On May 14, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the first quarter ended March 31, 2026 and other recent business developments.

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"With positive results in both cohorts of the pivotal VIKTORIA-1 study, we believe gedatolisib regimens have the potential to advance the standard of care in the second-line setting for a significant number of patients with HR+/HER2- advanced breast cancer, regardless of PIK3CA status," said Brian Sullivan, CEO and co-founder of Celcuity. "We are on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to bringing this important therapy to physicians treating patients with advanced breast cancer."

Mr. Sullivan added, "Our positive Phase 3 results, combined with our promising Phase 1b clinical trial results in treatment-naive late-stage patients, provide a strong scientific rationale to evaluate gedatolisib combinations as first-line therapy. By expanding our VIKTORIA-2 study to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, we are positioning gedatolisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status."

First Quarter 2026 Business Highlights and Other Recent Developments

● Celcuity reported positive topline results from the PIK3CA mutant-type ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial 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-"), PIK3CA MT locally advanced or metastatic breast cancer ("ABC").

○ The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib ("gedatolisib triplet") demonstrated a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared with alpelisib, a PI3Kα inhibitor, and fulvestrant.

○ The secondary endpoint comparing gedatolisib in combination with fulvestrant ("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.

○ Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.

○ Detailed data for the gedatolisib triplet and doublet regimens will be presented in a late-breaking abstract ("LBA") oral session on June 2, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, Illinois.

○ Celcuity intends to submit these data to the FDA in the third quarter as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

● The Phase 3 VIKTORIA-2 clinical trial now includes two studies, Study 1 and Study 2, each with independent statistical analysis plans that include primary endpoints for their respective intent-to-treat populations. Study 1, which is ongoing, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and fulvestrant in approximately 440 patients with endocrine-resistant HR+/HER2- ABC. Study 2, which was added in conjunction with a VIKTORIA-2 protocol amendment, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in approximately 740 patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Eligible patients include those whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Approximately 60,000 adults are newly diagnosed each year in the United States with endocrine-sensitive HR+/HER2- ABC.1

● To support its long-term lifecycle development plan, Celcuity submitted its first patent application to the United States Patent and Trademark Office ("USPTO") for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the 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.

● In January 2026, the FDA accepted the submission of Celcuity’s New Drug Application ("NDA") for gedatolisib in HR+/HER2- PIK3CA wild-type ("WT") ABC. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

First Quarter 2026 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2026, compared to the first quarter ended March 31, 2025.

Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share, for the first quarter of 2025. Non-GAAP adjusted net loss for the first quarter of 2026 was $46.8 million, or $0.86 per share, compared to non-GAAP adjusted net loss of $34.7 million, or $0.81 per share, for the first quarter of 2025. 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.

Total operating expenses were $50.5 million for the first quarter of 2026, compared to $36.1 million for the first quarter of 2025.

Research and development ("R&D") expenses were $33.1 million for the first quarter of 2026, compared to $29.8 million for the prior year period. The $3.3 million increase in R&D expenses was primarily due to a $3.0 million increase in employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial.

Selling, general and administrative ("SG&A") expenses were $17.4 million for the first quarter of 2026, compared to $6.3 million for the prior year period. The $11.1 million increase in SG&A expenses was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other launch-related activities, and a $2.4 million increase primarily due to software costs, professional fees and other costs.

Net cash used in operating activities for the first quarter of 2026 was $55.1 million, compared to $35.9 million for the prior year period. Cash, cash equivalents and short-term investments were $387.1 million at the end of the first quarter of 2026. We expect cash, cash equivalents, investments and drawdowns on our debt facility to finance our operations through 2027.

Webcast and Conference Call Information

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=2f73ec65ba. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, MAY 14, 2026, View Source [SID1234665699])