Q1 2022 Mersana Therapeutics Inc Earnings Call
Unknown Executive: Good morning, and welcome to Mersana Therapeutics' first quarter 2022 conference call and webcast. Currently, all participants are in a listen-only mode.
Good morning, and welcome to <unk> sign out Therapeutics first quarter 2022 conference call and webcast. Currently all participants are in a listen only mode.
Unknown Executive: There will be a question and answer session at the end of this call. I would now like to turn the call over to Jason Fredette, Senior Vice President, Investor Relations and Corporate Communications. Good morning, everyone.
There will be a question and answer session at the end of this call I would now like to turn the call over to Jason Fredette Senior Vice President Investor Relations and corporate Communications. Please proceed.
Yeah.
Jason Fredette: Before we begin, I'd like to mention that our call will contain forward-looking statements within the meaning of the federal securities laws. These statements include, but are not limited to, those related to the company's business strategy, platform potential, clinical trial, or preclinical study execution, data releases, regulatory plans and objectives, commercial opportunities, and cash runway. Each of these forward-looking statements is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.
Good morning, everyone before we begin I'd like to mention that our call will contain forward looking statements within the meaning of the federal Securities laws. These statements include but are not limited to those related to the company's business strategy platform potential clinical trial or preclinical study execution and data really.
This regulatory plans and objectives commercial opportunities and cash runway.
Each of these forward looking statements is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.
Jason Fredette: These risks and uncertainties are discussed in the company's annual report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 28, 2022, and in subsequent SEC filings. These documents are available at sec.gov or on our website, mersana.com.
These risks and uncertainties are discussed in the company's annual report on Form 10-K filed with the Securities and Exchange Commission or SEC on February 28 to 2022 and in subsequent SEC filings. These documents are available at SEC Gov or on our website Marsano dotcom.
As required by law, we assume no obligation to update forward looking statements publicly even if new information becomes available in the future.
Anna Protopappas: Except as required by law, we assume no obligation to update forward-looking statements publicly, even if new information becomes available in the future. With that, I will turn the call over to Anna Protopappas, Mersana's President and Chief Executive Officer. Good morning, everyone, and welcome to our first quarter 2022 conference call. Joining me today with prepared remarks are our Chief Medical Officer, Arvind Yang, our Chief Science and Technology Officer, Tim Loinger, and Chief Financial Officer, Brian DeSchuytner.
With that let me turn the call over to Ana Proto pop Us Mcdonald's President and Chief Executive Officer.
Good morning, everyone and welcome to our first quarter 2022 conference call. Joining me today with prepared remarks are chief Medical Officer RV Young.
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Anna Protopappas: I'm also joined by certain other members of management who will be available to answer questions. Before I start, I would like to officially welcome our new Senior VP of Investor Relations and Corporate Communications, Jason Fredette.
I'm also joined by other members of management will be available to answer questions before I start I would like to officially welcome to most sander, our new senior VP of Investor Relations and corporate Communications, Jason Fredette. We are excited to have him on board.
Anna Protopappas: We are excited to have him on board. 2022 is shaping up to be an incredibly exciting year as we continue to advance UPRI, prepare to bring two exciting new candidates into the clinic, and execute on our partnering strategy as we position Mersana for multiple important data readouts in 2023. Let me start by describing the progress we have made on our goal of establishing UPRI as a foundational medicine for patients with ovarian cancer. We believe the clinical data we've shared in the past have demonstrated UPRI's efficacy and important tolerability advantages, namely the lack of severe utropenia, neuropathy, and ocular toxicity that has been reported with other ADCs.
2022 is shaping up to be an incredibly exciting year as we continued to advance our pre <unk>.
We have two exciting new candidates into the clinic next acute on our partnering strategy as we position bousada multiple important data readouts in 2023, let.
Let me start by describing the progress we have made on our goal of establishing a brief visit foundational medicine for patients with ovarian cancer. We believe the clinical data we've shared in the past has demonstrated.
Efficacy and important tolerability advantages, namely the lack of severe neutropenia neuropathy and ocular toxicity that has been reported with other adcs.
Anna Protopappas: Our current slate of trials, Uplift, Upnext, and Upgrade, have the potential to further validate this profile while also generating data across a broad range of ovarian cancer settings in an expeditious and capital efficient manner. Our single-arm registration trial in platinum-resistant ovarian cancer is on track to complete enrollment in the third quarter of this year, positioning us for a 2023 readout and potential BLA filing. As Arvind will discuss in further detail, we are pleased to have been selected for an oral presentation at the Society of Cardiological Oncology, or SGO, to share additional analysis supporting our dose selection for options. Up next is a phase three trial of higher immunotherapy maintenance in NAPI2b high recurrent platinum sensitive ovarian cancer, which is an even larger patient population with significant unmet need.
Courage later trials.
Lift upticks that upgrade have the potential to further validate this profile, while also generating data across a broad range of ovarian cancer setting in an expeditious and capital efficient manner.
Lift or so.
Think of alarm registration trial in platinum resistant ovarian cancer.
On track to complete enrollment in the third quarter of this year positioning us for 2022 readout and potential BLA filing.
Robyn will discuss in further detail. We are pleased to have been selected for an oral presentation at the society of gynecological oncology or S. G. L to share additional analysis supporting our dose selection for uplift.
Next is our phase III trial of a pretty monotherapy maintenance he's happy to be high recurrent platinum sensitive ovarian cancer, which is an even larger patient population with significant unmet need.
Anna Protopappas: Next, has the potential to serve as a post-approval confirmatory trial in the U.S., support global registrations, and position ABRI as the first ADC in the platinum-sensitive space. An upgrade is our Phase 1-2 Umbrella Combination Trial in Early Aligned Platinum Sensitive Patients. Initially, we're evaluating the combination of Opry with carboplatin, followed by continuation of Opry monotherapy.
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And upgrade is a phase one two umbrella combination trials in earlier line platinum sensitive patients. Initially we're evaluating the combination of property with Carboplatin, followed by continuation of a pretty mono therapy. We believe the preliminary dose escalation data planned for late this.
Anna Protopappas: We believe the preliminary dose escalation data planned for late this year will provide valuable insights into Opry's safety and tolerability in a combination setting, which could support our plans to expand into earlier lines of therapy. Beyond UPRI, we're advancing a pipeline in a thoughtful and capital efficient manner, with 1660 and 2056 being our primary focus. Both of these candidates are on track to move to the clinic in mid-2022.
Yeah, well provide valuable insights into upper safety and Tolerability in a combination setting which could support our plans to expand into earlier lines of therapy.
Beyond <unk>, we're advancing our pipeline thoughtful capital efficient.
With 16, 16, and 2056 being a primary focus both of these candidates are on track to move into the clinic in mid 2022.
Anna Protopappas: XMT1660 is our dollar symptom ADC directed at B7H4. Preclinically, we have generated compelling efficacy data demonstrating 1660's potential in B7H4-expressing tumors of high unmet need, including breast, endometrial, and ovarian cancer. These will be the primary indications of focus as we move into phase one. XMT-2056 is expected to be the second addition to our clinical pipeline this year and our first immunosynth and stink agonist ADC to enter the clinic. It targets HER2, a validated target broadly expressed in a range of solid tumors, including breast, gastric, and non-small cell lung cancer. We have generated a robust preclinical data set demonstrating the potential to create a pipeline for a product with single agent activity in both high and low HER2-expressing models.
Except T 16, 60 is a dollar seem to D. C directed that'd be seven each for.
Clearly cut leave we have generated compelling efficacy data demonstrating 16 60 potential it'd be seven each for expressing tumors.
Unmet need including breast endometrial and ovarian cancer. These will be primary indications of book because it's moved into phase one.
<unk> 2056 is expected to be the second addition to our clinical pipeline this year and our first Sting agonist ADC to enter the clinic.
You're talking to.
They did talk it's broadly expressed in a range of solid tumors, including breast gastric and non small cell lung cancer, we have generated a robust preclinical dataset demonstrating 2056 potential to create a pipeline in a product with a single agent activity in both.
Hi, Lo to expressing models.
Anna Protopappas: Given that 2056 targets a novel epitope of HER2, we believe it has the potential to be synergistic with other HER2 agents, including those that have become standard of care in breast cancer and newer agents like HER2. Additionally, we have seen its potential to work in combination with checkpoint inhibitors in preclinical models. Now, as many of you know, we also have been evaluating another NAPI2P-targeted ADC, XMT1592, as a second shot on goal in non-small cell lung cancer.
Even the 2056 target adult the epitope of part two we believe it has the potential to be synergistic with other head to agents, including those that have become standard of care in <unk>.
Cats are a newer agents like can hurt too.
They should not leap, we have seen its potential to work in combination with checkpoint inhibitors.
Clearly called bottles.
Anna Protopappas: Given the lower prevalence of the NAPI2P biomarker in lungs, the increasingly competitive nature of this indication, our commitment to remain financially disciplined, and the substantial opportunities we see ahead for UPRI, XMT1660, and XMT2056, we have decided to discontinue development of XMT1592. In addition, we are deferring certain investments in our preclinical pipeline, including two of our earliest stage candidates, XMT 2068 Our success with our pre-XMT 1660 and 2056 has positioned us to have three candidates enabled by all three of our platforms, DolaFlexin, DolaSynthin, and Immunosynthin, in active clinical development this year. We view our platforms as capital-efficient product engines to fuel our own pipeline and position Mersana as the ABC partner of choice at this time. And there is a surge of interest in the field.
Now as many of you know we also have been evaluating another not be to be targeted to a D. C. Except he 15 92.
Second shot on goal in non small cell lung cancer.
The lower prevalence of the napping to be biomarker in lung.
Pleasingly competitive nature of this should be case should our commitment to remain financially disciplined.
The substantial opportunities we see ahead for our pre except T. 16, 60 addiction 2050 States, we have decided to discontinue development of exited 15 19 too.
In addition, we are deferring certain investments in our preclinical pipeline, including two of our earlier stage candidates ex emptied 2068, and 21 75 to focus our resources on most others can't be called pipeline.
Our success with our pre <unk> 16, 60, 2056 has positioned us to have three candidates enabled by all three of our platforms Golar flexi dulles into any human citizen.
Active clinical development this year with your platforms, it's capital efficient product engine to fuel our own pipeline and to position Lusaka is the a b C partner of choice at this time when there is a surge of interest in the field. This in turn provides the opportunity to expand.
Anna Protopappas: This, in turn, provides the opportunity to expand Mersana's reach and its ability to address patient needs while also bringing us non-dilutive capital that can be redeployed in the business. And so we're off to a strong start in 2022 as we lay the foundation for what we hope will be a BLA filing and approval of OPRI in the not-too-distant future. Important initial clinical data for 1660 and 2056 and additional potential value-creating partners
Bousada tweak and its ability to address patient needs, while also bringing us non diluted capital that can be redeployed in the business.
And so we're off to a strong start in 2022 as we lay the foundation for what we hope will be a BLA filing and approval of our pre in the not too distant future important initial clinical data for $60 60 in 2056 and additional potential value.
Create deep partnerships. We are excited by the opportunities that lie ahead, and where we'd be steadfastly focused on building value for patients who are waiting for new treatment options with that I would like to turn the call over to Avi to delve deeper into up we discuss are we.
Anna Protopappas: We are excited by the opportunities that lie ahead and will remain steadfastly focused on building value for patients who are waiting for new treatment options. With that, I would like to turn the call over to Arvind to delve deeper into OPRI and discuss our recent data at SGO. Thank you, Anna.
The data I guess G O.
Arvind Yang: With strong support from both the GOG and MGOT, the premier gynecologic oncology clinical trial networks in the U.S. and EU, we continue to make meaningful progress in advancing Opry's development across the ovarian cancer treatment landscape. We remain on track to complete Uplift enrollment in the third quarter of this year and report data in 2023. If positive, we believe this data will support a BLA submission for upgrade in platinum-resistant disease. At SGO, we were pleased to present details of an analysis from a phase one trial that bifurcated patients by dose. Desk Group 36 and Desk Group 43.
Thank you Anna with strong support from both the G O G F N b.
Premier kind of Collagic oncology clinical trial networks in the U S and U we continue to make meaningful progress in advancing <unk> development across the ovarian cancer treatment landscape.
We remain on track to complete uplift enrollment in the third quarter of this year and report data in 2023.
Positive. We believe this data will support a BLA submission for <unk> in platinum resistant disease.
Arvind Yang: This analysis reaffirmed 36 mg per m2 as the appropriate uplift dose, given it high. Additionally, fewer grade 3 or higher adverse events and fewer adverse events in general, longer durations of treatment, as well as fewer discontinuations due to treatment-related adverse events, including discontinuation before first scan. The SGL presentation also helped to clarify that in Dose Group 36, only two patients were non-evaluable in the NAPD2B high population, and four patients were non-evaluable in the overall population.
And that's G. O. We were pleased to present details of an analysis from our phase one trial at bifurcated patients by does Scripps desk at 36 and desk forty-three dish.
This analysis reaffirmed 36 migs per meter squared at the appropriate uplift us given its high efficacy fewer grade three or higher adverse events and fewer adverse events and general longer durations of treatment as well as fewer just continuations to treatment related adverse events, including discontinuation.
Before first scan.
Yes. Your presentation also help to clarify that and don't screw 36, only two patients where none of valuable in the NAFTA to be high population and for patients with non evaluable in the overall population.
Arvind Yang: Including these patients in an intent-to-treat or ITT analysis of the dose group 36, the overall response rate, or ORR, was 39% among patients with MAPI-2b high status and 31% among all patients. Both of these ORR figures are well above the 12% ORR seen with today's standard of care. Now, turning to the Phase 3, Up Next trial, that we expect will serve as our confirmatory trial, we are excited by its opportunity to position UPRI as a new ovarian cancer maintenance standard of care.
Including these patients in an intent to treat or ITT analysis of the dose group 36, the overall response rate or or or was 39% among patients with mapping to be high status and 31% among all patients both of these or our figures are well above the 12% or Ars gene.
With today's standard of care.
Now turning to phase III up next trial that we expect will serve as a confirmatory trial. We're excited by this opportunity to position <unk> as a new ovarian cancer maintenance standard of care.
Arvind Yang: Despite the approval of PARP inhibitors and Bevacizumab, the unmet medical need remains high for patients who have been previously treated with a platinum doublet. Through constructive FDA and CHP interactions, we've designed UpNext to enroll three important patient populations who are underserved by today's options. The first are patients who progress on a POTS inhibitor and Bevacizumab, whether taken in combination or in sequence. The second are patients who are poorly served by today's maintenance agents and are resorting to a watch and wait as their best option.
Despite the approval of PARP inhibitors, and Bevacizumab, the unmet medical need remains high for patients who have been previously treated with a platinum doublet.
Through constructive F E N C. H P interactions. We've designed up next to enroll three important patient populations, who are underserved by today's options. The first our patients who progressed on a PARP inhibitor and bevacizumab, whether taken in combination or in sequence.
Tim Loinger: And third, patients who achieve stable disease on platinum who are excluded from the PARC maintenance studies and, consequently, are excluded from treatment in the PARC inhibitor label. We have optimized the study design to address the unmet need in the maintenance setting, including selecting for NAPI-2B high patients and selecting a 30 mg per meter squared dose, and we are pleased to share that we submitted our up next protocol to cite institutional review boards, or IRBs, putting us on track to initiate patient screening for this trial by the end of Q2.
Second our patients who are poorly served by today's maintenance agents and are resorting to a watch and wait as their best option.
And the third are patients who achieved stable disease on platinum were excluded from the PARP maintenance studies, and consequently are excluded from treatment and the PARP inhibitor labels.
We have optimized the study designed to address the unmet need in the maintenance setting, including selecting forgot b to B high patients and selecting a 30 make per meter squared dose and we are pleased to share that we submitted our up next protocol to site institutional review boards or arby's, putting us on track to initiate patient screening for this trial.
By the end of Q2.
Tim Loinger: In addition to our near-term plans to complete enrollment for Uplift and initiate UPnext, we are planning to share interim combination data from our Upgrade Combination Phase 1-2 trial with Carboplatinum in the fourth quarter of this year. Upgrade safety and tolerability in combination will be the primary focus of this initial readout. Ultimately, we believe the combination therapy will be key to moving into earlier lines of ovarian cancer treatment. And finally, in parallel with all of these efforts, we are now gearing up to bring XMT-1660 and XMT-2056 into the clinic. To discuss these candidates further, let me turn the call over to Tiff. Thank you, Arvind.
In addition to our near term plans to complete enrollment for uplift and initiate up next we are planning to share interim combination data from our upgrade combination phase one two trial with carbo platinum in the fourth quarter of this year.
A brief safety and Tolerability in combination will be the primary focus of this initial readout ulta.
Ultimately, we believe the combination therapy will be key to moving into earlier lines of ovarian cancer treatment.
And finally in parallel with all of these efforts. We are now gearing up, particularly at 17, six and 16 and excellent 2056 into the clinic to discuss these candidates further let me turn the call over to Tim.
Thank you Arvind.
Tim Loinger: As you know, ADC innovation is at the very core of Mersana's strategy, and we have made significant progress in building out an innovative pipeline of potential cancer medicines. In fact, I've been here since Mersana's inception as an ADC company, and I can honestly say that I have never been more excited about where we are from both a technology and pipeline perspective. This is due both to UPRI's rapid progress and to the promise of our next clinical candidates, XMT 1660 and 2056.
As you know ADC innovation is at the very core of Marsano strategy and we have made significant progress in building out an innovative pipeline of potential cancer medicines.
In fact I've been here since Masada has been exceptional as an ADC company and I can honestly say that I have never been more excited about where we are from both a technology and pipeline perspective.
This is due both to upper east rapid progress and to the promise of our next clinical candidate X M. T 16, 60 in 2056.
Tim Loinger: The pre-clinical data packages on these new molecules are very compelling, and we recently had the opportunity to share additional data on both of them at AACR. XMT1660, our dolacentin ADC targeting B7H4, has a precise and target-optimized drug-to-antibody ratio of 6.
The preclinical data packages on these new molecules are very compelling and we recently had the opportunity to share additional data on both of them at ACR.
That's M. T 16, 60 are Don Hinson, ADC targeting <unk> seven age four has a precise target optimize drug to antibody ratio of six.
Tim Loinger: Also, similar to UPRI, it leverages our clinically-validated dololoc microtubule inhibitor payload to provide a controlled bystander effect and what we believe will be a similar tolerability profile. At AACR, we showed in multiple patient-derived Xenograft models that a single dose of 1660 has robust anti-tumor activity in both triple negative breast cancer and estrogen receptor positive breast cancer. Furthermore, the data demonstrate that B7H4 expression is correlated with anti-tumor activity consistent with our desired target effect.
Also similar to Opry it leverages, our clinically validated golar lock microtubule inhibitor payload to provide a controlled bystander effect and what we believe will be a similar tolerability profile.
A C. R. We showed in multiple patient derived xenograft models.
Single dose of 16, 60 has robust anti tumor activity in both triple negative breast cancer and estrogen receptor positive breast cancer.
Further the data demonstrate that <unk> four expression is correlated with the anti tumor activity consistent with our desired target effect.
Tim Loinger: As Anna mentioned, XMT2056 is our first immunosymptom sting agonist ADC targeting HER2-expressing tumors. The preclinical data we presented at AACR shows that 2056 demonstrates robust anti-tumor activity as a monotherapy in both high and low HER2-expressing models. We also shared data demonstrating how 2056 may combine and provide even greater efficacy with established agents like trastuzumab, pertuzumab, anti-PD-1, or trastuzumab-durox TK. The mechanistic data we presented on immunosymptons provide a clear road map of its unique position and differentiation from other molecules targeting HER2.
As I had mentioned <unk> 2056 is our first immuno symptom Sting agonist ADC targeting her two expressing tumors.
The preclinical data we presented at ACR so for.
2056 demonstrates robust anti tumor activity.
Monotherapy in both high and low her to express any model.
We also shared data demonstrating how 2056.
Combine and provide even greater efficacy with established agents like Trastuzumab herd took a mab anti PD, one or Trastuzumab director he can.
Mechanistic data, we presented on immuno Simpson provide a clear road map of its unique position and differentiation from other molecules targeting her too.
Tim Loinger: Additionally, we presented preclinical data at AACR elucidating how antitumor activity of the immunosymptom sting agonist ADCs involved the targeted activation of the sting pathway in both tumor resident immune cells and in tumor cells in an antigen-binding dependent manner. This one-two punch is a strong differentiator for immunosynthin versus other ADC-IO approaches, including those based on Toll- To further investigate this approach, we conducted studies on patient tumor samples, revealing that, when combined with 2056 ex vivo, myeloid cells present in the tumor activate the sting pathway and induce cancer cell death.
Additionally, we presented preclinical data at ACR elucidating, how anti tumor activity of immuno Symphony Sting agonist ADC.
All but targeted activation of the sting pathway in both tumor resident immune cells and in tumor cells and an antigen binding dependent manner.
This one two punch is a strong differentiator for immuno Simpson versus other ADC Io approaches, including those based on toll like receptor or T. O R agonists or those that directly target antigens on immune cells.
To further investigate this approach we conducted studies on patient tumor samples, revealing that when combined with 2056 ex vivo myeloid cells present in the tumor activate the sting pathway and induced cancer cell death.
Brian DeSchuytner: Translational research like this provides us with a strong rationale and a great deal of excitement to begin investigating 1660 and 2056 in a clinical setting mid-year. I'd now like to pass the call over to Brian to recap our financials.
Translational research like this provides us with a strong rationale and a great deal of excitement to begin investigating 16 60 in 2056 and a quote unquote studying mid year.
I'd now like to pass the call over to Brian to recap of our financials Bryan.
Brian DeSchuytner: Thank you, Tim. We summarized our first quarter financial results in this morning's press release, so let me focus on just a few key items. As you all know, Mersana, like a majority of similarly-situated biotechnology companies, has now been operating amid challenging market conditions for a prolonged period of time. This has caused us to evaluate our expenses even more carefully, contributing to decisions like the one Anna described earlier related to XMT-1592 and the deferment of certain investments in XMT-2068 and XMT-2175.
Thank you Tim we summarized our first quarter financial results in this morning's press release. So let me focus in on just a few key items.
As you all know Masada like a majority of similarly, situated biotechnology company has now been operating amid challenging market conditions for a prolonged period of time. This has caused us to evaluate our expenses, even more carefully contributing to decisions like the one Andy described earlier related to Accenture 15, 92, and the deferment of certain investments in X and Pete.
<unk> 68, and X M. T 21, 75 at the same time, we've been proactive in ensuring that Masada has access to the capital that we require to continue advancing uprate rapidly put toward potential approval into clinically demonstrate the strength of our data center.
Brian DeSchuytner: At the same time, we've been proactive in ensuring that Mersana has access to the capital that we require to continue advancing UPRE rapidly toward potential approval and to clinically demonstrate the strength of our dolacinthin and immunosynthin platform. Our debt refinancing in late 2021, recent business development accomplishments, and strategic use of the ATM are primary examples of the tools that have enabled us to keep Mersana on Net cash used in operating activities for Q1 was $8 million.
And in unison and platforms, our debt refinancing in late 'twenty or 'twenty, one recent business development accomplishments and strategic use of the ATM. A primary examples of the tools that have enabled us to keep persona on sound financial footing net cash used in operating activities for Q1 was $8 million. We ended the first quarter of 2022 with them.
Anna Protopappas: We ended the first quarter of 2022 with approximately $230 million in cash and cash equivalents. It should be noted that in April, we raised an additional $40 million in net proceeds from our ATM, primarily from investors with whom we have had long-term relationships, who believe strongly in Mersana's prospects, and who tend to have a long-term focus. Also, 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 discretion.
Approximately $230 million in cash and cash equivalents. It should be noted that in April we raised an additional $40 million in net proceeds from our ATM, primarily from investors with whom we've had long term relationships, who believes strongly in response prospects who tend to have a long term focus also our line of credit with Oxford and SBB probe.
Rides us with the opportunity to draw down an additional $35 million and low cost capital at our option.
Anna Protopappas: As a reminder, we expect that there will continue to be quarter-to-quarter fluctuations in R&D spending related to CMC work as we approach our anticipated BLA filing. Factoring all of this in, we believe we have the financing required to fund our operating plan commitments well into the second half of 2023. Additionally, we continue to view collaborations as an important tool within our financing arsenal and believe that the potential exists for further business development transactions in the quarters to come.
As a reminder, we expect that there will continue to be quarter to quarter fluctuations in R&D spending related to CMC work as we approach our anticipated BLA filings factoring all of this and we believe we have the financing required to fund our operating plan commitments well into the second half of 2023.
Additionally, we continue to view collaborations as an important tool within our financing Arsenal and believe that the potential exists for further business development transactions in the quarters to come the Janssen agreement that was signed in the first quarter was a Prime example of how our differentiated platforms enable us to raise meaningful non dilutive capital while expanding the reach in VAT.
Anna Protopappas: The Janssen Agreement that was signed in the first quarter was a prime example of how our differentiated platforms can enable us to raise meaningful, non-dilutive capital while expanding the reach and validation of our platform. With that, I'll now turn the call back to Anna. Thank you, Brian.
<unk> of our platforms with that I'll now turn the call back to Anna. Thank you, Brian with the bolstered balance sheet and the progress we have made across our platforms and pipeline. We believe we're well positioned to execute upon our commitment of building a leading ADC company with a focus on better for patients.
And shareholders well.
Anna Protopappas: With a bolstered balance sheet and the progress we have made across our platforms and pipelines, we believe we're well positioned to execute upon our commitment to building a leading ADC company with a focus on benefits for patients and shareholders. With that, I will turn the call over to the operator for Q&A. Thank you. And as a reminder, to ask a question, simply press star 1 on your telephone. To withdraw the question, press the pound or hash button again. Again, that is. Star 1 to get it. The first question comes from Jonathan Chang with SVV Learning.
That I would turn the call over to the old parade for Q&A.
Thank you and as a reminder to ask a question simply press star one on your telephone to withdraw that question press the pound or hash key.
Again that is <unk>.
Star one to get into queue.
Yeah.
First question comes from Jonathan Chang with SVP Leerink. Please go ahead.
Jonathan Chang: Please go ahead. Hi guys, good morning, and thanks for taking my questions. First question, can you provide any color on how the uplift enrollment has progressed? Is the study on track? Have you experienced any COVID and or geopolitical-related delays in the study? Thanks, Jonathan.
Hi, guys. Good morning, and thanks for taking my questions. First question can you provide any color on how the uplift enrollment has progressed.
The study on track have you experienced any COVID-19 and or geopolitical related delays in the study.
Anna Protopappas: It's great to hear from you. So, we remain on track. We're making good progress, and we remain on target in relationship to what we said about the Q3 timing.
Thanks, Jonathan it's great to hear from you. So we remain on track, we're making good progress and we remain on target in relationship to what we said about the Q3 timing.
Yeah.
Anna Protopappas: Thank you. And just a second question. Can you expand on your high-level thoughts regarding the prioritization of the pipeline and resources and specifically to 1592? Are there lessons learned from that program and experience that read through to upbringing?
Got it. Thank you and just second question can you expand on your high level thoughts regarding the prioritization of the pipeline and resources and specific to 15 92 are there lessons learned from that program and experience that read through to operate.
Anna Protopappas: So thank you, Jonathan, for the question. Our decision around 1592 really involved a number of factors. You know, the role of NAPI to be lung cancer, as we learned from our UPRI lung cancer expansion cohort, the very competitive nature of this indication, and the fact that we're pretty excited about not just UPRI but the potential of XMT 1660 and 2056. Focusing on Upbringth 1660 and 2056 gives us a very diversified portfolio, both in terms of targets, platforms, and indications. So that really drove our decision. Obviously, with every study we do, there are learnings, and the learnings we take from one study, from one program to the next. So there were obviously learnings with 1592.
So thank you Jonathan for the question.
Around 15, 92 really are involved a number of factors you know the role of not being to be lung cancer as we learned from our opry lung cancer expansion cohort the very competitive nature of this indication and the fact that we're pretty excited about not just upbeat but.
The potential of X M. T 16, 60 in 2056.
Focusing on a pre <unk> 16, 60, and 2056 gives us a very diversified portfolio. Both in terms of target platforms and indications. So so that's really drove our artist nation. Obviously with every study we do there are learnings that learnings.
Take from one study from one program to the next so Oh that were obviously learnings with 15 92, and as we wind down the study and clean and lock the database will have an opportunity to find the appropriate forum to disclose that data.
Anna Protopappas: And as we wind down the study and clean and lock the database, we'll have an opportunity to find the appropriate forum to disclose that data. Okay. Thank you. And just last question for me. Can you guys discuss how you're thinking about additional business development opportunities moving forward? Yeah, maybe I can. I can take that.
Understood. Thank you and just last question for me.
Can you guys discuss how you're thinking about additional business development opportunities moving forward.
Yeah.
Anna Protopappas: So the Janssen transaction, I think, really highlights what we can do with both our platforms and our products. You know, the we're sitting here in an ADC renaissance; a number of companies have recognized that they need ADCs as part of their arsenal. And I think we have positioned ourselves through the innovation that Tim talked about to be one of the prime partners for these. And so we think about our BD strategy in three pillars, the platforms that are, the phytotoxic platforms, whether it's Dolaflexin or DolaSynthin, where we can think about transactions that look similar to the Janssen transaction.
Yeah, maybe I can I can take that so that the Janssen transaction I think it really highlights what we can do with both our AR platform than are our products.
In the.
We're sitting here on a D C. Renaissance a number of companies have recognized that they need ADC as part of their armamentarium.
I think we have positioned ourselves through the innovation that Tim talked about to be one of them.
<unk> partners for four days and so we think about our BD strategy in three pillars.
That forms the cytotoxic platforms, whether to go with Watson or since then where we can think about transactions that look similar to the the Janssen transaction the immune at sinton platform.
Anna Protopappas: The Immunosynthin platform, where we, for every company that is interested in ADCs as a modality, is another company that has targeted innate immune stimulation in its sweet spot. And that's a substrate for partnering as well. And obviously, there are six Immunosynthin assets that we've advanced to various stages, 2056 being the most advanced. But we can't take all of those into the clinic on our own. So partners with the resources and the combined potential to really advance those would be interesting. You know, where we would be more reluctant to partner quickly is around Opry, where we don't want to cap the upside.
Where we are for every company that is interested in 86 of the modality is another company that has targeted innate immune.
Stimulation in their sweet spot and that's a substrate for partnering as well and.
And obviously there are six immuno Simpson assets, but we've advanced the various stages 2056 being the most advanced we can't take all of those into the clinic on our own so partners with the resources and the combination potential.
Really enhance those but it would be interesting to know where we would be more reluctant to a partner quickly is around operate where we don't want a copy oxide. We stand here with a wholly owned first in class only in class asset in a registration enabling study.
Anna Protopappas: We stand here with a fully owned first in class, only in class asset in a registration enabling study. And we're very close to the next value inflection points around Opry.
And we're very close to the so the next value inflection points around upwards.
Jonathan Chang: Thanks for taking the questions. Your next question comes from Boris Peaker with Cowen. Please go ahead. Good morning.
Got it thanks for taking my questions.
Your next question comes from Boris <unk> with Cowen. Please go ahead.
Boris Peaker: My first question is from the timing and regulatory perspective; I believe the FAA wants to make sure that the confirmatory trial is well underway prior to approving an accelerated application. So I'm just curious, how far do you anticipate UpNext to be enrolled around the time when the BLA is based on Uplift. Yeah, thanks for the question. And so, first off, just to start off, as we've indicated in our press release, we remain on track in relationship to initiation of the study in the Q2 fund trend that we referenced.
Good morning.
My first question is from the timing and regulatory perspective, I believe the FDA wants to make sure that the confirmatory trial is well underway prior to a proven accelerated about application. So I'm just curious how far do you anticipate up next to be enrolled around the time of when you'd be submitting a BLA based on uplift.
Yeah no. Thanks. Thanks for the question. So first off just to start off up as we've indicated in our press release, we remain on track in relationship to initiation of the study and into Q2 had a friend that we referenced.
Boris Peaker: In regards to the enrollment, we've been in ongoing discussions, as would be typical in relationship to discussing with FDA, in relation to the startup, as well as the enrollment. So those are points that have already been discussed with the regulators in relation to the confirmatory study. One thing to keep in mind, however, is that we're doing our confirmatory study in a different population relative to the uplift, the platinum-resistant ovarian cancer space.
In regards to the enrollment we'd been in ongoing discussions on as would be typical in relationship to discussing with F. D. A.
In relationship to the.
The startup as well as the enrollment so those are.
Points that have already been discussed with the regulators in relationship to the.
The confirmatory study one thing to keep in mind. However is that we're doing a confirmatory study in a different population relative to the uplift the platinum resistant ovarian cancer space. This obviously differentiates us with some of the other ovarian competitive landscape trial designs and this is advantageous from the standpoint of.
Boris Peaker: This obviously differentiates us from some of the other ovarian competitive landscape trial designs, and this is advantageous from the standpoint of, remember, this is not then a competing population in relationship to when the uplift data becomes available. The confirmatory study obviously still serves and addresses an unmet need in relation to interest in the study.
Remember this.
This is not then a competing population in relationship to them when the uplifted it data becomes available.
<unk> study, obviously still serves and it addresses an unmet need.
In relationship to interest in the study.
Arvind Yang: And my second question is for 1660 and 20... We can provide some data expectations of what we should be seeing later. So we have guided and are on track to be in the clinic, dosing patients mid-year. As for data disclosures beyond that, I think it's a little early for us to be providing that guidance. Great, thank you very much. Your next question comes from Jessica Fy of JP Morgan. Please go ahead. Good morning, this is Daniel speaking for Jessica Fi.
Got it and my second question is for $16 60 in 2056 and provide some.
So that's about an expectation of what we should be seeing a later this year in the middle of the year.
So we have guided to and are on track to be in the clinic dosing patients midyear.
As for data disclosures beyond that I think it's a little early for us to be providing that guidance.
Great. Thank you very much for taking my question.
Your next question comes from Jessica Fye with JP Morgan. Please go ahead.
Boris Peaker: Thank you for taking your question. A couple of questions, maybe to start with, regarding upgrade: can you provide the rationale for including all comers in the trial, including those with low expression of NAPI TB? Now, thanks for the question.
Good morning. This is Daniel for Jessica Fye. Thank you for taking my question.
Couple of questions maybe to start with regarding upgrade can you provide the rationale for including all comers in the trial, including with dose with low expression of an a P to P.
Jessica Fy: And so, keep in mind that, first off, starting in relation to the data that we've seen from the expansion cohort, we do see that there's activity across the board, but there is enrichment in relationship to the high NAPI 2B. And so in upgrade, as we're starting to combine it with chemotherapy and keep in mind, the initial steps are here to evaluate, again, our differentiated profile and that potential for non-overlapping toxicities, recognizing that we don't have with what we've seen with the up reagent, the severe neutropenias, the peripheral neuropathies, or the ocular toxicities.
Yeah no. Thanks for the question and so keep in mind that in first off I'm starting in relationship to the data that we've seen from the expansion cohort, we do see that there's activity across the board, but there is enrichment in relationship to the heightened up b to B and so an upgrade as we're starting.
Combined with chemotherapy and keep in mind. The initial steps are here to evaluate again, our differentiated profile and that potential for that non overlapping toxicities.
Recognizing that we don't have with what we've seen with the up reagent. The severe neutropenia is the peripheral neuropathy or ocular toxicities. So here in combination with Carboplatin them, which is the standard of care in the earlier line. The idea here is we'd like to see the activity in that broad population and then determined.
Jessica Fy: So, here, in combination with carboplatinum, which is a standard of care in the earlier line, the idea here is we'd like to see the activity in that broad population and then determine, obviously, ultimately, whether or not a biomarker on that B2B status would be useful in relationship to patient selection. Okay, got it. Helpful.
Obviously, ultimately whether or not a biomarker on that b to b status would be useful in relationship to patient selection.
Arvind Yang: And then regarding the recently announced project Optimist from the FDA, it seems that the FDA is focused on ensuring companies advance the right dose. Do you think the dose work you've done so far will satisfy the agency on this front? Yeah, so thank you for the question. I think we're, I think our data selection and our dose selection is quite consistent in relationship to evaluating the multiple doses that Project Optimist is really focused on here.
Okay got it helpful and then regarding the the previously the recently announced project Optimists from the F. D. It seems that the FDA is focused on ensuring companies advance the right. Dallas do you think that dose work you have done so far will satisfy the pages here on this front.
Yeah. So thank you for the question I think where were.
I think our data selection in our dose selection is quite consistent in relationship to evaluating the multiple doses that project. Optimus is really focused on here and remember one of the CT elements of project Optimus had been that it is not always necessarily the maximum tolerated dose, which is the optimal dose to move forward and hear you.
Arvind Yang: And remember, one of the core tenements of Project Optimist has been that it's not always necessarily the maximum tolerated dose that is the optimal dose to move forward. And here you can see that with the almost two hundred patients that have been evaluated in dose ranging, we've been able to robustly analyze the dose regimen that we believe can be optimal in relationship to bringing this drug forward for patients. Okay, one last question. Does the cash runway guidance of well into the second half of 2023 take into account the discontinuation of the 1592 program? Yeah, yes, it does.
Can see that with the over almost 200 patients that have been evaluated and dose ranging.
Been able to robustly analyze the dose regimen that we believe can be optimal in relationship to bring forward for patients.
Okay. One last question.
Does the cash runway guidance, so well into the second half of 2023, taking into account the discontinuation of the 15 92 program.
Yeah, Yes, it does.
Great. Thank you very much.
Alright. Your next question comes from Choline policy with Baird. Your line is open.
Brian DeSchuytner: All right, great. Thank you very much. Alright, your next question comes from Colleen Kusy with Bird. Your line is open.
Colleen Kusy: Hi, good morning, and thanks for taking our questions. So for the next trial, what are you stratifying for in the enrollment? And can you remind us the expectations for the placebo arm in that population? And I guess, would it depend on the breakdown of the percent of the three different populations you're looking to enroll?
Hi, good morning, and thanks for taking our questions. So first up next trial.
What do you stratify in core in the enrollment and can you remind us the expectations for the placebo arm and that population and I guess would it depend on the breakdown of the percent of the three different populations, you're looking in general and then I'll follow up thank you.
Arvind Yang: And then I will follow up. Thank you. So let me break down the question a little bit first, and just to remind the audience in relation to the up next study, our confirmatory study, this is in the recurrent platinum sensitive space, and we are selecting for high NAB B2B patients. And so, in regards to the stratification, we've essentially, based upon the sample size, determined the most important prognostic stratifiers in relation to those patients in order to then ensure that balance.
Hi, Julien So let me break down the question a little bit first and just to remind the audience in relationship to the next study our confirmatory study. This isn't the recurrent platinum sensitive space and we are selecting for high net b to b patients.
So in regards to the stratification, we've essentially based upon the sample size determined that most important prognostic strata fires.
In relationship to those patients.
In order to then ensure that balance because to your point, we are looking at multiple different populations, but where these populations all have standard of care as essentially vigilant observation as an acceptable standard of care for those patients.
Arvind Yang: Because, to your point, we are looking at multiple different populations, but where these populations all have the standard of care as essentially vigilant observation as an acceptable standard of care for those patients. And that actually speaks to your second question about the placebo in relation to that. Standard of Care, or what that time period would be. And so keep in mind that in the recurrent space, given the PARP inhibitor utilization and the BEV utilization in the earlier line space, that period is actually relatively short in relationship to progression-free survival. We haven't been sharing the actual time frames associated with that, but you can imagine that in recurrent space, it's relatively short.
That actually speaks to your second question about the placebo in relationship to that.
Standard of care or what that time period would be and so keep in mind that that recurrent space.
Given the PARP inhibitor utilization in the bed utilization in the earlier line space that period is actually relatively short and relationships of progression free survival, we haven't been sharing the actual timeframe associated with that but you can imagine that in the recurrent space it's relatively short.
Colleen Kusy: Okay, thank you. That's interesting. Thank you. And for the upgrade trial, what is the dose escalation regimen you're using? And do you think you'll be at an effective dose by the time of the readout before Q? Yeah, so we are using an approved dose of carboplatinum, and it's consistent with dose escalation studies in the phase one setting where, obviously, the goal here is to ensure safety tolerability initially. And then at a defined dose, start to evaluate the efficacy.
Okay. Thank you that's interesting thank you and for the upgrade trial, what is the dose escalation regimen youre using and do you think you'll be at an effective dose by the time of the read out for Q.
Yeah. So we are using an approved dose of the carbo platinum and that's consistent with a dose escalation studies in the phase one setting where obviously the goal here is to ensure the safety Tolerability initially.
Colleen Kusy: We're starting with the approved doses of carboplatinum, and then we're dose escalating the upper dose regimen. And keep in mind that we have seen activity down as low as twenty milligrams per meter squared with as we go.
And then at a defined dose start to evaluate the efficacy and we're starting with the approved doses of Carbo Platinum and then we're dose escalating the uprate dose regimen and keep in mind that we have seen activity down as low as 20 milligrams per meter squared with with upper yes, we're going through this and so as you get into Q4.
Arvind Yang: And so as you get into Q4, to a level set upon the expectations in that timeframe, this will be our initial or interim dose escalation period. And so the key here is to evaluate the safety tolerability in combination with carboplatin. And one last one, if I can, just at a higher level, as you're thinking about moving up into earlier lines of ovarian cancer, do you have data on how platinum exposure might impact the expression of NAPI 2B, if at all? Yeah, it's a great question.
Or to level set out upon the expectations in that timeframe on this will be our initial or interim of the dose escalation period and so the key here is to evaluate the safety tolerability and the combination with.
With Carboplatin.
Understood. Thank you and one last one if I can.
Just at a higher level as you.
Thinking about moving up into earlier lines of ovarian do you get data on how platinum exposure might impact the expression of napping to be if at all.
Colleen Kusy: And so what we've seen from not only our expansion dose cohorts, but as an expansion cohorts, but as well as additional tumor banks, is that NAPI-2B is a lineage marker. And the expression level appears to be consistent through time, which also means that through intervening therapies, including platinum therapies, and thus the expectations would be that the NAPI-2B expression would remain consistently high, which represents about two-thirds of the population as we've described in our expansion cohort, whether it be in the late line setting or in the earlier line setting, including the platinum sensor. Okay, great.
Yeah, It's a it's a great question and so what we've seen from not only our expansion dose cohorts, but as what an expansion cohort, but as well as additional tumor banks is that.
Not going to be it's a lineage marker and the expression level appears to be consistent through time, which also means that through intervening therapies, including platinum therapies, and thus the expectations would be that the nappy to the expression with remained consistently high which represents about two thirds of the population.
As we described in the expansion cohort of whether it be in the late line setting or in the earlier line setting of including the platinum sensitive space.
Okay, great. Thanks for taking the question.
Arvind Yang: Thanks for taking your questions. All right, your next question comes from David Nierengarten with... Please go ahead.
Our next question comes from David Nearing Garden with Wedbush Securities. Please go ahead.
David Nierengarten: Thanks for taking that question. Most of mine have been asked, but I was curious about developing 2056 with HER2 immunosynthon. I know it's differentiated from other HER2 targeting agents and its mechanism, but HER2 is also a crowded development space. So I was wondering if you were, I don't want to say targeting that to business development, but if you were thinking that that might be, you know, one of the prime business development opportunities, just looking at your pipeline, what is interesting but might be a relatively expensive development pathway.
Thanks for taking my question most of mine have been asked but I was curious on developing 2056 or something.
I know, it's differentiated from other her two targeting agents and its mechanism, but her two is also a crowded development space. So I was wondering if you were I don't know.
I say targeting that to business development, but if you were thinking that that might be you know one of our prime business development opportunities just looking at your pipeline and what you know.
What is interesting, but you know it might be.
Relatively expensive development pathway.
Brian DeSchuytner: Sure, I mean, you know, as we remarked before, when we think about our immunosympin assets, there are potential partnerships around both the platform, platform access, similar to Janssen, or there could be partnerships around the immunosympin products. You know, for that molecule, we're really excited about it because one, I think we've generated, Tim and his team have generated really tremendous preclinical data demonstrating a very broad therapeutic index, but we're using a novel antibody that is not competitive in binding with the existing HER2-directed agents. And then the third component of this, David, which I think is really important, is that we're using HER2 as a docking station, right? The objective here is not to interrupt HER2 signaling.
Sure I mean, I believe remarks before when we think about our immuno Simpson assets, there or potential partnerships around both the platform platform assets similar to the Janssen.
Or there could be partnerships around by municipal products.
For that molecule, we're really excited about it because one I think we've done or Tim and the team has been demonstrated really tremendous preclinical data demonstrating a third broad therapeutic index.
But we're using a novel antibody that is not competitive and binding with the existing her two directed agents and then the third component of this David which I think is really important is that we're using her two with a docking station right.
If youre not to interrupt purchased signaling.
Arvind Yang: And so that means that the universe of potential applications for this may be much broader than where HER2 agents are studied today. And so all of those things are pieces that we would explore as part of that phase one dose escalation. And maybe if I could just make a follow-up and are there any, you know, maybe less competitive indications you might be thinking about focusing on, or do we have to wait and see from phase one? I mean, I can speak to that just in relation to the tumor types in our dose escalation. As you know, HER2 is expressed, as you just indicated, in a variety of tumor types.
So that means that the universe of potential.
Potential applications of this maybe much broader than where her to agents.
Our studies today.
And so all of those things are are pieces that we would explore as part of that phase one dose escalation.
Maybe if I could sneak a follow up are there any.
Maybe less competitive.
Indications you might be thinking about focusing on or you'll have to wait and see from Mercedes one.
Well I mean, I can speak to that just in relationship to the tumor types in our in our dose escalation.
As you know her two is expressed as you just indicated in a variety of tumor types and so won't be evaluating I mean, the three that I would flag right now and clearly breast cancer gastric as well as non small cell, but we also will be evaluating additional tumor types, including bladder cancers and other tumor types that may express her two and back to <unk>.
Arvind Yang: And so we'll be evaluating. I mean, the three that I would flag right now include breast cancer, gastric cancer, as well as non-small cell. But we also will be evaluating additional tumor types, including bladder cancers and other tumor types that may express HER2. And you know, back to Brian's point just in relation to keeping in mind that this is really a docking station. And because of this, the expression levels may matter less relative to other HER2-targeted therapies, where inhibiting the biologic pathway has been the primary modality of action. I think the success of an HER2 and the HER2-low is probably the best prime example in relation to when using it as a docking station, you can potentially address a HER2-low population.
Ryan's point just in relationship to keeping in mind that this is really a docking station and because of such the expression levels may matter less relative to other her two targeted therapies. We're inhibiting the biologic pathway has been the primary modality of action I think the success.
And her two into her too low is probably the best Prime example in relationship to one unit as it is.
Talking station you potentially can address her.
Her two low population and so these are some of the hypotheses that we'll pursue that as we're going into the clinic.
Brian DeSchuytner: And so these are some of the hypotheses that we'll pursue as we go into the clinic. And I would add, Dave, that you appropriately have identified that this is a product that could really be a pipeline in a product. There are so many different potential opportunities if we can really realize in the clinic what we saw preclinically. So it might very well be a good candidate for partnering, but it could be now or it could be in the future.
And I would say that you're appropriately appropriately type identified that this is a product that could really be a pipeline in a product theres. So many different potential opportunities. If we can really realize at the clinic, what we saw pre clinically so it might very well be a good candidate for partnering.
But it could be now it could be in the future. We can we can build value along the way as we move through dose escalation and through the early proof of concept studies.
Got it thank you.
Okay.
Brian DeSchuytner: We can build value along the way as we move it into dose escalation and through the early proof of concept study. Got it. Thank you. Thank you. And our last question is from Kaveri Pohlman with BTIG.
Thank you and our last question is from Kai very poor man with B T. I G. Please proceed.
Kaveri Pohlman: Good morning, and thank you for the update. Regarding the Uplift trial, I believe the trial was started with patient enrollment in the 43 mg per meter square dose cohort. Will those patients be included in the ITT population? And my second question is also about the Uplift study.
Good morning, and thank you for the update.
Regarding the uplift trial I believe at the trial was started with patient enrollment in the 43 makes a meter square dose cohort.
Those patients are included in the ITT population.
And my second question is also regarding the uplift study if you could talk about the pneumonitis protocol you have implemented to mitigate the adverse events.
Arvind Yang: If you could talk about the pneumonitis protocol you have implemented to mitigate the adverse events. Thanks for taking my question. Okay, let me start with the first question.
Thanks for taking my question.
Arvind Yang: And just to clarify, we initially started with a 43 mg per meter squared dose regimen, and then based upon the 200 patients of evaluation and so forth, we had shifted to 36 mg per meter squared, what we consider to be the optimal dose regimen to move forward. Thus, the 36-dose cohort will be used as the efficacy population. Now, obviously, the totality of data will always be utilized in order to characterize the safety profile.
Okay, Let me start with the first question and just to clarify.
We had initially started with a 43 makes per meter squared dose regimen and then based upon the 200 patients self evaluation in stuff like we had shifted to the 36 <unk> per meter squared what we consider to be the optimal dose regimen to move forward. So the 36.
Dose cohort will be used as the efficacy population now obviously the totality of data will always be utilized in order to characterize the safety profile.
So I just wanted to give you context in relationship to the two different doses and how the data will be utilized.
Arvind Yang: So, I just wanted to give you context in relationship to the two different doses and how the data will be utilized. Now, shifting gears to the question you had about the pneumonitis management algorithms and so forth, I think it starts actually from the standpoint of the learnings we've had from our expansion cohorts in relationship to, A, ensuring the inclusion criteria are set up in such a way that minimizes the potential that you have patients with less pulmonary reserve or the ability to essentially, if they were to develop the rare frequencies of pneumonitis, you know, overcome it, per se, or have that runway.
Now shifting gears to the question you had about the pneumonitis management algorithms and so forth I think.
It starts actually from the standpoint of the learnings we've had from our expansion.
Horton relationship to a ensuring the inclusion criteria are set up in such a way that minimizes the potential that you have patients with.
Les pulmonary reserve or the ability to essentially if they were that developed a rare frequencies of pneumonitis.
Arvind Yang: But then the management algorithm itself is really quite standard from the standpoint of, first, identifying and educating physicians who are quite comfortable and knowledgeable about pneumonitis but, in the early days, were probably less aware that this was a potential risk.
Overcome it per se or have that runway, but then the management algorithm itself, it's really quite standard from the standpoint of first identifying so educating the physicians who are quite comfortable and knowledgeable about pneumonitis, but in the early days, we're probably less aware that this was a potential risk so identification and then ultimately.
Arvind Yang: So, identification and then ultimately management, whether that be through dose reductions, dose delays, discontinuations, or as well as additional interventions, such as steroids. I hope that addresses your question. Thank you. And with that, ladies and gentlemen, we end our Q&A. I will pass the call back to Ana Protopapas for her final remarks. Thank you, everyone, for listening. We look forward to keeping you up to date on our progress and, hopefully, starting to see more of you in person on the conference circuit in the weeks ahead. Until then, thank you for your continued support. Thank you, ladies and gentlemen, for participating in today's program. You may now disconnect. Everyone have a great day. [music]
Similarly management, whether that be through dose reductions those delays discontinuation or as well as additional intervention such as steroids.
Alright, I hope that addresses your question.
Yeah.
And with that thank.
Thank you so much and with that ladies and gentlemen, we end our Q&A I will pass the call back to on a prototype has for her final remarks.
Thank you everyone for listening we look forward to keeping you up to date on our progress and hopefully starting to see more of you in person on the conference circuit in the weeks ahead until then thank you for your continued support.
Thank you, ladies and gentlemen for participating in today's program and you may now disconnect everyone have a great day.
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