Conference Transcript - CELC 2026-07-14

Operator

Hello, and welcome to Security Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to Jody Seavers, Head of Investor Relations and Corporate Communications. You may begin.

Jodi Sievers, Head of Investor Relations

Thank you, Operator. Good day, everyone, and thank you for joining us today to discuss FDA approval of Geta Talisib. Today's press release, U.S. prescribing information, and the slides we'll be reviewing today are available on our website, selcuity.com. Before we begin, I must point out that some of our comments today contain forward-looking statements that are subject to risks, uncertainties, and assumptions. In particular, our expectations around gadatalisip are uncertain and subject to change. Should our expectations fail to materialize or should our assumptions prove to be incorrect, actual company results could differ material from these forward-looking statements. A description of the risks, uncertainties, and assumptions is included in our SEC filings. With that, I will turn the call over to Brian Sullivan, co-founder and chief executive officer of Cellcuity. Brian?

Brian Sullivan, CEO

Thank you, Jody. And joining me on today's call are Dr. Igor Gorbachevsky, our chief medical officer, who will provide an overview of RevTorPIC's label and the supporting data for patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer. And Elvin Mayer, our chief commercial officer, will provide an update on our commercial strategy and preparations for the RevTorPIC launch. And then I'll wrap it up with some upcoming milestones. Let's please turn to slide four, and now slide five. Well, let me start with the reason for the call. Today, we received notification from the FDA. Get a felicit, or now RevTorPic, was granted full approval in the United States for the treatment of HR positive, HER2 negative, locally advanced, or metastatic breast cancer without a P3CA mutation detected following progression on or after one or more lines of endocrine therapy in the metastatic setting. RevTorPic is the first and only multi-target PI3K AKT mTOR or PAM pathway inhibitor that has received FDA approval. And we believe that RevTropik has a best-in-class benefit risk profile for patients and marks a significant step forward towards transforming treatment for patients with locally advanced metastatic breast cancer. Approval is a transformative milestone for Salcuity as we now transition to a fully integrated commercial stage company, and we seek to advance RevTropik with additional indications in breast cancer and prostate cancer. Let's turn now to slide six. The PAM pathway is one of the most important targets in cancer, but comprehensively and safely inhibiting it has stymied researchers and drug developers for nearly two decades. Reptropic addressed this 20-year challenge by potently targeting all class I isoforms of PI3K and mTORC1 and 2 without inducing the unacceptable levels of toxicity that prevented other comprehensive inhibitors from advancing. The primary reason why PAM inhibitors have had limited impact, despite the importance of the PAM pathway, is because it is very difficult to safely and efficaciously inhibit this pathway. It has multiple components, each of which need to be inhibited to comprehensively blockade the PAM pathway's activity. Otherwise, if only a single component is targeted, adaptive resistance arises and pathway shutdown is limited. Our published in vitro studies have found that Geta, or Reptor-BIC, is 300-fold more potent than the approved single-target PAM inhibitors, and the only one that is cytotoxic. The two positive Phase III readouts from Victoria I in the second-line setting establish a strong foundation for us as we prepare for launch. In breast cancer alone, when we include the potential opportunity in the first-line setting, the total potential patient population we could treat over the long term is over 130,000 patients, and the total addressable market potential is over $10 billion. I'd like to now turn the call over to Igor Gorbachevsky, who will review the U.S. prescribing information and key clinical data supporting the approval. Let's please turn now to slide 7.

Igor Gorbachevsky, Other

Thank you, Brian. Hello, everyone. At Silkuity, we are very proud and grateful for this opportunity to deliver Reptorpic to our patients. Our heartfelt thanks go out to all patients and their families and caregivers, investigators and their teams, FDA reviewers, and the dedicated Silkuity team whose efforts made Reptorpic approval possible. let's turn to slide eight overview restorative prescribing information restorative is approved in combination with fulvestrant with or without palbocyclic for the treatment of adult patients with hormone positive and her two negative locally advanced or metastatic breast cancer without peak 3ca mutation detected following progression on or after treatments with at least one line of endocrine therapy in the recommended dosage of restoric is 180 milligrams as an intravenous infusion over 30 minutes period once weekly on days one eight and fifteen of every 28 day cycle in combination with fulvestrant with or without palbicyclic. Treatment continues until disease progression or unacceptable toxicity. There are no contraindications and the warning and precautions include some of the classes stated side effects. Let's turn to slide number nine. i will now summarize some key data from the restorative date label related to efficacy of this treatment the approval of victor pic is based on positive clinical results from pixrecia wild type cohort of the phase 3 victoria 1 trial which is an open label global randomized clinical trials evaluating the efficacy and safety of riftorphic plus fulvestrant with or without bulbocyclic for treatment of patients with locally advanced or metastatic hormone-positive HER2-negative breast cancer following progression on or after CDK4-6 therapy and an aromatase inhibitor. In total, in this study, 392 patients were randomized equally, one to one to one, in three study arms. Two of these study arms were experimental, including riftorphic plus fulvestrant and pulbacyclid, or riftorphic in combination with fulvestrant, and the control arm included fulvestrant monotherapy. In the Victoria 1 trial, the median progression-free survival with riftorphic triplet was 9.3 months versus two months for fulvestrant. An incremental improvement of 7.3 months or hazard ratio of 0.2 to 95 percent confidence interval 0.17 to 0.35 and p-value below 0.0001 representing a reduction in the risk of disease progression or death by 76% or quadrupling medium progression-free survival compared to standard of care. The objective response rate of the retropic triplet regimen was 32% compared to 1% with for fulvestrants and the medium duration of response was 17.5 months just like 10 please now we will review results for restorative doublet regimens for restorative doublet or restorative in combination with fulvestrants the median progression free survival was 7.4 months versus two months for full restroom an incremental improvement of five five point four months or hazard ratio of 0.33 and 95 confidence interval 0.24 to 0.48 and p-value below 0.0001, representing a reduction in the risk of progression or this death by 67% versus fulvestrin or tripling median progression-free survival compared to standard of care. The objective response rate for restorative doublet was 28%, and the median duration response was 12 months. The median duration of response for fulvestrin was not determinable because there was only one response. And now let's turn to slide 11. Next slide. The safety data from the PIX3CA wild-type cohort of Phase III Victoria I trial shows that Reptorpic was generally well tolerated, with most adverse reactions being of grade 1 and 2. No dose reductions or treatment discontinuation of Reptorpic occurred due to hyperglycemia. Stomatitis was generally manageable, occurred early, and incidence of disreduced, including with severity with each treatment cycle. Serious adverse reactions occurring in more than 1% of patients, including pneumonia, thrombosis, stomatitis. And now I will turn over to Eldon Meyer, who will review the commercial strategy and launch plans for Rift Dorpik.

Eldon Mayer, Other

Thank you, Igor. I'd like to review some highlights of our launch plans for RevTorPic, and as I do, you'll see why we believe RevTorPic is positioned for strong market adoption. Turn to slide 13, please. We believe RevTorPic is well-positioned for strong market adoption in both PIK3CA wild type and, if approved, for mutant advanced breast cancer. To first address the market opportunity, within the U.S., approximately 37,000 patients with HR-positive HER2-negative advanced breast cancer, receive second-line treatment each year following progression on CDK4-6 inhibitors. Of these, roughly 60% are PIK3CA wild-type and 40% are PIK3CA mutant. And importantly, FDA approval of both indications would allow Reptorpic to address 100% of this market with the simplicity of a single PIK3CA agnostic treatment approach. This would be a major differentiator versus currently available therapies that are restricted to either mutant or wild-type patients. There remains a significant unmet need in this market for therapies that deliver better efficacy without compromising safety. RevTorPic's unique mechanism of action as a potent PAN PI3K mTOR inhibitor combined with its pharmacokinetic profile and IV route of administration provides a distinct efficacy safety profile relative to existing oral agents. Taken together, we believe RevTorpik will offer a compelling value proposition, best-in-class efficacy with a tolerable safety profile that positions it to become the new standard of care in this setting. We estimate a $6 billion-plus total serve market opportunity across both wild-type and mutant populations, excluding potential first-line usage. Turn to slide 14, please. Recent quantitative market research among breast cancer treating physicians has validated a clear medical need for new treatments in second-line PIC3CA wild-type advanced breast cancer. The chart here shows how physicians allocated their use of current treatment options. The sizes of the arcs are scaled to depict the relative market share of each treatment choice. What's clear is that this market is fragmented. There is no go-to treatment option in this setting, with each treatment option holding a minority market share among the various patient types. This sets the stage for a new treatment with strong benefit-risk ratio to potentially establish itself as a new standard of care. Turn to slide 15, please. We are entering this launch with significant market and organizational momentum. First, we have built important relationships with key stakeholders in this market. We've engaged over 1,500 key opinion leaders and community breast cancer experts, over 200 key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at panpathway.com has already driven awareness of the Pan Pathway, with metrics tracking well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have increased levels of education with the unmet need in HR positive, HER2 negative, advanced breast cancer. We have a robust launch plan in place that includes a comprehensive array of tactics and programs, including promotional materials, digital media campaign, speaker bureau, and peer-to-peer promotional programs, as well as an increased presence at national and regional ecology conferences. And importantly, we have a deeply experienced and trained teams that are already deployed and ready to deliver, including our sales force of 100 people, including sales management, teams for strategic accounts, payer and reimbursement, KOL-focused teams, and importantly, our medical science liaison team. This experienced customer-facing organization gives us immediate execution capability from day one of launch. Turn to slide 16, please. Patient access to drug is a critical priority, and therefore, we have designed comprehensive support solutions to offer patients and providers rapid and seamless access to RevTorPic. Prior to FDA approval, our market access field teams achieved 100% engagement with the top 36 strategic accounts and 100% engagement with top payer and provider pathways covering over 90% of U.S. medical benefit lives. We designed a tailored distribution model that is optimized for patient access to Reptorpic. And our comprehensive patient support programs include digital patient enrollment, benefits investigation, prior authorization and appeal support, copay assistance, and a patient assistance program. And in summary, these foundational healthcare provider and patient systems and programs are expected to support rapid uptake upon launch. Turn to slide 17, please. Our launch priorities are clear. Drive awareness, achieve rapid adoption, and deliver patient access to Reptorpic. Our sales force will cover approximately 9,000 healthcare providers that treat HR positive, HER2 negative, advanced breast cancer, with a focus on the 2,000 providers that treat a high volume of breast cancer patients. Their priorities will be to differentiate riptorpic by highlighting its unique mechanism of action strong efficacy and a tolerable adverse event profile as well as supporting patient access to drug with expected payer coverage and patient services our high performing team of 88 oncology sales specialists has an average of 24 years of industry experience and a track record of 362 president's club awards which means that they were in the top 10 percent of sales performers in their prior companies during the relevant years. Turn to slide 18, please. This approval truly marks the beginning of an exciting new chapter for patients with advanced breast cancer, for health care providers, and for Salkuity, as well as laying a foundation for multiple potential indications in first and second line advanced breast cancer. Considering the U.S. market alone, we believe that second First-line endocrine treatment-sensitive and first-line endocrine treatment-resistant markets represent addressable patient populations of approximately 37,000, 59,000, and 33,000, respectively, which, when combined, represent a potential U.S. market opportunity that exceeds $10 billion. Now, slide 14. And with that, I'll turn it back to Brian.

Brian Sullivan, CEO

Thank you, Eldon. Well, we've made a lot of progress over the past year. And if we're not on slide 20, let's please turn to slide 20 over this past year. And we're looking forward to continued data generation, regulatory filings, and news flow over the next six to nine months, including several of these key milestones. Well, today, of course, we're announcing the approval of Reptripic. Next, in the third quarter, we'll be submitting a supplemental NDA to the U.S. FDA, seeking approval for the treatment of HR-positive, HER2-negative patients that have PIC3CA mutations in the advanced breast cancer setting. And thirdly, we'll be submitting Victoria 1 PIC3CA wild-type cohort data to NCCN this quarter. Later in the quarter, we anticipate commercially launching Reptripic. And based on the company's commitment to ensuring broad, affordable, and unrestricted patient access to Reptropik, we've designed a comprehensive patient support program to make Reptropik available to patients prior to commercial launch program. And to make Reptropik available to patients prior to commercial launch, those who are eligible will be able to enroll in Salcuity's expanded access program. Additionally, Salcuity is qualified as second drug manufacturer and will be submitting a post-approval supplement to the recently approved NDA for FDA review. Throughout the rest of the year, we'll present additional data from our clinical programs, including an update to our Phase 1b metastatic castration-resistant prostate cancer study in the fourth quarter. And then we'll also be providing an update on Victoria 1 PIC3CA wild-type and mutant cohort data in the fourth quarter as well. We currently anticipate submitting an MAA for both the wild-type and mutant data to European Medicines Agency and similar filings with other regulatory authorities outside the U.S. following submission of the SNDA to the FDA. Let's now turn to slide 21. And I think now is the time for questions.

Operator

Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 1-1 on your telephone, then wait for your name to be announced. To withdraw your question, Please press start 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Maury Raycross with Jeffries. Your line is open.

Maury Raycroft, Analyst — Jefferies

Much congrats on the approval, and thank you for taking my questions. Maybe starting, I'm wondering if you can comment on pricing and what that looks like relative to other agents targeting Pick 3. And then I've got one other follow-up question.

Brian Sullivan, CEO

So we'll be announcing or rather releasing the pricing to the various compendia that compile pricing from drug companies. And those compendia are used by various constituents who will be either reimbursing or purchasing the drug to determine the pricing that they may ultimately access. And so, until that process is completed, we won't be announcing a specific price, but that will be announced soon after those compendia are available to our constituents. Got it. The price will be a premium relative to what currently available therapies are.

Maury Raycroft, Analyst — Jefferies

Understood. Good. And just comparing the safety profile in the label to what was previously reported in the wild-type study, there are some modest differences in some of the AEE rates. Can you just help understand what's driving these variances and is it a function of long follow-up patient population or reporting methodology?

Brian Sullivan, CEO

No, I'll answer that directly. We reported treatment-related adverse events, and those are events that the investigator, the person treating the patient, identified as related to specific therapy, whether it was getotelicib or some other therapy. The FDA reports all adverse events and they're labeled treatment emergent, whether or not they're related at all to or believed by the investigator to be related to other therapies that were prescribed. And so you will have, you know, the difference then would be in any of those numbers would be events that in the investigator's determination were not related to therapy. But the FDA takes a view that they will report and want to report on the label every event that was reported, whether or not it was related to the therapy itself.

Maury Raycroft, Analyst — Jefferies

Got it. That makes sense. Thanks for clarifying. Thanks for taking my questions. You're welcome.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Tara Bancroft with TD Cohen. Your line is open.

Sam, Analyst — TD Cowen

Hello, this is Sam on for Tara Bancroft. Thanks for taking our question and congratulations to the entire team for reaching this milestone. I just wanted to ask about the launch over the next year. How do you expect the initial sales ramp will evolve? And are there any key time points or gating items that we should be aware of after the launch in late Q3 that could lead to an inflection and uptake? For example, like a J-code activation or just the cadence of formulary reviews for practices?

Brian Sullivan, CEO

Sure. No, thank you for the question. I'll give a little preview and then Eldon can fill in the blanks. Obviously, at launch, there's more friction than there'll be over time. You mentioned J-code. At the outset, the company will launch with a temporary J-code. There are very specific time points when J codes are assigned now accounts are very used to working with new drugs and so our team or our market access team will be coordinating as well as our oncology sales specialist working with accounts to help facilitate on that process for getting the drug reimbursed one of the primary concerns that accounts have is the delay in getting reimbursed because this is a buy-in bill drug. And so we've put in place a program that will be offering accounts extended dating so that they won't in effect be cash flow negative when they prescribe this therapy. And that, in the experience of our team, really significantly addresses the potential barrier that a temporary J-code can create for the counts. Eldon, I don't know if you have any color to add to that.

Eldon Mayer, Other

No, Brian, I don't think I have anything significant to add to that.

Sam, Analyst — TD Cowen

Great. Thank you.

Operator

You're welcome. Please stand by for our next question. Our next question comes from Elana Brad-Canino with Guggenheim. Your line is open.

Brian Sullivan, CEO

I will add my congratulations as well. I want to ask about the treatment durations. This has come up in conversation with investors quite a bit. I know in the JCO and even this label, it reflects a median duration of exposure of about six months. When you do your TAM estimates, you're using 10-month treatment assumptions. So can you help us understand, like, this median metric?

Oliver McCammon, Analyst — LifeSci Capital

Is that the right thing to think about in terms of an average treatment duration you would expect when you get into these real-world patients? Thank you.

Brian Sullivan, CEO

No, that's a good question. And so the treatment duration is hampered by, or not hampered, but is significantly affected by the relatively short follow-up period. And so you essentially understate what is the actual experience that we expect patients to be on. And we estimate that patients, based on their persistence on the therapy, which is really the best way to look at that or calculate that, is looking at the average duration of patients, since that is obviously the number that would get plugged in any formula estimating drug usage. And so the 10 months that we allude to on the presentation reflects essentially nine, the the average between 9 and 11 that we reported for the triplet with the PIC3CA wild type and mutant therapies. But our persistence analysis with the data that we have suggests that PFS is a very good representation of the likely drug duration that the patients on average will experience when they're on treatment with getta please stand by for our next question our next question comes from the line of sylvan turkin with citizens your line is open thank you so much for taking that question and and congrats on this major milestone here i think there's a quick question on um you mentioned that this drug will be due by and bill uh is there any portion that will be especially pharma and they'll directly to patients or is it 100 buy and bill thank you Eldon, why don't you answer that question? I know it's a buy-in bill. None of the drug will be prescribed to patients directly. Obviously, it's an infused therapy that requires administration in a facility. But there might be some take up by specialty pharma. Eldon, could you maybe address that question?

Eldon Mayer, Other

Yes, that's correct. So, we have contracted with a specialty pharmacy that will be able to distribute and handle benefits investigation and other services that they offer for specific doctor's offices practices that are typically smaller and do not want to take on the burden of purchasing the drug and waiting for reimbursement. So at times they will do what's called white bagging, where they will have the drug shipped to the patient and the patient will bring it in. And we expect this is normal, and we expect this to be a very small portion of our business, probably low to mid-single digits at most on a percentage basis. So we're prepared for this, and we will offer this, but we don't expect it to be a significant portion of our business.

R.K., Analyst — H.C. Wainwright

Great.

Oliver McCammon, Analyst — LifeSci Capital

Thank you so much for being here, sir. And congrats.

Operator

Thank you. Our next question comes from the line with Eva for Tea with Wells Fargo. Your line is open.

Eva Fortea, Analyst — Wells Fargo

Hi, team.

Operator

Thanks for taking our question, and congrats on the progress. A quick one from us, you guided towards the late third quarter launch. We're just wondering, what are the gatekeeping steps before commercialization can begin? Thanks.

Brian Sullivan, CEO

The primary gate is just making sure we have sufficient drug available at time of launch. And, you know, you have a wide confidence interval in your estimate of drug requirements, and so we want to make sure we have sufficient drug available at that time, and so we're being somewhat conservative in our estimates of when that drug will be available.

Operator

Got it. Thanks. Thank you. Please stand by for our next question. Our next question comes from the line of Oliver Mack-Calman with LifeSci Capital. Your line is open.

Oliver McCammon, Analyst — LifeSci Capital

Hi. Congratulations on the approval decision, and thanks for taking my question. I'm just curious on when and whether you'd expect overall survival data, when mature, to potentially be added to the FDA label. And then I'm also wondering to what degree survival data could play into GETA on the NCCN guidelines and what the timing could potentially look like there. Thanks again.

Brian Sullivan, CEO

Thanks, Oliver. So the OS data, you know, at the time of initial reporting out the data was not mature. It's still not mature. It's an event-driven analysis, and we expect to reach that threshold probably the first half. Again, it's somewhat hard to predict sometime in the first half of 27. As far as NCSAN guidelines, obviously, in the second-line setting, no drugs have shown an overall survival statistically significant benefit. And that has been taken into account, I think, as they review the drugs and the data. Certainly in the first-line setting, there have been drugs that have achieved an overall survival significance milestone or endpoint. And those reviews of the data might place different weight on the OS analysis and the PFS analysis. Thanks again.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Gil Bloom with Needham. Your line is open.

Jonathan, Analyst — Needham

This is Jonathan on for Gil. Congrats on all the progress and as well as the approval. I just had a quick question on what percentage do you expect for patients that will be on the doublet versus the triplet? Thanks.

Brian Sullivan, CEO

So we have two data points that help inform our answer. The first is the percentage of doctors that selected the triplet versus the doublet when they crossed patients over from the Fulveston arm to one of the study treatment arms in the Victoria 1 study. In that case, roughly 85% of the patients were assigned to the triplet arm, the balance to the doublet arm, of those that crossed over. And as it turns out, the market research we've done, essentially quantitative research with physicians, treating physicians, oncologists, were asked that specific question, and it fell into kind of roughly the same proportion, 85%, 15%. Again, we'll see in actual practice, but at least early indications are that very, very significant majority will start with the triplet instead of the doublet. So, great.

Jonathan, Analyst — Needham

Thanks again, and congrats again. Thank you.

Operator

Thank you. Our next question comes from the line of Swai Amplica with H.C. Wainwright. Your line is open.

R.K., Analyst — H.C. Wainwright

Thank you. This is R.K. from H.C. Wainwright. Congratulations, Brian and team. This is a question thinking about community oncologists who would also be an important piece of the commercial structure for you folks. So with no FDA-approved, you know, PIC3CA companion diagnostic available, you know, how do you see a community oncologist identifying the wild-type patients at launch? And, you know, does that cause any slowing in terms of prescribing?

Brian Sullivan, CEO

No, thank you for the question. We don't think it will slow. And as it turns out, standard of care today is to test all second-line patients. That's in the NCCN guidance, and that's become a very expected assessment to be performed after patients progress on their first-line therapy. And so those results will be applicable to, or rather usable for determination of a patient's wild type status for treatment with gadethylisib. So we don't view that as a barrier because, again, PIC-3CA status is determined as standard of care practice.

R.K., Analyst — H.C. Wainwright

Thanks.

Brian Sullivan, CEO

Thank you. our next question comes from the line of chase knickerbocker with craig holland your line is open good afternoon uh i'll share my congrats as well uh maybe just brian quickly on uh you know as we kind of think about launch comps here um you know a lot of the a lot of the kind of indication comps we think about um maybe orally delivered um how do you kind of think about any difference in the early ramp slow early slope of of the launch curve as far as kind of an infused therapy versus oral?

Oliver McCammon, Analyst — LifeSci Capital

Is there anything that you guys kind of think about?

Brian Sullivan, CEO

I think it's hard to, you know, point to anything very specific that would affect the ramp. I mean, certainly there's a little bit more onboarding that's required. You know, all these sites, every site and physician that we'll be working with prescribes infused therapies for breast cancer patients. And some of the largest therapies used, the most significant therapies used in breast cancer are infused therapies. But there is some work, you know, in some cases it relates to order sets where, you know, providing details on how, you know, the drug should be handled, et cetera. And so that would be probably the main difference between an orally administered therapy versus an infused, just a little bit more set up for the accounts. But beyond that, we don't think there's any barrier just because it's, you know, these community docs as well as obviously academics are well versed in treating patients with infused therapies.

Jonathan, Analyst — Needham

Got it. Congrats again.

Operator

Please stand by for our next question. Our next question comes from the line of Stephen Willey with Stiefel. Your line is open.

Stephen Willey, Analyst — Stifel

Yeah, thanks for taking the questions and congratulations on the approval. I know that there was mention of bringing a second manufacturer online. Can you just speak to the timing? I think I missed the timing specifically. And then to what extent is that really just kind of good housekeeping from a redundancy perspective or is that necessary to meet your capacity objectives.

Brian Sullivan, CEO

No, thank you. Well, two things. It's for capacity and good housekeeping. And so we simultaneously, once we submitted the NDA, or rather prior to submitting the NDA, but we have been working to essentially transfer the process to another manufacturer, and you follow a separate process to get them reviewed, their data reviewed, and will be submitting a regulatory, you know, specific package to the FDA to get them approved to manufacture, but they've manufactured the product and the data's available and all the material is ready to go. And so that'll be something that, you know, we initiate this week. But, again, just good housekeeping, and certainly we want to be mindful of capacity as well.

Stephen Willey, Analyst — Stifel

Understood. Thanks for taking the question.

Operator

Thank you. Our next question comes from the line of Andrew Behrens with Lebrink Partners. Your line is open.

Oliver McCammon, Analyst — LifeSci Capital

This is Emily. I'm for Andy. I'm wondering if you could provide more color on the process that patients need to go through to actually receive the stomatitis mouthwash and how that will be made available to patients.

Brian Sullivan, CEO

So the patients at the time they come to the treatment facility will be given dexamethasone mouth rinse, and they'll use that prior to getting the therapy. And then they'll leave the hospital or the infusion center with the dexamethasone. That'll be prescribed and provided at the time. that they visit that infusion center. And, you know, the nurse, you know, will obviously educate the patient about best practice and general oral care in general. Again, because dexamethasone is widely used for cancer patients, you know, many other therapies induce stomatitis. So, it's something that the treating physicians as well as the nurses are very well, very familiar with and able to effectively, you know, train the patient and just educate them about that. And so it's very straightforward from an education and onboarding standpoint at the site. And then for the patient, it's very simple. It's just they call it a squish and spit, and it simply, you know, requires them to essentially use the equivalent of a mouthwash daily.

Operator

Thank you. Ladies and gentlemen, I'm Sean, no further questions in the queue. I would now like to turn the call back over to Brian Sullivan for closing remarks.

Brian Sullivan, CEO

Well, thank you very much, everyone, for attending the call. We appreciate that. And I'd like to close just by thanking, as you were, did the numerous patients and their families who participated in our trial and who are also participating in our other trials. We'd also like to thank the clinical investigators and the nurses, psych coordinators, and the support staff that's involved in fielding a study like this. And then finally, the team at TELCUITY did a fantastic job in working to now have this medicine available to patients. And so we feel privileged to be able to provide this medicine to these patients, and we're looking forward to a fantastic launch. We look forward to keeping you updated.

Operator

Ladies and gentlemen, that concludes today's conference call.