MIRA 10-K & 10-Q changes, risk factors and insider trading

We are an early development-stage company with no revenues and our financial condition raises substantial doubt as to our ability to continue as a going concern.revenues.

We have yet to generate revenues or achieve a profit and willmay not generate revenue or achieve a profit infor themany near future,years, if at all.

Because of the speculative nature of an investment in our company,risk, you may lose your entire investment.

Certain of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain actions requiring stockholder votevote.

Additionally, we filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered into an At The Market Offering Agreement with Rodman & Renshaw LLC, under which we may offer and sell shares of our Common Stock. The maximum amount eligible to be sold under the ATM Agreement is $75 million. However, although we have received net proceeds of $6.7 million for the year ended December 31, 2025 and $3.6 million duringfor the year ended December 31, 2024 from the ATM, there are no assurances that we will be successful in raising any additional capital from the ATM.

MIRALOGX licenses us the patent pending rights to KETAMIR-2. MIRALOGX is a separate intellectual property development company owned by the Bay Shore Trust. The Bay Shore Trust is also our largest stockholder. The interests of MIRALOGX are 100% owned by the Bay Shore Trust. Our relationship with MIRALOGX and the Bay Shore Trust may create, or may create the appearance of, conflicts of interest when we are faced with decisions that could have different implications for MIRALOGX than the decisions have for us. Furthermore, in light of the license agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us relating to our past or future relationship with MIRALOGX or with respect to intellectual property matters, these potential conflicts of interest may make it more difficult for us to favorably resolve such disputes. Mr. Aminov, the Chief Executive Officer of the Company, is also the son-in-law of Jonnie Williams, the owner of MIRALOGX.

MichelleAlan Yanez,Weichselbaum, our Chief Financial Officer, is not employed by our company on a full-time basis. As intended to be provided in her employment agreement with our company, she works on a part-time and as-needed basis. Because shehe does not work full time for our company, instances may occur where shehe may not be immediately available to provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely affect our business. In addition, shehe can become subject to conflicts of interest because she he devotes part of herhis working time to other business endeavors and may have responsibilities to other entities. Although Mrs.Mr. Yanez Weichselbaum is aware of herhis duties and accountability to our company and to applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well as what business opportunities should be presented to us.

We currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development or moving into clinical stages. Our business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization of our product candidates, principally Ketamir-2 and MIRA-55. Investors need to be aware that substantial additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to undertake clinical studies and market and commercialize our product candidates, if ever. It may be several years before we can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and other jurisdictions where we intend, if approved, to market our product candidates. Before obtaining regulatory approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for its specific application. This process can take many years and may include post- marketingpost-marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs in in development for approval in the United States (and the rest of the world), only a small percentage will successfully complete the FDA FDA regulatory approval financing to fund our planned research, development, and clinical programs, we cannot assure you that any of our our product candidates will be successfully developed or commercialized.

If we are unable to obtain regulatory approval for Ketamir-2Ketamir-2, MIRA-55 and MIRA-55SKNY-1 within the timeline we anticipate, we will not be able to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse adverse impact on our long-term business, results of operations, financial condition, and prospects.

In addition, as product candidates are developed through early to late-stageearly-to-late-stage clinical trials and then to approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are modified along the way to optimize the scale, process and results. Any changes to the manufacturing processes carry the risk that they will not achieve these intended objectives, or that the product candidates may not meet the rigorous quality standards necessary for use in our pre-clinical or clinical trials.

There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights, or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed. If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under a patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. Any such claims could also be expensive and time consumingtime-consuming to defend and divert management’s attention and resources. Our competitive position could suffer as a result. In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected. Thus, we cannot guarantee that our product candidates, or our commercialization thereof, does not and will not infringe any third party’s intellectual property.

The U.S. Drug Enforcement Administration (DEA)’s has completed its scientific review of both Ketamir-2 and MIRA-55 and concluded that itneither compound would not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

We had net losses of $7.9$10.4 million and $12.0$7.9 million for the yearyears ended December 31, 20242025 and December 31, 2023,2024, respectively.

General and administrative expenses consist of employee-related expenses, including salaries, benefits, and travel, and other administrative functions, as well as fees paid for legal, accountingaccounting, and tax services, consulting feesfees, and facilities costs not otherwise included in in research and development expense. Legal costs include general corporate legal fees. We expect to incur additional expenses asAs a result of becoming a public company, includingwe now incur additional expenses related to compliance with the rules and regulations of the SEC and Nasdaq, as well as additional costs for insurance, investor relationsrelations, professional accounting and legal services, and other administrative expenses and professional services.expenses.

Results of Operations for the yearyears ended December 31, 20242025 and 20232026 are as follows:

General and Administrative Expenses. We incurred $4.7$8.8 million and $6.5$4.7 million in general and administrative expenses during the yearyears ended December 31, 20242025 and December 31, 2023,2024, respectively. General and administrative expenses in 20242025 consisted of stock compensation expense of $1.9 $6.3 million, payroll expense of $0.9$1.3 million, accounting and legal expenses of $0.4$0.3 million, marketing, investor relations, advertising, and general corporate expenses of $1.0$0.5 million and insurance expenses of $0.5$0.4 million. The decreaseincrease in general and administrative expenses during 20242025 relate primarily to a decreaseincrease in personnelstock-based in 2024 compared to 2023compensation and apayroll concertedrelated effort to conserve cash until the shelf registration statement and at-the-market offering was put into place in August 2024.expenses.

Interest income (expense). We earned $0.2$0.1 million,million in interest income (expense) net, during the year ended December 31, 2024,2025, which consisted of income earned from funds in a money market account.account, Weas incurredcompared $3.5to million,less inthan interest$0.2 incomemillion (expense) net,earned during the year ended December 31, 2023, which consisted of $2.8 million of write-off of unamortized deferred financing costs, $0.7 million of debt issuance costs, offset by $0.02 million of interest income.2024.

Research and Development Expenses. During the year ended December 31, 2024,2025, we incurred $3.3$1.7 million in research and development expenses, which were primarily related to pre-IND submission work, consultantswork and stock compensation.consultants. During the year ended December 31, 2023, 2024, we incurred $1.6$3.3 million in research and development expenses, which wereexpenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The increasedecrease in research and development expenses during 20242025 areis relateddue to thedecreased INDdevelopment enablingcosts studies andfor submission.MIRA-55. Major components of research and development expenses during the year ended December 31, 20242025 are as follows:

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 2022.2022 and our IPO 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, including the proceeds from our completed IPO in August 2023, and through proceeds of an ATM offering. In the years ended December 31, 2025 and 2024 we raised $6.7 million and $3.6 million, respectively, in ATM financings. We may also enter into new licensing and commercial partnership agreements.

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 negative cash flow from operations of approximately $5.6$4.7 million for the year ended December 31, 20242025, and an accumulated deficit of approximately $29.1$39.6 million as of December 31, 2024.2025. As of December 31, 2024,2025, we had cash and cash equivalents of approximately $2.8$6.3 million. We currently expect that our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures throughinto at least the thirdfirst quarter of 2025.2027.

TheFor the year ended December 31, 2025, the cash used in operating activities of $4.7 million resulted primarily from our net losses,losses of $10.4 million, offset by $6.3 million stock-based compensation expense and changes$0.6 and million change in components of accounts payablepayable, and accruedprepaid liabilities.expenses.

For the year ended December 31, 2024, cash used in operating activities usedof $5.6 million ofresulted cash, primarily due tofrom a net loss of $7.9 million, offset by $1.9 million in stock-based compensation expense, and a $0.4 million change in accounts payable, accrued liabilities, and prepaid expenses. Accounts payable, accrued liabilities, and prepaid expenses waswere primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.

ForDuring the year ended December 31, 2024, financingthe activitiesCompany providedraise approximately $3.8 million offrom cash,financing resultingactivities, primarily fromincluding $3.6 million in proceeds from sale of common stock, lessnet of offering costs, and $0.1 million from the Bay Shore Trust short-swing disgorgement, and $0.03 million in advances from related party.disgorgement.

We currently anticipate that we will seek to monetize our product candidates, Ketamir-2Ketamir-2, MIRA-55, and MIRA-55,SKNY-1, 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. Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all.

For a discussion of risk factors, please read Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.2025 (the “2025 Annual Report”). Such risk factors continue to be relevant to an understanding of our business, financial condition and operating results.results AsThere of the date of this Quarterly Report on Form 10-Q, there have beenare no material changes from to the risk factors reportedset forth in Part I, Item 1A, in our 2025 Annual Report.Report, except as described below:

MIRA Pharmaceuticals, Inc. (the “Company” or “MIRA”) is a clinical-stage pharmaceutical development company focused on developing novel oral small-molecule therapeutics for neuropathicchemotherapy-induced pain,peripheral neuropathy (CIPN), chronic inflammatory pain, weight management, and addiction-related conditions.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 and addiction-related indications.

Ketamir-2 is a next-generationan oral selective N-methyl-D-aspartate (“NMDA”) receptor modulator that has completed a Phase 1 clinical trial in healthy 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.reported. The Company is preparingtargeting to initiateinitiation of a Phase 2a clinical trial in CIPN in the first halfquarter of 2026,2027, subject to regulatoryFDA feedbackclearance, site readiness, and siteother readiness.regulatory and operational factors.

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

We had net losses of $1.1$2.4 million and $1.8$3.3 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.

Other Income, Income and Expense, net

Other income, income and expense, net consists of interest income earned from investment of excess operating cash, less interest expense,cash and the unrealized loss onfrom short-termour investments.equity method investment in Telomir Pharmaceuticals, Inc., a related party.

Results of Operations for the three months ended MarchJune 31,30, 2026 and 2025 are as follows:

We incurred $0.6$0.5 million and $1.5$1.1 million in general and administrative expenses during the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease in general and administrative expenses for $0.9$0.6 million during three month ended MarchJune 31,30, 2026 relate primarily primarily to decrease in stock-based compensation for $0.8$0.5 million, and decrease in payroll related expenses for $0.2 million partially offset by an increaseand in professional services andin other general expenses forof $0.1 million.

During the three months ended MarchJune 31,30, 2026, we incurred $0.5$0.7 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the three months ended MarchJune 31,30, 2025, we incurred $0.3 $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 20252026 is due to increaseincreases in development costs across our pipeline, including pre-IND submission work for MIRA-55.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 March 31,June, 2026 and 2025 are as follows:

Since our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder stockholder and an affiliated company and through a private placement of shares of our Commoncommon Stockstock 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.

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$42.0 million as of June March 31,30, 2026. As of MarchJune 31,30, 2026, we had cash and cash equivalents of approximately $4.8$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.

We did not have any material non-cancellable contractual obligations as of MarchJune 31,30, 2026.

For the threesix months ended MarchJune 31,30, 2026, the cash used in operating activities of $1.2$2.4 million resulted from net losses of $1.2$2.4 million, offset by $0.1 million stock-based compensation expense, $0.1$0.2 million in loss from equity method investments, and lessby than $0.3$0.4 million change in accounts payable, related party accrued compensation, and prepaid expenses.

For the threesix months ended MarchJune 31,30, 2025, operating activities used $1.6$2.4 million of cash. This was primarily driven by a net loss of $1.8$3.3 million, offset by $1.4 million stock-based compensation expense and $0.7$0.5 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.

During the threesix months ended MarchJune 31,30, 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.

During the threesix months ended MarchJune 31,30, 2025, financing activities received less than $0.01$0.3 million of cash, resulting from proceeds from sale of Common Stock,Stock under our ATM, less offering costs.

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.shareholders.

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 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.

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. TheWe Companyevaluate evaluates itsour equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of the investment may not be recoverable.