CELC

LLM Evaluations

Transcript Summary

Celcuity's Q1 2026 earnings call reported significant progress toward the commercialization of gedatolisib. Key highlights include positive top-line results from the PIK3CA mutant cohort of the VIKTORIA-1 Phase III trial, confirming the drug's efficacy across the entire second-line HR-positive/HER2-negative advanced breast cancer population. The company also expanded its VIKTORIA-2 Phase III study into the first-line setting, aiming to treat approximately 90,000 patients annually. To support long-term indications, Celcuity is developing a subcutaneous formulation, for which a patent has been filed. Financially, the company reported a net loss of $52.8 million, with an increase in SG&A to $17.4 million due to scaling up the oncology sales force and commercial operations. With $387.1 million in cash, the company remains funded through 2027. CEO Brian Sullivan highlighted the $5 billion market opportunity and a potential peak annual revenue of $2.5 billion for the second-line indication. Management remains optimistic about a 2026 FDA approval, noting that payer and provider outreach is well underway. Detailed clinical data will be presented at the upcoming ASCO 2026 meeting.

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Celcuity Inc.: High-Stakes Clinical Bridge Funded by Toxic Debt and Relentless Dilution

Full Earnings Call Transcript — Q1 • 2026-05-14

Operator: Good afternoon, ladies and gentlemen, and welcome to the Celcuity First Quarter 2026 Financial Results Call Webcast. [Operator Instructions] I would now like to turn the conference over to Jodi Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead.
Jodi Sievers: Thank you, Matthew, and good afternoon, everyone. Thank you for joining us to review Celcuity's First Quarter 2026 Financial Results and Business Update. Earlier today, Celcuity released financial results for the first quarter ended March 31, 2026. The press release can be found on the Investors section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer; and Eldon Mayer, Chief Commercial Officer, who will also 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. 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 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 will turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead, Brian.
Brian Sullivan: Thank you, Jodi, and good afternoon, everyone. Thank you for joining our first quarter 2026 operating and financial update conference call. We continue to make great progress as we prepare for the potential approval and commercial launch of gedatolisib in the third quarter. Achieving these milestones would be a pivotal moment for the women with advanced breast cancer who need new therapeutic options. With the groundbreaking data we have previously reported from the wild-type cohort and the recent announcement of positive data from the mutant cohort of our VIKTORIA-1 study, we believe gedatolisib is well positioned to become the new standard of care second-line therapy for patients with HR-positive/HER2-negative advanced breast cancer. It's been an eventful past few months for Celcuity. Last week, we reported positive top line results for the PIK3CA mutant cohort of the Phase III VIKTORIA-1 clinical trial, and we look forward to presenting detailed results at a late-breaking abstract oral session at the 2026 ASCO meeting on June 2. Given the timing of our ASCO presentation, we'll not be answering questions regarding these results during the Q&A portion of our call. Second, this morning, we announced 2 important updates to our clinical development plan. First, we announced the expansion of our Phase III VIKTORIA-2 trial to include a second study evaluating gedatolisib as first-line treatment in patients with endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. We're now positioned to evaluate nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status. And this offers the potential to advance the standard of care for the approximately 90,000 women each year who are newly diagnosed in the U.S. with HR-positive/HER2-negative advanced breast cancer. And secondly, we also announced this morning that we are advancing the development of a gedatolisib formulation for subcutaneous injection and that we have submitted our first patent application to the U.S. Patent and Trademark Office. The subcutaneous formulation is aimed at supporting potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years. And finally, we remain optimistic about the outcome of the FDA's review of our NDA, assuming our NDA is approved, we intend to submit the FDA a supplemental new drug application based on the results of the PIK3CA mutant cohort, VIKTORIA-1 and to submit VIKTORIA-1 data for both the mutant and wild-type cohorts to other global regulatory authorities following the sNDA submission. Turning now to the top line results for the PIK3CA mutant cohort. The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib, which we refer to as the gedatolisib triplet, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib, which is a PI3K-alpha inhibitor and fulvestrant. The secondary endpoint of gedatolisib combined with fulvestrant, which we refer to as the gedatolisib doublet, which was not part of the primary efficacy analysis in a hierarchical order, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated with manageable safety profiles and no new safety signals. When considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient's tumor. We believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR or PAM pathway. And researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity. VIKTORIA-1 represents the first Phase III study that demonstrate that comprehensively blocking the PAM pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component of this pathway. Now as we've previously reported, the VIKTORIA-1 PIK3CA wild-type cohort set several new benchmarks for clinical trials evaluating patients with HR-positive/HER2-negative advanced breast cancer. The hazard ratios for the gedatolisib triplet and doublet were more favorable than has ever been reported by any Phase III trial for patients with HR-positive HER2-negative advanced breast cancer. 7.3 months incremental improvement in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any Phase III trial for patients with HR-positive/HER2-negative advanced breast cancer receiving at least their second line of endocrine therapy. And the 17.5 months of median duration of response for the gedatolisib triplet and 31% incremental increase in the objective response rate relative to the control for the gedatolisib triplet are the highest reported for an endocrine therapy-based regimen in the second-line setting. Now both regimens were found to have a manageable safety profile that was well tolerated by patients as evidenced by the 2% and 3% adverse event-related discontinuation rates for the triplet and doublet, respectively. We've also previously reported safety and tolerability-related analyses. In particular, for patients who experienced stomatitis, we reported that measures to mitigate it were generally effective. The median time to improvement from first onset to a lower grade of stomatitis for patients with Grade 2 or Grade 3 stomatitis who received the gedatolisib triplet was 12 and 14 days, respectively. Now to characterize the overall tolerability of the gedatolisib regimens, we reported results from patient-reported outcomes that capture a patient's perception of their overall well-being. A particular note was the stability of the patient's assessment of their well-being relative to their well-being prior to starting treatment with gedatolisib. Over the first 8 cycles of treatment with gedatolisib, patients reported no degradation in their sense of well-being, which we believe provides meaningful evidence that patients treated with gedatolisib tolerated it well. Now let's talk about our VIKTORIA-2 study. Results from the PIK3CA wild-type mutation cohort of our VIKTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in the second-line setting of HR-positive/HER2-negative advanced breast cancer. And these results confirm the role the PAM pathway plays in patients with or without PIK3CA mutations and the importance of multi-target inhibition of this pathway. Additionally, results from our Phase Ib clinical trial provided strong evidence that the PAM pathway is also an important disease driver in treatment-naive patients with advanced breast cancer. In the early phase study that we performed, we evaluated gedatolisib plus palbociclib and letrozole as first-line treatment in patients with endocrine-sensitive HR-positive/HER2-negative advanced breast cancer. Median progression-free survival or PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole and the objective response rate was 79%, which again compares favorably to historical data of 53% for ribociclib plus letrozole. In light of the positive results for the PIK3CA wild-type and mutant cohorts of VIKTORIA-1 and the promising preliminary data for gedatolisib triplet in first-line treatment, we have high confidence that we can successfully develop gedatolisib triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status. Successful development in the first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the United States. So to achieve this goal, we amended several important elements of the VIKTORIA-2 study design. First, VIKTORIA-2 will now evaluate the safety and efficacy of patients with endocrine-sensitive HR-positive, HER2-negative advanced breast cancer in addition to those with endocrine-resistant disease. which was the original study. Endocrine-sensitive patients represent approximately 2/3 or 60,000 of the 90,000 women in the U.S. newly diagnosed with advanced breast cancer each year. Current standard of care therapies for these patients provide median PFS of approximately 25 months. And patients will be assigned manually according to their endocrine sensitivity status to either study 1 if they're endocrine resistant or Study 2 if they're endocrine-sensitive and subsequently be randomized to a treatment arm. Each study will have independent statistical analysis plans that will include separate primary endpoints. Second, the primary efficacy analysis for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population enrolled in their respective study. Primary endpoints for patient cohorts based on their PIK3CA status are no longer included. And this revision of the primary analysis allowed us to reduce the sample size for Study 1. The endocrine-resistant study from 638 patients to 440 patients without affecting the power of the analysis. And third, the control arms for Study 1 and Study 2 will evaluate ribociclib combined with either fulvestrant for Study 1 or letrozole for Study 2. Study 1 will enroll patients with treatment-naive endocrine-resistant advanced breast cancer. And these are women whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. It's a more aggressive disease. The trial will evaluate the efficacy and safety of gedatolisib combined with palbo and fulvestrant in Arm A and compare that to ribociclib combined with fulvestrant in Arm B. We expect to have top line data by the end of 2028 for this study. Study 2 is expected to enroll approximately 740 subjects with treatment-naive endocrine-sensitive advanced breast cancer. And these are women whose cancer relapse or progressed 12 months or more after completion of adjuvant endocrine therapy or those with de novo metastatic disease who've had no prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole and compare itself to ribociclib combined with letrozole. The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are progression-free survival for RECIST 1.1 criteria as assessed by blinded independent central review. And we expect top line data for the Study 2 in the endocrine-sensitive patients to be available by 2030. And prior to finalizing this amended Phase III trial design, we conducted a Type B meeting with the FDA to obtain their feedback and to gain alignment on these planned amendments. Now knowing that our life cycle plan would eventually include indications that may offer several years of progression-free survival benefit, we initiated a program to develop a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. And this program is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. And this work has resulted in a submission to the United States Patent and Trademark Office of our first patent application for an injectable formulation of gedatolisib. Now let's turn to our Phase Ib/II trial that's evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented data for the Phase Ib portion of the study at a poster presentation at ESMO last year. And in this portion of the trial, 38 patients were randomly assigned to receive standard doses of darolutamide twice daily and either 120 milligrams of gedatolisib in Arm 1 or 180 milligrams of gedatolisib in Arm 2. The combination of gedatolisib and darolutamide was generally well tolerated in the trial and mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed in either arm and no patients discontinued study treatment due to an adverse event. For all patients treated, the 6-month radiographic PFS rate was 67% and the median radiographic PFS was 9.1 months. And these results compare favorably to historical results of a 40% 6-month radiographic PFS rate for patients with metastatic castration-resistant prostate cancer who were treated with an androgen receptor inhibitor as second-line treatment. Now enrollment of patients in the dose escalation portion of the trial is ongoing. We expect to provide a data update at an upcoming medical conference. Now as we near what we hope is an FDA approval for gedatolisib in 2026, our efforts to prepare for the potential launch of gedatolisib continue to ramp up for our strategic launch plan, and we began laying the groundwork for a potential gedatolisib launch over 24 months ago. Last call, we mentioned that we had largely completed building the commercial organization, except for the sales force. I'm excited to report now that we have since hired and onboarded all of our oncology sales specialists. They are a very experienced crew. On average, these individuals have 24 years of experience selling pharmaceuticals and 16 years of experience in oncology. They're an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics. Key efforts today include continuing our extensive outreach across the country to payers, strategic accounts, which include health systems, integrated delivery networks and community oncology practices. We're also very encouraged by the results of research we continue to field to gauge the willingness of community and academic oncologists to prescribe gedatolisib should it get approved. And these results make us optimistic about the possibility of establishing gedatolisib as the new standard of care in the second-line setting for HR-positive/HER2-negative advanced breast cancer in the wild-type patient population. Now with positive results from our study with patients whose tumors have PIK3CA mutations, we expect the gedatolisib combination regimens to be uniquely positioned to provide second-line therapy for patients regardless of the PIK3CA mutation status. Based on the analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive/HER2-negative advanced breast cancer. And using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for gedatolisib in the second-line setting is more than $5 billion annually. Given the significant penetration our research is suggesting we can achieve, we believe it's reasonable to estimate that a second-line indication for gedatolisib can potentially generate peak revenue of up to $2.5 billion annually. And so the progress we've made today is encouraging, and we look forward to providing you with updates over the next few quarters. Gedatolisib is well positioned to address critical needs in the second-line space with its unique mechanism of action and potential first-in-class and best-in-class safety and efficacy profile. And this gives us an exciting opportunity to advance potential blockbuster indications in breast cancer and prostate cancer, while also aggressively preparing for and potentially launching gedatolisib commercially should we receive FDA approval. And now I'd like to hand the call over to Vicky to review our finances.
Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the first quarter 2026. Our first quarter net loss was $52.8 million or $0.97 per share compared to a net loss of $37 million or $0.86 per share for the first quarter of 2025. Our non-GAAP adjusted net loss was $46.8 million or $0.86 per share for the first quarter of 2026 compared to non-GAAP adjusted net loss of $34.7 million or $0.81 per share for the first quarter of 2025. Research and development expenses were $33.1 million for the first quarter of 2026 compared to $29.8 million for the prior year period. The $3.3 million increase was primarily due to a $3 million increase in employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase III clinical trial. Selling, general and administrative expenses were $17.4 million for the first quarter of 2026 compared to $6.3 million for the prior year period. The $11.1 million increase was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other launch-related activities. The remaining $2.4 million increase was primarily due to software costs, professional fees and other administrative costs. Net cash used in operating activities for the first quarter of 2026 was $55.1 million compared to $35.9 million for the prior year period. The additional cash in operating activities quarter-over-quarter of $19.2 million was primarily due to non-GAAP adjusted net loss of $12.1 million and working capital adjustments of $7.1 million. Cash, cash equivalents and short-term investments were $387.1 million at the end of first quarter 2026. We expect cash, cash equivalents and investments and drawdowns on our debt facility to finance our operations through 2027. I will now hand the call back to Jodi.
Jodi Sievers: Thanks, Vicky. Before we turn the call to the operator for questions, I'll remind you, we will not be answering questions related to the VIKTORIA-1 mutant cohort data being presented at ASCO on June 2 or providing additional guidance on our expectations for data at this time. Matthew, could you please open the call for questions?
Operator: [Operator Instructions] And your first question comes from Maury Raycroft of Jefferies.
Maurice Raycroft: Congrats on the progress. Maybe starting off, just wondering if you can provide any perspective into the nature of questions and interactions with the [indiscernible] FDA that you're getting ahead of the PDUFA date? And have you submitted a draft label? And are you in labeling discussions at this point?
Brian Sullivan: Yes, we're not going to provide that level of detail about the interactions other than to say that there's nothing about the interactions to date that suggests that we will be off track for the PDUFA decision by July 17.
Maurice Raycroft: Got it. Okay. And then I wanted to ask about the subcu formulation as well. Wondering if there's anything more you could say about what you're seeing with preclinical data in respect to comparability on PK/PD and dosing frequency. And can you talk more about time line to move this version into the clinic and whether there could be any bridging efforts as it relates to the VIKTORIA-2 study?
Brian Sullivan: Sure. So as far as the internal work, I mean, we're not going to be providing a play-by-play of the internal work. But I can speak to the time line and the steps. I mean, obviously, the first step is optimizing the formulation itself. And it's required and you work with multiple candidates to ensure you've optimized it. Then you have to transfer that to manufacturing, scale it, ensure you have stability, et cetera. And ultimately, you end up with PK studies, Phase I to confirm the PK profile and map its equivalents to the IV formulation. And then finally, we expect the FDA to probably require equivalent study, Phase III study. They've laid out some guidance on that front. And so the goal is to have a subcu form available basically along the same time line that we would expect to get an approval or hope to get an approval for the endocrine-sensitive population.
Operator: And your next question comes from Tara Bancroft of TD Cowen.
Tara Bancroft: So my question is not about the mutant data, more about some educational historical background. So because in thinking about the range for alpelisib and fulvestrant in 5 to 7 months, can you just -- from your view of historical trials, some context around the bookends of that range from BYLieve Cohort C to then Cohort A and [ EPICB5 ] in terms of patient characteristics that you think most contributed to the difference there, just to help us understand.
Brian Sullivan: Yes. I don't want to speak directly other than to say that there's always a certain amount of heterogeneity between trials and the patient populations that get enrolled. And so any time you're looking at potential results for a particular therapy, we think it's best to look at the range and not get overly fixated on trying to calculate the probability. It's just not practically possible. And so the data that's been reported is really the only, we think, data that can be assessed to understand what the performance of a drug like alpelisib can do.
Operator: And your next question comes from Andrew Berens of Leerink Partners.
Andrew Berens: On the progress, Brian. Looking forward to seeing the data at ASCO in Chicago. My questions are about the subcu announcement today. We've been trying to think of an analog of a small molecule that was given IV and then was changed to subcutaneous. Most of them are antibiotics and there's not really a benefit going subcu there. Is there one that you could point us to, to get an idea of kind of the process, the regulatory process? And then also, would you expect that the PK and the Cmax would change when you go from intravenous to subcu. And we've heard some speculation about the mucositis maybe being related to Cmax. I'm just wondering if you think that would come down with the subcu version?
Brian Sullivan: Okay. So as far as -- thanks for the question. As far as the regulatory process, I think there's a general process that FDA requires to assess drugs that are injected in some form, whether it's injected or infused. And we expect that our process or our program will follow those requirements. And I outlined those in one of the prior questions, essentially where you have to characterize the PK profile for a variety of reasons, but then also then characterize the equivalence from an efficacy standpoint. To date, it appears that when you are introducing a new formulation that has a different route, even if it's still being systemically administered directly. You need to demonstrate clinical equivalence. And based on some recent guidance, it appears that the FDA's position is that if you demonstrate equivalence in one indication that, that data will then in that approval will allow that new formulation to be used for any other indications that may exist. And so we expect that to be the path forward for us, and we'll take it from there.
Andrew Berens: Okay. And then what about the PK and the Cmax? Any insights on how.
Brian Sullivan: No, I mean, obviously, from a development standpoint, I mean, the perfect world is you match PK profile as closely as you can or at least you kind of focus on certain ranges. As far as speculating about the stomatitis effect like that, it's just too premature to get into that. It's certainly, we think, a function of the Cmax but -- and the fact that concentration settles in after a few hours at a much lower concentration and basically remains stable. And we think that's one of the reasons why patients have reported the drug to be very well tolerated, not affecting their quality of life. And so certainly, there's ways of thinking about administering the drug or formulating it that would allow you to try to optimize that. And those are all -- will be elements of the development program that we'll be evaluating.
Andrew Berens: Okay. Well, congrats again on continuing to move the needle.
Operator: And your next question comes from Stephen Willey of Stifel.
Stephen Willey: Congrats on the announcement today. I know that we've seen frontline market share in the endocrine-sensitive setting kind of largely influenced by longer-term OS data. So just curious as you were thinking about the sizing of VIK-2 Study 2, kind of how this factored into the design and whether you might be able to provide just any preliminary powering assumptions on either OS or PFS?
Brian Sullivan: Well, OS becomes in effect, the way to break the tie when you have 3 regimens that offer almost equivalent progression-free survival. And that was the case with the CDK4/6 drugs. And ribo then subsequently demonstrated that it offered a survival benefit. But we'll be comparing ourselves to ribo. And if we offer a progression-free survival period that's superior to ribo. And we show that there's no decrement in overall survival that would, in effect, achieve the goal of demonstrating that there's a clinical benefit for these patients. Certainly, for any study you do, you'd like to show that there's a survival advantage relative to what you're comparing to. But if we achieve PFS and show no decrement in OS, we'll essentially satisfied certainly the regulatory requirements, and we think we'll satisfy the clinical expectations for a drug. Certainly, the drug has to offer a meaningful increase in incremental PFS. 3 months on top of 10 is different than 3 months on top of 25. So we're mindful of that and then design the study to reflect the expectations that you need more than 3 months to demonstrate a clinically meaningful benefit.
Operator: And your next question comes from Brad Canino's of Guggenheim Securities.
Bradley Canino: Great to see the strong progress on my end as well. For the subcu, and sorry if I missed this on the call, I missed some of the prepared remarks. Is the formulation completed? And have you conducted animal models with it yet? Or is this still in process?
Brian Sullivan: Well, I mean, again, we're not going to give play by play on each stage of the program other than to say that we have multiple candidates that we're advancing, and we're in the middle of doing a variety of both stability studies to confirm and to characterize the formulation itself as well as evaluating the other nonclinical parameters, including animal studies and work like that.
Bradley Canino: Okay. And maybe it would be helpful, are there any certain properties about GEDA that support its translation to a subcu formulation that could give investors confidence?
Brian Sullivan: Well, other than we're confident we'll be able to develop it. Every drug has its own challenges when it comes to converting it to a more concentrated form. And I think part of the advance that we've made is that it requires invention and which is good because it's not an obvious approach, and it's one that we think will certainly enhance our intellectual property position significantly. But as far as signaling how to interpret the likelihood that we'll be successful, I would say we're very confident.
Bradley Canino: And then just anything you can say about what you're seeing so far about predicted dose, not so much disclosure of the dose, but how that might shape the specific device that you can use for the patient and the administration time?
Brian Sullivan: I think you're referring to the volume. The dose itself will be the same, and it's just a matter of translating that dose into a smaller volume, so it's injectable. We have targets internally. We have functional requirements that we're targeting. And so far, we fully expect to meet the functional requirements that would allow it to be an injectable form.
Operator: And your next question comes from Oliver McCammon of LifeSci Capital.
Oliver McCammon: Just thinking about the endocrine-sensitive study, I'm wondering if there are any learnings to take from the PALOMA trial experience in terms of being thoughtful about patient follow-up and powering for OS.
Brian Sullivan: There's a lot of learnings from the PALOMA-2 and also from the MONALEESA-2 ribo study. And believe me, we've taken in the learnings from the ribo study more than the PALOMA study. So we think there's certainly a way to design the study in a way that maximizes your opportunity to potentially demonstrate an overall survival advantage.
Operator: And your next question comes from Eva Fortea of Wells Fargo.
Eva Fortea-Verdejo: Congrats on the progress. Do you have any updated thoughts on the competitive positioning for GEDA versus other PIK3 inhibitors in development? And how do you see this evolving with a subcutaneous formulation coming online?
Brian Sullivan: Well, I think details to follow, but we did report that GEDA doublet just been a head-to-head a replacement for an existing PIK3CA approved drug was statistically significantly and clinically meaningfully differentiated from a single target inhibitor. And ultimately, what we think we've been saying has been confirmed, which is that multi-target inhibition of this pathway is required to optimize antitumor control and that single target inhibitors are going to be limited. If you look at the data for alpelpsib and capivasertib, you'd see that the hazard ratios that they have reported in patients who had prior CDK treatment are very similar, roughly 0.5 compared to fulvestrant. And so we've demonstrated that we're superior to that. And what we think that means is that the approach will be at a disadvantage going forward just from a benefit standpoint, we will not be able to -- that approach, we do not believe offers the potential to provide comparable efficacy.
Operator: And your next question comes from Gil Blum of Needham & Company.
Gil Blum: Congrats on the progress and the impressive results, Brian. So just a couple of quick ones from us. One, as it relates again to the potential for a subcu formulation, is there any chance that would change kind of the -- you currently have a very specific schedule of dosing. Were there could be any changes to that? Or how do you view this? And I have a follow-up.
Brian Sullivan: Sure. Those are factors that go beyond simply the formulation because it gets to the overall PK profile of GEDA and what's required to sustain sufficient target engagement. And so I think that question is broader than simply subcu. I think it relates more generally to how to administer or rather how frequently it needs to be administered. And so how we answer that question, if it's different over time, will be the byproduct of studies probably involving the infused form because we have that now and we can evaluate that. And then to the extent that we find ways to potentially alter the administration schedule, that would be applied if that were to happen to a potential subcutaneous formulation.
Gil Blum: Yes. That makes sense. And just interesting to hear your thoughts of recent news from one of your competitors, [indiscernible] decided to move away from a PIK3 selective mutant to an alpha specific, if you have any thoughts on that?
Brian Sullivan: Well, I think, again, there's only so much biological potential that targeting the alpha -- [indiscernible] gives you. And I think that's less a function maybe of the targeting and more a function of increasing the potential patient population that they're hoping to treat. They had a more selective approach that essentially meant that they would have a smaller patient population. And I would imagine they found some results that indicated they didn't need to be that specific. And alpelisib generally targets and their indications include the 12 or 13 most common mutations. And there's been some evidence of variation in response to those patients depending on their mutations. But I'm not sure that, that is this positive in how you think about developing for that population. So they've got data, I'm sure that is guiding their decisions. And again, it is in the context of what we think is limited biological potential to reduce a treatment effect when you limit targeting to the alpha isoform.
Operator: And your next question comes from Kalpit Patel of Wolfe Research.
Kalpit Patel: One from us, another one on the subcu formulation. Would you characterize GEDA's antitumor effect as being Cmax-driven or AUC driven? And how does that inform your confidence on the subcu formulation that it can achieve clinical equivalence to an IV?
Brian Sullivan: Yes. Those are -- I mean, those are good questions. And I think every drug company tries to tease that out. There's been a lot of work that people have done to try to kind of determine whether a drug is more Cmax versus total volume, total exposure. I think an argument could be made that it's both, you've got to benefit the high Cmax and [indiscernible] and then the sustained target engagement. So again, your road map is going to factor in what we've seen to date. So that's the best approach to take and see how close you can match that curve, knowing that it won't be exact, but there are other ways you can affect that. And we're taking those other factors into account.
Operator: And your next question comes from Silvan Tuerkcan of Citizens.
Silvan Tuerkcan: Congrats on all the progress and looking forward to ASCO. Maybe if I can ask around ASCO, not about the data, but in general, it seems it's a very important venue for you, especially with the PDUFA in the wild-type patients ahead. What's your strategy there to interact with doctors? What sort of events do you have planned? And what is your messaging on the wild-type population here ahead of the approval?
Brian Sullivan: Well, we'll have an army of folks at ASCO with -- that are mostly there to medical professionals to be able to engage with doctors and exchange information. But there's a lot of other work that can be done as well. Certainly, it's a big venue, a lot of doctors will have good opportunity to communicate the results. But no, we view it as a great staging ground to lay the groundwork for what we hope is a future launch over the summer. And so no, we're very excited about the timing of ASCO and its alignment with the schedule we're on, we hope, to get an approval.
Silvan Tuerkcan: Great. And have you done already some payer feedback discussions and kind of around coverage? Do you have any comments around that?
Brian Sullivan: We've had a lot of discussions. We built our payer team, which includes a team focused on strategic accounts and then a team focused on payers, national accounts. And we've been engaging in great depth and length with them for almost a year and been very, very encouraged by the feedback we've gotten. Their formal review really doesn't take place until you have an approval and you submit a dossier. But along the way, you can certainly get their input about their expectations. You can learn about the system and exactly what their requirements are and ensure that when it comes time to make decisions that everybody on these various committees is well informed and feels comfortable with getting and from their perspective, the proposition that it offers to their patients and to the relative reimbursement expectations. And so no, we've made a lot of -- we're, I would say, very, very well along in laying that groundwork and being in a great, great position once the approval comes to really move expeditiously with the various accounts I described.
Operator: And your next question comes from Chase Knickerbocker of Craig-Hallum.
Chase Knickerbocker: Just wanted to maybe just assess kind of your current kind of commercial readiness. In the past couple of months, there's been a couple of early oncology approvals relative to PDUFA date. So Brian, I just want to get your thoughts on kind of where you think you sit from an innings perspective is kind of having your team ready for a potential launch in wild-type.
Brian Sullivan: Sure. Again, all of the situations with some of these early approvals are, I would say, situationally based. There was an approval recently for a drug that had a regular review, and it came in a few weeks early. We have a priority review for a new drug, 6-month review period. And historically, RTOR reviews of drugs with priority designation occur pretty much in line with the PDUFA date. And that's been our governing assumption. Now internally, we've identified a launch ready date that's before PDUFA. So we make sure that we are ready to roll when we hope the approval decision comes.
Operator: And there are no further questions at this time. I'd now like to turn the call back over to Brian Sullivan, Chief Executive Officer and Co-Founder, for closing comments.
Brian Sullivan: Great. Well, thank you very much for your participation in our call. We appreciate the questions, and we look forward to seeing some of you at ASCO. Take care. Goodbye.
Operator: Ladies and gentlemen, this concludes today's conference. We thank you for participating and ask that you please disconnect your lines.