MIRA PHARMACEUTICALS, INC.

Current report

Risks Related to SKNY and SKNY-1

Current report

SKNY has yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.

Current report

SKNY does not own rights to SKNY-1

Current report

Conflicts of interest may arise between SKNY and MIRALOGX.

Current report

Risks Related to SKNY and SKNY-1

Current report

SKNY has yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.

Current report

SKNY does not own rights to SKNY-1.

Current report

All of SKNY’s rights in SKNY-1 are granted to it under a license (“License”) from MIRALOGIX LLC, a Florida corporation (“Licensor”), so SKNY does not have an ownership interest in SKNY-1. The License give SKNY the right to make, use and sell SKNY-1 only in the US, Canada, and Mexico. The Licensor retained the rights to SKNY-1 everywhere outside of the US, Canada and Mexico. If SKNY breaches the License or if the Licensor goes bankrupt, SKNY could lose its rights to SKNY-1 and all of such rights would revert back to the Licensor. Further, Licensor will control the process of applying for and obtaining any patents or other intellectual property rights in SKNY-1, all at the expense of SKNY. All of such patents and intellectual rights will be owned by Licensor, subject to SKNY’s rights under the License. Furthermore, SKNY has no control over the patent prosecution strategy, which is fully managed by the Licensor.

Current report

SKNY’s rights to SKNY-1 are subject to royalties.

Current report

SKNY entered into an exclusive licensing agreement with MIRALOGIX LLC, a Florida corporation (“MIRALOGIX”) for the licensing by MIRALOGX to SKNY the commercial rights of SKNY-1, or M308 (the “SKNY-1 Licensing Agreement”) in the United States, Mexico and Canada. Under the SKNY-1 Licensing Agreement SKNY will owe MIRALOGX a royalty of 8% on all revenue it receives from SKNY-1, with a minimum annual royalty of $250,000 that begins in the first year that there is any revenue from SKNY-1. This $250,000 will be owed even if in any later year there is no revenue from SKNY-1 or if the 8% royalty rate on actual revenues yields less than $250,000. SKNY’s failure to pay minimum royalties in any year would be a breach of the SKNY-1 Licensing Agreement and such breach would let the Licensor terminate SKNY’s rights to SKNY-1.

Current report

Conflicts of interest may arise between SKNY and MIRALOGX.

Current report

SKNY’s product candidates, if approved, may not achieve the expected market acceptance and, consequently, limit SKNY’s ability to generate revenue.

Current report

We are dependent on SKNY’s current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

Previous report

We depend on rights to Ketamir-2 that are or will be licensed to us.

Previous report

We have been granted a license to the right to develop Ketamir-2 in the United States in human and pet application, but we have not been granted a license to the rights to patents covering Ketamir-2 in foreign jurisdictions.

Previous report

We will need to raise additional financing for the continuation of our operations.

Previous report

Our operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues and succeed overall.

Previous report

We may not successfully integrate with SKNY following our potential upcoming acquisition

Previous report

We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing our growth and executing our growth strategy.

Previous report

Any failure by us to comply with existing regulations could harm our reputation and operating results.

Previous report

We may not be successful in the integration of our potential acquisition of SKNY.

Previous report

As discussed earlier in this Annual Report of Form 10-K, we have entered into a binding letter of intent to acquire SKNY. Integrating SKNY’s business, processes, and operations presents new risks to the business that must be managed carefully. If not, it could have a material impact on operations and cause results to differ significantly from expectations.

Previous report

Acquisitions involve a number of risks and difficulties, including: (i) expansion into new markets and business ventures; (ii) the requirement to understand local business practices; (iii) the diversion of management’s attention to the assimilation of acquired operations and personnel; (iv) being bound by client or vendor contracts with unfavorable terms; and (v) potential adverse effects on a company’s operating results for various reasons, including, but not limited to, the following items: (a) the inability to achieve financial targets; (b) the inability to achieve certain operating goals and synergies; (c) costs incurred to exit current or acquired contracts or activities; (d) costs incurred to service any acquisition debt; and (e) the amortization or impairment of intangible assets.

Previous report

Due to the multiple risks and difficulties associated with any acquisition, there can be no assurance that we will be successful in achieving our expected strategic, operating, and financial goals for any such acquisition.

Previous report

Should we later determine if it is in our best interest to develop a sales force, we may be unable to effectively train and equip our sales force, therefore our ability to successfully commercialize our products may be harmed.

Previous report

We will be required to expend significant time and resources to train our sales force to be credible, persuasive and compliant with applicable laws in marketing Ketamir-2 and MIRA-55 or our other product candidates to physicians for their approved uses. In addition, we must continue to train our sales force to ensure that a consistent and appropriate message about Ketamir-2 and MIRA-55 or our other product candidates are being delivered to our potential customers. If we are unable to effectively train our sales force and equip them with effective materials, including medical and sales literature, to help them inform and educate potential customers about the benefits of Ketamir-2 and MIRA-55 and our product candidates and its proper administration, our efforts to successfully commercialize Ketamir-2 and MIRA-55 and our product candidates could be jeopardized, which would negatively impact our ability to generate product revenues.

Previous report

We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing our growth and executing our growth strategy.

Previous report

Our management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth. As a result, we may need to further expand certain areas of our organization.

Previous report

Our need to effectively manage our operations, growth and various projects requires that we:

Previous report

In addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions. Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward. If we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors, we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing, and commercialization activities and, accordingly, may not achieve our research, development and commercialization goals.

Previous report

Any failure by us to comply with existing regulations could harm our reputation and operating results.

Previous report

We are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing through the approval process.

Previous report

We must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting and recordkeeping requirements. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval cGMP requirements, then FDA could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. Ketamir-2 and MIRA-55, and any of our product candidates that may be approved in the U.S. in the future, will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including both federal and state requirements in the U.S. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP. As such, we, and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with whom we work must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label.

Previous report

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product, it may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may:

Previous report

In addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our business and our operating results may be adversely affected.

Previous report

Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation. We expend significant resources on compliance efforts and such expenses are unpredictable and might adversely affect our results. Changing laws, regulations and standards might also create uncertainty, higher expenses and increase insurance costs. As a result, we intend to invest all reasonably necessary resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.

Previous report

We maintain our cash at financial institutions, at times in balances that exceed federally insured limits. The failure of financial institutions could adversely affect our ability to pay operational expenses or make other payments.

Previous report

Our cash held in non-interest-bearing and interest-bearing accounts can at times exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations. In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders’ access to their accounts and assets held in their accounts may be substantially delayed. Any material loss that we may experience in the future or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability to pay our operational expenses or make other payments, which could adversely affect our business.

Current report — wording carried from elsewhere

We depend on a limited number of suppliers for materials and components required to manufacture our product candidates.

Current report — wording carried from elsewhere

The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern*.*

Current report — wording carried from elsewhere

Our product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products.

Current report — wording carried from elsewhere

If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of Ketamir-2 and MIRA-55 and our product candidates.

Current report — wording carried from elsewhere

Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.

Current report — wording carried from elsewhere

Clinical trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history; we face a significant risk that the trials will not result in commercially viable drugs and treatments.

Current report — wording carried from elsewhere

We have no patent protection for MIRA-55, which could adversely impact MIRA-55’s potential competitive position.

Current report — wording carried from elsewhere

SKNY has not yet produced any revenues or profit and may not for many years, if at all. SKNY’s ability to generate revenue is dependent on the receipt of regulatory approval of SKNY’s product candidates, which will take years to achieve and may not be obtained. MIRA therefore cannot assure you SKNY will be able to ever generate sufficient revenue to pay for SKNY’s expenses or achieve profitability. SKNY’s ability to continue as a going concern in the future is dependent upon raising capital from financing transactions and keeping operating expenses below SKNY’s revenue levels in order to achieve positive cash flows, none of which can be assured.

Current report — wording carried from elsewhere

MIRALOGX is the license of SKNY’s rights to SKNY-1. MIRALOGX is a separate intellectual property development company owned by the Bay Shore Trust. The Bay Shore Trust is also SKNY’s largest stockholder. MIRALOGX is 100% owned by the Bay Shore Trust. SKNY’s relationship with MIRALOGX and the Bay Shore Trust may create, or may create the appearance of, conflicts of interest when SKNY is faced with decisions that benefit MIRALOGIX but do not benefit other holders of MIRA Common Stock. Furthermore, in light of the license agreement that SKNY has with MIRALOGX, if a dispute were to arise between MIRALOGX and MIRA relating to SKNY’s past or future relationship with MIRALOGX or with respect to intellectual property matters, there could be a conflict of interest that may make it more difficult for SKNY to resolve such disputes on terms that are acceptable to SKNY.

Current report — wording carried from elsewhere

Even when product development is successful and regulatory approval has been obtained, SKNY’s ability to generate sufficient revenue depends on the acceptance of its products by physicians and patients. There is no assurance that SKNY’s product candidates will achieve the expected level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label. Market acceptance can also be influenced by continued demonstrations of efficacy and safety in commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers, the price of the product, the nature of any post-approval risk management activities mandated by regulatory authorities, competition, and marketing and distribution support. Further, an ineffective or inefficient distribution model at launch may lead to the inability to fulfill demand, and consequently a loss of revenue. Any factors preventing or limiting the market acceptance of SKNY’s products could have a material adverse effect on SKNY’s business, results of operations and financial condition.

Current report — wording carried from elsewhere

Demand for SKNY’s product candidates will likely be dependent on a number of social, political, legislative, and economic factors that are beyond its control. While we believe that there will be a demand for such drugs, and that the demand will grow, there is no assurance that such demand will happen, that we will benefit from any demand or that its business, in fact, will ever generate revenues from its drug development programs or become profitable.

Current report — wording carried from elsewhere

The emerging markets for product candidates like SKNY’s and related medical research and development is and will likely remain competitive. The development and commercialization of drugs and medicines is highly competitive. SKNY competes with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research institutions. Many of SKNY’s competitors have developed, are developing, or will develop drugs and processes which may be competitive with SKNY’s drug candidates. Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted by the medical community and any new treatments that may enter the market. For some of SKNY’s drug development programs / areas of therapeutic interest, other treatment options are currently available, under development, and may become commercially available in the future. If any of SKNY’s product candidates are approved for the diseases and conditions SKNY is currently pursuing, they may compete with a range of medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.

Current report — wording carried from elsewhere

Established companies may have a competitive advantage over SKNY due to their size and experiences, financial resources, and institutional networks. Many of SKNY’s competitors may have significantly greater financial, technical, and human resources than SKNY does. Due to these factors, SKNY’s competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before SKNY is able to, which may limit its ability to develop or commercialize SKNY’s drug candidates. SKNY’s competitors may also develop drugs / medicines that are safer, more effective, more widely used and less expensive than SKNY’s. These advantages could materially impact SKNY’s ability to develop and, if approved, commercialize SKNY’s product candidates successfully. Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain market share.

Current report — wording carried from elsewhere

Moreover, as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially. Even if SKNY-1 is the first to obtain FDA approval of one of its product candidates, the future potential approval of generics could adversely affect the price SKNY is able to charge, and the profitability of SKNY’s product(s) will likely decline.

Current report — wording carried from elsewhere

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of SKNY’s competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Current report — wording carried from elsewhere

These companies may compete with SKNY in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to SKNY’s research projects.

Current report — wording carried from elsewhere

Our ability to progress SKNY’s plan will depend on SKNY’s ability to clinically develop, gain regulatory approval for and ultimately commercialize SKNY’s product candidates. SKNY’s ability to successfully commercialize SKNY’s product candidates will depend on, among other things, SKNY’s ability to:

Current report — wording carried from elsewhere

SKNY’s failure or delay with respect to any of the factors above could have a material adverse effect on SKNY’s business, results of operations and financial condition.

Current report — wording carried from elsewhere

If we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading market for our shares and make obtaining future debt or equity financing more difficult for the us.

Previous report — wording carried elsewhere

Our future success will largely depend on the success of Ketamir-2 and MIRA-55 and any future product candidates, which development will require significant capital resources and years of clinical development effort.

Previous report — wording carried elsewhere

We have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.

Previous report — wording carried elsewhere

If third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual property, our operating profits could be adversely affected.