Conference Transcript - CELC 2026-05-14

Operator

Good afternoon, ladies and gentlemen, and welcome to the Salkuity First Quarter 2026 Financial Results Call webcast. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. I would now like to turn the conference over to Jody Zievers, Corporate Communications and

Jodi Sievers, Head of Investor Relations

Investor Relations at Selkuity. Please go ahead. Thank you, Matthew, and good afternoon, everyone. Thank you for joining us to review Selkuity's first quarter 2026 financial results and business update. Earlier today, Selkuity released financial results for the first quarter ended March 31, 1st, 2026. The press release can be found on the Investor's section of CellCuity's website. Joining me on the call today are Brian Sullivan, CellCuity's Chief Executive Officer and Co-Founder, Vicki Hahn, Chief Financial Officer, as well as Igor Gorbachevsky, 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 involved 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 of 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 Cellcuity. Please go ahead, Brian. Thank you, Jody, and good

Brian Sullivan, CEO

Good afternoon, everyone. Thank you for joining our first quarter 2026 operating and financial update conference We continue to make great progress as we prepare for the potential approval and commercial launch of Geddesilisib 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 Victoria 1 study, we believe gadotelisib is well-positioned to become a new standard of care second-line therapy for patients with HR-positive or 2-negative advanced breast cancer. It's been an eventful past few months for CELCUITY. Last week, we reported positive top-line results for the PIC3CA mutant cohort of the Phase III Victoria I clinical trial. And we look forward to presenting detailed results at a late-breaking abstract oral session at the 2026 ASCO meeting on June 2nd. 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 two important updates to our clinical development plan. First, we announced the expansion of our Phase III Victoria II trial to include a second study, evaluating gadotelisib 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 PIC3CA 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 gadotelisib 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 gadotelisib 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 PIC3CA mutant cohort, Victoria 1, and to submit Victoria 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 PIC3CA mutant cohort. The primary efficacy analysis of gadotilisib combined with fulvestrin and tablocyclob, which we refer to as the gadotilisib triplet, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to alpalypsib, which is a PN3K alpha inhibitor, and fulvestrin. The secondary endpoint of gadatolisib combined with fulvestrin, which we refer to as the gadatolisib doublet, which was not part of the primary efficacy analysis in the hierarchical order, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpalypsib and fulvestrin. Both gadatolisib regimens were generally well-tolerated with manageable safety profiles and no new safety signals. When considered alongside previously presented data from the Victoria 1 PIC3CA wild-type cohort, the gadotelisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIC3CA status of a patient's And we believe the results from the Victoria 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. Victoria 1 represents the first phase 3 study that demonstrates 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 Victoria 1 PIC3CA 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 get-it-solicit 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. The 7.3 months incremental improvement in median PFS for the get-a-triplet over fulvestrin is higher than has ever been reported by any phase 3 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 get-a-triplet and 31% incremental increase in the objective response rate relative to the control for the get-a-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 dermatitis, 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 gaditalisib triplet was 12 and 14 days, respectively. Now, to characterize the overall tolerability of the gaditalisib regimens, we reported results from patient-reported outcomes that capture a patient's perception of their overall well-being. Of particular note was the stability of the patient's assessment of their well-being relative to their well-being prior to starting treatment with gadotelicid. Over the first eight cycles of treatment with gadotelicid, patients reported no degradation in their sense of well-being, which we believe provides meaningful evidence that patients treated with gadotelicid tolerate it well. Now let's talk about our Victoria 2 study. Results from the PIC3CA wild type of mutation cohort of our Victoria 1 study demonstrated the benefit of gadatilisib 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 BIC3CA mutations and the importance of multi-target inhibition of this pathway. Additionally, results from our Phase I-B 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 gaditalisib plus polycyclob 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 ribociclob plus letrozole. And the objective response rate was 79%, which, again, compares favorably to historical data of 53% for ribocyclob plus letrozole. In light of the positive results for the PIC3CA wild-type and mutant cohorts of Victoria 1 and the promising preliminary data for our gadotelosib triplet in this first-line treatment, we have high confidence that we can successfully develop the gadotelosib triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIC3CA 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 Victoria 2 study design. First, Victoria 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 two-thirds 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 medium PFS of approximately 25 months. Patients will be assigned manually according to their endocrine sensitivity status to either study one, if they're endocrine-resistant, or study two, 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 analyses for both study one and study two of Victoria 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 analyses allowed us to reduce the sample size for study one, the endocrine resistance study, from 638 patients to 440 patients without affecting the power of the analysis. And third, the control arms for study one and study two will evaluate ribociclid combined with either fulvestrin for study one or electrazole for study two. Study one 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 gadatholisib combined with palbo and fulvestrin in arm A and compare that to ribociclib combined with fulvestrin in arm B. We expect to have top-line data by the end of 2028 for this study. Study two is expected to enroll approximately 740 subjects with treatment-naive endocrine-sensitive advanced breast cancer, and these are women whose cancer relapsed 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 gadotelisib combined with pylaciclib and letrozole and compare itself to ribociclib combined with letrozole. The clinical trial primary endpoints for the Victoria II clinical trial are progression-free survival per RECIST 1.1 criteria, as assessed by blinded independent central review. And we expect top-line data for the study II 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 gaditolicid that would enable a patient to receive gaditolicid 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 gaditolicid. And this work has resulted in a submission to the United States Patent and Trademark Office of our first patent application for an injectable formation of gaditalisib. Now let's turn to our Phase 1b2 trial that's evaluating gaditalisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented data for the Phase 1b 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 gadotelisib in arm one or 180 milligrams of gadotelisib in arm two. The combination of gadotelisib 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 six-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 percent six-month radiographic PFS rate for patients with metastatic castration-resistant prostate cancer who are 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 gadotelisib in 2026, our efforts to prepare for the potential launch of gadotelisib continue to ramp up per our strategic launch plan, and we began laying the groundwork for a potential gadotelisib 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're 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. And 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've continued to feel to gauge the willingness of community and academic oncologists to prescribe gadotelisib should it get approved. And these results make us optimistic about the possibility of establishing gadotelisib as the new standard of care in the second-line setting for HR-positive, HER2-negative, advanced breast cancer, and the wild-type patient population. Now, with positive results from our study with patients whose tumors have PIC3C mutations, mutations, we expect the getotilisib combination regimens to be uniquely positioned to provide second-line therapy for patients regardless of their PIC3CA 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 gadotelisib 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 gadotelisib 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 with updates over the next few quarters, Get It Solisib 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 Get It Solisib commercially should we receive FDA approval. And now I'd like to hand the call over to Vicki to review our finances.

Vicki Hahne, CFO

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 Victoria I 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 Jody.

Jodi Sievers, Head of Investor Relations

Thanks, Vicki. Before we turn the call to the operator for questions, I'll remind you, we will not be answering questions related to the Victoria 1 mutant cohort data being presented at ASCO on June 2nd or providing additional guidance on our expectations for data at this time. Matthew, could you please open the call for questions?

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchstone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speakerphone, please leave the handset before pressing any keys. One moment, please, for your first question. And your first question comes from Maury Raycroft of Jefferies. Please go ahead.

Maury Raycroft, Analyst — Jefferies

Your line is open. Hi. Congrats on the progress, and thanks for taking my questions. Welcome. Maybe starting off, just wondering if you can provide any perspective into the nature of questions and interactions with 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, CEO

So, yeah, 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 PDUFMA decision by July 17th.

Maury Raycroft, Analyst — Jefferies

Got it. Okay. And then I wanted to ask about the sub-Q 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 PKPD and dosing frequency. And can you talk more about timeline to move this version into the clinic and whether there could be any bridging efforts as it relates to the

Brian Sullivan, CEO

Victoria 2 study? 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 timeline 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 then ultimately you end up with PK studies, you know, phase one, to confirm the PK profile and map its equivalence to the IV formulation. And then finally, we expect the FDA to probably require a equivalent study, phase three study. They've laid out some guidance on that front. And so, the goal is to have a sub-Q form available, basically along the same timeline that we would expect to get an approval or hope to get an approval for the endocrine-sensitive population.

Maury Raycroft, Analyst — Jefferies

Okay, that's helpful. Thanks for taking my questions, and I'll hop back in.

Operator

Thank you, and your next question comes from Tara Bancroft of TD Cowan. Please go ahead. Your line is open.

Tara Bancroft, Analyst — TD Cowen

Hi. Good afternoon. So my question is not about the mutant data, more about some educational historical background, So, you know, because in thinking about, you know, the range for apelosib and sylvesterin of five to seven months, can you just, from your view of historical trials, some context around the bookends of that range from by-leave cohort C to then cohort A and EPIC B5 in terms of patient characteristics that you think most contributed to the difference there just to help us understand?

Brian Sullivan, CEO

Yeah, I don't want to speak directly other than to say that, you know, there's always a certain amount of heterogeneity between trials on the patient populations that get enrolled. And so anytime 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 a probability. It's just not practically possible. And so, the data that's been reported is, you know, really the only, we think, data that can be assessed to understand, you know, what the performance of drug-like apolytsip can do.

Operator

Okay, great. Thanks.

Operator

Thank you.

Operator

And your next question comes from Andrew Behrens of Lear & Partners. Please go ahead. Your line is open.

Andrew Berens, Analyst — Lear & Partners

Hi. Thanks for taking the questions, and congrats on the progress, Brian. I'm looking forward to seeing the data at ASCO in Chicago. My questions are about the sub-Q 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 sub-Q 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, you know, the PK and the CMAX would change when you go from intravenous to sub-Q? And we've heard some speculation about, you know, the mucositis maybe being related to CMAX. I'm just wondering if you think that would come down with a sub-Q version.

Brian Sullivan, CEO

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, others 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, you know, 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, you know, even if it's still being systemically administered directly, you do 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 and 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, Analyst — Lear & Partners

okay and then what about the uh the pk and the cmax any insights on how no i mean obviously from

Brian Sullivan, CEO

a development standpoint i mean the perfect world is you match pk profile as as uh closely as you can or at least you you kind of focus on certain ranges as far as speculating about the somatitis effect like that it's just too premature to to get into to that it's certainly we think a function of the CMAX and the fact that, you know, the 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, you know, 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

Andrew Berens, Analyst — Lear & Partners

evaluating. Okay. Well, congrats again on continuing to move the

Operator

needle. Thank you. Thank you. And your next question comes from Stephen Willey of STIFO. Please go ahead. Your line is open.

Stephen Willey, Analyst — Stifel

Yeah, good afternoon. Thanks for taking the questions and congrats on the announcement today. So 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 VIC-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, CEO

Well, OS becomes, in effect, the way to break the tie when you have three regimens that offer almost the equivalent progression-free survival. And that was, you know, the case with the CDK for six 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 have essentially satisfied, you know, certainly the regulatory requirements, and we think will satisfy the clinical expectations for a drug. Certainly, the drug has to offer a meaningful increase in incremental PFS. You know, three months on top of 10 is different than three 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 three months to demonstrate clinically meaningful benefits.

Operator

I should take the question. You're welcome.

Operator

Thank you. And your next question comes from Brad Caninos of Guggenheim Securities. Please go ahead. Your line is in.

Brad Caninos, Analyst — Guggenheim Securities

Hey, Brian and team. Great to see the strong progress on my end as well.

Operator

You're welcome.

Brad Caninos, Analyst — Guggenheim Securities

For the sub-Q, is the, 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, CEO

Well, I mean, again, we're not going to get 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 non-clinical parameters, including animal studies and work like that.

Brad Caninos, Analyst — Guggenheim Securities

Okay, and maybe it'd be helpful, are there any certain properties about GEDA that support its translation to a sub-Q formulation that could give investors confidence?

Brian Sullivan, CEO

Well, other than we're confident we'll be able to develop it, you know, every drug has its own challenges when it comes to, you know, converting it to a more concentrated form. And I think part of the advance that we've made is that it requires invention, 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.

Brad Caninos, Analyst — Guggenheim Securities

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, CEO

I think you're referring to the volume. You know, 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. we're targeting. And so far, we fully expect to meet the functional requirements that would allow

Operator

it to be an injectable form. Great. Thanks for taking the questions, and look forward to seeing

Operator

it at ASCO. Great. Thank you. Thank you. And your next question comes from Oliver McCammon

Speaker 7

of LiveSite Capital. Please go ahead. Your line is open. Hi, Brian. Thanks for taking my questions. Just thinking about the endocrine-sensitive study, I'm wondering if there are any learnings to take from the PALOMA trials experience in terms of being thoughtful about patient follow-up and powering pro-OS. Thanks again.

Brian Sullivan, CEO

There's a lot of learnings from the PALOMA II and also from the Mona Lisa II ribo study. And believe me, we've taken in the learnings from the ribo study more than the PALOMA study. So, we think, you know, there's certainly a way to design the study in a way that maximizes your opportunity to potentially demonstrate an overall survival advantage.

Operator

Thanks again.

Operator

Thank you. And your next question comes from Eva Forty of Wells Fargo. Please go ahead. Your line is open.

Eva Privetera, Analyst — Wells Fargo

Hey, good afternoon. Congrats on the progress and thanks for taking our question. Do you have any updated thoughts on the competitive division for GEDA versus other PIC3 inhibitors? in development, and how do you see this evolving with a subcutaneous formulation coming online?

Brian Sullivan, CEO

Well, I think, you know, details to follow, but we did report that get a doublet, just in a head-to-head, a replacement for an existing PIK3CA-approved drug was, you know, 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 anti-tumor control and that single-target inhibitors are going to be limited. If you look at the data for alpalypsum and capovacitur, you'd see that the hazard ratios that they have reported in patients who've had prior CDK treatment are very similar, you know, roughly 0.5 compared to Fulvestrin. And so, we've demonstrated that we're superior to that. And what we think that means is that, you know, the approach will be at a, you know, a disadvantage going forward. Just from a benefit standpoint, it will not be able to,

Operator

that approach we do not believe offers the potential to provide comparable efficacy. Got it. Thanks.

Operator

Thank you. And your next question comes from Hugh Bloom of Needham and Company. Please go ahead. Your line is open.

Yasmeen Rahimi, Analyst — Needham & Company

Good afternoon, everyone, and congrats on the progress and the impressive results, Ryan. So just a couple of quick points from us. One, as it relates again to the potential for a sub-Q formulation, is there any chance that would change kind of the – you apparently have a very specific schedule of dosing. So where there could be any changes to that, or how do you view this? Can I have a follow-up?

Operator

Sure.

Brian Sullivan, CEO

Those are factors that go beyond simply the formulation because it gets to the overall PK profile of GETA and what's required to sustain sufficient target engagement. And so I think that question is broader than simply sub-Q, I think it relates more generally to how to administer or rather how frequently it kind of 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, you know, to the extent that we find ways to potentially alter the administration's schedule, you know, that would be applied if that were to happen to a potential subcutaneous formulation.

Yasmeen Rahimi, Analyst — Needham & Company

Yeah, that makes sense. And just interesting to hear your thoughts of recent news from one of your investigators on Cure. decided to move away from a X3 selective mutant to an alpha-specific, if you have any thoughts

Brian Sullivan, CEO

on that. Thank you. Well, you know, I think, again, there's only so much biological potential that targeting the alpha, you know, P10 alpha gives you. And I think that's less a function maybe of the targeting, it's more a function of, you know, increasing the potential patient population that they're hoping to treat. You know, 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 alpalipsib is generally targets, and their indications include, you know, 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, you know, I'm not sure that that is dispositive in how you think about developing for that population. So, you know, they've got data, I'm sure, that is guiding their decisions, and again, But it is in the context of, you know, what we think is limited biological potential to induce a treatment effect when you limit targeting to the alpha isoform.

Operator

Thank you for all that, Brian. You're welcome.

Operator

Thank you. And your next question comes from Kalpi Patel of Wolf Research. Please go ahead. Your line is open.

Kalpit Patel, Analyst — Wolfe Research

Yeah. Hey, good afternoon. And thanks for taking my question. One from us, another one on this sub-Q formulation, you know, would you characterize Geta's anti-tumor effect as being C-max-driven or AUC-driven, and how does that inform your confidence on the sub-Q formulation that it can achieve clinical equivalence to an IV?

Brian Sullivan, CEO

You know, 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. You know, I think an argument could be made that it's both, that you get a benefit, the high CMAX and the get a case, and then, you know, the sustained target engagement. So, you know, again, your roadmap is is going to factor in what we've seen today. So that's the best approach to take is 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

Okay, thank you. You're welcome.

Operator

And your next question comes from Sylvain Turkan of Citizens. Please go ahead, your line is open.

Sylvain Turkan, Analyst — Citizens

Yeah, thank you for taking my question and congrats on all the progress. I'm 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, CEO

Well, we'll have an army of folks at ASCO that are, you know, mostly there to, you know, 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 a 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.

Sylvain Turkan, Analyst — Citizens

Great. Thank you. And have you done already some payer feedback discussions and kind of around coverage? Do you have any comments around that?

Brian Sullivan, CEO

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 at 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 GATM. And from their perspective, the proposition that it offers to their patients and to the relative reimbursement expectations. But 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

Great. Well, thanks so much for the color.

Operator

Thank you. And your next question comes from Chase Knickerbocker of Create Hallow.

Chase Knickerbocker, Analyst — Craig-Hallum

Please go ahead. Their line is open. Good afternoon. Thanks for taking the questions. Just wanted to maybe just assess kind of your current kind of commercial readiness. You know, 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 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, CEO

Sure. Again, all of these 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, six-month review period. And historically, our tour reviews of drugs with priority designation occur pretty much in line with the PDUFMA date. And that's been our governing assumption. Now, internally, we've identified a launch ready date that's before PDUFMA. So we make sure that we are

Operator

ready to roll uh when uh and we hope the approval decision comes helpful thank you thank you and

Operator

there are no further questions at this time i'd not like to turn the call back over to brian sullivan chief executive officer and co-founder for closing comments all right well thank you

Brian Sullivan, CEO

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.