# Mira Pharmaceuticals, Inc.: Form 10-Q for the period ended Mar 31, 2024

- Company: [Mira Pharmaceuticals, Inc.](/companies/mira.md) (CIK 1904286)
- Form: 10-Q
- Filed: 2024-05-13
- Accepted by EDGAR: May 13, 2024, 20:31 ET
- Period: 2024-03-31
- Accession: 0001493152-24-018908
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1904286/000149315224018908/form10-q.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1904286/000149315224018908/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2024-03-31.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Research and development | 3 months, 2024-01-01 to 2024-03-31 | $762.3k | us-gaap:ResearchAndDevelopmentExpense |
| Interest expense | 3 months, 2024-01-01 to 2024-03-31 | −$50.4k | us-gaap:InterestExpense |
| Net income | 3 months, 2024-01-01 to 2024-03-31 | −$1.7m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2024-01-01 to 2024-03-31 | −$0.12 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2024-01-01 to 2024-03-31 | −$0.12 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2024-01-01 to 2024-03-31 | 19,707,847 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 3 months, 2024-01-01 to 2024-03-31 | −$1.0m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Cash and equivalents | at 2024-03-31 | $3.5m | us-gaap:Cash |
| Current assets | at 2024-03-31 | $3.7m | us-gaap:AssetsCurrent |
| Total assets | at 2024-03-31 | $3.8m | us-gaap:Assets |
| Current liabilities | at 2024-03-31 | $652.0k | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2024-03-31 | $652.0k | us-gaap:Liabilities |
| Shareholders' equity | at 2024-03-31 | $3.2m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 10,337 characters.

*The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” above.*

*As used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated, the terms “the Company”, “we”, “us”, “our” and similar terminology refer to MIRA Pharmaceuticals, Inc.*

### Background of the Company

We are a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for ***Ketamir-2***, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling TRD, MDSI and potentially PTSD.

Additionally, our novel oral pharmaceutical marijuana molecule, ***MIRA-55***, is being studied for its potential to alleviate neuropathic pain, as well as anxiety and cognitive decline, symptoms commonly associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.

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.

We were incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including our pharmaceutical development program, in late 2020.

### Critical Accounting Estimates

See Note 1 of the Notes to Condensed Financial Statements included in Item 1 of this Report for a summary of significant accounting policies and information on recently issued accounting pronouncements.

### Results of Operations

### For the three months ended March 31, 2024 compared to the three months ended March 31, 2023

*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.

*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.

*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.

*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.

### Liquidity and Capital Resources

### Sources of Liquidity and Going Concern

Since our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company, through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022, and by the proceeds from our completed initial public offering in August 2023. We intend to finance our clinical development programs and working capital needs from existing cash, and potentially new sources of debt and equity financing. We may enter into new licensing and commercial partnership agreements.

Historically, we have been primarily engaged in developing MIRA-55 and, more recently, have also been focusing on the development of Ketamir-2. During these activities, we have sustained substantial losses. Our ability to fund ongoing operations and future 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.

We expect to continue to generate losses in the foreseeable future. Our liquidity needs will be determined largely by the budgeted operational expenditure incurred in regard to the progression of our product candidates. We do not have sufficient cash and cash equivalents as of the date of filing this Report to support our operations for at least the 12 months. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date the financial statements included in this Report are issued.

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.

We did not have any material non-cancellable contractual obligations as of March 31, 2024.

#### Cash Flows

The following table provides information regarding our cash flows for the periods presented:

| Net cash flows from: | Three months Ended March 31, 2024 | 2023 |
| --- | ---: | ---: |
| Operating activities | $(1,049,536) | $(1,075,306) |
| Financing activities | (24,335) | 725,677 |
| Net change in cash | $(1,073,871) | $(349,629) |

#### Net Cash Flows from Operating Activities

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.

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.

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.

#### Net Cash Flows from Financing Activities

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.

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.

## Market risk

As filed, 189 characters.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information under this item per Item 305(e) of Regulation S-K.

## Controls and procedures

As filed, 3,456 characters.

#### Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Report, our management, with the participation of our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.

Readers are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.

Based on this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were not effective as of March 31, 2024.

#### Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act, during our first quarter of 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

#### 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 not effective to provide reasonable assurance that the objectives of our disclosure control system were met.

Filed May 13, 2024.
Source: SEC EDGAR, the filing index for accession 0001493152-24-018908. Last ingested by Listed: Oct 24, 2026, 15:16 ET. No prices; not investment advice.