Part I Part I. Financial Information This section provides the company's unaudited financial statements and management's analysis of its financial condition Condensed Financial Statements (unaudited) This section presents MIRA Pharmaceuticals' unaudited condensed financial statements for Q1 2025, showing no revenue, a net loss, and decreased cash and equity Condensed Balance Sheets As of March 31, 2025, the company's total assets were $1.4 million, a significant decrease from $2.9 million at December 31, 2024, primarily due to a reduction in cash and cash equivalents Condensed Balance Sheet Data (unaudited) | Account | March 31, 2025 (in dollars) | December 31, 2024 (in dollars) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $1,206,285 | $2,832,931 | | Total current assets | $1,364,899 | $2,887,660 | | Total assets | $1,400,338 | $2,923,099 | | Liabilities & Equity | | | | Total current liabilities | $106,173 | $723,349 | | Total liabilities | $106,173 | $723,349 | | Total stockholders' equity | $1,294,165 | $2,199,750 | | Total liabilities and stockholders' equity | $1,400,338 | $2,923,099 | Condensed Statements of Operations For the three months ended March 31, 2025, the company reported no revenue and a net loss of $1.78 million, compared to a net loss of $1.72 million for the same period in 2024 Condensed Statements of Operations (unaudited) | Metric | Three Months Ended March 31, 2025 (in dollars) | Three Months Ended March 31, 2024 (in dollars) | | :--- | :--- | :--- | | Revenues | $ - | $ - | | General and administrative expenses | $1,490,796 | $1,005,911 | | Research and development expenses | $314,404 | $762,276 | | Total operating costs | $1,805,200 | $1,768,187 | | Net loss | $(1,783,779) | $(1,717,771) | | Basic and diluted loss per share | $(0.11) | $(0.15) | | Weighted average shares outstanding | 16,645,119 | 14,780,885 | Condensed Statements of Changes in Stockholders' Equity Stockholders' equity decreased from $2.2 million at the end of 2024 to $1.3 million at March 31, 2025, primarily due to net loss partially offset by stock-based compensation - The main drivers for the change in stockholders' equity in Q1 2025 were the net loss of $1,783,779 and stock-based compensation of $874,81213 Condensed Statements of Cash Flows Net cash used in operating activities increased to $1.63 million in Q1 2025 from $1.05 million in Q1 2024, driven by net loss and changes in operating liabilities Cash Flow Summary (unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 (in dollars) | Three Months Ended March 31, 2024 (in dollars) | | :--- | :--- | :--- | | Net cash from operating activities | $(1,630,027) | $(1,049,536) | | Net cash from financing activities | $3,381 | $(24,335) | | Net change in cash | $(1,626,646) | $(1,073,871) | | Cash at end of period | $1,206,285 | $3,528,695 | Notes to Condensed Financial Statements (unaudited) The notes provide critical context to the financial statements, covering business overview, the SKNY Pharmaceuticals acquisition, going concern issues, and equity structure details - The company is a clinical-stage pharmaceutical firm developing two neuroscience programs, Ketamir-2 and MIRA-55, for neurologic and neuropsychiatric disorders, which the DEA has determined would not be considered controlled substances1718 - On March 19, 2025, MIRA entered a binding letter of intent to acquire SKNY Pharmaceuticals, Inc, which would add SKNY-1 to its pipeline and provide a $5 million capital infusion1921 - There is substantial doubt about the company's ability to continue as a going concern for the next 12 months, as cash of $1.2 million is insufficient to fund operations, which used $1.6 million in Q1 20253941 - The company has an exclusive license agreement with MIRALOGX to develop and commercialize Ketamir-2 in the U.S., Canada, and Mexico, including royalty payments and the issuance of a warrant to purchase 700,000 shares424344 - In Q1 2025, the company sold 2,802 shares of common stock under its At The Market (ATM) agreement, raising net proceeds of approximately $3,00051 - Subsequent to the quarter end, from April 1 to May 14, 2025, the company sold an additional 105,969 shares under the ATM agreement for net proceeds of approximately $0.1 million69 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's operational highlights, financial performance, liquidity challenges, and Nasdaq listing compliance, emphasizing its going concern risk and capital needs - The company is a clinical-stage pharmaceutical firm focused on developing Ketamir-2 (for pain, depression, PTSD) and MIRA-55 (for anxiety and cognitive decline)7778 - Key Q1 2025 and subsequent highlights include initiating a Phase 1 trial for Ketamir-2, signing a binding LOI to acquire SKNY Pharmaceuticals, and receiving positive neurotoxicity study results for Ketamir-283 Results of Operations Comparing Q1 2025 to Q1 2024, Research and Development expenses decreased as Ketamir-2 moved into Phase 1 trials, while General and Administrative expenses increased due to higher stock-based compensation Comparison of Operating Expenses (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 (in dollars) | Q1 2024 (in dollars) | Change (in dollars) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $300,000 | $800,000 | ▼ $500,000 | Ketamir-2 moved into Phase 1 trials in late Q1 2025, compared to R&D ramp-up in prior year | | General & Administrative | $1,500,000 | $1,000,000 | ▲ $500,000 | Increase in stock-based compensation | Liquidity and Capital Resources The company's current cash is insufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern, necessitating additional capital through equity financing - The company does not have sufficient cash to support operations for at least the next 12 months, which raises substantial doubt about its ability to continue as a going concern92 - To address the liquidity shortfall, the company plans to secure capital through public equity offerings under its ATM Agreement and potential strategic transactions, as failure to do so may require curtailing or ceasing operations93 Cash Flow Summary | Cash Flow Activity | Three months Ended March 31, 2025 (in dollars) | Three months Ended March 31, 2024 (in dollars) | | :--- | :--- | :--- | | Operating activities | $ (1,630,027) | $ (1,049,536) | | Financing activities | $ 3,381 | $ (24,335) | | Net change in cash | $ (1,626,646) | $ (1,073,871) | Nasdaq Listing Compliance Risk MIRA received a Nasdaq non-compliance notice for failing to meet the minimum $2.5 million stockholders' equity requirement but was granted an extension until October 6, 2025, based on its compliance plan - The company received a non-compliance notice from Nasdaq on April 8, 2025, for not meeting the minimum stockholders' equity requirement of $2.5 million101 - The compliance plan includes the merger with SKNY Pharmaceuticals (expected to add ~$5M in assets) and utilizing its ATM offering facility, with Nasdaq granting an extension until October 6, 2025, to regain compliance102 - Failure to regain compliance could result in the delisting of the company's common stock from the Nasdaq Capital Market103 Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, MIRA Pharmaceuticals, Inc. is not required to provide the information requested under this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide disclosures about market risk104 Controls and Procedures Management evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025, with no material changes in internal control over financial reporting during Q1 2025 - Based on an evaluation, the Certifying Officers concluded that the company's disclosure controls and procedures were effective as of March 31, 2025107 - There were no changes in internal control over financial reporting during Q1 2025 that materially affected, or are reasonably likely to materially affect, internal controls108 Part II Part II. Other Information This section presents other required information, including legal proceedings, risk factors, equity sales, and exhibits Legal Proceedings The company reports that there are currently no pending legal proceedings that are reasonably expected to have a material adverse effect on its business or financial condition - As of the filing date, no legal proceedings, government actions, or claims are pending against the company that management believes could have a material adverse effect110 Risk Factors As a smaller reporting company, MIRA Pharmaceuticals, Inc. is not required to present information under this item - Information under "Item 1A. Risk Factors" is not required as the company is a smaller reporting company112 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None113 Other Information The company reported no other information under this item - Not applicable115 Exhibits This section lists the exhibits filed with the Form 10-Q, including an amendment to the CEO's employment agreement and required certifications - Key exhibits filed include an amendment to the employment agreement for CEO Erez Aminov, and certifications pursuant to Sarbanes-Oxley Sections 302 and 1350116
MIRA Pharmaceuticals(MIRA) - 2025 Q1 - Quarterly Report