Prepared remarks
Good afternoon, ladies and gentlemen, and welcome to the Celcuity First Quarter 2026 Financial Results Call Webcast. I would now like to turn the conference over to Jodi 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 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.
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 topline 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 two 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 topline 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. 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 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 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. A 7.3-month 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 eight 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 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. 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 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 median PFS of approximately 25 months. 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. 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. 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 palbociclib and fulvestrant in Arm A and compare that to ribociclib combined with fulvestrant in Arm B. We expect to have topline 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. 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 gedatolisib combined with palbociclib and letrozole and compare it to ribociclib combined with letrozole. The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are progression-free survival per RECIST 1.1 criteria as assessed by blinded independent central review. We expect topline data for Study 2 in the endocrine-sensitive patients to be available by 2030. 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. This program is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. 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. 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 with 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. These results compare favorably to historical results of a 40% six-month radiographic PFS rate for patients with metastatic castration-resistant prostate cancer who were treated with an androgen receptor inhibitor as second-line treatment. 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. Our strategic launch plan 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 and 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. 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 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. 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. 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. 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.
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 used 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.
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?
Questions and answers
And your first question comes from Maurice Raycroft of Jefferies.
Congrats on the progress. Maybe starting off, just wondering if you can provide any perspective into the nature of questions and interactions with the 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?
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.
Got it. Okay. And then I wanted to ask about the subcutaneous 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 VIKTORIA-2 study?
Sure. So as far as the internal work, 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. Obviously, the first step is optimizing the formulation itself, and it's required that 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. 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 an equivalent study, possibly a Phase III study. They've laid out some guidance on that front. 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.
And your next question comes from Tara Bancroft of TD Cowen.
So my question is not about the mutant data, more about some educational historical background. Because in thinking about the range for alpelisib and fulvestrant in 5 to 7 months, can you just—from your view of historical trials—provide 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?
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. 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. The data that's been reported is really the only data that can be assessed to understand what the performance of a drug like alpelisib can do.
And your next question comes from Andrew Berens of Leerink Partners.
On the progress, Brian. Looking forward to seeing the data at ASCO in Chicago. My questions are about the subcutaneous 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 subcutaneous 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 subcutaneous? 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 subcutaneous version?
Okay. 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. We expect that our program will follow those requirements. I outlined those in one of the prior answers—essentially where you have to characterize the PK profile for a variety of reasons, and then also characterize the equivalence from an efficacy standpoint. To date, it appears that when you introduce a new formulation that has a different route of administration, you need to demonstrate clinical equivalence. Based on some recent guidance, it appears that the FDA's position is that if you demonstrate equivalence in one indication, that approval will allow that new formulation to be used for any other indications that may exist. We expect that to be the path forward for us, and we'll take it from there.
Okay. And then what about the PK and the Cmax? Any insights on how they might change?
No, I mean, from a development standpoint, the perfect world is you match the PK profile as closely as you can, or at least you focus on certain ranges. As far as speculating about the stomatitis effect, it's premature to get into that. It's likely a function of Cmax and the fact that concentration settles after a few hours at a much lower concentration and basically remains stable. 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. There are ways of thinking about administering the drug or formulating it that would allow you to try to optimize that, and those are elements of the development program we'll be evaluating.
And your next question comes from Stephen Willey of Stifel.
Congrats on the announcement today. I know that we've seen frontline market share in the endocrine-sensitive setting largely influenced by longer-term OS data. So just curious as you were thinking about the sizing of VIKTORIA-2 Study 2, how this factored into the design and whether you might be able to provide any preliminary powering assumptions on either OS or PFS?
Well, overall, overall survival becomes the way to break the tie when you have three regimens that offer almost equivalent progression-free survival. That was the case with the CDK4/6 drugs, and ribociclib subsequently demonstrated a survival benefit. We'll be comparing ourselves to ribociclib. If we offer progression-free survival that's superior to ribociclib and show no decrement in overall survival, that will achieve the goal of demonstrating clinical benefit for these patients. Certainly, for any study you do, you'd like to show a survival advantage relative to what you're comparing to. But if we achieve PFS and show no decrement in OS, we'll satisfy regulatory requirements and we think we'll satisfy clinical expectations. The drug has to offer a meaningful increase in incremental PFS: three months on top of 10 is different than three months on top of 25. We're mindful of that and design the study to reflect the expectations that you need more than three months to demonstrate a clinically meaningful benefit.
And your next question comes from Bradley Canino of Guggenheim Securities.
Great to see the strong progress on my end as well. For the subcutaneous formulation—sorry if I missed this in the prepared remarks—is the formulation completed? Have you conducted animal models with it yet? Or is this still in process?
Again, we're not going to give a play-by-play on each stage of the program other than to say that we have multiple candidates that we're advancing. We're in the middle of doing a variety of both stability studies to confirm and characterize the formulation itself as well as evaluating other nonclinical parameters, including animal studies and related work.
Okay. And maybe it would be helpful: are there any certain properties about gedatolisib that support its translation to a subcutaneous formulation that could give investors confidence?
Other than our confidence that we'll be able to develop it, every drug has its own challenges when converting it to a more concentrated form. Part of the advance we've made requires invention, which is good because it's not an obvious approach, and it's one that we think will enhance our intellectual property position significantly. As far as signaling how to interpret the likelihood of success, I would say we're very confident.
And your next question comes from Oliver McCammon of LifeSci Capital.
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.
There's a lot of learnings from PALOMA-2 and also from the MONALEESA-2 ribociclib study. We've taken in the learnings from the ribociclib study more than the PALOMA study. We think there's certainly a way to design the study to maximize your opportunity to potentially demonstrate an overall survival advantage.
And your next question comes from Eva Fortea of Wells Fargo.
Congrats on the progress. Do you have any updated thoughts on the competitive positioning for gedatolisib versus other PI3K inhibitors in development? And how do you see this evolving with a subcutaneous formulation coming online?
We did report that the gedatolisib doublet, as a head-to-head replacement for an existing PI3KCA-approved drug, was statistically significantly and clinically meaningfully differentiated from a single-target inhibitor. Ultimately, what we've been saying has been confirmed: multi-target inhibition of this pathway is required to optimize antitumor control and single-target inhibitors are going to be limited. If you look at the data for alpelisib and capivasertib, the hazard ratios they have reported in patients who had prior CDK treatment are very similar, roughly 0.5 compared to fulvestrant. We've demonstrated that we're superior to that. What we think that means is that the single-target approach will be at a disadvantage going forward from a benefit standpoint. We do not believe that approach offers the potential to provide comparable efficacy.
And your next question comes from Gil Blum of Needham & Company.
Congrats on the progress and the impressive results, Brian. Just a couple of quick ones. As it relates to the potential for a subcutaneous formulation, is there any chance that would change the dosing schedule? You currently have a very specific schedule of dosing. Could there be any changes to that? And how do you view this?
Those are factors that go beyond simply the formulation because it involves the overall PK profile of gedatolisib and what's required to sustain sufficient target engagement. The question is broader than simply subcutaneous; it relates more generally to how to administer or how frequently it needs to be administered. How we answer that will likely be determined by studies involving the infused form because we have that now and can evaluate it. To the extent we find ways to potentially alter the administration schedule, that would apply to a potential subcutaneous formulation.
That makes sense. And just interesting to hear your thoughts on recent news from one competitor who decided to move away from a PI3K selective mutant approach to an alpha-specific approach—do you have any thoughts on that?
I think there's only so much biological potential that targeting the alpha isoform gives you. That may be more a function of increasing the potential patient population they hope to treat. They may have found results indicating they didn't need to be as specific. Alpelisib generally targets the more common mutations, and there's been some evidence of variation in response depending on the specific mutations. I'm not sure that broadening or narrowing targeting is inherently positive; companies have to make decisions based on their data. Again, it's in the context of what we think is limited biological potential to reduce a treatment effect when you limit targeting to the alpha isoform.
And your next question comes from Kalpit Patel of Wolfe Research.
One from us, another one on the subcutaneous formulation. Would you characterize gedatolisib's antitumor effect as being Cmax-driven or AUC-driven? And how does that inform your confidence that the subcutaneous formulation can achieve clinical equivalence to an IV?
Those are good questions. A lot of work has been done by many to determine whether a drug is more Cmax-driven or driven by total exposure. An argument could be made that it's both: you get benefit from the initial high concentration and then the sustained target engagement. Our roadmap factors in what we've seen to date and aims to match that curve as closely as possible. It won't be exact, but there are other parameters you can adjust, and we're taking those into account.
And your next question comes from Silvan Tuerkcan of Citizens.
Congrats on all the progress and looking forward to ASCO. Maybe 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?
We'll have an army of folks at ASCO, mostly medical professionals, to engage with doctors and exchange information. There's a lot of other work that can be done; it's a big venue with many doctors and a good opportunity to communicate results. We view ASCO as great staging ground to lay the groundwork for what we hope is a future launch over the summer. We're very excited about the timing of ASCO and its alignment with the schedule we hope will lead to approval.
Great. And have you already done some payer feedback discussions around coverage? Do you have any comments around that?
We've had a lot of discussions. We built our payer team, which includes a team focused on strategic accounts and a team focused on national payers, and we've been engaging in depth for almost a year. Their formal review doesn't take place until you have an approval and submit a dossier, but along the way you can get input about expectations. You can learn about the system and their requirements and ensure that when it comes time to make decisions that everyone on these various committees is well informed and comfortable from their perspective about the proposition the therapy offers to their patients and the relative reimbursement expectations. We're very well along in laying that groundwork and in a strong position once approval comes to move expeditiously with the various accounts I described.
And your next question comes from Chase Knickerbocker of Craig-Hallum.
Just wanted to maybe assess kind of your current commercial readiness. In the past couple of months, there've been a couple of early oncology approvals relative to PDUFA date. Brian, where do you think you sit from an innings perspective in having your team ready for a potential launch in wild-type?
All of those situations with early approvals are situational. We have a priority review for a new drug, a six-month review period. Historically, RTOR reviews of drugs with priority designation occur pretty much in line with the PDUFA date, and that's been our governing assumption. Internally, we've identified a launch-ready date that's before PDUFA so we make sure we are ready to roll when we hope the approval decision comes.
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.
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.
Ladies and gentlemen, this concludes today's conference. We thank you for participating and ask that you please disconnect your lines.