Q1 2021 Mersana Therapeutics Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to my son of first quarter 2021 and earnings conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session you will need to press. The Star then the one key on your Touchtone telephone.
Operator: Thank you for standing by and welcome to Marsana's First Quarter 2021 Earnings Conference Call. At this time, all participants are on the list on only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during your session, you will need to press the start and the one key on your touch-town telephone.
Operator: If you would call our assistance, please, first start and zero. I would not like to hand the conference over to your speaker host, Sarah Carmody.
If he would call offer assistance. Please press Star then zero.
I would now like to hand, the conference over to your Speaker House.
Sarah Carmody go ahead.
Sarah Carmody: 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.
Good afternoon, welcome to marathon is first quarter 2021 conference call.
Earlier today, we issued a press release, reviewing our first quarter financial results and business update 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.
Sarah Carmody: 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 risks 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, That preclinical testing or early clinical results may not be predictive of the results or success of our ongoing or later preclinical or clinical study, 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 a These risks are discussed in the company's SEC filings, including, without limitation, the company's annual report on Form 10K filed on February 26, 2021, and subsequent files. 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 research, 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, quarantine, physical distancing and business closure requirements in the U.S. and in other and the effectiveness of actions taken globally to contain and treat the disease.
They 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 Companys plan to vary materially, including the risks that the results of our ongoing or future.
Clinical studies, maybe and conclusive with respect to the efficacy of our product candidate.
That we may not meet and clinical endpoints with statistical significance or there may be safety concerns or adverse events associated with our product candidate.
That preclinical testing our early clinical results may not be predictive of the results our success of our ongoing or later preclinical or clinical studies that the identification and development and testing of the company's product candidates and new platforms will take longer and cost more than planned and that our clinical study.
And may not be initiated or completed on schedule if at all.
These risks are discussed and the Companys 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 effort.
And its operations and financial results the extent of the impact on the company's operations and the value of the market for the Companys 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 and quarantines physical distancing and business closure requirements in the U S and and other countries and the effectiveness of actions taken globally globally to contain and treat the disease.
Sarah Carmody: Except as required by law, the company assumes no obligation to update these forward-looking statements, even if new information becomes available in, And with that, I'll turn the call over to Anna Proto-Popis, Mirosana, as president and chief executive officer. Thank you, Sarah.
And as required by law the company assumes no obligation to update update. These forward looking statements publicly even if new information becomes available and the future and with that I'll turn the call over to Ana Protopathic, MRSA, and our 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 RV Yung Chief Medical Officer, Tim low injure, our Chief Science, and Technology officer, and Brian and destroyed.
Anna Protopapas: Good afternoon, everyone, and welcome to our first quarter 2021 Corporate and Financial Update Call. Joining me today with prepared remarks are Arving Yang, Chief Medical Officer; Tim Loinger, our Chief Science and Technology Officer; and Brian DeShuydener, 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 Carval, Chief Legal Officer, who joined us in April.
And there were a senior VP of finance and product strategy cheap I'm also joined by the rest of the executive team, who will be available for your questions, including the newest member of the hundred Club book, Hong Chief Legal Officer, who joined US in April.
Anna Protopapas: 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 and Johnson. Brian, Michael, and I 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 Marsana. Welcome, Alejandra.
Before we start I want to take the opportunity to introduce and welcome and the Hunter on the hundred brings with her 20 years of legal and leadership experience and boost for most particularly biotech companies and a demonstrated ability to work cross functionally and most recently on the Congress to act as a cheap.
Legal officer momentum Pharmaceuticals, where she led the company's legal operations through both restructuring and the success from acquisition by Johnson and Johnson.
Brian Michael and I have had the pleasure of working with other entre millennium Pharmaceuticals, and we're very excited to have the opportunity to work with for again I am confident of the positive impact she will help with my son, well come out and Huntsville.
Anna Protopapas: 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 Uprria as a foundational medicine in the treatment of ovarian cancer and in building out our innovative pipeline of ADC candidates addressing areas of high unmetical needs. With respect to building up, In January, we disclosed further data from the expansion portion of the upper 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 pre-treated patients, and a tolerability profile without the severe utropenia, neuropathy, and ocular toxicity seen with other ADC clots.
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 up free as a foundational medicine in the treatment of ovarian cancer and in building out for <unk>.
For two pipeline of ADC candidate addressing areas of high unmet medical need.
With respect to building up price.
In January we disclose further data from the expansion portion of the pre 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.
And complete responses in heavily pretreated patients and the Tolerability profile without the severe neutropenia neuropathy and ocular toxicity seen with other ADC platforms. The data also demonstrated the clear biomarker response relationship which leads.
Anna Protopapas: 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 had initiated patient dosing.
Me too the next important step and building up free up.
Uplift a single arm registration strategy informed by FDA feedback in April we announced that we have initiated patient dosing and this is an important milestone and our efforts to bring up for each patient sleeping with heavily pretreated ovarian cancer, who have an acute need for user.
Anna Protopapas: 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 rolling out 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 Bavacizumab treatment, consistent with the Bevacism of Label, and there is no exclusion for baseline peripheral neuroprudence.
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And the design of a blip focuses both on and increasing the potential for label differentiation and the probability of success and so.
Minder uplift from say rolling a broader patient population that other studies in this space consistent with where we observed ex.
<unk> and 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 not be to be expression uplift.
Anna Protopapas: By enrolling patients regardless of NAPI-2B expression, Uplift also offers two shots on goal with a primary endpoint in the high NAPI-2-B population and a secondary endpoint in the overall population, allowing us to fully evaluate the role of the biomarker in enriching 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 Katoff, 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 UprI. Through this work, we believe we have done so.
And also offers two shots on goal with a primary endpoint in the high end up at two P population and the secondary end point and the overall population, allowing us to fully evaluate the role of the biomarker and enriching for patient outcomes, we plan to present, a trial and progress post.
Two and the upcoming virtual school 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 non P to P. Biomarker cutoff its role in uplift and our expected commercial diagnostic development path that day.
And of the diagnostic is a result of the multiyear program encompassing research translational and clinical work advanced at each stage in tandem with the development of Opry through this work. We believe we have designed and optimal diagnostic assay in terms of its robustness predictive Miss it.
Anna Protopapas: 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 the 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 TPS 75 cutoff, the high NAPB-2B patients had 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 school results that we have demonstrated today.
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Importantly, while we have previously shown that in each group of 100, and Ted and richest for a response, we demonstrated the tumor proportional score or P. P S greater than or equal to 75%, which is derived from the same value should as each school also enriches for response Justice.
Well and to be operationally more straightforward to perform when we looked at the same ovarian cancer expansion dataset that we showed you back in January but devaluated. This data by T. P. S methodology based on the TPS 75 cut off the high end up to be patients hub and enriched.
Overall response rate of 39% relative to the overall response rate of 28% of total population.
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These results are comparable to the H score results that we have demonstrated to date T. P. S. 75 is the pre defined thresholds that we will use to define a heightened up b to b population and uplift, where we would look to validate the proposed commercial capacity.
Anna Protopapas: TPS 75 is a predefined threshold that we will use to define our high NAPI-2B population in uplift, where we will look to validate the proposed commercial operations. 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 Upli, informed by FDA feedback, contribute to our belief that we will be able to deliver Uprito to patients that are in dire need of therapeutic operations.
In summary, the strong proof of concept data from the expansion cohort that will bump predictable and reproducible assay, we have developed and the design of a plea informed by FDA feedback contribute toward belief that we will be able to deliver a pre two patients that are in dire need of therapy.
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Anna Protopapas: Finally, for Upr, 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're on track to initiate this study in the third quarter of this year.
Finally for upgrades, we've made progress and preparing for the initiation of the upgrade umbrella study a first step and bringing a pre two patients in earlier lines of therapy as we seek to establish it as a foundational medicine and ovarian cancer.
And we will discuss the design of upgrades in a moment, but we believe we're on track to initiate this study in the third quarter of this year.
Anna Protopapas: With respect to building out the pipeline, the Upril Lung Adenocarsinoma 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 the doses exploration phase of the study, using clinical experience to validate the pre-clinical finding of greater potential. 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.
With respect to building out the pipe line.
And pre lung adenocarcinoma expansion cohort continues to enroll patients and we believe we were right and we remain on track to reach our goal of enrolling approximately 40 to 45 patients this year and plan to report data and the second half of this year.
At the same time ex empty and 15 92 is still and doses exploration phase of the study using the clinical experience to validate the preclinical findings of greater potency. We have exceeded the MTBE and are doing further exploration of dose and schedule we plan to do.
Disclose interim data in the second half of the year.
Anna Protopapas: Finally, we have continued to advance our next two earliest-state candidates, XMT 1660, our Dolarcynton B7H4 ADC, and XMT 2056, our first immunosynthens 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 the team will review briefly. 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 ATC 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. With that, I will turn the call over to Arvin to discuss the design of the upgrade study for Uphriin in Thank you, Anna, and thank you everyone for joining us today.
Finally, we have continued to advance our next two earliest stage candidate ex and <unk> 60, 60 odd dollars Sid can be seven each for ATC and ex empty 2056, our first immuno symptom Sting agonist ADC through I N D, enabling studies with the goal of initial.
Weighted clinical studies in early 2022.
In April we presented preclinical data highlighting the potential for both programs at the virtual ACR Conference, which Tim will review shortly and.
And as I stated earlier, we continued to make important progress across each of our programs and look forward to continuing to make progress with uplift upgrade and the rest of our ADC pipeline.
And the potential for multiple value inflection points, and bringing us even closer to reaching our overarching mission to develop life changing 86 for patients fighting cancer with that I will turn the call over to Arvind to discuss the design of the upgrade study.
For upgrades and ovarian cancer.
Thank you and.
And thank you everyone for joining us today.
Arvin Yang: 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 Uprie through our life cycle plans. To date, we've seen positive results with Uprean in heavily refractory patients, including complete responses in patients who have failed nevisinab and PARP inhibitor. Antitubulins are an established class in the ovarian cancer space, but both antitubulans 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.
Let's take a step back and recap what we've demonstrated with Opry 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 operating through our lifecycle plans.
To date, we've seen positive results with a free and heavily refractory patients, including complete responses in patients who failed bevacizumab and PARP inhibitors.
And type two billings are and establish class and the ovarian cancer space, but both anti tubular and and other ADC platforms and this space had been limited by severe adverse events, including peripheral neuropathy and neutropenia and also that is deeply concerning to patients like alopecia.
Arvin Yang: Upgrade is a Phase 1 umbrella study designed to evaluate Upree in combination with other ovarian cancer therapy, to explore the role of Upree in earlier stages of the disease. We first intend to combine it with platinum, as platinum therapy is currently the mainstay therapy in earlier-lined platinum-sensitive ovarian cancer, and we expect to initiate patient dosing in the third quarter of this year. This phase one 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 Uprim monotherapy will be continued in platinum sensitive patients with high-grade cirrus ovarian cancer who have received one to two prior platinum-based regimens.
Upgrade is a phase one umbrella study designed to evaluate upbeat and combination with other ovarian cancer therapies to explore the role of Opry and earlier stages of the disease, we first and tend to combined with platinum and.
Platinum therapy is currently the mainstay therapy and earlier and line platinum sensitive ovarian cancer, and we expect to initiate patient dosing and the third quarter of this year.
This stage one open label dose escalation portion of the study will determine the maximum tolerated dose and safety and Tolerability of and every four week administration of upright and combination with Q4 week administration of Carbo platinum for six cycles, and then a pre mono therapy will be continued and <unk>.
And sets of patients with high grade serous ovarian cancer, who have received one to two prior platinum based regimens patients.
Arvin Yang: Patients will not be pre-selected for NAP B2B 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 carpal platinum for 6x50, and then upree monotherapy will be continued to assess the feasibility of this combination therapy as well as the effort in approximately 30 patients in order to inform the next step.
Patients will not be pre selected for not be to be expression, but archival and 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 and combination with Carboplatin and for six cycles, and then a free mono therapy will be continued to assess the feasibility for this combination therapy, that's well its efficacy and approximately 30 patients in order to inform next steps.
Arvin Yang: This study could provide us with proof of concept by benefiting patients earlier in their disease, where they are platinum sensitive, as well as by continuing upbree monotherapy beyond what is achievable with carboplatinum and pachylactyl alone. Finally, we are excited about what this could mean for that B2B biomarker positive population. In addition, there is a higher unmet need for those patients who do not benefit from plastic. In the future, this umbrella study allows us to also evaluate non-platinum-based combinations.
This study could provide us a proof of concept of benefiting patients earlier and their disease, where there are platinum sensitive as well as by continuing our free mono therapy beyond what is achievable with Carboplatin and Paclitaxel alone.
Finally, we are excited for what this could mean for that would be to be biomarker positive patients.
In addition, there was a higher unmet need for those patients who do not benefit from platinum in.
And the future. This umbrella study allows us to also evaluate non platinum based combinations.
Arvin Yang: Future combinations could include liposomal doxarubicin, Bevacizumab, PARP inhibitors, and immunolology therapy. We look forward to getting this combination study under way. We believe that the differentiated tolerability profile without the severe neutropenia, peripheral neuropathy, and ocular toxicity that limit other ADC platforms provides Upris with a significant advantage in terms of its potential as a combination therapy. Importantly, moving Upris into earlier lines of therapy could significantly expand the number of patients with ovarian cancer that could benefit from Upris and the duration of time over which we can impact their disease. I will now turn the call over to Tim to discuss our exciting early stage A.D.C. candidate.
Future combinations could include like for example, doxorubicin, Bevacizumab and PARP inhibitors, and immuno oncology therapies.
We look for 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 operating with a significant advantage in terms of its potential as a combination therapy and.
Shortly moving upward into earlier lines of therapy could significantly expand the number of patients with ovarian cancer that could benefit from up rate and the duration of time for which we can impact their disease.
Now I'll turn the call to channel could discuss our exciting early stage ADC candidate.
Tim Loinger: Thanks, Harbin, and good afternoon, everyone. Today, I will focus on XMT 2056, our first immunosynthen Sting Agonist ADC, and XMT 1660, our B7H4 Dolosin ADC, both of which are advancing through I&D enabling studies, and we believe remain on track to enter the clinic in early 2020. 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 potions. I'll start with XMT 1660.
Thanks, Robin and good afternoon, everyone.
Today, I will focus on ex empty 2056, our first immuno timken Sting agonist, ADC and <unk> 16, and 60, RB seven H for Dol Essent and ADC, both of which are advancing through IND, enabling studies and we believe we remain on track to enter the clinic and <unk>.
Early 2022.
In April we were pleased to share additional encouraging preclinical data for both of these programs at the virtual ACR meeting in the form of three E posters.
I'll start with S&P 16, 60 day.
Tim Loinger: B7H4 is a promising target for adolescents and 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 Dolaloc ADCs lead to immunogenic cell death and that our Dolaloc payload can activate dendritic cells in the tumor microenvironment, leading to a potential anti-tumor immune response in addition to the direct cytotoxic antitubulin effect.
74 is a promising target for adults and can ADC due to its expression profile as well as its function.
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Based on preclinical studies, we have shown that our dollar lock adcs and lead to immunogenic cell death, and that our door lock payload can activate dendritic cells in the tumor microenvironment, leading to a potential anti tumor immune response. In addition to the direct cytotoxic and take tubular and effect.
Tim Loinger: 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.
Because these have and age for is expressed on tumor cells as well as immunosuppressive tumor associated macrophages. It provides a potential opportunity to co op, those macrophages and a targeted manner to further contribute to both the cytotoxic and immunogenic effects and create.
And what we describe as a perfect storm and the tumor microenvironment.
Tim Loinger: 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 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 PDL1 in breast tumors, suggests an opportunity for a B7H4 dolocinth and ADC to address unmet medical needs in patients who either do not respond to or progress on checkpoint inhibitors and supports the further development of XMP 1660.
At ACR, we showed that <unk> 16, 60 demonstrated robust and vivo activity against multiple triple negative breast cancer models, as well as and ER positive and her two negative breast cancer model and showed superior efficacy and matched payload doses versus other.
There are potential candidates VSAT and age for adcs, representing different doors and platforms consistent with our philosophy, but it's not one size fits all when it comes for ADC.
These encouraging preclinical data together with the lack of core expression of <unk>, seven and eight four and PDL, one and breast tumors suggests and opportunity for obese have and H for dollar since and ADC to address unmet medical need and patients who either do not respond or progress on <unk>.
Point inhibitors and supports the further development of ex <unk> 16 60.
Moving onto immuno sent and we also presented two posters, highlighting <unk> 2056 and.
Tim Loinger: Moving on to immunosynthen, we also presented two 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. Antitumer activity of immunosynthens 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.
And the state and mechanism of action data at ACR.
Our first poster showed preclinical data supporting the hypothesis that <unk> 2056 can overcome the limitations and the current therapeutic approaches enabling tumor targeted delivery of a sting agonist with improved efficacy and tolerability over a free IV Sting agonist.
And anti tumor activity of immuno symptoms Sting agonist ADC and involves targeted activation of the sting pathway and both tumor resident immune cells and tumor cells and delivering a one two punch to the tumor with the potential to increase the therapeutic index.
Our second immuno center and related poster focused on one of the key differentiators between our Sting approach and other approaches to innate immune activation.
Tim Loinger: Our second immunosynthene-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, Immuno-sentence sting agonist ADCs do activate sting in the same cancer cells in the presence of immune cell media, suggesting that the tumor cell intrinsic sting pathway can be activated in the presence of cues from immune cells.
In vitro studies showed that while most cancer cell lines do not respond to Sting agonism and standard monoculture conditions immune.
Immuno centre and Sting agonist Adcs do activate staying in the same cancer cells in the presence of the immune cell conditions and media, suggesting that the tumor cell intrinsic strength pathway can be activated in the presence of cues from immune cells.
Tim Loinger: This would be in contrast, for example, to TLR agonist approaches, as TLRs are not expressed in cancer cells. More detailed in vitro preclinical studies revealed that the immunosincentin 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.
This would be and contrast for example to T. L. R agonist approaches as <unk> are not expressed in the cancer cells.
More detailed in vitro preclinical studies revealed that the immuno simple ADC results and type three interferon induction and then blocking type three interferons inhibits the production of key cytokines and cancer cell, killing induced by Sting agonist ADC treatment pointing to a potential.
For the important role for type three interferons and <unk>.
And so tumor immune responses downstream of sting pathway activation and tumor cells.
Tim Loinger: All three of these posters are available on the publications page of our website. We are working diligently to advance XMT 2056 and XMP 1660 and believe these data further support the clinical development of both of these agents, which have the potential to address unmet medical needs 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.
All three of these posters are available on the publications page of our website.
We are working diligently to advance <unk> 2056, and ex <unk> 16, 60 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 Bryan for an overview of our financial results.
Thank you Tim and 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 and cash and cash equivalents net cash use.
Brian C. DeSchuytner: I will now review some of the key financial highlights from our first quarter 2021 results. I'll start with our cash. 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.
And operating activities and our first quarter was $27 million.
In addition to our current cash position, we have the option to drop bonds for the debt financing agreement with Silicon Valley Bank refinanced and August of last year we.
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 and 2020. The difference was primarily due to an increase and up re and SMT.
Brian C. DeSchuytner: In addition to our current cash position, we have the option to draw funds through the debt financing agreement with Silicon Valley Bank, which was 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.
And 92 manufacturing clinical and regulatory expenses and increase and manufacturing activities for our preclinical and discovery stage programs and an increase and head count.
Noncash stock based compensation expense included in these research and development expenses increased by $1 5 million, primarily related to an increase and 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.
Compared to $4 $9 million and the same period and 2020 the.
Brian C. DeSchuytner: The difference was primarily due to an increase in Upray and XMT 1592, manufacturing, clinical, and regulatory expenses. It also increased manufacturing activities for our preclinical and discovery stage programs and an increase in head count. 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 evaluation 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 and noncash stock based compensation expense included in these general and administrative expenses increased.
Increased by zero point $9 million, primarily related to an increase and the valuation of stock based awards as a result and stock price appreciation.
Net loss for the first quarter of 2021 was $34 7 million or <unk> 50 per share compared to a net loss of $16 $9 million or <unk> 35 per share for the same period and 2020 weighted.
Weighted average common shares outstanding for the quarters ended March 31, and 2021 and March 31, 2020 were approximately six 9 million and $48 million respectively.
I will now turn the call back to Ed.
Thank you, Brian and I believe we're well positioned to continue to execute against our 2021 goals of building up free is a foundational medicine and the treatment of ovarian cancer and building out our pipeline of innovative adcs addressing areas of high unmet medical need.
Brian C. DeSchuytner: The increase was primarily due to an increase in Hickat and consulting in 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 evaluation of stock-based awards as a result of stock price appreciation. The 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. The weighted average common shares outstanding for the quarters ended March 31st, 2021, and March 31st, 2020, were approximately $69 million and $48 million, respectively.
Before we take Q&A I'd like to mention debt. This past Sunday day may eight which world ovarian cancer day.
And I'd like to recognize the women living.
And with ovarian cancer survivors and 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.
And similar some employees, who are committed to improving outcomes and quality of life for women with ovarian cancer through their tireless work and developing upbeat and other potential life changing ADC therapies, because we know that patients are waiting with that I will turn.
Anna Protopapas: I will now turn the call back to Anna. 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 ADCs addressing areas of high-end medical needs. 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 who live with ovarian cancer, survivors, their families, and the many patient advocacy groups around the world promoting awareness about this devastating disease.
And the call over to the operator for Q&A.
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 Touchtone telephone to withdraw your question press the pound key.
Ladies and my while we compile the Q&A last time.
Now first question coming from the line of Jonathan Chang with SVP Leerink. Your line is now open.
Hi, Thanks for taking my questions first question, how much has COVID-19 impacted your up free 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.
Anna Protopapas: 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 Uprie and other potential life-changing ADC therapy, because we know that patients are waiting. With that, I will turn the call over to the operator for Q&A. 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-down telephone.
Jonathan and thanks for the question.
And we've been very fortunate they've got to date, we have seen robust enrollment and the expansion cohort.
And we as we have debt, we will provide guidance on.
On further enrollment for uplift, but we believe we're well positioned because if you know those are uplift is an amendment to the existing expansion cohort and we think we believe that that momentum will excuse me and enrollment and 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 and uplift as you know it's an amendment.
Operator: To draw your question, press the pound key. Please send by while we compiled the Q&A roster. Now, the first question coming from the line of Jonathan Chang with SB Lirink, Killan Is Elpen.
We do not require selection of patients for not being to be biomarker and we have broad inclusion criteria, including you know patients up to four lines of therapy, and we're not excluding patients who at baseline peripheral neuropathy Ah patient population very similar.
Jonathan Chang: Hi, thanks for taking my question. First question, how much has COVID-19 impacted your pre-ovarian cancer clinical trial experience to date? And how should we be thinking about the potential impact moving forward with the recent initiation of UphRQA? Jonathan, thanks for the question.
Anna Protopapas: 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 uplifts, but we believe we're well positioned because, as you know, the uplift is an amendment to the existing expansion cohort, and we believe 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.
What was in the expansion cohort and equally important with partnered with G O G and and got T. O Cheap, Inc. Cooperative group and the U S and and good thing the cooperative group and the EU. So we are quite optimistic that we will continue to see and a robust enrollment as.
We have seen and the expansion cohort.
Of course, as we get further.
It would be with uplift will be able to give more definitive guidance, but at this point, we feel pretty good about.
What where we are.
Anna Protopapas: We do not require selection of patients for NAPI to be based on biomarkers. We have broad inclusion criteria, including, you know, patients up to four lines of therapy. We're not exclusionary.
Got it thank you and.
Second question can you help set investor expectations for the up free and 15 92 lung cancer Readouts expected in the second half.
Yeah. So we are on track to and.
Anna Protopapas: including patients who have baseline peripheral neuropathy, a patient population very similar to what was in the expansion cohort, and equally important, we're partnered with GOG and NGG and NGGGG, GOG being the cooperative group in the U.S. and NGDD 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.
And wrote about 40 to 45.
Lung adenocarcinoma patients with up free and disclose the data and the second half for a big year, we did indicate at an earlier call.
That the prevalence of non peak to be high in the lung adenocarcinoma patient group is lowered any tis and ovarian and about a third of the patients have now appear to be high.
Defined and the ovarian cancer cohort, but we will have 40 to 45 patients.
And that our unselected and we'll be able to disclose that data in terms of fifth 16 15 92. We're also on track and the dose escalation to disclose data in the second half of the year.
Jonathan Chang: Got it, thank you. And second question, can you help set investor expectations for the up pre and 1592 lung cancer readouts expected in the second half? 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 NAPE to be high in the lung adenocarsinoma patient group is lower than it is in ovarian.
As I mentioned on the call we have exceeded MTT and are now and doses exploration and we'll be able to disclose that data a comprehensive update on the doses collation.
And the second half a day yeah.
Got it thanks for taking my questions.
And our next question coming from the line of Tom Shrader with B T. I G. Your line is open.
Anna Protopapas: About a third of the patients have NAPE to be high as defined in the ovarian cancer cohort, so we will have 40 to 45 patients that are unselected and will 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 mentioned on the call, we have exceeded MTD and are now in dose exploration and will be able to disclose that data, a comprehensive data update on the dose escalation in the second half of the year. I got it.
Hi, this is carrying on for Tom Thanks for taking our questions.
And my first one is regarding relation between not be to be expression and duration of response are there any studies preclinical or clinical and maybe based on gentex ADC that have shown whether or not and QB expression level changes post treatment and if that plays any role in defining the.
Durability of response.
And 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.
And if there's any evidence of changes in regards to not be to the expression.
Jonathan Chang: Thanks for taking the question. Now, next question coming from the line of Tom Schrader with BTIG. Your line is open. Hi, this is Kavari on behalf of Tom.
Based upon treatment for women in different lines of therapy, and so we've looked at our tumor banks as well as our samples and regards to archival versus fresh tissue and what we do see is consistency and regards to levels of expression, meaning that if a patient is a higher express there.
Kavari: Thanks for taking our questions. My first one is regarding the relation between not be-to-be expression and duration of response. Are there any studies pre-clinical or clinical, maybe based on genetic ADC, that have shown whether NN2B expression level changes post-treatment and if that it plays any role in defining the durability of response? Marvin, would you like to take that?
And it's concordant and relationship to their prior archival tissue versus a fresh tissue.
And the pull through and relationship to this can be that as we think about the lifecycle of outbreak. We do have anticipation that the levels of expression could be consistent and earlier lines of therapy.
Arvin Yang: Sure, thank you for the question. So let me break that question down first, just in relation to first, if there's any evidence of changes in regards to NAPD-2B 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 concordant in relationship to their prior archival tissue versus fresh tissue.
And regards to the pebble and its level.
And 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 and overall.
Check the response rate of approximately 28% and debt total population and with enrichment based upon a TPS cutoff of greater than 75%, we saw that and Richmond increased to 13, 9% or are relative to the 11% and seen and lower and that b to b expression. So.
So we do see the potential for enrichment of objective response rates and <unk>.
Arvin Yang: And the pull-through in relation to this can be that as we think about the life cycle of Uprie, we do have anticipation that the levels of expression could be consistent in earlier lines of therapy in regards to the prevalence level. Regarding the second question, regarding the duration of response, let me first remind you that, in the 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% of R relative to the 11% seen in the lower NAP B2B. expression.
Regards to duration of response, however, we do and this is based upon small sample sizes appear.
Appeared to have relatively consistent durations of responses from.
Whether they be and not be too be higher versus not be to be lower again, recognizing that there were and limited number of patients and the lower and happy to be population of type two patients.
That had objective responses.
Got it and for the pivotal study you have bevacizumab naive patients with one to two prior therapies and Youre exclusion criteria can you elaborate on the roll off of them and that setting and if you can share your thoughts on the possibility of adding a vast and it's just a flat.
And combination and the upgrade study.
And do you want to take that yes, absolutely. Thank you so and.
And regards to the Bevacizumab and <unk>.
Arvin Yang: 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 NAP B2B higher versus NB2B lower. Again, recognizing that there were a limited number of patients in the lower not B2P populations of two patients that had objective, Got it. And for the pivotal study, you have Bevacizumab naive patients with one to two prior therapies in your exclusion criteria.
Eligibility criteria, it's consistent with what the debt sits and that label is and.
So that this isn't that per label.
Is required for its indicated and regards to ovarian cancer patients with one to two prior lines of therapy. However, it is not indicated and those patients out three to four prior lines of therapy, and so what we've been able to achieve and one study.
In order to then be comprehensive and regards to being consistent with what the Bevacizumab and label is recognized.
Recognizing that and our expansion cohort.
Large proportion of patients from 70% did have prior bevacizumab therapy.
And so we do have a broader indication just based upon our our eligibility criteria.
Arvin Yang: Can you elaborate on the role of Bev in that setting? And if you can share your thoughts on the possibility of adding a VAS to the platinum combination in the upgrade study. Arvin, do you want to take that?
Now and regarding the second question and.
And in regards to the potential to combine with Bevacizumab.
As I've described earlier and relationship to our upgrade study.
We are first combining with carboplatin them because it is.
Arvin Yang: Yeah, absolutely. Thank you. So in regards to Bevacizumab, in the eligibility criteria, it's consistent with what the Bevacizumab label is. And so Bevacizumab per label is required for, or is indicated in regard to, ovarian cancer patients with one to two prior lines of therapy. However, it is not indicated in those patients who have three to four prior lines of therapy. And so what we've been
In earlier lines of therapy, a foundational regimen and relationship to platinum therapy.
As we think further and relationship to upgrade as an umbrella study where there can be multiple cohorts added.
We are thinking of multiple different regimens.
Other they'd be bevacizumab, and whether they'd be a non platinum combination.
<unk> inhibitor or even and immuno oncology agents.
That's helpful and maybe the last one for non small cell lung cancer. So a temporal and targeting chemotherapies are often used for these patients do you think that can impact the efficacy of your ADC or you think yours is a different type of cable and and inhibitor.
Arvin Yang: 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.
Inhibitor, but any thoughts there.
Yeah.
You know I think instead of speculating I think I would guide you to the second half a day year, where we will be able to disclose our expansion cohort data that day. So I said will include 40 to 45 patients.
Arvin Yang: Now, in regards to the second question in regards to the potential to combine with Bavis, a map, 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 relation to platinum therapy. As we think further in relation to upgrade as an umbrella study where there can be multiple cohorts added, we are thinking of multiple different regimens, whether they be Bavacizam, whether they be a non-futinom combination, a PARP inhibitor, or even immunoncology.
Great Thanks, and congrats on the progress.
Thanks.
And our next question coming from the line of Jessica Fye with.
J P. Morgan your line is open.
Hi, This is Daniel and for Jessica. Thank you very much for taking a question for.
First one you previously disclosed and duration of response of approximately five months for a pre and high expresses under the old diagnostic and methodology. What was the duration of response for a pre and high express centers, using the new TPS credit than or equal to 25% diagnostic and methodology.
It it does not change our RV and isn't that correct.
Arvin Yang: That's helpful. And maybe the last one for non-small lung cancer. So, cubillin targeting chemotherapies are often used for these patients. Do you think that can impact the efficacy of your ADCs, or do you think yours is a different type of cubillin inhibitor?
It could.
And that that's right, thank you and and so so Daniel.
And when you look at our webinar and relationship to the TPS, you'll see that the responders actually there.
And then there's the same number of responders there. So the duration of response does not change because it only looks at the responders.
Kavari: Any thoughts there? Yes. You know, I think instead of speculating, I think I would guide you to the second half of the year, when we will be able to disclose our expansion cohort data, which, as I said, will include 40 to 45 patients. Great.
Okay.
Got it and then moving maybe to the loan can you elaborate for us the enrollment dynamics for the lung cancer cohort and the expansion cohort of our price.
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.
Kavari: Great, thanks, and congrats on the progress. Thanks.
And what has been the push and pull and how enrollment and yeah I think thanks.
Jessica Fai: Now, next question coming from the line of Jessica Fai with J.P. Morgan, Yelanis Alphen. Hi, this is Daniel speaking on behalf of Jessica.
Thanks for the question I think last year, we did disclose that we were delayed and really initiating certain sites.
Daniel: Thank you very much for taking our questions. 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%? It does not change. Arvin, isn't that correct? Can you confirm that? That's right. That's right.
As a result of COVID-19 side.
Sites that we were counting on to be our primary lung and rollers.
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-19.
Think that those delays are behind us we've been able to overcome those challenges we faced last year and are on track to to recruit the 40 to 45 patients we're targeting.
Arvin Yang: Thank you, Anya. So, Daniel, when you look at our webinar in relation to the TPS, you'll see that the responders are actually, there are the same number of responders there, so the duration of response does not change because it only looks at the response. Got it. And then moving maybe to the long term, can you elaborate for us the enrollment dynamics for the lung cancer cohort and the expansion cohort of our, I'm sorry, what do you mean by enrollment? Can you clarify?
Okay makes sense and then can you provide us some color and the dose escalation algorithms and.
And utilized for the dose escalation study up 15, 92, and your strategy for exploration and destroy their doses and schedules from debt here.
I would say that you know I don't think we can share more detail tried do want us to remain disciplined and really share comprehensive.
Daniel: seems to have taken much longer than the ovarian cancer cohort to understand what has been the push and pull and how enrollment is going. Yeah, 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 in fires and then COVID.
Hence two data disclosures, rather than a really meaningful to investors rather than getting too.
Parts of the of the dataset.
And this is a very typical dose escalation.
And Ah study and we'll be able we are on track to disclose data and the second half of the year.
Okay, Great and maybe one last question.
MTV achieved from 15 92 can you remind us how much data you want to generate before making a call on the asset and equity and 92, our pre to advance and months and.
Anna Protopapas: 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 here? I would say that, you know, I don't think we can share more details.
And thank you for taking our questions.
Yeah, I again, and I think we want to be making robust data driven decisions in terms of the dose escalation for 15 92, we will have.
And understanding of exposure will have an understanding of the IMTT will have an understanding of the optimal dose regiment and I think obviously safety profile early signs of efficacy and that debt.
Anna Protopapas: I do want us to remain disciplined and really share comprehensive, have 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 study. and Maybe one last question. Would MTD achieve for 592? You know, can you remind us how much data you want to generate before making a call on the asset at a 592 R-pre to advance by a month?
The totality of that data would really guide us as to what the next appropriate step vans.
Great. Thank you very much.
Ladies and gentlemen, as a reminder to ask a question. Please press. The Star then the one key on your Touchtone telephone.
And our next question coming from the line up for your Speaker with Cowen Your line is open.
Great. My question is maybe initially on the pace of enrollment and ovarian uplift study earlier today, Immunogen announced a delay and a pivotal study readout due to COVID-19 impact just curious to see if you're seeing any impact compare it to your estimated time line of enrollment.
Daniel: And thank you for taking the time. 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 regimen, and I think obviously the 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.
So I think I can comment on the expansion portion of the study, which as you know, we're bringing to closure and we and and converting those sites to uplift I can tell you that we've got robust enrollment and the expansion cohort.
Daniel: Great. Thank you very much. Please send you all my next reminder to ask a question: please press the start and the one key on your touch-down telephone. Now, the next question coming from the lineup for a speaker with Kauin, Yelanis Alpin.
And we expect we'll be able to leverage that as we convert sites from the expansion cohort to uplift all day.
We're only at the beginning of uplift, but we are quite encouraged with the excitement we've seen from investigators and support we're getting from G O T and and code and of course, the design of uplift as we've said in the past it does provide for some streamlining debt.
Speaker: Great. My question is maybe initially on the pace of enrollment in the ovarian uplift study. Earlier today, Immunogen announced a delay in the epitial study readout due to COVID-19 impact.
Anna Protopapas: Just curious to see if you're seeing any impact compared to your estimated timeline for enrollment. 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.
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.
Anna Protopapas: Obviously, we're only at the beginning of uplift, but we are quite encouraged by 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, and we are not excluding patients with underlying neuropathy. So we hope all of these factors will help.
Though we're just starting uplift so we'd be able to give more definitive guidance for enrollment.
Target once we're a little further ahead in the study.
Great. Thank you very much for taking my question.
Our next question coming from the line of calling and can say with Baird. Your line is open.
Anna Protopapas: 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 or our enrollment targets once we're a little further ahead in the study. Great, thank you very much for taking my question. Now, next question coming from the line of Colleen-Cussi with there, the Alan is open. Hello, my name is Benjamin Palooch.
Hello, My name is done for and polar chime on for Colin.
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.
Or do you want to take sense, Yeah, no. Thanks, and thanks, Ben for the question in regards to the timelines for the diagnostics.
Let me first start that we've had a really robust.
Colleen Margaret Kusy: I'm on the phone for calling. 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? Arby, do you want to take this? Yeah, no, thanks, Anna.
Strategy and relationship and developing a diagnostic which started years ago and weak.
First and initiated the up redevelopment and so it's really been and parallel this entire process.
And so earlier this.
Year actually about a month ago, we had the webinar and relationship to declaring what is going to be a cut off for.
Arvin Yang: Thanks, Ben, for the question in regards to the timelines for the diagnostic. So, let me first start with that. We've had a really robust strategy and relationship to 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 or the identification of the higher and the lower NAP B2BP.
For the debt identification of the higher end of what we're not b to B patients and then.
So not only that but.
Diagnostic and relationship to the potential commercial diagnostic was announced and so both debt diagnostic assay as well as the applied cutoff will be utilized and our pivotal strategy of uplift and as a reminder, that's a two shot on goal and so we're enrolling all patients and <unk>.
Not pre selecting for higher or lower and not be to the patient and so that will obviously be for the efficiency and getting those patients on and then they will be.
Arvin Yang: And so not only that, but the diagnostic assay, as well as the applied cutoff, will be utilized in our pivotal strategy of up. And as a reminder, that's a two-shot on goal. And so we're enrolling all patients and not pre-selecting for a higher or lower net gain, 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.
And our prospective or retrospective analysis.
Determined to be high or low.
And utilizing that and we would then validate and cut off 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 will be able to validate the cutoff and lead us to the potential outcome of either having.
Complementary diagnostic whereby <unk> would potentially be indicated and a broad population, but having a diagnostic available in order to then complement whereas a complementary diagnostic and.
Regards to enriched activity or it would be a companion diagnostic in a scenario where only those patients with higher net book to bill.
Arvin Yang: This is specifically addressing your question as far as the next steps of the diagnostic assay itself. So using the Uplift cohort will be able to validate the cutoff and lead us to the potential outcome of either having a complementary diagnostic, whereby Upr 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 net status would be eligible for potential treatment without, And so that speaks to the next pet in relationship to the validation of our potential commercial diagnostica.
<unk> would be eligible for a potential treatment without free and.
So that speaks to the next pet pets and relationship to the validation of our potential commercial diagnostic assay.
Wonderful that's incredibly helpful. Thank you so much and then.
And what you'd 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 and the development of the diagnostic.
Maybe I'll take this RB we and we've been working with like a company that has a broad installed base of machines to do these tests are all over the world and we've been working with them for several years to develop to bring the program to date.
Benjamin Palooch: 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? Maybe I'll take this, Arvin. We've been working with Laika, 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 and bring the program to this stage.
Stage. The relationship however is not exclusive so if at some point in the future we want 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 like cut because of there.
Global infrastructure.
Anna Protopapas: The relationship, however, is not exclusive, so if at some point in the future, we want 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 Lyca because of their broad global infrastructure. That's fantastic. Thank you so much for elaborating. All from us, and I'm not showing any further questions at this time. I would not like to turn the call back over to an approach path for any closing remarks.
That's fantastic. Thank you so much for for elaborating.
All from us.
And I'm not showing any further questions at this time I would now like to turn the call back over to and that puts pappas for any closing remarks.
Wanted to thank all of you for joining us. This afternoon, we've made significant progress in advancing our pre with the initiation of uplift and the soon to be in Q3 initiation of upgrades. We're also making significant progress in advancing the pipeline with upright.
Anna Protopapas: 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-Q-3 initiation of upgrade. We're also making significant progress in advancing the pipeline with Uprie in Lung, XMT 1592, and our two new first-in-class molecules in IND-enabling studies.
And lung ex empty 15, 92, and our two new first in class molecules and I N D. Enabling studies. So we are on track to achieve our goals for this year and positioned the company for and important 2022. Thanks.
Anna Protopapas: 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 on future calls. Thanks. Ladies and gentlemen, that does end our conference call for today. Thank you for your participation. You may now disconnect.
Thanks for joining and we look forward to updating you.
And in future calls thanks.
Okay.
Ladies and gentlemen that that can call conference for today. Thank you for your participation you may now disconnect.
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