Celcuity at Jefferies Conference: Strategic Advances in Cancer Research

On Thursday, 05 June 2025, Celcuity (NASDAQ:CELC) presented at the Jefferies Global Healthcare Conference 2025, sharing updates on their innovative cancer treatment programs. The company is making strides with its studies targeting the PI3K AKT mTOR pathway, aiming to address unmet needs in breast and prostate cancer. While the outlook is optimistic, challenges such as regulatory hurdles and competitive pressures remain.

Key Takeaways

• Celcuity is progressing with three active cancer programs, focusing on the PI3K AKT mTOR pathway.
• The VICTORIA-one Phase III study in wild-type breast cancer is on track, with data expected in Q3 2025.
• The company plans to submit a New Drug Application (NDA) by the end of the year.
• Financially, Celcuity holds $206 million in cash, funding operations through 2026.
• The prostate cancer study will provide data by the end of this quarter.

Financial Results

• Celcuity ended Q1 with approximately $206 million in cash reserves.
• This financial position is projected to support clinical programs until the end of 2026.

Operational Updates

• VICTORIA-one Phase III Study (Wild-Type Breast Cancer):

- The study’s event threshold has been met, with data expected in Q3 2025.

- Four interim safety analyses showed no adverse feedback from the independent data monitoring committee.

• Mutant Type Cohort (Phase III Study):

- Enrollment is ongoing, with results anticipated by the end of 2025.

- Potential delays in event recording are the primary risk factor for the timeline.

• VICTORIA-two Study (Frontline Breast Cancer):

- Approximately 200 sites in 20 countries are planned for activation.

- The enrollment period is expected to mirror VICTORIA-one, spanning a couple of years.

• Prostate Cancer Study (Phase 1B):

- Data readout expected by the end of this quarter.

- Safety and progression-free survival (PFS) rate at six months are the primary endpoints.

Future Outlook

• Regulatory Pathway:

- Celcuity aims for a real-time oncology review and may seek priority review.

- The goal is to achieve approval by mid-2026.

• Commercial Adoption:

- Launch preparations began last year, with a mid-2026 target for market entry.

- The intravenous administration of their drug is not seen as a barrier to adoption.

Q&A Highlights

• Event Threshold:

- The VICTORIA-one study is on track to meet its event threshold in June.

• Top Line Readout:

- The readout will include median PFS for the three arms and the hazard ratio.

• Clinical Meaningfulness:

- A three-month median benefit is seen as practice-changing.

• Unmet Need:

- Addressing PIK3CA mutations is a critical unmet need in cancer treatment.

Celcuity continues to advance its strategic goals, with promising developments on the horizon. For further details, please refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Maury Urecroft, Biotech Analyst, Jefferies: All set? Yep. Okay. Morning, everyone. My name is Maury Urecroft, and I’m one of the biotech analysts at Jefferies.

It’s with great pleasure that I’d to welcome the CEO of CellCutti, Brian Sullivan. Thanks so much for joining us today, Brian. Oh, you’re welcome. And we’re gonna do fireside chat format. So maybe for those who are new to this story, if you

Brian Sullivan, CEO, CellCutti: can give a one minute intro to CellQID. Sure. So I started the company initially to develop a platform that could quantify the signaling activity in a patient’s live tumor cells. And we’ve since migrated to developing therapies that target the PI3K AKT T mTOR pathway or PAM pathway. This pathway, PAM pathway, is probably one of the most complex and also important pathways in cancer.

And that’s led it to be probably, we think, the largest untapped development opportunity in oncology. We have three current programs that are active, two in breast cancer, one in prostate cancer. Ones in breast cancer are both phase three. We’re currently expecting to read out soon results from a phase three study. And the second line for women who have HR positive HER2 negative advanced breast cancer, well we have two cohorts.

We’ll be reporting a cohort of patients that are PIK3CA wild type in the next few months. Second cohort, PIK3CA mutant patients will be reporting out sometime by the end of next year, of this year. Second breast cancer study is a phase three study in women with first line advanced breast cancer, HR positive, HER2 negative. And then the third study we have is at an earlier phase in prostate cancer. It’s evaluating men who have metastatic castration resistant prostate cancer in the second line.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Yeah, it’s a great overview. And you mentioned a big near term catalyst, your VICTORIA-one Phase III study in second line wild type patients. And that’s guided to have enough events by June with data expected in the third quarter of this year. Can you confirm whether the June event threshold has been met and if the data lock has occurred yet?

So we’re on track.

Brian Sullivan, CEO, CellCutti: We expect to be able to report data in the third quarter. So all things are going according to schedule we laid out previously.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. And you still expect to meet the event threshold in June then?

Brian Sullivan, CEO, CellCutti: Yes. Okay.

Maury Urecroft, Biotech Analyst, Jefferies: Got what are your latest thoughts on what will be included in the top line readout event? And what would be reserved for a medical meeting presentation or publication?

Brian Sullivan, CEO, CellCutti: Sure. We would expect to report out median PFS for the three arms. The three arms are triplet with geta, palbofilvestrant, another arm with geta, fulvestrant, the third arm, the control with fulvestrant. We’d report out the median PFS for each of those arms as well as the hazard ratio. There are two primary analyses, one comparing the triplet versus fulvestrant.

And then the second primary endpoint is comparing the doublet versus fulvestrant.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. Wondering, have there been any safety interim analyses from the wild type cohorts and have you had visibility into the safety signal from each specific arm?

Brian Sullivan, CEO, CellCutti: Sure. Our protocol required four interim safety analyses performed by an independent data monitoring committee. We didn’t get any feedback from those, which is generally favorable, nor did we get any requests to modify the protocol based on any safety signals they may have seen. So overall we interpret that as favorable, but it’s not very specific.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. And there have been a few adjustments to the readout timeline and you previously mentioned having visibility into the number of events every couple of weeks. Can you clarify if you only have visibility into the total number of trial events or do you have specific visibility into each treatment pair?

Brian Sullivan, CEO, CellCutti: Sure. So we’re blinded to the event data for the individual arms as we’re blinded to everything else. And so we only see the event totals in aggregate for all three arms. And then from that we try to correlate that to the two different event thresholds that we have to meet. One is for the A versus C analysis, triplet versus fulvestrant analysis, and then a separate one for the doublet versus fulvestrant analysis.

Both thresholds have to be met and that would trigger our ability to perform the primary analysis.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And so you don’t have any specific insight into those individual thresholds? No, we don’t. Kind of extrapolate.

Brian Sullivan, CEO, CellCutti: Right. We get told from a statistician that’s independent of us, it’s associated with the independent data monitoring committee, the IDMC. And when that threshold’s hit, he alerts us. Got it.

Maury Urecroft, Biotech Analyst, Jefferies: Okay. And then regarding OS data, when do you expect to see an early trends from the three arms? And what is the expected timeline for mature OS data?

Brian Sullivan, CEO, CellCutti: Sure. So at this stage of a study, the overall survival data is typically immature. You just don’t have enough events. There haven’t been enough deaths to draw any real statistical confidence in what the results mean. FDA typically is looking at interim OS data to, in effect confirm that there’s not a detriment in the study arm relative to the control in overall survival.

It takes typically at least a couple years for that data to mature And that’s why you see a significant lag factor with survival data relative to the initial study reports. In the second line setting, the overall survival data hasn’t typically been weighed heavily because it’s confounded by subsequent therapies and changes in therapeutic therapies used. So it’s really just a check for the most part.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. So basically no detriment is kind of what you want to Exactly. Got it. Okay. And with multiple SERDs being developed in both the second line and frontline settings, it seems likely that more are going be approved in those lines.

What are your thoughts on the SERDINO six study presented at ASCO and generally the SERD landscape? Sure.

Brian Sullivan, CEO, CellCutti: So the SERDINA six study is really a first line study. Basically these patients were continued treatment without a progression. The only change in their treatment was switching from letrozole to that SERD. And so we wouldn’t expect it to have any impact on us because those patients will progress eventually and they would become eligible for our treatment assuming everything works out the way we want. I think the biggest impact probably would be on oral SERDs because we’ve heard from a number of KOLs, ASCO just wrapped up and we had a lot of meetings with KOLs and that question came up.

And there are two issues with that study. One is just the practicality of it. So I think there’s some question about how widely deployed that regimen would be or that protocol. But secondly, I think there’ll be a question in some oncologists’ minds whether they want to retreat with a subsequent oral SERD if they’ve already given an oral SERD in the first line setting. So I think the impact, if there is any, would likely be confined to the different oral SERDs that are being developed.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And digging deeper into that, do you think there’s going to be potential for SERDs to be used in the ESR1 wild type population in second line, especially in light of Arvindis management’s 1Q earnings comments where they said they believe ER therapies will be restricted to patients of ESR1 mutations.

Brian Sullivan, CEO, CellCutti: I think these therapies, I mean, had great promise. I think everybody had high expectations. But I think we’re zero for five in oral SERDs being evaluated in this setting for ESR1 wild type patients. And so I think it would be very, very surprising, I guess, and you’d have to assign pretty low probability to them demonstrating activity or improvement in activity relative to fulvestrant in ESR1 wild type patients. So my sense is that’s going to be the population.

It’s roughly thirty to forty percent depending on the study of patients who have that mutation and that’s likely where that those drugs will primarily be used, in the second line at least.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And with the EMBER three study, we see a difference between the blinded independent central review and then the investigator assessment. But in the VERITECK II study, we’re not really seeing that difference. And that data was just presented at ASCO recently. Can you discuss the trade offs and historical differences in breast cancer outcomes between a BICR analysis and investigator assessed measures?

Brian Sullivan, CEO, CellCutti: Sure. So blinded independent central review, BICR, is typically required when the investigators, the oncologists, aren’t blinded to which treatment’s being used. And the reason why they want blinded assessment is they want to eliminate the bias that could come from interpretation of progression or not by these investigators. And so you saw with another SERD, elacitrant, the EMERALD study, well as VERITAC-two, both had blinded independent review Bicker assessed PFS as their primary endpoint. You tend in those studies not to see a wide discrepancy between the BICR result and the investigator assessed PFS.

It was interesting to us that the EMBER three study used investigator assessed PFS as their primary endpoint. And so when you have BICR as essentially a secondary endpoint, essentially it’s used as a confirmatory endpoint of the investigator assessed, you can have a less rigorous imaging charter. And so without seeing the details of that charter, it’s hard to really explain why they see that discrepancy. Because again, shouldn’t be much discrepancy. But if they have for instance, they don’t In our charter for instance, an example, you have multiple reviewers of the scans.

You have an adjudication if there’s a discrepancy between the two reviewers conclusions. And so you really confirm in a rigorous way whether there’s been a progression. Charters may have less substantive control over those assessments or rather less rigorous requirements for those assessments if it’s not the primary endpoint.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Anything else about the charter that you can say for yours? I guess is there a good benchmark in the space?

Brian Sullivan, CEO, CellCutti: Mean I think you basically comply with what’s expected. Now if you have a primary endpoint, you’re not inventing these charters. You’re using convention and you want to make sure you’re not deviating from what the FDA expects. And in our case, the FDA was pretty clear that given the different routes of administration, the investigators unblinded to the treatments. They expected us and essentially they always recommend, you know, that’s the FDA’s way of saying do it this way, that we use the BICR assessed PFS as our primary endpoint.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay, interesting. And is variability between these two different measures a key reason why you’re focusing on hazard ratio to compare data sets, or are there other factors?

Brian Sullivan, CEO, CellCutti: No, the hazard ratio focus isn’t really at all related to this BICR versus investigator assessed PFS. That gets more to study conduct and other factors. Got it. The hazard ratio really is a reflection where we think the relevance of the hazard ratio is important, particularly when you’re trying to compare results, which physicians have to do when they’re trying to select a therapy, between studies that have pretty substantial differences in the patient populations. Up until recently, you had fairly consistent homogenous populations that allowed you to just more easily compare the results side by side.

But recently, EMBER three is a good example. You had multiple subgroups being evaluated in one study. You had patients who were first line and second line, CDK, not prior CDK and one primary endpoint that’s in effect combining the analysis for all those patients. So very hard to interpret just the top line number because the control result is not possible to interpret. So then it’s important to evaluate the relative benefit that you get to control.

Hazard ratio allows you in a very rigorous way to assess that reduction in risk. Another, you know, kind of poor man’s hazard ratio is just to look at the ratio of the study drug result versus the control to compare that ratio that, you know, in effect the potential multiple improvement relative to control. And certainly investigators will look at the difference in PFS benefit from the control to the study drug. So they’ll do a holistic assessment. Hazard ratios is probably just the most rigorous way to really assess that reduction in risk, which is the whole point of these studies, is to demonstrate that the study drug reduces the risk of progression for these patients in a statistically significant way.

Maury Urecroft, Biotech Analyst, Jefferies: Got it, yeah, makes a lot of sense. You’ve got hazard ratio to account for the different subgroups within the study. And then you could also look at the PFS delta as a good indicator. Exactly.

Brian Sullivan, CEO, CellCutti: And then the ratio, right? You know, four month delta on top of five months is not as good as a four month delta on top of two months, as an On a relative basis, you really look for how that control did relative to the study drug.

Maury Urecroft, Biotech Analyst, Jefferies: Makes sense. Okay. And then given that Veritac II reported a median PFS of 3.6 months for the fulvestrant arm with a bicker analysis, do you think it’s reasonable to assume a medium PFS of three to four months for the control arm in your VICTORY-one study?

Brian Sullivan, CEO, CellCutti: I do, but I think it’s important to note that the VERITAC-two study excluded patients who are endocrine resistant. You know, these are patients who had less than six months median PFS on their prior endocrine therapy. And so they enriched essentially for endocrine sensitive patients. Our study doesn’t have that exclusion criteria. We essentially have an all comer when it comes to endocrine sensitivity status.

And so that would introduce probably an upward bias in the median PFS in that study. Interestingly at ASCO, another phase three study was reported in a patient population very similar to ours. It was the finer study compared an AKT inhibitor versus fulvestrant. That study reported 1.9 months median PFS. And that’s consistent with some other studies that have been performed.

Emerald study for instance where elastrotrin was 1.9 months. Three other randomized studies have shown results in that two to two and a half month range. So we’ll see soon enough, but probably south of three would, based on those studies, be more likely than north of three.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. Interesting. And another area of debate is the doublet arm. And so do you expect to see meaningful differences between the two active arms based on your preclinical and clinical observations?

Brian Sullivan, CEO, CellCutti: We would expect to see a difference and that’s primarily because our nonclinical data shown and other non clinical data from other researchers has shown that an inhibitor of this pathway, PAM pathway, can resensitize tumor cells to CDK inhibitors if those tumor cells had previously stopped responding to CDK4six inhibitors. So the inclusion of palbociclib in our study arm A is intended to essentially block the activity that GETA could induce, I. E. Reactivating that CDK4six inhibitor and then the PALO will block that activity. And as a result, we would expect to see a delta between arm A versus arm B.

Maury Urecroft, Biotech Analyst, Jefferies: Got him. And also on safety, how are you evaluating the tolerability trade offs between the triplet and doublet?

Brian Sullivan, CEO, CellCutti: Sure. Well in the early phase study with the phase three dosing, we reported treatment discontinuation rate due to adverse events of roughly four percent. So which is very good. Essentially it’s if you were to compare it to trials that just evaluate CDK4six and fulvestrant or letrozole, you you’d see discontinuation rates above six percent. So we’re not saying we’re better than that, but we’re saying it’s unlikely GETA adds, at least that data suggests adds incremental level of toxicity that prevents patients from staying on the regimen.

And so we think the only difference in outcome between, in safety related outcomes between the doublet and the triplet arms will likely just be associated with palbociclib. You know, GET is a very stable molecule, doesn’t metabolize. Drug drug interaction is really nominal and very little overlap between the different drugs in terms of their toxicity profiles. And so obviously you’d have to justify use of Palbo on the basis of incremental efficacy. But we don’t think the safety delta will be that relevant in comparing the two.

Depending on the patient. Certainly if they’re more immune compromised, if they’re elderly patients, potentially use of CDK inhibitor which potentially can, you know, just induces some myelosuppressive adverse events. And, you know, doctors may like to have that option of not including Palvo in the regimen. But for otherwise, you know, patients that have, you know, stronger immune systems, they’re, you know, more generally healthy. If the data warrants it, the efficacy data warrants it, I don’t think the safety of the triplet would be a barrier.

In fact, you know, we would hope the safety of our triplet, you know, at least with the early phase data suggests we could be safer than the other doublets that are being offered or more tolerable, I want to be careful, more tolerable than the doublets that are being developed in this space.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And so if both the triplet and the doublet succeed, you get both of those in the label and the doctor would have the option whether they

Brian Sullivan, CEO, CellCutti: would Potentially, sure. Okay.

Maury Urecroft, Biotech Analyst, Jefferies: Going back to the prior question, if you think the control arm comes in south of three months potentially, just based on how long the study’s been going, that implies that the treatment arms could be doing really well unless I’m missing something. I guess what are some of the other variables then?

Brian Sullivan, CEO, CellCutti: You know, just can’t really speculate at this stage. We’ll see. The data’s going to come out in just a bit and it’ll be what it is. I can hope what it’ll be, but we think with all the data out there for the control arm, can draw a reasonable estimate of what you think that’s likely to be and then draw your own conclusions about the implications the study drug.

Maury Urecroft, Biotech Analyst, Jefferies: Got it, okay. And assuming a positive wild type readout, how soon after top line disclosure do you expect to file the NDA and will you pursue the real time oncology review or priority review based on the strength of the PFS and hazard ratio data alone?

Brian Sullivan, CEO, CellCutti: Sure. We would like to be able to submit an NDA before the end of this year. Obviously it depends on the timing of when our data is available. But we’re working towards that. We’ve essentially been preparing the NDA and the various modules and the various documents required you know, for the past year and laying the groundwork for that.

As far as the regulatory pathway, we will request a real time oncology review. You know, it’s up to the agency’s discretion, somewhat dependent on their workload. We’ll provide a data package that will become the basis for their determination whether or not we qualify for that. Again, somewhat dependent on their workload. If we don’t get accepted into that pathway, certainly we would request a priority review.

You know, both pathways, again depending when our NDA is submitted, we think would lead to an approval or at least we would work towards an approval mid year ’26.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And for the real time oncology review, what do you need to demonstrate to justify eligibility?

Brian Sullivan, CEO, CellCutti: Sure. It’s somewhat similar to the criteria used to determine whether you qualify for breakthrough therapy designation. So, you know, our regimen qualified for breakthrough therapy designation in 2022 on the basis of our early phase data. And those determinations are a function of what the agency’s perception of the unmet need and the potential benefit that our regimen would offer of those patients. So if on the basis of the data, they think it’s important to advance as quickly as possible the regulatory review, then they would grant us, I mean that would be the expectation at least, that would be the hope.

But again, it is somewhat workload dependent because this puts a burden on the agency right away and essentially within weeks of getting, let’s say we qualify and they accept our request, you start submitting data. And so the review begins almost immediately. And the agency has to be ready and have reviewers in a position to keep up with the submission of data.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. And as it comes to commercial adoption, can you talk about launch prep and strategy for driving adoption in community oncology settings where familiarity with IV PI3K inhibitors for wild type patients may be limited?

Brian Sullivan, CEO, CellCutti: Sure. So we began initial preparation when we hired our chief commercial officer last year and then senior people under him. And so essentially we developed a launch plan. We’ve begun work on a variety of components of that plan that have long lead time items. And so we’re essentially tracking towards, let’s say a launch midyear next year, working back from that.

And so that work is included among other things, you know, interviews, research, blinded research with different types of oncologists, KOLs, community docs. One of the questions we ask is what impact, if any, does get us out of administration, intravenous administration, have on their likelihood of using the drug? And what’s important to note is that, you know, the guidelines as well as just obviously intuitively, these oncologists are focused and their priority is finding the therapeutic therapy or therapeutic regimen that offers the most efficacy. What’s gonna increase the likelihood of or reduce the risk of progression or death as much as possible? And then safety, how well can these patients tolerate it?

Is there a decrement in their quality of life? And then convenience. And so convenience, if let’s say it’s an oral therapy, is most relevant if these other two variables, I. E. Safety and efficacy are the same.

If it’s not the same, if let’s say our regimen offers incremental efficacy benefit and is well tolerated, The route of administration from what we’ve heard won’t be a barrier at all in community docs to using Ghetto as an intravenously administered drug. In fact, for a lot of these docs it’s actually an advantage. You know, an infused drug is considered a medical benefit. So it has a much easier pathway for reimbursement purposes. Medical benefits don’t involve co pays that patients may be responsible for.

So you have less financial risk for the patient. And these doctors are able to recover costs. They see these patients, there’s a benefit to that, just ensuring that the patients are seeing, are using the drug, etcetera. And it’s also important to point out that the largest drugs in breast cancer were amongst the largest drugs, are infused drugs. Know, Keytruda and HER2, Herceptin, Brigetta, you know, this whole class of or rather this whole this tumor type has really been advanced on the basis of infused therapy.

So these doctors are well, you know, very comfortable treating patients with drugs like Ghetto that have that route of administration.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Makes sense. And based on reimbursement, they’re somewhat incentivized to use an infused drug.

Brian Sullivan, CEO, CellCutti: Potentially. Yes, exactly.

Maury Urecroft, Biotech Analyst, Jefferies: Okay. And maybe shifting gears to the mutant part of the Phase III study. Those results are expected in fourth quarter of this year by the end of the year. Will the mutant type top line disclosure mirror the wild type format with showing PFS and hazard ratio? Or is it going to be are you going to have more details in there?

Brian Sullivan, CEO, CellCutti: It’s a little early for us to commit to any particular disclosure strategy since it’ll be somewhat dependent on the proximity towards to a major medical meeting. But certainly we understand the importance of being able to provide an update as soon as the data is available. But it’s somewhat circumstantial or situational.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. And what are the expectations for this readout and what delta and median PFS would you consider clinically meaningful?

Brian Sullivan, CEO, CellCutti: It’s somewhat similar to what we’ve heard from oncologists in the wild type setting. Essentially if you can offer patients and the physicians incremental benefit of three months median they’ll consider that practice changing and that would, you know, lead them to motivate them to prescribe that for their patients. And mutant would have a similar delta expectation.

Maury Urecroft, Biotech Analyst, Jefferies: Okay. And is enrollment now complete for the mutant type cohort? And do you expect the end of year readout timing to hold? Or what are the key risks to the timeline?

Brian Sullivan, CEO, CellCutti: Sure. No. So enrollment’s on track and ongoing. And we’re kind of monitoring the event threshold as we go. And we’re still on track to reporting data out before the end of this year.

To the extent it pushes out just based on the current enrollment trends and kind of consistency of those, we think it would be related just to delays in recording events.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay, makes sense. And I wanted to ask about the frontline study. Enrollment for the VICTORIA-two study is expected to start second quarter of this year. Have you started opening sites and how long do you anticipate full enrollment could take for this study?

Brian Sullivan, CEO, CellCutti: Sure. So we have started opening sites, activating them. We expect to activate roughly 200 sites in 20 different countries and that process has begun. We have a number of active sites now. And enrollment, you know, again, early to try to estimate that, but I think it would probably be similar to the enrollment period for Victoria one, you know, a couple years.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. And maybe talk about this study and expectations for PFS in the control arm here and also active arms. And do you expect learnings from Victoria one to influence any adjustments or how you view the probability success for the frontline?

Brian Sullivan, CEO, CellCutti: Sure. A study was done in the frontline for this patient population by Genentech and they used as a control, palbociclib and fulvestrant. And a study hadn’t really been done that evaluated these patients. And these are patients who are receiving their first treatment for metastatic disease, but they’re considered to be endocrine resistant. You know, they didn’t get a significant benefit from their adjuvant endocrine therapy.

They progressed either while they were receiving it or within twelve months. And so they reported about seven months median PFS for that control and that provides good foundation for our control assumption. It also happens to be about the same number, same median PFS that alpulipsib for instance, which is our control in our Victoria one study reported. And so in some ways this first line study given the patient population has the characteristics of a second line study in terms of duration and control assumptions.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. So you’ve got a good benchmark there to help you?

Brian Sullivan, CEO, CellCutti: Yes, yes we do. Got it.

Maury Urecroft, Biotech Analyst, Jefferies: Okay. And do you find the ANAVO-one 20 phase three study which tested Invalisib, Palbo, and Fulvestrant, do you find that to be a proper benchmark here? But this is only in the PIK3A mutant.

Brian Sullivan, CEO, CellCutti: I think it provides a proof of principle of what we’re doing. I’m not sure it’ll be a benchmark because that study and that drug is only approved for patients that have PIK3CA mutations. So it’s not going to treat the sixty percent of patients that lack PIK3CA mutations. And secondly, that drug has very similar characteristics as alpalypsib in terms of its ability to induce hyperglycemia. And so in the study to essentially manage that, they excluded patients who were either pre diabetic or were type two diabetic.

So they had to have very low A1C levels, you know, glucose levels for patients to enroll. We won’t have those exclusions. And so we’d essentially, if the trial works out the way we hope it would, we’d be able to essentially treat all comers independent of PIK3CA status, independent of glucose status. And as a result, we think our results, assuming we show benefit relative to control, would stand on their own and offer doctors a single regimen that they could use to treat all their patients.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And that frontline Genentech study that you just referenced, was that a phase three study? Which one? The AKT study? Bulbous fulvestrant.

Brian Sullivan, CEO, CellCutti: Yes, that was the INNOVA one hundred twenty study. Oh, got it. Yeah.

Maury Urecroft, Biotech Analyst, Jefferies: Okay. Got it. Yeah. And let’s shift gears to prostate cancer. Sure.

You’re testing gadadolizumab and darolutamide in combo at two different doses in a phase 1B with 18 patients in each cohort followed by a dose expansion at 12 patients at the recommended Phase two dose. What should we expect from the readout there expected by the end of this quarter? And will you disclose safety and RPFS data?

Brian Sullivan, CEO, CellCutti: Sure. The two primary endpoints in that study, one are safety endpoints. You know, essentially you’re assessing whether there are any dose limiting toxicities. So we would expect to report, you know, high level summary of safety as well as the efficacy endpoint which was PFS rate at six months, essentially landmark analysis at six months. And then we would present a more detailed, more complete dataset at a subsequent medical meeting.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Okay. And how are you thinking about the role of PSA response in this setting given gadalafib’s non AR medications? So we don’t

Brian Sullivan, CEO, CellCutti: think it’ll be relevant. Mean, certainly it’s one of the secondary endpoints. We’ll look at that. Other studies that have been done with PI3K inhibitors and with androgen receptor inhibitors haven’t necessarily shown significant deltas. So we’ll see.

I mean, obviously, the most relevant clinical characteristic is whether or not these patients’ disease is, the progression of it is being delayed. And that’s why PFS is the primary endpoint. PSA is an interim analysis that allows you to get a quick read on potential drug activity, confirms mechanism. But in our study PFS will be what determines the activity or allows us to assess the activity of the drug regimen in that patient population.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. And quickly for Victoria one, are you going to announce when the database is locked and enter a quiet period? Maybe just talk about the logistics. So we’ll

Brian Sullivan, CEO, CellCutti: we’ll you’ll see a press release cross the wire when we have the data, and that’ll include the top line results we just discussed. Got it.

Maury Urecroft, Biotech Analyst, Jefferies: Okay. And maybe just to close out, if you can comment on cash position and key catalysts ahead that

Brian Sullivan, CEO, CellCutti: So we ended Q1 with around $2.00 $6,000,000 in cash that would take us through the end of twenty six with our clinical programs. And so several key milestones. Just talked about the wild type in the second line patient population. We think that’s going to be a big deal. Significant patient population, big unmet need.

Know, preliminary data gives us a reason for optimism, but we’ll see. And we’ll have subsequent data in this study, another, you know, phase three readout for the mutant population end of this year. And then we’ll have an update with our prostate cancer study this quarter. And so we’ll have a fair amount of data for people to assess gadatholusib.

Maury Urecroft, Biotech Analyst, Jefferies: Got it. Look forward to these updates. Thanks so much for joining us today.

Brian Sullivan, CEO, CellCutti: You’re welcome.

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