Q1 2025 FibroGen Inc Earnings Call
Speaker Change: Good day and thank you for standing by. Welcome to FibroGen first quarter 2025 earnings conference call. At this time all participants are in a listen only mode. After the speakers presentation they'll be a question and answer session to ask a question during the session you need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question please press star one one again. Please be advised today's conference is being recorded. I would not like to end the conference over to your speaker today. Joanne Greller, please go ahead. Thank you.
Speaker Change: Such statements May include but are not limited to our collaborations with Astrazeneca and Astellas.
Speaker Change: Guidance.
Speaker Change: Initiation enrollment design conduct and results of clinical trials, our regulatory strategies and potential regulatory results.
Speaker Change: Our research and development activities commercial results and results of operations risks related to our business and certain other business matters. Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement or more.
Speaker Change: Description of these and other material risks can be found in <unk> filings with the SEC, including our most recent Form 10-K and Form 10-Q.
Speaker Change: <unk> does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise a press release reporting the 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.
Speaker Change: <unk> dot com with that I'd like to turn the call over to CEO thing Wedig Dane.
Wedig Dane: Thank you Joanne.
Wedig Dane: Afternoon, everyone and welcome to our first quarter 2025 earnings call.
Wedig Dane: On today's call I will provide a status update on the transformation of hydrogen which includes the divestiture of fibers in China and a laser focus on our U S pipeline opportunities specific really exciting prospects for FTE 32, 46, and <unk> 31, 80 or potential first in class antibody drug conjugate targeting <unk>.
Wedig Dane: Six and our pet imaging agent in metastatic castration resistant prostate cancer.
Wedig Dane: <unk> in the treatment of anemia, due to lower risk Myelodysplastic syndrome.
David: Then David <unk>, our CFO 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, we have set forth for fiber Gen. This year I'll begin by providing an update on the sale of fibers in China to Astrazeneca.
David: As we've stated previously this is a truly transformative transaction for fiber Jen.
David: Simplifies our operations allows for the payoff of our term loan facility with Morgan Stanley Tactical value and provides the most efficient pathway to access the company's net cash held in China at.
David: At the time of your 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 expected net cash in China of approximately $75 million. We are pleased to share that we expect the total consideration.
David: To now be approximately $185 million, which is a $25 million increase from our initial guidance due to greater than expected net cash in China at closing.
David: Importantly, the increase in expected proceeds extends the company's cash runway into the second half of 2027, we now expect the transaction to close in the third quarter of this year.
David: Second we remain hyper focused on advancing FG $32 46, and <unk> 31, 80 in metastatic castration resistant prostate cancer or MCR P. C in which we continued to make important progress. We recently announced in March the publication of the full trial results from the phase one monotherapy.
David: <unk> <unk> 30 to 46 in patients with Mci RPC in the journal of clinical oncology, which highlights the promising potential of anti cancer activity, especially when considering the unselected heavily pretreated patient population.
David: We believe the trailing 12 results demonstrate that the CD 46 target is active and provide key insights into the potential clinical impact of targeting CD 46 expressing tumors.
David: We are excited to share that we recently received notification from the FDA cleared the IND for FG 31, 80 or companion pet imaging agent. This marks an important achievement for fiber Jen as it paves the pathway for up to $31 80 to be used alongside FTE 30 to 46 in the upcoming phase II dose.
David: Optimization of monotherapy trial, which is expected to start in the third quarter.
David: Third <unk> produced at Biogen recently filed a type C meeting request with the FDA to gain feedback on the potential path forward for <unk> in anemia associated with lower risk Myelodysplastic syndromes and indications with significant unmet medical need.
David: In the post hoc subgroup analysis from the Matterhorn Phase III trial rock suggest that showed promise in reducing transfusion dependence and patients with a higher transfusion burden at baseline we expect FDA feedback in the third quarter that will provide important clarity on the path forward for <unk> in the U S with the aim of realizing additional value.
David: For this wholly owned asset.
David: Altogether, we are confident that our refined focus multiple near term catalysts across both clinical 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 FC 32, 46, and <unk> 31, 80 programs in M C RPC.
David: Slide five highlights the high unmet need in late stage prostate cancer.
David: There are approximately 290000 men diagnosed with prostate cancer each year in the U S.
David: 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% there remains a significant opportunity for new treatments that can extend survival for these men with a total addressable market of well over $5 billion.
Speaker Change: And annual sales FTE 30 to 46 could become a non P. SMA treatment option that is so desperately needed given the signet significant unmet need NMC RPC.
Speaker Change: Turning to slide six we highlight the novelty of our target tumor selective epitope of <unk> 46.
Speaker Change: CD 46, and this specific CD 46, epitope have several distinguishing features.
Speaker Change: First CD 46 is up regulated during tumor agenesis and helps tumors evade complement dependent cytotoxicity.
Speaker Change: The CD 46, epitope is highly expressed in M CIBC tissues with lower inter patient variability and higher median expression compared with PSA made as depicted in the graph on the right hand portion of the slide.
Speaker Change: Importantly, the expression of CD 46 is up regulated in the progression from localized castration sensitive prostate cancer to metastatic castration resistant prostate cancer and further over express following treatment with androgens signaling inhibitors.
Speaker Change: And the CD 46, Epitope is also over expressed in colorectal cancer and other solid tumors.
Turning to slide seven FTE 30 to 46 is a potential first in class ADC in development for <unk> with a novel targeting antibody Yf's, five which binds to the tumor selective epitope of CD 46, along with an MMA E payload.
Speaker Change: MMA is a validated payload that is approved as a part of a number of adcs in other oncology indications FG 30 to 46 represents an androgen receptor agnostic approach clinically differentiating it from other prostate cancer treatments currently in development.
Speaker Change: Our companion Pet imaging agent FG 31, 80 utilizes the same yf's five targeting antibody as FTE $32 46, and is also under clinical development.
Speaker Change: In preclinical studies the pet imaging agent has demonstrated specific targeting an 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 the phase III portion of the clinical development program. It would also enable differentiation.
Speaker Change: For FG 30 to 46 in the prostate cancer treatment paradigm.
Speaker Change: In addition, FG 31, 80 could represent an important commercial opportunity as a companion diagnostic to FG 30 to 46 similar to the existing Pea SMA pet agents such as <unk>.
Speaker Change: We're excited to announce that we have recently received clearance for up to $30 80, paving the way for the FG $31 80 to be an important component for the upcoming phase two dose optimization study that I will touch on in a moment.
Speaker Change: Slide eight recaps the topline results from the phase one monotherapy study with full details published in the peer reviewed journal of clinical oncology in March of this year. The completed monotherapy study included a total of 56 metastatic castration resistant prostate cancer patients who are biomarker unselected and we're.
Speaker Change: Billy Pretreated received a median of five lines of therapy prior to FG $32 46.
Speaker Change: And the efficacy evaluable population of 40 patients.
Speaker Change: And radiographic progression free survival of eight seven months was observed there was an overall response rate of 20% confirmed by resist one one and PSA reductions of greater than 50% were achieved and 36% of patients.
Speaker Change: Adverse events were consistent with those observed with other MMA E based ADC therapies.
Speaker Change: Additional highlights from the J C O publication include <unk>.
Speaker Change: Expression of CD 46, being observed in 80% of Evaluable biopsies in patients enrolled during the dose expansion phase, which is consistent with results previously reported from our prospective we obtained cohort of patients who wonder underwent metastatic CRP C biopsy.
Speaker Change: 20 patients had a valuable circulating tumor DNA at baseline on treatment defined as before the cycle two day, one dose and at the end of treatment more disease progression in nine of these 20 patients or 45% of those are valuable there was a greater than 50% decline from baseline in Cte DNA fraction.
Speaker Change: After just one cycle of treatment.
Speaker Change: A tighter dose response relationship appeared to be observed for objective tumor response by imaging as opposed to serum PSA decline, which may be related to the independence of CD 46 from the energen signaling pathway and expression of <unk> 46, and androgen receptor independent tumor clones and.
Speaker Change: And finally anti tumor activity was observed in patients who had received more than one previous line of RPI therapy as well as those who had received a taxane chemotherapy in the metastatic castration sensitive setting the latter being notable given similar mechanisms of action of Taxane and MMA E.
Speaker Change: Based on the totality of the data from the phase one monotherapy trial, we are encouraged by the clinical activity of Jeff FG, $32, 46, and targeting CD, 46% MCR PC.
Speaker Change: On slide nine we highlight the <unk> results of <unk> $32 46, and its phase one study versus other comparable early stage studies.
Speaker Change: As covered 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 affordably 40 heavily pre treated patients.
Speaker Change: While we cannot make direct comparisons to these trials due to the differences in study design and prior prostate cancer treatments. We are encouraged by these are PFS results, which is a recognized regulatory endpoint in prostate cancer trials.
Speaker Change: On slide 10, we highlight previously reported preliminary efficacy data from the phase <unk> portion of the ongoing investigator sponsored combination study. We then dilutive mind. These.
Speaker Change: These interim results included data on 17, biomarker unselected patients, 70% of which were pre treated with at least two prior <unk> and.
Speaker Change: In addition to establishing the phase II dose of FG $32 46. The IFC also demonstrated an encouraging 10, two months of radiographic progression free survival with PSA declines observed in 71% of Evaluable patients.
Speaker Change: We expect to report the phase II top line results in the fourth quarter of this year, which will also include data on CD 46 expression in patients treated with FG 31, 80, <unk> biomarker during the phase II portion of the IFC.
Speaker Change: On slide 11, we depict a comparison of the initial results from the monotherapy trial in heavily pretreated patients in the combination trial for FG 30 to 46 versus the Rpms results from second line therapies in late stage trials again, while we cannot make direct comparisons to these trials due to due to the differences in study.
Speaker Change: Design and previous prostate cancer treatments. We are encouraged that FG 30 to 46 demonstrates what we believe to be competitive or PFS results.
Speaker Change: Slide 12 highlights the phase II monotherapy dose optimization trial design that is based on our discussion with the FDA. We plan to initiate this study next quarter and expect 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 <unk>.
Speaker Change: K parameters. It is important to note that <unk> 31, 80 will be an integral part of the study as we seek to demonstrate the correlation between CD 46 expression and response to the ADC in this all comers population.
Speaker Change: One other important design element is the use of G. CSF as primary prophylaxis to mitigate grade three or greater adverse events associated with neutropenia, commonly seen with MMA E payloads.
Speaker Change: The addition of G. CSF may enable a better tolerated and more consistent treatment with the ADC minimizing dose interruptions or dose reductions extending duration of therapy and potentially enhancing the efficacy of the ADC.
Speaker Change: We are planning an interim analysis in the second half of 2026, which will include efficacy safety PK and exposure response data and we intend to share relevant data to all stakeholders as they become available given the open label design.
Slide 13 highlights we are why we are so optimistic about the potential for a phase II study to further build upon the strong efficacy seen in the phase one study.
Speaker Change: We believe there are three factors that could drive our PFS, even higher than the $8 seven months that was observed in the phase one monotherapy trial.
Speaker Change: 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.
Speaker Change: Second utilizing primary prophylaxis with G CSF to combat against neutropenia, potentially allowing patients more consistent exposure to the ADC with fewer dose interruptions or adjustments.
Speaker Change: Third enrolling patients in earlier lines of therapy versus the median five prior lines of therapy in the phase one trial.
Speaker Change: We believe that these design elements have the potential to improve upon the phase one results and achieve in Rps in the 10 to 12 month range, which we believe is the benchmark for commercial competitiveness.
Speaker Change: On Slide 14, we show our long term development strategy for FG, 32, 46, and <unk> 31, 80, <unk>, which we believe provides significant optionality in prostate cancer.
Speaker Change: We have a robust phase II monotherapy trial, and the pre chemo setting and M. CRP C to further build upon the compelling efficacy data at $8 seven months of our PFS and 40 heavily pretreated biomarker unselected patients from the phase one monotherapy study. In addition, this study will explore the correlation between CD 46 expression.
Speaker Change: In response to the ADC potentially validating FTE 31, 80, as a predictive patient selection biomarker in future studies.
Speaker Change: We are confident that our development pathway for FG $32, 46, unlocks sequential or parallel registration pathways as FG 30 to 46 will be evaluated in multiple lines of therapy in monotherapy and or in combination with an <unk> site and in an all comers population or patients with high expression of <unk>.
Speaker Change: 46.
Speaker Change: Slide 15 shows the recent and upcoming catalysts for the F. 32, 46, and <unk> 31, 80 program. We are very pleased to have received ianthe clearance for FG three 180 as this marks an important milestone as we explore its potential to be used as a diagnostic tool and potential biomarker for patient selection in the tree.
Speaker Change: And that of MCR P C.
Speaker Change: We plan to initiate the phase two monotherapy trial in the third quarter, which will include FG 31, 80 to enable assessment of its diagnostic performance and the potential correlation between CD 46 expression and response to ft 30 to 46.
Speaker Change: To summarize on slide 16, FTE $32 46 targets a novel epitopes on prostate cancer cells with first in class potential. It is important to note that there are no. Other CD 46 targeted projects in clinical development.
Speaker Change: Targeting CD 46 with Ft 30 to 46 has already demonstrated promising 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 Change: Turning to <unk> slide 18 highlights the unmet need and the potential for <unk> in patients with anemia associated with lower risk Mds, There's a lack of effective second line and beyond treatments given that the currently available therapies are only effective in approximately 50% of patients.
Speaker Change: 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.
Speaker Change: Moving on to Slide 19, we highlight data from the phase III Matterhorn study of <unk> in a subgroup of patients with anemia of lower risk Mds, who entered the trial with a higher transfusion burden.
Speaker Change: In this post hoc analysis <unk> demonstrated a meaningful difference in transfusion independence versus placebo results that are highly similar to the pivotal trials for two recently approved therapies for anemia associated with lower risk Mds.
Speaker Change: On slide 20, we highlight the significant opportunity for <unk> staff in lower risk Mds.
Speaker Change: Based on other lower risk Mds development programs, we believe the indications would support an orphan drug designation, which would provide seven years of data exclusivity in the U S.
Speaker Change: This potential exclusivity combined with an attractive market opportunity and efficient commercial model provides a significant significant economic opportunity for further development of <unk> staff.
Speaker Change: We look forward to near term discussions with the FDA, which could pave the way for developing <unk> staff for anemia associated with lower risk Mds on our own or through a potential partnership.
Speaker Change: With that I will now turn the call over to Dave to discuss the company's financials Dave.
Dave: Thank you fan.
Dave: I'll first review the updated fiber Gen. China transaction details and then provide the company's financial performance for the first 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 and continued operations moving forward on slide.
Dave: 22, we highlight the summary of key financial terms of the transaction.
Dave: Under the terms of the agreement fiber Gemma receive an enterprise value of $85 million plus fiber Gen. Net cash held in China at closing estimated to now be approximately $100 million.
Dave: Totaling approximately $185 million.
Dave: This is a $25 million increase from our initial net cash guidance in February given the company's current market capitalization of approximately $30 million. We believe this increase in expected net cash received upon the close of the transaction represents a meaningful outcome for shareholders as a reminder, the value.
Dave: You have five or 10 net cash in China includes fiber agenda portion of Polycom net cash, which is the joint distribution entity owned by fiber Jen and Astrazeneca importantly fiber Gen will continue to accrue cash generated in China until the closing of the transaction, which is expected in the third quarter of 2025 pending Custer.
Dave: Mary closing conditions, including regulatory review in China.
Dave: This transaction is truly transformative for fiber channel and allows the company to pay down our senior term loan facility with MSC V fully access our cash in China and extend the company's runway into the second half of 2027 to support U S development initiatives.
Dave: Now onto the company's financials for the first quarter for the first quarter of 2025 total revenue was $2 $7 million compared to $25 4 million for the same period in 2024 for.
Dave: For full year 2025, we reiterate total revenue to be between $4 million and $8 million.
Dave: Now moving down the income statement.
Dave: Operating costs and expenses for the first quarter of 2025 were $17 7 million compared to $74 5 million for the first quarter of 2024, a decrease of $56 8 million or 76% year over year.
Dave: R&D expenses for the first quarter of 2025 were $9 $2 million compared to $36 $5 million in the first quarter of 2024, a decrease of $27 $3 million or <unk>, 75% year over year.
SG&A expenses for the first quarter of 2025 were $8 $1 million.
Dave: Compared to $16 $7 million in the first quarter of 2024, a decrease of $8 6 million or 51% year over year.
Dave: During the first quarter of 2025, we recorded a net loss from continuing operations of $16 8 million or 16 net loss per basic and diluted share as compared to a net loss of $49 million or <unk> 49 per basic and diluted share for the first quarter of 2024.
Dave: For full year 2025, we reiterate our guidance for 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 $33 $8 million in cash cash equivalents and accounts receivable in the U S and $128 4 million and total consolidated cash cash equivalents and accounts receivable when including balances in China.
Dave: Company with cash flow positive in the first quarter of 2025 generating a total of $7 $3 million in cash flow on a total consolidated basis, when including balances in China.
Dave: And that the company will continue to accrue cash from its China operations until the close of the sale transaction. We expect the company to again be cash flow positive on a consolidated basis in the second quarter of 2025.
<unk> closed 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.
Dave: This includes the $75 million principal balance accrued and unpaid interest and an applicable prepayment penalty post the payoff of our <unk> term loan we expect the company to have runway into the second half of 2027. Thank you and we'll now turn the call back over to <unk>.
Speaker Change: Thank you Dave.
Speaker Change: To conclude we are extremely excited about their future prospects for <unk> with.
Speaker Change: With a number of important catalysts in the coming months, we plan to advance our exciting pipeline initiating the phase II monotherapy study next quarter <unk> $32 46, and <unk> 31, 80 and M. C. RPC, we will gain important feedback from the FDA regarding the potential development of <unk> in lower risk Mds.
Speaker Change: And we anticipate the close of the fibers in China sale pay off of the <unk> term loan and extension of our cash runway into the second half of 2027.
Speaker Change: In summary, we are committed to driving significant shareholder value by advancing our U S development initiatives and supported by our strong balance sheet. 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 Change: Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered who wished to move yourself from the queue. Please press star wouldn't want again, we'll pause for a moment, while we compile the Q&A roster.
Speaker Change: Our first question comes from Andy said with William Blair. Your line is open.
Andy: Okay. Thanks for taking my questions congratulations on the higher than expected proceeds from the Astrazeneca deal.
Speaker Change: Jay Seo publications so.
So we have three questions.
Speaker Change: One passage.
Speaker Change: Clinical development.
Speaker Change: Ftw's 30 to 46.
Speaker Change: And so.
Speaker Change: This has to do with some of the market dynamic changes after the date of approval based on the demand for studying the pre chemo setting.
Speaker Change: Curious if you had contemplated.
Speaker Change: And potentially running the monotherapy study or the pivotal program in the predictive experience population just to mitigate some of that risk.
Speaker Change: Associated with highly heterogeneous population and may be targeting a higher unmet medical need.
Speaker Change: That's question number one.
Speaker Change: Question number two has to do with some of the macro disruption that we have Brendan on easier reported by the media.
Speaker Change: I'm just curious if you can comment on some of the recent FDA correspondence or communication, especially with the Rockies that Mds.
Speaker Change: Opportunity.
Speaker Change: And third.
Speaker Change: Okay.
Speaker Change: Something you had mentioned a couple of times.
Speaker Change: Sure.
Speaker Change: In previous calls.
Just given the cash infusion from for matches any is it worthwhile maybe from a capital allocation perspective.
Speaker Change: Some feasibility studies in colorectal cancer, especially in light is Saito mixes success. This morning. Thank.
Speaker Change: Thank you very much.
Andy: Okay. Thanks, Andy.
Speaker Change: Comments and the questions I appreciate that so let me touch on the first one and then I'll ask Dave to comment as well, but as it relates to <unk>.
Speaker Change: Clinical development for 30 to 46 in some market dynamic changes with <unk>.
Speaker Change: Does that new indication.
Speaker Change: As part of our synopsis of protocol for the Phase II monotherapy trial, we are going to allow a clue Victor experienced patients.
Speaker Change: Who happened to progressed, while on <unk> in that pre chemo.
Speaker Change: Jose Rsi pre chemo setting to be entered into our trial.
Speaker Change: We don't think it makes sense to only or exclusively study those patients who are post predict because as I'm sure you can appreciate it Andy.
Speaker Change: Never have rapid adoption of an agent with a new indication and it usually takes time for clinicians to begin to adopt it and so if we would require all patients would be entered into our phase II monotherapy trial to have been Quebec to experience. We just think that that would that would create too much about <unk>.
Speaker Change: <unk> challenge, but we will be allowing patients who have been treated with the victim to be entered into our phase two monotherapy trial.
Speaker Change: Dave anything to add to that.
Dave: Nothing to add there thanks.
Speaker Change: And then in terms of the kind of the macro news in.
Dave: A lot of what's going on with respect to.
Dave: HHS and FDA and the like.
Dave: The only thing that we can point to our recent interactions that we've had with the agency and maybe I'll give you just a flavor of that the first one was when we.
Dave: Filed the IND for <unk>, 31, <unk>, which is our pet imaging agents everything progressed exactly on schedule.
Dave: The questions that were just a few of them.
It came in a timely way, we answered them the IMD got cleared right on time.
Dave: The example that we have for the agency was the reactivation of the rocks induce that IND in the U S. We are deactivated that once we got the license back from a Z a little over a year ago, we didn't need the did reactivate it in order to file the type C meeting request.
Dave: Requested the reactivation that was also achieved right on time and then in terms of the type C meeting request that we filed.
Dave: Typically the FDA has 21 days or so to get back to the sponsor wants a type C meeting request has been filed.
And then if they accept the type C meeting request. There is then a date that has been set.
Speaker Change: We filed the type C meeting request a week ago and have already heard back from the agency on the date that that type C. Meeting is set for and so the experiences that we have Andy I think are are very favorable in terms of.
Speaker Change: The FAA continuing to keep to certain timelines in fact, we haven't experienced anything thats different than that.
Speaker Change: And then finally in terms of cash from an AC in.
Speaker Change: Essentially doing the feasibility study for <unk> hundred $32 46, and CRC I think we're going to hold off on that.
Speaker Change: For now we continue to evaluate lifecycle opportunities. We wanted the most important thing that we need to do is get the phase II monotherapy trials started and then we'll be evaluating other opportunities that we think makes sense from a lifecycle perspective.
David: David anything to add to that.
David: No I think you hit the nail on the head there thing and I think for US obviously, we have identified as colorectal cancer as a potential opportunity for FTE 30, $32 46, given the expression of <unk> 46 in those patients, but the same point I think our goals.
David: This calendar year is really to close the transaction for China kickoff, our phase III studies, and really get the ball rolling around the development pathway for Roxanne Mds as well so great.
Andy: Great question Andy.
Andy: Great. Thank you so much any other follow up questions Andy.
Andy: I think that's it from US. Thanks, so much okay. Yeah. Thanks for the questions I appreciate it.
Speaker Change: One moment for our next question.
Andy: Okay.
Matthew Kelley: Our next question comes from Matthew Kelley with Acw. Your line is open.
Matthew Kelley: Hey, everyone congrats on the quarter and thanks for taking our questions.
Matthew Kelley: Two quick ones from us the first one I was wondering if you have any additional or any rate limiting steps ahead of the upcoming phase II monotherapy study.
Matthew Kelley: And then secondly, with the updates on today's call I was wondering how we should start to view, what I would say, maybe the evolving commercial opportunity for 31 area.
Speaker Change: Thanks, Matt for the questions I'll take them then.
Dave: Dave to add some additional commentary as well.
Speaker Change: Yes.
Speaker Change: Originally as it relates to the phase two monotherapy trial, we were certain that we were going to.
Speaker Change: Or how quickly we are going to get the <unk> 31, 80 <unk> cleared.
Speaker Change: So there was a point in time, where we thought that the majority of the patients.
Speaker Change: And the phase two monotherapy trial 75 patients the majority of them would be able to be treated with the <unk> biomarker. In addition to the ADC now with acquiring of the IMD.
Speaker Change: Alright.
Speaker Change: I wouldn't call it a rate limiter, but what that allows us to do is to.
Speaker Change: Get an amendment in front of the sites that has 31 <unk> as part of the phase II monotherapy study so that all of the patients in the phase two trial will be able to be treated with the with the <unk> biomarker in advance of receiving the ADC.
Speaker Change: And so we're going through that process right now as we speak.
Speaker Change: And so really the rate limiter is the close of the China transaction. So that we can move forward rapidly to then start the phase two monotherapy trial.
Speaker Change: In terms of the question around.
Matthew Kelley: But Matt you asked about the evolving.
Speaker Change: Inscape, what was that question again.
Speaker Change: Kind of like how we should view the commercial opportunity for our 31 80.
Speaker Change: As it evolves and both of you.
Speaker Change: On a standalone product or in combination with some of the other things you guys have going on as well.
Speaker Change: It's a really important question in the phase II trial, I think will tell us a lot it will give us even more information relative to what we have now there had been about I think 25 or 27 patients who had been treated with a pet imaging agent in the phase one slash two investigator sponsored trial at UCSF Thats in combination.
Speaker Change: With <unk>.
Speaker Change: We've seen those scans, it's clear that the target lights up with that.
Speaker Change: The <unk> imaging agent in and as you know it uses the same yf's five antibody.
Speaker Change: And then as a part of the ADC.
Speaker Change: And so the scans look really clear.
And the Phase III trial will then tell us do.
Speaker Change: We've continued to see the.
Speaker Change: The scans appropriately light up the lesions.
Speaker Change: Then what can we learn in terms of the.
Speaker Change: The assessment of the expression level of <unk> 46, and the response to the ADC is that will be a correlation analysis that we will do during the course of the trial and at the end of the trial. So that we can understand.
Speaker Change: The diagnostic performance.
Speaker Change: The agent itself.
Speaker Change: We have looked at.
Speaker Change: <unk>.
Speaker Change: <unk> space, we have looked at the PSM, a pet space clearly with.
Speaker Change: With the PSA pet imaging agents from <unk> that generate well over $1 billion in annual revenue. There is a clear commercial opportunity, but we're going to have to assess it.
Speaker Change: The performance of the of our pet imaging agent to be able to determine what that potential commercial opportunity could be.
Dave: Dave Please.
Speaker Change: Please add to that.
Speaker Change: Yes, I think the one thing that I want to add around the phase two and the fact that the importance of being able to dose. All 75 patients is that we're really trying to get to a point, where we can have a large swath of patients being able to be tested with <unk> 31, <unk>. So the fact that we could have 75 patients in the phase two we have the phase II portion of the.
Speaker Change: Combination therapy in the ISP with UCSF, so really the more and more patients that we can get treated with FG 3180 allows us to get really smart around what the levels of expression would be that could correlate with.
Speaker Change: With efficacy and allows us to better understand how it can be used in future studies.
Speaker Change: Yes look totally makes sense. Thanks again for taking my questions I. Appreciate it guys. Thank you Matt.
Speaker Change: And I'm not showing any further questions at this time I'd like to turn the call back over to <unk> for any closing remarks.
Speaker Change: We appreciate everybody's participation today and continued interest in fiber to and look forward to updating you over the coming weeks and months on the important catalysts that are ahead of us. Thank you for your time today.
Speaker Change: Thank you ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Good.