UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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As of September 15, 2023, there were shares of company common stock issued and outstanding.
MIRA Pharmaceuticals, Inc.
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
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
| 30-Jun | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Deferred offering costs | ||||||||
| Prepaid expenses | ||||||||
| Total current assets | ||||||||
| Deferred financing costs | ||||||||
| Operating lease, right of use assets | ||||||||
| Related party operating lease, right of use assets | ||||||||
| Due from related parties | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Trade accounts payable and accrued liabilities | $ | $ | ||||||
| Related party accounts payable | ||||||||
| Related party line of credit | ||||||||
| Related party accrued interest | ||||||||
| Current portion of operating lease liabilities | ||||||||
| Related party current portion of operating lease liabilities | ||||||||
| Total current liabilities | ||||||||
| Non-current operating lease liabilities | ||||||||
| Total liabilities | ||||||||
| Stockholders’ Deficit | ||||||||
| Preferred Stock, $ par value, and shares authorized and issued or outstanding, at June 30, 2023 and December 31, 2022. | ||||||||
| Common Stock, $ par value; and shares authorized, at June 30, 2023 and December 31, 2022. shares issued and outstanding at June 30, 2023 and December 31, 2022. | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity (deficit) | ( | ) | ||||||
| Total liabilities and stockholders’ equity (deficit) | $ | $ | ||||||
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)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Operating costs: | ||||||||||||||||
| General and administrative expenses | ||||||||||||||||
| Related party travel costs | ||||||||||||||||
| Research and development expenses | ( | ) | ||||||||||||||
| Total operating costs | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Basic and diluted loss per share | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common stock shares outstanding | ||||||||||||||||
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)
| Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total
Stockholders’ Equity | ||||||||||||||||||||
| Shares | Amount | Capital | Receivable | Deficit | (Deficit) | |||||||||||||||||||
| Balances, January 1, 2022 | ( | ) | ||||||||||||||||||||||
| Sale of common stock, net | ( | ) | ||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balances, March 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||
| Collection of stock subscription receivable | - | |||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balances, June 30, 2022 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||
| Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total
Stockholders’ Equity | ||||||||||||||||||||
| Shares | Amount | Capital | Receivable | Deficit | (Deficit) | |||||||||||||||||||
| Balances, January 1, 2023 | $ | ( | ) | $ | ( | ) | ||||||||||||||||||
| Sale of common stock, net | ||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balances, March 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||
| Issuance of Warrants | - | |||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balances, June 30, 2023 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||
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)
| Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Cash flows from Operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash from operations | ||||||||
| Non-cash interest expense | ||||||||
| Amortization of debt issuance costs | ||||||||
| Stock-based compensation expense | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Right of use lease, net | ( | ) | ||||||
| Accounts payable and accrued expenses | ( | ) | ( | ) | ||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Net cash flows used in operating activities | ( | ) | ( | ) | ||||
| Financing activities: | ||||||||
| Advances from (to) affiliates | ( | ) | ||||||
| Payment of deferred offering costs | ( | ) | ||||||
| Repayments under related party line of credit | ( | ) | ( | ) | ||||
| Proceeds from sale of common stock, less offering costs | ||||||||
| Net cash flows provided by financing activities | ||||||||
| Net change in cash | ( | ) | ( | ) | ||||
| Cash, beginning of year | ||||||||
| Cash, end of period | $ | $ | ||||||
| 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 shares of common stock issued to Bay Shore Trust during the six months ended
June 30, 2023 totaling approximately $
| 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
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 $ per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $ per share, is referred to as the “Preferred Stock”.
Initial Public Offering
On
August 7, 2023, the Company closed its initial public offering consisting of shares at a price of $ per share for approximately
$
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 $
| 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:
| June 30, 2023 | December 31, 2022 | |||||||
| Trade accounts payable | $ | $ | ||||||
| Prepaid insurance | ||||||||
| Accrued other | ||||||||
| $ | $ | |||||||
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 $
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 $
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 $
| 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 shares of common stock at an exercise price of $ 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, $
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 $
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
| 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
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:
| Six months ended June 31, | ||||||||
| Lease Costs | 2023 | 2022 | ||||||
| Operating Lease Cost | ||||||||
| Operating Lease | $ | $ | ||||||
| Variable Lease Costs | ||||||||
| Total Lease Cost | $ | $ | ||||||
Supplemental cash flow information related to leases were as follows:
| 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 | $ | $ | ||||||
| Six months ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Lease Term and Discount | ||||||||
| Weighted Average remaining lease term | | |||||||
| Weighted Average discount rate | % | % | ||||||
Maturity of Lease Liabilities
Future minimum lease payments under non-cancellable leases as of June 30, 2023 were as follows:
| Maturity of Lease Liabilities | ||||
| March 31, 2023 | ||||
| Remainder of 2023 | $ | |||
| 2024 | ||||
| 2025 | ||||
| Total Lease payments | ||||
| Less: Interest | ( | ) | ||
| Present Value of Lease Liabilities | $ | |||
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
Reverse stock-split
IPO stock issuances
At
IPO,
shares of the Company’s common stock were issued at a price of $
per share which resulted in gross proceeds of $
Additionally,
the Company issued its investor relations firm $
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 options to purchase Common Stock, with an aggregate fair market value of approximately $ 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 years from the grant date. These option vest as follows: (i) Board of Director options vest on date of grant and (ii) executive officer and management, employee and consultant options vest % on date of grant and the remaining vest ratably over a period.
Number of shares | Weighted average exercise price per share | Aggregate intrinsic value | ||||||||||
| Outstanding as January 1, 2023 | $ | |||||||||||
| Options granted | $ | |||||||||||
| Forfeitures | ( | ) | $ | |||||||||
| Outstanding as June 30, 2023 | $ | |||||||||||
The estimated fair value of stock options on date of grant was $ million. As of June 30, 2023, options exercisable totaled . There are approximately $ million of unrecognized compensation costs related to non-vested share-based compensation awards, which will be expensed through 2025.
| Expected price volatility | % | |||
| Risk-free interest rate | % | |||
| Weighted average fair values | $ | -$ | ||
| Weighted average expected life in years | - 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 shares of common stock at an exercise price
of $
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 $
| Expected price volatility | % | |||
| Risk-free interest rate | % | |||
| Weighted average fair values | $ | |||
| Weighted average expected life in years | 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
Earnings Per Share
During the six months ended June 30, 2023 and 2022, outstanding stock options and warrants of and , 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 and , 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 $
On
August 28, 2023, the Company amended Mr. Aminov’s employment agreement to increase his yearly compensation from its current amount
of $
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 $
| 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 $
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.
| Net Cash Bonus | ||||||||
| Erez Aminov | $ | |||||||
| Chris Chapman | ||||||||
| Michelle Yanez | ||||||||
| Christos Nicholoudis | ||||||||
| Total Net Cash Bonuses and Stock Option Grants | $ | |||||||
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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.
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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).
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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.
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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;
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● 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.
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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.
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Item 6. Exhibits.
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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) | ||
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