{"url_path":"/sec/celc/8-k/2026-06-02/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 **","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-02","source_url":"https://www.sec.gov/Archives/edgar/data/1603454/0001493152-26-026761-index.html","accession_number":"0001493152-26-026761","cik":"0001603454","ticker":"CELC","issuer_name":"Celcuity Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1603454/0001493152-26-026761-index.html","primary_entity_key":"0001603454","primary_entity_name":"Celcuity Inc."},"word_count":1015,"has_tables":true,"body_markdown":"**Item\n8.01**\n**Other\nEvents.**\n\n \n\nOn\nJune 2, 2026, the Company announced detailed efficacy and safety results from the *PIK3CA* MT cohort of the Phase 3 VIKTORIA-1 clinical\ntrial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human\nepidermal growth factor receptor 2 negative (“HER2-”), *PIK3CA* MT, locally advanced or metastatic breast cancer (“ABC”),\nfollowing progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical\ntrial to compare the efficacy of two PI3K/AKT/mTOR (“PAM”) inhibitors in this patient population.\n\n \n\nIn\nthe trial, the gedatolisib-triplet demonstrated a statistically significant and clinically meaningful improvement in median progression\nfree survival (“PFS”) among patients, increasing the likelihood of survival without disease progression or death by two times\ncompared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed\nby blinded independent central review, was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant.\nThe objective response rate (“ORR”) of the gedatolisib-triplet was 48.9% compared to 26.0% with alpelisib plus fulvestrant,\nand the median duration of response (“DOR”) for the gedatolisib-triplet was 15.7 months compared to 7.5 months for alpelisib\nplus fulvestrant.\n\n \n\nFor\nthe gedatolisib-doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant\n(HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib-doublet was 35.7%, and the median DOR was 24.2 months.\n\n \n\nThe\ntopline gedatolisib-triplet efficacy data from the VIKTORIA-1 *PIK3CA* MT cohort established several new milestones in the history\nof drug development for HR+/HER2- ABC:\n\n \n\n●First\nPhase 3 trial to demonstrate superiority of one PAM inhibitor versus another.\n\n \n\n●The\nmedian PFS of 11.1 months for the gedatolisib-triplet is the highest reported by any Phase\n3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as\nsecond-line treatment.\n\n \n\n●The\nORR of 48.9% for the gedatolisib-triplet is the highest reported by any Phase 3 clinical\ntrial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.\n\n \n\nThe\ngedatolisib-triplet and gedatolisib-doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse\nevents (“TRAEs”). The most common Grade 3+ TRAEs for the gedatolisib-triplet, the gedatolisib-doublet, and alpelisib plus\nfulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients,\nrespectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively).\nTRAEs led to the discontinuation of study treatment in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib-doublet\ngroup, and 7.1% in the alpelisib plus fulvestrant group. One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib,\nwas reported; no Grade 5 TRAEs were reported in the gedatolisib-doublet group, and two Grade 5 TRAEs were reported in the alpelisib plus\nfulvestrant group.\n\n \n\nOverall\nsurvival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib-triplet\nand the gedatolisib-doublet.\n\n \n\n \n\n \n\n \n\nThe\nCompany intends to submit these data to the U.S. Food and Drug Administration (the “FDA”) as a supplemental New Drug Application\n(“sNDA”) and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.\n\n \n\nThe\nCompany believes that it is on track to launch gedatolisib commercially, in anticipation of its potential FDA approval in the\nthird quarter of 2026.\n\n \n\nThe\nFDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-\n*PIK3CA* wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July\n17, 2026.\n\n \n\n**Forward-Looking\nStatements**\n\n \n\nThis\nCurrent Report on Form 8-K (including the exhibit thereto) contains statements that constitute “forward-looking statements”\nwithin the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic\nbenefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the status and\ntiming of the FDA’s review of our NDA for gedatolisib, including the PDUFA goal date assigned by the FDA; the ability of our data\nto support the filing of an sNDA with the FDA and comparable filings with other regulatory authorities; the market opportunity for gedatolisib;\nour expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing\nand commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect\nto gedatolisib including future subcutaneous formulations of gedatolisib; our anticipated use of cash; and the strength of our balance\nsheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,”\n“estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,”\n“targets,” “likely,” “may,” “will,” “would,” “should” and “could,”\nand similar expressions or words identify forward-looking statements. The forward-looking statements included in this report are based\non management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that\nour clinical results are based on an ongoing analysis of key efficacy and safety data, and such data may change following a more comprehensive\nreview of the data related to the clinical trial; unforeseen delays in our clinical trials or the FDA’s review of our NDA for gedatolisib;\nour ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development\nof therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. In addition, all forward-looking\nstatements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2025, and our Quarterly\nReport on Form 10-Q for the quarter ended March 31, 2026, as such risks may be updated in our subsequent filings with the Securities\nand Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the\ndate hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation\nto revise or update this report to reflect events or circumstances after the date hereof."}