Whitehawk Therapeutics, Inc. Q2 FY2024 Earnings Call

Good day and thank you for standing by. Welcome to the Aadi Bioscience Inc. Second Quarter 2024 Earnings 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. Please be advised that today's conference is being recorded. Now I will turn the call over to Audrey Gross, Head of Corporate Communications for Aadi Bioscience. Ms. Gross, please go ahead.

Thank you. Good morning and welcome to the Aadi Bioscience conference call to provide an operational update and review results for the second quarter of 2024. We will be presenting slides as part of the live webcast of this call. Such slides will be posted on the Investors & News page of the Aadi Bioscience website at aadibio.com following the conference call. A quick reminder that statements made on the call today will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factors section of our annual and quarterly filing with the Securities and Exchange Commission, which can be found at www.sec.gov or on our website at aadibio.com. In addition, any forward-looking statements made on this call represent our views only as of today, August 07, 2024, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. On the call is Dr. Dave Lennon, our President and CEO; Scott Giacobello, our CFO; and our Chief Medical Officer, Dr. Loretta Itri. Today, we will provide an overview of operational activity and financial results for the second quarter of 2024. We will then open the line for questions at the end of the call following closing comments. I'll now turn the call over to Dave for his opening statement. Dave?

Good morning, everyone, and thank you for joining us today to review our financial and operational results for the second quarter of 2024. I'd also like to take this opportunity to refresh everyone on Aadi's story, where we are today and where we're going in the weeks and months ahead. On Slide five, you'll see at Aadi, we are focused on unlocking the full potential of mTOR inhibition by uniquely combining nab technology and the potent mTOR inhibitor sirolimus. With more complete mTOR target inhibition, greater tumor suppression, and a wider therapeutic index, we believe nab-sirolimus has the potential to build on previous mTOR inhibitors to deliver better outcomes for people living with cancers that are dependent on that pathway. We've established the value of this approach with FYARRO for the treatment of advanced malignant PEComa, an ultra-rare soft tissue sarcoma with poor outcomes and high biological evidence of the mTOR pathway activation. FYARRO has cemented its position as preferential treatment for malignant PEComa after just two years on the market. Since launch in February 2022, we have achieved $51.1 million in sales. We're proud of the impact FYARRO has had and will continue to have for patients with this rare and aggressive cancer. Building on this commercial backbone, we're also exploring nab-sirolimus for larger indications across multiple types of mTOR-driven tumors. Most advanced of these studies is PRECISION1, a registration-intended tumor-agnostic trial in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. This trial is fully enrolled and expected to complete by the end of the year. In a moment, I'll talk more about PRECISION1 and the opportunity it represents for patients and providers. We're also evaluating nab-sirolimus in mTOR-driven cancers with promising potential. The first is advanced or recurrent endometrial type endometrial cancer or EEC, in combination with the aromatase inhibitor, letrozole. Endometrial cancer is the most common cancer of the female reproductive tract and one of the few cancers with increasing mortality. There's an estimated 10,000 cases of EEC diagnosed annually in the U.S. alone. Prior clinical studies of mTOR inhibitors combined with letrozole have yielded promising results and recent changes in the recommended standard-of-care for early-stage disease create a potential opportunity for this combination to be used in the first and second-line settings. The second trial is in neuroendocrine tumors of the lung, gastrointestinal tract, and pancreas. Neuroendocrine tumors or NETs are rare and have historically low response rates to treatment with oral rapalogs and other agents, which nonetheless are used clinically and recommended in treatment guidelines. In preclinical animal models, nab-sirolimus demonstrated improved target suppression relative to other mTORs, warranting further exploration of nab-sirolimus in this indication. These Phase II open-label studies are both enrolling well, and we look forward to presenting initial data from these trials later this year. Aadi is led by an accomplished team with deep expertise and a track record of responsible capital management with sustained commercial success of FYARRO. Cash runway is anticipated to extend into Q4 2025, with a catalyst-heavy 2024 and 2025 ahead of us. We believe Aadi is well positioned to achieve our goals. Now turning to Slide six. As mentioned, PRECISION1 is a registration-intended tumor-agnostic trial evaluating patients with solid tumors harboring either TSC1 or TSC2 inactivating alterations. As of May, the trial has fully enrolled 120 patients across a broad array of tumor types. TSC1 or TSC2-driven cancers are found across a wide range of tumor types, clustering in the lung, gastrointestinal, genitourinary, breast and gynecological locations and are often difficult to treat. Although PRECISION1 is a single trial, TSC1 and TSC2 arms are independently evaluated and effectively be viewed as two separate studies, each with its own outcome. Importantly, by design, patients in PRECISION1 have received all standard therapies appropriate for their tumor type and stage of disease, or in the opinion of the investigator, the patient would unlikely to tolerate or derive clinically meaningful benefit from the appropriate standard-of-care. In essence, for most patients enrolled in this study, this means they have limited, if any further treatment options, and an extremely poor prognosis. By the design of this trial, nab-sirolimus is the last available line of systemic therapy for these patients and truly tests the ability of nab-sirolimus to address TSC1 and TSC2 mutated cancers in the sickest patients. We remain on track for our next planned interim readout, which is expected in Q3 2024. This analysis will include a total of 80 patients who have been followed for a minimum of six months and will evaluate the primary endpoint of the study, independently assessed overall response rate. Now looking at Slide seven. As a reminder, in Q4, we provided top-line results for the planned interim evaluation of the first 40 patients enrolled in PRECISION1. These data demonstrated sustained tumor reductions in a heavily pretreated population based upon investigator-assessed responses across both arms. For TSC1, we reported an investigator-assessed overall response rate of 26%, which was within the range of our expectations. These responses appear to be early, deep and durable, which is especially noteworthy given this heavily pretreated population with a median of three prior lines of therapy. These responses were seen across four different tumor types, potentially supporting a tumor-agnostic indication. For the TSC2 arm, we reported an 11% overall response rate. This arm had a median of 3.5 prior treatments, including 50% who had at least five prior lines of therapy. To put these early interim data in context, the overall response rate for the Phase II trial of Everolimus in a pan-cancer cohort of patients with mTOR pathway alterations was 8% for TSC1 and 6% for TSC2, both in slightly earlier lines of treatment. While this isn't a one-to-one comparison and studies have important differences, these historical data are helpful as we think about the clinical significance of the responses we reported in the first interim analysis, especially in light of the late line of treatment. I also want to highlight that ongoing conversations with experts reinforce this view. We have heard from key opinion leaders that these data are compelling, especially for tumor types in late line for whom disease control is a meaningful outcome. Now turning to Slide eight. It's important to note that PRECISION1 closely follows the most up-to-date guidance from regulators on how they would like to see tumor-agnostic studies for targeted therapies run. As we've reiterated today, PRECISION1 is a truly tumor-agnostic trial, enrolling any solid tumor type harboring a TSC1 or TSC2, inactivating alteration. By design, PRECISION1 will not have more than 25% contribution of enrollment from any two tumor types combined. Additionally, patients in PRECISION1 are heavily pretreated with a median of three prior lines of therapy as reported in our December interim data. By contrast, when we look at other targeted therapies that have gained approval in the past, they relied on a cohort approach with significant enrollment from just one or two tumor types, as much as 79% in one case. Patients also appear to be less advanced with these interventions often coming in earlier line settings, which impacts the overall response rate seen in these trials. Based on these precedents, we feel confident in the design of PRECISION1 to meet the standard established for this type of study. We continue to believe that should these results be reported in the one-third interim hold or improve in a larger group of patients, we have a path to submission and potential approval for TSC mutations. Now looking at the market opportunity on Slide nine. TSC1 and TSC2 mutations define a large mutation-driven oncology population with broad distribution among tumor indications and specialties. Our latest internal analysis indicates there's approximately 16,000 patients with TSC1 and TSC2 mutations across a variety of tumor types, and these mutations are roughly evenly split between genes. Notably, we are seeing an increasing utilization of NGS testing by oncologists to help inform treatment decisions. There are some populations, in particular, for whom NGS testing is more common, so-called high NGS testing specialties. Nearly half of TSC1 and TSC2 tumors present in these high NGS testing specialties, which include tumors of gynecological and thoracic origin as well as melanomas and sarcomas. These physicians see roughly half of all TSC1 and TSC2 positive cancers. According to our research, for the product profile similar to our interim results to date, high NGS testing specialties indicate they would likely to use nab-sirolimus after second and third-line preferred treatments, which aligns with what we've observed in Precision1. We anticipate that market adoption would be led by these specialties with initial uptakes occurring in later line settings where patients are often thoroughly tested for mutations and physicians are looking for unique treatment options. Even if we limit the majority of nab-sirolimus utilization to be in the third line with these high NGS testing segments, TSC1 and TSC2 mutated cancers would represent a significant $300 million to $600 million projected market opportunity in the U.S. alone. So if PRECISION1 delivers similar results to our prior interim analysis, we know there is a significant unmet need that we're addressing. We remain confident that we've designed and conducted the appropriate tumor-agnostic trial for the FDA, and we remain bullish on the significant commercial potential for nab-Sirolimus beyond PEComa. With that, I'll now turn it over to Scott for updates on our Q2 financial progress. Scott?

Thanks, Dave. Looking at Slide 11 and starting with FYARRO. FYARRO product sales were $6.2 million for the second quarter, in line with the prior year period and up 15% over Q1. In the quarter, we saw a 14% increase in the number of ordering accounts compared to the first quarter, and growth was observed across all segments, including large accounts. Since launch in February 2022, we've achieved $51.1 million in cumulative sales. FYARRO has a high demand and penetration across both academic and community settings, and we have seen the consistent addition of new accounts ordering FYARRO with more than 200 accounts ordering since launch. Turning to Slide 12. We ended the second quarter of 2024 with $78.6 million in cash, cash equivalents, and short-term investments. Responsible capital management continues to support a healthy balance sheet and will fund operations into Q4 2025 based on current plans. Research and development expenses for the quarter amounted to $13.1 million compared to $13.3 million in the prior year quarter. R&D expenses were primarily related to the continued progress of the ongoing PRECISION1 trial and the programs in endometrial cancer and NET. Selling, general, and administrative expenses for the second quarter were $7.9 million compared to $11.8 million in the same period in 2023. This decrease was driven mainly by reduced commercial, marketing, and personnel expenses related to the rightsizing of our operations earlier in the year and reduced legal expenses versus the prior year quarter. Net loss for the second quarter was $14.6 million compared to $18 million in the second quarter of 2023. For more information on our financial performance in the second quarter, a detailed discussion of the results reported on this call will be provided in our Form 10-Q. I'll now hand the call back over to Dave.

As discussed today, we're making tremendous progress against our clinical development plans with two sizable markets in TSC1 and TSC2 inactivating alterations as well as other mTOR driven cancers. On Slide 14, what you'll see is the back half of the year will be an important time for Aadi, and we look forward to providing the anticipated two thirds interim analysis from PRECISION1 later this quarter, and if appropriate, sharing those data with the FDA thereafter. We expect to complete PRECISION1 by the end of the year. Additionally, we plan to provide an initial look at data coming out of the EEC and NET trials by the end of the year as well. Looking ahead to 2025, we expect to have full results of PRECISION1. And if the data continue to hold, we believe this would form the basis of a filing with the FDA in 2025 as well. With that, we can now open the line for questions. Operator?

And our first question comes from Roger Song with Jefferies. Your line is now open.

Thanks, Dave, for taking our question. Maybe we first talk about the PRECISION, Dave, if we may. Understanding you will have the second interim data in Q3. First of all, given the first-interim data, what kind of expectation do you have for TSC1 and 2? And the second part of the question is, you say you will discuss with the FDA the second interim data? And then just curious to what would be the key topic there and then what could be the potential outcome out of the FDA discussion after the second interim? I have a follow-up. Thank you.

Sure. Thanks, Roger. I'll make a couple of comments and ask Loretta if she has anything she'd like to add. Our PRECISION1 outcome in Q3 will present the primary endpoint analysis on two-thirds of the patients, meaning 80 patients or 40 patients in each arm. The primary endpoint of independently assessed overall response rate after a minimum of six months of follow-up will be reported, along with key demographic and select secondary data. I wouldn't draw any expectations regarding the direction of that data at this moment; we will need to wait for the report to see. If you want more specifics, just let me know. Since this represents the primary endpoint and is a preplanned interim analysis, we believe this will be a solid foundation for a data-driven discussion with the FDA about a potential submission path, which will be the goal of our next conversation with them. Loretta, do you have anything to add?

No, Dave, I think you covered it nicely. Thank you.

Got it. Yes. Thank you. The enrollment for the EEC and NET studies is progressing well, and I'm curious about what we should expect from the initial data update later this year. Will it focus on safety results, or are we anticipating some clinical activity from those initial results? How many patients should we expect to see in the data? Thank you.

Yes. I'll let Loretta start by commenting on where we are with those trials, and I can follow up if anything to add. So, Loretta, why don't you comment on this?

Thank you, Dave, and I appreciate the question. For the EEC trial, our recruitment has been progressing very quickly, which indicates strong community support for this combination. While we're not sharing exact numbers, we have finished enrolling the entire first cohort and are well into the second cohort now. I anticipate that by the end of the year, we will provide a comprehensive summary report on the first cohort of patients and likely some partial information on the second cohort. Regarding the NET program, we are also seeing rapid accrual, and I fully expect that by the end of the year, we will have a complete report on the first cohort of patients. Dave, do you want to add anything?

That's great, Loretta. Thank you. The only thing I might add is, right, that these are two indications where there is precedent data with mTOR inhibitors. And so, one of the opportunities we have here is to compare what we know from prior studies with mTOR inhibitors in these indications to the data we're seeing with nab-sirolimus, which will be something we'll bring forward as we look at that data, depending on the patients that we enroll in these early trials.

Dave, if I might add, I just want to remind everyone that these studies are open label unlike PRECISION. So there will be no problem statistically with reporting the information. Thank you.

Thanks, Roger. Can we move on to the next set of questions?

Thank you. Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.

Thank you for taking my question. I would like to follow up on what happens after the second two-thirds interim analysis regarding potential outcomes. I'm curious if there is any possibility that the design and execution of the remainder of PRECISION1 could be altered in any way. I remember there might have been some speculation about potentially increasing the target enrollment of the trial, depending on the outcome. Could you elaborate on that and the various scenarios that may develop?

Sure, Joe. Thanks for the question. It's a good one. We have discussed in the past the possibility of adjusting the trial at this time. The trial has been fully enrolled, and we expect to report on the complete data set of 120 patients in early 2025 once the follow-up period for those patients has concluded. We believe we are in a favorable position with the full trial enrollment. Currently, we do not foresee any changes to the trial based on the trajectory we've observed so far, and we do not expect any outcomes that would necessitate adjustments in the short term. However, we are still awaiting recommendations from our data monitoring committee as well as conducting our internal discussions. Any modifications we decide on will be included in our disclosures when we report that data later this quarter.

Okay. Got it. That's helpful. And then maybe one quick one on FYARRO. I know you've maybe previously have spoken to expectations to continue to see some incremental growth there. Just wondering if that's still your expectations and what would be sort of the driver of that? Thanks.

Yes, I want to highlight that we did have a low Q1, which we discussed was likely impacted by some cannibalization we were seeing at some of our large centers. Importantly, in Q2, we observed a strong rebound in demand across all of our key business segments. We believe that this momentum is sustainable as we head into the next quarter. From a demand perspective, our Q2 demand numbers actually exceeded our net sales since we had some deductions on a gross-to-net basis related to inventory movements in Q2. Therefore, we remain very positive about the outlook for continued incremental growth in the business in Q3 and Q4 of this year.

Okay, great. That's helpful. Thanks for taking my questions.

Yes. Thanks, Joe. Next question, Operator?

Thank you. Our next question comes from Tara Bancroft with TD Cowen. Your line is open.

This is Greg Weasner on behalf of Tara Bancroft. Is there any particular tumor type that you're favoring at this point for future trials? Or will this continue to be a pan-tumor approach? And if it's the latter, what guidance does the FDA give for registrational trial requirements? Thank you.

Sure, Greg. Thanks for the question. As I mentioned, this is truly a tumor-agnostic trial. The FDA does not provide guidance on favoring the trial for any specific indications. We will enroll any eligible patients regardless of tumor type based on their TSC1/TSC2 status and a few other inclusion criteria. We believe this will be conducted and reviewed as a tumor-agnostic trial, and our indication will not be tumor-specific. It will align with the tumor-agnostic label, assuming we submit and gain approval for that. To reiterate, we do not anticipate or guide this trial, PRECISION1, toward any specific tumor types. However, we are interested in considering our endometrial and neuroendocrine specific tumor indications where we know mTOR plays a role, regardless of TSC1 and TSC2 status. In fact, those trials exclude patients with those mutations, so we have not had any patients with those mutations in that trial. We are looking at the impact of the mTOR pathway in those specific indications where they are potentially more mTOR sensitive.

Okay. Wonderful. That's very helpful. And if I can just ask one quick follow-on question. Is there a particular conference that you're targeting for the second interim? Or would this be something that we can expect from a press release?

Yes, we would imagine this will be a company presentation at this point.

Thank you. Our next question comes from Ahu Demir with Ladenburg Thalmann. Your line is open.

Thank you for taking my question. I appreciate the additional information on the results today. I have two questions, possibly one more after the second. My first question is about the earlier lines of treatment, which you mentioned have a better impact, as we've seen in many targeted therapies. Are you planning to disclose this data in the next release? Will we see distinct populations where patients receive more than three lines of treatment compared to those treated earlier? Are you planning to share that information?

We will definitely share the overall response rate. The key question, once we analyze the data, will be whether there is a noticeable difference between treatment lines and if that distinction is significant based on our data set. This will depend heavily on the actual observations from the patient population. I can mention that in the early interim data we collected in December, we didn't observe any specific trends as it was a very limited data set, making it challenging to draw conclusions, but we did see responses distributed across various treatment lines.

Makes sense. And my second question is on the endometrial cancer program. You did mention the biggest idea of this trial is to compare it to the other mTOR inhibitors and the patient baseline demographics can impact the trial readouts significantly. So what was the other trial patient demographics look like? Are you planning to focus on those? Any particular populations that you would be targeting? Anything we should pay attention because sometimes it's very challenging when we are comparing apples to oranges and based on demographics that impacts a lot.

Yes. Understood. I probably oversimplified the comparison or statement in that. So I'm going to allow Loretta to comment on kind of our strategy with the endometrial trial and where we think the real benefit is here for patients. Loretta?

Sure, Dave. Good morning. And thank you for that question. As usual, it's a good one. So the design of the EEC study was largely based on an earlier study that was performed by GOG, the Gynecologic Oncology Group. This is a study GOG-209. And this is actually an older study that established platinum and paclitaxel as the standard-of-care for patients who had advanced endometrial cancer. And in that study, there was a cohort of patients who were chemo-naive. And in that group, they saw a response rate of about 51%. Now this was compared to a later study of the combination of Everolimus and letrozole in which the response rate in the chemo-naive patients was 47%. So not very different than what was seen with platinum and paclitaxel. But what was really riveting was the fact that the PFS reported for the platinum paclitaxel combination was 14 months, which is healthy. But for the Everolimus letrozole combination, it was 28 months, a doubling. And PFS in this population where quality of life is extremely important really was what was the driver behind the design of our advanced stage endometrial cancer. We had an opening a chance to put this combination in frontline or in second line, in some cases, to take a look at how well it would work and to see if we could repeat or improve on the original Everolimus letrozole combination data in a chemo-naive patient population. So that was the basis of the study design and the community has been extremely supportive of this idea and has enrolled very rapidly because of their wish to replace or try and replace chemotherapy as frontline treatment for this population. I hope that helped.

Okay. As I mentioned, Ahu, I do it too simply; Loretta does it wonderfully. So, thank you for the question. Do you have a follow-up?

Well, one last question I have, Dave, if I may. You have two distinct approaches to assess nab-sirolimus. So curious, when you talk to the KOL community, where do you see the most excitement? Is it for more of the TSC1/2 approach, the agnostic approach? Or do you see more of an excitement for the endometrial and NET where there is an indication-specific approach?

I'll let Loretta comment first and then...

So first of all, they are totally different populations. Remember that your PRECISION, we are dealing with sort of a pan-representation of specialties. So they don't necessarily talk to each other. But the ones who do talk to each other remain really very bullish on the fact that we are seeing responses in some of these very sick, late-stage patients, as Dave mentioned in his commentary. It's perhaps easier to see the enthusiasm in the community for EEC, where these tend to be a group of specialists who are together all the time. And they talk about this disease all the time, and they treat the same kind of patients all the time. So their excitement is palpable, and they are looking for the next big thing. So immunotherapy was, of course, big and changed the standard-of-care. And now they are looking for a way to replace chemotherapy. And they are hopeful and actually quite vocal that we will fill that gap. So that's as best as I can represent it, I think. Dave, you wanted to say something else?

I think that's a great summary of it, Loretta from first-hand experience. I would say we also went out with the TSC1 and 2 interim analysis, I mentioned and talked to a large number of physicians to get reactions to that profile and understand across different specialties what that reaction would be. And consistently, physicians are quite interested in finding solutions for late-line patients, particularly through targeted mutations where there's identifiable mutation and where often not just overall response rate but even stable disease is a meaningful outcome for those patients who progress through multiple lines of therapy. And we had excellent reactions to the profile of nab-sirolimus especially amongst folks who are familiar with the mTOR pathway and/or doctors who have seen this product in the PEComa setting. So thank you, Ahu, for the questions. So, Operator, next question?

Thank you. Our next question comes from Robert Burns with HC Wainwright. Your line is now open.

Good morning. This is Dan on for Rob. Thanks for taking our questions. We wanted to ask, given the data demonstrating preferential tumor uptake for nab-sirolimus versus sirolimus and Everolimus. Are you thinking of any drug combinations and subsequent target indications for the future? Or to rephrase: any ideas on future directions or expansions? And would you be able to give a little more color around when in this upcoming quarter you expect to report the interim analysis? And I'd like to have some follow-ups, if I could.

Thank you, Dan, for your questions. We have observed a preferential accumulation of sirolimus in the nab-sirolimus combination due to our nanoparticle-bound albumin technology, which we believe is a key advantage of this product. The TSC1 and 2 trial is focused on monotherapy, so there is no combination involved. However, the EEC trial includes a combination with letrozole, and the NET trial can be either monotherapy or in combination for functional tumors with standard-of-care. We are exploring additional combinations that could build on this, but it is too early for us to provide specific comments on that. We are awaiting results from these initial trials in the second half to help guide our future direction. As for timing, I can only say we expect to have updates later in Q3.

Thanks. That makes sense. So regarding follow-ups, what are you looking for from the Phase II program in neuroendocrine tumors concerning efficacy and safety? Are there specific tumor types where you expect to see the greatest impact? Do you have an update?

Go ahead. Finish.

Do you have an updated outlook on what maximum sales and the PEComas could look like in the United States and what that might be? I'm also curious about the comparison between the paclitaxel and Everolimus trials and how their overall survival rates compare to the past.

I can.

Yes. I'll let Loretta take the first question. Go ahead.

I'll answer the last question first since I lost track of the earlier ones. The overall survival for the combination of paclitaxel and Everolimus was 32 months. The data for the letrozole and Everolimus combination wasn't reported; however, given that the progression-free survival was 28 months, it suggests that the overall survival might be significantly better.

Loretta, thanks. The first question was in regards to the NET trial expectations and any particular tumor types that we might see better responses.

I understand the question now. If you're asking about subtypes of NET, it's important to note that NET can occur in various organ sites. Currently, we do not have sufficient information to determine which specific subtype of NET might exhibit a better response rate. At this time, we simply do not have enough data.

Yes. Dan, regarding the NET trial, historically, mTOR inhibitors have been used for neuroendocrine tumors. Approvals for these treatments were based on the benefit of progression-free survival. NET can be quite indolent and long-lasting, but mTOR inhibitors have shown some benefit by extending treatment time for patients compared to other methods. However, previous trials of mTOR inhibitors demonstrated very low overall response rates, often in the single digits. We believe that an early indication of our mTOR inhibitor’s potential would be to achieve better initial response rates, which could lead to improved long-term outcomes for patients. Regarding PEComa sales, we haven't provided guidance on its ultimate potential. PEComa is a very rare condition, with only about 200 to 300 patients in the U.S. This makes finding patients quite challenging, as many doctors may never encounter a PEComa patient. Our goal is to continue identifying these patients and ensuring they receive the appropriate treatment so they can benefit from nab-sirolimus during their disease journey. It's difficult to predict exactly where this will lead over time, but we believe we have made significant inroads in the market, and any future growth is likely to be incremental.

That makes sense. And I apologize for the inundation of questions.

No worries. We take notes as we go. So, thank you, Dan.

I apologize for my short attention span.

Thank you. Operator, are there any other questions on the line?

I'm showing no further questions at this time. I would now like to turn it back to Dave Lennon for closing remarks.

Thank you, Audrey, Loretta, Scott, for your comments today. Thank you, everyone, on the call for joining us for today's call. We appreciate your time and look forward to the opportunity in the near future to provide additional updates on our progress. Otherwise, have a great wonderful rest of your day and week and look forward to speaking to you all soon. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.