Q2 2025 Celcuity Inc Earnings Call

Yeah.

Following the presentation, we will conduct a question and answer session.

If at any time during this call you required immediate assistance. Please press star zero for the operator.

I would now like to turn the conference over to a poor virtually with ICR healthcare. Please go ahead.

Okay.

Thank you operator, and good afternoon to everyone. Thank you for joining us to review <unk> second quarter 2025 financial results and business update earlier today <unk> released financial results for the second quarter ended June 30th 2025.

The press release can be found on the investors section of <unk> website. Joining me on the call today are Brian Sullivan, <unk>, Chief Executive Officer, and co founder Vicky Hahn, Chief Financial Officer, as well as equal corporate Chucky, Chief Medical officer, who will be available during Q&A before we begin I would like to remind listeners that our comments.

Today, we 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 differ materially from those projected in the forward looking statements.

Speaker #3: Good afternoon, ladies and gentlemen, and welcome to the Celcuity second quarter 2025 financial results webcast and conference call. At this time, all lines are in listen-only mode.

Brian Sullivan: Good afternoon, ladies and gentlemen, and welcome to the Celcuity's second quarter 2025 financial results webcast and conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you're required to need assistance, please press star zero for the operator. I would now like to turn the conference over to Apoorva Chiluri with ICR Healthcare. Please go ahead.

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.

Speaker #3: Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press *0 for the operator.

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 management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations or process.

Speaker #3: I would now like to turn the conference over to Apoorva Chiluri with ICR Healthcare. Please go ahead.

Speaker #2: Thank you, operator. And good afternoon to everyone. Thank you for joining us to review Celcuity second quarter 2025 financial results and business update. Earlier today, Celcuity Inc. released financial results for the second quarter ended June 30th, 2025.

Apoorva Chiluri: Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's second quarter 2025 financial results and business update. Earlier today, Celcuity Inc. released financial results for the second quarter ended June 30th, 2025. The press release can be found on the investor section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder, Vicky Hahn, 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. Actual events or results may differ materially from those projected in the forward-looking statements.

For the future.

You can find a table reconciling the non-GAAP financial measures to GAAP measures in today's press release and with that I would now like to turn the call over to Brian Sullivan CEO of so acuity. Please go ahead.

Speaker #2: The press release can be found on the investors' section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's chief executive officer and co-founder, Vicky Hahne, chief financial officer, as well as Ykor Gorbachevsky, chief medical officer, who will be available during Q&A.

Thank you, Florida and good afternoon, everyone. Thank you for joining our second quarter financial results Conference call.

Past few months have been a vessel ones for South Jersey, we achieved several significant milestones and we believe these milestones laid the foundation for us to potentially establish got US Elisa is a new standard of care therapies for patients with HR positive <unk> negative advanced breast cancer.

Speaker #2: 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.

First and most importantly for US was the positive top line data, we reported from the <unk> Wild type cohort of our phase III, Victoria, one clinical trial.

Speaker #2: Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected.

In patients with HR positive merchandize mix, we see a wild type advanced breast cancer.

Apoorva Chiluri: Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP 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. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Elisa bustle bestial, and Paolo cichlid, where the guest wants a triplet.

And got US a lot to hustle, a restaurant or to get us all as a doublet.

Speaker #2: 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.

Metro study has two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression free survival or PFS versus full veteran.

Speaker #2: Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future.

We reported hazard ratios and improvements in medium PFS are unprecedented and HR positive for two negative a desk breast cancer.

We believe these data validate our hypothesis that the role of the <unk> or Pam pathway as a Castro driver.

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

Not solely a function of the presence of a pathway mutation.

Speaker #2: Please go ahead.

The implications are profound for patients with HR positive <unk> negative advanced breast cancer as we seek to invest get us Elisa is a therapeutic option for patients with or without <unk> mutations in both the second line and first line settings.

Speaker #4: Thank you, Apoorva. And good afternoon, everyone. Thank you for joining our second quarter financial results conference call. The past few months have been eventful once for Celcuity.

Brian Sullivan: Thank you, Apoorva, and good afternoon, everyone. Thank you for joining our second quarter financial results conference call. The past few months have been eventful ones for Celcuity. We achieved several significant milestones, and we believe these milestones laid the foundation for us to potentially establish GATA-TOLISSIM as a new standard of care therapy for patients with HR-positive, HER2-negative advanced breast cancer. First and most importantly, of course, was the positive top-line data we reported from the PIK3CA wild-type cohort of our phase three Victoria 1 clinical trial. In patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, GATA-TOLISSIM plus fulvestrant and palbociclib, or the GATA-TOLISSIM triplet, and GATA-TOLISSIM plus fulvestrant, or the GATA-TOLISSIM doublet, met the study's two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression-free survival, or PFS, versus fulvestrant.

Speaker #4: We achieved several significant milestones and we believe these milestones laid the foundation for us to potentially establish data to listen as a new standard of care therapy for patients with HR-positive or HER2-negative advanced breast cancer.

Second important milestone achieved was the dosing of the first patient in our phase III Victoria to clinical trial.

Trial is evaluating <unk> in combination with the CDK four six inhibitor and full vesting as first line treatment for patients with HR positive <unk> negative advanced breast cancer.

Speaker #4: First and most importantly, of course, was the positive top-line data we reported. From the PIC3CA wild-type cohort of our Phase III VICTORIA I clinical trial, in patients with HR-positive HER2-negative, PIC3CA wild-type advanced breast cancer, data from the lisocabtagene maraleucel plus fulvestrant and palbociclib were the data from the lisocabtagene maraleucel triplet.

The third milestone was the announcement of favorable preliminary topline results from two early phase clinical trials.

One evaluating <unk> in men with metastatic castration resistant prostate cancer and a second one that evaluated get obsolescence and Trastuzumab biosimilar in patients with her two positive picture sand mutated metastatic breast cancer.

Speaker #4: And data to listen plus fulvestrant, or the data to listen doublet, met the study's two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression-free survival, or PFS, versus fulvestrant.

Pork milestone was the extension of our patent exclusivity for get US Elisa into 2042 with the issuance of a new dosing regimen patent forget us a lesson.

Speaker #4: The reported hazard ratios and improvements in median PFS are unprecedented in HR-positive HER2-negative advanced breast cancer. We believe these data validate our hypothesis that the role of the PIC3CA or PI3K AKT-MTOR, or PAM pathway, as a cancer driver is not solely a function of the presence of a pathway mutation.

Brian Sullivan: The reported hazard ratios and improvements in median PFS are unprecedented in HR-positive, HER2-negative advanced breast cancer. We believe these data validate our hypothesis that the role of the PIK3CA or PI3K-AKT mTOR or PAM pathway as a cancer driver is not solely a function of the presence of a pathway mutation. The implications are profound for patients with HR-positive, HER2-negative advanced breast cancer, as we seek to advance GATA-TOLISSIM as a therapeutic option for patients with or without PIK3CA mutations in both the second-line and first-line settings. The second important milestone achieved was the dosing of the first patient in our phase three Victoria 2 clinical trial. In this trial, it's evaluating GATA-TOLISSIM in combination with a CDK-46 inhibitor and fulvestrant as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer.

And finally, we raised around $287 million through public offerings of convertible notes to common stock and pre funded warrants that provide the funding that should allow us to aggressively prepare for and Los Gatos Elisa should we get FDA approval next year.

Speaker #4: The implications are profound for patients with HR-positive HER2-negative advanced breast cancer, as we seek to advance data to listen as a therapeutic option for patients with or without PIC3CA mutations in both the second-line and first-line settings.

I'd like now to turn to the Victoria one trial.

Last month, we announced topline results from this trial medium progression free survival or PFS for the Dallas with triplet was 9.3 months compared to only two months for full vesting.

Speaker #4: The second important milestone achieved was the dosing of the first patient in our Phase III Victoria II clinical trial. In this trial, we are evaluating data to listen in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer.

Seven three months incremental improvement in median PFS.

The hazard ratio was 0.24, which translates to four two times higher likelihood of survival without disease progression for they get us a triplet central Vesta.

Speaker #4: The third milestone was the announcement of favorable preliminary top-line results from two early-phase clinical trials. One evaluating data to listen in daralutamide in men with metastatic castration-resistant prostate cancer, and a second one that evaluated data to listen and address Tuzumab biosimilar in patients with HER2-positive PIC3CA mutated metastatic breast cancer.

Brian Sullivan: The third milestone was the announcement of favorable preliminary top-line results from two early-phase clinical trials, one evaluating GATA-TOLISSIM and darolutamide in men with metastatic castration-resistant prostate cancer, and a second one that evaluated GATA-TOLISSIM and trastuzumab biosimilar in patients with HER2-positive, PIK3CA mutated metastatic breast cancer. The fourth milestone was the extension of our patent exclusivity for GATA-TOLISSIM into 2042 with the issuance of a new dosing regimen patent for GATA-TOLISSIM. And finally, we raised around $287 million through public offerings of convertible notes, common stock, and pre-funded warrants that provide the funding that should allow us to aggressively prepare for and launch GATA-TOLISSIM should we get FDA approval next year. I'd like now to turn to the Victoria 1 trial. Last month, we announced top-line results from this trial. Median progression-free survival, or PFS, for the GATA-TOLISSIM triplet was 9.3 months compared to only two months for fulvestrant.

But the Guy that's Alyssa doublet.

Median PFS was seven four months again compared to only two months for <unk>.

Five four months incremental improvement in median PFS.

The hazard ratio was <unk> 33, which.

Place to three times higher likelihood of survival without disease progression, where they got up to listen Dublin pencil for western.

Speaker #4: The fourth milestone was the extension of our patent exclusivity for data to listen into 2042, with the issuance of a new dosing regimen patent for data to listen.

Now these results established several new milestones in the history of drug development for this patient population.

First the hazard ratios reported for both to get a triplet and doublet. We're the most favorable ever reported by any phase III trial first line second line or third line in this population.

Speaker #4: And finally, we raised around $287 million to public offerings of convertible notes, common stock, and pre-funded warrants that provide the funding that should allow us to aggressively prepare for and launch data to listen should we get FDA approval next year.

And second the incremental improvements and median PFS for the triplet and doublet seven three and five four months, respectively were the highest ever reported by any phase III trial for this patient population receiving at least their second line of therapy for advanced disease.

Speaker #4: I'd like now to turn to the Victoria I trial. Last month, we announced top-line results from this trial, median progression-free survival, or PFS, for the data to listen triplet was 9.3 months, compared to only two months for fulvestrant.

And third <unk> is the first pan <unk> inhibitor to achieve a positive phase III data result in patients who have picked VCA wild type tumors, and whose disease progressed on or after treatment with the CDK four and six inhibitor.

Speaker #4: 7.3 months incremental improvement in median PFS. The hazard ratio was 0.24, which translates to 4.2 times higher likelihood of survival without disease progression for the data to listen triplet than fulvestrant.

Brian Sullivan: 7.3 months incremental improvement in median PFS. The hazard ratio was 0.24, which translates to 4.2 times higher likelihood of survival without disease progression for the GATA-TOLISSIM triplet than fulvestrant. For the GATA-TOLISSIM doublet, median PFS was 7.4 months, again compared to only two months for fulvestrant, with 5.4 months incremental improvement in median PFS. And the hazard ratio was 0.33, which translates to three times higher likelihood of survival without disease progression for the GATA-TOLISSIM doublet than fulvestrant. Now, these results established several new milestones in the history of drug development for this patient population. First, the hazard ratios reported for both the GATA triplet and doublet were the most favorable ever reported by any phase three trial, first-line, second-line, or third-line in this population.

For comparison purposes, it's important to note that several phase III studies in this patient population have reported data recently in these studies the incremental improvement in median PFS range from $1 seven to $3 nine months and the hazard ratio has ranged from zero point 55 to <unk> 73.

Speaker #4: With the data to listen doublet, median PFS was 7.4 months, again compared to only 2 months for fulvestrant, with a 5.4-month incremental improvement in median PFS.

Both gas Elisa regimens exhibited a favorable safety profile, including lower rates of hypoglycemia and summer Titus and the rate of discontinuation of all treatment due to treatment related adverse event was lower than what was reported in a phase <unk> study in this patient population.

Speaker #4: And the hazard ratio was 0.33, which translates to three times higher likelihood of survival without disease progression for the data to listen doublet than fulvestrant.

Speaker #4: Fulvestrant. Now, these results establish several new milestones in the history of drug development for this patient population. First, the hazard ratios reported for both the data triplet and doublet were the most favorable ever reported by any Phase III trial, first-line, second-line, or third-line, in this population.

In light of the favorable safety profile more favorable hazard ratios and longer incremental PFS, but to get us a lot less of regimens then the other currently available or investigational agents. We believe both together so it's a triplet and doublet each have the potential to establish a new standard of care for these patients.

Speaker #4: And second, the incremental improvements in median PFS for the triplet and doublet 7.3 and 5.4 months, respectively, were the highest ever reported by any phase III trial for this patient population, receiving at least their second-line of therapy for advanced disease.

Brian Sullivan: And second, the incremental improvements in median PFS for the triplet and doublet, 7.3 and 5.4 months respectively, were the highest ever reported by any phase three trial for this patient population receiving at least their second line of therapy for advanced disease. And third, GATA-TOLISSIM is the first PAM inhibitor to achieve a positive phase three data result in patients with PIK3CA wild-type tumors and whose disease progressed on or after treatment with a CDK-46 inhibitor. And for comparison purposes, it's important to note that several phase three studies in this patient population have reported data recently. In these studies, the incremental improvement in median PFS ranged from 1.7 to 3.9 months, and the hazard ratios ranged from 0.55 to 0.73.

We're on track to submit a new drug application to the FDA in the fourth quarter of 2025 for data based on data from the picture to say well site cohort and we're looking forward to presenting the full data set later this year at an upcoming medical conference.

Speaker #4: And third, data to listen is the first PAM inhibitor to achieve a positive phase III data result in patients who have PIC3CA wild-type tumors and whose disease progressed on or after treatment with a CDK4/6 inhibitor.

Additionally, we expect to release top line data for the Victoria, One picture mutation Corp cohort by the end of 2025.

Moving on I want to start just a quick overview of the market landscape, we see forget it's Elisa and how we're gearing up for a potential launch should we get FDA approval.

Speaker #4: And for comparison purposes, it's important to note that several Phase III studies in this patient population have reported data recently. In these studies, the incremental improvement in median PFS ranged from 1.7 to 3.9 months, and the hazard ratios ranged from 0.55 to 0.73.

We think the market looks very promising forget us listen we estimate there are 34000 patients moving to second line treatment after progressing on a CDK <unk> inhibitor and roughly 60% of them are fixed we see a wildfire.

That's a very large opportunity and there's also a significant need for more efficacious therapies than those currently available.

Speaker #4: Both data to listen regimens exhibited a favorable safety profile, including lower rates of hypoglycemia and stomatitis, and the rate of discontinuation of all treatment due to a treatment-related adverse event was lower than was reported in a phase IB study in this patient population.

Brian Sullivan: Both GATA-TOLISSIM regimens exhibited a favorable safety profile, including lower rates of hyperglycemia and stomatitis, and the rate of discontinuation of all treatment due to a treatment-related adverse event was lower than was reported in a phase one B study in this patient population. In light of the favorable safety profile, more favorable hazard ratios, and longer incremental PFS for the GATA-TOLISSIM regimens than the other currently available or investigational agents, we believe both the GATA-TOLISSIM triplet and doublet each have the potential to establish a new standard of care for these patients. We're on track to submit a new drug application to the FDA in the fourth quarter of 2025 for GATA based on data from the PIK3CA wild-type cohort, and we're looking forward to presenting the full data set later this year at an upcoming medical conference.

Currently approved therapy is only offered two to four months of median PFS, we've got us Elisa <unk> unique mechanism of action a corresponding clinical benefit.

Well positioned to address critical needs in the second line space.

Speaker #4: In light of the favorable safety profile, more favorable hazard ratios, and longer incremental PFS for the data to listen regimens than the other currently available or investigational agents, we believe both the data to listen triplet and doublet each have the potential to establish a new standard of care for these patients.

Unmet need has been verified and our market research, which shows that oncologists are hungry for options that are more effective than have a safety profile that can match and as we've discussed on prior calls.

Efficacy and safety are the two primary criteria oncologists use to select therapies for their patients.

Speaker #4: We're on track to submit a new drug application to the FDA in the fourth quarter of 2025, for data based on data from the PIC3CA wild-type cohort, and we're looking forward to presenting the full data set later this year, at an upcoming medical conference.

Also consistent with the criteria used by treatment guidelines, such as end CCN to determine recommendation categories for drug treatments.

Additionally, as an IV administered minister therapy, we believe get US elicit will be very well received in the community practice setting where over 80% of patients are treated.

Speaker #4: Additionally, we expect to release top-line data for the Victoria I PIC3CA mutation cohort by the end of 2025. Moving on, I want to share just a quick overview of the market landscape we see for data to listen and how we're gearing up for potential launch should we get FDA approval.

Brian Sullivan: Additionally, we expect to release top-line data for the Victoria 1 PIK3CA mutation cohort by the end of 2025. Moving on, I want to share just a quick overview of the market landscape we see for GATA-TOLISSIM and how we're gearing up for a potential launch should we get FDA approval. We think the market looks very promising for GATA-TOLISSIM. We estimate there are 34,000 patients moving to second-line treatment after progressing on a CDK-46 inhibitor, and roughly 60% of them are PIK3CA wild-type. That's a very large opportunity, and there's also a significant need for more efficacious therapies than those currently available. Currently, approved therapies only offer two to four months of median PFS. With GATA-TOLISSIM's unique mechanism of action and corresponding clinical benefit, it's well-positioned to address critical needs in the second-line space.

Elissa will fall under the medical benefit category, which means typically smoother reimbursement process compared to oral drugs that fall under the pharmacy benefit category.

Speaker #4: We think the market looks very promising for data to listen. We estimate there are 34,000 patients moving to second-line treatment after progressing on CDK4/6 inhibitors, and roughly 60% of them are PIK3CA wild-type.

Oral drugs payers tend to manage claims more heavily resulting in a more cumbersome prescribing and reimbursement process for practices.

And unlike oral drugs IV administered therapies also allow physicians to recover costs associated with the purchase and administration of therapy and to better ensure patient compliance with the treatment regimen.

Speaker #4: That's a very large opportunity. And there's also a significant need for more efficacious therapies than those currently available. Currently approved therapies only offer two to four months of median PFS.

And finally, the breast cancer community is active engaged and well supported by advocacy groups, which will help create awareness for new treatments in general and we think for <unk> specifically.

Speaker #4: With data to listen's unique mechanism of action, corresponding clinical benefit, the 12-position to address critical needs in the second-line space. And this unmet need has been verified in our market research, which shows that oncologists are hungry for options that are more effective and have a safety profile they can manage.

As a result, we believe so acuity is the opportunity to build a strong presence amongst medical oncologist to address this large underserved patient population and based on our projections. We believe the addressable market potential for a standard of care second line therapy to treat this patient population is roughly $5 billion.

Brian Sullivan: And this unmet need has been verified in our market research, which shows that oncologists are hungry for options that are more effective and have a safety profile they can manage. And as we've discussed on prior calls, ethical and safety are the two primary criteria oncologists use to select therapies for their patients. This is also consistent with the criteria used by treatment guidelines such as NCCN to determine recommendation categories for drug treatments. Additionally, as an IV-administered therapy, we believe GATA-TOLISSIM will be very well received in the community practice setting where over 80% of patients are treated. GATA-TOLISSIM will fall under the medical benefit category, which means a typically smoother reimbursement process compared to oral drugs that fall under the pharmacy benefit category. For oral drugs, payers tend to manage claims more heavily, resulting in a more cumbersome prescribing and reimbursement process for practices.

Speaker #4: And as we've discussed on prior calls, efficacy and safety are the two primary criteria oncologists use to select therapies for their patients. And there's also consistent with the criteria used by treatment guidelines, such as NCCN, to determine recommendation categories for drug treatments.

I'd like now to turn to our phase III Victoria to trial.

Last month, we announced that we dosed the first patient in Victoria through <unk>.

Evaluating get us Elisa.

Plus the CDK four six inhibitor that the investigator matures and full vesting as first line treatment for patients who have endocrine therapy resistant HR positive <unk> negative advanced breast cancer.

Speaker #4: Additionally, as an IV administered therapy, we believe data to listen will be very well received in the community practice setting. We're over 80% of patients are treated.

Speaker #4: Data to listen will fall under the medical benefit category, which means typically smoother reimbursement process compared to oral drugs that fall under the pharmacy benefit category.

The standard of care first line treatment for most endocrine therapy resistant patients includes it includes any one of three approved CDK four and six inhibitors combined with full restaurant.

Speaker #4: For oral drugs, payers tend to manage claims more heavily, resulting in a more cumbersome prescribing and reimbursement process for practices. And unlike oral drugs, IV administered therapies also allow physicians to recover costs associated with the purchase and administration of therapy, and to better ensure patient compliance with their treatment regimen.

And results from our recent trial suggest the median progression free survival period for patients receiving one of these three regimens, it's only about seven to eight months and highlighting.

Brian Sullivan: And unlike oral drugs, IV-administered therapies also allow physicians to recover costs associated with the purchase and administration of therapy and to better ensure patient compliance with their treatment regimen. And finally, the breast cancer community is active, engaged, and well-supported by advocacy groups, which will help create awareness for new treatments in general, and we think for GATA-TOLISSIM specifically. As a result, we believe Celcuity has the opportunity to build a strong presence amongst medical oncologists to address this large underserved patient population. And based on our projections, we believe the addressable market potential for a standard of care second-line therapy to treat this patient population is roughly $5 billion. I'd like now to turn to our phase three Victoria 2 trial.

The significant need for more efficacious frontline therapy for these patients.

We believe the positive topline data from the picture you say Wow type cohort of arbitrary one study augurs well for the <unk> triplet in this patient population.

Speaker #4: And finally, the breast cancer community is active and engaged and well supported by advocacy groups, which will help create awareness for new treatments in general, and we think for data to listen specifically.

I'd like now to turn to our phase <unk> clinical trial that is evaluating <unk> in combination with our <unk> in men with metastatic castration resistant prostate cancer.

Speaker #4: As a result, we believe Celcuity has the opportunity to build a strong presence among medical oncologists to address this large underserved patient population. Based on our projections, we believe the addressable market potential for a standard of care second-line therapy to treat this patient population is roughly $5 billion.

In late June we announced encouraging phase one be preliminary efficacy and safety data from this study, which enrolled 38 prostate cancer patients who were randomly assigned to either receive 80 milligrams <unk> twice daily.

Speaker #4: I'd like now to turn to our phase III Victoria II trial. Last month, we announced that we'd dose the first patient in Victoria through that's evaluating data to listen plus a CDK4/6 inhibitor that the investigator may choose, and fulvestrant as first-line treatment for patients who have endocrine therapy resistant HR-positive HER2-negative advanced breast cancer.

Bind with either 120 milligrams had got us less of an arm, one or 180 milligrams of <unk> and arm tube.

Brian Sullivan: Last month, we announced that we dosed the first patient in Victoria 3 that's evaluating GATA-TOLISSIM plus a CDK-46 inhibitor that the investigator may choose and fulvestrant as first-line treatment for patients who have endocrine therapy-resistant HR-positive, HER2-negative advanced breast cancer. The standard of care first-line treatment for most endocrine therapy-resistant patients includes any one of three approved CDK-46 inhibitors combined with fulvestrant. And results from a recent trial suggest the median progression-free survival period for patients receiving one of these three regimens is only about seven to eight months and highlighting the significant need for more efficacious front-line therapy for these patients. We believe the positive top-line data from the PIK3CA wild-type cohort of our Victoria 1 study augurs well for the GATA-TOLISSIM triplet in this patient population.

<unk> was administered once weekly for three weeks and then one week off and both arms.

The preliminary analysis for the combined arms. So the six month radiographic PFS rate was 66%, which compares favorably to published data for androgen receptor inhibitors in this setting.

Speaker #4: The standard of care for first-line treatment for most endocrine therapy-resistant patients includes any one of three approved CDK4/6 inhibitors combined with fulvestrant. Results from a recent trial suggest the median progression-free survival period for patients receiving one of these three regimens is only about seven to eight months, highlighting the significant need for more efficacious front-line therapy for these patients.

Additionally, the data highlighted the favorable safety profile of this novel combination there were no treatment related discontinuation in less than 3% of patients experienced grade three stomatitis.

Instead to indicate that the optimal get us Willis adult's dose for this patient population.

Speaker #4: We believe the positive top-line data from the PIC3CA wild-type cohort of our Victoria I study offers well for the data to listen triplet in this patient population.

Not yet have been reached and we believe it's important to explore additional dose options forget to listen.

As such we amended the clinical trial protocol to enable exploration of additional doses in the phase one portion of this clinical trial to determine the recommended phase II dose.

Speaker #4: I'd like now to turn to our phase IB II clinical trial that's evaluating data to listen in combination with daralutamide in men with metastatic castration-resistant prostate cancer.

Brian Sullivan: I'd like now to turn to our phase one B2 clinical trial that's evaluating GATA-TOLISSIM in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In late June, we announced encouraging phase one B preliminary efficacy and safety data from this study, which enrolled 38 prostate cancer patients who were randomly assigned to either receive 80 milligrams of darolutamide twice daily combined with either 120 milligrams of GATA-TOLISSIM in arm one or 180 milligrams of GATA-TOLISSIM in arm two. And GATA-TOLISSIM was administered once weekly for three weeks and then one week off in both arms. The preliminary analyses for the combined arms show the six-month radiographic PFS rate was 66%, which compares favorably to published data for androgen receptor inhibitors in this setting. Additionally, the data highlighted the favorable safety profile of this novel combination.

In addition to announcing encouraging preliminary data from our prostate cancer trial.

So announced encouraging data from an investigator sponsored phase II clinical trial in this trial 44 patients with her two positive <unk> mutated breast cancer were treated with <unk> plus standard doses of Trastuzumab Biosimilar.

Speaker #4: In late June, we announced encouraging phase IB preliminary efficacy and safety data from this study, which enrolled 38 prostate cancer patients who were randomly assigned to either receive 80 milligrams of daralutamide twice daily combined with either 120 milligrams of data to listen in one or 100 and 80 milligrams of data to listen in arm two.

No prophylaxis for stomatitis was administered <unk>.

Median number of prior anti <unk> therapies enrolled patients received in the metastatic setting was four or more 86% of patients had received at least three prior anti <unk> therapies. So these patients were heavily pretreated.

Speaker #4: And data to listen was administered once weekly for three weeks and then one week off in both arms. The preliminary analyses for the combined arms show the six-month radiographic PFS rate was 66%, which compares favorably to published data for androgen receptor inhibitors in this setting.

The overall response rate was 43% and no patients discontinued get us illicit due to a treatment related adverse events.

Excuse me, 43% overall response rate in patients receiving a fourth or fifth line of anti hurts your treatment for their disease is very encouraging and compares favorably to published data for other available therapies. In this group of patients. It also suggest to get US a list of in combination with her to targeted therapy may be an effective and well tolerated therapeutic option.

Speaker #4: Additionally, the data highlighted the favorable safety profile of this novel combination; there were no treatment-related discontinuations, and less than 3% of patients experienced grade III stomatitis.

Brian Sullivan: There were no treatment-related discontinuations, and less than 3% of patients experienced grade three stomatitis. These data indicate that the optimal GATA-TOLISSIM dose for this patient population may not yet have been reached, and we believe it's important to explore additional dose options for GATA-TOLISSIM. And as such, we amended the clinical trial protocol to enable exploration of additional doses in the phase one B portion of this clinical trial to determine the recommended phase two dose. In addition to announcing the encouraging preliminary data from our prostate cancer trial, we also announced encouraging data from an investigator-sponsored phase two clinical trial. In this trial, 44 patients with HER2-positive PIK3CA mutated breast cancer were treated with GATA-TOLISSIM plus standard doses of a trastuzumab biosimilar. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more.

Speaker #4: These data indicate that the optimal data to listen dose for this patient population may not yet have been reached, and we believe it's important to explore additional dose options for data to listen.

For patients with her two positive metastatic breast cancer.

Now I'd like to turn to a few corporate updates.

Speaker #4: And as such, we amended the clinical trial protocol to enable exploration of additional doses in the phase IB portion of this clinical trial to determine the recommended phase II dose.

First U S patent and trademark office issued sell acuity, a new patent covering the clinical dosing regimen forget it to listen and HR positive <unk> negative breast cancer patients.

Speaker #4: In addition to announcing the encouraging preliminary data from our prostate cancer trial, we also announced encouraging data from an investigator-sponsored phase II clinical trial.

<unk> extends <unk> patent exclusivity in the U S into 2042 and with this added patent exclusivity, we expect to have a long runway to optimize development of Gannett's Elisa.

Speaker #4: In this trial, 44 patients with HER2-positive PIC3CA mutated breast cancer were treated with data to listen plus standard doses of a trastuzumab biosimilar. No prophylaxis for stomatitis was administered.

And last but not least we also completed concurrent offerings of convertible notes to common stock and pre funded warrants with net proceeds of 286 million and a half.

Speaker #4: The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more, 86% of patients had received at least three prior anti-HER2 therapies, so these patients were heavily pretreated.

At the end of July and beginning of August.

With our current resources and other financing arrangements. We believe we are well positioned to advance multiple blockbuster indications in breast and prostate cancer and to aggressively prepare for and launch get US a list of commercially should we receive FDA approval.

Brian Sullivan: 86% of patients had received at least three prior anti-HER2 therapies, so these patients were heavily pretreated. The overall response rate was 43%, and no patients discontinued GATA-TOLISSIM due to a treatment-related adverse event. Achieving 43% overall response rate in patients receiving a fourth or fifth line of anti-HER2 treatment for their disease is very encouraging and compares favorably to published data for other available therapies in this group of patients. It also suggests that GATA-TOLISSIM in combination with HER2-targeted therapy may be an effective and well-tolerated therapeutic option for patients with HER2-positive metastatic breast cancer. Now, I'd like to turn to a few corporate updates. First, the US Patent and Trademark Office issued Celcuity a new patent covering the clinical dosing regimen for GATA-TOLISSIM in HR-positive, HER2-negative breast cancer patients. The patent extends GATA-TOLISSIM's patent exclusivity in the US into 2042.

Speaker #4: The overall response rate was 43%, and no patients discontinued data to listen due to a treatment-related adverse event. Achieving 43% overall response rate in patients receiving a fourth or fifth-line of anti-HER2 treatment for their disease is very encouraging, and compares favorably to published data for other available therapies in this group of patients.

Like now to hand, the call over to Vicki Hahn, our CFO to review our finances.

Thank you, Brian and good afternoon, everyone I'll provide a brief overview of our financial results for the second quarter of 2025.

Speaker #4: It also suggests the data to listen in combination with HER2-targeted therapy may be an effective and well-tolerated therapeutic option for patients with HER2-positive metastatic breast cancer.

Our second quarter net loss was $45 3 million or $1.04 per share compared to $23 7 million net loss or <unk> 62 per share for the second quarter of 2024.

Speaker #4: Now, I'd like to turn to a few corporate updates. First, the U.S. Patent and Trademark Office issued Celcuity a new patent covering the clinical dosing regimen for data to listen in HR-positive, HER2-negative breast cancer patients.

Our non-GAAP adjusted net loss was $40 5 million or <unk> 93.

Per share for the second quarter of 2025 compared to non-GAAP adjusted net loss of $22 2 million or <unk> 58 per share for the second quarter of 2024.

Speaker #4: The patent extends data to listen's patent exclusivity in the U.S. into 2042. With this added patent exclusivity, we expect to have a long runway to optimize the development of data to listen.

Brian Sullivan: And with this added patent exclusivity, we expect to have a long runway to optimize the development of GATA-TOLISSIM. And last but not least, we also completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of $286 million and a half million at the end of July and beginning of August. With our current resources and other financing arrangements, we believe we are well-positioned to advance multiple blockbuster indications in breast and prostate cancer and to aggressively prepare for and launch GATA-TOLISSIM commercially should we receive FDA approval. I'd like now to hand the call over to Vicky Hahn, our CFO, to review our finances.

Research and development expenses were $40 2 million for the second quarter of 2025 compared to $22 5 million for the second quarter of 2024 of the approximately $710 7 million increase in R&D expenses.

Speaker #4: And last but not least, we also completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of $286 million and a half million dollars at the end of July and beginning of August.

Speaker #4: With our current resources and other financing arrangements, we believe we are well positioned to advance multiple blockbuster indications in breast and prostate cancer, and to aggressively prepare for and launch data to listen commercially should we receive FDA approval.

$6 6 million was related to increased employee and consulting expenses $6 1 million, what's related to increased research and development costs, primarily attributable to activities supporting our ongoing clinical trials and $5 million is related to an anticipated development milestone payment under the license.

Speaker #4: I'd like now to hand the call over to Vicky Hahne, our CFO, to review our finances.

Speaker #2: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2025. Our second quarter net loss was $45.3 million, or $1.04 per share, compared to $23.7 million net loss, or $0.62 per share, for the second quarter of 2024.

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2025. Our second quarter net loss was $45.3 million or $1.04 per share, compared to $23.7 million net loss or $0.62 per share for the second quarter of 2024. Our non-GAAP adjusted net loss was $40.5 million or $0.93 per share for the second quarter of 2025, compared to non-GAAP adjusted net loss of $22.2 million or $0.58 per share for the second quarter of 2024. Research and development expenses were $40.2 million for the second quarter of 2025, compared to $22.5 million for the second quarter of 2024.

Agreement with Pfizer.

General and administrative expenses were $3 8 million for the second quarter of 2025.

Compared to $1 8 million for the second quarter of 2024.

Of the 2 million.

The dollar increase in general and administrative expenses $1 6 million was related to increased employee and consulting expenses.

Speaker #2: Our non-GAAP adjusted net loss was $40.5 million, or $0.93 per per share, for the second quarter of 2025, compared to non-GAAP adjusted net loss of $22.2 million, or $0.58 per share, for the second quarter of 2024.

The remaining <unk> 4 million of the $2 million increase resulted from professional fees expanding infrastructure and other administrative expenses.

Net cash used in operating activities for the second quarter of 2025 was $36 2 million compared to $18 1 million for the second quarter of 2024.

Speaker #2: Research and development expenses were $40.2 million for the second quarter of 2025, compared to $22.5 million, for the second quarter of 2024. Of the approximately $7.7 million increase in R&D expenses, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development costs, primarily attributable to activities supporting our ongoing clinical trials, and $5 million is related to an anticipated development milestone payment under the license agreement with Pfizer.

We ended the quarter with approximately $168 4 million of cash cash equivalents and short term investments. However on a pro forma basis, taking into account the net proceeds of our financing activities in Q3 cash cash equivalents and short term investments.

Vicky Hahne: Of the approximately $17.7 million increase in R&D expenses, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development costs, primarily attributable to activities supporting our ongoing clinical trials, and $5 million is related to an anticipated development milestone payment under the license agreement with Pfizer. General and administrative expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the second quarter of 2024. Of the $2 million increase in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2 million increase resulted from professional fees, expanding infrastructure, and other administrative expenses. Net cash used in operating activities for the second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter of 2024.

As of the end of Q2 2025 with approximately $455 million. Additionally.

Additionally, existing financing arranged arrangements are expected to give us access to an incremental $116 million of cash over the next few quarters.

Speaker #2: General and administrative expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the second quarter of 2024. Of the $2 million increase, in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses, the remaining $0.4 million of the $2 million increase resulted from professional fees expanding infrastructure and other administrative expenses.

$80 million from our current term loan agreement and $36 million from the exercise of soon to expire in the money warrants.

As a result, we believe we have the resources and financing in place to fund our operations through 2027.

I will now hand, the call back to Brian.

Thank you Vicky operator could you. Please open the call for questions.

Yeah.

Speaker #2: Net cash used in operating activities for the second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter of 2024.

Thank you very much ladies and gentlemen, we will now begin the question and answer session.

Could you have a question. Please press star followed by the number one on your Touchtone phone.

You'll hear a prompt that your hand has been raised.

Speaker #2: We ended the quarter with approximately $168.4 million of cash, cash equivalents, and short-term investments. However, on a pro forma basis, taking into account the net proceeds of our financing activities in Q3, cash, cash equivalents, and short-term investments as of the end of Q2 2025 was approximately $465 million.

Vicky Hahne: We ended the quarter with approximately $168.4 million of cash, cash equivalents, and short-term investments. However, on a pro forma basis, taking into account the net proceeds of our financing activities in Q3, cash, cash equivalents, and short-term investments as of the end of Q2 2025 was approximately $455 million. Additionally, existing financing arrangements are expected to give us access to an incremental $116 million of cash over the next few quarters, $80 million from our current term loan agreement, and $36 million from the exercise of soon-to-expire in-the-money warrants. As a result, we believe we have the resources and financing in place to fund our operations through 2027. I will now hand the call back to Brian.

Should you wish to decline from the polling process. Please press star followed by the number two.

If you are using a speaker phone make sure to lift your handset before pressing any case.

Your first question comes from the line of Maury Raycroft from Jefferies. Please go ahead.

Hi, This is on for Maury. Thank you for taking our questions and congrats on all the progress a couple of questions from US first regarding the upcoming full data presentation. Later this year for victory <unk> Wild type portion of the phase III study.

Speaker #2: Additionally, existing financing arrangements are expected to give us access to an incremental $116 million of cash over the next few quarters. $80 million from our current term loan agreement and $36 million from the exercise of soon-to-expire in the money warrants.

Can you elaborate on what we should expect to see specifically will you be sharing subgroup analysis, such as PFS analysis for ESR, one wild type and mutant cohorts there.

Speaker #2: As a result, we believe we have the resources and financing in place to fund our operations through 2027. I will now hand the call back to Brian.

And then I have a follow up.

Sure. So we'll be focused on our initial data presentation on the primary analysis. The primary endpoints and then we would expect to present data at subsequent meetings.

Speaker #4: Thank you, Vicky. Operator, could you please open the call for questions?

Additional subgroup analysis.

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

Okay.

Okay sounds good and for the PTC mute population.

Speaker #3: Thank you very much. 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 and we will hear a prompt that your hand has been raised.

Operator: Thank you very much. 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, make sure to list your handset before pressing any case. Your first question comes from the line of Mauri Rakov from Jeffries. Please go ahead.

How are you thinking about the benchmark benchmark for success here is there a specific has as a ratio or PFS delta that youre, considering a meaningful threshold there.

Speaker #3: Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speakerphone, make sure to lift your handset before pressing any case.

And could be considered clinically meaningful.

Sure.

So I think there are two thresholds to consider when you were.

Reviewing.

Speaker #3: Your first question comes from the line of Maury Raycroft from Jeffries. Please go ahead.

The data on that cohort.

First is the comparisons to the control, which in this case is uplifts in for question.

Speaker #5: Hi, this is Amin An for Maury. Thank you for taking our questions and congrats on all the progress. A couple of questions from us.

As it turns out given what we think is the likely outcome based on historical data for uplifts had been this population of between.

Amin Ahmad: Hi, this is Amin Ahmad from Mauri. Thank you for taking our questions and congrats on all the progress. A couple of questions from us. First, regarding the upcoming full data presentation later this year for PIK3CA wild-type portion of the phase three study, can you elaborate on what we should expect to see? Specifically, will you be sharing subgroup analysis such as PFS and OS for ESR-1 wild-type and mutant cohorts there? And then I have a follow-up.

Speaker #5: First, regarding the upcoming full data presentation later this year for the PIC3CA wild-type portion of the Phase III study, can you elaborate on what we should expect to see? Specifically, will you be sharing subgroup analyses such as PFS and OS for the ESR1 wild-type and mutant cohorts there?

Let's say seven to eight months.

Statistically significant.

Result would also be a clinically meaningful result.

A little less than three months.

So we think if we have a positive study will also be reporting.

Clinically meaningful results. Additionally.

Additionally, because uplifts.

No longer.

The primary option that physicians are relying on.

Speaker #5: And then I have a follow-up.

Speaker #4: Sure. So we'll be focused on our initial data presentation on the primary analyses, the primary endpoints, and then we would expect to present data at subsequent meetings additional subgroup analyses.

We think from a practical standpoint.

Brian Sullivan: Sure. So we'll be focused on our initial data presentation on the primary analyses, the primary endpoints, and then we would expect to present data at subsequent meetings, additional subgroup analyses.

The benchmark data that physicians will consider will be the data for cathode passenger or an <unk> inhibitor and.

And Capa data as reported data in the post CDK population of about five and a half months of median PFS.

Speaker #5: Okay, sounds good. And for the PIC3CA mutant population, how are you thinking about the benchmark for success here? Is there a specific hazard ratio or PFS delta that you are considering a meaningful threshold there and could be considered clinically meaningful?

Amin Ahmad: Okay, sounds good. And for the PIK3CA mute population, how are you thinking about the benchmarks for success here? Is there a specific hazard ratio or PFS delta that you are considering a meaningful threshold there and could be considered clinically meaningful?

So if we're able to report positive results relative to uplifts of those will be especially positive relative to a catheter kept divestiture.

Yeah.

Okay sounds good thank you.

Youre welcome.

Your next question is from the line of Tara Bancroft from TD Cowen. Please go ahead.

Speaker #4: Sure. So I think there are two thresholds to consider when we're reviewing the data in that cohort. The first is the comparison to the control which, in this case, is uplifted fulvestrant.

Brian Sullivan: Sure. So I think there are two thresholds to consider when we're reviewing the data in that cohort. The first is the comparison to the control, which in this case is opposite fulvestrant. As it turns out, given what we think is the likely outcome based on historical data for opposite in this population of between, let's say, seven to eight months, a statistically significant result would also be a clinically meaningful result of a little less than three months. So we think if we have a positive study, we'll also be reporting clinically meaningful results. Additionally, because opposite is probably no longer the primary option that physicians are relying on, we think from a practical standpoint, the benchmark data that physicians will consider will be the data for kappa-vasoturbine AKT inhibitor.

Hi, This is <unk> on for Tara Bancroft. So just one question on our end. So this is the full safety data isn't broken out in the top line is there any more detail you can offer how does that if theres better rates observed was that overall rate or does great three stomatitis.

Speaker #4: As it turns out, given what we think is the likely outcome based on historical data for uplifted in this population, up between let's say seven to eight months, statistically significant result would also be a clinically meaningful result of a little less than three months.

And.

Sure so we'll be providing that data.

Speaker #4: So we think if we have a positive study, we'll also be reporting clinically meaningful results. Additionally, because uplifted is probably no longer the primary option that physicians are relying on, we think from a practical standpoint, the benchmark data that physicians will consider will be the data for kappa vasotropin AKT inhibitor.

At the upcoming conference we were really only at this stage able to provide a general.

Summary of what we saw but.

Additional details will be forthcoming.

Thank you.

Youre welcome.

The next question is from the line of Andrew Burns from Leerink Partners. Please go ahead.

Speaker #4: And Kappa data is reported data in the post-CDK population of about five and a half months of median PFS. So, if we're able to report positive results relative to uplifted, those will be especially positive relative to a Kappa Vasotropin.

Brian Sullivan: And kappa data is reported data in the post-CDK population of about five and a half months of median PFS. So if we're able to report positive results relative to opposite, those will be especially positive relative to kappa-vasoturbine.

Hi, Good afternoon. This is Ethan on for Andy Congrats on all the progress and thanks for taking our questions just a two parter if I can.

So we noticed across various pivotal trials in HR positive <unk> negative breast cancer space, there's been mixed whether the PFS primary endpoint was based on bigger as is the case in Victoria, one or based on investigator assessment.

Speaker #5: Okay, sounds good. Thank you.

Amin Ahmad: Okay, sounds good. Thank you.

Speaker #4: You're welcome.

Brian Sullivan: You're welcome.

Speaker #3: Your next question is from the line of Tara Bancroft from TD College. Please go ahead.

And so first question is can we expect the PFS analysis based on investigator assessment to be presented at an upcoming meeting later this year and then second what is the company's understanding on the concordance between bigger versus investigator assessment based on what we've seen in prior HR positive <unk> negative trials as well as how is this aspect.

Operator: Your next question is from the line of Tara Bancroft from TD Cowen. Please go ahead.

Speaker #6: Hi, this is Frances on for Tara Bancroft. So just one question. On our end, so since the full safety data isn't broken out in the top line, is there any more detail you can offer ahead of it if there's better rates observed?

Frances: Hi, this is Frances on for Tara Bancroft. So just one question on our end. So since the full safety data isn't broken out in the top line, is there any more detail you can offer ahead of it? If there's better rates observed, was that overall rates or just grade three stomatitis?

Weighted by FDA and other regulatory agencies. Thank you sure.

Speaker #6: Was that overall rates or just grade III stomatitis and?

So the selection of Becker for our study as the assessment method was a function of our study being an open label study.

Speaker #4: Sure. We'll be providing that data at the upcoming conference. We were really only at this stage able to provide a general summary of what we saw, but the additional detail will be forthcoming.

Brian Sullivan: Sure. So we'll be providing that data at the upcoming conference. We were really only at this stage able to provide a general summary of what we saw, but the additional detail will be forthcoming.

This reflects the cash flow such as an IV administered drug and you can't really have a plausible a placebo and you use blinded assessment of the scans to ensure that you're eliminating the potential for investigator bias and that's why you saw.

Speaker #6: Thank you.

Frances: Thank you.

Speaker #4: You're welcome.

Brian Sullivan: You're welcome.

Is that the.

The trial store.

Speaker #3: The next question is from the line of Andrew Barons from Moliering Partners. Please go ahead.

Operator: Your next question is from the line of Andrew Berens from Leering Partners. Please go ahead.

The recent oral Serge the Emerald trial.

And the <unk> II trial were also bigger studies, because again not plausible to create a placebo full vesting.

Speaker #5: Hi, good afternoon. This is Ethan on for Andy. Congrats on all the progress and thanks for taking our questions. Just a two-parter if I can.

Ethan: Hi, good afternoon. This is Ethan offer Andy. Congrats on all the progress and thanks for taking our questions. Just a two-parter if I can. So we noticed across various pivotal trials in the HR-positive, HER2-negative breast cancer space, it's been mixed whether the PFS primary endpoint was based on BICR, as is the case in Victoria 1, or based on investigator assessment. So first question is, can we expect the PFS analysis based on investigator assessment to be presented at an upcoming meeting later this year? And then second, what is the company's understanding on the concordance between BICR versus investigator assessment based on what we've seen in prior HR-positive, HER2-negative trials, as well as how is this aspect evaluated by FDA and other regulatory agencies? Thank you.

And so bigger is the method that the FDA actually encourages or recommend.

Speaker #5: So we noticed across various pivotal trials in the HR-positive HER2-negative breast cancer space, it's been mixed, whether the PFS primary endpoint was based on bigger as is the case in Victoria I or based on investigator assessment.

When you do have an open label study for that purpose.

And so.

In this case then the investigator data is really simply collected as part of our ongoing assessment and it's more for exploratory sensitivity analysis and so it's not a fundamental analysis and we'll be reporting data as I indicated earlier in the sequence.

Speaker #5: So, first question is, can we expect the PFS analysis based on investigator assessment to be presented at an upcoming meeting later this year? And then, what is the company's understanding on the concordance between bigger versus investigator assessment based on what we've seen in prior HR-positive HER2-negative trials?

As we.

Move from one conference to it to another.

Speaker #5: As well as how is this aspect evaluated by the FDA and other regulatory agencies? Thank you.

But to your question regarding Concordance I think I saw one study that showed.

Speaker #4: Sure. No, thanks. So the selection of bigger for our study, as the assessment method, was a function of our study being an open-label study, and that just reflects that data to listen is an IV administered drug and you can't really have a plausible placebo.

Brian Sullivan: Sure. No, thanks. So the selection of BICR for our study as the assessment method was a function of our study being an open-label study, and that just reflects that GATA-TOLISSIM is an IV-administered drug and you can't really have a plausible placebo. And you use blinded assessment of the scans to ensure that you're eliminating the potential for investigator bias. And that's why you saw see that the trials for the recent oral SURGE, the AMBREL trial, and the VERITECH 2 trial were also BICR studies because, again, not plausible to create a placebo for fulvestrant. And so BICR is the method that the FDA actually encourages or recommends when you do have an open-label study for that purpose. And so in this case, then the investigator data is really simply collected as part of ongoing assessment, and it's more for exploratory sensitivity analysis.

The concordance.

Between the hazard ratios are bigger PFS.

And the investigator.

Assess PFS, where I think correlated.

Well over 90% of the 95% and so there is no we do not expect to have any any issues on that front.

Speaker #4: And you use blinded assessment of the scans to ensure that you're eliminating the potential for investigator bias. And that's why you saw see that the the trial score the recent oral surge you know the Emerald trial and the Veritech II trial were also bigger studies because, again, not plausible to create a placebo for fulvestrant.

We've.

And the processes, we prepare for NDA doing sensitivity analysis, many of which are prescribed by the FDA in our discussions with them about our statistical analysis plan.

And all of a sensitivity analyses or are.

Indicating that their data is very robust and we're very comfortable and confident about the package that we expect to submit to the FDA.

Speaker #4: And so bigger is the method that the FDA actually encourages or recommends when you do have an open-label study for that purpose. And so in this case, then the investigator data is really simply collected as part of ongoing assessment and it's more for exploratory sensitivity analysis.

Great. Thank you.

Your next question is from the line of Stephen Wiley from Sighful. Please go ahead.

Yeah. Good afternoon, thanks for taking the question.

Speaker #4: And so it's not a fundamental analysis and we'll be reporting data as I indicated earlier in the sequence. As we move from one conference to another.

Brian Sullivan: And so it's not a fundamental analysis, and we'll be reporting data, as I indicated earlier, in a sequence as we move from one conference to another. But to your question regarding concordance, I think I saw one study that showed the concordance between the hazard ratios of a BICR PFS and the investigator-assessed PFS were, I think, correlated well over 90%. It might even have been 95%. And so we do not expect to have any issues on that front. We've in the processes, we prepare for NDA doing sensitivity analyses, many of which are prescribed by the FDA in our discussions with them about our statistical analysis plan. And all those sensitivity analyses are indicating that our data is very robust, and we're very comfortable and confident about the package that we expect to submit to the FDA.

Wondering how you're now thinking about launch readiness youre going to be filing an NDA here in the fourth quarter, you've got breakthrough, presumably theres an <unk> pathway you can leverage so what are some of the comps I guess that you look to in terms of the requisite amount of infrastructure build that you did in <unk>.

Speaker #4: But to your question regarding concordance, I think I saw one study that showed the concordance between the hazard ratios of a bigger PFS and the investigator assessed PFS were I think correlated well over 90%.

How do you think about scaling.

Scaling that infrastructure here over the near term as.

Given the 26.

Sure No that's a great question so.

So.

It's a couple a couple of points to highlight firstly, we began building our team last year, we hired our chief commercial officer Eldon Mayer.

Speaker #4: It might even have been 95%. And so there's we do not expect to have any issues on that front. We've in the processes, we prepare for NDA doing sensitivity analyses many of which are prescribed by the FDA in our discussions with them about our statistical analysis plan.

And our first quarter 2024, and then hand turn brought on board a head of marketing head of market access head of commercial operations and they focused on.

Speaker #4: And all those sensitivity analyses are indicating that our data is very robust and we're very comfortable and confident about the package that we expect to submit to the FDA.

Projects that.

Have a long lead time and there are a variety of those that can take up to 18 months to get done and so essentially we have been working back from a launch date.

You have to assume an earlier launch date or you are kind of aggressive on when you think that will occur just so youre not blindsided and youre ready under any circumstance and now as we've gotten closer to launch. These past few months, we've begun hiring the individuals who report up to the heads of these various departments and an interim Nathan takes me on on <unk>.

Speaker #5: Great. Thank you.

Ethan: Great. Thank you.

Speaker #3: Your next question is from the line of Steven Wiley from SIFO. Please go ahead.

Operator: Your next question is from the line of Stephen Wiley from Siphal. Please go ahead.

Speaker #4: Yeah, good afternoon. Thanks for taking the question. I was just wondering how you're now thinking about launch readiness. You're going to be filing an NDA here in the fourth quarter.

Steve: Yeah, good afternoon. Thanks for taking the question. I was just wondering how you're now thinking about launch readiness. You're going to be filing an NDA here in the fourth quarter. You've got breakthrough. Presumably, there's an RTOR pathway you can leverage. So what are some of the comps, I guess, that you look to in terms of the requisite amount of infrastructure build that you need? And how do you think about scaling that infrastructure here over the near term and as we get into '26?

Projects now that we have our data we have what we think is a clear path to an approval decision, which we can kind of where we can define with some degree of confidence a launch date will.

Speaker #4: You've got a breakthrough; presumably, there's an RTOR pathway you can leverage. So what are some of the comps, I guess, that you look to in terms of the requisite amount of infrastructure build that you need?

We will be taking that next step and so that will involve additional infrastructure associated in the commercial operations are at a square foot salesforce, the supporting MSL force theirs.

Speaker #4: And how do you think about scaling that infrastructure here over the near term and as we get into '26? Sure. No, that's a great question.

Activities in the market access area, you're engaging with payers strategic accounts.

Brian Sullivan: Sure. No, that's a great question. So it's a couple of points to highlight. First, we began building our team last year. We hired our Chief Commercial Officer, Eldon Meyer, in the first quarter of 2024. And then he, in turn, brought on board a head of marketing, head of market access, head of commercial operations. And they focused on projects that have a long lead time, and there are a variety of those that can take up to 18 months to get done. And so essentially, we've been working back from a launch date. You have to assume an earlier launch date, or you're kind of aggressive on when you think that'll occur just so you're not blindsided and you're ready under any circumstance.

Speaker #4: So it's a couple points to highlight. First, we began building our team last year. We hired our chief commercial officer, Elgin Meyer, in first quarter of 2024.

In ways that are appropriate at this stage.

And then in turn you start to build out your sales force management structure, starting with head of sales and then regional management.

Speaker #4: And then he in turn brought on board a head of marketing, head of market access, head of commercial operations. And they focused on projects that have a long lead time and there are a variety of those that can take up to 18 months to get done.

In turn.

It requires you to have defined sales territories number of territories.

Geographic alignment et cetera. So all of those projects are on track as far as how are we doing well what is our benchmark now.

Speaker #4: And so essentially, we've been working back from a launch date you have to assume an earlier launch date or you're kind of aggressive on when you think that'll occur just so you're not blindsided.

Now we've been very deliberate about hiring folks in all of these key positions.

People, who have been involved in first launch of a company's first drug launch for our company and that's critical because there's so much infrastructure.

Speaker #4: And you're ready under any circumstance. And now as we've gotten closer to launch, these past few months, we've begun hiring the individuals who report up to the heads of these various departments.

Brian Sullivan: And now, as we've gotten closer to launch these past few months, we've begun hiring the individuals who report up to the heads of these various departments. And in turn, they've been taking on more projects. Now that we have our data, we have what we think is a clear path to an approval decision, which we can kind of where we can define with some degree of confidence a launch date, we'll be taking that next step. And so that'll involve additional infrastructure associated in the commercial operations area to support Salesforce, to supporting them as Salesforce. There's activities in the market access area, engaging with payers, strategic accounts in ways that are appropriate at this stage.

Operational support activities that are required to be.

The effective as a commercial organization.

It's not a plug and play somebody coming from Big Pharma has never had to set up.

Speaker #4: And in turn, they've been taking on more projects. Now that we have our data, we have what we think is a clear path to an approval decision, which we can kind of where we can define with some degree of confidence a launch date.

All of this infrastructure or to establish these processes and these functions from scratch. So I think we've been very very fortunate we've hired a great team incredibly experienced a very focused and I think we're absolutely on track to having what we think.

Speaker #4: We'll be taking that next step, and so that'll involve additional infrastructure associated with the commercial operations area to support Salesforce and MSLforce. There are activities in the market access area engaging with payers and strategic accounts in ways that are appropriate at this stage.

No. We're we're optimistic about the launch and our ability to be very very effective in communicating.

The benefits of that what we believe are the benefits of data too.

Two medical oncologists.

Speaker #4: And then, in turn, you start to build out your Salesforce management structure, starting with Head of Sales and then regional management. Which, in turn, requires you to define sales territories, number of territories, the geographic alignment, etc.

Alright, thanks for taking question.

Brian Sullivan: And then in turn, you start to build out your Salesforce management structure, starting with head of sales and then regional management, which in turn requires you to define sales territories, number of territories, and a geographic alignment, et cetera. So all those projects are on track. And as far as how are we doing or what is our benchmark, we've been very deliberate about hiring folks in all of these key positions, people who have been involved in the first launch of a company's drug, first drug launch for a company. And that's critical because there's so much infrastructure, operational support activities that are required to be effective as a commercial organization. It's not a plug-and-play of somebody coming from Big Pharma and has never had to set up all of this infrastructure or to establish these processes and these functions from scratch.

Brooklyn.

Your next question is from the line of <unk> <unk> from Needham <unk> Company. Please go ahead.

Hi, This is Jim on for Gal, So just a couple from us.

Speaker #4: So all those projects are on track. And as far as how we are doing or what our benchmark is, we've been very deliberate about hiring folks in all of these key positions.

Can you put into context, the practical ramifications for physicians now that they may have optionality with both the doublet and triplet and I have a follow on.

Speaker #4: People who have been involved in first launch of a company's first drug launch for a company. And that's critical because there's so much infrastructure operational support activities that are required.

Well I think.

The primary I think goal of all of these physicians is to optimize.

And delay as long as possible and the progression of a patient's disease and the triplet offers that to these office now with triplet because it includes power segment also induces a mile of suppression.

Speaker #4: To be effective, as a commercial organization, it's not a plug and play. Somebody coming from Big Pharma has never had to set up all of this infrastructure.

For patients who could be elderly.

Speaker #4: We're to establish these processes and these functions from scratch. So I think we've been very, very fortunate. We've hired a great team, incredibly experienced.

Or have immune and immune system that may be more compromised.

Brian Sullivan: So I think we've been very, very fortunate. We've hired a great team, incredibly experienced, very focused, and I think we're absolutely on track to having what we think. We're optimistic about the launch and our ability to be very, very effective in communicating the benefits of what we believe are the benefits of GATA to medical oncologists.

They may consider not to be.

Appropriate and so they'll have the option of still getting very very.

Speaker #4: Very focused and I think we're absolutely on track to having what we think we're optimistic about the launch and our ability to be very, very effective in communicating the benefits of what we believe are the benefits of data to medical oncologists.

We believe.

<unk> incremental benefit in PFS.

And and so what we think having either regimen available does.

Does allow us to.

Have a.

Access to as broad a range of patients as possible and that's that's always great and then I think as we get into.

Speaker #5: All right.

Steve: All right. Thanks for taking the question.

Speaker #4: Take a

Speaker #4: second question.

Speaker #5: You're welcome.

Brian Sullivan: You're welcome.

And describe.

Speaker #3: Your next question is from the line of Yale Blum from Needham and Company. Please go ahead.

Operator: Your next question is from the line of Gil Blum from Needham & Company. Please go ahead.

Our results for different subgroups.

I think that will help guide some of the decision making for different subgroups as for physicians and how they might want to think about the doublet versus the triplet as an example.

Speaker #5: Hi, this is Gilman from Yale. So just a couple from us. Can you put into context the practical ramifications for physicians now that they may have optionality with both a doublet and a triplet and have a follow-on?

Amin Ahmad: Hi, this is Gil Blum for Gil. So just a quick quote from us. Can you put into context the practical ramifications for the physicians now that they may have optionality with both a doublet and a triplet? And I have a follow-on.

Thank you very helpful.

Just as a follow on to Steve's question is there any consideration on commercial partnering strategy for a launch.

Speaker #3: Well, I think

Brian Sullivan: Well, I think the primary, I think, goal of all these physicians is to optimize and delay as long as possible the progression of a patient's disease, and the triplet offers that to these doctors. Now, the triplet, because it includes palbociclib, also induces some myelosuppression, you know, which for patients who could be elderly or have an immune system that may be more compromised, you know, they may consider not to be appropriate. And so they'll have the option of still getting very, very, what we believe, extended incremental benefit in PFS. And so what we think having either regimen available does is allow us to have access to as broad a range of patients as possible. And that's always great.

Speaker #4: the primary, I think, goal of all these physicians is to optimize and delay as long as possible the progression of a patient's disease and the triplet offers that to these doctors.

It looks like it might be a very large investment just given the size of the market.

Yeah.

No we were expecting and planning to.

To launch ourselves, we think we understand what's required we know what's required we have a very very detailed operating plan and operating budget.

Speaker #4: Now, the triplet, because it includes polycyclin, also induces some myelosuppression. Which for patients who could be elderly, or have an immune system that may be more compromised, they may consider not to be appropriate.

We know what the head count is and why we need to bring them on.

The investment is not insignificant.

Speaker #4: And so they'll have the option of still getting very, very what we believe extended incremental benefit in PFS. And so what we think having either a regimen available does is allow us to have access to as broad a range of patients as possible.

But it's not ridiculous to be Frank.

And relative to the size of the opportunity.

It's very.

Uh huh.

Manageable and so we've financed ourselves accordingly, that's the other part of the equation, obviously is having sufficient capital.

To invest aggressively in our launch and we think we've set ourselves up very well with our balance sheet to do that and so it's just purely from a financial.

Speaker #4: And that's always great. As we get into and describe results for different subgroups, I think that will help guide some of the decision-making for different subgroups for physicians and how they might want to think about the doublet versus the triplet, as an example.

Brian Sullivan: And then I think as we get into and describe results for different subgroups, I think that will help guide some of the decision-making for different subgroups for physicians and how they might want to think about the doublet versus the triplet as an example.

Perspective, and a financial return perspective, it makes absolute sense for us to be watching this ourselves and not to be partnering with somebody.

Thanks for taking our questions.

Youre welcome.

Speaker #5: Thank you. Very helpful. And just as a follow-on to Steve's question, is there any consideration on commercial partnering strategy for a launch? I mean, it looks like it might be a very large investment just given the size of the market.

Amin Ahmad: Thank you. Very helpful. And just as a follow-on to Steve's question, is there any consideration on commercial partnering strategy for a launch? I mean, it looks like it might be a very large investment just given the size of the market. Thank you.

Your last question comes from the line of Chase Sneaker Barbara from Craig Hallum. Please go ahead.

Good afternoon, thanks for taking the questions maybe Brian just to start.

Can you kind of just give us your general thoughts on kind of the competitive landscape in the mutant in the mutant.

Speaker #5: Thank you.

Speaker #4: No, we're expecting and planning to launch ourselves. We think we understand what's required. We know what's required. We have a very, very detailed operating plan and operating budget.

Brian Sullivan: No, we're expecting and planning to launch ourselves. We think we understand what's required. We know what's required. We have a very, very detailed operating plan and operating budget. We know what the headcount is and why we need to bring them on. You know, the investment is not insignificant, but it's not ridiculous, to be frank. And you know, relative to the size of the opportunity, it's very manageable. And so we've financed ourselves accordingly. That's the other part of the equation, obviously, is having sufficient capital to invest aggressively in a launch. And you know, we think we've set ourselves up very well with our balance sheet to do that. And so just purely from a financial perspective and a financial return perspective, it makes absolute sense for us to be launching this ourselves and not to be partnering with somebody.

Population, there's obviously some other actionable mutations in there with ESR et cetera.

So can you just give us your general too early thoughts as far as the competitive environment, there and how you see kind of get a fitting in.

Speaker #4: We know what the headcount is and why we need to bring them on. The investment is not insignificant, but it's not ridiculous, to be frank.

Right.

I think two.

Two things I mean for pictures that mutation.

Patients will be reported out that data later this year.

Speaker #4: And relative to the size of the opportunity, it's very manageable. And so we've financed ourselves accordingly. That's the other part of the equation, obviously, is having sufficient capital.

If our data is.

Positive and shows.

Benefit relative to uplift said, we think that will position us very well to establish get us as a new potential standard of care.

Speaker #4: To invest aggressively in a launch and we think we've set ourselves up very well with our balance sheet to do that. And so just purely from a financial perspective and financial return perspective, it makes absolute sense for us to be launching this ourselves and not to be partnering with somebody.

So we'll be taking.

Yeah.

We think that will speak for itself as far as the ESR. One mutations we just don't think there'll be as relevant.

Given.

The the nature of the drug combination that we have.

In the absence of inhibition of let's say CDK four six or.

Speaker #5: Thanks for taking our questions.

Amin Ahmad: Thanks for taking our questions.

Pam pathway.

Speaker #4: You're welcome.

Brian Sullivan: You're welcome.

Potentially in ESR, one mutant patients I mean data suggests that you can get some incremental benefit to us in oral surgery to address.

Speaker #3: Your last question comes from the line of Chase Nicaragua from Crate Helen. Please go ahead.

Operator: Your last question comes from the line of Chase Neckerberger from Craig Hallen. Please go ahead.

Speaker #5: Good afternoon. Thanks for taking the questions. Maybe Brian, just to start, could you kind of give us your general thoughts on the competitive landscape in the mutant population?

Chase Knickerbocker: Good afternoon. Thanks for taking the questions. Maybe Brian, just to start, can you kind of just give us your general thoughts on kind of the competitive landscape in the mutant population? You know, there's obviously some other actionable mutations in there with ESR, et cetera. So can you just give us your general, you know, too early thoughts as far as the competitive environment there and how you see kind of GATA fitting in?

That pathway.

And at the same time, we think if you are addressing the pan pathway CDK four six.

The relative difference in outcomes between ESR, one mutant and wild type patients.

Speaker #5: There's obviously some other actionable mutations in there with ESR, etc. So can you just give us your general two early thoughts as far as the competitive environment there and how you see kind of data fitting in?

As unlikely to be meaningfully different.

Got it mainly.

Maybe just on the on the meat side to dig in a little bit there.

Speaker #4: Right. So I think two things. I mean, for PIC3CA mutation, patients will be reporting out that data later this year. Obviously, if our data is positive and shows benefit relative to uplifted, we think that'll position us very well to establish data as a new potential standard of care.

Brian Sullivan: Right. So you know, I think two things. I mean, for PIK3CA mutation patients, we'll be reporting out that data later this year. Obviously, if our data is positive and shows benefit relative to opposite, we think that'll position us very well to establish GATA as a new potential standard of care. So we'll be taking, we think that'll kind of speak for itself. As far as the ESR-1, we.Patients.

The most recent approval.

There with the <unk> I mean can you just give us some thoughts as far as kind of how the market has changed in the last kind of 10 to 12 months in and then you also are comparisons there.

Sure so.

Got it so usually a generic name.

And Ah Melissa that drugs that often have theatrical alpha inhibitor approved for treating.

Patients, who have a picture sand mutation.

Speaker #4: So we'll be taking we think that'll kind of speak for itself. As far as the ESR I mutations, we just don't think they'll be as relevant given the nature of the drug combination that we have.

And the first line setting for a woman who of endocrine treatment resistant.

Disease that disease, and Thats actually the patient population that will be that we're addressing in our Victoria to study.

Operator: We just don't think they'll be as relevant, you know, given the nature of the drug combination that we have. You know, in the absence of inhibition of, let's say, CDK4/6 or of the PAM pathway, potentially in ESR1 mutant patients, I mean, data suggests that you can get some incremental benefit if you use an oral SIRG to address that pathway. And at the same time, we think if you are addressing the PAM pathway in CDK4/6, the relative difference in outcomes between the ESR1 mutant and wild type patients is unlikely to be meaningfully different.

So that that population doesn't overlap at all of the population that will be.

Speaker #4: In the absence of inhibition of, let's say, CDK4/6 or the PAM pathway, potentially in ESR1 mutant patients, I mean, data suggests that you can get some incremental benefit if you use an oral surge to address that pathway.

Addressing with.

The Victoria one study.

Study results and so that data does provide confirmation that in.

In the frontline setting treatment naive patients have involvement of the pan pathway in their disease and they'll benefit.

Speaker #4: And at the same time, we think if you are addressing the PAM pathway and CDK4/6, the relative difference in outcomes between ESR1 mutant and wild-type patients is unlikely to be meaningfully different.

In this case this drug has only shown activity unfavorable activity.

And patients that had a picture of <unk> mutation that drug also has some.

Yeah.

These levels of hyperglycemia that Ken.

Apoorva Chiluri: Got it. Maybe just on the mutant side to dig in a little bit there. You know, obviously the most recent approval there with Idevabi, I mean, can you just give us some thoughts as far as kind of how the market's changed in the last kind of 10, 12 months and any relevant comparisons there?

Ken potentially limit its use.

<unk>, who are healthy metabolically, which means they are not pre diabetic or or or not diabetic at all.

And we would hope and that's what our trial will evaluate that.

<unk>.

It can be effective in treating patients independent of their pictures here status and independent of the metabolic status and independent of their age.

Operator: Sure. So, you know, I kind of still use the generic name in Ovalycin. That drug's an alpha p3K alpha inhibitor. It's approved for treating patients who have a PIK3CA mutation in the first-line setting for women who have endocrine treatment-resistant disease, advanced disease. And that's actually the patient population that we'll be that we're addressing in our VICTORIA 2 study. So that population doesn't overlap at all with the population that we'll be addressing with the VICTORIA 1 study results. And so the data does provide confirmation that in the front-line setting, treatment-naive patients have involvement of the PAM pathway in their disease and they'll benefit. In this case, you know, this drug has only shown activity, favorable activity in patients that have a PIK3CA mutation.

Once he levels or glucose levels.

And so ultimately if if our data.

From Wild type recapitulates and.

Victoria to study and we show activity generally.

We think we have another opportunity to establish <unk> as a potential standard of care.

Thanks, Brian and maybe just one more if I could sneak it in.

On the CMC portion of your filing resubmit in Q4 can you just remind us.

Your your manufacturer are there any specifics you wanted to give as far as your kind of confidence around your CMC package.

We're very confident about the CMC package, we have all the data we are modules are complete for CMC. So.

So very prescribed set of studies that are expected <unk> to be performed.

Operator: That drug also, you know, has some induced levels of hypoglycemia that, you know, can potentially limit its use to patients who are healthy metabolically, you know, which means they are not pre-diabetic or not diabetic at all. And we would hope, and that's what our trial will evaluate, that GETA can be effective in treating patients independent of their PIK3CA status and independent of their metabolic status and independent of their HbA1c levels or glucose levels. And so ultimately, if our data from wild type recapitulates in the VICTORIA 2 study and we show activity generally, we think we have another opportunity to establish GETA as a potential standard of care.

The number of.

The demonstration of consistency of your processing and that's all been done so we're.

Very confident just based on the.

The robustness of the package that we've built and the data that we've generated that.

We should.

Satisfy the Fda's requirements and we've also engaged directly with the FDA.

And ensured that Oh there.

There aren't any open questions based on and outlined that we've provided to them all of the data we expect to provide and so so we think we should be in good shape on that front.

Great. Thanks, Brent.

Youre welcome.

There are no further questions at this time I'd like to turn the call back to Mr. Brian Sullivan for closing comments Sir. Please go ahead.

Apoorva Chiluri: Thanks, Brian. And maybe just one more if I could sneak it in. On the CMC portion of your filing, when you submit it in Q4, can you just remind us, you know, your manufacturer there, you know, any specifics you're wanting to give as far as your kind of confidence around your CMC package?

Well, thank you for participating in our call today and.

Thank you for your ongoing support and I look forward to catching up with you at various conferences along the way.

Take care.

Ladies and gentlemen. This concludes today's conference call. Thank you very much for your participation you may now disconnect.

Operator: We're very confident about the CMC package. You know, we have all the data. Our modules are complete for CMC. You know, there's a very prescribed set of studies that are expected, analyses to be performed, you know, kind of a number of demonstrations of consistency of your process, and that's all been done. So we're very confident just based on the robustness of the package that we've built and the data that we've generated that, you know, we should satisfy the FDA's requirements. And we've also engaged directly with the FDA and ensured that there aren't any open questions based on an outline that we've provided to them of the data we expect to provide. And so we think we should be in good shape on that front.

Yeah.

Apoorva Chiluri: Great. Thanks, Brian.

Operator: You're welcome.

Brian Sullivan: There are no further questions at this time. I'd like to turn the call back to Mr. Brian Sullivan for closing comments. Sir, please go ahead.

Operator: Well, thank you for participating in our call today, and thank you for your ongoing support. And I look forward to catching up with you at various conferences along the way. Take care.

Brian Sullivan: Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.