Q1 2020 Earnings Call
This conference is being recorded at this time I like to turn the call over to corneal chronic senior director of corporate Communications and Investor Relations. Please go ahead.
Coordinator Yolkonik: At this time, I'd like to turn the call over to Coordinator Yolkonik.
Unknown Executive: Senior Director of Corporate Communications and Investor Relations. Please go ahead. Good morning, and thank you for joining today's call. Earlier today...
Good morning, and thank you for joining today's call.
Unknown Executive: Today, we issued a press release that included a summary of our recent progress.
Earlier today, we issued a press release. It includes a summary of our recent progress in first quarter 2020 financial result.
Unknown Executive: 1st Quarter 2020 Financial Results This press release and a web stream of this call can be found under the Investor and Media section of our website at ImmunoGen.com. With me today are Mark Enyedy,
This press release in a web stream of this call can be found under the Investor and media section of our web site at Immunogen Dotcom.
With me today are mark entity, our president and CEO, and Anna Burke and blood, our Chief Medical Officer, Steve Foster, our Chief Accounting Officer will also join us for QNX.
Unknown Executive: Mark Enyedy, our President and CEO, and Anna Berkenblit, our Chief Medical Officer.
Unknown Executive: Stay fine.
Unknown Executive: Dave Foster, our Chief Accounting Officer, will also join us for Q&A. During today's call, we will review key accomplishments for the business over the last three months, our financial results, and upcoming milestones. During the discussion, we will use forward-looking statements, and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings. And with that, I'll turn the call over to Mark.
During today's call, we will review key accomplishments for the business over the last three months, our financial results and upcoming milestones during the discussion we will use forward looking statements and our actual results may differ materially from such statements descriptions of the risks and uncertainties associated with an investment in immunogen are included in our S. T SEC filings with them.
In the called over to Mark.
Mark Joseph Enyedy: Thanks, Courtney. Good morning, everyone, and thank you for joining us today. During the first quarter, we moved forward with our registration studies for Mervituximab and advanced our portfolio of earlier stage programs while adapting to meet the evolving challenges of COVID-19. Despite the potential hurdles of operating remotely, we opened Saraya and expanded our activated sites for Mirasol during the quarter and expect to maintain the timelines for top-line results for both studies. In parallel, we are pleased to have data from our Avastin Expansion Cohort in Platinum Agnostic Ovarian Cancer selected for a virtual oral presentation at ASCO in late May, and as Anna will describe in more detail in a moment, our preclinical programs remain on track for key milestones this quarter.
Thanks, Courtney good morning, everyone and thank you for joining us today during the first quarter, we move forward with our registration studies for Mirvetuximab and advanced our portfolio of earlier stage programs, while adapting to meet the evolving challenges of covert 19.
Despite the potential hurdles of operating remotely we opened ceria and expanded our activated sites for mirasol during the quarter expect to maintain the timeline for topline results for both studies.
In parallel we are pleased to have data from our a vast and expansion cohort and platinum agnostic ovarian cancer selected for a virtual oral presentation at ASCO in late May and as animal will describe in more detail in a moment our preclinical programs remain on track for key milestones. This quarter finally building on the momentum Gen.
Mark Joseph Enyedy: Finally, building on the momentum generated at the close of 2019, we strengthened our balance sheet with an upsized and oversubscribed follow-on offering in January, which raised approximately $98 million in net proceeds. In terms of our ongoing response to the pandemic, with the benefit of early indications of COVID-19's impact here in Boston, we implemented business continuity plans in the first half of March. These plans have allowed us to operate our core functions effectively in a virtual working environment and rapidly adapt in response to new developments.
Traded at the close of 2019, we strengthened our balance sheet with an upsized and oversubscribed follow on offering in January which raised approximately $98 million and net proceeds.
In terms of our ongoing response to the pandemic with the benefit of early indications of cobot, 19th impact here in Boston, We implemented business continuity plans in the first half March. These plans have allowed us to operate our core functions effectively in a virtual working environment and rapidly adopt in response to new developments.
Focusing on our key development programs I want to share with you our experience to date on three parameters drug supply regulatory interactions and clinical trial execution.
Mark Joseph Enyedy: Focusing on our key development programs, I want to share with you our experience to date on three parameters, drug supply, regulatory interactions, and clinical trial execution. From a supply chain perspective, we entered the year with ample drug product and have more than enough inventory on hand to complete all of our ongoing Mervituximab monotherapy and combination trials, IMGN 632 expansion studies, and the upcoming Phase I trial for IMGC 936. Furthermore, our partners at ALMAC have taken precautionary measures to ensure that our currently activated sites have sufficient safety stocks of drugs to weather any potential disruptions in transport. Finally, we have no planned production runs during the first three quarters of the year, and the manufacturing slots we've reserved for the fourth quarter and beyond remain in place. From a regulatory perspective, we've received timely reviews of our submissions to FDA, EMA, and the national competent authorities covering our CTAs. With regard to clinical execution, while it's still early days, we've yet to encounter significant issues with our studies.
From a supply chain perspective, we entered the year with ample drug product and have more than enough inventory on hand complete all of our ongoing mirvetuximab monotherapy and combination trials I am G.N. Sixthree two expansion studies and the upcoming phase one trial for I Mtc 936. Furthermore, our partners that al.
Mac have taken prospective measures to ensure that are currently activated sites has sufficient safety stock of drugs to whether any potential disruptions in transport. Finally, we have no planned production runs during the first three quarters of the year and the manufacturing slots, we've reserved for the fourth quarter and beyond remain in place.
From a regulatory perspective, we've received timely reviews of our submissions the F.D.A.M.A. and the national competent authorities covering our CTO days.
With regard to clinical execution, while it's still early days, we've yet to encounter significant issues with our studies in order to mitigate risk going forward. We've incorporated recent regulatory guidance that enable studies startup and ongoing patient accrual during the pandemic, while ensuring sufficient oversight of patient safety and data integrity.
Mark Joseph Enyedy: In order to mitigate risk going forward, we've incorporated recent regulatory guidance that enables studies to start up and ongoing patient accrual during the pandemic, while ensuring sufficient oversight of patient safety and data integrity. These efforts have included innovative approaches such as remote monitoring, patient transportation services, virtual clinic visits, and digital engagement with investigative site personnel. The key area of focus for us is site activation, where we do see individual clinics experiencing staffing constraints, limited availability of PPE and testing, and other institutional adjustments such as the timing of IRB meetings. However, in the aggregate, these challenges have not resulted in a material impact on our expected timelines.
These efforts have included innovative approaches such as remote monitoring patient transportation services virtual clinic visit and digital engagement with investigative site personnel.
A key area of focus for us the site activation, where we do see individual clinics experiencing staffing constraint limited availability of P.P. and testing and other institutional adjustments such as the timing of IR be meetings in the aggregate. These challenges have not resulted in a material impact to our expected time.
In lines, we continue to monitor trial progress on a global scale and maintain close contact with RCR rose sites in IR be used to ensure enrollment activation and data collection keep pace in accordance with good clinical practice, so active in effective engagement in a complex and evolving environment.
Mark Joseph Enyedy: We continue to monitor trial progress on a global scale and maintain close contact with our CROs, sites, and IRBs to ensure enrollment, activation, and data collection keep pace in accordance with good clinical practice, so active and effective engagement in a complex and evolving environment. I'll now turn to our financials, the details of which are covered in the press release issued this morning. For the first quarter of 2020, we generated $13.3 million in revenue, nearly all of which came from non-cash royalty revenue. Operating expenses were approximately $37 million, comprised of $27.4 million in R&D expenses compared with $38.9 million for the first quarter of 2019. This $11.5 million decrease was driven by lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, partially offset by greater clinical trial costs related to advancing our Mirasol, SIREA, and IMGN 632 combination studies. G&A expenses were $8.9 million compared to $10.8 million in the first quarter of 2019, primarily due to lower personnel expenses resulting from the restructuring partially offset by higher allocation of facility-related expenses for excess In addition, we incurred an $800,000 restructuring charge during the quarter.
I'll now turn to our financials the details of which are covered in the press release issued this morning.
For the first quarter of 2020, we generated $13.3 million in revenue nearly all of which came from non cash royalty revenues operating expenses were approximately $37 million comprised of 27.4 million in R&D expenses compared with 38.9 billion for the first quarter of 29 team.
This 11.5 million dollar decrease was driven by lower expenses, resulting from the restructuring of the business at the end of the second quarter of 2019, partially offset by greater clinical trial costs related to advancing our marisol, Serbia and I am G.N. Sixthree two combination studies.
Gina expenses were 8.9 million compared to 10.8 million in the first quarter of 2019, primarily due to lower personnel expenses, resulting from the restructuring partially offset by higher allocation of facility related expenses for excess laboratory and office space. In addition, we incurred at an 800000.
Texturing charge in the quarter.
As I mentioned earlier, we strengthened our cash position with an upsized follow on offering that was completed in January which added approximately $98 million net proceeds to our balance sheet with the addition of this raise we ended the first quarter with $247.3 million in cash.
Our 2020 financial guidance remains unchanged, we continue to expect revenues to be between 60, and 65 million operating expenses to be between 165, and 170 million and our cash at the yearend to be between 170, and 175 million, we expect that our current cash.
Mark Joseph Enyedy: As I mentioned earlier, we strengthened our cash position with an upsized follow-on offering that was completed in January, which added approximately $98 million in net proceeds to our balance sheet. With the addition of this raise, we ended the first quarter with $247.3 million in cash. Our 2020 financial guidance remains unchanged. We continue to expect revenues to be between $60 and $65 million, operating expenses to be between $165 and $170 million, and our cash at year end to be between $170 and $175 million. We expect that our current cash and anticipated cash receipts from partners will fund operations into the second half of 2022. With that, I'll turn the call over to Anna to review progress with our programs in more detail. Anna?
Anticipated cash receipts from partners will fund operations into the second half of 2022 with that I'll turn the call over to entered a review progress with our programs in more details Ana.
Thanks Mark.
I'll start by reiterating that all of our clinical studies essentially remain on track in large part due to the high unmet need across our patient populations and due to our rapid pivot to a more flexible approach to clinical trial execution consistent with recent regulatory guidance.
Wherever possible, we have converted to a remote model that allows us to continue activating sites for ceria, Mirasol and our I M. GE and 632 program enrolling patients across all studies and monitoring our clinical trials.
Turning to Mirvetuximab recall that late last year, we worked closely with F.D.A. to define an accelerated pathway for approval of Mirvetuximab Vias ceria, our pivotal single arm study evaluating mirvetuximab monotherapy and approximately 110 women with platinum resistant ovarian.
Anna Berkenblit: Thanks, Mark. I'll start by reiterating that all of our clinical studies essentially remain on track, in large part due to the high unmet need across our patient populations and due to our rapid pivot to a more flexible approach to clinical trial execution, consistent with recent regulatory guidance. Wherever possible, we have converted to a remote model that allows us to continue activating sites for Soraya, Mirasol, and our IMGN 632 program, enrolling patients across all studies, and monitoring our clinical trials. Turning to Mervituximab, recall that late last year, we worked closely with FDA to define an accelerated pathway for approval of Mervituximab via SREA, our pivotal single-arm study evaluating Mervituximab monotherapy in approximately 110 women with platinum-resistant ovarian cancer whose tumors are folate receptor alpha high as measured by PS2 plus scoring and who have previously received Avastin.
In cancer, whose tumors are fully receptor alpha high as measured by P.S., two plus scoring and who have previously received a vast and.
Ray I could support accelerated approval for Mirvetuximab provided that the overall response rate and duration of response surpass those of the best available therapy at the time of regulatory action.
As a reminder, the relevant overall response rate benchmark for currently available therapy is 12%, whereas for Mirvetuximab.
70 patients who were previously enrolled in our program and would have met the key eligibility criteria for psoriasis, we have demonstrated a 31.4% response rate.
I'm pleased to share the rail opened on time in the first quarter and we remain on track expecting topline data in mid 2021, a b L. A submission in the second half of 2021 and the potential approval in 2022.
In parallel we continue to enroll patients and open additional sites in Mirasol, our confirmatory phase three study which began in December.
Anna Berkenblit: SREA could support accelerated approval for Mervituximab provided that the overall response rate and duration of response surpassed those of the best available therapy at the time of regulatory action. As a reminder, the relevant overall response rate benchmark for currently available therapy is 12 percent, whereas for Mervituximab, in 70 patients who were previously enrolled in our program and would have met the key eligibility criteria for psoriasis, we have demonstrated a 31.4 percent response rate. I'm pleased to share that Saraya opened on time in the first quarter, and we remain on track, expecting top-line data in mid-2021, a BLA submission in the second half of 2021, and a potential approval in 2022.
Recall that Mirasol will enroll approximately 430 patients with full late receptor Alpha high platinum resistant ovarian cancer, who have been treated with up to three prior regimens patients will be randomized one to one to receive mirvetuximab or an investigators choice of chemotherapy, namely Paclitaxel.
Pegylated, liposomal doxorubicin or till boutique him.
The primary endpoint is progression free survival and the secondary endpoints. Our overall response rate overall survival and patient reported outcomes.
Mirasol remains on track and we expect to report topline data for this study in the first half of Twentytwenty too.
Regarding our Mirvetuximab combination studies, we are pursuing doublets and triplets cohorts with Carboplatin and Bevacizumab in order to expand into earlier lines of treatment and provide longer duration of treatment.
We continue to follow patients enrolled in both combinations and we look forward to presenting data from both studies later this year.
At the upcoming virtual ASCO meeting on Friday may 29th Dr., Lucy Gilbert will give an oral presentation of our initial efficacy and safety data from the forward to platinum agnostic doublet evaluating mirvetuximab in combination with Bevacizumab in 60 patients.
Anna Berkenblit: In parallel, we continue to enroll patients and open additional sites in Mirasol, our confirmatory Phase III study, which began in December. Recall that Mirasol will enroll approximately 430 patients with folate receptor alpha-high, platinum-resistant ovarian cancer who have been treated with up to three prior regimens. Patients will be randomized one-to-one to receive mervitoximab or an investigator's choice of chemotherapy, namely paclitaxel, pegylated liposomal doxorubicin, or topotecum. The primary endpoint is progression-free survival, and the secondary endpoints are overall response rate, overall survival, and patient-reported outcome.
These data will build on the encouraging mirv Bev data, we previously generated in a separate platinum resistant cohort and presented at ASCO last year, where we show durable activity overall and in particular, the efficacy measures observed for the or really unmatched subset within overall response rate of 56 per se.
And and the median progression free survival of 9.9 month, which are compelling when considering outcomes reported for Bevacizumab plus chemotherapy.
We also expect to present updated data with longer follow up from the platinum sensitive triplet cohort evaluating mirvetuximab in combination with Carboplatin and Bevacizumab in the fall.
Anna Berkenblit: Mirosol remains on track, and we expect to report top-line data for this study in the first half of 2022. Regarding our mirvotoximab combination studies, we are pursuing doublet and triplet cohorts with carboplatin and bevacizumab in order to expand into earlier lines of treatment and provide longer duration of treatment. We continue to follow patients enrolled in both combinations, and we look forward to presenting data from both studies later this year.
Lastly, we are delighted to support a new investigator sponsored trial evaluating mirvetuximab in combination with carbo platinum. This is a randomized phase two trial of over 100 patients comparing mirvetuximab plus carboplatin, followed by Mirvetuximab maintenance to standard platinum based therapy, followed by.
Standard of care maintenance in recurrent platinum sensitive disease.
Looking to our early stage portfolio, we have progressed three additional programs targeting a range of tumor types in both hematological malignancies and solid tumors.
Anna Berkenblit: At the upcoming virtual ASCO meeting on Friday, May 29, Dr. Lucy Gilbert will give an oral presentation of our initial efficacy and safety data from the Forward II Platinum Agnostic Doublet evaluating Mervituximab in combination with Bevacizumab in 60 patients. These data will build on the encouraging MIRV-BEV data we previously generated in a separate platinum-resistant cohort and presented at ASCO last year, where we showed durable activity In particular, the efficacy measures observed for the Aurelia-matched subset, with an overall response rate of 56% and a median progression-free survival of 9.9 months, which are compelling when considering outcomes reported for Bevacizumab plus chemotherapy.
For I MGM 632, monotherapy, we continued patient enrollment in phase one expansion cohorts with a focus on B P. D C N and minimal residual disease positive at Mel following frontline induction therapy.
We're also advancing I am GE and 632 combination studies with visa siding with Venetoclax and that's a tripling in relapsed refractory AML patients and look forward to presenting data from each of these studies before the ended the year.
We have further progressed I, Andy enabling activities for I MGC 936, our novel, Adam nine targeting AIDC in co development with Macrogenics, we anticipate the I N D for 936 will be filed this quarter.
Finally, we are advancing I am G.N. 151, our next generation AIDC designed to more fully addressed the unmet needs of lower expressing folate receptor alpha tumor type.
151 incorporates several key design innovations, including a by parity topic antibody that recognizes two epitopes on fr alpha to enhance binding.
Anna Berkenblit: We also expect to present updated data with longer follow-up from the platinum-sensitive triplet cohort evaluating mirvotoximab in combination with carboplatin and bevacizumab in the fall. Lastly, we are delighted to support a new investigator-sponsored trial evaluating mirvotuximab in combination with carboplatin. This is a randomized phase two trial of over 100 patients comparing mirvotuximab plus carboplatin followed by mirvotuximab maintenance to standard platinum-based therapy followed by standard of care maintenance in recurrent platinum-sensitive disease.
Protease cleavable linker with enhanced stability and longer half life, and and next generation Maytansinoid, DM 21, which along with the linker provides improved bystander, killing in preclinical models I am GE on one side, one shows improved activity in low and medium fr Alpha expressing tumors.
We look forward to sharing the full preclinical data for 151 at the virtual a CR meeting in June.
With that I'll turn the call back over to Mark.
Thanks, Anna just a few closing remarks before we open the call for questions as we look to the you're ahead coven 19 is no doubt created uncertainty and instability I am however, im encouraged by the strength of our business and the determination of our people to continue moving forward to deliver more good days for patients with cancer to that end.
Anna Berkenblit: Looking to our early stage portfolio, we have progressed three additional programs targeting a range of tumor types in both hematological malignancies and solid tumors. For IMGN 632 monotherapy, we continued patient enrollment in phase one expansion cohorts with a focus on BPDCN and minimal residual disease positive AML following frontline induction therapy. We are also advancing IMGN 632 combination studies with azacitidine, with venetoclax, and as a triplet in relapsed refractory AML patients, and look forward to presenting data from each of these studies before the end of the year. Additionally, we have further progressed IND-enabling activities for IMGC 936, our novel ADAM9-targeting ADC, in co-development with Mac We anticipate that the IND for 936 will be filed this quarter.
We've implemented contingency plans in a concerted effort to manage risk and positioned the business for success in a volatile environment. Our balance sheet is strong providing us with cash runway well into 2022, and we will continue to execute on our strategic priorities. We have a number of important milestones in 2020 and I look forward to updating you on our pro.
Congrats throughout the remainder of the year would that we'll open the call for questions operator.
Thank you to ask a question you'll need to press star one on your telephone to withdraw your question touched upon key please stand by what we compared to Q1 day roster.
Our first question comes from John Newman with Canaccord. Your line is now open.
Hi, guys. Good morning, Thanks, very much for taking my questions and opportunities.
Isn't something that they're in Boston.
Anna Berkenblit: Finally, we are advancing IMGN-151, our next-generation ADC, designed to more fully address the unmet needs of lower-expressing folate receptor alpha tumor types. 151 incorporates several key design innovations, including a bi-paratopic antibody that recognizes two epitopes on FR-alpha to enhance binding, a protease cleavable linker with enhanced stability and longer half-life, and a In preclinical models, IMGN151 shows improved activity in low and medium FR-alpha-expressing tumors. We look forward to sharing the full preclinical data for 151 at the virtual AACR meeting in June. With that, I'll turn the call back over to Mark.
You first question I think your first question I've got.
I'm, sorry, I never saw it definitely sounds like you've taken some steps to ensure that those studies proceed smoothly, but just wondered if if you could talk about perhaps any flexibility that you've been able to build into the protocol for example.
Are you able to allow any flexibility resorting regarding the exact.
Listen date for an infusion.
Maybe perhaps could you take any of the C.T. scans.
Alternate centers.
And then on forward to at ASCO, just curious if.
Some of the patients that we would see data on would have previously received a vast and things.
Yeah.
Thanks, John.
Regarding Syria, and Mirasol and the flexibility that we are employing AD formats getting most of these studies fully up and running.
Mark Joseph Enyedy: Thanks, Anna. Just a few closing remarks before we open the call for questions. As we look to the year ahead, COVID-19 has no doubt created uncertainty and instability. I am, however, encouraged by the strength of our business and the determination of our people to continue moving forward to deliver more good days for patients with cancer. To that end, we've implemented contingency plans in a concerted effort to manage risk and position the business for success in a volatile environment. Our balance sheet is strong, providing us with cash runway well into 2022, and we will continue to execute on our strategic priorities. We have a number of important milestones in 2020, and I look forward to updating you on our progress throughout the remainder of the year. With that, we'll open the call to questions. Operator?
We have taken measures as we can consistent with the regulatory guidance is that had been put out both here and across the pond.
Specifically on things that we have started to implement include where possible, allowing patients to consent.
No lease for the initial a pre screening for full late receptor Alpha you may recall on patients need to have their tumor tissue sent for fr Alpha.
And so they don't need didn't necessarily come into the sites to have the conversation and find the paper work pretty important.
Can be done remotely.
You know along with the site.
Policies and procedures in the <unk>. So I think that's a step that will allow us to keep up the momentum.
We have always had some flexibility.
Regarding the windows for dosing date.
Yes.
It really to allow for things like holidays or.
A scheduling shift by a few days.
More than that we have not.
The protocol.
We really do need to me data integrity of the trial that being said you know if protocol deviations at her they will be documented appropriately certainly for C.T. scans. They could be done at other local more easily accessible and lower risk site.
Operator: Thank you. To ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from John Newman with Canaccord.
So those are the things that we are building in and we're monitoring closely for that.
John Lawrence Newman: Your line is now open. Hey, guys. Good morning. Thanks very much for taking my question, and I hope everybody is safe and sound up there in Boston. Thank you.
Pivoting toward your second question regarding forward too and the data to be expected it asks though.
This is a.
Cohort at 60, new patients all of whom are receiving mirvetuximab and bevacizumab.
Unknown Executive: First question I've got, on Seria and Mirasol. It definitely sounds like you've taken some steps to ensure that those studies proceed smoothly, but just wondered if you could talk about perhaps any flexibility that you've been able to build into the protocol. For example, are you able to allow any flexibility regarding the exact dosing date for an infusion? Maybe, perhaps, could you take any of the CT scans at alternate centers? And then on Forward 2 at ASCO? I was just curious if... Some of the patients that we would see data on would have previously received Avastin. Thank you.
Certainly some of them have received prior bevacizumab, but that was not a requirement for enrollment side.
Cohort.
Okay, great. Thank you.
Thank you.
Next question comes on Debjit Chet up at the high with H.C. Wainwright. Your line is now open.
Hi, Good morning, everyone is healthy.
Before we put in for did you can you hear me.
Yes, if you could speak up just a little bit your voice is a little thing.
Got it can you hear me know perfect.
Okay. So couple of questions on off but.
As you explore the opportunity in platinum ignores the cohorts you observed in any market changes and folate receptor alpha expression compared to later line patients.
Anna Berkenblit: Anna?
Anna Berkenblit: Thanks, John. Regarding SREA and Mirasol and the flexibility that we are employing as we're getting both of these studies fully up and running, we have taken measures as we can, consistent with the regulatory guidance that has been put out both here and across the pond. Specifically, things that we have started to implement include, where possible, allowing patients to consent remotely for the initial prescreening for folate receptor alpha. You may recall patients need to have their tumor tissue sent for FR alpha, and so they don't necessarily need to come into the site to have the conversation and sign the paperwork for the informed consent format. It can be done remotely, along with the site policies and procedures in the IRBs.
Basically the ones that part.
Teksid altered expression.
And the second question, though we have.
Will you continue to use the Pos to assay or would you consider in each school for the new program. Thank you.
Yeah. So I'll give this a shot and then if you have any additional color. Please jump in so.
The level of folate receptor alpha expression has been markedly uniform over lines of therapy or irrespective of prior treatment. So what we have seen we now have screen well over 2000 samples in the in the program.
Is that about 40% of ovarian cancer patients Express folate receptor alpha at high levels measured by the P.S., two plus I say, another 20% of medium levels, another 20% at low levels.
Anna Berkenblit: So, I think that's a step that will allow us to keep up the momentum. We have always had some flexibility regarding the windows for dosing dates and PT scans to allow for things like holidays or, you know, a scheduling shift by a few days. More than that, we have not built it into the protocol. We really do need to maintain the data integrity of the trial. That being said, you know, if protocol deviations occur, they will be documented appropriately. Certainly, for CT scans, they could be done at other local, more easily accessible, and lower risk sites. So those are the things that we are building in, and we're monitoring closely for that. Pivoting toward your second question regarding Forward 2 and the data to be expected at ASCO, this is a cohort of 60 new patients, all of whom are receiving mervituximab and bevacizumab. Certainly, some of them have received prior bevacizumab, but that was not a requirement for enrollment in this platinum agnostic cohort.
And then the remaining 20% with negligible levels of expression and as I say that is true whether you're talking about earlier line pace in late line patients.
It doesn't vary a in terms of prior therapy. So a very consistent a across the board a and for purposes of the screening for the program on a go forward basis, we will be using the P.S. two plus a scoring method to identify patients.
So if I may add a little color. So the the tumor tissue for our trials is based on archival tissue.
And so additional data that we have showing the stability of folate receptor alpha overtime and lines of therapy come from.
Other groups it had reported retrospective data as well as our biopsy cohort that showed a greater than 70% concordance between archival tissue and fresh biopsies. So we do believe fr Alpha expression is a stable overtime.
Regarding the PS two plus methodology versus the H. score.
What I would say I totally agree that with Mark that we are moving forward with the PS two plus methodology, but please please understand that the pathologist.
Anna Berkenblit: Okay, great, thank you. Thank you. Our next question comes from Debjit Chatterthade, with H.G. Wainwright.
Operator: Your line is now open. Hi, good morning. I hope everyone is healthy and safe. This is Earl D'Souza from InfoDevJet. Can you hear me?
Score based on the percent of cells positive and a level of intensity. So the the way. They go about scoring is quite similar to the age score. We had just validated the P.S. two plus cut off of at least 75% of cells, having at least two plus staining intensity by agency Oh for.
Unknown Executive: Yes, if you could speak up just a little bit, your voice is a little faint.
Unknown Executive: Kadi, can you hear me now?
Unknown Executive: Perfect.
Unknown Executive: Okay, so a couple questions on our front. As you explore this opportunity in platinum-agnostic cohorts, are you observing any marked changes in folate receptor alpha expression compared to later line patients? So basically, the ones that have PARPs, PEVs, taxanes, altered expression? And the second question that we have, will you continue to use the PS2 assay, or would you consider an H-score for the new program? Thank you.
For inclusion in our trials moving forward.
Thank you so much good.
Good.
Thank you.
Our next question comes from Kennen Mackay with RBC capital markets. Your line is now open.
Hi, Thanks, so much for taking my question and congrats on me operational progress. Despite a this global and governments or.
Looking forward to steer in quite a bit more on.
151 out the now virtual HCR conference, but was hoping maybe you could talk a little bit more about the importance of epitopes here on on the folate receptor is what was the protease cleavable linker and really how about stability and when we differs from we'll be talking not especially as it relates to.
Mark Joseph Enyedy: Yeah, so I'll give this a shot, and then Anna, if you have any additional color, please jump in. So what we have seen, we have now screened well over 2,000 samples in the program, is that about 40% of ovarian cancer patients expressed folate receptor alpha at high levels measured by the PS2 plus assay, another 20% at medium levels, another 20% at low levels, and then the remaining 20% with negligible levels of expression. And as I say, that is true whether you're talking about earlier line patients or late line patients, and it doesn't So very consistent across the board. And for purposes of the screening for the program, on a go-forward basis, we will be using the PS2 plus scoring method to identify patients.
Central currently release.
For actually binding.
Being brought into the capital to deliver the payload. Thanks, so much and congrats again.
Thanks, Yeah, Yeah short so as you heard 151 is our next generation folate receptor alpha targeted AIDC and one of the key.
Innovations that we have incorporated is that it is a by para topic.
So that means that it binds to epitopes on fully receptor alpha.
That basically give the antibody drug conjugate more opportunities to buying fr Alpha and therefore more opportunities to internalize. So we have a preclinical data showing that this approach is quite effective, particularly for patients' tumors with lower levels of fr Alpha and.
Anna Berkenblit: So, if I may add a little color, so the tumor tissue for our trials is based on archival tissue. And so additional data that we have showing the stability of folate receptor alpha over time in lines of therapy come from other groups that have reported retrospective data as well as our biopsy cohort, which showed greater than 70 percent concordance between archival tissue and fresh biopsies. So, we do believe FR-alpha expression is stable over time.
Rations. So that is a key key a innovation in 151, the protease cleavable linker also has some very attractive features in terms of improved stability.
And then the payload itself is a next generation maytansinoid that is.
Anna Berkenblit: Regarding the PS2 plus methodology versus the H-score, what I would say is that I totally agree with Mark that we are moving forward with the PS2 plus methodology, but please understand that the pathologists... score based on the percent of cells positive and the level of intensity. So the way they go about scoring is quite similar to the age score. We have just validated the PS2 plus cutoff of at least 75 percent of cells having at least 2 plus staining intensity by IHC for inclusion in our trials moving forward.
More hydrophobic, allowing for better bystander, killing again, a with the intent to really address the remaining unmet need and fr Alpha ER positive tumors, specifically that are positive, but at lower medium levels of expression. So that's what I can share now and abstract will be released on mid.
All of May I think may 15th and then the poster will be in mid June at the the next.
Tranche of a virtual AC aren't meeting.
And then maybe just to elaborate on that.
Listen beautiful potentially to antibodies to bond to do the same receptor is there some level of competitive inhibition, despite being a pipe her topics like though.
Anna Berkenblit: Thank you so much, guys. Thank you. Our next question comes from Kenan McKay with RBC Capital Markets. Your line is now open. Hi, thanks so much for taking the question and congratulations on the operational progress despite this global pandemic here. I'm looking forward to hearing quite a bit more on 1.51 at the now virtual AACR conference, but was hoping maybe you could talk a little bit more about the importance of the epitopes here on the folate receptor, as well as the protease-cleavable linker and really how that stability and release differs Thanks so much and congrats again.
No. It's it wouldn't be competitive inhibition kennen, rather you could have won 80 see.
Construct bind in two different locations or you could have to 80 sees bind.
Also in two different locations. So there wouldn't be really competitive inhibition because both of both molecules are are active in the more binding there is the more internalization. So more binding is better for internalization.
Thank you.
Thank you.
Next question comes from Andy She with William Blair. Your line is now open.
Great. Thanks for taking my question and hopefully the immunogen team is staying safe and well.
Kind of following up on tendons question.
Anna Berkenblit: Thanks, Anna.
Why is David finding I'm, just wondering with with the logic do you expect potentially a cleaner safety profile I'm, just kind of thinking about the logic here, you know having and and.
Anna Berkenblit: Yeah, sure. So, as you heard, 151 is our next-generation folate receptor alpha-targeted ADC, and one of the key innovations that we have incorporated is that it is bi-paratopic. So that means that it binds to two epitopes on folate receptor alpha. So that basically gives the antibody drug conjugate more opportunities to bind FR-alpha and, therefore, more opportunities to internalize. We have preclinical data showing that this approach is quite effective, particularly for patients' tumors with lower levels of FR-alpha expression. So that is a key innovation in 1.5.1. The protease-cleavable linker also has some very attractive features in terms of improved stability. And then the payload itself is a next-generation metansinoid that is a bit more hydrophobic, allowing for better bystander killing, again, with the intent to really address the remaining unmet need in FR-alpha-positive tumors, specifically those that are positive but at low or medium levels of expression.
You know logic problem, we still like for smaller population of cell receptors to target is that right way to think about that.
So we've really designed 151 to address a patients with lower levels of fr Alpha expression on their tumors retaining all the desirable features of 80 sees in terms of targeting tumor tissue and sparing normal tissue.
So you know with that in mind, we're certainly in the process of doing the required safety studies that will be needed a when we file the I N. D. You know mirvetuximab itself has a very nice safety profile.
The the features of it that are are unique in terms of the ocular really are not target related but rather payload related in terms of any of these tubulin directed payloads can cause the appeal or so you know I think there's a potential for the safety profile to be.
Anna Berkenblit: So that's what I can share now. And the abstract will be released in the middle of May, I think May 15th. And then the poster will be released in mid-June at the next tranche of virtual AACR meetings.
Anna Berkenblit: Anna, maybe just to elaborate on that, so does this enable potentially two antibodies to bind to the same receptor, or is there some level of competitive inhibition despite being biparatopic like that?
The improved but I think it's just early days and a you know once we have done nonclinical. The tox data and then once we have clinical data will really be able to stack it up but really our focus is on.
Anna Berkenblit: No, it wouldn't be competitive inhibition, Kenan; rather, you could have one ADC inhibitor. Dr. Swayampakula Ramakanth, Dingding Shi, Boris Peaker, Etzer Darout, Anna Berkenblit, Renee
Creating another safe well tolerated 80 see that can target a broader population with lower levels of out of our alpha expression.
Unknown Executive: That's it. Thank you. Thank you. Our next question comes from Andy Seelig, William Blair. Your line is now open.
Okay that makes sense and in terms of the ice TV you outlined.
Operator: Great, thanks for taking my question. And, you know, hopefully, the ImmunoGen team is staying safe and well. Kind of following up on Kenan's question, you know, with a bivalent binding, I'm just wondering with this logic, do you expect potentially a cleaner safety profile? I'm just kind of thinking about the logic here, you know, having an and Um, you know, logic would probably select for a smaller population of cell receptors to target. Is that a right way to think about that?
100 patients targeting.
I guess in combination with a couple of Clinton just.
For the maintenance phase is there.
Duration or at the treatment duration is pretty flexible and kind of related to that too poor patient who does continue in the you know quote unquote induction phase.
Could they continue again into in the maintenance fees for that trial.
So so this is an investigator sponsored trial led by Philip harder in Germany, and it is in recurrent platinum sensitive disease. So these patients we know I'm not going to be cured and win maintenances given in this setting its generally given a until progression and so.
Anna Berkenblit: So, we've really designed 151 to address patients with lower levels of FR-alpha expression in their tumors, retaining all the desirable features of ADCs in terms of targeting tumor tissue and sparing normal tissue. And with that in mind, we're certainly in the process of doing the required safety studies that will be needed when we file the IND. You know, Mervituximab itself has a very nice safety profile. The features of it that are unique in terms of the ocular really are not target-related but rather payload-related in terms of any of these tubulin-directed payloads can cause the ocular. So, you know, I think there's potential for the safety profile to be improved, but I think it's just early days, and once we have the non-clinical, the TOCS data, and then once we have clinical data, we'll really be able to compare it. But really, our focus is on creating another safe, well-tolerated ADC that can target a broader population with lower levels of FR-alpha expression.
For both arms.
The trial maintenance will be given really according to standard of care practice, so as long as patients are benefiting overall from from the therapy. So there will be no difference across the arms in terms of duration of maintenance therapy be it either mirvetuximab on an experimental basis for a whatever standard.
Of care maintenance option the physician chooses.
And I'm blanking sorry, Andy on the second part of your question Oh, if they stop any induction phase so right typically on when you have recurrent platinum sensitive disease are you assuming you have a healthy enough bone marrow and you don't have hypersensitivity reactions, you generally get between four and eat.
Cycles of Carbo plot. So you know as long as a the patient has gotten you know a significant number of doublet cycles. Then they can move on to Mirvetuximab and again the treatment in both arms is gonna be or the way physicians manage the carboplatin based doublet is gonna be this.
Anna Berkenblit: Okay, that makes sense. And in terms of the IST that you outlined, you know, a hundred patients targeting... I guess in combination with carboplatin. Just for the maintenance phase, is there a set duration, or is the treatment duration pretty flexible? And kind of related to that, so for patients who discontinue in the, you know, quote, unquote, induction phase, could they continue again in the maintenance phase for that trial?
Same across both arms and will be consistent with really how they just take care of patients size standard of care.
Great. Yeah. That's that's very interesting trial. It lastly, if you don't mind I think you've provided.
A lot as you know commentary regarding koby 19, and contingency plans and so much appreciated so in terms of fee assay development with partners and Panna, obviously, a lot of diagnostic companies are re purposing.
Anna Berkenblit: So this is an investigator-sponsored trial led by Philip Harter in Germany, and it is in recurrent platinum-sensitive disease. So these patients are not going to be cured, and when maintenance is given in this setting, it's generally given until progression. And so for both arms of the trial, maintenance will be given really according to standard of care practice, so as long as patients are benefiting overall from the therapy. So there will be no difference across the arms in terms of duration of maintenance therapy, be it either mervituximab on an experimental basis or whatever standard of care maintenance option the physician chooses. And I'm blanking, sorry, Andy, on the second part of your question, oh, if they stop in the induction phase. Right.
You know gotta refocusing their their corporate strategy, just wondering about the latest dialogue with intrinsic kind of pushing through a regulatory preparation.
We're on track with Ventana, they've done all the work to validate the assay. So that we've got it up and running in Serbia, and Marisol and we have a very frequent meetings with them.
To plan ahead for a the regulatory requirements and for commercialization so that remains on track.
Okay awesome.
Thank you very much take care.
And thanks for answering all my questions.
Sure.
Thank you.
Next question comes from John Newman with Canaccord. Your line is now open.
Anna Berkenblit: So, typically, when you have recurrent platinum-sensitive disease, assuming you have a healthy enough bone marrow and you don't have hypersensitivity reactions, you generally get between four and eight cycles of carboplatin. So, you know, as long as the patient has gotten a significant number of doublet cycles, then they can move on to myrbatoximab. And again, the treatment in both arms is going to be, or the way physicians manage the carboplatin-based doublet is going to be the same across both arms and will be consistent with, really, how they just take care of patients as standard of care.
Hey, guys. Thanks for taking additional question.
I just wondered if you could comment a bit about the competitive landscape for folate receptor fully receptor alpha targeted therapies, obviously, you've had a lot of experience year.
You have your own second generation molecule in development.
We've seen a number of other companies in passive.
<unk> pretty significant challenges I think there's been some recent data that of surface, but just wondered if you could give us a sense as to how you.
You envision things you're obviously your.
Quite late in development, but just curious as to how you think about the rest of the field. Thanks.
Anna Berkenblit: Great. Yeah, that's a very interesting trial. And lastly, if you don't mind, I think you've provided a lot of commentary regarding COVID-19 and contingency plans. It is so much appreciated. So in terms of the assay development with partner Ventana, obviously, a lot of the diagnostic companies are repurposing and refocusing their corporate strategies. I was wondering about the latest dialogue with them in terms of kind of pushing through regulatory preparation.
Yeah, I mean, just more broadly on the competitive situation and then I'll ask anybody to talk about some of the earlier stage programs, but what we see it in the first instance is you know the potential to launch Mirvetuximab and 2022 into a a relatively open field and what I mean.
And by that is.
You know apart from the advances with the PARP inhibitors, which are predominantly focused or in the front line in recurrent platinum sensitive setting there's limited activity or in terms of competitive programs in platinum resistant disease. There's a number of trials ongoing so I don't mean to diminish that but.
In terms of near term approvals, we think that mirvetuximab with that benefited the survey outcome will be the first new approval in platinum resistant as you know initial therapy in a in some time. So we're we're we're comfortable in terms of you know where our.
Anna Berkenblit: We're on track with Ventana. They've done all the work to validate the assay so that we've got it up and running in Saraya and Mirasol, and we have very frequent meetings with them to plan ahead for the regulatory requirements and for commercialization, so that remains on track.
<unk> competitive positioning lies with our initial program and as we think about label expansion, what we see is mirvetuximab being complimentary.
To the newer developments in a in recurrent platinum sensitive disease and so our expectation is that you know given our ability to combined with other other products as demonstrated by you know the data we've generated to date and you'll see more of that at ASCO a next.
Unknown Executive: Okay, awesome. Well, thank you very much. Take care. And thanks for answering all my questions. Sure.
I actually later this month.
We think we're in a very strong competitive position and then you know as we think about some of these earlier stage programs, you know and I will give you some more detail as we've looked at Penn for example, the program from Sutro and also the work that Mersana us doing with nappy to be as you say that were.
Operator: Thank you. And our next question comes from John Newman with Canaccord. Your line is now open. Hey guys.
John Lawrence Newman: Thanks for taking an additional question. I just wondered if you could comment a bit about the competitive landscape for folate receptor alpha-targeted therapies. Obviously, you've had a lot of experience here. You have your own second-generation molecule in development. We've seen a number of other companies in the past that have faced pretty significant challenges. I think there's been some recent data that have surfaced, but I just wondered if you could give us a sense as to how you envision things here. Obviously, you're quite late in development, but I'm just curious as to how you think about the rest of the field. Thanks.
You know a lot further along than a than those programs and our you know our view is that those agents ultimately ought to be compared to what we're doing with a with 151 as we go forward, but let me, let and I'd talk to you a little bit more about what we're seeing from the earlier stage programs.
Thanks, Mark So yeah, I think Sutro's fr Alpha targeted 80 see is probably the most relevant at this point and Mersana has some data on there.
Now b to B.
So a couple of earlier a fr Alpha 80 sees a guy has a naked antibody for it with using that that they've looked up to a revealing and exclude it has won in preclinical development, but focusing on citrus and suggest that third some data at a CR you know the four points that we're really looking at our ER dose and schedule number one.
Mark Joseph Enyedy: Yeah, I mean, just more broadly on the competitive situation, and then I'll ask Anna to talk about some of the earlier stage programs, but, you know, what we see in the first instance is, you know, the potential to launch Mervituximab in 2022 into a relatively open field. And what I mean by that is, apart from the advances with the PARP inhibitors, which are predominantly focused in the frontline and recurrent platinum- There are, you know, a number of trials ongoing, so I don't mean to diminish that, but in terms of near-term approvals, we think that Mervituximab, with the benefit of the SREA outcome, will be the first new approval in platinum-resistant as initial therapy in some time.
Safety number two.
The number three and patient selection number four so.
From a dose and schedule perspective, it seems that based on the safety profile, they're seeing with some significant grade three and four neutropenia, a there they're trying to figure out you know.
What their optimal a weather recommended phase two dose and schedule is.
They are exploring several different dose levels I'm not clear Q3, or Q4 week is gonna be the dose schedule.
From a safety profile perspective, the neutropenia that they're seeing.
Well it hasn't resulted in any febrile neutropenia could really pose a problem for longer term plans in terms of combinability.
Mirvetuximab doesn't have any grade three or greater neutropenia as a monotherapy and that's one of the key features of Mirvetuximab that has allowed us to combine full those mirvetuximab with full does everything that we have a combined with.
Mark Joseph Enyedy: So we're comfortable in terms of, you know, where our competitive positioning lies with our initial program, and as we think about label expansion, what we see is Mervituximab being complementary to the newer developments in recurrent platinum-sensitive disease, and so our expectation is that, you know, given our ability to combine with other products as demonstrated by, you know, the data we've generated to date, and you'll see more of that at ASCO next, actually later this month, you know, we think we're in a very strong competitive position, and then, you know, as we think about some of these earlier stage programs, you know, Anna will give you some more detail as we've looked at, for example, the program from Sutro and also the work that Mursana's doing with NAPI 2B. As you say, we're, you know, a lot further along than those programs, and our, you know, our view is that those agents ultimately ought to be compared to what we're doing with 151 as we go forward, but let me let Anna talk to you a little bit more about what we're
In terms of other Oh.
Safety features no mirvetuximab, we have low grade manageable okcular adverse events and I would just note that when we did our initial I N D. Enabling GLP Tox studies, we did not see any ocular adverse event in this you know.
Monkeys, so not clear to me, how predictive Ah that negative is for them.
Moving to efficacy. They certainly have shown some CA 125 drops a in patients and a they have one partial response I believe in and around 20 patients and you know for phase one dose escalation ramp.
Pretty consistent you know with what what we had seen previously.
Anna Berkenblit: Thanks, Mark. So, yeah, I think Sutro's FR-alpha-targeted ADC is probably the most relevant at this point, and Mursana has some data on their NAPI 2B. There are also a couple earlier FR-alpha ADCs. AZI has a naked antibody, farlatuzumab, that they've hooked up to aribulin, and Exuda has one in preclinical development. But focusing on Sutro, since they just shared some data at AACR, you know, the four points that we're really looking at are dose and schedule, number one; safety, number two; efficacy, number three; and patient selection, number four. So, you know, from a dose and schedule perspective, it seems that, based on the safety profile they're seeing with some significant grade three and four neutropenia, they're trying to figure out what their optimal or their recommended phase two dose and schedule is.
And it's it's you know early signs that there is some activity, but no I would just point out that CA 125 responses by themselves really are not sufficient for regulatory approval and.
I would also point out that as they're thinking about patient selection you know.
We've done a lot of work on patient selection to figure out which patients benefit most from mirvetuximab and being able to have a sufficient dataset with us sufficient number of responses.
To guide that is going to be really important and certainly they showed some stable disease, but it's really not clear what their tumor shrinkage is and how much anti tumor activity there seeing other than what they've demonstrated with they're seeing 120 [noise].
Sponsors and the one CR.
You know early days for Sutro I'm, certainly we were there and a you know we're going to continue to follow.
They're developments I would say that our next generation fr Alpha targeted agent I am GE and 151 with the by pair atopic targeting of Fr Alpha really is gonna be something for us to think about as we benchmark, but at the next generation of Fr Alpha compound.
Anna Berkenblit: You know, they're exploring several different dose levels, and it's not clear if Q3 or Q4 week is going to be the dose and schedule. From a safety profile perspective, the neutropenia that they're seeing, while it hasn't resulted in any febrile neutropenia, could really pose a problem for longer-term plans in terms of combinability. Mervituximab doesn't have any grade three or greater neutropenia as monotherapy, and that's one of the key features of Mervituximab that has allowed us to combine full-dose Mervituximab with full-doses of everything that we have combined it with.
And then pivoting to Mersana earlier this year they presented data in under 40 patients again, they they have seen some activity with some partial responses or they are having a you know there selecting patients were figuring out their patient selection strategy as well, they're taking that approach with a high Dar a and that could have.
Potential issues, if the thurber hypothesis really continues.
Anna Berkenblit: In terms of other safety features, Mervituximab, we have low-grade, manageable ocular adverse events, and I would just note that when we did our initial IND-enabling GLP tox studies, we did not see any ocular adverse events in the CINO monkeys, so it is not clear to me how predictive that negative is for them. So moving to efficacy, they certainly have shown some CA-125 drops in patients, and they have had one partial response, I believe, in around 20 patients. And, you know, for a Phase I dose escalation program, it's pretty consistent with what we had seen previously. And it's early signs that there is some activity. But, you know, I would just point out that CA-125 responses by themselves are not really sufficient for regulatory approval.
Joe.
Evidence that if you have a very very potent lots and lots of you may have trouble penetrating tumor cells.
They tuned and you know we're excited about Mirvetuximab were in phase three we've got a two trials set up now so that we hopefully we'll get accelerated approval followed by a confirmatory trial and we have nice data at ASCO for Merck that that should support Compendia listing.
And so on my desk, one additional quick question.
We know about targeting for late receptor alpha across multiple tumor types.
Possibility that.
Some point in time.
The 151 molecule could be tested perhaps than something like lung cancer or would you probably see absolutely gone camco triple negative breast cancer endometrial cancer you bet John.
Anna Berkenblit: And I would also point out that as they're thinking about patient selection, you know, we've done a lot of work on patient selection to figure out which patients benefit most from mervituximab. And, you know, being able to have a sufficient data set with a sufficient number of responses to guide that is going to be really important. And certainly they've shown some stable disease, but it's really not clear what their tumor shrinkage is and how much anti-tumor activity they're seeing other than what they've demonstrated with their CA-125 responses and the one CR. So, you know, early days for Sutro.
Okay Super Thank you.
Thank you.
As a reminder to asked the question you'll need to best Star one on your telephone.
She's meet your line. If you are not speaking a fresh and next question comes on board speaking with Cowen.
Let's now open.
Fourth.
If your line is muted.
[laughter].
And our next question comes from buying the men with Jefferies. Your line is now open.
Yeah, Hey, guys. Thanks for taking my question.
Oh I hope you guys are doing well all banks on murph I want to on the AAA and platinum sensitive with bad and car will flatten I think you had data last year at ESMO.
Anna Berkenblit: Certainly, we were there, and, you know, we're going to continue to follow their development. I would say that our next generation FR-alpha targeted agent, the IMGN-151 with the biparatopic targeting of FR-alpha, really is going to be something for us to think about as we benchmark sort of the next generation of FR-alpha compounds. And then pivoting to Mirsana, earlier this year, they presented data on under 40 patients. Again, they have seen some activity with some partial responses. They are having, you know, they're selecting patients or figuring out their patient selection strategy as well. They're taking an approach with a high DAR. And that could have some potential issues if the Therber hypothesis really continues to show evidence that if you have a very, very potent loss and loss of payload, you may have trouble penetrating tumors. So, stay tuned. And, you know, we're excited about mirvotoximab. We're in phase three. We've got two trials set up now so that we hopefully will get accelerated approval followed by a confirmatory trial. And we have nice data that we'll share at ASCO for mirv plus bev that should support compendia listing.
Just wanted to see when we can expect an update from that trial and what are your thoughts on moving forward in this setting given yeah. The highest he also with the doublet now as well.
Yeah. So we're.
Planning to submit an abstract to ESMO with updated data for the trip. Let you may recall last year was the first reveal of the data and we had response rate data, but we didn't have a sufficient follow up for a duration and so now we do a and we will share that data at ESMO. So then thinking of.
About you know future plans I would say you know once were able to share the data with the merger Beth doublet from the platinum agnostic cohort at ask though a it'll be clear that we do have a several options to move forward a in earlier lines of therapy with longer durations built them or that's a combination and the trip.
But so I think that's where I'll leave it at this point I don't know Mark if you want to add anything.
No I think you've covered it nicely. Thanks.
All right and then maybe a second question on high MGC night three six.
I think you're planning a falling in line the and the second or later this quarter.
Anna Berkenblit: And if I might ask one additional quick question. Given what we know about targeting folate receptor alpha across multiple tumor types, is there a possibility that, at some point in time, the 151 molecule could be tested perhaps in something like lung cancer, or would you?
So as a plan to start the phase one later this year and you're using it defrain payload figure using d. and 21 versus the four.
So you know given your comments earlier on you know seen all model not a good predicted for ocular Tox, how do you think about ocular tox flip that payload.
Unknown Executive: lung cancer, and triple negative breast cancer
Unknown Executive: lung cancer, triple negative breast cancer, endometrial cancer, you bet. Okay, super. Thank you. Thank you.
And then I guess for the Phase one would you look at using a diagnostic and add a mine diagnostic event.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. Please mute your line if you are not speaking. Our next question comes from Boris Peaker on Cowen. Your line is now open.
You've got certain solid tumors, where it's highly expressed like patent gastric and colorectal and are those the tumors that you're going after the seasonal.
Boris Peaker: Boris?
Unknown Executive: If your line is muted, please unmute it. And our next question comes from Byron Amin with Jefferies.
Yeah. So a lot so for I.M.D.C. 936, which targets Adam nine we are using diem 21, and you know I think it's it's again early days I'm certainly we have learned a lot in the Mirvetuximab program in terms of optimizing management of corneal care a top but they should it occur a so you know I think we'll be able.
Operator: Yeah, hey guys, thanks for taking the question. I hope you guys are doing well.
Unknown Executive: On MIRV, I want to ask about the triplet in platinum sensitive patients with BEV and carboplatin. I think you had data last year at ESMO. I just wanted to see when we can expect an update from that trial and what are your thoughts on moving forward in this setting given the IST also with the doublet now as well.
To get ahead of it if it does occur but right now we have no no data that suggest that it will or won't occur.
But you know if it does were prepared and then moving toward a patient selection. Adam nine is expressed its a number of the matrix metallic pretty and his family and its expressed on a wide variety of tumors as you mentioned, a and spared relatively on normal cells on and we do anticipate that potentially we may need.
Anna Berkenblit: Yeah, so we're planning to submit an abstract to ESMO with updated data for the triplet. You may recall last year was the first reveal of the data, and we had response rate data, but we didn't have sufficient follow-up for duration. And so now we do, and we will share that data at ESMO. So then thinking about, you know, future plans, I would say once we're able to share the data with the MIRV-BEV doublet from the platinum agnostic cohort at ASCO, it will be clear that we do have several options to move forward in earlier lines of therapy with longer durations, both the MIRV-BEV combination and the triplet So I think that's where I'll leave it at this point. I don't know, Mark, if you want to add anything.
To select patients based on 936 expression and so we are well positioned to do that should we need to when we do plan to incorporate the appropriate activities in the phase one trial to gather data.
To support a efforts for patient selection, if we need it and you know early on will be targeting for tumor types in the phase one trial.
You mentioned, we'll be going after gastric that pancreatic triple negative breast and lung.
And then we'll see a you know will follow the science and we'll go after the tumor types, where we're really demonstrating nice activity and a in a good safety profile.
Great. Thank you.
Mark Joseph Enyedy: No, I think you've covered it nicely, thanks.
Sure.
Thank you I.
Next question comes from Jonathan Chang with SBB. The Inc. Your line is now open.
Operator: All right, and then maybe a second question on IMGC 936. I think you're planning on filing an IND in the second half of the year.
Hi, guys getting David Reshot for Jonathan Thanks for taking your question.
Just with regard to ask a patient population how much detail can we expect on the publish in terms of prior therapy I know someone previously that's about prior avastin, but what do you expect in terms of prior parks.
Unknown Executive: So there's a plan to start Phase I later this year, and you're using a different payload. I think you're using DM21 versus DM4. So given your comments earlier on the SINEL model not being a good predictor for ocular TOCS, how do you think about ocular TOCS with that payload? And then I guess for the Phase I, would you look at using a diagnostic, an ADAM9 diagnostic, given you've got certain solid tumors where it's highly expressed, like gastric and colorectal, and are those the tumors that you're going after in the Phase I?
Yes, so we will share demographic data from this population I'm not surprisingly overtime as you look back at all of the cohorts. We have enrolled a the percent of patients who have a prior PARP is increasing and so we'll share that data you know. These this is a platinum agnostic cohort so well.
We are details around the percent of patients who are considered platinum resistant versus platinum sensitive and give a sense of how platinum sensitive they are well share person to patients with prior bed with prior PARP certainly prior taxanes, so you'll get a good feel of the population.
Anna Berkenblit: Yeah, so for IMGC 936, which targets ADAM9, we are using DM21, and, you know, I think it's, again, early days. Certainly, we have learned a lot in the Myrvotoximab program in terms of optimizing management of corneal keratopathy, should it occur. So, you know, I think we'll be able to get ahead of it if it does occur But, you know, if it does, we're prepared.
Great. Thank you and if the ASCO data are promising are encouraging what does the regulatory path forward look like in the platinum agnostic setting and what studies would you point to has benchmarks for Africa's being in this patient population.
Yeah. So you know certainly from a regulatory perspective, the most conservative approach could be for us say, a randomized trial from or better versus Merv chemo and you know the benchmark firmer chemo is a pretty underwhelming, 27% response rate and median PFS of 6.7 months specifically.
Anna Berkenblit: And then, moving toward patient selection, ADAM9 is expressed; it's a member of the matrix metalloproteinase family, and it's expressed in a wide variety of tumors, as you mentioned, and spared relatively in normal cells. And we do anticipate that, potentially, we may need to select patients based on 936 expression, and so we are well positioned to do that, should we need to, and we do plan to incorporate the appropriate activities in the phase one trial to gather data to support efforts for patient selection, if we need it. And, you know, early on, we'll be targeting four tumor types in the phase one trial. As you mentioned, we'll be going after gastric, pancreatic, triple negative breast, and lung, and then we'll see. You know, we'll follow the science, and we'll go after the tumor types where we're really demonstrating nice activity and a good safety profile.
In platinum resistant disease, I think you know going into a broader population that includes platinum sensitive patients a would require dialogue with a F.D.A. a and certainly the recent approvals you know in ovarian cancer in patients who had a number of lines of prior therapy, you know regardless.
They're platinum sensitivity suggests that we could have you know a productive conversations with F.D.A. in that regard.
In terms of a benchmark for non platinum doublets and platinum sensitive disease, there really aren't a lot, but the one that I've been you know starting to look at a from a European perspective is tribeca didn't or young Dallas a was approved in combination with doxil having.
Unknown Executive: Great, thank you.
Operator: Thank you. Our next question comes from Jonathan Chang with SVB-Liank. Your line is now open. Hey guys, this is David Ruchoff for Jonathan.
Unknown Executive: Thanks for taking our questions. Just with regard to the ASCO patient population, how much detail can we expect on the population in terms of prior therapy? I know someone previously asked about prior avastin, but what do you expect in terms of prior parts?
Beat and a single agent Doxil in platinum sensitive patients that was a subset from the phase three trial, a and so it wasn't sufficient for approval in the U.S., but you know for our purposes from an efficacy benchmarking perspective.
You know the them or if that combination is is quite encouraging. So I think certainly there's there's more work for us to do longer in terms of figuring out which of the regulatory options is is most favorable for us.
Anna Berkenblit: Yeah, so we will share demographic data from this population. Not surprisingly, over time, as you look back at all of the cohorts we have enrolled, the percent of patients who have a prior PARP is increasing. So we'll share the data, you know, this is a platinum-agnostic cohort, so we'll share details around the percent of patients who are considered platinum-resistant versus platinum-sensitive and give a sense of, you know, how platinum-sensitive they are. We'll share percent of patients with prior BEV, with prior PARP, certainly prior taxing, so you'll get a good feel for the population.
And in the short term a we've now generated data in two separate cohorts from them or if that combination a that we believe our robust and often not sufficient to support compendia listing that should be available right around the time that we get our initial <unk> monotherapy approval. So that physicians in the U.S. will have the option to use either Murphy.
Monotherapy or plus seven their patients with platinum resistant disease.
Got it thanks, and then just one more clarification with regard to six three too you mentioned an update later this year, that's still expected to be ash and could you give some color on the okay. Great and then any color on your expectations for durability duration of response data and and what kind of.
Anna Berkenblit: Great, thank you. And if the ASCO data are promising or encouraging, what does the regulatory fast-forward look like in the platinum agnostic setting? And what studies would you point to as benchmarks for efficacy in this patient population?
Anna Berkenblit: Yeah, so, certainly from a regulatory perspective, the most conservative approach could be for us to say, a randomized trial for MIRV-Bev versus MIRV-CHEMO, and you know, the benchmark for MIRV-CHEMO is a pretty underwhelming 27% response rate and median PFS of 6.7 months, specifically in platinum-resistant disease. I think, you know, going into a broader population that includes platinum-sensitive patients would require dialogue with FDA, and certainly the recent approvals for ovarian cancer in patients who've had a number of lines of prior therapy, regardless of their platinum sensitivity, suggest that we could have, you know, productive conversations with FDA in that regard. In terms of the benchmark for non-platinum doublets in platinum-sensitive disease, there really aren't a lot, but the one that I've been, you know, starting to look at from a European perspective is Trebectadine, or Yandelis, which was approved in combination with Doxil, having beaten single-agent Doxil in platinum-sensitive patients.
What's what's the patient population that you would be.
Most hi, highlighting the most as far as a company for next steps regulatory wise, yes. So I MTN 632 is RCD 123 targeted 80 see with our potent IDN payload and we are developing it as a monotherapy for.
Blasting plasma cited injured excel neoplasms, and also as a monotherapy for AML patients with minimal residual disease. After a front line.
Induction therapy, we are also developing in combination with either siding with venetoclax and as a triplet and those are currently in dose escalation in moving along so we would anticipate sharing all the data we have from this program at Ash.
And are a we continue to remain focused on gathering sufficient data and B P. D. C N, where there's a high unmet need to to allow us to engage in the with the regulatory authorities on a path for approval. There a while we are continuing to progress. It also in monotherapy for him.
Anna Berkenblit: That was a subset from the Phase III trial, and so it wasn't sufficient for approval in the U.S., but, you know, for our purposes from an efficacy benchmarking perspective, you know, the MIRV-BEV combination is quite encouraging. So I think certainly there's more work for us to do longer in terms of figuring out which of the regulatory options is most favorable for us, and in the short term, we've now generated data in two separate cohorts from the MIRV-BEV combination that we believe are robust enough and sufficient to support compendia listing that should be available, you know, right around the time that we get our initial MIRV monotherapy approval so that physicians in the U.S. will have the option to use either MIRV monotherapy or MIRV plus BEV in their patients with platinum-resistant disease.
R&D positive disease and in combination.
Got it thank you so much.
Thank you.
Our next question comes from Michael Schmidt with Guggenheim. Your line is open.
Hey, guys. Thanks for taking my question.
Maybe a high level question just round 151.
I guess.
How do you you know how do you balance I guess investment into mirvetuximab longer term.
You know where.
As well as as 151, I mean do you see 151, eventually replacing more.
Mirvetuximab or is there a email.
Indications or you know patient populations, where you could see books, a 1.1, succeeding at both drugs or I guess up and Jane.
Anna Berkenblit: Got it. Thanks. And just one more clarification. With regard to 6.3.2, you mentioned an update later this year. Is that still expected to be ASH? And could you give some color on the – okay, great. And then any color on your expectations for durability, duration of response data, and what kind of – what's the patient population that you would be most interested in highlighting as far as something for next steps regulatory-wise?
So to speak.
Yes, so priority one my goal is to get Mirvetuximab approved.
Given the data that we've generated the focus of that molecule should be on patients with high levels of expression and got a pretty robust program today in terms of securing the initial approval based on a survey a expanding to full approval and then adding comedy.
Nations to expand the patient populations into earlier lines of therapy, and so you are that we you know we expect that program to roll out and those data to unfold over the next you know securing an approval initial approval in 2022, a week the read out a mirror saw.
Anna Berkenblit: Yeah, so IMGN-632 is our CD123 targeted ADC with our potent IgN payload, and we are developing it as a monotherapy for blastic plasma cytoid dendritic cell neoplasm and also as a monotherapy for AML patients with minimal residual disease after frontline induction therapy. We are also developing it in combination with azacitidine, with venetoclax, and as a triple So, we would anticipate sharing all the data we have from this program at ASH, and we continue to remain focused on gathering sufficient data in BPD-CN, where there is a high unmet need to allow us to engage with the regulatory authorities on a path for approval there, while we are continuing to progress it also as monotherapy for MRD-positive disease and in combination.
And the first half and then you know moving to full approval and then having the combination data come on line, but again all focused on a patients a would fr Alpha high.
Levels of expression and so as we think about.
151, you know the goal there was the engineers something that could address lower levels of expression.
Both our to address a broader segment of ovarian cancer, but also as was pointed out is one of the earlier questions.
To move into additional tumor types endometrial, a triple negative long et cetera, and so you know I think our you know the initial focus for 151 will be a in those segments of the market not addressable.
Anna Berkenblit: Got it. Thank you so much. Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is now open. Hey guys, thanks for taking my questions. Just maybe a high-level question just around
By Mirvetuximab and then.
As you know as time goes by we can look at potential you know complement parity or you know ultimately whether a the day to tell US that you know cannibalization is the is what's going to happen here, but I think we're very long ways away from from that and the potential opportunity.
Operator: I guess, how do you balance, I guess, investment in Mirvotaximab longer term as well as 1.5.1? I mean, do you see 1.5.1 eventually replacing Mirvotaximab, or are there, you know, alternative indications or, you know, patient populations where you could see both 1.5.1 succeeding and both drugs maintaining relevance, so to speak?
Before 151 is sufficiently distinct at this point to allow us to develop them in non overlapping indications.
Got it thanks, and then just on the one phase one maybe just if you just.
Little bit more on the choice, but no. It I think I heard you say the payload is a made comments.
Maybe just talk about the choice of that as opposed to for example, using one of yoga.
Yeah.
So.
Mark Joseph Enyedy: Yeah, priority one, Michael, is to get mervituximab approved. You know, given the data that we've generated, the focus of that molecule should be on patients with high levels of expression. And, you know, we've got a pretty robust program today in terms of securing the initial approval based on SREA, expanding to full approval, and then adding combinations to expand the patient populations into earlier lines of therapy. And so, you know, we expect that program to roll out and those data to unfold over the next, you know, securing an approval, initial approval in 2022, the readout of Mirasol in the first half, and then, you know, moving to full approval, and then having the combination data come online.
There's a couple points to make here one is we talked a little bit about this but the stability of the linker. So this is a linker that's made up of three alanine residues in the middle L. Anine as a de ice summer.
So that's you know you don't normally find that a in nature and so it makes it very resist into this year and protease is and so you know from our perspective that gave a enhanced stability.
In terms of the of the engineering to the payload.
You know we looked at a the idea and so you know.
One of the things that was a hallmark of the research organization here was to examine multiple payloads and you know when we looked at.
Therapeutic index or where we were going with this DM 21 payload more broadly so we're using it in.
In the 96.
Program or use we use it in the Abcam program that we licensed to say told mix.
Mark Joseph Enyedy: But again, all focused on patients with FR-alpha high levels of expression. And so, as we think about 151, you know, the goal there was to engineer something that could address lower levels of expression, both to address a broader segment of ovarian cancer but also, as was pointed out, it's one of the earlier questions, to move into additional tumor types, endometrial, triple negative, lung, et cetera. And so, you know, I think our initial focus for 151 will be those segments of the market not addressable by mirvotoximab. And then, you know, as time goes by, we can look at potential complementarity or, you know, ultimately, whether the data tell us that, you know, cannibalization is what's going to happen here. But I think we're a very long way away from that, and the potential opportunity for 151 is sufficiently distinct at this point to allow us to develop it for non-overlapping indications.
And also to as part of a of 151.
So you know the medchem exercise here was a really built around adjusting the carbon Adams relative to the M. for.
To improve the Oh, Hi, Hydrophobicity.
Which gave us better bystander, killing there's also some work is done in terms of the cleavage in the license some odd to also improve improve those those properties and so altogether you know we've got a very nice payload.
In a stable linker attached to it which we think is going to give US you know a significant improvement in these lower levels of fully receptor alpha expression.
Great. Thank you Mark and congrats on a the progress and keeping everything up and running.
Thanks.
Thank you. Our next question comes from Jessica Fye with JP Morgan. Your line is now open.
Hey, guys. Good morning, Thanks for taking my questions I had to do more.
Unknown Executive: Got it. Thanks.
Maybe first on Sixthree too when we think about the M.L. am R&D positive setting can you lay out what the efficacy bar is in that setting what you want to see in that data later this year and then second on the financial side. When you talk about anticipated cash receipts from partners can you give us a bit of a framework for how to think about.
Mark Joseph Enyedy: And then just on 151, maybe you could just comment a little bit more on the choice of the payload. I think I heard you say the payload is a metantinoid derivative. Maybe you could talk about the choice of that as opposed to, for example, using one of your calculators.
Mark Joseph Enyedy: Yeah, um, so... There's a couple points to make here.
The size and timing of those potential payments.
Mark Joseph Enyedy: One is, we talked a little bit about this, but the stability of the linker. So this is a linker that's made up of three alanine residues. In the middle, alanine is a de-isomer. So that's, you know, you don't normally find that in nature.
Ample how much if any is baked into the 2020 guidance. Thank you.
Yeah sure you want to cover email yeah got good yeah. So suggests that the MRT positive cohort a this is taking patients who are.
Mark Joseph Enyedy: And so it makes it very resistant to serum proteases. And so, from our perspective, that gives it enhanced stability. In terms of the engineering of the payload, we looked at the IGN. So, you know, one of the things that was a hallmark of the research organization here was to examine multiple payloads and, you know, when we looked at the therapeutic index, where we were going with this DM21 payload more broadly, so we're using it in the 936 program. We used it in the EPCAM program that we licensed to Cytomics and also as part of 151. And so, you know, the MedChem exercise here was really built around adjusting the carbon atoms relative to DM4 to improve the hydrophobicity, which gave us better bystander killing. There's also some work that's done in terms of the cleavage in the lysosome to also improve those properties. And so, altogether, you know, we've got a very, you know, nice payload and a stable linker attached to it, which we think is going to give us a significant improvement in these lower levels of folate receptor alpha expression.
Complete response, and so you know they have less than 5% blasts in.
In their merrell, but they have minimal residual disease on its detectable by either Pcr or or flow and we want it to basically see conversion from M. R&D positivity to MRT negativity, because we know I'm really the lower the blast counted that are patients.
To do and we know that MRT positivity bodes poorly for patients.
The recently completed a randomized phase three trial of oral ease a site in RCC for eight six versus placebo.
Will be a helpful benchmark for US now it was slightly different because they took all patients a after completion of their initial induction therapy, and then randomized them. So they didn't specifically focused on the M. R&D positive cohort. They took they took everybody.
And so that that is going to be a helpful benchmark for us, but right now really from a proof of concept perspective is we would like to see a reasonable percentage of patients convert from MRT positive T. M. R. D negative within you know a few cycles of I am GE GE and six three too.
Mark Joseph Enyedy: Great. Thank you, Mark, and congratulations on the progress and keeping everything up and running. Thanks. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is now open. Hey guys, good morning. Thanks for taking my questions. I have two. Hey Mark. Maybe first on 632, when we think about the AML MRD positive setting, can you lay out what
I don't think we're ready at this point to you know say Oh. This is our go no go criterion, but I think between a you know understanding the orally deciding data and then looking at the percent of patients who get to MRT negativity in the tempo of that that should help guide us regarding next steps you know just as Ed.
A note of caution on conversion from MRT positivity to NRT negative <unk> in itself does not have a regulatory precedent in an email, but you know if our data are quite encouraging obviously, we will engage the regulators on the path forward for registration for this indication.
Unknown Executive: And then, on the financial side, when you talk about anticipated cash receivables,
Unknown Executive: Transcripts provided by Transcription Outsourcing, LLC.
Unknown Executive: For example, how much, if any, is baked into the 2020 guidance? Thank you. Yeah, you want to cover AML? Yeah, good.
Great. So just on the on the cash piece there are really two components built into the partnering element of it one of which relates to milestone payments from our legacy partnering deals whether it's an erosion novartis et cetera.
Anna Berkenblit: Yeah, so, Jess, the MRD-positive cohort, this is taking patients who are in a complete response, and so, you know, they have less than 5% blasts in their marrow, but they have minimal residual disease. It's detectable by either PCR or flow cytometry, and we want to basically see conversion from MRD-positivity to MRD-negativity because we know that the lower the blast count, the better patients do, and we know that MRD-positivity bodes poorly for patients.
And at some of the newer deals in fact, if I told mix, we just aren't a a milestone there and so there's an element of that and then there is a separate component related to active partnering discussions.
We have inbound interest for a partnership in China.
And so we have assumed in 2020 that we will get a partnering deal done for Mirvetuximab in China and so both of those components are built into the cash forecast I guess, what I would say is we don't we won't break those elements out separately.
Anna Berkenblit: The recently completed randomized phase 3 trial of oral azacitidine or CC486 versus placebo will be a helpful benchmark for us. Now, that was slightly different because they took all patients after completion of their initial induction therapy and then randomized them, so they didn't specifically focus on the MRD-positive cohort; they took everybody, and so that is going to be a helpful benchmark for us, but right now, really, from a proof-of-concept perspective, we would like to see a reasonable percentage of patients convert from MRD-positive to MRD-negative within a I don't think we're ready at this point to say, oh, this is our go-no-go criterion, but I think between understanding the oral azacitidine data and then looking at the percent of patients who get to MRD-negativity and the tempo of that, that should help guide us regarding next steps. So, just as a note of caution, conversion from MRD-positivity to MRD-negativity in itself does not have a regulatory precedent in AML, but if our data are quite encouraging, obviously, we will engage the regulators on the path forward for registration for this indication.
And part for competitive reasons as we think about you know negotiating upfront fees with potential partners in China.
What I would say is you know we've got a pretty strong track record here have you know completing the deals that we put in scope a as as a business certainly over the last couple of years and so we won't we don't put those numbers in unless we have you know reasonable degree you confidence that we can you know effect as a those deal.
Great. Thank you.
Sure.
Thank you I'm not showing any further questions at this time I would now like to turn the call back over to Mark entity for closing remarks.
Well. Thank you all for joining us. This morning, I Hope you in your families are safe and well and we look forward to a emerging from this and continuing to report out our progress I in particular looking very much forward to the ASCO presentation and also a the.
PCR poster so thanks, very much and look forward to talking again soon.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Mark Joseph Enyedy: Great. So, Jess, on the cash piece, there are really two components built into the partnering element of it, one of which relates to milestone payments from our legacy partnering deals, whether it's Roche, Novartis, et cetera, and some of the newer deals. In fact, Citomix, we just earned a milestone there. And so there's an element of that, and then there is a separate component related to active partnering discussions. We have inbound interest in a partnership in China, and so we have assumed in 2020 that we will get a partnership deal done for Mervituximab in China. And so both of those components are built into the cash forecast. I guess what I would say is we won't break those elements out separately, in part for competitive reasons as we think about negotiating upfront fees with potential partners in China. But what I would say is we've got a pretty strong track record here of completing the deals that we put in scope as a business, certainly over the last couple of years. And so we don't put those numbers in unless we have a reasonable degree of confidence that we can make those deals.
[music].
Unknown Executive: Great. Thank you. Sure. Thank you. I am not showing any further questions at this time. I would now like to turn the call back over to Mark Enyedy for closing remarks.
Mark Joseph Enyedy: Great. Well, thank you all for joining us this morning. I hope you and your families are safe and well, and we look forward to emerging from this and continuing to report our progress. In particular, I am very much looking forward to the ASCO presentation and also the ACR poster. So thanks very much and look forward to talking again soon. Ladies and gentlemen, this concludes today's conference call. Thank you for participating.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: [inaudible] BF-WATCH TV 2021