Q2 2025 FibroGen Inc Earnings Call

Station, there will be a question and answer session to ask a question. During this session you will need to press star one on your telephone. If your question has been answered and you'd like to remove yourself from the queue simply press Star One again as a reminder, today's program is being recorded and now I'd like to introduce your host for today's program Gaia Seamus for life.

Speaker #2: And now I'd like to introduce your host for today's program, Gaia Shamus, Life Sci Advisors. Please go head.

Thane Wettig: Great, Andy. Thanks for the questions. Clearly, the question about phase 3, we are getting a little bit ahead of ourselves, I think. We have done some thinking about it, and I am going to ask Carol Geddam to maybe share some initial thoughts that we have. But again, I want to caveat by saying that we have got a lot of time and space between where we are now and ultimately, you know, what a phase 3 design could look like. But Carol, I would be interested in any thoughts you might have.

Speaker #3: Thank ou, Jonathan. Good afternoon, everyone. Thank you joining us today to discuss FIBROGEN second quarter 2025 financial and business results. I'm Gaia Shamus with Life Sci Advisors.

Si advisors. Please go ahead.

Okay.

Speaker #3: Joining me on today's call are Thane Wettig, Chief Executive Officer, David DeLucia, Chief Financial Officer, and Carol Geddem, Product Team Lead for FG 3246, FG 3180, and Roxadustet.

Good afternoon, everyone. Thank you for joining us today to discuss <unk> second quarter, 2025 financial and business results and guys, Jamie let's lifestyle.

Carol Geddam: Thank you, Andy, for the question. As you said, this is an evolving field, and we are certainly observing what is happening. At the right point in time, we need to make that decision as to what the right control arm is for our phase 3. 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. This is an area and field to definitely keep an eye on.

Joining me on today's call are aimed petty Chief Executive Officer, David <unk>, Chief Financial Officer, and Carol <unk>.

Speaker #3: Following the preferred 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.

Tim lead RFG or at 246 F. G 31, 80, and Rockford does that.

Speaker #3: 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, risk related to our business, and certain other business matters.

Following the prepared remarks, we will open the call to your questions I would like to remind you that the remarks made on today's call includes forward looking statements about fiber churn.

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.

Thane Wettig: Thanks, Carol. Andy, in terms of the Q4 update on the combo trial with enzalutamide, I think what we are going to be interested in seeing is the more mature RPFS data. The 10.2 months that we previously disclosed was in 17 patients in the escalation phase. There is going to be an additional 24 patients from the expansion phase at 2.1 milligrams per kilogram plus enzalutamide. I think we are going to be interested in seeing if that RPFS number kind of sticks in there. We were really excited about 10.2 months previously. If we see something similar across the broader population of 41 patients in addition to what we have seen across the 17 patients in the escalation phase, I think we would be pretty satisfied with that. Carol, I do not know if you have any additional comments.

Regulatory strategies and potential regulatory results research and development activities.

Speaker #3: 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.

Actual results and results of operations risks related to our business and certain other business matters.

Speaker #3: A more complete description of these and other material risks can be found in FIBROGEN's filing with the SEC, including our most recent Form 10-K and Form 10-Q.

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 pyrogen filing with the SEC, including our most recent Form 10-K and form 10.

Speaker #3: 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 Investor section of FIBROGEN's site, at www.fibrogen.com.

Thank you.

<unk> does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.

Carol Geddam: No additional comments.

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 <unk> website at Www Dot fiber Gen Dot com.

Thane Wettig: Okay, thanks.

Speaker #3: With that, I would like to turn the call over to the CEO, Thane Wettig. Thane.

Andy Hsieh: Great. Moving on to roxadustat, you have had an interesting commercial opportunity here, and also the 7-year exclusivity from the orphan drug designation. I am curious about your most updated thoughts on the IP landscape for roxadustat, matter of composition and other IP that can be layered on to give us an estimate about potential market exclusivity here in the U.S. That is number one. Number two, since we got the minutes back, I am curious about a plausible control arm in the ESA-treated population. Should we be thinking about a placebo control or perhaps an active control? If you can 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.

Speaker #4: Thank you, Gaia. Good afternoon, everyone, and welcome to our second quarter 2025 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, FG 3246, 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 Roxadustet for the treatment of anemia due to lower-risk myelodysplastic syndromes.

That I would like to turn the call over to the CEO and body pain.

Thank you Gary and good afternoon, everyone and welcome to our second quarter 2025 earnings call on today's call I will provide an update on our ongoing efforts to transform <unk> with a focus on our three main priorities the sale of hydrogen China. The advancement of our lead asset. She is $32 46, a potential first in class antibody drug <unk>.

Conjugate targeting CD 46, and its companion pet imaging agent in metastatic castration resistant prostate cancer.

Speaker #4: Then David DeLucia, our FO, will review the financials after which we will open the call for your questions. On slide three, I would ike to update you on our near-term strategic priorities, starting with the sale of FIBROGEN China to AstraZeneca.

And the crystallization of the pathway forward for <unk> for the treatment of anemia due to lower risk Myelodysplastic syndromes, then David <unk>, Our CFO will review the financials after which we will open the call for your questions.

Speaker #4: 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.

On slide three I would like to update you on our near term strategic priorities, starting with the sale of fibers in China to Astrazeneca as.

Thane Wettig: Yeah, thanks, Andy. The first question related to exclusivity, I think what we would want to be thinking about is a minimum of seven years of exclusivity with the orphan drug designation. We do have other opportunities to extend that with various forms of IP. So, I think we would be looking at a minimum of seven years, but we are not going to comment any further at this point in time. We will save that, obviously, if we get into confidential discussions with the potential partners as well. In terms of the phase 3 design and the plausible control arm, this will be a placebo-controlled trial that has been agreed to with the agency. As we articulated in the comments, this is in the post-ESA setting. So, these are patients who are refractory to and eligible for or intolerant to ESAs.

As we've stated previously this is a truly transformative transaction for <unk> as it simplifies our operations allow us 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.

Speaker #4: At the time of the announcement in February, the total consideration for the sale was expected to be approximately $160 million, which included an equity value of $85 million and an expected net cash in China of approximately $75 million upon the close of the transaction.

At the time of the announcement in February the total consideration for the sale was expected to be approximately $160 million.

Speaker #4: During our Q1 earnings call in May, we increased the guidance of our expected net cash in China by $25 million. We are pleased to share that we now expect the total consideration to be approximately $210 million, which is a $50 million increase from our initial guidance and a $25 million increase from our Q1 guidance due to greater-than-expected net cash in China at closing.

Which included an equity value of $85 million and expected net cash in China of approximately $75 million 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 million. We are pleased to share that we now expect the total consideration to be approximately $210 million, which is a $50 million increase from our initial guidance and a $25 million increase from our Q1 <unk>.

Speaker #4: 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.

<unk> due to greater than expected net cash in China at closing.

Thane Wettig: They will be randomized either to roxadustat, 2.5 milligram per kilogram starting dose, or to placebo. We are not going to comment right now on any of the statistical assumptions. We do believe that the trial will be approximately 200 patients. That is pretty consistent with both the iMERGE and the METLUST trials for METLUSTAT and for Luspatercept. The Luspatercept trial, I believe, was 229 patients. The METLUSTAT was, I think, 178 patients. So, we are thinking kind of right in the midpoint or close to the midpoint of those two trials. But we are not going to comment anymore in terms of statistical considerations or assumptions. Carol, anything else to add to that?

This increase in cash further extends the company's cash runway into 2028.

Speaker #4: Second, we remain hyper-focused on advancing FG 3246 and FG 3180 in metastatic castration-resistant prostate cancer, or MCRPC, where we continue to progress trial initiation activities and are on track to begin the phase two monotherapy trial of FG 3246 and FG 3180 in the third quarter of this year, consistent with the timing of the sale of FIBROGEN China.

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 FG $32 46, and <unk> 31, 80 in metastatic castration resistant prostate cancer or <unk>, where we continue to progress trial initiation activities and are on track to begin the phase II monotherapy trial of FG $32 46 and <unk>.

Speaker #4: 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 Roxadustet for the treatment of anemia associated with lower-risk myelodysplastic syndromes, in patients with high transfusion burden.

<unk> thousand 180 in the third quarter this year consistent with the timing of the sale of fibers in 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 III trial in Caracas do step for the treatment of anemia associated with lower risk Myelodysplastic syndromes in patients with high transfusion burden.

Carol Geddam: Just the fact that I think with those inclusion and exclusion criteria that Thane outlined, we are positioning roxadustat in the second-line to third-line setting. So, it is in ESA failure patients, and we allowed trial Luspatercept. So, it is a second-line, third-line setting where it will be a placebo-controlled trial.

Speaker #4: The Type C meeting request was based on the results of a post-hoc subgroup analysis from the Matterhorn phase three trial where Roxadustet demonstrated a meaningful effect in patients with a high transfusion burden at baseline.

The type C meeting request was based on the results of a post hoc subgroup analysis from the Matterhorn phase III trial, where <unk> demonstrated a meaningful effect in patients with a high transfusion burden at baseline.

Speaker #4: 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 fourth quarter of this year.

Andy Hsieh: Got it. That is helpful. Thank you so much.

Thane Wettig: Any additional questions, Andy?

Andy Hsieh: is it for us. Thank you so much.

Thane Wettig: No, appreciate it.

Jonathan: Thank you. Our next question comes from the line of Matthew Keller from H.C. Wainwright. Your question, please.

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 III trial and plan to submit the final protocol to the FDA in the fourth quarter of this year.

Speaker #4: 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.

Matthew Keller: Hey, good afternoon, everyone, and thanks for taking our question. I will join the course of congrats on the call and the regulatory updates. My question is, you kind of touched on this subject, but following the publication of that FG-3246 Phase 1 data, I am kind of curious what kind of additional feedback you might have received since then, particularly from the physician community around those results.

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.

Speaker #4: I will now provide an overview of our FG 3246 and FG 3180 programs in MCRPC. Slide five highlights the high unmet need in late-stage prostate cancer.

I will now provide an overview of our ft, $32 46, and <unk> 31, 80 programs NMC RPC.

Speaker #4: Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S. Of these, there are 65,000 drug-treatable patients, where the cancer has metastasized and become castrate-resistant, resulting in a grim five-year survival rate of approximately 30%.

Thane Wettig: Yeah, thanks, Matt, for the question. You know, 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 was 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 2.7 milligrams per kilogram. People continue to be excited about the program. We've had conversations, obviously, with clinical sites. We've got the sites already selected.

Slide five highlights the high unmet need in late stage prostate cancer.

Approximately 290000 men diagnosed with prostate cancer each year in the U S.

Speaker #4: 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 billion in annual sales in the U.S. alone.

There are 65000 drug treatable patients, where the cancer has metastasized and become castrate resistant, resulting in a grim five year survival rate of approximately 30%.

There remains a significant opportunity for new treatments that can extend survival for these men. We estimate this translates into a total addressable market of over $5 billion in annual sales in the U S alone FG $32 46 could be this new treatment option.

Speaker #4: FG 3246 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.

Speaker #4: It is upregulated during tumorogenesis and helps tumors evade complement-dependent cytotoxicity. Importantly, the expression of CD46 is also upregulated in the progression from localized to castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer.

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

Thane Wettig: 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 FG-3246 with a companion PET imaging agent, not only because of the unmet need in that space, but because it offers a non-PSMA opportunity. That's what we hear from a lot of these clinical sites as well, is that they're excited about the targets, 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. Any additional comments from you would be appreciated.

It is up regulated during tumor agenesis and helps tumors abate complement dependent cytotoxicity.

Importantly, the expression of <unk> 46 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 energen signaling inhibitors.

Speaker #4: And further over-expressed following treatment with androgen signaling inhibitors. As you see in the graph on the right, CD46 is highly expressed in MCRPC tissues, with lower inner patient variability and higher median expression compared with PSMA, making it an attractive therapeutic target.

As you can see in the graph on the right. <unk> 46 is highly expressed in EMC RPC tissues with lower inter patient variability and higher median expression compared with PSA made making it an attractive therapeutic target.

Speaker #4: Turning to slide seven, FG 3246 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.

Carol Geddam: Just echoing the fact that we are getting very good feedback from sites in our phase 2 preparation efforts in terms of that being an area of unmet need where the antibody-drug conjugate can really fit. Thank you.

Turning to slide seven FTE 30 to 46 is our potential first in class ADC in development for metastatic castration resistant prostate cancer the.

Speaker #4: FG 3246 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, FG 3180, utilizes the same YS5 targeting antibody as FG 3246 and is also under clinical development.

The ADC combines the yf's five antibody within MMA payload to specifically target the tumor selective epitope of CD 46 ft.

Matthew Keller: Yeah, great. Very helpful. Excuse me. Thank you very much.

Thane Wettig: Other questions, Matt?

Matthew Keller: Nope, that is it from us as well.

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

Thane Wettig: Okay.

Jonathan: Thank you. This does conclude the question and answer session of today's program. I would like to hand the program back to Thane Wettig for any further remarks.

Thane Wettig: Thank you, John. We appreciate everybody joining us for today's second quarter earnings call and for your continued interest in FibroGen Inc. Enjoy the rest of your day. Thanks, everybody.

Speaker #4: 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 FG 3246 and the prostate cancer treatment paradigm.

The companion Pet imaging agent Fg's 31, <unk> utilizes the same <unk> targeting antibody as FG $32 46, and is also under clinical development and preclinical.

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

<unk> studies, the pet imaging agent has demonstrated specific targeting up and uptake by CD 46 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 III trial, but it would also enable differentiation of <unk> $32 46 in the prostate cancer treatment paradigm in.

Speaker #4: 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 eight recaps the top-line results from the Phase One monotherapy study.

In addition, FG 31, 80 could represent an important commercial opportunity as a companion diagnostic to FG $32 46, similar to the existing <unk> pet agents.

Speaker #4: The study included 56 metastatic castration-resistant prostate cancer patients who were biomarker unselected and were heavily pretreated. Receiving a median of five lines of therapy prior to FG 3246.

Slide eight recaps the topline results from the phase one monotherapy study.

The study included 56, metastatic castration resistant prostate cancer patients, who are biomarker and selected and we will and we're heavily pretreated received a median of five lines of therapy prior to FG $32 46, and the efficacy Evaluable population of 40 patients a mean radiographic progression free survival.

Speaker #4: In the efficacy evaluable population of 40 patients, a mean radiographic progression-free survival of 8.7 months was observed. In addition, there was an overall response rate of 20% confirmed by RECISC 1.1, and PSA reductions of greater than 50% were observed in 36% of patients.

Of eight seven months was observed.

In addition, the result, there was an overall response rate of 20% confirmed by resist one one and PSA reductions of greater than 50% were observed in 36% of patients.

Speaker #4: 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 one monotherapy study FG 3246 showed what we believe to be compelling clinical activity.

Adverse events were consistent with those observed with other <unk> 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 one monotherapy study FG $32 46 showed what we believe to be compelling clinical activity.

Speaker #4: Putting the results in the context on slide nine, when we look across the RPFS results, a recognized regulatory endpoint in prostate cancer treatment of FG 3246 in its phase one study versus other comparable early-stage studies.

Putting the results into context on slide nine when we look across the our PFS results are recognized regulatory endpoint in prostate cancer treatment.

Speaker #4: FG 3246 demonstrated an RPFS of 8.7 months across a robust sample size of 40 heavily pretreated patients. While we cannot make direct comparisons to these trials, due to differences in study design and prior prostate cancer treatments, we are encouraged by these RPFS results.

$232 46 in its phase one study versus other comparable early stage studies FG $32 46 demonstrated in our PFS of $8 seven months across a robust sample size of 40 40 heavily pretreated patients.

Speaker #4: 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, 70% of whom were pretreated with at least two prior ARSIs.

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 are PFS results.

On slide 10, we highlight previously reported preliminary efficacy data from the phase <unk> portion of the ongoing investigator sponsored combination study with <unk>.

Speaker #4: In addition to establishing the phase two dose of FG 3246, this IST also demonstrated an encouraging 10.2 months of radiographic progression-free survival, with PSA declines observed in 71% of evaluable patients.

These interim results included data on 17, biomarker unselected patients, 70% of which were pretreated with at least two prior <unk>.

In addition to establishing the phase II dose of <unk> $32 46.

Speaker #4: We remain on track to report the Phase Two top-line results in the fourth quarter of 2025, which will also include data on CD46 expression in patients treated with FG 3180 or PET biomarker during the Phase Two portion of the IST.

This ISP also demonstrated an encouraging $10 two months of radiographic progression free survival with PSA declines observed in 71% of Evaluable patients we.

We remain on track to report the phase two topline results in the fourth quarter of 2025, which will also include data on CD 46 expression in patients treated with FG 31, 80 or biomarker during the phase two portion of the ISP.

Speaker #4: 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 FG 3246 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.

On Slide 11, there is a cross trial comparison of the initial results from the monotherapy trial in heavily pretreated patients in the combination trial for FG 3246 versus the Rpms 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.

Speaker #4: We believe FG 3246 shows competitive RPFS results in the monotherapy and the combination therapy settings. Based on these results, slide 12 highlights the phase two monotherapy dose optimization trial design that will commence in the third quarter of this year.

And previous prostate cancer treatments, we believe that <unk> $32 46 shows competitive <unk> results in the monotherapy and the combination therapy settings.

Speaker #4: We plan to enroll 75 patients in the post-ARSI pre-chemo setting across three dose levels to determine the optimal dose for Phase 3, based on efficacy, safety, and PK parameters.

Based on these results slide 12 highlights the phase two monotherapy dose optimization trial design that will commence in the third quarter. This year.

We plan to enroll 75 patients in the post <unk> pre chemo setting across three dose levels to determine the optimal dose for phase III based on efficacy safety and PK parameters.

Speaker #4: It is important to note that the 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-comer's population.

It is important to note that the <unk> 31, 80 will be an integral part of the study as we seek to demonstrate the correlation between <unk> 46 expression and response to the ADC in this all comers population.

Speaker #4: 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.

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 MMA payloads and experienced in the phase one monotherapy trial.

Speaker #4: The addition of GCSF 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.

Speaker #4: An interim analysis of the Phase Two trial is planned for the second half of 2026. We'll include efficacy, safety, PK, and exposure-response data that we will report as they become available.

The addition of UCSF is designed to reduce dose reductions and interruptions and may enable a better tolerated and more consistent treatment.

In the phase III.

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 we will report as they become available given the open label design.

Speaker #4: Given the open-label design, slide 13 articulates why. So optimistic about the potential for a phase two study to further on the efficacy results. In our phase one study, we believe there are three factors that could drive an improved RPFS relative to 8.7 months that was observed in the phase one monotherapy trial.

Slide 13, articulate why so optimistic about the potential for our phase II study to further upon the efficacy of was a little bit.

Speaker #4: First, leveraging the preliminary evidence of an exposure-response relationship from the phase one dose escalation and expansion study, thereby enabling the focus of the phase two study on three of the highest doses from the phase one trial.

In our phase one study.

There are three factors that could drive an improved RP are positive to the $8 seven months that was observed in the phase one monotherapy trial.

First leveraging the preliminary evidence of an exposure response relationship from the phase one 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.

Speaker #4: Second, utilizing primary prophylaxis with GCSF 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.

Second utilizing primary prophylaxis with 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.

Speaker #4: 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 median by prior lines of therapy in the Phase One trial.

Speaker #4: Together, we believe these design elements have the potential to improve upon the phase one results and achieve an RPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness.

Third enrolling healthier patients in earlier lines of therapy versus the median by prior lines of therapy in the phase one trial.

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

Speaker #4: Slide 14 depicts our long-term development strategy for FG 3246 and FG 3180, which in our view provides important optionality in prostate cancer. We have a robust phase two monotherapy trial in the post-ARSI prechemo setting in MCRPC to further build upon the compelling 8.7 months of RPFS seen in the phase one study.

Slide 14 depicts our long term development strategy for <unk>, $32, 46, and <unk> 31, 80, which in our view provides important optionality in prostate cancer we.

We have a robust phase two monotherapy trial in the post rsi pre chemo setting NMC RPC to further build upon the compelling eight seven months of our PFS seen in the phase one study.

Speaker #4: In addition, the Phase Two 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.

In addition, the phase II study will explore the correlation between <unk> 46 expression and response to the ADC potentially validating FG 31, 80, as a predictive patient selection biomarker in future studies.

Speaker #4: 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, and monotherapy and/or in combination with an ARSI, and in an all-comer's population or patients with high expression of CD46.

We are confident that our development pathway for FG three to 46 unlocks sequential or parallel registrational pathways as FG, 3% to 46 will be evaluated in multiple lines of therapy in monotherapy <unk> in combination with an IRR side.

Speaker #4: Slide 15 highlights the recent and upcoming catalysts for the FG 3246 and FG 3180 program. We are on track to initiate the phase two monotherapy trial this quarter, in which all patients will be treated with FG 3180 to enable assessment of both its diagnostic performance and the potential correlation between CD46 expression and response to FG 3246.

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

Slide 15 highlights the recent and upcoming catalysts for the $32 46, and <unk> 31, 80 program. We are on track to initiate the phase II monotherapy trial this quarter in which all patients will be treated with FG $3 80 to enable assessment of both its diagnostic performance and the potential correlation between <unk> 46.

Speaker #4: Additionally, in the fourth quarter, we expect the top-line results from the Phase 2 IST of FG 3246 and Enzalutamide, as well as data from FG 3180.

<unk> expression and response to FG $32 46.

Speaker #4: As I previously mentioned, we expect to report interim results from the phase two monotherapy trial in the second half of 2026. To summarize, on slide 16, FG 3246 targets a novel epitope on prostate cancer cells, with potential first-in-class given that there are no other CD46-targeted projects in linical development.

Additionally, in the fourth quarter, we expect topline results from the phase II <unk> <unk>.

<unk> $32 46, and <unk> as well as data from FG $30 80 as I previously mentioned, we expect to report interim results from the phase two monotherapy trial in the second half of 2026.

To summarize on slide 16, FG 30 to 46 targets and novel Epitope on prostate cancer cells with potential first in class.

Speaker #4: Targeting CD46 with FG 3246 has already demonstrated promising early efficacy signals with an acceptable safety profile both in monotherapy and combination settings. We are excited for the upcoming milestones and look forward to updating you on the program as the studies progress.

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

Turning to 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. We're excited for the upcoming milestones and look forward to updating you on the program as the studies progress.

Speaker #4: Turning Roxadustet, slide 18 highlights unmet need and the potential for Roxadustet in patients with anemia associated with lower-risk MDS. Current treatments are only effective in approximately 50% of patients.

Turning to <unk> slide 18 highlights the unmet need and the potential for <unk> in patients with anemia associated with lower risk Mds.

Speaker #4: 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.

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

Speaker #4: 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.

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 U S.

Speaker #4: This potential exclusivity, combined with an attractive market opportunity and an 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.

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 <unk> in anemia associated with lower risk Mds.

Speaker #4: 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 Matterhorn study of Roxadustat with a high transfusion burden.

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 III Matterhorn study of <unk> with a high transfusion burden.

Speaker #4: 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.

Speaker #4: 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, Roxadustet showed a meaningful difference with 36% of patients on Roxadustet achieving transfusion independence for greater than or equal to 56 days versus only 7% in the placebo group, with a nominal P value of 0.041.

In this analysis, we use 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 and our proposed phase III trial as you can see <unk> that showed a meaningful difference with 36% of patients are actually used at achieving transfusion independence for greater than or equal to 56 days versus only <unk> <unk>.

Speaker #4: 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 a post-hoc analysis that was previously presented at ASH in late 2023—and which we have highlighted on previous calls—higher transfusion burden was defined as two or more units in four weeks in that subgroup. 36.1% of patients on Roxadustat achieved transfusion independence versus 11.5% on placebo.

7% 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 2023, and which we have highlighted on previous calls higher transfusion burden was defined.

As two or more units in four weeks in that subgroup 36, 1% of patients on <unk> achieved transfusion independence versus 11, 5% on placebo.

Speaker #4: The consistency of results from both of these post-hoc analyses give us confidence that Roxadustet can demonstrate a meaningful treatment effect in a phase three trial focused on the high transfusion burden population.

The consistency of results from both of these post hoc analyses give us confidence that rock for oxygen that can demonstrate a meaningful treatment treatment effect in a phase III trial focused on the high transfusion burden population.

Speaker #4: 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 three trial summarized on slide 21.

We had a positive type C meeting with the FDA in July and have received the formal meeting minutes from the agency. We are 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 and to.

Speaker #4: 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.

Speaker #4: We also agreed with the FDA on the dose regimen including the starting dose of 2.5 milligrams per kilogram and on the management of potential thrombotic risk through trial eligibility, dose modification, and discontinuation criteria.

<unk> eight week periods prior to randomization, who are refractory to intolerant to or an eligible for prior erythropoiesis stimulating agents.

We also agreed with the FDA on the dose regimen, including the starting dose of two 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 16 week RBC transfusion independence as the <unk>.

Speaker #4: We are currently evaluating eight-week and 16-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 three study design, and we anticipate submitting the final protocol for the phase three trial evaluating Roxadustet for patients with lower-risk MDS and anemia with high transfusion burden to the FDA in the fourth quarter of 2025.

Potential primary endpoint for the trial.

Based on the feedback we received from the FDA. The team is actively working on finalizing that pivotal phase III study design and we anticipate submitting the final protocol for the phase III trial evaluating <unk> for patients with lower risk Mds and anemia with high transfusion burden to the FDA in the fourth quarter of 2025.

Speaker #4: In the meantime, we continue to explore our clinical development options which include maintaining Roxadustet as a wholly-owned asset and running the phase three trial on our own or partnering the program.

In the meantime, we continue to explore our clinical development options, which include maintaining rocks and use that as a wholly owned asset and running the phase III trial on our own or partnering the program.

Speaker #4: 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.

Speaker #4: Dave.

We have initiated outreach and will ultimately choose the path that we believe is in the best interest of shareholders.

Speaker #5: Thank you, Thane. I will first review the updated FIBROGEN China transaction details and then provide the company's financial performance for the second quarter of 2025.

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

Eric.

Speaker #5: As a reminder, our China operations are reflected as discontinued operations throughout our financials. We will continue to report our China operations in discontinued operations moving forward.

Thank you. Thanks, I will first review the updated fabrics in China transaction details and then provide the company's financial performance for the second quarter of 2025 as a reminder, our China operations are reflected as discontinued operations throughout our financials. We will continue to report our China operations.

Speaker #5: 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 million plus FibroGen net cash held in China at closing, estimated to now be approximately $125 million.

Discontinued operations moving forward on.

On slide 23, we highlight the summary of the key financial terms of the transaction.

Under the terms of the agreement fiber, Germany receive an enterprise value of $85 million cloth fibre net cash held in China closing estimated to now be approximately $125 million with a total consideration now expected to be approximately $210 million.

Speaker #5: With the total consideration now expected to be approximately $210 million. This is a $50 million increase from our initial net cash guidance in February and a $25 million increase from our updated guidance in May.

Speaker #5: As a reminder, the value of FibroGen net cash in China includes FibroGen's portion of FoleyCong net cash, which is the joint distribution entity owned by FibroGen and AstraZeneca.

This is a $50 million increase from our initial guidance in February and a $25 million increase from our updated guidance in may as a reminder, the value of fiber just like cash in China includes fiber portion of Folly Tong net cash which is the joint distribution entity owned by fiber gender and Astrazeneca.

Speaker #5: Given the company's current market capitalization of approximately $40 million, we believe these increases in expected net cash received upon the close of the transaction represent a meaningful outcome for shareholders and further extend the company's cash runway all the way into 2028.

Given the company's current market capitalization of approximately $40 million. We believe these increases and 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 import.

Speaker #5: 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.

<unk> fiber, Jim will continue to accrue cash generated in China until the closing of the transaction.

Truly transformative transaction allows us to pay down our senior term loan facility with MF PV provide full access to our cash in China and extends the company's runway into 2028 to support U S development initiatives.

Speaker #5: Now, onto the company's financials for the second quarter. For the second quarter of 2025, total revenue was $1.3 million, compared to $1 million for the same period in 2024.

Now onto the company's financials for the second quarter for the second quarter of 2025 total revenue was $1 3 million compared to $1 million for the same period in 2024.

Speaker #5: For a full year of 2025, we are raising the lower end of our revenue guidance to $6 million. We expect total revenues to be between $6 million and $8 million.

For full year 2025, we are raising the lower end of our revenue guidance of $6 million and expect total revenues to be between $6 million and $8 million.

Speaker #5: Now, moving down the income statement. Total operating costs and expenses for the second quarter of 2025 were $13.4 million, compared to $47.4 million for the second quarter of 2024.

Now moving down the income statement total operating costs and expenses for the second quarter of 2025, or $13 4 million compared to $47 4 million for the second quarter of 2024, a decrease of $34 million or 72% year over year.

Speaker #5: A decrease of $34 million or 72% year over year. R&D expenses for the second quarter of 2025 were $5.9 million, compared to $32.4 million in the second quarter of 2024, a decrease of 26.5 million or 82% year over year.

R&D expenses for the second quarter of 2025, or $5 9 million compared to $32 $4 million in the second quarter of 2024, a decrease of $26 5 million or <unk>, 82% year over year.

Speaker #5: SG&A expenses for the second quarter of 2025 were $7.1 million, compared to $14.9 million in the second quarter of 2024, a decrease of $7.8 million, or 53%, year over year.

SG&A expenses for the second quarter of 2025 or $7 1 million.

Speaker #5: During the second quarter of 2025, we recorded a net loss from continuing operations of $13.7 million or $3.38 net loss per basic and diluted share as compared to a net loss of $47.1 million or $11.79 per basic and diluted share for the second quarter 2024.

Compared to $14 $9 million in the second quarter of 2024, a decrease of $7 8 million or.

Or 53% year over year.

During the second quarter of 2025, we recorded a net loss from continuing operations of $13 7 million or $3 38, net loss per basic and diluted share as compared to a net loss of $47 1 million or $11 79 per basic and.

Speaker #5: For a full year of 2025, we are updating our guidance for our total operating costs and expenses including stock-based compensation to be between $65 million and $75 million.

Diluted share for the second quarter of 2024 four.

For full year 2025, we are updating our guidance for our total operating costs and expenses, including stock based compensation to be between $65 million and $75 million, which represents a $5 million reduction at the midpoint from our previous guidance.

Speaker #5: Which represents a $5 million reduction at the midpoint from our previous guidance. This also represents a 61% reduction from full year 2024. Now shifting towards cash.

Speaker #5: As of June 30th, we reported $23.5 million in cash. Cash equivalence and accounts receivable in the US. And $142.1 million in total consolidated cash, cash equivalence, and accounts receivable when including balances in China.

Also represents a 61% reduction from full year 2024.

Now shifting towards cash as of June 30, we reported $23 $5 million in cash cash equivalents of accounts receivable in the U S and $142 1 million and total consolidated cash cash equivalents and accounts receivable when including balances in China The company with cash.

Speaker #5: The company was cash flow positive in the second quarter of 2025. Generating a total of $13.7 million in cash flow on a total consolidated basis.

Speaker #5: 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 third quarter 2025.

So positive in the second quarter of 2025, generating a total of $13 $7 million in cash flow on a total consolidated basis given.

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 third quarter of 2025.

Speaker #5: Upon close of the China transaction, we plan to pay off our senior secured term loan with Morgan Stanley Tactical Value, resulting in a cash outflow of approximately $80 million.

Speaker #5: This includes the $75 million principal balance, accrued and unpaid interest, and an applicable prepayment penalty. Post the payoff of our MSTV term loan, we expect the company to have cash runway into 2028.

Upon close of the China transaction, we plan to pay off our senior secured term loan with Morgan Stanley tactical value, resulting in a cash outflow of approximately $80 million.

This includes the $75 million principal balance accrued and unpaid interest.

Speaker #5: Thank you, and now I will turn the call back over to Thane.

And an applicable prepayment penalty post the payoff of our MSC. The term loan we expect the company to have cash runway into 2028. Thank you and now I will turn the call back over to Fame.

Speaker #2: Thank you, Dave. In summary, we're extremely excited about our clinical development programs for FG 3246 and Roxadustet. We are oking forward to the close of the FIBROGEN China sale in the near future and continue to advance our US development initiatives with our strong balance sheet and extended cash runway into 2028.

Thank you Dave.

In summary, we are extremely excited about our clinical development programs for FG three to $46 <unk>.

Speaker #2: We have multiple near-term catalysts across our exciting pipeline, first the upcoming initiation of the phase two monotherapy study for FG 3246, our potential first-in-class ADC, and FG 3180, its companion PET imaging agent in MCRPC.

We're looking forward to the close of the fibers in 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 <unk> hundred 46, our potential first in class ADC Mfg, 31, 80, its companion pet imaging agent NMC RPC.

Speaker #2: Second, we are on track to report top-line results from the Phase Two portion of the IST for FG-3246 in combination with Enzalutamide in the fourth quarter of this year.

Speaker #2: Third, with a positive feedback received from the FDA, we now have a path forward to advance Roxadustet for the treatment of anemia associated with lower-risk MDS.

We are on track to report top line results from the phase II portion of the ISC grip to $32 46 in combination with <unk> in the fourth quarter. This year.

Speaker #2: We are finalizing the pivotal phase three protocol and anticipate submitting it in the fourth quarter of 2025. Together, these events are setting the stage for an exciting second half of 2025 and beyond.

Third with the positive feedback received from the FDA. We now have a path forward to advance <unk> for the treatment of anemia associated with lower risk Mds, we are finalizing the pivotal phase III protocol and anticipate submitting it in the fourth quarter of 2025 together.

Speaker #2: 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.

Together these events are setting the stage for an exciting second half of 2025 and beyond.

Speaker #6: Certainly. And our first question for today comes from Angie Shea from William Blair. Your question, please.

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 #7: Hello. Great. Congratulations on all the regulatory and business development progress. And thanks for taking our question. So beginning with FG 3246, I'm curious about your take on this.

Certainly and our first question for today comes from line of AMG Shea from William Blair. Your question. Please.

Great Congratulations on all the regulatory and business development.

Speaker #7: Just because speaking with some of the KOLs, there's an emerging desire to have dose tactical included in the control arm for Phase 3. 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 the dose tactical just as a preparation for a Phase 3 program in the future.

And thanks for taking our question so beginning with FTE 70 246.

I'm curious about your take on this just because speaking with some of the Kols.

There is.

Emerging desire.

Should have docetaxel included in the control arm for phase III, I know thats far away, but I'm curious if it's important as you develop this asset to have some data in combination.

Speaker #7: 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.

Tax so just as a preparation for our phase III program in the future.

And then the second part is mostly about the Q4 update.

Speaker #7: So they can be informative to 3,246 clinical profiles. And I have a couple of follow-ups for Roxette as well. Great, Andy. Yeah. Thanks for the questions.

Just curious if you have any clinical parameters that you are particularly focused on.

And the bar for success.

They can be informative too.

Speaker #7: Clearly, the question about phase three, 're getting a little bit ahead of ourselves, I ink. We have done some thinking it, and I'm going to k Carol to maybe share some initial thoughts that we have.

30, <unk> hundred 46 clinical profile and I have a couple of follow ups for rocket as well.

Great Dan Thanks.

Thanks for the questions.

Speaker #7: 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 3 design could look like.

Clearly the question about phase III, and 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 <unk>.

Speaker #7: But Carol would be interested in any thoughts you might have.

Speaker #8: 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 three.

Time and space between where we are now and ultimately.

<unk> III design could look like that Carol will be interested in any thoughts you might have.

Thank you Andy for the question.

As you said this is an evolving field and <unk>.

Speaker #8: We certainly recognize that it might include a physician's choice control arm, including an ARSI switch and potentially dose tactical. And maybe there will be others.

Certainly.

<unk>, what's happening and it's the right point in time, we need to make that decision as to what the right control arm. It's for our phase III, we certainly recognize that and.

Speaker #8: So, an area and field to definitely keep an eye on.

It might include a physician's choice control arm.

Speaker #7: Thanks, Carol. And then Andy, in terms of the Q4 update on the combo trial with Enzalutamide, I think what we're going to be interested in seeing is the more mature RPFS data.

And AISI switch and potentially Docetaxel and maybe there will be others. So an ariane field to definitely keep an eye on.

Thanks Carol.

Speaker #7: So the 10.2 months that we previously disclosed was in 17 patients in the escalation phase. There's going to be an additional 24 patients from the expansion phase at 2.1 milligrams per kilogram plus Enzalutamide.

And then Andy in terms of the Q4 update on the combo trial with <unk> I think what we're going to be interested in seeing is.

The more mature PFS data so the $10 two months that we previously disclosed was in 17 patients in the escalation phase there's going to be an additional 24 patients from the expansion phase at $2, one milligrams per kilogram, plus <unk> and so I think we're going to be interested in seeing if that rpms numbers.

Speaker #7: And so I think we're going to be interested in seeing if that RPFS number kind of sticks in there. And you know, we're really excited about 10.2 months previously.

Speaker #7: And if we see something similar across the broader population of 41 patients, in addition to what we've seen across the 17 patients in the escalation phase, I think we'd be pretty satisfied with that.

Six in there and we're really excited about $10 two months previously.

If we see something similar across the broader population of 41 patients. In addition to what we've seen across the 17 patients in the escalation phase I think we'd be pretty pretty satisfied with that Carol I don't if you have any additional comments.

Speaker #7: Carol, I don't know if you have any additional comments.

Speaker #3: No additional comments.

Speaker #2: Okay. Thanks.

Speaker #6: Great. So moving on to Roxette, you kind of laid out the interesting commercial opportunity here. And also the seven-year exclusivity from the orphan and drug designation.

No additional comments.

Okay. Thanks.

Great so moving on to the rocks.

Speaker #6: And so I'm curious about your most updated thoughts on the IP landscape for Roxette, nanocomposition, and other IP that can be layered on. To give us an estimate about potential market exclusivity here in the United States.

You kind of lay out the.

Interesting commercial opportunity here.

And then also the 70 year.

Excuse me from the orphan drug designation.

So I'm curious about your most updated thoughts on the IP landscape for Roxanne.

Speaker #6: 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.

Net of the composition and other IP.

IP that can be layered on.

Can you give us your estimate about potential market exclusivity here in the United States.

Thats number one and number two since you got the minutes back.

Speaker #6: Should we be thinking about maybe like a placebo control or perhaps an active control? And then if you can, maybe share with us some of the statistical assumptions that you have?

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.

Speaker #6: Is it just based on the Matterhorn subset analysis? We're baking in some sort of margins for error. Thank you.

And then.

You can maybe.

Share with us some of the.

Speaker #7: Yeah. Thanks, Andy. The first question related to exclusivity; I think what we would want to be thinking about is a minimum of seven years of exclusivity with the orphan drug designation.

Statistical assumptions that you have is it just based on the Matterhorn subset analysis, we're baking in some sort of margin for error.

Thanks, Andy.

The first question related to exclusivity I think what we wouldn't.

Speaker #7: 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 seven years.

What we want to be thinking about is a minimum of seven years of exclusivity with the orphan drug designation we.

Speaker #7: We're not going to comment any further at this point in time. And you know we'll save that obviously if we get into you know confidential discussions with the potential partners as well.

We do have other opportunities to extend that.

Various forms of IP. So I think we would be looking at a minimum of seven years, we're not going to comment any further at this point in time, and we will say that obviously, if we get into confidential discussions with potential partners as well in terms of the.

Speaker #7: In terms of the Phase 3 design and you know the plausible control arm, this will be a placebo-controlled trial. That's been agreed to with the agency.

Speaker #7: And so, as we articulated in the comments, this is in the post-ESA setting. These are patients who are refractory to and are either eligible for or intolerant to ESAs.

The phase III design, the plausible control arm. This will be a placebo controlled trial that has been agreed to with the agency and so.

As we articulated in the in the comments. This is in the post Esa setting. So these are patients who are refractory refractory to an eligible for or intolerant to <unk> and then they will be randomized either to rocks induced at two five milligram per kilogram.

Speaker #7: And then they will be randomized either to Roxadustat 2.5 milligrams per kilogram starting dose or to placebo. We're not going to comment right on any of the statistical assumptions.

Speaker #7: We do believe the trial will be approximately 200 patients. That's pretty consistent with both the iMERGE and the MEDLIST trials for MEDLIST and for Luspatercept.

Starting dose or to placebo.

We're not going to comment right now on any of the statistical assumptions. We do believe that the trial will be approximately 200 patients thats pretty consistent with both the <unk> emerge in the metals trials for.

Speaker #7: The Luspatercept trial, I believe, was 229 patients. The MEDLIST was, I ink, 178 patients. And so we're thinking kind of right in the midpoint of or close to the midpoint of those two trials.

And metal staff and for <unk>.

Speaker #7: But we're not going to comment anymore in terms of statistical considerations or assumptions. Carol, anything else to add to that?

A trial I believe was 229 patients see.

<unk> I think a 178 patients and so we're thinking kind of right in the midpoint of closer to the midpoint of those two trials.

Speaker #3: Just the fact that I think with those inclusion-exclusion criteria that Thane outlined, we're positioning Roxadustet in the second line to third line setting. So if in ESA failure patients and we allow prior Luspatercept, and so it's a second line, third line setting where it'll be a placebo-controlled al.

We're not going to comment any more on that in terms of statistical considerations or assumptions Carol anything else to add to that.

Just the fact that I think with the inclusion exclusion criteria that <unk> outlined we're positioning Rockford you said in the second line to third line setting.

In Esa nave patients and allow us buyout of this quarter's deck and so it's that second line third line setting where it will be a placebo controlled trial.

Speaker #6: Got it. That's helpful. Thank you so much.

Speaker #7: Any additional questions, Andy?

Speaker #6: That's it for us. Thank you so much.

Speaker #2: Great. No, I appreciate it.

Speaker #6: Thank you. And our next question comes from the line of Matthew Keller from HC Wainwright. Your question, please.

Okay.

Got it that's helpful. Thank you so much any additional questions Andy.

Speaker #9: Hey, good afternoon, everyone. And thanks for taking our question. I'll join the chorus of congrats on the court and the story updates. But my question is, you kind of touched on this subject, but following the publication of that 3246 Phase 1 data, I'm kind of curious what kind of additional feedback you might have received since then.

That's it for us thank you so much.

Got it.

Thank you and our next question comes from the line of Matthew <unk> from HC Wainwright. Your question. Please.

Hey, good afternoon, everyone.

Thank for taking my question ill join the chorus congrats on.

According to regulatory updates.

But my question is you kind of touched on the subject, but following the publication of that three to four phase one data.

Speaker #9: Particularly from the physician community around those results.

Speaker #2: Yeah. Thanks, Matt. For the question, you know it's 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.

Im curious what kind of additional feedback you might have received something particularly from the physician community around those results.

Yes, 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.

Speaker #2: 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 was 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 2.7 milligrams per kilogram.

Are very attuned to ongoing developments in the metastatic castration resistant prostate cancer space they.

They are encouraged by the data I think one that you. Another data point that was in that Jay Seo a publication that we don't necessarily talk a lot about but it was clearly there is is that there seem to be a dose response, given the fact that all of the five.

Borrowers were achieved in patients who were on at least $2 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 ASI pre chemo setting there was a clear place for an opportunity like <unk> 30 to 46 with a companion.

That engine agents.

Not only because of the unmet need in that space, but because it offers and non PSA opportunity and Thats, what we hear from a lot of these clinical sites as well as that they are excited about the targets and they are excited about the fact that there is now a non PSA may approach that can potentially help patients.

You've got a good pulse on this as well so any additional comments from you would be appreciated.

Just echoing the fact that we're getting very good feedback from sites in our phase II preparation efforts in terms of that being an area of unmet need where the ADC can really fit thank you.

Yes, great very very helpful. Excuse me. Thank you very much.

Other questions Matt.

That's it from us as well.

Okay.

Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to things waiting for any further remarks, yes. Thank you John and we appreciate everybody joining us for todays second quarter earnings call and for your continued interest in fiber to and enjoy the rest of your day. Thank you everybody.

Ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.