

Current wording

Additionally, our novel oral pharmaceutical marijuana molecule, MIRA-55, is being studied for its potential to alleviate anxiety and cognitive decline, symptoms commonly associated with early-stage dementia. If approved by the FDA, MIRA-55 could represent a significant advancement in the treatment of various neuropsychiatric, inflammatory, and neurologic disorders.

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The DEA’s scientific review of Ketamir-2 and MIRA-55 concluded that neither would be considered a controlled substance or listed chemical under the CSA and its governing regulations.

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The 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 CSA and its governing regulations.

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For the three months endedSeptember 30, 2024 compared to the three months ended September 30, 2023

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For the three months ended March 31, 2025 compared to the three months ended March 31, 2024

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Research and Development Expenses. During the three months ended September 30, 2024, we incurred $1.1 million in research and development expenses, which were primarily related to initial payments for pre-clinical research projects. We incurred $1.0 million in research and development expenses during the three months ended September 30, 2023, relating to initial payment for toxicology study costs. Research and development expenses include pre-clinical, toxicology and consultant expenses.

Current wording

Research and Development Expenses. We incurred $0.3 million in research and development expenses during the three months ended March 31, 2025, relating to initial payment for toxicology study costs. Research and development expenses include clinical, toxicology and consultant expenses. During the three months ended March 31, 2024, we incurred $0.8 million in research and development expenses, which were primarily related to initial payments for clinical research projects for Ketamir-2. The decrease is primarily due to Ketamir-2 moving into Phase 1 trials that began in the later part of Q1 2025 compared to Ketamir-2 R&D ramping up in the prior year.

Previous wording

General and Administrative Expenses. We incurred $1.0 million and $2.1 million in general and administrative expenses during the three months ended September 30, 2024 and September 30, 2023, respectively. General and administrative expenses are composed primarily of compensation, insurance, professional fees, stock-based compensation, administration and other related costs. The decrease is primarily due to stock-based compensation, debt issuance costs, and compensation related to the IPO efforts of the executive team that occurred in 2023 and is not reoccurring.

Current wording

General and Administrative Expenses. We incurred $1.5 million and $1.0 million in general and administrative expenses during the three months ended March 31, 2025 and 2024, 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 related to compensation to the officers, directors, and employees.

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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, through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022, by the proceeds from our completed initial public offering in August 2023 and through the proceeds of an ATM offering during the third quarter of 2024. We intend to finance our clinical development programs and working capital needs from existing cash, and potentially new sources of debt and equity financing. 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, through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022, and by the proceeds from our completed initial public offering in August 2023. We intend to finance our clinical development programs and working capital needs from existing cash, and potentially new sources of debt and equity financing. We may enter into new licensing and commercial partnership agreements.

Previous wording

Historically, we have been primarily engaged in developing MIRA-55 and, more recently, have also been focusing on the development of Ketamir-2. During these activities, we have sustained substantial losses. Our ability to fund ongoing operations and future pre-clinical and clinical trials required for FDA approval is dependent on our ability to obtain significant additional external funding in the near term. We expect to be able to fund operations through the fourth quarter of 2025, with the issuance of common stock under our shelf registration as described in Note 7 of the accompanying financial statements.

Current wording

Historically, we have been primarily engaged in developing MIRA-55 and, more recently, have also been focusing on the development of Ketamir-2. During these activities, we have sustained substantial losses. Our ability to fund ongoing operations and future clinical and clinical trials required for FDA approval is dependent on our ability to obtain significant additional external funding in the near term. We expect to be able to fund operations through the fourth quarter of 2025, with the issuance of common stock under our shelf registration statement described in Note 5 of the accompanying financial statements. We will require additional financing to fund our operations, to continue and complete clinical and clinical development activities and to commercially develop and ultimately launch our product candidates. However, and particularly given our early-stage nature and the significant time and capital required to implement our business plan, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.

Previous wording

We expect to continue to generate losses in the foreseeable future. Our liquidity needs will be determined largely by the budgeted operational expenditure incurred in regard to the progression of our product candidates. We do not have sufficient cash and cash equivalents as of the date of filing this Report to support our operations for at least 12 months. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date the financial statements included in this Report are issued.

Current wording

We expect to continue to generate losses in the foreseeable future. Our liquidity needs will be determined largely by the budgeted operational expenditure incurred in regard to the progression of our product candidates. We do not have sufficient cash and cash equivalents as of the date of filing this Report to support our operations for at least the 12 months. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date the financial statements included in this Report are issued.

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Net Cash Used in Operating Activities

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The cash used in operating activities resulted primarily from our net losses, stock-based compensation expense, changes in prepaid expenses and changes in components of accounts payable and accrued expenses.

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For the nine months ended September 30, 2024, operating activities used $3.8 million of cash, primarily due to a net loss of $5.5 million, offset by $1.4 million in stock-based compensation expense and $0.3 million in change in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.

Current wording

For the three months ended March 31, 2024, operating activities used $1.0 million of cash, primarily due to a net loss of $1.7 million, offset by $0.5 million in stock-based compensation expense and $0.2 million in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, and insurance costs.

Previous wording

For the nine months ended September 30, 2024, financing activities provided $3.3 million of cash, resulting primarily from $3.1 million in proceeds from sale of common stock, less offering costs from the ATM agreement, and $0.2 million in proceeds from short swing disgorgement and related party advances.

Current wording

For the three months ended March 31, 2025, financing activities provided $0.003 million of cash, resulting from proceeds from sale of common stock, less offering costs.