Asked about the number of sites/doctors participating in the EAP, patient enrollment status, and whether quarterly updates would be provided. Also asked if EAP patients would convert to commercial drug.

The EAP started last week with drug already shipping to sites. They hope not to provide quarterly updates as the program is temporary. Patients are expected to transition to commercial supply once available, which is standard protocol. “we just got the program started last week... and we've already begun shipping drug to sites where physicians are treating patients.”

Asked about the potential for gedatolisib in endometrial cancer, given competitor activity and prior data.

Management stated there's a strong rationale for considering endometrial cancer due to preliminary data showing objective response as monotherapy and the role of the PIK3CA pathway. They will update on development plans later in the year. “There's certainly a strong rationale for us to consider that, and we'll be updating folks on our development plans as we get further into the year.”

Asked how capivasertib data in prostate cancer informs the opportunity for gedatolisib, considering differences.

Capivasertib's approval in breast cancer (comparable efficacy to alpelisib, which gedatolisib doubled) and its approval for P10 loss in prostate cancer (earlier stage than Celcuity's focus) bodes well. It demonstrates the PAM pathway's role and potential for improvement when combined with androgen receptor inhibitors. “We have encouraging data. We'll be updating that data later this year. And we believe that they demonstrate that this pathway, the PAM pathway plays a role as a driver and that when combined with an androgen receptor inhibitor, you can induce an improvement in outcomes relative to androgen receptor alone.”

CELC

Celcuity (CELC) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 13, 2026

Source: earnings call transcript

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

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

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

Category	Target	Timeline	Confidence
REVTORPYK Commercial Shipments	Begin shipping REVTORPYK high materiality	Q3 · FY26	High
sNDA Submission for PIK3CA Mutant Cohort	Submit sNDA medium materiality	Q3 · FY26	High
Global Regulatory Submissions for VIKTORIA-1 Data	Submit VIKTORIA-1 Phase III data medium materiality	Post-Q3 FY26	High
Prostate Cancer Program Update	Provide updated clinical data and additional visibility into development strategy medium materiality	Q4 · FY26	High
Cash Runway	Finance operations at least into 2029 high materiality	FY29	High
REVTORPYK Wholesale Acquisition Cost (WAC)	$10,000 per vial or $30,000 per cycle high materiality	Commercial availability	High
REVTORPYK Total Addressable Market (TAM)	Over $6 billion annually high materiality	Annual	High

Risks & headwinds

Manufacturing site approval delay Q3-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 therapies Ongoing

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 data Q4 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

REVTORPYK Commercial Shipments

Late Q3 2026

Current Expanded Access Program (EAP) shipments started last week.

Target Commercial 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.

Find out whether CELC delivers this. Inve re-checks your case every morning.

Q&A highlights

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 read 5 chapters

Detailed narrative

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.

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%).

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.