Transcript: Celcuity Q1 2026 Earnings Conference Call

Celcuity (NASDAQ:CELC) held its first-quarter earnings conference call on Thursday. Below is the complete transcript from the call. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. Access the full call at https://viavid.webcasts.com/starthere.jsp?ei=1760785&tp_key=2f73ec65ba Summary Celcuity reported a net loss of $52.8 million for Q1 2026, an increase from the previous year's loss due to higher R&D and administrative expenses, primarily related to commercial launch preparations. The company is progressing towards the potential approval and launch of gatalisib for HR positive HER2 negative advanced breast cancer, emphasizing its potential as a new standard of care with positive Phase 3 trial results. Celcuity announced the expansion of its clinical trials, including a new study for gatalisib as a first-line treatment, and is developing a subcutaneous formulation of gatalisib to support longer treatment durations. Management expressed confidence in FDA approval timelines and highlighted extensive preparations for the commercial launch, including hiring a seasoned sales force and engaging with payers. Celcuity projects a significant market opportunity for gatalisib, estimating a $5 billion annual addressable market for second-line treatments and potential peak revenues of up to $2.5 billion annually. Full Transcript OPERATOR Good afternoon ladies and gentlemen and welcome to the Celcuity 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 0 for the operator. I would now like to turn the conference over to Jody Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead. Thank you Matthew and good afternoon everyone. Thank you for joining us to review Celcuity's first quarter 2026 financial results and business updates. Earlier today, Cellcuity 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, 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 and A. Before we begin, I would like to remind listeners that our comments today will include some forward looking statements. These statements involve a number of risks and uncertainties which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward looking statements. Such forward looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. On this call we will also refer to non-GAAP financial measures. These non-GAAP financial 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 Cellcuity. Please go ahead Brian thank you, Jody Brian Sullivan (Chief Executive Officer and Co-Founder) 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 Gatalisib 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 gatalisib is well positioned to become a 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 cellcuity. Last week we reported positive top line results for the PIK3CM mutant cohort of the Phase 3 Victoria 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 and 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 3 Victoria 2 trial to include a second study evaluating gatalisib as first line treatment in patients with endocrine Sens 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 US with HR positive virtu negative advanced breast cancer. And secondly, we also announced this morning that we are advancing the development of a Gatalisib formulation for subcutaneous injection and that we have submitted our first patent application to the US Patent and Trademark Office. The subcutaneous formulation is aimed at supporting potential future indications for Gatalisib 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 of Victoria 1 and to submit Victoria 1 data for both the mutant 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 gatalisib combined with fulvestrin and cabociclib, which we refer to as the gatalisib triplet, demonstrated a statistically significant and clinically meaningful improvement in progression free survival compared to alpelipsib, which is a PI3K alpha inhibitor, and fulvestrin, the secondary endpoint of getatulisib combined with fulvestrin, which we refer to as the gatalisib 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 Alpelisib and fulvestrin. Both gadathilosib regimens were generally well tolerated with manageable safety profiles and no new safety signals when considered alongside previously presented data from the Victoria 1 PIK3CA wild type cohort. The Gatalisib 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 VICTORIA one 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 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 Victoria One 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 Gatalisib, triplet and doublet were more favorable than has ever been reported by any phase 3 trial. For patients with HR positive HER 2 negative advanced breast cancer 7.3 months incremental improvement in median PFS for the Gatalisib triplet over fulvestren 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 and a half months of median duration of response for the Gatalisib 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 experience 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 gadatilisib triplet was 12 and 14 days respectively. Now, to characterize the overall tolerability of the gadotillisib regimens, we reported results from patient reported outcomes to 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 Getatilisib. Over the first eight cycles of treatment with Getatilisib, patients reported no degradation in their sense of well being, which we believe provides meaningful evidence that patients treated with Gatalisib tolerate it well. Now let's talk about our Victoria 2 study. Results from the PIK3CA wild type of mutation cohort of our Victoria 1 study demonstrated the benefit of gatalisib 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 1b 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 ganachelisib plus palaciclab and leprazole as first line treatment in patients with endocrine sensitive HR positive hertz 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 with letrozole. In light of the positive results for the PIK3CA wild type and mutant cohorts of Victoria 1 and the promising preliminary data for a gadatosib triplet in this first line treatment, we have high confidence that we can successfully develop the gadatoisib triplet for nearly all patients in the first line setting irrespective of their endocrine sensitivity or PEC3CS 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 2/3 or 60,000 of the 90,000 women in the US 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 1 and Study 2 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 1, the Endocrine Resistance 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 fovestran for Study 1 or lectrozole 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 gadotilisib 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 progress 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 gadactilisib combined with pilaciclib and letrozole and compare itself to ribociclib combined with letrozole. The clinical trial primary endpoints for the Victoria 2 clinical trial are progression free survival per rhesus 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 Prior to finalizing this amended phase 3 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 lifecycle plan would eventually include indications that may offer several years of progression free survival benefits, we initiated a program to develop a subcutaneous formulation of Getatilisib that would enable a patient to receive GET 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 Getatilisib 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 gatalisibilities. Now let's turn to our phase one B2 trial that's evaluating Gadifulisib 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, another 120mg of getaflicib in ARM1 or 180mg of gatalisab in ARM2. The combination of gadotilisab and Darolidomide was generally well tolerated in the trial and mostly low grade treatment related adverse events. No dose limiting toxicities were observed in either arm. 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 the historical Results of a 40% 6 month radiographic PFS rate for patients with metastatic castration resistant prostate cancer 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 gatatolisib in 2026, our efforts to prepare for the potential launch of gatalisib continue to ramp up per our strategic plan and we began laying the groundwork for a potential data to the sub 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. 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 get it to Listen sure to Get Approved and these results make us optimistic about the possibility of establishing gatalisib 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 PIK3C mutations, we expect the GETT's LISIB combination regimens to be uniquely positioned to provide second line therapy for patients regardless of their PIK3CA mutation status. Based on the analysis of published epidemiological data, we estimate there are 37,000 patients in the US 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 GET at thalisib 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 get it to Listen 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. Get it to Listen to 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 Gatalisib commercially should we receive FDA approval. And now I'd like to hand the call over to Vicki to review our finances. Vicki Hahn (Chief Financial Officer) 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 1 Phase 3 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 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. Jody Sievers (Corporate Communications and 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 2 or providing additional guidance on our expectations for data at this time. Operator, 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 touch-tone 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 use the handset before pressing any keys. One moment please for your first question. And your first question comes from Maury Raycroft of Jeffers. Please go ahead. Your line is open. Maury Raycroft (Equity Analyst) Hi, congrats on the progress and thanks for taking my questions. 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 day and have you submitted a draft label and are you in labeling discussions at this point? Brian Sullivan (Chief Executive Officer and Co-Founder) So, yeah, we're not going to provide that low 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 17th. Maury Raycroft (Equity Analyst) Got it. Okay. And then 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 PK PD 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 Victoria 2 study? Brian Sullivan (Chief Executive Officer and Co-Founder) 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, etc. And then ultimately you end up with pharmacokinetics (PK) studies phase one to confirm the pharmacokinetics (PK) profile and map its equivalence to the IV formulation. And finally, we expect the FDA to probably require equivalent study, phase three study, they've laid out some guidance on that front. And so the goal is to have a subcutaneous 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. Got it. Okay, that's helpful. Thanks for taking my questions and I'll hop back in. You're welcome. Okay, OPERATOR thank you. And your next question comes from Tara Bancroft of TD Cowan, please. Go ahead. Your line is open. Tara Bancroft Hi, good afternoon. So my question is, you know, not about the mutant data, more about some educational historical background. So, you know, because in thinking about, you know, the range for Alpelisib and fulvestrant in five to seven 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 EPIC-B5 in terms of patient characteristics that you think most contributed to the difference there just to help us understand. Brian Sullivan (Chief Executive Officer and Co-Founder) 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, 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 really the only, we think, data that can be assessed to understand what the performance of drug like Alpelisib can do. Okay, great. Thanks. Thank you. OPERATOR And your next question comes from Andrew Behrens of Learning Partners. Please go ahead. Your line is open. Andrew Behrens Hi, thanks for taking the questions and congrats on the progress, Brian. 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. You know, 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, the process, 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. 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 or 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 PKA 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, you know, 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, you know, we'll we'll take it from there. Okay, and then what about the, the PK and the CMax? Any insights on how, I mean, obviously from a development standpoint, I mean the perfect world is you match PK profile as, as 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 that. It's certainly, we think a function of the C maximum, but in fact 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 certainly there's ways of thinking about administering the drug or formulating it that would allow you to try to optimize. And those are all will be the elements of the development program that we'll be evaluating. Okay, well, congrats again on continuing to move the needle. Thank you, OPERATOR thank you. And your next question comes from Stephen Wheely of Spivo. Please go ahead. Your line is open. Stephen Wheely Yeah, good afternoon. Thanks for taking the questions and congrats on the announcements 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 VIC2, Study 2, kind of how this factored into the design and whether you might be able to provide just any preliminary assumptions on either OS or pfs. Brian Sullivan (Chief Executive Officer and Co-Founder) Well, OS becomes in effect the way to break the tie when you have three regimens that offer almOSt equivalent progression free survival. And that was the case with the CDK4/6 drugs. And ribociclib then subsequently demonstrated that it offered a survival benefit. But we'll be comparing ourselves to ribociclib and if we offer a, a progression free survival period that's superior to ribociclib 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 an OS, we'll have essentially satisfied 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. All right, thanks for taking the question. OPERATOR Thank you. And your next question comes from Brad Caninos of Guggenheim Securities. Please go ahead. Your line in. Brad Caninos Hey, Brian and team, it's great to see the strong progress on my end as well. You're welcome. 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 models with it yet or is this still in process? 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 clinical parameters, including animal studies and work like that. Okay. And maybe it'd be helpful. Are there any certain properties about GETA that support its translation to a sub Q formulation that could give investors confidence? 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 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. 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. 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 that we're targeting and so far we fully expect to meet the functional requirements that would allow it to be an injectable form. Okay, great. Thanks for taking the questions and look forward to seeing it. Asco. Great, thank you. OPERATOR Thank you. And your next question comes from Oliver McCammon of Livestock Capital. Please go ahead. Your line is open. Oliver McCammon 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, empowering Pro OS. Thanks again. Brian Sullivan (Chief Executive Officer and Co-Founder) There's a lot of learnings from the Paloma 2 and also from the Mona Lisa 2 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. Thanks again. OPERATOR Thank you. And your next question comes from Eva Forte of Wells Fargo. Please go ahead. Your line is open. Eva Forte Hey, good afternoon. Congrats on the progress and thanks for taking our questions. Do you have any updated thoughts on the competitive provisioning for GETA versus other PIK3 inhibitors in development? And how do you see this evolving with a subcutaneous formulation coming online? Thanks. Brian Sullivan (Chief Executive Officer and Co-Founder) Well, I think, you know, details to follow, but we did report that get a doublet, just 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 Alpelisib and Copanlisib, 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 disadvantage going forward. Just from a benefit standpoint. It will not be able to. 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. Hugh Bloom Good afternoon, everyone, and congrats on the progress and impressive results. Brian. So just a couple of quick ones 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. We currently have a very specific schedule of dosing where there could be any changes to that or how do you view this? I have a follow up. Brian Sullivan (Chief Executive Officer and Co-Founder) Sure. Those are factors that go beyond simply the formulation because it gets to the overall PK profile of Ghetta and what's required to sustain sufficient target engagement. And so I think that question is broader than simply sub Q. I think it's a. It's, you know, relates more generally to how to administer or rather how frequently GETA needs to be administered. And so, you know, how we answer that question, if it's different over time, will be the byproduct of, you know, 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 schedule, you know, that that would be applied if that were to happen to a potential subcutaneous formulation. Hugh Bloom Yeah, that makes sense. And just interesting to hear your thoughts of recent news from one of your competitors. Oncure decided to move away from a PIK3 selective mutants to an alpha specific. If you have any thoughts on that. Thank you. Brian Sullivan (Chief Executive Officer and Co-Founder) Well, you know, I think again, there's only so much biological potential that targeting the alpha, you know, pten alpha gives you. And I think that's less a function maybe of the targeting and more function of, you know, 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. But apelipsib is generally targets in 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 dispositive 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 induce a treatment effect when you limit targeting to the alpha ISIS form. Thank you for all that, Brian. OPERATOR Thank you. And your next question comes from Kalpi Patel of Wolf Research. Please go ahead. Your line is open. Brian Sullivan (Chief Executive Officer and Co-Founder) 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 antitumor effect as being CMax 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? Kalpi Patel Yeah, those are. I mean, those are great 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 CNX versus more total volume Total exposure. You know, I think an argument could be made that it's both 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 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, but there are other ways you can affect that and you know, we're taking those other factors into account. Brian Sullivan (Chief Executive Officer and Co-Founder) Okay, thank you. You're welcome. OPERATOR And your next question comes from Sylvan Turkan of Citizens. Please go ahead. Your line is open. Sylvan Turkan Yeah, thank you for taking my question and congrats on all the progress and looking forward to aspo. 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? Thank you. Very welcome. Well, we'll have an army of folks at ASCO 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 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. Great, thank you. Brian Sullivan (Chief Executive Officer and Co-Founder) And have you done already some payer feedback discussions and kind of around coverage? Do you have any comments around that? We've had a lot of discussions. You know, we built our payer team which includes, you know, 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. Gavin 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. Well, thanks so much for the color. OPERATOR Thank you. And your next question comes from Chase Knickerbocker of Craig. Hello. Please go ahead. Your line is over. Chase Knickerbocker Been good afternoon. Thanks for taking the questions. Just wanted to maybe just assess kind of your, your current kind of commercial readiness. You know, in the past couple months there's been a, 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 (Chief Executive Officer and Co-Founder) Thanks. Sure. Again, all of these situations with some of these early approvals are I would say, situationally based. You know, there was an approval recently for a drug that had a regular review and it came in a few weeks early. Yeah, we have a priority review for new drugs, six month review period. And historically RTOR 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 make sure that we are ready to roll when we hope the approval decision comes helpful. Thank you. OPERATOR Thank you. 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 (Chief Executive Officer and Co-Founder) 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 includes today's conference. We thank you for participating and ask that you please disconnect your lines. Disclaimer: This transcript is provided for informational purposes only. 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