Q3 2025 FibroGen Inc Earnings Call

After the speaker's presentation, there will be a question and answer session.

I ask the question during the session you will need to press star one on your telephone you would then her automated message advising your hand is raised to withdraw your question. Please press star one again.

I would now like to hand, the conference over to Guy you Seamus you may begin.

Thank you Samantha good afternoon, everyone and thank you for joining us today to discuss <unk> first quarter 2025 financial and business results I'm guys. Jamie from lifestyle Advisors. Joining me on today's call are <unk>, Chief Executive Officer, and David <unk>, Chief Financial Officer.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone.

Thane Wettig: Moving to slide 16, I would like to briefly highlight the data from a post-hoc analysis in a subgroup of patients with anemia of lower risk MDS who entered the phase three Matterhorn study of roxadustat with a high transfusion burden. In this analysis, using the International Working Group definition for high transfusion burden of four or more RBC units in two consecutive eight-week periods, roxadustat showed a meaningful treatment effect, with 36% of patients achieving transfusion independence for greater than or equal to eight weeks versus only 7% in the placebo group, with a nominal P value of 0.041. These results are highly similar to the pivotal trial results for the two most recently approved therapies for anemia associated with lower risk MDS.

Sure.

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 fiber Jen.

Speaker #1: You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to Gaia Shamus.

Such statements May include but are not limited to collaborations with Astrazeneca and Astellas financial guidance, the initiation enrollment design conduct and results of clinical trials.

Speaker #1: You may begin.

Speaker #2: Thank you, Joanne. Good afternoon, everyone, and thank you for joining us today to discuss FIBROGEN's third quarter, 2025 financial and business results. I'm Gaia Shamus from Lightside Advisors.

Military 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.

Speaker #2: Joining me on today's call are Thane Wettig, Chief Executive Officer, and David DeLucia, Chief Financial Officer. Following the prepared remarks, we will open the call to your questions.

Each forward looking statement is subject to risks and uncertainty uncertainties that could cause actual results and events to differ materially from those projected in that statement EMR complete description of these and other materials risks can be found in fiber gen filing with the SEC, including our most recent form.

Speaker #2: 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 collaborations 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.

Thane Wettig: Based on these results, as we turn to slide 17, our target indication for roxadustat is in patients with lower MDS and high transfusion burden who are refractory to or ineligible for prior ESA treatment, where we believe roxadustat has the potential to elevate the standard of care in the second line and beyond treatment settings. In July, we had a positive type C meeting with the FDA, where we aligned on key design elements and a regulatory path forward for roxadustat. The potential pivotal phase three trial, summarized on slide 18, will include patients requiring four or more RBC units in two consecutive eight-week periods prior to randomization, who, as I alluded to on the previous slide, are refractory to, intolerant to, or ineligible for prior ESAs.

<unk> 10-K and Form 10-Q.

<unk> does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information or future events or otherwise the press release reporting the company's financial results and business update and a webcast of today's conference call can be found on the investors section of fiber.

Speaker #2: Each forward-looking statement is subject to risks and aren't centered uncertainties that could cause actual results and events to differ materially from those projected in that statement.

<unk> web site at Www Dot fiber Gen Dot com.

Speaker #2: A more complete description of these and other materials' risks can be found in FIBROGEN's filing with the SEC, including our most recent Form 10-K and Form 10-Q.

With that I would like to turn the call over to CEO of Spain, whether Spain.

Thank you <unk> good afternoon, everyone and welcome to our third quarter 2025 earnings call.

Speaker #2: 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.

Thane Wettig: We also agreed with the FDA on important dosing elements, including the starting dose of 2.5mg per kg, and on the management of potential thrombotic risk, which could include trial eligibility, dose modification, and discontinuation criteria. We are currently evaluating eight-week and 16-week RBC transfusion independence as the primary endpoint for the trial. The team continues to work diligently on finalizing the phase three protocol, and we remain on course for submission in the fourth quarter of this year. We are currently exploring our clinical development options, which include maintaining roxadustat as a wholly owned asset and running the phase three trial on our own, or partnering the program. We are actively engaged in this process, and will ultimately choose the path that we believe is in the best interest of shareholders.

On today's call I will provide an update on our ongoing efforts with a focus on our three main priorities. The completion of the sale of fiber in China. The continued progress with our lead asset <unk> <unk> $32 46, a potential first in class antibody drug conjugate targeting CD 46, and its companion pet imaging agent.

Metastatic castration resistant prostate cancer and the path forward for Roger do staff as a potential treatment for anemia due to lower risk modest classic syndromes.

Speaker #2: With that, I would like to turn the call over to CEO Thane Wettig. Thane.

Speaker #3: Thank you, Gaia. Good afternoon, everyone, and welcome to our third quarter, 2025 earnings call. On today's call, I will provide an update on our ongoing efforts with a focus on our three main priorities: the completion of the sale of FIBROGEN China, the continued progress with our lead asset, FG 3246, a potential first-in-class antibody drug conjugate targeting CD46, and its companion PET imaging agent, and metastatic castration-resistant prostate cancer.

And then David <unk>, our CFO will review the financials after which we will open the call for your questions.

On slide three I would like to start with the sale of fibers in China to Astrazeneca that we recently completed for approximately $220 million. This was a truly transformative transaction that provided us with the most efficient means to access the company's cash held in China, extending our cash runway into 2028.

Thane Wettig: To summarize, on slide 19, there is significant opportunity for roxadustat in anemia associated with lower risk MDS, with no other oral treatments currently available or in late-stage development. Furthermore, we believe our target indication would support an orphan drug designation, which, if granted, would provide us with seven years of data exclusivity in the US. This potential exclusivity, combined with an attractive market opportunity, and an efficient commercial model, represents a substantial economic opportunity for roxadustat in anemia associated with lower risk MDS. With that, I will now turn the call over to Dave to discuss the company's financials. Dave? Thank you, Thane. I will first review the updated FibroGen China transaction details and then provide the company's financial performance for the third quarter of 2025. As a reminder, our China operations are reflected as discontinued operations throughout our financials.

Speaker #3: And the path forward for Roxadustat as a potential treatment for 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 On slide 3, I would like to start with the sale of FIBROGEN China to AstraZeneca that we recently completed for approximately $220 million.

Following the.

Transaction, we successfully paid off the term loan facility with Morgan Stanley Tactical value.

Second we continued to progress Fg's $32 46, and <unk> 31, 80 in metastatic castration resistant prostate cancer or EMC RPC and initiated the phase II monotherapy trial of FG three to 46 <unk> hundred 31, 80 earlier this quarter. Additionally, we expect the topline results from the <unk>.

Speaker #3: This was a truly transformative transaction that provided us with the most efficient means to access the company's cash held in China extending our cash runway into 2028.

The Gators sponsored trial of FG $32 46 in combination with <unk> and <unk> to be presented at a medical conference in the first quarter of 2026.

Speaker #3: Following the transaction, we successfully paid off the term loan facility with Morgan Stanley Tactical Value. Second, we continued to progress FG 3246 and FG 3180 in metastatic castration-resistant prostate cancer, or MCRPC, and initiated the phase 2 monotherapy trial of FG 3246 and FG 3180 earlier this quarter.

Third as we have previously stated we had a successful type C meeting with the FDA in July providing us with a clear regulatory path forward for <unk>, we remain on track to submit the phase III trial protocol for <unk> for the treatment of lower risk come out as plastic syndrome in patients with high transfusion burden later this.

Thane Wettig: On slide 21, we highlight the summary of the key financial terms of the transaction. Upon the close of the transaction in August 2025, FibroGen received an enterprise value of $85 million, plus FibroGen net cash held in China at closing of approximately $135 million, with a total consideration of approximately $220 million. This is a $60 million increase from our initial net cash guidance in February. Upon close of the China transaction, we paid off our senior secure term loan with Morgan Stanley Tactical Value, resulting in a cash outflow of approximately $80.9 million. This includes the $75 million principal balance, accrued and unpaid interest, and an applicable prepayment penalty. The net cash payable at closing is subject to holdbacks of $10 million, which is comprised of a $6 million holdback to offset final net cash adjustments, and a $4 million holdback to satisfy any indemnity claims.

Speaker #3: Additionally, we expect the top-line results from the investigator-sponsored trial of FG 3246 in combination with enzalutamide in MCRPC to be presented at a medical conference in the first quarter of 2026.

Quarter.

We are confident that with our mid and late stage assets simplified capital structure and upcoming near term catalysts across both clinical programs, we are well positioned to advance meaningful therapeutic options for patients and significant value for shareholders.

Speaker #3: Third, as we have previously stated, we had a successful type C meeting with the FDA in July, providing us with a clear regulatory path forward for Roxadustat.

I will now provide a brief over overview of our FG $32 46 in FG 3080 programs in MCR PC.

Speaker #3: We remain on track to submit the phase 3 trial protocol for Roxadustat for the treatment of lower-risk myelodysplastic syndromes in patients with high transfusion burden later this quarter.

Slide five summarizes the high unmet need in late stage prostate cancer <unk>.

Approximately 200 290000 men are diagnosed with prostate cancer each year in the U S with about 65000 drug treatable patients, where the cancer has metastasized and become castrate resistant.

Speaker #3: We are confident that with our mid and late-stage assets, simplified capital structure, and upcoming near-term catalysts across both clinical programs, we are well-positioned to advance meaningful therapeutic options for patients and significant value for shareholders.

This group of patients is a grim five year survival rate of approximately 30%.

Underscoring the significant opportunity for new life extending treatments.

Speaker #3: I will now provide a brief overview of our FG 3246 and FG 3180 programs in MCRPC. Slide 5 summarizes the high unmet need in late-stage prostate cancer.

We believe that <unk> 30 to 46 could be this new treatment option and estimate the total addressable market to be well over $5 billion annually.

Thane Wettig: I am happy to announce that we have received $6.4 million associated with the first holdback last week. We expect to receive the second holdback of $4 million in the second quarter of 2026. This truly transformative transaction allowed us to pay down our senior term loan facility with MSTV, provided full access to our cash in China, and extended the company's runway into 2028 to support US development initiatives. Given the company's current market capitalization of approximately $45 million, we believe these increases in expected net cash received upon the close of the transaction represent a meaningful outcome for shareholders. Now, on to the company's financials for the third quarter. For the third quarter of 2025, total revenue was $1.1 million compared to $0.1 million for the same period in 2024. For a full year of 2025, we reiterate total revenues to be between $6 million and $8 million.

On slide six we highlight the novelty of <unk> 46, a tumor selective target that has several distinguishing features.

Speaker #3: Approximately 290,000 men are diagnosed with prostate cancer each year in the US, with about 65,000 drug-treatable patients where the cancer has metastasized and become castrate-resistant.

First CD 46 is up regulated dirt during tumor agenesis and helps tumors evade complement dependent cytotoxicity.

Speaker #3: This group of patients has a grim five-year survival rate of approximately 30%, underscoring the significant opportunity for new life-extending treatments. We believe that FG 3246 could be this new treatment option and estimate the total addressable market to be well over $5 billion annually.

Second its expression is also up regulated in the progression from localized castration sensitive prostate cancer to metastatic castration resistant prostate cancer and further over expressed following treatment with androgens signaling inhibitors.

Notably CD 46 is highly expressed in MCR PC tissues with lower inter patient variability and higher median expression compared with PSA may making it an attractive therapeutic target.

Speaker #3: On slide 6, we highlight the novelty of CD46. A tumor selective target that has several distinguishing features. First, CD46 is upregulated during tumor genesis, and helps tumors evade complement-dependent cytotoxicity.

Turning to slide seven.

332, 46 is our potential first in class ADC in development for MCU RPC the.

Speaker #3: Second, its expression 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.

Thane Wettig: Now, moving down the income statement, total operating costs and expenses for the third quarter of 2025 were $6.5 million compared to $47.8 million for the third quarter of 2024, a decrease of $41.3 million, or 86% year over year. R&D expenses for the third quarter of 2025 were $1.2 million compared to $20 million in the third quarter of 2024, a decrease of $18.8 million, or 94% year over year. SG&A expenses for the third quarter of 2025 were $5.3 million compared to $9.4 million in the third quarter of 2024, a decrease of $4.1 million, or 43% year over year. During the third quarter of 2025, we recorded a net loss from continuing operations of $13.1 million, or $3.25 net loss per basic and diluted share, as compared to a net loss of $48.3 million, or $12.01 per basic and diluted share for the third quarter of 2024.

The ADC combines the <unk> five antibody within MMA payload to specifically target the tumor selective epitope of <unk> 46.

<unk> is a fully human <unk> monoclonal antibody that was engineered to specifically target the tumor selective epitope of CD 46, whose expression is limited in normal tissue.

Speaker #3: Notably, CD46 is highly expressed in MCRPC tissues, with lower interpatient variability and higher median expression compared with PSMA making it an attractive therapeutic target.

FTE $32 46 represents an androgen receptor agnostic approach clinically differentiating it from other prostate cancer treatments currently in development, many of which target <unk>.

Speaker #3: Turning to slide 7, FG 3246 is our potential first-in-class ADC in development for MCRPC. The ADC combines the YS5 antibody with an MMAE payload to specifically target the tumor-selective epitope of CD46.

The companion Pet imaging agent FG 31, 80 utilizes the same wireless <unk> targeting antibody as achieved $32 46 and is also under clinical development.

Speaker #3: YS5 is a fully human IgG1 monoclonal antibody that was engineered to specifically target the tumor selective epitope of CD46, whose expression is limited in normal tissue.

We believe that having a patient selection biomarker with not only allow us to better enrich the patient population in a future phase III trial. It could also enable differentiation of <unk> $32 46 in the prostate cancer treatment paradigm in.

Speaker #3: FG 3246 represents an androgen receptor agnostic approach clinically differentiating it from other prostate cancer treatments currently in development, many of which target PSMA. The companion PET imaging agent, FG 3180, utilizes the same YS5 targeting antibody as FG 3246 and is also under clinical development.

In addition, <unk> 31, <unk> could represent an important commercial opportunity as a companion diagnostic to FG $32 46, similar to the existing <unk> pet agents.

Thane Wettig: For full year 2025, we are updating our guidance for our total operating costs and expenses, including stock-based compensation, to be between $50 million and $60 million. At the midpoint, this represents a 70% reduction from full year 2024. Now, shifting towards cash. As of 30 September 2024, we reported $121.1 million in cash, cash equivalents, accounts receivable, and investments in the US. We expect the company to now have cash runway into 2028. In summary, we believe we have taken important steps to reduce our fixed cost infrastructure across both project and FTE spend to maximize our cash runway and enable investment in our US pipeline opportunities. Thank you, and I will now turn the call back over to Thane. Thank you, Dave.

Slide eight recaps the topline results from the two FG $32 46 clinical trials to date.

Speaker #3: We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in a future phase 3 trial, it could also enable differentiation of FG 3246 in the prostate cancer treatment paradigm.

On the left side, we highlight the phase one monotherapy study, where a median radiographic progression free survival of $8. Seven months was observed in patients with <unk> that were heavily pretreated and we're not biomarker selected.

Speaker #3: In addition, FG 3180 could represent an important commercial opportunity as a companion diagnostic to FG 3246, similar to the existing PSMA PET agents. Slide 8 recaps the top-line results from the two FG 3246 clinical trials to date.

PSA reductions of greater than 50% were achieved and 36% of these patients.

On the right. We highlight the previously reported preliminary efficacy data from the phase <unk> portion of the investigator sponsored combination study with <unk>, which demonstrated a preliminary estimate of $10 two months of radiographic progression free survival with PSA declines observed in 71% of Evaluable patients.

Speaker #3: On the left side, we highlight the Phase 1 monotherapy study, where a median radiographic regression-free survival of 8.7 months was observed in patients with MCRPC who were heavily pretreated and were not biomarker-selected.

Thane Wettig: To conclude today's remarks, with a substantially strengthened financial position and an extended cash runway through multiple clinical milestones into 2028, we are well positioned to advance our mid and late-stage clinical development programs for FG-3246 and roxadustat, respectively. We look forward to reporting the top-line results from the investigator-sponsored study of FG-3246 in combination with enzalutamide at a medical conference in Q1 2026. The recently initiated phase two monotherapy trial of FG-3246 is progressing as planned, and we expect to report the interim results in the second half of 2026. Finally, with the positive feedback received from the FDA, we now have a regulatory path forward to advance roxadustat for the treatment of anemia associated with lower-risk MDS, and will submit the pivotal phase three protocol before the end of this year.

The topline results from the ISC are expected to be presented at a medical conference in the first quarter of 2026.

Speaker #3: PSA reductions of greater than 50% were achieved in 36% of these patients. On the right, we highlight the previously reported preliminary efficacy data from the phase 1B portion of the investigator-sponsored combination study with enzalutamide, which demonstrated a preliminary estimate of 10.2 months of radiographic progression-free survival with PSA declines observed in 71% of evaluable patients.

Together. These results highlight what we believe is compelling clinical activity with FG three to 46 with competitive our PFS results compared to other approved and investigational treatments and both the monotherapy and combination settings.

Moving to slide nine based on the phase one monotherapy results, we initiated the AFG $32 46 phase II monotherapy dose optimization trial in September.

Speaker #3: The top-line results from the IST are expected to be presented at a medical conference in the first quarter of 2026. Together, these results highlight what we believe is compelling clinical activity with FG 3246, with competitive RPFS results compared to other approved and investigational treatments in both the monotherapy and combination settings.

We plan to enroll 75 patients in the post RPI 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 31, <unk> will be an integral part of the study as we seek to demonstrate the correlation between CD 46 expression and response to the ADC in this all comers population.

Thane Wettig: We have made substantial progress this year, transforming FibroGen into a lean and laser-focused organization, firmly positioning us to finish this year on a high note, with an exciting future ahead. We look forward to providing further updates to our stakeholders over the coming months. I would now like to turn the call over to the operator for Q&A. Thank you. Ladies and gentlemen, as a reminder, to ask the question, please press star 11 on your telephone, then wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andy Shay with Wimbleder. Your line is open. Yeah, thanks for taking our question. Congratulations on closing that $220 million deal with AstraZeneca. Just really transformative for the company. We have three questions across the pipeline program.

Speaker #3: Moving to slide 9, based on the phase 1 monotherapy results, we initiated the FG 3246 phase 2 monotherapy dose optimization trial in September. We plan to enroll 75 patients in the post-ARPI pre-chemo setting across three dose levels to determine the optimal dose for phase 3 based on efficacy, safety, and PK parameters.

One other important design element is the use of G. CSF as primary prophylaxis to mitigate grade three or greater neutropenia, commonly seen with MMA payloads and also experienced in the phase one monotherapy trial.

The addition of G. CSF is designed to reduce dose interruptions and downward adjustments in may a neighbor may enable a better tolerated and more consistent treatment with the ADC.

Speaker #3: 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-commerce population.

An interim analysis of the phase II trial is planned for the second half of 2026 and will include efficacy safety PK and exposure response data that will be reported as they become available given the open label design of the trial.

Speaker #3: One other important design element is the use of GCSF as primary prophylaxis to mitigate grade 3 or greater neutropenia commonly seen with MMAE payloads and also experienced in the phase 1 monotherapy trial.

On slide 10, I'd like to highlight three important steps we've taken with the design of the phase two monotherapy trial with the aim of building on the $8 seven months of our PFS demonstrated in the phase one monotherapy trial.

Speaker #3: The addition of GCSF is designed to reduce dose interruptions and downward adjustments, and may enable a better tolerated and more consistent treatment with the ADC.

Thane Wettig: One is on the roxadustat MDS pivotal trial. You mentioned the potential thrombotic risk. Very prudent thing to incorporate into the trial. I'm just curious, maybe from an epidemiology perspective, in that second line or later setting, refractory, intolerable to ESAs, what proportion of patients do you think might be screened out because of the thrombotic risk? Related to that, basically, I'm just curious about the cost of running that phase three trial and whether or how that would impact the 2028 cash guidance that you provided. I have a quick follow-up. Thank you. Yeah, thanks, Andy. Nice to hear from you, and I appreciate the questions. As it relates to the thrombotic risk and what that can potentially do to the size of the patient population, I think it'll be dependent really upon two things.

First leveraging the preliminary evidence of an exposure response relationship the phase II study will use three of the highest doses from the phase one dose escalation and expansion study.

Speaker #3: In interim analysis of the phase 2 trial is planned for the second half of 2026 and will include efficacy, safety, PK, and exposure response data that will be reported as they become available given the open-label design of the trial.

Second primary prophylaxis with G. CSF will be utilized to potentially mitigate 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 the duration of therapy and potentially enhance the efficacy of the ADC.

Speaker #3: On slide 10, I'd like to highlight three important steps we have taken with the design of the Phase 2 monotherapy trial, with the aim of building on the 8.7 months of RPFS demonstrated in the Phase 1 monotherapy trial.

Third enrolling healthier patients in earlier lines of therapy versus the <unk> median lines of therapy in the phase one trial.

Speaker #3: First, leveraging the preliminary evidence of an exposure response relationship, the phase 2 study will use three of the highest doses from the phase 1 dose escalation and expansion study.

Together, we believe that these design elements have the potential to improve upon the phase one results and achieving our PFS of 10 months or greater which we believe is the benchmark for commercial competitiveness.

Speaker #3: Second, primary prophylaxis with GCSF will be utilized to potentially mitigate neutropenia which could enable more consistent exposure to the ADC with fewer dose interruptions or adjustments early in the course of treatment.

Slide 11 shows our long term development strategy for <unk>, $32, 46, and <unk> 31, 80, <unk>, which provides us with important optionality in prostate cancer.

Speaker #3: This could consequently extend the duration of therapy and potentially enhance the efficacy of the ADC. Third, enrolling healthier patients in earlier lines of therapy versus the five median lines of therapy in the phase 1 trial.

Thane Wettig: One is, what is the ultimate kind of exclusion criteria that we align on with the FDA? Then, ultimately, what does the data report from the phase three trial? I think it's too early for us to even kind of estimate is it a really small proportion of the total population of phase two and beyond patients in lower risk MDS, or is it more of a moderate portion of the population? Our hypothesis is it's a pretty small amount of the patient potential, but we won't know that until we really align on the inclusion and exclusion criteria with the agency, ultimately run the trial, see the data, and then figure out exactly what the label says should we have a positive trial and a positive registration.

We have a well designed phase II monotherapy trial in the post <unk> pre chemo setting NMC RPC to attempt to further build upon the $8 seven months of PFS demonstrated in the phase one monotherapy study.

Speaker #3: Together, we believe that these design elements have the potential to improve upon the phase 1 results and achieve an RPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness.

In addition, the phase II study will explore the correlation between CD 46 expression and response to the ADC potentially validating FG $30 80, as a predictive patient selection biomarker in future studies.

Speaker #3: Slide 11 shows our long-term development strategy for FG 3246 and FG 3180, which provides us with important optionality in prostate cancer. We have a well-designed phase 2 monotherapy trial in the post-ARPI pre-chemo setting in MCRPC to attempt to further build upon the 8.7 months of RPFS demonstrated in the phase 1 monotherapy study.

We are confident that our development pathway for <unk> $32, 46, unlocks sequential or parallel registrational pathways as FTE 30 to 46 will be evaluated in multiple lines of therapy in monotherapy <unk> in combination with an AARP.

And in an all comers population or patients with high expression of <unk> 46.

Speaker #3: In addition, the phase 2 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.

Thane Wettig: In terms of the cost of the trial, we're estimating it will cost in the neighborhood of $50 to $60 million. That's assuming about 200 patients, an enrollment period of 18 to 24 months. I'll let Dave comment on how we're thinking about that in terms of our cash runway and our guidance. Dave? Yeah, sure. Thank you, Thane. Right now, our current guidance reflects a cash runway into 2028, and that does not contemplate taking on the phase three study on our own. To your point, Andy, obviously, it would impact our cash guidance. We think that it could bring, if we decide to take it on our own without raising incremental capital, it could take the cash guidance into the second half of 2027, give or take.

Slide 12 highlights the recent and upcoming catalysts for the <unk> hundred $32 46 in the AFP achieved <unk> 180 program.

Looking ahead, we expect the top line results from the <unk> of <unk> $32 46 in combination with <unk> to be presented at a medical conference in the first quarter of 2026 with the recent initiation of the phase II monotherapy trial, we expect to report the interim results in the second half of 2026.

Speaker #3: 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 ARPI, and in an all-commerce population or patients with high expression of CD46.

To summarize on slide 13, <unk> hundred $32 46 targets a novel epitopes on prostate cancer cells with first in class potential.

Speaker #3: Slide 12 highlights the recent and upcoming catalysts for the FG 3246 and the FG 3180 program. Looking ahead, we expect the top-line results from the IST of FG 3246 in combination with enzalutamide to be presented at a medical conference in the first quarter of 2026.

Given there are no other CD 46 targeted projects in clinical development.

Targeting CD 46, with FG three $2 46 has already demonstrated promising early efficacy signals with an acceptable safety profile, both in monotherapy and combination settings.

Thane Wettig: We do expect that we would be looking to bring on incremental capital to help support the cost of running the phase three study if we were to take it on our own. Okay. Andy, maybe one—yeah, so one final comment on that, Andy, as we said in our prepared remarks, as we are evaluating the potential to run the trial on our own versus the partnering process, which we have commenced, ultimately, it's going to come down to kind of a combination of what we would call strategic and economic considerations. On the economic front, we would have to bring in additional capital per Dave's point. We've started to have those conversations just to see what the potential or the likelihood for us to be able to do that. We will compare that as we advance the partnering process.

Speaker #3: With the recent initiation of the phase 2 monotherapy trial, we expect to report the interim results in the second half of 2026. To summarize, on slide 13, FG 3246 targets a novel epitope on prostate cancer cells with first-in-class potential.

We are excited for the upcoming milestones and look forward to updating you as the program progresses.

Turning now to rocks induced at slide 15 highlights the unmet need and the potential for <unk> and the approximately 49000 patients with anemia associated with lower risk Mds in the U S alone.

Speaker #3: Given 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 in combination settings.

Current treatments are effective and less than 50% of patients with no oral options currently on the market or in late stage development, a significant opportunity exists to offer a potential new treatment that is durable with convenient oral administration to patients in the second line and beyond setting.

Speaker #3: We are excited for the upcoming milestones and look forward to updating you as the program progresses. Turning now to Roxadustat, slide 15 highlights the unmet need and the potential for Roxadustat in the approximately 49,000 patients with anemia associated with lower-risk MDS in the U.S. alone.

Moving to slide 16, I would like to briefly highlight the data from a post hoc analysis in a subgroup of patients with anemia of lower risk Mds, who entered the phase III Matterhorn study of <unk> debt with a high transfusion burden.

Thane Wettig: We'll be able to compare that kind of side by side and ultimately do what we think is in the best interest of shareholders. I see. Okay. Great. Maybe kind of a big picture question on prostate cancer landscape. There's a lot of targets out there: PSMA, C1, DLL3, CD46, obviously, and then, I guess, most interestingly, Bombasin, which has a negative expression correlation profile versus PSMA. I guess, do we have additional, maybe, academic work that looks at some of the overlapping expression profiles that could actually be advantageous for CD47 to kind of position based on the expression levels? Just kind of curious about your thinking on that front. Thanks. No, thanks, Andy. It's a really good question and one that we talk about on a pretty regular basis.

In this analysis using the international working group definition for high transfusion burden of four or more RBC units in two consecutive eight week periods <unk> showed a meaningful treatment effect with 36% of patients achieving transfusion independence for greater than or equal to eight weeks versus only 7% in the play.

Speaker #3: Current treatments are effective in less than 50% of patients. With no oral options currently on the market or in late-stage development, a significant opportunity exists to offer a potential new treatment that is durable with convenient oral administration to patients in the second line and beyond setting.

Speaker #3: Moving to slide 16, I would like to briefly highlight the data from a post-hoc analysis in a subgroup of patients with anemia of lower-risk MDS who entered the phase 3 Matterhorn study of Roxadustat with a high transfusion burden.

<unk> group with a nominal P value of 0.041.

These results are highly similar to the pivotal trial results for the two most recently approved therapies for anemia associated with lower risk Mds.

Speaker #3: In this analysis, using the International Working Group definition for high transfusion burden of four or more RBC units in two consecutive eight-week periods, Roxadustat showed a meaningful treatment effect, with 36% of patients achieving transfusion independence for greater than or equal to eight weeks, versus only 7% in the placebo group, with a nominal p-value of 0.041.

Based on these results as we turn to slide 17.

Our target indication for <unk> is in patients with lower Mds and high transfusion burden, who are refractory to or an eligible for prior Esa treatment, where we believe <unk> has the potential to elevate the standard of care in the second line and beyond treatment settings.

Thane Wettig: We've got a great group of KOLs who are beginning to help us think through this as well. If we think about expression levels of CD46, we probably can best characterize it as it relates to expression levels of PSMA. We know that there is a great degree of concordance of patients who express the CD46 epitope and those that express PSMA. We do know that as patients are treated with androgen receptor inhibitors and are treated with ataxane or potentially even Plevicto, we see some resistance to PSMA develop. We actually see PSMA expression levels go down. We're going to be able to tell a lot more, we believe, from our phase two monotherapy trial, where we're going to treat all the patients with the CD46 PET imaging agent to be able to characterize the very expression levels.

In July we had a positive type C meeting with the FDA, where we aligned on key design elements in a regulatory path forward for <unk> the.

Speaker #3: These results are highly similar to the pivotal trial results for the two most recently approved therapies for anemia associated with lower-risk MDS. Based on these results, as we turn to slide 17, our target indication for Roxadustat is in patients with lower MDS and high transfusion burden who are refractory to or ineligible for prior ESA treatment, where we believe Roxadustat has the potential to elevate the standard of care in the second line and beyond treatment settings.

The potential pivotal phase III trial summarized on slide 18 will include patients requiring four or more RBC units in two consecutive eight week periods prior to randomization, who as I alluded to on the previous slide are refractory to intolerant to or an eligible for prior Esa.

We also agreed with the FDA unimportant dosing elements, including the starting dose of two five milligrams per kilogram and on the management of potential thrombotic risk, which could include trial eligibility dose modification and ditched in discontinuation criteria.

Speaker #3: In July, we had a positive type C meeting with the FDA, where we aligned on key design elements and a regulatory path forward for Roxadustat.

Speaker #3: The potential of pivotal phase 3 trial, summarized on slide 18, will include patients requiring four or more RBC units in two consecutive eight-week periods prior to randomization, who, as I alluded to on the previous slide, are refractory to, intolerant to, or ineligible for prior ESAs.

We are currently evaluating eight week 16 week RBC transfusion independence as the primary endpoint for the trial.

Thane Wettig: We do think we'll have some data on many of those patients in terms of their previous PSMA expression levels as well. We'll be able to then do a correlation assessment based upon those expression levels in response to the ADC. We'll also be able to look at the data, albeit in probably a smaller number of patients, of how our ADC performs in patients who were previously on Plevicto and those that weren't, again, given this kind of signal that we've seen where it seems that as patients progress and are treated with ataxanes and potentially with Plevicto, their PSMA levels are altered to some degree. We're not probably going to have much data from our phase two as it relates to any of the other targets.

The team continues to work diligently on finalizing the phase III protocol and we remain on course for submission in the fourth quarter of this year. We are currently exploring our clinical development options, which include maintaining rock should use that as a wholly owned asset and running the phase III trial on our own or partnering the program we're actively.

Speaker #3: We also agreed with the FDA on important dosing elements, including the starting dose of 2.5 milligrams per kilogram, and on the management of potential thrombotic risk, which could include trial eligibility, dose modification, and discontinuation criteria.

Gauged in this process and will ultimately choose the path that we believe is in the best interest of shareholders.

Speaker #3: We are currently evaluating eight-week and 16-week RBC transfusion independence as the primary endpoint for the trial. The team continues to work diligently on finalizing the phase 3 protocol, and we remain on course for submission in the fourth quarter of this year.

To summarize on slide 19, there is significant opportunity for <unk> in anemia associated with lower risk Mds with no. Other oral treatments currently available or in late stage development.

Furthermore, we believe our target indication would support an orphan drug designation, which if granted would provide us with seven years of data exclusivity in the U S.

Speaker #3: We are currently exploring our clinical development options, which include maintaining Roxadustat as a wholly owned asset and running the phase 3 trial on our own, or partnering the program.

Thane Wettig: As you stated, there is some academic work that's been done that looks at expression levels of STEAP1, Trop-2, CD46, PSMA, etc. It's probably premature for us to comment at this point in time as it relates to how CD46 might overlap with the expression of some of those other targets. Great, that's helpful. Look forward to the second half 2026 interim readout. Thank you. Thanks, David. Our next question comes from the line of Matthew Keller with H.C. Wainwright. Your line is open. Yeah, hey, guys. Thanks for the update, and thanks for taking our question. Just one from us on 3246. I was wondering if you could provide a little bit more color or what your thoughts are and what we can expect specifically from the top-line data out of the IST study.

This potential exclusivity combined with an attractive market opportunity and an efficient commercial model represents a substantial economic opportunity for <unk> in anemia associated with lower risk Mds.

Speaker #3: We are actively engaged in this process and will ultimately choose the path that we believe is in the best interest of shareholders. To summarize on slide 19, there is significant opportunity for Roxadustat in anemia associated with lower-risk MDS, with no other oral treatments currently available or in late-stage development.

With that I will now turn the call over to Dave to discuss the Companys financials Dave.

Thank you <unk>.

I will first review the updated fiber Gen. China transaction details and then provide the company's financial performance for the third quarter of 2025.

Speaker #3: Furthermore, we believe our target indication would support an orphan drug designation, which, if granted, would provide us with seven years of data exclusivity in the US.

As a reminder, our China operations are reflected as discontinued operations throughout our financials.

Speaker #3: This potential exclusivity, combined with an attractive market opportunity, and an efficient commercial model, represents a substantial economic opportunity for Roxadustat in anemia associated with lower-risk MDS.

On slide 21, we highlight the summary of the key financial terms of the transaction.

Upon the close of the transaction in August 2025, 5% received an enterprise value of $85 million plus fiber had net cash held in China at closing of approximately $135 million with a total consideration of approximately $220 million. This is a $16 million <unk>.

Thane Wettig: Really what I'm trying to get at is more specifically, what are you considering a success from this data readout? Yeah. Thanks, Matt. I'll go ahead and start, and Dave, feel free to add comments afterwards as well. In the preliminary efficacy data from the 1B portion of the combination trial, there was a preliminary efficacy estimate of 10.2 months. If we would see something consistent with that, I think that would be pretty encouraging for us. I think it's going to be important to look at the data on the roughly 44 patients or so, and how that data shakes out based upon the number of prior ARPIs that a particular patient has been on. We think that will be a part of the disclosure.

Speaker #3: With that, I will now turn the call over to Dave to discuss the company's financials. Dave?

Speaker #2: Thank you, Thane. I will first review the updated Fibrogen China transaction details and then provide the company's financial performance for the third quarter of 2025.

<unk> from our initial net cash guidance in February.

Speaker #2: As a reminder, our China operations are reflected as discontinued operations throughout our financials. On slide 21, we highlight the summary of the key financial terms of the transaction.

Upon close of the China transaction, we paid off our senior secured term loan with Morgan Stanley tactical value, resulting in a cash outflow of approximately $89 million. This.

Speaker #2: Upon the close of the transaction in August 2025, Fibrogen received an enterprise value of $85 million plus Fibrogen net cash held in China at closing of approximately 135 million dollars.

This includes the $75 million principal balance accrued and unpaid interest and an applicable prepayment penalty.

The net cash payable at closing is subject to hold backs of $10 million, which is comprised of a $6 million hold back to offset final net cash adjustment and a $4 million hold back to satisfy any indemnity claims.

Speaker #2: With a total consideration of approximately 220 million dollars, this is a $60 million increase from our initial net cash guidance in February. Upon close of the China transaction, we paid off our senior secure term loan with Morgan Stanley Tactical Value resulting in a cash outflow of approximately 80.9 million dollars.

Thane Wettig: Given the IST nature of that particular trial, clearly, we're hands-off on the disclosure and what that disclosure, that information will say. I think that that will be also an important part of the learning. We do know that the higher the number of ARPIs that patients are treated with, obviously, regardless of what comes next, you see a declining rPFS. I think that that will be an important part of the disclosure. Dave, anything to add to that? No, I think you hit the nail on the head, Thane. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Chen Lin with Lin Asset Management. Your line is open. Hi, guys. Thank you for taking my questions. Many of my questions have been answered. Just curious, there's a line of liability of $63 million on your report.

I am happy to announce that we have received $6 $4 million associated with the first hold back last week, we expect to receive the second hold back a $4 million in the second quarter of 2026.

Speaker #2: This includes the $75 million principal balance, accrued and unpaid interest, and an applicable prepayment penalty. The net cash payable at closing is subject to holdbacks of $10 million, which is comprised of a $6 million holdback to offset final net cash adjustments and a $4 million holdback to satisfy any indemnity claims.

This truly transformative transaction allowed us to pay down our senior term loan facility with MST provided full access to our cash in China and extended the companys runway into 2028 to support U S development initiatives.

Given the Companys current market capitalization of approximately $45 million.

We believe these increases and expected net cash received upon the close of the transaction represents a meaningful outcome for shareholders.

Speaker #2: I am happy to announce that we have received 6.4 million dollars associated with the first holdback last week. We expect to receive the second holdback of 4 million dollars in the second quarter of 2026.

Now onto the company's financials for the third quarter for the third quarter of 2025 total revenue was $1 1 million compared to <unk> 1 million for the same period in 2024.

Speaker #2: This truly transformative transaction allowed us to pay down our senior term loan facility with MSTV, provided full access to our cash in China, and extended the company's runway into 2028 to support US development initiatives.

Thane Wettig: Is that related to the milestone payment for the ADC asset? I'll take that. I'll take that. No, that liability is actually related to the royalties associated with our royalty financing with NovaQuest Capital Management. That is associated with our royalty stream from Roxadustat sales and CKD in the European and Japanese territories where we are partnered with Astellas. Oh, okay. Okay. Great. That's a royalty stream. You own royalty, right? Then you sell some royalty. That's for that. Okay. Is there a minimum payment for that royalty, or what's the liability look like, or it will just your future revenue will be covered then? Yeah. Currently, the way the deal is structured is that we owe NovaQuest 22.5% of any of the royalties received in those territories.

For full year 2025, we reiterate total revenues to be between $6 million and $8 million.

Now moving down the income statement total operating costs and expenses for the third quarter of 2025 or $6 5 million.

Speaker #2: Given the company's current market capitalization of approximately 45 million dollars, we believe these increases in expected net cash received upon the close of the transaction represent a meaningful outcome for shareholders.

Compared to $47 8 million for the third quarter of 2024, a decrease of $41 3 million or.

Speaker #2: Now onto the company's financials for the third quarter. For the third quarter of 2025, total revenue was 1.1 million dollars compared to 0.1 million dollars for the same period in 2024.

We're 86% year over year.

R&D expenses for the third quarter of 2025 or $1 2 million.

Compared to $20 million in the third quarter of 2024, a decrease of $18 8 million or <unk>, 94% year over year.

Speaker #2: For a full year 2025, we reiterate total revenues to be between 6 million dollars and 8 million dollars. Now moving down the income statement, total operating costs and expenses for the third quarter of 2025 were 6.5 million dollars compared to 47.8 million dollars for the third quarter of 2024.

SG&A expenses for the third quarter of 2025, or $5 3 million compared to $9 4 million in the third quarter of 2024, a decrease of $4 1 million or 43% year over year. During the third quarter of 2025, we recorded a net loss from continuing operations of <unk>.

Speaker #2: A decrease of 41.3 million dollars or 86 percent year over year. R&D expenses for the third quarter of 2025 were 1.2 million dollars compared to 20 million dollars in the third quarter of 2024, a decrease of 18.8 million dollars or 94 percent year over year.

<unk> dollars 1 million or.

Thane Wettig: FibroGen owns 77.5%, and then the 22.5% are paid out to NovaQuest Capital Management on an annual basis. Okay. Great. So it's a line item, not actually the royalty that you own going forward. Great. Thank you for this clarification. Do you have any other line item for the potential future milestone you need to pay for the ADC going forward in the financial report? Yeah, Dave, I'll take that one. Chen, the only future milestone that we would have in the relatively near term related to the agreement that we struck with Fortis in May of 2023 would be if we decide, based upon the phase two data, to move the program into phase three. We would then exercise the option to acquire Fortis Therapeutics for $80 million. We would then run the phase three trial.

Or $3 25, net loss per basic and diluted share as compared to a net loss of $48 3 million or $12 <unk> per basic and diluted share for the third quarter of 2024 for.

Speaker #2: SG&A expenses for the third quarter of 2025 were $5.3 million, compared to $9.4 million in the third quarter of 2024, a decrease of $4.1 million or 43 percent year over year.

For full year 2025, we are updating our guidance for our total operating cost and expenses, including stock based compensation to be between $50 million $60 million at the midpoint. This represents a 70% reduction from full year 2024, now shifting towards cash as of September 30, We reported 100.

Speaker #2: During the third quarter of 2025, we recorded a net loss from continuing operations of 13.1 million dollars or $3.25 net loss per basic and diluted share, as compared to a net loss of 48.3 million dollars or $12.01 per basic and diluted share for the third quarter of 2024.

$21 1 million in cash cash equivalents accounts receivable and investments in the U S. We expect the company to now have cash runway into 2028 in summary, we believe we have taken important steps to reduce our fixed cost infrastructure across both project and FTE spend to maximize our cash runway.

Speaker #2: For a full year 2025, we are updating our guidance for our total operating costs and expenses, including stock-based compensation, to be between 50 million dollars and 60 million dollars.

And enable investment in our U S pipeline opportunities. Thank you and I'll now turn the call back over to <unk>.

Speaker #2: At the midpoint, this represents a 70 percent reduction from full year 2024. Now shifting towards cash, as of September 30th, we reported 121.1 million dollars in cash, cash equivalents, accounts receivable, and investments in the US.

Thank you Dave to conclude today's remarks, with a substantially strengthened financial position and an extended cash runway through multiple clinical milestones into 2028, we are well positioned to advance our mid and late stage clinical development programs for <unk>, $32 46, and <unk> respectively.

Thane Wettig: If the data supports, then a filing and the product were ultimately to get approved in either the US or Europe, we would then owe them an additional milestone based on approval of $75 million. There would be no royalty obligation on net sales to Fortis after that. There would be a very small single-digit royalty obligation to UCSF, but not to Fortis. Just to add to that, the reason why we don't carry the liability on the balance sheet is because it is fully at our discretion. As Thane pointed out, if the phase two trial is successful and we like what we see, we can exercise that option. If we do not like what we see, then we can return the asset back to Fortis Therapeutics.

Speaker #2: We expect the company to now have cash runway into 2028. In summary, we believe we have taken important steps to reduce our fixed cost infrastructure across both project and FTE spend to maximize our cash runway and enable investment in our US pipeline opportunities.

We look forward to reporting the top line results from the investigator sponsored study of FG three $2 46 in combination with <unk> at a medical conference in the first quarter of 2026. The recently initiated phase II monotherapy trial of FG $3 46 is progressing as planned and we expect to report the interim results in the.

Speaker #2: Thank you, and I will now turn the call back over to Thane.

Speaker #3: Thank you, Dave. To conclude today's remarks, with a substantially strengthened financial position and an extended cash runway through multiple clinical milestones into 2028, we are well positioned to advance our mid and late-stage clinical development programs for FG3246 and Roxadustat, respectively.

Half of 2026.

Finally, with the positive feedback received from the FDA. We now have a regulatory path forward to advanced rock reduce debt for the treatment of anemia associated with lower risk Mds and we'll submit the pivotal phase III protocol before the end of this year.

Thane Wettig: It is fully in FibroGen's discretion based upon the outcome of the phase two study of FG-3246. Okay. Great. Thank you. That's clarifying a lot. When do you expect to decide which pathway you go with low-risk MDS, this new phase three trial? Do you want to wait for the phase two interim results, or do you plan to move it forward before that? Yeah. Thanks, Chen. These are completely independent of one another. We're looking at the low-risk MDS opportunity for roxadustat by itself as a standalone. I would think that we'd be able to have some clarity on the path forward, whether we do it on our own versus whether we partner it. Probably in the second quarter of next year, we'll have better clarity on that. Thank you.

Speaker #3: We look forward to reporting the top-line results from the investigators-sponsored study of FG3246 in combination with enzalutamide at a medical conference in the first quarter of 2026.

We have made substantial progress this year transforming <unk> into a lean and laser focused organization firmly positioning us to finish this year on a high note with an exciting future ahead.

Speaker #3: The recently initiated Phase II monotherapy trial of FG3246 is progressing as planned, and we expect to report the interim results in the second half of 2026.

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.

Speaker #3: Finally, with the positive feedback received from the FDA, we now have a regulatory path forward to advance Roxadustat for the treatment of anemia associated with lower-risk MDS.

Thank you.

Ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.

Speaker #3: And we'll submit the pivotal Phase III protocol before the end of this year. We have made substantial progress this year, transforming Fibrogen into a lean and laser-focused organization firmly positioning us to finish this year on a high note with an exciting future ahead.

Your question. Please press Star one again, please stand by while we compile the Q&A roster.

Our first question comes from the line of Andy.

Sandy <unk> with William Blair. Your line is open.

Speaker #3: 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.

Yes, Thanks for taking my question and congratulations on closing that $220 million deal with Astrazeneca.

Thane Wettig: Ladies and gentlemen, I'm sure no further questions in the queue. I would now like to turn the call back over to Thane for closing remarks. Yeah. Thank you, and thanks, everybody, for joining us for today's third quarter earnings call. We appreciate your continued interest in FibroGen. Have a great rest of your day. Thank you. Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker #4: Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 11 on your telephone. Then wait for your name to be announced.

Really transformative for the company.

We have three questions.

The Cros.

One is on the rocks at Dd's that Mds pivotal trial.

Speaker #4: To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andy Shay with Wembleyer.

You mentioned about the potential thrombotic risks.

They're a very prudent thing to incorporate into the trial, but I'm just curious maybe from the epidemiology.

Speaker #4: Your line is open.

Respected in that second line.

Speaker #5: Yeah, thanks for taking our question. Congratulations on closing that 220 million dollar deal with AstraZeneca. Just, you know, really transformative for the company. We have three questions.

Steady.

III intolerable to yet what.

A portion of patients do you think might be the outlook.

Yes.

Robotics.

Speaker #5: Across the pipeline program, so one is on the Roxadustat MDS pivotal trial. You mentioned about the potential thrombotic risk. Very, very prudent thing to incorporate into the trial.

And maybe related to that.

Basically just.

Curious about the cost of running that.

The trial.

Whether or how would that impact 2028.

Speaker #5: But I'm just curious, maybe from an epidemiology perspective, in that second line or later setting, refractory intolerable to ESAs, what proportion of patients do you think might be screened out because of the thrombotic risk?

Cash guidance.

That you provided.

Thank you.

Yes, Thanks, Andy Nice to hear from you and I appreciate the questions.

As it relates to the thrombotic risk and what that can potentially due to the size of the patient population I think that it will be dependent really upon two things. One is what is the ultimate kind of exclusion criteria.

Speaker #5: And maybe related to that, basically, I'm just curious about the cost of running that Phase III trial. And whether or how would that impact the 2028 cash guidance that you provided?

That we align on with the FDA.

And then second ultimately what does the data report from the from the Phase III trial, I think it's too early for us even kind of estimates.

Speaker #5: And I have a quick follow-up. Thank you.

Is it a really small proportion of the total population of phase II and beyond patients in lower risk Mds.

Is it more of a moderate a portion of the population.

Our hypothesis is it's a pretty small.

Out of the patient potential, but we won't know that until we really align on the.

The inclusion and exclusion criteria with the agency ultimately run the trial see the data and then figure out exactly what the label says should we have a positive trial and a positive registration.

In terms of the cost of the trial.

We're estimating that that will cost in the neighborhood of $50 million to $60 million.

And that's assuming about 200 patients and enrollment period of 18 to 24 months, but I'll, let Dave comment on how we're thinking about that in terms of our cash runway and our guidance Dave Yeah sure. Thank you.

The inclusion and exclusion criteria with the agency ultimately run the trial see the data and then figure out exactly what the label says should we have a positive trial and a positive registration.

So right now our current guidance reflects a cash runway into 2028 and that does not contemplate taking on the phase III study on our own so to your point, Andy obviously, it would impact our cash guidance.

And in terms of the cost of the trial.

We're estimating that that will cost in the neighborhood of $50 million to $60 million.

Think that it could bring if we decided to take it on our own without raising incremental capital it could take the cash guidance into the second half of 2027 give or take but.

And that's assuming about 200 patients and enrollment period of 18 to 24 months.

We do expect that we'll be looking to bring on incremental capital to help support the cost of running the phase III study, if we were to take it on our own.

But I'll, let Dave comment on how we're thinking about that in terms of our cash runway and our guidance Dave Yeah. Sure. Thank you think so right now our current guidance reflects a cash runway into 2028 and that does not contemplate taking on the phase III study on our own. So you know to your point, Andy obviously, it would impact our.

Okay, and then Andy maybe one.

So one final comment on that Andy as we said in our prepared remarks, and as we are evaluating the potential to run the trial on our own versus the partnering process, which we have commenced but ultimately it's going to come down to kind of a combination of what we would call strategic and economic considerations.

Cash guidance, we think that it could bring if we decided to take it on our own without raising incremental capital it could take the cash guidance into the second half of 2027 give or take but.

On the economic front, we would have to bring in additional capital per data point. We've started to have those conversations just to see what the potential or the likelihood for us to be able to do that and then we will compare that as we advanced the partnering process will be able to compare that kind of side by side.

We do expect that we'll be looking to bring on incremental capital to help support the cost of running the phase III study, if we were to take it on our own.

Okay, and then Andy maybe.

Yes, so one final comment on that Andy as we said in our prepared remarks, and as we are evaluating the potential to run the trial on our own versus the partnering process, which we have commenced but ultimately it's going to come down to kind of a combination of what we would call strategic and economic considerations on the on the.

And ultimately do what we think is in the best interest of shareholders.

Okay, Great and then maybe.

Kind of a big picture question on prostate cancer landscape. There is a lot of targets out there. If you get to May one PL 3046, obviously and then I guess, both interestingly, Bob the thing, which has a negative correlation profile versus PSM may So I guess.

Make fronts, we wouldn't have to bring in additional capital per data point. We've started to have those conversations just to see what the potential or the likelihood for us to be able to do that and then we will compare that as we advanced the partnering process will be able to compare that kind of side by side and ultimately do what we.

Do we have additional academic work that look at some of the overlapping expression profile.

I think is in the best interest of shareholders.

Actually it has.

Pages for CD 47.

Okay, Great and then maybe.

Big picture question on prostate cancer landscape. There is a lot of targets out there if you get to May one.

Position based on the expression levels.

Just kind of curious about your thinking on that front. Thanks.

846, obviously in I guess, both interestingly, Bob the thing, which has a negative expressed any correlation profile versus P. SMA. So I guess.

Thanks, Andy.

Good question and one that.

We talk about on a pretty regular basis.

We've got a great group of Kols, who are beginning to help us think through this as well.

Do we have additional academic work that look at some of the overlapping expression profile.

If we think about the expression levels of CD 46, we probably can best characterize it as it relates to expression levels.

Actually.

<unk> and when we know that there's a great degree of concordance patients who express the CD 46, epitope and those that express <unk>. We don't we do know that as patients are treated with androgen receptor inhibitors and are treated with <unk>.

Being cages for CD 47.

Position based on the expression levels.

Just kind of curious about your thinking on that front. Thanks.

Thanks, Andy.

Really good question and one that.

Taxane or potentially even <unk> that.

We talk about on a pretty regular basis.

We see some resistance to PSA development <unk> expression levels go down.

We've got a great group of Kols, who are beginning to help us think through this as well.

We're going to be able to tell a lot more we believe.

If we think about expression levels of CD 46, we probably can best characterize it as it relates to expression levels of P. SMA and we know that there is a great degree of concordance patients who express the CD 46, epitope and those that express <unk>. We don't we do know that as patients are treated with androgen receptor inhibitor.

Our phase two monotherapy trial, where we're going to treat all patients with the CD 46, pet imaging agent to be able to characterize the very expression levels. We do think we'll have some some data on many of those patients in terms of their previous <unk> expression levels as well, we'll be able to then do a correlation assessment base.

And are treated with <unk>.

Upon those expression levels in response to the ADC.

Taxane or potentially even <unk>.

And then we will also be able to to look at the data, albeit in a probably a smaller number of patients of how the how our ADC performs in patients who were previously <unk> and those that Werent again, given this kind of the signal that we've seen where it seems that as patients progress and are treated with <unk> with a taxane and <unk>.

That we see some resistance to PSA developing we actually Cps may expression levels go down.

We're going to be able to tell a lot more we believe from our phase two monotherapy trial, where we're going to treat all patients with the CD 46, pet imaging agent to be able to characterize the very expression levels that we do.

Potential with <unk> therapy, SMA levels or altered to some degree.

Do think we'll have some some data on many of those patients in terms of their previous <unk> expression levels as well, we will be able to then do a correlation assessment based upon those expression levels in response to the ADC.

We're not probably going to have much data from our phase II as it relates to any of the other targets. There is as you stated there is some academic work that's been done that looks at expression levels of <unk>.

Then we will also be able to to look at the data, albeit in a probably a smaller number of patients of how the how our ADC performs in patients who were previously uncle Victor when those that Werent again, given this kind of the signal that we've seen where it seems that as patients progress and are treated with that with a taxane and.

Steep one throat to CD 46, P SMA et cetera, and so it's probably premature for us to comment on this point in time as it relates to how CD 46 might overlap with the expression of some of those other targets.

Great.

Helpful look forward to the.

Second half okay great.

With <unk> that their PMA levels or altered to some degree.

Peter laid out.

Great. Thank you.

We're not probably going to have much data from our phase II as it relates to any of the other targets. There is as you stated there is some academic work that's been done that looks at expression levels.

Our next question comes from the line of Matthew Taylor with HC Wainwright. Your line is open.

Oh, Yeah, Hey, guys. Thanks for the update and thanks for taking my question. So just one from us.

Steep one throat to CD 46, P SMA et cetera, and so it's probably premature for us to comment on this point in time as it relates to how CD 46 might overlap with the expression of some of those other targets.

Brito three to four six I was wondering if you could provide a little bit more color on what your thoughts are and what we can expect specifically from the topline data out of the ISP study and really what I'm trying to get out more specifically what are you considering a success.

Great. That's helpful look forward to the second half for the 2006.

From this data readout.

Yes.

Interim readout.

Matt I'll go ahead, and start and Dave feel free to add comments afterwards as well.

Great. Thank you.

Thanks, Dan.

In the preliminary efficacy data from the <unk> portion of the combination trial. There was a preliminary efficacy estimate of $10 two months. So we would see something.

Our next question comes from the line of Matthew Keller with H C. Wainwright. Your line is open.

Oh, Yeah, Hey, guys. Thanks for the update and thanks for taking my question. So just one from us.

Consistent with that I think that that would be.

Brito three to four six I was wondering if you could provide a little bit more color or what your thoughts are and what we can expect specifically from the topline data out of the ISR study and really what I'm trying to get out more specifically what are you considering a success.

Pretty encouraging for us I think it is going to be important to look at the data.

The roughly 44 patients or so and how that data shakes out based upon the number of prior <unk> that a particular patient has been on.

From this data readout.

We think that that will be a part of the disclosure given the IFC nature of that particular trial clearly we're hands off on on the disclosure.

Yeah. Thanks, Matt I'll go ahead, and start and Dave feel free to add comments afterwards as well.

In the preliminary efficacy data from the <unk> portion of the combination trial. There was a preliminary efficacy estimate of $10. Two months. So we would see something consistent with that I think that that would be pretty.

And what that.

That disclosure of that information will say, but I think that that will be also an important part of the learning we do know that the more the.

Pretty encouraging for us I think it's going to be important to look at the data.

The higher the number of ERP is that patients are treated with obviously, regardless of what comes next you'll see a declining our PFS and so I think that that will be an important part of the disclosure.

The roughly 44 patients or so and how that data shakes out based upon the number of prior ERP is that a particular patient has been on.

Dave anything to add to that.

We think that that will be a part of the disclosure given the IFC nature of that particular trial clearly we're hands off on on the disclosure.

No I think you hit the nail on the head thing. Thank you.

Thank you.

Please standby for our next question.

And what that.

Our next question comes from the line of Chen Lin with Lin asset management. Your line is open.

That disclosure and that information will say, but I think that that would be also an important part of the learning we do know that the more.

Alright, guys. Thank you for taking my questions. Many of my question has been answer right.

The higher the number of ERP is that patients are treated with obviously, regardless of what comes next you see a declining our PFS and so I think that that will be an important part of the disclosure.

Curious if there's a line of liability of 63 million on.

On your report.

Is that related to the milestone payment.

Dave anything to add to that.

A D C asset.

No I think you hit the nail on the head thing. Thank you.

I'll take I'll take that.

Thank you.

So now that <unk> liability is actually related to the royalties associated with our a royalty financing with no request capital management and that is associated with our royalty stream from rocks induce that sales and CK D in the European and Japanese territories, where <unk>.

Please standby for our next question.

Our next question comes from the line of Chen Lin with Lin asset management. Your line is open.

Alright, guys. Thank you for taking my questions. Many of my question has been answered right.

Curious if there is a line of liability of $63 million.

We are partnered with Astellas.

In your report.

Oh, okay. Okay, great. So that's a royalty stream and you own royalty right. So you know you saw some royalties.

Is that related to the milestone payment for the.

ADC asset.

Okay.

I'll take I'll take that.

Is there a minimum payment for that royalty or whats the liability looks like Lori just hey, we'll just oh.

Okay.

So now that <unk> liability is actually related to the royalties associated with our a royalty financing with no request capital management and that is associated with our royalty stream from rocks induce that sales and CK D. In the European and Japanese territories, where we are partnered with Astellas.

Future revenue will be covered that.

Yes currently the way the deal is structured is that we own no requests 22.5% of any of the royalties received in those territories. So fiber Jenne, Inc. Owned 77, 5% and then the 22, 5% are paid out to Novo Quest capital management on an annual basis.

Oh, okay, okay, great. So that's a royalty stream.

Your own royalty right. So you know you saw some royalty.

This.

Okay.

Okay. Okay, great. So it's a it's a line item I'm not actual the royalty that you owned them going forward.

Is there a minimum payment for that royalty or whats the liability looks like war chest.

Thank you for that.

Your future revenue will be covered that.

Clarification.

So.

Yes currently the way the deal is structured is that we own no requests 22.5% of any of the royalties received in those.

You have any other.

Item four the potential future milestone you need to pay for the ADC going forward.

Territories, So fiber Jenne, Inc. Owns 77, 5% and then the 22, 5% are paid out to notebook West capital management on an annual basis.

No financial report.

Yes, David I'll take that ill take that one so agenda.

The only.

Future milestone that we would have in the relatively near term related to the agreement that we struck with Fortis in may of 2023 would be if we decide based upon the phase II data, if we decided to move the program into phase III. We will then exercise the option to acquire <unk> therapeutics for <unk>.

Okay. Okay, great. So it's a it's a line item I'm not actual the royalty.

Oh.

Going forward.

Thank you for that.

Clarification.

So.

Do you have any other.

Item four the potential future milestone you would need to pay for the ADC going forward.

$80 million, we would then run the phase III trial and if the data supports then a filing in the product where ultimately to get approved in either the U S or Europe. We would then ODM and an additional milestone based on approval of $75 million.

No financial report.

Yes, Dave I'll take that.

Agenda.

The only.

Future milestone that we would have in the relatively near term related to the agreement that we struck with Fortis in may of 2023 would be if we decide based upon the phase II data, if we decided to move the program into phase III. We will then exercise the option to acquire <unk> therapeutics for <unk>.

And then there would be no.

Royalty obligation on net sales two to four months after that there will be a very small single digit royalty obligation to UCSF, but not to fortis.

And just to add to that the reason why we don't carry the liability on the balance sheet is because it is fully at our discretion. So ethane pointed out if the phase III trial is successful and we like what we see we can exercise that option. If we do not like what we see and we can return the asset back to afford us therapeutics. So what it is.

$80 million, we would then run the phase III trial and if the data supports then a filing in the product where ultimately to get approved in either the us or Europe. We would then ODM and as an additional milestone based on approval of $75 million.

Fully in fiber Jens discretion based upon the outcome of the phase III study of FG $32 46.

And then there would be no.

Royalty obligation on net sales two to four months after that there will be a very small single digit royalty obligation to UCSF, but not to fortis.

Okay, great. Thank you that's the clear cut out a lot when do you decide to decide.

Decide which possibly could go with them.

And just to add to that the reason why we don't carry the liability on the balance sheet is because it is fully at our discretion. So ethane pointed out if the phase III trial is successful and we like what we see we can exercise that option. If we do not like what we see and we can return the asset back to afford us therapeutics so in it.

M D S.

But it's a new phase III trial.

Do you need to do we wanted to wait for the phase two.

Interim resolved or you plan to move that forward before that.

Yes, Thanks Jen.

Completely independent of one another.

Fully in Fibrogenesis discretion based upon the outcome of the phase III study of FG 30 to 46.

And so we're looking at the low risk Mds opportunity for us to stand by itself was a stand alone I would think that we'd be able to have some clarity on the path forward, whether we do it on our own versus whether we partner it probably in the second quarter of next year, we will have better clarity on that.

Okay, great. Thank you that's a clarify a lot when you decide to frankly decide which possibly could go with them.

Our Mds.

It's a new phase III trial.

Thank you.

Ladies and gentlemen, I'm showing no further questions in the queue I would now like to turn the call back over to Dan for closing remarks.

Do you need to do you want to wait for the phase two.

Interim resolved or.

Do you plan to move forward before that.

Yes, Thank you and thanks, everybody for joining us for today's third quarter earnings call and we appreciate your continued interest in <unk> and have a great rest of your day. Thank you.

Yes, Thanks Jen.

They are completely independent of one another.

And so we're looking at the low risk Mds opportunity for us to stand by itself was a stand alone.

Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.

Think that we'd be able to have some clarity on the path forward, whether we do it on our own.

Versus whether we partner it probably in the second quarter of next year, we will have better clarity on that.

Thank you.

Ladies and gentlemen, I'm showing no further questions in queue.

I would now like to turn the call back over to Dan for closing remarks.

Yes, Thank you and thanks, everybody for joining us for today's third quarter earnings call and we appreciate your continued interest in <unk>.

Great rest of your day. Thank you.

Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.

Okay.

[music].

Okay.