MIRA PHARMACEUTICALS INC
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 13, 2024
MIRA$0.57+5.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-13.
0001493152-24-018908
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001493152-24-031612
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 31 previous paragraphs and 33 current paragraphs.
16 unchanged; 11 reworded; 6 added; 4 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Interest income (expense). We earned $0.04 million in interest income related to money market accounts in the three months ended June 30, 2024 and incurred $0.3 million in interest expense during the three months ended June 30, 2023. Interest expense during 2023 included $0.29 of debt issuance costs.
Current report
For the six months endedJune 30, 2024 compared to the six months ended June 30, 2023
Current report
Research and Development Expenses. During the six months ended June 30, 2024, we incurred $1.4 million in research and development expenses, which were primarily related to the initial payments for pre-clinical research projects for Ketamir. We incurred $0.6 million in research and development expenses during the six months ended June 30, 2023, which were offset by $0.4M in research and development credits. The credits were primarily related to toxicology expenses for projects and milestones that were not performed by our vendors.
Current report
*General and Administrative Expenses.*We incurred general and administrative expenses of $2.1 million and $1.7 million during the six months ended June 30, 2024 and June 30, 2023, 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 increase is primarily related to stock compensation expense
Current report
Interest income (expense). We recognized $0.09 million in interest income from money market accounts and $0.3 million in interest expense during the six months ended June 30, 2024 and June 30, 2023, respectively. Interest expense during 2023 included $0.3 of debt issuance costs.
Current report
On August 12, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to completion of any such offering
Removed paragraphs (4)
Previous report
Interest income (expense), net. We earned $0.05 million in interest income, net during the three months ended March 31, 2024 and incurred $0.002 million interest expense, net during the three months March 31, 2023, respectively. Interest income during the three months ended March 31, 2024 consisted of interest earned on bank accounts. Interest expense during the three months ended March 31, 2023 consists of accrued interest on a related party line of credit.
Previous report
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if they are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected, or, in the worst case scenario, we could be forced to cease operations and dissolve. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about its ability to meet our contractual obligations.
Previous report
We did not have any material non-cancellable contractual obligations as of March 31, 2024.
Previous report
The cash used in operating activities resulted primarily from our net losses, stock-based compensation expense, amortization of debt issuance costs and changes in components of accounts payable and accrued liabilities.
Reworded paragraphs (11)
Previous wording
The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” above.
Current wording
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” above.
Previous wording
The DEA’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the CSA and its governing regulations. Additionally, we have submitted the required paperwork for MIRA-55 to be evaluated by the DEA.
Current wording
The DEA’s scientific review of Ketamir-2 and MIRA-55 concluded that both would not be considered a controlled substance or listed chemical under the CSA and its governing regulations.
Previous wording
For the three months endedMarch 31, 2024 compared to the three months ended March 31, 2023
Current wording
For the three months endedJune 30, 2024 compared to the three months ended June 30, 2024
Previous wording
Research and Development Expenses. During the three months ended March 31, 2024, we incurred $0.8 million in research and development expenses, which were primarily related to initial payments for pre-clinical research projects for Ketamir. We incurred $0.3 million in research and development expenses during the three months ended March 31, 2023, relating to initial payment for toxicology study costs. Research and development expenses include pre-clinical, toxicology and consultant expenses.
Current wording
Research and Development Expenses. During the three months ended June 30, 2024, we incurred $0.6 million in research and development expenses, which were primarily related to initial payments for pre-clinical research projects for Ketamir. We incurred $0.3 million in research and development expenses during the three months ended June 30, 2023, 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.
Previous wording
General and Administrative Expenses. We incurred $1.0 million and $0.7 million in general and administrative expenses during the three months ended March 31, 2024 and March 31, 2023, respectively. General and administrative expenses are composed primarily of compensation, insurance, professional fees, stock-based compensation, administration and other related costs. The increase is primarily due to an increase in stock-based compensation.
Current wording
General and Administrative Expenses. We incurred $1.1 million and $1.0 million in general and administrative expenses during the three months ended June 30, 2024 and June 30, 2023, 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.
Previous wording
Related Party Travel Costs. We incurred $0.5 million in related party travel costs during the three months ended March 31, 2023. Related party travel costs consisted of a lease and use of an airplane with an entity owned by Bay Shore Trust, a related party. The decrease in related party travel costs is due to the termination of the lease in March 2023. There was no such related party travel costs during the same period in 2024.
Current wording
Related Party Travel Costs. We incurred $0.0 million and $0.5 million in related party travel costs during the six months ended June 30, 2024 and June 30, 2023, 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.
Previous wording
Historically, we have been primarily engaged in developing MIRA-55 and, more recently, have also been focusing on the development of Ketamir-2. During these activities, we have sustained substantial losses. Our ability to fund ongoing operations and future pre-clinical and clinical trials required for FDA approval is dependent on our ability to obtain significant additional external funding in the near term. We expect to be able to fund operations through the fourth quarter of 2024, with available borrowings from the related-party loan described in Note 5 in the accompanying financial states. We will require additional financing to fund our operations, to continue and complete pre-clinical and clinical development activities and to commercially develop and ultimately launch our product candidates. However, and particularly given our early-stage nature and the significant time and capital required to implement our business plan, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
Current wording
Historically, we have been primarily engaged in developing MIRA-55 and, more recently, have also been focusing on the development of Ketamir-2. During these activities, we have sustained substantial losses. Our ability to fund ongoing operations and future pre-clinical and clinical trials required for FDA approval is dependent on our ability to obtain significant additional external funding in the near term. We expect to be able to fund operations through the fourth quarter of 2024, with available borrowings from the related-party loan described in Note 5 in the accompanying financial statements. We will require additional financing and equity raises to fund our operations, to continue and complete pre-clinical and clinical development activities and to commercially develop and ultimately launch our product candidates. However, and particularly given our early-stage nature and the significant time and capital required to implement our business plan, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
Previous wording
For the three months ended March 31, 2024, operating activities used $1.0 million of cash, primarily due to a net loss of $1.7 million, offset by $0.5 million in stock-based compensation expense and $0.2 million in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, and insurance costs.
Current wording
For the six months ended June 30, 2024, operating activities used $1.9 million of cash, primarily due to a net loss of $3.4 million, offset by $1.1 million in stock-based compensation expense and $0.3 million in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, and insurance costs.
Previous wording
For the three months ended March 31, 2023, operating activities used $1.1 million of cash, primarily due to a net loss of $1.3 million and $0.06 million change in prepaid expenses, offset by $0.2 million in accounts payable and accrued expenses and $0.1 million in stock-based compensation expense. Accounts payable, accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, insurance costs and legal expenses.
Current wording
For the six months ended June 30, 2023, operating activities used $1.7 million of cash, primarily due to a net loss of $2.6 million and $0.2 million change in accounts payable, offset by $0.3 million in debt issuance cost and accrued expenses and $0.9 million in stock-based compensation expense. Accounts payable, accrued and prepaid expenses were primarily composed of research and development payables, consultant costs, insurance costs and legal expenses.
Previous wording
For the three months ended March 31, 2024, financing activities used $0.02 million of cash, resulting from $0.02 million in advances to affiliates.
Current wording
For the six months ended June 30, 2024, financing activities used $0.1 million of cash, resulting from $0.02 million in advances to affiliates.
Previous wording
For the three months ended March 31, 2023, financing activities provided $0.7 million of cash, resulting primarily from $0.7 million in advances from affiliates and $0.08 million of repayments under related party line of credit, offset by $0.05 million paid in deferred offering costs.
Current wording
For the six months ended June 30, 2023, financing activities provided $1.4 million of cash, resulting primarily from $1.7 million in advances from affiliate, offset by $0.1 million of repayments under related party line of credit, offset by $0.2 million paid in deferred offering costs.