Mira Pharmaceuticals, Inc.: Form 10-Q for the period ended Mar 31, 2025

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.

As used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated, the terms “the Company”, “we”, “us”, “our” and similar terminology refer to MIRA Pharmaceuticals, Inc.

Background of our Company

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.

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.

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.

We were incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including our pharmaceutical development program, in late 2020.

Highlights- First Quarter and Beyond

• March 4, 2025: We announced the approval and upcoming initiation of our Phase 1 clinical trial for Ketamir-2, with subject recruitment beginning in Q1 2025.
• March 19, 2025: We announced that we had signed a binding letter of intent (LOI) to acquire SKNY Pharmaceuticals, Inc. The transaction includes a $5 million capital infusion—comprised of cash or equivalent consideration—into MIRA, reinforcing our financial position and supporting the advancement of SKNY-1, a preclinical-stage oral drug candidate for weight loss and smoking cessation.
• April 1, 2025: We announced the enrollment of the first subjects in our Phase 1 clinical trial of Ketamir-2, being conducted in Israel.
• April 16, 2025: We announced compelling data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy.
• April 23, 2025: We announced the completion of in vitro release testing (IVRT) for our topical formulation of Ketamir-2. The formulation is under investigation for localized applications in pain-related conditions.
• May 6, 2025: We announced positive results from a neurotoxicity study of Ketamir-2, a novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration (FDA) prior to initiating human dosing in the United States.
• May 8, 2025: We announced that our Board of Directors had approved the planned acquisition of SKNY Pharmaceuticals, Inc. (the “Merger”), following the completion of independent valuation reports on both companies. The Merger remains subject to shareholder approval from both MIRA and SKNY.

Amendment to Employment Agreement

On May 13, 2025, Erez Aminov amended his employment with the Company to adjust his annual base salary to $485,000 (the “Amendment”). For the full text of the Amendment, please see Exhibit 10.1 of this Form 10-Q.

Critical Accounting Estimates

Research and development expenses

Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract research organizations and consultants, who conduct research and development activities on our behalf. Patent-related costs, including registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in which they are incurred.

Stock-based compensation

We account for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation”, which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants based on estimated fair values on the grant date. We estimate the fair value of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. We have elected to account for forfeiture of stock-based awards as they occur.

Results of Operations

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

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.

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.

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.

Liquidity and Capital Resources

Sources of Liquidity and Going Concern

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.

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.

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.

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.

To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, through public equity offerings under the ATM Agreement and strategic transactions, including potential alliances and drug product collaborations; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if they are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected, or, in the worst case scenario, we could be forced to cease operations and dissolve. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about its ability to meet our contractual obligations.

We did not have any material non-cancellable contractual obligations as of March 31, 2025.

Cash Flows

The following table provides information regarding our cash flows for the periods presented:

Net Cash Flows from Operating Activities

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.

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.

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.

Net Cash Flows from Financing Activities

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.

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.

Nasdaq Listing Compliance Risk Due to Stockholders’ Equity Deficiency

We have received a notice from Nasdaq indicating that we are not in compliance with its minimum stockholders’ equity requirement, and there can be no assurance that we will be able to regain compliance or maintain our listing.

On April 8, 2025, we received a notification from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as of the filing of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, we were not in compliance with Nasdaq Listing Rule 5550(b)(1), or the Rule, which requires listed companies to maintain a minimum of $2.5 million in stockholders’ equity. In accordance with Nasdaq’s procedures, we submitted a plan to regain compliance.

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.

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.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information under this item per Item 305(e) of Regulation S-K.

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Report, our management, with the participation of our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.

Readers are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.

Based on this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were effective as of March 31, 2025.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act, during our first quarter of 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.