Q2 2026 Celcuity Inc Earnings Call

August 13, 2026

Speaker #1: Good afternoon, ladies and gentlemen. Welcome to Celcuity's second quarter 2026 financial results conference call and webcast. At this time, all lines are in a listen-only mode.

Operator: Good afternoon, ladies and gentlemen. Welcome to Celcuity's Q2 2026 financial results conference call and webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. I would now like to turn the conference over to Jodi Gentry, Corporate Communications and Investor Relations at Celcuity. Please go ahead.

Operator: Good afternoon, ladies and gentlemen. Welcome to Celcuity's Q2 2026 financial results conference call and webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. I would now like to turn the conference over to Jodi Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead.

Speaker #1: Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press the star or zero for the operator.

Speaker #1: I would now like to turn the conference over to Jody Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead.

Speaker #2: Thank you, Lydie. And good afternoon to everyone. Thank you for joining us today to review Celcuity's second quarter 2026 financial results and business update.

Jodi Gentry: Thank you, Ludy, and good afternoon to everyone. Thank you for joining us today to review Celcuity's Q2 2026 financial results and business update. Earlier today, Celcuity released financial results for the quarter ended 30 June 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.

Jodi Sievers: Thank you, Ludy, and good afternoon to everyone. Thank you for joining us today to review Celcuity's Q2 2026 financial results and business update. Earlier today, Celcuity released financial results for the quarter ended 30 June 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.

Speaker #2: 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.

Speaker #2: Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and co-founder; Vicky Hahne, Chief Financial Officer; Ivor Gorbachevsky, Chief Medical Officer; and Eldon Mayer, Chief Commercial Officer.

Speaker #2: 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.

Speaker #2: 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.

Jodi Gentry: 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 a 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.

Jodi Sievers: 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 a 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: You can find the table reconciling the non-GAAP financial measures to the GAAP measures in today's press release. And with that, I would like to turn the call over to Brian Sullivan.

Speaker #2: CEO of Celcuity, please go ahead, Brian.

Speaker #3: Thank you, Jody. And good afternoon, everyone. Thank you for joining our second quarter 2026 operating and financial update conference call. Celcuity continues to make monumental progress.

Brian Sullivan: Thank you, Jodi Gentry, and good afternoon, everyone. Thank you for joining our Q2 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 Q3 2026, and we look forward to making this important therapy available to patients with advanced breast cancer.

Brian Sullivan: Thank you, Jodi Sievers, and good afternoon, everyone. Thank you for joining our Q2 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 Q3 2026, and we look forward to making this important therapy available to patients with advanced breast cancer.

Speaker #3: Advancing clinical development of getatelissib for patients with HR positive HER2 negative, advanced breast cancer. With the FDA approval of Revtropic, positive results from the PIK3CA mutant cohort of our pivotal Victoria 1 study, and a preferred category 1 recommendation in the NCCN guidelines, we're 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.

Speaker #3: We remain on track to begin shipping Revtropic late in the third quarter of 2026, and we look forward to making this important therapy available to patients with advanced breast cancer.

Speaker #3: Based on the positive data from the PIK3CA mutant cohort of the phase 3 Victoria 1 study, we plan to submit a supplemental NDA, or SNDA, in the third quarter of 2026.

Brian Sullivan: 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 Q3 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 have had an eventful past few months. I would 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.

Speaker #3: Additionally, our Victoria-2 study was expanded to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, positioning getatelisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status.

Speaker #3: 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 Revtropic.

Speaker #3: On July 14, a few days before our producement date, we received notice from the FDA that Revtropic in combination with Silvestrant 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.

Brian Sullivan: On 14 July, a few days before our production 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 are 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.

Speaker #3: Following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting, a little over two weeks later, NCCN updated their guidelines for HR-positive, HER2-negative breast cancer treatment, recommending both the Revtropic triplet and doublet regimens as preferred Category 1 regimens for second-line or subsequent treatment for tumors without a PIK3CA mutation.

Speaker #3: 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 Victoria meeting.

Speaker #3: Primary efficacy analysis of the getatelissib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS, progression-free survival, compared to apolipsib of PI3K alpha inhibitor and Silvestrant.

Brian Sullivan: 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.

Speaker #3: Median PFS was 11.1 months with the getatelissib triplet, versus 5.6 months with apolipsib plus Silvestrant, with a hazard ratio of 0.5. The secondary endpoint, comparing the getatelissib doublet versus apolipsib plus Silvestrant, 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 apolipsib and Silvestrant.

Speaker #3: Median PFS was 11.3 months with the getatelissib doublet versus 5.6 months with apolipsib plus Silvestrant, with a hazard ratio of 0.51. The safety data for the getatelissib triplet and doublet were consistent with previously reported data from the wild-type cohort of Victoria 1.

Speaker #3: Now, we've since updated the analyses of the treatment discontinuation rate due to an adverse event for getatelissib and apolipsib 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 Revtropic label.

Brian Sullivan: Now, we have 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.

Speaker #3: For patients who received the getatelissib triplet and getatelissib doublet, 5.2% and 3.8% of patients discontinued getatelissib due to an adverse event, respectively. For patients who received apolipsib, 19% discontinued treatment with apolipsib due to an adverse event.

Speaker #3: Now, we believe the lower getatelissib 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 Victoria 1 study and then fell as physicians gained experience.

Speaker #3: Since a much higher proportion of wild-type patients were enrolled during this period, the mutant patients, the impact of this initial higher discontinuation rate early in the study felt disproportionately on the wild-type cohort.

Brian Sullivan: 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% to 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 in VIKTORIA-1 as of 2 August 2026. 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.

Speaker #3: And thus, we believe the treatment discontinuation rate for getatelissib reported for the mutant cohort—roughly 4% to 5%—best represents what we expect to see in a real-world setting.

Speaker #3: We also updated analyses of the mean number of getatelissib treatment cycles patients received in the wild-type, the mutant cohorts of Victoria 1 as of October 2, 2026.

Speaker #3: 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 getatelissib triplet in the wild-type cohort, the mean number of treatment cycles for getatelissib was 9, 0.0, and 16 of these patients representing 12% of those dosed are still receiving getatelissib.

Speaker #3: For those treated with the getatelisib triplet in the mutant cohort, the mean number of treatment cycles for getatelisib was 10.0. Thirty-four of these patients, representing 20% of those dosed, are still receiving getatelisib.

Brian Sullivan: For those treated with gedatolisib triplet in the mutant cohort, the mean number of treatment cycles for gedatolisib was 10.0. 34 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.

Speaker #3: For patients treated with the getatelissib doublet in the wild-type cohort, the mean number of treatment cycles for getatelissib was 9.7, and 15 of these patients, representing 12% of those dosed, were still receiving getatelissib.

Speaker #3: And 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.

Speaker #3: Now, analyses of mean treatment cycles for Revtropic in the Victoria-1 trial are particularly relevant for assessing the commercial potential of Revtropic, since they incorporate the effect that patients who remain on Revtropic for extended periods of time have on the likely usage expected in the real world.

Brian Sullivan: 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.

Speaker #3: 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 Victoria 1 at medical conferences later in the year.

Speaker #3: 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 '26.

Brian Sullivan: 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 Q3 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. 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.

Speaker #3: And we expect to submit Victoria-1 Phase 3 data for both the wild-type and mutant cohorts to global regulatory authorities following the sNDA submission.

Speaker #3: Now, the getatelisib 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.

Speaker #3: And we believe the results from the VICTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K, AKT, mTOR, or PAM pathway.

Speaker #3: Additionally, these results augur well for the phase 3 Victoria 2 trial we have underway to advance development of getatelissib in the first-line setting for patients with advanced breast cancer.

Speaker #3: In May, we announced that we were expanding the Victoria-2 trial to include a second study, Study 2, evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naïve, i.e., endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer.

Brian Sullivan: In May, we announced that we were expanding the VIKTORIA-2 trial to include a second study, Study 2, evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naive, endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. These are women 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. Endocrine-sensitive patients represent approximately two-thirds of the women in the US newly diagnosed with advanced breast cancer each year. Current standard of care therapies for these patients provide median progression-free survival of approximately 25 months. Study 1 of the VIKTORIA-2 trial, which was already ongoing, is evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with treatment-naive, endocrine-resistant, HR-positive, HER2-negative advanced breast cancer.

Speaker #3: And these are women, 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.

Speaker #3: Endocrine-sensitive patients represent approximately two-thirds of the woman in the US newly diagnosed with advanced breast cancer each year, and current standard of care therapies for these patients provide median progression-free survival of approximately 25 months.

Speaker #3: Study 1 of the Victoria-2 trial, which was already ongoing, is evaluating getatelissib in combination with palbociclib and fulvestrant in patients with treatment—i.e., endocrine-resistant, HR-positive, HER2-negative advanced breast cancer. These are patients whose breast cancer progressed while receiving, or within 12 months of completing, adjuvant endocrine therapy.

Brian Sullivan: These are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. Results from the phase I-B clinical trial that we ran several years ago provided strong evidence that the PAM pathway is an important disease driver in treatment-naive patients with advanced breast cancer. In this early phase I study, we evaluated gedatolisib plus palbociclib and letrozole as first-line treatment in 41 patients with endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole. Ribociclib plus letrozole are the therapy that we are using as the control in our VIKTORIA-2 trial for endocrine-sensitive patients. The objective response rate was 79%, which again compares favorably to historical data of 53% in the first-line setting for ribociclib plus letrozole.

Speaker #3: Now, results from the phase 1b clinical trial that we ran several years ago provided strong evidence that the PAM pathway is an important disease driver in treatment, i.e., patients with advanced breast cancer.

Speaker #3: In this early Phase 1 study, we evaluated getatelisib plus palbociclib and letrozole as first-line treatment in 41 patients with endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer.

Speaker #3: Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole. Ribociclib plus letrozole are the therapy that we're using as the control in our VICTORIA-2 trial for endocrine-sensitive patients.

Speaker #3: The objective response rate was 79%, which again compares favorably to historical data of 53% in the first-line setting for ribociclib plus letrozole. In light of the positive results for the PIK3CA wild-type and mutant cohorts of Victoria 1, and the promising preliminary data for getatelissib triplet as first-line treatment, we're optimistic about the results of both our first-line studies.

Brian Sullivan: In light of the positive results for the PIK3CA wild type and mutant cohorts in VIKTORIA-1 and the promising preliminary data for gedatolisib triplet as first-line treatment, we are optimistic about the results of both our first-line studies. Successful development in this first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late stage HR-positive, HER2-negative advanced breast cancer in the US, irrespective of their endocrine sensitivity or PIK3CA status. Our advancement of a subcutaneous gedatolisib formulation is ongoing, with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. Subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years. Now let us turn to our phase I-B/II trial.

Speaker #3: Successful development in this first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the U.S., irrespective of their endocrine sensitivity or PIK3CA status.

Speaker #3: Our advancement of subcutaneous getatelissib formulation is ongoing, with the goal of demonstrating clinical equivalence to the current intravenous formulation of getatelissib. Subcutaneous formulation is aimed to support potential future indications for getatelissib regimens that may result in duration of treatment periods greater than several years.

Speaker #3: And now, let's turn to our Phase 1b/2 trial that's evaluating getatelisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In the dose-finding portion of the Phase 1b study, evaluation of a 240-milligram dose of getatelisib was completed. No adverse events led to treatment discontinuation of getatelisib, and dose-limiting toxicity criteria for dose reduction were not met.

Brian Sullivan: That is evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In the dose-finding portion of the phase I-B study, evaluation of a 240 milligram dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib, and dose-limiting toxicity criteria for dose reduction were not met. This allowed us to begin evaluation of a 300 milligram dose, which is ongoing. Once the dose-finding portion of the study is completed, we expect to select two potential recommended phase II dose levels and control arm options for the randomized phase II portion of the study. We expect to provide updated clinical data and additional visibility into our development strategy for prostate cancer during Q4 2026. Now I would like to discuss our launch plans and the commercial opportunity for Revtorpyk.

Speaker #3: And this allowed us to begin evaluation of a 300-milligram dose, which is ongoing. Once the dose-finding portion of the study is completed, we expect to select two potential recommended phase 2 dose levels and control our options for the randomized phase 2 portion of the study.

Speaker #3: We expect to provide updated clinical data and additional visibility into our development strategy for prostate cancer during the fourth quarter of 2026. Now, I'd like to discuss our launch plans and the commercial opportunity for Revtropic.

Speaker #3: We began laying the groundwork for potential getatelissib launch over 24 months ago, and during this period, we've engaged over 1,000 key opinion leaders and community breast cancer experts over 250 key accounts, major oncology organizations including GPOs, state societies, and special interest groups, as well as patient advocacy groups.

Brian Sullivan: We began laying the groundwork for a potential gedatolisib launch over 24 months ago. During this period, we have engaged over 1,000 key opinion leaders and community breast cancer experts, over 250 key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at pampathway.com has already driven awareness of the PAM pathway, with metrics tracking well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have further increased levels of awareness about the unmet need in the second-line setting. The build-out of the commercialization infrastructure needed to support successful launch of Revtorpyk is now complete, and commercial launch activities for Revtorpyk commenced immediately after approval.

Speaker #3: Our unbranded marketing campaign at PAM Pathway dot com has already driven awareness of the PAM pathway, with metrics tracking well ahead of industry benchmarks.

Speaker #3: CME and third-party peer-to-peer programs and regional events have further increased levels of awareness about the unmet need in the second-line setting. Now, the build-out of the commercialization infrastructure needed to support a successful launch of Revtropic is complete, and commercial launch activities for Revtropic will commence immediately after approval.

Speaker #3: Our 88 oncology sales specialists who have an average of 24 years of industry experience are calling on physicians, supporting installation of Revtropic order sets within the electronic health record systems of their accounts, and in-servicing infusion centers and pharmacies.

Brian Sullivan: Our 88 oncology sales specialists, who have an average of 24 years of industry experience, are calling on physicians and supporting installation of Revtorpyk order sets within the electronic health record systems of their accounts and in servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical science liaison, and KOL focus teams are following through on the groundwork they laid prior to Revtorpyk approval. Payer and strategic account pathway dossiers have been submitted, and formal efforts to get included on formularies and pathways are in process. All of these efforts are designed to offer patients and providers with rapid access and seamless support. Shipments of Revtorpyk are expected to begin late in Q3 of 2026.

Speaker #3: Our strategic accounts pair reimbursement, medical science liaison, and KOL-focused teams are following through on the groundwork they laid prior to Revtropic approval. Payer and strategic account pathway dossiers have been submitted, and formal efforts to get included on formularies and pathways are in process.

Speaker #3: All of these efforts are designed to offer patients and providers with rapid access and seamless support. Shipments of Revtropic are expected to begin late in the third quarter of 2026.

Speaker #3: Now, the wholesale acquisition costs or WAC of Revtropic, which has been reported to the Drug Pricing Compendia, will be $10,000 per vial or $30,000 per cycle of treatment once Revtropic is commercially available.

Brian Sullivan: Now, the wholesale acquisition cost, or WAC, of Revtorpyk, which has been reported to the drug pricing compendium, will be $10,000 per vial or $30,000 per cycle of treatment once Revtorpyk is commercially available. To enable treating physicians to obtain gedatolisib on behalf of their eligible patients prior to commercial availability of Revtorpyk, Celcuity opened an expanded access program last week, and shipments to these physicians have begun. Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the US receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment for Revtorpyk per patient at the WAC price, we estimate the total addressable market for Revtorpyk in the wild type and mutant setting combined is potentially over $6 billion annually. That concludes my remarks.

Speaker #3: To enable treating physicians to obtain getatelissib on behalf of their eligible patients prior to commercial availability of Revtropic, Celcuity opened an expanded access program last week, and shipments to these physicians have begun.

Speaker #3: Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the US receiving second-line treatment for HR-positive HER2-negative advanced breast cancer.

Speaker #3: Assuming an average of roughly 10 cycles of treatment for Revtropic per patient at the WAC price, we estimate the total addressable market for Revtropic in the wild-type and mutant setting combined is potentially over $6 billion annually.

Speaker #3: And that concludes my remarks. I'd now like to hand the call over to Vicky to review our finances.

Brian Sullivan: I'd now like to hand the call over to Vicky to review our finances.

Speaker #1: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2026. Our second quarter net loss was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share, for the prior year period.

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for Q2 of 2026. Our Q2 net loss was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share, for the prior year period. Our non-GAAP adjusted net loss was $58.7 million, or $1.07 per share, for Q2 of 2026, compared to non-GAAP adjusted net loss of $40.5 million, or $0.93 per share, for the prior year period. Research and development expenses were $31.1 million for Q2 of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease was primarily due to a $7 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 phase III clinical trial.

Speaker #1: Our non-GAAP-adjusted net loss was $58.7 million, or $1.07 per share, for the second quarter of 2026, compared to non-GAAP-adjusted net loss of $40.5 million, or $93 per share, for the prior year period.

Speaker #1: Research and development expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease was primarily due to a $7 million decrease in clinical trial costs, which was primarily driven by decreased costs for the Victoria 1 phase 3 clinical trial.

Speaker #1: The remaining decrease was primarily due to a $5 million decrease in licensed milestone costs partially offset by a $3.8 million increase in employee-related and consulting expense, and $2.9 million increase in manufacturing and other costs.

Vicky Hahne: The remaining decrease was primarily due to a $5 million decrease in licensed milestone costs, partially offset by a $3.8 million increase in employee-related and consulting expense, and $2.9 million increase in manufacturing and other costs. Selling, general, and administrative expenses were $35 million for Q2 2026, compared to $7.6 million for the prior year period. The $27.4 million increase was primarily due to a $14.5 million increase in employee-related expenses, largely driven by the hiring of additional personnel within our commercial function to support the anticipated launch of Revtorpyk. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees, and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses.

Speaker #1: Selling general and administrative expenses were $35 million, for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase was primarily due to a $14.5 million increase in employee-related expenses, largely driven by the hiring of additional personnel within our commercial function to support the anticipated launch of Revtropic.

Speaker #1: The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses and expanded infrastructure costs.

Speaker #1: And a $2.1 million increase in other administrative expenses. In aggregate, $23.4 million of the $27.4 million selling general and administrative increase related to commercial headcount additions and other launch-related activities.

Vicky Hahne: In aggregate, $23.4 million of the $27.4 million selling, general, and administrative increase related to commercial headcount additions and other launch-related activities. Net cash used in operating activities for Q2 2026 was $55.4 million, compared to $36.2 million for the prior year period. The additional cash used in operating activities quarter-over-quarter of $19.2 million was primarily due to non-GAAP adjusted net loss of $18.2 million and working capital adjustments of $1 million. Cash, cash equivalents, and short-term investments were $754 million as of 30 June 2026, compared to $441.5 million as of 31 December 2025. The $312.5 million increase was primarily driven by the convertible note offering completed in June 2026. This resulted in gross proceeds of $575 million and net proceeds of $557.2 million.

Speaker #1: Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period. The additional cash used in operating activities quarter-over-quarter of $19.2 million was primarily due to a non-GAAP adjusted net loss of $18.2 million and working capital adjustments of $1 million.

Speaker #1: Cash, cash equivalents, and short-term investments were $754 million, as of June 30, 2026, compared to $441.5 million, as of December 31, 2025. The $312.5 million increase was primarily driven by the convertible note offering completed in June 2026, this resulted in gross proceeds of $575 million, and net proceeds of $557.2 million.

Speaker #1: The proceeds were offset by $137 million repayment of our term loan, and $110.5 million cash used in operating activities. Additional cash provided by financing activities of $2.8 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases.

Vicky Hahne: The proceeds were offset by a $137 million repayment of our term loan and $110.5 million cash used in operating activities. Additional cash provided by financing activities of $2.8 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash equivalents, and investments to finance our operations at least into 2029. I will now hand the call back to Jodi.

Speaker #1: We expect cash, cash equivalents, and investments to finance our operations at least into 2029. I will now hand the call back to Jody.

Speaker #2: Operator, could you please open the call for questions?

Jodi Gentry: Operator, could you please open the call for questions?

Jodi Sievers: Operator, could you please open the call for questions?

Speaker #3: Thank you, and ladies and gentlemen, we will now begin the question-and-answer session to ask a question. You may press the star, followed by the number 1 on your telephone keypad.

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press star followed by the number 1 on your telephone keypad. To withdraw your question, please press star followed by the number 2. One moment please for your first question. Your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.

Speaker #3: Do we draw your question? Please press the star, followed by the number 2. While moment, please for your first question. And your first question comes from the line of Tara Bancroft with 2D Common.

Speaker #3: Please go ahead.

Speaker #4: Hi. Thanks so much for taking the question. So I guess what I'd really like to understand is more of what underscores your confidence in the late Q3 shipments.

Tara Bancroft: Hi. Thanks so much for taking the question. I guess what I'd really like to understand is more of what underscores your confidence in the late Q3 shipments. For instance, are you initially launching with the existing clinical supply? If so, how long would that last you? How long is the process for set up with the backup manufacturing, and what does that entail? I know that sounds like a lot of questions, but I'm just getting at the same thing of your level of confidence in supplying the launch without delay.

Speaker #4: Like, for instance, are you initially launching with the existing clinical supply, and if so, how long would that last you? And, you know, how long is the process for setup with the backup manufacturing, and what does that entail?

Speaker #4: I know that sounds like a lot of questions, but I'm just getting at the same thing: your level of confidence in supplying the launch without delay.

Brian Sullivan: Sure. As I explained a couple weeks ago, we want to have confidence that our review process with the FDA will proceed according to what we expect to occur, that there are no surprises. We're very confident about being able to ship beginning at the end of this quarter. Nothing's changed.

Speaker #4: Sure. As I explained, you know, last couple of weeks ago, I mean, you know, we want to have confidence that our review process with the FDA will proceed according to what we expect to occur.

Speaker #4: That there are no surprises. And we're very confident about being able to ship beginning at the end of this quarter. So nothing's changed. Okay.

Tara Bancroft: Okay, great. I guess just as a follow-up, as part of that review process, do you need an inspection?

Speaker #4: Great. I guess just as a follow-up, as part of that review process, do you need an inspection? Well, the FDA can do whatever they want.

Brian Sullivan: Well, the FDA can do whatever they want, but typically

Speaker #4: But typically, if you are with a manufacturer, that has met requirements, they don't necessarily require that. It would, again, you don't want to really be in the position of projecting what the FDA does or won't do.

Tara Bancroft: Yeah

Brian Sullivan: if you are with a manufacturer that has met requirements, they do not necessarily require that. Again, you do not want to really be in the position of projecting what the FDA does or will not do. But we believe the validation data that we have is very consistent with the validation from our first site, and so we would anticipate that the review process will be straightforward.

Speaker #4: But we believe the validation data that we have is very consistent with the validation from our first site, and so we would anticipate that the review process will be straightforward.

Speaker #4: Okay, great. Thanks so much. You're welcome.

Tara Bancroft: Okay, great. Thanks so much.

Brian Sullivan: You are welcome.

Speaker #3: And your next question comes from the line of Maury Wycroft with Jeffries. Please go ahead.

Operator: Your next question comes from the line of Maury Raycroft with Jefferies. Please go ahead.

Speaker #5: Hi. Congrats on the progress, and thanks for taking my questions. I'll follow up on Tara's questions, just wondering if you can clarify if you've submitted that validation work, the necessary information to FDA yet, or what are the rate limiting steps remaining there?

Maury Raycroft: Hi. Congrats on the progress and thanks for taking my questions. I will follow up on Tara's questions. Just wondering if you can clarify if you have submitted that validation work, the necessary information to FDA yet, or what are the rate limiting steps remaining there? Do you need FDA to provide any type of sign-off before you can launch with products from that site?

Speaker #5: And do you need the FDA to provide any type of sign-off before you can launch with products from that site?

Speaker #4: Well, two things. We submitted the data almost immediately after we got the approval. We had, you know, validation, the package of information required to get the FDA to review.

Brian Sullivan: Well, two things. We submitted the data almost immediately after we got the approval. We had validation, the package of information required to get the FDA to review and for approval of the use of that site. So that has begun, and you cannot ship from that new site until you have received the go-ahead from the FDA. That is the limitation on getting access to material from that second site. But again, as we have indicated, we want visibility on the review process for that site. Again, we are confident about our ability to ship in Q3, late Q3.

Speaker #4: And for approval, the use of that site—so that's begun. And you can't ship from that new site until you have received the go-ahead from the FDA.

Speaker #4: That's the limitation on getting access to material from that second site. But again, as we've indicated, we want visibility on the review process. For that site.

Speaker #4: And again, we're confident about our ability to ship in the third quarter, late third quarter.

Speaker #5: Got it. Okay, maybe one other question, just program-related. I'm wondering how many sites or doctors are participating in it, and do you have some patients enrolled already?

Maury Raycroft: Got it. Okay. Maybe one other question just on the expanded access program. Wondering how many sites or doctors are participating in it, and do you have some patients enrolled already, and will you provide quarterly updates on where you are at with enrollment there? I guess, is that something that could

Speaker #5: And will you provide quarterly updates on where you're at with enrollment there? I guess, is that something that could.

Speaker #4: Hopefully, we're not providing quarterly updates, right? Because it’ll go away. But yes, we just, you know, got the program started last week. I mean, essentially had to get, you know, approval—you know, submit to the FDA, as well as get IRB approval, central IRB approval.

Brian Sullivan: Hopefully we are not providing quarterly updates, right? Because it will go away. We just got the program started last week, and we essentially had to get approval, submit to the FDA as well as get IRB approval, central IRB approval. So that occurred last week, and we have already begun shipping drug to sites where physicians are treating patients.

Speaker #4: So that occurred last week, and we've already begun shipping drug to physicians or to sites where physicians are treating patients.

Speaker #5: Got it. And then presumably, once you have drug launched, then those patients would convert over to commercial drug, then?

Maury Raycroft: Got it. Then presumably once you have drug launched, those patients will convert over to commercial drug then.

Speaker #4: Exactly, and that was reflected in the protocol.

Brian Sullivan: Exactly. That was reflected in the protocol.

Speaker #5: Got it. Okay. Okay. Thanks for taking my questions.

Maury Raycroft: Got it. Okay. Thanks for taking my questions.

Speaker #4: You're welcome.

Brian Sullivan: You are welcome.

Speaker #3: The next question comes from the line of Brad Canino with Guggenheim. Please go ahead.

Operator: The next question comes from the line of Brad Canino with Guggenheim. Please go ahead.

Speaker #5: Hey, Brian. Thanks for the update, especially around the prostate cancer progress—it's good to hear. I'm actually wondering about a different cancer center, because I know one of your competitors in the space is doing a lot of work in endometrial cancer, and I'm wondering how you think about that as an opportunity for giredestrant.

Brad Canino: Hey, Brian. Thanks for the updates.

Brian Sullivan: Hey, Brad.

Brad Canino: especially around the prostate cancer progress. It is good to hear. I am actually wondering about a different cancer center, because I know one of your competitors in the space is doing a lot of work in endometrioid cancer, and I am wondering how you think about that as an opportunity for gedatolisib. I know there is probably some old data that Pfizer conducted, probably not the right regimen and treatment line and setting, et cetera. How do you think about bringing that into the development portfolio, if that is an opportunity for you guys? Thank you.

Speaker #5: So I know there’s probably some old data that Pfizer conducted—probably not the right regimen, treatment line, and setting, et cetera. So how do you think about bringing that into the development portfolio, if that’s an opportunity for you guys?

Speaker #5: Thank you.

Speaker #4: Sure, there's certainly a strong rationale for us to consider that. And, you know, we'll be updating folks on our—excuse me—our development plans as we get further into the year.

Brian Sullivan: Sure. There is certainly a strong rationale for us to consider that, and we will be updating folks on our, excuse me, our development plans as we get further into the year. Until then, I can simply say that some preliminary data that was generated previously was indicating that even as monotherapy, gedatolisib can induce an objective response. The underlying drivers of the disease include the role of the PIK3CA pathway and for a certain significant cohort, the endometrioid patient population, the hormonal pathway is also involved. So there is certainly a strong rationale for us to consider developing in that setting.

Speaker #4: But until then, I can simply say that some preliminary data that was generated previously was indicating that, even as monotherapy, gedatolisib can induce an objective response.

Speaker #4: And, you know, the underlying drivers of the disease include the role of the PIK3CA pathway. And for a certain significant cohort, the endometroid patient population, the hormonal pathway is also involved.

Speaker #4: So, there's certainly a strong rationale for us to consider developing in that setting.

Speaker #5: Right. And then in prostate specifically, too, you know, I'm tracking this somewhat from afar, and I'm hearing KOLs have a pretty intense conversation around capivasertib and its potential role there, as the first inaugural pathway inhibitor on the PAM pathway to go after that.

Brad Canino: Right. Then in prostate specifically, too, I am tracking this somewhat from afar, and I am hearing KOLs have a pretty intense conversation around capivasertib and its potential role there as the first inaugural pathway inhibitor on the PAM pathway to go after that. What do you think, as you have the conversations with those same investigators and KOLs, we can actually learn from the capivasertib data and it as a foreshadow of the opportunity for something like gedatolisib, and what should we keep in mind that could be different as you approach it? Thank you.

Speaker #5: What do you think, as you have the conversations with those same investigators and KOLs, we can actually learn from the capobicertib data and it as a foreshadow of the opportunity for something like get a toll of SIB?

Speaker #5: And what should we keep in mind that could be different for—as you approach it? Thank you.

Speaker #4: Sure. So CAPI, as you know, is approved in breast cancer to treat patients who have a PIK3CA mutation. It's efficacy was comparable to the efficacy for alpha-lipsid.

Brian Sullivan: Sure. So capivasertib, as you know, is approved in breast cancer to treat patients who have a PIK3CA mutation. Its efficacy was comparable to the efficacy for alpelisib in its phase III study in a similar setting as what we were just studying. Gedatolisib, as we announced recently, showed double the activity relative to alpelisib, which we think is a reasonable proxy for what capivasertib is capable of doing. We think the fact that capivasertib got an approval for the PTEN loss population, essentially that is the most relevant mutation of the PAM pathway in prostate cancer. That drug is limited to that roughly 40% of patients with PTEN loss. But we think it augurs well for us. They are evaluating, rather, they got an approval in patients who are at an earlier stage than the patients we are evaluating. They were evaluating hormone-sensitive prostate patients.

Speaker #4: In its phase three study, in a similar setting as what we were just studying, and getatoll, as we announced recently, showed double the activity relative to alpelisib.

Speaker #4: Which we think is a reasonable proxy for what CAPI is capable of doing. And so, we think the fact that CAPI got an approval for the P10 loss population is essentially—that’s the most relevant mutation of the PAM pathway in prostate cancer.

Speaker #4: And so that drug is limited to that roughly 40 percent of patients with P10 loss. But we think it augurs well for us. They're evaluating—or rather, they got an approval in patients who are at an earlier stage than the patients we're evaluating.

Speaker #4: They were evaluating hormone-sensitive prostate patients, you know, we're evaluating castration-resistant patients. But the fact they got over the line with a positive study in a mutant cohort, similar to what they did in breast cancer, we think is translatable to what we may be able to do.

Brian Sullivan: We are evaluating castration-resistant patients. But the fact they got over the line with a positive study in a mutant cohort, similar to what they did in breast cancer, we think is translatable to what we may be able to do. We have encouraging data. We will 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. And that is ultimately our hypothesis. We are going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of this pathway in this disease.

Speaker #4: 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.

Speaker #4: And that's ultimately our hypothesis. We're going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of this pathway in this disease.

Speaker #5: All right. Thanks, Brian.

Brad Canino: All right. Thanks, Brian.

Speaker #4: You're welcome.

Brian Sullivan: You are welcome.

Speaker #3: Your next question comes from the line of Eva Forteo with Wells Fargo. Please go ahead.

Operator: Your next question comes from the line of Eva Fortea Verdejo with Wells Fargo. Please go ahead.

Operator: Your next question comes from the line of Eva Fortea-Verdejo with Wells Fargo. Please go ahead.

Speaker #6: Hi team. Congrats on the progress, and thanks for taking our question. A quick one from us on the EAP. Can you provide more color on how long do you expect it will take to transition the patient from the EAP to commercial following the launch in late Q3?

Eva Fortea Verdejo: Hi, team. Congrats on the progress, and thanks for taking our question. A quick one from us on the EAP. Can you provide more color on how long do you expect it will take to transition the patients from the EAP to commercial following the launch in late Q3? Thanks.

Eva Fortea-Verdejo: Hi, team. Congrats on the progress, and thanks for taking our question. A quick one from us on the EAP. Can you provide more color on how long do you expect it will take to transition the patients from the EAP to commercial following the launch in late Q3? Thanks.

Speaker #6: Thanks.

Speaker #4: You know, I don't want to get committed to a particular timeline. I mean, certainly, we have to be very sensitive to the needs of the patient and make sure that, you know, there's no risk of an interruption in supply.

Brian Sullivan: I don't want to get committed to a particular timeline. Certainly, we have to be very sensitive to the needs of the patient and make sure that there's no risk of an interruption in supply. Again, it could be very site-specific, patient-specific, depending on their insurance situation and other factors that may be relevant. But the intent is certainly to transition those patients to commercial supply. That's embedded within the protocol and is well understood by the participating investigators. That's a very standard approach. Again, we would expect that transition to occur. It may occur in that 2-week gap from day 15 to the next cycle of treatment, in effect, day 29.

Speaker #4: And so again, it could be very site-specific, patient-specific, depending on their insurance situation and other factors that may be relevant. But the intent is certainly to transition those patients to commercial supply.

Speaker #4: That's, you know, embedded within the protocol and is well understood by the participating investigators. So, you know, and that's, you know, a very standard approach.

Speaker #4: But again, we would expect that transition to occur. You know, it may occur in that two-week gap from day 15 to the next cycle of treatment, you know, in effect day 29.

Speaker #4: But again, the overall goal is to make sure that there's no disruption to the patient's access to the therapy, and we'll essentially accommodate, you know, whatever might be required to ensure that the transition occurs smoothly.

Brian Sullivan: The overall goal is to make sure that there's no disruption to the patient's access to the therapy, and we'll essentially accommodate whatever might be required to ensure that that transition occurs smoothly.

Speaker #6: Got it. It's very helpful. Thanks.

Eva Fortea Verdejo: Got it. Very helpful. Thanks.

Eva Fortea-Verdejo: Got it. Very helpful. Thanks.

Operator: Your next question comes from the line of Andrew Berens with Leerink Partners. Go ahead.

Speaker #3: question comes from the line of Andrew Barrents with Luring Partners Please go ahead.

Speaker #6: Hi, this is Isabel on for Andy. Thanks for taking our question. We were wondering if you could give more color on the expected gross-to-net.

[Analyst] (Leerink Partners): Hi, this is Isabelle on for Andy. Thanks for taking our question. We were wondering if you could give more color on the expected gross to net. Thanks.

Speaker #6: Thanks.

Speaker #4: Sure. So we've done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts.

Brian Sullivan: Sure. We've done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts. They don't involve discounts that reflect discounting of the drug per se, but they reflect channel differences that are just a function of the makeup of those channels. For our drug, we expect the gross to net percentage to be about 80%. The discounts involved from WAC will be about 20%. Based on data we've seen for oral therapies, that gross to net discount can be about 30%. We think we'll be able to capture a higher percentage of the WAC than the corresponding oral therapies in this category are able to capture.

Speaker #4: And they don't involve discounts, you know, to, you know, that reflect discounting of the drug per se, but they reflect channel differences that are just a function of, you know, the makeup of those channels.

Speaker #4: But for our drug, we expect the gross to net percentage to be about 80 percent, the discount, the discounts involved from WACC will be about 20 percent.

Speaker #4: And based on data, we've seen for oral therapies, you know, that the gross to net discount can be about 30 percent. So, you know, so we think we'll be able to capture a higher percentage of the WACC than the, you know, corresponding oral therapies in this category are able to capture.

Speaker #3: All right. Thank you. And your next question comes from the line of Oliver McCammon with Lifesci Capital Please go ahead.

Operator: All right. Thank you. Your next question comes from the line of Oliver McCammon with LifeSci Capital. Please go ahead.

Speaker #5: Hi. Thanks for taking my questions. Maybe just a broader question on the commercialization and your work engaging physicians, but curious what proportion of community oncology practices as you think about associated infusion centers as well as geography you think would be amenable to IV therapy in this setting?

Oliver McCammon: Hi. Thanks for taking my questions. Maybe just a broader question on the commercialization and your work engaging physicians, but curious what proportion of community oncology practices, as you think about associated infusion centers as well as geography, you think would be amenable to IV therapy in this setting? Relatedly, do you think there are any learnings to take from what we hear is fairly common use of IV administered in HER2, even in second line? Thanks again.

Speaker #5: And then, relatedly, do you think there are any learnings to take from what we hear is fairly common use of IV administered in HER2, even in second line?

Speaker #5: Thanks again.

Speaker #4: Sure. Well, we think nearly every community practice has access to infusion centers because some of the most important therapies used to treat breast cancer are infused therapies.

Brian Sullivan: Well, we think nearly every community practice has access to infusion centers because some of the most important therapies in breast cancer, used to treat breast cancer, are infused therapies. HER2 is one you mentioned, pembrolizumab, and TNBC is another. Herceptin and Perjeta, which are two anti-HER2 antibodies, are also standard of care treatments in advanced breast cancer, HER2-positive breast cancer. All the chemotherapies, or many of the chemotherapies that are prescribed are infused. The practice of medicine treating breast cancer patients requires access to infusion centers. So, we don't think there's going to be any barrier to a community oncologist prescribing gedatolisib and ensuring their patient can get infused. These docs represent the community treaters, treat about 80% of phys-

Speaker #4: And HER2 is one you mentioned, pembrolizumab and TNBC is another. Herceptin or and Perjeta, which are two anti-HER2 antibodies are also standard of care treatments in advanced breast cancer.

Speaker #4: HER2 positive breast cancer. And then all the chemotherapies or many of the chemotherapies that are prescribed are infused. And so, you know, the practice of medicine treating breast cancer patients requires access to infusion centers.

Speaker #4: So, we don't think there's going to be any barrier to a community oncologist prescribing, getting us lisinopril, and ensuring their patient can get infused.

Speaker #4: And these docs represent the community treaters treat about 80 percent of.

Operator: Excuse me, ladies and gentlemen, please continue to stand by. Your conference will resume momentarily. Thank you. Ladies and gentlemen, we will now resume our conference. We do apologize for the technical difficulties. Brian, please go ahead.

Speaker #3: Excuse me, ladies and gentlemen. Please continue to stand by. Your conference will resume momentarily. Thank you. Ladies and gentlemen, we will now resume our conference video.

Speaker #3: Apologies for the technical difficulties. Brian, please go ahead.

Speaker #4: Well, thank you. I hope you all heard the last answer to my question. Operator, if there's an additional questions, happy to answer those.

Brian Sullivan: Well, thank you. I hope you all heard the last answer to my question. Operator, if there's additional questions, happy to answer those.

Speaker #3: Oliver, do you still have any additional questions? All right, thank you. Your next question comes from the line of Colpeet Patel with Wolfe Research.

Operator: Oliver, do you still have any additional questions? All right. Thank you. Your next question comes from the line of Kalpit Patel with Wolfe Research. Please go ahead.

Speaker #3: Please go ahead.

Speaker #5: Yeah. Hey, good afternoon and thanks for taking my question. Just one from us on the prostate cancer program. Can you give us a little more granularity on what to expect in fourth quarter?

Kalpit Patel: Yeah. Hey, good afternoon, and thanks for taking my question. Just one from us on the prostate cancer program. Can you give us a little more granularity on what to expect in Q4? Is it just PSA response data, or are we going to see rPFS data as well? Then what would success look like to you in that area? Thank you.

Speaker #5: Is it just PSA response data, or are we going to see rPFS data as well? And then, what would be a—what would success look like to you in that area?

Speaker #5: Thank you.

Speaker #4: Sure. So we expect to provide additional data to include PSA 50 data as well as updated progression-free survival data. And looking at different subgroups of patients, as well as data from the 240 milligram dose.

Brian Sullivan: Sure. We expect to provide additional data that could include PSA 50 data as well as updated progression-free survival data, and looking at different subgroups of patients, as well as data from the 240 milligram dose. As well, the data with 300 milligram dose may not be mature enough to present. So it will be data that hasn't been presented before that we think will hopefully shed some good light on the program itself.

Speaker #4: As well, the data with the 300 milligram dose may not be mature enough to present. But it will be data that hasn't been presented before, that we think will hopefully shed some good light on the program itself.

Speaker #5: Okay. And any color on what would be encouraging, in your view, for RPFS?

Kalpit Patel: Okay. Any color on what would be encouraging in your view for rPFS?

Speaker #4: Well, I think the standard of care today—or rather, I would say there's kind of two components to that answer. Current patients in the second-line setting who've progressed on, let's say, prior abiraterone can expect to receive five to six months median PFS.

Brian Sullivan: Well, I think the standard of care today, or rather, I would say, there is two components to that answer. Current patients in the second-line setting who have progressed on, let us say, prior abiraterone can expect to receive 5 to 6 months median PFS. Similarly, if they are treated with docetaxel instead of a hormonal therapy. The minimum bar to beat would be 3 to 4 months better than those options. PLUVICTO is out there as an option as well. They are offering patients north of 10 months. Our expectation would be that we would need at least to be comparable to PLUVICTO. We think there would be advantages to use of our drug versus their drug in that setting, and certainly, we would hope to be superior to that.

Speaker #4: Similarly, if they are treated with docetaxel, as opposed to a hormonal therapy, the minimum bar to beat would be, you know, three to four months better than those options.

Speaker #4: Blavit goes out there as an option as well. They're offering patients, you know, north of 10 months. And so our expectation would be that we would need at least to be comparable to Blavit go.

Speaker #4: We think there would be advantages to the use of our drug versus their drug in that setting, and certainly, we would hope to be superior to that.

Speaker #4: But that if we're able to demonstrate typical three to four months superiority relative to, you know, what would be an add-on therapy, with Geta versus a switched androgen receptor inhibitor, or at least comparable efficacy to Blavitgo, that, you know, we would could potentially play an important role in that treatment.

Brian Sullivan: But that if we are able to demonstrate typical 3 to 4-month superiority relative to what would be an add-on therapy with gedatolisib versus a switched androgen receptor inhibitor, or at least comparable efficacy to PLUVICTO, that we could potentially play an important role in that treatment. Of course, we know there is some other data that could be coming down the pipe, and that will be very relevant to any assessment that we make.

Speaker #4: Of course, you know, we know there’s some other data that could be coming down the pike, and that’ll be very relevant to any assessment that we make.

Speaker #5: Okay, that's super helpful. Thank you.

Kalpit Patel: Okay. That is super helpful. Thank you.

Speaker #4: You're welcome.

Brian Sullivan: You are welcome.

Speaker #3: Your next question comes from the line of Gill Bloom with Needham. Please go ahead.

Operator: Your next question comes from the line of Gil Blum with Needham. Please go ahead.

Speaker #5: Hi guys. This is Jonathan on for Gill. Just a quick question about the secondary manufacturing site. For the supplemental filing, what is the timeline that you guys are expecting for hearing back from the FDA?

[Analyst] (Needham): Hi, guys. This is Jonathan on for Gil. Just a quick question about the secondary manufacturing site. For the supplemental filing, what is the timeline that you guys are expecting for hearing back from the FDA? Is it similar to an sNDA timeline?

Speaker #5: Is it similar to an SNDA timeline?

Speaker #4: Not an SNTA. There's multiple processes and steps along the way, but, you know, it can involve a review as brief as two months or, you know, or four months.

Brian Sullivan: Not an sNDA. There is multiple processes and steps along the way, but it can involve a review as brief as 2 months or 4 months. Again, if there are issues, which again, we do not expect to occur, it can take longer. There is a standard process, a 4-month review process. It can be shorter. Again, you are interacting with the agency during that process, and you will gain an understanding from that initial feedback what, if any, issues they may have or considerations they may be wanting us to address. That is what we think we will find out relatively early in the process.

Speaker #4: And again, if there are issues, which again, we don't expect to occur, you know, it can take longer. And so, you know, there's a standard process of four-month review process.

Speaker #4: It can be shorter. And—but again, you're interacting with the agency during that process, and you'll gain an understanding from that initial feedback of what, if any, issues they may have, or considerations they may be wanting us to address.

Speaker #4: But that's what we think we'll find out, you know, relatively early in the process.

Speaker #5: And just a quick follow-up. If this supplemental filing was approved, what percent of supply would you expect would be coming from the second site at full capacity, or...?

[Analyst] (Needham): Just a quick follow-up. If this supplemental filing was approved, what percent of supply would you expect would be coming from the second site at full capacity or-

Speaker #4: You know, that's a very tactical. It'll be appropriate. We'll be using, you know, inventory from both sites. And, you know, managing inventory accordingly. It's important to keep both sites going.

Brian Sullivan: That is very tactical. It will be appropriate. We will be using inventory from both sites and managing inventory accordingly. It is important to keep both sites going. You want to create a rhythm for them. You are always going to be balancing mix of product between those two sites.

Speaker #4: It's just, you know, you want to create a rhythm for them. And so you're always going to be balancing the mix of product between those two sites.

Speaker #5: Sounds good. Yeah. Thanks again, and congrats again on all the progress.

[Analyst] (Needham): Got it. Thanks again, and congrats again on all the progress.

Speaker #4: You're welcome.

Brian Sullivan: You are welcome.

Speaker #3: And your next question comes from the line of Stephen Wheely with Staple. Please go ahead.

Operator: Your next question comes from the line of Stephen Willey with Stifel. Please go ahead.

Speaker #2: Yeah. Good afternoon. Thanks for taking the questions. Just curious where you are in terms of preparing a publication of the mutant data and whether you believe a compendium listing for use in these patients could be achieved before formal label expansion.

Stephen Willey: Yeah, good afternoon. Thanks for taking the questions. Just curious where you are in terms of preparing a publication of the mutant data.

Stephen Willey: A compendia listing for use in these patients could be achieved before formal label expansion. I was also just wondering how you are thinking about communicating launch progress to The Street, and what metrics you think you might be providing to us over the next quarters. Thanks.

Speaker #2: And then I was also just wondering how you're thinking about communicating launch progress to the Street, and what metrics you think you might be providing to us over the next few quarters.

Speaker #2: Thanks.

Speaker #4: Sure. Regarding the article, we have submitted an article to a journal, and, you know, that process is variable in time. It can take three months.

Brian Sullivan: Sure. Regarding the article, we have submitted an article to a journal, and that process is variable in time. It can take 3 months, it can take 6 months. We would hope to have it be on the shorter range of that timeline, but it is not 100% in our control, obviously. That process is well underway. As far as mutant usage, we cannot promote mutant usage. We would have the opportunity potentially to, and it is up to the NCCN panels to have NCCN make a recommendation based on published data. They cannot make recommendations just based on, for instance, a presentation given at a major medical conference. They need to see data from a peer-reviewed journal before they would consider making changes to their recommendations.

Speaker #4: It can take six months. We would hope to have it be on the shorter range of that timeline, but it's not 100 percent in our control, obviously.

Speaker #4: But that process is well underway. As far as, you know, mutant usage, I mean, we can't promote mutant usage. But we would have the opportunity potentially to, and it's up to the NCCN, panels to have the NCCN make a recommendation based on published data.

Speaker #4: They can't make recommendations just based on, for instance, a presentation given at a major medical conference. Say, they need to see data from a peer-reviewed journal.

Speaker #4: Before they would consider making changes to their recommendations. But if they made recommendations, those are widely followed by payers, and if the recommendations are appropriate for what the payers require, then the physicians would be in a position to prescribe the medicine and their patients to get reimbursed for it.

Brian Sullivan: If they made recommendations, those are widely followed by payers, and if the recommendations are appropriate what the payers require, then physicians would be in a position to prescribe the medicine and their patients to get reimbursed for it. Again, not something we can certainly drive or really discuss at all in the clinical context. Those are variables that could be present in the marketplace. As far as progress, we will be reporting sales, obviously, as we go. We do not have the granularity of data that you have with oral therapies. We ship to a site. That is buy and bill. We do not get a prescriber name on that therapy, and so we do not get as much visibility. There is not a name on the prescription, for instance. So we do not get as much visibility as, let us say, an oral medication gets.

Speaker #4: But again, not something we can certainly drive or really discuss at all in the clinical context. But those are variables that, you know, could be present in the marketplace.

Speaker #4: And as far as progress, you know, we'll be reporting sales, obviously, as we go. You know, we don't have the granularity of data that you have with oral therapies.

Speaker #4: You know, we have a—we ship to a site by and bill. But we don't get a prescriber name on that therapy, and so we don't get as much visibility.

Speaker #4: There's not a name on the prescription, for instance, so we don't get as much visibility as, let's say, an oral medication gets. So the granularity of data won't be as high as people might be used to for oral therapies.

Brian Sullivan: The granularity of data won't be as high as people might be used to for oral therapies. We will be doing survey data that will give us a view on probably 40% to 50% of patients treated. But there'll be a lag in that. That'll be two to three months lag. It won't be current or necessarily representative. It'll provide us important information to help manage the business, but it won't be a real-time evaluation. We internally will be certainly tracking and be able to intuit based on our analyses where the drug is going, who's at the locations, and be able to do analysis like that. But we won't have the sufficient specificity to, for instance, identify how many docs prescribing, how many re-prescribed it, how many patients on therapy. We'll simply have in real time setting the actual number of vials shipped to sites.

Speaker #4: We will be doing survey data. That will give us a view on probably 40 to 50 percent of patients treated. But there'll be a lag in that.

Speaker #4: That will be a two- to three-month lag, so it won't be current or necessarily representative. It will provide us with important information to help manage the business.

Speaker #4: But it won't be real-time evaluation internally. It will be certainly tracking and be able to intuit based on our analyses. You know, where the drug is going, who's at the locations, and be able to do analysis like that.

Speaker #4: But we won't have the sufficient specificity to, for instance, identify, you know, how many docs are prescribing and how many re-prescribed it, how many patients are on therapy. You know, we'll simply have that in a real-time setting.

Speaker #4: The actual number of vials shipped to sites—and we expect that to represent demand. You know, there really won't be inventorying of this drug, and the distributor or 3PL will be delivering this drug overnight.

Brian Sullivan: And we expect that to represent demand. There really won't be inventorying of this drug. Our distributor, our 3PL, will be delivering this drug overnight in a great majority of cases. And some of the larger sites, depending on their overall approach, may maintain some stock based on the number of patients they have on the drug. So there could be, in certain facilities, a little bit of loading, but we wouldn't expect that to represent, let's say, more than a cycle of treatment. We think that would be unlikely.

Speaker #4: The great majority of cases. And so we don't expect, and some of the larger sites, you know, depending on their overall approach, you know, may maintain some stock based on the number of patients they have on the drug.

Speaker #4: So there could be in certain facilities a little bit of loading, but we wouldn't expect that to represent, you know, let's say more than a cycle of treatment.

Speaker #4: We think that would be unlikely.

Speaker #2: All right. That's very helpful. Thank you.

Stephen Willey: All right. That's very helpful. Thank you.

Speaker #4: You're welcome.

Brian Sullivan: You're welcome.

Speaker #3: And your next question comes from the line of Silvan Turjan with Citizens. Please go ahead.

Operator: Your next question comes from the line of Silvan Tuerkcan with Citizens. Please go ahead.

Speaker #5: Hey, this is Josh on for Silvan. Thanks for taking the question. Yeah. So you mentioned plans to submit the FNDA for the mutant population in 3Q.

[Analyst] (Citizens): Hey, this is Josh on for Silvan. Thanks for taking the question. You mentioned plans to submit the sNDA for the mutant population in Q3. Could you maybe just walk us through some of the potential regulatory timelines, maybe submission to filing and then potential for a more rapid review period? Thanks.

Speaker #5: Could you maybe just walk us through some of the potential regulatory timelines? Maybe submission to filing and then, you know, potential for a more rapid review period?

Speaker #4: Sure.

Speaker #5: Thanks.

Speaker #4: Yes, sure. No—because it's an SNDA. While they will need to accept the SNDA, the clock starts for the review when the final submission is made.

Brian Sullivan: Yes, sure. Because it is an sNDA, while they will need to accept the sNDA, the clock starts for the review when the final submission is made. From the time we complete our submission to whatever the prescribed production date is, would be the expected review cycle. If it is a priority review, it would be 6 months from submission. If it is a regular review, it would be 10 months from submission.

Speaker #4: And so, from the time we complete our submission to whatever the prescribed PDUFA date is, that would be the expected review cycle. If it's a priority review, it would be six months from submission.

Speaker #4: If it's a regular review, it would be 10 months from submission.

Speaker #5: Great. Thank you.

[Analyst] (Citizens): Great. Thank you.

Speaker #4: Welcome.

Brian Sullivan: Welcome.

Speaker #3: And I'm showing no further questions at this time. I would like to turn it back to our CEO, Brian Sullivan, for closing remarks.

Operator: I am showing no further questions at this time. I would like to turn it back to our CEO, Brian Sullivan, for closing remarks.

Speaker #4: Well, thank you for participating in our call today. For your ongoing support and look forward to seeing you potentially at conferences over the next few months.

Brian Sullivan: Well, thank you for participating in our call today, for your ongoing support. I look forward to seeing you potentially at conferences over the next few months. Take care.

Speaker #4: Take care.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.