Celcuity Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 14, 2025

Key Takeaways

  • Positive Sentiment: Top‐line Phase 3 VICTORIA-one data: getafelicitinib triplet and doublet met both co-primary endpoints in PIK3CA wild-type HR+ HER2- advanced breast cancer, showing unprecedented hazard ratios of 0.24 & 0.33 and 9.3 & 7.4 months median PFS vs 2 months for fulvestrant.
  • Positive Sentiment: First patient dosed in Phase 3 VICTORIA-two trial evaluating getafelicitinib with a CDK4/6 inhibitor and fulvestrant as first-line therapy in HR+ HER2- advanced breast cancer.
  • Positive Sentiment: Early-phase trials showed encouraging efficacy and safety: a 66% six-month radiographic PFS rate in metastatic castration-resistant prostate cancer and a 43% overall response rate in heavily pretreated HER2+ PIK3CA mutant breast cancer.
  • Positive Sentiment: A new dosing regimen patent extends getafelicitinib’s U.S. exclusivity into 2042, ensuring long-term protection and a clear development runway.
  • Positive Sentiment: Completed concurrent financings raising $286 M and holds pro forma ~$455 M in cash and equivalents, securing funding into 2027 to support development and potential commercial launch.
AI Generated. May Contain Errors.
Earnings Conference Call
Celcuity Q2 2025
00:00 / 00:00

There are 9 speakers on the call.

Operator

Good afternoon, ladies and gentlemen, and welcome to the CellCurity Second Quarter twenty twenty five 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. I would now like to turn the conference over to Apara Vachaluri with ICR Health Care. Please go ahead.

Speaker 1

Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's second quarter twenty twenty five financial results and business update. Earlier today, Celcuity, Inc. Released financial results for the second quarter ended 06/30/2025. The press release can be found on the Investors section of Celcuity's website.

Speaker 1

Joining me on the call today are Brian Sullivan, Pell Cudi's Chief Executive Officer and Co Founder Vicki Hahn, Chief Financial Officer as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q and 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. 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.

Speaker 1

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 Silcuity.

Speaker 1

Please go ahead.

Speaker 2

Thank you, Oforova, and good afternoon, everyone. Thank you for joining our second quarter financial results conference call. Past few months have been eventful once for Celcuity. We achieved several significant milestones, and we believe these milestones lay the foundation for us to potentially establish get us a listen as a new standard of care therapy for patients with HR positive or two negative advanced breast cancer. First, and most importantly, of course, with the positive top line data we've reported from the PIK3CA wild type cohort of our phase three, Victoria one clinical trial in patients with HR positive HER2 negative PIK3CA wild type advanced breast cancer.

Speaker 2

Gadgets elicit plus fulvestrant and polycyclic or the gadgets elicit triplet and gadgets elicit plus fulvestrant or gadgets elicit doublet met the studies two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression free survival or PFS versus fulvestrant. 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 PIK3K 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, virtue negative advanced breast cancer as we seek to advance get it to listen as a therapeutic option for patients with or without PIK3CA mutations in both the second line and first line settings. Second, important milestone achieved was the dosing of the first patient in our phase three Victoria to clinical trial.

Speaker 2

This trial is evaluating get a solicit in combination with a CDK, four, six inhibitor and fulvestrant as first line treatment for patients with HR positive for two negative advanced breast cancer. The third milestone was the announcement of favorable preliminary top line results from two early phase clinical trials. One evaluating get a felicitinib and darolutamide and then with metastatic castration resistant prostate cancer. And the second, one that evaluated get a solicit and a trastuzumab biosimilar in patients with HER2 positive, PIK3CA mutated metastatic breast cancer. Fourth milestone was the extension of our patent exclusivity for get a solicit into 2042 with the issuance of a new dosing regimen patent for get a solicit.

Speaker 2

And finally, we raised around $287,000,000 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 Get It To Listen should we get FDA approval next year. I'd like now to turn to the VICTORIA-one trial. Last month we announced top line results from this trial. Medium progression free survival or PFS for the gadatholitinib triplet was nine point three months compared to only two months for fulvestrant, seven point three months incremental improvement in medium PFS. The hazard ratio was 0.24, which translates to four point two times higher likelihood of survival without disease progression for the gadgets elicit triplet than fulvestrant.

Speaker 2

For the gadatholicit doublet, median PFS was seven point four months again compared to only two months for fulvestrant, five point four months incremental improvement in median PFS. The hazard ratio was 0.33, which translates to three times higher likelihood of survival without disease progression where they get a solicit doublet and 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 get a triplet and doublet were the most favorable ever reported by any phase three trial first line, second line or third line in this population. And second, the incremental improvements in median PFS for the triplet and doublet seven point three and 5.4 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.

Speaker 2

And third, getafelicitinib 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 foursix inhibitor. 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 range from 1.7 to 3.9 months And the hazard ratios ranged from 0.55 to 0.73. Both gadgets elicit 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 1b study in this patient population. In light of the favorable safety profile, more favorable hazard ratios and longer incremental PFS with the GetaFelicit regimens than the other currently available or investigational agents, we believe both GetaFelicit triplet and doublet each have the potential to establish a new standard of care for these patients.

Speaker 2

We're on track to submit a new drug application to the FDA in the 2025 for data 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. Additionally, we expect to release top line data for the VICTORIA-one PIK3CA mutation cohort by the 2025. Moving on, I want to share just a quick overview of the market landscape we see for get it to listen and how we're gearing up for potential launch should we get FDA approval. We think the market looks very promising for get us to listen.

Speaker 2

We estimate there are thirty four thousand patients moving to second line treatment after progressing on a CDK foursix inhibitor and roughly sixty percent of them are PIK3CA wild site. 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 medium PFS. We've got a solicit unique mechanism of action corresponding clinical benefit.

Speaker 2

It's well positioned 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. And as we've discussed on prior calls, efficacy and safety are the two primary criteria oncologists use to select therapies for their patients. It's 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 Gadafelicit will be very well received in the community practice setting where over eighty percent of patients are treated.

Speaker 2

Gadafelicit will fall under the medical benefit category, which means 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. And unlike oral drugs, IV administered therapies also allow physicians to recover costs associated with a purchase and administration of therapy and to better ensure patient compliance with a 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 get us listed specifically. As a result, we believe Celcuity has the opportunity to build strong presence amongst medical oncologists to address this large underserved patient population.

Speaker 2

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 $5,000,000,000 I'd like now to turn to our phase three VICTORIA-two trial. Last month we announced that we dosed the first patient in Victoria two that's evaluating get a solicit plus a CDK foursix 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 foursix 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. It's only about seven to eight months and highlighting the significant need for more efficacious frontline therapy for these patients.

Speaker 2

We believe the positive top line data from the PIK3 say wild type cohort of our Victoria one study, ours well for the get a solicit triplet in this patient population. I'd like now to turn to our phase 1btwo clinical trial that's evaluating gadaselicit in combination with darolutamide in men with metastatic castration resistant prostate cancer. In late June, we announced encouraging Phase 1b preliminary efficacy and safety data from this study, which enrolled thirty eight prostate cancer patients who were randomly assigned to either receive eighty milligrams of darolutamide twice daily combined with either one hundred and twenty milligrams of getafelecip in arm one or one hundred and eighty milligrams of getafelecipin arm two. And getafelecipin administered once weekly for three weeks and then one week off in both arms. The preliminary analyses for the combined arms.

Speaker 2

Show the six month radiographic PFS rate was sixty six percent, 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. There were no treatment related discontinuations and less than three percent of patients experienced grade three stomatitis. Instead indicate that the optimal get a felicit dose for this patient population may not yet have been reached. And we believe it's important to explore additional dose options for get it to listen.

Speaker 2

And as such, we amended the clinical trial protocol to enable exploration of additional doses in the Phase 1b 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, forty four patients with HER2 positive PIK3CA mutated breast cancer were treated with getathelicit plus standard doses of a trastuzumab biostimulant. 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 2

Eighty six percent of patients had received at least three prior anti HER2 therapies, so these patients were heavily pretreated. The overall response rate was forty three percent and no patients discontinued getathelicit due to a treatment related adverse event. Achieving forty three percent 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 to get it listed in combination with HER2 targeted therapy, maybe 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.

Speaker 2

First, U. S. Patent and Trademark Office issued Celcuity a new patent covering the clinical dosing regimen for Gettifilicit and HR positive HER2 negative breast cancer patients. The patent extends Gettifilicit's patent exclusivity in The U. S.

Speaker 2

Into 02/1942. And with this added patent exclusivity, we expect to have a long runway to optimize development of Geditalisib. And last but not least, we also completed concurrent offerings of convertible notes, common stock and pre funded warrants with net proceeds of $286,000,000 and a half million dollars at the July and 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 gadgets elicit commercially should we receive FDA approval. I'd like now to hand the call over to Vicki Hahn, our CFO to review our finances.

Speaker 3

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the 2025. Our second quarter net loss was $45,300,000 or $1.04 per share, compared to $23,700,000 net loss, or $0.62 per share, for the 2024. Our non GAAP adjusted net loss was $40,500,000 or $0.93 per share for the 2025, compared to non GAAP adjusted net loss of $22,200,000 or $0.58 per share for the 2024. Research and development expenses were $40,200,000 for the 2025, compared to $22,500,000 for the 2024.

Speaker 3

Of the approximately 17,700,000 increase in R and D expenses, dollars 6,600,000.0 was related to increased employee and consulting expenses, 6,100,000.0 was related to increased research and development costs, primarily attributable to activities supporting our ongoing clinical trials, and $5,000,000 is related to an anticipated development milestone payment under the license agreement with Pfizer. General and administrative expenses were $3,800,000 for the 2025, compared to $1,800,000 for the 2024. Of the $2,000,000 increase in general and administrative expenses, 1,600,000.0 was related to increased employee and consulting expenses. The remaining $400,000 of the $2,000,000 increase resulted from professional fees, expanding infrastructure, and other administrative expenses. Net cash used in operating activities for the 2025 was 36,200,000.0 compared to $18,100,000 for the 2024.

Speaker 3

We ended the quarter with approximately $168,400,000 of cash, cash equivalents, and short term investments. However, on a pro form a 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 twenty twenty five was approximately $455,000,000 Additionally, existing financing arrangements are expected to give us access to an incremental $116,000,000 of cash over the next few quarters. Dollars 80,000,000 from our current term loan agreement, and $36,000,000 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.

Speaker 2

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

Operator

Thank you very much. Ladies and gentlemen, we will now begin the question and answer session. Your first question comes from the line of Maury Raycroft from Jefferies. Please go ahead.

Speaker 4

Hi, this is Amin 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 PIC3CL wild type portion of the Phase III 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 one wild type and mutant cohorts there?

Speaker 4

And then I have a follow-up.

Speaker 2

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.

Speaker 4

Okay, sounds good. And for the PQC 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?

Speaker 2

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 epilepsy at fulvestrant. As it turns out, given what we think is the likely outcome based on historical data for Alpelipsib 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.

Speaker 2

Additionally, because epilepsy 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 Capavacitor and AKT inhibitor. And Capadata has 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 apolipsid, those will be especially positive relative to our Capavacitor.

Speaker 4

Okay, sounds good. Thank you.

Speaker 2

You're welcome.

Operator

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

Speaker 5

Hi, this is Frances on for Tara Bancroft. So, 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 with that overall rates or just grade three stomatitis?

Speaker 2

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.

Speaker 4

Thank you. Welcome.

Speaker 5

The next question is from

Operator

the line of Andrew Berens from Leerink Partners. Please go ahead.

Speaker 6

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 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-one or based on investigator assessment.

Speaker 6

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.

Speaker 2

Sure, 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 get a fluxib 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 the trials for the recent oral surge, the Emerald trial and the Veritec II trial were also BICR studies because again, not plausible to create a placebo for fulvestrant.

Speaker 2

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. 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. But into 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%, it might even have been 95%. And so we do not expect to have any issues on that front.

Speaker 2

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

Speaker 6

Great, thank you.

Speaker 5

The next question is from the

Operator

line of Stephen Wiley from Stifel. Please go ahead.

Speaker 7

Yes, 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.

Speaker 7

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?

Speaker 2

Sure. No, that's a great question. 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 twenty twenty four.

Speaker 2

And then he in turn brought on board head of marketing, 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 eighteen 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. 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.

Speaker 2

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 a Salesforce. There's activities in the market access area, engaging with payers, strategic accounts in ways that are appropriate at this stage.

Speaker 2

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, etcetera. So all those projects are on track. And as far as how are we doing, what is our benchmark, 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 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.

Speaker 2

It's not a plug and play if somebody coming from big pharma has never had to set up 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, 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 data, what we believe are the benefits of data to medical oncologists.

Speaker 7

All right. Thanks for taking the question. You're welcome.

Speaker 5

Your next question is from

Operator

the line of Gil Blum from Needham and Company. Please go ahead.

Speaker 6

Hi, this is Gil Blum for Gil. 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 I have a follow on.

Speaker 2

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 filaciclib also induces some myelosuppression, which for patients who could be elderly or have immune and immune system that may be more compromised, 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 and PFS. And so what we think having either regimen available does is allow us to have access to as broad range of patients as possible. And that's always great.

Speaker 2

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.

Speaker 6

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.

Speaker 2

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

Speaker 8

know what

Speaker 2

the headcount is and why we need to bring them on. The investment is not insignificant, but it's not ridiculous, to be frank. And relative to the size of the opportunity, 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 the launch.

Speaker 2

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.

Speaker 6

Thanks for taking our questions.

Speaker 7

You're welcome.

Operator

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

Speaker 8

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? There's obviously some other actionable mutations in there with ESR, etcetera. 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 it fitting in?

Speaker 2

So I think two things. I mean, for PIKTRSA mutation patients, we'll be reporting out that data later this year. Obviously, if our data is positive and shows benefit relative to epilepsy, we think that'll position us very well to establish 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 ESR1 mutations, we just don't think they'll be as relevant given the nature of the drug combination that we have.

Speaker 2

In the absence of inhibition of let's say CDK foursix 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 SERD to address that pathway. And at the same time, we think if you are addressing the pan pathway in CDK foursix, the relative difference in outcomes between the SR1 mutant and wild type patients is unlikely to be meaningfully different.

Speaker 8

Got it. Mainly maybe just on the mutant side to dig in a little bit there. Obviously, the most recent approval there with itavebi, I mean, can you just give us some thoughts as far as kind of how the market's changed in the last kind of ten, twelve months any relevant Sure. Comparisons

Speaker 2

So kind of still use the generic name inovolipid. That drug is an alpha inhibitor, it's approved for treating patients who have 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're addressing in our VICTURIA-two study. So that population doesn't overlap at all of the population that we'll be addressing with the Victoria one study results. And so the data does provide confirmation that in the frontline setting treatment naive patients have involvement of the PAM pathway in their disease and they'll benefit.

Speaker 2

In this case, this drug has only shown activity, unfavorable activity in patients that have a PIK3CA mutation. That drug also has some induces levels of hypoglycemia that can potentially limit its use to patients who are healthy metabolically, 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 get a 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-two study and we show activity generally, we think we have another opportunity to establish data as a potential standard of care.

Speaker 8

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 your manufacturer there, any specifics you want to give as far as your kind of confidence around your CMC package?

Speaker 2

We're very confident about the CMC package. We have all the data. Our modules are complete for CMC. There's a very prescribed set of studies that are expected analyses to be performed, you know, kind of number of demonstration 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 we should satisfy the FDA's requirements.

Speaker 2

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.

Speaker 4

Great. Thanks, Brian.

Speaker 2

You're welcome.

Operator

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.

Speaker 2

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

Operator

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

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