UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2026
☐
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 001-41765
MIRA
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Florida
85-3354547
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
1200
Brickell Avenue , Suite 1950 #1183 , Miami , Florida
33131
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number (including area code):
( 786) 432
9792
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
Common
stock, par value $0.0001
MIRA
The
Nasdaq Capital Market
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. Yes ☒
No ☐
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). Yes
☒ No ☐
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
☐
Non-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 May 14, 2026, there were 42,022,087
shares of the registrant’s common stock, par value $ 0.0001
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
15
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
17
Item
3.
Quantitative
and Qualitative Disclosures about Market Risk
22
Item
4.
Controls
and Procedures
22
Part
II. Other Information
23
Item
1
Legal
Proceedings
23
Item
1A.
Risk
Factors
23
Item
2
Unregistered
Sales of Equity Securities and Use of Proceeds
23
Item
3
Defaults
upon Senior Securities
23
Item
4
Mine
Safety Disclosures
23
Item
5
Other
Information
23
Item
6.
Exhibits
23
Signatures
24
i
PART I. FINANCIAL INFORMATION
MIRA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
March 31,
December 31,
2026
2025
(unaudited)
ASSETS
Current assets:
Cash
$ 4,815,031
$ 6,346,921
Prepaid expenses
21,748
28,146
Short-term investments
4,591,518
4,683,099
Total current assets
9,428,297
11,058,166
Related party receivable
35,439
35,439
Total assets
$ 9,463,736
$ 11,093,605
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Trade accounts payable and accrued liabilities
$ 34,008
$ 129,203
Accrued compensation – related party
80,753
242,258
Advance payable to related party
—
330,607
Total current liabilities
114,761
702,068
Total liabilities
114,761
702,068
Commitments and contingencies (Note 6)
-
-
Stockholders’ Equity
Preferred Stock, no par value, 10,000,000 shares authorized and none issued or outstanding.
—
—
Common Stock, no par value; 100,000,000 shares authorized, 42,022,087 and 41,938,587 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively.
4,202
4,194
Additional paid-in capital
50,075,131
49,967,549
Accumulated deficit
( 40,730,358 )
( 39,580,206 )
Total stockholders’ equity
9,348,975
10,391,537
Total liabilities and stockholders’ equity
$ 9,463,736
$ 11,093,605
The
accompanying notes are an integral part of these condensed consolidated financial statements.
1
MIRA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2026
2025
Three Months Ended March 31,
2026
2025
Revenues
$ —
$ —
Operating costs:
General and administrative expenses
578,698
1,490,796
Research and development expenses
524,781
314,404
Total operating costs
1,103,479
1,805,200
Other income (expense):
Interest income
44,909
21,421
Loss from equity method investment
( 91,582 )
—
Total other income (expense), net
( 46,673 )
21,421
Net Loss
( 1,150,152 )
( 1,783,779 )
Basic and diluted loss per share
$ ( 0.03 )
$ ( 0.11 )
Basic weighted average common stock shares outstanding
41,941,370
16,645,119
The
accompanying notes are an integral part of these condensed consolidated financial statements.
2
MIRA
PHARMACEUTICALS, INC.
CODENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balances, December 31, 2024
16,560,852
$ 1,656
$ 31,335,815
$ ( 29,137,721 )
$ 2,199,750
Issuance of common stock under ATM, net of costs
2,802
1
3,381
—
3,382
Shares issued for vested RSUs
250,000
25
( 25 )
—
—
Stock-based compensation
—
—
874,812
—
874,812
Net loss
—
—
—
( 1,783,779 )
( 1,783,779 )
Balances, March 31, 2025
16,813,654
$ 1,682
$ 32,213,983
$ ( 30,921,500 )
$ 1,294,165
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balances, December 31, 2025
41,938,587
$ 4,194
$ 49,967,549
$ ( 39,580,206 )
$ 10,391,537
Balance
41,938,587
$ 4,194
$ 49,967,549
$ ( 39,580,206 )
$ 10,391,537
Stock-based compensation
—
—
21,585
—
21,585
Shares issued for vested RSU
83,500
8
85,997
—
86,005
Net loss
—
—
—
( 1,150,152 )
( 1,150,152 )
Balances, March 31, 2026
42,022,087
$ 4,202
$ 50,075,131
$ ( 40,730,358 )
$ 9,348,975
Balance
42,022,087
$ 4,202
$ 50,075,131
$ ( 40,730,358 )
$ 9,348,975
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
MIRA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2026
2025
Three Months Ended March 31,
2026
2025
Cash flows from operating activities
Net loss
$ ( 1,150,152 )
$ ( 1,783,779 )
Adjustments to reconcile net loss to net cash used in operations
Stock-based compensation expense
107,590
874,812
Loss from equity method investments
91,582
—
Change in operating assets and liabilities:
Prepaid expenses
6,397
( 103,884 )
Trade accounts payable and accrued expenses
( 95,195 )
( 617,176 )
Related party accrued interest and accrued compensation
( 161,505 )
—
Net cash used in operating activities
( 1,201,283 )
( 1,630,027 )
Financing activities:
Repayment of advance payable to related party
( 330,607 )
—
Proceeds from sale of common stock
—
3,381
Net cash (used) provided by financing activities
( 330,607 )
3,381
Net decrease in cash
( 1,531,890 )
( 1,626,646 )
Cash, beginning of period
6,346,921
2,832,931
Cash, end of period
$ 4,815,031
$ 1,206,285
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 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 development company focused on developing novel oral small-molecule
therapeutics for neuropathic pain, inflammatory pain, weight management, and addiction-related conditions. The Company’s
pipeline includes three product candidates: Ketamir-2, MIRA-55, and SKNY-1.
Ketamir-2
is a next-generation oral N-methyl-D-aspartate (“NMDA”) receptor modulator that has completed Phase 1 clinical trial in
healthy volunteers and is being advanced toward Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy
(“CIPN”) under an active Investigational New Drug (“IND”) application.
MIRA-55 is a novel oral cannabinoid
analog in preclinical development for inflammatory pain and related inflammatory conditions.
SKNY-1 is a preclinical oral therapeutic
candidate designed to modulate CB1, CB2, and monoamine oxidase B (“MAO-B”) pathways and is being evaluated for weight management
and addiction-related indications, including nicotine dependence.
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 stockholders and a shared licensor. 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 $ 0.0001 per share, is referred to as the “Common Stock” and the
Company’s Preferred Stock, par value $ 0.0001 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 Pharmaceuticals, Inc. 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.
As
of March 31, 2026, the Company had cash of approximately $ 4.8 million. The Company used approximately $ 1.2 million of cash in operations
during the three months ended March 31, 2026, had a net loss of $ 1.2 million for the three months ended March 31, 2026 and had stockholders’
equity of approximately $ 9.3 million at March 31, 2026.
5
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
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 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. The Company is
seeking to raise capital through additional debt and/or equity financings to fund its operations in the future. 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 $ 242,258 ,
previously included within due to related party on the consolidated balance sheet as of December 31, 2025, has been reclassified to accrued
compensation – related party to conform to the current period classification.
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.
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 $ 250,000 . On March 31, 2026, the Company had cash in excess of FDIC limits of approximately $ 4.6 million. To reduce its risk associated
with the failure of such financial institution, the Company evaluates at least annually the rating of the financial institution in which
it holds deposits.
6
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
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 March 31, 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
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.
7
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
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 9 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, stockholder 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.
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.
8
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
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 and 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 recognized as a deemed dividend.
Loss
per Share
Basic
loss per share of Common Stock is computed by dividing net loss attributable to common stockholders 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 earnings 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.
The
following outstanding shares of common stock equivalents were excluded from the computation of the diluted net loss per share attributable
to Common Stock for the periods in which a net loss is presented because their effect would have been anti-dilutive.
Schedule of diluted net
loss per share attributed to common stock
2026
2025
March 31,
2026
2025
Stock options
6,072,242
4,452,154
Common stock warrants
1,763,750
1,763,750
Totals
7,835,992
6,215,904
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.
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 of 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.
9
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
Note
2. Prepaid expenses
Prepaid
expense consisted of the following at the dates indicated:
Schedule of prepaid expenses
March 31, 2026
December 31, 2025
Prepaid expense:
Prepaid insurance
$ 16,750
$ 19,847
Other prepaid expense
4,998
8,299
Total prepaid expenses
$ 21,748
$ 28,146
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 to sublicense the
licensed intellectual property. The Company and MIRALOGX have the same founder, who is also related to Company’s largest
stockholder 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 $ 0.1 million upon the signing of the Agreement and will be obligated to pay quarterly royalty payments on sales of the Ketamir-2
in the Territory of 8% of net sales and 8% of other revenue (such as milestone or sublicense payments) from licensed products.
Also,
in consideration of the License Agreement, the Company issued to MIRALOGX a common stock purchase warrant to purchase up to 700,000 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 $ 2.00 per share.
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 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. 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 8 % of net sales, with a minimum annual royalty of $ 250,000 , beginning in the calendar year during which revenue is first received
for a licensed product. Unless earlier
terminated, the SKNY License Agreement will continue in effect until the last to expire of the patent rights licensed pursuant to the
SKNY License.
10
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
Note
4. Asset acquisition and short-term investment
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 stockholders and
licensor. 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 United States to its drug candidate under license from MIRALOGX, a related party of the Company (see
Note 3, License Agreement, Related Party). The Merger was recorded as an asset acquisition from a related party at acquired cost
basis with two assets acquired, a license agreement and 3,521,127
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 3,521,127
shares of Telo common stock were contributed to the Company on behalf of SKNY by SKNY’s largest stockholder. The 3,521,127
shares 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”), the Company received the SKNY License with MIRALOGX which was recorded at its carryover basis of zero
and received the Telo shares and recorded their value as of the closing date as $ 4,718,310
based on the Telo closing price on September 29, 2025 of $ 1.34
per share. The 3,521,127
shares in Telo were recorded on the MIRA balance sheet as a Short-term equity investment.
Short-Term
Investment
The
Company owns approximately 10 % of the outstanding common stock of Telo and accounts for its investment under the equity method of accounting,
as it has the ability to exercise significant influence over Telo but does not control the entity. The investment is initially recorded
at cost and subsequently adjusted for the Company’s proportionate share of Telo’s net income or loss, which is included in
equity method loss in the accompanying statements of operations. For the three months ended March 31, 2026, the Company recognized equity
method loss of $ 91,582 . The carrying value of the investment was $ 4,591,518 and $ 4,683,099 as of March 31, 2026 and December 31, 2025,
respectively.
Summarized
unaudited financial information for Telo for the three months ended March 31, 2026, derived from the Company’s equity method
investee’ consolidated financial statements, which are prepared in accordance with U.S. GAAP, is as follows:
Schedule
of consolidated financial statements
March 31,
December 31,
2026
2025
Current assets
$ 5,789,536
$ 7,341,361
Noncurrent assets
—
—
Current liabilities
827,310
1,427,991
Noncurrent liabilities
—
—
For the Quarter Ended
March 31, 2026
Net revenue
$ —
Net loss
( 990,947 )
Note
5. Related party transactions
Due
from Related Party
Amounts
due from MIRALOGX as of March 31, 2026 and December 31, 2025, which are presented as a related party receivable, in the accompanying
condensed consolidated balance sheets, totaled $ 35,439 for both periods. These aforementioned amounts are composed of accounts payable
paid on behalf of a related party, specifically, research and development payables.
Due
to Related Party – Accrued Compensation and Advances Payable
As of March 31, 2026 and December
31, 2025, the Company owed an aggregate of $ 80,753 and $ 242,258 of accrued compensation, respectively, to its Chairman and Chief Executive
Officer, Erez Aminov, primarily related to deferred salary and bonus obligations.
As of December 31, 2025, advances
made by Mr. Aminov to the Company to cover certain Company-related payables totaled $ 330,607 . The outstanding advances payable were repaid
during the three months ended March 31, 2026, and no amounts remained outstanding as of March 31, 2026.
Asset
Acquisition
See
Note 4 for asset acquisition from a related party.
11
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
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 March 31, 2026 and December 31, 2025, no amounts have been accrued related to such indemnification provisions.
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 March 31, 2026 and December 31,
2025.
Note
7. Stockholders’ equity
Capital
stock
The
Company is authorized to issue 110,000,000
shares of capital stock, consisting of 100,000,000
shares of Common Stock and 10,000,000
shares of undesignated Preferred Stock, whose rights and privileges will be defined by the Board of Directors when a series of
Preferred Stock is designated.
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 $ 19,268,571 . On September 24, 2024, the Company
filed a prospectus supplement to amend the shelf registration statement to update the maximum amount eligible to be sold under the ATM
Agreement to $ 75 million.
During
the three months ended March 31, 2026 and 2025, the Company did not sell or issue any shares of Common Stock.
During the three months ended
March 31, 2025, under the ATM Agreement, the Company has sold and issued 2,802 shares of Common Stock at an average price
per share of $ 1.33 and received net proceeds of approximately $ 3,000 , after deducting commissions and other fees of approximately
$ 300 .
Common
Stock issued upon stock option exercise
There
were no stock options exercised during the three months ended March 31, 2026 and 2025.
Common
Stock issued for vested RSUs
On
March 29, 2026, the Board of Directors and the Compensation Committee determined that a Phase I clinical trial milestone had been achieved.
As a result, the Company issued 83,500 fully vested RSUs to Erez Aminov, its Chairman and Chief Executive Officer, under the Company’s
Executive Incentive Compensation Plan (the “EICP”) The RSUs vested immediately, and 83,500 shares of common stock were issued,
with approximately $ 86,005 recognized as compensation expense on the vesting date.
12
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
2022
Omnibus Incentive Plan
In
June 2022, the Company’s Board of Directors adopted, and its stockholders 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 Stockholders (the “2025 Annual Meeting”) in which it was voted upon to
increase the shares of Common Stock reserved under the plan from 5,000,000
shares to 8,000,000
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) 500,000
shares, (b) 5.0 %
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 March 31, 2026, the 2022 Omnibus Plan provides that 9,280,939 shares of the Common Stock are reserved for issuance
under the 2022 Omnibus Plan, all of which may be issued pursuant to the exercise of incentive stock options.
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.
During
the three months ended March 31, 2026 and 2025, there were no options were granted to the Company’s executive officers, management,
and consultants of the Company.
The
following table summarizes the Company’s employee and non-employee stock option activity under the 2022 Omnibus Plan for the following
period:
Schedule
of option activity
Number of
Shares
Weighted
Average
Exercise Price
Per Share
Weighted
Average
Remaining
Contractual
Life (Years)
Aggregate
Intrinsic Value
Outstanding as of December 31, 2025
6,072,242
$ 1.34
9.4
$ 1,067,000
Granted
—
—
—
—
Expired
—
—
—
—
Forfeitures
—
—
—
—
Outstanding as of March 31, 2026
6,072,242
$ 1.34
9.1
$ —
Exercisable as of March 31, 2026
6,018,075
$ 1.34
9.1
$ —
The
Company recognized approximately $ 21,585
and $ 874,812
in stock-based compensation which includes compensation for stock options and vested RSUs in the three months ended March 31, 2026
and 2025, respectively. No options were granted as of March 31, 2026 and 2025. As of March 31, 2026, there was approximately $ 10,312
of unrecognized compensation cost related to unvested stock options granted under the 2022 Omnibus Plan that is expected to
be recognized over the next year.
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 will be eligible for
certain long-term awards of up to 500,000 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.
On
March 29, 2026, the Board of Directors and the Compensation Committee determined the 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 $ 80,753
in cash and 83,500
vested restricted stock units, with the restricted stock units having an aggregate fair market value of $ 86,005 .
13
MIRA
PHARMACEUTICALS, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2026 AND 2025
The
following is RSU activity during the three months ended March 31, 2026:
Schedule
of restricted stock unit activity
Number of
Restricted Shares
Unvested as December 31, 2025
—
Granted
83,500
Expired and forfeitures
—
Vested
83,500
Unvested as March 31, 2026
—
Warrants
In
connection with various transactions and the initial public offering of the Company, the Company issued warrants. Warrant activity
for the three months ended March 31, 2026 is summarized below:
Schedule
of warrant activity
Weighted
Weighted
Average
Number of
Average
Exercise
Remaining
Contractual
Aggregate
Warrants
Price
Term (Years)
Intrinsic Value
Balance Outstanding as January 1, 2026
1,763,570
$ 3.88
2.60
$ —
Granted
—
—
—
—
Exercised
—
—
—
—
Balance outstanding as March 31, 2026
1,763,570
$ 3.88
2.35
$ —
Exercisable, March 31, 2026
1,763,570
$ 3.88
2.35
$ —
Note
8. Segment information
The
Company operates in one reportable segment related to the development and commercialization of pharmaceuticals targeting neurologic and
neuropsychiatric disorders. The CODM for the Company is the Chief Executive Officer (the “CEO”). The Company’s 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.
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.
Schedule
of segment expenses and other segment expenses
2026
2025
For the three months ended March 31,
2026
2025
Revenues
$ —
$ —
Operating costs:
General and administrative expenses
578,698
1,490,796
Research and development expenses
524,781
314,404
Total operating costs
1,103,479
1,805,200
Other income (expense):
Interest income
44,909
21,421
Loss from equity method investments
( 91,582 )
—
Total other income, net
( 46,673 )
21,421
Segment net loss
( 1,150,152 )
( 1,783,779 )
14
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;
15
●
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 Report, 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 Report. 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 Report, they may not be predictive
of results or developments in future periods.
Any
forward-looking statement that we make in this Report 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 Report.
16
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 neuropathic pain, inflammatory pain, weight management,
and addiction-related conditions. 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 and addiction-related indications.
Ketamir-2
is a next-generation oral 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; however, the database remains blinded
and final audited safety and pharmacokinetic analyses are ongoing. The Company is preparing to initiate a Phase 2a clinical trial in CIPN
in the first half of 2026, subject to regulatory feedback and site readiness.
MIRA-55
is a novel oral cannabinoid analog under preclinical investigation for inflammatory pain and related inflammatory conditions. Recent preclinical
studies demonstrated that MIRA-55 produced analgesic effects in validated inflammatory pain models and did not demonstrate cannabinoid-like
central nervous system side effects in behavioral safety assays. These findings support continued advancement toward IND-enabling studies.
SKNY-1 is a preclinical
oral therapeutic candidate designed to modulate CB1, CB2, and MAO-B pathways to influence appetite, energy balance, lipid metabolism,
and craving behavior. Preclinical studies demonstrated reductions in body weight gain, food consumption, and nicotine-seeking behavior,
while supporting a differentiated CNS safety profile relative to earlier CB1-targeting agents. The Company is currently evaluating potential
development pathways and indications for SKNY-1 as it advances toward IND-enabling studies.
Separately, the Company owns an undivided 50% interest, together with MIRALOGX LLC, in certain worldwide intellectual
property rights relating to SKNY-1 and MIRA-55, 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 $1.1 million and $1.8 million for the three months ended March 31, 2026 and 2025, respectively.
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.
17
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, net
Other
income, net consists of interest income earned from investment of excess operating cash, less interest expense, and the unrealized loss
on short-term investments.
Results
of Operations for the three months ended March 31, 2026 and 2025 are as follows:
Three Months Ended March 31,
2026
2025
Revenues
$ —
$ —
Operating costs:
General and administrative expenses
578,698
1,490,796
Research and development expenses
524,781
314,404
Total operating costs
1,103,479
1,805,200
Other income (expense):
Interest income
44,909
21,421
Loss from equity method investments
(91,582 )
—
Total other income, net
(46,673 )
21,421
Net Loss
(1,150,152 )
(1,783,779 )
General
and Administrative Expenses
We
incurred $0.6 million and $1.5 million in general and administrative expenses during the three months ended March 31, 2026 and 2025,
respectively. The decrease in general and administrative expenses for $0.9 million during three month ended March 31, 2026 relate primarily
to decrease in stock-based compensation for $0.8 million, payroll related expenses for $0.2 million partially offset by an increase in
professional services and other expenses for $0.1 million.
18
Interest
income (expense)
We earned less than $0.1 million in interest income during the three months ended March 31, 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 March
31, 2025.
Research
and Development Expenses
During the three months ended March 31, 2026, we incurred $0.5 million in research and development expenses,
which were primarily related to pre-IND submission work and consultants. During the three months ended March 31, 2025, we incurred $0.3
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 2025 is due to increase in development costs for MIRA-55. Major components of
research and development expenses during the three months ended March 31, 2026 and 2025 are as follows:
Three months ended March 31,
2026
2025
Consultants
$ 63,988
$ 114,006
Research
460,793
155,578
Toxicology
—
24,786
Compensation
—
20,034
Total research and development expenses
$ 524,781
$ 314,404
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
stockholder 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 $1.2 million in operating activities during the three months ended March 31, 2026, compared to $1.6 million in operating activities
during the three months ended March 31, 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 $40.7 million as of March
31, 2026. As of March 31, 2026, we had cash and cash equivalents of approximately $4.8 million. We currently expect that our cash and
cash equivalents 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 March 31, 2026.
Cash
Flows
The
following table provides information regarding our cash flows for the periods presented:
Three months ended March 31,
2026
2025
Net cash (used in) provided by:
Operating activities
$ (1,201,283 )
$ (1,630,027 )
Financing activities
(330,607 )
3,181
Net change in cash
$ (1,531,890 )
$ (1,626,646 )
19
Net
Cash Used in Operating Activities
For
the three months ended March 31, 2026, the cash used in operating activities of $1.2 million resulted from net losses of $1.2 million,
offset by $0.1 million stock-based compensation expense, $0.1 million in loss from equity method investments, and less than $0.3 million
change in accounts payable, related party accrued compensation, and prepaid expenses.
For
the three months ended March 31, 2025, operating activities used $1.6 million of cash. This was primarily driven by a net loss of $1.8
million and $0.7 million used to pay down accounts payable and prepaid expenses. These outflows were partially offset by $0.8 million
in stock-based compensation expense. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development
costs, consultant fees, and insurance expenses.
Net
Cash Provided by Financing Activities
During
the three months ended March 31, 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 three months ended March 31, 2025, financing activities received less than $0.01 million of cash, resulting from proceeds from sale of Common
Stock, 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.
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 stockholders.
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.
20
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. 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.
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. 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.
21
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.
Item
4. Controls and Procedures.
Evaluation of Disclosure Controls
and Procedures
As of the
end of the period covered by this Quarterly Report, our management, with the participation of our Chief Executive Officer (our principal
executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), conducted
evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls and other
procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files
or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and
forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure that information
required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to
the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.
Readers
are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting
will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide
only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within
our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood
of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all potential
future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies
or procedures may deteriorate.
Based on
this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were effective as of March 31, 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 first quarter of 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
22
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. Such risk factors continue to be relevant to an understanding of our business,
financial condition and operating results. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from
the risk factors reported in our 2025 Annual Report.
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.
Number
Description
3.1
Third Amended and Restated Articles of Incorporation of MIRA Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 to Form S-1 filed July 28, 2023).
3.2
Second Amended and Restated Bylaws of MIRA Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.2 to Form 10-K filed March 31, 2026)
31.1*
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of the Interim Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2**
Certification of the Interim Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL
Instance Document
101.SCH
Inline XBRL
Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive
Data File (embedded within the Inline XBRL document)
*
Filed
herewith
**
Furnished
herewith
23
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:
May 14, 2026
By:
/s/
Erez Aminov
Name:
Erez
Aminov
Title:
Chief
Executive Officer
(Principal
Executive Officer)
Date:
May 14, 2026
By:
/s/
Alan Weichselbaum
Name:
Alan
Weichselbaum
Title:
Chief
Financial Officer
(Principal
Financial Officer)
24
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.