MIRA 10-Q
Mira Pharmaceuticals, Inc. (MIRA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________to_________
Commission
file number
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number (including area code):
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of exchange on which registered | ||
| The
|
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
| ☒ | Smaller reporting company | |||
| Emerging growth company |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 10, 2026, there were shares of the registrant’s common stock issued and outstanding.
MIRA Pharmaceuticals, Inc.
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
| Page | ||
| Part I. Financial Information | 1 | |
| Item 1. | Condensed Financial Statements (unaudited) | |
| Condensed Consolidated Balance Sheets | 1 | |
| Condensed Consolidated Statements of Operations (unaudited) | 2 | |
| Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited) | 3 | |
| Condensed Consolidated Statements of Cash Flows (unaudited) | 4 | |
| Notes to Condensed Consolidated Financial Statements (unaudited) | 5 | |
| Cautionary Note on Forward Looking Statements | 18 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 20 |
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 26 |
| Item 4. | Controls and Procedures | 27 |
| Part II. Other Information | 28 | |
| Item 1 | Legal Proceedings | 28 |
| Item 1A. | Risk Factors | 28 |
| Item 2 | Unregistered Sales of Equity Securities and Use of Proceeds | 28 |
| Item 3 | Defaults upon Senior Securities | 28 |
| Item 4 | Mine Safety Disclosures | 28 |
| Item 5 | Other Information | 28 |
| Item 6. | Exhibits | 28 |
| Signatures | 29 | |
| i |
PART I. FINANCIAL INFORMATION
MIRA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Prepaid expenses | ||||||||
| Short-term investments – related party | ||||||||
| Total current assets | ||||||||
| Related party receivable | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Trade accounts payable and accrued liabilities | $ | $ | ||||||
| Accrued compensation – related party | ||||||||
| Advance payable to related party | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ Equity | ||||||||
| Preferred Stock, $ par value, shares authorized and issued or outstanding. | ||||||||
| Common Stock, $ par value; shares authorized, and shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively. | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 1 |
MIRA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Operating costs: | ||||||||||||||||
| General and administrative expenses | ||||||||||||||||
| Research and development expenses | ||||||||||||||||
| Total operating costs | ||||||||||||||||
| Other (expense) income: | ||||||||||||||||
| Interest income | ||||||||||||||||
| Other expense | ( | ) | ( | ) | ||||||||||||
| Loss from equity method investment – related party | ( | ) | ( | ) | ||||||||||||
| Total other (expense) income, net | ( | ) | ( | ) | ||||||||||||
| Net Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Basic and diluted loss per share | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Basic weighted average common stock shares outstanding | ||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 2 |
MIRA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balances, December 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Shares issued for vested RSU | ||||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, March 31, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, June 30, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balances, December 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common stock under ATM, net of costs | ||||||||||||||||||||
| Shares issued for vested RSUs | ( | ) | ||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, March 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common stock under ATM, net of costs | ||||||||||||||||||||
| Shares issued for vested RSUs | ( | ) | ||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, June 30, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 3 |
MIRA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operations | ||||||||
| Stock-based compensation expense | ||||||||
| Loss from equity method investment | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Trade accounts payable and accrued expenses | ( | ) | ( | ) | ||||
| Accrued compensation – related party | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Financing activities: | ||||||||
| Repayment of advance payable to related party | ( | ) | ||||||
| Offering costs | ( | ) | ||||||
| Proceeds from ATM equity offering | ||||||||
| Net cash (used) provided by financing activities | ( | ) | ||||||
| Net decrease in cash | ( | ) | ( | ) | ||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for taxes | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 4 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
Note 1. Description of business and summary of significant accounting policies
Overview
MIRA Pharmaceuticals, Inc. (the “Company” or “MIRA”) is a clinical-stage pharmaceutical company focused on the developing novel oral small-molecule therapeutics for chemotherapy-induced peripheral neuropathy (“CIPN”), chronic inflammatory pain, and obesity. The Company’s pipeline includes three product candidates: Ketamir-2, MIRA-55, and SKNY-1.
Ketamir-2 is an oral selective NMDA receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers and is being advanced toward Phase 2a clinical trial in CIPN under an active Investigational New Drug (“IND”) application.
MIRA-55 is an investigational oral small-molecule drug candidate in preclinical development targeting chronic inflammatory pain. The Company is advancing MIRA-55 toward IND-enabling studies, subject to successful completion of ongoing preclinical development activities and regulatory feedback.
SKNY-1 is an investigational oral small-molecule drug candidate in preclinical development for obesity. The Company is advancing SKNY-1 toward IND-enabling studies, subject to successful completion of ongoing preclinical development activities and regulatory feedback.
On June 13, 2025, the Company formed MIRAPHARM Acquisition, Inc., a wholly owned Delaware subsidiary, to support the acquisition of SKNY Pharmaceuticals, Inc., a private company developing SKNY-1 (see Note 5, Asset Acquisition) (“SKNY”). SKNY is considered a related party due to common shareholders and a shared licensor (see Note 3, License Agreement, Related Party). On September 29, 2025, the Company completed a stock-for-stock merger, pursuant to which SKNY became a wholly owned subsidiary of the Company.
As used herein, the Company’s Common Stock, par value $ per share, is referred to as the “Common Stock” and the Company’s Preferred Stock, par value $ per share, is referred to as the “Preferred Stock”.
Basis of Presentation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the condensed consolidated balance sheet, statements of operations, statements of changes in stockholders’ equity and cash flows for the interim periods presented. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.
The condensed consolidated financial statements include the accounts of MIRA and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated in consolidation.
Liquidity and going concern
The accompanying unaudited condensed financial statements have been prepared assuming the Company will continue as a going concern which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business.
| 5 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
As
of June 30, 2026, the Company had cash of approximately $
Historically, the Company has been primarily engaged in developing its product candidates. During these activities, the Company sustained substantial losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company’s ability to obtain significant additional external funding in the near term. Since inception, the Company has financed its operations through related party financings, its initial public offering, and ATM financings. Additional sources of financing may be sought by the Company. However, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
As of the date of filing this Quarterly Report on Form 10-Q, the Company has not generated revenues, continued to generate losses, and has insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date these unaudited condensed financial statements are issued. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of twelve months from the issuance date of this Quarterly Report. Management cannot provide assurance that the Company will ultimately achieve profitable operations or become cash flow positive or raise additional debt and/or equity capital. If the Company is unable to raise additional capital or secure additional lending in the near future, management expects that the Company will need to curtail its operations. These financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Reclassifications
Certain
prior period amounts have been reclassified to conform to the current period presentation. Specifically, related party accrued compensation
in the amount of $
Use of estimates
The preparation of these condensed consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results may differ from such estimates and such differences could be material. Significant estimates during the reporting periods include the value of equity investments held, value of shares of Common Stock issued in an acquisition, stock-based compensation and the deferred tax asset valuation allowance.
Certain Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties, including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
| 6 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
Cash
The
Company considers all highly liquid debt instruments and other short-term investments with maturities of three months or less, when purchased,
to be cash equivalents. The Company maintains cash and cash equivalent balances at two financial institutions that are insured by the
Federal Deposit Insurance Corporation (“FDIC”). The Company’s account at these institutions are insured by the FDIC
up to $
Investments in Equity Securities, Equity Method Investments
Investments in entities over which the Company has the ability to exercise significant influence, but does not control, are accounted for under the equity method of accounting in accordance with ASC Topic 323, Investments — Equity Method and Joint Ventures (“ASC 323”). Under the equity method, investments are initially recorded at cost and subsequently adjusted to reflect the Company’s proportionate share of the investee’s net income or loss, which is recorded in equity method income (loss) in the statements of operations. Distributions received from investees reduce the carrying amount of the investment. The Company evaluates its equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of the investment may not be recoverable.
Fair Value of Financial Instruments
The Company measures the fair value of financial instruments in accordance with GAAP, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of deferred offering costs to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value:
Level 1 - quoted prices in active markets for identical assets or liabilities.
Level 2 - quoted prices for similar assets and liabilities in active markets or inputs that are observable.
Level 3 - inputs that are unobservable (for example cash flow modeling inputs based on assumptions).
Revenue Recognition
The Company has not generated revenue from contracts with customers as of June 30, 2026. The Company will recognize revenue in accordance with ASC 606, Revenue from Contracts with Customers, when it satisfies its performance obligations by transferring control of promised goods or services to customers, in an amount that reflects the consideration to which the Company expects to be entitled.
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 behalf of the Company. 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.
General and Administrative Expenses
| 7 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
General and administrative expenses are primarily comprised of personnel costs, insurance expenses, professional services fees, travel and office expenses, and stock-based compensation. General and administrative expenses are expensed as incurred.
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of FASB ASC 718, Compensation - Stock Compensation. Stock-based compensation cost for equity-classified awards is measured at the grant-date fair value of the award and is recognized as expense over the requisite service period, generally on a straight-line basis. The Company estimates the fair value of stock-based awards on the date of grant using the Black-Scholes option pricing model, which requires the use of subjective assumptions including expected volatility, expected term, risk-free interest rate, and expected dividends. The Company has elected to account for forfeiture of stock-based awards as they occur.
Income Taxes
Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense.
Operating Segments
The Company’s Chief Operating Decision Maker (CODM) is its Chief Executive Officer, who reviews financial information presented for purposes of making operating decisions, assessing financial performance, and allocating resources. The Company operates as a single operating and reportable segment, consistent with the manner in which the CODM evaluates performance and allocates resources, see Note 8 for further information.
Leases
The Company has accounted for leases under the provisions of FASB ASC Topic 842, “Leases”, which requires the Company to recognize right-to-use (ROU) assets and lease liabilities for operating leases on the balance sheet.
Contingencies
In the normal course of business, the Company may be subject to loss contingencies, such as legal proceedings, amounts arising from contractual arrangements and claims arising out of the Company’s business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (ASC 450), the Company records accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company, in accordance with this guidance, does not recognize gain contingencies until realized or realizable.
| 8 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480) and FASB ASC Topic 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Common Stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The Company generally determines fair value of the warrants using a Black-Scholes valuation methodology.
A change in any of the terms or conditions of warrants is accounted for as a modification. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification which may result in a reduction of additional paid-in capital, recognition of costs for services rendered, or recognition as a deemed dividend.
Basic loss per share of Common Stock is computed by dividing net loss attributable to common shareholders by the weighted-average number of shares of Common Stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if stock options, restricted stock awards and warrants were to vest and be exercised. Diluted loss per share excludes, when applicable, the potential impact of stock options, common stock warrant shares, convertible notes, and other dilutive instruments because their effect would be anti-dilutive in the periods in which the Company incurs a net loss.
| June 30, | ||||||||
| 2026 | 2025 | |||||||
| Stock options | ||||||||
| Common stock warrants | ||||||||
| Totals | ||||||||
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date.
| 9 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”) and in January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, which clarified the effective date of ASU 2024-03. ASU 2024-03 will require the Company to disclose the amounts of purchases of inventory, employee compensation, depreciation, and intangible asset amortization, as applicable, included in certain expense captions in the Consolidated Statements of Operations, as well as qualitatively describe remaining amounts included in those captions. ASU 2024-03 will also require the Company to disclose both the amount and the Company’s definition of selling expenses. The Company is currently evaluating the impact of adopting ASU 2024-03.
Management has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will have a significant impact on the Company’s results of operations or financial position.
Note 2. Prepaid expenses
Prepaid expense consisted of the following at the dates indicated:
| June 30, 2026 | December 31, 2025 | |||||||
| Prepaid expense: | ||||||||
| Prepaid insurance | $ | $ | ||||||
| Other prepaid expense | ||||||||
| Total prepaid expenses | $ | $ | ||||||
Note 3. License agreement, related party
MIRALOGX
On November 15, 2023, the Company and MIRALOGX, LLC, a Florida limited liability company (“MIRALOGX”) entered into an exclusive license agreement (the “License Agreement”) to develop and commercialize Ketamir-2, a drug product containing 2-(2- chlorophenyl)-2-(methylamino) cyclopentan-1-one as an active agent in the United States, Canada and Mexico (the “Territory”). The exclusive license in the License Agreement includes the right of the Company and its subsidiaries to grant corresponding Sublicenses of the licensed intellectual property. On May 21, 2026, the parties entered into Amendment No. 1 to the License Agreement, which expanded the Licensed Territory to all countries in which Patent Rights exist. The Company and MIRALOGX have the same founder, who is also related to Company’s largest shareholder and thus MIRALOGX is considered a related party.
Pursuant
to the terms of the License Agreement, and subject to the conditions set forth therein, the Company paid MIRALOGX a one-time, nonrefundable
payment of $
Also,
in consideration of the License Agreement, the Company issued to MIRALOGX a common stock purchase warrant to purchase up to shares
of Common Stock (the “MIRALOGX Warrant”). The MIRALOGX Warrant is exercisable, in whole or in part, any time prior to November
15, 2028 at a cash exercise price of $
| 10 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
The Company and MIRALOGX have made customary representations and warranties in the License Agreement and have agreed to certain other customary covenants, including confidentiality, cooperation, and indemnity provisions. Either party may terminate the License Agreement for cause if the other party materially breaches or defaults in the performance of its obligations, and, if curable, such material breach remains uncured for thirty (30) days, except that Licensee’s breach of its obligation to use commercially reasonable efforts to develop the Licensed Product may be cured within one hundred twenty (120) days. Unless earlier terminated, the License Agreement will continue in effect until the last to expire of the patent rights licensed pursuant to the License Agreement.
In
the SKNY asset acquisition (See Note 4), the Company acquired the license to SKNY-1, a preclinical drug candidate (the “SKNY
License”) originally licensed from MIRALOGX by SKNY. In acquiring the rights to the SKNY License, the Company gained the
rights to commercialize SKNY-1 in the United States. On June 2, 2026, the parties entered into an Amended & Restated Exclusive
License Agreement, effective retroactively to March 16, 2025, which expanded the territory to worldwide and extended coverage to
include MIRA-55. Pursuant to the terms of the SKNY License, and subject to the conditions set forth therein, the Company will be
obligated to pay a royalty payment of
Note 4. Asset acquisition and short-term investment – related party
Acquisition of SKNY Pharmaceuticals, Inc.
On
March 19, 2025, the Company entered into a binding letter of intent (the “LOI”) with SKNY Pharmaceuticals, Inc.
(“SKNY”), a privately held Delaware corporation, which is a related party due to certain common shareholders and
licensor (see Note 3, License Agreement, Related Party). The LOI provided for the acquisition of SKNY by the Company through a
stock-for-stock merger with the Company’s merger subsidiary, which we formed on June 13, 2025 (the “Merger”). On
September 29, 2025 (the “Closing Date”), this merger was consummated. SKNY was the survivor of this merger and became
our wholly owned subsidiary. 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 worldwide to its drug candidate under license from MIRALOGX, a
related party of the Company (see Note 3, License Agreement, Related Party). As of June 2, 2026, the parties entered into an Amended
& Restated Exclusive License Agreement, effective retroactively to March 16, 2025, which expanded the Licensed Territory
worldwide and extended coverage to include MIRA-55 in addition to SKNY-1. The Merger was recorded as an asset acquisition from a
related party at acquired cost basis with two assets acquired, a license agreement and
shares in common stock of Telomir Pharmaceuticals, Inc. (NASDAQ: TELO) (“Telo”), a publicly traded preclinical stage
biotechnology company, which is a related party to MIRA due to certain common ownership, officers and directors. The
shares of Telo common stock were contributed to the Company on behalf of SKNY by SKNY’s largest stockholder. The
shares in Telo represented $
Short-Term Investment – Related Party
As
of June 30, 2026 and December 31, 2025, the Company owns approximately
| 11 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
Summarized unaudited financial information for Telo for the three and six months ended June 30, 2026, derived from the Company’s equity method investee’s unaudited consolidated financial statements, which are prepared in accordance with U.S. GAAP, is as follows:
| June 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Current assets | $ | $ | ||||||
| Noncurrent assets | ||||||||
| Current liabilities | ||||||||
| Noncurrent liabilities | ||||||||
| For the three months ended | For the six months ended | |||||||
| June 30, 2026 | June 30, 2026 | |||||||
| Net revenue | $ | $ | ||||||
| Net loss | ( | ) | ( | ) | ||||
Note 5. Related party transactions
Related party receivable
Amounts
due from MIRALOGX as of June 30, 2026 and December 31, 2025, which are presented as a related party receivable, in the accompanying condensed
consolidated balance sheets, totaled $
Accrued Compensation and Advances Payable to Related Party
As
of June 30, 2026 and December 31, 2025, the Company owed an aggregate of $ and $
As
of December 31, 2025, advances made by Mr. Aminov to the Company to cover certain Company-related payables totaled $
Asset Acquisition and Short-Term Investment
See Note 4 for asset acquisition from a related party and short term investment in a related party.
License Agreement
See Note 3.
Note 6. Commitments and contingencies
In the ordinary course of business, the Company enters into various agreements containing standard indemnification provisions. The Company’s indemnification obligations under such provisions are typically in effect from the date of execution of the applicable agreement through the end of the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. As of June 30, 2026 and December 31, 2025, no amounts have been accrued related to such indemnification provisions.
| 12 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
From time to time, the Company may be exposed to litigation in connection with its operations. The Company’s policy is to assess the likelihood of any adverse judgments or outcomes related to legal matters, as well as ranges of probable losses.
In April 2024, the Company moved to a virtual office model and does not have a physical office space as of June 30, 2026 and December 31, 2025.
Note 7. Stockholders’ equity
Capital stock
The
Company is authorized to issue
Common Stock sold under ATM
On
August 12, 2024, the Company filed a shelf registration statement with the SEC to facilitate the issuance of its Common Stock and entered
into an At-the-Market Offering Agreement (the “ATM Agreement”) with Rodman & Renshaw LLC, under which the Company may
offer and sell shares of its Common Stock, with an aggregate offering amount sold of up to $
During the three and six months ended June 30, 2026, the Company did not sell or issue any shares of Common Stock under ATM Agreement.
During
the three months ended June 30, 2025, under the ATM Agreement, the Company has sold and issued
shares of Common Stock at an average price per share of $
and received net proceeds of approximately $
Common Stock issued upon stock option exercise
There were no stock options exercised during the three and six months ended June 30, 2026 and 2025.
Common Stock issued for vested RSUs
On
March 29, 2026, Compensation Committee and the Board of Directors determined that a Phase I clinical trial milestone had been
achieved. As a result, the Company issued fully
vested restricted stock units (“RSU”) to its Chairman and Chief Executive Officer, under the Company’s Executive
Incentive Compensation Plan (as defined below) and the 2022 Omnibus Incentive Plan (as defined below). The RSUs vested
immediately, and shares
of Common Stock were issued, with $
During
the year ended December 31, 2024, the Company granted RSUs to its Chairman and Chief Executive Officer under the 2022 Omnibus
Incentive Plan, with an aggregate grant-date fair value of approximately $ million. The RSUs vested
| 13 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
In June 2022, the Company’s Board of Directors adopted, and its shareholders approved, the Company’s 2022 Omnibus Incentive Plan, as amended and restated in August 2023, (“2022 Omnibus Plan”). The 2022 Omnibus Plan authorizes the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any of its parent and subsidiary corporations’ employees, and for the grant of non- statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to the Company’s employees, directors, and consultants and any of its future subsidiary corporations’ employees and consultants. On September 11, 2025, the Company held its 2025 Annual Meeting of Shareholders (the “2025 Annual Meeting”) in which it was voted upon to increase the shares of Common Stock reserved under the plan from shares to shares. In addition, the number of shares available for issuance under the 2022 Omnibus Plan includes an annual increase on the first day of each fiscal year equal to the lesser of (a) shares, (b) % of the outstanding shares of all classes of its Common Stock as of the last day of the immediately preceding fiscal year, or (c) such other amount as the Company’s Board of Directors may determine.
As of June 30, 2026, the 2022 Omnibus Plan provides that shares of the Common Stock are reserved for issuance under the 2022 Omnibus Plan, with shares of Common Stock remaining available for issuance under the 2022 Omnibus Plan.
Stock-based compensation
The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Historically, the Company estimated expected price volatility based on the historical volatilities of a peer group as the Company did not have a multi-year trading history for its shares. Industry peers consist of several public companies in the biotech industry similar to the Company in size, stage of life cycle, and product indications. In September 2025, the Company commenced using the historical volatility of its shares as an estimate of expected share price volatility, as sufficient trading activity of the Company’s common stock had developed to provide a reasonable basis for estimating volatility.
Expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the 5-year U.S. Treasury yield curve in effect at the time of grant. The Company recognizes forfeitures as they occur.
| 14 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
| Number of Shares | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding as of December 31, 2025 | $ | $ | ||||||||||||||
| Granted | — | — | ||||||||||||||
| Forfeitures and Expired | — | — | ||||||||||||||
| Exercised | — | — | ||||||||||||||
| Outstanding as of March 31, 2026 | $ | $ | ||||||||||||||
| Granted | $ | — | $ | |||||||||||||
| Forfeitures and Expired | ( | ) | $ | — | — | |||||||||||
| Exercised | — | — | ||||||||||||||
| Outstanding as of June 30, 2026 | $ | $ | ||||||||||||||
| Vested and Exercisable as of June 30, 2026 | $ | $ | ||||||||||||||
On
June 12, 2026, the Company granted an aggregate of
The stock options granted on June 12, 2026 were valued using the Black-Scholes option-pricing model with the following assumptions: a stock price of $, an exercise price of $, a risk-free interest rate of %, expected volatility of %, an expected dividend yield of %, and an expected term of years.
The Company recognized $ and $ in stock-based compensation which includes compensation for stock options and vested RSUs in the three months ended June 30, 2026 and 2025, respectively. The Company recognized approximately $ and $ in stock-based compensation which includes compensation for stock options and vested RSUs in the six months ended June 30, 2026 and 2025, respectively.
As of June 30, 2026, there was approximately $ of unrecognized compensation cost related to unvested stock options granted under the 2022 Omnibus Plan that is expected to be recognized over the years.
Restricted Stock Units
On March 26, 2025, the Compensation Committee of the Company adopted the Company’s Executive Incentive Compensation Plan (the “EICP”) for Erez Aminov, its Chairman and Chief Executive Officer. Under the EICP, Mr. Aminov is eligible for certain long-term awards of up to performance-based and market condition-based restricted stock units of Common Stock based upon the Company reaching certain market capitalization values and the progress of the Company’s drug candidates. All awards under the EICP are subject to the approval of the Board of Directors and its Compensation Committee, and are not considered granted until such time. Furthermore, the Board of Directors and the Compensation Committee, each in its sole discretion, generally retain the right to amend, supplement, supersede or cancel any awards under the EICP for any reason, and reserve the right to determine whether and when to pay out any bonus amounts pursuant to or outside of the EICP, regardless of the achievement of the performance targets.
| 15 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
On
March 29, 2026, the Board of Directors and the Compensation Committee determined that certain milestone in Company’s Phase I clinical
trial had been achieved. As a result, on March 29, 2026, the grant date, the Company issued Mr. Aminov $
| Number of Restricted Shares | ||||
| Unvested as December 31, 2025 | ||||
| Granted | ||||
| Expired and forfeitures | ||||
| Vested | ( | ) | ||
| Unvested as March 31, 2026 | ||||
| Granted | ||||
| Expired and forfeitures | ||||
| Vested | ||||
| Unvested as June 30, 2026 | ||||
Warrants
In connection with various transactions and the initial public offering of the Company, the Company issued warrants. Warrant activity for the six months ended June 30, 2026 is summarized below:
| Weighted | ||||||||||||||||
| Weighted | Average | |||||||||||||||
| Number of | Average Exercise | Remaining Contractual | Aggregate | |||||||||||||
| Warrants | Price | Term (Years) | Intrinsic Value | |||||||||||||
| Balance Outstanding as January 1, 2026 | $ | $ | ||||||||||||||
| Granted | — | — | — | |||||||||||||
| Exercised | — | — | — | |||||||||||||
| Balance outstanding as June 30, 2026 | $ | $ | ||||||||||||||
| Exercisable, June 30, 2026 | $ | $ | ||||||||||||||
Note 8. Segment information
The Company operates in one reportable segment related to the development and commercialization of pharmaceuticals targeting neuropathic pain, inflammatory pain, weight management, and addiction-related disorders. The CODM for the Company is the Chief Executive Officer (the “CEO”). The CEO reviews operating results on an aggregate basis and manages the Company’s operations as a whole for the purpose of evaluating financial performance and allocating resources. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The CEO uses aggregate net loss to allocate resources in the annual budgeting and forecasting process and also uses that measure as a basis for evaluating financial performance regularly by comparing actual results with established budgets and forecasts.
| 16 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026 AND 2025
The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies within Note 1. The CEO assesses performance for the Company and decides how to allocate resources based on the aggregate net loss that is also reported on the income statement as net loss. The measure of segment assets is reported on the balance sheets as total assets.
The table below provides information about the Company’s revenue, significant segment expenses and other segment expenses.
| For the three months ended June 30, | For the six months ended June 30, |
|||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Operating costs: | ||||||||||||||||
| General and administrative expenses | ||||||||||||||||
| Research and development expenses | ||||||||||||||||
| Total operating costs | ||||||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | ||||||||||||||||
| Other expense | ( | ) | ( |
) | ||||||||||||
| Loss from equity method investments | ( | ) | ( |
) | ||||||||||||
| Total other income (expense), net | ( | ) | ( |
) | ||||||||||||
| Segment net loss | $ | ( | ) | $ | ( | ) | $ |
( |
) | $ |
( |
) | ||||
Note 9. Subsequent Events
On
July 28, 2026, the Company granted an aggregate of
| 17 |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Report”) contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act) that reflect our current expectations and views of future events. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. In particular, statements about our pre-clinical and clinical trials and expectations regarding such trials, the markets in which we operate, including growth of such markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this Report generally under the headings “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements.
We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed in this Report under the headings “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:
| ● | our ability to obtain and maintain regulatory approval of our product candidates; | |
| ● | our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately; | |
| ● | the implementation of our business model and strategic plans for our business, product candidates, and technology; | |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; | |
| ● | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; | |
| ● | the timing of anticipated regulatory filings; | |
| ● | the timing and availability of data from our clinical trials; | |
| ● | the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives; | |
| ● | our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; | |
| ● | our ability to advance product candidates into, and successfully complete, clinical trials; | |
| ● | our ability to recruit and enroll suitable patients in our clinical trials; |
| 18 |
| ● | our future expenses, capital requirements, need for additional financing, and the period over which we believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements; | |
| ● | our ability to obtain additional funding for our operations and development activities; | |
| ● | the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing; | |
| ● | the pricing and reimbursement of our product candidates, if approved; | |
| ● | the rate and degree of market acceptance of our product candidates, if approved; | |
| ● | developments relating to our competitors and our industry; | |
| ● | our ability to successfully commercialize and market our product candidates, if approved; | |
| ● | the potential market size, opportunity, and growth potential for our product candidates if approved. | |
| ● | the development of major public health concerns and the future impact of such concerns on our clinical trials, business operations and funding requirements; and | |
| ● | other risks and factors listed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2025. |
Given the risks and uncertainties set forth in this Quarterly Report on Form 10-Q, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this Report are not guarantees of future performance and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this Quarterly Report on Form 10-Q, they may not be predictive of results or developments in future periods.
Any forward-looking statement that we make in this Quarterly Report on Form 10-Q speaks only as of the date of such statement. Except as required by federal securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Quarterly Report on Form 10-Q.
| 19 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the condensed financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and in our most recent Annual Report on Form 10-K. In addition to historical information, this discussion contains forward-looking statements that involve risks, uncertainties and assumptions that could cause actual results to differ materially from our management’s expectations. See “Cautionary Note Regarding Forward-Looking Statements” contained above in this Quarterly Report on Form 10-Q. The Company assumes no obligation to update any of these forward-looking statements, unless required to do so by applicable law.
Overview
MIRA Pharmaceuticals, Inc. (the “Company” or “MIRA”) is a clinical-stage pharmaceutical development company focused on developing novel oral small-molecule therapeutics for chemotherapy-induced peripheral neuropathy (CIPN), chronic inflammatory pain, and obesity. The Company’s pipeline includes three product candidates: Ketamir-2, MIRA-55, and SKNY-1. On September 29, 2025, the Company completed the acquisition of SKNY Pharmaceuticals (“SKNY”), a related-party private company developing SKNY-1, expanding the Company’s pipeline into metabolic indications.
Ketamir-2 is an oral selective N-methyl-D-aspartate (“NMDA”) receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers and is being advanced toward a Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy (“CIPN”) under an active Investigational New Drug (“IND”) application. The Phase 1 study included both single-ascending-dose (“SAD”) and multiple-ascending-dose (“MAD”) cohorts, and dosing has been completed across all cohorts. Based on preliminary safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported. The Company is targeting initiation of a Phase 2a clinical trial in CIPN in the first quarter of 2027, subject to FDA clearance, site readiness, and other regulatory and operational factors.
MIRA-55 is an investigational oral small-molecule drug candidate being developed as a potential non-opioid therapy for chronic inflammatory pain. In preclinical studies, oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model, outperforming injected morphine, and acts through a mechanism distinct from THC without producing associated central nervous system effects. The Company has completed formulation optimization and is advancing chemistry, manufacturing and controls (CMC) activities to support future nonclinical and regulatory development. The Company has completed exploratory 7-day repeated-dose toxicology and toxicokinetic studies in both rat and dog models, with analysis ongoing. These findings support continued advancement toward IND-enabling studies.
SKNY-1 is an investigational oral small-molecule drug candidate being developed for obesity. In peer-reviewed preclinical studies published in the International Journal of Molecular Sciences, oral SKNY-1 demonstrated dose-dependent reductions in body weight, lipid normalization, and reduced hepatic triglyceride accumulation. The compound attenuated compulsive feeding and nicotine-seeking behaviors in validated experimental models and demonstrated a differentiated CNS safety profile without anxiety-related effects despite engaging central cannabinoid pathways, distinguishing it from earlier CB1-targeting agents. The Company has completed formulation optimization and is advancing chemistry, manufacturing and controls (CMC) activities to support future nonclinical and regulatory development. The Company has completed exploratory 7-day repeated-dose toxicology and toxicokinetic studies in both rat and dog models, with analysis ongoing. These findings support continued advancement toward IND-enabling studies.
Separately, the Company owns an undivided 50% interest, together with MIRALOGX LLC, in certain worldwide intellectual property rights relating to MIRA-55 and SKNY-1, for which global patent protection is pending.
The U.S. Drug Enforcement Administration (“DEA”) has completed its scientific review of Ketamir-2, MIRA-55, and SKNY-1 and concluded that each compound is not currently considered a controlled substance or listed chemical under the Controlled Substances Act (“CSA”) and applicable regulations.
We had net losses of $2.4 million and $3.3 million for the six months ended June 30, 2026 and 2025, respectively.
| 20 |
Components of our Results of Operations
Research and Development Expenses
Research and development expenses represent costs incurred to conduct research and development activities for our product candidates. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:
● contracted research, development, and manufacturing activities;
● clinical trial and regulatory-related expenses;
● patent-related costs;
● consulting arrangements; and
● other expenses incurred to advance our research and development activities.
Our operating expenses have historically consisted primarily of costs associated with patent prosecution, preclinical research and development activities, and clinical development activities for Ketamir-2. We expect research and development expenses to increase in future periods as we continue advancing Ketamir-2 toward Phase 2a clinical development in CIPN, progress MIRA-55 and SKNY-1 through IND-enabling activities, expand manufacturing capabilities, and pursue additional regulatory and clinical development activities.
In addition, we may evaluate opportunities to acquire, license, or otherwise develop additional product candidates and technologies, which could result in increased research and development expenses, including upfront payments, milestone obligations, and additional development costs.
The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.
General and Administrative Expenses
General and administrative expenses consist of employee-related expenses, including salaries, benefits, and travel, and other administrative functions, as well as fees paid for legal, accounting, and tax services, consulting fees, and facilities costs not otherwise included in research and development expense. Legal costs include general corporate legal fees. As a result of becoming a public company, we now incur additional expenses related to compliance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and The Nasdaq Stock Market (“Nasdaq”), as well as additional costs for insurance, investor relations, professional accounting and legal services, and other administrative expenses.
Other Income and Expense, net
Other income and expense, net consists of interest income earned from investment of excess operating cash and loss from our equity method investment in Telomir Pharmaceuticals, Inc., a related party.
Results of Operations for the three months ended June 30, 2026 and 2025 are as follows:
| Three Months Ended June 30, | Change in | |||||||||||
| 2026 | 2025 | Dollars | ||||||||||
| Revenues | $ | — | $ | — | $ | |||||||
| Operating costs: | ||||||||||||
| General and administrative expenses | 450,330 | 1,049,903 | (599,573 | ) | ||||||||
| Research and development expenses | 705,789 | 496,197 | 209,592 | |||||||||
| Total operating costs | 1,156,119 | 1,546,100 | (389,981 | ) | ||||||||
| Other (expense) income: | ||||||||||||
| Interest income | 35,130 | 8,623 | 26,507 | |||||||||
| Other expense | — | (235 | ) | 235 | ||||||||
| Loss from equity method investments – related party | (87,545 | ) | — | (87,545 | ) | |||||||
| Total other (expense) income, net | (52,415 | ) | 8,388 | (60,803 | ) | |||||||
| Net Loss | $ | (1,208,534 | ) | $ | (1,537,712 | ) | $ | 329,178 | ||||
| 21 |
General and Administrative Expenses
We incurred $0.5 million and $1.1 million in general and administrative expenses during the three months ended June 30, 2026 and 2025, respectively. The decrease in general and administrative expenses for $0.6 million during three month ended June 30, 2026 relate primarily to decrease in stock-based compensation for $0.5 million, and decrease in payroll related expenses and in in other general expenses of $0.1 million.
Research and Development Expenses
During the three months ended June 30, 2026, we incurred $0.7 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the three months ended June 30, 2025, we incurred $0.5 million in research and development expenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The increase in research and development expenses during 2026 is due to increases in development costs across our pipeline, including pre-IND submission work for MIRA-55 and SKNY-1, Phase 2a protocol advancement for Ketamir-2, and associated consulting and research activities. Major components of research and development expenses during the three months ended June, 2026 and 2025 are as follows:
| Three months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Consultants | $ | 139,982 | $ | 87,159 | ||||
| Research | 452,520 | 365,827 | ||||||
| Toxicology | 113,287 | 33,257 | ||||||
| Compensation | — | 9,954 | ||||||
| Total research and development expenses | $ | 705,789 | $ | 496,197 | ||||
Other Expense
We recognized loss from equity method investment of less than $0.1 million during the three months ended June 30, 2026, representing our proportionate share of the net loss of Telomir Pharmaceuticals, Inc. (“Telo”), in which we account for our investment under the equity method of accounting. No equity method loss was recognized during the three months ended June 30, 2025.
We earned less than $0.1 million in interest income during the three months ended June 30, 2026, which consisted of income earned from funds in a money market account, as compared to less than $0.1 million earned during the three months ended June 30, 2025.
| 22 |
Results of Operations for the six months ended June 30, 2026 and 2025 are as follows:
| Six Months Ended June 30, | Change in | |||||||||||
| 2026 | 2025 | Dollars | ||||||||||
| Revenues | $ | — | $ | — | $ | |||||||
| Operating costs: | ||||||||||||
| General and administrative expenses | 1,029,028 | 2,540,699 | (1,511,671 | ) | ||||||||
| Research and development expenses | 1,230,570 | 810,601 | 419,969 | |||||||||
| Total operating costs | 2,259,598 | 3,351,300 | (1,091,702 | ) | ||||||||
| Other (expense) income: | ||||||||||||
| Interest income | 80,038 | 30,044 | 49,994 | |||||||||
| Other expense | — | (235 | ) | 235 | ||||||||
| Loss from equity method investments – related party | (179,126 | ) | — | (179,126 | ) | |||||||
| Total other (expense) income, net | (99,088 | ) | 29,809 | (128,897 | ) | |||||||
| Net Loss | $ | (2,358,686 | ) | $ | (3,321,491 | ) | $ | 962,805 | ||||
General and Administrative Expenses
We incurred $1.0 million and $2.5 million in general and administrative expenses during the six months ended June 30, 2026 and 2025, respectively. The decrease in general and administrative expenses for $1.5 million during the six months ended June 30, 2026 relate primarily to decrease in stock-based compensation for $1.2 million, payroll related expenses for $0.2 million and in other general expenses for $0.1 million, partially offset by increased professional expense of less than $0.1 million.
Research and Development Expenses
During the six months ended June 30, 2026, we incurred $1.2 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the six months ended June 30, 2025, we incurred $0.8 million in research and development expenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The increase in research and development expenses during 2026 is due to increases in development costs across our pipeline, including pre-IND submission work for MIRA-55 and SKNY-1, Phase 2a protocol advancement for Ketamir-2, and associated consulting and research activities. Major components of research and development expenses during the six months ended June, 2026 and 2025 are as follows:
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Consultants | $ | 203,970 | $ | 201,165 | ||||
| Research | 913,313 | 521,403 | ||||||
| Toxicology | 113,287 | 58,045 | ||||||
| Compensation | — | 29,988 | ||||||
| Total research and development expenses | $ | 1,230,570 | $ | 810,601 | ||||
Other Expense
We recognized loss from equity method investment of less than $0.2 million during the six months ended June 30, 2026, representing our proportionate share of the net loss of Telo, in which we account for our investment under the equity method of accounting. No equity method loss was recognized during the six months ended June 30, 2025.
We earned less than $0.1 million in interest income during the six months ended June, 2026, which consisted of income earned from funds in a money market account, as compared to less than $0.1 million earned during the six months ended June 30, 2025.
| 23 |
Liquidity and Capital Resources
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 and through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022 and our initial public offering that occurred in August 2023. We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, and through proceeds of the ATM offering.
We used $2.4 million of cash in operating activities during the six months ended June 30, 2026, compared to $2.4 million in operating activities during the six months ended June 30, 2025.
We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit. We had an accumulated deficit of approximately $42.0 million as of June 30, 2026. As of June 30, 2026, we had cash and cash equivalents of approximately $3.6 million. The Company has insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date these unaudited condensed financial statements are issued. We currently expect that our cash and cash equivalents will be sufficient to fund our operations, development plans, and capital expenditures into at least the first quarter of 2027.
We did not have any material non-cancellable contractual obligations as of June 30, 2026.
Cash Flows
The following table provides information regarding our cash flows for the periods presented:
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Net cash (used in) provided by: | ||||||||
| Operating activities | $ | (2,406,872 | ) | $ | (2,429,678 | ) | ||
| Financing activities | (330,607 | ) | 327,222 | |||||
| Net change in cash | $ | (2,737,479 | ) | $ | (2,102,456 | ) | ||
Net Cash Used in Operating Activities
For the six months ended June 30, 2026, the cash used in operating activities of $2.4 million resulted from net losses of $2.4 million, offset by $0.1 million stock-based compensation expense, $0.2 million in loss from equity method investments, and by $0.4 million change in accounts payable, related party accrued compensation, and prepaid expenses.
For the six months ended June 30, 2025, operating activities used $2.4 million of cash. This was primarily driven by a net loss of $3.3 million, offset by $1.4 million stock-based compensation expense and $0.5 million used to pay down accounts payable and prepaid expenses. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development costs, consultant fees, and insurance expenses.
Net Cash Provided by Financing Activities
During the six months ended June 30, 2026, the Company repaid $0.3 million to a related party. The repayments were made pursuant to the terms of the underlying arrangements and reflect routine settlement of obligations as they became due.
During the six months ended June 30, 2025, financing activities received $0.3 million of cash, resulting from proceeds from sale of Common Stock under our ATM, less offering costs.
We currently anticipate that we will seek to monetize our product candidates, Ketamir-2, MIRA-55, and SKNY-1, at the end of our planned Phase II studies. Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development. Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all.
| 24 |
Accordingly, we may need to raise additional capital, which may be available to us through a variety of sources, including:
| ● | public equity markets; |
| ● | private equity financings; |
| ● | commercialization agreements and collaborative arrangements; |
| ● | sale of product royalty; |
| ● | grants and new license revenues; |
| ● | bank loans; and |
| ● | public or private debt. |
Additional funding, capital, or loans (including, without limitation, milestone, or other payments from potential commercialization agreements) may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug formulations or potential markets, any of which could have a material adverse effect on us, our financial condition, and our results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities or exercise of warrants and options, the issuance of such securities would result in ownership dilution to existing shareholders.
If we are unable to attract additional funds on commercially acceptable terms, it may adversely affect our ability to achieve our development and commercialization goals, which could have a material and adverse effect on our business, results of operations and financial condition.
We believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they become due into the first quarter of 2027. We do not have sufficient cash and cash equivalents as of the date of filing this Quarterly Report on Form 10-Q to support our operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date that the financial statements 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, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations; however, none of these alternatives are committed at this time. On July 27, 2026, the Company received notice from Nasdaq that it was not in compliance with the $1.00 minimum bid price requirement. The Company's common stock continues to trade on the Nasdaq Capital Market, and the Company intends to regain compliance. Failure to do so could adversely affect its ability to raise capital. 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 available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. 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. 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 our ability to meet our contractual obligations.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
| 25 |
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 1 to our financial statements.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
Summary of Critical Accounting Policies and 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.
Investments in Equity Securities, Equity Method
Investments in entities over which the Company has the ability to exercise significant influence, but does not control, are accounted for under the equity method of accounting in accordance with ASC Topic 323, Investments — Equity Method and Joint Ventures (“ASC 323”). Under the equity method, investments are initially recorded at cost and subsequently adjusted to reflect the Company’s proportionate share of the investee’s net income or loss, which is recorded in equity method income (loss) in the statements of operations. Distributions received from investees reduce the carrying amount of the investment. We evaluate our equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of the investment may not be recoverable.
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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The Company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore is not required to provide the information under this item per Item 305(e) of Regulation S-K.
| 26 |
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report on Form 10-Q, 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 June 30, 2026.
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 second quarter of 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 27 |
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.
We anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.
Item 1A. Risk Factors.
For a discussion of risk factors, please read Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “2025 Annual Report”). Such risk factors continue to be relevant to an understanding of our business, financial condition and operating results There are no material changes to the risk factors set forth in Part I, Item 1A, in our 2025 Annual Report, except as described below:
Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
On July 27, 2026, we received a letter from Nasdaq notifying us that for the preceding 30 consecutive business days the Company’s common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a period of 180 calendar days, or until January 25, 2027, in which to regain compliance. In order to regain compliance with the Minimum Bid Price Requirement, the closing bid price of the Company’s common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. In the event the Company does not regain compliance within this 180-day period, the Company may be eligible to seek an additional compliance period of 180 calendar days provided it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and further provides written notice to Nasdaq of its intent to cure the deficiency during this second compliance period by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq staff (the “Staff”) that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff’s delisting determination to a Nasdaq Hearings Panel (a “Panel”). However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by the Staff to a Panel, such appeal would be successful.
There is no guaranty that we will continue to meet the continued listing requirements to be traded on Nasdaq. If our common stock is delisted, an active trading market for our common stock may not be sustained and the market price of our common stock could decline. Delisting of our common stock could adversely affect our ability to raise additional capital through the public or private sale of equity securities, would significantly affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our common stock. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None
Item 3. Defaults upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
Item 6. Exhibits.
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this Form 10-Q.
| * | Filed herewith |
| ** | Furnished herewith |
| 28 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Date: August 12, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| Date: August 12, 2026 | ||
| By: | /s/ Andriy Mushak | |
| Name: | Andriy Mushak | |
| Title: | Chief Financial Officer | |
| (Principal Financial Officer) | ||
| 29 |