FibroGen Q4 2024 Earnings Call Transcript

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March 17, 2025
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Operator

and welcome to the PhibroGen Fourth Quarter and Full Year twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. Now it's my pleasure to turn the call over to Joanne Geller.

Operator

The floor is yours.

Joanne Greller
Managing Director, IR Communications at LifeSci Advisors, LLC

Thank you, operator. Good afternoon, everyone. Thank you for joining today to discuss FibroGen's fourth quarter and full year twenty twenty four financial and business results. I'm Joanne Guller from LifeSci Advisors. Joining me on today's call are Thane Wedig, our Chief Executive Officer and David DeLucia, our Chief Financial Officer.

Joanne Greller
Managing Director, IR Communications at LifeSci Advisors, LLC

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 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 ks and Form 10 Q.

Joanne Greller
Managing Director, IR Communications at LifeSci Advisors, LLC

FibroGen does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information, future events or otherwise. A 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 Wedig. Thane?

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Thank you, Joanne. Good afternoon, everyone, and welcome to our fourth quarter and full year twenty twenty four 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 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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Then David Della Chia, 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 for our company. First, the announcement of the sale of FibroGen China to AstraZeneca for approximately $160,000,000 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 mid year. Second, advancing FG3246 and FG3180 in mCRPC remains a key priority.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

In the second quarter of twenty twenty four, we shared important data from two Phase one studies, highlighting the potential of FG3246 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 twenty twenty five 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 twenty twenty five to further explore this opportunity, which we are considering developing on our own or via a potential partnership. We believe the regulatory interaction with the FDA next quarter will provide important clarity on the best path forward with the aim of realizing additional value for roxadustat in an indication of significant unmet need.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Altogether, we are confident that our refined focus, multiple near term catalysts across both 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 U. S.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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. There remains a significant opportunity for new treatments that can extend survival for these men with a total addressable market of over $5,000,000,000 in annual sales. FG3246 could be this new treatment option. 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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

CD46 is upregulated during tumorigenesis and helps tumors abate complement dependent cytotoxicity. The CD46 epitope is highly expressed in mCRPC tissues with lower inter patient 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 over expressed following treatment with androgen signaling inhibitors. And the CD46 epitope is also overexpressed in colorectal cancer and other solid tumors. I would also like to highlight that CD46 was referenced at this year's ASCO GU meeting as one of the promising non PSMA targets in advanced prostate cancer due to its high sensitivity, stable expression and positive correlation to tumor burden.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Turning to Slide seven, FG3246 is a potential first in class ADC in development for metastatic castration resistant prostate cancer with a novel targeting antibody, YS5, which binds to the tumor selective epitope of CD46 and an MMAE payload. MMAE is a validated payload that is approved as 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 an uptake by CD46 positive tumor cells.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in the Phase three portion of the clinical development program, it would also enable differentiation of FG3246 in the prostate cancer treatment paradigm. In addition, FG3180 could represent an important commercial opportunity as a companion diagnostic to FG3246, similar to the existing PSMA PET agents. Slide eight recaps the top line results from the Phase one monotherapy study reported in the second quarter of twenty twenty four. 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, we observed a median radiographic progression free survival of eight point seven months, overall response rate of twenty percent confirmed by RECIST one point one and PSA reductions of greater than fifty percent in thirty six percent of the patients.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Adverse events were consistent with those observed with other MMAE based ADC therapies. The manuscript describing the Phase one monotherapy trial has been submitted and we anticipate publication soon. On Slide nine, we highlight the performance of FG3246 in its Phase one study versus other comparable early stage studies. As highlighted on the previous slide, the Phase one study of FG3246 demonstrated an RPFS of eight point seven months across a robust sample size of 40 heavily pretreated patients. While we cannot make direct comparisons to these trials due to differences in study design and prior prostate cancer treatments, we are encouraged by the RPFS results, which is a recognized regulatory endpoint in prostate cancer trials.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

On Slide 10, we highlight interim results of the Phase 1b portion of the ongoing investigator sponsored combination study with enzalutamide as reported at ASCO in June of twenty twenty four. 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 a Phase two dose of FG3246, the IST also demonstrated an encouraging preliminary estimate of 10.2 of radiographic progression free survival with PSA declines observed in seventy one percent of evaluable patients. The trial is continuing to enroll and is now set for top line results in the second half of twenty twenty four, which will also include data on CD46 expression on patients treated with FG3180, our PET biomarker during the Phase two 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 FG3246 versus the RPFS results from second line therapies in late stage trials.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Again, while we cannot make direct comparisons to these trials due to differences in study design and previous prostate cancer treatments, we are encouraged that FG3246 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 enroll 75 patients in the post ARSI pre chemo setting across three dose levels to determine the optimal dose for Phase three based on efficacy, safety and PK parameters. It is important to note that FG3180 will be an important 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 primary prophylaxis with G CSF, which is intended to mitigate adverse events associated with neutropenia commonly seen with MMAE payloads.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

The addition of G CSF may enable a better tolerated and more consistent treatment with the ADC, thereby extending duration of therapy and potentially enhancing efficacy of the ADC. We are planning an interim analysis in mid-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 the development strategy for FG3246 and FG3180, 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 eight point seven months of RPFS in 40 heavily pretreated biomarker unselected patients from the Phase one monotherapy study. The Phase two monotherapy trial is designed to select the optimal dose for Phase three based upon the benefit risk profile from this Phase two trial.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

We believe there are three factors that could drive RPFS even higher than was observed in the Phase one monotherapy trial. 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 and allow patients more consistent exposure to the ADC with fewer dose interruptions or adjustments. Third, enrolling healthier patients in earlier lines of therapy versus the median five prior lines of therapy in the Phase one trial. 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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

We are confident that our development pathway for FT3146 unlocks sequential or parallel registrational pathways as FC3246 will be evaluated in multiple lines of therapy, in monotherapy or in combination with an ARSI and in an all comers population or patients with high expression of CD46. Slide 14 shows the recent and upcoming catalyst for the FG3246 program. We have potential value inflection points in the near term with the anticipated initiation of the Phase two dose optimization study in mCRPC by mid-twenty twenty five and the top line results from the Phase two portion of the combination study with enzalutamide, which are expected in the second half of twenty twenty five. To summarize on Slide 15, FT3246 targets a novel epitope on prostate cancer cells with first in class potential. It has already demonstrated promising efficacy signals with an acceptable safety profile both in monotherapy and in combination settings.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

We are excited for the upcoming milestones and look forward to updating you on the program as the studies progress. Slide 17 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 18, in late twenty twenty three, subgroup analysis from the Phase III MATTERHORN study of roxadustat in patients with anemia of lower risk MDS were presented at the American Society of Hematology Annual Meeting.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

In patients with anemia associated with lower risk MDS who entered the trial with a higher transfusion burden, 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 19, 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 in The U.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

S. We look forward to our FDA meeting planned for the second quarter of twenty twenty five, which could pave the way for developing roxadustat for anemia associated with lower risk MDS, either on our own or through a partnership. With that, I will now turn the call over to Dave to discuss the company's financials. Dave?

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

Thank you, Same. 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.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

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 be approximately $75,000,000 totaling approximately $160,000,000 The value of FibroGen net cash in China includes FibroGen's portion of Folly Kong 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-twenty twenty five pending customary closing conditions, including regulatory review in China. The transaction does not include the IllumiNex 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 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 2027 to support U.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

S. Development initiatives. Now on to the company's financials for the fourth quarter and full year 2024. For the fourth quarter of twenty twenty four, total revenue was $3,100,000 compared to $3,600,000 for the same period in 2023. For full year 2024, total revenue was $29,600,000 compared to $46,800,000 in full year 2023.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

In the fourth quarter of twenty twenty four, we recorded $400,000 in development revenue compared to $2,600,000 during the fourth quarter of twenty twenty three. For full year 2024, we recorded $1,900,000 in development revenue compared to $18,400,000 during full year 2023. In the fourth quarter of twenty twenty four, we recorded $2,700,000 of drug product revenue compared to $1,100,000 during the fourth quarter of twenty twenty three. And for full year 2024, we recorded $27,700,000 of drug product revenue compared to $18,800,000 during full year 2023. Now for full year 2025, we expect total revenue to be between $4,000,000 and $8,000,000 Now moving down the income statement.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

Total operating costs and expenses for the fourth quarter of twenty twenty four were $10,300,000 compared to $66,300,000 for the fourth quarter of twenty twenty three, a decrease of $56,000,000 or 84% year over year. Total operating costs and expenses for full year 2024 were $180,000,000 compared to $369,500,000 for full year 2023, a decrease of $189,500,000 or 51% year over year. R and D expenses for the fourth quarter of twenty twenty four were $6,900,000 compared to $48,700,000 in the fourth quarter of twenty twenty three, a decrease of $41,800,000 or 86% year over year. R and D expenses for full year 2024 were $95,700,000 compared to $266,500,000 in full year 2023, a decrease of $170,800,000 or 64% year over year. SG and A expenses for the fourth quarter of twenty twenty four were $8,300,000 compared to $16,400,000 in the fourth quarter of twenty twenty three, a decrease of $8,100,000 or 49% year over year.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

SG and A expenses for full year 2024 were $49,300,000 compared to $86,500,000 in full year 2023, a decrease of $37,200,000 or 43% year over year. During the fourth quarter of twenty twenty four, we recorded a net loss from continuing operations of $8,700,000 or $0.08 net loss per basic and diluted share as compared to a net loss of $62,500,000 or $0.63 per basic and diluted share for the fourth quarter of twenty twenty three. During full year 2024, we recorded a net loss from continuing operations of $153,100,000 or $1.53 net loss per basic and diluted share as compared to a net loss of $323,000,000 or $3.32 per basic and diluted share for the full year 2023. As we have previously stated, we initiated a significant cost reduction plan in the second half of twenty twenty four to become laser focused on our FG3246, FG3180 and roxadustat assets. We have reduced our headcount by approximately 5% in The U.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

S. We have moved to a work virtual work environment after terminating our lease and substantially reduced our operating costs to maximize our cash runway. I am happy to announce that we have completed our restructuring efforts and the team will continue to work diligently to find operational efficiencies throughout 2025. Now for full year 2025, we expect 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. Now shifting towards cash.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

As of December 31, we reported $51,000,000 in cash, cash equivalents and accounts receivable in The U. S. And $121,100,000 in total consolidated cash, cash equivalents and accounts receivable 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 be cash flow positive on a consolidated basis in the first 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.

David DeLucia
David DeLucia
Vice President of Corporate FP&A and Investor Relations at FibroGen

Post the payoff of our MSCV term loan, we expect the company to have cash runway into 2027. Thank you. And I will now turn the call back over to Fane.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

With an extended cash runway into 2027, we plan to advance our exciting pipeline in the coming months, initiating the Phase II monotherapy study for FG3146 and FG3180 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 two portion of the IST for FG3246 in combination with enzalutamide in the second half of twenty twenty five as well as interim results from the Phase two monotherapy study in mid-twenty twenty six. 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 two ready CD46 targeting ADC and our potential Phase three 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 and A.

Operator

Thank you so much. Our first question comes from the line of Andy Xie with William Blair. Please go ahead.

Andy Hsieh
Research Analyst at William Blair

Thanks for taking our questions and congratulations on that transformative deal. I got two quick ones for the ADC franchise. So you mentioned about the futility analysis that's coming up in mid year twenty twenty six. 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, it would be would the passing of that fragility analysis be a very good sign from an efficacy standpoint?

Andy Hsieh
Research Analyst at William Blair

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 radioligand a patient who had experience with radioligand be eligible for the trial?

Andy Hsieh
Research Analyst at William Blair

On the clinical trial that website it only says no radioligand prior basically within the prior twenty eight days. And I have a follow-up on MBS. Thank you.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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 ARS I 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 03/1946.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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 ARSIs 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, close to ARSI, pre chemo, that's exactly where the trial is designed to recruit patients.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

And we are allowing patients who have been treated with Pluvicto previously, just not within the prior twenty eight 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 II 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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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.

Andy Hsieh
Research Analyst at William Blair

Okay. That's very helpful. And for MDS, so I'm curious about the ability to leverage some of the safety database from rostadustat's 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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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 modusplastic syndrome, that patient population is very different than the patient population of anemia associated with chronic kidney disease.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

We think that just based upon not only trials that have been done for luspatercept and Imetelstat, but also a recent Phase three trial that just started. We think the trial size will be roughly about two hundred 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 two hundred patients. And so 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.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

So not only looking at transfusion independence in the first twenty eight weeks of the trial, then looking at the same efficacy parameter over fifty two weeks, but then some safety follow-up that would extend beyond fifty two weeks as well.

Andy Hsieh
Research Analyst at William Blair

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

Operator

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

Matthew Keller
Equity Research Associate at H.C. Wainwright & Co., LLC

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?

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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

Matthew Keller
Equity Research Associate at H.C. Wainwright & Co., LLC

Oh, yes. No, it's okay. I was wondering with your strong balance sheet and the cost saving measures that you're leaving open a 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?

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Yes. Thanks for the question. Not at this time. We've got a laser focus as we stated on the call of advancing FG3246 and FG3180 into the Phase II monotherapy trial, waiting for the results of the FG3246 trial in combination with enzalutamide and then seeking FDA feedback on potential to take roxadustat into further development and lower risk MDS anemia. And so that's where we're going to stay focused.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

We think if we try 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.

Matthew Keller
Equity Research Associate at H.C. Wainwright & Co., LLC

Yes. No, no, totally makes sense. I guess the second one, if I may, switching gears to Rockwood and UniMDS. 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?

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Yes, it's a great question. I think our wish list would be that based upon the previous Phase twothree 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, one point five two and two point five mgkg of roxadustat, eight patients in each one of those three dose cohorts. Two point five mg per kilogram was chosen to be the dose that was then taken in to the Phase III 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 three point five milligrams per kilogram. So our preferred response from 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 II, Phase III trial and that we would be able to go in right with a two point five milligram per kilogram dose and then not have to do additional dose finding work as part of another Phase twothree trial.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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 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 MATTERWAN trial a few years ago.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

You've got Luspatercept approved and you've had METALSTAT 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 secondthird 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.

Matthew Keller
Equity Research Associate at H.C. Wainwright & Co., LLC

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

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

Yes, thanks Matt.

Operator

Thank you. And this concludes Q and A session. I will turn it back to Tim Wittek for his final remarks.

Thane Wettig
Thane Wettig
CEO & Director at FibroGen

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.

Operator

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

Executives
    • Thane Wettig
      Thane Wettig
      CEO & Director
    • David DeLucia
      David DeLucia
      Vice President of Corporate FP&A and Investor Relations
Analysts
    • Joanne Greller
      Managing Director, IR Communications at LifeSci Advisors, LLC
    • Andy Hsieh
      Research Analyst at William Blair
    • Matthew Keller
      Equity Research Associate at H.C. Wainwright & Co., LLC
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Earnings Conference Call
FibroGen Q4 2024
00:00 / 00:00

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