Earnings call transcript: FibroGen Q2 2025 revenue falls short, stock drops

FibroGen Inc., with a market capitalization of approximately $34 million, reported its Q2 2025 earnings on August 11, revealing a significant earnings miss with an EPS of -$1.88 compared to the forecast of -$0.09. The company’s revenue also fell short of expectations, coming in at $1.3 million against a forecast of $2.88 million. Following the announcement, FibroGen’s stock price fell by 3.9% to close at $8.71. According to InvestingPro analysis, the company appears overvalued at current levels, with 11 additional key insights available to subscribers.

Key Takeaways

• FibroGen’s EPS and revenue significantly missed forecasts.
• The company reported a net loss from continuing operations of $13.7 million.
• FibroGen’s stock price dropped by 3.9% post-earnings announcement.
• Operating costs decreased by 72% year-over-year.
• The company is advancing its clinical development programs.

Company Performance

FibroGen’s overall performance in Q2 2025 was marked by a substantial earnings miss, with a net loss from continuing operations of $13.7 million, or $3.38 per share. Despite this, the company showed progress in reducing operating costs, which decreased by 72% year-over-year, and R&D expenses, which went down by 82%. The company also managed to generate $13.7 million in positive cash flow during the quarter.

Financial Highlights

• Revenue: $1.3 million, up from $1 million in Q2 2024.
• Earnings per share: -$1.88, compared to -$0.09 forecast.
• Operating costs: Decreased 72% year-over-year to $13.4 million.
• R&D expenses: Decreased 82% year-over-year to $5.9 million.

Earnings vs. Forecast

FibroGen’s Q2 2025 EPS of -$1.88 was a substantial miss compared to the forecast of -$0.09, resulting in a negative surprise of 1988.89%. Revenue also fell short by 53.13%, with actual figures at $1.3 million versus the expected $2.88 million. This performance marks a significant deviation from forecasts, raising concerns about the company’s near-term financial trajectory.

Market Reaction

Following the earnings announcement, FibroGen’s stock dropped by 3.9%, closing at $8.71. This movement places the stock closer to its 52-week low of $4.50, reflecting investor concerns over the earnings miss and revenue shortfall. Despite recent challenges, InvestingPro data shows the stock has achieved a notable 20.8% return over the past week and maintains a relatively moderate beta of 0.77. The stock’s decline contrasts with broader market trends, indicating specific investor apprehension towards FibroGen’s financial outlook. Discover more detailed analysis and 1,400+ comprehensive Pro Research Reports available on InvestingPro.

Outlook & Guidance

Looking ahead, FibroGen has provided a full-year 2025 revenue guidance of $6 million to $8 million. The company is focused on advancing its clinical development programs, including initiating a Phase II trial for its prostate cancer treatment, FG3246, in Q3 2025. Additionally, the company has extended its cash runway to 2028, providing a buffer for ongoing and future projects.

Executive Commentary

CEO Thane Wedi expressed optimism about the company’s clinical programs, stating, "We are extremely excited about our clinical development programs." CFO David Biluchia highlighted financial strategies, noting, "These increases in expected net cash represent a meaningful outcome for shareholders." The executive team remains focused on reducing expenses and advancing key projects.

Risks and Challenges

• Revenue Miss: The significant revenue shortfall could impact investor confidence and future financing opportunities.
• Clinical Trial Risks: Upcoming trials for FG3246 and roxadustat carry inherent risks, including potential delays or failures.
• Competitive Market: The prostate cancer and anemia treatment markets are highly competitive, posing challenges for market penetration.
• Financial Sustainability: Despite a positive cash flow, maintaining financial health amidst ongoing losses remains a challenge.
• Regulatory Hurdles: The company’s reliance on successful regulatory approvals for its pipeline products adds an element of uncertainty.

Q&A

During the earnings call, analysts focused on the design of potential Phase III trials and the intellectual property landscape for roxadustat. Executives confirmed a placebo-controlled trial design, underscoring their commitment to rigorous clinical standards.

Full transcript - FibroGen Inc (FGEN) Q2 2025:

Conference Operator: Thank you for standing by and welcome to the FibroGen Second Quarter twenty twenty five 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. Star one one again. As a reminder, today’s program is being recorded.

And now I’d like to introduce your host for today’s program, Gaye Sheamus from LifeSci Advisors. Please go ahead.

Gaye Sheamus, LifeSci Advisors Representative, LifeSci Advisors: Thank you, Jonathan. Good afternoon, everyone. Thank you for joining us today to discuss FibroGen’s second quarter twenty twenty five financial and business results. I’m Gaia Shamis with LifeSci Advisors. Joining me on today’s call are Thane Wedi, chief executive officer, David Biluchia, chief financial officer, and Carol Gedham, product team lead for FG 3,246, FG 3,180, and roxadustat.

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, collaboration with AstraZeneca and Astellas financial guidance the initiation, enrollment, design, conduct and results of clinical trials regulatory strategies and potential regulatory results 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.

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 updates and a webcast of today’s conference call can be found on the Investors section of FibroGen website at www.fibrogen.com. With that, I would like to turn the call over to the CEO, Stain Wedig. Stain?

Thane Wedi, Chief Executive Officer, FibroGen: Thank you, Gaye. Good afternoon, everyone, and welcome to our second quarter twenty twenty five earnings call. On today’s call, I will provide an update on our ongoing efforts to transform FibroGen with a focus on our three main priorities: the sale of FibroGen China the advancement of our lead asset, FG3246, a potential first in class antibody drug conjugate targeting CD46 and its companion PET imaging agent in metastatic castration resistant prostate cancer and the crystallization of the pathway forward for roxadustat for the treatment of anemia due to lower risk myelodysplastic syndromes. 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 update you on our near term strategic priorities, starting with 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 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 upon the close of the transaction. During our Q1 earnings call in May, we increased the guidance of our expected net cash in China by $25,000,000 We are pleased to share that we now expect the total consideration to be approximately $210,000,000 which is a $50,000,000 increase from our initial guidance and a $25,000,000 increase from our Q1 guidance due to greater than expected net cash in China at closing. Importantly, this increase in cash further extends the company’s cash runway into 2028. The review by the China State Administration of market regulation is ongoing, and we expect the transaction to be approved and closed this quarter.

Second, we remain hyper focused on advancing FG3246 and FG3180 in metastatic castration resistant prostate cancer, or mCRPC, where we continue to progress trial initiation activities and are on track to begin the Phase II monotherapy trial of FG3246 and FG3180 in the third quarter this year consistent with the timing of the sale of FibroGen China. Third, we had a positive Type C meeting with the FDA in mid July and have received formal minutes from the agency. We have alignment on a number of the key elements of a pivotal phase three trial for roxadustat for the treatment of anemia associated with lower risk mild dysplastic syndromes in patients with high transfusion burden. The Type C meeting request was based on the results of a post hoc subgroup analysis from the Matterhorn Phase III trial where roxadustat demonstrated a meaningful effect in patients with a high transfusion burden at baseline. This group of patients is in need of and would benefit from a convenient and durable treatment.

We are working diligently to finalize the study design for the phase three trial and plan to submit the final protocol to the FDA in the fourth quarter of this year. Ultimately, we remain confident that our refined focus, simplified capital structure, and multiple near term catalysts across both clinical programs position us to create value for both patients and shareholders in the near term. I will now provide an overview of our FG3246 and FG3180 programs in MCRPC. Slide five highlights the high unmet need in late stage prostate cancer. Approximately two hundred and ninety thousand men are 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. There remains a significant opportunity for new treatments that can extend survival for these men. We estimate this translates into a total addressable market of over $5,000,000,000 in annual sales in The US alone. FG3246 could be this new treatment option. On slide six, we highlight the novelty of our target, a tumor selective epitope of CD46, which has several distinguishing features.

It is upregulated during tumorigenesis and helps tumors evade complement dependent cytotoxicity. Importantly, the expression of CD46 is also 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. As you can see in the graph on the right, CD46 is highly expressed in mCRPC tissues with lower interpatient variability and higher median expression compared with PSMA, making it an attractive therapeutic target. Turning to slide seven. FT3246 is our potential first in class ADC in development for metastatic castration resistant prostate cancer.

The ADC combines the YS5 antibody with an MMAE payload to specifically target the tumor selective epitope of CD46. FG3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development, most of which target PSMA. The 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 a future phase three trial, but 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. The study included 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 mean radiographic progression free survival of eight point seven months was observed. In addition, there an overall response rate of twenty percent confirmed by RECIST one point one, and PSA reductions of greater than fifty percent were observed in thirty six percent of patients.

Adverse events were consistent with those observed with other MMAE based ADC therapies. The full results of the study were published earlier this year in the Journal of Clinical Oncology and altogether in the Phase I monotherapy study, FG-three thousand two hundred forty six showed what we believe to be compelling clinical activity. Putting the results into context on slide nine, when we look across the RPFS results, a recognized regulatory endpoint in prostate cancer treatment of FG3246 in its phase one study versus other comparable early stage studies, 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 these RPFS results. 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 17 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, this IST also demonstrated an encouraging ten point two months of radiographic progression free survival with PSA declines observed in seventy one percent of evaluable patients. We remain on track to report the phase two top line results in the 2025, which will also include data on CD46 expression in patients treated with FG3180, our PET biomarker, during the Phase II portion of the IST. On slide 11, there is a cross trial 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. While again, we cannot make direct comparisons to these trials due to differences in study design and previous prostate cancer treatments, we believe FTU-three thousand two hundred forty six shows competitive RPFS results in the monotherapy and the combination therapy settings.

Based on these results, slide 12 highlights the Phase II monotherapy dose optimization trial design that will commence in the third quarter this year. We plan 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 the 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. One other important design element is the use of G CSF as primary prophylaxis to mitigate against grade three or greater neutropenia commonly seen with MMAE payloads and experienced in the phase one monotherapy trial. The addition of G CSF is designed to reduce dose reductions and interruptions and may enable a better tolerated and more consistent treatment with the ADC in the Phase two.

An interim analysis of the Phase II trial is planned for the 2026 and will include efficacy, safety, PK, and exposure response data that we will report as they become available given the open label design. Slide 13 articulates why we’re so optimistic about the potential for our Phase II study to further on the efficacy results created in our Phase I study. We believe there are three factors that could drive an improved RPS relative to the eight point seven months that was observed in the Phase I monotherapy trial. First, leveraging the preliminary evidence of an exposure response relationship from the Phase I dose escalation and expansion study, thereby enabling the focus of the Phase II study on three of the highest doses from the phase one trial. Second, utilizing primary prophylaxis, the G CSF, to potentially mitigate against neutropenia, which could enable more consistent exposure to the ADC with fewer dose interruptions or adjustments early in the course of treatment.

This could consequently extend duration of therapy and potentially enhance the efficacy of the ADC. Third, enrolling healthier patients in earlier lines of therapy versus the median by prior lines of therapy in the Phase I trial. Together, we believe that these design elements have the potential to improve upon the Phase I results and achieve an RPFS of ten months or greater, which we believe is the benchmark for commercial competitiveness. Slide 14 depicts our long term development strategy for FG3246 and FG3180, which in our view provides important optionality in prostate cancer. We have a robust phase two monotherapy trial in the post ARSI pre chemo setting in mCRPC to further build upon the compelling eight point seven months of RPFS seen in the phase one study.

In addition, the phase two 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 registrational 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 highlights the recent and upcoming catalysts for the FG3246 and FG3180 program. We are on track to initiate the Phase II monotherapy trial this quarter in which all patients will be treated with FG3180 to enable assessment of both its diagnostic performance and the potential correlation between CD46 expression and response to FG3246. Additionally, in the fourth quarter, we expect the top line results from the Phase II IST of FG3246 and enzalutamide, as well as data from FG3180.

As I previously mentioned, we expect to report interim results from the Phase II monotherapy trial in the 2026. To summarize, on slide 16, FG3246 targets a novel epitope on prostate cancer cells with potential first in class, given that there are no other CD46 targeted projects in clinical development. Targeting CD46 with FG3246 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. Current treatments are only effective in approximately fifty percent of patients with no oral options currently on the market or in late stage development. A significant opportunity for roxadustat exists to offer a potential new treatment that is durable with convenient oral administration to patients in the second line and beyond setting. Moving to slide 19, I would like to elaborate on the substantial opportunity that exists in lower risk MDS. Based on other lower risk MDS development programs, we believe the indication would support an orphan drug designation, which, if approved, would provide us with seven years of data exclusivity in The US.

This potential exclusivity, combined with an attractive market opportunity and efficient commercial model, represents a substantial economic opportunity. Taken together, we believe these market dynamics could potentially translate into a substantial commercial opportunity for roxadustat in anemia associated with lower risk MDS. Moving to slide 20. I would like to highlight data from a post hoc analysis in a subgroup of patients with anemia of lower risk MDS who entered the phase three MATERHORN study of roxadustat with a high transfusion burden. In this analysis, we used the international working group definition for high transfusion burden of four or more RBC units in two consecutive eight week periods.

This definition is widely accepted by the scientific community and will also be used as the inclusion criteria in our proposed phase three trial. As you can see, roxadustat showed a meaningful difference with thirty six percent of patients on roxadustat achieving transfusion independence for greater than or equal to fifty six days versus only seven percent in the placebo group, with a nominal p value of 0.041. These results are highly similar to the pivotal trial results for two recently approved therapies for anemia associated with lower risk MDS. As a reminder, in the post hoc analysis that was previously presented at ASH in late twenty twenty three and which we have highlighted on previous calls, higher transfusion burden was defined as two or more units in four weeks. In that subgroup, thirty six point one percent of patients on roxadustat achieved transfusion independence versus eleven point five percent on placebo.

The consistency of results from both of these post hoc analyses give us confidence that roxadustat can demonstrate a meaningful treatment effect in a Phase III trial focused on the high transfusion burden population. We had a positive Type C meeting with the FDA in July and have received the formal meeting minutes from the agency. We have aligned on important design elements for the pivotal Phase III trial summarized on slide 21. As I alluded to in the previous slide, the study population will include patients requiring four or more RBC units in two consecutive eight week periods prior to randomization who are refractory to and tolerant to or ineligible for prior erythropoiesis stimulating agents. We also agreed with the FDA on the dose regimen, including the starting dose of two point five milligrams per kilogram and on the management of potential thrombotic risk through trial eligibility, dose modification, and discontinuation criteria.

We are currently evaluating eight week and sixteen week RBC transfusion independence as the potential primary endpoint for the trial. Based on the feedback we received from the FDA, the team is actively working on finalizing the pivotal Phase III study design, and we anticipate submitting the final protocol for the Phase III trial evaluating roxadustat for patients with lower risk MDS and anemia with high transfusion burden to the FDA in the 2025. In the meantime, we continue to explore our clinical development options, which include maintaining roxadustat as a wholly owned asset and running the Phase III trial on our own or partnering the program. We have initiated outreach and will ultimately choose the path that we believe is in the best interest of shareholders. With that, I will now turn the call over to Dave to discuss the company’s financials.

Dave?

David Biluchia, Chief Financial Officer, FibroGen: Thank you, Thane. I will first review the updated FibroGen China transaction details and then provide the company’s financial performance for the 2025. As a reminder, our China operations are reflected as discontinued operations throughout our financials. We will continue to report our China operations and discontinued operations moving forward. On slide 23, we highlight the summary of the key financial terms of the transaction.

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 $125,000,000 with the total consideration now expected to be approximately $210,000,000 This is a $50,000,000 increase from our initial net cash guidance in February and a $25,000,000 increase from our updated guidance in May. As a reminder, the value of FibroGen net cash in China includes FibroGen’s portion of Falicon net cash, which is the joint distribution entity owned by FibroGen and AstraZeneca. Given the company’s current market capitalization of approximately $40,000,000 we believe these increases in expected net cash received upon the close of the transaction represent a meaningful outcome for shareholders and further extends the company’s cash runway all the way into 2028. Importantly, FibroGen will continue to accrue cash generated in China until the closing of the transaction. This truly transformative transaction allows us to pay down our senior term loan facility with MSTV, provides full access to our cash in China and extends the company’s runway into 2028 to support U.

S. Development initiatives. Now on to the company’s financials for the second quarter. For the 2025, total revenue was $1,300,000 compared to $1,000,000 for the same period in 2024. For full year 2025, we are raising the lower end of our revenue guidance to $6,000,000 and expect total revenues to be between $6,000,000 and $8,000,000 Now, moving down the income statement.

Total operating costs and expenses for the 2025 were $13,400,000 compared to $47,400,000 for the 2024, a decrease of $34,000,000 or 72% year over year. R and D expenses for the 2025 were $5,900,000 compared to $32,400,000 in the 2024, a decrease of $26,500,000 or 82% year over year. SG and A expenses for the 2025 were $7,100,000 compared to $14,900,000 in the 2024, a decrease of $7,800,000 or 53% year over year. During the 2025, we recorded a net loss from continuing operations of $13,700,000 or $3.38 net loss per basic and diluted share as compared to a net loss of $47,100,000 or $11.79 per basic and diluted share for the 2024. For full year 2025, we are updating our guidance for our total operating costs and expenses, including stock based compensation, to be between $65,000,000 and $75,000,000 which represents a $5,000,000 reduction at the midpoint from our previous guidance.

This also represents a 61% reduction from full year 2024. Now shifting towards cash. As of June 30, we reported $23,500,000 in cash, cash equivalents and accounts receivable in The US and $142,100,000 in total consolidated cash, cash equivalents and accounts receivable when including balances in China. The company was cash flow positive in the second quarter of twenty twenty five, generating a total of $13,700,000 in cash flow on a total consolidated basis. 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 through the expected close of the China sale transaction in the 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 $80,000,000 This includes the $75,000,000 principal balance, accrued and unpaid interest, and an applicable prepayment penalty. Post the payoff of our MSCD term loan, we expect the company to have cash runway into 2028. Thank you. And now, I will turn the call back over to Fane.

Thane Wedi, Chief Executive Officer, FibroGen: Thank you, Dave. In summary, we’re extremely excited about our clinical development programs for FG-three thousand two hundred forty six and roxadustat. We are looking forward to the close of the FibroGen China sale in the near future and continue to advance our U. S. Development initiatives with our strong balance sheet and extended cash runway into 2028.

We have multiple near term catalysts across our exciting pipeline. First, the upcoming initiation of the Phase II monotherapy study for FG3246, our potential first in class ADC and FG3180, its companion PET imaging agent, NMCRPC. Second, we are on track to report top line results from the Phase II portion of the IST for FT3246 in combination with enzalutamide in the fourth quarter this year. Third, with the positive feedback received from the FDA, we now have a path forward to advance roxadustat for the treatment of anemia associated with lower risk MDS. We are finalizing the pivotal Phase III protocol and anticipate submitting it in the 2025.

Together, these events are setting the stage for an exciting 2025 and beyond. 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.

Conference Operator: Certainly. And our first question for today comes from the line of Angie Hsieh from William Blair. Your question please.

Angie Hsieh, Analyst, William Blair: Great. Congratulations on all the regulatory and business development progress and thanks for taking our questions. So, beginning with FG3246, I’m curious about your take on this just because speaking with some of the KOLs, there’s an emerging desire to have docetaxel included in the control arm for Phase III. I know that’s far away, but I’m curious if it’s important as you develop this asset to have some data in combination with dose c taxa just as a preparation for a phase three program in the future. And then the second part is mostly about the Q4 update.

I’m just curious if you have any clinical parameters that you’re particularly focused on and the bar for success so they can be informative to 03/1946 clinical profile. And I have a couple of follow ups for Roxette as well.

Thane Wedi, Chief Executive Officer, FibroGen: Great, Andy. Thanks for the questions. Clearly, question about Phase III, we’re getting a little bit ahead of ourselves, I think. We have done some thinking about it, and I’m going to ask Carol to maybe share some initial thoughts that we have. But again, I want to caveat by saying that we’ve got a lot of time and space between where we are now and ultimately what a phase III design could look like.

But Carol, be interested in any thoughts you might have.

Carol Gedham, Product Team Lead, FibroGen: Thank you, Andy, for the question. As you said, this is an evolving field, and we’re certainly observing what’s happening. And at the right point in time, we need to make that decision as to what the right control arm is for our Phase III. We certainly recognize that it might include a physician’s choice control arm, including an ARSI switch and potentially docetaxel. And maybe there will be others.

So an area and field to definitely keep an eye on.

Thane Wedi, Chief Executive Officer, FibroGen: Thanks, Carol. And then Andy, in terms of the Q4 update on the combo trial within zolutamide, I think what we’re going to be interested in seeing is, the more mature RPFS data. So the ten point two months that we previously disclosed was in seventeen patients in the escalation phase. There’s going to be an additional 24 patients from the expansion phase at two point one milligrams per kilogram, plus enzalutamide. And so, I think we’re going be interested in seeing if that RPFS number kind of sticks in there.

And, you know, we were really excited about ten point two months previously. And if we see something similar across the broader population of forty one patients, in addition to what we’ve seen across the seventeen patients in the escalation phase, I think we’d be pretty satisfied with that. Carol, I don’t know if you have any additional comments.

Carol Gedham, Product Team Lead, FibroGen: No additional comments.

Conference Operator: Okay. Thanks.

Angie Hsieh, Analyst, William Blair: Great. So moving on to Vraxa, you kind of lay out the interesting commercial opportunity here and also the seven year exclusivity from the orphan drug designation. And so I’m curious about your most updated thoughts on the IP landscape for Raxa, matter of composition and other IP that can be layered on to give us an estimate about potential market exclusivity here in The United States. So that’s number one. And number two, since you got the minutes back, I am curious about kind of a plausible control arm in the ESA treated population.

Should we be thinking about maybe like a placebo control or perhaps an active control? And then, you know, if you can, maybe share with us some of the statistical assumptions that you have. Is it just based on the Matterhorn subset analysis or baking in some sort of margins for error? Thank you.

Thane Wedi, Chief Executive Officer, FibroGen: No, thanks Andy. And the first question related to exclusivity, think what we would, you know, want to be thinking about is, know, a minimum of seven years of exclusivity with the orphan drug designation. You know, we do have other opportunities to extend that, with various forms of IP. So I think we would be looking at a minimum of of seven years. We’re not gonna comment any further at this point in time.

And we’ll say that, obviously, if we get into confidential discussions with potential partners as well. In terms of the phase III design and the plausible control arm, This will be a, placebo controlled trial. That’s been agreed to with the agency. And so as as we articulated in the in the comments, this is in the, post ESA settings. So these are patients who are refractory refractory to ineligible for or intolerant to ESAs, and then they will be randomized, either to roxadustat two point five milligram per kilogram starting dose or to placebo.

We’re not going to comment right now on any of statistical assumptions. We do believe that the trial will be approximately 200 patients. That’s pretty consistent with both the IMerge and the MEDALIST trials for MEDALIST stat and for luspatercept. The luspatercept trial, I believe, was two twenty nine patients. The emetostat was, I think, 178 patients.

And so we’re thinking kind of right in the midpoint or close to the midpoint of those two trials. But we’re not going to comment anymore in terms of statistical considerations or assumptions. Carol, anything else to add to that?

Carol Gedham, Product Team Lead, FibroGen: Just the fact that I think with those inclusionexclusion criteria that Tain outlined, we’re positioning roxadustat in the second line to third line setting. So, it’s in ESA failure patients and we allow trial with Luspatercept. And so, it’s a second line, third line setting where it will be a placebo controlled trial.

Angie Hsieh, Analyst, William Blair: Got it. That’s helpful. Thank you so much.

Thane Wedi, Chief Executive Officer, FibroGen: Any additional questions, Andy?

Angie Hsieh, Analyst, William Blair: That’s it for us. Thank you so much.

Thane Wedi, Chief Executive Officer, FibroGen: I appreciate it.

Matthew Keller, Analyst, H.C. Wainwright: Thank you.

Conference Operator: And our next question comes from the line of Matthew Keller from H. C. Wainwright. Your question please.

Matthew Keller, Analyst, H.C. Wainwright: Hey, good afternoon everyone and thanks for taking our question. I’ll join the chorus of congrats on the quarter and the regulatory update. But my question is, you kind of touched on this subject, but following the publication of that 3246 Phase I data, I’m kind of curious what kind of additional feedback you might have received since then, particularly from the physician community around those results?

Thane Wedi, Chief Executive Officer, FibroGen: Yeah, thanks, Matt, for the question. We haven’t, I would say, engaged deeply in the broad physician community. Clearly, we have a close set of advisors that are very attuned to ongoing developments, in the metastatic castration resistant prostate cancer space. They’re encouraged, by the data. I think another data point that was in, that JCO publication that we don’t necessarily talk a lot about, but it’s clearly there, is that there seemed to be a dose response, given the fact that, all of the five, ORRs were, achieved in patients who were on at least two point seven milligrams per kilogram.

But people continue to be excited about the program. And we’ve had conversations, obviously, with clinical sites. We’ve got the sites already selected. And so I think what we are hearing from the clinical sites is in this post ARSI pre chemo setting, there is a clear place for an opportunity like FG3246 with a companion PET imaging agent, not only because of the unmet need in that space, but because it offers a non PSMA opportunity. And that’s what we hear from a lot of these clinical sites as well, is that they’re excited about the target and they’re excited about the fact that there’s now a non PSMA approach that can potentially help patients.

Carol, you’ve got a good pulse on this as well. So any additional comments from you would be appreciated.

Carol Gedham, Product Team Lead, FibroGen: Just echoing the fact that we’re getting very good feedback from sites in our phase two preparation efforts in terms of that being an area of unmet need where the ADC can really fit. Thank you.

Matthew Keller, Analyst, H.C. Wainwright: Yeah, great. Very helpful. Excuse me. Thank you very much.

Thane Wedi, Chief Executive Officer, FibroGen: Other questions, Matt?

Matthew Keller, Analyst, H.C. Wainwright: No, that’s it from us as well. Okay.

Conference Operator: Thank you. This does conclude the question and answer session of today’s program. I’d like to hand the program to Dane Wedding for any further remarks.

Thane Wedi, Chief Executive Officer, FibroGen: Yes. Thank you, John. And we appreciate everybody joining us for today’s second quarter earnings call and for your continued interest in FibroGen. Enjoy the rest of your day. Thanks, everybody.

Conference Operator: Thank you, ladies and gentlemen, for your participation in today’s conference. This does conclude the program. You may now disconnect. Good day.

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