Celcuity Inc. (CELC) Q2 2026 Earnings Call Transcript

Good afternoon, ladies and gentlemen. Welcome to SoQBD's 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 music assistance, please press the star zero for the operator. I would now like to turn the conference over to Jody Sievers, Corporate Communications and Investor Relations at SoQBD. Please go ahead.

Thank you, Ludi, and good afternoon to everyone. Thank you for joining us today to review Cellcuity's second quarter 2026 financial results and business updates. Earlier today, Cellcuity released financial results for the quarter ended June 30, 2026. The press release can be found on the Investor's section of Cellcuity's website. Joining me on the call today are Brian Sullivan, CellCuity's Chief Executive Officer and Co-Founder, Vicki Hahn, Chief Financial Officer, as well as Eva Gorbachevsky, Chief Medical Officer, and Eldon Mayer, Chief Commercial Officer, 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 with 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 CellCurity. Please go ahead, Brian.

Thank you, Jody, and good afternoon, everyone. Thank you for joining our second quarter 2026 operating and financial update conference call. CellCurity continues to make monumental progress, advancing clinical development of gadotelisib for patients with HR-positive, HER2-negative advanced breast cancer. With the FDA approval of ReftorPIC, 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 Richter PIC 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 PIC3CA mutant cohort of the Phase III Victoria I study, we plan to submit a supplemental NDA, or SNDA, in the third quarter of 2026. Additionally, our Victoria II study was expanded to enable evaluation of treatment naive patients who have endocrine-sensitive breast cancer, positioning gadotelicid regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIC3CA 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 RevTorPic. On July 14th, a few days before our produfment date, we received notice from the FDA that RevTorPic, in combination with sylvesterin with or without palvaciclid, was approved for the treatment of patients with an HR-positive, HER2-negative, locally advanced, or metastatic breast cancer without a PIC3CA 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 for T-negative breast cancer treatment, recommending both the RevTripic triplet and doublet regimens as preferred Category 1 regimens for second line or subsequent treatment for tumors without a PIC-3CA 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 I Phase III trial at the ASCO annual meeting. Primary efficacy analysis of the gadatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS, progression-free survival, compared to alpalipsib, a PI3K-alpha inhibitor, and fulvestrin. Median PFS was 11.1 months with the gadatolisib triplet versus 5.6 months with alpalipsib plus fulvestrin with a hazard ratio of 0.5. The secondary endpoint comparing the gadotilisib doublet versus alpalypsid 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 alpalypsid and fulvestrin. Median PFS was 11.3 months with the gadotilisib doublet versus 5.6 months with alpalypsid plus fulvestrin with a hazard ratio of 0.51. The safety data for the gaditalisib triplet and doublet were consistent with previously reported data from the wild-type cohort of Victoria I. Now, we've since updated the analyses of the treatment discontinuation rate due to an adverse event for gaditalisib and alpalipsib in the PIC3CA mutant cohort using the same methodology that determined the discontinuation rate due to an adverse event for the PIC3CA wild-type cohort presented in the Reftripic label. For patients who received the gadethylisib triplet and gadethylisib doublet, 5.2% and 3.8% of patients discontinued gadethylisib due to an adverse event, respectively. For patients who received alpalypsib, 19% discontinued treatment with alpalypsib due to an adverse event. Now, we believe the lower gadethylisib 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 I study, and then fell as physicians gained experience. Since a much higher proportion of wild-type patients were enrolled during this period than mutant patients, the impact of this initial higher discontinuation rate early in the study fell disproportionately on the wild-type cohort. And thus, we believe the treatment discontinuation rate for getatelicid 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 gadatelicid treatment cycles patients received in the wild-type and mutant cohorts of Victoria I as of August 2, 2026. And 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 gadatelicid triplet in the wild-type cohort, the mean number of treatment cycles for gadatelicid was 9.0, and 16 of these patients, representing 12% of those dosed, are still receiving gadatelicid. For those treated with the gadatelicid triplet in the mutant cohort, the mean number of treatment cycles for gadatelicid was 10.0. 34 of these patients, representing 22% of those dosed, are still receiving gadatelicid. For patients treated with the gadatelicid doublet in the wild-type cohort, the mean number of treatment cycles for gadatelicid was 9.7, and 15 of these patients, representing 12% of those doses, were still receiving getatelicid. And for patients treated with the getatelicid doublet in the PIC3CA mutant cohort, the mean number of treatment cycles for patients receiving getatelicid was 11.3. And 10 of these patients, representing 19% of those doses, are still receiving getatelicid. Now, analyses of mean treatment cycles for ReftorPIC in the Victoria I trial are particularly relevant for assessing the commercial potential of ReftorPIC, since they incorporate the effect that patients who remain on ReftorPIC 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 I 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 I Phase III data for both the wild-type and mutant cohorts to global regulatory authorities following the SNDA submission. Now, the getothelicid regimens have demonstrated the potential to improve the standard of care in the second-line setting, regardless of the PIC3CA status of a patient's tumor. And we believe the results from the Victoria I 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 II trial we have underway to advance development of getothelicid in the first-line setting for patients with advanced breast cancer. In May, we announced that we were expanding the Victoria 2 trial to include a second study, study 2, evaluating the efficacy and safety of gadotelisib in combination with polycyclob and letrozole in patients with treatment-naive, endocrine-sensitive, HR-positive, HER2-negative, advanced breast cancer. And these are women whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Endocrine-sensitive patients represent approximately two-thirds of the woman in the U.S. newly diagnosed with advanced breast cancer each year, and current standard-of-care therapies for these patients provide median progression-free survival of approximately 25 months. Study one of the Vittoria 2 trial, which was already ongoing, is evaluating getotilicib in combination with pavociclip and fulvestrin in 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 I-B 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 one study, we evaluated gadatilisib plus palociclib 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 ribociclib plus letrozole. Ribociclib plus letrozole are the therapy that we're using as the control in our Victoria II trial for endoconsensitive patients. The objective response rate was 79%, which again compares favorably to historical data of 53% in the first-line setting for ribociclib 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 gadotilicid 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 are diagnosed with late-stage HR-positive HER2-negative advanced breast cancer in the U.S., irrespective of their endocrine sensitivity or PIC3CA status. Our advancement of subcutaneous gadatilicid formulation is ongoing, with the goal of demonstrating clinical equivalence to the current intravenous formulation of gadatilicid. Subcutaneous formulation is aimed to support potential future indications for getotilisib regimens that may result in duration of treatment periods greater than several years. And now let's turn to our Phase I-B II trial. That's evaluating getotilisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In the dose-finding portion of the Phase I-B study, evaluation of a 240 milligram dose of getotilisib was completed. No adverse events led to treatment discontinuation of ketatelicin, 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 Reptripit. We began laying the groundwork for a potential Get It to Lissab 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 PAM pathway, 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 Rev2PIC is now complete, and commercial launch activities for Rev2PIC 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 RevTorPIC 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 RevTorPIC 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 RevTropik are expected to begin late in the third quarter of 2026. Now, wholesale acquisition costs, or WAC, of RevTropik, which has been reported to the drug pricing compendia, will be $10,000 per vial or $30,000 per cycle of treatment once RevTropik is commercially available. To enable treating physicians to obtain getotilisib on behalf of their eligible patients prior to commercial availability of Reftripic, Salkuity 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 HR-positive HER2-negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment for ReftraPIC per patient at the WAC price, we estimate the total addressable market for ReftraPIC in the wild-type and mutant setting combined is potentially over $6 billion annually. And that concludes my remarks. I'd now like to hand the call over to Vicki 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 decrease in licensed milestone costs, partially offset by a $3.8 million increase in employee-related and consulting expense, and $2.9 million increase in manufacturing and other costs. 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 RevTorpec. 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 note 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 repayments 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 one on your telephone keypad. To withdraw your question, please press a star followed by the number two. One moment, please, for your first question. And your first question comes from the line of Tara Bancroft with Titi Cowan. 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 first set up 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 of 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 very confident about being able to ship beginning at the end of this quarter. So nothing's changed.

Okay, great. And 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. Again, you don't want to really be in the position of projecting what the FDA 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 Raycrop with Jeffries. Please go ahead.

Hi, congrats on the progress. Thanks for taking my questions. I'll follow up on Tara's questions, just wondering if you can clarify if you've 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 with products from that site?

Well, two things. We submitted the data almost immediately after we got the approval. We had, you know, validation of 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 in the third quarter, late third quarter.

Got it. Maybe one other question just on the expanded access program. Wondering how many sites or doctors are participating in it, 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 providing quarterly updates, right, because it'll go away. But, yes, we just got the program started last week. I mean, 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 drug then.

Exactly. And that was reflected in the protocol.

Got it.

Thanks for taking my questions. You're welcome.

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

Hey, Brian. Thanks for the updates, especially around the prostate cancer progress. It's good to hear. I'm actually wondering about a different cancer setting, because I know one of your 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 Get-A-Tolseb. I know there's probably some old data that Pfizer conducted, probably not the right regimen and treatment line and setting, et cetera. So how do you think about bringing that into the development portfolio, if that's an opportunity for you guys?

Sure. There's certainly a strong rationale for us to consider that. And, you know, we'll be updating folks 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 get a can induce an objective response. And, you know, the underlying drivers of the disease include the role of the PIC3CA pathway. And for a certain significant cohort, the endometroid patient population, the hormonal pathway is also involved. So there's certainly a strong rationale for us to consider developing in that setting.

Right. And then in prostate specifically, too, I'm tracking this somewhat from afar, and I'm hearing KOLs have a pretty intense conversation around capibacertib and its potential role there as the first inaugural pathway inhibitor on the PAM pathway to go after that. But what do you think, as you have the conversations with those same investigators and KOLs, we can actually learn from the CAPI of Assertive data, and it has a foreshadow of the opportunity for something like getatolacid, and what should we keep in mind that could be different as you approach it?

So CAPI, as you know, is approved in breast cancer to treat patients who have a PIC3C mutation. Its efficacy was comparable to the efficacy for alpalypsid in its Phase III study in a similar setting as what we were just studying. And gadatsilisib, as we announced recently, showed double the activity relative to alpalypsid, which we think is a reasonable proxy for what CAPI is capable of doing. And so we think the fact that CAPI got an approval for the P10 loss population And essentially, that's the most relevant mutation of the PAM pathway in prostate cancer. And so that drug is limited to roughly 40% of patients with P10 loss. But we think it augurs well for us. They're evaluating, or rather they got an approval in patients who are at an earlier stage than the patients were evaluating. They were evaluating hormone-sensitive prostate patients. We're evaluating castration-resistant patients. But the fact they got off 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, you know, that they demonstrate that this pathway, the PAM pathway, plays a role as a driver and that when combined with an androgen receptor inhibitor, you can induce an improvement in outcomes relative to androgen 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, Brent. You're welcome.

Your next question comes from the line of Eva Forteo with Will Spargo. 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 on how long do you expect it will take to transition the patient from the EAP to commercial following the launch in late Q3?

You know, I don't want to get committed to a particular timeline. line. I mean, certainly we have to be very sensitive to the needs of the patient and make sure that, you know, there's no risk of interruption in supply. And so, you know, again, it could be very site-specific, patient-specific, you know, 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. So, you know, and that's a very standard approach. But again, we would expect that transition to occur. You know, it may occur in that two-week gap from day 15 to the next cycle of treatment, you know, 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 will essentially accommodate, you know, whatever might be required to ensure that that transition occurs smoothly.

Got it.

Very helpful.

And your next question comes from the line of Andrew Behrens with Luring Partners, Peace to Head.

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 net. 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 that reflect discounting of the drug per se, but they reflect channel differences that are just a function of 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, you know, so we think we'll be able to capture a higher percentage of the WAC than the corresponding oral therapies in this category are able to capture.

All right. Thank you. And your next question comes from the line of Oliver McCommon 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. but 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, pembolizumab, and TNBC is another. Herceptin 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 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 barrier to a community oncologist prescribing Gettyslisib and ensuring their patient can get infused. And these docs represent community treaters, treat about 80% of physicians. 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 Kalpik 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 fourth quarter? Is it just PSA response data, or are we going to see RPFS data as well? And then what would be a you know, what would success look like to you in that area? Thank you. Sure.

So we expect to provide additional data that 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, but 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 our PFS? 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, you know, three to four months better than, you know, those options. Plavitco is out there as an option as well. They're offering patients, you know, north of 10 months. And so our expectation would be that we would need at least to be comparable to Plavitco. We think there would 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, you know, typical three to four months of priority relative to, you know, what would be an add-on therapy with Getta versus a switched androgen 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 will be very relevant to any assessment that we make.

Okay. That's super helpful.

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

Hi, guys. This is Jonathan on 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 SNDA timeline?

Not an SNDA. 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, four months. And, again, if there is issues, which, again, we don't expect to occur, you know, it can take longer. And so, you know, there's a standard process, a four-month review process. It can be shorter. But, again, you're interacting with the agency during that process, and you'll gain an understanding from that initial feedback what, if any, issues they may have or considerations they may be wanting us to address. 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, you know, managing inventory accordingly. It's important to keep both sites going. It's just you want to create a rhythm for them. And so you're always going to be balancing. mix of product, you know, between those two sites. Thanks again, and congrats again on all the progress. You're welcome.

And your next question comes from the line of Stephen Wheeler with Steeple. Please go ahead.

Yeah, good afternoon. Thanks for taking the questions. 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 I 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.

Regarding the article, we have submitted an article to a journal, and, you know, that process, you know, is variable in time. It can, you know, take, you know, 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 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 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, you know, certainly drive or really discuss at all in the clinical context. But those are variables that, you know, could be present in the marketplace. And as far as progress, you know, we'll be reporting sales, obviously, as we go. You know, we don't have the granularity of data that you have with oral therapies. You know, we ship to a site, 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. So 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 will be a lag in that. That will be a two to three months lag, so it won't be current or necessarily representative. It will 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, 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 how many docs are prescribing, how many re-prescribed 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. You know, there really won't be inventorying of this drug. Our distributor, our 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, you know, depending on their overall approach, you know, 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 treatment. We think that would be unlikely.

All right.

That's very helpful. You're welcome.

And your next question comes from the line of Sylvain Torchang with the citizens. Please go ahead.

Hey, this is Josh on for Sylvain. Thanks for taking the question. Yeah, so you mentioned plans to submit the SNDA 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 SNDA, while they will need to accept the SNDA, 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 production 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. 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. You may now, this is the NAC.