Hello everyone, and welcome to the FibroGen Fourth Quarter and Full Year 2024 Earnings 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. [Operator Instructions] Please be advised that today's conference, is being recorded. Now, it's my pleasure to turn the call over to, Joanne Greller. The floor is yours.

Thank you, operator. Good afternoon, everyone. Thank you for joining today, to discuss FibroGen's fourth quarter and full year 2024 financial and business results. I'm Joanne Greller from LifeSci Advisors. Joining me on today's call are Thane Wettig, our Chief Executive Officer and David DeLucia, our Chief Financial Officer. Following our prepared remarks, we will open the call to your questions. 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 FibroGen'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 statements, whether as a result of new information, future events or otherwise. The press release reporting the sale of FibroGen China and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com. With that, I'd like to turn the call over to our CEO, Thane Wettig. Thane?

Thank you, Joanne. Good afternoon everyone, and welcome to our fourth quarter and full year 2024 earnings call. On today's call, I will provide a status update on the transformation of FibroGen, which includes the divestiture of FibroGen China, and a laser focus on our U.S. pipeline opportunities, which includes the exciting prospects for FG-3246 and FG-3180. Our potential first-in-class antibody drug conjugate, targeting CD46 and our PET imaging agent in metastatic castration-resistant prostate cancer, and for roxadustat in the treatment of anemia, due to lower risk myelodysplastic syndrome. Then David DeLucia, our CFO, will review the financials after, which we will open the call for your questions. On Slide 3, I would like to highlight the strategic priorities for our company. First, the announcement of the sale of FibroGen China to AstraZeneca for approximately $160 million. This transaction simplifies our operations, allows for the payoff of our term loan facility with Morgan Stanley tactical value, and provides the most efficient pathway to access the company's net cash held in China, extending the company's cash runway into 2027. This is a truly transformative transaction for our company, which we are expecting to close by midyear. Second, advancing FG-3246 and FG-3180 in mCRPC, remains a key priority. In the second quarter of 2024, we shared important data from two Phase 1 studies, highlighting the potential of FG-3246 as both monotherapy and in combination with enzalutamide. I'll provide a more detailed overview of where we are with the program, and the upcoming 2025 catalysts in a moment. Third, we believe that roxadustat represents an important potential therapy, for patients with anemia associated with lower-risk MDS. We plan to meet with the FDA in the second quarter of 2025, to further explore this opportunity, which we are considering developing on our own, or…

Thank you, Thane. I will first review the FibroGen China transaction details, and then provide the company's financial performance, for the fourth quarter and full year 2024. Given the announced sale of FibroGen China, our China operations are now reflected, as discontinued operations throughout our financials. We will continue to report our China operations, and discontinued operations moving forward. On Slide 21, we highlight the summary of key financial terms of the transaction. Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, estimated to be approximately $75 million, totaling approximately $160 million. The value of FibroGen net cash in China, includes FibroGen's portion of Falikang net cash, which is the joint distribution entity owned by FibroGen and AstraZeneca. Importantly, FibroGen will continue to accrue cash generated in China, until the closing of the transaction. The transaction is expected to close, by mid-2025 pending customary closing conditions, including regulatory review in China. The transaction does not include the Eluminex license agreement, whose rights will continue to be retained by FibroGen going forward. This transaction is truly transformative for FibroGen, and allows the company to paydown its senior term loan facility, with Morgan Stanley Tactical Value, fully access our cash in China, and extend the company's runway into 2027, to support U.S. development initiatives. Now, on to the company's financials for the fourth quarter, and full year 2024. For the fourth quarter of 2024, total revenue was $3.1 million, compared to $3.6 million for the same period in 2023. For full year 2024, total revenue was $29.6 million, compared to $46.8 million in full year 2023. In the fourth quarter of 2024, we recorded $0.4 million in development revenue, compared to $2.6 million, during the fourth quarter…

Thank you, Dave. To conclude, we believe the sale of FibroGen China is a transformative transaction for FibroGen, and we are excited about the next chapter in the company's story. We are confident that the shift, to a lean U.S. organization focused on high value indications in oncology, and oncology related diseases has the potential to create tremendous value, for patients and stakeholders alike. With an extended cash runway into 2027, we plan to advance our exciting pipeline in the coming months, initiating the Phase 2 monotherapy study for FG-3246 and FG-3180 in mCRPC, and meeting with the FDA, to determine the potential development path for roxadustat, in the treatment of anemia associated with lower-risk MDS. These events will set the stage, for the remainder of 2025 and beyond, which include top line results from the Phase 2 portion of the IST, for FG-3246 in combination with enzalutamide in the second half of 2025, as well as interim results from the Phase 2 monotherapy study in mid-2026. In summary, as a leaner and more focused organization, we will continue to execute on our strategic plan, with the aim of achieving evaluation that we believe is more reflective, of our first-in-class Phase 2 ready CD46 targeting ADC, and our potential Phase 3 ready opportunity, in anemia associated with lower-risk MDS, bolstered by our strengthened balance sheet, and extended cash runway. We look forward, to providing further updates to our stakeholders, over the coming months. I would now like to turn the call over, to the operator for Q& A.

Thank you so much. [Operator Instructions] Our first question comes from the line of Andy Sieh with William Blair. Please go ahead.

Thanks for taking our questions, and congratulations on that transformative deal. Got two quick ones for the ADC franchise. So you mentioned about the futility analysis that's coming up in midyear 2026, and I'm just curious if you can characterize the level of stringency for that fertility. So in other words, maybe from an investor perspective would the passing of that fertility analysis be a very good sign from an efficacy standpoint? And second one, it's a quick one. I'm just curious, it's not very clear on the ClinicalTrials.gov website, but curious when you said pre-chemo but post ARPI, what's the qualification for radioligand? Would - a patient who had experience with radioligand be eligible for the trial? On the ClinicalTrials that website it only says no radioligand prior basically within the prior 28 days. And I have a follow-up on MDS? Thank you.

Thanks, Andy for the questions. Hope you're doing well. I'll answer the last one first. We in terms of maybe set the stage for this post-ARSI, pre-chemo setting. We've learned a lot from some of the KOLs in the past several months about what the sweet spot is, for an opportunity like FG-3246. And with the ARSIs moving into the castration-sensitive phase, we've also learned that especially at academic centers, you're seeing less of an ARSI switch regimen. So in other words, it is not uncommon for a patient to be treated with one ARSI, and then to be switched to another. And I think what we're hearing, especially from the academic centers, is that the incremental benefit of switching from one to another, is not that great. And at the same time, patients are desiring to put up chemotherapy, for as long a period of time as possible. So we think in this castration-resistant space post-ARSI pre-chemo, that's exactly where the trial is designed to recruit patients. And we are allowing patients, who have been treated with Pluvicto previously, just not within the prior 28 days. So if they have been treated with Pluvicto and are no longer responding, then those patients would be eligible to be enrolled in our Phase 2 monotherapy trial. In terms of the futility analysis, we're not going to speak very much about that at this point in time. Just suffice it to say that, we're going to ensure that when we look at the data, and this will be data on 12 patients at each one of the dose cohorts, that the therapy is being appropriately tolerated, and that we're not seeing any untoward adverse events. We're also going to be looking at efficacy parameters, at that point in time. Clearly, if we're seeing efficacy results, combined with safety results that are not favorable to the patient, then that will be an important consideration. But we're not going to go into detail at this point in time, in terms of exactly what that futility analysis is.

Okay. That's very helpful. And for MDS, so I'm curious about the ability to leverage some of the safety database from roxadustat - prior clinical programs. I'm just trying to get a sense, of how big that MDS program would have to be. So I'm just curious if you can speak, to the ability to leverage prior clinical results?

Yes, thanks for that question. I think we'll learn a lot. I know we'll learn a lot, when we speak with the FDA next quarter. Anemia associated with lower-risk myelodysplastic syndrome. That patient population is very different, than the patient population of anemia associated, with chronic kidney disease. What we think that, just based upon not only trials that have been done for luspatercept and imetelstat, but also a recent Phase 3 trial that just started, we think the trial size would be roughly about 200 patients. And again, we're going to get some feedback from the FDA, both in terms of dosing as well as the patient population that we would aim to target, but about 200 patients. And so that, the previous safety database for roxadustat and CKD anemia would be informative, but I don't think that instructive relative to this particular patient population. And I think, it's pretty apparent that based upon previous trials that, there will be some important safety follow-up. So not only looking at transfusion independence in the first 28 weeks of the trial, then looking at the same efficacy parameter over 52 weeks, but then some follow-up, safety follow-up that would extend beyond 52 weeks as well.

That's very helpful. Thank you so much for taking our questions.

Thank you, Andy.

Thank you. Our next question comes from Matthew Keller with H.C. Wainwright. Please go ahead.

Yes, good afternoon everyone. Congrats on the quarter, and thanks for the update. Just two again, quick questions from us as well. The first one, I was wondering if the recent cost saving measures that you commented about, and really a strong cash balance open up any possibility for, possibly some new assets, or any possible new indications in the future?

Yes, Matthew, one more time on that. I couldn't catch the last part of that.

Oh yes, no, it's okay. I was wondering with your strong balance sheet, and the cost saving measures that, you're leaving open the possibility, or if you're considering any new possible assets to add to the pipeline, or possible like new indications to consider as well going forward?

Yes, thanks for the question. Not at this time. We've got a laser focus as we stated, on the call of advancing FG-3246 and FG-3180 into the Phase 2 monotherapy trial, waiting for the results of the FG-3246 trial, in combination with enzalutamide and then seeking FDA feedback, on the potential to take roxadustat into further development in lower-risk MDS anemia. And so that's where we're going to stay focused. We think if we tried to branch, outside of that, it just wouldn't benefit the programs that we have in front of us right now. We need to stay laser focused on those two programs.

Yes, no, totally makes sense. And just the second one, if I may, switching gears to roxa and anemia MDS. But I was wondering if you could maybe provide a little more color, or highlight maybe what your expectations are, if you have a wish list kind of going into your upcoming meeting with the FDA?

Yes. It's a great question. I think our wish list would be that, based upon the previous Phase 2/3 trial, the MATTERHORN trial, which was conducted, where there was a small amount of kind of dose finding work across 24 patients at three different doses, 1.5, 2 and 2.5 migs per kg of roxadustat, eight patients in each one of those three dose cohorts. 2.5 milligrams per kilogram was chosen to be the dose that was then taken in to the Phase 3 portion of the trial. And then there was an algorithm based upon, hemoglobin levels that then let the clinician allow the clinician, to further titrate from there with a maximum of 3.5 milligrams per kilogram. So our preferred response to the FDA is that we've done the appropriate amount of dose finding work across the more than 100 patients that were treated in the Phase 2/3 trial, and that we would be able to go in right with a 2.5 milligram per kilogram dose. And then not have to do additional dose finding work, as part of another Phase 2/3 trial. That's the preferred approach. That's what our request is going to be. And then in terms of the specific patient population, we'll have a key question that we'll ask the agency, on the most appropriate patient population for this particular trial. We desire to do a placebo-controlled trial just, because of the fact that by doing a non-inferiority trial versus a physician's choice that, would be a much larger and much more expensive trial. But the treatment paradigm has changed a bit since we started the MATTERHORN trial a few years ago. You've got luspatercept approved, and you've had imetelstat approved. And so, what we're going to find out from the agency is, in this kind of ESA refractory patient population, who has been tried on one additional therapy, let's call it luspatercept, we would then like them to be randomized to either roxadustat or placebo, and not have to go through another therapy before then they would be randomized, to roxadustat and placebo. And so it's what we would call the second/third line in lower-risk MDS. And that would allow us, to then do a direct comparator versus placebo and size the trial, as I said to Andy's question, with about 200 patients or so.

Yes, totally makes sense. That was very helpful. Thanks again for taking our questions and congrats again on the quarter.

Yes, thanks Matt.

Thank you. And this concludes Q&A session. I will turn it back to Thane Wettig, for his final remarks.

Yes. Thanks, Carmen, and thanks, everybody, for joining us today for our fourth quarter earnings call, and your continued interest in FibroGen. Enjoy the rest of your day. Thank you.

Thank you all who participated in today's conference. You may now disconnect.