On August 13, 2026 Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the second quarter ended June 30, 2026 and other recent business developments.
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"Celcuity made monumental progress these past few months, achieving critical clinical and regulatory milestones related to gedatolisib. With the FDA approval of REVTORPYK, positive results from the PIK3CA MT cohort of the pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN Guidelines, we are well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy," said Brian Sullivan, CEO and co-founder of Celcuity. "We are on track to begin shipping REVTORPYK late in the third quarter of 2026, and we look forward to making this important therapy available to patients with locally advanced or metastatic breast cancer."
Mr. Sullivan added, "Based on the positive data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, we plan to submit an sNDA to FDA in the third quarter of 2026. Additionally, our VIKTORIA-2 study was expanded to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, positioning gedatolisib regimens to potentially be available for nearly all patients in the first- and second-line setting, irrespective of their endocrine sensitivity or PIK3CA mutation status."
Clinical Highlights
HR+/HER2- Advanced Breast Cancer
2nd Line Setting – PIK3CA Wild-Type
Following the unprecedented results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, on July 14, 2026 Celcuity announced that the U.S. Food and Drug Administration ("FDA") had approved REVTORPYK, the company’s pan-PI3K, mTORC1/2 inhibitor, for the treatment of patients with hormone receptor positive ("HR+"), human epidermal growth factor 2 receptor negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Celcuity subsequently announced that REVTORPYK in combination with fulvestrant, with or without palbociclib, was recommended by the National Comprehensive Cancer Network ("NCCN") as a preferred Category 1 second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy.
The build-out of the commercialization infrastructure needed to support a successful launch of REVTORPYK is complete and commercial launch activities for REVTORPYK commenced immediately after approval. Shipments of REVTORPYK are expected to begin late in the third quarter of 2026.
To make gedatolisib available to patients prior to commercial availability of REVTORPYK, last week Celcuity opened an Expanded Access Program (EAP) to participating physicians on behalf of eligible patients, and we have begun to distribute gedatolisib to those physicians.
2nd Line Setting – PIK3CA Mutant-Type
Gedatolisib continued to demonstrate a differentiated clinical profile across different patient populations when combined with fulvestrant, with or without palbociclib. At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, detailed results from the PIK3CA MT cohort of the global VIKTORIA-1 Phase 3 study were presented at a late-breaking abstract Oral Session. The study demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival ("PFS") compared with alpelisib plus fulvestrant, with a manageable safety profile.
Gedatolisib plus fulvestrant and palbociclib (the "gedatolisib-triplet") reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib plus fulvestrant (the "gedatolisib-doublet") reduced the risk of disease progression or death by 49% vs. alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013). Median PFS was 11.3 months with the gedatolisib-doublet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib regimens demonstrated robust and durable responses: 49% objective response rate ("ORR") and median duration of response ("DoR") of 15.7 months for the gedatolisib-triplet and 36% ORR and median DoR of 24.2 months for the gedatolisib-doublet.
The safety data for the gedatolisib-triplet and -doublet were consistent with previously reported data from the PIK3CA wild-type cohort of VIKTORIA-1. Analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA MT cohort were updated using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA WT cohort presented in the REVTORPYK label. For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib due to an adverse event.
Celcuity intends to submit these data to the FDA in the third quarter as an sNDA and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.
Analyses of the mean number of gedatolisib treatment cycles patients received in the PIK3CA WT and MT cohorts of the VIKTORIA-1 Phase 3 trial were also updated as of August 2, 2026, with a median follow-up period of approximately 21 months and 17 months for the PIK3CA WT and MT cohorts, respectively. For patients who received the gedatolisib-triplet, the mean number of treatment cycles on gedatolisib was 9.0 and 10.0 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (16) and 22% (34) of patients still receiving gedatolisib therapy in each cohort, respectively. For patients who received the gedatolisib-doublet, the mean number of treatment cycles on gedatolisib was 9.7 and 11.3 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (15) and 19% (10) of patients still receiving gedatolisib therapy in each cohort, respectively.
Celcuity expects to provide further updates to results from both the PIK3CA MT and WT cohorts of VIKTORIA-1 at medical conferences in the fourth quarter.
1st Line Setting
Celcuity continues to advance gedatolisib combined with palbociclib and endocrine therapy in the first-line setting for patients with HR+/HER2- ABC through its ongoing Phase 3 VIKTORIA-2 clinical trial. The VIKTORIA-2 trial was expanded in the second quarter 2026 to include a second study (Study 2) evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Study 1 of the VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with treatment-naive endocrine-resistant HR+/HER2- ABC.
Metastatic Castration-Resistant Prostate Cancer ("mCRPC")
Development of gedatolisib in combination with darolutamide continues to advance. In the dose finding portion of Celcuity’s Phase 1b study, evaluation of a 240 mg dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib and dose limiting toxicity criteria for dose reduction were not met. Evaluation of a 300 mg dose is ongoing. Once the Phase 1/1b portion of the study is completed, Celcuity expects to select the recommended phase 2 dose level(s) and control arm options for the randomized Phase 2 portion of the study. The company expects to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026.
Other Recent Developments
In June 2026, the Company conducted a public offering of 0.250% convertible senior notes due 2032. The net proceeds from the offering were $557.2 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses. The Company utilized $137.0 million of the net proceeds to prepay term loan debt.
Celcuity’s advancement of a subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
Second Quarter 2026 Financial Results
Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2026, compared to the second quarter ended June 30, 2025.
Net loss for the second quarter of 2026 was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share, for the prior year period. Non-GAAP adjusted net loss for the second quarter of 2026 was $58.7 million, or $1.07 per share, compared to non-GAAP adjusted net loss of $40.5 million, or $0.93 per share, for the prior year period. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, non-cash investment (income) expense and loss on debt extinguishment. 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.
Total operating expenses were $66.1 million for the second quarter of 2026, compared to $44.0 million for the prior year period.
Research and development ("R&D") expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease in R&D expenses was primarily due to a $7.0 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs. These decreases were partially offset by a $3.8 million increase in employee-related and consulting expenses, of which $0.9 million related to stock-based compensation, and a $2.9 million increase in manufacturing and other costs.
Selling, general and administrative ("SG&A") expenses were $35.0 million for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase in SG&A expenses was primarily due to a $14.5 million increase in employee-related expenses, of which $3.3 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses. In the aggregate, $23.4 million of the $27.4 million SG&A increase related to commercial headcount additions and other launch-related activities.
Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period. Cash, cash equivalents and short-term investments were $754.0 million at the end of the second quarter of 2026. We expect that our current cash, cash equivalents and short-term investments will finance our operations at least into 2029.
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About REVTORPYK (gedatolisib)
REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Please click here for Important Safety Information and Full Prescribing Information for REVTORPYK.
(Press release, Celcuity, AUG 13, 2026, View Source [SID1234670094])