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MIRA PHARMACEUTICALS, INC.

For the period ended Jun 30, 2026. Filed Aug 12, 2026.

View on SEC.gov

About this filing

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, 2026 · Filed Aug 12, 2026

MIRA$0.57+5.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-14.

0001493152-26-023005

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-12.

0001493152-26-037366

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 64 previous paragraphs and 69 current paragraphs.

41 unchanged; 17 reworded; 7 added; 6 removed; 0 previous and 4 current paragraphs rearranged.

Tables are not compared: 4 previous and 6 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 (7)

Current report

MIRA-55 is an investigational oral small-molecule drug candidate being developed as a potential non-opioid therapy for chronic inflammatory pain. In preclinical studies, oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model, outperforming injected morphine, and acts through a mechanism distinct from THC without producing associated central nervous system effects. The Company has completed formulation optimization and is advancing chemistry, manufacturing and controls (CMC) activities to support future nonclinical and regulatory development. The Company has completed exploratory 7-day repeated-dose toxicology and toxicokinetic studies in both rat and dog models, with analysis ongoing. These findings support continued advancement toward IND-enabling studies.

Current report

SKNY-1 is an investigational oral small-molecule drug candidate being developed for obesity. In peer-reviewed preclinical studies published in the International Journal of Molecular Sciences, oral SKNY-1 demonstrated dose-dependent reductions in body weight, lipid normalization, and reduced hepatic triglyceride accumulation. The compound attenuated compulsive feeding and nicotine-seeking behaviors in validated experimental models and demonstrated a differentiated CNS safety profile without anxiety-related effects despite engaging central cannabinoid pathways, distinguishing it from earlier CB1-targeting agents. The Company has completed formulation optimization and is advancing chemistry, manufacturing and controls (CMC) activities to support future nonclinical and regulatory development. The Company has completed exploratory 7-day repeated-dose toxicology and toxicokinetic studies in both rat and dog models, with analysis ongoing. These findings support continued advancement toward IND-enabling studies.

Current report

We recognized loss from equity method investment of less than $0.1 million during the three months ended June 30, 2026, representing our proportionate share of the net loss of Telomir Pharmaceuticals, Inc. (“Telo”), in which we account for our investment under the equity method of accounting. No equity method loss was recognized during the three months ended June 30, 2025.

Current report

We recognized loss from equity method investment of less than $0.2 million during the six months ended June 30, 2026, representing our proportionate share of the net loss of Telo, in which we account for our investment under the equity method of accounting. No equity method loss was recognized during the six months ended June 30, 2025.
Removed paragraphs (6)

Previous report

MIRA-55 is a novel oral cannabinoid analog under preclinical investigation for inflammatory pain and related inflammatory conditions. Recent preclinical studies demonstrated that MIRA-55 produced analgesic effects in validated inflammatory pain models and did not demonstrate cannabinoid-like central nervous system side effects in behavioral safety assays. These findings support continued advancement toward IND-enabling studies.

Previous report

SKNY-1 is a preclinical oral therapeutic candidate designed to modulate CB1, CB2, and MAO-B pathways to influence appetite, energy balance, lipid metabolism, and craving behavior. Preclinical studies demonstrated reductions in body weight gain, food consumption, and nicotine-seeking behavior, while supporting a differentiated CNS safety profile relative to earlier CB1-targeting agents. The Company is currently evaluating potential development pathways and indications for SKNY-1 as it advances toward IND-enabling studies.
Reworded paragraphs (17)

Previous wording

MIRA Pharmaceuticals, Inc. (the “Company” or “MIRA”) is a clinical-stage pharmaceutical development company focused on developing novel oral small-molecule therapeutics for neuropathic pain, inflammatory pain, weight management, and addiction-related conditions. The Company’s pipeline includes three product candidates: Ketamir-2, MIRA-55, and SKNY-1. On September 29, 2025, the Company completed the acquisition of SKNY Pharmaceuticals (“SKNY”), a related-party private company developing SKNY-1, expanding the Company’s pipeline into metabolic and addiction-related indications.

Current wording

MIRA Pharmaceuticals, Inc. (the “Company” or “MIRA”) is a clinical-stage pharmaceutical development company focused on developing novel oral small-molecule therapeutics for chemotherapy-induced peripheral neuropathy (CIPN), chronic inflammatory pain, and obesity. The Company’s pipeline includes three product candidates: Ketamir-2, MIRA-55, and SKNY-1. On September 29, 2025, the Company completed the acquisition of SKNY Pharmaceuticals (“SKNY”), a related-party private company developing SKNY-1, expanding the Company’s pipeline into metabolic indications.

Previous wording

Ketamir-2 is a next-generation oral N-methyl-D-aspartate (“NMDA”) receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers and is being advanced toward a Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy (“CIPN”) under an active Investigational New Drug (“IND”) application. The Phase 1 study included both single-ascending-dose (“SAD”) and multiple-ascending-dose (“MAD”) cohorts, and dosing has been completed across all cohorts. Based on preliminary safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported; however, the database remains blinded and final audited safety and pharmacokinetic analyses are ongoing. The Company is preparing to initiate a Phase 2a clinical trial in CIPN in the first half of 2026, subject to regulatory feedback and site readiness.

Current wording

Ketamir-2 is an oral selective N-methyl-D-aspartate (“NMDA”) receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers and is being advanced toward a Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy (“CIPN”) under an active Investigational New Drug (“IND”) application. The Phase 1 study included both single-ascending-dose (“SAD”) and multiple-ascending-dose (“MAD”) cohorts, and dosing has been completed across all cohorts. Based on preliminary safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported. The Company is targeting initiation of a Phase 2a clinical trial in CIPN in the first quarter of 2027, subject to FDA clearance, site readiness, and other regulatory and operational factors.

Previous wording

Separately, the Company owns an undivided 50% interest, together with MIRALOGX LLC, in certain worldwide intellectual property rights relating to SKNY-1 and MIRA-55, for which global patent protection is pending.

Current wording

Separately, the Company owns an undivided 50% interest, together with MIRALOGX LLC, in certain worldwide intellectual property rights relating to MIRA-55 and SKNY-1, for which global patent protection is pending.

Previous wording

We had net losses of $1.1 million and $1.8 million for the three months ended March 31, 2026 and 2025, respectively.

Current wording

We had net losses of $2.4 million and $3.3 million for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

Other income, net consists of interest income earned from investment of excess operating cash, less interest expense, and the unrealized loss on short-term investments.

Current wording

Other income and expense, net consists of interest income earned from investment of excess operating cash and loss from our equity method investment in Telomir Pharmaceuticals, Inc., a related party.

Previous wording

During the three months ended March 31, 2026, we incurred $0.5 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the three months ended March 31, 2025, we incurred $0.3 million in research and development expenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The increase in research and development expenses during 2025 is due to increase in development costs for MIRA-55. Major components of research and development expenses during the three months ended March 31, 2026 and 2025 are as follows:

Current wording

During the three months ended June 30, 2026, we incurred $0.7 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the three months ended June 30, 2025, we incurred $0.5 million in research and development expenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The increase in research and development expenses during 2026 is due to increases in development costs across our pipeline, including pre-IND submission work for MIRA-55 and SKNY-1, Phase 2a protocol advancement for Ketamir-2, and associated consulting and research activities. Major components of research and development expenses during the three months ended June, 2026 and 2025 are as follows:

Previous wording

We incurred $0.6 million and $1.5 million in general and administrative expenses during the three months ended March 31, 2026 and 2025, respectively. The decrease in general and administrative expenses for $0.9 million during three month ended March 31, 2026 relate primarily to decrease in stock-based compensation for $0.8 million, payroll related expenses for $0.2 million partially offset by an increase in professional services and other expenses for $0.1 million.

Current wording

We incurred $1.0 million and $2.5 million in general and administrative expenses during the six months ended June 30, 2026 and 2025, respectively. The decrease in general and administrative expenses for $1.5 million during the six months ended June 30, 2026 relate primarily to decrease in stock-based compensation for $1.2 million, payroll related expenses for $0.2 million and in other general expenses for $0.1 million, partially offset by increased professional expense of less than $0.1 million.

Previous wording

Since our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major stockholder and an affiliated company and through a private placement of shares of our Common Stock that occurred during the fourth quarter 2021 and during 2022 and our initial public offering that occurred in August 2023. We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, and through proceeds of the ATM offering.

Current wording

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 and through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022 and our initial public offering that occurred in August 2023. We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, and through proceeds of the ATM offering.

Previous wording

We used $1.2 million in operating activities during the three months ended March 31, 2026, compared to $1.6 million in operating activities during the three months ended March 31, 2025.

Current wording

We used $2.4 million of cash in operating activities during the six months ended June 30, 2026, compared to $2.4 million in operating activities during the six months ended June 30, 2025.

Previous wording

We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit. We had an accumulated deficit of approximately $40.7 million as of March 31, 2026. As of March 31, 2026, we had cash and cash equivalents of approximately $4.8 million. We currently expect that our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures into at least the first quarter of 2027.

Current wording

We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit. We had an accumulated deficit of approximately $42.0 million as of June 30, 2026. As of June 30, 2026, we had cash and cash equivalents of approximately $3.6 million. The Company has insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date these unaudited condensed financial statements are issued. We currently expect that our cash and cash equivalents will be sufficient to fund our operations, development plans, and capital expenditures into at least the first quarter of 2027.

Previous wording

For the three months ended March 31, 2026, the cash used in operating activities of $1.2 million resulted from net losses of $1.2 million, offset by $0.1 million stock-based compensation expense, $0.1 million in loss from equity method investments, and less than $0.3 million change in accounts payable, related party accrued compensation, and prepaid expenses.

Current wording

For the six months ended June 30, 2026, the cash used in operating activities of $2.4 million resulted from net losses of $2.4 million, offset by $0.1 million stock-based compensation expense, $0.2 million in loss from equity method investments, and by $0.4 million change in accounts payable, related party accrued compensation, and prepaid expenses.

Previous wording

For the three months ended March 31, 2025, operating activities used $1.6 million of cash. This was primarily driven by a net loss of $1.8 million and $0.7 million used to pay down accounts payable and prepaid expenses. These outflows were partially offset by $0.8 million in stock-based compensation expense. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development costs, consultant fees, and insurance expenses.

Current wording

For the six months ended June 30, 2025, operating activities used $2.4 million of cash. This was primarily driven by a net loss of $3.3 million, offset by $1.4 million stock-based compensation expense and $0.5 million used to pay down accounts payable and prepaid expenses. Accounts payable, as well as accrued and prepaid expenses, primarily related to research and development costs, consultant fees, and insurance expenses.

Previous wording

During the three months ended March 31, 2026, the Company repaid $0.3 million to a related party. The repayments were made pursuant to the terms of the underlying arrangements and reflect routine settlement of obligations as they became due.

Current wording

During the six months ended June 30, 2026, the Company repaid $0.3 million to a related party. The repayments were made pursuant to the terms of the underlying arrangements and reflect routine settlement of obligations as they became due.

Previous wording

During the three months ended March 31, 2025, financing activities received less than $0.01 million of cash, resulting from proceeds from sale of Common Stock, less offering costs.

Current wording

During the six months ended June 30, 2025, financing activities received $0.3 million of cash, resulting from proceeds from sale of Common Stock under our ATM, less offering costs.

Previous wording

Additional funding, capital, or loans (including, without limitation, milestone, or other payments from potential commercialization agreements) may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug formulations or potential markets, any of which could have a material adverse effect on us, our financial condition, and our results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities or exercise of warrants and options, the issuance of such securities would result in ownership dilution to existing stockholders.

Current wording

Additional funding, capital, or loans (including, without limitation, milestone, or other payments from potential commercialization agreements) may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug formulations or potential markets, any of which could have a material adverse effect on us, our financial condition, and our results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities or exercise of warrants and options, the issuance of such securities would result in ownership dilution to existing shareholders.

Previous wording

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 available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. 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. 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 our ability to meet our contractual obligations.

Current wording

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. On July 27, 2026, the Company received notice from Nasdaq that it was not in compliance with the $1.00 minimum bid price requirement. The Company's common stock continues to trade on the Nasdaq Capital Market, and the Company intends to regain compliance. Failure to do so could adversely affect its ability to raise capital. 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 available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. 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. 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 our ability to meet our contractual obligations.

Previous wording

Investments in entities over which the Company has the ability to exercise significant influence, but does not control, are accounted for under the equity method of accounting in accordance with ASC Topic 323,Investments — Equity Method and Joint Ventures(“ASC 323”). Under the equity method, investments are initially recorded at cost and subsequently adjusted to reflect the Company’s proportionate share of the investee’s net income or loss, which is recorded in equity method income (loss) in the statements of operations. Distributions received from investees reduce the carrying amount of the investment. The Company evaluates its equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of the investment may not be recoverable.

Current wording

Investments in entities over which the Company has the ability to exercise significant influence, but does not control, are accounted for under the equity method of accounting in accordance with ASC Topic 323,Investments — Equity Method and Joint Ventures(“ASC 323”). Under the equity method, investments are initially recorded at cost and subsequently adjusted to reflect the Company’s proportionate share of the investee’s net income or loss, which is recorded in equity method income (loss) in the statements of operations. Distributions received from investees reduce the carrying amount of the investment. We evaluate our equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of the investment may not be recoverable.
Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

We incurred $0.5 million and $1.1 million in general and administrative expenses during the three months ended June 30, 2026 and 2025, respectively. The decrease in general and administrative expenses for $0.6 million during three month ended June 30, 2026 relate primarily to decrease in stock-based compensation for $0.5 million, and decrease in payroll related expenses and in in other general expenses of $0.1 million.

Current report — wording carried from elsewhere

Results of Operations for the six months ended June 30, 2026 and 2025 are as follows:

Current report — wording carried from elsewhere

During the six months ended June 30, 2026, we incurred $1.2 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the six months ended June 30, 2025, we incurred $0.8 million in research and development expenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The increase in research and development expenses during 2026 is due to increases in development costs across our pipeline, including pre-IND submission work for MIRA-55 and SKNY-1, Phase 2a protocol advancement for Ketamir-2, and associated consulting and research activities. Major components of research and development expenses during the six months ended June, 2026 and 2025 are as follows:

Current report — wording carried from elsewhere

We earned less than $0.1 million in interest income during the six months ended June, 2026, which consisted of income earned from funds in a money market account, as compared to less than $0.1 million earned during the six months ended June 30, 2025.