Celcuity Inc.

Ladies and gentlemen, welcome to the Q&A second quarter 2026 financial results conference call and webcast. 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 any assistance, please press star zero for the operator. I would now like to turn the conference over to Jody Severs, Corporate Communications and Investor Relations at CQD. Please go ahead.

Thank you, Lili, and good afternoon to everyone. Thank you for joining us today to review Salcuity's second quarter of 2026 financial results and business update. Earlier today, Salcuity released financial results for the quarter ended June 30th, 2026. 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, , Vicky Hahne , as well as Igor Gorbatchevsky , and Eldon Mayer , who will be available during Q&A. As 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 for the SEC. Actual events and 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 core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to the GAAP measures in today's press release. And with that, I would like to turn the call over to Brian Sullivan, CEO of CellCuity. Please go ahead, Brian.

Thank you, Jodi, and good afternoon, everyone. Thank you for joining our second quarter 2026 operating and financial update conference call. CellCuity continues to make monumental progress advancing clinical development of gettalizib for patients with HR-positive HER2-negative advanced breast cancer. With the FDA approval of RepterPIC, positive results from the PIC3CA mutant cohort of our pivotal Victoria 1 study, and a preferred Category 1 recommendation in the NCCN guidelines, we're well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR-positive HER2-negative advanced breast cancer. We remain on track to begin shipping RepterPIC late in the third quarter of 2026, and we look forward to making this important therapy available to patients with advanced breast cancer. Based on the positive data from the PIK3CA mutant cohort of the Phase 3 Victoria 1 study, we plan to submit a supplemental NDA or SNDA in the third quarter of 2026. Additionally, our Victoria 2 study was expanded to enable evaluation of treatment IE patients who have endocrine sensitive breast cancer Positioning get us a list of regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status. In sum, we've had an eventful past few months. I'd first like to review in a bit more depth the status of our clinical development programs and then provide an update on the commercial launch of RevTripIt. On July 14th, a few days before our procurement date, We received notice from the FDA that RevtorPIC in combination with Fulvestrin with or without polycycline was approved for the treatment of patients with the HR-positive HER2-negative locally advanced or metastatic breast cancer without a PIC3CN mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. A little over two weeks later, NCCN updated their guidelines for HR-positive HER2-negative breast cancer treatment. recommending both the RetroPIC triplet and doublet regimens as preferred Category 1 regimens for second-line or subsequent treatment for tumors without a PIC3CA mutation. We're very encouraged by the panel's rapid review and recommendation. In June, we presented positive efficacy and safety results from the PIC3CA mutant cohort of the Victoria 1 Phase 3 trial at the ASCO annual meeting. The primary efficacy analysis of the gadathelizib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS, progression-free survival, compared to alpalypsin, a PF3K alpha inhibitor, and fulvestrin. Median PFS was 11.1 months with the gadathelizib triplet versus 5.6 months with alpalypsin plus fulvestrin with a hazard ratio of 0.5. The secondary endpoint comparing the gadathelizib doublet versus alpalypsin plus fulvestrin which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to epilepsy and fulvestrin. Median PFS was 11.3 months with the get-up solicit doublet versus 5.6 months with epilepsy plus fulvestrin with a hazard ratio of 0.51. The safety data for the get-up solicit triplet and doublet were consistent with previously reported data from the wild-type cohort of Victoria 1. Now, we've since updated the analyses of the treatment discontinuation rate due to an adverse event for Geta-Felicitib and Alpalypsib in the PIK3CA-Newton cohort using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA-Wildtype cohort presented in the Ref2Pik label. For patients who received the Geta-Felicitib triplet and Geta-Felicitib doublet, 5.2% and 3.8% of patients discontinued Geta-Felicitib due to an adverse event, respectively. for patients who received epilepsy, 19% discontinued treatment with epilepsy due to an adverse event. Now, we believe the lower get a solicit treatment discontinuation rate for the mutant cohort than was reported in the wild type cohort reflects the fact that the discontinuation rate was higher early in the overall Victoria 1 study and then fell as physicians gained experience. Since a much higher proportion of wild type patients were enrolled during this period than the mutant patients, the impact of this initial higher discontinuation rate early in the study all disproportionately on the wild-type cohort. And thus, we believe the treatment discontinuation rate for getafilicid reported for the mutant cohort, roughly 4% to 5%, best represents what we expect to see in a real-world setting. We also updated analyses of the mean number of getafilicid treatment cycles patients received in the wild-type and mutant cohorts in Victoria 1 as of August 2, 2026. This analysis had a median follow-up period of approximately 21 months for the wild-type cohort and 17 months for the mutant cohort. For patients treated with the gadathelicid triplet in the wild-type cohort, the mean number of treatment cycles for gadathelicid was 9.0, and 16 of these patients, representing 12% of those dosed, are still receiving gadathelicid. For those treated with the gadathelicid triplet in the mutant cohort, the mean number of treatment cycles for gadathelicid was 10.0. 34 of these patients, representing 22% of those doses, are still receiving Geta-Felicit. For patients treated with the Geta-Felicit doublet in the wild-type cohort, the mean number of treatment cycles for Geta-Felicit is 9.7, and 15 of these patients, representing 12% of those doses, are still receiving Geta-Felicit. And for patients treated with the Geta-Felicit doublet in the PIC3CA mutant cohort, The mean number of treatment cycles for patients receiving Geta-Felicit was 11.3. And 10 of these patients, representing 19% of those doses, are still receiving Geta-Felicit. Analyses of mean treatment cycles for Reftropik in the Victoria 1 trial are particularly relevant for assessing the commercial potential of Reftropik since they incorporate the effect that patients who remain on Reftropik for extended periods of time have on the likely usage expected in the real world. The median duration of treatment metric truncates this effect and thus underestimates drug usage for a patient population. We expect to provide further updates to results from both the wild-type and mutant cohorts of Victoria 1 at medical conferences later in the year. Now, with the FDA approval of our NDA in hand and positive data from the mutant cohort, we expect to submit the data from the mutant cohort to the FDA as an SNDA in the third quarter of 26. And we expect to submit Victoria 1 Phase 3 data for both the wild-type and mutant cohorts the global regulatory authorities following the SMDA submission. Now the get it to list regimens have demonstrated the potential to improve the standard of care in the second line setting regardless of the PIK3CA status of the patient's tumor. And we believe the results from the VICTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K, AKT, mTOR, or PAM pathway. Additionally, these results augur well for the Phase III VICTORIA-2 trial we have underway to advance in the first-line setting for patients with advanced breast cancer. In May, we announced that we were expanding the Victoria 2 file to include a second study, study 2, evaluating the efficacy and safety of getafilicib in combination with pylosiclip and letrozole in patients with treatment-naive endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. And these are women whose cancer relapse will progress 12 months or more after completion of adjuvant endocrine therapy. or those with de novo metastatic disease without prior endocrine therapy exposure. Endocrine-sensitive patients represent approximately two-thirds of the women in the U.S. newly diagnosed with advanced breast cancer each year. The current standard of care therapies for these patients provide median progression-free survival of approximately 25 months. Study 1 of the Victoria True Trial, which was already ongoing, is evaluating getotelicib in combination with tablacyclib and fulvestrin. and patients with treatment-naive endocrine-resistant HR-positive HER2-negative advanced breast cancer. And these are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. Now, results from the Phase 1B clinical trial that we ran several years ago provided strong evidence that the PAM pathway is an important disease driver in treatment-naive patients with advanced breast cancer. In this early Phase 1 study, re-evaluated getotelicid plus polycyclob and letrozole as first-line treatment in 41 patients with endocrine-sensitive HR-positive HER2-negative advanced breast cancer. Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribocyclob plus letrozole. Ribocyclob plus letrozole is the therapy that we're using as the control in our VICTORIA-II trial for endocrine-sensitive patients. The objective response rate was 79%, which, again, compares favorably to historical data of 53% in the first-line setting for rhodocyclib plus letrozole. In light of the positive results for the PIC3CA wild-type and mutant cohorts of VICTORIA-1 and the promising preliminary data for get-its-licit triplet as first-line treatment, we're optimistic about the results of both our first-line studies. Successful development in this first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who were diagnosed with late-stage HR-positive HER2-negative advanced breast cancer in the U.S., irrespective of their endocrine sensitivity or PIK3CA status. Our advancement of subcutaneous Geta-Felicit formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of Geta-Felicit. Subcutaneous formulation is aimed to support potential future indications for Geta-Felicit regimens that may result and duration of treatment periods greater than several years. And now let's turn to our Phase 1b-2 trial. That's evaluating getathelizib in combination with darolutamide and then with metastatic castration-resistant prostate cancer. In the dose-finding portion of the Phase 1b study, evaluation of a 240-milligram dose of getathelizib was completed. No adverse events led to treatment discontinuation of getathelizib, and dose-limiting toxicity criteria for dose reduction were not met. and this allowed us to begin evaluation of a 300-milligram dose, which is ongoing. Once the dose-finding portion of the study is completed, we expect to select two potential recommended Phase II dose levels and control arm options for the randomized Phase II portion of the study. We expect to provide updated clinical data and additional visibility into our development strategy for prostate cancer during the fourth quarter of 2026. Now I'd like to discuss our launch plans and the commercial opportunity for Reptipix. We began laying the groundwork for a potential get-up solicit launch over 24 months ago. During this period, we've engaged over 1,000 key opinion leaders and community breast cancer experts, over 250 key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at PAMPathway.com has already driven awareness of the PAMPathway, with metrics tracking well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have further increased levels of awareness about the unmet need in the second-line setting. Now, the build-out of the commercialization infrastructure needed to support the successful launch of Rev2Pick is now complete, and commercial launch activities for Rev2Pick commenced immediately after approval. Our 88 oncology sales specialists, who have an average of 24 years of industry experience, are calling on physicians and supporting installation of RetroPIC order sets within the electronic health record systems of their accounts and in servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical science liaison, and KOL-focused teams are following through on the groundwork they laid prior to RetroPIC approval. Payer and strategic account pathway dossiers have been submitted, and formal efforts to get included on formularies and pathways are in process. All of these efforts are designed to offer patients and providers with rapid access and seamless support. Shipments of Reptripic are expected to begin late in the third quarter of 2026. Now, wholesale acquisition costs, or WAC, of Reptripic, which has been reported to the drug pricing compendium, will be $10,000 per vial or $30,000 per cycle of treatment once Reptripic is commercially available. To enable treating physicians to obtain, get a solicit on behalf of their eligible patients prior to commercial availability of Reptripic, So Acuity opened an expanded access program last week, and shipments to these physicians have begun. Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for ASR-positive for T-negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment for Reptripic per patient at the WAC price, we estimate the total addressable market for Reptripic in the wild-type N-mutant setting combined is potentially over $6 billion annually. And that concludes my remarks. I'd now 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 second quarter of 2026. Our second quarter net loss was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million or $1.04 per share for the prior year period. Our non-GAAP adjusted net loss was $58.7 million or $1.07 per share for the second quarter of 2026 compared to non-GAAP adjusted net loss of $40.5 million or $0.93 per share for the prior year period. Research and development expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease was primarily due to a $7 million decrease in clinical trial costs, which was primarily driven by decreased costs for the Victoria I Phase III clinical trial. The remaining decrease was primarily due to a $5 million and others. Selling, general and administrative expenses were $35 million for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase was primarily due to a $14.5 million increase in employee-related expenses largely driven by the hiring of additional personnel within our commercial function to support the anticipated launch of Reptorpic. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees, and expanding infrastructure costs and a $2.1 million increase in other administrative expenses. In aggregate, $23.4 million of the $27.4 million selling general and administrative increase related to commercial headcount additions and other launch-related activities. Net cash used in operating activities for the second quarter of 2026 was $55.4 million compared to $36.2 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 $18.2 million and working capital adjustments of $1 million. Cash, cash equivalents, and short-term investments were $754 million as of June 30, 2026, compared to $441.5 million as of December 31, 2025. The $312.5 million increase was primarily driven by the convertible moat offering completed in June, 2026. This resulted in gross proceeds of $575 million and net proceeds of $557.2 million. The proceeds were offset by $137 million Repayment of our term loan and 110.5 million cash used in operating activities. Additional cash provided by financing activities of 2.8 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash, cash equivalents, and investments to finance our operations at least into 2029. I will now hand the call back to Jody.

Operator, could you please open the call for questions?

Thank you. And ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press the star followed by the number 1 on your telephone keypad. To withdraw your question, please press the star followed by the number 2.

One moment please for your first question. and your first question comes from the line of Tara Bancroft with Cutie Commons.

Please go ahead.

Hi. Thanks so much for taking the question. So I guess what I'd really like to understand is more of what underscores your confidence in the late Q3 shipments. Like, for instance, are you initially launching with the existing clinical supply? And if so, how long would that last you? And, you know, how long is the process for setup with the backup manufacturing and what does that entail? I know that that sounds like a lot of questions, but I'm just getting at the same thing of your level of confidence in supplying the launch without delay.

Sure. As I explained a couple weeks ago, we want to have confidence that our review process with the FDA will proceed according to what we expect to occur, that there are no surprises, and we're are very confident about being able to ship beginning at the end of this quarter. So nothing's changed.

Okay, great. But I guess just as a follow-up, as part of that review process, do you need an inspection?

Well, the FDA can do whatever they want. But typically, if you are with a manufacturer that has met requirements, they don't necessarily require that. It would Again, you don't want to really be in the position of projecting what the FTA does or won't do, but we believe the validation data that we have is very consistent with the validation from our first site, and so we would anticipate that the review process will be straightforward.

Okay, great. Thanks so much.

You're welcome.

And your next question comes from the line of Mario Raycroft, which, please go ahead.

Thanks for taking my questions. I'll follow up on Tara's questions. Just wondering if you can clarify if you submitted that validation work, the necessary information to FDA yet, or what are the rate-limiting steps remaining there? And do you need FDA to provide any type of sign-off before you can launch the product from that site?

Well, two things. We submitted the data almost immediately after we got the approval. We had the package of information required to get the FDA to review and for approval the use of that site. So that's begun. And you can't ship from that new site until you have received the go-ahead from the FDA. That's the limitation on getting access to material from that second site. But, again, as we've indicated, we want visibility on the review process. for that site. And again, we're confident about our ability to ship on the third quarter, late third quarter.

Got it. Okay. Maybe one other question just on the expanded access program. Wondering how many sites or doctors are participating in and do you have some patients enrolled already? And will you provide quarterly updates on where you're at with enrollment there? I guess Is that something that could... Hopefully we're not provided quarterly updates, right?

Because it'll go away. But yes, we just got the program started last week and we essentially had to get approval, submit to the FDA as well as get IRB approval, central IRB approval. So that occurred last week and we've already begun shipping drug to sites where physicians are treating patients.

Got it. And then presumably once you have drug launch, then those patients will convert over to commercial drugs then?

Exactly. And that was reflected in the protocol.

Got it. Okay.

Okay. Thanks for taking my questions. You're welcome.

The next question comes from the line of Brad Canino with Guggenheim. Please go ahead.

Thanks for the updates, especially around the prostate cancer progress. It's good to hear. I'm actually wondering about a different cancer study, because I know one of your colleagues and many competitors in the space is doing a lot of work in endometrial cancer. And I'm wondering how you think about that as an opportunity for . I know there's probably some old data that Pfizer conducted, probably not the right regimen and treatment line setting, et cetera. So, how do you think about bringing that into the development portfolio if that's an opportunity for you guys? Thank you.

Sure. There's certainly strong rationale for us to consider that. And, you know, we'll be updating folks on our, excuse me, on our development plans as we get further into the year. But until then, I can simply say that some preliminary data that was generated previously was indicating that even as monotherapy, it can induce an objective response. And, you know, the underlying drivers of the disease include the role of the PIK3CA pathway and for a certain significant cohort, the endometrioid patient population. The hormonal pathway is also involved. So there's certainly a strong rationale for us to consider developing in that setting.

Great. And then in prostate specifically, too, I'm tracking this somewhat from afar, and I'm hearing K-wells have a pretty intense conversation around capupacertib and its potential role there as the first inaugural pathway inhibitor on the PAM pathway to go after that. What do you think? as you have the conversations with those same investigators and KOLs, we can actually learn from the Kathy Bussard data and it adds a foreshadow of the opportunity for something like get a tolicid and what should we keep in mind that could be different as you approach it. Thank you.

Sure. So Kathy, as you know, is approved in breast cancer to treat patients who have a PIK3C mutation. Its efficacy was comparable to the efficacy for opalipsid in its Phase III study in a similar setting as what we were just studying. And GADETS, as we announced recently, showed double the activity relative to apelipsid, which we think is a reasonable proxy for what CAPI is capable of doing. And so we think the fact that CAPI got approval for the P10 loss population is essentially that's the Thank you very much. Prostate patients were evaluating castration-resistant patients. But the fact they got out of the line with a positive study in a mutant cohort, similar to what they did in breast cancer, we think is translatable to what we may be able to do. We have encouraging data. We'll be updating that data later this year. And we believe that they demonstrate that this pathway, the PAM pathway, plays a role as a driver and that when combined with an antigen receptor inhibitor, you can induce an improvement in outcomes relative to antigen receptor alone. And that's ultimately our hypothesis. We're going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of this pathway and this disease. Thanks, Brian. You're welcome.

Your next question comes from the line of Eva Forteo with Wells Fargo. Please go ahead.

Hi, team. Congrats on the progress and thanks for taking our question. A quick one from us on the EAP. Can you provide more color and how long do you expect it will take to transition the patient from the EAP to commercial following the launch in late Q3? Thanks.

You know, I don't want to get committed to a particular timeline. I mean, certainly we have to be very sensitive. to the needs of the patient and make sure that there's no risk of interruption in supply. And so again, it could be very site-specific, patient-specific, depending on their insurance situation and other factors that may be relevant. But the intent is certainly to transition those patients to commercial supply. That's embedded within the protocol and is well understood. by the participating investigators. And that's a very standard approach. But again, we would expect that transition to occur. It may occur in that two-week gap from day 15 to the next cycle of treatment, in effect day 29. But again, the overall goal is to make sure that there's no disruption to the patient's access to the therapy and we'll essentially accommodate, you know, whatever might be required to ensure that that transition occurs smoothly.

Got it. Very helpful. Thanks.

And your next question comes from the line of Andrew Berens with Lurie Partners East Ahead.

Hi. This is Isabel on for Andy. Thanks for taking our question. We were wondering if you could give more color on the expected growth to that. Thanks.

Sure. So we've done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts. And they don't involve discounts, you know, to, you know, that reflect discounting of the drug per se, but they reflect channel differences that are just a function of, you know, the makeup of those channels. But for our drug, we expect the gross to net percentage to be about 80%. The discounts involved from WAC will be about 20%. And based on data we've seen for oral therapies, that gross to net discount can be about 30%. So we think we'll be able to capture a higher percentage of the WAC than the and corresponding oral therapies in this category are able to capture.

All right. Thank you. And your next question comes from the line of Oliver McCarmon with LifeSci Capital.

Please go ahead.

Hi. Thanks for taking my questions. Maybe just a broader question on the commercialization and your work engaging physicians, I'm curious what proportion of community oncology practices, as you think about associated infusion centers as well as geography, do you think would be amenable to IV therapy in this setting? And then relatedly, do you think there are any learnings to take from what we hear is fairly common use of IV administered in HER2 even in second line? Thanks again.

Sure. Well, we think nearly every community practice has access to infusion centers because Some of the most important therapies in breast cancer used to treat breast cancer are infused therapies. And HER2 is one you mentioned, Pembrolizumab, and TMBC is another. Perceptin and Progetta, which are two HER2 antibodies, are also standard of care treatments in advanced breast cancer, HER2-positive breast cancer. And then all the chemotherapies or many of the chemotherapies that are prescribed are infused. And so, you know, the practice of medicine treating breast cancer patients requires access to infusion centers. So we don't think there's going to be any barriers for community oncologists prescribing Ketocelizumab and ensuring the patient can get infused. And these docs represent the community treaters, treat about 80% of physicians.

Excuse me, ladies and gentlemen, please continue to stand by your conference will resume momentarily. Thank you. . . . . Thank you for watching.

Ladies and gentlemen, we will now resume our conference. We do apologize for the technical difficulties. Brian, please go ahead.

Well, thank you. I hope you all heard the last answer to my question. Operator, if there's additional questions, happy to answer those.

Oliver, do you still have any additional questions?

All right, thank you. Your next question comes from the line of Kalpit Patel with Wolf Research. Please go ahead.

Yeah, hey, good afternoon, and thanks for taking my question. Just one from us on the prostate cancer program. Can you give us a little more granularity on what to expect in the fourth quarter? Is it just TSA response data, or are we going to see RPFS data as well? And then what would be a What success looked like to you in that area? Thank you.

Sure. So we expect to provide additional data. It could include PSA 50 data as well as updated progression-free survival data and looking at different subgroups of patients as well as data from the 240 milligram dose as well. The data with 300 milligram dose may not be mature enough to present. So it'll be data that hasn't been presented before that we think will hopefully shed some good light on the program itself.

Okay, and any color on what would be encouraging in your view for RPFS?

Well, I think the standard of care today, or rather I would say there's kind of two components to that answer. Current patients in the second-line setting who've progressed on, let's say, prior abiturone can expect to receive five to six months median PFS. Similarly, if they are treated with docetaxel instead of hormonal therapy. So the minimum bar to beat would be three to four months better than those options. Plavitco's out there as an option as well. They're offering patients north of 10 months. And so our expectation would be that we would need at least to be comparable to Plavitco. We think there'd be advantages to use of our drug versus their drug in that setting. And certainly we would hope to be superior to that. But that if we're able to demonstrate typical three to four month superiority relative to what would be an add-on therapy, with Geta versus a switched antigen receptor inhibitor, or at least comparable efficacy to Plavitco that, you know, we would, could potentially play an important role in that treatment. Of course, you know, we know there's some other data that could be coming down the pike, and that'll be very relevant to any assessment that we make.

Okay. That's super helpful. Thank you.

You're welcome.

Your next question comes from the line of Gil Bloom. If you need him, please go ahead.

Hi, guys. This is Jonathan for Gil. Just a quick question about the secondary manufacturing site. For the supplemental filing, what is the timeline that you guys are expecting for hearing back from the FDA? Is it similar to an SNTA timeline?

Not an SNTA. There's multiple processes and steps along the way, but, you know, it can involve a review as brief as two months or, you know, Thank you very much. but that's what we think we'll find out relatively early in the process.

And just a quick follow-up. If this supplemental filing was approved, what percent of supply would you expect would be coming from the second site at full capacity?

You know, that's a very tactical. It'll be appropriate. We'll be using, you know, inventory from both sites and managing. and Vicky Hahne. Thanks again and congrats again on all the progress. You're welcome.

Just curious where you are in terms of preparing a publication of the median data and whether you believe the compendia listing for use of these patients could be achieved before formal label expansion. And then was also just wondering how you're thinking about communicating launch progress to the street and what metrics you think you might be providing to us over the next few quarters. Thanks.

Sure. Regarding the article, we have submitted an article to Journal, and that process is variable in time. It can take three months, it can take six months. We would hope to have it be on the shorter range of that timeline, but it's not 100% in our control, obviously. But that process is well underway. As far as mutant usage, I mean, we can't promote mutant usage, but we would... have the opportunity potentially to, and it's up to the NCCN panels to have the NCCN make a recommendation based on published data. They can't make recommendations just based on, for instance, a presentation given at a major medical conference. They need to see data from a peer-reviewed journal before they would consider making changes to their recommendations. But if they made recommendations, those are widely followed by payers and and if the recommendations are appropriate what the payers require then physicians would be in a position to prescribe the medicine and their patients to get reimbursed for it. But again, not something we can certainly drive or really discuss at all in the clinical context. But those are variables that could be present in the marketplace. And as far as progress, we'll be reporting a sales obviously, as we go. You know, we don't have the granularity of data that you have with oral therapies. You know, we have a – we ship to a site, you know, to buy and bill, but we don't get a prescriber name on that therapy. And so we don't get as much visibility. There's not a name on the prescription, for instance. So we don't get as much visibility as, let's say, an oral medication gets. The granularity of data won't be as high as people might be used to for oral therapies. We will be doing survey data that will give us a view on probably 40% to 50% of patients treated. But there'll be a lag in that. That'll be two to three months lag. So it won't be current or necessarily representative. It'll provide us important information to help manage the business. but it won't be real-time evaluation. We internally will be certainly tracking and be able to intuit based on our analyses, you know, where the drug is going, who's at the locations and be able to do analysis like that but we won't have sufficient specificity to, for instance, identify, you know, how many doctors prescribe it, how many re-prescribes it, how many patients on therapy. You know, we'll simply have in real-time setting the actual number of vials shipped to sites. And we expect that to represent demand. There really won't be inventorying of this drug. Our distributor, 3PL, will be delivering this drug overnight in the great majority of cases. And so we don't expect, and some of the larger sites, depending on their overall approach, may maintain some stock based on the number of patients they have on the drug. So there could be in certain facilities a little bit of loading, but we wouldn't expect that to represent, you know, let's say more than a cycle of treatments, and we think that would be unlikely. All right. That's very helpful. Thank you. You're welcome.

And your next question comes from the line of Sylvan Torchan with Citizens. Please go ahead.

Hey, this is Josh on for Sylvan. Thanks for taking the question. Yeah, so you mentioned plans to submit the SMDA for the mutant population in 3Q. Could you maybe just walk us through some of the potential regulatory timelines, maybe, you know, submission to filing and then, you know, potential for a more rapid review period?

Yeah, sure. No, because it's an SMDA, while they will need to accept the SMDA, the clock starts for the review. when the final submission is made. And so, you know, from the time we complete our submission to whatever the prescribed date is would be the expected review cycle. If it's a priority review, it would be six months from submission. If it's a regular review, it would be 10 months from submission.

Great. Thank you. You're welcome.

And I'm showing no further questions at this time. I would like to turn it back to our CEO, Brian Sullivan, for closing remarks.

Well, thank you for participating in our call today, for your ongoing support, and look forward to seeing you potentially at conferences over the next few months. Take care.

Ladies and gentlemen, this concludes today's conference call. Thank you all for joining me now. This connects.