FibroGen Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 12, 2025

There are 6 speakers on the call.

Operator

Please be advised today's conference is being recorded.

Operator

I would now like to hand the conference over to your speaker today, Joanne Greller. Please go ahead.

Speaker 1

Thank you, operator. Good afternoon, everyone. Thank you for joining today to discuss FibroGen's first quarter twenty twenty five financial and business results. I'm Joanne Greller from LifeFi Advisors. Joining me on today's call are Thane Wedig, our Chief Executive Officer and David DeLuccia, our Chief Financial Officer.

Speaker 1

Following the 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 Acelis, financial guidance 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 ks and Form 10 Q.

Speaker 1

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 company's financial results and business update 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 CEO, Thane Wedig. Thane?

Speaker 2

Thank you, Joanne. Good afternoon, everyone, and welcome to our first quarter twenty twenty five 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 US pipeline opportunities, specifically the exciting prospects for FG3246 and FG3180, 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 three, I would like to highlight the strategic priorities we've set forth for FibroGen this year.

Speaker 2

I'll begin by providing an update on the sale of FibroGen China to AstraZeneca. As we've stated previously, this is a truly transformative transaction for FibroGen as it 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. At the time of the announcement in February, the total consideration for the sale was expected to be approximately $160,000,000 which included an equity value of $85,000,000 and expected net cash in China of approximately $75,000,000 We are pleased to share that we expect the total consideration to now be approximately $185,000,000 which is a $25,000,000 increase from our initial guidance due to greater than expected net cash in China at closing. Importantly, the increase in expected proceeds extends the company's cash runway into the second half of twenty twenty seven. We now expect the transaction to close in the third quarter of this year.

Speaker 2

Second, we remain hyper focused on advancing FG-three thousand two hundred forty six and FG3180 in metastatic castration resistant prostate cancer or MCRPC, in which we continue to make important progress. We recently announced in March the publication of the full trial results from the Phase I monotherapy study of FG3246 in patients with mCRPC in the Journal of Clinical Oncology, which highlights the promising potential of its anticancer activity, especially when considering the unselected heavily pretreated patient population. We believe the trial results demonstrate that the CD46 target is active and provide key insights into the potential clinical impact of targeting CD46 expressing tumors. We are excited to share that we recently received notification from the FDA clearing the IND for FG-three thousand one hundred eighty, our companion PET imaging agent. This marks an important achievement for FibroGen as it paves the pathway for FG-three thousand one hundred eighty to be used alongside FG-three thousand two hundred forty six in the upcoming Phase II dose optimization monotherapy trial, which is expected to start in the third quarter.

Speaker 2

Third, for roxadustat, FibroGen recently filed a Type C meeting request with the FDA to gain feedback on the potential path forward for roxadustat in anemia associated with lower risk myelodysplastic syndromes, an indication with significant unmet medical need. In the post hoc subgroup analysis from the MADERHORN Phase III trial, roxadustat showed promise in reducing transfusion dependence in patients with a higher transfusion burden at baseline. We expect FDA feedback in the third quarter that will provide important clarity on the path forward for roxadustat in The U. S. With the aim of realizing additional value for this wholly owned asset.

Speaker 2

Altogether, we are confident that our refined focus, multiple near term catalysts across both clinical programs, and our existing strong foundation position us well to create value for shareholders now and in the future. I will now provide a brief overview of our FG3246 and FG3180 programs in MCRPC. Slide five highlights the high unmet need in late stage prostate cancer. There are approximately two hundred and ninety thousand men diagnosed with prostate cancer each year in The US. Of these, there are sixty five thousand drug treatable patients where the cancer has metastasized and become castrate resistant, resulting in a grim five year survival rate of approximately thirty percent.

Speaker 2

There remains a significant opportunity for new treatments that can extend survival for these men with a total addressable market of well over $5,000,000,000 in annual sales. FG-three thousand two hundred forty six could become a non PSMA treatment option that is so desperately needed given the significant unmet need in mCRPC. Turning to slide six, we highlight the novelty of our target, a tumor selective epitope of CD46. CD46 and this specific CD46 epitope have several distinguishing features. First, CD46 is upregulated during tumorigenesis and helps tumors evade complement dependent cytotoxicity.

Speaker 2

The CD46 epitope is highly expressed in mCRPC tissues with lower interpatient variability and higher median expression compared with PSMA as depicted in the graph on the right hand portion of the slide. Importantly, the expression of CD46 is upregulated in the progression from localized castration sensitive prostate cancer to metastatic castration resistant prostate cancer and further overexpressed following treatment with androgen signaling inhibitors. And the CD46 epitope is also overexpressed in colorectal cancer and other solid tumors. Turning to slide seven. FG3246 is a potential first in class ADC in development for mCRPC with a novel targeting antibody YS5, which binds to the tumor selective epitope of CD46 along with an MMAE payload.

Speaker 2

MMAE is a validated payload that is approved as a part of a number of ADCs and other oncology indications. FG3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development. A companion PET imaging agent, FG3180, utilizes the same YS5 targeting antibody as FG3246 and is also under clinical development. In preclinical studies, the PET imaging agent has demonstrated specific targeting of and uptake by CD46 positive tumor cells. We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in the Phase III portion of the clinical development program, it would also enable differentiation for FG-three thousand two hundred forty six in the prostate cancer treatment paradigm.

Speaker 2

In addition, FG-three thousand one hundred eighty could represent an important commercial opportunity as a companion diagnostic to FG-three thousand two hundred forty six, similar to the existing PSMA PET agents such as Pilarify. We are excited to announce that we have recently received IND clearance for FG3180, paving the way for the FG3180 to be an important component for the upcoming phase two dose optimization study that I will touch on in a moment. Slide eight recaps the top line results from the phase one monotherapy study with full details published in the peer reviewed Journal of Clinical Oncology in March of this year. The completed monotherapy study included a total of fifty six metastatic castration resistant prostate cancer patients who were biomarker unselected and were heavily pretreated receiving a median of five lines of therapy prior to FG3246. In the efficacy evaluable population of forty patients, a median radiographic progression free survival of eight point seven months was observed.

Speaker 2

There was an overall response rate of twenty percent confirmed by RECIST one point one and PSA reductions of greater than fifty percent were achieved in thirty six percent of patients. Adverse events were consistent with those observed with other MMAE based ADC therapies. Additional highlights from the JCO publication include expression of CD46 being observed in eighty percent of evaluable biopsies in patients enrolled during the dose expansion phase, which is consistent with results previously reported from a prospectively obtained cohort of patients who underwent metastatic CRPC biopsy. Twenty patients had a valuable circulating tumor DNA at baseline, on treatment defined as before the cycle two day one dose and at the end of treatment or disease progression. In nine of these twenty patients or forty five percent of those evaluable, there was a greater than fifty percent decline from baseline in ctDNA fraction after just one cycle of treatment.

Speaker 2

A tighter dose response relationship appeared to be observed for objective tumor response by imaging as opposed to serum PSA decline, which may be related to the independence of CD46 from the androgen signaling pathway and expression of CD46 in androgen receptor independent tumor clones. And finally, antitumor activity was observed in patients who had received more than one previous line of ARPI therapy as well as those who had received taxane chemotherapy in the metastatic castration sensitive setting, the latter being notable given similar mechanisms of action of taxanes and MMAE. Based on the totality of the data from the phase one monotherapy trial, we are encouraged by the clinical activity of GET FC3246 in targeting CD46 in mCRPC. On slide nine, we highlight the RPFS results of FG3246 in its Phase I study versus other comparable early stage studies. As covered on the previous slide, the Phase I study of FG3246 demonstrated an RPFS of eight point seven months across a robust sample size of 40 heavily pretreated patients.

Speaker 2

While we cannot make direct comparisons to these trials due to the differences in study design and prior prostate cancer treatments, we are encouraged by these RPFS results, which is a recognized regulatory endpoint in prostate cancer trials. On slide 10, we highlight previously reported preliminary efficacy data from the phase 1b portion of the ongoing investigator sponsored combination study with enzalutamide. These interim results included data on seventeen biomarker unselected patients, seventy percent of which were pretreated with at least two prior ARSIs. In addition to establishing the phase two dose of FG3246, the IST also demonstrated an encouraging 10.2 of radiographic progression free survival with PSA declines observed in seventy one percent of evaluable patients. We expect to report the Phase II top line results in the fourth quarter of this year, which will also include data on CD46 expression in patients treated with FG3180, our PET biomarker, during the Phase II portion of the IST.

Speaker 2

On slide 11, we depict a comparison of the initial results from the monotherapy trial in heavily pretreated patients and the combination trial for FG-three thousand two hundred forty six versus the RPFS results from second line therapies in late stage trials. Again, while we cannot make direct comparisons to these trials due to the differences in study design and previous prostate cancer treatments, we are encouraged that FG-three thousand two hundred forty six demonstrates what we believe to be competitive RPFS results. Slide 12 highlights the Phase II monotherapy dose optimization trial design that is based on our discussion with the FDA. We plan to initiate the study next quarter and expect to enroll seventy five patients in the post ARSI pre chemo setting across three dose levels to determine the optimal dose for Phase III based on efficacy, safety, and PK parameters. It is important to note that FG3180 will be an integral part of the study as we seek to demonstrate the correlation between CD46 expression and response to the ADC in this all comers population.

Speaker 2

One other important design element is the use of G CSF as primary prophylaxis to mitigate grade three or greater adverse events associated with neutropenia commonly seen with MMAE payloads. The addition of G CSF may enable a better tolerated and more consistent treatment with the ADC, minimizing dose interruptions or dose reductions, extending duration of therapy, and potentially enhancing the efficacy of the ADC. We are planning an interim analysis in the second half of twenty twenty six, which will include efficacy, safety, PK and exposure response data, and we intend to share relevant data to all stakeholders as they become available given the open label design. Slide 13 highlights why we are so optimistic about the potential for our Phase II study to further build upon the strong efficacy seen in the Phase I study. We believe there are three factors that could drive RPFS even higher than the eight point seven months that was observed in the Phase I monotherapy trial.

Speaker 2

First, preliminary evidence of an exposure response relationship, which allows us to focus our phase two study on three of the highest tolerated doses from the phase one dose escalation and expansion study. Second, utilizing primary prophylaxis with G CSF to combat against neutropenia, potentially allowing patients more consistent exposure to the ADC with fewer dose interruptions or adjustments. Third, enrolling patients in earlier lines of therapy versus the median five prior lines of therapy in the phase one trial. We believe that these design elements have the potential to improve upon the phase one results and achieve an RPFS in the ten to twelve month range, which we believe is the benchmark for commercial competitiveness. On slide 14, we show our long term development strategy for FG3246 and FG3180, which we believe provides significant optionality in prostate cancer.

Speaker 2

We have a robust phase two monotherapy trial in the pre chemo setting in MCRPC to further build upon the compelling efficacy data of eight point seven months of RPFS in 40 heavily pretreated biomarker unselected patients from the Phase I monotherapy study. In addition, this study will explore the correlation between CD46 expression and response to the ADC, potentially validating FG3180 as a predictive patient selection biomarker in future studies. We are confident that our development pathway for FG3246 unlocks sequential or parallel registration pathways as FG3246 will be evaluated in multiple lines of therapy, in monotherapy, and or in combination with an ARSI and in an all comers population or patients with high expression of CD46. Slide 15 shows the recent and upcoming catalysts for the FG3246 and FG3180 program. We are very pleased to have received IND clearance for FG3180 as this marks an important milestone as we explore its potential to be used as a diagnostic tool and potential biomarker for patient selection in the treatment of MCRPC.

Speaker 2

We plan to initiate the Phase II monotherapy trial in the third quarter, which will include FG3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG3246. To summarize, on slide 16, FG3246 targets a novel epitope on prostate cancer cells with first in class potential. It is important to note that there are no other CD46 targeted projects in clinical development. Targeting CD46 with FT3246 has already demonstrated promising early efficacy signals with an acceptable safety profile, both in monotherapy and combination settings. We are excited for the upcoming milestones and look forward to updating you on the program as the studies progress.

Speaker 2

Turning to roxadustat. Slide 18 highlights the unmet need and the potential for roxadustat in patients with anemia associated with lower risk MDS. There is a lack of effective second line and beyond treatments given that the currently available therapies are only effective in approximately fifty percent of patients. In addition, there are no oral options available or in late stage development, which could be a meaningful differentiator for roxadustat and potentially translate into a significant commercial opportunity. Moving on to slide 19, we highlight data from the Phase III MATERHORN study of roxadustat in a subgroup of patients with anemia of lower risk MDS who entered the trial with a higher transfusion burden.

Speaker 2

In this post hoc analysis, roxadustat demonstrated a meaningful difference in transfusion independence versus placebo, results that are highly similar to the pivotal trials for two recently approved therapies for anemia associated with lower risk MDS. On slide 20, we highlight the significant opportunity for roxadustat in lower risk MDS. Based on other lower risk MDS development programs, we believe the indication would support an orphan drug designation, which would provide seven years of data exclusivity in The US. This potential exclusivity, combined with an attractive market opportunity and efficient commercial model, provides a significant economic opportunity for further development of roxadustat. We look forward to near term discussions with the FDA, which could pave the way for developing roxadustat for anemia associated with lower risk MDS on our own or through a potential partnership.

Speaker 2

With that, I will now turn the call over to Dave to discuss the company's financials. Dave?

Speaker 3

Thank you, Sane. I will first review the updated FibroGen China transaction details and then provide the company's financial performance for the first quarter of twenty twenty five. As a reminder, our China operations are reflected as discontinued operations throughout our financials. We will continue to report our China operations and continued operations moving forward. On slide 22, we highlight the summary of key financial terms of the transaction.

Speaker 3

Under the terms of the agreement, FibroGen will receive an enterprise value of $85,000,000 plus FibroGen net cash held in China at closing estimated to now be approximately $100,000,000 totaling approximately $185,000,000 This is a $25,000,000 increase from our initial net cash guidance in February. Given the company's current market capitalization of approximately $30,000,000 we believe this increase in expected net cash received upon the close of the transaction represents a meaningful outcome for shareholders. As a reminder, the value of FibroGen net cash in China includes FibroGen's portion of Falikong 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, which is expected in the third quarter of twenty twenty five pending customary closing conditions, including regulatory review in China. This transaction is truly transformative for FibroGen and allows the company to pay down its senior term loan facility with MSTV, fully access our cash in China and extend the company's runway into the second half of twenty twenty seven to support U.

Speaker 3

S. Development initiatives. Now onto the company's financials for the first quarter. For the first quarter of twenty twenty five, total revenue was $2,700,000 compared to $25,400,000 for the same period in 2024. For full year 2025, we reiterate total revenue to be between $4,000,000 and $8,000,000 Now moving down the income statement.

Speaker 3

Total operating costs and expenses for the first quarter of twenty twenty five were $17,700,000 compared to $74,500,000 for the first quarter of twenty twenty four, a decrease of $56,800,000 or 76% year over year. R and D expenses for the first quarter of twenty twenty five were $9,200,000 compared to $36,500,000 in the first quarter of twenty twenty four, a decrease of $27,300,000 or 75% year over year. SG and A expenses for the first quarter of twenty twenty five were $8,100,000 compared to $16,700,000 in the first quarter of twenty twenty four, a decrease of $8,600,000 or 51% year over year. During the first quarter of twenty twenty five, we recorded a net loss from continuing operations of $16,800,000 or $0.16 net loss per basic and diluted share as compared to a net loss of $49,000,000 or $0.49 per basic and diluted share for the first quarter of twenty twenty four. For full year 2025, we reiterate our guidance for our total operating costs and expenses including stock based compensation to be between $70,000,000 and $80,000,000 which at the midpoint represents a 58% reduction from full year 2024.

Speaker 3

Now shifting towards cash. As of December 31, we reported $33,800,000 in cash, cash equivalents and accounts receivable in The US and $128,400,000 in total consolidated cash, cash equivalents and accounts receivable when including balances in China. The company was cash flow positive in the first quarter of twenty twenty five, generating a total of $7,300,000 in cash flow on a total consolidated basis when including balances in China. Given that the company will continue to accrue cash from its China operations until the close of the sale transaction, we expect the company to again be cash flow positive on a consolidated basis in the second quarter of twenty twenty five. Upon close of the China transaction, we plan to pay off our senior secured term loan with Morgan Stanley Tactical Value resulting in a cash outflow of approximately $80,000,000 This includes the $75,000,000 principal balance, accrued and unpaid interest and an applicable prepayment penalty.

Speaker 3

Post the payoff of our MSCV term loan, we expect the company to have runway into the second half of twenty twenty seven. Thank you. And we'll now turn the call back over to Fain.

Speaker 2

Thank you, Dave. To conclude, we are extremely excited about the future prospects for FibroGen with a number of important catalysts in the coming months. We plan to advance our exciting pipeline, initiating the Phase II monotherapy study next quarter for FG3246 and FG3180 in mCRPC. We will gain important feedback from the FDA regarding the potential development of roxadustat in lower risk MDS, and we anticipate the close of the FibroGen China sale, payoff of the MSTV term loan, and extension of our cash runway into the second half of twenty twenty seven. In summary, we are committed to driving significant shareholder value by advancing our U.

Speaker 2

S. Development initiatives and supported by our strong balance sheet. 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 and A.

Operator

Thank you. Our first question comes from Andy Sayer with William Blair. Your line is open.

Speaker 4

Great. Thanks for taking our questions. Congratulations on the higher than expected proceeds from the AstraZeneca deal and the JCO publication. So we have three questions. One has to do with clinical development on FG3246.

Speaker 4

And so this has to do with some of the market dynamic changes after the Pluvicto approval based on the PSMA-four study in the pre chemo setting. I'm curious if you have contemplated on potentially running the monotherapy study or the pivotal program in the Pluvicto experience population just to mitigate some of the risks associated with the highly heterogeneous population and maybe targeting a higher unmet medical need. So that's question number one. Question number two has to do with some of the macro disruptions that we have read on the news or reported by the media. And I'm just curious if you can comment on some of the recent FDA either correspondence or communication, especially with the roxadustat MMBS opportunity.

Speaker 4

And third, I think this is something you have mentioned a couple times in previous calls, just given the cash infusion from AstraZeneca, is it worthwhile maybe from a capital allocation perspective to conduct some feasibility studies in colorectal cancer, especially in light of CytomX's success this morning. Thank you very much.

Speaker 2

Hey, thanks, for the comments and questions. Appreciate that. So let me touch on the first one, and then I'll ask Dave to comment as well. But as it relates to clinical development for 03/1946 and some market dynamic changes with Plavicto's new indication, As part of our synopsis or protocol for the Phase II monotherapy trial, we are going to allow Pluvicto experienced patients who happen to progress while on Pluvicto in that pre chemo or that post ARSI pre chemo setting to be entered into our trial. We don't think it makes sense to only or exclusively study those patients who are post Plavicto because, as I'm sure you can appreciate, Andy, you never have rapid adoption of an agent with a new indication.

Speaker 2

It usually takes time for clinicians to begin to adopt it. And so if we would require all patients who would be entered into our Phase II monotherapy trial to have been Plavicto experienced. We just think that that would create too much of an enrollment challenge. But we will be allowing patients who have been treated with Plavicto to be entered into our phase two monotherapy trial. Dave, anything to add to that?

Speaker 3

Nothing to add there, Thane.

Speaker 2

Okay. And then in terms of the macro news and a lot of what's going on with respect to HHS and FDA and the like, The only thing that we can point to are recent interactions that we've had with the agency. And maybe I'll give you just a flavor of that. The first one was when we filed the IND for which is our PET imaging agent. Everything progressed exactly on schedule.

Speaker 2

The questions and there were just a few of them. They came in a timely way. We answered them. The IND got cleared right on time. The next example that we have with the agency was the reactivation of the roxadustat IND in The US.

Speaker 2

We had deactivated it once we got the license back from AZ a little over a year ago. We then needed to reactivate it in order to file the Type C meeting request. We requested the reactivation. That was also achieved right on time. And then in terms of the Type C meeting request that we filed, typically, FDA has twenty one days or so to get back to the sponsor once a Type C meeting request has been filed.

Speaker 2

And then if they accept the Type C meeting request, there is then a date that has been set. We filed that Type C meeting request a week ago and have already heard back from the agency on the date that that Type C meeting is set for. And so the experiences that we have, Andy, I think are very favorable in terms of the FDA continuing to keep to certain timelines. In fact, we haven't experienced anything that's different than that. And then finally, in terms of cash from the AC and potentially doing a feasibility study for FG3246 in CRC, I think we're going to hold off on that for now.

Speaker 2

We continue to evaluate lifecycle opportunities. We want the most important thing that we need to do is get phase two monotherapy trial started. And then we'll be evaluating other opportunities that we think makes sense from a lifecycle perspective. Dave, anything to add to that?

Speaker 3

No, I think you hit the nail on the head there saying that. I think for us, obviously, we have identified as colorectal cancer as a potential opportunity for FT3246 given the expression of CD46 in those patients. But to Steynes point, I think our goals for this calendar year is really to close the transaction for China, kick off our Phase II studies and really get the ball rolling around the development pathway for ROXAN MDS as well. So great question, Andy, though.

Speaker 4

Great. Thank you so much.

Speaker 2

Any other follow-up questions, Andy?

Speaker 4

I think that's it from us. Thank you so much.

Speaker 2

Okay. Yeah. Thanks for the questions. Appreciate it.

Operator

One moment for our next question. Our next question comes from Matthew Keller with ACW. Your line is open.

Speaker 5

Hey, everyone. Congrats on the quarter and thanks for taking our questions. Just two quick ones from us. The first one, I was just wondering if you have any additional or any rate limiting steps ahead of the upcoming Phase two monotherapy study. And then secondly, with the updates on today's call, I was wondering how we should start to view what I would say is maybe the evolving commercial opportunity for 03/1980?

Speaker 2

Thanks, Matt, for the questions. I'll take them and then ask Dave to add some additional commentary as well. Originally, as it relates to the Phase II monotherapy trial, we weren't certain that we were going to or how quickly we were going to get the FG-three thousand one hundred eighty IND cleared. So there was a point in time where we thought that the majority of the patients in the Phase II monotherapy trial, so the seventy five patients, the majority of them would be able to be treated with the PEP biomarker in addition to the ADC. Now with the clearing of the IND, really, wouldn't call it a rate limiter, but what that allows us to do is to get an amendment in front of the sites that has 3,180 as a part of the phase two monotherapy study so that all of the patients in the phase two trial will be able to be treated with the PET biomarker in advance of receiving the ADC.

Speaker 2

And so we're going through that process right now as we speak. So really, the rate limiter is the close of China transaction so that we can move forward rapidly to then start the Phase II monotherapy trial. Terms of the question around Matt, you asked about the evolving landscape. What was that question again?

Speaker 5

Kind of like how we should view the commercial opportunity for 03/1980 as it evolves in both as a standalone product or in combination with some of the other things you guys have going on as well.

Speaker 2

Yeah, it's a really important question. And the phase two trial, I think, will tell us a lot. It will give us even more information relative to what we have now. There have been about, I think, five or twenty seven patients who have been treated with the PET imaging agent in the phase onetwo investigator sponsored trial at UCSF that's in combination with enzalutamide. We've seen those scans.

Speaker 2

It's clear that the target lights up with the PSMA imaging agent. And as you know, it uses the same YS5 antibody a part of the ADC. And so the scans look really clear. And the phase two trial will then tell us, do we continue to see, the scans appropriately light up the lesions? And then what, can we learn in terms of the assessment of the expression level of CD46 and the response to the ADCs.

Speaker 2

That will be a correlation analysis that we will do during the course of the trial and at the end of the trial so that we can, understand, the diagnostic performance of the agent itself. We have looked at the radioligand space. We've looked at the PSMA PET space. Clearly, with the PSMA PET imaging agents from Lantheus and from Telx that generate well over $1,000,000,000 in annual revenue, there is a clear commercial opportunity. But we're going to have to assess the performance of our PET imaging agent to be able to determine what that potential commercial opportunity could be.

Speaker 2

Dave, please add to that.

Speaker 3

Yeah, I think the one thing that I want to add around the phase two and the fact that the importance of being able to dose all 75 patients is that we're really trying to get to a point where we can have a large swath of patients being able to be tested with FG3180. So, the fact that we could have seventy five patients in the Phase II, we have the Phase II portion of the combination therapy and the IST with UCSF. So, the more and more patients that we can get treated with FG3180 allows us to get really smart around what the levels of expression would be that could correlate with efficacy and allows us to better understand how it can be used in future studies.

Speaker 5

Yep. No, totally makes sense. Thanks again for taking our questions. Appreciate it, guys.

Speaker 2

Thank you, Matt.

Operator

I'm not showing any further questions at this time. I'd like to turn the call back over to Thane for any closing remarks.

Speaker 2

Appreciate everybody's, participation today and continued interest in FibroGen. Look forward to, updating you, over the coming weeks and months on the important catalysts that are ahead of us. Thank you, for your time today.

Operator

Thank Thank you, ladies and gentlemen. This does conclude today's presentation. You may now disconnect, and have a wonderful day.

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Earnings Conference Call
FibroGen Q1 2025
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