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spk06: Good day and thank you for standing by. Welcome to the Fiverr Gents second quarter 2022 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. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Tong. Please go ahead.
spk05: Thank you, Bella, and good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at Fiverrgin. Joining me on today's call are Enrique Quintero, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, Juan Graham, our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer, Thayne Wettig, our Chief Commercial Officer, and Chris Chong, our Senior Vice President of China Operations. The format for today's call includes prepared remarks from Enrique and Juan, after which we will open up the call for Q&A. I would like to remind you that remarks made on today's call include forward-looking statements about FibroGen. Such statements may include but are not limited to our collaborations with AstraZeneca and Astellas, financial guidance, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results and results of operations, risks related to our business, and certain other business matters. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in FiberGEN's filings with the SEC including our most recent Form 10-K and Form 10-Q. Fibrogen does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise. The press release reporting our financial results and business update in a webcast of today's conference call can be found on the investor section of Fibrogen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique?
spk04: Very good. Thank you, Mike, and good afternoon, everyone, and welcome to our second quarter of 2022 earnings call. On today's call, I will provide a high-level summary of the most important accomplishments and developments in the second quarter of 2022. Juan Graham, our CFO, will then review the financials, after which we will open the call for your questions. Starting with slide three. Fibrogen is positioned to create significant value for patients and shareholders by executing on our three areas of focus. Number one, accelerating the development of pembrelumab in three indications with significant unmet medical need. Idiopathic pulmonary fibrosis, or IPF. Locally advanced and resectable pancreatic cancer, or LAPC. and Duchenne muscular dystrophy, or DMD. Number two, ensuring commercial success of Rosodusta in patients with chronic kidney disease outside the U.S. while continuing to explore a path forward in the U.S. And number three, increasing our research productivity to advance novel programs that leverage internal expertise and accessing external innovation for additional pipeline opportunities. Let's move to our clinical trials, beginning with pembrelumab on slide four. Pembrelumab is a wholly owned asset in phase three clinical trials for three high-value indications, IPF, LAPC, and DND. Each one of these diseases represents an important unmet medical need, and each constitutes a significant market opportunity. As we recently announced, During the second quarter, we completed an enrollment of the LELANTIS-2 Phase III clinical trial of pembrelumab in ambulatory patients with DMV. This brings the number of fully enrolled pivotal pembrelumab trials to four, the Cephras-1 trial in IPF, the LELANTIS-1 and LELANTIS-2 trials in non-ambulatory and ambulatory DMV, respectively, and the LAPIS trial in LAPC. Enrollment continues in our second Cephris Phase III study in IPF, and we look forward to updating you as the trial progresses. Moving now to locally advanced pancreatic cancer. As previously discussed, we set a very high bar for event-free survival that would have enabled us to file for accelerated approval. An independent interim analysis of event-free survival in the LAPIS Phase III study was conducted in the second quarter. Based on the interim analysis, we will not be filing a BLA for accelerated approval. As planned, the study will continue to its primary endpoint of overall survival with top-line data expected in the first half of 2024. It is very exciting to be expecting data readouts from four pivotal Phase III trials in 2023. the Cephras-1 phase III trial in IPF mid-2023, the Lelantus-1 and Lelantus-2 phase III trials in DMD in the first half of 2023 and the second half of 2023, respectively, and the Matterhorn phase III trial of Roxadustat in MDS in the first half of 2023. I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity we see with panbrelumab in each of the three disease areas on slide five, beginning with IPF. With a diagnosed prevalence of approximately 330,000 patients across the U.S., EU, China, and Japan, IPF represents a significant opportunity with the two approved IPF therapies generating almost $4 billion in net revenue in 2021. Despite this market size, there remains significant unmet need with these two approved therapies, as characterized by continued disease progression and challenging correlability. There is sentiment in the IPF community of limitation with the current therapies and a desire for additional therapeutic options. In the Phase III Cephras program produces similar results to the Phase II PRACE trial we believe panbreloma has the potential to help a sizable number of patients with IPF and be a very significant medicine for 5G. In the middle column, you can see the locally advanced pancreatic cancer opportunity. Pancreatic cancer represents one of the largest unmet needs in oncology, given the diagnosed prevalence of over 90,000 patients across the major regions combined with a low five-year disease-free survival rate of around 10%. There have been limited treatment advances in the non-metastatic setting over the last two decades, with immune oncology therapies failing to demonstrate survival benefits over the current standard of care. There is limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful commercial opportunity for Panvelma in LAPC if it can demonstrate a significant improvement in overall survival. In addition, the pancreatic cancer action network's precision PROMIS adaptive trial platform, evaluating panbreloin in combination with standard of care for patients with metastatic pancreatic cancer continues to progress. And finally, in the third column, we wrap up the panbreloin market section with a snapshot of the DMV opportunity. Given the devastating nature of DMD and the relentless progression of the disease, we're hopeful that the Lelantus Phase III program can lead to an approved therapy that is desperately needed by the DMD community. While the currently approved exon skipping therapies produce an increase in the dystrophin levels, they are targeted at a small proportion of DMD patients. There is a clear need for therapies. that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function and prolong ambulation. We believe the anti-fibrotic mechanism of Panbreluma may be a solution that can help these patients and their families. Now let's move to Roxadustat on slide six. Roxadustat continues to be approved in additional countries and was recently approved in Mexico and South Africa. It is now approved in China, Europe, Japan, and numerous other countries for the treatment of CKD patients on dialysis and non-dialysis. Evrenso has an important first-mover advantage in the EU relative to other HIF-PHIs, and Astellas recently received positive reimbursement decisions in the UK, Finland, Slovakia, and Sweden. We believe the anemia of CKD opportunity in Europe is significant. And while initial uptake has been slower than expected in the EU countries where Avrenso has launched, the early feedback from healthcare providers prescribing Avrenso has been positive. As noted earlier, we continue development of Roxodustat in MBS with the partners AstraZeneca and Astellas. And moving now to China, Roxadusta continues its strong performance. As you can see on slide seven, we are reporting second quarter total Roxadusta net sales in China of $53.1 million by Fibrogen and the Joint Distribution Entity, compared to $52.8 million in the second quarter of 2021. This was driven by an increase of over 80% in volume offset benefiting from the price reduction of the NRDL. We continue to expect Roksodusta net sales growth for the full year in China driven by significant growth in volume. Fibergen's proportion of Roksodusta net product revenue in China was $23.3 million for the second quarter on a U.S. GAAP basis. Juan will elaborate further in the financial update. Turning now to the updated external market data on slide eight. Broxibustat continues to be the number one branded treatment for an EMEOS CKD as measured by the value shared in the category which includes all ESA products on Broxibustat. We split this category leadership to continue, as Roxadustat volume continues to grow at a fast pace. Next, slide 9 provides a snapshot of Roxadustat unit growth as indexed to December 2020 on the chart on the left, as well as year-over-year growth in the table on the right. Of note is a significant unit growth of Roxadustat, while the leading ESI brand is slightly up, reflecting the anemia of CKD market expansion that has been driven by Roxas-Bustam since its original energy leasing in 2020. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan?
spk08: Thank you, Enrique. Before jumping into my financial remarks, I would like to highlight the remarkable effort by our team in China that despite COVID lockdown challenges, they continue to put patients with CKD anemia at the forefront of everything they do, enabling the outstanding financial results for the quarter. As mentioned by Enrique, we continue to build momentum on our clinical trial execution and enrollment for pomeraglumab. I also want to take some time to thank our colleagues for the day-to-day energy and passion to move our clinical trials forward, which we hope will have a significant impact on patients suffering from idiopathic pulmonary fibrosis, locally advanced and respectable pancreatic cancer, and Duchenne muscular dystrophy. Now getting into other financials, total revenue for the quarter was $29.8 million compared to $24.4 million for the same period in 2021. This represents growth of 22% quarter over quarter. Breakdown of revenue sources is as follows. we recorded $23.3 million of net product revenue for Roxa-Dustat sales in China compared to $13.4 million in the second quarter of 2021. During the quarter, we also recorded development revenue of $5.5 million associated with co-development efforts for Roxa-Dustat with our partners as compared to $19.6 million during the second quarter of 2021. Given the stage of Roxa-Dustat development, and as anticipated, we expect a reduction in co-development revenue in the coming quarters. Finally, we recorded $1.1 million in drug product revenue for Roxadustat bulk drug or active pharmaceutical ingredient sold to Astellas as compared to a negative 8.6 in the same period last year. Diving deeper into the operational results of our Roxadustat business in China, Total RozaDusta net sales from the Joint Distribution Entity jointly owned by AstraZeneca and FibreGen or JDE was $53.1 million this quarter compared to $52.8 million in the second quarter of 2021. It is worth noting that this quarter's sales include a one-time gross to net adjustment resulting in a net sales reduction of $3 million related to distributor adjustment due to the new NRDL price. Excluding this impact, underlying ROC-seduced sales growth versus Q2 2021 was 6%. Further, this sales performance is the result of a significant volume increase of over 80% offsetting the 2021 NRDL price renewal. As I previously mentioned, the growth experienced by our China operations continues to be strong and in line with our expectations of year-over-year growth in sales. Moving from total ROXADUSTA net sales in China, CyberGen's net transfer price from sales to the JDE was $18.2 million for the second quarter, consistent with the 30% to 45% range of the JDE's ROXADUSTA net sales, which we have continuously guided. During this quarter, we released $1.5 million from deferred revenue due to the change in our future estimates as per U.S. GAAP. As we have communicated in the past, the deferred revenue balance in FibreGen China fluctuates based on management estimates of future revenue. It is worth highlighting that we expect further release of deferred revenue in future quarters. As a result, FibreGen recorded $19.7 million in net revenue for the quarter from Ruxa-Dusta sales to the JDE and $3.5 million of direct-to-distributor sales from FibreGen China. Making our way down to P&L, operating costs and expenses were $108 million compared to $158.2 million for the second quarter in 2021. This decrease in operating costs is driven by a one-time charge of $25 million related to our partnership with HiFiBio incurred in the prior year period. lower R&D expenses with our Phase III clinical trials, including drug supply costs associated with our PEMREDLMA programs, and overall cost management efforts in our infrastructure despite inflationary pressures. During the second quarter of 2022, net loss was $72.6 million, or 78 cents net loss for both basic and diluted shares, as compared to net loss of $134 million, or $1.45 per basic and diluted shares for the second quarter last year. At June 30th, we reported $517.6 million in cash, cash equivalents, investments, and accounts receivable. We estimate our 2022 ending balance of cash, cash equivalents, investments, and accounts receivable to be in the range of $330 to $360 million. This is a significant improvement to our initial 2022 ending cash guidance. This improvement has been driven through execution, enhancements, unlocking efficiencies, as well as investment prioritization throughout the organization. As I have mentioned in prior quarters, we believe we're appropriately financed through key initial time revenue map data readouts, and we are privileged with a wide array of options to consider, as we continue to look for opportunities to strengthen our cash position over time. We'll conclude my financial remarks by mentioning that today we are refreshing our S3 shelf registration statement and have filed a prospective supplement for an at-the-market or ATM equity offering. We have no near-term plans to utilize the ATM. We view this as good corporate housekeeping and financial management. Thank you. And now I would like to turn the call back over to Enrique.
spk04: In closing, and thank you, Juan, we remain committed to advancing pembrelumar as a potential first-in-class medicine in Phase III development in three indications with significant unmet medical needs, idiopathic pulmonary fibrosis, locally advanced and respectable pancreatic cancer, and EUSHIN muscular dystrophy. Notably, We expect top-line data in 2023 from Pambrelumab's Cephers 1 phase 3 trial in IPF and the Lelantis 1 and Lelantis 2 phase 3 trials in non-ambulatory and ambulatory DMV, respectively, as well as Roxedusta's Marajon phase 3 trial in MDS. Roxedusta continues to perform very well in China. Our partner, Stellas, is moving forward with commercialization of breakfast in Europe. And in addition to the recent regulatory approvals, we have additional regulatory submissions under review in other geographies. We continue to have a strong financial position with $517.6 million in cash and expect to end 2022 with $330 to $360 million in cash. We have multiple options to consider to further strengthen our balance sheet to ensure our long-term success. Now, I would like to turn the call back to the operator for questions. Bella?
spk06: As a reminder, to ask a question, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please stand by while we compile the Q&A roster. And our first question comes from the line of Michael Yee with Jefferies. Your line is now open.
spk07: Hey, guys. Thank you for the update. We had two questions.
spk12: Appreciating the LAPC study, I guess, passed the initial analysis and it's going to continue. Can you tell us if the IPF Jefferies 1 study has any sort of interim or what can you say about what you're looking at, is DSMB looking at it, or is there any interim on that study? And with the DMD studies as well that are reading out, what can you say about interims on those studies as well? Thank you.
spk04: Thank you, Michael. I'm going to ask Dr. Eisner to answer your questions.
spk07: Thanks for the questions. Appreciate it. The answer is no. There's no further interim analysis for any of the studies, including IPF or DMD. All of them, of course, have independent DMCs to monitor safety, but there are no planned interim analyses.
spk12: Okay. And one final question as a follow-up. With the DMD studies, I appreciate these are novel endpoints, and this is sort of a on a traveled path. Have you talked with FDA on these endpoints and what you need to show and what data is required there to be deemed a successful study? Thanks.
spk07: Yes. So we do have endpoints for both the non-ambulatory and ambulatory studies. We have discussed those with FDA. The performance of the upper limb score is the endpoint for the non-ambulatory. And for ambulatory, it's the North Star ambulatory assessment. These are standardized measures for both types of DMD patients. So we expect that if we demonstrate efficacy based on these endpoints, that there will be a path forward for filing an approval. Okay, thank you.
spk06: And your next question comes from the line of Anna Bosunumi with People. Your line is now open.
spk10: Hi, this is Jack calling in for Annabelle. Thanks for taking our question. For Pam, could you provide a little more color on how we should think about the IPF opportunity in the context of the current treatments available, what background treatments are allowed in those trials, and how you expect to eliminate the noise around that? Thanks.
spk04: Very good. Thank you for the question. And I'm going to ask Mark, to discuss our trial design for IPF. I'm saying to share a bit about what we've learned about the opportunity that we would have with PAM.
spk07: All right, so thanks for the question. So for the Zephyrus Phase III program of PAM-Revel now, but it's placebo-controlled trials of PAM versus placebo for the treatment of IPF, patients are not to be on background therapy when they enter the trial. We do allow both treatment-naive and treatment-experienced patients on the trial, but when they enter the study, they're not on either profinadone or nintedinib. So it's a monotherapy trial design.
spk09: Thanks, Mark. So as we think about the commercial opportunity, I think there's a couple of things to keep in mind. First is that we were able to replicate in our Phase III Zephyrus program what we've seen in the Phase II PRAISE trial, we would expect an indication for Pemrevrimab for the treatment of patients with IPF. As we have investigated the current state related to the current standards of care, it's pretty clear, and this is based upon published literature, that given the tolerability challenges associated with both OPEV and Esprit, upwards of 40% to 50% of patients who start on either of those therapies have stopped taking it by the end of the first year And so there's a significant unmet need, not only as it relates to disease progression, but really as it relates to keeping patients on therapy. And, again, if we reflect on the PRAISE Phase 2 data and we look at the tolerability profile, while not head-to-head against either OPEB or Esprit, we're pretty confident that we've got a product that not only demonstrated very significant efficacy, but also a tolerability profile that we think could lead to differentiation relative to the two current available therapies.
spk10: Great, thanks so much.
spk06: And your next question comes from the line of Andy Hsieh with William Blair. Your line is now open.
spk11: Oh, great. Thanks for taking my questions, and congratulations on the very robust China launch, well, continued China launch, and also the clinical progress with Pembrelumab. I have 2 questions, both on and rebel map. So the 1st, 1 has to do with the fertility analysis from the lab study. I'm just curious about how the risking is that the futility analysis. So, is that kind of like a garden variety has a ratio greater than 1 or it's more intricate than that. And also. when looking at the fertility analysis, is that based on EFS or OS? And my second question has to do with the, also the LAPIS study design. I noticed that in 2019, when the trial was first initiated, only gemabraxane was included. Subsequently, fofiranox was added. And so, I'm just trying to get an appreciation about how the incorporation of Fofirinox might affect the primary analysis down the road. Thanks for taking my question.
spk04: Thank you, Andy. I'm going to have Mark answer both of your questions on the futility analysis for lapis and then on the incorporation of Fofirinox as background, accepted background therapy. for that trial?
spk07: Sure. So the independent statistician conducted an analysis of event-free survival, and that was actually to look for efficacy that could have supported an early accelerated filing. So we are, based on that analysis, we're moving forward with the overall survival endpoint as planned, which was and remains the primary endpoint for the trial. So it wasn't really a futility analysis as much as it was an early look at efficacy based on the surrogate endpoint of event-free survival. Now, recall we've said previously that we saw this as a very high bar to cross over, and we thought it was unlikely that we would hit the event-free survival. But given the just very high medical need in pancreatic cancer and the desperate need patients have for therapy, we did put this interim EFS analysis in place. But we are moving forward with the OS, which was our base case and what we were planning. In terms of the background chemotherapy, you're quite right. The initial design was a GEM-NAB, and now it also allowed for Fulfirinox as well. So about a third of the patients, I think, are on Fulfirinox as a background chemotherapy. The rationale is that this is a commonly prescribed chemotherapy regimen. It's particularly favored by oncologic surgeons. So we thought it would be important to allow both of these commonly used backbone chemotherapy regimens into the trial of PAM versus placebo on top of backbone chemotherapy. So we'll be able to look at both the overall population and the subgroups with both of the individual chemotherapy backgrounds.
spk11: That's very helpful. Thank you so much.
spk07: Sure.
spk03: your next question comes from the line of aaron rubber with colin your line is now open hi guys this is brendan on figure on thanks for taking the question uh just a couple quick ones on dmd from us as well um i guess looking ahead to those readouts next year and maybe also the evolving treatment landscape that i know you uh you acknowledge in your prepared remarks um that that i guess are more so for the specific uh dmd genotype I guess first, are you all tracking the different subtypes of patients in your study and the different background therapies they're on? Can you just remind us, do you require them to come off of maybe some of the exon skipping therapies? And I guess kind of related to that, based on your conversations with regulators up to now, do you expect any additional studies might be necessary to incorporate chemo lab into the current paradigm, maybe where there are genetically targeted therapies available? And maybe just let us know if that's something you're considering moving forward. Thanks very much.
spk04: Very good. I think those are questions for Mark. Mark, could you address the questions around BMD?
spk07: Sure. So both Lolanthus 1 and 2 patients are on background corticosteroids as per standard of care, but they're not on exon skipping therapies or other gene therapies. So those are the exclusion criteria for a trial. And then in terms of your question about will additional studies be necessary for approval, We don't think additional studies would be necessary for approval. We think the Lampus 1 and 2, either individually or together, could serve as the basis for an approval for DMD. There are, of course, other interesting clinical questions that we are thinking about that we could be answering down the road, but those would not be necessary for the initial approval.
spk00: Okay, great. Thanks very much.
spk06: And your next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.
spk02: Hi, thank you. Good afternoon and thanks for taking our questions. I had one question on the commercial side perhaps for either Enrique or Chris. Just as you think about the impact from COVID during your Q2 performance, can you maybe just quantify for us, you know, how many patients or any, you know, slowdown in treatment you may have observed and how you're thinking about that impact on the forward here over the balance of 2022. And my second question is on penrevlimab. You completed enrollment for the Zephyrus 1 trial, but I was just wondering if you provide a status update on the second trial, its enrollment status, and whether if Zephyrus 1 is successful, whether that plus your phase two study could potentially serve as a basis for a filing.
spk04: Very good. Thank you, Paul. And I'm going to ask Chris to answer the first question on China and Mark to answer the question around CFRS 2 and the ability to file with CFRS 1 plus price. Chris?
spk01: Thank you, Enrique. Thank you, Paul, for the question. I believe you asked if there's a way for us to quantify the impact of COVID on our first half performance. So as background, and this is publicly available information, the multinationals in China have just disclosed on average they have lost about 10% of revenues for the first half of the year due to COVID. Obviously, has seen an uptake involving not a decrease. It'd be very difficult for us to tell you net-net what we would have done had it not been for COVID. However, I believe generally the market sees the oral administration of Roxy D-STAT as a significant advantage, so we suspect we've benefited from it. We also came out of the NLDL price reduction with tremendous momentum, and that accounts for a lot of the market uptake. And generally, we have a team between AstraZeneca and FibroGen who are experienced, now almost three years after launch and executing very well. So on the positive side, there were many things going for us. It's hard for me to tell you how much more business we would have done without COVID, but we're obviously very pleased with the results. And I don't think those factors I just mentioned would continue to bring us a good, good top line in the second half of the year. Mark?
spk07: Yeah, so back to Pemrebel now, for Zephyrus 2, we have not yet provided guidance on when we anticipate enrollment to complete, but we are making very good progress, and we're very excited about our efforts there. In terms of the filing strategy, I think as we've said before, our base case is Zephyrus 1 and Zephyrus 2 will be needed to file. That said, if we have strong Zephyrus 1 data, because those data will be coming first, we would potentially explore with FDA whether that Jeffress 1 trial could be filed with the Phase 2 PRAISE study for an initial approval, as you suggested. Okay. Thank you very much.
spk06: And your last question comes from the line of Jason Turberry with Bank of America. Your line is now open.
spk02: Hey, guys. Thanks for taking my questions. First on DMV, apologies if I missed this. It was stated in the past, but are the ambulatory, non-ambulatory populations potentially like separate at the basis of separate filings if one works versus another not working? Just curious how that would pan out and just wanted to get your views. Is it sort of non-ambulatory, the higher risk trial of the two from your perspective? And then Shifting over to Roxa, just commercially, as we think ahead to kind of this growth dynamic where you kind of work through with higher volumes, offset the NRDL impact, and you have maybe a one- or two-year period of no NRDL comp to deal with, do you expect the NRDL cuts to get smaller with each successive cut? If you have a perspective on that or any analogs that you think are relevant, that would be helpful. Thanks.
spk04: Very good. Why don't we start with the China question first? I'm going to have Chris tackle that one, and then Mark, you can address the question about the Lantus 1 and the Lantus 2 and the potential of filing those based on independent results.
spk01: So first, I want to make sure I understand the question correctly. We did state that we believe part of the volume uptake in the current calendar year is due to the NRDL price cut. And the question is whether we expect subsequent price cuts to be of a lower range. So not talking about ROXADUSE specifically, but about NRDL generally, the industry expects the first cut to be the most significant, which is what we experienced in 2019. We have to concede a certain amount on pricing to get into the NRDL. Subsequent Pricing cuts are dependent on a variety of factors. First, the rules for price cuts change every single year. Many will tell you, and this is publicly disclosed, that the 2020 round, 2021 round was significant because budget allocations were diverted to COVID controls. So it's hard to predict, but as a general rule, the price cuts do decrease with time. It's hard for us to predict if our next cut would be less than what we experienced in the past. That's certainly what we would hope for. It would depend on how much volume we actually uptake and how much of the national budget we actually take, the pricing of our competitors at that time, which is visas, a variety of factors. But we're certainly hopeful that the next cut would be smaller than the one we just experienced. I hope I answered your question.
spk02: Yep, that's helpful. Thank you.
spk07: And then your question about DMD, I think it's a really good question about the ambulatory and non-ambulatory populations. I mean, if you think about the approvals to date, right, based on skipping therapies have been approved on biomarker data without any real clinical evidence besides the biomarker, I think we'd have a very good chance at filing either of the LLANTOS one or two studies, non-ambulatory or ambulatory alone together. just depending on the data. If the data are strong, I think they could support a filing. So it's something we're actively discussing internally. We'll see what the data show. Of course, non-ambulatory Volantis 1 is coming first. But, you know, the unmet need here is so high, and the patients and their parents are so desperately in need of new therapies that we would do everything possible with positive data in hand to try to get that approved as expeditiously as possible.
spk02: Thanks.
spk06: And I see no further questions at this time. I would now like to turn the conference back over to Enrique Conterno.
spk04: Thank you, Bella, and thank you to everyone for your participation in today's investor call and your interest in FibreGen. Enjoy the rest of your day. Thank you very much.
spk06: This concludes today's conference call. Thank you for your participation. You may now disconnect.
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