Q2 2022 Mersana Therapeutics Inc Earnings Call
Good afternoon, and welcome to Marcello Therapeutics second quarter, 2022 conference call and webcast.
Unknown Executive: Good afternoon, and welcome to Mersana Therapeutics' second quarter 2022 conference call and webcast. Currently, all participants are in listen-only mode.
Unknown Executive: There will be a question-and-answer session at the end of this call.
Currently all participants are in listen only mode. There will be a question and answer session at the end of this call.
Unknown Executive: I would now like to turn the call over to Jason Fredette, Senior Vice President, Investor Relations and Corporate Communications.
Ryan DeSchuytner: Thank you, Arvind.
Colleen Kusy: Please go ahead.
I'd now like to turn the call over to Jason Fredette, Senior Vice President Investor Relations and corporate Communications. Please proceed.
Unknown Executive: Please proceed.
Ryan DeSchuytner: Let's begin by sharing some additional context about our collaboration with GSK, which we view as a significant achievement for Mirsana. This global collaboration provides GSK with an exclusive option to co-develop and commercialize XMT-2056 for an upfront option purchase fee of $100 million. Should GSK choose to exercise this option, we will be entitled to receive an additional $90 million payment and up to approximately $1.3 billion in development, regulatory, and commercial milestones.
Colleen Kusy: Hi.
Good afternoon, everyone before we begin please note that this call will contain forward looking statements within the meaning of federal securities laws.
These statements May include but are not limited to those relating to the company's business strategy platform potential clinical trial preclinical study initiations execution and data releases regulatory plans and objectives commercial opportunities collaborations and potential associated payments operating expenses and <unk>.
Cash runway.
Each of these forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. These.
These risks and uncertainties are discussed in the company's quarterly report on Form 10-Q filed.
Filed with the Securities and Exchange Commission on May 19, 2022, and in subsequent SEC filings our filings are available at SEC Gov and on our web site <unk> Dot com.
As required by law, we assume no obligation to update forward looking statements publicly even if new information becomes available in the future.
Jason Fredette: Good afternoon, everyone.
Ryan DeSchuytner: As Anna indicated, if GSK opts in, they will fund a majority of the development costs for, XMT 2056, and our cash contribution would be generally offset by development milestones and other features.
Colleen Kusy: Good afternoon.
With that let me turn the call over to Ana Protocol, our President and Chief Executive Officer.
Jason Fredette: Before we begin, please note that this call will contain forward-looking statements within the meaning of federal securities laws. These statements may include, but are not limited to, those relating to the company's business strategy, platform potential, clinical trial or preclinical study initiations, execution and data releases, regulatory plans and objectives, commercial opportunities, collaborations, and potential associated payments, operating expenses, and a number of other items.
Ryan DeSchuytner: We also have the ability to benefit from the potential longer-term value of this exciting, program. For instance, the deal structure allows us to retain options for profit share and to, co-promote XMT 2056 in the U.S.
Colleen Kusy: Congrats on the partnership as well, and thanks for taking our questions.
Hello, everyone and welcome to our conference call. Joining me today with prepared remarks are chief Medical officer are being done and our Chief Financial Officer, Brian Just shine. There I'm also joined by other members of management, who will be available to answer your questions.
Jason Fredette: Expenses and cash runway.
I'd much sander, we aspire to be the leader in D C space.
In recent months, we have made significant advances towards innovation.
Jason Fredette: Each of these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.
Approach enrollment completion in uplift a potential registration trial initiated patient screening in up next.
So a confirmatory trial.
Here, the IND with the FDA for X M. T 16 16.
In New York and D for exon 2050, shakes and announced that the FDA has granted orphan drug designation for this candidate in gastric cancer and finally, as we just announced we entered into yet another exciting strategic partnership that provides significant no.
Our Youtube capital to extend our cash run rate, while also allowing us to reach a longer term strategic and financial upside potential.
Jason Fredette: These risks and uncertainties are discussed in the company's quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on May 9th, 2022, and in subsequent SEC filings.
Ryan DeSchuytner: If we opt in to the profit share, we would receive royalties on net sales outside of, the U.S.
Colleen Kusy: Starting with 2056, was there any new data that was shared with GSK in the diligence process?
Let me begin with this most recent accomplishment we are excited to share the news after market today that we have entered into a global collaboration providing GSK with an exclusive option to co develop and commercialize <unk> $20 56, which is our.
First stimulus seems to an ADC.
Jason Fredette: Our filings are available at sec.gov and on our website, mirsana.com.
Colleen Kusy: And I know you mentioned enriching for breast cancer.
Jason Fredette: Except as required by law, we assume no obligation to update forward-looking statements publicly, even if new information becomes available in the future.
56 targets are known epitope of her two and is designed to activate the innate immune system to sting's signaling in both tumor resident immune cells and itchy them ourselves.
Ryan DeSchuytner: If we do not opt in, we would receive tiered double-digit royalties ranging up to the mid-20s, on global net sales. Further information is contained in the 8K that we just filed with the SEC.
Colleen Kusy: So is it a fair interpretation that GSK has prioritized that indication?
There are several financial and strategic aspects that make this deal, particularly noteworthy.
Ryan DeSchuytner: This agreement follows our research collaboration with Janssen earlier this year and demonstrates, once again how we can leverage our platforms and product candidates as tools within our financing arsenal.
Colleen Kusy: And will you still enroll the other gastric and lung in that study as well?
First and foremost from a financial perspective. This is a very meaningful deal. We're in the early stage ADC asset. We believe it's not me tooth surfaces recognition of our differentiated immuno symptom platform.
Colleen Kusy: So, as you can imagine, the diligence was very, very comprehensive, involved not only the data we have shared publicly, but a lot of the other data we have been generated to support the potential of 2056 and the immunosymptom platform.
Colleen Kusy: Very comprehensive, including a review of the IND that we have recently cleared with the FDA.
Thanks about preclinical data and the transformational potential of exon 52056.
Ryan DeSchuytner: So let's talk about our financial resources to fund our operating plan. We ended the quarter with approximately $225 million in cash, cash equivalents, and marketable, security. Additionally, our line of credit with OXFORD and SVB provides us with the opportunity to, draw down an additional $35 million in low-cost capital at our option. When combined with the $100 million upfront payment from GSK, we believe we have the financing, required to fund our operating plan commitment into the first half of 2024.
Secondly, the upfront option purchase fee over 100 million extends our runway into the first half of 2024, well beyond important inflection points.
Thirdly, assuming GSK opt in they will fund a majority of the development costs for <unk> for 2056, and the deal is structured so that our cash contribution will generally be offset by development milestones and other features.
All while retaining participation in the potential longer term value of this exciting program.
Ryan DeSchuytner: And now for a brief recap of our P&L for the second quarter. Collaboration revenue for the second quarter of 2022 was $4.3 million compared to an immaterial, amount in the same period in 2021. The year-over-year increase was related to revenue recognized under our collaboration, agreement with Janssen.
Ryan will share some additional information on the financials in just a few minutes.
Colleen Kusy: As for the development program, I think GSK shares our vision that 2056 has very broad potential, in HER2-expressing tumors, which include lung, but also include other indications, include breast and other indications. So breast happens to be the largest indication. So we want to make sure that our dose escalation includes sufficient number of breast cancer patients, but our interests are very broad.
We believe GSK would be an ideal partner for <unk> 2056, given our shared vision for the potential of this program well, so local development and commercial capabilities and deep experience in ADC <unk> space.
Colleen Kusy: Great.
Colleen Kusy: That's helpful.
Space and the Sting pathway.
Colleen Kusy: Thank you.
And finally from a strategic perspective, we view. This agreement is a strong endorsement of the potential of our immune medicine platform and exiting 2056, when coupled with the research collaboration that we formed with Jan said earlier this year leveraging our chicken platform we believe.
Colleen Kusy: And just a follow-up.
Colleen Kusy: For the upgrade data that we'll see in the fourth quarter of this year, can you help us set expectations on how many patients and maybe how much follow-up we could see?
Colleen Kusy: Sure.
It also reaffirms the adverse Sunday is increasingly being viewed as a partner of choice. During this momentous period in the broader ADC space.
Colleen Kusy: So thanks, Colleen, for the question.
Ryan DeSchuytner: Research and development expenses for the second quarter of 2022 were $41.2 million, compared to $32 million for the same period in 2021. Non-cash R&D-related stock-based compensation expense for the second quarter of 2022 was, $2.7 million. The year-over-year increase in R&D was primarily driven by clinical and manufacturing costs, for XMT-1660 and the DolaSymptom platform, higher upgrade manufacturing and clinical costs, and an increase in headcount.
Colleen Kusy: And so this will be our initial interim data just in relationship to Upgrade B, really from the standpoint of following that hypothesis that there's non-overlapping toxicities in relationship to these compounds in a way that's prevented other combinations from effectively being developed.
Now, let's touch on the progress we have made recently in executing against our plan to position <unk> as a foundational medicine in ovarian cancer, which remains our top priority.
Ryan DeSchuytner: As we have previously described, we expect to incur non-recurring costs in the near term, related to antibody manufacturing runs for uplift in anticipation of a potential BLA filing and our efforts to ensure long-term supply of DolaSymptom conjugation components to support both XMT-1660 and our Janssen collaboration.
Ryan DeSchuytner: General and administrative expenses for the second quarter of 2022 were $14.8 million, compared to $8.9 million in the same period in 2021. Non-cash G&A-related stock-based compensation expense for the second quarter of 2022 was, $2.6 million. The year-over-year increase in G&A was primarily related to an increase in consulting and professional, fees and increased headcount.
Continue to be piece by the pace of them well, maybe uplift our single arm registration trial in platinum resistant ovarian cancer and are on track to announce enrollment completion around the end of the third core debt. This would position us for a top line readout in potential BLA in this indication.
In 2023.
Next is our phase III clinical trial of <unk> monotherapy maintenance is lumpy to be high recurrent platinum sensitive ovarian cancer. We are pleased to report that we recently initiated patient screening in this trial.
And then there's upgrade our phase <unk> combination trial in early line platinum sensitive patients dose escalation is underway. The first arm of the trial, which is looking at the combination of <unk> with Carboplatin.
Three ongoing clinical trials have the potential to demonstrate efficacy and confirming <unk> safety and Tolerability, while also generating data across a broad range of ovarian cancer settings.
And beyond <unk>, we are actively diversifying our clinical pipeline.
Todd and strategic manner with eczema, <unk> 60, <unk> 60, and <unk> 2056, both of which recently cleared our IND DS.
Arvind will share more information on these efforts in just a moment.
Ryan DeSchuytner: Mersona's net loss for the second quarter of 2022 was $52.2 million, or 55 cents per, share, compared to a net loss of $40.9 million, or 59 cents per share, for the same period in 2021.
In summary, this has been another very productive period for <unk>, we made substantial progress in our clinical trials and our position for the top line data readout and potential BLA filing next year.
Dancing to exciting and highly differentiated molecules with exiting 16, 60, <unk> 17th 2056, and we are substantially strengthening our balance sheet through the partnership with GSK. We look forward to continuing this momentum in the second half of the year as we approach what we havent.
So big to be a transformative 2023.
With that I will ask our chief Medical Officer, Arvind young to delve more deeply into our clinical progress and plans.
Jason Fredette: With that, let me turn the call over to Anna Protopapos, our President and Chief Executive Officer.
Ryan DeSchuytner: Finally, net cash used in operating activities was $44.7 million for the second quarter of
Colleen Kusy: And so we'll see that in the fourth quarter of this year.
Thank you Ella and good afternoon, everyone.
Thanks in part to solid support from both the <unk> element that we continue to make meaningful progress in advancing <unk> development across the ovarian cancer treatment.
Anna Protopappas: Hello, everyone, and welcome to our conference call.
Anna Protopappas: Now, Anna will close our formal remarks.
Colleen Kusy: And so this would be an eye toward that safety and tolerability, knowing that the efficacy is intended to be characterized further when we have the expansion data.
Let me start with uplift.
Anna Protopappas: Joining me today with prepared remarks are our Chief Medical Officer, Arvind Yang, and our Chief Financial Officer, Brian De Scheidner.
Anna Protopappas: Before we take your questions, Anna.
Colleen Kusy: Okay, great.
As Anna mentioned enrollment in this Registrational trial has been robust and we remain on track to complete enrollment around the end of the third quarter.
Anna Protopappas: I'm also joined by several other members of management who will be available to answer your questions.
Anna Protopappas: Thanks, Brian.
Colleen Kusy: Thank you.
Turning to our phase III <unk> trial, we're excited by its potential to serve as a post approval confirmatory trial in the U S to support global registration and to expand up right into earlier lines of therapy.
Anna Protopappas: At Mirsana, we aspire to be the leader in the ADC space, and in recent months, we have made significant advances towards this vision. As we approach enrollment completion in Uplift, our potential registration trial, initiated patient screening in UpNext, our potential confirmatory trial, cleared our IND with the FDA for XMT-1660, cleared our IND for XMT-2056, and announced that the FDA has granted orphan drug designation for this candidate in gastric cancer.
Anna Protopappas: We're incredibly proud of all the progress we have made thus far in 2022. From working to build upgrades to foundational medicine in ovarian cancer with uplift, upmix, and upgrade, to our progress with 1660 and 2056, and the meaningful new strategic partnerships with Janssen and GSK. Simply put, we're excited about our prospects and believe we're in a strong position to execute on our plans.
Unknown Executive: Once again, ladies and gentlemen, to ask a question, simply press star, then the number one on your telephone keypad.
Despite the relatively recent approval of PARP inhibitors, and Bevacizumab there remains a high unmet medical need in the maintenance setting following platinum therapy.
Anna Protopappas: And finally, as we just announced, we entered into yet another exciting strategic partnership that provides significant non-diluted capital to extend our cash runway, while also allowing us to retain longer-term strategic and financial upside potential.
Anna Protopappas: Let me begin with this most recent accomplishment.
Unknown Executive: With that, let's open the call to your questions.
Unknown Executive: And at this time, there appear to be no further questions.
Up next is designed to address the needs of three primary groups of patients are underserved by today's standard of care. The first our patients who progress on PARP inhibitors, and bevacizumab, whether taken in combination sequence.
Unknown Executive: Operator, would you please provide the instructions?
Anna Protopappas: I will return the call back to CEO Anna Protopappas for closing remarks.
Anna Protopappas: Thank you, Operator.
And are patients who are poorly served by today's maintenance agents and are resorting to watch and wait as their best option.
And the third are patients who achieved stable disease on platinum were excluded from the maintenance studies and consequently are excluded from treatment and the PARP inhibitor labels.
<unk> provides the potential to establish <unk> as the first ADC maintenance therapy in the platinum sensitive space there.
There is an even larger patient population that is being evaluated and uplift.
Initial clinical sites for <unk> have been activated and patient screening is underway.
Ultimately we are targeting the enrollment of approximately 350 patients worldwide in this trial.
In addition to uplift and up next we are seeking to bring up right into earlier lines of therapy through upgrade as Anna mentioned the first portion of this trial is investigating <unk> in combination with carboplatin them.
We are in early dose escalation at this stage and plan to provide a first looked at the safety and Tolerability of <unk> in combination with Carboplatin with the initial interim dose escalation data during the fourth quarter of this year.
We believe we will gain even more valuable insights into the potential efficacy and tolerability of this combination to the dose expansion portion of the trial.
Anna Protopappas: We are excited to share the news after market today that we have entered into a global collaboration, providing GSK with an exclusive option to co-develop and commercialize XMT-2056, which is our first immunosymptom ADC. 2056 targets a novel epitope of HER2 and is designed to activate the innate immune system through sting signaling in both tumor-resident immune cells and in tumor cells.
Now, let's move on to our earlier stage candidates at <unk> 60, and <unk> 2056. As a reminder, 16 60 is our <unk> directed dollars Symphony ADC with a precise target optimized drug to antibody ratio of six and Marseilles clinically validated dull microtubule.
Anna Protopappas: There are several financial and strategic aspects that make this deal particularly noteworthy. First and foremost, from a financial perspective, this is a very meaningful deal for an early, stage ADC asset.
<unk> inhibitor payload with a controlled bystander effect. So a lot of course already has shown its potential to drive efficacy in heavily pretreated ovarian cancer patients without severe neutropenia peripheral neuropathy or ocular toxicity.
And we see <unk> H for as a compelling target.
Given its limited expression in healthy tissue and its high expression in a range of cancers, including breast cancer endometrial and ovarian cancer.
In triple negative breast cancer, where PD one agent is approved.
And even greater unmet need as there appears to be an apparent lack of overlap between <unk> expression and PDL one expression.
We've generated promising preclinical efficacy and tolerability data for <unk> and we're happy to report that our R&D for this candidate was recently cleared by the FDA.
Initial phase one clinical sites have been activated and dosing is expected to begin imminently.
This phase one trial will investigate <unk> hundred 60 in solid tumors, including breast endometrial and ovarian cancer.
Anna Protopappas: We believe its magnitude serves as recognition of our differentiated immunosymptom platform, the strength of our preclinical data, and the transformational potential of XMT 2056.
And then there is <unk> 2056, which we will expect will enter the clinic in the second half of this year 2056 is directed at FERC to which of course is a very well established target.
Expressed in breast and non small cell lung cancer gastric cancer. Among others. This molecule has been tested extensively in preclinical models with impressive results we have.
The observed 2056 activity as a single agent and books are too high and hurts you low expressing models. It's also shown synergistic activity when used in combination with checkpoint inhibitors and with other hurt to standard of care agents in breast cancer such as inherited.
This is made possible because <unk> hundred 56 targets or her two epitopes that is distinct from Trastuzumab and purchase a lab.
And notably 2056 has demonstrated the potential for a very wide therapeutic index in preclinical models.
And so we're excited to have these three programs in motion and we're looking forward to generating clinical data from all three of our ADC platforms with that let's turn the call over to our Chief Financial Officer, Brian to China, Ryan. Thank you Barbara let's begin by sharing some additional context about our collaboration with GSK.
Anna Protopappas: And thanks to all of you who turned in for this conference call and your questions.
Anna Protopappas: And again, thank you so much for your time.
Which we view as a significant achievement for Barcelona. This global collaboration provides GSK with an exclusive option to co develop and commercialize <unk> 2056, or an upfront option purchase fee of $100 million.
Anna Protopappas: Secondly, the upfront option purchase fee of $100 million extends our runway into the, first half of 2024, well beyond important inflection points.
So GSK choose to exercise this option will be entitled to receive an additional $90 million payment and up to approximately $1 3 billion in development regulatory and commercial milestone payments as Anna indicated if GSK option. They will fund a majority of the development costs for accident years, 2056, and our cash card.
Anna Protopappas: Thirdly, assuming GSK opts in, they will fund a majority of the development costs for 2056, and the deal is structured so that our cash contribution will generally be offset by development milestones and other features, all while retaining participation in the potential longer-term value of this exciting program.
<unk> will be generally offset by development milestones and other features.
We also have the ability to benefit from the potential longer term value of this exciting program for instance, the deal structure allows us to retain options and profit share and to co promote <unk> 2056 in the U S. If we opt into the profit share we would receive royalties on net sales outside of the U S.
We do not often we would receive tiered double digit royalties ranging up to the mid twenties on global net sales further information is contained in the 8-K that we just filed with the SEC.
This agreement follows our research collaboration with Janssen earlier, this year and demonstrates once again, how we can leverage our platforms and product candidates as tools within our financing Arsenal.
Anna Protopappas: Brian will share some additional information on the financials in just a few minutes.
So let's talk about our financial resources to fund our operating plan, we ended the quarter with approximately $225 million in cash cash equivalents and marketable securities. Additionally, our line of credit with Oxford, and SBB provides us with the opportunity to draw down an additional $35 million and low cost capital at our option.
Anna Protopappas: We believe GSK would be an ideal partner for XMT 2056, given our shared vision for the, potential of this program, their wealth of global development and commercial capabilities, and their deep experience in ADCs, the I.O. space, and the Sting pathway.
When combined with the $100 million upfront payment from GSK. We believe we have the financing required to fund our operating plan commitments into the first half of 2024.
And now for a brief recap of our P&L for the second quarter.
Collaboration revenue for the second quarter of 2022 was $4 3 million.
Paired to an immaterial amount in the same period in 2021 the year over year increase was related to revenue recognized under our collaboration agreement with Janssen.
Research and development expenses for the second quarter of 2022 were $41 2 million compared.
Compared to $32 million for the same period of 2021 noncash R&D related stock based compensation expense for the second quarter of 2022 was $2 $7 million a year over year increase in R&D was primarily driven by clinical and manufacturing costs for 2016, 60, and dosing and platform higher up.
Manufacturing and clinical costs and an increase in head count as we have previously described we expect to incur nonrecurring costs and near term related to antibody manufacturing runs for offerings in anticipation of a potential BLA filing and our efforts to ensure long term supply of bolus insulin conjugation components to support both.
<unk> hundred $60 60, and our Janssen collaboration general.
And administrative expenses for the second quarter of 2022 were $14 8 million compared.
Compared to $8 9 million in the same period in 2021 noncash G&A related stock based compensation expense for the second quarter of 2022 was $2 6 million a year over year increase in G&A was primarily related to an increase in consulting and professional fees and increased headcount.
<unk> net loss for the second quarter of 2022 was $52 2 million or.
<unk> <unk> 55 per share compared to a net loss of $40 9 million or <unk> 59 per share for the same period in 2021.
Finally, net cash used in operating activities was $44 7 million for the second quarter of 2022 now.
And now Anna will close our formal remarks before we take your questions.
Anna Protopappas: And we'll see you next time.
Thanks, Brian we're incredibly proud of all the progress we have made thus far in 2022 from working to build a pretty it's a foundational medicine in ovarian cancer with uplift up mix of upgrades to our progress was $16 60 in 2056 and the meaningful new strategic partnership.
Anna Protopappas: And finally, from a strategic perspective, we view this agreement as a strong endorsement, of the potential of our immunosymptom platform and XMT 2056.
Anna Protopappas: Thank you.
Ships, we began sending GSK simply put we're excited about our prospects and believe we're in a strong position to execute on our plans with that let's open the call to your questions. Operator would you please provide instructions.
Anna Protopappas: When coupled with the recent collaboration that we formed with Janssen earlier this year, leveraging our dollar symptom platform, we believe it also reaffirms that Mirsana is increasingly being viewed as a partner of choice during this momentous period in the broader ADC space.
Anna Protopappas: Now let's touch on the progress we have made recently in executing against our plan to position UPRE as a foundational medicine in ovarian cancer, which remains our top priority.
Anna Protopappas: We continue to be pleased by the pace of enrollment in UPLIFT, our single-arm registration trial, in platinum-resistant ovarian cancer, and are on track to announce enrollment completion around the end of the third quarter.
Anna Protopappas: This would position us for a top-line readout and potential BLA in this indication in 2023.
Unknown Executive: As a reminder, to ask a question, simply press star and then the number one on your telephone keypad.
As a reminder to ask a question simply press Star then the number one the audio telephone keypad. Once again press star one on your telephone keypad, if you would like to ask a question.
Anna Protopappas: Up next is our phase three clinical trial of upper immunotherapy maintenance in NAPI-2b high recurrent platinum-sensitive ovarian cancer. We are pleased to report that we recently initiated patient screening in this trial.
Anna Protopappas: And then there's UPGRADE, our phase one to umbrella combination trial in early-line platinum-sensitive, patients.
Unknown Executive: Once again, press star one on your telephone keypad if you would like to ask a question.
Anna Protopappas: Dose escalation is underway in the first arm of the trial, which is looking at the combination, of UPRE with carboplatin. These three ongoing clinical trials have the potential to demonstrate UPRE's efficacy and, confirm its safety and tolerability while also generating data across a broad range
Anna Protopappas: And beyond OPRI, we're actively diversifying our clinical pipeline in a thoughtful and strategic manner with XMT-1660 and XMT-2056, both of which recently cleared INDs.
Unknown Executive: First question is from the line of Jonathan Jang with SB Securities.
First question is from the line of Jonathan Chang with SB Securities. Please go ahead.
Anna Protopappas: Arvind will share more information on these efforts in just a moment.
Jonathan Jang: Please go ahead.
Hi, guys congrats on the partnership and thanks for taking my questions.
Anna Protopappas: In summary, this has been another very productive period for Mersana. We made substantial progress in our uplink clinical trials and our position for the top line data readout and potential BLA filing next year.
Jonathan Jang: Hi, guys.
First question on <unk> 2056, just for clarity are you guys still running the phase one study and how our decisions on data disclosure made.
Jonathan Jang: Congrats on the partnership and thanks for taking my questions.
Anna Protopappas: We are advancing to exciting and highly differentiated molecules with XMT-1660 and XMT-2056.
Jonathan Jang: First question on XMT 2056.
Brian will take that yes, absolutely we continue to.
Run the phase one study in fact, SMT 2056 remains wholly owned by Inmarsat.
Anna Protopappas: And we are substantially strengthening our balance sheet through the partnership with GSK.
Jonathan Jang: Just for clarity, are you guys still running the phase one study and how are decisions on data disclosure made?
Anna Protopappas: We look forward to continuing this momentum in the second half of the year as we approach what we anticipate to be a transformative 2023.
Phase one will be a fairly typical first in human dose escalation design.
With an eye towards enriching for breast cancer.
Brian DeSchuytner: Brian will take this.
And he said that the completion of that where GSK has an option to op gain Jonathan Chen.
Brian DeSchuytner: Yeah, absolutely.
Got it so the option exercise is.
I guess.
Sorry, just any additional color on the timelines for the option exercise.
Brian DeSchuytner: We continue to run the phase one study. In fact, XMT 2056 remains wholly owned by MRSADA. That phase one will be a fairly typical first in human dose escalation design with an eye towards enriching for breast cancer.
It's too early for us to really provide timelines, but I think we've given you a sense of how far we need to we will take the <unk>.
Program.
Got it.
And on the immuno symptom platform more broadly.
You guys have efforts here beyond her two how should we be thinking about the strategy here and potential business development opportunities beyond 2056, specifically.
Yeah well.
We're in the very fortunate position as you know to have three platforms all of which are supported by substantial data. Soon all three will be in the clinic and that puts us in a position to leverage these platforms to bring additional exciting products for what and frankly.
There's more debt here and potential that we could take it for any one company can take advantage and harness so partnerships remain a very important part of our strategy, where they're thinking platform.
Anna Protopappas: With that, I will ask our Chief Medical Officer, Arvind Yang, to delve more deeply into our clinical progress and plans.
Brian DeSchuytner: And it's at the completion of that where GSK has an option to opt in, Jonathan.
<unk> like the one we did we began.
Whether they are asset deals like the one we've done with GSK. So we have continued to engage in discussions and the interest in the ADC space is quite high at this point and.
Brian DeSchuytner: Got it.
And we find ourselves really in it.
Great position to leverage that interest.
Yeah.
Understood Congrats again.
Thanks, Jonathan.
Your next question is from the line of choline Cousy with Baird. Please go ahead.
Arvind Yang: Thank you, Anna, and good afternoon, everyone.
Brian DeSchuytner: So the option exercise is, I guess, sorry, just any additional color on the timelines for the option exercise?
Arvind Yang: Thanks in part to strong support from both the GOG and MDOT, we continue to make meaningful progress in advancing OPRI's development across the ovarian cancer treatment landscape.
Brian DeSchuytner: It's too early for us to really provide timelines, but I think we've given you a sense of how far we will take the program.
Hi, good afternoon, congrats on the partnership as well and thanks for taking our questions.
Arvind Yang: Let me start with uplift.
Brian DeSchuytner: Got it.
Starting with 2056 was there any new data that was shared with GSK in the diligence process and.
Arvind Yang: As Anna mentioned, enrollment in this registrational trial has been robust, and we remain on track to complete enrollment around the end of the third quarter.
Brian DeSchuytner: And on the immunosymptom platform more broadly, you guys have efforts here beyond HER2.
And I know you mentioned enriching for breast cancer. So is it fair interpretation that GSK is prioritized that indication and will you still enroll.
Brian DeSchuytner: How should we be thinking about the strategy here and potential business development opportunities beyond 2056 specifically?
The other gastric and lung and steady as well.
Arvind Yang: According to our Phase 3 UPnext trial, we're excited by its potential to serve as a post-approval confirmatory trial in the U.S. to support global registrations and to expand OPRI into earlier lines of therapy.
So.
As you can imagine the diligence was very very comprehensive involved not only the data we have shared publicly but a lot of the other day that we have been generated to support the potential of <unk> 2056, and a mirrored our central platform very comprehensive including a REIT.
Arvind Yang: Despite the relatively recent approval of PARP inhibitors and bevacizumab, there remains a high medical need in the maintenance setting following platinum therapy.
Arvind Yang: UPnext is designed to address the needs of three primary groups of patients who are underserved by today's standard of care.
Arvind Yang: First are patients who progress on PARP inhibitors and bevacizumab, whether taken in combination or in sequence.
Arvind Yang: Second are patients who are poorly served by today's maintenance agents and are resorting to watch and wait as their best option.
Arvind Yang: And the third are patients who achieve stable disease on platinum who are excluded from the PARP maintenance studies and consequently are excluded from treatment in the PARP inhibitor labels.
Arvind Yang: UPnext provides the potential to establish OPRI as the first ABC maintenance therapy in the platinum sensitive space.
Arvind Yang: There's an even larger patient population that is being evaluated in UPnext.
Arvind Yang: Initial clinical sites for UPnext have been activated and patient screenings underway.
Few of the <unk>.
We have recently cleared with the FDA.
As for the development program I think GSK shares our vision that 2056 is very broad potential in her two expressing tumors, which include lung but also include other indications.
Uh huh.
Gastric.
Brent and other indications.
So breast happens to be the largest indication. So we wanted to make sure that our dose escalation include sufficient number of breast cancer patients, but our interests are very broad.
Great. That's helpful. Thank you and just a follow up for the upgrade data that we'll see in the fourth quarter of this year.
Arvind Yang: Ultimately, we are targeting the enrollment of approximately 350 patients worldwide in this trial.
Help us set expectations on how many patients how much follow up we could see.
Arvind Yang: In addition to UPLIFT and UPnext, we are seeking to bring OPRI into earlier lines of therapy through UPGRADE. As Anna mentioned, the first portion of this trial is investigating OPRI in combination with carboplatinum.
Yeah sure. So thanks, Colin for the question and so this will be our initial interim data.
Just in relationship to upgrade fee.
From the standpoint of following that hypothesis that there is non overlapping toxicities in relationship to these.
Arvind Yang: We're in early dose escalation at this stage and plan to provide a first look at the safety and tolerability of OPRI in combination with carboplatinum with the initial interim dose escalation data during the fourth quarter of this year. We believe we will gain even more valuable insights into the potential efficacy and tolerability of this combination through the dose expansion portion of the trial.
These compounds in a way that's prevented other.
Arvind Yang: Now let's move on to our earlier stage candidates, XMT-1660 and XMT-2056.
Other combinations from effectively being developed and so this would be an eye towards that safety and tolerability knowing that the efficacy is intended to be characterized further when we have the expansion data.
Arvind Yang: As a reminder, XMT-1660 is our B7H4-directed dolacinthin ADC with a precise target-optimized drug-to-antibody ratio of 6. And Mersana's clinically validated dolaloc microtubule inhibitor payload with a controlled bystander effect.
Arvind Yang: Dolaloc, of course, already has shown its potential to drive efficacy in heavily pretreated ovarian cancer patients without severe neutropenia, peripheral neuropathy, or ocular toxicity.
Arvind Yang: And we see B7H4 as a compelling target, given its limited expression in healthy tissue and its high expression in a range of cancers, including breast cancer, endometrial, and ovarian cancer.
Arvind Yang: In triple negative breast cancer, where a PD-1 agent is approved, there may be an even greater unmet need, as there appears to be an apparent lack of overlap between B7H4 expression and PD-L1 expression.
Arvind Yang: We've generated promising preclinical efficacy and tolerability data for 1660, and we're happy to report that our IND for this candidate was recently cleared by the FDA. Initial phase 1 clinical sites have been activated, and dosing is expected to begin imminently. This phase 1 trial will investigate 1660 in solid tumors, including breast, endometrial, and ovarian cancer.
Arvind Yang: And then there's XMT-2056, which we expect will enter the clinic in the second half of this year. 2056 is directed at HER2, which, of course, is a very well-established target, and it's overexpressed in breast, non-small cell lung cancer, gastric cancer, among others. This molecule has been tested extensively in preclinical models with impressive results. We have observed 2056 activity as a single agent in both HER2 high and HER2 low expressing models. It's also shown synergistic activity when used in combination with checkpoint inhibitors and with other HER2 standard of care agents in breast cancer, such as in HER2. This is made possible because 2056 targets a HER2 epitope that is distinct from trastuzumab and pertuzumab. And notably, 2056 has demonstrated the potential for a very wide therapeutic index in preclinical models.
Arvind Yang: And so we're excited to have these three programs in motion, and we're looking forward to generating clinical data from all three of our ADC platforms.
Ryan DeSchuytner: With that, let's turn the call over to our Chief Financial Officer, Ryan DeShiner.
Okay, great. Thank you.
Once again, ladies and gentlemen to ask a question simply press Star then the number one the onshore telephone keypad.
Brian DeSchuytner: Yeah.
Brian DeSchuytner: Well, we're in a very fortunate position, as you know, to have three platforms, all of which are supported by substantial data.
Brian DeSchuytner: Soon all three will be in the clinic, and that puts us in a position to leverage these platforms to bring additional exciting products forward.
Brian DeSchuytner: And frankly, there's more than here in potential that we could take it for anyone company can take advantage and harness.
Brian DeSchuytner: So partnerships remain a very important part of our strategy, whether they be platform deals like the one we did with Janssen, or whether they are asset deals like the one we've done with GSK.
And at this time there appear to be no further questions I will return the call back to CEO , Anna <unk> for closing remarks.
Brian DeSchuytner: So we continue to engage in discussions, and the interest in the ADC space is quite high at this point.
Brian DeSchuytner: And we find ourselves really in a great position to leverage that interest.
Brian DeSchuytner: Understood.
Thank you operator, and thanks to all of you who turned in for your for this conference call and your continued support we look forward to seeing many of you at the PD <unk> Biotech conference Tomorrow, and Wedbush back Hawk growth Healthcare conference we hope.
Anna Protopappas: Thank you for sitting during this conference call and your continued support.
Anna Protopappas: We look forward to seeing many of you at the BDIG Biotech Conference tomorrow, and the Webb Bush Backpack Growth Healthcare Conference.
And we want to enjoy the rest of their summer and we look forward to keeping you updated on our progress.
Anna Protopappas: We hope everyone enjoys the rest of their summer.
Anna Protopappas: And we look forward to keeping you updated on our progress.
Ryan DeSchuytner: Ryan?
Jonathan Jang: Congrats again.
Unknown Executive: Thank you all for joining today's conference call.
Jonathan Jang: Thanks, Jonathan.
Unknown Executive: You may now disconnect.
Thank you all for joining today's conference call you may now disconnect.
Colleen Kusy: Your next question is from the line of Colleen Kusy with Baird.
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Okay.
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Okay.