Mersana Therapeutics Inc (MRSN) 2021 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to Mersana's First Quarter 2021 Earnings Conference Call. (Operator Instructions) I would now like to hand the conference over to your speaker host, Sarah Carmody. Go ahead.

Good afternoon. Welcome to Mersana'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 are 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, quarantines, 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 Protopapas, Mersana's President and Chief Executive Officer.

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 Arvin Yang, Chief Medical Officer; Tim Lowinger, our Chief Science and Technology Officer; and Brian DeSchuytner, 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 I 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 UpRi 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 NaPi2b expression, UPLIFT also offers 2 shots on gold 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 and 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 NaPi2b biomarker cut off, its role in UPLIFT in our expected commercial diagnostic development path. The development of the diagnostic is a result of a multiyear program, encompassing research, translational and clinical work, advanced at each stage in tandem with the development of UpRi. 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 H-score of 110 enriches for a response, we demonstrated the tumor proportion score or TPS greater than or equal to 75%, which is derived from the same value as H-score also enriches for response just as well and can be operationally more straightforward to perform. When we look 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 TPS 75 cutoff, the high NaPi2b 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 H-score results that we have demonstrated to date. TPS 75 is the predefined threshold that we will use to define our high NaPi2b 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 UPLIFT 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. Arvin will discuss the design of UPGRADE in a moment, but we believe we are 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 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, XMT-1592 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 2 earlier stage candidates, XMT-1660, our Dolasynthen B7-H4 ADC and XMT-2056, our first Immunosynthen 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, UPGRADE and the rest of our ADC pipeline, providing the potential for multiple value inflection points and bringing us even closer to reaching our overarching mission to develop life-changing ADCs for patients fighting cancer.

With that, I will turn the call over to Arvin to discuss the design of the UPGRADE study for UpRi in ovarian cancer.

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.

To date, 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 antitubulins 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 I 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 4-week administration of UpRi in combination with Q4 week administration of carboplatinum for 6 cycles. And then UpRi monotherapy will be continued in platinum-sensitive patients with high-grade serious ovarian cancer who have received 1 to 2 prior platinum-based regimens.

Patients will not be preselected for NaPi2b 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 6 cycles. And then UpRi monotherapy 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 UpRi monotherapy beyond what is achievable with carboplatinum and paclitaxel alone.

Finally, we are excited for what this could mean for NaPi2b 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.

Thanks, Arvin, and good afternoon, everyone. Today, I will focus on XMT-2056, our first Immunosynthen STING-Agonist ADC; and XMT-1660, our B7-H4 Dolasynthen 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 3E posters. I'll start with XMT-1660. B7-H4 is a promising target for adolescent in ADC due to its expression profile as well as its function. B7-H4 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 DolaLock ADCs lead to immunogenic cell death and that our DolaLock payload can activate dendritic cells in the tumor microenvironment, leading to a potential antitumor immune response in addition to the direct cytotoxic antitubulin effect. Because B7-H4 is expressed on tumor cells as well as immunosuppressive tumor-associated macrophages, it provides a potential opportunity to co-op 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 XMT-1660 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 B7-H4 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 B7-H4 and PD-L1 in breast tumors suggest an opportunity for our B7-H4 Dolasynthen ADC to address unmet medical need in patients who either do not respond or progress on checkpoint inhibitors and supports the further development of XMT-1660.

Moving on to Immunosynthen. We also presented 2 posters highlighting XMT-2056 and the STING mechanism of action data at AACR. Our first poster showed preclinical data supporting the hypothesis that XMT-2056 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 Immunosynthen STING agonist ADCs involves targeted activation of the STING pathway in both tumor resident immune cells and tumor cells, delivering a 1, 2 punch to the tumor with the potential to increase the therapeutic index.

Our second immuno symptom related poster focused on one of the key differentiators between our STING approach and other approaches to innate immune activation. In vito studies show that while most cancer cell lines do not respond to STING agonism in standard monoculture conditions, Immunosynthen STING agonist ADCs do activate STING in the same cancer cells in the presence of immune cell condition 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 reveal that the Immunosynthen 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 3 of these posters are available on the publications page of our website.

We are working diligently to advance XMT-2056 and XMT-1660 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.

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 2 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. Noncash, 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 in 2020. The increase was primarily due to an increase in headcount and consulting and professional fees. Noncash 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 $0.50 per share compared to a net loss of $16.9 million or $0.35 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.

Thank you, Brian. I believe we are 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 ADCs addressing areas of high unmet medical need.

Before we take Q&A, I'd like to mention that this past Saturday, May 8 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 Mersana 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.

(Operator Instructions) First question coming from the line of Jonathan Chang with SVB Leerink.

First question, how much has COVID-19 impacted your UpRi 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?

Jonathan, thanks for the question. We've been very fortunate in that to date, we have seen robust enrollment in the expansion cohort. And we -- as we have said, we will provide guidance on further enrollment for UPLIFT, but we believe we're well positioned because, as you know, those UPLIFT is an amendment to the existing expansion cohort. And we think -- we believe that, that the 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 NaPi2b biomarker. We have broad inclusion criteria, including patients up to 4 lines of therapy. We are not excluding patients who are baseline peripheral neuropathy, a patient population, very similar to what was in the expansion cohort. And equally important, we've partnered with GOG and ENGOT, GOG being the cooperative group in the U.S. and ENGOT the cooperative group in the EU. So we are quite optimistic that we will continue to see a 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 what -- where we are.

And second question, can you help set investor expectations for the UpRi and 1592 lung cancer readouts expected in the second half?

Yes. 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 NaPi2b high in the lung adenocarcinoma patient group is lower than it is in ovarian. About 1/3 of the patients have NaPi2b 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.

Our next question coming from the line of Tom Shrader with BTIG.

This is Kaveri for Tom. My first one is regarding relation between NaPi2b expression and duration of response. Are there any studies preclinical or clinical, maybe based on Genentech's ADC that have shown whether or not NaPi2b expression level changes post treatment? And if that, it plays any role in defining the durability of response?

Arvin, 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 that NaPi2b expression based upon treatment or within different lines of therapy. And so 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 concorded 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 UpRi, 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've previously shared, we've seen an overall -- an 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 increase to 39% ORR relative to the 11% seen in the lower NaPi2b 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, appear to have relatively consistent durations of responses, whether they be in NaPi2b higher versus NaPi2b lower, again, recognizing that there were a limited number of patients in the lower NaPi2b population, so 2 patients that had objective responses.

And for the pivotal study, you have bevacizumab-naive patients with 1 to 2 prior therapies in your exclusion criteria. Can you elaborate on the roll-off of 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?

Arvin, do you want to take that?

Yes. Absolutely. Thank you. So in regards to the bevacizumab ineligibility 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 1 to 2 prior lines of therapy. However, it is not indicated in those patients on 3 to 4 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, from 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 the 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 nonplatinum combination, a PARP inhibitor or even an immuno-oncology agent.

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?

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.

Our next question coming from the line of Jessica Fye with JPMorgan.

This is Daniel for Jessica. First one, you previously disclosed a duration of response of approximately 5 months for UpRi in high expressors under the old diagnostic methodology. What was the duration of response for UpRi in high expressors using the new TPS greater than or equal to 25% diagnostic methodology?

It does not change. Arvin, isn't that correct? Can you confirm that?

That's right. That's right. Thank you, Anna. So Daniel, when you look at our webinar in relationship to the TPS, you'll see that the responders actually there are the same number of responders there. So the duration of response does not change because it only looks at the responders.

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 UpRi?

I'm sorry, what do you mean with enrollment? Can you clarify?

It seems to have taken much longer than the ovarian cancer cohort.

Yes.

And I am trying to understand what has been the push and pull in how enrollment...

Yes. I think -- thanks for the question. 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.

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 that year.

Yes. I would say that I don't think we can share more details. I do want us to remain disciplined and really share comprehensive data disclosures rather -- 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'll be -- we're on track to disclose data in the second half of the year.

And maybe one last question. What MTD achieved for 1592, can you remind us how much data you want to generate before making a call on the asset on 1592 [UpRi] to advance in a month?

Yes. I -- 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 regimen. 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.

(Operator Instructions) And our next question coming from the line of Boris Peaker with Cowen.

My question is maybe initially on the pace of enrollment in the ovarian UPLIFT study. Earlier today, Immunogen announced a delay in their pivotal study readout due to COVID-19 impact. Just curious to see if you're seeing any impact compared to your estimated time line of enrollment?

So I think I can comment on the expansion portion of the 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 ENCOG. 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 are not selecting. We have broad inclusion criteria. We are not excluding patients with underlying neuropathy. So we hope all 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.

Our next question coming from the line of Colleen Kusy with Baird.

My name is Benjamin Paluch. I'm on for Colleen. From a diagnostic, what are the next steps to completely validate the diagnostic? And then maybe could you also touch on what the time lines look like?

Arvin, do you want to take this?

Yes. No, thanks, Anna. Thanks, Ben, for the question in regards to the time lines for the diagnostics. So as -- let me first start that, we've had a really robust strategy and relationship with developing the diagnostic, which started years ago when we actually first initiated the UpRi development. So it's really been in parallel on 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 NaPi2b patients. And so not only that, but the diagnostic and 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 2 shot on goal. And so we're enrolling all patients and not preselecting for higher or lower NaPi2b patients. And so that will obviously speak to 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 UpRi 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 NaPi2b status would be eligible for potential treatment with UpRi. And so that speaks to the next [pats] in relationship to the validation of our potential commercial diagnostic assay.

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?

Maybe I'll take this, Arvin. 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 multiyear relationship to bring the program to this point, and we selected Leica because of their broad global infrastructure.

And I'm not showing any further questions at this time. I would now like to turn the call back over to Anna Protopapas for any closing remarks.

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, XMT-1592 and our 2 new first-in-class molecules in IND enabling studies. So we are 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.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.