UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2025
☐
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
Name
of each exchange on which registered
Common
Stock, par value $0.0001 per share
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, 2025, there were 16,919,623 shares of company common stock issued and outstanding.
MIRA
Pharmaceuticals, Inc.
Quarterly
Report on Form 10-Q
TABLE
OF CONTENTS
Page
Part
I. Financial Information
Item
1.
Condensed
Financial Statements (unaudited)
Condensed Balance Sheets as of March 31, 2025 (unaudited) and December 31, 2024
1
Condensed Statements of Operations for the three months ended March 31, 2025 and 2024 (unaudited)
2
Condensed Statements of Changes in Stockholders’ Equity for the three months ended March 31, 2025 and 2024 (unaudited)
3
Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (unaudited)
4
Notes to Condensed Financial Statements (unaudited)
5
Cautionary Note on Forward Looking Statements
13
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item
3.
Quantitative and Qualitative Disclosures about Market Risk
18
Item
4.
Controls and Procedures
18
Part II. Other Information
19
Item
1
Legal Proceedings
19
Item
1A.
Risk Factors
19
Item
2
Unregistered Sales of Equity Securities and Use of Proceeds
19
Item
3
Defaults upon Senior Securities
19
Item
4
Mine Safety Disclosures
19
Item
5
Other Information
19
Item
6.
Exhibits
20
Signatures
21
i
MIRA
PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS
March 31,
December 31,
2025
2024
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 1,206,285
$ 2,832,931
Prepaid expenses
158,614
54,729
Total current assets
1,364,899
2,887,660
Related party receivable
35,439
35,439
Total assets
$ 1,400,338
$ 2,923,099
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 100,673
$ 423,349
Accrued liabilities
5,500
300,000
Total current liabilities
106,173
723,349
Total liabilities
$ 106,173
$ 723,349
Stockholders’ Equity
Preferred Stock, $ 0.0001 par value, 10,000,000 shares authorized and none issued or outstanding.
-
-
Common Stock, $ 0.0001 par value; 100,000,000 shares authorized, 16,813,654 and 16,560,852 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively.
1,682
1,656
Additional paid-in capital
32,213,983
31,335,815
Accumulated deficit
( 30,921,500 )
( 29,137,721 )
Total stockholders’ equity
1,294,165
2,199,750
Total liabilities and stockholders’ equity
$ 1,400,338
$ 2,923,099
See
notes to condensed unaudited financial statements
1
MIRA
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
2025
2024
Three Months Ended
March 31,
2025
2024
Revenues
$ -
$ -
Operating costs:
General and administrative expenses
1,490,796
1,005,911
Research and development expenses
314,404
762,276
Total operating costs
1,805,200
1,768,187
Interest income
21,421
50,416
Net loss attributable to common stockholders
$ ( 1,783,779 )
$ ( 1,717,771 )
Basic and diluted loss per share
$ ( 0.11 )
$ ( 0.15 )
Weighted average common stock shares outstanding
16,645,119
14,780,885
See
notes to condensed unaudited financial statements
2
MIRA
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Shares
Amount
Capital
Deficit
Equity
Common Stock
Additional Paid-In
Accumulated
Total Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balances, December 31, 2023
14,780,885
$ 1,478
$ 25,657,930
$ ( 21,285,062 )
$ 4,374,346
Stock-based compensation
-
-
500,210
-
500,210
Net loss
-
-
-
( 1,717,771 )
( 1,717,771 )
Balances, March 31, 2024
14,780,885
1,478
$ 26,158,140
( 23,002,833 )
$ 3,156,785
Balances, December 31, 2024
16,560,852
$ 1,656
$ 31,335,815
$ ( 29,137,721 )
$ 2,199,750
Balances
16,560,852
$ 1,656
$ 31,335,815
$ ( 29,137,721 )
$ 2,199,750
Issuance of common stock for cash
2,802
1
$ 3,381
-
$ 3,381
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
Balances
16,813,654
1,682
32,213,983
( 30,921,500 )
1,294,165
See
notes to condensed unaudited financial statements
3
MIRA
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
2025
2024
Three
Months Ended
March 31,
2025
2024
Cash flows from operating activities
Net loss
$ ( 1,783,779 )
$ ( 1,717,771 )
Adjustments to reconcile net loss to net cash from operations
Stock-based compensation expense
874,812
500,210
Change in operating assets and liabilities:
Accounts payable and accrued expenses
( 617,176 )
97,697
Prepaid expenses
( 103,884 )
58,466
Other receivables
-
11,862
Net cash flows from operating activities
$ ( 1,630,027 )
$ ( 1,049,536 )
Financing activities:
Advances to affiliates
-
( 24,335 )
Proceeds from sale of common stock, less offering costs
3,381
-
Net cash flows provided by (used in) financing activities
$ 3,381
$ ( 24,335 )
Net change in cash and cash equivalents
( 1,626,646 )
( 1,073,871 )
Cash and cash equivalents, beginning of period
2,832,931
4,602,566
Cash and cash equivalents, end of period
$ 1,206,285
$ 3,528,695
Supplemental disclosure of cash flow information
Cash paid for interest
$ -
$ -
Cash paid for income taxes
$ -
$ -
See
notes to condensed unaudited financial statements
4
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Note
1. Description of business and summary of significant accounting policies :
Overview
MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical development company advancing two neuroscience programs targeting
neurologic and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55,
two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function.
The
U.S. Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 and MIRA-55 concluded that it would not be considered
a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.
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”.
Operating
updates
Acquisition
letter of intent
On
March 19, 2025, we entered into a binding letter of intent (the “LOI”)
with SKNY Pharmaceuticals, Inc. (“SKNY”), a privately held Delaware corporation, to acquire SKNY through a stock exchange
transaction (the “Acquisition”). The Acquisition will bring SKNY-1, a novel oral drug candidate targeting weight loss and
smoking cessation-two of the leading causes of preventable death-into MIRA’s development pipeline. Under the LOI, SKNY
will provide a $ 5 million capital infusion in cash or cash equivalents, further strengthening MIRA’s financial position and
supporting future growth initiatives.
SKNY
holds exclusive rights to its compounds in the United States, Canada, and Mexico which is license from Miralogx, a related party of the
Company. Under the terms of the LOI, SKNY will merge into us through a stock exchange, with each outstanding share of SKNY’s
common stock being exchanged for shares of our common stock. The exact exchange ratio will be determined by an independent third-party
valuation firm (the “Independent Valuator”) based on the relative values of both companies. The completion of the Acquisition
is contingent upon the Independent Valuator determining that SKNY’s valuation is at least equal to or greater than that of ours.
We expect to account for the Acquisition as an asset acquisition
and the purchase price and related costs will be allocated to the various assets on a relative fair value basis in accordance with FASB
ASC 805, Business Combinations. Upon completion of the Acquisition, all SKNY’s assets, including its drug candidates,
will become wholly owned by us, further expanding our development pipeline. On May 8, 2025, we announced that our Board of Directors had approved our planned acquisition of SKNY Pharmaceuticals,
Inc. (the “Merger”), following the completion of independent valuation reports on both companies. The Merger remains subject
to MIRA and SKNY’s shareholder approval.
Basis
of presentation
The
accompanying unaudited condensed financial statements include the accounts of the Company and have been prepared in accordance
with accounting principles generally accepted in the United States (“GAAP”) for interim financial information, the instructions
to Quarterly Report on Form 10-Q, and Regulation S-X. These financial statements do not include all information and notes required
by GAAP for annual financial statements. However, except as disclosed herein, there has been no material change in the information disclosed
in the notes to the financial statements included in our Form 10-K for the year ended December 31, 2024. In the opinion of management, all adjustments,
consisting of normal recurring adjustments considered necessary for a fair presentation of interim financial information, have been included.
Operating results for the periods presented are not necessarily indicative of expected results for the full year. Additionally, certain
prior period amounts have been reclassified to conform to current period presentation in the accompanying unaudited condensed consolidated
financial statements.
5
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
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, marketing expenses, amortization, insurance expenses, professional
services fees, travel and office expenses, and stock-based compensation
Use
of estimates
The
preparation of financial statements in accordance with GAAP requires the Company’s management to make estimates and assumptions
that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from such estimates
and such differences could be material. Significant estimates during the reporting periods include stock-based compensation and the deferred
tax asset valuation allowance.
Cash
and cash equivalents
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 is insured by the FDIC
up to $ 250,000 . On March 31, 2025, the Company had cash in excess of FDIC limits of approximately $ 1.0 million. Any material loss that the Company may experience in the future could have
an adverse effect on its ability to pay its operational expenses or make other payments and may require the Company to move its cash to
other high quality financial institutions. The Company deems these institutions to be of high caliber and, to date, has not experienced
any losses related to these holdings.
Stock-based
compensation
The
Company accounts 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. The Company estimates 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. The Company has elected to account for forfeiture of stock-based awards as
they occur.
6
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
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).
Earnings
(loss) per Share
Earnings
(loss) per share is computed in accordance with ASC Topic 260, “ Earnings per Share ” Basic weighted-average
number of shares of common stock outstanding for the period ended March 31, 2025 and March 31, 2024 include the shares of the
Company issued and outstanding during such period, on a weighted average basis. The basic weighted average number of shares of
common stock outstanding excludes common stock equivalents such as stock options and warrants, while diluted weighted average number
of shares outstanding includes such stock options and warrants. During the three months ended March 31, 2025 and 2024, outstanding
aggregate stock options and warrants of 6,215,904
and 3,551,904
respectively, were not included in the computation of diluted earnings per share, because to do so would have had an antidilutive
effect.
Recent
accounting pronouncements not yet adopted
In
November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic
220-40), which requires entities to provide more detailed disaggregation of expenses in the income statement, focusing on the nature
of the expenses rather than their function. The new disclosures will require entities to separately present expenses for significant
line items, including but not limited to, depreciation, amortization, and employee compensation. Entities will also be required to provide
a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively,
disclose the total amount of selling expenses and, in annual reporting periods, provide a definition of what constitutes selling expenses.
This pronouncement is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning
after December 15, 2027, with early adoption permitted. The Company does not expect the adoption of this new guidance to have a material
impact on the consolidated financial statements.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . This new standard
requires a company to expand its existing income tax disclosures, specifically related to the rate reconciliation and income taxes paid.
The standard will be effective beginning in fiscal year 2025, with early adoption permitted. The new standard is expected to be applied
prospectively, but retrospective application is permitted. We are currently evaluating the impact of ASU 2023-09 on the consolidated
financial statements and related disclosures. The Company does not expect the adoption of this new guidance to have a material impact
on the consolidated financial statements.
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.
7
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Note
2. Going concern
The
accompanying 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, 2025, the Company had cash of approximately $ 1.2 million, and historically the Company has had no revenues. The Company
has used approximately $ 1.6 million of cash in operations during the three months ended March 31, 2025, had a net loss of approximately
$ 1.8 million in the three months ended March 31, 2025 and had stockholders’ equity of approximately $ 1.3 million at March
31, 2025, versus stockholders’ equity of approximately $ 2.2 million at December 31, 2024.
Historically,
the Company has been primarily engaged in developing Ketamir-2 and MIRA-55. 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. The Company maintains
an effective shelf registration statement with the Securities and Exchange Commission (SEC) for the issuance of shares of common
stock under various types of equity offerings, including the shares of common stock under our At The Market (ATM) equity program
(Note 5). The Company expects to be able to fund operations to the third quarter of 2025, with the cash on hand. However, the
Company has the ability to issue common stock under its shelf registration statement to assist in liquidity needs.
As
of the date of filing this Report, the Company will continue to generate losses and have insufficient cash and cash equivalents on hand
to support its operations for at least the 12 months following the date the 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 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
our 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.
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 our 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 $ 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 the Company’s 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.
8
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
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, unless earlier terminated.
Note
4. Related party transactions :
Due
from related parties – Amounts due from MIRALOGX as of March 31, 2025 and December 31, 2024, which are presented as a related
party receivable, in the accompanying condensed balance sheets, totalled $ 0.04 million. These aforementioned amounts are composed of accounts
payable paid on behalf of a related party, specifically research and development payables. There has been no related party activity since
December 31, 2024.
License
agreement - See Note 3.
Note
5. Stockholders’ equity :
Capital
stock
The
Company has the authority 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.
On
August 12, 2024, the Company filed a shelf registration statement with the SEC to facilitate the issuance of our 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.
For
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 .
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. Expected price volatility is based on the historical
volatilities of a peer group as the Company does 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. The Company intends
to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information
regarding the volatility of the Company’s own stock price becomes available, or unless circumstances change such that the identified
companies are no longer similar to the Company, in which case, more suitable companies whose share prices are publicly available would
be utilized in the calculation.
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.
9
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
During
the three months ended March 31, 2024, a total of 725,000 options to purchase Common Stock, with an aggregate fair market value
of approximately $ 0.8 million were granted to the members of the Company’s Board of Directors, executive officers and consultants
of the Company. Options have a term of 10 years from the grant date. These option vest as follows: (i) Board of Director and
consultant options vested 50% at grant and the remaining vest at one-year anniversary of date of grant, and (ii) executive officer
option grants vest 50% at 6 months from date of grant and at one-year anniversary of grant date.
During
the three months ended March 31, 2025, there were no grants of stock options.
The
following is option activity during the three months ended March 31, 2025 and 2024.
Schedule
of option activity
Number of Shares
Weighted Average Exercise Price Per Share
Weighted Average Remaining Contractual Life (Years)
Aggregate Intrinsic
Value
Outstanding as December 31, 2023
1,215,001
$ 5.29
8.7
$ -
Options granted
725,000
$ 1.20
-
$ -
Forfeitures
( 151,667 )
$ 5.0
-
$ -
Outstanding as March 31, 2024
1,788,334
4.07
$ -
Outstanding as December 31, 2024
4,235,666
$ 1.83
9.2
$ -
Options granted
-
$ -
-
$ -
Forfeitures
( 33,332 )
$ 2.19
-
$ -
Outstanding as March 31, 2025
4,202,334
$ 1.83
9
$ -
Exercisable, March 31, 2025
2,702,888
$ 2.09
8.7
$ -
As
of March 31, 2025, options exercisable totaled 2,702,888 . There is approximately $ 0.4 million of unrecognized compensation costs related
to non-vested share-based compensation awards, which will be expensed through 2026.
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 restricted stock units of the Company’s common stock, par value $ 0.001
upon the Company achieving specified milestones 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 and the
Committee. Furthermore, the Board and the 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. As the awards have not
been granted officially through board approval, there is no grant date under ASC 718, and therefore no measurement date
for the value of such awards and no expense has been
recorded for the awards granted during the three months ended March 31, 2025.
10
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
The
following is RSU activity during the three months ended March 31, 2025:
Schedule
of restricted stock unit activity
Number of Restricted Shares
Outstanding
as December 31, 2024
500,000
RSU’s granted
-
Vested
( 250,000 )
Expired
-
Forfeitures
-
Outstanding as March 31,
2025
250,000
During
the year ended December 31, 2024, a total of 500,000 restricted
stock units (“RSU”), with an aggregate fair market value of approximately $ 0.6 million
were granted to the Company’s Chief Executive Officer under the 2022 Omnibus Incentive Plan. These RSU’s vest as
follows: (i) 50 %
on February 12, 2025 (ii) 50 %
at 6-month anniversary of the date of grant. The awards were fair valued using the closing price of the stock of $ 1.19 on
December 6 th , 2024.
As
of March 31, 2025, there was approximately $ 0.2 million unrecognized compensation cost related to unvested RSU’s awards granted.
These costs will be expensed through second quarter of 2025.
Warrants
The
Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements.
Warrant activity for the three months ended March 31, 2025 and 2024 is summarized below:
Schedule of warrant activity
Weighted
Weighted
Average
Number of
Average
Exercise
Remaining
Contractual
Aggregate
Warrants
Price
Term (Years)
Intrinsic Value
Outstanding as December 31, 2023
1,763,570
$ 3.88
4.6
-
Granted
-
$ -
-
-
Outstanding as March 31, 2024
1,763,570
$ 3.88
4.4
-
Outstanding as December 31, 2024
1,763,570
$ 3.88
3.6
-
Granted
-
$ -
-
-
Outstanding as March 31, 2025
1,763,570
$ 3.88
3.4
-
Exercisable, March 31, 2025
1,763,570
$ 3.88
3.4
-
11
MIRA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Note
6. Segment Information
The
Company operates in one reportable segment related to the development and commercialization of pharmaceuticals targeting neurologic and
neuropsychiatric disorders. The Chief Operating Decision Maker for the Company is 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 herein and in the 2024 Annual Report. 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
2025
2024
Three Months Ended March 31,
2025
2024
Revenues
$ —
$ —
Less segment expenses:
Research and development
314,404
762,276
General and administrative
1,490,796
1,005,911
Loss from operations
$ 1,805,200
1,768,187
Plus:
Interest income
21,421
50,416
Segment net loss
$ ( 1,783,779 )
$ ( 1,717,771 )
Note
7. Subsequent Events
ATM
Offering
On
April 16, 2025, 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 $ 7 million.
From
April 1, 2025 through May 14, 2025, under the ATM Agreement, the Company sold and issued 105,969 shares of Common Stock at
an average price per share of $ 0.90 , and received net proceeds of approximately $ 0.1 million, after deducting commissions and other
fees of $ 0.003 million.
12
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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 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 heading “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 heading “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
reliance on related parties for potential funding and our license for Ketamir-2;
●
our potential transaction with SKNY Pharmaceuticals, Inc.;
●
our
ability to obtain and maintain regulatory approval of our product candidates;
●
our
ability to successfully commercialize and market our product candidates, if approved;
●
our
ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;
●
the
potential market size, opportunity, and growth potential for our product candidates, if approved;
●
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
initiation, timing, progress and results of our clinical studies and clinical trials, and our research and development programs;
●
the
timing of anticipated regulatory filings;
●
the
timing of availability of data from our clinical trials;
●
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 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;
13
●
the
timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;
●
the
pricing and reimbursement of our product candidates, if approved;
●
the
rate and degree of market acceptance of our product candidates, if approved;
●
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;
●
developments
relating to our competitors and our industry;
●
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” in our Annual Report on Form 10-K for the year ended December 31, 2024
and elsewhere in this Report.
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. In evaluating our business, you should carefully consider the information set forth under
the heading “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the
SEC on March 28, 2025.
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.
14
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere
in this Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s
actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a
result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Report and in the Company’s
other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” above.
As
used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated,
the terms “the Company”, “we”, “us”, “our” and similar terminology refer to MIRA Pharmaceuticals,
Inc.
Background
of our Company
We are a clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range
of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada, and Mexico for Ketamir-2, a novel,
patent-pending oral ketamine analog currently under clinical investigation. Ketamir-2 is being developed for the treatment of neuropathic
pain, with a Phase 1 clinical trial currently underway in healthy subjects. Preclinical studies have been conducted and are ongoing as
part of the oral development program to further evaluate its potential in treating depression and post-traumatic stress disorder (PTSD).
In addition, we have successfully formulated a topical cream version of Ketamir-2 and will be initiating preclinical studies to evaluate
its efficacy in treating inflammatory pain.
Additionally,
our novel oral pharmaceutical marijuana molecule, MIRA-55, is being studied for its potential to alleviate anxiety and cognitive decline,
symptoms commonly associated with early-stage dementia. If approved by the FDA, MIRA-55 could represent a significant advancement in
the treatment of various neuropsychiatric, inflammatory, and neurologic disorders.
The
DEA’s scientific review of Ketamir-2 and MIRA-55 concluded that it would not be considered a controlled substance or listed
chemical under the CSA and its governing regulations.
We
were incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including our pharmaceutical
development program, in late 2020.
Highlights-
First Quarter and Beyond
● March
4, 2025: We announced the approval and upcoming initiation of our Phase 1 clinical
trial for Ketamir-2, with subject recruitment beginning in Q1 2025.
● March
19, 2025: We announced that we had signed a binding letter of intent (LOI) to acquire
SKNY Pharmaceuticals, Inc. The transaction includes a $5 million capital infusion—comprised
of cash or equivalent consideration—into MIRA, reinforcing our financial position and
supporting the advancement of SKNY-1, a preclinical-stage oral drug candidate for weight
loss and smoking cessation.
● April
1, 2025: We announced the enrollment of the first subjects in our Phase 1 clinical
trial of Ketamir-2, being conducted in Israel.
● April
16, 2025: We announced compelling data demonstrating the efficacy of the oral ketamine
analog, Ketamir-2, in a validated animal model of diabetic neuropathy.
● April
23, 2025: We announced the completion of in vitro release testing (IVRT) for our
topical formulation of Ketamir-2. The formulation is under investigation for localized applications
in pain-related conditions.
● May
6, 2025: We announced positive results from a neurotoxicity study of Ketamir-2,
a novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration
(FDA) prior to initiating human dosing in the United States.
● May
8, 2025: We announced that our Board of Directors had approved the planned acquisition
of SKNY Pharmaceuticals, Inc. (the “Merger”), following the completion of independent
valuation reports on both companies. The Merger remains subject to shareholder approval from
both MIRA and SKNY.
Amendment to Employment Agreement
On May 13, 2025, Erez Aminov amended his employment with the Company to adjust his annual base salary to $485,000
(the “Amendment”). For the full text of the Amendment, please see Exhibit 10.1 of this Form 10-Q.
Critical
Accounting Estimates
Research
and development expenses
Research
and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract
research organizations and consultants, who conduct research and development activities on our behalf. Patent-related costs, including
registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in which they
are incurred.
Stock-based
compensation
We
account for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation”, which requires
the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants based
on estimated fair values on the grant date. We estimate the fair value of stock-based awards on the date of grant using the Black-Scholes
model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service
periods using the straight-line method. We have elected to account for forfeiture of stock-based awards as they occur.
15
Results
of Operations
For
the three months ended March 31, 2025 compared to the three months ended March 31, 2024
Research
and Development Expenses. We incurred $0.3 million in research and development expenses during the three months ended March 31,
2025, relating to initial payment for toxicology study costs. Research and development expenses include clinical, toxicology and
consultant expenses. During the three months ended March 31, 2024, we incurred $0.8 million in research and development expenses,
which were primarily related to initial payments for clinical research projects for Ketamir-2. The decrease is primarily due to
Ketamir-2 moving into Phase 1 trials that began in the later part of Q1 2025 compared to Ketamir-2 R&D ramping up in the prior
year.
General
and Administrative Expenses . We incurred $1.5 million and $1.0 million in general and administrative expenses during the three
months ended March 31, 2025 and 2024, respectively. General and administrative expenses are composed primarily of compensation,
insurance, professional fees, stock-based compensation, administration and other related costs. The increase is primarily due to an
increase in stock-based compensation related to compensation to the officers, directors, and employees.
Interest
income . We earned $0.02 and $0.05 million in interest income during the three months ended March 31, 2025 and 2024, respectively.
Interest income during the three months for each respective period consisted of interest earned on bank accounts.
Liquidity
and Capital Resources
Sources
of Liquidity and Going Concern
Since
our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder
and an affiliated company, through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and
during 2022, and by the proceeds from our completed initial public offering in August 2023. We intend to finance our clinical development
programs and working capital needs from existing cash, and potentially new sources of debt and equity financing. We may enter into new
licensing and commercial partnership agreements.
Historically,
we have been primarily engaged in developing MIRA-55 and, more recently, have also been focusing on the development of Ketamir-2. During
these activities, we have sustained substantial losses. Our ability to fund ongoing operations and future clinical and clinical trials
required for FDA approval is dependent on our ability to obtain significant additional external funding in the near term. We expect to
be able to fund operations through the fourth quarter of 2025, with the issuance of common stock under our shelf registration statement
described in Note 5 of the accompanying financial statements. We will require additional financing to fund our operations, to continue
and complete clinical and clinical development activities and to commercially develop and ultimately launch our product candidates.
However, and particularly given our early-stage nature and the significant time and capital required to implement our business plan,
there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
On
August 12, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC. The terms of any offering under the shelf
registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the
SEC prior to completion of any such offering.
We
expect to continue to generate losses in the foreseeable future. Our liquidity needs will be determined largely by the budgeted operational
expenditure incurred in regard to the progression of our product candidates. We do not have sufficient cash and cash equivalents as of
the date of filing this Report to support our operations for at least the 12 months. These conditions raise substantial doubt about our
ability to continue as a going concern through 12 months after the date the financial statements included in this Report are issued.
16
To
alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional
capital, through public equity offerings under the ATM Agreement and strategic transactions, including potential alliances and drug product
collaborations; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful
in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic
transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise
substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if they are not available
on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations. The failure to obtain
sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities
and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations
will be materially adversely affected, or, in the worst case scenario, we could be forced to cease operations and dissolve. In addition,
the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns
about its ability to meet our contractual obligations.
We
did not have any material non-cancellable contractual obligations as of March 31, 2025.
Cash
Flows
The
following table provides information regarding our cash flows for the periods presented:
Three months Ended March 31,
2025
2024
Net cash flows from:
Operating activities
$ (1,630,027 )
$ (1,049,536 )
Financing activities
3,381
(24,335 )
Net change in cash
$ (1,626,646 )
$ (1,073,871 )
Net
Cash Flows from Operating Activities
The
cash used in operating activities resulted primarily from our net losses, stock-based compensation expense, changes in prepaid expenses
and changes in components of accounts payable and accrued 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.
For
the three months ended March 31, 2024, operating activities used $1.0 million of cash, primarily due to a net loss of $1.7 million, offset
by $0.5 million in stock-based compensation expense and $0.2 million in accounts payable, accrued and prepaid expenses. Accounts payable,
accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, and insurance costs.
Net
Cash Flows from Financing Activities
For
the three months ended March 31, 2025, financing activities provided $0.003 million of cash, resulting from proceeds from sale of common
stock, less offering costs.
For
the three months ended March 31, 2024, financing activities used $0.02 million of cash, resulting from $0.02 million in advances to affiliates.
17
Nasdaq
Listing Compliance Risk Due to Stockholders’ Equity Deficiency
We
have received a notice from Nasdaq indicating that we are not in compliance with its minimum stockholders’ equity requirement, and there
can be no assurance that we will be able to regain compliance or maintain our listing.
On
April 8, 2025, we received a notification from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as of the filing
of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, we were not in compliance with Nasdaq Listing Rule
5550(b)(1), or the Rule, which requires listed companies to maintain a minimum of $2.5 million in stockholders’ equity. In
accordance with Nasdaq’s procedures, we submitted a plan to regain compliance.
Our
plan includes a number of steps intended to cure the deficiency, including the anticipated closing of a strategic merger with SKNY
Pharmaceuticals, Inc. in the second or third quarter of 2025, which we expect will add approximately $5 million in cash or other
assets to our balance sheet. In addition, we currently have access to approximately $7 million in available capital through our
at-the-market (ATM) offering facility (Note 5 of accompanying financial statements), which we may utilize to further strengthen our
stockholders’ equity position. On May 7, 2025, Nasdaq accepted our plan and granted an extension to regain compliance with the Rule. The terms of
the extension are as follows: on or before October 6, 2025 the company must complete the financing transactions and evidence compliance
with the Rule.
While
we believe these actions will enable us to regain compliance with Nasdaq’s listing requirements, there can be no assurance
that we will be able to execute the necessary steps successfully or within the permitted timeframe. If we fail to regain compliance
with the Rule, our common stock may be subject to delisting from the Nasdaq Capital Market, which could materially and adversely affect the
liquidity and market price of our common stock and limit our access to capital.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are 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 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,
2025.
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 2025 that materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
18
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.
As
a smaller reporting company, information under this “Item 1A. Risk Factors” is not required to be presented.
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.
19
Item
6. Exhibits.
Number
Description
10.1*
Amendment to Employment Agreement, dated May 13, 2025, between MIRA Pharmaceuticals and Erez Aminov
31.1*
Certification of Chief Executive Officer Pursuant to Sarbanes-Oxley Section 302
31.2*
Certification of Interim Chief Financial Officer Pursuant to Sarbanes-Oxley Section 302
32.1**
Certification Pursuant To 18 U.S.C. Section 1350 (*)
32.2**
Certification Pursuant To 18 U.S.C. Section 1350 (*)
101.ins*
Inline
XBRL Instance Document
101.sch*
Inline
XBRL Taxonomy Extension Schema Document
101.cal*
Inline
XBRL Taxonomy Calculation Linkbase Document
101.def*
Inline
XBRL Taxonomy Definition Linkbase Document
101.lab*
Inline
XBRL Taxonomy Label Linkbase Document
101.pre*
Inline
XBRL Taxonomy Presentation Linkbase Document
104*
The
cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, formatted in Inline XBRL.
*
Filed
herewith.
**
Furnished
herewith.
20
SIGNATURES
Pursuant
to the requirements of the Exchange Act, 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, 2025
By:
/s/
Erez Aminov
Erez
Aminov
Chief
Executive Officer
(Principal
Executive Officer)
Date:
May 14, 2025
By:
/s/
Michelle Yanez
Michelle
Yanez
Chief
Financial Officer, Treasurer and Secretary
(Principal
Financial Officer)
21
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.