MIRA PHARMACEUTICALS, INC.

Previous 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).

Current wording

We are a clinical-stage pharmaceutical development company advancing three 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. The single-ascending-dose (SAD) portion of the study has been completed, and data remain blinded pending full analysis. The multiple-ascending-dose (MAD) portion is underway, and a Phase 2a study in chemotherapy-induced peripheral neuropathy (CIPN) is planned to begin in the first half of 2026, subject to regulatory feedback and site readiness. Preclinical studies are also ongoing 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. Initial preclinical studies evaluating its efficacy in treating inflammatory pain have been initiated and completed, with additional studies currently ongoing to further assess its therapeutic potential.

Previous 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.

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. Recent animal studies demonstrated that MIRA-55 produced analgesic and anti-inflammatory effects in validated preclinical pain models without evidence of local irritation or psychoactive side effects. These findings support continued advancement toward IND-enabling studies. If approved by the FDA, MIRA-55 could represent a significant advancement in the treatment of various neuropsychiatric, inflammatory, and neurologic disorders.

Previous wording

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.

Current wording

The U.S. Drug Enforcement Administration (DEA) has completed its scientific review of both Ketamir-2 and MIRA-55 and concluded that neither compound would be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

Previous wording

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

Current wording

For the three and nine months ended September 30, 2025 compared to the three and nine months ended September 30, 2024

Previous 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.

Current wording

*Research and Development Expenses.*We incurred $0.4 million in research and development expenses during the three months ended September 30, 2025, and during the three months ended September 30, 2024, we incurred $1.0 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

We incurred $0.8 million in research and development expenses during the six months ended June 30, 2025, and during the six months ended June 30, 2024, we incurred $1.4 million in research and development expenses. The decrease from 2024 to 2025 is primarily due to decreased costs in for the development of MIRA-55.

Current wording

We incurred $1.2 million in research and development expenses during the nine months ended September 30, 2025, and during the nine months ended September 30, 2024, we incurred $2.4 million in research and development expenses. The decrease from 2024 to 2025 is primarily due to decreased costs in for the development of MIRA-55.

Previous 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.

Current wording

General and Administrative Expenses. We incurred $0.9 million and $1.0 million in general and administrative expenses during the three months ended September 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 for officers, directors, and employees.

Previous wording

We incurred $2.5 million and $2.1 million in general and administrative expenses during the six 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 difference is primarily due to an increase in stock-based compensation related to compensation to the officers, directors, and employees during the 2025 fiscal year.

Current wording

We incurred $3.4 million and $3.1 million in general and administrative expenses during the nine months ended September 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 difference is primarily due to an increase in stock-based compensation related to compensation to the officers, directors, and employees during the 2025 fiscal year.

Previous 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.

Current wording

Interest income. We earned $0.02 and $0.04 million in interest income during the three months ended September 30, 2025 and 2024, respectively. Interest income during the three months for each respective period consisted of interest earned on bank accounts.

Previous wording

We earned $0.03 and $0.09 million in interest income during the six months ended June 30, 2025 and 2024, respectively. The difference is primarily due to cash balances.

Current wording

We earned $0.05 and $0.1 million in interest income during the nine months ended September 30, 2025 and 2024, respectively. The difference is primarily due to cash balances.

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 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.

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. On September 29, 2025, we acquired the rights to develop SKNY-1. Supporting 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 third quarter of 2026, with the issuance of common stock under our shelf registration statement described in Note 6 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

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.

Current wording

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. Proceeds raised in the ATM financing supported by this shelf registration statement as of the filing date have totaled $6.7 million, net of $0.3 million in fees and transaction costs.

Previous 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.

Current wording

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

Previous 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.

Current wording

For the nine months ended September 30, 2025, operating activities used $3.5 million of cash. This was primarily driven by a net loss of $4.5 million and $0.6 million used to pay down accounts payable and prepaid expenses and an unrealized gain of $0.18 million. These outflows were partially offset by $1.8 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.

Previous 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.

Current wording

For the nine months ended September 30, 2024, operating activities used $3.7 million of cash. This was primarily driven by a net loss of $5.4 million and $0.3 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 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.

Current wording

For the nine months ended September 30, 2025, financing activities provided $3.4 million of cash, resulting from $3.0 million proceeds from sale of common stock from the ATM, less offering costs, and $0.29 million proceeds from stock option exercises.

Previous 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.

Current wording

For the nine months ended September 30, 2024, financing activities provided $3.3 million of cash, resulting primarily from $3.1 million in sales of common stock.

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 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.

Current wording

On May 7, 2025, Nasdaq accepted our plan and granted an extension to regain compliance with the Rule. The terms of the extension were as follows: on or before October 6, 2025 the company was required to evidence compliance with the Rule.

Previous 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.

Current wording

There can be no assurance that we will be able to maintain compliance with Nasdaq’s listing requirements. If we fail to maintain 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.