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spk07: Ladies and gentlemen, thank you for standing by, and welcome to Marsana First Quarter 2021 Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press the star, then the one key on your touch-tone telephone. If you recall our assistance, please press star, then zero. I would now like to hand the conference over to your speaker host, Sarah Karmody. Go ahead. Good afternoon. Welcome to Mursana's first quarter 2021 conference call. Earlier today, we issued a press release reviewing our first quarter financial results and business updates, which will be covered on this call. A replay of today's call will be available on the Investors and Media section of our website. After our prepared remarks, we will open the call for Q&A. Before we begin, I'd like to mention that our call will contain forward-looking statements within the meaning of the federal securities laws. These are not statements of historical facts and are based on management's beliefs and assumptions and on information currently available. They're subject to risks and uncertainties that could cause the actual results and the implementation of the company's plans to vary materially, including the risk that the results of our ongoing or future clinical studies may be inconclusive with respect to the efficacy of our product candidates, that we may not meet clinical endpoints with statistical significance, or there may be safety concerns or adverse events associated with our product candidates. That preclinical testing or early clinical results may not be predictive of the results or success of our ongoing or later preclinical or clinical studies. That the identification, development, and testing of the company's product candidates and new platforms will take longer and or cost more than planned. and that our clinical studies may not be initiated or completed on schedule, if at all. These risks are discussed in the company's SEC filings, including, without limitation, the company's annual report on Form 10-K filed on February 26, 2021, and subsequent filings. In addition, while we expect that the COVID-19 pandemic might adversely affect the company's preclinical and clinical development efforts, business operations, and financial results, The extent of the impact on the company's operations and the value of the market for the company's stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantine, physical distancing, and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. Except as required by law, the company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future. And with that, I'll turn the call over to Anna Protopopis, Murasana's President and Chief Executive Officer.
spk05: Thank you, Sarah. Good afternoon, everyone, and welcome to our first quarter 2021 Corporate and Financial Update call. Joining me today with prepared remarks are Arvind Yang, Chief Medical Officer, Tim Loewinger, our Chief Science and Technology Officer, and Brian Descheidner, our Senior VP of Finance and Product Strategy. I'm also joined by the rest of the executive team, who will be available for your questions, including the newest member, Alejandra Carvajal, Chief Legal Officer, who joined us in April. Before we start, I want to take the opportunity to introduce and welcome Alejandra. Alejandra brings with her 20 years of legal leadership experience in various pharmaceutical and biotech companies and a demonstrated ability to work cross-functionally. Most recently, Alejandra served as the chief legal officer of Momenta Pharmaceuticals, where she led the company's legal operations through both restructuring and the successful acquisition by Johnson & Johnson. Brian, Michael, and I have had the pleasure of working with Alejandra at Millennium Pharmaceuticals, and we are very excited to have the opportunity to work with her again. I am confident of the positive impact she will have on MERSANA. Welcome, Alejandra. I'll now move on to the business update. Since the beginning of the year, we've made important progress in our endeavors to build UPRI as a foundational medicine in the treatment of ovarian cancer. and in building out our innovative pipeline of ADC candidates addressing areas of high unmet medical need. With respect to building UPRI, in January we disclosed further data from the expansion portion of the UPRI phase one study in ovarian cancer and showed consistent robust activity with a response rate of approximately 30%, substantially above the current standard of care including complete responses in heavily pretreated patients and a tolerability profile without the severe neutropenia, neuropathy, and ocular toxicities seen with other ADC platforms. The data also demonstrated a clear biomarker response relationship, which leads me to the next important step in building UPRI, Uplift, our single arm registration strategy informed by FDA feedback. In April, we announced that we have initiated patient dosing. This is an important milestone in our efforts to bring Uplift to patients living with heavily pretreated ovarian cancer who have an acute need for new therapeutic options. The design of Uplift focuses both on increasing the potential for label differentiation and the probability of success. As a reminder, Uplift is enrolling a broader patient population than other studies in this space, consistent with where we observed activity in the expansion cohort. More prior lines, more flexible inclusion of prior Bevacizumab treatment, consistent with the Bevacizumab label, and there is no exclusion for baseline peripheral neuropathy. By enrolling patients regardless of NAPI-to-be expression, Uplift also offers two shots on goal with a primary endpoint in the high NAPI2B population and a secondary endpoint in the overall population, allowing us to fully evaluate the role of the biomarker in enriching for patient outcomes. We plan to present a trial in progress poster at the upcoming virtual ASCO meeting in June, detailing the design of the Uplift study. In addition to initiating Uplift, we also provided an update on the final selection of the NAPI-2B biomarker cutoff, its role in Uplift, and our expected commercial diagnostic development path. The development of the diagnostic is a result of a multi-year program encompassing research, translational, and clinical work, advanced at each stage in tandem with the development of Uplift. Through this work, we believe we have designed an optimal diagnostic assay in terms of its robustness, predictiveness, and reproducibility. Importantly, while we have previously shown that an age score of 110 enriches for a response, we demonstrated that tumor proportion score, or TPS, greater than or equal to 75%, which is derived from the same values as age score, also enriches for response just as well and can be operationally more straightforward to perform. When we looked at the same ovarian cancer expansion data set that we showed you back in January, but evaluated this data by TPS methodology based on the TPS75 cutoff, the high NAPI-2B patients have an enriched overall response rate of 39%. relative to the overall response rate of 28% in the total population. These results are comparable to the age score results that we have demonstrated to date. TPS 75 is the predefined threshold that we will use to define our high NAPI 2B population in Uplift, where we will look to validate the proposed commercial assay. In summary, the strong proof of concept data from the expansion cohort, the robust, predictable, and reproducible assay we have developed, and the design of UPRI informed by FDA feedback contribute to our belief that we will be able to deliver UPRI to patients that are in dire need of therapeutic options. Finally, for UPRI, we've made progress in preparing for the initiation of the upgrade umbrella study. a first step in bringing UPRI to patients in earlier lines of therapy as we seek to establish it as a foundational medicine in ovarian cancer. Arvind will discuss the design of UPRI in a moment, but we believe we're on track to initiate this study in the third quarter of this year. With respect to building out the pipeline, the UPRI lung adenocarcinoma expansion cohort continues to enroll patients and we believe we will remain on track to reach our goal of enrolling approximately 40 to 45 patients this year and plan to report data in the second half of this year. At the same time, XMT1592 is still in dose exploration phase of the study, using the clinical experience to validate the preclinical finding of greater potency. We have exceeded the MTD, and are doing further exploration of dose and schedule. We plan to disclose interim data in the second half of the year. Finally, we have continued to advance our next two earliest stage candidates, XMT1660, our dolosynthin B7 H4 ADC, and XMT2056, our first immunosynthin sting agonist ADC. through IND-enabling studies with the goal of initiating clinical studies in early 2022. In April, we presented preclinical data highlighting the potential for both programs at the virtual AACR conference, which Tim will review shortly. As I stated earlier, we continue to make important progress across each of our programs and look forward to continuing to make progress on uplift, and the rest of our ATC pipeline, providing the potential for multiple value inflection points and bringing us even closer to reaching our overarching mission to develop life-changing ATCs for patients fighting cancer. With that, I will turn the call over to Arvind to discuss the design of the upgrade study for upbringing in ovarian cancer.
spk06: Thank you. Anna, and thank you everyone for joining us today. Let's take a step back and recap what we've demonstrated with UPRI, why we're so encouraged by Uplift, and how we envision doubling or tripling the number of patients with ovarian cancer that could benefit from UPRI through our life cycle plans. Today, we've seen positive results with UPRI in heavily refractory patients, including complete responses in patients who have failed Bevacizumab and PARP inhibitors. Antitubulins are an established class in the ovarian cancer space, but both anti-cubulants and other ADC platforms in this space have been limited by severe adverse events, including peripheral neuropathy and neutropenia, and also events deeply concerning to patients like alopecia. UPGRADE is a phase one umbrella study designed to evaluate UPRI in combination with other ovarian cancer therapies to explore the role of UPRI in earlier stages of the disease. We first intend to combine with platinum, as platinum therapy is currently the mainstay therapy in earlier-line platinum-sensitive ovarian cancer, and we expect to initiate patient dosing in the third quarter of this year. This Phase I open-label dose escalation portion of the study will determine the maximum tolerated dose and safety and tolerability of an every-four-week administration of UPRI in combination with Q4 week administration of carboplatinum for six cycles, and then upremonotherapy will be continued in platinum-sensitive patients with high-grade serous ovarian cancer who have received one to two prior platinum-based regimens. Patients will not be preselected for NAPB2B expression, but archival or fresh tissue will be required for retrospective assessment of expression. Upon completion of the dose escalation portion of the study, we plan to initiate the expansion portion in combination with carboplatinum for six cycles, and then up remonotherapy will be continued to assess the feasibility for this combination therapy, as well as efficacy in approximately 30 patients in order to inform next steps. This study could provide us proof of concept by benefiting patients earlier in their disease where they are platinum sensitive as well as by continuing up-ring monotherapy beyond what is achievable with carboplatinum and paclitaxel alone. Finally, we are excited for what this could mean for NAPI to be biomarker-positive patients. In addition, there is a higher unmet need for those patients who do not benefit from platinum. In the future, this umbrella study allows us to also evaluate non-platinum-based combinations. Future combinations could include liposomal doxorubicin, bevacizumab, PARP inhibitors, and immuno-oncology therapies. We look forward to getting this combination study underway. We believe that the differentiated tolerability profile without the severe neutropenia, peripheral neuropathy, and ocular toxicity that limit other ADC platforms provides UPRI with a significant advantage in terms of its potential as a combination therapy. Importantly, Moving UPRI into earlier lines of therapy could significantly expand the number of patients with ovarian cancer that could benefit from UPRI and the duration of time over which we can impact their disease. I will now turn the call to Tim to discuss our exciting early stage ADC candidates.
spk01: Thanks, Arvind, and good afternoon, everyone. Today, I will focus on XMT2056, our first immunosynthin sting agonist ADC, and XMT1660 are B7H4 dolusynthin ADC, both of which are advancing through IND-enabling studies, and we believe remain on track to enter the clinic in early 2022. In April, we were pleased to share additional encouraging preclinical data for both of these programs at the virtual AACR meeting in the form of three e-posters. I'll start with XMP1660. B7H4 is a promising target for a dolacentin ADC due to its expression profile as well as its function. B7H4 is expressed on multiple tumor types with high unmet medical need, including breast, endometrial, and ovarian. Based on preclinical studies, we have shown that our dolalog ADCs lead to immunogenic cell death and that our dololoc payload can activate dendritic cells in the tumor microenvironment, leading to a potential anti-tumor immune response in addition to the direct cytotoxic anti-tubulin effect. Because B7H4 is expressed on tumor cells, as well as immunosuppressive tumor-associated macrophages, it provides the potential opportunity to co-opt those macrophages in a targeted manner to further contribute to both the cytotoxic and immunogenic effects and create what we describe as a perfect storm in the tumor microenvironment. At AACR, we showed that XMT1660 demonstrated robust in vivo activity against multiple triple negative breast cancer models as well as an ER positive HER2 negative breast cancer model and showed superior efficacy at matched payload doses versus other potential candidate B7H4 ADCs representing different DARS and platforms, consistent with our philosophy that it's not one size fits all when it comes to ADCs. These encouraging preclinical data, together with the lack of co-expression of B7H4 and PD-L1 in breast tumors, suggests an opportunity for a B7H4 dolesynthin ADC to address unmet medical need in patients who either do not respond or progress on checkpoint inhibitors and supports the further development of XMT1660. Moving on to immunosynthin, we also presented two posters highlighting XMT2056 and the sting mechanism of action data at AACR. Our first poster showed preclinical data supporting the hypothesis that XMT2056 can overcome the limitations of the current therapeutic approaches, enabling tumor-targeted delivery of a sting agonist with improved efficacy and tolerability over a free IV sting agonist. Antitumor activity of immunosynthin sting agonist ADCs involves targeted activation of the sting pathway in both tumor resident immune cells and tumor cells, delivering a one-two punch to the tumor with the potential to increase the therapeutic index. Our second immunosymptom-related poster focused on one of the key differentiators between our STING approach and other approaches to innate immune activation. In vitro studies show that while most cancer cell lines do not respond to STING agonism in standard monoculture conditions, immunosynthin sting agonist ADCs do activate sting in the same cancer cells in the presence of immune cell conditioned media, suggesting that the tumor cell intrinsic sting pathway can be activated in the presence of cues from immune cells. This would be in contrast, for example, to TLR agonist approaches, as TLRs are not expressed in the cancer cells. More detailed in vitro preclinical studies revealed that the immunosymptom ADC results in type 3 interferon induction and that blocking type 3 interferons inhibits the production of key cytokines and cancer cell killing induced by sting agonist ADC treatment, pointing to a potentially important role for type 3 interferons in antitumor immune responses downstream of sting pathway activation in tumor cells. All three of these posters are available on the publications page of our website. We are working diligently to advance XMT2056 and XMT1660 and believe these data further support the clinical development of both of these agents, which have the potential to address unmet medical need across multiple different tumor types. With that, I'll turn the call over to Brian for an overview of our financial results.
spk04: Thank you, Tim. Good afternoon, everyone, and thank you for joining us. I will now review some of the key financial highlights from our first quarter 2021 results. I'll start with our cash position. We ended the first quarter of 2021 with $228 million in cash and cash equivalents. Net cash used in operating activities in the first quarter was $27 million. In addition to our current cash position, we have the option to draw funds through the debt financing agreement with Silicon Valley Bank, refinanced in August of last year. We expect that our available funds will allow us to meet our current operating plan commitments for approximately the next two years. And now, some of the key highlights from our first quarter 2021 financial results. Research and development expenses for the first quarter of 2021 were approximately $27.4 million, compared to $12.2 million for the same period in 2020. The difference was primarily due to an increase in UPRI and XMT 1592 manufacturing, clinical, and regulatory expenses, an increase in manufacturing activities for our preclinical and discovery stage programs, and an increase in headcount. Non-cash, stock-based compensation expense included in these research and development expenses increased by $1.5 million. primarily related to an increase in the valuation of stock-based awards as a result of stock price appreciation. General and administrative expenses for the first quarter of 2021 were approximately $7.2 million, compared to $4.9 million in the same period of 2020. The increase was primarily due to an increase in headcount and consulting and professional fees. Non-cash stock-based compensation expense included in these general and administrative expenses increased by $0.9 million, primarily related to an increase in the valuation of stock-based awards as a result of stock price appreciation. Net loss for the first quarter of 2021 was $34.7 million, or 50 cents per share, compared to a net loss of $16.9 million, or 35 cents per share, for the same period of 2020. Weighted average common shares outstanding for the quarters ended March 31, 2021 and March 31, 2020, were approximately 69 million and 48 million, respectively. I will now turn the call back to Anna.
spk05: Thank you, Brian. I believe we're well positioned to continue to execute against our 2021 goals of building UPRI as a foundational medicine in the treatment of ovarian cancer and building out our pipeline of innovative ATCs addressing areas of high medical need. Before we take Q&A, I'd like to mention that this past Saturday, May 8th, was World Ovarian Cancer Day. And I'd like to recognize the women living with ovarian cancer, survivors, their families, and the many patient advocacy groups around the world promoting awareness about this devastating disease. Unfortunately, there remains a significant unmet medical need and limited treatment options for these women. I would also like to take this opportunity to thank the Mursana employees who are committed to improving outcomes and quality of life for women with ovarian cancer through their tireless work in developing UPRI and other potential life-changing ADC therapies, because we know that patients are waiting. With that, I will turn the call over to the operator for Q&A.
spk07: Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press the star then the one key on your touch-tone telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Now, first question coming from the line of Jonathan Cheng with SBB Lyric. Your line is open.
spk03: Hi. Thanks for taking my questions. First question, how much has COVID-19 impacted your upper ovarian cancer clinical trial experience to date? And how should we be thinking about the potential impact moving forward with the recent initiation of Uplift?
spk05: Jonathan, thanks for the question. We've been very fortunate in that to date we have seen robust enrollment in the expansion cohort. And as we have said, we will provide guidance on further enrollment for Uplift, but we believe we're well-positioned because, as you know, Uplift is an amendment to the existing expansion cohort, and we believe that that momentum we've seen in enrollment in the expansion cohort will be able to carry forward to Uplift. And Uplift also has some design features that I think could contribute to our optimism about recruitment on Uplift. As you know, it's an amendment. We do not require selection of patients for NABI to be biomarkered. We have broad inclusion criteria, including, you know, patients up to four lines of therapy. We're not excluding patients who have baseline peripheral neuropathy. A patient population very similar to what was in the expansion cohort. And equally important, we've partnered with GOG and NGOT, GOG being the cooperative group in the U.S. and NGOT being the cooperative group in the EU. So we are quite optimistic that we will continue to see robust enrollment as we have seen in the expansion cohort. Of course, as we get further ahead with Uplift, we'll be able to give more definitive guidance. But at this point, we feel pretty good about where we are.
spk03: Got it. Thank you. And second question, can you help set investor expectations for the UPRI and 1592 lung cancer readouts expect in the second half?
spk05: Yeah. So we are on track to enroll about 40 to 45 lung adenocarcinoma patients with UPRI and disclose the data in the second half of the year. We did indicate at an earlier call that the prevalence of NAPI to be high in the lung adenocarcinoma patient group is lower than it is in ovarian. About a third of the patients have NAPI to be high as defined in the ovarian cancer cohort. But we will have 40 to 45 patients that are unselected and we'll be able to disclose that data. In terms of 1592, we are also on track in the dose escalation to disclose data in the second half of the year. As I mentioned on the call, we have exceeded MTD and are now in dose exploration, and we'll be able to disclose that data, a comprehensive data update on the dose escalation in the second half of the year.
spk03: Got it. Thanks for taking the questions.
spk07: Our next question coming from the line of Tom Schroeder with BTIG. Your line is open. Hi, this is Kaveri for Tom. Thanks for taking our questions. My first one is regarding relation between not B2B expression and duration of response. Are there any studies preclinical or clinical maybe based on Genentech's ADC that have shown whether NAPI-2B expression level changes post-treatment and if that it plays any role in defining the durability of response.
spk06: Arvind, would you like to take that? Sure. Thank you for the question. So let me break that question down first just in relationship to first if there's any evidence of changes in regards to NAPI-2B expression based upon treatment or within different lines of therapy. we've looked at our tumor banks as well as our samples in regards to archival versus fresh tissue. And what we do see is consistency in regards to levels of expression, meaning that if a patient is a higher expressor, then it's concordant in relationship to their prior archival tissue versus a fresh tissue. And the pull-through in relationship to this can be that as we think about the life cycle of upbreak, we do have anticipation that the levels of expression could be consistent in earlier lines of therapy in regards to the prevalence level. In regards to the second question, in regards to duration of response, let me first remind you that in our expansion cohort data that we previously shared, we've seen an overall objective response rate of approximately 28% in the total population. And with enrichment based upon a TPS cutoff of greater than 75%, we saw that enrichment increased to 39% ORR relative to the 11% seen in the lower NatB2B expression. So we do see the potential for enrichment of objective response rates. In regards to duration of response, however, we do, and this is based upon small sample sizes, appeared to have relatively consistent durations of responses, whether they be NAPB2B higher versus NAPB2B lower. Again, recognizing that there were a limited number of patients in the lower NAPB2B populations of two patients that had objective responses.
spk07: Got it. And for the pivotal study, you have bevacizumab naive patients with one to two prior therapies in your exclusion criteria. Can you elaborate on the role of a BEV in that setting? And if you can share your thoughts on the possibility of adding Avastin to the platinum combination in the upgrade study?
spk05: Arvind, do you want to take that?
spk06: Yeah, absolutely. Thank you. So in regards to the Bevacizumab in eligibility criteria, it's consistent with what the Bevacizumab label is. And so Bevacizumab per label is required for or is indicated in regards to ovarian cancer patients with one to two prior lines of therapy. However, it is not indicated in those patients' three to four prior lines of therapy. And so what we've been able to achieve in one study is in order to then be comprehensive in regards to being consistent with what the Bevacizumab label is, recognizing that in our expansion cohort, a large proportion of our patients, 70%, did have prior bevacizumab therapy. And so we do have a broader indication just based upon our eligibility criteria. Now, in regards to the second question, in regards to the potential to combine with bevacizumab, as I've described earlier in relationship to our upgrade study, we are first combining with carboplatinum because it is... in earlier lines of therapy, a foundational regimen in relationship to platinum therapy. As we think further in relationship to upgrade as an umbrella study where there can be multiple cohorts added, we are thinking of multiple different regimens, whether they be Bevacizumab, whether they be a non-platinum combination, a PARP inhibitor, or even an immunology agent.
spk07: That's helpful. And maybe the last one for non-small cell lung cancer, So tubulin targeting chemotherapies are often used for these patients. Do you think that can impact the efficacy of your ADCs or you think yours is a different type of tubulin inhibitor? Any thoughts there?
spk05: You know, I think instead of speculating, I think I would guide you to the second half of the year. where we will be able to disclose our expansion cohort data that, as I said, will include 40 to 45 patients.
spk07: Great. Thanks and congrats on the progress.
spk05: Thanks.
spk07: Our next question coming from the line of Jessica with JP Morgan . Hi.
spk08: This is Daniel for Jessica. Thank you very much for taking our question. First one, you previously disclosed a duration of response of approximately five months for a pre in high expressors under the old diagnostic methodology. What was the duration of response for a pre in high expressors using the new TPS greater than or equal to 75% diagnostic methodology?
spk05: It does not change. Arvind, isn't that correct? That's right.
spk06: That's right. Thank you, Anya. So, Daniel, when you look at our webinar in relationship to the TPS, you'll see that the responders actually, there's the same number of responders there, so the duration of response does not change because it only looks at the responders.
spk08: Okay. Got it. And then moving maybe to the lung, can you elaborate for us the enrollment dynamics for the lung cancer cohort and the expansion cohort of our priests? I'm sorry, what do you mean with enrollment? Can you clarify? It seems to have taken much longer than the ovarian cancer cohort and I'm trying to understand what has been the push and pull and how enrollment is... Yeah, I think, thanks for the question.
spk05: I think last year we did disclose that we were delayed in really initiating certain sites as a result of COVID. Sites that we were counting on to be our primary lung enrollers. That's behind us now. These were sites that some of them were in Australia where there were delays due to fires and then COVID. I think that those delays are behind us. We've been able to overcome those challenges we faced last year and are on track to recruit the 40 or 45 patients. we're targeting.
spk08: Okay, excellent. And then can you provide us some color on the dose escalation algorithm utilized for the dose escalation study of 1592 and your strategy for exploration of further doses and schedules from the here?
spk05: I would say that, you know, I don't think we can share more details. I do want us to remain disciplined. and really share comprehensive data disclosures that are really meaningful to investors rather than get into parts of the data set. This is a very typical dose escalation and a study, and we're on track to disclose data in the second half of the year.
spk08: Okay, great. And maybe one last question. With MTD achieved for 1592, can you remind us how much data you want to generate before making a call on the asset at a 1592 or pre to advance in month? And thank you for taking our questions.
spk05: Yeah. Again, I think we want to be making robust data-driven decisions. In terms of the dose escalation for 1592, we will have an understanding of exposure, we'll have an understanding of the MTD, we'll have an understanding of the optimal dose regiment. And I think, obviously, safety profile, early signs of efficacy, and that the totality of that data would really guide us as to what the next appropriate step is.
spk08: Great, thank you very much.
spk07: Ladies and gentlemen, as a reminder, to ask a question, please press the start and the one key on your touch-tone telephone. Our next question coming from the lineup for a speaker with Colin, your line is open.
spk02: Great. My question is maybe initially on the pace of enrollment in the ovarian uplift study. Earlier today, Immunogen announced a delay in the pivotal study readout due to COVID-19 impact. Just curious to see if you're seeing any impact compared to your estimated timeline of enrollment.
spk05: So I think I can comment on the expansion portion of this study, which, as you know, we're bringing to closure and converting those sites to uplift. I can tell you that we've had robust enrollment in the expansion cohort, and we expect we'll be able to leverage that as we convert sites from the expansion cohort to uplift. Obviously, we're only at the beginning of Uplift, but we are quite encouraged with the excitement we've seen from investigators, the support we're getting from GOG and NCOD. And, of course, the design of Uplift, as we've said in the past, does provide for some streamlining that we believe could help with enrollment. So we're not selecting. We have broad inclusion criteria. We are not excluding patients with underlying neuropathy. So we hope all of these factors will allow us to really achieve our enrollment goals for uplift. Again, though, we're just starting uplift. So we'll be able to give more definitive guidance for our enrollment targets once we are a little further ahead. in the study.
spk02: Great. Thank you very much for taking my question.
spk07: Our next question coming from the line of Colleen Kissett with Barrett. Your line is open.
spk00: Hello. My name is Benjamin Paluch. I'm on for Colleen. Thank you so much for taking our question. For the diagnostic, what are the next steps to completely validate the diagnostic? And then maybe could you also touch on what the timelines look like?
spk05: Arvin, do you want to take this?
spk06: Yeah, no, thanks, Anna. Thanks, Ben, for the question in regards to the timelines for the diagnostic. So let me first start that. We've had a really robust strategy and relationship in developing the diagnostic, which started years ago when we actually first initiated the UP redevelopment. So it's really been in parallel, this entire process. And so earlier this year, actually about a month ago, we had the webinar in relationship to declaring what is going to be our cutoff for the identification of the higher and the lower NAPB2B patients. And so not only that, but the diagnostic in relationship to the potential commercial diagnostic was announced. And so both that diagnostic assay as well as the applied cutoff will be utilized in our pivotal strategy of uplift. And as a reminder, that's a two shot on goal. And so we're enrolling all patients and not pre-selecting for higher or lower, not B2B patients. And so that will obviously be the efficiency in getting those patients on. And then they will be in a prospective retrospective analysis determined to be high or low. And utilizing that, we would then validate the cutoff as well as the diagnostic assay. This is specifically addressing your question as far as the next steps of the diagnostic assay itself. So using the uplift cohort, we'll be able to validate the cutoff and lead us to the potential outcome of either having a complementary diagnostic, whereby uproot would potentially be indicated in a broad population, but having a diagnostic available in order to then complement or as a complementary diagnostic in regards to enriched activity, or it would be a companion diagnostic in a scenario where only those patients with higher NAPI 2B status would be eligible for potential treatment with UPRI. And so that speaks to the next path in relationship to the validation of our potential commercial diagnostic assay.
spk00: Wonderful. That's incredibly helpful. Thank you so much. And then... Might you be able to comment a little bit on the agreement with the potential diagnostic partner? Do you have an exclusive agreement there, or are you able to work non-exclusively with multiple companies on the development of the diagnostic?
spk05: Maybe I'll take this, Arvind. We've been working with Leica, a company that has a broad installed base of machines to do these tests. all over the world, and we've been working with them for several years to develop, to bring the program to this stage. The relationship, however, is not exclusive, so if at some point in the future we wanted to expand even further, we could do that. But we've had a multi-year relationship to bring the program to this point, and we selected Leica because of their broad global infrastructure.
spk00: That's fantastic. Thank you so much for elaborating. All from us.
spk07: And I'm not showing any further questions at this time. I would now like to turn the call back over to Anna Protopappas for any closing remarks.
spk05: I just want to thank all of you for joining us this afternoon. We've made significant progress in advancing UPRI with the initiation of Uplift and the soon-to-be-in Q3 initiation of Upgrade. We're also making significant progress in advancing the pipeline with UPRI in lung, XMT1592, and our two new first-in-class molecules in IND enabling studies. So we're on track to achieve our goals for this year. and position the company for an important 2022. Thanks for joining, and we look forward to updating you in future calls. Thanks.
spk07: Ladies and gentlemen, that's the conference for today. Thank you for your participation. You may now disconnect.
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