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 June 30, 2023
☐
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.)
855
N Wolfe Street , Suite 601
Baltimore ,
Maryland
21205
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number (including area code):
(737)
289-0835
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 Stock Market LLC
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, or a non-accelerated filer or a smaller reporting
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 September 15, 2023, there were 14,780,885 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 June 30, 2023 and December 31, 2022
1
Condensed Statements of Operations for the three and six months ended June 30, 2023 and 2022
2
Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022
3
Condensed
Statements of Cash Flows for the six months ended June 30, 2023 and 2022
4
Notes
to Condensed Financial Statements
6
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
15
Item
3.
Quantitative
and Qualitative Disclosures about Market Risk
17
Item
4.
Controls
and Procedures
17
Cautionary
Note on Forward Looking Statements
18
Part
II. Other Information
20
Item
1
Legal
Proceedings
20
Item
1A.
Risk
Factors
20
Item
2
Unregistered
Sales of Equity Securities and Use of Proceeds
20
Item
3
Defaults
upon Senior Securities
20
Item
4
Mine
Safety Disclosures
20
Item
5
Other
Information
20
Item
6.
Exhibits
21
Signatures
22
From
time to time, we may use our website, our Facebook page at facebook.com/profile.php?id=100087641460083, our Twitter at twitter.com/PharmaMira
and our LinkedIn at linkedin.com/company/mira-pharmaceuticals-inc/ to distribute material information. Our financial and other material
information is routinely posted to and accessible on the “Investors” section of our website, available at www.mirapharmaceuticals.com .
Investors are encouraged to review the Investors section of our website because we may post material information on that site that is
not otherwise disseminated by us. Information that is contained in and can be accessed through our website, our Facebook page, our LinkedIn
page and our Twitter posts are not incorporated into, and does not form a part of, this Quarterly Report.
MIRA
PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS
AS
OF JUNE 30, 2023 AND DECEMBER 31, 2022
2023
2022
30-Jun
December
31,
2023
2022
(Unaudited)
ASSETS
Current
assets:
Cash
$ 24,823
$ 350,978
Deferred
offering costs
353,372
143,427
Prepaid
expenses
42,524
-
Total
current assets
420,719
494,405
Deferred
financing costs
3,222,083
-
Operating
lease, right of use assets
132,334
164,910
Related
party operating lease, right of use assets
-
198,759
Operating lease, right of use assets
-
198,759
Due
from related parties
50,000
-
Total
assets
$ 3,825,136
$ 858,074
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current
liabilities:
Trade
accounts payable and accrued liabilities
$ 659,101
$ 811,738
Related
party accounts payable
-
116,350
Related
party line of credit
1,802,971
133,062
Related
party accrued interest
39,611
34,987
Current
portion of operating lease liabilities
75,362
75,143
Related
party current portion of operating lease liabilities
-
198,759
C urrent
portion of operating lease liabilities
-
198,759
Total
current liabilities
2,577,045
1,370,039
Non-current
operating lease liabilities
51,472
84,267
Total
liabilities
2,628,517
1,454,306
Stockholders’
Deficit
Preferred
Stock, $ 0.0001 par value, 10,000,000 and 5,000,000 shares authorized and none issued or outstanding, at June 30, 2023 and December
31, 2022.
-
-
Common
Stock, $ 0.0001 par value; 100,000,000 and 95,000,000 shares authorized, at June 30, 2023 and December 31, 2022. 13,313,000 shares
issued and outstanding at June 30, 2023 and December 31, 2022.
6,657
6,657
Additional
paid-in capital
13,099,830
8,699,830
Accumulated
deficit
( 11,909,868 )
( 9,302,719 )
Total
stockholders’ equity (deficit)
1,196,619
( 596,232 )
Total
liabilities and stockholders’ equity (deficit)
$ 3,825,136
$ 858,074
See
notes to condensed financial statements
1
MIRA
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
2023
2022
2023
2022
Three
months ended June 30,
Six
months ended June 30,
2023
2022
2023
2022
Revenues
$ -
$ -
$ -
$ -
Operating
costs:
General
and administrative expenses
1,071,239
1,590,474
1,685,475
2,204,409
Related
party travel costs
-
560,800
453,550
935,700
Research
and development expenses
( 101,019 )
269,390
170,587
751,740
Total
operating costs
970,220
2,420,664
2,309,612
3,891,849
Interest
expense
( 295,887 )
( 2,315 )
( 297,540 )
( 6,177 )
Net
loss attributable to common stockholders
$ ( 1,266,107 )
$ ( 2,422,979 )
$ ( 2,607,152 )
$ ( 3,898,026 )
Basic
and diluted loss per share
$ ( 0.10 )
$ ( 0.19 )
$ ( 0.20 )
$ ( 0.30 )
Weighted
average common stock shares outstanding
13,313,000
13,093,000
13,313,000
13,076,000
See
notes to condensed financial statements
2
MIRA
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE SIX MONTHS AND THREE MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Shares
Amount
Capital
Receivable
Deficit
(Deficit)
Common
Stock
Additional
Paid-In
Stock
Subscription
Accumulated
Total
Stockholders’ Equity
Shares
Amount
Capital
Receivable
Deficit
(Deficit)
Balances,
January 1, 2022
12,673,800
6,337
4,499,550
-
( 2,244,529 )
2,261,358
Sale
of common stock, net
402,200
201
1,718,799
( 135,000 )
-
1,584,000
Net
loss
-
-
-
-
( 1,475,046 )
( 1,475,046 )
Balances,
March 31, 2022
13,076,000
$ 6,538
$ 6,218,349
$ ( 135,000 )
$ ( 3,719,575 )
$ 2,370,312
Stock-based
compensation
-
-
1,001,000
-
-
1,001,000
Collection
of stock subscription receivable
-
-
-
135,000
-
135,000
Net
loss
-
-
-
-
( 2,422,979 )
( 2,422,979 )
Balances,
June 30, 2022
13,076,000
$ 6,538
$ 7,219,349
$ -
$ ( 6,142,554 )
$ 1,083,333
Common
Stock
Additional
Paid-In
Stock
Subscription
Accumulated
Total
Stockholders’ Equity
Shares
Amount
Capital
Receivable
Deficit
(Deficit)
Balances,
January 1, 2023
13,313,000
6,657
8,699,830
-
$ ( 9,302,719 )
$ ( 596,232 )
Balances
13,313,000
6,657
8,699,830
-
$ ( 9,302,719 )
$ ( 596,232 )
Sale
of common stock, net
-
-
147,800
-
-
147,800
Net
loss
-
-
-
-
( 1,341,044 )
( 1,341,044 )
Balances,
March 31, 2023
13,313,000
$ 6,657
$ 8,847,630
$
$ ( 10,643,763 )
$ ( 1,789,476 )
Stock-based
compensation
-
-
737,200
-
-
737,200
Issuance
of Warrants
-
-
3,515,000
-
-
3,515,000
Net
loss
-
-
-
-
( 1,266,107 )
( 1,266,107 )
Balances,
June 30, 2023
13,313,000
$ 6,657
$ 13,099,830
$ -
$ ( 11,909,868 )
$ 1,196,619
Balances
13,313,000
$ 6,657
$ 13,099,830
$ -
$ ( 11,909,868 )
$ 1,196,619
See
notes to condensed financial statements
3
MIRA
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
2023
2022
Six
Months Ended June 30,
2023
2022
Cash
flows from Operating activities
Net
loss
$ ( 2,607,152 )
$ ( 3,898,026 )
Adjustments
to reconcile net loss to net cash from operations
Non-cash
interest expense
4,623
6,177
Amortization
of debt issuance costs
292,917
-
Stock-based
compensation expense
885,000
1,001,000
Change
in operating assets and liabilities:
Right
of use lease, net
-
( 5,500 )
Accounts
payable and accrued expenses
( 268,983 )
( 367,984 )
Prepaid
expenses
( 42,524 )
( 50,000 )
Net
cash flows used in operating activities
( 1,736,119 )
( 3,314,333 )
Financing
activities:
Advances
from (to) affiliates
1,752,971
( 278,236 )
Payment
of deferred offering costs
( 209,945 )
-
Repayments
under related party line of credit
( 133,062 )
( 110,000 )
Proceeds
from sale of common stock, less offering costs
-
1,719,000
Net
cash flows provided by financing activities
1,409,964
1,330,764
Net
change in cash
( 326,155 )
( 1,983,569 )
Cash,
beginning of year
350,978
2,809,552
Cash,
end of period
$ 24,823
$ 825,983
Cash
paid for interest
-
-
See
notes to condensed financial statements
4
SUPPLEMENTAL
CASH FLOW INFORMATION
Non-cash
Operating, Financing and Investing Activities:
The
Company recorded the fair value of a total of 1,000,000 shares of common stock issued to Bay Shore Trust during the six months ended
June 30, 2023 totaling approximately $ 3.5 million to deferred finance costs. The Company has amortized approximately $ 0.3 million of
deferred offering costs as non-cash amortization of debt issuances costs in accordance with Generally Accepted Accounting Principles.
5
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Note
1. Description of business and summary of significant accounting policies :
Overview
MIRA
Pharmaceuticals, Inc. (“MIRA” or the “Company” and formerly known as MIRA1a Therapeutics, Inc.) was formed in
September 2020 and is a Florida-based pre-clinical-stage pharmaceutical development company developing an unscheduled novel synthetic THC analog. This
novel compound is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated
with early-stage dementia. MIRA1a, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric,
inflammatory, and neurologic diseases and disorders. Based on pre-clinical and animal studies conducted by the Company, the Company believes
that MIRA1a may enhance the therapeutic potential for treating anxiety, cognitive decline, and neuropathic pain without the side effects
of plant-based THC. Furthermore, the Company’s studies indicate that MIRA1a may counteract the adverse cognitive effects often seen with
THC, thereby potentially unmasking previously unseen positive therapeutic effects, such as cognitive performance enhancement.
Substantive
operations began in late 2020 and the Company’s Investigative New Drug application is anticipated to be filed with the U.S. Food
and Drug Administration (“FDA”) end of third quarter 2024. The Company owns U.S. Patent 10,787,675
B2, titled “Purified Synthetic Marijuana
and Methods of Treatment by Administering Same,” which covers the MIRA1a compound as a new molecular entity as well as pharmaceutical
formulations of the compound and methods of treating Alzheimer’s disease, anxiety, depression, and addictions.
The
accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America
(“GAAP”).
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”.
Initial
Public Offering
On
August 7, 2023, the Company closed its initial public offering consisting of 1,275,000 shares at a price of $ 7.00 per share for approximately
$ 8.9 million in gross proceeds. After deducting the underwriting commission and other offering expenses totaling $ 0.8 million, the net proceeds to the Company was $ 8.1 million (the “IPO”).
The
shares were offered and sold pursuant to the Company’s Registration Statement on Form S-1, as amended (File No. 333-273024), originally
filed with the Securities and Exchange Commission (the “SEC”) on June 29, 2023 (the “Registration Statement”)
and the final quarterly report filed with the Commission pursuant to Rule 424(b)(4) of the Securities Act of 1933, as amended. The Registration
Statement was declared effective by the Commission on August 2, 2023. The common stock began trading on The Nasdaq Capital Market on
August 3, 2023 under the symbol “MIRA”. The closing of the IPO occurred on August 7, 2023.
As
of the completion of the IPO, among other things, certain of the Company’s then-outstanding convertible debt was converted into
shares of common stock. See Note 5 for more information.
Income
taxes
The
Company is taxed as a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable
to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred
tax assets are recognized for temporary differences that will result in deductible amounts in future years and for loss carryovers. A
valuation allowance is recognized regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred
tax asset will not be realized.
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.
6
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Leases
The
Company accounts 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.
Use
of estimates
The
preparation of financial statements in accordance with generally accepted accounting principles in the United States of America 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.
Cash
The
Company maintains cash balances with financial institutions that management believes are of high credit quality. The Company’s
cash account at times may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes
it is not exposed to any significant credit risk from its cash account.
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.
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).
Note
2. Liquidity and capital resources :
As
of June 30, 2023, the Company had cash of approximately $ 0.02 million. The Company used approximately $ 1.7 million of cash in operations
during the six months ended June 30, 2023 and had stockholders’ equity of approximately $ 1.2 million, versus stockholders’
deficit of approximately $ 0.6 million at December 31, 2022
7
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Historically,
the Company has been primarily engaged in developing MIRA1a. 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 financed its operations through the sale
of Common Stock, the IPO and related party 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.
Note
3 Accounts payable and accrued liabilities :
The
following table represents the components of accounts payable and accrued liabilities as of:
Schedule
of Accounts Payable And Accrued Liabilities
June
30, 2023
December
31, 2022
Trade
accounts payable
$ 645,143
$ 789,204
Prepaid
insurance
13,958
-
Accrued
other
-
22,534
Accounts
payable and accrued liabilities
$ 659,101
$ 811,738
Note
4. License agreement, related party :
Effective
April 26, 2023 (the “Effective Date”), the Company and MyMD Pharmaceuticals, Inc. (“MYMD”) entered into an Amended
and Restated Limited License Agreement with MyMD. The license grants our company a perpetual, worldwide, royalty-free non-exclusive right
to use MyMD’s Supera-CBD compound, a different compound than MIRA1a, as a synthetic intermediate in the manufacture of MIRA1a for
all purposes (including clinical development and commercial production). This license is perpetual, and MyMD does not have a right to
terminate it. In consideration of this license, we agreed to share with MyMD technical information and know-how that pertains to the
synthetic manufacture and/or formulation of our MIRA1a product candidate and granted a license to MyMD to use improvements to MIRA1a
made under the agreement, agreement, and the agreement does not involve any prior or future cash payments by us .
The
Company and MYMD have similar members of the Board, as well as officers from the respective companies.
Note
5. Line of credit, related party :
In
May 2021, the Company entered into a revolving credit facility which allowed for borrowings of up to $ 5 million from Starwood Trust,
a shareholder of the Company. The facility had an initial term of 24 months (extended to 36 months in March 2023), with a new maturity
date of May 10, 2024 , at which time all outstanding borrowings and accrued interest, if any, were due in full. Borrowings accrued interest
at a rate of 5 % per annum.
In
April 2023, the Company entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by a shareholder
of the Company. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), the Company has the right to borrow
up to an aggregate of $ 5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note
or, if earlier, upon the completion of the Company’s IPO. The Company’s right to borrow funds under the Bay Shore Note is
subject to the absence of a material adverse change in the Company’s assets, operations, or prospects. The Bay Share Note, together
with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid
at any time without penalty. The Bay Shore Note will accrue interest at a rate equal 7 % per annum, simple interest, during the first
year that the note is outstanding and 10 % per annum, simple interest, thereafter. The Bay Shore Note is unsecured.
The
Bay Shore Note replaced the revolving credit facility that the Company entered into with Starwood Trust, a separate trust established
by a shareholder of the Company, in May 2021 and pursuant to which the Company had an outstanding principal balance of $ 0.2 million as
of the date of the Bay Shore Note (which outstanding balance was retired with an advance under the Bay Shore Note).
8
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
In
consideration of the loan facility provided by the Bay Shore Trust, in April 2023, the Company issued to the Bay Shore Trust a common
stock purchase warrant giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of
$ 5.00 per share, which warrant will expire five years after the date of grant. Pursuant to a registration rights agreement, the Company
has granted to Bay Shore Trust the right to require the Company, at any time after one year following the Company’s IPO, to register
for resale the shares issuable upon the exercise of the warrant, with such registration rights being in the form of demand and “piggyback”
registration rights that are subject to customary limitations and restrictions. See Note 8 for additional details related to these warrants.
On
July 20, 2023, the Company entered into a conversion agreement with the Bay Shore Trust under which the Bay Shore Trust had agreed to
convert, upon the completion of the IPO, $ 1.1 million of the outstanding principal balance of the Bay Shore Note into shares of
the Company’s common stock at a conversion price equal to the Company’s IPO price, which resulted in the issuance of 157,170
shares to the Bay Shore Trust. On August 14, 2023, the Company paid $ 1.0 million in full to Bay Shore Trust, which was the amount due.
The company also paid accrued interest of $ 0.03 million. As of the date of this report, a remaining amount of $ 0.003 million of accrued
interest remains payable.
Note
6. Related party transactions :
Due
from related parties – During the six months ended June 30, 2023, the Company paid payables on behalf of a related party.
Advances
from affiliates – During the six months ended June 30, 2023, the Company received working capital advances from the Bay Shore
Trust LOC, which was used to pay off advances from affiliates.
Related
party accounts payable – Amounts due to related parties as of June 30, 2023 and December 31, 2022, are recorded as Accounts
payable related parties, in the accompanying balance sheets.
Travel
expenses – In April 2021, the Company entered into an airplane lease with an entity under common control that the Company incurs
approximately $ 0.05 million of lease charges per month. The lease was renewable, at the Company’s discretion, for an additional
one to three years, however, the Company terminated the lease at March 31, 2023, without any penalties. The Company may continue to incur
related party travel-related expenses as they occur, which will be recorded in Related Party Travel Costs, in the condensed statement
of operations. During the six months ended June 30, 2023, the Company incurred $ 0.5 million, for travel-related expenses to the related
party for monthly rental charges and airplane-related expenses.
License
agreement - See Note 3.
Line
of credit - See Note 4.
Lease
and lease reimbursements - See Note 6.
Note
7. Leases :
The
Company’s corporate headquarters is in Baltimore, Maryland, which includes a lease for office space. This lease began in November
2021 and was amended in April 2023. This space is approximately 550 square feet and has a remaining base rent of $ 0.01 million payable
through April 2024. Rent is payable in monthly installments and is subject to yearly price increases.
9
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
The
Company also has leased an office in Tampa, Florida, for its finance and general operations, which began in March 2022 for 37 months.
This space is approximately 2,300 square feet and has a remaining base rent of $ 0.14 million payable through March 2025. Rent is payable
in monthly installments and is subject to yearly price increases. The Company splits the monthly rent and variable costs with two related
parties. As such, the Company will be reimbursed each month for 2/3 rds of the rent expense, which will be recorded as a reduction
in lease expenses.
The
Company also leased a jet (Note 5) from a related party, which lease the Company terminated on March 31 2023.
Variable
lease costs
Variable
lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. Variable lease
costs related to the aircraft include usage expenses, which includes pilot expenses, jet fuel and general flight expenses.
The
components of lease expense were as follows:
Schedule of Lease Expense
Six
months ended June 31,
Lease
Costs
2023
2022
Operating
Lease Cost
Operating
Lease
$ 192,409
$ 316,523
Variable
Lease Costs
309,872
637,420
Total
Lease Cost
$ 502,281
$ 953,943
Supplemental
cash flow information related to leases were as follows:
Schedule
of Cash Flow Information Related to Leases
Six
months ended June 30,
Other
Lease Information
2023
2022
Cash
paid for amounts included in the measurement of lease liabilities
Operating
cash flows from operating leases
$ 500,788
$ 953,943
Schedule
of Remaining Weighted-average Lease Term and Weighted-average Discount Rate
Six
months ended June 30,
2023
2022
Lease
Term and Discount
Weighted
Average remaining lease term
1.79
years
3
years
Weighted
Average discount rate
5.0 %
5.0 %
Maturity
of Lease Liabilities
Future
minimum lease payments under non-cancellable leases as of June 30, 2023 were as follows:
Schedule
of Maturity
of Lease Liabilities
Maturity
of Lease Liabilities
March
31, 2023
Remainder
of 2023
$ 41,408
2024
73,129
2025
17,444
Total
Lease payments
131,981
Less:
Interest
( 5,147 )
Present
Value of Lease Liabilities
$ 126,834
On
April 1, 2023 the Company entered into an Agreement For Shared Lease Costs with MIRALOGX, LLC, (the “Shared Agreement”)
who is a related party for the jet usage. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance with
its monthly use of shared aircraft toward rent payments. However, the Company has not used the aircraft after the termination of the
lease and there are no minimum payments due without usage.
10
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Note
8. 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 (as amended and restated on June 28, 2023), whose rights and privileges will be defined by the
Board of Directors when a series of preferred stock is designated.
Reverse
stock-split
Effective
June 28, 2023, the Company completed a 1-for-5 reverse stock split of its outstanding common stock upon the filing of the Company’s
Third Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were issued
in connection with the reverse stock split, and all such fractional shares resulting from the reverse stock split were rounded
up to the nearest whole number. The shares issuable upon the exercise of our outstanding options and warrants, and the exercise prices
of such options and warrants, have been adjusted to reflect the reverse stock split.
IPO
stock issuances
At
IPO, 1,275,000
shares of the Company’s common stock were issued at a price of $ 7.00
per share which resulted in gross proceeds of $ 8.9
million and net proceeds of $ 8.1
million to the Company after the underwriter discount but before other IPO related expenses.
Additionally,
the Company issued its investor relations firm $ 0.25 million worth of restricted common stock upon closing of the IPO, which resulted
in issuance of 35,715 shares of stock.
Stock-based
compensation
The
Company may grant options under its 2022 Omnibus Incentive Plan, as amended and restated (the “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
nonstatutory 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.
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 trading history for its shares prior to its IPO. 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.
11
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
In
April 2023, a total of 400,001 options to purchase Common Stock, with an aggregate fair market value of approximately $ 1.5 million were
granted to the Company’s Board of Directors, executive officers and management, and a consultant of the Company. Options have a
term of 10 years from the grant date. These option vest as follows: (i) Board of Director options vest 100 % on date of grant and (ii)
executive officer and management, employee and consultant options vest 33.3 % on date of grant and the remaining vest ratably over a two-year
period.
The
following is option activity during the six months the six months ended June 30, 2023.
Schedule of Stock
option Activity
Number of
shares
Weighted
average exercise price per share
Aggregate
intrinsic value
Outstanding
as January 1, 2023
750,000
$ 5.00
Options
granted
400,001
$ 5.00
Forfeitures
( 170,000 )
$ 5.00
Outstanding
as June 30, 2023
980,001
$ 5.00
-
The
estimated fair value of stock options on date of grant was $ 1.5 million. As of June 30, 2023, options exercisable totaled 382,501 . There
are approximately $ 1.7 million of unrecognized compensation costs related to non-vested share-based compensation awards, which will be
expensed through 2025.
Key
assumptions used to value stock options during the six months ended June 30, 2023 are as follows:
Schedule of Key Assumptions Used to Value Stock Options
Expected
price volatility
87.70 %
Risk-free
interest rate
4.13 %
Weighted
average fair values
$ 0.706 -$ 0.751
Weighted
average expected life in years
5 - 6
years
Dividend
yield
-
Warrants
Bay
Shore Trust warrants
In
consideration of the line of credit provided by the Bay Shore Trust, the Company issued to the Bay Shore Trust a common stock purchase
warrant on April 28, 2023 giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price
of $ 5.00 per share. This warrant will expire five years after the date of grant.
The
fair value of the warrants were estimated on the grant date using the Black-Scholes valuation model and level 3 inputs based on assumptions
for expected volatility, expected dividends, expected term, and the risk-free interest rate, which resulted in $ 3.5 million of deferred
financing costs. This cost was recorded as deferred financing costs and additional paid in capital on the accompanying condensed balance
sheet and is amortized straight-line over the term of the line of credit (which is 24 months). Associated amortization of deferred finance
costs is recorded to interest expense on the condensed income statement of operations.
Key
assumptions used to value warrants during the six months ended June 30, 2023 are as follows:
Schedule of Key Assumptions Used to Value Warrants
Expected
price volatility
88.01 %
Risk-free
interest rate
3.51 %
Weighted
average fair values
$ 0.703
Weighted
average expected life in years
5
years
Dividend
yield
-
12
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Underwriter
warrants
In
connection with the IPO, the Company issued 63,750
warrants to purchase common stock to the IPO underwriter (or its designees) at an exercise price of $ 7.00
which will expire in the four-and-a-half-year period commencing six months after the commencement of sales in the IPO. The warrants
will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period commencing six
months after the commencement of sales in the IPO. The warrants provide for registration rights (including a one-time demand
registration right and piggyback registration rights that expire 5 years from the commencement of sales of the offering) and
customary anti-dilution provisions as permitted under FINRA Rule 5110(g)(8).
Earnings
Per Share
During
the six months ended June 30, 2023 and 2022, outstanding stock options and warrants of 1,980,001 and 750,000 , respectively, were not
included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.
During
the three months ended June 30, 2023 and 2022, outstanding stock options, and warrants of 1,400,001 and 750,000 , respectively, were not
included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.
Note
9. Employment Agreements :
Erez
Aminov
On
April 28, 2023, the Company entered into an employment agreement with Mr. Erez Aminov pursuant to which Mr. Aminov serves as the
Company’s Chief Executive Officer on a full-time basis. Mr. Aminov’s employment agreement provides that his employment
will be on an at-will basis and can be terminated by either Mr. Aminov or the Company at any time and for any reason. Under the
agreement, Mr. Aminov will receive an initial base salary of $ 0.11
million per year. In the event that Mr. Aminov’s employment is terminated by the company without “Cause” or is
terminated by Mr. Aminov for “Good Reason”, Mr. Aminov will be entitled to severance compensation in the form of salary
continuation for a period of three months (subject to Mr. Aminov executing and delivering a customary general release in favor of
the company).
On
August 28, 2023, the Company amended Mr. Aminov’s employment agreement to increase his yearly compensation from its current amount
of $ 0.11 million to $ 0.2 million per year, effective August 1, 2023.
Michelle
Yanez
On
April 28, 2023, the Company entered into an employment agreement with Ms. Michelle Yanez pursuant to which Ms. Yanez serves as
the Company’s Chief Financial Officer on a full-time basis. Ms. Yanez’s employment agreement provides that her
employment will be on an at-will basis and can be terminated by either Ms. Yanez or the company at any time and for any reason.
Under the agreement, Ms. Yanez will receive an initial base salary of $ 0.17
million per year. In the event that her employment is terminated by the company without “Cause” or is terminated by Ms.
Yanez for “Good Reason”, Ms. Yanez will be entitled to severance compensation in the form of salary continuation for a
period of three months (subject to Ms. Yanez executing and delivering a customary general release in favor of the
company).
13
MIRA
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
Chris
Chapman
On
April 28, 2023, the Company entered into an employment agreement with Dr. Chris Chapman pursuant to which Dr. Chapman serves as
the Company’s Executive Chairman. Dr. Chapman’s employment agreement provides that his employment will be on a part-time
basis whereby Dr. Chapman will devote 50% of his full business time and effort to the business and affairs of the company, and it
further provides that such employment will be on an at-will basis and can be terminated by either Dr. Chapman or the company at any
time and for any reason. Under the agreement, Dr. Chapman will receive an initial base salary of $ 0.15
million per year. In the event that Dr. Chapman’s employment is terminated by the company without “Cause” or is
terminated by Dr. Chapman for “Good Reason”, Dr. Chapman will be entitled to severance compensation in the form of
salary continuation for a period of three months (subject to Dr. Chapman executing and delivering a customary general release in
favor of the company).
On
August 28, 2023, the Company amended Dr. Chapman’s employment agreement to indicate that he works part-time, on an as needed basis
for the Corporation, rather than fifty percent (50%) of the time, effective August 1st, 2023.
Note
10 – Subsequent events :
IPO
bonus compensation
On
August 17, 2023, the following executive officers and a director were granted bonus compensation in the form of cash and stock
option grants subsequent to the IPO. All stock option grants vested immediately from the effective date of August 17, 2023, and were
granted under the 2022 Omnibus Plan.
Cash
bonus amounts listed are net of federal, state, local income and payroll taxes:
Schedule of Cash and Stock Options Awarded as Bonus
Net Cash Bonus
Stock Option Grant
Erez
Aminov
$ 120,000
150,000
Chris
Chapman
50,000
50,000
Michelle
Yanez
50,000
20,000
Christos
Nicholoudis
25,000
10,000
Total
Net Cash Bonuses and Stock Option Grants
$ 245,000
230,000
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 Quarterly 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 Quarterly Report and in the Company’s
other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.
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 the Company
We are an early pre-clinical-stage pharmaceutical
company focused on the development and commercialization of a new molecular synthetic THC analog under investigation for the treatment
of adult patients with anxiety and cognitive decline typically associated with early-stage dementia. Our target patient population is
also typically presenting with neuropathic pain. Our drug candidate, MIRA1a, if approved by the FDA, may be a significant advancement
in the treatment of neuropsychiatric, inflammatory, and neurologic diseases and disorders. Based on pre-clinical and animal studies conducted
by us, we believe that MIRA1a enhances the therapeutic potential for treating anxiety, cognitive decline and neuropathic pain by potentially
striking a balance between the beneficial effects of THC and CBD. MIRA1a achieves this by selectively targeting the cannabinoid type
1 (“CB1”) and cannabinoid type 2 (“CB2”) receptors. Cannabinoid receptors, located throughout the body, are part
of the endocannabinoid system, which is involved in a variety of physiological processes and responses including appetite, pain-sensation,
mood, and memory. With respect to THC, our pre-clinical studies have shown that MIRA1a may have less potency at CB1 but maintains high
activation at CB2. Since CB1 activation corresponds to intoxication, we believe that MIRA1a is potentially less intoxicating than THC
while still providing beneficial therapeutic effects. In addition, by curbing the negative effects of THC (e.g. cognitive impairment),
preclinical studies suggest that MIRA1a may be capable of unmasking positive therapeutic effects not previously seen with THC (e.g. cognitive
performance enhancement).
Substantive
operations began in late 2020 and the Company’s Investigative New Drug application is anticipated to be filed with the U.S. Food
and Drug Administration (“FDA”) end of third quarter 2024. The Company owns U.S. Patent 10,787,675 B2, titled “Purified
Synthetic Marijuana and Methods of Treatment by Administering Same,”
which
covers the MIRA1a compound as a new molecular entity as well as pharmaceutical formulations of the compound and methods of treating Alzheimer’s
disease, anxiety, depression, and addictions.
Critical
Accounting Policies
See
Note 2 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting
policies and information on recently issued accounting pronouncements.
Results
of Operations
For
the three months ended June 30 ,
2023 compared to the three months ended June 30 , 2022
Research
and Development Expenses. During the three months ended June 30, 2023, we incurred $0.3 million in research and development expenses,
which were offset by $0.4 million in research and development credits. The credits were primarily related to toxicology expenses for
projects and milestones that were not performed by our vendors. We incurred $0.3 million in research and development expenses during
the three months ended June 30, 2022, relating to pre-clinical costs. Research and development expenses include pre-clinical, toxicology
and consultant expenses.
General
and Administrative Expenses . We incurred $1.1 million and $1.6 million in general and administrative expenses during the three months
ended June 30, 2023 and June 30, 2022, respectively. General and administrative expenses are composed primarily of compensation, insurance,
professional fees, stock-based compensation, administration and other related costs. The decrease is due primarily to a decrease in stock-based
compensation expense in 2023.
15
Related
Party Travel Costs . We incurred $0.6 million in related party travel costs during the three months ended June 30, 2022. There was
no such expense incurred during the same period ended June 30, 2023. Related party travel costs consisted of a lease and use of an airplane
with an entity under common control. The decrease in related party travel costs is due to the termination of the lease in March 2023.
Interest
expense . We recognized $0.3 million and $0.002 million in interest expense during the three months ended June 30, 2023 and June 30,
2022, respectively. Interest expense during 2023 included $0.29 of debt issuance costs. The remaining 2023 and 2022 interest expense
consists of accrued interest on a related party line of credit.
For
the six months ended June 30 ,
2023 compared to the six months ended June 30 , 2022
Research
and Development Expenses. During the six months ended June 30, 2023, we incurred $0.6 million in research and development expenses,
which were offset by $0.4 million in research and development credits. The credits were primarily related to toxicology expenses for
projects and milestones that were not performed by our vendors. We incurred $0.8 million in research and development expenses during
the six months ended June 30, 2022, relating to pre-clinical costs. Research and development expenses include pre-clinical, toxicology
and consultant expenses.
General
and Administrative Expenses. We incurred general and administrative expenses of $1.7 million and $2.2 million during the six months
ended June 30, 2023 and June 30, 2022, respectively. General and administrative expenses consists of payroll, consulting fees, IT-related
costs, legal and accounting costs, office and rent expenses, investor relations and stock-based compensation expenses. The decrease is
due primarily to a decrease in stock-based compensation expense in 2023.
Related
Party Travel Costs . We incurred $0.5 million and $0.9 million in related party travel costs during the six months ended June 30,
2023 and June 30, 2022, respectively. Related party travel costs consisted of a lease and use of an airplane with an entity under common
control. The decrease in related party travel costs is due to the termination of the lease in March 2023.
Interest
expense . We recognized $0.3 million and $0.006 million in interest expense during the six months ended June 30, 2023 and June 30,
2022, respectively. Interest expense during 2023 included $0.29 of debt issuance costs. The remaining 2023 and 2022 interest expense
consists of accrued interest on a related party line of credit.
Liquidity
and Capital Resources
Since
the Company’s inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a
major shareholder and through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during
2022. We intend to finance our research and development and working capital needs from existing cash, potential new sources of debt and
equity financing, including the proceeds from our IPO. We may enter into new licensing and commercial partnership agreements.
On
April 28, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, Jonnie
R. Williams, Sr., and under which various of his family members are beneficiaries. Under this Promissory Note and Loan Agreement (the
“Bay Shore Note”), we had the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to
the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our IPO. The Bay Share Note, together
with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid
at any time without penalty. The Bay Shore Note will accrue interest at a rate equal 7% per annum, simple interest, during the first
year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. As of June 1, 2023,
we have borrowed an aggregate of $0.2 million under the Bay Shore Note. The Bay Shore Note replaced a Line of Credit Agreement that we
entered into with The Starwood Trust, a separate trust established by our founder, in May 2021 and pursuant to which we had an outstanding
principal balance of $0.2 as of the date of the Bay Shore Note (which outstanding balance was retired with an advance under the Bay Shore
Note).
16
On
July 20, 2023, we entered into a conversion agreement with the Bay Shore Trust under which the Bay Shore Trust had agreed to convert,
upon the completion of the IPO, $1.1 million of the outstanding principal balance of the Bay Shore Note into shares of our common stock
at a conversion price equal to our IPO price, which resulted in the issuance of 157,170 shares to the Bay Shore Trust upon the completion
of the IPO (the “Bay Shore Trust Conversion Agreement”). On August 14, 2023, the Company paid $1.0 million in full to Bay
Shore Trust, which was the amount due. The company also paid accrued interest of $0.03 million. As of the date of this report, the remaining
amount of $0.003 million of accrued interest remains payable.
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.
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 June 30,
2023.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during our second quarter of 2023 that materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
17
Limitations
on the Effectiveness of Internal Controls
Our
disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure
control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
that all control issues, if any, within a company have been detected. Our Chief Executive Officer and Chief Financial Officer have concluded,
based on their evaluation as of the end of the period covered by this Report that our disclosure controls and procedures were sufficiently
effective to provide reasonable assurance that the objectives of our disclosure control system were met.
CAUTIONARY
NOTE ON FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements. 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 the markets in which we operate, including growth of our various markets, and our expectations, beliefs, plans, strategies, objectives,
prospects, assumptions, or future events or performance contained in this quarterly report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and “Business” 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 quarterly report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and “Business,” 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 use of the net proceeds from our recent offering;
●
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 pre-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 the net proceeds
from this offering, together with 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;
18
●
our ability to advance product candidates into, and successfully complete, clinical trials;
●
our ability to recruit and enroll suitable patients in our clinical trials;
●
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, including the novel coronavirus outbreak or other pandemics arising globally, and the
future impact of it and COVID-19 on our clinical trials, business operations and funding requirements; and
●
other risks and factors listed under “Risk Factors” and elsewhere in this quarterly report.
Given
the risks and uncertainties set forth in this quarterly report, you are cautioned not to place undue reliance on such forward-looking statements.
The forward-looking statements contained in this quarterly report are not guarantees of future performance and our actual results of operations,
financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking
statements contained in this quarterly report. In addition, even if our results of operations, financial condition and liquidity, and events
in the industry in which we operate, are consistent with the forward-looking statements contained in this quarterly report, they may not be
predictive of results or developments in future periods.
Any
forward-looking statement that we make in this quarterly 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 quarterly report.
19
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.
Not
required for smaller reporting companies.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
Use
of Proceeds from IPO of Common Stock
On
August 7, 2023, we completed our IPO pursuant to which we issued and sold an aggregate of 1,275,000 shares of our common stock at the
IPO price of $7.00 per share.
The
offer and sale of all of the shares of our common stock in the IPO were registered under the Securities Act pursuant to our Registration
Statement on Form S-1, as amended (File No. 333-273024), which was declared effective on August 2, 2023. Kingswood Investments,
division of Kingswood Capital Partners, LLC acted as representative of the underwriters.
We
received gross proceeds from our IPO of approximately $8.93 million, and net proceeds of approximately $7.61 million, after deducting
underwriting discounts and commissions and other offering expenses. None of the underwriting discounts and commissions or other offering
expenses were incurred or paid, directly or indirectly, to any of our directors or officers or their associates or to persons owning
10% or more of our common stock or to any of our affiliates.
The
net proceeds from the IPO have been used and are expected to be used, primarily to fund our clinical development programs, including
our preclinical animal toxicology studies and CMC activities, our initial IND application, and our Phase 1 clinical trials for MIRA1a.
We intend to use the remainder for working capital and general corporate purposes. Since the completion of our IPO, we have used
approximately $0.3 million of the net proceeds to fund preclinical toxicology studies and R&D consultants, $0.7 million in general
and administrative expenses and $1 million of the net proceeds to repay a portion of our outstanding debt payable under our line of credit
with Bay Shore Trust, a greater-than-10% stockholder of the Company. Subject to the foregoing, there has been no material change
in our intended use of proceeds from our IPO as described in the Prospectus.”
Item
3. Defaults upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
Not
applicable.
20
Item
6. Exhibits.
Number
Description
3.1
Third Amended and Restated Articles of Incorporation of MIRA Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form S-1 filed June 29, 2023).
3.2
Amended and Restated Bylaws of MIRA Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.3 of the Company’s Current Report on Form S-1/A filed July 14, 2023).
4.1
Representative’s Warrant, dated August 7, 2023 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed August 7, 2023).
4.2
Common Stock Purchase Warrant, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Bay Shore Trust (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form S-1 filed June 29, 2023).
10.1
Employment Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Erez Aminov (incorporated by reference to Exhibit 10.7 of the Company’s Current Report on Form S-1 filed June 29, 2023).
10.2
Amendment to Employment Agreement, August 28, 2023, between MIRA Pharmaceuticals, Inc. and Erez Aminov (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed August 31, 2023).
10.3
Employment Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Michelle Yanez. (incorporated by reference to Exhibit 10.8 of the Company’s Current Report on Form S-1 filed June 29, 2023).
10.4
Employment Agreement, dated April 28, 2023 between MIRA Pharmaceuticals, Inc. and Chris Chapman. (incorporated by reference to Exhibit 10.9 of the Company’s Current Report on Form S-1 filed June 29, 2023).
10.5
Amendment to Employment Agreement, dated August 28, 2023, between MIRA Pharmaceuticals and Dr. Chris Chapman (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed on August 31, 2023).
10.6
Promissory Note and Loan Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Bay Shore Trust. (incorporated by reference to Exhibit 10.10 of the Company’s Current Report on Form S-1 filed June 29, 2023).
10.7
Registration Rights Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Bay Shore Trust. (incorporated by reference to Exhibit 10.11 of the Company’s Current Report on Form S-1 filed June 29, 2023).
10.8
Agreement for Shared Lease Costs, dated April 1, 2023, between MIRA Pharmaceuticals, Inc., Telomir Pharmaceuticals, Inc., and MIRALOGX LLC. (incorporated by reference to Exhibit 10.12 of the Company’s Current Report on Form S-1/A filed July 14, 2023).
10.9
Conversion Agreement, dated July 20, 2023, between MIRA Pharmaceuticals, Inc. and the Bay Shore Trust. (incorporated by reference to Exhibit 10.14 of the Company’s Current Report on Form S-1/A filed July 21, 2023).
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 June 30, 2023, formatted in Inline XBRL.
*
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request.
21
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:
September 15, 2023
By:
/s/
Erez Aminov
Erez
Aminov
Chief
Executive Officer
(Principal
Executive Officer)
Date:
September 15, 2023
By:
/s/
Michelle Yanez
Michelle
Yanez
Chief
Financial Officer, Treasurer and Secretary
(Principal
Financial Officer)
22
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.