Q2 2022 ImmunoGen Inc Earnings Call
Operator: Good morning and welcome to ImmunoGen's second quarter 2022 Financial and Operating Results Conference call.
Operator: Today's conference is being recorded.
Good morning, and welcome to Immunogen second quarter 2022 financial and operating results Conference call. Today's conference is being recorded.
Operator: At this time, I'd like to turn the call over to Anabel Chan, Head of Investor Relations.
Anabel Chan: Please go ahead.
At this time I'd like to turn the call over to Andy Bell Chan head of Investor Relations. Please go ahead.
Anabel Chan: Good morning, and thank you for joining today's call.
Mark Enyedy: We feel very good about where we are in the process with the agency.
Operator: Your line is open.
Good morning, and thank you for joining today's call.
Anabel Chan: Earlier today, we issued a press release that includes a summary of our recent operating progress and second quarter 2022 financial results.
Earlier today, we issued a press release that includes a summary of our recent operating call back in second quarter 2022 financial results.
Anabel Chan: This press release and a recording of this call can be found under the investors and media section of our website at immunogen.com.
This press release and a recording of this call can be found under the investors and media section of our website at <unk> dot.
Anabel Chan: With me today are Mark Enyedy, our President and CEO, Anna Birkenblith, our Chief Medical Officer, Kristen Harrington-Smith, our Chief Commercial Officer, and Susan Altshuler, our CFO.
Dot com.
With me today are mark entity, our president and CEO and Lewis, our Chief Medical Officer, Christopher Harrington Smith, our Chief commercial officer, and Susan Altshuler, our CFO .
Anabel Chan: During today's call, we will review recent accomplishments for the business, our Q2 financial results, and highlight upcoming anticipated events.
During today's call. We will review our recent accomplishments for the business, our Q2 financial results and highlight upcoming anticipated about.
Anabel Chan: We will be making forward looking statements based on our current expectations and beliefs. These statements are subject to risks and uncertainties and our actual results may differ materially. Please consult the risks outlined in our press release issued this morning, in the risk factor section of our most recent annual report on Form 10-K, in quarterly report on Form 10-Q, and in our other SEC filings, which are available at sec.gov and immunogen.com.
We will be making forward looking statements based on our current expectations and beliefs.
These statements are subject to risks and uncertainty and our actual results may differ materially.
Please pick up the risks outlined in our press release issued decline in the risk factors section of our most recent annual report on Form 10-K, and quarterly report on Form 10-Q.
And our other SEC filings, which are available at SEC Gov.
Mark Enyedy: And with that, I'll turn the call over to Mark.
Mark Enyedy: And I think a blow-by-blow on sort of where we are in terms of individual components of the inspection wouldn't be helpful.
Kelly Shee: Congrats on all the progress and thank you for taking my questions.
Dot com.
And with that I'll turn the call over to Mark.
Good morning, and thank you for joining us today. This past quarter, we made significant progress across the business and importantly, FDA accepted the BLA for Merck with a priority review designation and further producer date of November 28.
Mark Enyedy: Good morning, and thank you for joining us today.
Mark Enyedy: But what I'd say is we're tracking, you know, as we would hope given the, you know, the time frame knowledge, of the PDUCA.
Anna Birkenblith: The first question is for Anna.
Mark Enyedy: This past quarter, we made significant progress across the business, and importantly, FDA accepted the BLA for MIRV with a priority review designation and set a PDUFA date of November 28th.
Mark Enyedy: Okay, perfect.
Our ongoing interactions with FDA have been productive and in conjunction with our mid cycle review, we were advised that the agency had no plans for an advisory committee at this time.
Mark Enyedy: Our ongoing interactions with FDA have been productive, and in conjunction with our mid-cycle review, we were advised that the agency had no plans for an advisory committee at this time.
Michael Schmidt: And then on IMGN 632 where, you know, we'll get data later this year as well.
As we transition into a global fully integrated oncology company. We are actively preparing for the potential launch of mirv monotherapy for patients with folate receptor Alpha positive ovarian cancer Christian who will provide an update on our watch readiness progress later in the call in terms of ongoing development. We're pleased to report that our confirmatory phase III mirror.
Mark Enyedy: As we transition into a global, fully integrated oncology company, we are actively preparing for the potential launch of MIRV monotherapy for patients with folate receptor alpha positive ovarian cancer.
I saw trial is now fully enrolled and we expect to share top line results from this study in early 2023, we're also advancing our efforts to move merv into broader patient populations to that end, we are expanding our development program and are in the process of initiating the glorious and trial for <unk> studies moving to our second pivotal program.
Feedback we are pursuing a cohort in <unk> AML and anticipate reporting important data in both of these indications later this year and it will cover both the mirv and feedback programs in more detail.
Lastly, with the progress in our pivotal programs, we are reinvesting in our research capabilities and deepening our earlier stage pipeline as exemplified by our recent research collaboration with Oxford Biotherapeutics to develop novel Adcs, We look forward to deploying a proprietary linker payload technology against the targets identified by OTT.
To address cancers of high unmet need so it was an exciting first half of the year in a number of important milestones ahead. We believe we are well positioned to create meaningful value for our patients and our shareholders in both the short and long term with that I'll turn the call over to Anna to provide additional color on our clinical programs Anna.
Michael Schmidt: You know, just maybe could you help us frame the commercial opportunity in terms of the, you know, the market potential for this drug?
Kelly Shee: So, recently VBL's Phase 3, trial showed a 5.3 months of medium CFS for palytexel arm in PROC settings.
Anna Birkenblith: I'm just curious of thoughts on this.
Anna Birkenblith: Is it viewed as outperformed the control arm?
Thanks Mark.
We were excited to prevent additional efficacy data from the pivotal study and an integrated safety summary of single agent <unk> across multiple studies.
Anna Birkenblith: And should we expect a worse outcome for palytexel in FR or for high patients?
Is there any update included tumor reduction and over 70% of patients and a disease control rate of over 50%.
Appreciated population.
But luminary median overall survival was 13 eight months and the Kaplan Meier curve for PFS shows a long tail consistent with a significant portion of patients having prolonged benefit from Merck.
The retrospective analysis.
Forward, one and our phase one study demonstrated a remarkably consistent tolerability profile with differentiated safety, consisting primarily of low grade reversible gastrointestinal and ocular events.
Treatment options remain limited for patients with platinum resistant ovarian cancer.
For those who have received prior bevacizumab and are associated with lower clock rate short durations of response and considerable toxicity.
Against this background of high unmet need we believe the benefit demonstrated in theory further support our potential to become a new standard of care in this population.
As Mark mentioned, we have fully enrolled our confirmatory Mirasol study and anticipate top line data early next year.
Also advance patient enrollment in our single arm study of <unk> monotherapy in recurrent platinum sensitive ovarian cancer patients with high expression of folate receptor alpha intended to support label expansion.
As we look to position <unk> as the combination agent of choice in ovarian cancer and expanded reach we are in the process of initiating our phase three glorioso study, which will evaluate the benefit of mirv, plus bevacizumab maintenance versus bevacizumab maintenance alone in the second line platinum sensitive setting.
S trial for 'twenty, which is intended to inform a potential path to registration in recurrent platinum sensitive ovarian cancer.
Cloud for 'twenty is a single arm phase II study of <unk> plus.
Carboplatin, followed by Europe continuation in approximately 110 platinum sensitive ovarian cancer patients with low medium or high expression of folate receptor alpha.
Looking ahead, we're excited to present additional data from our <unk> program at ESMO and Gcs.
We also anticipate preliminary efficacy data from our pivotal cadenza study conducted in frontline bpd CN by the end of this year.
In addition, patient enrollment is advancing in our expansion cohort of the phase <unk> study evaluating <unk> <unk> and another.
In relapsed and frontline AML patients and we expect to share initial data from this study at Ash in December .
Regarding our earlier stage pipeline, we anticipate sharing initial data before year end.
Phase one dose escalation trial of <unk> 936, our first in class Adam <unk> targeting ADC in co development with Macrogenics.
We also made meaningful progress addressing with CMC information requests from FDA regarding our phase one study of IMG and 151 in multiple solid tumor types and expect to enroll our first patient with.
Mark Enyedy: Kristen will provide an update on our launch readiness progress later in the call.
Michael Schmidt: I know the, you know, sales figures in the market are a bit out of date, but I'm just wondering how you think about the, you know, the market size in terms of dollars in BPD-CN initially.
Anna Birkenblith: Thanks, Kelly.
Now I'll turn the call over to Christian to touch on our commercial preparations Kristen.
Mark Enyedy: Yeah.
Mark Enyedy: So, I think a little bit early to talk about, you know, kind of price.
Anna Birkenblith: So, the study that you're referring to added O4VF to palytexel and compared it to palytexel alone in, platinum-resistant ovarian cancer.
Mark Enyedy: In terms of ongoing development, we're pleased to report that our confirmatory Phase 3 Mirasol trial is now fully enrolled, and we expect to share top-line results from this study in early 2023.
Mark Enyedy: And so, this is a, you know, a rare indication, right?
Anna Birkenblith: And both arms had a median progression pre-survival, as you mentioned, of about 5.3 months.
Thanks, Anna we were pleased with the Fda's acceptance of our BLA with priority review and in anticipation of a potential approval. Later this year, we are advancing the build out of our medical and commercial infrastructure.
Anna Birkenblith: You know, this is really disappointing for patients that this is not going to advance the field.
Anna Birkenblith: But to your question around the 5.3 months there, you know, we really look forward to seeing the demographics of the patients enrolled because the eligibility criteria in their study is a bit different. They allowed patients with what was probably a pretty platinum-sensitive disease in the sense that they allowed patients with up to five prior lines of therapy.
Anna Birkenblith: However, they excluded patients with three prior lines of therapy for platinum-resistant ovarian cancer. They also allowed patients with or without prior anti-angiogenic therapy.
Anna Birkenblith: And so, you know, until we see the demographics, it's hard for me to put their PFS data into context except to say that we know that prior therapies matter. You know, also don't know how many of them had a prior taxa in one or two lines.
Anna Birkenblith: And so, you know, certainly there are other studies where the PFS has been in that range for palytexel.
Anna Birkenblith: And you may recall that in our exploratory PS2 plus analysis, the control arm had a median PFS of 3.2 months, and the mervituximab arm was 5.2.
Anna Birkenblith: But what I would point you to is we've already demonstrated an improvement in progression-free survival and even overall survival, you know, from a subset analysis perspective from Forward 1, even in our 10x FR-alpha-high subset that, as we know, is not as selective as the PS2 plus subset.
Anna Birkenblith: And so, we've already, demonstrated a benefit for mervituximab over paclitaxel in FR-alpha-high patients, and I anticipate that we will do the same in mirosol. And to your point, it may be that patients with high FR-alpha expression do have a worse prognosis.
Mark Enyedy: And even the epi data are a little bit thin.
Kelly Shee: I have a follow-up.
To that end, we are focused on four key imperative to ensure a successful launch. These are with the compelling data from survey redefining expectations for positive outcome with Merck in platinum resistant ovarian cancer.
Mark Enyedy: So, our best estimates are there are somewhere between 500 and, 1,000 newly diagnosed patients here in the U.S. and a similar size market in Europe at this point.
Kelly Shee: In terms of launch prep, you previously mentioned targeting 4,600 physicians initially.
Mark Enyedy: So, you know, rare disease, you know, one would expect consistent with that, you know, pricing, you know, in the range of what, you know, what one sees for rare oncology products.
Mark Enyedy: So, you know, I think if there's an effort to model this, I think those are the kind of benchmarks that I, would look at.
Mark Enyedy: We are also advancing our efforts to move MIRV into broader patient populations.
Mark Enyedy: To that end, we are expanding our development program and are in the process of initiating the Gloriosa and Trial 420 studies.
Mark Enyedy: Moving to our second pivotal program, PVEC, we are pursuing cohorts in BPDCN and AML, and anticipate reporting important data in both of these indications later this year.
<unk> adoption of early folate receptor alpha testing and establishing standards for in house and centralized testing upon approval.
Mark Enyedy: So, you know, again, rare indication.
Kristen Harrington-Smith: Do you focus on academic centers and community settings equally, or do you have a preference, initially?
<unk> broad payer access and reimbursement to deliver a seamless patient experience and finally, ensuring positive physician and patient experiences through tailored of vacation and guidance for patient management.
Mark Enyedy: I think the thing to focus on with this drug, though, is both the development strategy and the upside opportunity here, right?
Mark Enyedy: So, what we've chosen to do is take a speed to market approach with BPD-CN focusing on the rare indication and align with FDA on this 20 patient study and frontline patients to try and get this drug approved in the near term.
Mark Enyedy: And then look at, you know, expanded indications to reach the full potential of the drug.
Kelly Shee: Thanks.
Importantly, as our educational efforts progress around awareness of folate receptor alpha and the adoption of early fr Alpha testing receive physician enthusiasm and support continued to grow in anticipation of potential approval later this year.
Mark Enyedy: And the lead there is, of course, AML.
Kristen Harrington-Smith: Sure.
Mark Enyedy: We have moved forward with expansion cohorts with the triplet in combination with imidaclax and azacitidine.
Kristen Harrington-Smith: So, we will absolutely focus on both academic and the community setting equally.
Mark Enyedy: We'll have data at ASH from the expansion cohorts, fully the relapsed patients and, you know, what we can gather from the frontline cohort.
Kristen Harrington-Smith: When we look at our customer base and where the business will come from, there is a very, concentrated call point, particularly among the higher utilization, the folks who utilize chemotherapy or single-agent chemotherapy the most.
Kristen Harrington-Smith: So, when we look at – there are 400 physicians that account for 33% of the market, and they, are equally split between academic and community.
Mark Enyedy: So, we're excited about the opportunity. You know, I think thinking about it, not dissimilar to what we talked about, which is smaller indication and then, you know, with an accelerated approval or a faster market strategy and then significant upside from label expansion.
Kristen Harrington-Smith: So, the customer model, if you will, that we've designed has folks who are dedicated, to the academic setting and folks who are dedicated to the community setting so that we can address both with a very tailored approach.
Our partner Roche tissue diagnostics is planning for the potential approval and commercialization of companion diagnostic that will be used to test patients for folate receptor alpha expression at the time of launch.
Mark Enyedy: So, that's how we're approaching this molecule.
Mark Enyedy: Anna will cover both the MIRV and PVEC programs in more detail.
Michael Schmidt: Great.
Mark Enyedy: Lastly, with the progress in our pivotal programs, we are reinvesting in our research capabilities and deepening our earlier stage pipeline, as exemplified by our recent research collaboration with Oxford Biotherapeutics to develop novel ADCs. We look forward to deploying our proprietary linker payload technology against the targets identified by OVT to address cancers of high unmet need.
Michael Schmidt: Thank you.
As a reminder, this diagnostic is an IAC test run on those Ventana benchmark Ultra system, which has a large installed base that includes the majority of our targeted institutions labs.
Operator: Our next question comes from Etzer Darout with BMO Capital Markets.
Operator: Your line is open.
At launch we expect two to four central labs will be ready to accept patient samples per day, one testing readiness.
Post launch institutions will have the ability to bring testing in house, if they so choose.
To minimize access barriers, we plan to offer sponsored testing program that will cover 100% of the cost cap.
For patients.
Etzer Darout: Great.
Kristen Harrington-Smith: And while we do see the academic setting being the first to adopt MIRV because they already, have hands-on experience from our clinical trial, what we also know in speaking to folks in the community, they are equally as eager to have an option for these patients that are really, you know, as they say, their backs are against the wall and they have nothing to give them.
As we prepare for more to come to market.
This remains a key priority.
Etzer Darout: Thanks for taking the question.
To provide a range of services aimed at delivering a positive and seamless patient experience our market access team is engaging with payers and working to finalize the build of our patient hub.
Etzer Darout: First one for me, just if you can speak to the nature of the presentations for Mervituximab, ESMO, and IGCS, and maybe what new data we could get at the meetings.
Anna Birkenblith: Sure, Etzer.
Mark Enyedy: So, with an exciting first half of the year and a number of important milestones ahead, we believe we are well-positioned to create meaningful value for our patients and our shareholders in both the short and long term.
Anna Birkenblith: So ESMO is early September in Paris.
Kristen Harrington-Smith: So, they are equally eager to have MIRV or Tuxenab available.
We look forward to keeping you up to date on our commercial preparations as we get closer to launch with that I will turn the call over to Susan to cover our financials Susan.
Anna Birkenblith: The abstracts will be released September 5th.
Kelly Shee: Great.
Mark Enyedy: With that, I'll turn the call over to Anna to provide additional color on our clinical programs.
Anna Birkenblith: And we'll have a couple of clinical pharmacology abstracts, so physicians understand really, you know, the ClinPharm profile of our drugs.
Anna Birkenblith: Anna?
Anna Birkenblith: And we're also going to have an abstract data presented from our patient-reported outcomes data from Forward One. The data that we collected in Forward One for patient-reported outcomes show an improved quality of life with regard to disease-related symptoms for Mervituximab over chemotherapy, the magnitude of which looks like BevChemo over chemo.
Anna Birkenblith: Thanks, Mark.
Anna Birkenblith: And so those data are really important to understand the potential benefits to patients in terms of their quality of life.
Operator: Thank you.
Anna Birkenblith: And we use those data to inform the collection of quality of life data in the Mirafall study that has completed enrollment and is, you know, on track for data early next year.
Anna Birkenblith: At ASCO, we were excited to present additional efficacy data from the, pivotal SREA study and an integrated safety summary of single-agent MERS across multiple studies. The SREA update included tumor reduction in over 70% of patients and a disease control rate of over 50% in a heavily pretreated population.
Anna Birkenblith: At IGCS, which is at the end of September and early October in New York City, we're going to have long-term data from our combinations of Merv plus Bev and Merv plus carboplatin. And we'll share additional information from this array of studies.
Thank you Kristen for the second quarter of 2022, we generated $14 $2 million in revenue $7 1 million of which came from noncash royalty revenues and the remainder coming from substantially from license and milestone fees, which include recognition of $6 9 million of fees previously received under the company's.
Anna Birkenblith: Preliminary median overall survival was 13.8 months, and the Kaplan-Meier curve, or PFS, shows a long tail consistent with a significant portion of patients having prolonged benefits of MERS.
Anna Birkenblith: Great.
Etzer Darout: Thank you.
Collaboration agreement with water and medicine.
Operating expenses were $75 2 million comprised of 51 4 million of research and development expenses and $23 $8 million of selling general and administrative expenses. We ended the second quarter with $373 9 million.
Etzer Darout: And, you know, the enrollment update, I think, is an important milestone.
Operator: Our next question comes from Swayam Pakula Ramakanth with HC Wainwright.
Cash on the balance sheet.
Our financial guidance for 2022 remains unchanged and we continue to expect revenues to be between 75 and $85 million.
Anna Birkenblith: And I guess for Mirasol, that is.
Operating expenses between 285 and $295 million in cash and cash equivalents at year end between $245 million to $255 million.
Anna Birkenblith: And I guess, you know, I assume because we are only a few months away from the Mirasol data readout, at least the top line, that I'd assume that there's no plans for another interim look at Mirasol.
Anna Birkenblith: Is that correct?
Given the range of the timing of the potential approval of the revenue guidance does not reflect product sales operating.
Anna Birkenblith: That's correct.
Anna Birkenblith: Great.
<unk> expenses are expected to increase in the second half of the year as we continue to ramp up launch readiness activities generate additional supply of Merck and further advance our pipeline.
Operator: Thank you.
We expect that our current cash combined with anticipated product and collaboration revenues will fund operations into 2024 with that we'll open the call for questions.
Anna Birkenblith: The retrospective pooled analysis of SREA, Forward I, and our Phase I study demonstrated a remarkably consistent tolerability profile, with differentiated safety consisting primarily of low-grade reversible gastrointestinal and ocular events.
Operator: Our next question comes from Boris Peeker with Cohen.
Anna Birkenblith: Treatment options remain limited for patients with platinum-resistant ovarian cancer, particularly for those who have received prior Bevacizumab and are associated with low response rates, short durations of response, and considerable toxicity.
Anna Birkenblith: Against this background of high unmet needs, we believe the benefit demonstrated in SREA further supports MERS potential to become a new standard of care in this population.
Anna Birkenblith: As Mark mentioned, we have fully enrolled our confirmatory mirafol study and anticipate top-line data early next year.
Anna Birkenblith: We also advanced patient enrollment in PICOLO, our single-arm study of MERS monotherapy in recurrent platinum-sensitive ovarian cancer patients with high expression of folate receptor alpha, intended to support label expansion.
As a reminder to ask a question. Please press star one one.
Okay.
Anna Birkenblith: As we look to position MIRV as the combination agent of choice in ovarian cancer and expand its reach, we are in the process of initiating our Phase III gloriota study, which will evaluate the benefit of MIRV plus Bevacizumab maintenance versus Bevacizumab maintenance alone in the second-line platinum-sensitive setting, and Trial 420, which is intended to inform a potential path to registration in recurrent platinum-sensitive ovarian cancer.
Yes.
Our first question comes from John Newman with Canaccord Genuity. Your line is open.
Anna Birkenblith: Trial 420 is a single-arm Phase II study of MIRV plus carboplatin, followed by MIRV continuation in approximately 110 platinum-sensitive ovarian cancer patients with low, medium, or high expression of folate receptor alpha.
Boris Peaker: Your line is open.
Swayam Pakula Ramakanth: Your line is open.
Anna Birkenblith: Looking ahead, we're excited to present additional data from our MIRV program at ESMO and IGCS, both in September.
Boris Peaker: Great.
Swayam Pakula Ramakanth: Thank you.
Anna Birkenblith: We also anticipate preliminary efficacy data from our Pivotal Cadenza study of Bevacizumab in front-line, BPD-PN by the end of this year.
Boris Peaker: My first question is on the Piccolo study.
Swayam Pakula Ramakanth: This is RK from HC Wainwright.
Anna Birkenblith: In addition, patient enrollment is advancing in our expansion cohort of the Phase I-V2 study, evaluated PVAX, azacitidine, and venetoclax in relapsed and front-line AML patients, and we expect to share initial data from this study at ASH in December.
Anna Birkenblith: Regarding our earlier-stage pipeline, we anticipate sharing initial data before year-end, from the Phase I dose escalation trial of IMGC936, our first-in-class ADAM9-targeting ABC in co-development with macrogenics.
Hey, guys. Good morning, Thanks for the update and thanks for taking my question.
Anna Birkenblith: We also make meaningful progress addressing the, CMC information requests from FDA regarding our Phase I study of IMGN151 in multiple solid tumor types and expect to enroll our first patients this fall.
Swayam Pakula Ramakanth: Most of my questions have been answered, but I have just a couple of quick ones.
Kristen Harrington-Smith: So, Kristin, thinking about, you know, the launch of MIRV, you know, what sort of a commercial, structure are you planning to have, especially when, you know, you're trying to tailor your forces for both academic and to the, you know, community physicians?
Just one question to start on the <unk> study.
Just wondering if youll be able to utilize the same centers that have recently completed the enrollment in mirasol.
There will be some additional centers.
Thanks for calling us that are a bit different.
Mirasol study thanks.
Anna Birkenblith: With that, I'll turn the call over to Kristen to touch on our commercial preparations.
Anna Birkenblith: I'm curious, what do you need to see in the single-arm trial and kind of maybe more generally, are you considering further development of myrmetoxin monotherapy in platinum-sensitive patients, or kind of what is the strategic focus of this trial?
Kristen Harrington-Smith: Sure.
Thanks, John So Gloria Elsa is a randomized phase III study.
We're in the process of initiating right now and look forward to enrolling patients later this year are looking.
Kristen Harrington-Smith: Kristen?
Looking at <unk>, plus bevacizumab maintenance in the recurrent platinum sensitive setting versus bevacizumab alone and we already have wonderful relationships with well over 100 sites.
Kristen Harrington-Smith: Thanks, Anna.
Kristen Harrington-Smith: So, our commercial model will comprise of 45 field associates.
Kristen Harrington-Smith: We have 15, what we call strategic account managers, and they are provider account managers.
Kristen Harrington-Smith: We were pleased with FDA's acceptance of our BLA with priority review, and in anticipation, of a potential approval later this year, we are advancing the build-out of our medical and commercial infrastructure. To that end, we are focused on four key imperatives to ensure a successful launch.
Actually over 200 sites from the Mirasol study throughout the U S Europe as well as some countries in Asia Pacific and so we certainly are going to invite them in already has engaged a bunch of sites to get up and running.
And then we will of course branch out into additional areas. So that new countries new sites, new investigators can have the opportunity to participate in <unk> clinical trials, including Gloria.
Kristen Harrington-Smith: They will cover those top tier institutions, the academic settings that are a little harder, to navigate, but yet at the same time do have MIRV or Tuxenab experience.
Kristen Harrington-Smith: Then we have 30 field associates, oncology field specialists, who will focus on the community, practices and be responsible for driving demand there.
Kristen Harrington-Smith: They're a little easier to navigate, but at the same time equally as important when it, comes to where chemotherapy is used, and that is really what MIRV or Tuxenab will be replacing upon launch.
And then if I can.
Kristen Harrington-Smith: These are, with the compelling data from Psoriasis, redefining expectations for positive, outcomes with MIRV and platinum-resistant ovarian cancer, supporting adoption of early folate receptor alpha testing, and establishing standards for in-house and centralized testing upon approval, seeking broad payer access and reimbursement to deliver a seamless patient experience, and finally, ensuring positive physician and patient experiences through tailored education and guidance for patient management.
Can I ask one additional question.
Kristen Harrington-Smith: Importantly, as our educational efforts progress around awareness of folate receptor alpha, and the adoption of early FR alpha testing, we see physician enthusiasm and support continue to grow in anticipation of potential approval later this year.
You spoke about.
The initial plan for the diagnostic testing for folate receptor alpha.
Any expectation in terms of how long after launch individual centers might start to explore.
Bringing the test in house or is your plan simply too.
Accommodate whatever.
Path they choose.
Kind of how that shakes out.
Kristen Harrington-Smith: Our partner, Roche Tissue Diagnostics, is planning for the potential approval and commercialization, of the companion diagnostic that will be used to test patients for folate receptor alpha expression at the time of MIRV's launch. As a reminder, this diagnostic is an IHC test run on Roche Santana's Benchmark Ultra system, which has a large installed base that includes the majority of our target institution's labs.
Kristen Harrington-Smith: Thank you for that.
Sure. So thanks for that question and what we have heard based on speaking to our customer base.
Swayam Pakula Ramakanth: And then, Anna, regarding PVAC.
The larger institutions that have lapped on site. They are very eager to start testing in house of course that the time. It takes for them to get trained and can start that process, we'll have central labs.
Kristen Harrington-Smith: At launch, we expect two to four central labs will be ready to accept patient samples, for day one testing readiness.
Immediately upon approval.
Kristen Harrington-Smith: Post-launch, institutions will have the ability to bring testing in-house if they so choose.
It doesn't become a barrier in any way in that.
Our customer base can utilize central labs may bring it in house.
We do hear that many of them want to have that capability.
Kristen Harrington-Smith: To minimize access barriers, we plan to offer a sponsored testing program that will cover, 100% of the cost of the test for patients.
Swayam Pakula Ramakanth: So, with your data from Cadenza coming out in the fourth quarter, what are the plans, in terms of filing, I mean, timeline for filing that application with the FDA?
Okay, great. Thank you.
Our next question comes from Michael Schmidt with Guggenheim Partners. Your line is open.
Kristen Harrington-Smith: As we prepare for MIRV to come to market, access remains a key priority.
Anna Birkenblith: Yeah, so we haven't disclosed at a granular level what our timeline is for the BLA there, RK.
Kristen Harrington-Smith: To provide a range of services aimed at delivering a positive and seamless patient experience, our market access team is engaging with payers and working to finalize the build of our patient hub.
Kristen Harrington-Smith: We look forward to keeping you up to date on our commercial preparations as we get closer, to launch.
Kristen Harrington-Smith: With that, I will turn the call over to Susan to cover our financials.
Hey, guys. Thanks for taking my questions.
Yes, Mark great to hear sounds like you had some some confirmation from the FDA that there won't be a panel.
<unk>.
Could you just share.
Anything else around the BLA review process I guess how are you.
We're tracking with.
With respect to CMC facility inspections et.
Et cetera.
Susan Altshuler: Susan?
Anna Birkenblith: Certainly, CRC is the primary endpoint and duration of a complete response is also an, important endpoint.
Anna Birkenblith: So, taking that into consideration, you know, once we're, once we've locked into a BLA timeline, and can provide guidance, we certainly will share that.
Thanks, Michael So tracking as expected given were inside four months from the date at this point.
Susan Altshuler: Thank you, Kristen.
Swayam Pakula Ramakanth: Thank you.
Susan Altshuler: For the second quarter of 2022, we generated $14.2 million in revenue, $7.1 million of, which came from non-cash royalty revenues, and the remainder coming substantially from license and milestone fees, which include recognition of $6.9 million of fees previously received under the company's collaboration agreement with Hwadam Medicine.
Susan Altshuler: Operating expenses were $75.2 million, comprised of $51.4 million of research and development, expenses, and $23.8 million of selling, general, and administrative expenses.
Susan Altshuler: We ended the second quarter with $373.9 million in cash on hand. Our financial guidance for 2022 remains unchanged, and we continue to expect revenues to be between, $75 and $85 million, operating expenses between $285 and $295 million, and cash and cash equivalents at year-end between $245 and $255 million.
Susan Altshuler: Given the range and timing of the potential approval of MERV, revenue guidance does not, reflect product sales. Operating expenses are expected to increase in the second half of the year as we continue, to ramp up launch readiness activities, generate additional supply of MERV, and further advance the pipeline.
Susan Altshuler: We expect that our current cash, combined with anticipated product and collaboration, revenues, will fund operations into 2024.
Constructive dialogue.
Operator: With that, we'll open the call for questions.
Swayam Pakula Ramakanth: Thanks for taking the questions.
Operator: As a reminder, to ask a question, please press star 11.
The mid cycle review and importantly.
Advice from the agency that they've got no plans for an advisory committee at this time inspections proceeding as one would expect.
Operator: Our next question comes from Jonathan Chang with SVB Securities.
Operator: Our first question comes from John Newman with Canaccord Genuity.
Operator: Your line is open.
At this point in time, we feel very.
Jonathan Chang: Hi, guys.
Jonathan Chang: Thanks for taking my questions.
Hey, good about where we are.
Jonathan Chang: First question, just for clarity, for Mirasol, are you still expecting to reach the requisite, number of events for primary analysis in the fourth quarter?
The process.
The agencies I think jetblue.
John Newman: Your line is open.
Sort of where we are in.
Digital components.
John Newman: Hi, guys.
Perhaps it would be helpful, but what I'd say is we're tracking as we wanted to Copenhagen.
John Newman: Good morning.
John Newman: Thanks for the update, and thanks for taking my question.
Relative to to do so.
Okay, perfect and then.
On <unk> six three to where we'll get data later this year as well.
John Newman: Just had one question to start.
John Newman: On the Gloriosa study, I'm just wondering if you'll be able to utilize the same centers, that have recently completed the enrollment in Mirosol, or if there will be some additional centers that you're using for Gloriosa that are a bit different than the Mirosol study.
Just maybe could you help us frame the commercial opportunity in terms of the market potential for this drug.
John Newman: Thanks.
<unk>.
I know.
Sales figures in the market are a bit at scale, but just wondering how you think about the market size in terms of dollars in PPD CN initially.
Anna Birkenblith: Thanks, John.
Anna Birkenblith: So, Gloriosa is our randomized phase three study that we're in the process of initiating, right now and look forward to enrolling patients later this year. We're looking at Mervitoximab plus Bevacizumab maintenance in the recurrent platinum-sensitive, setting versus Bevacizumab alone.
Yes sure.
Anna Birkenblith: We already have wonderful relationships with well over 100 sites, actually over 200 sites, from the Mirosol study throughout the U.S., Europe, as well as some countries in Asia, Pacific.
Let me go a little bit early to talk about kind of price and service.
Anna Birkenblith: We certainly are going to invite them and already have engaged a bunch of sites to get, up and running.
Anna Birkenblith: And then we'll, of course, branch out into additional areas so that new countries, new, sites, new investigators can have the opportunity to participate in Mervitoximab clinical trials, including Gloriosa.
This is a.
Anna Birkenblith: Okay.
On rare indication right in either in the Abbvie data are a little bit things that are our best estimates are.
John Newman: Great.
Anywhere between 500000.
We diagnosed patients here in the U S and a similar size market.
John Newman: And then, if I could ask one additional question.
In Europe at this point, so rare disease.
One would expect consistent with that pricing in the range of one.
Once these four oncology products.
The effort to model.
Those are the kind of benchmark that I would look at it. So again rare indication I think the thing to focus on this drug that we're focused development strategy in the upside opportunity here right. So what we've chosen to do is take a speed to market approach with BBVA.
John Newman: You spoke about the initial plan for the diagnostic testing for folate receptor alpha.
John Newman: Do you have any expectation in terms of how long after launch individual centers might, start to explore bringing the test in-house?
John Newman: Or is your plan simply to accommodate whatever path they choose?
John Newman: And let's see kind of how that shakes out.
Focusing on the rare indications and aligned with FDA on this 2000 patients.
Study in frontline patients to try and get this drug approved in the near term.
I look at <unk>.
Branded indications that it reached the full potential of the drug in the lead there is of course AML.
As we move forward with expansion cohorts with the triplet in combination with <unk>.
We'll have data.
Cash.
The expansion cohorts fully.
Relapsed patients.
We can gather towards the frontline cohort. So we're excited about the opportunity I think thinking about it.
Not dissimilar to what we've talked about which is a smaller indication and then.
Accelerated approval of our fast to market strategy, and then significant upside from label expansion. So that's how we're approaching this molecule.
Great. Thank you.
Kristen Harrington-Smith: Sure.
Anna Birkenblith: Yes.
Our next question comes from Edward <unk> with BMO capital markets. Your line is open.
Kristen Harrington-Smith: So, thanks for that question.
Anna Birkenblith: Got it.
Kristen Harrington-Smith: And what we have heard based on speaking to our customer base, the larger institutions, that have labs on site, they are very eager to start testing in-house.
Oh, great. Thanks for taking the question first one for me just if you can speak to the nature of the presentations for <unk>.
No.
Gcs in.
And maybe what new data.
Jonathan Chang: Thank you.
Yet.
At the meetings.
Sure.
Ethanol is early September in Paris, the abstracts will be released September 5th and we will have a couple of clinical pharmacology abstract so physicians understand really quantify and profile of our drug.
And we're also going to have.
Abstract.
Data presented from our patient reported outcome data from forward one.
The data that we collected and forward one for patient reported outcomes show and.
An improved quality of life with regard to disease related symptoms for <unk> over chemotherapy and magnitude of which looks like that the chemo over chemo and so those data are really important to understand the potential benefit to patients in terms of their quality of life and we are.
Use those data to inform the collection of quality of life data in the Mirasol study that has completed enrollment.
On track for data early next year.
Gcs, which is at the end of September and early October in New York City, we're going to have long term data from our combinations of Mirv, plus Bev, Edinburgh, plus Carboplatin and will share additional information from the <unk> study.
Great. Thank you.
The enrollment update I think is an important milestone and I guess.
For members, so that isn't I guess.
Assume because we are only a few months away from the nearest data readout at least the topline that I'd assume there's no plans for another interim look.
So is that correct.
That's correct.
Great. Thank you.
Yeah.
Kristen Harrington-Smith: And second question, just as you think about the Mervituximab commercialization strategy, how are you thinking about ocular toxicities as potential barriers to commercial uptake?
Kristen Harrington-Smith: Sure.
Our next question comes from Boris <unk> with Cowen Your line is open.
Great. My first question is on the Piccolo study.
I'm curious what do you need to see in the single arm trial and kind of maybe more generally are you considering further development murmured talks about mono therapy in platinum sensitive patients or kind of what are the strategic point.
Anna Birkenblith: So, the Piccolo study is Merv monotherapy in F-alpha high patients with later-line platinum-sensitive disease.
Kristen Harrington-Smith: So, I can start, and Anna, chime in if you want.
Kristen Harrington-Smith: But our goal with the commercial launch is to establish Mervituximab as the standard, of care for platinum-resistant ovarian cancer patients with F or alpha high expression.
Focus of this trial.
Kristen Harrington-Smith: At the same time, we are anticipating that we might need to remove any barrier that could, get in our way.
Kristen Harrington-Smith: You know, you think about market access, we have a market access team that is removing, any barriers around cost, out-of-pocket for patients, reimbursement challenges.
Kristen Harrington-Smith: We also have our team that is focused on making sure that we manage expectations around ocular, adverse events, and we will do this not only by having our local team work with their prescriber base to understand which ophthalmologists their patients go to, and educating both the ophthalmologists plus the physicians and infusion nurses so that they can manage expectations and manage them that the ocular AEs that we see with Mervituximab are generally low-grade and they resolve, and also when they can expect them if they do get them.
So the Piccolo study mirv monotherapy in Fr Alpha high patients later line platinum sensitive disease and this is a growing population for us where as more and more patients are getting a PARP inhibitor as maintenance either in the frontline setting or in a recurrent platinum sensitive setting.
Kristen Harrington-Smith: So we will have a full educational effort around this, and what we do hear from folks, in our trial is that once they experience them, they know what to expect, and they can best educate their patients.
Anna Birkenblith: Yeah, and I would just add that, you know, in the clinical trials as we expanded our, reach to more and more sites who were new to Mervituximab, you know, I think the clinical trial data speak to the fact that Mervituximab is really well-tolerated, and we've had less than 1% of patients discontinue for ocular adverse events, and so we're sharing those lessons learned from an education perspective with our commercial colleagues so that we can really successfully do this together.
Jonathan Chang: Got it.
Operator: Thanks for taking my questions.
Operator: There are no further questions.
Mark Enyedy: I'd like to turn the call back over to the team for closing remarks.
Mark Enyedy: Great.
Mark Enyedy: Well, thanks for joining us this morning.
Mark Enyedy: We had a very productive first half of the year, and with some key regulatory clinical milestones as well as our first product approval ahead of us in the back half of this year, we're excited about the prospects of the business and look forward to keeping you updated on our progress.
Mark Enyedy: Thanks again and have a nice weekend.
Operator: This concludes the program.
Operator: You may now disconnect.
Operator: The conference will begin shortly.
They are extending their platinum free interval and when.
Anna Birkenblith: And this is a growing population for us where, you know, as more and more patients are getting a PARP inhibitor as maintenance, either in the frontline setting or the recurrent platinum-sensitive setting, they are extending their platinum-free interval. And when they do relapse, they technically have platinum-sensitive disease with a PFI or platinum-free interval greater than six months.
When they do relax they technically have platinum sensitive disease, with a PFS or platinum free interval greater than six months.
Anna Birkenblith: And yet, it's not like in the pre-PARP days when that meant that patients had nothing in between. Their tumor has been under continuous selective pressure from a PARP inhibitor, which can breed potential crop resistance.
And yet it's not like in the pre park days when that meant that patients had nothing in between their tumor has been under control with selective pressure from our PARP inhibitor, which can breed potential crop.
Anna Birkenblith: And so, these patients with later-line platinum-sensitive disease may not be as sensitive to yet another round of platinum. And the more platinum you get, the more you're at risk for hypersensitivity reactions that can be quite significant.
So these patients with later line platinum sensitive disease may not be as sensitive to yet another round of platinum and the more platinum you get the more you are at risk for hypersensitivity reactions that can be quite significant.
Anna Birkenblith: So, in that context, we've already generated data from our phase one study showing very nice, I would call it anecdotal activity for Merv in later-line platinum-sensitive disease.
In that context, we've already generated data from our phase one study showing very nice I would call. It anecdotal activity for Merck in later line platinum sensitive disease, and so we are enrolling the single arm study to gather additional data that would then allow us to engage with FDA on what the benchmark would be.
Anna Birkenblith: And so, we are enrolling the single-arm Piccolo study to gather additional data that would then allow us to engage with FDA on what the benchmark would be in this newly emerging population.
In this newly emerging population and.
Anna Birkenblith: And I think that over the next year or so, we will see data being published. I mean, it's already beginning to come out showing that patients who've had a PARP inhibitor are no longer quite as sensitive to platinum-based therapy.
And I think that.
Over the next year or so we will see data being.
<unk> published I mean, it's already beginning to come out showing that patients who've had a PARP inhibitor are no longer quite a sensitive too.
Anna Birkenblith: And I think the emerging data will help us align with FDA on a benchmark that will support potential approval from the Piccolo study.
To platinum based therapy, and I think the data will help us align with FDA on a benchmark that will support potential approval from the Piccolo studies.
Boris Peaker: My last question on the Cadenza study, can you set some efficacy expectations of what, we should look forward to?
Got it and just my last question on the condensed. The study can you set some efficacy expectation for what you can look forward to.
Anna Birkenblith: So the Cadenza study, we aligned with FDA on a pivotal cohort of up to 20 patients, with the primary endpoint being CR-CRC, this is the same endpoint that Elzonris used and allowed them to get approval in the frontline setting.
So the CONTEMPO study, we aligned with FDA on a pivotal cohort of up to 20 patients with the primary endpoint being C. RFC RFC.
This is the same endpoint that <unk> used.
It allowed them to get approval in the frontline setting.
Anna Birkenblith: And so from a statistical perspective, we aligned with FDA that we are ruling out a, CR-CRC rate of 10%, knowing that really in this small population, we anticipate seeing response rates as good as or perhaps better than Elzonris, and with a better tolerability profile in terms of no potential fatal capillary leak syndrome, you don't need to be hospitalized for the first cycle, less hepatotoxicity, less heme toxicity.
And so from a statistical perspective, we aligned with FDA that we are ruling out.
<unk> rate of 10%.
Knowing that really in this small population, we anticipate seeing response rates as good as or perhaps better than alzheimers and with a better tolerability profile in terms of no potential.
It'll capillary leak syndrome.
Hospitalized for the first cycle.
Let the patent toxicity less heme toxicity itself.
Anna Birkenblith: And so, you know, FDA was quite encouraged with the data that we shared with them that, led to breakthrough therapy designation, and then they guided us towards the design of this frontline pivotal cohort that is currently underway.
I was quite encouraged with the data that we shared with them that led to breakthrough therapy designation and then they guided us toward the design of the frontline pivotal cohort that is currently underway.
Boris Peaker: Great.
Operator: To raise your hand during Q&A, you can dial star 1-1.
Boris Peaker: Thank you very much for taking my question.
Great. Thank you very much for taking my questions.
Yeah.
Operator: Our next question comes from Andy Shea with William Blair.
Our next question comes from Andy Shay with William Blair.
Operator: Your line is open.
Yeah.
Andy Shea: Oh, hi.
Your line is open.
Andy Shea: Can you guys hear me?
Andy Shea: Yep.
Okay.
Mark Enyedy: How are you, Andy?
Andy Shea: Oh, great, great, great.
Andy Shea: Thanks.
Hi.
Andy Shea: Thanks for taking my question, and congratulations on all the progress in the past couple months.
Can you guys hear me.
How are you Andy.
Great great great. Thanks, Thanks for taking my question and congratulations on all the.
All the progress in the past couple of months.
Andy Shea: I do have a question for Mark.
I do have a question for Mark I think you mentioned that you successfully guide.
Andy Shea: I think you mentioned that you've successfully gone through the mid-cycle review.
<unk> through the mid cycle review.
Mark Enyedy: I am curious about the FDA's resection of the broad label that you proposed.
I am curious about the fda's.
Reception of the broad label that you you proposed.
Mark Enyedy: Yeah.
Mark Enyedy: So, no label negotiations at this point, so I think the goal here is to get through the, relative inspections here on each of the core components of the application, and then move forward with a discussion on the specifics of the label.
Yes, so no label negotiations at this point so I think the goal here is to get through the relative inspections here on each of the core components of the application and then move forward with the discussion on the specifics of the label.
Mark Enyedy: Got it.
Got it got it.
Kristen Harrington-Smith: Of course, the time it takes for them to get trained and to start that process will have, central labs starting immediately upon approval so that it doesn't become a barrier in any way in that our customer base can utilize central labs while they bring it in-house.
Kristen Harrington-Smith: And one for Kristen.
And one for for Christina.
Kristen Harrington-Smith: But we do hear that many of them want to have that capability.
Andy Shea: I'm curious about the two to four central labs that would be online right after approval.
John Newman: Okay.
John Newman: Great.
I'm curious about the two to four central labs.
Operator: Thank you.
That would be online.
Right after approval.
Kristen Harrington-Smith: I'm curious, at this stage, how could you communicate that with physicians that could, potentially use MIRV in locations where there's no in-house equipment available?
I'm curious at this stage.
How could you communicate that with physicians that could potentially use merv.
In locations, where there is no in house.
Kristen Harrington-Smith: Is there any sort of detailed identity of these labs where they could just seamlessly, kind of transition into that upon approval?
Equipment available.
Is there any sort of detailed.
The entity of these labs, where they could just seamlessly you kind of transition into that upon approval.
Kristen Harrington-Smith: Yeah.
Kristen Harrington-Smith: So, we actually surveyed a broad customer base of the most commonly used labs, and that's, what helped guide us to identify.
So we actually.
Surveyed broad customer base the.
Most commonly used labs and that's what helped guide us to identify and we say two to four.
Kristen Harrington-Smith: And we say two to four.
Kristen Harrington-Smith: We think two would be sufficient, given how often they're used, but our plan is to get, a broader base so that, you know, if someone has a preferred lab, they can use them day one of approval, and that's the goal.
Two would be sufficient given how often they're used up our plan is to get a broader base.
If someone has a preferred lab they can use them day, one of approval and Thats the goal.
Kristen Harrington-Smith: Got it.
Yeah.
Got it got it.
Great and lastly.
A question for Anna regarding kind of the.
Primary platinum free interval and subsequent platinum free interval.
I believe that the forward one pattern of about 40% of the patients in that study.
The platinum free interval between zero and three is about 40%.
I think <unk>.
Primary refractory patients were excluded but about 30% or 40% also III.
III just curious about.
First for Mirasol, our primary refractory patients excluded and also.
How would you expect Scott.
The secondary or subsequent platinum free interval between zero to three months.
Won't fall.
Sure Andy So the rollout and mirror saw both had the same exclusion criteria for patients with really really bad disease. These are patients with primary platinum refractory disease.
Who.
Progressed within three months of their last dose.
Their primary their first platinum regimen.
That's a little more stringent than what we did in forward one in Poland. One we excluded patients with a primary platinum free interval with like a month.
And so I would say overall that that has a slight effect of improving the population at Tcs for Korea in Mirasol.
The percent of patients with primary platinum refractory disease is quite small.
And so what I can say is <unk>.
And Mirasol are.
The eligibility criteria are essentially identical except first array of you must have had prior bevacizumab.
We anticipate that the demographics and marathon will be quite similar to what we see right now.
Operator: Our next question comes from Michael Schmidt with Guggenheim Partners.
Andy Shea: Got it.
Our next question comes from Kelly <unk> with Jefferies. Your line is open.
Michael Schmidt: Your line is open.
Andy Shea: Great.
Congrats on all the progress.
For taking my questions. My first question is for Angela So recently, the ABL phase III trial.
Michael Schmidt: Hey, guys.
Anna Birkenblith: And lastly, a question for Anna regarding kind of the primary platinum-free, interval and subsequent platinum-free interval.
Anna Birkenblith: I believe that the forward one, about 40% of the patients in that study, the platinum-free interval between zero and three is about 40%.
Anna Birkenblith: I think psoriasis primary refractory patients were excluded, but about 30% or 40% also zero to three.
As shown.
Quantum is three miles of median PFS.
Pallet Texel on in Charles is that I'm, just curious on silicon. There is is it viewed as a outperform the control arm and that should we expect a worse outcome for paclitaxel in fr Alpha high patients.
Michael Schmidt: Thanks for taking my questions.
Anna Birkenblith: Just curious about first for Marisol, are primary refractory patients excluded?
Thanks Kelly.
The study that you're referring to added <unk> to paclitaxel and compared it to paclitaxel alone in platinum resistant ovarian cancer in both arms had a median progression free survival as you mentioned of about five three months.
Michael Schmidt: Yeah, Mark, great to hear.
Anna Birkenblith: And also, you know, how would you expect that, you know, the secondary or subsequent platinum-free interval between zero to three months, you know, will fall?
Michael Schmidt: Sounds like, you know, you had some confirmation from the FDA that there won't be a panel.
Michael Schmidt: You know, could you just share, you know, anything else, you know, around the BLA review process?
This is really disappointing for patients that this is not going to advance the field.
But to your question around.
The five three months there.
We really look forward to seeing the demographics of the patients enrolled because the eligibility criteria in their study.
It is a bit different.
They allowed patients with what was probably.
Pretty platinum sensitive disease in the sense that they allowed patients with up to five prior lines of therapy. However, they excluded patients with three prior lines of therapy for platinum resistant ovarian cancer.
So allowed patients with or without prior anti angiogenic therapy, and so until we see the demographics.
It's hard for me to put their PFS data into context, except to say that we know that.
Prior therapies matter.
Also don't know how many of them had a prior taxane one or two lines.
And so certainly there are other studies, where the PFS has has been in that range for paclitaxel, but what I would point you to is we've already demonstrated an improvement in progression free survival and even overall survival.
From a subset analysis perspective, some forward one even in our Tenex fr Alpha high subset.
As we know is not as selective as the PFS two plus subset and so we've already demonstrated a benefit for <unk> over paclitaxel in fr Alpha high patients and I anticipate that we will do the same in Mirasol and to your point it may be that patients with high fr Alpha expression.
Do you have a worse prognosis and you may recall that in our exploratory Aps two plus analysis.
The control arm had a median PFS of $3 two months and then Rituximab arm was five six months.
Great. Thanks for the color I also have a follow up in terms of the launch prep that you previously mentioned targeting.
Michael Schmidt: I guess, how are you tracking with respect to CMC, you know, facility inspections, and et cetera?
All 4600 physicians initially.
Mark Enyedy: Thanks, Michael.
Do you focus on academic centers and community setting.
<unk> all you have a preference initially.
Anna Birkenblith: Sure, Andy.
Mark Enyedy: So, tracking as expected given we're, you know, inside four months from the, PDUCA date at this point.
Anna Birkenblith: So, Soraya and Marisol both had the same exclusion criteria for patients with really, really bad, disease. These are patients with primary platinum refractory disease, who progress within three months of their last dose of their primary, their first platinum regimen.
Sure. So we will absolutely focus on both academic and the community setting equally when we look at our customer base and where the business will come from.
Mark Enyedy: So, you know, constructive dialogue in the mid-cycle review, and importantly, you know, advice from the agency that they've got no plans for an advisory committee at this time.
There is a very concentrated call point, particularly among the higher utilization.
The folks who utilize chemotherapy or single agent chemotherapy.
When we look at.
Theres 400 physicians that account for 33% of the market and they were equally split between academic and community.
The.
The customer model, if you will that we've designed.
As folks who are dedicated to the academic setting and folks who are dedicated to the community setting. So that we can address both with a very tailored approach and while we do see the academic setting being the first to adopt <unk> because they already have hands on experience from.
Our clinical trial, what we also know in speaking to folks in the community. They are equally as eager to have an option for these patients that are really.
As they say their backs are against the wall and they have nothing to give them. So they are equally eager to have <unk> available.
Great. Thank you.
Okay.
Our next question comes from swam popular Rama comp with H C. Wainwright Your line is open.
Thank you emphasis.
From hits right.
Most of my questions have been answered, but just a couple of quick ones.
So Christian thinking.
Thinking about.
The launch of Merck.
And what sort of her and our commercial structure are you planning to have.
Especially then.
Turning to Taylor.
There are forces.
For both academic and mature.
Community physicians.
Sure. So our commercial model will comprise of 45 field associates, we have 15, what we call strategic account managers and they are provider account managers. They will cover those top tier institutions. The academic settings that are a little harder to navigate but yet at the same time.
Do you have an architecture that experience then we have 30 sales associates oncology field specialists, who will focus on the community practices.
And David talked about for driving demand there there are little easier to navigate but at the same time equally as important when it comes to work chemotherapy.
And that is really what <unk> will be replacing upon launch.
Thank you for that and then.
Regarding.
Piggyback.
Sure.
Glen.
Data.
From <unk> coming.
In the fourth quarter.
What we're.
All of the plans in terms of.
Filing.
Timeline profiling filing that application.
The FDA.
Yes, so we haven't.
Disclosed at a granular level, what our timeline is for the BLA there RK.
<unk> CR CRC is the primary endpoint and duration of a complete responses also an important endpoint so taking that into consideration.
Where once we'd locked into a BLA timeline and can provide.
The guidance, we certainly will share that.
Thank you thanks for taking my questions.
Yeah.
Our next question comes from Jonathan Chang with SBB Securities. Your line is open.
Hi, guys. Thanks for taking my questions first question just for clarity for mirror. So are you still expecting to reach requisite number of events for primary analysis in the fourth quarter.
Yes.
Got it. Thank you and second question just as you think about the <unk> commercialization strategy. How are you thinking about ocular toxicities of potential barriers to commercial uptake.
Sure. So I can certainly chime in.
If you want but.
Our goal with the commercial launch is to establish <unk> as the standard of care for platinum resistant ovarian cancer patients with fr Alpha high expression.
At the same time, we are anticipating that we might need to remove any barriers that could get in our way you think about market access.
Our market access team that is removing any barriers around cost out of pocket for patients reimbursement challenges. We also have our team that is focused on making sure that we manage expectations around the ocular adverse events and.
We will do this not only by having our local team.
Work with there.
Prescriber base to understand which ophthalmologist theyre patients go to educating both the ophthalmologist plus the physicians and infusion nurses, so that they can manage expectations and manage them that the ocular aes that we see with <unk> are generally low grade.
And they resolve and also when they can expect them if they do get them.
We will have a full.
Educational effort around this.
And what we do hear from folks in our trial is that once they experience and they know what to expect and they can they can best educate their patients yes and.
And I would just add that in the clinical trials as we expanded our reach to more and more sites.
Who were new to <unk>.
I think the clinical trial data speak to the fact that we're flexible.
Flexibility is really well tolerated and we've had less than 1% of patients.
For ocular adverse events and so we're sharing those lessons learned from an education perspective with our commercial colleagues. So that we can really successfully do this together.
Okay.
Got it thanks for taking my questions.
There are no further questions I'd like to turn the call back over to the team for closing remarks.
Great well thanks for joining us. This morning, we had a very productive first half of the year with some key regulatory and clinical milestones as well as our first product approval ahead of us in the back half of this year. We're excited about the prospects of the business and look forward to keeping you updated on our progress. Thanks, again and have a nice.
Weekend.
This concludes the program you may now disconnect.
Mark Enyedy: Inspections proceeding as one would expect at this point in time.
Anna Birkenblith: That's a little more stringent than what we did in forward one. In forward one, we excluded patients with a primary platinum-free interval of like a month.
Anna Birkenblith: And so, I would say overall, that has a slight effect of improving the population at PC bit for Soraya and Marisol.
Anna Birkenblith: But, you know, the percent of patients with primary platinum refractory disease is quite small.
Anna Birkenblith: And so, you know, what I can say is Soraya and Marisol are, you know, the eligibility criteria are essentially identical, except for Soraya, you must have had, prior medicines in that.
Anna Birkenblith: And so, we anticipate that the demographics in Marisol will be quite similar to what we see in, Soraya.
Operator: Our next question comes from Kelly Shee with Jeffries.
Okay.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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Hmm.
Okay.
Okay.
Yes.
Hum.
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Yes.