Q2 2024 Celcuity Inc Earnings Call

Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Selkiewity second quarter 2024 financial results conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session.

Operator: Results Conference Call. At this time, all lines are in listen-only mode.

Operator: At this time, all lines are in listen-only mode.

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

Operator: 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. This call is being recorded today, August 14th, 2024. I would now like to turn the conference over to Maria Yonkoski with ICR Westwick, please go ahead. Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Celcuity's second quarter 2024 financial results and business update. Earlier today, Celcuity released financial results for the second quarter ending June 30, 2024. The press release can be found on the investors section of the website.

Speaker Change: If at any time during this call you require immediate assistance, please press star zero for the operator.

Operator: This call is being recorded today August 14th, 2024.

Maria Yonkoski: I would now like to turn the conference over to Maria Yonkoski with ICR Westwick. Please go ahead.

Maria Yonkoski: 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 Gorbachevsky, Chief Medical Officer, who will be available during Q&A. Before 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 Change: This call is being recorded today, August 14th, 2024.

Speaker Change: I would now like to turn the conference over to Maria Yonkoski with ICR Westwick. Please go ahead.

Maria Yonkoski: Thank you, operator, and good afternoon. Thank you for joining us to review Celcuity's second quarter 2024 financial results and business updates. Earlier today, Celcuity released financial results for the second quarter ending June 30th, 2024. The press release can be found on the investor's section of the website.

Speaker Change: Unknown Attendee, Vicky Hahne, Maria Yonkoski

Maria Yonkoski: Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Selcuity's 2nd Quarter 2024 Financial Results and Business Update.

Speaker Change: Earlier today, Celcuity released financial results for the second quarter ending June 30, 2024. The press release can be found on the Investors section of the website.

Maria Yonkoski: 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, who will be available during Q&A. Before 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 or results may defer 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 defer materially from those projected on this call.

Speaker Change: Joining me on the call today are Brian Sullivan, cell Q and E's Chief Executive Officer in co-founder, Vicky Hahne, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q and E.

Maria Yonkoski: Actual events or results may differ materially from those projected in the forward-looking statement. 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-gap financial measures. These non-gap measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance.

Speaker Change: Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements.

Speaker Change: 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 or results may differ materially from those projected in the forward-looking statements.

Speaker Change: 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.

Maria Yonkoski: Management believes the presentation of these non-gap 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-gap financial measures to gap measures in today's press release. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Maria Yonkoski: We will also refer to non gap financial measures. These non-GAAP 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 GAAP measures in today's press release.

Speaker Change: On this call, we will also refer to non- GAAP financial measures. These non- GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance.

Speaker Change: 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 Change: You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release.

Brian Sullivan: And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Speaker Change: And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Brian Sullivan: Thank you, Maria.

Brian Sullivan: Thank you, Maria. And good afternoon, everyone. We appreciate your interest in Celcuity. We made significant strides advancing the clinical development of getatelicib this quarter. Overall enrollment in Victoria 1, our Phase 3 study evaluating getatelicib plus fulvestrin with and without pelvisiclib as second-line treatment for patients with HR-positive, HER2-negative advanced breast cancer, remains robust and on track. Our Phase 1b2 trial evaluating patients with metastatic castration-resistant prostate cancer is also enrolling on schedule, and we further expanded the patient population eligible for ghetto to listen when we initiated efforts In our view, each of these three programs has the potential to generate blockbuster levels of revenue.

Brian Sullivan: And good afternoon, everyone. We appreciate your interest in Celcuity. We made significant strides advancing the clinical development of get a to list of this quarter. Overall enrollment in Victoria One, our phase three study evaluating Get a to list of blissful vestra with and without palbacic libous second line treatment for patients with HR positive HER2 negative advanced breast cancer remains robust and on track. Our phase one B to trial evaluating patients with metastatic castration-resistant prostate cancer is also enrolling on schedule. And we further expanded the patient population eligible for get a to list of when we initiated efforts to launch Victoria to phase three study designed to evaluate get a to list of as a first line treatment option for patients with HR positive HER2 negative advanced breast cancer.

Brian Sullivan: Thank you, Maria, and good afternoon, everyone. We appreciate your interest in Selkurity.

Speaker Change: We made significant strides advancing the clinical development of getatelicib this quarter. Overall enrollment in Victoria 1, our Phase 3 study evaluating getatelicib plus fulvestrin with and without palviciclib as second-line treatment.

Speaker Change: for patients with HR positive HER2 negative advanced breast cancer remains robust and on track. Our phase 1b2 trial evaluating patients with metastatic castration resistant prostate cancer is also enrolling on schedule.

Speaker Change: And, we further expanded the patient population eligible for Getatelicib when we initiated efforts to launch Victoria 2, a Phase 3 study designed to evaluate Getatelicib as a first-line treatment option for patients with HR-positive, HER2-negative advanced breast cancer.

Brian Sullivan: In our view, each of these three programs has the potential to generate blockbuster levels of revenue. If these three programs ultimately result in regulatory approvals. We estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with get a solicit.

Speaker Change: In our view, each of these three programs has the potential to generate blockbuster levels of revenue.

Brian Sullivan: These three programs ultimately result in regulatory approvals. We estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with ketotilicin. We first announced our plans to conduct the Frictoria 1 study over two years ago, in May 2022. At that time, we estimated that 65% of the patients enrolled would lack detectable PIK3CA mutations, and would thus be assigned to the study's PIK3CA wild-type co-op. And this assumption was used to estimate enrollment by cohort and, in turn, the timing of events for primary analysis.

Speaker Change: if these three programs ultimately result in regulatory approvals.

Speaker Change: We estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with ketotilicidin.

Brian Sullivan: We first announced our plans to conduct the Frictorial One study over two years ago in May 2022. At that time, we estimated that 65 percent of the patients enrolled would lack detectable PIC-3CA mutations and would thus be assigned to the studies PIC-3CA wild type cohort. And this primary analysis. We estimated that the threshold number of events required to trigger the primary analysis for this PIC-3CA wild type cohort of patients would be reached in the second half of 2024. And while the study's overall enrollment remains on track and robust relative to the estimate we made over two years ago.

Speaker Change: We first announced our plans to conduct the Victoria 1 study over two years ago, in May 2022. At that time, we estimated that 65% of the patients enrolled would lack detectable PIK3CA mutations, and would thus be assigned to the study's PIK3CA wild-type cohort.

Speaker Change: And this assumption was used to estimate enrollment by cohort and, in turn, the timing of events for primary analysis.

Brian Sullivan: We estimated that the threshold number of events required to trigger the primary analysis for this PIK3CA wild-type cohort of patients would be reached in the second half of 2024. However, while the study's overall enrollment remains on track and robust relative to the estimate we made over two years ago, the total proportion of patients enrolled who have PIK3CA wild-type tumors has recently shifted lower. We now project that 60% of the patients enrolled in the study will be enrolled in the PIC3CA wild-type cohort, rather than the 65% originally estimated, and this proportion, while lower than our original estimate, because within the ranges reported in other studies, and thus we don't believe this shift is study related but simply a result of normal sample variation within a population.

Speaker Change: We estimated that the threshold number of events required to trigger the primary analysis for this PIK3CA wild-type cohort of patients would be reached in the second half of 2024.

Speaker Change: And while the study's overall enrollment remains on track and robust relative to the estimate we made over two years ago.

Brian Sullivan: A total proportion of patients enrolled who have PIC-3CA wild type tumors has recently shifted lower. We now project that 60 percent of the patients enrolled in the study will be enrolled in the PIC-3CA wild type cohort rather than the 65 percent originally estimated. And this proportion, while lower than our original estimate, is within the ranges reported in other studies. And thus we don't believe this shift is study-related but simply a result of normal sample variation within a population. Despite the lower proportion of PIC-3CA wild type patients completed, enrollment for the PIC-3CA wild type cohort is over 80 percent complete.

Speaker Change: The total proportion of patients enrolled who have PIK3CA wild-type tumors has recently shifted lower.

Speaker Change: We now project that 60% of the patients enrolled in the study will be enrolled in the PIC3CA wild-type cohort, rather than the 65% originally estimated.

Speaker Change: And this proportion, while lower than our original estimate, is within the range reported in other studies. And thus, we don't believe this shift is study-related, but simply a result of normal sample variation within a population.

Brian Sullivan: Despite the lower proportion of PIC3CA wild-type patients completed, enrollment for the PIC3CA wild-type cohort is over 80% complete. We expect to reach the enrollment target for the PIC3CA wild-type cohort during the fourth quarter rather than the end of the third quarter as we originally forecast. We now expect a primary analysis event for a shoulder trigger for the Pix3CA well-typed cohort. We'll be reached sometime between late Q424 and the end of Q1 2025.

Speaker Change: Despite the lower proportion of PIC3CA wild-type patients completed, enrollment for the PIC3CA wild-type cohort is over 80 percent complete. We expect to reach the enrollment target for the PIC3CA wild-type cohort during the fourth quarter rather than the end of the third quarter, as we originally forecast.

Brian Sullivan: We expect to reach the enrollment target for the PIC-3CA wild type cohort during the fourth quarter rather than the end of the third quarter as we originally forecast. We now expect the primary analysis event threshold trigger for the PIC-3CA wild type cohort will be reached sometime between late Q4 24 and the end of Q1 2025.

Speaker Change: We now expect the primary analysis event threshold trigger for the PIC3CA wild-type cohort will be reached sometime between late Q4-24 and the end of Q1-2025. Our guidance regarding the PIC3CA mutant patient subgroup remains unchanged, and we expect primary analysis for this cohort to be triggered during the first half of 2025.

Brian Sullivan: Our guidance regarding the Pix3CA mutant patient subgroup remains unchanged and we expect primary analysis for this cohort to be triggered during the first half of 2025. Turning now to our Victoria 2 study, we announced our plans to initiate this phase three clinical trial this past May. Study will evaluate gadotilicid plus a CDK4-6 inhibitor in fulvestrin, as first-line treatment for patients with HR-positive or 2-negative advanced breast cancer, whose disease recurs while receiving or within 12 months of completing adjuvant endocrine therapy. Now these patients are considered to have endocrine therapy resistant disease.

Brian Sullivan: Our guidance regarding the PIC-3CA mutant patient subgroup remains unchanged, and we expect primary analysis for this cohort to be triggered during the first half of 2025.

Brian Sullivan: Turning now to our Victoria 2 study, we announce our plans to initiate this phase-3 clinical trial this past May. Study will evaluate get a list of plus a CDK46 inhibitor and full vestrine. As first line treatment for patients with HR positive, virtue negative, advanced breast cancer, whose disease occurs while receiving or within 12 months of completing adjuvant endocrine therapy. All these patients are considered to have endocrine therapy-resistant disease and have a significantly poorer prognosis than endocrine therapy-sensitive patients whose disease occurs more than 12 months after completing their adjuvant endocrine therapy. Current standard of care first line treatment for endocrine therapy resistant patients includes any of the three approved CDK46 inhibitors combined with fulvestrant.

Speaker Change: Turning now to our Victoria 2 study. We announced our plans to initiate this phase 3 clinical trial this past May. The study will evaluate gadotilicid plus a CDK4-6 inhibitor and fulvestrin.

Speaker Change: as first-line treatment for patients with HR-positive or 2-negative advanced breast cancer whose disease recurs while receiving, or within 12 months of completing, adjuvant endocrine therapy.

Brian Sullivan: They have a significantly poorer prognosis than endocrine therapy sensitive patients, whose disease recurs more than 12 months after completing their adjuvant endocrine therapy. Current standard of care first-line treatment for endocrine therapy resistant patients includes any of the three approved CDK4-6 inhibitors combined with Fulvestra. The limited efficacy these regimens offer endocrine therapy resistant patients, though, was not well understood until the NF0120 study, phase three clinical trial for the PIK3K-alpha inhibitor in Inovalisin.

Speaker Change: Now these patients are considered to have endocrine therapy-resistant disease. They have a significantly poorer prognosis than endocrine therapy-sensitive patients whose disease recurs more than 12 months after completing their adjuvant endocrine therapy.

Speaker Change: Current standard of care first-line treatment for endocrine therapy resistant patients includes any of the three approved CDK4-6 inhibitors combined with Fulvestrin.

Brian Sullivan: Delimited efficacy, these measurements offer endocrine therapy-resistant patients though. It was not well understood until the end of 120 study.

Speaker Change: The limited efficacy these regimens offer endocrine therapy resistant patients, though, was not well understood until the NF0120 study, phase 3 clinical trial for the PIK3K alpha inhibitor in Inovlucid.

Brian Sullivan: Phase-3 clinical trial for the PIC-3K alpha inhibitor in of listed reported results last December. As part of this trial, the efficacy of standard of care, polycyclic, and full vestrine was evaluated as first line treatment in patients who were resistant to endocrine therapy. For these patients, median PFS was only 7.3 months, and for those patients whose disease relapse within the first two years of their adjuvant endocrine therapy, the median PFS was only 3.7 months. These results compare poorly to the median PFS of 27 months reported for patients who are sensitive to endocrine therapy and who receive the same regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy.

Brian Sullivan: Reported results last December. Part of this trial, the efficacy of standard of care paloiciclib and fulvestrin was evaluated as first-line treatment in patients who were resistant to endocrine therapy. And for these patients, median PFS was only 7.3 months. And for those patients whose disease relapsed within the first two years of their adjuvant enterprise. The median PFS was only three points.

Speaker Change: Reported results last December .

Speaker Change: As part of this trial, the efficacy of standard of care, power, sick, live, and full vestuant was evaluated as first line treatment in patients who were resistant to endocrine therapy and for these patients, median PFS was only 7.3 months.

Speaker Change: And for those patients whose disease relapsed within the first two years of their adjuvant endocrine therapy, the median PFS was only 3.7 months.

Brian Sullivan: And these results compare poorly to the median PFS of 27 months reported for patients who are sensitive to endocrine therapy and who receive the same regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy. We reported last year the preliminary clinical data from our Phase 1B trial. Forget it's listed as first-line treatment in patients with advanced breast cancer. As you may recall. The Median, Progress and Free Survival, and endoconsensitive patients, who were treatment naïve and were treated with gadotelicib in combination with polycyclic and letrozole, was 48.6 months, and the Objective Response Rate. 79.

Speaker Change: And these results compare poorly to the median PFS of 27 months reported for patients who are sensitive to endocrine therapy and who receive the same regimen, highlighting a significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy.

Brian Sullivan: We reported last year the preliminary clinical data from our Phase I B trial for get-up to list as first-line treatment in patients with advanced breast cancer. As you may recall, the median progression for survival in endoconsensitive patients were treatment naive and were treated with get-up to list of in combination with polycyclic and let-resol, was 48.6 months and the objective response rate was 79%. And these results compare very favorably to the results reported for polycyclic plus let-resol in this population. Additionally, the NVO 120 study that evaluated in a velocity combined with polycyclic infolestrant in the endocrine-resistant patients reported positive data.

Speaker Change: We reported last year the preliminary clinical data from our Phase 1B trial for Gettysburg as first-line treatment in patients with advanced breast cancer.

Speaker Change: As you may recall...

Speaker Change: The Media and Progress and Free Survival.

Speaker Change: and endoconsensitive patients who were treatment naïve and were treated with gadotilisib in combination with polycycline and letrozole was 48.6 months.

Brian Sullivan: And these results compare very favorably to the results reported for polycyclic plus letrozole, in this population. Additionally, the interval 120 study that a guy who waited in a volition, combined with Pablo Ciclop and Fulvester, in the endocrine-resistant patients reported positive data. Now, these patients had tumors with PIK3CA mutations, and the patients were not pre-diabetic or diabetic. So this subgroup only represents about 20% of the total endocrine-resistant patient. However the results reported were positive relative to the control, providing further evidence of the critical role. The PICC-3CA pathway plays as a driver of disease and treatment in the eye of patients, in the Victoria 2 study for the CDK4-6 inhibitor.

Speaker Change: and the objective response rate was 79%.

Speaker Change: And these results compare very favorably to the results reported for Paulus Cyclopus let's resolve.

Speaker Change: in this population.

Speaker Change: Additionally, the ANOVA-120 study that evaluated in a illicit

Speaker Change: combined with polycyclic infelestrin in the endocrine-resistant patients reported positive data. Now these patients had tumors with PIK3CA mutations and the patients were not prediabetic or diabetic.

Brian Sullivan: Now these patients had tumors with PIC3CA mutations, and the patients were not pre-diabetic or diabetic. So this subgroup only represents about 20% of the total endocrine-resistant patient population. However, the results reported were positive relative to the control, providing further evidence of the critical role the PIC3CA pathway plays as a driver of disease in treatment-naive patients. In the Victoria II study for the CDK46 inhibitor, investigators might choose either ribocyclic or polycyclic. Safety profile of get-up to list of combined with polycyclic is well described, but the investigational combination of get-up to list of with ribocyclic is not yet been clinically tested.

Speaker Change: So this subgroup only represents about 20% of the total endocrine-resistant patient population.

Speaker Change: However, the results reported were positive relative to the control, providing further evidence of the critical role.

Speaker Change: The PICC-3CA pathway plays as a driver of disease in treatment of naive patients.

Speaker Change: Dr. Bancroft, Alexander Nowak

Speaker Change: In the Victoria 2 study for the CDK4-6 inhibitor,

Brian Sullivan: Investigators may choose either ribociclib or palbociclib. The Safety Profile of Geddes-Ellisib combined with Fulvestrin and Powicyclob is well described, but the investigational combination of Geddes-Ellisib with Rivasin has not yet been clinically tested. Therefore, the safety run-in of approximately 12 to 36 patients will evaluate the safety profile of Getatolizum combined with Raviciclib and Fulvestrum. Safety run-in will be completed, and Gatatilisib's Phase 3 dose with RawaCyc will be confirmed before enrolling patients in the Phase 3 portion of the study.

Speaker Change: Investigators might choose either ribociclib or palviciclib. Safety profile of getatelicib combined with fulvestrin and palviciclib is well described, but the investigational combination of getatelicib with ribociclib.

Brian Sullivan: And therefore, the safety run-in of approximately 12 to 36 patients will evaluate the safety profile of get-up to list of combined with ribocyclic infolestrant. Safety run-in will be completed and get-up to list of phase 3 dose with ribocyclic confirmed before enrolling patients in the phase 3 portion of the study. For this study, approximately 638 subjects will be assigned to a cohort based on the PIC3CA mutation status. After the investigator selects the CDK46 inhibitor for a subject, the subject will then be randomly assigned on a one-to-one basis to either be treated with get-up to list of full vestrant and either ribocyclic and polycyclic, or be assigned to an arm that treats patients with full vestrant and either ribo or palpo.

Speaker Change: has not yet been clinically tested and therefore a safety run-in of approximately 12 to 36 patients will evaluate the safety profile of Gedatolism combined with Raviciclib and Fulvestrin.

Speaker Change: Safety run-in will be completed and Gattatilisib's phase 3 dose with ribocyclic will be confirmed before enrolling patients in the phase 3 portion of the study.

Brian Sullivan: For this study, approximately 638 subjects will be assigned to a cohort based on the PIX-RCA, After the investigator selects the CDK46 inhibitor. For a subject, subject will then be randomly assigned on a one-to-one basis to either be treated with gadotilicib, fulvestrin, and either ribosaccharide. PowerCyclib, or be assigned to an arm, that treats patients with Fulvestrin and either Ribo.

Speaker Change: For this study, approximately 638 subjects will be assigned to a cohort based on their PIK3CA mutation status. After the investigator selects the CDK46 inhibitor,

Speaker Change: For a subject, the subject will then be randomly assigned on a one-to-one basis to either be treated with Gadotilicib, Fulvestrin, and either Ribocyclic and Powicyclic, or be assigned to an arm that treats patients with Fulvestrin and either Ribo or Powbo.

Brian Sullivan: The clinical trial primary endpoints are progression-free survival per recessed 1.1 criteria as assessed by blind independent sensual review. And the primary PFS endpoint for each of the two cohorts will be evaluated independently.

Brian Sullivan: The clinical trial primary endpoints are progression-free survival per RECIS 1.1 criteria as assessed by blind and independent sensory review. The primary PFS endpoint for each of the two cohorts will be evaluated independently. The study design was reviewed and discussed with the U.S. FDA during a Type C meeting in the first quarter, and then we've also just recently received feedback from the FDA on the study protocol as part of a Type D meeting, so we can now focus on our feasibility and site selection.

Speaker Change: The clinical trial primary endpoints are progression-free survival per RECIS 1.1 criteria as assessed by blind and independent central review.

Speaker Change: and the primary PFS endpoint for each of the two cohorts will be evaluated independently.

Brian Sullivan: The study design was reviewed and discussed with the US FDA during a Type C meeting in the first quarter, and then we've also just recently received feedback from the FDA on the study protocol as part of the Type D meeting, so we can now focus on our feasibility and site selection activities. We expect to activate roughly 200 clinical sites across North America, Europe, Latin America, and Asia, and we expect to enroll the first patient in the second quarter of 2025. We estimate that 15 to 20,000 patients with endocrine therapy-resistant advanced breast cancer are diagnosed each year in the United States alone.

Speaker Change: Studies design was reviewed and discussed with USFDA during a Type C meeting in the first quarter and then we've also just recently received feedback from the FDA on the study protocol as part of a Type D meeting so we can now focus on our feasibility and site selection activities.

Brian Sullivan: We expect to activate roughly 200 clinical sites across North America, Europe, Latin America, and Asia, and we expect to enroll the first patient in the second quarter of 2025. We estimate that 15 to 20,000 patients with endocrine therapy-resistant advanced breast cancer are diagnosed each year in the United States alone.

Speaker Change: We expect to activate roughly 200 clinical sites across North America, Europe, Latin America, and Asia, and we expect to enroll the first patient.

Speaker Change: and the second quarter of 2025.

Speaker Change: We estimate that 15 to 20,000 patients with endocrine therapy resistant advanced breast cancer are diagnosed each year in the United States alone. Since this population does not overlap with the patient population we're evaluating in our Victoria One study.

Brian Sullivan: Since this population does not overlap with the patient population we're evaluating in our Victoria I study, and approval to treat these patients would increase the size of the addressable US market potential forget it's elicit by up to $3 billion. Given the importance of developing a more efficacious therapeutic regimen for these patients and the scale of the financial app.

Brian Sullivan: This population does not overlap with the patient population we are evaluating in our Victoria One Study. An approval to treat these patients would increase the size of the addressable U.S. market potential for Gettatelicib by up to $3 billion. Given the importance of developing a more efficacious therapeutic regimen for these patients and the scale of the financial resources, we decided it was important to proceed as quickly as possible to initiate a phase three study for the Spatian Pop to accomplish this.

Speaker Change: and approval to treat these patients would increase the size of the addressable U.S. market potential forget it's a list of five up to three billion dollars.

Speaker Change: Given the importance of developing a more efficacious therapeutic regimen for these patients and the scale of the financial opportunity.

Brian Sullivan: We decided it was important to proceed as quickly as possible to initiate a phase three study for this patient population. To accomplish this, we needed to strengthen our balance sheet, which we did this quarter when we raised $129 million gross proceeds from equity and debt offerings.

Speaker Change: We decided it was important to proceed as quickly as possible to initiate a phase 3 study for this patient population.

Brian Sullivan: We needed to strengthen our balance sheet, which we did this quarter when we raised $129 million gross proceeds from equity and debt offerings, by initiating this trial now, 12 months earlier than we would have been able to do so without this funding. We estimate we added over $1 billion to the net present value of the potential revenue stream from this indication.

Speaker Change: to accomplish this.

Speaker Change: We needed to strengthen our balance sheet, which we did this quarter when we raised $129 million gross proceeds from equity and debt offerings.

Speaker Change: by initiating this trial now, 12 months earlier than we would have been able to do so without this financing.

Speaker Change: We estimate we added over $1 billion to the net present value of the potential revenue stream from this indication.

Brian Sullivan: I'd like to turn now to our phase one B2 trial that's evaluating the safety and efficacy of get a list of in combination with Daralutamide and energy and receptor inhibitor in patients with metastatic castration resistant prostate cancer. Study does its first patient in February of this year, and enrollments on track. We continue to expect to report preliminary data in the first half of 2025.

Brian Sullivan: I'd like to turn now to our Phase 1B2 trial that's evaluating the safety and efficacy of getatelizumab in combination with darolutamide, an androgen receptor inhibitor, and patients with metastatic castration-resistant prostate, study-dosed its first patient in February of this year, and Enrollments on Track. We continue to expect to report preliminary data in the first half of 2025. We're also pleased that our non-clinical research describing getatolysibs activity in different tumor types was recently published in two leading journals.

Speaker Change: I'd like to turn now to our Phase 1B2 trial that's evaluating the safety and efficacy of getatelizumab in combination with darolutamide, an androgen receptor inhibitor.

Speaker Change: and patients with metastatic castration-resistant prostate cancer.

Speaker Change: Study dosed its first patient in February of this year.

Speaker Change: and Enrollments on Track. We continue to expect to report preliminary data in the first half of 2025.

Brian Sullivan: We're also pleased that our non-clinical research describing get a list of activity in different tumor types was recently published in two leading journals in June. Nature Breast Cancer published results from various in vitro and in vivo studies we conducted that compared get a list of activity and several approved single node PI3K, AKT, MTOR, or PAM inhibitors in various breast cancer models. In August, Molecular Oncology published results of similar studies in prostate cancer models. Both sets of studies demonstrated the get a list of exhibited more potent and cytotoxic effects compared to the single node PAM inhibitors, regardless of the PAM pathway mutational status of the cell lines.

Speaker Change: We're also pleased that our non-clinical research describing data-to-lists activity in different tumor types.

Brian Sullivan: In June, Nature Breast Cancer published results from various in vitro and in vivo studies we conducted that compared getatolysibs activity in several approved single-node PI3K, AKT, mTOR, or PAM inhibitors in various breast cancer, and in August, Molecular Oncology published results of similar studies in prostate cancer. Both sets of studies demonstrated that getatolisib exhibited more potent and cytotoxic effects compared to the single-node PAM inhibitors, regardless of, Japan Pathway Mutational Status of the Cell Lines.

Speaker Change: Both recently published in two leading journals in June , Nature Breast Cancer, published results from various in vitro and in vivo studies we conducted that compared get-its-less abjectivity and several approved single-node PI3K, AKT, MTOR, or PAM inhibitors in various breast cancer models.

Speaker Change: And in August , Molecular Oncology published results of similar studies in prostate cancer models.

Speaker Change: Both sets of studies demonstrated the catalyst of exhibited more potent and cytotoxic effects compared to the single-node PAM inhibitors regardless of

Brian Sullivan: And these results indicate that inhibition of multiple PAM pathway nodes by a PAM piece PI3K, MTOR inhibitor like get a list of more effective at inducing any tumor activity and single node PAM inhibitors in vitro and animal models.

Brian Sullivan: And these results indicate that inhibition of multiple PAM pathway nodes by a PAM-P PI3K mTOR inhibitor, like gaditolis, is more effective at inducing any tumor activity than single node PAM inhibitors in vitro. Overall, it was a very busy and productive quarter; I am very pleased with the progress we made.

Speaker Change: the PAM pathway mutational status of the cell lines.

Speaker Change: and these results indicate that inhibition of multiple PAM pathway nodes by a PAM-P PI3K mTOR inhibitor like gaditolisib.

Speaker Change: That's more effective at inducing antitumor activity than single node PAM inhibitors in vitro and in animal models.

Brian Sullivan: Overall, it was a very busy and productive quarter. Very pleased of the progress we made.

Speaker Change: Overall, it was a very busy and productive quarter, I'm very pleased with the progress we made. I'd like now to turn the call over to Vicky, who will review our finances.

Vicky Hahne: I'd like now to turn the call over to Vicki, who will review our finances. Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter 2024. Our second quarter net loss was 23.7 million, or 62 cents per share, compared to 14.6 million net loss, or 66 cents per share, for the second quarter of 23. Because these quarterly net loss losses include significant non-cash items including stock-based compensation and interest. We also included in our press release non-GAAP adjusted net loss for the quarter ending June 30th, 2024. Our non-GAAP adjusted net loss was 22.2 million or 58 cents per share for the second quarter of 24 compared to non-GAAP adjusted net loss of 11.1 million or 51 cents per share for the second quarter of 23.

Vicky Hahne: I'd like now to turn the call over to Vicky, who will review our... Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2024. Our second quarter net loss was 23.7 million, or 62 cents per share, compared to 14.6 million net loss, or 66 cents per share, for the second quarter of. Because these quarterly net losses include significant non-cash items, including stock-based compensation and interest, we also included in our press release a non-gap adjusted net loss for Our non-GAAP-adjusted net loss was $22.2 million, or $0.58 per share, for the second quarter of 2004, compared to a non-GAAP-adjusted net loss of $11.1 million, or $0.51 per share, for the second quarter of 2003.

Vicky Hahne: Research and development expenses were $22.5 million for the second quarter of 2024, compared to $13.8 million for the same period in 2023. Of the approximately $8.7 million increase in R&D expenses, $6.6 million primarily related to activities supporting the Victoria 1 Phase 3 trial and the initiation of the Phase 1b2 prostate trial, and $2.1 million was related to increased employee and consulting expenses. General and Administrative Expenses were $1.8 million for the second quarter of 2004 compared to $1.3 million for the second quarter of 2003.

Vicky Hahne: Employee and consulting related expenses accounted for 0.3 million of the income. Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million. Net cash used in operating activities for the second quarter of 24 was $18.1 million compared to $9.7 million for the second quarter of 20.

Speaker Change: Hey, what are you doing?

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter 2024.

Vicky Hahne: Our second quarter net loss was $23.7 million, or $0.62 per share, compared to $14.6 million net loss, or $0.66 per share, for the second quarter of 2023.

Speaker Change: Because these quarterly net losses include significant non-cash items, including stock-based compensation and interest, we also included in our press release non-gap adjusted net loss for the quarter ending June 30, 2024.

Speaker Change: Our non-GAAP-adjusted net loss was $22.2 million, or $0.58 per share, for the second quarter of 2004, compared to non-GAAP-adjusted net loss of $11.1 million, or $0.51 per share, for the second quarter of 2003.

Vicky Hahne: Research and development expenses were 22.5 million for the second quarter of 24 compared to 13.8 million for the same period in 2023. Of the approximately 8.7 million increase in R&D expenses, 6.6 million primarily related to activities supporting the Victoria I Phase III trial and the initiation of the Phase I B to prostate trial. And 2.1 million was related to increased employee and consulting experience. General and administrative expenses were 1.8 million for the second quarter of 24, compared to 1.3 million for the second quarter of 23. Employee and consulting-related expenses accounted for 0.3 million of the increase.

Speaker Change: Research and development expenses were $22.5 million for the second quarter of 2004 compared to $13.8 million for the same period in 2023. Of the approximately $8.7 million increase in R&D expenses,

Speaker Change: $6.6 million primarily related to activities supporting the Victoria 1 Phase 3 trial and the initiation of the Phase 1B2 prostate trial. And $2.1 million was related to increased employee and consulting expenses.

Speaker Change: General and administrative expenses were $1.8 million for the second quarter of 24 compared to $1.3 million for the second quarter of 23. Employee and consulting related expenses accounted for $0.3 million of the increase.

Vicky Hahne: Professional fees and other administrative expenses accounted for the remaining increase of approximately 0.2 million. Netcatch used in operating activities for the second quarter of 24 was 18.1 million compared to 9.7 million for the second quarter of 23. We ended the quarter with approximately 283.1 million in cash, cash equivalence, and short term investments compared to 180.6 million at December 31, 2023. The increase of approximately 102 million in cash and cash equivalence and short term investments was the result of several financing activities that occurred in the first half of 2024 and yielded net proceeds of 137.5 million.

Speaker Change: Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million.

Speaker Change: Netcatch used in operating activities for the second quarter of 24 was 18.1 million compared to 9.7 million for the second quarter of 23.

Vicky Hahne: We ended the quarter with approximately $283.1 million in cash, cash equivalents, and short-term investments, compared to $180.6 million at December 31, 2020. The increase of approximately $102 million in cash and cash equivalents and short-term investments was the result of several financing activities that occurred in the first half of 2024 and yielded net proceeds of $137.5 million. We closed on two financing activities in May, resulting in gross proceeds of $122 million and net proceeds of $115.5 million.

Speaker Change: We ended the quarter with approximately $283.1 million in cash, cash equivalents, and short-term investments, compared to $180.6 million at December 31, 2023.

Speaker Change: The increase of approximately $102 million

Vicky Hahne: The first activity was an equity financing resulting in $60 million of gross proceeds with net proceeds of $56.3 million. The second activity was a debt offering resulting in gross proceeds of $61.7 million with net proceeds of $59.3 million. Additional financing activities in the first half of the year resulted from warrant exercises of $14.2 million, accessing our at-the-market offering of $7.3 million, and stock option exercises and employee stock purchases of $0.5 million. The $137.5 million was offset by year-to-date operating cash use of $35.1 million.

Speaker Change: In cash and cash equivalents and short-term investments was the result of several financing activities that occurred in the first half of 2024 and yielded net proceeds of $137.5 million.

Operator: All Results Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session.

Vicky Hahne: We closed on two financing activities in May, resulting in gross proceeds of 122 million and net proceeds of 115.5 million. The first activity was an equity financing resulting in 60 million of gross proceeds with net proceeds of 56.3 million. The second activity was a debt offering resulting in gross proceeds of 61.7 million, with net proceeds of 59.2. Additional financing activities in the first half of the year resulted from more and exercises of 14.2 million. Accessing are at the market offering of 7.3 million and stock option exercises and play stack purchases of 0.5 million. The 137.5 million was offset by year-to-date operating cash used of 35.1 million.

Operator: If at any time during this call you require immediate assistance, please press tar zero for the operator. This call is being recorded today August 14th, 2024.

Speaker Change: We closed on two financing activities in May, resulting in gross proceeds of $122 million and net proceeds of $115.5 million.

Maria Yonkoski: I would now like to turn the conference over to Maria Yonkoski with ICR Westwick. Please go ahead.

Speaker Change: The first activity was an equity financing resulting in 60 million of gross proceeds.

Maria Yonkoski: Thank you operator. And good afternoon to everyone on the call. Thank you for joining us to review Celcuity's second quarter, 2024 Financial Results and Business Update. Earlier today, Celcuity released financial results for the second quarter ending June 30th, 2024. The press release can be found on the investor's section of the website.

Speaker Change: with net proceeds of $56.3 million. The second activity was a debt offering resulting in gross proceeds of $61.7 million with net proceeds of $59.2.

Speaker Change: Additional financing activities in the first half of the year resulted from Warren exercises of $14.2 million, accessing our at-the-market offering of $7.3 million, and stock option exercises and employee stock purchases of $0.5 million.

Maria Yonkoski: 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 Gorbachevsky, Chief Medical Officer who will be available during Q&A.

Speaker Change: The $137.5 million was offset by year-to-date operating cashews of $35.1 million. I will now hand the call back to Brian .

Vicky Hahne: I will now hand the call back to Brian. Thank you, Vicki.

Brian Sullivan: I will now hand the call back to Brian. Thank you, Vicky. Operator, could you please open the call for questions? Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number 2. If you are using a speakerphone, please make sure to lift the handset before pressing any keys.

Maria Yonkoski: Before 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 or results may defer 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 defer materially from those projected.

Operator: Operator, could you please open the call for questions? Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the number one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speaker phone, please make sure to lift the headset before pressing any keys.

Brian Sullivan: Thank you, Vicky. Operator, could you please open the call for questions?

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number 1 on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number 2.

Speaker Change: If you are using a speaker phone, please make sure to lift the handset before pressing any keys.

Maury Recruft: Your first question comes from the line of Maury Recruft from Jeffries. The line is not open.

Operator: Your first question comes from the line of Maurice Raycroft from Jeffreys, your line is now open. Hi, thanks for taking my question. Just checking on the enrollment, I appreciate that the timeline is moving a little bit. Based on the shift in proportion of wild type and mutant populations, Is it possible that the wild-type and mutant readouts could happen at the same time?

Speaker Change: Your first question comes from the line of Maury Raycroft from Jeffries. Your line is now open.

Maria Yonkoski: On this call, we will also refer to non-gap financial measures. These non-gap 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-gap 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-gap financial measures to gap measures in today's press release.

Maury Recruft: Hi, thanks for taking my question. Just checking on the enrollment. I appreciate that the timeline is moving a little bit.

Brian Sullivan: Or are you confident that the wild-type and mutant readouts will be staggered? And secondly, is it fair to assume you'll do another update on enrollment in fourth quarter and provide more specifics on the plan for the readout at that point? Thanks, Maury, and thanks for your question.

Speaker Change: Hi, thanks for taking my question. Just checking on the enrollment, I appreciate that the timeline is moving a little bit. Based on the shift in proportion of wild type mutant populations,

Brian Sullivan: Based on the shift in proportion of wild type and mutant populations, is it possible that the wild type and mutant readouts could happen at the same time, or are you confident that the wild type and mutant readouts will be staggered? And secondly, if fair to assume you'll do another update on enrollment in fourth quarter and provide more specifics on the plan for the readout at that point.

Speaker Change: Is it possible that the wild-type and mutant readouts could happen at the same time, or are you confident that the wild-type and mutant readouts will be staggered?

Speaker Change: And secondly, is it fair to assume you'll do another update on enrollment in fourth quarter and provide more specifics on the plan for the readout at that point?

Brian Sullivan: And with that, I would now like to turn the call over to Brian Sullivan, CEO of CellCuity. Please go ahead. Thank you, Maria, and good afternoon everyone. We appreciate your interest in CellCuity. We made significant strides advancing the clinical development of GEDA to list of this quarter. Over on-rollment in Victoria 1, our phase 3 study evaluating GEDA to list a plus full of estrogen, within without palbacic libous second line treatment for patients with HR positive, her 2 negative advanced breast cancer, remains robust and on track.

Brian Sullivan: Bill, thanks; Murray, and thanks for your question. As far as the timing of announcement of results for mutated, we're maintaining our guidance that we would expect to have those results available sometime in the first half. We're enrolling the same number of patients in each cohort of the studies, wild type versus mutant, and 40% of the patients are mutated, so that enrollment period will take longer to come back.

Brian Sullivan: As far as the timing of the announcement of results for Mutated, we're maintaining our guidance that we would expect to have those results available sometime in the first half. We're enrolling the same number of patients in each cohort of the studies, wild type versus mutant. 40% of the patients are mutated, so that enrollment period will take longer to complete, albeit a little bit sooner than we originally planned because of the higher proportion of mutated patients.

Speaker Change: Thanks, Maury, and thanks for your question. As far as the timing of announcement of results for mutated, we're maintaining our guidance that we would expect to have.

Speaker Change: those results available sometime in the first half. We're enrolling the same number of patients in each cohort of the studies, wild-type versus mutant, and

Speaker Change: 40% of the patients are mutated, so that enrollment period will take longer to complete, albeit a little bit sooner than we originally planned because of the higher proportion of mutated patients. But we're not changing our guidance at this time.

Brian Sullivan: I'll be it a little bit sooner, and we originally planned because of the higher proportion of mutated patients, but we're not changing our guidance at this time. And as far as updating enrollment, we'll continue to update guidance as we have every quarter on when we expect to report top-line results.

Brian Sullivan: Our phase 1 B2 trial evaluating patients with metastatic castration resistant prostate cancer is also enrolling on schedule. And we further expanded the patient population eligible for GEDA to list when we initiated efforts to launch Victoria 2. Phase 3 study designed to evaluate GEDA to list as a first line treatment option for patients with HR positive, her 2 negative advanced breast cancer. In our view, each of these 3 programs has the potential to generate blockbuster levels of revenue. If these 3 programs ultimately result in regulatory approvals. We estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with ghetto solicit.

Brian Sullivan: But we're not changing our guidance at this time. And as far as updating enrollment, you know, we'll continue to update guidance as we have every quarter on when we expect to report top-line results. Okay, makes sense.

Speaker Change: Unknown Attendee, Vicky Hahne, Maria Yonkoski

Maury Recruft: Okay, make sense.

Brian Sullivan: And then for Victoria 2 in the frontline setting, can you talk more about the safety run-in with the 12 to 36 patients? Why is there such a range of patients that you could enroll? And are you assessing any variations with the dosing strategy, and how long will you have to treat these? I'll give you an initial high-level summary, and then Igor could maybe fill in the blanks.

Brian Sullivan: And then for Victoria, too, in the front line setting, can you talk more about the safety run-in with the 12 to 36 patients? Why is there a range of patients that you can enroll? Are you assessing any variations with dosing strategy and how long we have to treat these patients?

Speaker Change: Okay, makes sense. And then for Victoria 2 in the frontline setting, can you talk more about the safety run-in with the 12 to 36 patients? Why is there a range of patients that you can enroll? And are you assessing any variations with dosing strategy and how long will you have to treat these patients?

Brian Sullivan: I'll give you an initial high-level summary, and then Igor could maybe fill in the blanks. Essentially, the study is designed to evaluate, if needed, various dose levels of ghetto-to-lissib to find the phase three dose. If we don't need to reduce the dose of ghetto-to-lissib in the first cohort of patients that we're evaluating, then we'll be able to proceed with the data from that group of 12 patients. And then subsequently, if we find that we need to dose reduce ghetto, we would enroll in other 12 patients and do the same thing again if we had to enroll in other 12 patients.

Brian Sullivan: We first announced our plans to conduct the Fractorial One study over two years ago in May 2022. At that time, we estimated that 65% of the patients enrolled would lack detectable PIC-3CA mutations and would thus be assigned to the studies PIC-3CA wild type cohort. And this assumption was used to estimate enrollment by cohort and in turn the timing of events for primary analysis. We estimated that the threshold number of events required to trigger the primary analysis for this PIC-3CA wild type cohort of patients would be reached in the second half of 2024.

Igor: I'll give you an initial high-level summary and then Igor could maybe fill in the blanks.

Brian Sullivan: Essentially, the study is designed to evaluate, if needed, various dose levels of getatelicib to find the phase III dose. If we don't need to reduce the dose of getatelicib in the first cohort of patients that we're evaluating, then we'll be able to proceed with the data from that group of 12 patients. And then subsequently, if we find that we need to dose-reduce geta, we would enroll another 12 patients, do the same thing again if we had to, and enroll another 12 patients.

Brian Sullivan: And while the study's overall enrollment remains on track in robust relative to the estimate we made over two years ago, a total proportion of patients enrolled who have PIC-3CA wild type tumors has recently shifted lower. We now project that 60% of the patients enrolled in the study will be enrolled in the PIC-3CA wild type cohort rather than the 65% originally estimated. And this proportion, while lower than our original estimate, is within the range reported in other studies.

Igor: Essentially, the study is designed to evaluate, if needed,

Igor: various dose levels of getatelicib to find the phase 3 dose.

Speaker Change: If

Speaker Change: Unknown Attendee, Vicky Hahne, Maria Yonkoski

Speaker Change: group of 12 patients. And then subsequently, if we we find that we need to dose reduce get up, we would enroll another 12 patients and

Brian Sullivan: And thus, we don't believe this shift is study related, but simply a result of normal sample variation within a population. Despite the lower proportion of PIC-3CA wild type patients completed, enrollment for the PIC-3CA wild type cohort is over 80% complete. We expect to reach the enrollment target for the PIC-3CA wild type cohort during the fourth quarter rather than the end of the third quarter as we originally forecast. We now expect the primary analysis of end threshold trigger for the PIC-3CA wild type cohort.

Brian Sullivan: So essentially, you know, depending on what the results and the outcome of that of each cohort or one cohort will or may or may not lead you to enroll additional patients. As far as the thresholds, I mean, it's a standard safety run and design.

Igor Gorbatchevsky: So essentially, depending on what the results in the outcome of each cohort or one cohort may or may not lead you to enroll additional patients. As far as the thresholds, I mean, it's a standard safety run-in design.

Speaker Change: You know, do the same thing again if we had to, and enroll another 12 patients. So essentially, you know, depending on what the results and the outcome of that, of each cohort or one cohort will

Igor: or may or may not lead you to enroll additional patients. As far as the thresholds, I mean, it's a standard safety run and design. Igor, maybe you could provide a little bit more color on that question.

Igor Gorbatchevsky: Igor, maybe you could provide a little bit more color on that question.

Igor Gorbachevsky: Igor, maybe you could provide a little bit more color on that question. Thank you, Brian. As Brian pointed out, it's very straightforward, safety running.

Igor Gorbatchevsky: Thank you, Brian. As Brian pointed, it's very straightforward safety running. Three dose levels will be tested, 12 subjects for each dose level, and DLT will be assessed after one cycle of treatment is completed. It's a very safe and straightforward design that has been discussed with regulators and agreed upon.

Igor: Thank you, Brian . As Brian pointed, it's very straightforward safety running. Three dose level will be tested, 12 subject for each dose level, and DLT will be assessed after one cycle of treatment is completed.

Igor Gorbachevsky: Three dose levels will be tested, 12 subjects for each dose level, and DLT will be assessed after one cycle of treatment is completed. It's a very... safe and straightforward design that has been discussed and agreed upon, and to Brian's point, the decision about the initiation of a randomized phase 3 study could be done as early as completion of initial co-work.

Igor: It's a very, uh...

Speaker Change: This is a safe and straightforward design that has been discussed with regulators and agreed upon. To Brian's point, the decision about initiation of randomized phase 3 study could be done as early as the completion of the Initial Cohort 12 Subject.

Brian Sullivan: And to Brian's point, the decision about initiation over under my C-3 study could be done as early as completion of initial cohort 12 subjects. Got it.

Brian Sullivan: We'll be reached sometime between late Q424 and the end of Q1 2025. Our guidance regarding the PIC-3CA mutant patients of group remains unchanged and we expect primary analysis for this cohort to be triggered during the first half of 2025.

Brian Sullivan: Okay, thanks for taking my questions. You're welcome. Your next question comes from the line of Tara Bancroft from TD Cowen. Your line is now open.

Maury Recruft: Okay. Thanks for taking my questions. You're welcome.

Speaker Change: Got it. Okay. Thanks for taking my questions. You're welcome.

Tara Bancroft: Your next question comes from the line of paragraph, Bancroft from TD Cohen. Your line is now open.

Brian Sullivan: Turning now to our Victoria 2 study, we announce our plans to initiate this phase-3 clinical trial this past May. Study will evaluate, get a list of plus a CDK-46 inhibitor and full vestrine, as first line treatment for patients with HR-positive, virtue-negative, advanced breast cancer, whose disease occurs while receiving or within 12 months of completing adjuvant endocrintherapy. All these patients are considered to have endocrintherapy resistant disease, and they have a significantly poorer prognosis than endocrintherapy's sensitive patients whose disease occurs more than 12 months after completing their adjuvant endocrintherapy.

Speaker Change: Your next question comes from the line of Tara Bancroft from TD Cowen, your line is now open.

Tara Bancroft: Hi, good afternoon. I was hoping you could tell us exactly what you're seeing now for the percentage of the split of wildpeg versus mutant that you think you're observing now versus what your previous expectations were. And also just the point of clarification: by target enrollment, you mean completion, right? Right. There's always variation. You may have patients in screening at the end of a period and enroll additional patients just because you can't not enroll patients that you've potentially already approved the screen once you hit that target. But completed enrollment is correct. So we were at 65% at the end of 23.

Tara Bancroft: Hi, good afternoon. I was hoping you could tell us exactly what you're seeing now for the percentage of the split of wild type versus mutant that you think you're observing now versus what your previous expectations were and also just a point of clarification: by target enrollment, you mean completion right right right. There's always variation. You may have patients in screening at the end of a period and enroll additional patients just because you can't, you know, not enroll patients that you've potentially already approved to screen once you hit that target. But completed enrollment is correct. So we were at 65% at the end of 23.

Speaker Change: Hi, good afternoon. I was hoping you could tell us,

Tara Bancroft: exactly what what you're seeing now for the percentage of the split of wild-type versus mutant that you think you're observing now versus what your previous expectations were and also just a point of clarification by target enrollment you you mean completion right right right

Speaker Change: There's always variation. You may have patients in screening at the end of a period and enroll additional patients just because you can't, you know, not enroll patients that you've potentially already.

Brian Sullivan: Current standard of care for first line treatment for endocrintherapy resistant patients includes any of the three approved CDK-46 inhibitors combined with full vestrine. Delimited efficacy, these regimens offer endocrintherapy resistant patients though, was not well understood until the end of O120 study, phase-3 clinical trial for the PIC-3K alpha inhibitor in a listed reported results last December. As part of this trial, the efficacy of standard of care, polycyclic, and full vestrine was evaluated as first line treatment in patients who were resistant to endocrintherapy.

Speaker Change: Approved to screen once you hit that target but but completed enrollment is correct. So we were at 65% at the end of 23 and so over the course of 23 you'd see fluctuations month-to-month which is

Brian Sullivan: And so, over the course of 23, you'd see fluctuations month to month, which is kind of expected; fluctuations are normal. So again, we were cautious in interpreting variation, but because we ended the year, the target number we had set in May 22, nearly 18 months prior. We thought that estimate was solid and what we would continue. Once we hit 80% enrollment, which we did recently, of the wild type cohort, and we were at 60%. We just decided that we should update our forecast to the current ratio, cumulative ratio, which is 60%. Okay, great.

Brian Sullivan: And so over the course of 23, you'd see fluctuations month-to-month, which Unknown Attendee, Swayampakula Ramakanth, Boris Peaker, Vicky Hahne, Sara Hurvitz, nearly 18 months prior, you know, we thought that that estimate was solid and what we would continue. Once we hit 80% enrollment, which we did recently, of the wild-type cohort, and we were at 60%, we just decided that we should update our forecast to the current cumulative ratio, which is 60%. Okay, great. And then, so I guess late Q4 for potentially meeting the event timeline, that would potentially fit into the San Antonio conference timeline. Is this still maybe what you're primarily hoping for?

Speaker Change: kind of expected fluctuations in Rommel. So, again, we were cautious in interpreting variation, but because we demanded the year, the target number we had set in May 22, you know.

Neil: Nearly 18 months prior, you know, we thought that that estimate was solid and what we would continue.

Brian Sullivan: For these patients, median PFS was only 7.3 months, and for those patients whose disease relapsed within the first two years of their adjuvant endocrintherapy, the median PFS was only 3.7 months. And these results compare poorly to the median PFS of 27 months reported for patients who are sensitive to endocrintherapy and who receive the same regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrintherapy.

Speaker Change: Once we hit 80% enrollment, which we did recently, the wild type cohort, and we were at 60%, we just decided that we should update our forecast to the current ratio, cumulative ratio, which is 60%.

Tara Bancroft: And then, so I guess late Q4 for potentially meeting the event timeline, that would potentially fit into the San Antonio conference timeline.

Speaker Change: Okay, great. And then, so I guess late Q4.

Brian Sullivan: Because I know that the abstract deadline passed early to mid-July. So did you submit an abstract or plan on presenting there? So we haven't, yeah, we aren't going to until we get it, I have an announcement to make about the data. We aren't really going to go into details about what venue we'll be reporting that data, and it's going to be very situational depending on the timing and relative to the next most relevant meeting.

Speaker Change: for potentially meeting the event timeline.

Brian Sullivan: We reported last year the preliminary clinical data from our Phase I B trial for get-up to list as first line treatment in patients with advanced breast cancer. As you may recall, the median progression for survival in endoconsensitive patients were treatment naive and were treated with get-up to list of in combination with polycyclic and let result was 48.6 months and the objective response rate was 79%. And these results compare very favorably to the results reported for polycyclic plus let result in this population.

Brian Sullivan: Is this, is this still maybe what you're primarily hoping for? If I know that the abstract deadline passed early to mid July. So, did you submit an abstract or plan on presenting now?

Speaker Change: Unknown Attendee, Vicky Hahne, Maria Yonkoski

Brian Sullivan: So we haven't, yeah, we aren't going to, until we get having an announcement to make about the data, we aren't really going to go into details about what venue will be reporting that data. And it's going to be a very situational, depending on the timing and relative to the next most relevant meeting. And so, once the data is available, we'll report the top line as soon as we have it. And then we'll provide guidance on when we would go into more detail at a meeting or go into some detail in the announcement press release.

Speaker Change: Did you submit an abstract or plan on presenting there?

Speaker Change: So we haven't, yeah, we aren't going to, until we get...

Speaker Change: have an announcement to make about the data. We aren't really going to go into details about what venue we'll be reporting that data in. It's going to be very situational, depending on the timing and relative to, you know, the next most relevant meeting.

Brian Sullivan: Additionally, the NVO 120 study that evaluated in a velocity combined with polycyclic infolestrant in the endocrine resistant patients reported positive data. Now these patients had tumors with PIC3C amutations and the patients were not pre-diabetic or diabetic. So this subgroup only represents about 20% of the total endocrine resistant patient population. However, the results reported were positive relative to the control providing further evidence of the critical role the PIC3C A pathway plays as a driver of disease in treatment naive patients.

Brian Sullivan: And so once the data is available, we'll report the top line, as soon as we have it, and then we'll provide guidance on when we would go into more detail a lot of meeting or go into some detail in the announcement. Pressure.

Speaker Change: And so once once the data is available, we'll report the top line.

Speaker Change: As soon as we have it, and then we'll provide guidance on when we would go into more detail at a meeting or go into some detail in the announcement press release.

Tara Bancroft: Okay, great. Thanks so much for taking the questions.

Brian Sullivan: Okay, great. Thanks so much for taking the questions. You're welcome. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star followed by the number one on your touchtone phone. And if you're using a speakerphone, please make sure to lift the handset before pressing any key.

Tara Bancroft: You're welcome.

Speaker Change: Okay, great. Thanks so much for taking the questions. You're welcome.

Operator: Ladies and gentlemen, just a reminder: if you would like to ask a question, please press tar followed by the number one on your touch-tone phone. And if you're using a speaker phone, please make sure to lift the handset before pressing any keys.

Speaker Change: Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star followed by the number one on your touchtone phone.

Brian Sullivan: In the Victoria II study for the CDK-46 inhibitor, investigators might use either ribocyclic or polycyclic. Safety profile of get-up to list of combined with polycyclic and polycyclic is well described, but the investigational combination of get-up to list of with ribocyclic is not yet been clinically tested. And therefore, the safety run-in of approximately 12 to 36 patients will evaluate the safety profile of get-up to list of combined with ribocyclic infolestrant. Safety run-in will be completed and get-up to list of phase 3 dose with ribocyclic confirmed before enrolling patients in the phase 3 portion of the study.

Speaker Change: And if you're using a speakerphone, please make sure to lift the handset before pressing any keys.

Brad Canino: Your next question comes from the line of Brad Canino from Stifel. Your line is now open.

Operator: Your next question comes from the line of Brad Canino from Stiefel, the line is now open. Hi, thanks for taking the question. Brian, I just wondered, can you talk about how the potential forthcoming approval of Roche's intervals factors into your clinical and regulatory strategy for frontline, at least for the proportion who will have the mutations? And also, how important is the ultimate label outcome around the metabolic parameter eligibility as you think about this? Thank you. I'm not sure I understand your question regarding... Anna Velysov, as it relates to us, are you asking that question about how that might affect our first line study? Yeah, Brad.

Speaker Change: Your next question comes from the line of Brad Canino from Stiefel. The line is now open.

Brad Canino: I think you're taking the question. Brian, I just want to, can you talk about how the potential forthcoming approval of Roche's intervals of factors into your clinical and regulatory strategy for frontline, at least for the proportions who will have the mutations, and also how important is the ultimate label outcome around the metabolic parameter eligibility as you think about this. Thank you.

Speaker Change: Hi, thanks for taking the question. Brian , I just wondered, can you talk about how the potential forthcoming approval of Roche's intervals factors into your clinical and regulatory strategy for frontline, at least for the proportion who will have the mutations?

Brad Canino: and also how important is the ultimate label outcome around the metabolic parameter eligibility as you think about this. Thank you.

Brian Sullivan: I'm not sure I understand. Your question regarding the interval as it relates to us, are you asking that question about how that might affect our first line study? Yeah, Brad. We don't think it will, because they're only evaluated, you know, patient. who A. Had to pick through the amutation, but B. We're not prediabetic or diabetic, which, depending on the estimates, you can narrow that indication down to 50% of the mutated population. So it really is not a drug that could fully treat the indicated population, which is woman who have endocrine resistant disease. And as a result, when we've reviewed this information and with the FDA in several settings, so we're confident in our design and that that's what we'll be evaluating.

Brian Sullivan: For this study, approximately 638 subjects will be assigned to a cohort based on the PIC3C A mutation status. After the investigator selects the CDK-46 inhibitor for a subject, subject will then be randomly assigned on a one-to-one basis to either be treated with get-up to list of infolestrant and either ribocyclic and polycyclic or be assigned to an arm that treats patients with infolestrant and either ribo or palpo. The clinical trial primary endpoints are progression-free survival per recessed one-to-one criteria as assessed by blind and independent sensual review.

Speaker Change: I'm not sure I understand your question regarding...

Speaker Change: Unknown Attendee, Vicky Hahne, Maria Yonkoski

Brian Sullivan: We don't think it will because, you know, they're only evaluated, you know, patients, who A, had the PIK3CA mutation, but B, were not pre-diabetic or diabetic, which, Depending on the estimates, you can, narrow that indication down to 50% of the mutated population. So it really is not a drug that could fully treat the indicated population, which is women who have endocrine-resistant disease. And as a result, when we've reviewed this information, [inaudible] with the FDA in several settings. So we're confident in our design and that's what we'll be evaluating. So we don't think that data will affect us. It provides, we think, validation of what we're doing.

Speaker Change: Yeah, right. We don't think it will because, you know, they're only evaluated, you know, patients.

Speaker Change: who A, had the PIK3CA mutation, but B, were didn't have, were not pre-diabetic or diabetic, which.

Speaker Change: depending on the estimates you can

Brian Sullivan: And the primary PFS endpoint for each of the two cohorts will be evaluated independently. Study design was reviewed and discussed with the US FDA during a Type-C meeting in the first quarter. And then we've also just recently received feedback from the FDA on the study protocol as part of the Type-D meeting so we can now focus on our feasibility and site selection activities. We expect to activate roughly 200 clinical sites across North America, Europe, Latin American, Asia.

Speaker Change: narrow that indication down to 50% of the mutated population. So it really is not a drug that could fully treat the indicated population, which is women who have endocrine-resistant disease.

Speaker Change: And as a result, you know, we're when we've reviewed this information and with the FDA in several settings, so we're confident in our design and that's what we'll be evaluating. So we don't think that data will affect us. It provides, we think,

Brian Sullivan: So we don't think that data will affect us. It provides, we think, validation of what we're doing. They showed in that population that the pathways involved in the vision of that pathway can induce a meaningful treatment benefit. As far as what's on the label, the drug hasn't tested in patients without the strict limitations used in this most recent study, the interval 120. I think the eligibility criteria were informed by the results in that study. And if I recall correctly, from data they reported, I think, in 2021, where patients may have had a cut off of A1C similar to Alpilipsib.

Brian Sullivan: And we expect to enroll the first patient in the second quarter of 2025. We estimate that 15 to 20,000 patients with endocrine therapy resistant events breast cancer are diagnosed each year in the United States alone. Since this population does not overlap with the patient population we're evaluating in our Victoria I study and approval to treat these patients would increase the size of the addressable US market potential forget it's elicit by up to $3 billion.

Brian Sullivan: They showed in that population that the pathways involved and inhibition of that pathway can induce a meaningful treatment. As far as what's on the label, you know, the drug had been tested in patients without the strict limitations used in this most recent study, the Inovo 120. I think the eligibility criteria were informed by the results in that study. And if I recall correctly, you know, from from data they reported, I think in 2021, You know, we're, we're patient, may have had a cutoff of A1C similar to Alpalypsin.

Speaker Change: validation of what we're doing. They showed in that population that the pathways involved and inhibition of that pathway can induce a meaningful treatment benefit.

Speaker Change: As far as what's on the label,

Speaker Change: The drug had been tested in patients without the strict

Speaker Change: limitations used in this most recent study, the Innovo 120. I think the eligibility criteria were informed by the results in that study.

Brian Sullivan: Given the importance of developing a more efficacious therapeutic regimen for these patients and the scale of the financial app. Opportunity. We decided it was important to proceed as quickly as possible to initiate a phase three study for this patient population. To accomplish this, we needed to strengthen our balance sheet, which we did this quarter when we raised $129 million gross proceeds from equity and debt offerings. By initiating this trial now, 12 months earlier than we would have been able to do so without this financing, we estimate we added over $1 billion to the net present value of the potential revenue stream from this indication.

Speaker Change: and if I recall correctly, you know, from data they reported, I think, in 2021.

Speaker Change: You know, we're, we're patients.

Speaker Change: may have had a cut off of A1C similar to Alpalypsid. I think in one of the cohorts they treated roughly 40%.

Brian Sullivan: I think in one of the cohorts, they treated roughly 40%. Grade 3 hyperglycemia. So I think. It would be unlikely that the label wouldn't address the hyperglycemia risk and the fact that the drug has not been evaluated in patients, who are pre-diabetic or diabetic. N N N N, To the extent doctors decide they want to ignore that based on the results that at least were reported on a preliminary basis in these other studies. It would seem that the likelihood of inducing grade 3 hyperglycemia would be pretty significant.

Brian Sullivan: I think in one of the cohorts they treated roughly 40% grade 3, hyperglycemia. So I think it would be unlikely that the label wouldn't address the hyperglycemia risk and the fact that the drug has not been evaluated in patients who are pre-diabetic or diabetic. And to the extent doctors decide they want to ignore that based on the results that at least were reported on a preliminary basis in this other studies, it would seem that the likelihood of inducing a grade 3 hypergocemia would be pretty significant. So I think that drug is a similar profile in some ways as Alpilipsib; they just narrow their patient population as a way to avoid inducing high levels of grade 3 hypergocemia.

Speaker Change: Grade 3 hyperglycemia. So I think it would be unlikely that the label wouldn't address the hyperglycemia risk and the fact that the drug has not been evaluated in patients.

Brian Sullivan: I'd like to turn now to our phase one B2 trial that's evaluating the safety and efficacy of get a list of in combination with Daralutamide and energy and receptor inhibitor and patients with metastatic castration resistant prostate cancer. Study does its first patient in February of this year and enrollments on track.

Speaker Change: who are pre-diabetic or or diabetic and

Speaker Change: To the extent doctors decide they want to ignore that based on the results that least were reported on a preliminary basis in this other studies.

Brian Sullivan: We continue to expect to report preliminary data in the first half of 2025. We're also pleased that our non-clinical research describing get a list of activity in different tumor types was recently published in two leading journals in June, Nature Breast Cancer, published results from various in vitro and in vivo studies we conducted that compared get a list of activity and several approved single node PI3K, AKT, MTOR or PAM inhibitors in various breast cancer models.

Speaker Change: You know, it would seem that the likelihood of inducing grade 3 hyperglycemia would be

Brian Sullivan: So, I think that drug has a similar profile in some ways as Opalypsib; they just narrow their patient population as a way to avoid inducing high levels of grade 3 hyperglycemia. Appreciate it. Thank you. You're welcome.

Speaker Change: Pretty significant.

Speaker Change: So, I think that drug has a similar profile in some ways as Opalypsib, they just narrow their patient population as a way to avoid inducing high levels of grade 3 hyperglycemia.

Brad Canino: Appreciate it. Thank you.

Brian Sullivan: You're welcome.

Speaker Change: Appreciate it. Thank you. You're welcome.

Brian Sullivan: In August, molecular oncology published results of similar studies in prostate cancer models. Both sets of studies demonstrated the get a list of exhibited more potent and cytotoxic effects compared to the single node PAM inhibitors regardless of the PAM pathway mutational status of the cell lines. And these results indicate that inhibition of multiple PAM pathway nodes by a PAM piece PI3K, MTOR inhibitor like get a list of more effective at inducing any tumor activity and single node PAM inhibitors in vitro and animal models.

Operator: There are no further questions at this time.

Brian Sullivan: There are no further questions at this time. I would now like to turn the call over to Brian Sullivan, CEO of Celcuity, for closing remarks. Thank you very much for attending our call. We appreciate your interest in our company, and I look forward to reporting to you next quarter. Good evening. Ladies and gentlemen, this concludes today's conference. Thank you very much for your participation.

Speaker Change: [inaudible]

Brian Sullivan: I would now like to turn the call over to Brian Sullivan, CEO of CellQIT, for closing remarks. Thank you very much for attending our call. We appreciate your interest in our company, and I look forward to reporting to you next quarter.

Speaker Change: There are no further questions at this time. I would now like to turn the call over to Brian Sullivan, CEO of CellQ80, for closing remarks.

Brian Sullivan: Thank you very much for attending our call. We appreciate your interest in our company and I look forward to reporting to you next quarter.

Brian Sullivan: Good evening.

Operator: Ladies and gentlemen, this concludes today's conference. Thank you very.

Brian Sullivan: Good evening.

Brian Sullivan: Overall, it was a very busy and productive quarter, very pleased of the progress we made.

Vicky Hahne: I'd like now to turn the call over to Vicki who will review our finances. Thank you, Brian and good afternoon everyone. I'll provide a brief overview of our financial results for the second quarter 2024. Our second quarter net loss was 23.7 million or 62 cents per share compared to 14.6 million net loss or 66 cents per share for the second quarter of 23. Because these quarterly net loss losses include significant non-catch items, including stock-based compensation and interest, we also included in our press release non-gap adjusted net loss for the quarter ending June 30th, 2024.

Vicky Hahne: Our non-gap adjusted net loss was 22.2 million or 58 cents per share for the second quarter of 24 compared to non-gap adjusted net loss of 11.1 million or 51 cents per share for the second quarter of 23. Research and development expenses were 22.5 million for the second quarter of 24 compared to 13.8 million for the same period in 2023. Of the approximately 8.7 million increase in R&D expenses, 6.6 million primarily related to activities supporting the Victoria I Phase III trial and the initiation of the Phase I B to prostate trial.

Vicky Hahne: And 2.1 million was related to increased employee and consulting experience. General and administrative expenses were 1.8 million for the second quarter of 24 compared to 1.3 million for the second quarter of 23. Employee and consulting related expenses accounted for 0.3 million of the increase. Professional fees and other administrative expenses accounted for the remaining increase of approximately 0.2 million. Netcatch used in operating activities for the second quarter of 24 was 18.1 million compared to 9.7 million for the second quarter of 23.

Vicky Hahne: We ended the quarter with approximately 283.1 million in cash, cash equivalence and short-term investments compared to 180.6 million at December 31, 2023. The increase of approximately 102 million in cash and cash equivalence and short-term investments was the result of several financing activities that occurred in the first half of 2024 and yielded net proceeds of 137.5 million. We closed on two financing activities in May resulting in gross proceeds of 122 million and net proceeds of 115.5 million.

Vicky Hahne: The first activity was an equity financing resulting in 60 million of gross proceeds with net proceeds of 56.3 million. The second activity was a debt offering resulting in gross proceeds of 61.7 million with net proceeds of 59.2. Additional financing activities in the first half of the year resulted from more exercises of 14.2 million. Accessing are at the market offering of 7.3 million and stock option exercises and playstack purchases of 0.5 million.

Vicky Hahne: The 137.5 million was offset by year-to-date operating cash used of 0.35.1 million.

Brian Sullivan: I will now hand the call back to Brian. Thank you, Vicki.

Operator: Operator, could you please open the call for questions? Thank you.

Operator: Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchstone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speaker phone, please make sure to lift the handset before pressing any keys.

Murray E. Recruft: Your first question comes from the line of more e-recruft from Jeffries.

Murray E. Recruft: The line is not open. Hi, thanks for taking my question. Just checking on the enrollment, I appreciate that the timeline is moving a little bit. Based on the shift in proportion of wild type in mutant populations, is it possible that the wild type in mutant readouts could happen at the same time, or are you confident that the wild type in mutant readouts will be staggered? Secondly, is it fair to assume you will do another update on enrollment in fourth quarter and provide more specifics on the plan for the readout at that point?

Brian Sullivan: Thanks, Murray. Thanks for your question. As far as the timing of announcement of results for mutated, we're maintaining our guidance that we would expect to have those results available sometime in the first half. We're enrolling the same number of patients in each cohort of the studies, wild type versus mutant, and 40% of the patients are mutated, so that enrollment period will take longer to come back. I'll be at a little bit sooner, and we originally planned because of the higher proportion of mutated patients, but we're not changing our guidance at this time. And as far as updating enrollment, we'll continue to update guidance as we have every quarter on when we expect to report top line results.

Murray E. Recruft: Okay, make sense.

Murray E. Recruft: And then for Victoria too, in the front line setting, can you talk more about the safety run-in with the 12 to 36 patients? Why is there a range of patients that you can enroll, and are you assessing any variations with dosing strategy and how long we have to treat these patients?

Brian Sullivan: I'll give you an initial high-level summary, and then Igor could maybe fill in the blanks. Essentially, the study is designed to evaluate if needed, various dose levels of ghetto-tilisib to find the Phase III dose. If we don't need to reduce the dose of ghetto-tilisib in the first cohort of patients that we're evaluating, then we'll be able to proceed with the data from that group of 12 patients. And then subsequently, if we find that we need to dose reduce ghetto, we would enroll in other 12 patients and do the same thing again if we had to and enroll in other 12 patients.

Brian Sullivan: So essentially, depending on what the results in the outcome of each cohort or one cohort may or may not lead you to enroll additional patients. As far as the thresholds, I mean, it's a standard safety run-in design.

Igor Gorbachevsky: Igor, maybe you could provide a little bit more color on that question. Thank you, Brian. As Brian pointed, it's very straightforward safety running. Three dose level will be tested, 12 subjects for each dose level. DLT will be assessed after one cycle of treatment is completed. It's a very safe and straightforward design that has been discussed with regulators and agrees upon. And to Brian's point, the decision about initiation over under my Phase III study could be done as early as completion of initial cohort 12 subjects. Got it.

Murray E. Recruft: Okay, thanks for taking my questions. You're welcome.

Tara Bancroft: Your next question comes from the line of TARA, Bancroft from TD Cohen. Your line is now open. Hi, good afternoon. I was hoping you could tell us exactly what you're seeing now for the percentage of the split of Wild Pit versus Mutant that you think you're observing now versus what your previous expectations were. And also just the point of clarification by target enrollment, you mean completion, right? Right. There's always variation. You may have patients in screening at the end of a period and enroll additional patients just because you can't, you know, not enroll patients that you've potentially already approved the screen once you hit that target.

Tara Bancroft: But completed enrollment is correct. So we were at 65% at the end of 23. And so over the course of 23, you'd see fluctuations month to month, which is kind of expected fluctuations are normal. So again, we were cautious in interpreting variation, but because we ended the year, the target number we had set in May 22, you know, 18 months prior. You know, we thought that that estimate was solid and what we would continue.

Tara Bancroft: Once we hit 80% enrollment, which we did recently, of the wild type cohort, and we were at 60%. We just decided that we should update our forecast to the current ratio, cumulative ratio, which is 60%. Okay, great.

Tara Bancroft: And then, so I guess late Q4 for potentially meeting the event timeline, that would potentially fit into the San Antonio conference timeline. Is this, is this still maybe what you're primarily hoping for? If I know that the abstract deadline passed early to early to mid July. So did you, did you submit an abstract or plan on presenting there? So we haven't, yeah, we aren't going to, until we get, have an announcement to make about the data, we aren't really going to go into details about what venue we'll be reporting that data.

Tara Bancroft: And it's going to be very situational, depending on the timing, and relative to, you know, the next most relevant meeting. And so once the data is available, we'll report the top line, as soon as we have it. And then we'll provide guidance on when we would go into more detail out of meeting, or go into some detail in the announcement, press release. Okay, great. Thanks for that.

Operator: Ladies and gentlemen, just a reminder, if you would like to ask a question, please press tar followed by the number one on your touch-tone phone. And if you're using a speaker phone, please make sure to lift the handset before pressing any keys.

Brad Canino: Your next question comes from the line of Brad Canino from Stiefel. Your line is now open. I think you're taking the question.

Brian Sullivan: Brian, I just want to, can you talk about how the potential forthcoming approval of Roche's intervals of factors into your clinical and regulatory strategy for frontline, at least for the proportions who will have the mutations, and also how important is the ultimate label outcome around the metabolic parameter eligibility as you think about this. Thank you. I'm not sure I understand your question regarding the intervalist as it relates to us. Are you asking that question about how that might affect our first line study?

Brian Sullivan: Yeah, Brad. We don't think it will because they're only evaluated, you know, patient, who A, had to pick through the amutation, but B. We're not prediabatic or diabetic, which, depending on the estimates, you can narrow that indication down to 50% of the mutated population. So it really is not a drug that could fully treat the indicated population, which is woman who have endocrine resistant disease. And as a result, you know, when we've reviewed this information and with the FDA in several settings, so we're confident in our design and that that's what we'll be evaluating.

Brian Sullivan: So we don't think that data will affect us. It provides, we think, validation of what we're doing. They showed in that population that the pathway is involved in the vision of that pathway can induce a meaningful treatment benefit. As far as what's on the label, you know, the drug haven't tested in patients without the strict limitations used in this most recent study, the interval 120. I think the eligibility criteria were informed by the results in that study.

Brian Sullivan: And if I recall correctly, from data they reported, I think, in 2021, you know, where patients may have had a cut off of A1C similar to Albalypsid. I think in one of the cohorts, they treated roughly 40% grade 3 hypoglycemia. So I think it would be unlikely that the label wouldn't address the hypoglycemia risk and the fact that the drug has not been evaluated in patients who are prediabatic or diabetic. And to the extent doctors decide they want to ignore that, based on the results that at least were reported on a preliminary basis in this other studies, you know, it would seem that the likelihood of inducing a grade 3 hypoglycemia would be pretty significant. So I think that drug similar profile in some ways is Albalypsid. They just narrow their patient population as a way to avoid inducing high levels of grade 3 hypoglycemia. Appreciate it. Thank you. You're welcome.

Unknown Executive: There are no further questions at this time.

Brian Sullivan: I would now like to turn the call over to Brian Sullivan, CEO of CellQity for closing remarks. Thank you very much for attending our call. We appreciate your interest in our company and I look forward to reporting to you next quarter.

Operator: Good evening. Ladies and gentlemen, this concludes today's conference. Thank you very much for your participation. You may now disconnect.