Celcuity Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Thank you, Ludy, and good afternoon to everyone.

Thank you for joining us today to review Celcuity's second quarter 2026 financial results and business update. Earlier today, Celcuity released financial results for the quarter ended June 30, 2026. The press release can be found on the investors section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-founder, Vicky Hahne, Chief Financial Officer, as well as Igor Gorbatchevsky, Chief Medical Officer, and Eldon Mayer, Chief Commercial Officer, who will be available during Q&A. As we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events and results may differ materially from those projected in the forward-looking statements.

Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP financial measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to the GAAP measures in today's press release. With that, I would like to turn the call over to Brian Sullivan, CEO of Celcuity.

Please go ahead, Brian. Thank you, Jodi, and good afternoon, everyone.

Thank you for joining our second quarter 2026 operating and financial update conference call. Celcuity continues to make monumental progress advancing clinical development of gedatolisib for patients with HR-positive, HER2-negative advanced breast cancer. With the FDA approval of REVTORPYK, positive results from the PIK3CA mutant cohort of our 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-positive, HER2-negative advanced breast cancer. We remain 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 advanced breast cancer.

Based on the positive data from the PIK3CA mutant cohort of the phase III VIKTORIA-1 study, we plan to submit a supplemental NDA, or sNDA, 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-line setting, irrespective of their endocrine sensitivity or PIK3CA status. In sum, we've had an eventful past few months. I'd first like to review in a bit more depth the status of our clinical development programs, and then provide an update on the commercial launch of REVTORPYK.

On July 14th, a few days before our PDUFA date, we received notice from the FDA that REVTORPYK in combination with fulvestrant, with or without palbociclib, was approved for the treatment of patients with HR-positive, 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. A little over 2 weeks later, NCCN updated their guidelines for HR-positive, HER2-negative breast cancer treatment, recommending both the REVTORPYK triplet and doublet regimens as preferred Category 1 regimens for second-line or subsequent treatment for tumors without a PIK3CA mutation. We're very encouraged by the panel's rapid review and recommendation. In June, we presented positive efficacy and safety results from the PIK3CA mutant cohort of the VIKTORIA-1 phase III trial at the ASCO annual meeting.

Primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS, progression-free survival, compared to alpelisib, a PI3K alpha inhibitor, and fulvestrant. Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant, with a hazard ratio of 0.5. The secondary endpoint comparing the 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 compared to alpelisib and fulvestrant. Median PFS was 11.3 months with the gedatolisib doublet versus 5.6 months with alpelisib plus fulvestrant, with a hazard ratio of 0.51. The safety data for the gedatolisib triplet and doublet were consistent with previously reported data from the wild type cohort of VIKTORIA-1.

Now we've since updated the analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA mutant cohort using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA wild type 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% discontinued treatment with alpelisib due to an adverse event. Now, we believe the lower gedatolisib treatment discontinuation rate for the mutant cohort than was reported in the wild-type cohort reflects the fact that the discontinuation rate was higher early in the overall VIKTORIA-1 study and then fell as physicians gained experience.

Since a much higher proportion of wild-type patients were enrolled during this period than mutant patients, the impact of this initial higher discontinuation rate early in the study fell disproportionately on the wild-type cohort. Thus, we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort, roughly 4%-5%, best represents what we expect to see in a real-world setting. We also updated analyses of the mean number of gedatolisib treatment cycles patients received in the wild-type and mutant cohorts of VIKTORIA-1 as of August 2, 2026, and this analysis had a median follow-up period of approximately 21 months for the wild-type cohort and 17 months for the mutant cohort. For patients treated with the gedatolisib triplet in the wild-type cohort, the mean number of treatment cycles for gedatolisib was 9.0, and 16 of these patients, representing 12% of those dosed, are still receiving gedatolisib.

For those treated with the gedatolisib triplet in the mutant cohort, the mean number of treatment cycles for gedatolisib was 10.0. Thirty-four of these patients, representing 22% of those dosed, are still receiving gedatolisib. For patients treated with the gedatolisib doublet in the wild-type cohort, the mean number of treatment cycles for gedatolisib was 9.7, and 15 of these patients, representing 12% of those dosed, were still receiving gedatolisib. For patients treated with the gedatolisib doublet in the PIK3CA mutant cohort, the mean number of treatment cycles for patients receiving gedatolisib was 11.3, and 10 of these patients, representing 19% of those dosed, are still receiving gedatolisib.

Now, analyses of mean treatment cycles for REVTORPYK in the VIKTORIA-1 trial are particularly relevant for assessing the commercial potential of REVTORPYK, since they incorporate the effect that patients who remain on REVTORPYK for extended periods of time have on the likely usage expected in the real world. The median duration of treatment metric truncates this effect and thus underestimates drug usage for a patient population. We expect to provide further updates to results from both the wild-type and mutant cohorts of VIKTORIA-1 at medical conferences later in the year.

Now, with the FDA approval of our NDA in hand and positive data from the mutant cohort, we expect to submit the data from the mutant cohort to the FDA as an sNDA in the third quarter of 2026, and we expect to submit VIKTORIA-1 phase III data for both the wild-type and mutant cohorts to global regulatory authorities following the sNDA submission. Now, the gedatolisib regimens have demonstrated the potential to improve the standard of care in the second-line setting, regardless of the PIK3CA status of a patient's tumor. We believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR or PAM pathway. Additionally, these results augur well for the phase III VIKTORIA-2 trial we have underway to advance development of gedatolisib in the first-line setting for patients with advanced breast cancer.