On November 12, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the third quarter ended September 30, 2025 and other recent business developments.

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"We made significant clinical and regulatory progress in the third quarter," said Brian Sullivan, CEO and co-founder of Celcuity. "At the ESMO (Free ESMO Whitepaper) Congress, we presented potentially practice-changing safety and efficacy results for the gedatolisib regimens from the PIK3CA wild-type cohort of our Phase 3 VIKTORIA-1 trial at a late breaking oral presentation. We remain on track to submit the New Drug Application for gedatolisib later this year based on data from the PIK3CA wild-type cohort. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected in late Q1 2026 or during Q2 2026."

"There is an urgent need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. With our strengthened balance sheet, and unprecedented efficacy results in this patient population, we are well positioned to bring gedatolisib to patients should we get FDA approval."

Third Quarter 2025 Business Highlights and Other Recent Developments

● The Company announced positive topline data for both primary endpoints of the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+, HER2- advanced breast cancer ("ABC") whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. Detailed safety and efficacy results were subsequently presented at a late breaking oral presentation at the 2025 ESMO (Free ESMO Whitepaper) Congress. The results demonstrate the potential for the gedatolisib regimens to be practice changing for patients with HR+, HER2- ABC.

◌ The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median progression free survival ("PFS") was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
◌ The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.
◌ Clinical benefit of the gedatolisib regimens was consistent across patient subgroups.
◌ The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively); rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively).
◌ Study treatment discontinuation due to TRAEs was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doublet.
◌ The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected sometime in late Q1 2026 or during Q2 2026.

● Updated data from a Phase 1b study evaluating gedatolisib plus darolutamide in men with mCRPC was presented at a poster session at the 2025 ESMO (Free ESMO Whitepaper) Congress.

◌ In this Phase 1b study, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2.
◌ The six-month radiographic PFS ("rPFS") rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.
◌ The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE.

● The FDA accepted the Company’s request to submit an NDA for gedatolisib under the Real-Time Oncology Review ("RTOR") program based on data from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial. The Company made its first NDA pre-submission in September 2025 and completion of the NDA submission is targeted for the fourth quarter of 2025.

● In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

● In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $287 million, after deducting underwriting discounts and commissions and the Company’s offering expenses.

● In September 2025, the Company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus"), and Oxford Finance LLC and certain of its affiliates (together, "Oxford"). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders.

◌ With the release of the topline data from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, Celcuity achieved the Term D milestone under the term loan facility and was eligible to draw an additional $30 million. In connection with the amendment, the $30.0 million Term D loan was disbursed and the Company received net proceeds of $27.8 million.
◌ The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations for gedatolisib and other strategic initiatives.

● In the third quarter of 2025, investors exercised warrants generating cash proceeds of $12.8 million. The warrants were issued pursuant to a private placement that closed on December 9, 2022 and had an expiration date of 75 days from the release of the topline data from the PIK3CA WT cohort of the VICTORIA-1 Phase 3 clinical trial.

Third Quarter 2025 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2025, compared to the third quarter ended September 30, 2024.

Total operating expenses were $42.8 million for the third quarter of 2025, compared to $30.1 million for the third quarter of 2024.

Research and development ("R&D") expenses were $34.9 million for the third quarter of 2025, compared to $27.6 million for the prior-year period. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch-related activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.

General and administrative ("G&A") expenses were $7.9 million for the third quarter of 2025, compared to $2.5 million for the prior-year period. Of the approximately $5.4 million increase in general and administrative expenses, $4.9 million was related to increased employee and consulting expenses. Of this $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase was primarily related to professional fees, expanding infrastructure and other administrative expenses.

Net loss for the third quarter of 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss for the third quarter of 2025 was $37.2 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2025 was $44.8 million, compared to $20.6 million for the third quarter of 2024.

At September 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $455.0 million. We expect cash, cash equivalents, investments and drawdowns on our debt facility to fund operations through 2027.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=9d6c00e337. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, NOV 12, 2025, View Source [SID1234659815])