Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
−Removed: common stock began trading August 3, 2023, on The Nasdaq Capital Market under the symbol “MIRA.”
+Added: common stock has been public traded on The Nasdaq Capital Market under the symbol “MIRA” since August 3, 2023.
+Added: that date, there was no public trading market for our common stock.
of Common Stock
of March 28, 2025, we had approximately 55 holders of record of our common stock.
−Removed: dividends have been paid on the common stock to date.
−Removed: We currently intend to retain earnings for further business development and do
−Removed: not expect to pay cash dividends in the foreseeable future.
+Added: No cash dividends have been paid on the common
+Added: stock to date.
+Added: We currently intend to retain earnings for further business development and do not expect to pay cash dividends in the
+Added: foreseeable future.
Authorized for Issuance Under Equity Compensation Plans
15 unchanged sentences
for any period in the future.
−Removed: are a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and
−Removed: neuropsychiatric disorders.
−Removed: We have an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog
−Removed: under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant
−Removed: depression (TRD), major depressive disorder with suicidal ideation (MDSI) and potentially post-traumatic stress disorder (PTSD).
−Removed: Additionally,
−Removed: our novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety
−Removed: and cognitive decline, often associated with early-stage dementia.
−Removed: MIRA-55, if approved by the FDA, could mark a significant advancement
−Removed: in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.
−Removed: Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 concluded that it would not be considered a controlled
−Removed: substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.
−Removed: Additionally, we have filed the
−Removed: required paperwork for MIRA-55 to be evaluated by the U.S.
+Added: Pharmaceuticals, Inc.
+Added: MIRA) is a clinical-stage pharmaceutical development company advancing two neuroscience programs targeting
+Added: neurologic and neuropsychiatric disorders.
+Added: The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55,
+Added: two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function.
+Added: Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 and MIRA-55 concluded that it would not be considered
+Added: a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.
had net losses of $7.9 million and $12.0 million for the year ended December 31, 2024 and December 31, 2023, respectively.
−Removed: early February 2024, we made a significant discovery during the manufacturing and scale-up process of our patented molecule known as
−Removed: “MIRA1a,” which we had been utilizing with a contract manufacturer.
−Removed: Through this process, we identified a novel and improved
−Removed: version of the molecule, MIRA-55.
−Removed: MIRA-55 exhibits enhanced potency and holds promise for improved efficacy compared to MIRA1a.
−Removed: part of our due diligence and subsequent testing, we discovered that the pre-clinical studies we conducted, previously attributed to
−Removed: MIRA1a, were in fact performed on MIRA-55.
−Removed: Following this revelation, we promptly filed a provisional patent for MIRA-55, which encompasses
−Removed: all pre-clinical studies disclosed in our two registration statements on Form S-1, declared effective on August 2, 2023 and December
−Removed: 27, 2023 (File Nos.
−Removed: 333-273024 and 333-276118, respectively).
−Removed: based on our pre-clinical analyses to date, we believe that MIRA-55 is an improvement over MIRA1a in that it displays enhanced potency
−Removed: and potential for efficacy.
−Removed: In early March 2024, we filed a provisional patent application for MIRA-55, aiming for global patent protection.
−Removed: If such patent is issued, we would own the patent rights to both MIRA1a and MIRA-55.
−Removed: Based on our discoveries to date, we have decided to advance MIRA-55
−Removed: as our lead compound for our oral pharmaceutical marijuana drug candidate while still retaining our rights to MIRA1a.
June 28, 2023, we completed a 1-for-5 reverse stock split of our outstanding common stock.
7 unchanged sentences
Research and development expenses consist primarily of the following:
−Removed: and benefits;
−Removed: research and manufacturing;
−Removed: arrangements;
−Removed: expenses incurred to advance our research and development activities.
+Added: contracted research and manufacturing;
+Added: patent-related costs;
+Added: consulting arrangements;
+Added: other expenses incurred to advance our research and development activities.
operating expenses have historically been the costs associated with our patent prosecution and initial investment in pre-clinical research
18 unchanged sentences
research and development expense.
−Removed: Legal costs include general corporate legal fees and patent costs.
+Added: Legal costs include general corporate legal fees.
We expect to incur additional expenses
3 unchanged sentences
of Operations for the year ended December 31, 2024 and 2023
+Added: and administrative expenses
+Added: party travel costs
+Added: and development expenses
operating costs
−Removed: General and administrative expenses
−Removed: Related party travel costs
−Removed: Research and development expenses
−Removed: Total operating costs
−Removed: Interest expense, net
−Removed: Net loss attributable to common stockholders
+Added: income (expense), net
+Added: loss attributable to common stockholders
$ (7,852,659 )
$ (11,982,343 )
−Removed: Basic and diluted loss per share
−Removed: Weighted average common stock shares outstanding
+Added: and diluted loss per share
+Added: average common stock shares outstanding
and Administrative Expenses .
1 unchanged sentence
December 31, 2024 and December 31, 2023, respectively.
−Removed: General and administrative expenses are composed primarily of compensation, insurance,
−Removed: professional fees, stock-based compensation, administration and other related costs.
−Removed: The increase is primarily due to an increase in
−Removed: stock-based compensation, debt issuance costs, and compensation related to the IPO efforts of the executive team.
+Added: General and administrative expenses in 2024 consisted of stock compensation expense
+Added: of $1.9 million, payroll expense of $0.9 million, accounting and legal expenses of $0.4 million, marketing, investor relations, advertising,
+Added: and general corporate expenses of $1.0 million and insurance expenses of $0.5 million.
+Added: The decrease in general and administrative expenses
+Added: during 2024 relate primarily to a decrease in personnel in 2024 compared to 2023 and a concerted effort to conserve cash until the shelf
+Added: registration statement and at-the-market offering was put into place in August 2024.
Party Travel Costs .
−Removed: We incurred $0.4 million and $1.7 million in related party travel costs during the year ended December 31, 2023
−Removed: and December 31, 2022 respectively.
−Removed: Related party travel costs consisted of a lease and use of an airplane with an entity under common
−Removed: The decrease in related party travel costs in 2023 is due to the termination of the lease in March 2023.
−Removed: We incurred $3.5 million, net in interest expense and interest income during the year ended December 31, 2023, and $0.01
−Removed: million interest expense during the year ended December 31, 2022, respectively.
−Removed: Interest expense during 2023 included $2.8 million of
−Removed: write-off of unamortized deferred financing costs, $0.44 million of debt issuance costs and $0.02 million of interest income.
−Removed: The remaining 2023 and 2022
−Removed: interest expense consists of accrued interest on a related party line of credit.
+Added: We incurred $0.5 million in related party travel costs during the year ended December 31, 2023.
+Added: There were no
+Added: related party travel costs incurred during the year ended December 31, 2024.
+Added: Related party travel costs consisted of a lease and use
+Added: of an airplane with an entity under common control.
+Added: The airplane lease was terminated in March 2023, and hence, we ceased use of the
+Added: airplane and there were no further costs incurred.
+Added: income (expense) .
+Added: We earned $0.2 million, in interest income (expense) net, during the year ended December 31, 2024, which consisted
+Added: of income earned from funds in a money market account.
+Added: We incurred $3.5 million, in interest income (expense) net, during the year ended
+Added: December 31, 2023, which consisted of $2.8 million of write-off of unamortized deferred financing costs, $0.7 million of debt issuance
+Added: costs, offset by $0.02 million of interest income.
and Development Expenses.
During the year ended December 31, 2024, we incurred $3.3 million in research and development expenses,
−Removed: which were primarily related to initial payments for toxicology studies, consultants and stock compensation.
−Removed: We incurred $2.4 million
−Removed: in research and development expenses during the three months ended December 31, 2022, relating to initial payment for toxicology study
−Removed: Research and development expenses include pre-clinical, toxicology and consultant expenses.
−Removed: Major components of research and development
−Removed: expenses during the year ended December 31, 2023 are as follows:
−Removed: R&D consultants
−Removed: $ 0.25 million
−Removed: $ 0.37 million
−Removed: R&D toxicology
−Removed: $ 0.21 million
−Removed: R&D stock compensation
−Removed: $ 0.74 million
+Added: which were primarily related to pre-IND submission work, consultants and stock compensation.
+Added: During the year ended December 31, 2023,
+Added: we incurred $1.6 million in research and development expenses, which were primarily related to initial payments for toxicology studies,
+Added: consultants and stock compensation.
+Added: The increase in research and development expenses during 2024 are related to the IND enabling studies
+Added: and submission.
+Added: Major components of research and development expenses during the year ended December 31, 2024 are as follows:
+Added: stock compensation
and Capital Resources
3 unchanged sentences
We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources
−Removed: of debt and equity financing, including the proceeds from our completed IPO in August 2023.
−Removed: We may enter into new licensing and commercial
−Removed: partnership agreements.
−Removed: April 28, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder,
−Removed: and under which various of his family members are beneficiaries (the “Bay Shore Trust”).
−Removed: Under this Promissory Note and
−Removed: Loan Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5,000,000 from the Bay Shore
−Removed: 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
−Removed: initial public offering.
−Removed: Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change
−Removed: in our assets, operations, or prospects.
−Removed: The Bay Share Note, together with accrued interest, will become due and payable on the
−Removed: second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty.
−Removed: The Bay Shore Note will
−Removed: accrue interest at a rate equal 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum,
−Removed: simple interest, thereafter.
−Removed: The Bay Shore Note is unsecured.
−Removed: As of December 31, 2023, the Bay Shore Note was paid in full except
−Removed: for an unpaid interest balance of $.01 million.
−Removed: In consideration of
−Removed: the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on April 28,
−Removed: 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
−Removed: share, which warrant will expire five years after the date of grant.
+Added: of debt and equity financing, including the proceeds from our completed IPO in August 2023, and through proceeds of an ATM offering.
+Added: We may also enter into new licensing and commercial partnership agreements.
+Added: August 12, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC.
+Added: The terms of any offering under the shelf
+Added: registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the
+Added: SEC prior to completion of any such offering
+Added: April 28, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, and
+Added: under which various of his family members are beneficiaries (the “Bay Shore Trust”).
+Added: Under this Promissory Note and Loan
+Added: Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5,000,000 from the Bay Shore Trust at
+Added: any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public
+Added: Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in our assets, operations,
+Added: or prospects.
+Added: The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance
+Added: of the note, provided that it may be prepaid at any time without penalty.
+Added: The Bay Shore Note will accrue interest at a rate equal 7%
+Added: per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter.
+Added: Shore Note is unsecured.
+Added: As of December 31, 2024, the Bay Shore Note was paid in full.
+Added: In consideration of the loan facility provided
+Added: by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on April 28, 2023, giving the Bay Shore Trust
+Added: 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
+Added: years after the date of grant.
January 1, 2023, MIRALOGX, LLC, an intellectual property development and holding company owned by Bay Shore Trust (“MIRALOGX”),
19 unchanged sentences
As of December
−Removed: 31, 2023, we had cash and cash equivalents of approximately $4.6 million and working capital of $4.4 million.
−Removed: We currently expect that
−Removed: our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures through at least the
−Removed: fourth quarter of 2024.
+Added: 31, 2024, we had cash and cash equivalents of approximately $2.8 million.
+Added: We currently expect that our cash and cash equivalents be sufficient
+Added: to fund our operations, development plans, and capital expenditures through at least the third quarter of 2025.
did not have any material non-cancellable contractual obligations as of December 31, 2024.
following table provides information regarding our cash flows for the periods presented:
−Removed: Year ended December 31,
−Removed: Net cash provided by (used in):
−Removed: Operating activities
+Added: ended December 31,
+Added: cash provided by (used in):
$ (5,560,606 )
$ (4,532,403 )
−Removed: Financing activities
−Removed: Net change in cash
+Added: change in cash
$ (1,769,635 )
Cash Used in Operating Activities
−Removed: cash used in operating activities resulted primarily from our net losses, stock-based compensation expense, amortization of debt issuance
−Removed: costs and changes in components of accounts payable and accrued liabilities.
−Removed: For the year ended December 31,
−Removed: 2023, operating activities used $4.5 million of cash, primarily due to a net loss of $12 million, a $0.6 million change in accounts payable,
−Removed: accrued and prepaid expenses, offset by $2.5 million in stock-based compensation expense, $0.7 million in amortization of debt issuance
−Removed: costs, $3.5 million of interest expense, and $1.1 million of repayments under related party line of credit.
−Removed: Interest expense, net
−Removed: was primarily composed of warrant expense and line of credit expense, offset by interest income.
−Removed: Accounts payable, accrued and prepaid
−Removed: expenses was primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.
−Removed: the year ended December 31, 2022, operating activities used $5.6 million of cash, primarily due to a net loss of $7.1 million, a $0.06
−Removed: million change in accounts payable, accrued and prepaid expenses, offset by $1.3 million in stock-based compensation expense.
+Added: cash used in operating activities resulted primarily from our net losses, stock-based compensation expense and changes in components
+Added: of accounts payable and accrued liabilities.
+Added: the year ended December 31, 2024, operating activities used $5.6 million of cash, primarily due to a net loss of $7.9 million, offset
+Added: by $1.9 million in stock-based compensation expense, and a $0.4 million change in accounts payable, accrued and prepaid expenses.
payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs
and investor relations expenses.
+Added: the year ended December 31, 2023, operating activities used $4.5 million of cash, primarily due to a net loss of $12 million, a $0.6
+Added: million change in accounts payable, accrued and prepaid expenses, offset by $2.5 million in stock-based compensation expense, $0.7 million
+Added: in amortization of debt issuance costs, $3.5 million of interest expense, and $1.1 million of repayments under related party line of
+Added: Interest income (expense), net was primarily composed of debt issuance costs, offset by interest income.
+Added: Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance
+Added: costs and investor relations expenses.
Cash Provided by Financing Activities
−Removed: For the year ended December 31,
−Removed: 2023, financing activities provided $8.8 million of cash, resulting primarily from $7.7 million in proceeds from sale of common stock,
−Removed: less offering costs and $2.1 million in advances from related party line of credit, offset by $1.1 million of repayments under related party line of credit.
the year ended December 31, 2024, financing activities provided $3.8 million of cash, resulting primarily from $3.6 million in proceeds
−Removed: from sale of common stock, less offering costs, offset by $0.16 million of repayments under related party line of credit.
−Removed: currently anticipate that we will seek to monetize our product candidates, Ketamir-2 and MIRA-55, at the end of our planned Phase 2 studies.
+Added: from sale of common stock, less offering costs, $0.1 million from the Bay Shore Trust short-swing disgorgement, and $0.03 million in
+Added: advances from related party.
+Added: the year ended December 31, 2023, financing activities provided $8.8 million of cash, resulting primarily from $7.7 million in proceeds
+Added: from sale of common stock, less offering costs and $2.1 million in advances from related party line of credit, offset by $1.1 million
+Added: of repayments under related party line of credit.
+Added: currently anticipate that we will seek to monetize our product candidates, Ketamir-2 and MIRA-55, at the end of our planned Phase II studies.
Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development.
21 unchanged sentences
believe that we have sufficient resources available to support our development activities and business operations and timely satisfy
−Removed: our obligations as they become due into the fourth quarter of 2024.
+Added: our obligations as they become due into the third quarter of 2025.
We do not have sufficient cash and cash equivalents as of the date
24 unchanged sentences
description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of
−Removed: operations is disclosed in Note 8 to our financial statements appearing at the end of this
+Added: operations is disclosed in Note 1 to our financial statements appearing at the end of this Report.
Sheet Arrangements
the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
−Removed: of Critical Accounting Policies
−Removed: are a C corporation.
−Removed: Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
−Removed: the financial statement carrying amount of existing assets and liabilities and their respective tax bases.
−Removed: Deferred tax assets are recognized
−Removed: for temporary differences that will result in deductible amounts in future years and for loss carryovers.
−Removed: A valuation allowance is recognized
−Removed: 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.
+Added: Summary of Critical Accounting Policies and Estimates
and development expenses
4 unchanged sentences
are incurred.
−Removed: preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires
−Removed: our company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the
−Removed: disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the
−Removed: reporting period.
−Removed: Actual results may differ from such estimates and such differences could be material.
account for stock-based compensation under the provisions of FASB ASC 718, “ Compensation - Stock Compensation ”, which
30 unchanged sentences
and comparisons of the Chief Executive Officer’s compensation to median employee compensation.
−Removed: will remain an emerging growth company under the JOBS Act until the earliest of (a) December 31,
−Removed: 2028, (b) the last date of our fiscal year in which we had total annual gross revenue of at least $1.07 billion, (c) the date
−Removed: on which we are deemed to be a “large accelerated filer” under the rules of the SEC or (d) the date on which we have issued
−Removed: more than $1.0 billion in non-convertible debt securities during the previous three years.
+Added: will remain an emerging growth company under the JOBS Act until the earliest of (a) December 31, 2028, (b) the last date of our fiscal
+Added: year in which we had total annual gross revenue of at least $1.07 billion, (c) the date on which we are deemed to be a “large accelerated
+Added: filer” under the rules of the SEC or (d) the date on which we have issued more than $1.0 billion in non-convertible debt securities
+Added: during the previous three years.
Quantitative and Qualitative Disclosures About Market Risk.
reporting companies are not required to provide the information required by this item.
−Removed: Financial Statements and Supplementary Data.
−Removed: Consolidated Financial Statements and Notes thereto and the report of Cherry Bekaert, our independent registered public accounting firm
−Removed: 677 ), are set forth on pages F-1 through F-22
−Removed: of this Report.
−Removed: Changes In and Disagreements With Accountants on Accounting and Financial Disclosure.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.