Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

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 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.

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.

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.

On September 29, 2025, we acquired SKNY Pharmaceuticals ("SKNY"), a related party private company. SKNY merged with MIRAPHARM Acquisition, Inc., a Delaware corporation and a wholly owned subsidiary of the Company ("Mira Sub"), with SKNY surviving as a wholly owned subsidiary of MIRA. SKNY's preclinical drug candidate, SKNY-1, is designed to modulate CB1, CB2, and MAO-B pathways to address energy storage, lipid metabolism, appetite, cravings, and reward - without the psychiatric side effects that limited earlier CB1-targeting drugs. SKNY holds exclusive rights in the United States, Canada, and Mexico to SKNY-1 under license from Miralogx, a related party of the Company.

SKNY-1 has been evaluated in preclinical behavioral and metabolic models. In zebrafish models that mimic human obesity and craving behaviors, oral SKNY-1 administration was associated with reductions in food consumption, body-weight gain, and nicotine-seeking behavior compared with controls. In a rodent behavioral assay used to assess CB1-related anxiety-like effects, SKNY-1 did not induce the anxiety-related responses observed with earlier CB1-targeting compounds. These findings support continued preclinical development of SKNY-1 in models of metabolic and behavioral modulation.

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- Third Quarter and Beyond

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On July 2, 2025, MIRA announced preclinical results demonstrating that its proprietary drug candidate, Mira-55, a non-psychoactive marijuana analog, delivered morphine-comparable pain relief in a validated animal model of inflammatory pain, without inducing local inflammation.

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On July 10, 2025, MIRA announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor (CB1)-related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, distinguishing it from earlier CB1-targeting drugs that were discontinued due to unfavorable safety profiles.

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On July 28, 2025, MIRA announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Ketamir-2, the Company's novel oral NMDA receptor antagonist for the treatment of neuropathic pain. The clearance enables MIRA to initiate U.S.-based clinical trials.

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On July 29, 2025, MIRA announced new preclinical data evaluating the analgesic effects of its topical Ketamir-2 formulation in a validated rodent model of pain. The study demonstrated that topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, with a rapid onset of action, durable effect, and efficacy comparable to injected morphine across both phases of the pain model. These findings support continued development of topical Ketamir-2 for localized pain conditions, including diabetic neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathy, osteoarthritis, and other forms of inflammatory pain.

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On August 12, 2025, MIRA announced the acceptance of a second peer-reviewed manuscript describing its lead oral drug candidate, Ketamir-2, in Frontiers in Pharmacology. The newly accepted publication reports that Ketamir-2 outperformed ketamine, pregabalin, or gabapentin-depending on the comparator used-in restoring sensory function and reversing pain behaviors across two gold-standard rodent models of neuropathic pain.

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On August 19, 2025, MIRA announced the successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco, demonstrated a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed to date.

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On September 12, 2025, MIRA announced that its stockholders approved the acquisition of SKNY Pharmaceuticals, Inc. ("SKNY") at the Company's 2025 Annual Meeting of Stockholders. All proposals at the meeting were approved by shareholders, including the SKNY acquisition.

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On September 16, 2025, MIRA announced positive results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD). Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.

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On September 22, 2025, MIRA announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of its lead oral candidate, Ketamir-2, in healthy volunteers. The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and PK characterization.

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On September 29, 2025, MIRA Pharmaceuticals, Inc. acquired SKNY, a related party private company under common control with MIRA.

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On October 16, 2025, MIRA announced new preclinical data showing that oral Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of inflammatory pain.

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On October 24, 2025, MIRA announced the initiation of the multiple ascending dose (MAD) portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company also announced that it has selected chemotherapy-induced peripheral neuropathy (CIPN) - a common and debilitating side effect of cancer treatment - as the lead indication for its planned Phase 2a clinical evaluation.

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

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.

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.

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.

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.

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.

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.

Unrealized gain on short-term investments. On September 30, 2025, the value of the 3,521,127 Telomir Pharmaceuticals, Inc. shares received in the SKNY acquisition increased from $4,718,310, as recorded on September 29, 2025, the Closing Date of the SKNY acquisition, to $4,894,366, based on the closing price of the stock on September 30, 2025. This resulted in an unrealized gain recorded in other income of $176,056. We did not have short-term investments in the nine months ended September 30, 2024

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.

On September 29, 2025, MIRA Pharmaceuticals, Inc. acquired SKNY, a related party private company under common control with MIRA. SKNY merged with MIRAPHARM Acquisition, Inc., a Delaware corporation and a wholly owned subsidiary of the Company ("Mira Sub"), with SKNY surviving as a wholly owned subsidiary of MIRA. SKNY's largest shareholder contributed to the Company, on behalf of SKNY 3,521,127 shares of common stock in Telomir Pharmaceuticals, Inc. (NASDAQ: TELO), a publicly traded preclinical stage biotechnology company that is a related party with MIRA and SKNY. The 3,521,127 share in TELO represented $5,000,000 based on the 10-day average of the closing share price of TELO stock, $1.42, for the ten trading days prior to September 25, 2025, (the "Measurement Date"). On September 29, 2025 (the "Closing Date"), MIRA Pharmaceuticals, Inc. received the TELO shares and recorded their value as of the Closing Date as $4,718,310. See Note 5, Asset Acquisition. The 3,521,127 shares in TELO were recorded on the MIRA balance sheet as a Short-term investment. On September 30, 2025, the value of these shares was adjusted to $4,894,366 based on the TELO closing price on September 30, 2025, with a corresponding credit to other income of $176,056.

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.

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.

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 September 30, 2025.

Cash Flows

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

		Nine Months Ended
		September 30,
		2025				2024
Net cash provided by (used in):
Operating activities		$	(3,526,632	)		$	(3,755,576	)
Financing activities			3,335,240				3,297,570
Net change in cash		$	(191,392	)		$	(458,006	)

Net Cash Flows from Operating Activities

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.

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.

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.

Net Cash Flows from Financing Activities

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.

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.

Nasdaq Listing Compliance Risk Due to Stockholders' Equity Deficiency

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.

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.

On September 29, 2025, MIRA Pharmaceuticals, Inc. acquired SKNY, a related party private company under common control with MIRA. SKNY's largest shareholder contributed to the Company on behalf of SKNY 3,521,127 shares of common stock in Telomir Pharmaceuticals, Inc. (NASDAQ: TELO), a publicly traded preclinical stage biotechnology company under common control with MIRA and SKNY. The 3,521,127 shares in TELO represented $5,000,000 based on the stock's closing price on September 26 (the "Measurement Date"). On September 29, 2025 (the "Closing Date"), MIRA Pharmaceuticals, Inc. received the TELO shares and recorded their value as of the Closing Date as $4,718,310. See Note 5, Asset Acquisition. The 3,521,127 shares in TELO were recorded on the MIRA balance sheet as a Short-term investment. On September 30, 2025, the value of these shares was adjusted to $4,894,366 based on the TELO closing price on September 30, 2025, with a corresponding credit to other income of $176,056.

As of the date of this filing, we have sold 4,133,402 shares in ATM transactions, with net proceeds of $6.7 million. As of September 30, 2025, our shareholder's equity was $7.6 million. On October 7, 2025, we received a notification from The Nasdaq Stock Market LLC ("Nasdaq") indicating that NASDAQ had determined that we are in compliance with Nasdaq Listing Rule 5550(b)(1).

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.