Celcuity Inc.

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Good afternoon, ladies and gentlemen, and welcome to the Selcuity fourth quarter and full year 2025 financial call. At this time, all lines are in a 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 Seavers, Corporate Communications and Investor Relations at Selcuity. Please go ahead.

Thank you, John, and good afternoon, everyone. Thank you for joining us to review Salcuity's fourth quarter and full year 2025 financial results and business update. Earlier today, Salcuity Incorporated released financial results for the fourth quarter and full year ended December 31st, 2025. The press release can be found on the investor section of Salcuity's website. Joining me on the call today are Brian Sullivan, Salcuity'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 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 may 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 presentations of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures GAAP financial measure in today's press release. And with that, I would like to turn the call over to Brian Sullivan, CEO of Selcuity. Please go ahead.

Brian Sullivan Thank you, Jodi. Good afternoon, everyone, and thank you for joining our fourth quarter and full year 2025 operating and financial update conference call. The past year has laid the groundwork for what we expect to be a transformative year for Selcuity as we prepare for the potential approval and commercialization of GAAP solicits. In 2025, we made remarkable progress, achieving a number of clinical and regulatory milestones while also significantly bolstering our balance sheet. And these achievements and the groundbreaking data reported to date are foundational to our goal of establishing Get It Solicit as a new standard of care therapy for patients with HR-positive, HER2-negative, advanced breast cancer. Among the key clinical and regulatory milestones achieved recently include, first, The FDA accepted our new drug application, or NDA, granted it priority review with a Prescription Drug User Fee Act, or PDUFMA, goal date of July 17th, 2026. The NDA was submitted under the FDA's real-time oncology review program, which is utilized for drugs offering substantial improvements over available therapies. In light of the unprecedented efficacy data from the PIK3CA wild-type cohort of the Phase 3 Victoria 1 clinical trial, We're optimistic about the outcome of the FDA's review of our NDA. Second, all these data were presented at a late-breaking oral presentation at the European Society for Medical Oncology and San Antonio Breast Cancer Symposium in December. More recently, these data were published a few weeks ago in a peer-reviewed manuscript in the Journal of Clinical Oncology. And third, we completed enrollment of the PIK3CA mutant cohort of our Phase 3 Victoria 1 trial late last year. Reporting results from this cohort of this phase three trial will be another incredibly important milestone for CellQA. We expect to announce these results in a top line press release in the second quarter and to present full results at a medical conference in 2026, where we also intend to host an investor call. Given how close we are to this disclosure, we will not be answering questions about trial progress or offering additional guidance on expectations for the results of the PIC3CA mutant cohort during the Q&A portion of our call. We've discussed previously the historic nature of the results from the PIK3CA wild-type cohort of the VICTORIA-1 trial and the new milestones they achieved in HR-positive for 2-negative advanced breast cancer. And just to recap, median progression-free survival, or PFS, for the getafilicib triplet, which is getafilicib, albaciclib, and fulvestrin, was 9.3 months compared to only two months for fulvestrin. And the hazard ratio was 0.24. Overall, these results set several new benchmarks for clinical trials evaluating patients in this disease setting. First, the hazard ratio for the Gettys-Wilson triplet is more favorable than has ever been reported by any Phase III trial for patients with HR-positive HER2-negative advanced breast cancer. And second, the 7.3 months incremental improvement in median PFS for the Gettys-Wilson triplet over a full breast strip. 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 a regimen, including an endocrine therapy. And third, gadotelicib is the first inhibitor targeting the PI3K-AKT mTOR pathway to demonstrate positive Phase III results in patients with HER2-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, whose disease progressed on or after treatment with a CDK4-6 inhibitor. And fourth, the 17.5 months of median duration of response and the 31% incremental increase in the objective response rate relative to control for the Leveson triplet, for the Gettys-Lissab triplet, are the highest reported for an endocrine therapy-based regimen in second-line HR-positive HER2-negative advanced breast cancer. Additionally, the results demonstrated that the clinical benefit of the Gettys-Lissab triplet was consistent across all patient subgroups. One patient, subgroup of note, patients enrolled in the United States or Canada, achieved median PFS of 19.3 months with the gadotilis subtriplet versus two months for fulvestrin, which resulted in a hazard ratio of 0.13. Further analysis that included patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, representing nearly 60% of those enrolled, found that median PFS was 16.6 months with the gadotilis subtriplet versus 1.9 months for fulvestrin, which resulted in a hazard ratio relative to fulvestrin of 0.14. Safety results showed that gadotelicib triplet was generally well-tolerated in the trial with mostly low-grade adverse events. Study treatment discontinuation due to treatment-related adverse events was reported in 2.3 of patients treated with the gadotelicib triplet. We presented additional safety analyses in an oral presentation at the San Antonio Breast Cancer Symposium. 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 two or three stomatitis who received the Gettys-Elizabeth triplet was 12 and 14 days respectively. We also reported that Gettys-Elizabeth did not induce meaningful changes in patient glucose levels. Unlike other approved drugs targeting PI3K-alpha, getatilicin did not induce clinically relevant hypoglycemia and required no dose reductions or withdrawals due to hypoglycemia. To characterize the tolerability of the getatilicin regimens, we also reported results from patient-reported outcomes that capture a patient's perception of their overall well-being. And these measures include a patient's assessment of their mobility, ability to care for themselves, ability to conduct their usual activities, their pain or discomfort, and anxiety-depression. The result of these assessments is then summarized as the patient's time to definitive deterioration and changes in well-being relative to the measures reported prior to the patient's starting treatment on the trial. For the Addis Elissa triplet, the median time to definitive deterioration was 23.7 months versus four months for Fulvestrin, with a hazard ratio of 0.39. Additionally, for the first eight cycles of treatment, The patient's assessment of their well-being remains stable relative to their assessment prior to starting treatment with getotelicib. And based on these assessments, we believe this provides meaningful evidence that patients treated with getotelicib tolerated it well. And let's turn now to our Victoria 2 study, which is a Phase 3 clinical trial evaluating getotelicib plus a CDK4-6 inhibitor and fulvestrin as first-line treatment for patients with HR-positive HER2-negative advanced breast cancer or endocrine therapy resistance. We're wrapping up the safety run-in, and we expect to provide an update on our final Phase 3 study design in the second quarter. We believe the positive results from the PIK3CA wild-type cohort of our Victoria 1 study augurs well for the potential efficacy our getotelicid triplet may induce in this patient population. Now, let's turn now to our Phase 1B2 clinical trial that is evaluating getotelicid in combination with darolutamide, an antigen receptor inhibitor. And we're evaluating this in men with metastatic castration-resistant prostate cancer. We present a detailed data for the phase 1b portion of the study at a poster presentation at ESMO. And in this portion of the phase 1b2 study, 38 patients were randomly assigned to receive standard doses of darolutamide twice daily in either 120 milligrams of getatilicid in arm 1 or 180 milligrams of getatilicid in arm 2. The six-month radiographic BFS or RPFS rate was 67%, and the median RPFS for patients was 9.1 months in both arms combined. And these results compare favorably to historical results of a 40% six-month RPFS survival rate for patients with metastatic castration-resistant prostate cancer who were treated with an androgen receptor inhibitor as second-line treatment. The combination of getatilisib 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. We're continuing to enroll patients in the dose escalation portion of the trial to evaluate higher doses of getatilisib to determine the recommended phase two dose. Now, as we near what we hope is an FDA approval for getatilisib in 2026, Our efforts to prepare for the potential launch of Get Up to Listen continue to ramp up for our strategic launch plan. We began laying the groundwork for a potential Get Up to Listen launch nearly two years ago, and we've since largely completed building the organization, including our sales force and internal systems required to operate as a commercial stage company. We're very fortunate to have attracted an incredibly talented group of individuals who have strong track records of successfully launching novel oncology therapeutics. Key efforts today include extensive outreach across the country to payers, strategic accounts, and population health decision makers in various treatment settings, including health systems, integrated delivery networks, and community oncology practices. Each of these groups are expected to play a key role in providing oncologists access to get a solicit for their patients. We've made strong progress engaging with these decision makers, and we're very pleased with the feedback and the enthusiastic response these efforts have yielded. We're also very encouraged by the results of research we fielded to gauge the willingness of community and academic oncologists to prescribe GATA to listen should it get approved. And these results make us optimistic about the possibility of establishing GATA to listen 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. And should we report positive results from our study with patients whose tumors have PIK3CA mutations, the get-up-solicit triplet will be uniquely positioned to provide second-line therapy for patients regardless of the PIK3CA mutation status. Based on analysis of published epidemiological data, we estimate there are approximately 37,000 patients in the U.S. with HR-positive HER2-negative advanced breast cancer who've progressed after treatment with a CDK4-6 inhibitor. 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 Geta-Telicib in the second-line setting is more than $5 billion. And given the significant penetration our research is suggesting we can achieve, we believe it is reasonable to estimate that a second-line indication for Geta-Telicib can potentially generate peak revenue of up to $2.5 billion annually. We're excited about the opportunity now that we're approaching potential launch to advance multiple potential blockbuster indications over the years in breast and prostate cancer, while also aggressively preparing for potentially launching Get It to LISP commercially, should we receive an FDA approval. Get It to LISP is well-positioned to address critical needs in the second-line space with its unique mechanism of action and potential first-in-class, best-in-class safety and efficacy profile.

I'd like now to hand the call over to Vicky to review our finances. It seems like we lost Vicky.

Well, if Vicky is having trouble connecting, I can review the remarks that she was prepared to give. Operator, is she no longer on the line?

Oh, yes. She's reconnecting right now. Oh. Well, why don't I continue?

Brian, I apologize. I think I'm back on.

Okay, so why don't you get going?

Yes. Well, good afternoon, everyone. I will provide a brief overview of our financial results for the fourth quarter and full year 2025. Our fourth quarter net loss was 51 million, or 97 cents per share, compared to 36.7 million net loss, or 85 cents per share, for the fourth quarter of 2024. Net loss for the full year was $177 million or $3.79 per share compared to $111.8 million or $2.83 per share compared to the same period in 2024. Our non-GAAP adjusted net loss was $38.4 million or $0.73 per share for the fourth quarter of 2025 compared to non-GAAP adjusted net loss of $32.3 million or $0.75 per share for the fourth quarter of 2024. Non-GAAP adjusted net loss for the full year of 2025 was $150.8 million or $3.22 per share, compared to non-GAAP adjusted net loss of $101.9 million or $2.58 per share for 2024. Research and development expenses were 37.6 million for the fourth quarter of 2025, compared to 33.5 million for the prior year period. Of the 4.1 million increase in R&D expenses, 8.6 million was related to increased employee and consulting expenses, of which 5.3 million related to commercial headcount additions and other launch-related activities. These amounts were partially offset by a 4.5 million decrease primarily related to costs supporting ongoing activities for the Victoria I Phase III trial. R&D expenses for the full year 2025 were 145 million compared to 104.2 million for the prior year. Of the approximately 40.8 million increase in R&D expenses, 26.7 million was related to increased employee and consulting expenses, of which 13.1 million related to commercial headcount additions and other launch-related activities. The remaining 14.1 million increase was primarily related to activities supporting our ongoing clinical trials, a development milestone payment under the license agreement with Pfizer, and other commercial launch-related activities. General and administrative expenses were $11.6 million for the fourth quarter of 2025, compared to $3 million for the prior year period. Of the approximately $8.6 million increase in G&A expenses, $6.9 million was related to increased employee and consulting expenses, of which $5.4 million related to non-cash stock-based compensation. The remaining $1.7 million increase was primarily related to professional fees, expanding infrastructure costs, and other administrative expenses. G&A expenses for the full year 2025 were $27.2 million compared to $9.1 million for the prior year. Of the $18.1 million increase in G&A expenses, 14.9 million was related to increased employee-related and consulting expenses, of which 10.4 million related to non-cash stock-based compensation. The remaining 3.2 million increase was primarily related to professional fees, expanding infrastructure costs, and other administrative expenses. Net cash used in operating activities for the fourth quarter of 2025 was 36.4 million, compared to $27.8 million for the fourth quarter of 2024. Net cash used in operating activities for the full year 2025 was $153.3 million, compared to $83.5 million for the full year 2024. Cash, cash equivalents, and in short-term investments were $441.5 million at the end of fiscal year 2025, and are expected to finance our operations through 2027. I will now hand the call back to Jody.

Thanks, Vicki. Before we turn the call over to the operator for questions, I'll remind you, we will not be answering questions related to the progress or status of the mutant cohort of the Victoria 1 study or providing any additional guidance on our expectations for data at this time. John, could you please open the call for questions?

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're using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Our first question comes from the line of Marty Raycroft from Jefferies. Your line is now open.

Hi, congrats on the progress, and thanks for taking my questions. Not sure if this fits within your criteria or not for status update, but I'm wondering if, for the mutant data, if you could say if the database lock is already in place, if that's something you can comment on.

No, I can't comment on that.

Okay, understood. And I know you've already commented on this in the past too, but if you could just recap how the disclosure is going to take place and what exactly you'll share in the readout.

Well, as I indicated, we'll provide top line data in a press release, and then we will provide details at an upcoming medical conference.

Got it. Okay. And then when thinking about when we could see more details at a medical conference, Can you say if that's going to be like relatively soon or is it more likely going to be a second half update?

I think you'll just have to wait and see. Sorry, I can't provide any more details.

Understood. Okay, those were the questions I'll ask.

Okay. Thank you. Thank you, Martin. Your next question comes from the line of Tata Brancroft from TD Cowen.

Your line is now open.

Hi, good afternoon. So I guess I'll shift to maybe a question on the launch. I was hoping maybe you could give us some feedback of what you're hearing from physicians on which segments may be treated immediately upon the wild type approval and which ones may be more gradual, just to get an idea of how you're planning ahead for cadence once you receive approval.

Thanks. Well, thanks. Now, so as we launch, we aren't going to be targeting or narrowcasting our approach to doctors or patient segments. We believe Get a Felicit Regimens offer an opportunity to get the best option relative to what's available today. And so, we would expect our sales force, you know, upon approval, assuming that occurs, you know, to reach out generally to doctors and essentially help them understand how GADATS-LISB and the data can offer, again, what we believe is an improvement in the alternatives that are currently available.

Okay, great. Thanks. And I guess in that feedback that you are hearing in these discussions with physicians, do you Do you think or have any inkling whether they would be willing to potentially use it off-label in mutants ahead of a potential mutant approval if the data are positive?

That's just not something that we have any conversations with doctors about.

Okay.

Okay. All right. Thank you. Thank you.

As a reminder, please ask one question and one follow-up. Your next question comes from the line of Stephen Willey from Stiefel. Your line is now open.

Yeah, good afternoon. Thanks for taking the questions, and sorry to badger you, Brian, on the top-line release of the meeting data. But just curious if that will include any details just with respect to headline PFS numbers and risk reduction, or would this just simply be a statement regarding the achievement of STATSIG?

It'll be the latter. I mean, we're mindful of embargo requirements to, you know, that we need to adhere to in order to be in a position to have a podium presentation at one of these medical conferences.

Okay. And then maybe just a question on prostate, and then maybe just a quick one on the second live breast opportunity that you spoke to. So in prostate, Just curious how high you think you can push dose kind of north of the 180 megs that is used in the Victoria trial. And then just curious, you know, what metrics, I mean, obviously there's a balance of safety and tolerability you need to consider in terms of nominating a recommended phase two dose, but are there any efficacy metrics that you're going to be prioritizing? I know you've shown us the radiographic PFS data, but just curious how things like PSA response maybe even a resist response for those patients with measurable lesions, how that kind of factors into dose nomination.

Sure. Well, just to recap, relative to what we announced previously, we were pleasantly surprised by the safety profile that the 180 milligram dose reported. No dose-limiting toxicities, very limited grade three adverse events. Hypoplasemia was consistent with our breast cancer. Stomatitis was significantly less frequent at that dose in these men. And so that's what led us to decide to increase the dose or rather to evaluate higher doses. And essentially we're using some standard methodology to stepwise increase the dose. And basically, depending on achievement or levels of dose-limiting toxicities, we'll keep going. But we're in the midst of that, so I can't really comment on where we'll end up. But again, it's always a balance. We can't sacrifice tolerability to such an extent that it's self-defeating. But to the extent that we believe there's a dose response that would, you know, lead to improved response at higher doses, we want to explore where that might take us. And so, we would expect to have some look at that data by the end of this year or sometime early next year.

Okay, that's helpful. And then maybe just lastly, with respect to breast, I appreciate some of the color and kind of the peak revenue opportunity here in the second line setting. I think you mentioned just kind of using historical pricing and duration of therapy. Obviously, the pricing is kind of readily available, but what's the duration of therapy estimate that you're using to inform the peak numbers that you mentioned. Thanks.

If you just use a round number of 10 months, and again, that's not a projection. That's just an assumption to drive an estimate. You would be consistent with how we're modeling the market.

All right. Much appreciated. Thanks.

Our next question comes from the line of Josh Bowen from Guggenheim. Your line is now open.

Hey, guys. This is Josh, on for Brad. Just wanted to know, with most of the commercial build complete for second line, what is the key gating factor in getting the frontline endocrine-sensitive trial up and running? Thanks.

The key gating factor is just completing the safety run. And just to look back a little bit, we were evaluating GATA and combination with Rivociclib as a potential CDK4-6 option for doctors to use in the treatment arm. And because we haven't evaluated yet with Rivociclib before, we needed to evaluate it in a sufficient number of patients to make a decision about, you know, dosing and how to move forward. And so that's wrapping up. And, you know, based on those results, we'll update the study design accordingly.

And, you know, we expect to kind of provide an update on the study design in the second quarter and proceed at pace to begin enrolling the phase three study.

Our next question comes from the line of Gil Blum from Needham and Company. Your line is now open.

Thanks for taking our questions. I'll try to keep this brief. So a commercial question that we've gotten a couple of times is surrounding potential challenges in getting patients to come in for infusions. Can you discuss a bit how you plan to avoid these kind of challenges, or are they actually challenges?

Thanks for the question. We heard this question from investors. We've done a number of rounds of market research where we not only engage with doctors on a qualitative basis where we're able to have conversations and have a back and forth, but also in a quantitative setting where it's non-interactive and doctors are essentially going stepwise through information prompts that we provide. And they both allow us to gauge how they interpret the data, how they think about that data relative to other regimens that are currently available, what factors they like, dislike, how strong a factor that is, are they neutral on different factors. And one thing that's very clear when we review the results of that research, is that A, the efficacy is clearly the most important factor for them as they're evaluating the regimen, and B, the IV administration shows up as a negative factor in meaningfully less than 10 percent of the responses we have in this research. Secondly, we also, you know, do research with patients, and again, that's primarily qualitative And again, except in cases where we believe there's a geographic limitation for a patient, simply clinics too far, or if there's some other considerations, you know, their mobility, we do not expect that there'll be significant patient pushback on the IV. I mean, we have some interesting anecdotes, you know, from these conversations that suggest that women take very seriously their obligation for their family to do everything they can to maximize, you know, the time that they can be with their family and to use what they believe are the best drugs that they may have an option to take. So we think all in just reinforces what we believe, which is certainly a terminal disease like metastatic breast cancer. the most important criteria that's going to guide selection of therapy, both the physician and then the preference for the patient, is going to be related to the efficacy that the regimen can induce, and then also to how well-tolerated the regimen is. And the feedback we've received, again, is very positive on that front as well. And so, you know, finally, you know, as it relates to the administration route, Again, we think that's going to be an exigent issue for only a small number of patients, you know, for the reasons I mentioned, and we don't believe that it is going to restrict preference for physicians to prescribe the therapy.

Thank you for all that. And maybe as a follow-up, can you help us understand the commercial advantages of having to get a label across metastatic breast cancer subtypes? Thank you.

Sure. Well, as anybody that's followed this space knows, one word that gets used to describe the landscape is it's very complex, a lot of activity. And so what we hope to be able to provide and the way we expect to position the drug is that we can simplify the decision making process for these physicians. by giving them an option that we believe for any patient subgroup that, you know, they may be treating the best potential risk benefit relative to the alternatives. Now, it doesn't mean there aren't, you know, available options that some doctors may select or prefer in certain patient segments. But we think overall, you know, we'll be in a very strong position by being able to offer essentially biomarker agnostic alternative that doesn't require them to, you know, evaluate, you know, some complex decision making around, you know, biomarker subgroups. And we think ultimately, you know, that, you know, hitting the easy button isn't to diminish the importance of the decision for the doctors, but particularly in the community setting, you know, the challenges of keeping up with the alternatives, you know, can make it difficult for them to make the right decisions in some cases. And so, to the extent we can leverage the data that we, A, have now and we hope to have at the mutant setting, we think that'll be a very significant advantage.

Our next question comes from the line of Oliver McCammon from LifeSci Capital. Your line is now open. Thanks for taking my questions.

So switching gears a little bit, you know, we're roughly one and a half years into the launch of an abolition for the PIK3C mutant endocrine therapy resistance setting. I'm curious if there are any learnings from the launch, the label, and or KOL feedback that you think are supportive of the positioning of GETA in the Victoria 2 trial. Thanks.

Oh, thank you. So, you know, they've reported very good data. And unfortunately, though, the patient population that really is appropriate to treat with that drug is fairly limited. The study only enrolled patients who essentially were metabolically healthy, you know, patients who had an HPA C1 level below six, and essentially, you know, ruling out patients that were either pre-diabetic or diabetic, you know, type 2 diabetes. And it has since been, you know, several dear doctor letters for very significant adverse events that have been reported. And, you know, the label requires fairly extensive glucose monitoring, both by the physician as well as the patient while they're at home. And so, overall, this is based on our assessment of the claims data. It appears those restrictions are having an impact on the usage in the clinic to date. So, from a learning standpoint for us, I mean, it essentially highlights just how unique a drug data is. A, we're addressing this pathway, but more importantly, or rather very importantly, we're not inducing the levels of glycolic system disruption. that can lead to hyperglycemia that requires significant management, or any management at all, actually. And we do not believe that patients who are pre-diabetic or type 2 diabetes will be restricted in their ability to receive treatment with ketazolecin. And so, it really goes back to the drug and the overall safety profile. when you don't have a safety profile like GETA, when you hit this pathway, you'll run into challenges and really being able to treat a broad group of patients or to treat patients in a way that does create some potentially significant adverse event risk.

Very helpful.

And just one sort of frontline follow-up. Given the Persevera results we saw recently, your prior Phase 1B data that you've shared in frontline patients, as well as the number of oral PI3K inhibitors looking at the frontline setting, I'm curious what your level of interest is in a frontline endocrine-sensitive study.

Well, it would be very logical, given the very favorable data that we've reported in that setting in our Phase 1B study. And just as a reminder to folks, in that study, sample size of 41, We reported median PFS of, you know, over 48 months and an objective response rate of 79 percent. And with Getacolizum combined with Palvocyclib and Letrozole. So, those really compare very favorably to what's been published to date for currently approved therapies. So, I think there's a very strong case to be made for us conducting a study in that space. And, you know, we will keep people posted on our thinking.

Thank you for taking my questions.

Our next question comes from the line of Eva Fortea from Wells Fargo. Your line is now open.

Good afternoon. Thanks for taking our question. A quick one from us. Do you have any updated thoughts on the European commercial strategy for GEDA in terms of like timing for a potential update or approach to partnering or how you expect EU to sequence versus the U.S.?

Sure. So, our current plan, if our grand plan comes to fruition, is that if we have, as we hope and expect, a positive readout with our mutant cohort, we would then follow up with a supplemental MDA, assuming we get the initial approval for . And then once that MDA is complete, or that S-MDA package is completed, we would then utilize the documents and essentially most of the documentation will translate, but essentially use the information from both the wild-type and mutant data sets and the NDA modules overall to create an MEA submission in the fourth quarter of this year. That's roughly a 13-month process to potentially get it accelerated, but 13 months with a regular review. And so, in the meantime, after we submit, you know, that would be the window of time that we would use to explore finding partners to collaborate with launching, you know, not only in Europe but potentially globally. You know, simultaneously, we've also been engaging with the regulators in Japan and to identify the regulatory path forward for submission in Japan. We think we've kind of gained alignment so far on that front. And so even though we haven't identified a partner at this time, we are not – we're proceeding apace with regulatory activities. in the most significant markets, which would include the major five European countries as well as Japan. And so we will, you know, in this window have ample time to, you know, find the right partner without delaying at all our ability to have KEDA launched in those markets.

Got it. Thanks. Our next question comes from the line of Kalpeet Patel.

from Wolf Research. Your line is now open.

Hey, thanks for taking the question. One from us on the mutant update. Do you need to hit both the doublet and triplet arms to file later in the year, or can you file on a successful hit on triplet alone?

Well, without getting into any more detail, just limit it to, you know, the study design. The study design's primary endpoint is a comparison of the triplet to apalypsib. And so that is the primary endpoint and that would form the basis for any potential regulatory submission. The analysis comparing the doublet to apalypsib is an exploratory analysis or secondary analysis.

Got it. Thank you. You're welcome.

Our next question comes from the line of Chase Knickerbocker from Craig Haldim. Your line is now open.

Good afternoon. Thanks for the questions. We'll be curious what you and your market access team have heard in your early prelaunch discussions with payers on a number of items around the profile of Geta and Wildtype. Maybe kind of foremost amongst them, how that's solidified or altered any of your thoughts around potential pricing.

I guess, you know, just the overall reception to information that we've shared with, you know, payers and strategic accounts, which we're able to do on a safe harbor basis since they're not healthcare providers, has been very, very positive. I think it's interesting to get the feedback they provide. You know, they're in the business of helping ensure, you know, that individuals who they are ensuring have access to therapies or are ultimately responsible for treating and have access to the right therapies. And so we've been very pleased with how they've reacted to the data and their collaboration, is how I would say it, in working with us to lay the groundwork to ensure that as early as practically possible, get a, rather, patients would have access to this drug and the regimen.

Maybe just as a follow-up around the competitive environment, we saw recently another acquisition of a mutant-selective PI3K alpha inhibitor. Can you just refresh us on your thoughts on, you know, the potential future competition for you from that angle and then just kind of generally on kind of the next generation assets coming up in competition here?

Sure. No, thank you. Again, I think there's been, you know, since Epilepsib received its approval, I guess, seven years ago, there have been a number of companies that have sought to potentially provide an alternative that would be safer than opalipsid, and that's a worthy project. But the underlying biological assumption that's really driving those projects, we think, is not necessarily current. We think get ethylizid and the approach we've taken of inhibiting Paul, class one, PS we get isoforms as well as mTORC1 and 2. is the approach that's required to optimize anti-tumor control, you know, to provide maximum anti-tumor control. And so, we just think there's a biological limit on the benefit that a single-target inhibitor like a PSVA-alpha inhibitor can induce. And, you know, having more, as we've seen with SIRDS, doesn't necessarily yield different results. I think, you know, five phase three reports later, I think we've seen very, very similar results. Now, in this case, in this setting, I think it's reasonable to expect that based on the way these drugs are distinguishing their targeting between the mutant form of PI3K-alpha and the wild-type form, that they can improve upon safety profile relative to epilepsy. I think that seems pretty reasonable. But ultimately, I think there's going to be a limited biological potential to induce an optimal outcome for efficacy. And I think the results today for GETA certainly, we think, demonstrate the value and importance of providing comprehensive inhibition of this pathway as opposed to selective inhibition of this pathway. So as far as, you know, impact on us, we actually – we think, again, that targeting approach will be obsoleted if the data we hope to report out soon is what we hope and expect.

Got it. Thanks, Brent. You're welcome.

There are no further questions at this time. I will now turn the call over to Brian Sullivan, Solicuity's Chief Executive Officer, for closing remarks. Sir, please go ahead.

Well, thank you for participating in our call today, for your ongoing support. I look forward to reporting back to you soon. Take care.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you.