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

We have havenot yet commercialized a limitedpharmaceutical operating historyproduct, and we may never generate revenue or profit.

We are a clinical-stage biotechnology company that commenced activities in January 2012. We have not yet commercialized a pharmaceutical limited operating history,product, and our commercial business plan has not been tested. Since inception, we have had no revenue and have incurred significant operating losses. We have financed our operations primarily through equityprivate placements and debtregistered offerings offerings.of our equity securities, unsecured convertible notes, and borrowings under loan agreements. To generate revenue and become and remain profitable, we need to successfully complete our existing clinical trials, cultivate partnerships with pharmaceutical companies,trials and developdevelop, obtain regulatory approval for, and commercialize gedatolisib pursuant to our license agreement with Pfizer. We must also build operational and financial infrastructure to support commercial operations, train and manage employees, and market and sell our anticipated drug product.product, if approved.

We will may require additional capital to finance operating expenses and capital expenditures overin the nextfuture severalas yearswe prepare to launch, and if we launch, launch gedatolisibgedatolisib, and expand our infrastructure, commercial operations and research and development activities. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives. In addition, we may have to work with a partner on one or more of our products or market development programs, which could lower the economic value of those programs to our company.

We may be exposed to the risk of product liability claims that is inherent in the biopharmaceuticalpharmaceutical industry. A product liability claim may damage our reputation by raising questions about our product’s safety and efficacy and could limit our ability to sell one or more products by preventing or interfering with commercialization of our drug candidate.product. In addition, product liability insurance for the biopharmaceuticalpharmaceutical industry is generally expensive to the extent it is available at all. There can be no assurance that we will be able to obtain or maintain such insurance on acceptable terms for any product we bring to market. Further, our product liability insurance coverage may not provide coverage or may be insufficient to reimburse us for any or all expenses or losses we may suffer. A successful claim against us with respect to uninsured liabilities or in excess of insurance coverage could have a material adverse effect on our business, financial condition and results of operations.

We are expect to expandexpanding our development and regulatory capabilities and potentially implementimplementing sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We are expect to experienceexperiencing significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs and, ifin anticipation of our product candidate receivespotentially receiving marketing approval, sales, marketing and distribution. To manage our anticipated futurethis growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limitedfinite financial and human resources, we may not be able to effectively manage the expansion of our operations or recruit and train sufficient numbers of additional qualified personnel. The expansion of our operations mayis lead to significant costscostly and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Our near-term revenue prospects depend on the success of our initial drug product, gedatolisib. If we are unable to successfully complete clinical development of, obtain regulatory approval forfor, or commercialize commercialize, gedatolisib, or if we experience delays in doing so, including supply chain interruptions, our business will be materially harmed.and adversely impacted.

To date, we have not yet completed any registrationalOur clinical trials or the development of our initial drug candidate, gedatolisib. Our future success and ability to generate revenue, which we do not expect until 2026 or later, if ever, is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize gedatolisib for one or more intended uses. We may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, our current or future product candidates if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, gedatolisib, including:

We had no involvement with or control over the initial preclinical and clinical development of gedatolisib. We are dependent on third parties having conducted their research and development in accordance with the applicable protocols and legal, regulatory and scientific standards; having accurately reported the results of all preclinical studies and clinical trials conducted with respect to such drug product; and having correctly collected and interpreted the data from these trials. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of our drug product will be delayed and may be adversely affected.

We will need to successfully completeachieve primary clinical endpoints in registrational clinical trialstrials, in order to obtain and maintain the approval of the FDA or comparable foreign regulatory authorities to market our drug product. Carrying out clinical trials, including later-stage registrational clinical trials, is a complicated process. As an organization, we have not previously completed any registrational clinical trials. In order to do so, we arecontinue buildingto build and expandingexpand our clinical development and regulatory capabilities, and there is risk that we may be unable to recruit and train qualified personnel. We also expect to continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any product candidates. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to submission submission, approval, and maintaining approval of our drug product. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approval of any drug products that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our drug products.

Our business depends on the successful development of biopharmaceuticals,our pharmaceutical products, which is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons including, among other things, that clinical trial results may show the product candidates to be less effective than expected or to have unacceptable side effects or toxicities; we may fail to receive the necessary regulatory approvals or there may be a delay in receiving such approvals; or the proprietary rights of others and their competing products and technologies may prevent our product candidates from being commercialized.

In addition, if gedatolisib receives marketing approval for the intended uses that we are pursuing, we will continue to be subject to significant post-approval regulatory obligations. Compliance with these requirements is costly, and any failure to comply or other issues with our drug products post-approval could adversely affect our business, financial condition and results of operations. In addition, there is always the risk that we, a regulatory authority authority, or a third party might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency.

Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more data becomesbecome available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or toplineinterim data from our clinical studies, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the toplinepreliminary or interim results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results once additional data have been received and fully evaluated. Topline Preliminary or interim data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, toplinepreliminary or interim data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical studies. Interim data from clinical studies that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as more patient data becomes available. Adverse differences between between preliminary or interim data and final data could significantly harm our reputation and marketing efforts.

Further, others, including healthcare providers or payors, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding our business. If the toplinepreliminary or interim data that we report differ from actual results, or if others, including healthcare providers or payors, disagree with the conclusions reached, our ability to commercialize our product candidate may be harmed, which could harm our business, operating results, prospects or financial condition.

To obtain the requisite regulatory approvals to commercialize any drug products,product, we must demonstrate through extensive preclinical studies and clinical trials that such drug product is safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. We may be unable to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful, and a clinical trial can fail at any stage of testing.

Successful completion of clinical trialstrials, or achievement of a predefined primary endpoint, is a prerequisite to submitting aan new drug application,NDA, or NDA,NDA supplement, to the FDAFDA, and similar marketing applications to comparable foreign regulatory authorities authorities, for each drug product and, consequently, the ultimate approval and commercial marketing of any drug products. We may experience delays in initiating or completing clinical trials, or achieving event thresholds, including if it takes longer than expected to activate the targeted number of clinical sites, if the enrollment of patients is slower than anticipated or negatively affected by staffing shortages at clinical sites, or by other unanticipated factors, factors, or if the FDA or other regulatory authorities require us to pause one or more of our clinical trials due to unexpected safety issues. issues. We also may experience numerous unforeseen events during, or as a result of, any future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our current product candidates or any future product candidates.

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 our lead product candidate, gedatolisib. Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical and diagnostic companies, and universities and other research institutions. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces.

Cybersecurity threats are becoming increasingly difficult to detect, and come from a variety of sources, including without limitation, nation-state actors and activists that create disruption for geopolitical reasons and in conjunction with military conflicts and defense activities. This risk is heightened duringas timesa result of war global wars and other major conflicts, including the war between Russia and Ukraine, the conflict between Israel and Hamas and the risk of a larger regional conflict.conflicts. In addition, we and the third parties upon which we rely face an evolving cybersecurity threat landscape, which includes social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, attacks enhanced or facilitated by artificial intelligence (“AI”), software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, natural disasters, terrorism, and other similar threats.

If we are unable to obtain approval from the FDA or comparable foreign regulatory authorities to market our products for their intended use, we will not be able to generate revenue. For a new drug to be approved for marketing, the FDA and other regulatory authorities must determine that the drug is safe and effective. Because all drugs can have adverse effects, the data from our Phase 3 clinical study must demonstrate to the satisfaction of the FDA and other health authorities that the benefits of gedatolisib in combination with palbociclib fulvestrant, and fulvestrant, gedatolisib in combination with fulvestrant,or without palbociclib, or gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, outweigh its risks. Failure to demonstrate sufficient magnitude of benefit, even if the benefit is found to be statistically significant, may not support regulatory approval.

If a drug meets its primary efficacy endpoint objective in a Phase 3 clinical trial, and the drug sponsor has additional nonclinical and and clinical data required by the FDA or other regulatory authorities, the drug sponsor may submit an NDA seeking marketing approval. Upon submission of an NDA, these health authorities perform a benefit-risk assessment that considers the strength and quality of evidence available and takes remaining uncertainties into account. These considerations include an assessment of the strengths and limitations of clinical trials, including design, and potential implications for assessing drug efficacy, the magnitude of benefit and interpretation of clinical importance, the benefit attributed to the drug when studied in combination with other therapies, and the clinical relevance of the study endpoints. We are currently conducting a Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib, in patients with HR+/HER2- advanced breast cancerABC after progression on CDK4/6 therapy, conducting a Phase 3 clinical clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer,ABC, and conducting a Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer. In November 2025, we completed our NDA submission to the FDA for gedatolisib in HR+/HER2- ABC based on clinical data from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial. On January 16, 2026, the FDA accepted our NDA, designated it for Priority Review, and identified July 17, 2026 as our PDUFA target goal date.

We have sought feedback from the FDA and other regulatory authorities on the design of gedatolisib clinical trials, with the goal of addressing these these considerations in the clinical trials’ design. However, due to the complexity of clinical trials, the uncertainty of outcomes, and and the uncertainty of how the FDA and other regulatory authorities may balance benefits and risks in their review of an NDA, it may not be practical or possible to address all benefit-risk assessment considerations in a clinical trial so that sufficient evidence is generated generated to support a marketing approval, even if the primary endpoint objective is achieved in the Phase 3 stage of the trial. The FDA or other regulatory authorities may require us to redesign or conduct additional unplanned clinical trials before granting any approval and we may not get approval at all. Regulatory approval may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. We cannot predict whether our research and clinical approaches will result in a drug that the FDA considers safe for humans and effective for indicated uses. In light of these uncertainties, the results from clinical trials that we conduct may not support approval of gedatolisib.

Additionally, if the size of the FDA group dedicated to reviewing oncology-related submissions is reduced, further delays of anyour regulatory submission by Celcuity submissions may be encountered.

Breakthrough Therapy Designation orDesignation, Fast Track DesignationDesignation, NDA submission via RTOR, and being awarded Priority Review from the FDA may not actually lead to a faster development or regulatory review or approval process.

If a drug is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the product sponsor may apply for Fast Track Designation. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and to ensure collection of appropriate data needed to support drug approval, as well as eligibility for submission of aan New Drug Application.NDA.

Both Fast Track and Breakthrough Therapy DesignationsDesignations, as well as seeking to submit our NDA on a rolling basis pursuant to the FDA’s RTOR program, and receiving Priority Review, are within the discretion of the FDA. While theThe FDA has granted both designations to our lead drug candidate, gedatolisib, and has accepted our NDA which was filed via RTOR and designated it for Priority Review. However, such designations and programs may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA FDA review procedures, and neithernone designationof these designations and awards assures ultimate approval by the FDA. In addition, the FDA may later decide that the product no longer meets the qualification conditions and may rescind eithersuch designations or bothprograms, suchor designations.the FDA may not approve our NDA by the Priority Review PDUFA target goal date of July 17, 2026.

Obtaining and maintaining regulatoryFDA approval of our product candidates in onethe jurisdictionU.S. does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

Obtaining and maintaining regulatoryFDA approval of our product candidates in onethe jurisdictionU.S. does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatoryFDA approval in onethe jurisdictionU.S. may have a negative effect on the regulatory regulatory approval process in others.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.

If any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, storage,distribution, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacysafety 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.

We depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidate, and termination of this license could result in the loss of significant rights, which would harm materially and adversely impact our business.

We are dependent on patents, know-howpatents and proprietary technology,know-how, both our own and licensed from others.Pfizer. AllKey patents covering gedatolisib and any combination therapies using our product candidates are licensed from thirdPfizer parties.pursuant to the Gedatolisib License Agreement. Any termination of athe product license could result in the loss of significant rights and would cause material adverse harm to our ability to commercialize our product candidates.

Disputes may also arise between us and ourPfizer licensors regarding intellectual property subject to athe licenseGedatolisib agreement,License Agreement, including:

We are a party to a license agreement with Pfizer pursuant to which we in-license key patents for gedatolisib. This license imposes various diligence, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, Pfizer may have the right to terminate the license, in which event we would not be able to develop or market the products covered by such licensed intellectual property. Further, we cannot be certain that the activities conducted by thesePfizer, licensorsor its predecessors, were conductedperformed in compliance with applicable laws and regulations or will result in additional valid and enforceable patents and other intellectual property rights.

We rely on trade secret protection to protect our interests in proprietary know-how and in processes for which patents are difficult to obtain or enforce. We may not be able to protect our trade secrets adequately. We have a policy of requiring our consultants, advisors and strategic partners to enter into confidentiality agreements and our employees to enter into invention, non-disclosure and non-competerestrictive covenant agreements. However, no assurance can be given that we have entered into appropriate agreements with all parties that have had access to our trade secrets, know-how or other proprietary information. There is also no assurance that such agreements will provide meaningful protection of our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of information. Furthermore, we cannot provide assurance that any of our employees, consultants, contract personnel, or strategic partners, either accidentally or through willful misconduct, will not cause serious damage to our programs and/or our strategy, for example by disclosing important trade secrets, know-how or proprietary information to our competitors. It is also possible that our trade secrets, know-how or other proprietary information could be obtained by third parties as a result of breaches of our physical or electronic security systems. Any disclosure of confidential data into the public domain or to third parties could allow our competitors to learn our trade secrets and use the information in competition against us. In addition, others may independently discover our trade secrets and proprietary information. Any action to enforce our rights is likely to be time consuming and expensive, and may ultimately be unsuccessful, or may result in a remedy that is not commercially valuable. These risks are accentuated in foreign countries where laws or law enforcement practices may not protect proprietary rights as fully as in the United States. Any unauthorized disclosure of our trade secrets or proprietary information could harm our competitive position.

We have applied for patents that protect our product candidates, and our patent portfolio currently includes, for CELsignia, six issued U.S. patents and 30 issued international patents, and, for our drug candidatecandidate, gedatolisib, 12includes 13 grantedissued patents in the U.S. and more than 290297 patents granted in numerous foreign jurisdictions including Australia, Canada, China, France, Germany, Spain, United Kingdom and Japan.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 commercial success of our products depends upon our ability to usemanufacture, proprietarymarket technologiesand sell our products without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the medical technology, biotechnology and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products. Additionally, because current and future employees may have been previously employed at universities or other biotechnology, diagnostic technology or pharmaceutical companies, including our competitors or potential competitors and strategic partners, third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, or they may allege that our employees or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Litigation may be necessary to defend against these claims.

Patent litigation could result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection of our technology and potential diagnostic tests.products. If we are found to infringe a third party’s intellectual property rights, we could be required to obtain additional licenses from such third party to continue developing and marketing our applicable products. products. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product.

We depend upon third parties to execute certain aspects of our operational plans and to conduct certain aspects of our preclinical studies. Additionally, we depend on third parties, including independent investigators, to conduct our clinical trials, under agreements with universities, medical institutions, contract research organizations, or CROs, strategic partners and others. Our reliance on third parties may affect our development timelines and increase our costs.

Our reliance on third parties to formulateformulate, manufacture and manufacturedistribute our drug product will exposeexposes us to risks that may delay the development, regulatory approval and commercialization of our drug product or result in higher product and operational costs.

We do not directly formulateformulate, manufacture or manufacturedistribute our drug product candidate and do not intend to establish our own formulation, manufacturing or distribution facilities. We willhave contractcontracted with onethird-party or morecontract manufacturers to formulate, manufacture and supply our drug product, and we will use other third parties to package, store and distribute drug suppliesproduct for our clinical trials. If our drug product receives FDA approval, we will rely on one or more third-party contractorscontract manufacturers to manufacture and package our commercial drug product, and we will use a 3PL to distribute our commercial drug product.

Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a potent,kinase well-tolerated, small molecule reversible inhibitor, administered intravenously, that selectively targets all Class I isoformsinhibitor of phosphatidylinositol-3-kinase the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein andkinase theprotein twokinase B (“AKT”), mechanistic targetstarget of rapamycin (“mTOR”) sub-complexes,pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORmTORC1 alone or together. A Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer is(“ABC”) currently enrolling patients. Site selection activities arehas completed enrollment and activationreported activitiesdetailed results for acohort 1, patients with PIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort 2, patients with PIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a CDK4cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer has commenced, and the first patientABC is expected to be dosed in the second quarter of 2025.ongoing. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with mCRPC,metastatic castration resistant prostate cancer (“mCRPC”), is currently underway.ongoing.

In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer Inc. Pfizer. We believe gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration offer distinct advantages over currently approved and investigational therapies that target PI3K, PI3Kα, AKT, or mTORmTORC1 alone or together.

Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms and andthe mTORC1 and mTORC2 complexes. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PAM pathway. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits a single Classclass I PI3K isoform (e.g., alpelisib, a PI3K-PI3Kα inhibitor), AKT (e.g., capivasertib, an AKT inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units. This, in turn, induces compensatory resistance that reduces the efficacy of isoform specific PI3Kα, AKT, or single mTORmTORC1 kinase complex inhibitors. Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoformsisoforms, AKT, and mTOR.

Gedatolisib is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisibgedatolisib’s stabilizescomprehensive inhibition of the PAM pathway at lowerlow concentrationnanomolar potency, IV route of administration, and pharmacokinetic properties enables it to achieve optimal anti-proliferative effects on tumor cells without inducing the levels inof plasmahyperglycemia, comparedrash, toand orallydiarrhea administeredtypically associated with PI3Koral inhibitors,single-component resultinginhibitors inof lessthe toxicity,PAM while maintaining concentrations sufficient to inhibit PI3K/mTOR signaling.pathway.

Isoform-specific PI3K PI3Kor mTORC1 inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specificsingle-component PAM inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis can still leadslead to challenging toxicities. The experience with an FDA approvedFDA-approved oral p110-α specific inhibitor, PIQRAY, illustrates the challenge. In its Phase 3 pivotal trial, PIQRAY was found to induce a Grade 3 or 4 adverse event (“AE”) related to hyperglycemia in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to treatment related AEs. By contrast, in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 9% discontinued treatment.

As of December 31, 2024,2025, 4921,127 patients and healthy volunteers have received gedatolisib in 12 completed or ongoing clinical trials. Of these, 123 patients with solid tumors have received gedatolisib in eight clinical trials sponsored by Pfizer. Of the 492 patients, 129 were treated with gedatolisib as a single agent in threetwo clinical trials.trials, The36 healthy volunteers were treated in two clinical trials, and the remaining 363968 patients received gedatolisib in combination with other anti-cancer agents in fiveeight clinical trials. Additional patients received gedatolisib in combination with other anti-cancer agents in nine 10 investigator sponsored clinical trials.

We have arecompleted currentlyenrollment enrollingof patients in aour Phase 3, open-label, randomized clinical trial,VIKTORIA-1,trial, VIKTORIA-1, to evaluate the efficacy and safety of gedatolisib twotreatment regimens in adults with HR+/HER2- advanced breast cancerABC whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor: 1) gedatolisib in combination with palbociclib and fulvestrant; and 2) gedatolisib in combination with fulvestrant.inhibitor. Over two hundred200 clinical sites in North America, Europe, Latin America, and Asia-Pacific are participating in the study. The first patient was dosed in this trial in December 2022.

The VIKTORA-1 Phase 3 clinical trial willinvolves two study cohorts that enable separate evaluation of subjects according to their PIK3CA status. Subjects who meetmet eligibility criteria and arehad PIK3CA WT willtumors be(cohort 1) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). The WT enrollment target was achieved in During the fourth quarter of 2024.2024, we achieved our enrollment goal of 351 subjects for the PIK3CA WT cohort. The primary completion date for this cohort was achieved in May 2025 and the database cut-off date for this cohort was May 30, 2025. Subjects who meetmet eligibility criteria and arehad PIK3CA MT will betumors (cohort 2) were randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant (Arm E), or gedatolisib and fulvestrant (Arm F). ToplineEnrollment of approximately 350 subjects who have PIK3CA MT tumors is complete. We expect topline data fromfor Armscohort A,2 Bto andbe Cavailable in the second quarter of this clinical trial are expected in Q2 2025.2026.

AIn July 2025, we dosed the first patient in VIKTORIA-2, a Phase 3, multi-center, open-label, randomizedrandomized, clinical trial designed to evaluate the efficacy and safety of gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer that is endocrine treatment resistant (“VIKTORIA-2”)ABC. is currently activating clinical trial sites. For the CDK4/6 inhibitor, investigators may choose either ribociclib or palbociclib. This multi-center, international trial isenrolled expected to enroll approximately 12–3635 evaluable subjects in the safety run-in portion of the study to evaluate the safety of gedatolisib when combined with ribociclib and fulvestrant. The safety run-in was completed in the first quarter of 2026. In the Phase 3 portion of the study, approximately 638 subjects willare expected to be randomized and assigned to Cohort 1 (PIK3CA WT) or Cohort 2 (PIK3CA MT) based on their PIK3CA status. Subjects in each cohort willare expected to be randomized on a 1:1 basis to either Arm A (gedatolisib with fulvestrant and ribociclib or palbociclib) or Arm B (fulvestrant and ribociclib or palbociclib). We intend to provide an update on our final Phase 3 study design in the second quarter of 2026. It is expected that approximately 200 clinical sites across North America, Europe, Latin America, and Asia-Pacific will participate.participate, Theincluding first patientmany issites expected to be dosedincluded in the secondVIKTORIA-1 quarterclinical of 2025.trial.

To date, we have not generated any revenue. WithUpon the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive world-wide licensing rights to develop and commercialize gedatolisib, gedatolisib. In 2022, we initiated VIKTORIA-1, a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support potential regulatory approval to market gedatolisib. In AugustOur 2023,Phase we3 initiatedclinical atrial, VIKTORIA-2, and Phase 1b/2 clinical trial, CELC-G-201, are and we have initiated a second Phase 3 clinical trial, VIKTORIA-2, with dosing of the first patient planned in Q2 2025 to support submission to the FDA seeking approval for this indication for gedatolisib. If we obtain regulatory approvals to market gedatolisib, we expect to generate revenue from sales of the drug for the treatment of breast cancer patients.ongoing.

Since our inception, we have primarily focused on research and development of gedatolisib, a PI3K/mTOR targeted therapy, and our CELsignia platform and corresponding tests.therapy. Research and development development expenses primarily include:

General and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and support functions. Other general and administrative expenses include professional fees for auditing, tax, and legal services associated with being a public company, director and officer insurance, software costs, investor relations and travel expenses for our general and administrative personnel.

Expenses and costs related to themarketing, initiationsupply chain, distribution, market access and operation ofother ourcommercial medicaloperations andrelated marketing teams, supply chain and distribution networkactivities are being incurred in anticipation of the commercialization of our first drug candidate, gedatolisib. These expenses consist primarily of employee-related expenses, professional professional and consulting fees related to these functions and operations, software costs, and the acquisition of data required to support our market analysis for our drug product.gedatolisib. We would expect to begin to incur sales force, sales support staff and marketing expenses to increase as we get closer to a potential FDA approval date.

Interest expense expenseto date is primarily duerelated to athe A&R Loan Agreement.Agreement and the Notes (each as defined below).

Interest income consists of interest income earned on our cash, cash equivalentsequivalents, and investment balances.

You should read the following discussion and analysis of our financial condition and results of operations together in conjunction with our unaudited condensed financial statements and the related notes included elsewhere in this Quarterly Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and expected financial results, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” discussed in Part I, Item 1A of the 2025 10-K, and the cautionary statements elsewhere in this Quarterly Report, 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 the following discussion and analysis.

Celcuity isWe are a clinical-stage biotechnology company focused on thedeveloping developmentand ofcommercializing targeted therapies for the treatment of multiple solid tumor indications. Our leadfirst therapeuticFDA-approved candidateproduct is gedatolisib,REVTORPYKTM (gedatolisib), a kinasepotent, inhibitor of the PI3K/AKT/mTOR (“PAM”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoformspan-PI3K and mTORC1/2,2 gedatolisib inducesinhibitor comprehensivethat inhibitioncomprehensively ofblockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT,AKT or mTORC1 alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluatingevaluated gedatolisib in combination with fulvestrantfulvestrant, with or without palbociclibpalbociclib, infor the treatment of patients with HR+/HER2- ABC,ABC. hasData reported detailedfrom resultsthis trial is the basis for StudyFDA 1,approval whichof evaluatedREVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA WTmutation tumors,detected andfollowing announcedprogression toplineon resultsor after treatment with at least one line of endocrine therapy in the metastatic setting. Results for Study 2, which evaluated patients withthe PIK3CA MTmutant tumors.cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing andtrial incorporatesincorporating two independent studies, Study 1 and Study 2, evaluatingin two separate cohorts of patients with ABC who are treatment-naïve in the advanced setting. Study 1 is evaluating gedatolisib combinedin combination with palbociclib and fulvestrant as first-line treatment for patients with endocrineendocrine-resistant resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib combinedin combination with palbociclib and letrozole as first-line treatment for patients with endocrine endocrine- sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with mCRPC, is ongoing.

In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer. We believebelieved gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration offeroffered distinct advantages over currently approved and investigational therapies that targettargeted PI3Kα, AKT, or mTORC1mTORC1, alone or together.

Isoform-specific PI3K or mTORC1 inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with single-component PAM inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis can still lead to challenging toxicities. The experience with an FDA-approved oral p110-α specific inhibitor, PIQRAY, illustrates the challenge. In its Phase 3 pivotal trial, PIQRAY was found to induce a Grade 3 or 4 adverse event (“AE”) related to hyperglycemia in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to treatment related AEs. By contrast, in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 9% discontinued treatment.

As of MarchJune 31,30, 2026, 1,127at least 1,130 patients and healthy volunteers have received gedatolisib in 12 completed or ongoing clinical trials. Of these, 123 patients with solid tumors were treated with gedatolisib as a single agent in two clinical trials, 36 healthy volunteers were treated in two clinical trials, and the remaining 968971 patients received gedatolisib in combination with other anti-cancer agents in eight clinical trials. Additional patients received gedatolisib in combination with other anti-cancer agents in 10 investigator-sponsored clinical trials.

A total of 138 patients with HR+/HER2- ABC were dosed in the clinical trial. FourAs of June 30, 2026, four patients from this study continue to receive study treatment, as of March 31, 2026, each of whom has received study treatment for more than six years.

Source: Layman SABCSR., 2021et. al, Lancet Oncol., 2024

VIKTORIA-1 Phase 3 Trial (Second-Line Setting)

We have completed primary analysis of ourOur Phase 3, open-label, randomized3 clinical trial, VIKTORIA-1, thatevaluated isgedatolisib evaluatingin combination with fulvestrant, with or without palbociclib, for the efficacy and safetytreatment of gedatolisib treatment regimens in adultspatients with HR+/HER2- ABCABC, whoseand diseaseis hasthe progressedbasis afterfor priorthe CDK4/6FDA therapy in combination with an aromatase inhibitor.Approval. Over 200 clinical sites in North America, Europe, LatinSouth America, and Asia-Pacific are participatingparticipated in the study.

On July 28, 2025, we announced topline data from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial and on October 18, 2025, at the ESMO congress, we presented additional efficacy and safety results from this cohort were presented.cohort. The key efficacy and safety data from the PIK3CA WT cohort showed:

In December 2025, we presented updated efficacy and safety results from the VIKTORIA-1 Phase 3 VIKTORIA-1 PIK3CA WT cohort were presented at the 2025 San Antonio Breast Cancer Symposium including patient sub-group analyses, safety analyses and patient reported outcomes for well-being measures.

On May 1, 2026, we announced positive topline results from Study 2 (the PIK3CA MT cohort) of the VIKTORIA-1 Phase 3 clinical trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- PIK3CA MT ABC, following progression on or after treatment with a CDK4/6 inhibitortrial, and anon aromataseJune inhibitor.2, Detailed results will be presented2026, in a late-breaking abstract (“LBA”) oral session on June 2, 2026, at the American Society of Clinical Oncology (“ASCO”) Annual MeetingMeeting, in Chicago,we Illinois.presented additional efficacy and safety results from this cohort.

The primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing the gedatolisib doublet versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and presented no new safety signals.

We intend to submit thesethe data from Study 2, the MT cohort, of the VIKTORIA-1 Phase 3 clinical trial to the FDA in the third quarter of 2026 as an sNDAsNDA. andWe intend to submit VIKTORIA-1 Phase 3 clinical trial data to other regulatory authorities outside the U.S. following the sNDA submission.

VIKTORIA-2 Phase 3 Trial (First-Line Setting)

In February 2026, we conducted a Type B meeting with the FDA in order to obtain the FDA’s feedback on our proposed study design changes. From this meeting, we gained general alignment with the FDA on our planned amendments to the VIKTORIA-2 studyis design and protocol. First, VIKTORIA-2 will now evaluateevaluating the safety and efficacy of patients with endocrineendocrine-resistant sensitiveand endocrine-sensitive HR+/HER2- ABC,ABC who are treatment-naïve in additionthe tometastatic those with endocrine-resistant disease.setting. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized to a treatment arm. Each study will have independent statistical analysis plans that will include separate primary endpoints. Second, theThe primary efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population enrolled in their respective study (combined WT and MT); primary endpoints for patient cohorts based on their PIK3CA status (e.g., WT or MT) are no longernot included. And third, theThe control arms for Study 1 and Study 2 will evaluate ribociclib combined with either fulvestrant (Study 1) or letrozole (Study 2); palbociclib will no longer be included as an option in the control arms..

Subjects in each study will be randomized 1:1 to either investigational treatment (Arm A, Study 1; Arm C, Study 2) or standard-of-care control (Arm B, Study 1; Arm D, Study 2). Approximately 200 clinical sites in North America, Europe, South America and Asia-Pacific will participate in the study, including many sites included in the VIKTORIA-1 clinical trial.

We received approval from the FDA in mid-2023 to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC. We have since initiated athe CELC-G-201 Phase 1b/2 clinical trial, CELC-G-201, that will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor. The first patient was dosed in this trial in February 2024.