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    CELC
    Earnings call· Jun 2026(Q2 FY26)

    Celcuity Q2 FY26 earnings call CELC

    Aug 13, 2026 Source

    Executive summary

    Celcuity Q2 FY26 — REVTORPYK Approval, NCCN Recommendation, and PIK3CA Mutant Cohort Data

    Celcuity reported Q2 FY26 results highlighted by the FDA approval of REVTORPYK and a rapid NCCN Category 1 recommendation for HR+/HER2- advanced breast cancer. Positive Phase III VIKTORIA-1 data for the PIK3CA mutant cohort further strengthens the drug's profile, with an sNDA submission planned for Q3 FY26. The company is preparing for REVTORPYK shipments in late Q3 FY26, targeting a significant market opportunity, while also expanding its first-line VIKTORIA-2 study and advancing a prostate cancer program.

    Highlights

    5

    • FDA approval of REVTORPYK for HR+/HER2- advanced breast cancer without PIK3CA mutation.

    • NCCN updated its guidelines to recommend REVTORPYK triplet and doublet regimens as preferred Category 1 for second-line or subsequent treatment.

    • Positive efficacy and safety results from the PIK3CA mutant cohort of the VIKTORIA-1 Phase III trial, demonstrating median PFS of 11.1 months (triplet) and 11.3 months (doublet) versus 5.6 months for alpelisib.

    • Expansion of the VIKTORIA-2 trial to include treatment-naive endocrine-sensitive patients, potentially covering nearly all first-line patients.

    • Strong cash, cash equivalents, and short-term investments of $754 million as of June 30, 2026, expected to finance operations at least into 2029.

    Concerns

    4

    • Net loss increased to $78.9 million ($1.44 per share) in Q2 FY26, compared to $45.3 million ($1.04 per share) in the prior year period.

    • Non-GAAP adjusted net loss increased to $58.7 million ($1.07 per share) in Q2 FY26, compared to $40.5 million ($0.93 per share) in the prior year period.

    • Cash used in operating activities increased to $55.4 million in Q2 FY26, compared to $36.2 million for the prior year period.

    • Reliance on FDA review and approval for the secondary manufacturing site to ensure supply, with potential for variable timelines.

    Guidance & targets

    7
    CategoryTargetConfidence
    REVTORPYK Commercial Shipments
    Begin shipping REVTORPYK
    high materiality
    High
    sNDA Submission for PIK3CA Mutant Cohort
    Submit sNDA
    medium materiality
    High
    Global Regulatory Submissions for VIKTORIA-1 Data
    Submit VIKTORIA-1 Phase III data
    medium materiality
    High
    Prostate Cancer Program Update
    Provide updated clinical data and additional visibility into development strategy
    medium materiality
    High
    Cash Runway
    Finance operations at least into 2029
    high materiality
    High
    REVTORPYK Wholesale Acquisition Cost (WAC)
    $10,000 per vial or $30,000 per cycle
    high materiality
    High
    REVTORPYK Total Addressable Market (TAM)
    Over $6 billion annually
    high materiality
    High

    Operational metrics

    25
    Non-GAAP adjusted net loss
    $58.7 millionvs $40.5 million prior year
    Q2 FY26

    Non-GAAP adjusted net loss for the second quarter of 2026.

    Cash, cash equivalents and short-term investments
    $754 millionvs $441.5 million as of December 31, 2025
    as of June 30, 2026

    Company's cash position at the end of the second quarter.

    Net proceeds from convertible note offering
    $557.2 million
    June 2026

    Proceeds from the convertible note offering completed in June 2026.

    Additional cash provided by financing activities
    $2.8 million
    Q2 FY26

    Cash generated from other financing activities.

    REVTORPYK Wholesale Acquisition Cost (WAC) per vial
    $10,000
    Commercial availability

    The reported wholesale acquisition cost for one vial of REVTORPYK.

    REVTORPYK Wholesale Acquisition Cost (WAC) per cycle
    $30,000
    Commercial availability

    The reported wholesale acquisition cost for one cycle of REVTORPYK treatment.

    REVTORPYK expected gross to net percentage
    80%
    Future

    Expected gross to net percentage for REVTORPYK, indicating lower discounts compared to oral therapies.

    Estimated total addressable market for REVTORPYK
    Over $6 billion
    Annually

    Estimated annual market opportunity for REVTORPYK in the wild-type and mutant settings combined.

    Estimated patients in U.S. receiving second-line treatment for HR+/HER2- advanced breast cancer
    37,000
    Annually

    Estimate of the patient population for REVTORPYK.

    Estimated average cycles of treatment for REVTORPYK per patient
    Roughly 10
    Per patient

    Average number of treatment cycles expected for REVTORPYK patients.

    Historical Objective Response Rate (ORR)
    53%
    First-line setting

    Historical data for comparison with gedatolisib's Phase Ib results.

    Objective Response Rate (ORR) for gedatolisib triplet
    79%vs 53% historical data
    Phase Ib study

    Results from the early Phase Ib study for gedatolisib as first-line treatment.

    R&D expense decrease
    $5.3 millionYoY
    Q2 FY26

    Decrease in Research and Development expenses for the quarter.

    SG&A expense increase
    $27.4 millionYoY
    Q2 FY26

    Increase in Selling, General and Administrative expenses, primarily driven by launch preparations.

    Cash used in operating activities increase
    $19.2 millionYoY
    Q2 FY26

    Increase in cash utilized for operating activities.

    Mean number of treatment cycles for gedatolisib triplet
    9.0
    VIKTORIA-1 wild-type cohort

    Average treatment cycles for gedatolisib triplet in the wild-type cohort of VIKTORIA-1.

    Mean number of treatment cycles for gedatolisib triplet
    10.0
    VIKTORIA-1 mutant cohort

    Average treatment cycles for gedatolisib triplet in the mutant cohort of VIKTORIA-1.

    Mean number of treatment cycles for gedatolisib doublet
    9.7
    VIKTORIA-1 wild-type cohort

    Average treatment cycles for gedatolisib doublet in the wild-type cohort of VIKTORIA-1.

    Mean number of treatment cycles for gedatolisib doublet
    11.3
    VIKTORIA-1 mutant cohort

    Average treatment cycles for gedatolisib doublet in the mutant cohort of VIKTORIA-1.

    Median follow-up period
    Approximately 21 months
    VIKTORIA-1 wild-type cohort

    Median follow-up duration for the wild-type cohort of the VIKTORIA-1 trial as of August 2, 2026.

    Median follow-up period
    Approximately 17 months
    VIKTORIA-1 mutant cohort

    Median follow-up duration for the mutant cohort of the VIKTORIA-1 trial as of August 2, 2026.

    Treatment discontinuation rate due to adverse event
    5.2%
    VIKTORIA-1 mutant cohort

    Rate of patients discontinuing gedatolisib triplet due to an adverse event in the mutant cohort.

    Treatment discontinuation rate due to adverse event
    3.8%
    VIKTORIA-1 mutant cohort

    Rate of patients discontinuing gedatolisib doublet due to an adverse event in the mutant cohort.

    Treatment discontinuation rate due to adverse event
    19%
    VIKTORIA-1 mutant cohort

    Rate of patients discontinuing alpelisib due to an adverse event in the mutant cohort.

    Oncology sales specialists
    88
    Current

    Number of oncology sales specialists hired to support the REVTORPYK launch.

    Industry KPIs

    5
    MetricValueDetails
    Launch access metricsNCCN Category 1 recommendation
    Pipeline read out calendarVIKTORIA-1 (PIK3CA mutant cohort) results presented; VIKTORIA-2 (Study 2) expanded; Prostate cancer Phase Ib/II ongoing
    Regulatory approvals filingsREVTORPYK FDA Approved
    Peak long term sales guidanceOver $6 billionUSD
    Clinical trial efficacy safety dataMedian PFS 11.1 months (triplet) / 11.3 months (doublet)months

    Risks & headwinds

    3
    Manufacturing site approval delayQ3-Q4 FY26

    Review process can be 2 to 4 months, but can take longer if issues arise.

    Mitigation: Data for the secondary manufacturing site was submitted immediately after approval; company is confident in validation data and expects a straightforward review.

    Granularity of sales data for infused therapiesOngoing

    Less visibility on prescriber names and patient-specific data compared to oral therapies.

    Mitigation: Will use survey data (with a 2-3 month lag) and internal tracking to understand drug flow and manage the business.

    Publication timeline variability for clinical dataQ4 FY26 - Q1 FY27

    Publication process can take 3 to 6 months and is not entirely within the company's control.

    Mitigation: An article for the mutant cohort data has been submitted to a journal.

    What to watch in Q3 FY26

    5

    REVTORPYK Commercial Shipments

    Late Q3 2026
    CurrentExpanded Access Program (EAP) shipments started last week.
    TargetCommercial shipments begin.

    Why it matters

    Marks the official commercial launch and revenue generation for Celcuity's first approved product.

    We remain on track to begin shipping REVTORPYK later in the third quarter of 2026, and we look forward to making this important therapy available to patients with advanced breast cancer.

    Q&A highlights

    7

    Inquired about the basis for confidence in late Q3 shipments, whether existing clinical supply would be used, its duration, and the process/timeline for backup manufacturing setup and FDA sign-off.

    Management expressed confidence in shipping by late Q3, stating that the review process for the secondary manufacturing site is underway and they expect it to be straightforward, though FDA can do what they want. They confirmed that the new site cannot ship until FDA approval.

    “We're very confident about being able to ship beginning at the end of this quarter. So nothing's changed.”

    asked by Tara Bancroft · answered by Brian Sullivan

    2 min read5 chapters

    Detailed Narrative

    01

    REVTORPYK Approval and NCCN Recommendation

    The FDA approved REVTORPYK in combination with fulvestrant with or without palbociclib on July 14, 2026, for HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation, following progression on at least one line of endocrine therapy. Shortly after, NCCN updated its guidelines to recommend both the triplet and doublet regimens as preferred Category 1 for second-line or subsequent treatment in this patient population, reflecting rapid panel review and recommendation.

    02

    VIKTORIA-1 PIK3CA Mutant Cohort Results

    Positive efficacy and safety results from the PIK3CA mutant cohort of the VIKTORIA-1 Phase III trial were presented at ASCO in June. The gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median Progression-Free Survival (PFS) of 11.1 months versus 5.6 months for alpelisib plus fulvestrant (HR 0.5). The gedatolisib doublet also showed a median PFS of 11.3 months versus 5.6 months (HR 0.51). Safety data were consistent with previous reports, with lower treatment discontinuation rates due to adverse events for gedatolisib (5.2% for triplet, 3.8% for doublet) compared to alpelisib (19%).

    03

    VIKTORIA-2 Expansion and First-Line Potential

    The VIKTORIA-2 trial was expanded in May 2026 to include Study 2, which evaluates gedatolisib in combination with palbociclib and letrozole in treatment-naive endocrine-sensitive HR+/HER2- advanced breast cancer patients. This expansion aims to position gedatolisib regimens for potential use in nearly all first-line patients, irrespective of endocrine sensitivity or PIK3CA status. Early Phase Ib data for this regimen showed a median PFS of 48.6 months and an objective response rate of 79% in endocrine-sensitive patients, comparing favorably to historical data of approximately 25 months PFS and 53% ORR for ribociclib plus letrozole.

    04

    Prostate Cancer Program Update

    The Phase Ib/II trial evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer completed the 240mg dose-finding portion. No adverse events led to treatment discontinuation, and dose-limiting toxicity criteria were not met. Evaluation of a 300mg dose is currently ongoing. The company expects to provide updated clinical data and further details on its development strategy for prostate cancer during the fourth quarter of 2026.

    05

    Commercial Launch Preparations and Market Opportunity

    Celcuity has completed its commercial infrastructure build-out, including an 88-person oncology sales team, in preparation for REVTORPYK's launch. Pre-commercial activities involved extensive engagement with key opinion leaders, major oncology organizations, and patient advocacy groups. An unbranded marketing campaign has driven awareness of the PAM pathway. Shipments of REVTORPYK are expected to commence late in Q3 2026, with a wholesale acquisition cost (WAC) of $10,000 per vial or $30,000 per cycle. An expanded access program has already begun shipping drug to eligible patients. The estimated total addressable market for REVTORPYK is over $6 billion annually, based on 37,000 estimated patients and approximately 10 treatment cycles per patient.

    AI-generated summary of the company’s earnings call. Not investment advice.