Celcuity Inc.

In addition to other information set forth in this Quarterly Report, including the important information in the section entitled “Special Note Regarding Forward-Looking Statements,” you should carefully consider the “Risk Factors” discussed in the 2025 10-K, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report. Except as set forth below, there have been no material changes to the risk factors previously disclosed in the 2025 10-K. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or operating results.

Risks Related to Our Product Strategy

We face significant competition, and our operating results will suffer if we fail to compete effectively.

Our industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results than REVTORPYK. Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, and universities and other research institutions. Many of our competitors have substantially greater financial, technical and other resources than we do.

REVTORPYK competes with other approved therapies for HR+/HER2- ABC, including other approved inhibitors of PI3K, AKT or mTOR pathways, such as alpelisib, capivasertib and everolimus, as well as other endocrine-based regimens. Competitors may also develop follow-on or next-generation PI3K, AKT or mTOR inhibitors, alternative formulations or combination regimens that do not infringe on our patent rights. In addition, following the expiration of regulatory exclusivity, or upon expiration of or earlier resolution of challenges to our patents, we expect to face competition from generic versions of gedatolisib, which are typically sold at substantially lower prices and preferred by formularies and payors.

Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors, either alone or with collaboration partners, may succeed in developing, acquiring or licensing on an exclusive basis products that are more effective, safer, more easily commercialized or less costly than REVTORPYK or any future product candidates, or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products. If we are unable to demonstrate to physicians and payors that the differentiating features of REVTORPYK translate into clinical benefit or lower overall cost of care versus our competitors, we may be unable to compete effectively.

Even following regulatory approval of drug products, the availability and price of our competitors’ products could limit the demand and the price we are able to charge for REVTORPYK and any future product candidates. We may not be able to implement our business plan if the acceptance of REVTORPYK or any future product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to REVTORPYK or any future product candidates, or if physicians switch to other new drug or biologic products or choose to reserve REVTORPYK or any future product candidates for use in limited circumstances.

Risks Related to Product Development and Product Regulation

REVTORPYK is, and any future approved indications or products will be, subject to ongoing regulatory and legal obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with REVTORPYK or any of our product candidates.

REVTORPYK is, and any additional indications or product candidates that may be approved will be, subject to ongoing regulatory and legal requirements for manufacturing, labeling, packaging, storage, distribution, advertising, promotion, record-keeping, conduct of post-marketing commitments and requirements, and submission of safety and other post-marketing information, including both federal and state requirements in the U.S. and requirements of comparable foreign regulatory authorities. In addition, we will be subject to continued compliance with requirements for any clinical trials that we conduct post-approval.

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

Any additional regulatory approvals that we receive for REVTORPYK or any future product may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. Certain endpoint data we hope to include in any approved product labeling also may not make it into such labeling, including exploratory or secondary endpoint data such as patient-reported outcome measures. The FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with REVTORPYK or any of our future approved products, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-marketing studies or clinical trials to assess new safety risks or imposition of distribution restrictions or other restrictions under a Risk Evaluation and Mitigation Strategy (REMS) program. Other potential consequences include, among other things:

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REVTORPYK is currently approved only for adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. In August 2026, we submitted an sNDA to the FDA seeking approval of REVTORPYK for patients with HR+/HER2- ABC with a PIK3CA mutation, based on results from the PIK3CAMT cohort of the VIKTORIA-1 Phase 3 clinical trial. The FDA may not approve our sNDA on a timely basis or at all, may approve it for a narrower patient population than we seek or with labeling restrictions, or may require us to provide additional clinical data. Unless and until the sNDA or any future supplemental application is approved, we may not promote REVTORPYK for those uses, which may limit our commercial opportunity. The FDA does not regulate the practice of medicine or behavior of physicians in their choice of treatments. However, the FDA does regulate marketing, labeling, advertising and promotion of products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. If our promotional activities fail to comply with these regulations or guidelines, we may be subject to warnings from, or enforcement action by, these authorities. If we are slow or unable to adapt to changes in existing requirements or adopt new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

In addition, our failure to follow FDA, or any applicable foreign regulatory authority, rules and guidelines relating to promotion and advertising may cause the FDA, or such applicable foreign regulatory authority, to suspend or withdraw REVTORPYK or another approved product from the market, require a recall or institute fines or penalties, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business. The law or regulatory policies governing pharmaceutical products may also change. New statutory requirements or additional regulations may be enacted that could prevent or delay regulatory approval of our future product candidates. We cannot predict the likelihood, nature, extent or effects of government regulation that may arise from future legislation or administrative action, either in the U.S. or internationally. If we are not able to maintain regulatory compliance, we might not be permitted to market any future approved products and our business could suffer.

Obtaining and maintaining FDA approval of REVTORPYK in the U.S. does not mean that we will be successful in obtaining regulatory approval of REVTORPYK or any future product candidates in other jurisdictions.

Obtaining and maintaining FDA approval of our product candidates in the U.S. does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, and a failure or delay in obtaining FDA approval in the U.S. may have a negative effect on the regulatory approval process in other jurisdictions. For example, even if the FDA grants marketing approval of a product candidate, a comparable foreign regulatory authority must also approve the manufacturing, marketing and promotion of the product candidate in those countries.

Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S., including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, or fail to obtain acceptable pricing or reimbursement, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

We intend to submit VIKTORIA-1 Phase 3 clinical trial data to regulatory authorities outside the U.S. Currently, we supply gedatolisib outside the U.S. only through an international distributor for clinical study. We may implement a named-patient program which would be subject to varying local laws. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, or if we fail to obtain acceptable pricing or reimbursement, our target market will be reduced and our ability to realize the full market potential of REVTORPYK and any future product candidates will be harmed.

Risks Related to Commercializing Our Products

We are subject to U.S. and foreign governmental regulations as well as private payor policies that mandate price controls or limitations on patient access to our products or establish prices paid by government entities or programs for our products. Our business and our future results could be adversely affected by changes in such regulations.

Commercial success of REVTORPYK and any other future approved products will depend in large part on the availability of insurance coverage and adequate reimbursement from third-party payors, including government payors such as the VA, Medicare and Medicaid programs, 340B, and managed care organizations in the U.S. or country specific governmental organizations in foreign countries. Government and private payors routinely seek to manage utilization and control costs, and there is considerable public and government scrutiny of pharmaceutical pricing. Efforts by states and the federal government, and similar government entities outside the U.S., to regulate prices or payment for pharmaceutical products, including proposed actions to facilitate drug importation, limit reimbursement to lower international (i.e., most favored nation) reference prices, require deep discounts, and require manufacturers to report and make public price increases and sometimes provide a written justification for such price increases, could adversely affect our business if and as implemented.

Throughout 2025, the U.S. federal government pursued multiple initiatives aimed at tying U.S. drug prices to those paid in certain other developed countries through an MFN pricing framework. These actions included a 2025 executive order entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” in which Centers for Medicare & Medicaid Services ("CMS") was instructed to create plans to impose MFN pricing on drug manufacturers. Following the executive order, CMS advanced three MFN-based payment models through the Center for Medicare and Medicaid Innovation: the “Global Benchmark for Efficient Drug Pricing”, which would implement a new, mandatory drug rebate program tied to MFN pricing for select drugs in Medicare Part B and is proposed to go into effect on January 1, 2027; “Guarding U.S. Medicare Against Rising Drug Costs”, which would implement a similar mandatory drug rebate program for select drugs in Medicare Part D and is proposed to go into effect on January 1, 2027; and “GENErating cost Reductions for U.S. Medicaid”, launched in January 2026, under which manufacturers who choose to participate in the model would pay MFN-based supplemental rebates under the Medicaid program in exchange for standardized coverage criteria in participating states. These models are likely to face legal and operational challenges, and the implementation of these models remains uncertain. In parallel to these CMS initiatives, several major pharmaceutical manufacturers have entered into voluntary agreements with the U.S. federal government to provide discounted prices aligned to MFN prices on certain of the manufacturers’ drugs to the Medicaid program and direct to patients.

Availability of reimbursement may also be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare, including the Inflation Reduction Act, which requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replaces the Part D coverage gap discount program with a new discounting program. Some states have implemented, and others are considering implementing, patient access constraints or cost cutting under the Medicaid program, and some are considering measures that would apply to broader segments of their populations that are not Medicaid-eligible. State legislatures also have continued to focus on addressing drug costs, generally by increasing price transparency or limiting drug price increases.

Third-party payors could also require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product and appropriateness for specific patient populations, to qualify for reimbursement, which could be costly and divert our resources. If government and other healthcare payors do not provide coverage and adequate reimbursement for REVTORPYK and any other future approved products, market acceptance and commercial success would be reduced. Even if coverage is provided, the approved reimbursement amount may not be high enough to support pricing that results in a sufficient return on our research and development investment.

We expect pricing pressures will continue globally. U.S. and foreign governmental regulations that mandate price controls or limitations on patient access to our products or establish prices paid by government entities or programs for our products could impact our business, and our future results could be adversely affected by changes in such regulations or policies.

Risks Related to Intellectual Property

If we are unable to obtain and maintain intellectual property protection for REVTORPYK and any future product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize REVTORPYK or any future product candidates may be impaired.

We have applied for patents that protect our product candidates, and our patent portfolio for our drug candidate, gedatolisib, includes 14 issued patents in the U.S. and more than 300 patents granted in numerous foreign jurisdictions. We cannot ensure that our intellectual property position will not be challenged or that all patents for which we have applied will be granted. We cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

The patent prosecution process is expensive and time-consuming, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner, or in all jurisdictions. We may choose not to seek patent protection for certain innovations and may choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope. Additionally, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. There also may be patent reforms in foreign jurisdictions that could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents in those jurisdictions. It is also possible that we will fail to identify patentable aspects of our discovery and non-clinical development output before it is too late to obtain patent protection.

As a result of these factors, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued that protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive product candidates. Moreover, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

REVTORPYK has been awarded New Chemical Entity (NCE) exclusivity in the United States, and a patent covering REVTORPYK may be eligible for patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984. However, we may not obtain any such extension, or the extension may be shorter than we request. Third parties may submit abbreviated NDAs or 505(b)(2) applications referencing REVTORPYK that contain certifications challenging the validity or enforceability of, or asserting non-infringement of, our listed patents. Any such challenge will require us to engage in costly and time-consuming patent litigation and could result in the earlier introduction of generic competition. In addition, generic entry would substantially reduce our revenue from REVTORPYK.