FibroGen - Earnings Call - Q1 2025

Transcript

Operator (participant)

Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joanne Greller. Please go ahead.

Joanne Greller (Head of Investor Relations)

Thank you, Operator. Good afternoon, everyone. Thank you for joining today to discuss FibroGen's first quarter 2025 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 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 Astellas, 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-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 company's financial results and business update, and 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'd like to turn the call over to CEO Thane Wettig. Thane.

Thane Wettig (CEO)

Thank you, Joanne. Good afternoon, everyone, and welcome to our first quarter 2025 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, specifically the exciting prospects for FG-3246 and FG-3180, our potential first-in-class antibody-drug conjugate targeted in 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. 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 million, which included an equity value of $85 million and expected net cash in China of approximately $75 million. We are pleased to share that we expect the total consideration to now be approximately $185 million, which is a $25 million 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 2027.

We now expect the transaction to close in the third quarter of this year. Second, we remain hyper-focused on advancing FG-3246 and FG-3180 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 FG-3246 in patients with MCRPC in the Journal of Clinical Oncology, which highlights the promising potential of its anti-cancer 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-3180, our companion PET imaging agent.

This marks an important achievement for FibroGen, as it paves the pathway for FG-3180 to be used alongside FG-3246 in the upcoming phase II dose optimization monotherapy trial, which is expected to start in the third quarter. 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 Matterhorn 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.

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 FG-3246 and FG-3180 programs in MCRPC. Slide five highlights the high unmet need in late-stage prostate cancer. There are approximately 290,000 men diagnosed with prostate cancer each year in the U.S. Of these, there are 65,000 drug-treatable patients where the cancer has metastasized and become castrate-resistant, resulting in a grim five-year survival rate of approximately 30%. There remains a significant opportunity for new treatments that can extend survival for these men, with a total addressable market of well over $5 billion in annual sales. FG-3246 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 tumorogenesis and helps tumors evade complement-dependent cytotoxicity. 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. The CD46 epitope is also overexpressed in colorectal cancer and other solid tumors. Turning to slide seven, FG-3246 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.

MMAE is a validated payload that is approved as a part of a number of ADCs and other oncology indications. FG-3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development. A companion PET imaging agent, FG-3180, utilizes the same YS5 targeting antibody as FG-3246 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-3246 in the prostate cancer treatment paradigm. In addition, FG-3180 could represent an important commercial opportunity as a companion diagnostic to FG-3246, similar to the existing PSMA PET agents such as Pylarify.

We are excited to announce that we have recently received IND clearance for FG-3180, paving the way for FG-3180 to be an important component for the upcoming phase II dose optimization study that I will touch on in a moment. Slide eight recaps the top-line results from the phase I 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 56 metastatic castration-resistant prostate cancer patients who were biomarker unselected and were heavily pretreated, receiving a median of five lines of therapy prior to FG-3246. In the efficacy evaluable population of 40 patients, a median radiographic progression-free survival of 8.7 months was observed. There was an overall response rate of 20% confirmed by RECIST 1.1, and PSA reductions of greater than 50% were achieved in 36% 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 80% 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 evaluable 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 20 patients, or 45% of those evaluable, there was a greater than 50% decline from baseline in CT DNA fraction after just one cycle of treatment.

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. Finally, anti-tumor 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 I monotherapy trial, we are encouraged by the clinical activity of FG-3246 in targeting CD46 in MCRPC. On slide nine, we highlight the RPFS results of FG-3246 in its phase I study versus other comparable early-stage studies.

As covered on the previous slide, the phase I study of FG-3246 demonstrated an RPFS of 8.7 months across a robust sample size of 40 heavily pretreated patients. 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 ten, we highlight previously reported preliminary efficacy data from the phase Ib portion of the ongoing investigator-sponsored combination study with enzalutamide. These interim results included data on 17 biomarker unselected patients, 70% of which were pretreated with at least two prior ARSIs. In addition to establishing the phase II dose of FG-3246, the IST also demonstrated an encouraging 10.2 months of radiographic progression-free survival, with PSA declines observed in 71% 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 FG-3180, our PET biomarker, during the phase II portion of the IST. 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-3246 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-3246 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 75 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 FG-3180 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. One other important design element is the use of GCSF as primary prophylaxis to mitigate grade three or greater adverse events associated with neutropenia commonly seen with MMAE payloads. The addition of GCSF 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 2026, 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 8.7 months that was observed in the phase I monotherapy trial. First, preliminary evidence of an exposure response relationship, which allows us to focus our phase II study on three of the highest tolerated doses from the phase I dose escalation and expansion study.

Second, utilizing primary prophylaxis with GCSF 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 I trial. We believe that these design elements have the potential to improve upon the phase I results and achieve an RPFS in the 10-12 month range, which we believe is the benchmark for commercial competitiveness. On slide 14, we show our long-term development strategy for FG-3246 and FG-3180, which we believe provides significant optionality in prostate cancer. We have a robust phase II monotherapy trial in the pre-chemo setting in MCRPC to further build upon the compelling efficacy data of 8.7 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 FG-3180 as a predictive patient selection biomarker in future studies. We are confident that our development pathway for FG-3246 unlocks sequential or parallel registration pathways, as FG-3246 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 FG-3246 and FG-3180 program. We are very pleased to have received IND clearance for FG-3180, 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.

We plan to initiate the phase II monotherapy trial in the third quarter, which will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246. To summarize on slide 16, FG-3246 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 FG-3246 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. 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 50% 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 MATTERHORN study of roxadustat in a subgroup of patients with anemia of lower risk MDS who entered the trial with a higher transfusion burden. 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 U.S. 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. With that, I will now turn the call over to Dave to discuss the company's financials. Dave?

David DeLucia (CFO)

Thank you, Thane. I will first review the updated FibroGen China transaction details and then provide the company's financial performance for the first quarter of 2025. As a reminder, our China operations are reflected as discontinued operations throughout our financials.

We will continue to report our China operations in continued operations moving forward. On slide 22, 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 now be approximately $100 million, totaling approximately $185 million. This is a $25 million increase from our initial net cash guidance in February. Given the company's current market capitalization of approximately $30 million, 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 Polypharma 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 2025, 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 Morgan Stanley Tactical Value, fully access our cash in China, and extend the company's runway into the second half of 2027 to support U.S. development initiatives. Now, on to the company's financials for the first quarter. For the first quarter of 2025, total revenue was $2.7 million compared to $25.4 million for the same period in 2024. For full year 2025, we reiterate total revenue to be between $4 million and $8 million.

Now, moving down the income statement, total operating costs and expenses for the first quarter of 2025 were $17.7 million compared to $74.5 million for the first quarter of 2024, a decrease of $56.8 million, or 76% year over year. R&D expenses for the first quarter of 2025 were $9.2 million compared to $36.5 million in the first quarter of 2024, a decrease of $27.3 million, or 75% year over year. SG&A expenses for the first quarter of 2025 were $8.1 million compared to $16.7 million in the first quarter of 2024, a decrease of $8.6 million, or 51% year over year.

During the first quarter of 2025, we recorded a net loss from continuing operations of $16.8 million, or $0.16 net loss per basic and diluted share, as compared to a net loss of $49 million, or $0.49 per basic and diluted share for the first quarter of 2024. For full year 2025, we reiterate our guidance for our total operating costs and expenses, including stock-based compensation, to be between $70 million and $80 million, which at the midpoint represents a 58% reduction from full year 2024. Now, shifting towards cash. As of December 31st, we reported $33.8 million in cash, cash equivalents, and accounts receivable in the U.S., and $128.4 million 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 2025, generating a total of $7.3 million 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 2025. 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 million. This includes the $75 million principal balance, accrued and unpaid interest, and an applicable prepayment penalty. Post the payoff of our Morgan Stanley Tactical Value term loan, we expect the company to have runway into the second half of 2027. Thank you, and we'll now turn the call back over to Thane.

Thane Wettig (CEO)

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 FG-3246 and FG-3180 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 MSCV term loan, and extension of our cash runway into the second half of 2027. In summary, we are committed to driving significant shareholder value by advancing our U.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&A.

Operator (participant)

Thank you.

Ladies and gentlemen, if you have a question or a comment at this time, please press star one and one on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star one and one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Andy Sayer with William Blair. Your line is open.

Andy Sayer (Analyst)

Oh, great. Thanks for taking down 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 FG-3246. And so this has to do with some of the market dynamic changes after the Pluvicto approval based on the PSMA4 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 experienced population just to mitigate some of the risk associated with the highly heterogeneous population and maybe targeting a higher unmet medical need. That is 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. I'm just curious if you can comment on some of the recent FDA either correspondence or communication, especially with the roxadustat MDS opportunity. Third, I think this is something you have mentioned a couple of 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.

Thane Wettig (CEO)

Hey, thanks, Andy, for the comments and the questions. Appreciate that. Let me touch on the first one, and then I'll ask Dave to comment as well. As it relates to clinical development for 3246 and some market dynamic changes with Pluvicto'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-Pluvicto because, as I'm sure you can appreciate, Andy, you never have rapid adoption of an agent with a new indication. It usually takes time for clinicians to begin to adopt it.

If we would require all patients who would be entered into our phase II monotherapy trial to have been Pluvicto-experienced, we just think that that would create too much of an enrollment challenge. We will be allowing patients who have been treated with Pluvicto to be entered into our phase II monotherapy trial. Dave, anything to add to that?

David DeLucia (CFO)

Nothing to add there, Thane.

Thane Wettig (CEO)

Okay. In terms of kind 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 our recent interactions that we've had with the agency. Maybe I'll give you just a flavor of that. The first one was when we filed the IND for FG-3180, which is our PET imaging agent. Everything progressed exactly on schedule.

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 U.S. We had deactivated it once we got the license back from AstraZeneca 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. In terms of the type C meeting request that we filed, typically the FDA has 21 days or so to get back to the sponsor once a type C meeting request has been filed. 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 I've already heard back from the agency on the date that that type C meeting is set for. 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 is different than that. Finally, in terms of cash from AstraZeneca and potentially doing a feasibility study for FG-3246 in CRC, I think we're going to hold off on that for now. We continue to evaluate lifecycle opportunities. The most important thing that we need to do is get the phase II monotherapy trial started, and then we'll be evaluating other opportunities that we think make sense from a lifecycle perspective. Dave, anything to add to that?

David DeLucia (CFO)

No, I think you hit the nail on the head there, Thane. I think for us, obviously, we have identified colorectal cancer as a potential opportunity for FG-3246, given the expression of CD46 in those patients. To Thane's point, I think our goals for this calendar year are really to close the transaction for China, kick off our phase II studies, and really get the ball rolling around the development pathway for roxadustat in MDS as well. Great question, Andy, though.

Andy Sayer (Analyst)

Great. Thank you so much.

Thane Wettig (CEO)

Any other follow-up questions, Andy?

Andy Sayer (Analyst)

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

Thane Wettig (CEO)

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

Operator (participant)

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

Matthew Keller (Equity Research Associate)

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 II monotherapy study. 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 3180.

Thane Wettig (CEO)

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-3180 IND cleared. There was a point in time where we thought that the majority of the patients in the phase II monotherapy trial, so the 75 patients, the majority of them would be able to be treated with the PET biomarker in addition to the ADC.

Now, with the clearing of the IND, really, I would not call it a rate limiter, but what that allows us to do is to get an amendment in front of the sites that has 3180 as a part of the phase II monotherapy study so that all of the patients in the phase II trial will be able to be treated with the PET biomarker in advance of receiving the ADC. We are going through that process right now as we speak. Really, the rate limiter is the close of the China transaction so that we can move forward rapidly to then start the phase II monotherapy trial. In terms of the question around, Matt, you asked about the evolving landscape. What was that question again?

Matthew Keller (Equity Research Associate)

Kind of how would you view the commercial opportunity for 3180 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?

Thane Wettig (CEO)

No, it's a really important question. The phase II 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, 25 or 27 patients who have been treated with the PET imaging agent in the phase I/II, investigator-sponsored trial at UCSF that's in combination with enzalutamide. We've seen those scans. It's clear that the target lights up with the PSMA imaging agent. As you know, it uses the same YS5 antibody that is a part of the ADC. The scans look really clear.

The phase II trial will then tell us, do we continue to see the scans appropriately light up the lesions? What can we learn in terms of the assessment of the expression level of CD46 and the response to the ADC? 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 have looked at the PSMA PET space. Clearly, with the PSMA PET imaging agents from Lantheus and from Telix that generate well over $1.5 billion in annual revenue, there is a clear commercial opportunity.

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. Dave, please add to that.

David DeLucia (CFO)

Yeah. I think the one thing that I want to add around the phase II 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 FG-3180. The fact that we could have 75 patients in the phase II, we have the phase II portion of the combination therapy and the IST with UCSF.

Really, the more and more patients that we can get treated with FG-3180 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.

Matthew Keller (Equity Research Associate)

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

David DeLucia (CFO)

Thank you, Matt.

Operator (participant)

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.

Thane Wettig (CEO)

We 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 (participant)

Thank you, ladies and gentlemen. That concludes today's presentation. You may now disconnect and have a wonderful day.