Celcuity reports Q3 2026 financial results

Item 2.02 Results of Operations and Financial Condition.

On November 05, 2026, Celcuity Inc. (the "Company") issued a press release regarding the Company's financial results for the quarter ended September 30, 2026.^{1 1}A copy of the Company's press release is furnished as Exhibit 99.1 to this report¹ and is incorporated herein by reference.

The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934², as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1³

Press release dated November 05, 2026³

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 05, 2026

CELCUITY INC.

By

/s/ Brian F. Sullivan³

Brian F. Sullivan³

Chief Executive Officer³

Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update

MINNEAPOLIS, November 5, 2026 — Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced financial results for the third quarter ended September 30, 2026, and other recent business developments.

Celcuity announced on September 30, 2026, that REVTORPYK™ (gedatolisib) became commercially available in the United States for use in combination with fulvestrant, with or without palbociclib, for the treatment of HR+/HER2- locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting.

"Our commercial and medical affairs teams have laid the foundation for a strong launch over the past few years, and their efforts are paying off," said Brian Sullivan, CEO and co-founder of Celcuity. "Physicians are enthusiastic and eager to treat their patients with REVTORPYK, and we are pleased with their interest in getting eligible patients on treatment in the initial weeks since we launched. "

"We estimate over 90% of commercial and Medicare lives are in health plans that cover REVTORPYK. The unprecedented efficacy results from the wild-type cohort of the pivotal VIKTORIA-1 study, and the preferred Category 1 recommendation in the NCCN Guidelines, provide physicians with a compelling value proposition to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, PIK3CA wild-type advanced breast cancer. "

Business Highlights and Other Recent Developments

2 nd Line HR+/HER2- ABC – PIK3CA wild-type

• FDA approval. On July 14, 2026, the US Food and Drug Administration ("FDA") approved REVTORPYK for the treatment of patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting.

• NCCN preferred Category 1 recommendation. On July 30, 2026, NCCN included REVTORPYK as a preferred Category 1 recommendation for second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation following progression on or after at least one line of endocrine therapy.

• Early launch off to a positive start. 78% of the top 36 strategic accounts, representing ~50% of the total addressable patient population, have ordered REVTORPYK.⁵ Over 3,400 sites, many of which are affiliated with one of the top 36 strategic accounts, have directly engaged with Celcuity oncology sales specialists. These sites treat 82% of breast cancer patients. Additionally, over 1,100 health care providers have attended REVTORPYK educational programs.

• Broad payor coverage and major provider pathway inclusion. 91% of U.S. commercial and Medicare lives are in health plans that cover REVTORPYK, and REVTORPYK has already been incorporated in 3 of the 4 largest health care provider pathways.

• Median progression-free survival ("PFS") was 21.5 months with the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) and 11.5 months with the gedatolisib doublet (gedatolisib + fulvestrant) versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases.

• Objective response rate ("ORR") and median duration of response for patients with evaluable disease were 59% and 19.4 months, respectively, for the gedatolisib triplet and 43% and 27.8 months, respectively, for the gedatolisib doublet, compared to 33% and 7.5 months, respectively, for alpelisib + fulvestrant.

• The discontinuation rate for gedatolisib due to adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib + fulvestrant.

Based on the positive data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, Celcuity submitted a supplemental New Drug Application ("sNDA") to the FDA in the third quarter of 2026.⁶ Celcuity expects to submit VIKTORIA-1 Phase 3 data for both the wild-type and mutant cohorts to global regulatory authorities later this year or early next year.

1 st Line HR+/HER2- ABC

• VIKTORIA-2. Enrollment is ongoing in the Phase 3 VIKTORIA-2 clinical trial that is evaluating gedatolisib combined with palbociclib and fulvestrant in the first-line setting for patients with endocrine resistant HR+/HER2- ABC (Study 1) or gedatolisib combined with palbociclib and letrozole in the first-line setting for patients with endocrine sensitive HR+/HER2- ABC (Study 2).

Metastatic Castration-Resistant Prostate Cancer ("mCRPC")

Updated data from a