Q4 2024 FibroGen Inc Earnings Call
Hello, everyone and welcome to the fabric in fourth quarter and full year 2024 earnings conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to participate you will need to press star one one on your telephone.
You put in here in message advising your hand this waste to withdraw your question simply press Star one again.
Be advised that today's conference is being recorded now it's my pleasure to turn the call over to Joanne girl or the floor is yours.
Joanne Girl: Thank you operator, good afternoon, everyone. Thank you for joining today to discuss <unk> fourth quarter and full year 2024 financial and business results.
Joanne color from lifestyle advisors.
thin Wedig: Joining me on today's call are thin Wedig, our chief Executive Officer, and David <unk>, Our Chief Financial Officer.
thin Wedig: 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 five again.
thin Wedig: Such statements May include but are not limited to our collaborations with Astrazeneca and Astellas financial guidance, the initiation enrollment design conduct and results of clinical trials or <unk>.
thin Wedig: Tori strategies and potential regulatory results, our research and development activities commercial results and results of operations risks related to our business and certain other business matters.
Each forward looking statement is subject to risks and uncertainties that could actual that could cause actual results any sense to differ materially from those projected in that statement a more complete description of these and other material risks can be found in fibrogenesis filings with the SEC, including our most recent form 10.
thin Wedig: K and Form 10-Q.
thin Wedig: <unk> does not undertake any obligation to upload update publicly any forward looking statements, whether as a result of new information future events or otherwise.
thin Wedig: A press release reporting the sale of fibers in China, and a webcast of today's conference call can be found on the investors section of <unk> website at Www dot pathogen dot com with that I'd like to turn the call over to our CEO thing Wedig Lane.
Speaker Change: Thank you Joanne and good afternoon, everyone and welcome to our fourth quarter and full year 2024 earnings call on today's call I will provide a status update on the transformation of five region, which includes the divestiture of fibers in China.
Speaker Change: Laser focus on our U S pipeline opportunities, which includes the exciting prospects for FTE $32 46, and <unk> 31, 80 or potential first in class antibody drug conjugate targeting CD 46, and our pet imaging agent in metastatic castration resistant prostate cancer and <unk> in the treatment of <unk>.
Speaker Change: Nemea due to lower risk Myelodysplastic syndrome.
David: And then David <unk>, our CFO, who will review the financials after which we will open the call for your questions.
David: On slide three I would like to highlight the strategic priorities for our company first the announcement of the sale of beverage in China to Astrazeneca for approximately $160 million.
David: This transaction simplifies our operations.
David: It allows for the payoff of our term loan facility with Morgan Stanley Tactical value and provides the most efficient pathway to access the company's net cash held in China, extending the company's cash runway into 2027. This is a truly transformative transaction for our company, which we are expecting to close by mid year.
David: Advancing FG 32, 46, and <unk> 31, 80, <unk> remains a key priority in the second quarter of 2024, we shared important data from two phase one studies highlighting the potential of FTE 30 to 46 as both monotherapy and in combination with <unk>.
David: I will provide a more detailed overview of where we are with the program and the upcoming 2025 catalysts in a moment.
David: Third we believe that <unk> represents an important potential therapy for patients with anemia associated with lower risk Mds.
David: We plan to meet with the FDA in the second quarter of 2025 to further explore this opportunity, which we are considering developing on our own or be a potential partnership.
David: We believe the regulatory interactions with the FDA next quarter will provide important clarity on the best path forward with the aim of realizing additional value for <unk> and an indication of significant unmet need.
David: Altogether, we are confident that our refined focus multiple near term catalysts across both programs and our existing strong foundation positions us well to create value for shareholders now and in the future.
David: I will now provide a brief overview of our FTE $32 46, and <unk> 31, 80 programs in MCR PC.
David: Slide five highlights the high unmet need in late stage prostate cancer. There are approximately 290000 men diagnosed with prostate cancer each year in the U S.
These 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%.
David: There remains a significant opportunity for new treatments that can extend survival for these men with a total addressable market of over $5 billion in annual sales.
David: FTE 30 to 46 would be this new treatment option.
David: Turning to slide six we highlight the novelty of our targets at tumor selected epitope of <unk> 46.
David: CD 46, and this specific CD 46, epitope had several distinguishing features.
David: <unk> 46 is up regulated during tumor Genesis and helps tumors abate complement dependent cytotoxicity.
David: The CD 46, epitope is highly expressed in M. C RPC tissues with lower inter patient variability and higher median expression compared with PSNH as depicted in the graph on the right hand portion of the slide.
David: Importantly, the expression of CD 46 is up regulated in the progression from localized castration sensitive prostate cancer metastatic castration resistant prostate cancer and further over express following treatment with androgens signaling inhibitors.
David: And the CD 46, Epitope is also over expressed in colorectal cancer and other solid tumors.
David: I would also like to highlight the CD 46 was referenced at this year's <unk> meeting as one of the promising non MSA P. SMA targets in advanced prostate cancer due to its high sensitivity stable expression and positive correlations of tumor burden.
David: Turning to slide seven FTE 30 to 46 is a potential first in class ADC in development for metastatic castration resistant prostate cancer with a novel targeting antibody yf's, five which binds to the tumor selective epitope of <unk> 46, and in MMA E payload.
David: <unk> is a validated pay yard that is approved as part of a number of adcs and other oncology indications.
David: FG 30 to 46 represents an androgen receptor agnostic approach clinically differentiating it from other prostate cancer treatments currently in development.
David: Our companion Pet imaging agent FG 31, 80 utilizes the same wireless five targeting antibody as FTE 32, 46 and is also under clinical development and preclinical studies the pet imaging agent and has demonstrated specific targeting oven uptake by CD 46 positive tumor cells.
David: We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in the phase III portion of the clinical development program. It would also enable differentiation of FTE 30 to 46 in the prostate cancer treatment paradigm. In addition at <unk> 31, 80 could represent an important commercial opportunity.
David: As a companion diagnostic to F. G 30 to 46 similar to the existing Pea SMA pet agents.
David: Slide eight recaps the topline results from the phase one monotherapy study reported in the second quarter of 2024.
The completed monotherapy study included a total of 56 metastatic castration resistant prostate cancer patients who are biomarker unselected and were heavily pretreated receiving received a median of five lines of therapy prior to achieve 30 to 46.
David: And the efficacy Evaluable population of 40 patients we observed in median radiographic progression free survival of eight seven months overall response rate of 20, 20% confirmed by resist one one and.
David: And PSA reductions of greater than 50% and 36% of the patients adverse events were consistent with those observed with other <unk> based ADC therapies. The manuscript describing the phase one monotherapy trial has been submitted and we anticipate publication soon.
David: On slide nine we highlight the performance of FG $32 46 in this phase one study versus other comparable early stage studies.
David: As highlighted on the previous slide the phase one study of FG 30 to 46 demonstrated in our PFS of $8 seven months across a robust sample size of 40 heavily pretreated patients.
David: We cannot make direct comparisons to these trials due to differences in study design and prior prostate cancer treatments. We are encouraged by the <unk> results, which is a recognized regulatory endpoint in prostate cancer trials.
David: On slide 10, we highlight interim results of the phase one portion of the ongoing investigator sponsored combination study with <unk> <unk> as reported at <unk> in June of 2024.
David: These interim results included data on 17, biomarker unselected patients, 70% of which were pre treated with at least two prior <unk>.
David: In addition to establishing the phase two dose of <unk> 32, 46. The ISP also demonstrated an encouraging preliminary estimate at $10 two months of radiographic progression free survival with PSA declines observed in 71% of Evaluable patients with <unk>.
David: Trial is continuing to enroll and is now set for top topline results in the second half of 2024, which will also include data on CD 46 expression on patients treated with FG 31, 80, our pet biomarker during the phase II portion of the I S T.
David: On slide 11, we depict a comparison of the initial results from the monotherapy trial in heavily pretreated patients in the combination trial RFG 30 to 46 versus the Rps results from second line therapies in late stage trials again, while we cannot make direct comparisons to these trials due to <unk>.
David: <unk> is the study design and previous prop prostate cancer treatments. We are encouraged the AFG 30 to 46 demonstrates what we believe to be competitive or PFS results.
David: Slide 12 highlights the phase II monotherapy dose optimization trial design that is based on our discussion with the F. D. A.
David: We plan to enroll 75 patients in the post a rsi pre chemo setting across three dose levels to determine the optimal dose for three phase III based on efficacy safety and PK parameters.
David: It is important to note that F. G 31, 80 will be an important 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.
David: One other important design element is the primary prophylaxis with G. CSF, which is intended to mitigate adverse events associated with neutropenia, commonly seen with MMA payloads.
David: The addition of G. CSF may enable a better tolerated and work consistent treatment with the ADC.
David: Thereby extending duration of therapy and potentially enhancing efficacy of the ADC.
David: We are planning an interim analysis in mid 2026, which will include efficacy safety PK and exposure response data and we intend to share relevant data to allstate stakeholders as they become available given the open label design.
David: Slide 13 highlights the development strategy for FG, $32, 46, and <unk> 31, 80, <unk>, which we believe provides significant optionality and prostate cancer.
David: We have a robust phase II monotherapy trial, and the pre chemo setting and M. C. RPC to further build upon the compelling efficacy data of $8 seven months of our PFS of 40 heavy heavily pretreated biomarker selected patients from the phase one monotherapy study.
David: The phase two monotherapy trial is designed to select the optimal dose for phase III based upon the benefit risk profile from this phase II trial.
David: We believe there are three factors that can drive our PFS, even higher than was observed in the phase one monotherapy trial.
David: First preliminary evidence of an exposure response relationship which allows us to focus our phase II study on three of the highest tolerated doses from the phase one dose escalation and expansion study.
David: Second utilizing primary prophylaxis with G CSF to combat against neutropenia and allow patients more consistent exposure to the ADC with fewer dose interruptions or adjustments.
David: Third enrolling healthier patients in earlier lines of therapy versus the median prior.
David: Prior lines of therapy in the phase one trial.
David: In addition, this study will explore the correlation between CD 46 expression and response to the ADC potentially validating FG 31, 80, as a predictive patient selection biomarker in future studies.
We are confident that our development pathway for FTE 30 to 46 unlocks sequential or parallel registrational pathways as Etsy 30 to 46 will be evaluated in multiple lines of therapy.
David: In monotherapy or in combination within a rsi and in an all comers population or patients with high expression of <unk> 46.
David: Slide 14 shows the recent and upcoming catalysts for the FG 30 to 46 program we.
David: We have potential value inflection points in the near term with the anticipated initiation of the phase two dose optimization study and M. CRP C by mid 2025, and the topline results from the phase II portion of the combination study with <unk>, which are expected in the second half of 2025.
David: To summarize on slide 15 FTE.
<unk> 32, 46 targets and novel Epitope on prostate cancer cells with first in class potential.
David: It is all rated already demonstrated promising efficacy signals with an acceptable safety profile, both in monotherapy and in combination settings. We are excited for the upcoming milestones and look forward to updating you on the program as the studies progress.
David: Slide 17 highlights the unmet need and the potential for <unk> in patients with anemia associated with lower risk Mds.
David: There isn't a lack of effective second line and beyond treatments given that the currently available therapies are only effective in approximately 50% of patients.
David: In addition, there are no oral options available or in late stage development, which could be a meaningful differentiator for <unk> and potentially translate into a significant commercial opportunity.
David: Moving on to Slide 18, and late 2023 subgroup analysis from the Phase III Matterhorn study of <unk> in patients with anemia of lower risk Mds were presented at the American Society of Hematology annual meeting.
David: In patients with anemia associated with lower risk Mds, who entered the trial with a higher transfusion burden.
David: <unk> demonstrated a meaningful difference in transfusion independence versus placebo.
David: <unk> that are highly similar to the pivotal trials for two recently approved therapies for anemia associated with lower risk Mds.
David: On slide 19, we highlight the significant opportunity for rocks reduce debt in low risk Mds.
David: Based on other lower risk Mds development programs, we believe the indication would support an orphan drug designation, which would provide seven years of data exclusivity in the U S.
David: This potential exclusivity combined with an attractive market opportunity and efficient commercial model provides a significant economic opportunity for further development of Brexit used yet in the U S.
David: We look forward to our FDA meeting planned for the second quarter of 2025, which could pave the way for developing <unk> for anemia associated with lower risk Mds, either on our own or through a partnership.
David: With that I will now turn the call over to Dave to discuss the company's financials Dave.
Dave: Thank you Sam.
Dave: I will first review the fibers in China transaction details and then provide the company's financial performance for the fourth quarter and full year 2024.
Dave: Given the announced sale of fiber Qian, China, our China operations are now reflected as discontinued operations throughout our financials. We will continue to report our China operations and discontinued operations moving forward.
Dave: On slide 21, we highlight the summary of key financial terms of the transaction.
Dave: Under the terms of the agreement <unk> will receive an enterprise value of $85 million.
Dave: Fiber Gen net cash held in China at closing.
It made it to be approximately $75 million totaling approximately $160 million.
Dave: Value of fiber Gen net cash in China includes fiber agenda portion of Polycom net cash, which is the joint distribution entity owned by fiber and Astrazeneca and.
Dave: Importantly, <unk> will continue to accrue cash generated in China until the closing of the transaction. The transaction is expected to close by mid 2025 pending customary closing conditions, including regulatory review in China.
Dave: The transaction does not include the alumina license agreement, whose rights will continue to be retained by fiber Gen going forward.
Dave: This transaction is truly transformative for fiber channel and allows the company to pay down its senior term loan facility with Morgan Stanley Tactical value full.
Dave: Fully access our cash in China and extend the company's runway into 2027 to support U S development initiatives.
Dave: Now onto the company's financials for the fourth quarter and full year 2024.
Dave: For the fourth quarter of 2024 total revenue was $3 1 million compared.
Dave: Compared to $3 $6 million for the same period in 2023 four.
Dave: For full year 2024, total revenue was $29 6 million compared to $46 $8 million and full year 2023.
Dave: In the fourth quarter of 2024, we recorded zero point $4 million in development revenue compared to $2 $6 million during the fourth quarter of 2023 four.
Dave: For full year 2024, we recorded $1 $9 million in development revenue compared to $18 $4 million during full year 2023.
Dave: In the fourth quarter of 2024, we recorded $2 $7 million of drug product revenue compared to $1 $1 million during the fourth quarter of 2023.
Dave: For full year 2024, we recorded $27 $7 million of drug product revenue compared to $18 $8 million during full year 2023.
Dave: Now for full year 2025, we expect total revenue to be between $4 million and $8 million.
Dave: Now moving down the income statement total operating costs and expenses for the fourth quarter of 2024 were $10 3 million compared to $66 3 million for the fourth quarter of 2023, a decrease of $56 million or 84% year over year.
Dave: <unk> operating costs and expenses for full year 2020 for $180 million compared to $369 $5 million for full year 2023, a decrease of $189 5 million or 51% year over year.
Dave: R&D expenses for the fourth quarter of 2024 were $6 $9 million compared to $48 $7 million in the fourth quarter of 2023, a decrease of $41 $8 million or <unk>, 86% year over year.
Dave: R&D expenses for full year, 2024 were $95 $7 million compared to $266 $5 million in full year 2023, a decrease of $178 million or 64% year over year.
Dave: SG&A expenses for the fourth quarter of 2024 were $8 3 million compared to $16 $4 million in the fourth quarter of 2023, a decrease of $8 1 million or 49% year over year.
Dave: SG&A expenses for full year, 2024 were $49 3 million compared to $86 5 million and full year 2023, a decrease of $37 2 million or 43% year over year.
Dave: During the fourth quarter of 2024, we recorded a net loss from continuing operations of $8 7 million or <unk> <unk> net loss per basic and diluted share as compared to a net loss of $62 5 million or.
Dave: Or <unk> 63 per basic and diluted share for the fourth quarter of 2023.
Dave: During full year 2024, we recorded a net loss from continuing operations of $153 1 million or.
Dave: Or $1 53, net loss per basic and diluted share.
Dave: Compared to a net loss of $323 million or $3 32 per basic and diluted share for the full year 2023.
Dave: As we have previously stated we initiated a significant cost reduction plan in the second half of 2024 to become laser focused on our FTE 30 to 46 Ft 31, 80 in Rockford does that asset.
Dave: We have reduced our head count by approximately.
Dave: 5% in the U S. We have moved to a work virtual work environment after terminating our lease and substantially reduced our operating cost to maximize our cash runway.
Dave: I am happy to announce that we have completed our restructuring efforts and the team will continue to work diligently to find operational efficiencies throughout 2025.
Dave: Now for full year 2025, we expect our total operating costs and expenses, including stock based compensation to be between $70 million and $80 million, which at the midpoint represents a 58% reduction from full year 2024.
Dave: Now shifting towards cash.
Dave: As of December 31, we reported $51 million in cash cash equivalents and accounts receivable in the U S and $121 1 million in total consolidated cash cash equivalents and accounts receivable when including balances in China.
Dave: Given that the company will continue to accrue cash from its China operations until the close of the sale transaction, we expect the company to be cash flow positive on a consolidated basis in the first quarter of 2025.
Dave: <unk> closed the <unk> 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.
Dave: This includes the $75 million principal balance accrued and unpaid interest and an applicable prepayment penalty.
Fame: Post the payoff of our <unk> term loan we expect the company to have cash runway into 2027. Thank you and I'll now turn the call back over to Fame.
Speaker Change: Thank you Dave to conclude we believe the sale of fibers in China is a transformative transaction for fibers and we are excited about the next chapter in the company's story, we are confident that the shift to a lean U S organization focused on high value indications in oncology and oncology related diseases.
Has the potential to create tremendous value for patients and stakeholders alike.
Speaker Change: With an extended cash runway into 2027, we plan to advance our exciting pipeline in the coming months initiating the phase II monotherapy study for FG 32, 46, and <unk> 31, 80 and M C RPC and meeting with the FDA to determine the potential development path for rocks do stat in the treatment of anemia.
Speaker Change: Associated with lower risk Mds.
Speaker Change: These events will set the stage for the remainder of 2025 and beyond which include top line results from the phase II portion of the IFC for FTE $32 46 in combination with <unk>.
Speaker Change: In the second half of 2025.
Speaker Change: As well as interim results from the Phase II monotherapy study in mid 2026 in summary, as a leaner and more focused organization. We will continue to execute on our strategic plan with the aim of achieving a valuation that we believe is more reflective of our first in class phase II ready CD 46 targeting ADC.
Speaker Change: And our potential phase III ready opportunity in anemia associated with lower risk Mds bolstered by our strengthened balance sheet and extended cash runway.
Speaker Change: We look forward to providing further updates to our stakeholders over the coming months.
Speaker Change: I would now like to turn the call over to the operator for Q&A.
Speaker Change: So Martin as a reminder to ask a question.
Speaker Change: Press Star one one on your telephone and wait for your name to be announced to remove yourself press star one again.
Speaker Change: Standby, while we compile the Q&A roster.
Speaker Change: Yes.
Our first question comes from the line of Andy <unk> with William Blair. Please go ahead.
Andy: Thanks for taking my questions and congratulations on that transformative deal.
Speaker Change: Got it got two quick ones for for the ADC franchise. So you mentioned about the futility analysis, that's coming up in.
Andy: Midyear 2026.
Andy: Just curious if you can characterize the level of stringency for that.
Andy: With that utility so in other words, maybe from an investor perspective.
Andy: Yes.
Andy: With the passing of that futility analysis, the very good sign from an efficacy standpoint.
Andy: And second one it's a quick one I was just curious it sounds very clear on clinical trials Gov website.
Andy: But curious when he said.
Andy: The pre chemo post.
Andy: Hi.
Andy: Sure.
What's the qualification for radio ligand.
Andy: Radio like a patient who had experience with radio like <unk> would be eligible for the trial.
Andy: The clinical trials website, it only says no.
Andy: Radio lagging prior year basically within the prior 28 days and as a follow up on the Mds. Thank you.
Thanks, Andrew for the questions Hope Youre doing well I'll answer the last one first.
Andy: And in terms of maybe set the stage for this post <unk> pre chemo setting.
Andy: We've learned a lot from some of the Kols and the <unk>.
Andy: Past several months about what the sweet spot is for an opportunity like <unk> 30 to 46 and with the <unk> moving into the castration sensitive phase. We've also learned that especially the academic centers.
Andy: <unk> seen less of an <unk> switch regimen. So in other words.
Andy: It is not uncommon for a patient to be treated with <unk> and then to be switched to another and I think what were hearing for especially from the academic centers is that the incremental benefit of switching from one to another is not that great and at the same time patients are desiring to put up chemotherapy for as long a period of time as possible. So we think in this cast.
Andy: Creation resistant space close to air Assai pre chemo, that's exactly where the trial is designed to recruit patients and we are allowing patients who have been treated with <unk> previously just not within the prior 28 days. So if they had been treated with <unk> and are no longer responding then those patients would be.
Eligible to be enrolled in our phase two monotherapy trial.
Andy: In terms of the futility analysis, we're not going to speak very much about that at this point in time.
Andy: Suffice it to say.
Debt.
Andy: We're going to ensure that when we look at the data and this will be.
Andy: Data on 12 patients at each one of the dose cohorts.
Andy: <unk>.
Andy: The therapy is being appropriately tolerated in that we're not seeing any untoward.
Andy: <unk> events, we're also going to be looking at efficacy parameters at that point in time, clearly if we're seeing efficacy results.
Andy: Combined with the safety results that are not favorable to the patient then that would be an important consideration, but we're not going to go into detail at this point in time in terms of exactly what that futility analysis says.
Andy: Okay great.
Andy: Very helpful and for Mds.
Andy: So I'm curious about the.
Andy: The ability to leverage some of the safety database from brought to be used at Pryor.
Andy: Prior clinical programs.
Andy: I'm, just trying to get a sense of how how big that NPS program would have to be.
Andy: So I'm just curious if you can speak to the ability to leverage prior clinical results.
Andy: Yes, thanks for that question.
Andy: I think we'll learn a lot I know, we'll learn a lot when we speak with the FDA next quarter.
Andy: Anemia associated with lower risk Myelodysplastic syndrome that patient population is.
Andy: Is very different than the patient population of anemia associated with chronic kidney disease.
We think that just based upon not only trials that have been done for those better stepped in a metal staff, but also.
Andy: A phase III of recent phase III trial that just started we think the trial size will be roughly about 200 patients.
Andy: And again, we're going to get.
Andy: So feedback from the FDA, both in terms of dosing as well as the patient population that we would aim to targets.
Andy: But about 200 patients and so.
Andy: The previous safety database for <unk> anemia would be informative, but I don't think that instructive relative to this particular patient population and I think it's pretty apparent that based upon previous trials that there will be some important safety follow up so not only looking at transfusion.
Andy: Independence in the first.
Andy: 28 weeks of the trial and then looking at the same efficacy parameter over 52 weeks, but then some.
Andy: Safety follow up that would extend beyond 52 weeks as well.
Speaker Change: That's very helpful. Thank you so much for taking my questions. Thank.
Thank you Andy.
Speaker Change: Thank you. Our next question comes from my T O Keller with H C. Wainwright. Please go ahead.
Speaker Change: Yes, good afternoon, everyone. Congrats on the quarter and thanks for the update just to again quick questions from us as well.
Speaker Change: The first one I was wondering if the recent cost saving measures that you commented about and really a strong cash balance open up any possibility for hopefully the new assets or any possible new indications in the future.
Speaker Change: Okay.
Speaker Change: Yes, Matthew one more time on that I couldnt catch the last part of that Oh, Yeah. No. It's okay. I was wondering with your strong balance sheet and the cost saving measures that.
Speaker Change: You are leaving open the possibility or if you're considering any new possible assets to add to the pipeline or possible new indications to consider as well going forward. Yes. Thanks for the question you're not at this time.
Speaker Change: We've got a laser focus as we stated on the call.
Speaker Change: Dancing FG 32, 46, and <unk> 31, 80 into the phase II monotherapy trial waiting for the results of the FG three to 46 trial in combination with <unk> and then seeking FDA feedback on potential to take <unk> into further development in lower risk Mds anemia, and so that's where we're going.
Speaker Change: Stay focused we think if we tried to branch outside of that.
Speaker Change: Would benefit the programs that we have in front of US right now we need to stay laser focused on those two programs.
Speaker Change: Yes, no no totally makes sense.
Speaker Change: The second one if I may switching.
Speaker Change: Switching gears to our Rockford in EMEA Mds I.
Speaker Change: I was wondering if you can maybe provide a little more color or highlight maybe what your expectations are if you are a wishlist kind of going into your upcoming meeting with the FDA.
Speaker Change: Yes, I'd say, it's a great question I think our wish list would be.
Speaker Change: Based upon the previous phase two slash III trial, the Matterhorn trial, which was conducted where there was a small amount of kind of dose finding work across 24 patients at three different doses, 152% and 2.5 mix per gig of rocks reduce debt.
Speaker Change: Eight patients in each one of those three.
Speaker Change: Cohorts.
Speaker Change: $2 five milligrams per kilogram was chosen to be the dose that was then taken in to the phase III portion of the trial and then there was a an algorithm based upon hemoglobin levels that then let the commission allowed the condition to further titrate from there with a maximum of three five milligrams per kilogram. So our.
Speaker Change: Preferred.
Speaker Change: Possibly the FDA is that we've done the appropriate amount of dose finding work across that.
Speaker Change: The more than 100 patients that were treated in the phase II <unk> III trial, and we will be able to go in right with a two five milligram per kilogram dose.
Speaker Change: And then not have to do additional dose finding work as part of another phase II <unk> III trial. That's the that's the preferred approach that's what our our request is going to be and then in terms of the specific patient population.
Speaker Change: We will have a key question that we will ask the agency.
Speaker Change: On.
Speaker Change: The most appropriate patient population for this particular trial, we desire to do a placebo controlled trial, just because of the fact that by doing a non inferiority trial.
Speaker Change: Purses physician's choice that would be a much larger and much more extensive trial.
Speaker Change: But the treatment paradigm has changed a bit since we started the Matterhorn trial, a few years ago, you got better Sept approved when you've had metal stat approved.
Speaker Change: So what we're going to find out from the agency is in this kind of east refractory patient population, who has been Ah trial on one additional therapy, let's call it the spatter steps.
Speaker Change: Then like them to be randomized to either <unk> or placebo will not have to go through another therapy. Before then they would be randomized direction do stand on placebo and so it's what we would call the.
Speaker Change: Second slashed third line in lower risk Mds and that would allow us to then do a direct competitor.
Speaker Change: <unk> placebo and size of the trial as I said that to Andy's question about 200 patients or so.
Speaker Change: Yeah totally makes sense and that was very helpful. Thanks again for taking my questions and congrats on the quarter. Thanks, Matt.
Speaker Change: Thank you and this concludes our Q&A session I will turn it back to Tim <unk> for his final remarks.
Speaker Change: Yeah, Thanks, Carmen and thanks to everybody for joining us today for our fourth quarter earnings call and your continued interest in partners and enjoy the rest of your day. Thank you.
Thank you all who participated in today's conference you may now disconnect.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: [music].