Celcuity Expenses Jump 81 Percent

Celcuity (CELC -0.92%), a clinical-stage biotechnology company developing targeted therapies for cancer, released its second quarter 2025 earnings on August 14, 2025. The highlight was topline Phase 3 data for lead drug gedatolisib, which showed unprecedented results in advanced breast cancer patients. The company posted a non-GAAP EPS loss of ($0.93), wider than the analyst consensus estimate of ($0.88) non-GAAP. Total operating expenses climbed to $44.0 million as development efforts expanded, contributing to a net loss (non-GAAP) that missed expectations. Despite the higher loss, Celcuity showcased strong clinical momentum and increased its cash position with a major capital raise, supporting operations through 2027. The quarter positioned Celcuity at a turning point as it transitions from research to pursuing commercial drug approval.

Source: Analyst estimates for the quarter provided by FactSet.

What Celcuity Does and Where It’s Focused

Celcuity is a clinical-stage biotechnology company focused on discovering and developing targeted therapies for cancer. Its core strategy centers around gedatolisib, an investigational small molecule designed to inhibit multiple cancer-driving enzymes in cell signaling pathways. Gedatolisib targets two major molecular pathways, PI3K and mTOR, which are often implicated in resistance to existing cancer treatments.

The company’s value depends on progressing gedatolisib through key clinical trials in breast and prostate cancer, aiming for regulatory approval and future commercialization. Success relies on distinct clinical efficacy, positive safety results, and regulatory recognition, supported by an exclusive global license with Pfizer. Fast Track and Breakthrough Therapy designations from the Food and Drug Administration (FDA) may help accelerate the path to market. Capital efficiency, pipeline development, and addressing the competitive landscape are also key focus areas.

Quarter in Review: Clinical Breakthroughs and Rising Costs

The quarter was defined by major clinical milestones for gedatolisib in multiple cancer types. Data from the Phase 3 VIKTORIA-1 trial showed that, in patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer lacking PIK3CA mutations, the combination of gedatolisib, fulvestrant, and palbociclib reduced the risk of disease progression or death by 76%. Median progression-free survival was 9.3 months for the gedatolisib regimen, far exceeding the control group’s 2.0 months, as reported for the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. For the two-drug combination, progression-free survival reached 7.4 months in the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, still outperforming the control group.

These results surpassed industry benchmarks. Recent drugs in similar indications have achieved only 1.9 months of incremental median progression-free survival (PFS) benefit or less, making Celcuity’s findings stand out. Safety results were also favorable, with adverse event–related discontinuations lower than prior studies. The company is on track to submit a New Drug Application (NDA) for this patient population in the fourth quarter of 2025. Enrollment for the PIK3CA-mutant cohort of VIKTORIA-1 is ongoing, with results expected in late 2025.

Additionally, Celcuity dosed its first patient in the VIKTORIA-2 Phase 3 trial, which targets first-line treatment for HR+/HER2– advanced breast cancer resistant to hormonal therapies. The prostate cancer program reported that 66% of patients were progression-free at six months in a Phase 1b trial as of the May 30, 2025 data cut-off, with no treatment discontinuations due to side effects. A Phase 2 trial in HER2+/PIK3CA-mutated metastatic breast cancer showed a 43% objective response rate, as presented in June 2025. Celcuity also extended key US patent protection for gedatolisib into 2042, securing long-term intellectual property rights.

Rapid clinical advancement increased spending. Operating expenses increased 81.1% to $44.0 million in Q2 2025, up from $24.3 million in Q2 2024. Most of this increase was due to research and development, which included a $5.0 million milestone payment to Pfizer and higher costs for clinical trials and staff. General and administrative expenses also grew with business expansion, primarily hiring and consulting costs. The spike in expenses, combined with the absence of product revenue, led to a net loss nearly doubling compared to the same period last year (GAAP).

The company's strategic partnership with Pfizer continued without new adjustments. Cash used for day-to-day operations nearly doubled year over year, reflecting the intensifying pace of study enrollment and data generation. Following a $286.5 million capital raise, Celcuity's cash balance increased sharply to $455 million in cash, cash equivalents, and short-term investments as of the end of Q2 2025 on a pro forma basis, with a total of $455 million once the financing fully closed. Management projects this will support operations through 2027.

Product Pipeline and Competitive Landscape

Gedatolisib is Celcuity’s main product candidate. It is a pan-PI3K/mTOR inhibitor, meaning it blocks several enzymes (PI3K isoforms as well as mTORC1 and mTORC2) that play critical roles in cancer growth and treatment resistance. Most drugs in this category, such as Novartis’s PI3K alpha inhibitors or AstraZeneca’s AKT inhibitors, target just one enzyme or “node.” By attacking multiple nodes, gedatolisib aims to prevent the cancer cell from bypassing the drug’s effect.

The company’s competitive advantage hinges on gedatolisib’s broad mechanism and favorable early data profile. Regulatory momentum is reinforced by Fast Track and Breakthrough Therapy designations for HR+/HER2– advanced breast cancer from the FDA, potentially expediting the approval process. Celcuity holds global rights to develop and commercialize gedatolisib through an exclusive licensing partnership with Pfizer. The agreement could bring in up to $335.0 million in milestone payments and additional royalties upon commercialization. Intellectual property was further strengthened by the granting of a US dosing patent lasting through 2042.

Besides breast cancer, Celcuity is expanding to other cancers. Early results from metastatic castration-resistant prostate cancer (mCRPC) showed encouraging six-month progression-free rates in a Phase 1b study. A separate Phase 2 effort in HER2+/PIK3CA-mutated metastatic breast cancer also indicated promising response rates. A new collaboration with Dana Farber Cancer Institute and Massachusetts General Hospital will evaluate gedatolisib combinations in endometrial cancer, broadening the clinical pipeline.

Despite progress, Celcuity faces competition from several established pharmaceutical companies with similar drugs in development or on the market. Differentiating gedatolisib through clinical data, safety profile, and regulatory designations is essential for eventual commercial success. The company’s financial future depends on securing FDA approval and successfully launching its first drug—Celcuity does not currently generate commercial revenue.

Looking Forward: Outlook and Investor Considerations

Management reiterated key upcoming milestones, including an NDA submission for gedatolisib in HR+/HER2– advanced breast cancer by the fourth quarter of 2025 and topline data for the PIK3CA-mutant subpopulation before the end of 2025. The VIKTORIA-2 first-line trial has now enrolled its initial patient, and prostate cancer clinical data is expected to be updated soon. No formal numerical financial guidance was issued for the remainder of the year. Instead, Celcuity’s leadership emphasized its strengthened cash runway, which is expected to fund clinical operations into 2027, assuming current spend rates and timelines continue.

Investors will want to monitor clinical readouts for both breast and prostate cancer programs, particularly as regulatory and commercial inflection points approach. The company’s transition from a clinical-stage to a potential commercial-stage business hinges on approval of gedatolisib and its acceptance by prescribers. There were no dividend announcements or changes—CELC does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.