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spk01: Good morning, and welcome to Mursano Therapeutics' first quarter 2023 conference call and webcast. Currently, all participants are in listen-only mode. There will be a question and answer session at the end of this call. Please note, this event is being recorded. I would now like to turn the call over to Jason Fredette, Senior Vice President, Investor Relations and Corporate Communications. Please proceed.
spk10: Good morning, everyone. Before we begin, please note that this call will contain forward-looking statements within the meaning of federal securities laws. These statements include, but are not limited to, those related to the therapeutic potential of our product candidates and the potential of our platforms, business strategy, clinical trial design, execution, and data releases, regulatory plans and objectives, commercial opportunities, collaborations, and potential associated payments, operating expenses, and cash runways. Each of these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. These risks and uncertainties are discussed in our annual report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2023, and in subsequent SEC files. Our filings are available at sec.gov and on our website, mursana.com. except as required by law, we assume no obligation to update forward-looking statements publicly, even if new information becomes available in the future. So with that, let me turn the call over to Anna Protopapas, our president and chief executive officer.
spk02: Thank you, Jason, and hello, everyone. Welcome to our conference call. Joining me today with prepared remarks are Mursana's chief medical officer, Arvin Yang, and Chief Financial Officer, Brian Descheidner. We also have other members of management here who will be available to answer your questions. 2023 is shaping up to be a potentially transformational year for Mursana. We are on the verge of a top-line data readout for a first-in-class ADC, APRI, while we also execute on a comprehensive clinical development plan for this candidate, with the potential to address significant unmet medical needs for patients suffering from ovarian cancer. We are advancing our own pipeline and are also collaborating with several other organizations, utilizing our three proprietary ADC platforms. And thanks in a large part to the successes we've had on the business development front, we are doing all of this on a strong financial footing. We are pursuing our objectives during a historic period for ADCs, as evidenced by numerous new collaborations, additional approvals, exciting new data presentations, and one of the largest biotech acquisitions to date. In platinum-resistant ovarian cancer specifically, virvotuximab just recently reaffirmed the single-arm accelerated approval pathway. And from a commercial perspective, the early uptake of testing and treatment for this product has demonstrated both the high unmet medical need in platinum-resistant ovarian cancer and the willingness of treating physicians to embrace a targeted approach to therapy. And so we're in the midst of a very exciting period. Thanks to a decade of hard work by the team here at Mursana, the innovative approach that we have taken to ADC platform development and our advanced stage of clinical development with Apri, we believe we're well-positioned to add to the momentum in the field. We are putting a heavy emphasis on our strategy to establish Apri as a foundation on medicine in ovarian cancer as we advance three ongoing clinical trials that seek to address areas of high unmet medical needs. The first is UPLIFT, a single arm registration trial in platinum resistant ovarian cancer. As evidenced by a rapid enrollment of approximately 270 patients in this trial and recent product uptake in the platinum resistance phase, the unmet medical need for these late stage patients is very high. Up next is our Phase III clinical trial of UPRI as a monotherapy maintenance treatment in recurrent platinum-sensitive ovarian cancers. This trial is designed to serve as a post-approval confirmatory trial of UPRI in the U.S., significantly increase our potential market opportunities by supporting expansion into earlier lines of therapy and support potential approvals outside the U.S. And then there's UPGRADE-A, our phase one combination trial of UPRI with carboplatin in platinum-sensitive ovarian cancer. We hope this data will inform our path to earlier lines of treatment. With top-line data from UPLIFT planned for mid-year after the upcoming oncology conferences in June and a potential BLA submission around the end of the year, we have began to prepare for potential commercialization. For instance, we have formed a small core team of commercial professionals with deep ovarian cancer experience, build our medical affairs function, and we're working diligently to ensure we can hit the ground running with NAPI GP testing. Beyond UPRI, we continue to make progress in our phase one trial of XMT1660 our B7H4 dollar Simpson product candidate, and our working to address the clinical hold the FDA recently placed on our Phase I clinical trial of XMP2056. To further discuss our clinical plans and progress, I turn the call over to Arvind.
spk04: Thank you, Anna. Let's begin by discussing uplift. Platinum-resistant ovarian cancer remains an area of significant unmet medical need. Patients at this most advanced stage of disease are heavily pretreated and have a very poor prognosis. For most patients, treatment options are limited to single-agent chemotherapy, which has consistently demonstrated an objective response rate of approximately 12% in previous trials. We're seeking to fill this significant gap in care with UPRI. Following the release of data from Mirasol and based on Mervituximab's labels, it is worth noting several key differences in our trial populations. In Uplift, we enrolled an all-comers population and retrospectively are determining NAPE2B positive status as compared to Mirasol, which pre-selected for folate receptor alpha positive patients. We believe that at least a majority of ovarian cancer patients have NAPE2B positive expression. In fact, The large SNAPI-2B dataset that has been presented to date, assessing roughly 400 unique tissue samples, suggests that 59% of ovarian cancer patients are SNAPI-2B positive. In contrast, available data suggests that only a minority of ovarian cancer patients have folate receptor alpha positive expression. We also enrolled patients in Uplift who have received one to four prior lines of therapy, compared to both Soraya and Mirasol. which enrolled patients who had received one to three prior lines. We believe the differences observed between Soraya and Mirasol serve as a reminder how ORR can be influenced by the type and level of patient pretreatment. We also enrolled patients with grade two underlying neuropathy and uplift, while these patients were excluded from both Soraya and Mirasol. Our broad inclusion criteria were based largely on the encouraging data from our dose expansion cohort. Uplift's primary endpoint is the investigator-assessed objective response rate, or ORR, in the NAPI 2B positive population. The primary endpoint will aim to exclude the 12% objective response rate for single-agent chemotherapy from the 95% confidence interval. In addition to ORR, we expect the FDA to evaluate duration of response, or DOR, along with safety and tolerability in the overall context of the Uplift data. In addition to Uplift, we are continuing to enroll patients in our Phase 3 UpNext trial. There is a substantial need for new ovarian cancer maintenance treatments, as many patients have already exhausted available maintenance options by the time they have recurrent disease. And with the recent label restrictions related to PARP inhibitors, this need is only getting larger. UpNext is enrolling 350 patients. These patients must be MAPI-TV positive, and they must have achieved stable disease or better in response to their prior induction chemotherapy. In recognition of the lack of standard of care in the recurrent maintenance, the trial is randomizing patients two to one to receive UPRI or placebo. Our primary endpoint for the trial is progression-free survival, or PFS, by blinded independent central review. Our third ongoing UPRI trial, Upgrade A, is evaluating UPRI in combination with carboplatinum, Historically, the combination of carboplatinum and paclitaxel has served as the standard of care in earlier lines of ovarian cancer treatment. However, distinct tolerability challenges, including high rates of severe neutropenia, peripheral neuropathy, and alopecia, have limited the ability to dose this combination beyond six cycles. In upgrade A, patients receive UPRI in combination with carboplatinum for up to six cycles as an induction treatment, and UPRI is then continued as a monthly maintenance monotherapy. We believe the differentiated tolerability profile we observed for UPRI in our monotherapy dose expansion trial without toxicities commonly seen with other ADC platforms may position it well for use in combinations. We were pleased to complete dose escalation in upgrade A and move into dose expansion in the first quarter. And we're looking forward to sharing initial interim data in the second half of this year. Before delving into our other clinical stage, cytotoxic ADC, XMT1660, let's touch on XMT2056, which is our HER2-directed immunosymptom sting agonist ADC. In March, we voluntarily suspended our phase one trial of this product candidate following a grade five serious adverse event, or SAE, that was deemed to be related to XMT2056. The FDA then placed the trial on clinical hold. The SAE occurred in the second patient enrolled at the initial dose level in the dose escalation portion of the trial, and it was obviously quite unfortunate and unexpected. In recent weeks, we've received plasma PK and cytokine data for the two patients who are dosed in the trial prior to the clinical hold, and we're continuing to analyze these data. We're evaluating next steps for the program, and we'll prepare our response to the FDA's clinical hold letter. We will provide an update on our plans once they've been solidified. Now, let's turn to XMT1660, our dolusynthin product candidate targeting B7H4. we see B7H4 as a particularly compelling target given its high expression in a variety of tumors and its limited expression in healthy tissue. XMT1660 is equipped with a precise target-optimized drug-to-antibody ratio of 6 and our DOLA lock payload with controlled bystander effect. I'm happy to report that we are making good progress in the dose escalation portion of our multi-center phase 1 trial, which is enrolling patients with breast, endometrial, and ovarian cancers, and remain firmly on track to complete this portion of the trial later this year. With that, let's turn the call over to our Chief Financial Officer, Brian Descheidner, for an update on our financials. Brian?
spk09: Thank you, Arvind. We are approaching our upcoming top-line data readout in a strong financial position. Beyond the $170 million in upfront payments we received from collaborations over the past year, we're beginning to see the downstream benefit of those transactions. in the form of initial discovery milestone revenues. We ended the first quarter with approximately $274 million in cash equivalents and marketable securities, and we also have a line of credit available to us. We expect our available funds to support our operating plan commitments into the second half of 2024, well past several potential milestones of significance. It should also be noted that our cash runway guidance does not assume any potential milestone payments from our current collaborations or proceeds that we may realize from future collaborations. Now for a brief recap of our P&L for the first quarter. Net cash used in operating activities was approximately $29 million for the first quarter of 2023. Collaboration revenue for the first quarter of 2023 was $7.8 million, compared to $2 million for the same period in 2022. The year-over-year increase was primarily related to our collaboration agreements with Merck KGA and Asana. Research and development expenses for the first quarter of 2023 were $47.3 million, compared to $35.8 million for the same period in 2022. Non-cash R&D-related stock-based compensation expense for the first quarter of 2023 was $3.3 million. The year-over-year increase in R&D expenses was primarily related to higher manufacturing and clinical costs related to Opry and an increase in headcount. General and administrative expenses for the first quarter of 2023 were $18.3 million compared to $12.8 million during the same period in 2022. Non-cash, G&A-related stock-based compensation expense for the first quarter of 2023 was $3.1 million. The year-over-year increase in G&A expenses was primarily related to increases in medical affairs and pre-commercial activities and headcounts. Mursana's net loss for the first quarter of 2023 was $56.2 million, compared to a net loss of $47.3 million for the same period in 2022. Now I'll turn the call back over to Anna for a few closing remarks.
spk02: Thanks, Brian and our friends. In summary, 2023 is lining up to be a transformative year for Mursana, and we're excited by all that lies ahead. We expect to report top-line data for Uplift, mid-year following the major oncology conferences in June with a potential BLA submission plan for around the end of the year. We plan to significantly advance enrollment in our confirmatory trial up next. We will also advance the dose expansion portion of upgrade A and expect to report initial interim data from this trial in the second half of the year. Our team will continue to work to evaluate next steps related to our development of X&T 2056. And finally, we plan to complete the dose escalation portion of our phase one trial of X&T 1660 this year. We look forward to keeping you updated on all our progress. Now, let's open the call to your questions. Operator, would you please provide the instructions?
spk01: Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. And today's first question comes from Brian Chang with JP Morgan. Please go ahead.
spk08: Hey, guys. Thanks for taking my question this morning. Maybe just one on ASCO. Heading into ASCO, we saw that you have a presentation there on expression of fully receptor alpha and also NAPI2B. So can you shed some light on what that presentation entails and what should we be looking for there? And I have a follow-up. Thank you.
spk04: Thanks, Brian. This is Arvind. I can address that question. So we look forward to sharing information at ASCO. And it's a data set that comes from our expansion cohort of our upper east study, the phase one study. And really the purpose of it is to evaluate NAPI2B expression and folate receptor alpha expression, recognizing that in other data sets external to the one that we're presenting, we've described how NAPI2B is approximately 59% based on 400 tumor samples relative to what we've seen from the FDA review of mervituximab, where 29% was the positivity for folate receptor alpha.
spk08: Great. And maybe just one on uplift top line. Heading into uplift top line later this year, later mid-year, outside of overall response rate and duration response, are there any additional efficacy measures that we could get at the top of the top line?
spk02: So I think, as we've said, the top line will be mid-year after the June oncology conferences, and we will be showing overall response rate in the primary endpoint as well as the secondary endpoint, duration of response, and, of course, the key safety overview for the study.
spk08: Thanks, Anna. Thank you.
spk01: Thank you. And our next question today comes from Jonathan Chang with SBB Securities. Please go ahead.
spk03: Good morning. Thanks for taking my questions. First question, on the recent Mirasol results, how does that impact your thinking on the UPRI opportunity and strategy?
spk02: We remain very excited about the UPRI opportunity, Jonathan. As you know, and this is evident from what we've seen from Immunogen, this is an area of high-end medical need. There's a desperate need by physicians and patients for new agents, and we remain very excited about UPRI. We've shown robust efficacy and a differentiated tolerability profile in the expansion cohort. And of course, as Arvind just alluded to, we have an agent that has a very significantly different prevalence, and the overlap between folate high and NAPI 2B high is quite limited. So there's a desperate need for new agents for these patients, and we hope UPRI will fill that gap.
spk03: Got it. Thank you. And second question, when could we see initial data from the B7H4 program?
spk02: What we've guided to, and I think Arthur mentioned on the call, is that we expect to complete dose escalation by the end of this year. Our dose escalation is proceeding as planned. And at that point, I think we'll have not yet guided to data disclosures. But we're very excited about the program. We think this is a great target for an ADC and for our platform. So we'll make that decision on data disclosure as we approach completion of the doses donation.
spk03: Got it. Thanks for taking my questions.
spk01: Thank you. And our next question today comes from Colleen Cussey with Baird. Please go ahead.
spk12: Hi, good morning, and thanks for taking our questions. On the Uplift readout that's coming up in midyear, Would you expect to also report data in the overall patient population? And do you have any expectations on what you'd need to show in the NAPI 2B low patient population to get a broad label?
spk04: Sure. Thanks, Colleen. So we do expect to share data not only in the NAPI 2B positive population, which is our primary endpoint, but the overall population is a key secondary endpoint. So a response rate in the key secondary endpoint could also support a broader indication. This alludes to actually your second question in relationship to what would you need to see in the low population. So keeping in mind that the benchmark for approval for both of these populations in discussion with FDA really is a single agent chemotherapy response rates of 12%. Now that being said, the response rate in the overall population we would imagine could not be completely driven by the NAPI 2B positive population in order to generate that overall population response rate.
spk12: Got it. That's helpful. Thank you. And then on the upgrade data later this year, are you able to say roughly how many patients you'd expect and how much follow-up you'd expect to have?
spk04: We had announced last year that we had completed or that we had approximately 12 patients within the dose escalation portion. And then in the first quarter of this year, we had indicated that we had completed dose escalation and initiated the expansion phase. So you can approximate in relationship to how many patients we would have within dose escalation. And a determination will be made just in relationship to how many patients will then be available for presentation in the second half of this year. That also gives you some sense of the follow-up that would be available for those patients.
spk12: Got it. That's helpful. Thank you. And then just last follow-up on the upgrade study that's reading out later. So would the focus there be mainly on safety, or can you kind of help us set a bar for efficacy in that readout?
spk04: Sure. So the primary focus absolutely is safety. It's a phase one study, and it is really driven off the premise that UPRI provides a differentiated profile with non-overlapping toxicities, affording it a great opportunity to combine with standard of care platinum, for instance. In addition to that, obviously being able to continue the UPRI portion of it after completion of the six cycles of combination into the monotherapy. So safety will be the primary focus of this presentation, recognizing that the follow-up to get into the maintenance may not be sufficient at that time point. We will plan to present also efficacy for the available information, but it's in the context, obviously, of recognizing safety as the primary focus.
spk12: Great. Thanks for taking our questions.
spk01: Thank you. And again, if you have a question, please press star then 1. Our next question today comes from Kaveri Pullman with BTIG. Please go ahead.
spk11: Good morning. Thanks for the updates and for taking my questions. For the upcoming ASCO data for expression studies, is that specifically for platinum-resistant populations Do you expect to see any changes in NAPI 2B expression or the overlap when you move to earlier lines?
spk04: Thanks for the question, Kavari. So just for context, obviously we want to share the presentation for ASCO. But as I mentioned earlier, this will be on a data set that comes from our Phase 1 study. And so that included primarily platinum-resistant ovarian cancer patients. There was a proportion of patients that were fourth line plus that could have been platinum sensitive. But again, these were a minority of the patients. But to your second point in relationship to the prevalence of NAPI 2B, we shared actually a variety of different presentations in the past from tumor banks, from our own internal studies that support the consistency of NAPI 2B expression by line of therapy. as well as from a local and metastatic site perspective. There I'll remind folks that 59% would not be 2B positivity when looking at one of the largest, the largest tumor bank analysis of individual tissue samples of approximately 400 samples.
spk11: That's very helpful. Thank you. And for the up next study, It's a novel design, but any insight you could provide on addressable patient population, how different it is from the platinum resistant market? And in terms of benchmarks for PFS, what would you expect out of the placebo arm?
spk02: So maybe Arvind can talk to the placebo arm and the protection benefit here. As for the size of the market, we have not given specific numbers, but we do believe that this trial will bring us to a large unmet medical need, potentially larger than platinum resistant, with a positive up next trial.
spk04: And maybe just before I jump into the placebo effect, I'll just comment that given the emerging landscape of the PARP inhibitors, with the recent FDA changes where PARP inhibitors are no longer approved or restricted primarily to the BRCA and the HRD positives, we see that actually as increasing the unmet need in that recurrent platinum maintenance setting, platinum-sensitive maintenance setting. Kaveri, just to your second question as far as the activity of placebo, One of the best benchmarks may be the NOVA study. So it's a study of a PARP inhibitor in the recurrent platinum sensitive maintenance setting. And there the placebo arm had a performance of PFS of approximately four and a half months. But I do want to provide context to that figure because that was a study performed in an earlier time period where patients may not have received or would not have actually received prior PARP or BEV in that era. where the study was conducted. In addition to that, this patient population was less heavily pretreated and less refractory because they did not include stable disease patients to the prior platinum therapy in acknowledgement that the PARP inhibitor and platinum mechanism of action has sufficient similarity that they did not want to include stable disease patients for their study as opposed to in up next where we do include these patients.
spk11: Got it. And maybe the last one on B7H4 ADC. From the competitive landscape standpoint and from your experience with APRI and 1529, can you tell us what advantages the single species ADCs provide?
spk02: We didn't hear the second part of your question. You're asking for the differentiation versus other B7H4 ADCs. Kaveri, was that the question?
spk11: Yes. And you have intensive experience with Opry and 1529, which was also a single species ADC. So I just wanted to get some sense what advantages these homogeneous ADCs provide.
spk04: Sure. I can start and if the team wants to add to that. So, I mean, first off, we're very excited about B7H4. We think it's a good target. Given the competitive landscape, I would argue that others agree with us in relationship to that. Before diving into that, actually, let me just clarify. We do actually have extensive knowledge with the dolaflexin molecule, and it's differentiated the safety profile given that it's the same payload that's utilized in opry, again, without the severe neutropenias, the ocular toxicities, or the neuropathies. We did evaluate it also in the 1592 program. I just wanted to clarify that that was a dolacinthin molecule with the same payload. Just to clarify, it wasn't 1529. Now, with that being said, we are excited about B7H4 because it does differentiate relative to, and I'll flag two different companies that are also developing B7H4. So, Cgen is developing a B7H4 molecule, but We have a DAR of a homogeneous DAR of six, alluding to sort of the point you're raising, and we believe that through our preclinical data that the DAR of six did have differential benefit from the standpoint of greater efficacy when looking at our preclinical models. In addition to that, we do expect that from a PILA perspective, it'll have that differentiated safety profile relative to the MMAE that the cGen molecule is being developed at, where they also have a lower DAR of approximately 3.5. So I think that addresses your question just as far as the differentiated profile.
spk11: Yeah, that's very helpful. And, yeah, I meant 92 instead of 29. Sorry about that. No problem.
spk01: Thank you. And our next question today comes from Ashik Mubarak with Citi. Please go ahead.
spk07: Hi, team. Thanks for taking my questions. I know you made some comments related to building out the commercial infrastructure in the past quarter. Can you comment at all on the size and the reach of the sales force for upgrade you're building out, and maybe any general commentary on how much of an educational uplift you think there needs to be with an IP2B biomarker testing in the sort of real-world setting?
spk02: Our commercial efforts are very much focused on pre-launch activities. We're some ways away from really defining the exact size and details of the sales force. So let me focus on what we're doing now. We have a very small but impactful medical affairs group that is really working with investigators to increase the awareness of the importance of NAPI2P as a biomarker and to educate on UPRI as a potential therapy in ovarian cancer. We have really a handful of people with deep ovarian cancer commercial expertise that are really preparing the market plans and ensuring that our diagnostic is available on day one. So that is the effort. A very small group of people has, I believe, been very impactful in ensuring all the work is done for us to be ready with positive data, with a BLA, and then potentially an upcoming approval to be able to build out that effort.
spk07: Got it. That's really helpful. I'm going to ask one more also on the commercial plan. I think in the past you've alluded to your plan to partner Uppery in Europe and in other regions globally. And I'm just wondering if you can remind us why that's the right move. I think Immunogen made some commentary last week related to the idea that the European market is actually pretty concentrated around a limited number of centers, which maybe covers the majority of the market. So I'm wondering if you are thinking about the European opportunity in a similar or very different way, given you're planning to partner.
spk02: Our thoughts are really based on extensive experience across the biotech industry, really investing in an infrastructure in Europe, although eventually might pay off. It's a significant investment. And as you're aware, getting reimbursement in Europe always takes time. So by the time that European infrastructure becomes cash flow positive, it takes a lot longer to get there than in the U.S. And I think that's what's driving our thinking, which of course will be refined as we get top-line data, will be further refined. But I think history will say that small biotech companies that expand to both the U.S. and Europe would require significant investments. before that commercial infrastructure can really begin to be cash flow positive.
spk07: Got it. Thanks for taking my questions.
spk01: Thank you. And our next question today comes from Boris Peeker with Cowan. Please go ahead.
spk06: Great. Thanks for taking my questions. First question on the uplift study, can you set expectations for duration of response? And if that is something that you've discussed with the FDA, what the agency may be looking for in terms of duration of response?
spk04: Thanks for the question, Boris. So in discussions with FDA, we've aligned that response rates is the primary endpoint for evaluation of efficacy, and that's 12% based upon the multiple phase-through studies that we've described in the past. Duration of response certainly will be expected. It'll be in the context, again, of the overall efficacy and safety profile that it'll be taken into context.
spk06: Great. And maybe in terms of baseline characteristics, you mentioned that you allowed baseline grade 2 or just lower neuropathy in the uplift trial while these patients were excluded from Sirea and Mirasol. Just curious, can you comment what fraction of these platinum refractory patients have this baseline neuropathy?
spk04: So we know that most of the patients, actually, if not all of the patients that become platinum resistant will have received an agent that can induce neuropathy, given that Taxol is a heavy offender, and other chemotherapics certainly can contribute to that. I don't have the numbers specifically for the expansion data available in reference to that, but based on what I just described earlier is that, you know, we do expect a fair proportion of patients to have some degree of neuropathy. That could obviously be impacted if they were to receive further therapy that could cause neuropathy, whereby with Opry, we have not seen the severe neuropathies.
spk06: Great. Thank you very much for taking my questions.
spk01: Thank you. And our next question comes from with . Please go ahead.
spk13: Hi, guys. Good morning. Thanks for taking the questions. So the mirror cell study, the ORR surprises positively getting to the 40% plus range. And I guess one could attribute that to being the study recruiting a more homogenous population than the phase ones and potentially a less sicker patient population than Soraya. You guys have already set a very high bar with ORR in your phase one expansion work. So would it be unreasonable to expect your ORR to look better on uplift as well?
spk02: Well, thanks for the question. We saw robust activity in the expansion cohort, particularly with the 36 milligram per meter squared. But I think the differences in overall response rate between Mirasol and Soraya do serve as a reminder that the type and level of patient pretreatment can influence impact And again, as Arvin mentioned on the call, we do have a population that is more heavily pretreated than Soraya and definitely even more heavily pretreated than Marisol. So I think we'll have to wait and see the results mid-year, but we're confident based on the robust activity we saw in the expansion cohort.
spk13: Great, thanks guys. And then maybe just a quick, two quick questions. Do you plan to report the upgrade aid data at a medical meeting or would that be more geared to its investment community? And then on the diagnostic test, our KOL checks suggested that there was some bottlenecks faced with the diagnostic test for Mervitacizumab. with one of the centers in particular, take a little bit of a while to turn the test around. What have you learned from that from the competitive experience and what are you doing to kind of make sure that you don't run into the same issues? Thanks.
spk02: On the diagnostic, we're working with our diagnostic partner to ensure that the test is available on day one and that we appropriately prepare in terms of supply of reagents to ensure there is no disruption in availability of the test. And what was the other question? Was there a second question?
spk04: Yeah, I can address the first question. Just as far as upgrade A, we've indicated that we'll share the data in the second half of this year. We haven't expressed sort of what type of forum that we'll be in, and we'll disclose that at the appropriate time.
spk13: Great. Thanks a lot, guys.
spk01: Thank you. And our next question today comes from David Nierengarten with Red Bush Security. Please go ahead.
spk05: Maybe as a follow-up on the diagnostic or the testing question, just if you had any particularly updated thoughts on how physicians would, when presented with a patient in an earlier line, or I guess in any line of setting, react to the patient. Should they tests with folate first are they going to do both tests do you think you know kind of how you know and treat appropriately you know kind of how how do you see that evolving with the positive marisol results thanks we are very encouraged by the testing that is taking place with with folate positive patients
spk02: And we believe that what will happen once both agents are in the market is that when a patient is diagnosed with ovarian cancer, they will undergo a set of tests that will include both folate and NAPI-2B. And that is the desired sort of state of affairs in the future. And I think the uptake we've seen on the folate test is encouraging that that will be the case.
spk05: Got it.
spk02: And, David, we are definitely working to make sure that our test is available on day one after launch for anyone at any stage who wants to take the test, at any stage of their disease. Yep.
spk05: Great. Thank you.
spk01: And, ladies and gentlemen, as a reminder, if you'd like to ask a question, please press star then 1. Our next question is a follow-up from Colleen QC with Baird. Please go ahead.
spk12: Hi, good morning again. Thanks for taking the follow-up. Just one more. So on the uplift readout and kind of understanding that the patient pretreatment is going to impact the ORR, can you remind us how many patients in the dose expansion were fourth line or later? And would you expect that proportion of patients to be similar or different in the uplift study?
spk04: Thanks for the question, Colleen. So approximately 33% of the patients in the expansion portion of the phase one study for UPRI was fourth line or later. Obviously, we'll disclose the broader demographics at the top line, per se, but for context, we enrolled in the U.S. as well as in the EU for the UPLIFT study, globally, in relation to the UPLIFT study, but we would expect practice patterns to be relatively similar in the platinum resistance space.
spk02: Pauline, I would add one other point. The fact that we have enrolled so robustly in Uplift, I think might give us an opportunity to look at how pretreatment impacts overall response in subgroup analysis and really help us better understand the profile of the agent.
spk12: Great. Thank you.
spk01: And ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to Anna and Pratap Pappas for any closing remarks.
spk02: Thank you, Operator, and thanks to all those who listened and for your continued support. We're looking forward to participating in the Bank of America Healthcare Conference tomorrow, sharing several poster presentations at ASCO next month, and presenting at the Jeffries Healthcare Conference a few days later. Hope to see many of you at those events. Enjoy the rest of the day.
spk01: Thank you. Ladies and gentlemen, this concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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