Core Insights - Visionstate Corp. has officially launched MIRA, a new software-as-a-service (SaaS) platform aimed at digitizing inspections in public-facing facilities, available to customers since June 2025 [1][2] - MIRA is designed to enhance operational efficiency and accountability in facility management, serving as an extension of the existing Wanda platform [2][4] - The platform features mobile usability, real-time reporting, customizable checklists, QR code scanning, and secure cloud storage, facilitating compliance tracking and standardization of processes [3][4] Product Features - MIRA allows facility teams to conduct audits, safety checks, and operational inspections with improved accuracy and efficiency [2][4] - The platform is offered on a recurring monthly SaaS model, either standalone or bundled with WandaLITE, catering to clients needing both cleaning compliance and broader inspection capabilities [5] - Initial pilots of MIRA are underway in sectors such as education, healthcare, and municipal government, highlighting its value in compliance-heavy industries [6] Business Impact - The launch of MIRA represents a significant business milestone for Visionstate, introducing a new recurring revenue stream that complements existing offerings without complicating implementation [4][5] - The company has invested in expanding its platform capabilities, including the development of AI-powered features for predictive task scheduling, indicating a commitment to innovation in facility management [7] - MIRA is now available across Canada, with onboarding support and customization options for enterprise clients, enhancing the company's market reach [8]

Part I [Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) This section provides the company's unaudited financial statements and management's analysis of its financial condition [Condensed Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(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](index=4&type=section&id=Condensed%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) 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 $874,812**[13](index=13&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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)](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20(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 substances**[17](index=17&type=chunk)[18](index=18&type=chunk) - 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 infusion**[19](index=19&type=chunk)[21](index=21&type=chunk) - 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 2025**[39](index=39&type=chunk)[41](index=41&type=chunk) - 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 shares**[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - In Q1 2025, the company sold **2,802 shares** of common stock under its **At The Market (ATM) agreement**, raising **net proceeds of approximately $3,000**[51](index=51&type=chunk) - 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 million**[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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)[77](index=77&type=chunk)[78](index=78&type=chunk) - 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-2**[83](index=83&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) 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](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) 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 concern**[92](index=92&type=chunk) - 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 operations**[93](index=93&type=chunk) 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](index=22&type=section&id=Nasdaq%20Listing%20Compliance%20Risk) 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 million**[101](index=101&type=chunk) - 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 compliance[102](index=102&type=chunk) - Failure to regain compliance could result in the **delisting of the company's common stock** from the Nasdaq Capital Market[103](index=103&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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 risk**[104](index=104&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) 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, 2025**[107](index=107&type=chunk) - There were **no changes in internal control over financial reporting** during Q1 2025 that materially affected, or are reasonably likely to materially affect, internal controls[108](index=108&type=chunk) Part II [Part II. Other Information](index=23&type=section&id=Part%20II.%20Other%20Information) This section presents other required information, including legal proceedings, risk factors, equity sales, and exhibits [Legal Proceedings](index=23&type=section&id=Item%201%20Legal%20Proceedings) 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 effect**[110](index=110&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) 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 company**[112](index=112&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[113](index=113&type=chunk) [Other Information](index=23&type=section&id=Item%205%20Other%20Information) The company reported no other information under this item - Not applicable[115](index=115&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) 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 1350**[116](index=116&type=chunk)

[Part I](index=7&type=section&id=PART%20I) [Business Description](index=7&type=section&id=Item%201.%20Description%20of%20Business) MIRA Pharmaceuticals develops neuroscience drug candidates Ketamir-2 and MIRA-55, and is acquiring SKNY Pharmaceuticals - The company's two lead candidates, Ketamir-2 and MIRA-55, have been reviewed by the DEA and are **not classified as controlled substances**, which is a significant regulatory and commercial advantage[24](index=24&type=chunk) - On March 19, 2025, MIRA entered into a binding letter of intent to acquire SKNY Pharmaceuticals, which includes SKNY-1, a drug candidate for weight loss and smoking cessation, and a **$5 million capital infusion** from SKNY[33](index=33&type=chunk) - MIRA holds **exclusive rights** in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55, targeting conditions like diabetic neuropathy, depression, PTSD, and cognitive decline[19](index=19&type=chunk) [Drug Pipeline and Development](index=7&type=section&id=1.1%20Drug%20Pipeline%20and%20Development) MIRA's pipeline features Ketamir-2 in Phase I for diabetic neuropathy and preclinical MIRA-55 for cognitive function - Ketamir-2 is in an ongoing **Phase I clinical trial** in Israel for diabetic neuropathy, with Phase IIa studies planned to start in **Q4 2025**[20](index=20&type=chunk)[42](index=42&type=chunk) - An Investigational New Drug (IND) application for Ketamir-2 was **submitted to the FDA** in December 2024; human dosing in the U.S. is pending completion of a neurotoxicity study expected by **May 2025**[41](index=41&type=chunk) - MIRA-55 is a **preclinical THC analog** that acts as a partial agonist at the CB1 receptor, potentially avoiding the negative effects of high-dose THC, and is **8-fold more potent** than THC at the CB2 receptor[53](index=53&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) [Market Opportunity and Strategy](index=14&type=section&id=1.2%20Market%20Opportunity%20and%20Strategy) MIRA targets the growing North American neuropathic pain market with Ketamir-2, focusing on proof-of-concept and strategic exits - The North American neuropathic pain market is projected to reach **$5.20 billion by 2030**, growing at a **9.0% CAGR**, representing a significant opportunity for Ketamir-2[68](index=68&type=chunk) - Ketamir-2's competitive advantages include **oral bioavailability**, a **selective receptor profile** reducing side effects and abuse potential, and potential superiority over current treatments like gabapentinoids and opioids[71](index=71&type=chunk)[75](index=75&type=chunk) - The company's strategy for Ketamir-2 involves establishing **proof-of-concept** in human trials and then pursuing a **strategic exit** via partnership, licensing, or acquisition[74](index=74&type=chunk)[76](index=76&type=chunk) [Intellectual Property](index=25&type=section&id=1.3%20Intellectual%20Property) MIRA licenses Ketamir-2 patents from MIRALOGX with an 8% royalty, and has a pending patent for MIRA-55 - The company licenses Ketamir-2 patents for the U.S., Canada, and Mexico from MIRALOGX and is obligated to pay an **8% royalty** on net sales and other revenue[119](index=119&type=chunk)[120](index=120&type=chunk) - A **provisional patent application** has been filed for MIRA-55, covering its structure and methods of use[122](index=122&type=chunk) - MIRA owns a U.S. patent for the MIRA1a compound but has **no current plans** for its development[123](index=123&type=chunk)[125](index=125&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial financial, operational, and drug development risks, including going concern issues and third-party reliance - The company is a development-stage entity with no revenue, an **accumulated deficit of $29.1 million** as of December 31, 2024, and its financial condition raises **substantial doubt** about its ability to continue as a going concern[152](index=152&type=chunk) - The independent auditor's report includes an explanatory paragraph regarding the company's ability to continue as a **going concern**, which could make it difficult to obtain future financing[155](index=155&type=chunk)[514](index=514&type=chunk)[522](index=522&type=chunk) - The business is **entirely dependent** on the successful clinical development, regulatory approval, and commercialization of its two lead candidates, Ketamir-2 and MIRA-55[141](index=141&type=chunk)[173](index=173&type=chunk) - MIRA **relies on third parties** for manufacturing and conducting clinical trials, and its rights to Ketamir-2 are **licensed from MIRALOGX**, a related party, creating operational dependencies and potential conflicts of interest[150](index=150&type=chunk)[168](index=168&type=chunk)[267](index=267&type=chunk) [Unresolved Staff Comments](index=64&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[322](index=322&type=chunk) [Cybersecurity](index=64&type=section&id=Item%201C.%20Cyber%20Disclosure) The company integrates cybersecurity into risk management, using third-party platforms, with CFO oversight and no material incidents - The company uses the **Coalition Control platform**, a third-party service, to proactively detect, assess, and mitigate cyber risks across its digital footprint[327](index=327&type=chunk) - The **Chief Financial Officer (CFO)** is responsible for daily oversight of cybersecurity risks and keeps the Board informed[328](index=328&type=chunk) - As of the report date, the company has **not identified any cybersecurity threats or incidents** that have materially impacted its operations, strategy, or financial results[326](index=326&type=chunk) [Properties](index=26&type=section&id=Item%202.%20Description%20of%20Property) The company's principal executive office is a virtual office in Miami, Florida - The company utilizes a **virtual office** for its business address[125](index=125&type=chunk) [Legal Proceedings](index=26&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings with a material adverse effect - There are **no pending legal proceedings** against the company that management believes could have a material adverse effect[127](index=127&type=chunk) [Part II](index=65&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=65&type=section&id=Item%205.%20Market%20for%20Common%20Equity%20and%20Related%20Stockholder%20Matters) MIRA's common stock trades on Nasdaq since August 2023, with 55 holders, and no cash dividends paid or planned - The company's common stock has been traded on The **Nasdaq Capital Market** under the symbol 'MIRA' since **August 3, 2023**[332](index=332&type=chunk) - As of March 28, 2025, there were approximately **55 holders of record** of the common stock[334](index=334&type=chunk) - The company has **not paid any cash dividends** and does not plan to in the foreseeable future[334](index=334&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=66&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MIRA reported a $7.9 million net loss in 2024 with no revenue, increased R&D, and faces liquidity issues with a going concern warning Results of Operations (2024 vs. 2023) | Financial Metric | 2024 | 2023 | | :--- | :--- | :--- | | **Revenues** | $0 | $0 | | General and administrative expenses | $4.7 million | $6.5 million | | Research and development expenses | $3.3 million | $1.6 million | | **Net Loss** | **($7.9 million)** | **($12.0 million)** | | Basic and diluted loss per share | ($0.51) | ($0.85) | - Research and development expenses more than doubled to **$3.3 million** in 2024, driven by IND-enabling studies and submission work[351](index=351&type=chunk) - The company had cash and cash equivalents of approximately **$2.8 million** as of December 31, 2024, and expects this will only be sufficient to fund operations through the **third quarter of 2025**, raising **substantial doubt** about its ability to continue as a going concern[358](index=358&type=chunk)[370](index=370&type=chunk) Cash Flow Summary (2024 vs. 2023) | Cash Flow | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5.6 million) | ($4.5 million) | | Net cash provided by financing activities | $3.8 million | $8.8 million | [Quantitative and Qualitative Disclosures About Market Risk](index=73&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MIRA is not required to provide market risk disclosures - The company is **not required** to provide this information as it qualifies as a **smaller reporting company**[381](index=381&type=chunk) [Financial Statements and Supplementary Data](index=73&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited financial statements for 2024 and 2023, including auditor reports with 'going concern' paragraphs - The independent auditor's report for FY 2024 highlights that the company's lack of revenue, **net loss of $7.9 million**, and **cash used in operations of $5.6 million** raise **substantial doubt** about its ability to continue as a going concern[514](index=514&type=chunk) Balance Sheet Summary (as of Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Cash | $2,832,931 | $4,602,566 | | Total Assets | $2,923,099 | $4,932,443 | | Total Liabilities | $723,349 | $558,097 | | Total Stockholders' Equity | $2,199,750 | $4,374,346 | [Changes In and Disagreements With Accountants on Accounting and Financial Disclosure](index=73&type=section&id=Item%209.%20Changes%20In%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes or disagreements with its accountants on accounting and financial disclosure - None[383](index=383&type=chunk) [Controls and Procedures](index=73&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal financial reporting controls were effective as of December 31, 2024, with prior weaknesses remediated - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2024[384](index=384&type=chunk) - Management believes that previously identified material weaknesses in internal control over financial reporting were **remediated** in 2024[385](index=385&type=chunk) - The company is **not required** to include an auditor's attestation report on internal control over financial reporting because it is an emerging growth and smaller reporting company[387](index=387&type=chunk) [Part III](index=74&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=74&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) MIRA's governance features CEO Erez Aminov, CFO Michelle Yanez, a five-member Board with four independent directors, and three standing committees Executive Officers and Directors | Name | Position | | :--- | :--- | | Erez Aminov | Chief Executive Officer and Chairman | | Michelle Yanez | Chief Financial Officer, Secretary and Treasurer | | Matthew Pratt Whalen | Director | | Matthew Paul Del Giudice, M.D. | Director | | Denil Nanji Shekhat, M.D. | Director | | Edward MacPherson | Director | - The Board has determined that **four of its five directors are independent** under Nasdaq listing rules[403](index=403&type=chunk) - The Board has **three standing committees**: Audit (chaired by Matthew Whalen), Compensation (chaired by Dr. Denil Shekhat), and Nominating and Corporate Governance (chaired by Dr. Matthew Del Giudice)[406](index=406&type=chunk)[408](index=408&type=chunk)[412](index=412&type=chunk) [Executive Compensation](index=79&type=section&id=Item%2011.%20Executive%20Compensation) In 2024, CEO Erez Aminov's total compensation was $3.14 million, and CFO Michelle Yanez's was $444,021, including significant equity awards 2024 Named Executive Officer Compensation | Name and Position | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) | All Other Comp ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Erez Aminov, CEO | 259,999 | 300,000 | 595,000 | 1,919,120 | 66,194 | **3,140,313** | | Michelle Yanez, CFO | 158,219 | - | - | 258,900 | 26,902 | **444,021** | - In December 2024, CEO Erez Aminov received a **$300,000 milestone bonus** and was awarded **500,000 Restricted Stock Units (RSUs)**[430](index=430&type=chunk)[617](index=617&type=chunk) - The 2022 Omnibus Incentive Plan authorizes up to **5,000,000 shares** of common stock for equity awards to employees, directors, and consultants[445](index=445&type=chunk)[610](index=610&type=chunk) [Security Ownership of Certain Beneficial Owners and Management](index=90&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 28, 2025, Brian McNulty is the largest beneficial owner at 29.14%, with CEO Erez Aminov holding 13.78% Beneficial Ownership (as of March 28, 2025) | Name / Group | Percentage of Class | | :--- | :--- | | Brian McNulty (as Trustee) | 29.14% | | Erez Aminov (CEO & Chairman) | 13.78% | | All current directors and officers as a group | 14.82% | - As of December 31, 2024, there were **412,142 securities** remaining available for future issuance under the company's equity compensation plans[479](index=479&type=chunk) [Certain Relationships and Related Transactions](index=91&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has significant related-party transactions with MIRALOGX and Bay Shore Trust, including licensing agreements and warrant issuances - The company entered into an exclusive license agreement with related party MIRALOGX for KETAMIR-2, paying **$100,000 upfront** and agreeing to an **8% royalty** on sales[486](index=486&type=chunk)[577](index=577&type=chunk) - In connection with the license agreement, MIRA issued **700,000 warrants** to MIRALOGX exercisable at $2.00 per share[486](index=486&type=chunk)[578](index=578&type=chunk) - The company had a line of credit with the Bay Shore Trust, which was paid off in 2023. In consideration for the facility, MIRA issued **1,000,000 warrants** to the trust exercisable at $5.00 per share[482](index=482&type=chunk)[483](index=483&type=chunk) [Principal Accountant Fees and Services](index=94&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) In 2024, the company incurred $0.13 million in audit fees to Cherry Bekaert LLP and Salberg & Company P.A., with all services pre-approved Accountant Fees for Fiscal Year 2024 | Fee Type | Amount | | :--- | :--- | | Audit Fees (Cherry Bekaert LLP) | $0.08 million | | Audit Fees (Salberg & Company P.A) | $0.05 million | | Audit-Related Fees (Cherry Bekaert LLP) | $0.05 million | | Tax Fees | $0 | | All Other Fees | $0 | - The company appointed **Salberg & Company P.A.** as its new audit firm effective **December 19, 2024**[497](index=497&type=chunk) [Part IV](index=95&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=95&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section indexes all exhibits filed with Form 10-K, including governance documents, material contracts, and employment agreements - Key filed exhibits include the **2022 Omnibus Incentive Plan** (10.1), the **Exclusive License Agreement with MIRALOGX** (10.13), and **employment agreements** for CEO Erez Aminov (10.7, 10.8) and CFO Michelle Yanez (10.9, 10.15)[503](index=503&type=chunk)[504](index=504&type=chunk)

Core Viewpoint - Mira Pharmaceuticals experienced a significant stock rally followed by a notable decline, driven by positive pre-clinical study results for its drug candidate Ketamir-2 [1][2]. Stock Performance - On Monday, Mira Pharmaceuticals' stock surged by 627.4%, with over 153 million shares traded, compared to its average daily trading volume of approximately 3.2 million shares [1][2]. - As of Tuesday morning, the stock dropped by 27.4%, with more than 5.5 million shares changing hands, indicating a decline from the previous day's trading activity [3]. Drug Development - The rally in Mira Pharmaceuticals' stock was primarily due to the release of positive data from a pre-clinical study of Ketamir-2, an oral ketamine analog aimed at treating neurological and neuropsychiatric disorders [2]. - The company is optimistic about advancing the development of Ketamir-2 and plans to submit an investigational new drug (IND) application [2].

Core Insights - MIRA Pharmaceuticals is advancing its investigational compound Ketamir-2, a novel oral ketamine analog, which shows promise in treating mental health disorders without inducing psychotic symptoms [6][12][15] - The development of Ketamir-2 could lead to significant cost savings in healthcare, particularly for treatment-resistant depression, which currently imposes a financial burden of $43.8 billion annually in the U.S. [2] Company Overview - MIRA Pharmaceuticals, Inc. is a pre-clinical-stage pharmaceutical company focused on developing treatments for neurologic and neuropsychiatric disorders [13][20] - The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2, which is under investigation for its potential to deliver ultra-rapid antidepressant effects [13] Product Development - MIRA is on track to submit an Investigational New Drug (IND) application for Ketamir-2 to the FDA by the end of this year, marking a significant milestone toward clinical trials [3][7] - The company is also conducting further safety and efficacy studies on Ketamir-2, with additional research planned for cancer pain and PTSD [3][12] Safety and Efficacy - New preclinical studies indicate that Ketamir-2 does not induce hyper-locomotor activity, a side effect associated with traditional ketamine, suggesting a safer profile for patients [6][15] - The findings highlight Ketamir-2's potential to mitigate adverse effects commonly linked with traditional ketamine, enhancing patient compliance and treatment success [11][12] Broader Applications - Ketamir-2's improved safety profile allows for potential use in a wider range of psychiatric and neurologic conditions, positioning it as a versatile option in the pharmaceutical landscape [16] - MIRA's other investigational product, MIRA-55, is under investigation for treating neuropathic pain, anxiety, and cognitive decline, further expanding the company's therapeutic portfolio [5][18] Regulatory Considerations - The U.S. Drug Enforcement Administration has concluded that Ketamir-2 and MIRA-55 will not be classified as controlled substances, facilitating their development and commercialization [18]

Core Insights - The company achieved positive preclinical study results for Ketamir-2, a novel oral ketamine analog, which were characterized as "highly encouraging" [2][5] - Ketamir-2 demonstrated significant improvements in locomotor activity, travel speed, and reduced anxiety levels in treated mice [2][3] - The company aims to submit an Investigational New Drug (IND) application to the FDA for Ketamir-2 by the end of the year [5] Preclinical Study Results - In the Open Field Test (OFT), mice treated with Ketamir-2 showed reduced swimming distances and speed, indicating an antidepressant effect [8] - The Elevated Plus Maze (EPM) results indicated that Ketamir-2 treated mice spent more time in open arms, suggesting reduced anxiety [3][8] - The Forced Swim Test (FST) revealed significantly reduced immobility times in mice treated with Ketamir-2, highlighting its potential antidepressant properties [4] Company Overview - MIRA Pharmaceuticals is a preclinical-stage pharmaceutical company focused on developing a new synthetic cannabinoid analog for treating neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [7] - The company has acquired rights to Ketamir, a potential derivative of ketamine, which may have fewer side effects and a faster onset of action compared to existing treatments [7] Market Potential - The positive results from the preclinical studies are expected to validate the potential benefits of Ketamir-2, positioning it as a safer and more effective option for treating depression in home settings [5] - The company is focusing on Ketamir-2 due to its potential for rapid market entry, which could attract significant investor interest [10]

The highly encouraging study results further MIRA's goal of submitting an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) later this year which, if granted, would allow for human clinical trials of Ketamir-2. The following findings were observed: "We are thrilled with the promising results from these preclinical trials, which demonstrate Ketamir-2's efficacy and improved safety profile over traditional ketamine," said Erez Aminov, Chairman & CEO of Mira Pharmaceutic ...

Core Viewpoint - MIRA Pharmaceuticals, Inc. announced that its product MIRA-55 is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA), which facilitates its development and commercialization in treating neurologic and neuropsychiatric disorders [2][7][9]. Group 1: Product Overview - MIRA-55 is being investigated for treating adult patients with neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [3][9]. - Pre-clinical studies indicate that MIRA-55 can improve memory by 100% in wild-type mice, contrasting with THC, which can impair cognitive function [3][4]. Group 2: Market Potential - The company estimates a significant market opportunity with access to a $90 billion traditional neurological market and a $30 billion cannabis market [5]. - Anxiety disorders affect approximately 40 million U.S. adults, while cognitive impairment impacts around 16 million people, indicating a substantial patient population for MIRA-55 [5]. Group 3: Competitive Advantages - MIRA-55 offers a more stable anti-anxiety effect compared to THC, which has a biphasic effect [7]. - The product exhibits lower potency at the CB1 receptor, responsible for psychoactive effects, while maintaining higher activation of the CB2 receptor, suggesting therapeutic benefits with minimal intoxicating effects [7]. - MIRA-55 aims to provide quicker relief and fewer side effects compared to current treatments like SSRIs and SNRIs, which can take weeks to show effects [5][7]. Group 4: Regulatory Status - The DEA's ruling on MIRA-55 provides a regulatory advantage, allowing for more accessible research and development processes compared to marijuana, which is classified as a controlled substance [7][9]. - MIRA Pharmaceuticals also holds exclusive rights for Ketamir-2, another product not classified as a controlled substance, indicating a favorable regulatory environment for its pipeline [8].

Core Viewpoint - MIRA Pharmaceuticals is advancing its novel oral ketamine analog, Ketamir-2, in collaboration with Memorial Sloan Kettering Cancer Center to evaluate its effectiveness in managing cancer pain and associated depression [1][2][4]. Company Overview - MIRA Pharmaceuticals is a pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, holding exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico [9]. - The company is also developing MIRA-55, a novel oral pharmaceutical marijuana for treating anxiety and cognitive decline [10]. Collaboration with Memorial Sloan Kettering - The partnership with MSK aims to validate Ketamir-2's potential and broaden its applications beyond treatment-resistant depression and PTSD [2][4]. - MSK currently uses intravenous ketamine for refractory cancer pain, and the oral formulation of Ketamir-2 could offer a safer, more convenient alternative [3][5]. Clinical Development and Market Potential - The collaboration will assess Ketamir-2's efficacy in a rodent model for cancer pain, potentially streamlining the regulatory approval process for clinical trials [6]. - Successful preclinical outcomes could accelerate the FDA approval pathway for Ketamir-2, enhancing MIRA's capacity to deliver innovative treatments [6]. Cancer Pain Statistics - Approximately 44% of cancer patients experience pain, with 31% suffering from moderate to severe pain [8]. - Around 25% of cancer patients also suffer from depression, significantly higher than the general population [8].

Core Viewpoint - MIRA Pharmaceuticals is advancing the development of Ketamir-2, an oral ketamine analog, for the treatment of PTSD, depression, and neuropathic pain, with preclinical studies underway and plans for human testing in 2025 [1][2][9]. Group 1: Preclinical Studies and Development - MIRA has initiated preclinical trials in collaboration with Pharmaseed to evaluate Ketamir-2's efficacy against ketamine in a rat model of severe PTSD, focusing on chronic stress and fear memory processing [3]. - A head-to-head study with Biotrial will assess the locomotor activity effects of Ketamir-2 compared to ketamine, providing insights into its pharmacodynamics and potential side effects [4]. - MIRA has also started 7-day toxicology studies in rats and dogs with Frontage Laboratories, which are essential for ensuring the safety and efficacy of Ketamir-2 before human trials [5]. Group 2: Manufacturing and Regulatory Progress - Significant advancements have been made in the manufacturing process of Ketamir-2, optimizing the synthetic process and reducing production costs, which is crucial for scaling up under Good Manufacturing Practices (GMP) [6]. - MIRA anticipates submitting an Investigational New Drug Application (IND) to the FDA by the end of this year, contingent on positive preclinical results [2]. Group 3: Market Potential and Therapeutic Applications - PTSD affects approximately 8 million adults annually in the U.S., with current treatments often providing limited relief, highlighting the potential market for Ketamir-2 as a safer and more effective alternative [7]. - The U.S. market for PTSD treatments is projected to reach $26 billion by 2031, indicating significant growth potential for Ketamir-2 [9]. - MIRA is exploring collaborations with research centers to study Ketamir-2's efficacy in treating cancer pain, which could broaden its therapeutic applications [8]. Group 4: Management Insights - The management emphasizes the importance of these preclinical trials in addressing severe mental health disorders and neuropathic pain, with a focus on the financial impact of treatment-resistant depression in the U.S., estimated at $92.7 billion annually [9]. - The unique properties of Ketamir-2, including high oral bioavailability and lack of mu opioid interaction, position it as a promising option for rapid relief from depression in a home setting [9].