MIRA PHARMACEUTICALS, INC.

Previous 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.

Current wording

We are a clinical-stage pharmaceutical development company advancing 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 are also ongoing to further evaluate its potential in treating depression and post-traumatic stress disorder (PTSD).

Previous 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.

Current wording

Our second development program, MIRA-55, is a novel oral pharmaceutical marijuana molecule being studied for its potential to alleviate anxiety and cognitive decline, symptoms commonly associated with early-stage dementia. We have conducted, and continue to evaluate, preclinical studies to assess MIRA-55’s potential efficacy in treating inflammatory pain. If approved by the FDA, MIRA-55 could represent a significant advancement in the treatment of various neuropsychiatric, inflammatory, and neurologic disorders.

Previous wording

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

Current wording

For the three and six months ended June 30, 2025 compared to the three and six months ended June 30, 2024

Previous 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.

Current wording

Research and Development Expenses. We incurred $0.5 million in research and development expenses during the three months ended June 30, 2025, and during the three months ended June 30, 2024, we incurred $0.6 million in research and development expenses. The decrease from 2024 to 2025 is primarily due to decreased costs for the development of MIRA-55.

Previous 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.

Current wording

General and Administrative Expenses. We incurred $1.0 million and $1.1 million in general and administrative expenses during the three months ended June 30, 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 decrease from 2024 to 2025 was primarily due to a decrease in stock-based compensation related to compensation to the officers, directors, and employees.

Previous wording

Interest income. We earned $0.02 and $0.05 million in interest income during the three months ended March 31, 2025 and 2024, respectively. Interest income during the three months for each respective period consisted of interest earned on bank accounts.

Current wording

Interest income. We earned $0.01 and $0.04 million in interest income during the three months ended June 30, 2025 and 2024, respectively. Interest income during the three months for each respective period consisted of interest earned on bank accounts.

Previous wording

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.

Current wording

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

Previous wording

For the three months ended March 31, 2025, operating activities used $1.6 million of cash. This was primarily driven by a net loss of $1.8 million and $0.7 million used to pay down accounts payable and prepaid expenses. These outflows were partially offset by $0.8 million in stock-based compensation expense. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development costs, consultant fees, and insurance expenses.

Current wording

For the six months ended June 30, 2025, operating activities used $2.4 million of cash. This was primarily driven by a net loss of $3.3 million and $0.5 million used to pay down accounts payable and prepaid expenses. These outflows were partially offset by $1.4 million in stock-based compensation expense. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development costs, consultant fees, and insurance expenses.

Previous 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.

Current wording

For the six months ended June 30, 2024, operating activities used $1.9 million of cash from the ATM. This was primarily driven by a net loss of $3.4 million and $0.4 million used to pay down accounts payable and prepaid expenses. These outflows were partially offset by $1.1 million in stock-based compensation expense. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development costs, consultant fees, and insurance expenses.

Previous 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.

Current wording

For the six months ended June 30, 2025, financing activities provided $0.3 million of cash, resulting from proceeds from sale of common stock from the ATM, less offering costs.

Previous wording

For the three months ended March 31, 2024, financing activities used $0.02 million of cash, resulting from $0.02 million in advances to affiliates.

Current wording

For the six months ended June 30, 2024, financing activities provided $0.1 million of cash, resulting primarily from $0.1 million in disgorgement proceeds.

Previous wording

Our plan includes a number of steps intended to cure the deficiency, including the anticipated closing of a strategic merger with SKNY Pharmaceuticals, Inc. in the second or third quarter of 2025, which we expect will add approximately $5 million in cash or other assets to our balance sheet. In addition, we currently have access to approximately $7 million in available capital through our at-the-market (ATM) offering facility (Note 5 of accompanying financial statements), which we may utilize to further strengthen our stockholders’ equity position. On May 7, 2025, Nasdaq accepted our plan and granted an extension to regain compliance with the Rule. The terms of the extension are as follows: on or before October 6, 2025 the company must complete the financing transactions and evidence compliance with the Rule.

Current wording

Our plan includes a number of steps intended to cure the deficiency, including the anticipated closing of a strategic merger with SKNY Pharmaceuticals, Inc. in the third quarter of 2025, which we expect will add approximately $5 million in cash or other assets to our balance sheet. In addition, we currently have access to approximately $6.6 million in available capital through our at-the-market (ATM) offering facility (Note 5 of accompanying financial statements), which we may utilize to further strengthen our stockholders’ equity position. On May 7, 2025, Nasdaq accepted our plan and granted an extension to regain compliance with the Rule. The terms of the extension are as follows: on or before October 6, 2025 the company must complete the financing transactions and evidence compliance with the Rule.

Previous wording

While we believe these actions will enable us to regain compliance with Nasdaq’s listing requirements, there can be no assurance that we will be able to execute the necessary steps successfully or within the permitted timeframe. If we fail to regain compliance with the Rule, our common stock may be subject to delisting from the Nasdaq Capital Market, which could materially and adversely affect the liquidity and market price of our common stock and limit our access to capital.

Current wording

There can be no assurance that we will be able to maintain compliance with Nasdaq’s listing requirements. If we fail to regain compliance with the Rule, our common stock may be subject to delisting from the Nasdaq Capital Market, which could materially and adversely affect the liquidity and market price of our common stock and limit our access to capital.