Q4 2020 ImmunoGen Inc Earnings Call
Good morning, and welcome Tim You know Jan sports quarter, and full year, 'twenty and 'twenty financial and operating results Conference call. Today's conference is being recorded at this time I'd like to turn the call of the Courtney O'connor senior director of <unk>.
Unknown Executive: Welcome to ImmunoGen's 4th Quarter and Full Year 2020 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Bob.
Courtney O'Connick: And now, I'm going to turn the call over to Courtney O'Connick, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
Corporate communications and Investor Relations. Please go ahead.
Courtney O'Connick: Good morning, and thank you for joining today's call. Earlier today, we issued a press release that included a summary of our recent progress and fourth quarter and full year 2020 financial results. This press release and a recording of this call can be found in the Investors and Media section of our website at ImmunoGen.com. With me today are Mark Enyedy, our President and CEO, Anna Berkenblit, our Chief Medical Officer, and Susan Altshuler, our CFO.
Good morning, and thank you for joining today's call earlier today, we issued a press release that includes the summary of our recent progress and fourth quarter and full year 'twenty and 'twenty financial results. This press release and a recording of this call can be found under the investors and media section of our website at Immunogen Dot Com with me today are mark entity, our president and CEO.
And and broken Blitt, our Chief Medical Officer, and Susan Altshuler, our CFO during today's call. We will review key accomplishments of the business over the last 12 months, our financial results and highlight upcoming anticipated events.
Courtney O'Connick: During today's call, we will review key accomplishments for the business over the last 12 months, our financial results, and highlight upcoming anticipated events. 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 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 and investment in the Immunogen are included in our SEC filings and with that I'll turn the call over to Mark.
Mark Joseph Enyedy: Thanks, Courtney. Good morning, everyone, and thank you for joining us today. Despite the challenges of the pandemic, 2020 was a transformative year for ImmunoGen, as we adjusted to new ways of working, advanced our portfolio, strengthened our management team and balance sheet, and positioned the business for two potential product launches next year. Just to expand on a few of these points, beginning with our lead program, Mervituximab, and ovarian cancer. As a reminder, our goals for this program are to obtain initial approval as monotherapy in patients with platinum-resistant disease in 2022 and to expand into earlier lines of therapy with an emphasis on combination therapy. We made significant progress towards each of these objectives over the last year.
Thanks, Courtney and good morning, everyone and thank you for joining us today. Despite the challenges of the pandemic 'twenty and 'twenty was the transformative year for immunogen as we adjusted to new ways of working advanced our portfolio strengthen our management team and balance sheet and position the business for two potential product launches next year just to.
And on a few of these points beginning with our lead program or if it talks of mab and ovarian cancer.
As a reminder of our goals for this program are to obtain initial approval as mono therapy and patients with platinum resistant disease, and 2022 and to expand into earlier lines of therapy with an emphasis on combination regimens, we made significant progress towards each of these objectives over the last year with our monotherapy program.
Mark Joseph Enyedy: With our monotherapy program, we expect to deliver top-line results in the third quarter and to submit the BLA by the end of this year to support accelerated approval in 2022. For our combination studies, we presented impressive data at both ASCO and ESMO last year, demonstrating that mirvotuximab has the potential to serve as the combination agent of choice in both platinum-sensitive and platinum-resistant ovarian cancer. Anna will cover these results in more detail later in the call.
We expect to deliver top line results and the third quarter and to submit the BLA by the end of this year to support accelerated approval in 2022.
For our combination studies, we presented impressive data at both <unk> and ESMO last year, demonstrating that more of a tux of mab has the potential to serve as the combination agent of choice and both platinum sensitive and platinum resistant ovarian cancer and I will cover these results in more detail later in the call with the benefit of the data generated thus far we.
Mark Joseph Enyedy: With the benefit of the data generated this far, we believe there is the potential to obtain compendia listings for combination use of mervitoximab in close proximity to our initial monotherapy approval. Turning to our second pivotal program, IMGN-632, which is our CD123-targeting ADC. We were pleased to receive breakthrough therapy designation for relapsed refractory BPD-CN in the fourth quarter and to align with FDA on a path to support potential full approval in patients with BPD-CN.
Believe there's the potential to obtain compendium listings for combination use of more of a talks of mab and close proximity to our initial monotherapy approval.
Turning to our second pivotal program I M G and 632, which is our CD 123 targeting ADC. We were pleased to receive breakthrough therapy designation and relapsed refractory B P. D C N and the fourth quarter and to align with the F. D. A on a path to support potential full approval and patients with B P. D C and updated data presented at Ash.
Mark Joseph Enyedy: Updated data presented at ASH 2020 demonstrated the encouraging anti-tumor activity and favorable safety profile we've seen with 632 in the clinic and increased our confidence in its potential to become the best-in-class treatment option for patients with BPD-CN. In addition to our late-stage portfolio, our pipeline includes two additional innovative ADCs. In November, we enrolled the first patient in the Phase I Dose Escalation Study of IMGC-936, which we are co-developing with Macrogenics. IMGC-936 is a first-in-class ADC directed to ADAM9, which is a novel target expressed on a wide range of solid tumors. In tandem, we advanced our next-generation anti-FR-alpha ADC, IMGN-151, into preclinical development.
2020 demonstrated the encouraging antitumor activity and favorable safety profile, we've seen with 632, and the clinic and increase our confidence and its potential to become the best in class treatment option for patients with B P. D C N and.
In addition to our late stage portfolio or pipeline includes two additional innovative adcs and November we enrolled the first patient and the phase one dose escalation study of <unk> nine and three six which we are co developing with Macrogenics 936 is the first in class ADC directed the Adam line, which is a novel target expressed on.
The wide range of solid tumors and tandem we advanced our next generation anti F. Our alpha ADC I M G and 151 into preclinical development.
Mark Joseph Enyedy: 151 integrates innovation into each of the three components of the ADC, which should allow us to address patient populations with lower levels of FR-alpha expression, including tumor types outside of ovarian cancer. A key element of our strategy is partnering, where we made notable progress in 2020 with our agreement with Huadong Medicine to develop and commercialize Mervituximab in Greater China. This collaboration is off to a strong start, with Huadong recently receiving acceptance of an IND application for Mervituximab in China from the NMPA. Finally, through a combination of business development and activity under our ATM facility, we added more than $140 million to our balance sheet in the fourth quarter.
151 integrates innovation into each of the three components of the ADC, which should allow us to address patient populations with lower levels of fr alpha expression, including tumor types outside of ovarian cancer.
A key element of our strategy of partnering where we made notable progress in 'twenty and 'twenty with our agreement with what on the medicine to develop and commercialize Rituximab and greater China. This collaboration is off to a strong start with hard on recently, receiving acceptance of and I N D application from Marvin talks of Mab and China from the and M. P. A.
Finally through a combination of business development and activity under our ATM facility, we added more than $140 million to our balance sheet and the fourth quarter on the strength of our performance in 'twenty and 'twenty. We were excited about the year ahead. The several important milestones as I mentioned earlier on the call from more of a tux and map, we expect to report top line data.
Mark Joseph Enyedy: On the strength of our performance in 2020, we are excited about the year ahead with several important milestones. As I mentioned earlier in the call, for Mervituximab, we expect to report top-line data for psoriasis in the third quarter, followed by a submission by the end of the year. We also anticipate sharing final data from the Forward II doublet cohort evaluating Mervituximab in combination with Evazizumab and recurrent ovarian cancer at ASCO in June.
It's a rare and the third quarter, followed by a submission by the end of the year. We also anticipate sharing final data from the floor to doublet cohort evaluating bavituximab in combination with Bevacizumab and recurrent ovarian cancer at Astro in June for Us.
Mark Joseph Enyedy: For IMGN 632, we expect to complete enrollment and share top-line data for our pivotal front-line cohort in the Phase I-II BPD-CN study in 12 to 18 months. We also plan to report data from our combination regimens evaluating IMGN 632 with azacitidine and or venetoclax in patients with relapsed refractory and front-line AML at ASH. For IMGC 936, we will continue to enroll patients in the phase one dose escalation study and anticipate initial data late this year or early next.
The M G and 632, we expect to complete enrollment and share top line data for our pivotal frontline cohort and the phase one to be P. D C and study and 12 to 18 months. We also plan to report data from our combination regimens of evaluating IMG and 62 with the he's decided in an or of a need of clocks and patients with relapsed refractory and frontline.
Line AML at Ash.
And for IMG see 936, we will continue to enroll patients and the phase one dose escalation study and anticipate initial data late this year or early next and for IMT and 151, we plan to submit the IND by year and so with a full calendar of the important events. We look forward to of productive 2021 with that I'll turn the call over.
Mark Joseph Enyedy: And for IMGN 151, we plan to submit the IND by year end. So with a full calendar of important events, we look forward to a productive 2021. With that, I'll turn the call over to Anna to provide some additional color on our clinical programs.
And the Ana to provide some additional color on our clinical programs Anna.
Thanks, Mark we have covered the ongoing progress and upcoming milestones for a member of a toxin that monotherapy program. So I'll direct my comments this morning to our combination studies.
Anna Berkenblit: Thanks, Mark. We have covered the ongoing progress and upcoming milestones for our mirvotoximab monotherapy program. So I'll direct my comments this morning to our combination studies. Starting with the Mervitoximab plus Bevacizumab combination, we presented initial efficacy and safety data of the doublet from our Phase 1b Forward 2 study in platinum agnostic recurrent ovarian cancer at an oral session at ASCO 2020. We are particularly encouraged by the overall response rate of 64% observed in patients with high FR-alpha expression, regardless of platinum status, and look forward to the continued evaluation of mirvotoximab with bevacizumab in this growing population of recurrent ovarian cancer patients for whom a non-platinum-based regimen would be appropriate.
Starting with the merger took the Mab plus Bevacizumab combination, we presented initial efficacy and safety data of the doublet from our phase one be forward to study and platinum agnostic recurrent ovarian cancer and and oral session at <unk> 'twenty and 'twenty, we're particularly encouraged by the overall response rate of.
64% observed in patients with high Fr Alpha expression, regardless of platinum status and look forward to the continued evaluation of more of a it talks about with Bevacizumab and this growing population of recurrent ovarian cancer patients for whom of non platinum based regimen would be appropriate.
As Mark mentioned, we plan to present mature data from this study at <unk> This year.
We also presented final data from our forward two triplet cohort evaluating <unk> in combination with Carboplatin and Bevacizumab at ESMO, 'twenty and 'twenty and this cohort of patients with medium or high levels of folate receptor Alpha we observed the confirmed overall response rate of 83 per cent.
Anna Berkenblit: As Mark mentioned, we plan to present mature data from this study at ASCO this year. We will also present final data from our Forward 2 Triplet Cohort, evaluating mirvotuximab in combination with carboplatin and bethasizumab at ESMO 2020. In this cohort of patients with medium or high levels of folate receptor alpha, we observed a confirmed overall response rate of 83% with a median duration of response of 10.9 months and a median progression-free survival of 12.8 months.
With the median duration of response of 10.9 months and the median progression free survival of 12.8 months. These efficacy data are noteworthy as the population enrolled is more heavily pretreated with a greater percentage of patients having had more than one prior line of therapy as well as more prior targeted therapies, including deficits and.
And that and PARP inhibitors, then and previously published triplet trials and recurrent platinum sensitive ovarian cancer.
Anna Berkenblit: These efficacy data are noteworthy as the population enrolled is more heavily pretreated, with a greater percent of patients having had more than one prior line of therapy as well as more prior targeted therapies, including bevacizumab and PARP inhibitors, than in previously published triplet trials in recurrent platinum-sensitive ovarian cancers. Going forward, we will be supporting two investigator-sponsored trials to generate additional data for the mervitoximab plus carboplatin doublet this year, a randomized phase 2 study of about 140 patients with recurrent platinum-sensitive ovarian cancer and a 70-patient neoadjuvant study.
Going forward, we will be supporting two investigator sponsored trials to generate additional data for the merger talks of Nab plus carboplatin doublet the seer.
The randomized phase two study of about 140 patients and recurrent platinum sensitive ovarian cancer and the 70 patient and Neo adjuvant study.
Having generated a wealth of data demonstrating encouraging efficacy and favorable tolerability merger talks of Mab continues to show promise and combination. In addition to the potential for compendium listing contemporaneous with more of a tux of Matt's initial approval. We are working to define a formal path to label expansion for them or if it talks of Mad.
Yeah.
Moving to I M G and six three to having received breakthrough designation and alignment on a path to full approval and B P. D C and with FDA, we are enrolling up to 20 patients and the pivotal frontline cohort of the phase one and two study of I M. G and 632 in B P. D C N and expect to complete enrollment.
Anna Berkenblit: Having generated a wealth of data demonstrating encouraging efficacy and favorable tolerability, Mervituximab continues to show promise in combination. In addition to the potential for Compendia listing contemporaneous with Mervituximab's initial approval, we are working to define a formal path to label expansion for Mervituximab.
<unk> and generate top line data in 12 to 18 months.
Anna Berkenblit: Moving to IMGN-632, having received breakthrough designation and alignment on a path to full approval in BPD-CN with FDA, we are enrolling up to 20 patients in the pivotal frontline cohort of the Phase I-II study of IMGN-632 in BPD-CN and expect to complete enrollment and generate top-line data in 12 to 18 months. Notably, we have previously enrolled three patients who meet the frontline eligibility criteria and have observed clinical complete responses in all three of these patients. While we are unable to count these patients towards our prospective cohort of 20 patients, these data are encouraging.
Notably we have previously enrolled three patients who meet the frontline eligibility criteria and have observed clinical complete responses and all three of these patients.
While we are unable to count these patients towards our prospective cohort of 20 patients. These data are encouraging.
At Ash in December of last year, we presented updated safety and efficacy findings from the phase one two study of the I M. G and 632 in patients with relapsed refractory B P. D C and these.
And these data demonstrated an overall response rate of 29% in all of relapsed refractory patients.
This activity demonstrates the potential for I M G and six three too, particularly in patients who received prior intensive therapy, including those who received prior to grafts of Us E. R. E S.
Anna Berkenblit: At ASH in December last year, we presented updated safety and efficacy findings from the Phase 1-2 study of IMGN 632 in patients with relapsed refractory BPD-CN. These data demonstrated an overall response rate of 29% in all relapsed refractory patients. This activity demonstrates the potential for IMGN 632, particularly in patients who have received prior intensive therapy, including those who have received prior Tegraxifus ERZF. Importantly, IMGN 632 has a favorable safety profile without capillary leak syndrome, drug-related discontinuations, or drug-related deaths, and with a 0% 30-day mortality rate. Accordingly, it is well-tolerated as a brief outpatient infusion once every three weeks without the need for hospitalization for initial administration.
Importantly, I M. G and 632 has a favorable safety profile without capillary leak syndrome drug related discontinuation or drug related deaths and with the zero percent 30 day mortality rate.
Accordingly, it is well tolerated as a brief outpatient infusion once every three weeks without need for hospitalization for initial administration.
Taken together, the safety efficacy and convenience of I M G and six three to reinforce the potential of this C. D 123 targeting ADC as the best in class treatment option for the P. D C on patients.
Also at Ash, our collaborators at MD Anderson Cancer Center presented preclinical data in relapsed refractory AML that further support the combination of I M. G and 632 with a decided in and the need of clocks.
And AML cell lines and patient derived xenograft models. The triplet has demonstrated synergistic cell death with the potential to overcome resistance to then Asia and superior anti leukemia activity over both then Asia as the doublet and I M. G and 632 mono therapy. These data further support the and.
Anna Berkenblit: Taken together, the safety, efficacy, and convenience of IMGN 632 reinforce the potential of this CD123 targeting ADC as a best-in-class treatment option for BPDCN patients. Also at ASH, collaborators at MD Anderson Cancer Center presented preclinical data in relapsed refractory AML that further support the combination of IMGN 632 with azacitidine and venetoclax. In AML cell lines and patient-derived xenograft models, the triplet has demonstrated synergistic cell death with the potential to overcome resistance to VenAsa and superior anti-leukemia activity over VenAsa as a doublet and IMGN 632 monotherapy. These data further support the addition of a CD123 targeted ADC with a novel DNA damaging payload to standard of care in AML.
Dish and of of C. D 123 targeted ADC with a novel DNA damaging payload to standard of care in the AML.
Our phase one b slash two eight O. Two study is designed to determine the safety tolerability and preliminary anti leukemia activity of IMG and 632, when administered in combination with ease of siding and or the need of class two patients with relapsed and frontline C. D. One twenty-three Pos.
<unk> a M. L. The study is in the dose escalation phase and enrolling relapsed and refractory patients to determine the recommended phase two dose of IMG and 632 and combination we continue to observe encouraging initial anti leukemia activity and a well tolerated safety profile without dose limiting toxicity observed and.
Anna Berkenblit: Our Phase 1B-2802 study is designed to determine the safety, tolerability, and preliminary anti-leukemia activity of IMGN 632 when administered in combination with azacitidine and or venetoclax to patients with relapsed and frontline CD123 positive AML. The study is in the dose escalation phase and enrolling relapsed and refractory patients to determine the recommended phase 2 dose of IMGN We continue to observe encouraging initial anti-leukemia activity and a well-tolerated safety profile without dose-limiting toxicity observed in the triplets.
And the triplet.
We look forward to the continued evaluation of the IMG and 632 triplet and anticipate sharing data from this study at ash. Once we have identified a recommended phase two dose and schedule for the combination for further study.
We also continue to evaluate I M G and 632 as monotherapy and minimal residual disease positive AML.
With that I'll turn the call over to Susan to cover our financials Susan.
Anna Berkenblit: We look forward to the continued evaluation of the IMGN 632 triplet and anticipate sharing data from this study at ASH once we have identified a recommended phase 2 dose and schedule for the combination for further study. We also continue to evaluate IMGN 632 as monotherapy in minimal residual disease positive AML.
Thanks, Anna starting with our results for the full year, 'twenty and 'twenty, we generated $132 $3 million and revenue $68 $5 million of which came from noncash royalty revenue the remainder of coming from license and milestone fees, which include recognition of $60 5 million from the upfront fees previously.
We received under the collaboration with jet.
Susan Altshuler: With that, I'll turn the call over to Susan to cover our financials. Susan? Thanks, Anna. Starting with our results for the full year 2020, we generated $132.3 million in revenue, $68.5 million of which came from non-cash royalty revenues, the remainder coming from license and milestone fees, which include recognition of $60.5 million from the upfront fee previously received under the collaboration with GAD. Operating expenses were $154.7 million, comprised of $114.6 million of R&D expenses, compared with $114.5 million in 2019.
Operating expenses were $154 $7 million comprised of $114 $6 million of R&D expenses, compared with $114 $5 million and 2019, G&A expenses were $38 $6 million compared to $38 5.002 million 19.
In addition, we incurred a $1 5 million dollar of restructuring charge comprised substantially of retention cost.
We ended 2020 with $293 $9 million and cash on the balance sheet.
Subsequent to yearend and January we sold an additional $4 5 million shares of common stock through our ATM facility generating additional growth proceeds of approximately $35 million.
Susan Altshuler: G&A expenses were $38.6 million compared to $38.5 million in 2019. In addition, we incurred a $1.5 million restructuring charge comprised substantially of retention costs. We ended 2020 with $293.9 million in cash on the balance sheet. Subsequent to year-end, in January, we sold an additional 4.5 million shares of common stock through our ATM facility, generating additional gross proceeds of approximately $35 million. Turning to our financial guidance for 2021, we expect revenues to be between $65 and $75 million, operating expenses between $200 and $210 million, and cash and cash equivalents at year end to be between $140 and $150 million.
Turning to our financial guidance for 'twenty and 'twenty one.
We expect revenues to be between 65 and $75 million operating expenses between 202 hundred $10 million and cash and cash equivalents at year end to be between 140 and $150 million.
And this provides us with sufficient runway to fund operations into the second half of 'twenty and 'twenty two.
I'll point out that revenue guidance includes the assumption and a portion of the $40 million upfront license fee from Padang medicine will be recognized in 'twenty and 'twenty, one and the.
The upfront fee will be amortized overtime as clinical supply requirements are delivered.
In addition, immunogen expects its noncash royalty revenue to reduce starting in the second half of this year based on the terms of prior royalty transactions for kids and Iowa.
With that I will turn the call over to Mark for closing comments Mark. Thanks, Susan So after the transformative 2020, we entered this year with significant momentum and strong prospects for the business with an important near term pivotal readout for our lead program. Our second pivotal program with data and 12 to 18 months are earlier stage.
Folio of accelerating and a strong cash position to carry us past, our first approval we of the right strategy team and resources in place to generate value and the near and long term as we transition to a fully integrated oncology company and bring our first two products to market and 2022 with that we'll open the call for questions.
Susan Altshuler: This provides us with sufficient runway to fund operations into the second half of 2022. I'll point out that revenue guidance includes the assumption that a portion of the $40 million upfront license fee from Huadong Medicine will be recognized in 2021, as the upfront fee will be amortized over time as clinical supply requirements are delivered. In addition, ImmunoGen expects its non-cash royalty revenues to decrease starting in the second half of this year based on the terms of prior royalty transactions for Quetzala.
Thank you ladies and gentlemen, if you have a question at this time. Please press the star followed by the number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key once again to ask the question. Please press Star and then one now.
Mark Joseph Enyedy: With that, I will turn the call over to Mark for closing comments. Mark?
And our first question comes from John Newman from Canaccord. Your line is open.
Mark Joseph Enyedy: Thanks, Susan. After a transformative 2020, we entered this year with significant momentum and strong prospects for the business. With an important near-term pivotal readout for our lead program, a second pivotal program with data in 12 to 18 months, our earlier stage portfolio accelerating, and a strong cash position to carry us past our first approval, we have the right strategy, team, and resources in place to generate value in the near and long term as we transition to a fully integrated oncology company and bring our first two products to market in 2022.
Hi, guys. Good morning, Thanks for taking my question just two quick questions here first one.
For the forward one study from Rituxan Mab and I believe you had previously over enrolled the study a bit.
And obviously I know that things are difficult of different and the COVID-19 environment.
But I'm just curious as to whether you would be open to some additional patient enrollment for Surya if the demand is there. Thanks.
Unknown Executive: With that, we'll open. Thank you. Ladies and gentlemen, if you have a question at this time, please press the star followed by the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Once again, to ask a question, please press.
Thanks, John.
We over enrolled forward one by about 10%, which is really the upper limit that's considered acceptable when you're thinking about study design are you know you want to enroll the patients to answer the question that you set out to answer.
It turned out debt with forward one enrollment at the end was very brisk and so it worked out to patients a benefit because of where patients who met all of the eligibility criteria had consented and thankfully we were able to accommodate you know about 10% more than we had originally designed the study.
John Lawrence Newman: Please press star and then 1 now. And our first question comes from John Newman from Canaccord. Your line is open.
Mark Joseph Enyedy: Hi, guys. Good morning. Thanks for taking my question. I just have two quick questions here. The first one... For the Forward One study from Rivertuximab, I believe you had previously over-enrolled that study a bit. Obviously, I know that things are difficult and different in the COVID environment, but I'm just curious whether you would be open to some additional patient enrollment for psoriasis if the demand is there
Before I wouldn't be surprised if the same of course with the rep and mirasol.
Great. Thank you.
And the second question I have regarding compendium listing potential companion listing for more of a tuck Smith of combination therapy.
Just curious how soon after Merck protection of approval as a monotherapy might you be able to file for that compare delisting. Thanks.
Mark Joseph Enyedy: Thanks, John. So we over-enrolled Forward One by about 10%, which is really the upper limit that's considered acceptable when you're thinking about study design. You know, you want to enroll patients to answer the question that you set out to answer. It turned out that with Forward One, enrollment at the end was very brisk, and so it worked out, you know, to patients' benefit, because there were patients who met all the eligibility criteria and consented. And thankfully, we were able to accommodate, you know, about 10% more than we had originally designed the study for. I wouldn't be surprised if the same happens with psoria and Neurosoft.
Yeah, almost immediately John so what's required of US two peer reviewed publications and so the expectation is to get the results of of the two cohorts that we've run so far with Mers and Sars.
And to journals and then use that as the basis for the submission, but the expectation is to move very quickly. Following the initial approval to work with the companion to have those studies.
Studies included in their treatment guidelines.
Okay, great. Thank you very much.
Thank you. Our next question comes from Michael Schmidt from Guggenheim Securities. Your line is open.
Hi, Good morning. This is ebay on for Michael Congrats on the progress and thanks for taking the question.
Mark Joseph Enyedy: Great, thank you. The second question I have regarding compendialistin, potential compendialistin for myrvituximab combination therapy. I'm just curious, how soon after Mervituximab approval as a monotherapy might you be able to file for that compendialistin? Yeah, almost immediately, John.
Our first question is on or with US. The maps are maybe can you provide any color on the mirv of asking combo of maturity that will be presented nasco.
Mark Joseph Enyedy: So, you know, two peer-reviewed publications. And so, the expectation is to get the results of the two cohorts that we've run so far with Merck and Bev into journals and then use that as the basis for the submission. But the expectation is to move very quickly following the initial approval to work with the compendium to have those studies included in their treatment guidelines.
And since there isn't the no one standard of care treatment for platinum agnostic ovarian cancer.
How should we think of the efficacy bar in this population to inform the next steps.
Yeah. So as a reminder of last year and Lucy Gilbert and ask on presented data from the platinum agnostic cohort of more of a talks of math, plus avastin and and the fr Alpha high population.
Anna Berkenblit: Okay, great, thank you very much. Thank you. Our next question comes from Michael Schmidt from Guggenheim Security. Your line is open. Hi, good morning, this is Ige Unvermeyko, congratulations on the progress and thanks for taking our question. Our first question is about the Mervitux map. Maybe can you provide any color on the Merv vaccine combo maturity that will be presented at ASCO? And since there isn't a known standard of care treatment for plasma agnostic ovarian cancer, how should we think of the efficacy bar in this population to inform the next step?
And overall response rate was 64 per cent in patients with platinum resistant disease. So that subset. The response rate was 59% and and the platinum sensitive recurrent subset.
And the high Sixty's both of these number of risk.
Spot rates compare favorably to what you would see the standard of care and these populations. So for Avastin plus chemotherapy. The confirmed response rate is 27 and 28%. So the arbitrage and <unk> plus avastin data on look quite nice relative to that and the platinum resistant disease turning to of recurrent platinum sensitive.
Anna Berkenblit: Yeah, so as a reminder, last year, Lucy Gilbert and ASCO presented data for the platinum agnostic cohort of Mervituximab plus Avastin, and in the FR-alpha high population, the confirmed overall response rate was 64%. In patients with platinum-resistant disease, so that subset, the response rate was 59%, and in the platinum-sensitive recurrent subset, it was in the high 60%. Both of these numbers, these response rates, compare favorably to what you would see with standard of care in these populations.
These are with platinum based doublet with just one prior line of therapy, you typically get a response rate and the and the low fifty's and so our response rate and the sixties us quite nice when you think about the fact that we're not exposing patients again to platinum based therapy. So I think this will give us.
Really some nice options to consider as we think about the form of label expansion and in the meantime, as you heard from Mark will be solidifying the the approach for compendium listing.
Got it thanks, and then the next question 632.
Anna Berkenblit: So, for Avastin plus chemotherapy, the confirmed response rate is 27-28 percent. So, the Mervituximab plus Avastin data look quite nice relative to that in Latin resistant disease. Turning to recurrent platinum-sensitive disease, with platinum-based doublets, with just one prior line of therapy, you typically get a response rate in the low 50s, and so our response rate in the 60s is quite nice when you think about the fact that we're not exposing patients again to platinum-based therapy. So I think this will give us really some nice options to consider as we think about formal label expansion, and in the meantime, as you heard from Mark, we'll be solidifying the approach to compendia listing.
And said you enroll up to 20 frontline patients to clear bars, and 10% CR or Cri can you maybe elaborate a little on.
On the potential scenario that you don't need to enroll 20 patients to meet the primary endpoint or is.
In other words, what would be the minimum number of patients you need and this cohort.
Sure I would point you to Alzheimer's as a relevant regulatory precedent.
When you look at their label you will see that they've received full approval based on their CR CRC range, and 13 and frontline V. P. D C on patients.
Got it that's helpful. That's all from all the questions. Thank you very much.
Anna Berkenblit: Got it. Thanks, Anna.
Anna Berkenblit: And then in the next question, 632, you said you would enroll up to 20 frontline patients to clear a bar of 10% CR or CRI. Can you maybe elaborate a little on the potential scenario that you don't need to enroll all 20 patients to meet the primary endpoint? Or in other words, what would be the minimum number of patients you need in this cohort?
Thank you.
Next question comes from Boris Speaker from Cowen Your line is open.
Good morning, My first question I, just wanted to ask from a Rituximab can you talk about the manufacturing specifically where is it manufactured on which companies are involved and what other steps are required to do and manufacturer and whether its assay validation and or any kind of studies prior to submitting the BLA.
Anna Berkenblit: Sure. I would point you to Alzheimer's as a relevant regulatory precedent. When you look at their label, you will see that they received full approval based on their CR-CRC rate in 13 frontline BPD-CN patients.
Sure.
You have the you'll all recall and key components to new and ADC together, where the conjugation step to bring each of the components together so the antibody.
Anna Berkenblit: Got it. That's helpful. That's all for our questions. Thank you very much. Thank you. Our next question comes from Boris Peaker from Cowen. Your line is open. Good morning.
It's produced by Beringer Ingelheim.
Linker and produce.
And that's AFC Sigma Aldrich.
Mark Joseph Enyedy: My first question is, from Irva Tuxenow, can you talk about the manufacturing, specifically where it is manufactured, which companies are involved, and what other steps are required to do in manufacturing, whether it's assay validation or any kind of studies prior to submitting the BLA? Sure, so you all recall three components to an ADC together with a conjugation step to bring each of those components together. So the antibody is produced by Behringer Engelheim, the linker is produced by... at SAFC, Sigma Aldridge, and the payload is produced by Tevis P-Core, and then we use BFP for the conjugation steps.
And the payload is produced by the US kind of C Corps, and then we use the FSP and worse.
Of the conjugation steps so.
We're in good shape in terms of validation for the talks on that and we have all of the relevant assay.
And place.
And so we should be and good shape concern.
At the time that we are ready for inspection following the BLA submission for this facility.
Great and my last question Us on 632 on P. B D C and I'm, just curious kind of where you would take us on how it'll compete with El Zol and <unk> commercially if approved.
Mark Joseph Enyedy: So we're in good shape in terms of validation for myelotoximab, we have all of the relevant assays in place, and so we should be, you know, in good shape in terms of, you know, at the time that we're ready for inspection following a BLA submission for this facility. Great. And my last question is on 632MPBDCN.
Yeah.
I think on the basis of the key parameters of.
Of the pharmaceutical commercialization so.
Those are efficacy safety and patient convenience and.
And that's based on the data and we generated the day, we're going to compare quite favorably and particularly as it relates to safety and convenience.
Mark Joseph Enyedy: I'm just curious kind of what your take is on how it'll compete with Alzheimer's commercially if approved. Yeah, we would compete, I think, on the basis of the key parameters of pharmaceutical commercialization. So, you know, those are efficacy, safety, and patient convenience. And I think that based on the data we've generated today, we're going to compare quite favorably, particularly as it relates to safety and convenience, you know, looking at their label versus the efficacy that we've generated to date.
And their label versus the Michigan that we've generated to date.
All of the relevant parameters there.
Think built and our favorite based on the data we've generated the day.
Look at those onerous.
Patient is required to be admitted into the hospital for at least five days.
<unk> therapy treatment with <unk>.
The minute outpatient infusion so on all of those parameters of the emerge.
The <unk> profile, we see and we think we will compare quite favorably and that would be the basis for competition.
Mark Joseph Enyedy: You know, all the relevant parameters there, we think, tilt in our favor based on the data we've generated to date. Now, if you look at Alzheimer's, you know, a patient is required to be admitted into the hospital for at least five days to initiate therapy treatment with 632, the 30-minute outpatient infusion.
Great. Thanks for taking my questions.
Thank you. Our next question comes from Andy Shay from William Blair. Your line is open.
Oh, great. Thanks for taking my questions and very much look forward to the very eventful 2021.
Mark Joseph Enyedy: So, on all those parameters, you know, the emerging profile we see, we think, will compare quite favorably, and that would be the basis for competition. Great, thank you for taking my question. Thank you.
So.
And I just have a couple of questions for four and in terms of kind of framing expectations for ESCO and so first of all.
With this fee the same 60, roughly 60 patient population with longer follow up and.
Unknown Executive: This call comes from Andy Shea from William Blair. Your line is open.
Unknown Executive: Oh, great. Thanks for taking my questions, and I very much look forward to a very eventful 2021. So, I just have a couple of questions for Anna in terms of kind of framing expectations for ASCO. So, first off, would this be the same roughly 60 patient population with longer follow-up at ASCO this year?
And as I'm sure.
Yes, Sandy so I'm.
And I, probably should've mentioned that one of the previous question was asked yes, it's the same number of patients.
And what you will see in addition to Oh, our R&D and on which we shared last year you will know the duration of response data and PFS data and now that we've been following patients.
For a longer period of time, and we remain quite encouraged about the potential with the combination.
Anna Berkenblit: Yes, Andy. I probably should have mentioned that when the previous question was asked. Yes, it's the same number of patients. And what you will see, in addition to ORR data, which we shared last year, you will now see duration of response data and PFS data now that we've been following patients for a longer period of time. And we remain quite encouraged about the potential for this combination.
Great great.
And do you mind reminding me. So I believe there were about 40% of the patients who have previous of Boston.
Did you see the higher efficacy activity.
And that the naive patients among the the 60 enrolled.
Anna Berkenblit: Great, great. And Do you mind reminding me, so I believe there were about 40% of the patients who had previous Avastin treatment. Did you see higher efficacy activity in Avastin naive patients among the 60 enrolled?
When we look at that Andy It was kind of hard to tease apart because of that and used was also correlated with the number of prior.
You know given the small data set you couldn't take them apart.
I see okay.
And that makes sense and then.
For the two Isps.
Anna Berkenblit: When we looked at that, Andy, it was kind of hard to piece apart because the vast number of priors was also correlated with the number of priors. So, you know, given the small data set, you couldn't pick them apart.
I didn't really catch that so did you say that.
The the 145 patients and the 70 patients after the.
The.
You say us news are on.
Anna Berkenblit: I see. Okay, that's, yeah, that makes sense. And then for the two ISTs, I didn't really catch that. So did you say that the 145 patients and the 70 patients are progressing well and could have data soon?
And are progressing well and have data soon.
So these two Isps are exploring Marvin talked from the App, plus carboplatin and with very encouraging data from our phase one dose escalation study for the doublet. It looks basically like the mirv Carbo doublet performs like you would expect per our platinum based triple and without the benefit of the math on the basis of those.
Anna Berkenblit: So, these two ISTs are exploring myrbatoxamab plus carboplatin, and we have very encouraging data from our phase one dose escalation study for the doublet. It looks basically like a myrb-carbo-doublet performs like you would expect for a platinum-based triplet without the bevacizumab. On the basis of these encouraging preliminary data, two investigators came to us with ideas for further exploration of this myrb-carbo-doublet. The first is Dr. Harder in Germany, we're working with the AGO, and they're doing a randomized phase two myrb-carbo, this myrbatoxamab, continued outback as maintenance versus standard platinum-based therapy with or without maintenance in the recurrent platinum-sensitive setting, and that study is getting up and running.
The encouraging preliminary data to investigators came to us with ideas for further exploration of this mark Carbo doublet, the first and Dr. Harder in Germany, we're working with the AGL and Theyre doing a randomized phase two.
Cargo and <unk>.
And that continues and how fast is maintenance.
<unk> platinum based therapy with or without maintenance.
Platinum sensitive setting and that study is getting up and running.
Similarly, Rebecca.
And Ohio State came to us from many of the adjuvant concept, that's being run at several centers and the US here and this is really the first opportunity for us to get more of a toxin that into the front line setting.
And so that's the 70 patients it's really the feasibility study and with some translational and correlative science built in and that also is getting up and running.
Anna Berkenblit: Similarly, Rebecca Arendt at Ohio State came to us with a neoadjuvant concept that's being run at several centers in the U.S. here, and this is really the first opportunity for us to get myrbatoxamab into the frontline setting, so that's a 70 patient feasibility study with some translational and correlative science built in, and that also is getting up and running. I think I can't speak for the investigators regarding when the data will be available.
I can't speak for the investigators regarding when data will be available.
Okay got.
Got it and that's that's helpful. Thank you very much.
Yeah.
Thank you. Our next question comes from Kennan Mackay from RBC capital markets. Your line is open.
Hi, Congrats on the progress in 2000, and Tony and Thanks for taking the question I.
I guess and Bruce Wood.
What most of the understand.
Anna Berkenblit: Okay, I got it. That's helpful. Thank you very much.
And how you're thinking about sort of of commercial build you know ahead of us and anticipated.
Unknown Executive: Thank you very much. Thank you. Our next question comes from Kenan McKay from RBC Capital Markets. Your line is open.
Our BLA filing and sort of the back half of the Europe, you'll be retrained.
Unknown Executive: Hi, congrats on the progress in 2020. And thanks for taking the question. I guess first, we'd love to understand how you're thinking about sort of a commercial build, you know, ahead of the anticipated BLA filing and sort of the back half of the year, if you'll be returning to sort of the pre-hiring strategy utilized previously, or again, just how you're thinking about that. And then secondly, ahead of the IND for 151, just wanted to sort of understand your perspective on the unmet Thanks.
We're trying to sort of the pre hiring us strategy.
And as previously and again, just how you're thinking about that and then secondly.
How does the the R&D for the 151, just wanted to sort of understand.
And your perspective on on the unmet.
Unmet need, but that antibodies address and doses versus more.
The other prior.
Prior full of targeted ADC.
Adcs or small molecule. Thanks.
Sure I'll start with the commercial planning and then hand, it over to Anne and I'll talk about 151 and so.
This is a relatively concentrated market, Kevin and when do you think about physician targets.
Mark Joseph Enyedy: Sure, I'll start with the commercial planning and then hand it over to Anna to talk about 151. This is a relatively concentrated market, Kennan, when you think about physician targets and referral patterns and the like. And so we think that the commercial investment required to support a robust launch will be well within our ability to finance and manage.
And and.
Referral patterns and the like and so we think that the commercial and investment required to support of robust.
Launch will be well within our ability to finance and manage and so on.
Mark Joseph Enyedy: So our efforts at this point are concentrated more on market research, understanding, you know, physician-patient segmentation, where these patients are, their pay or mix, those kinds of issues. And once we have the benefit of the Saraya readout, we will move in earnest in terms of recruiting a sales force, sales management, and the like. In parallel with that, we, of course, are developing a distribution Plan, again working with some outside support to define, you know, how we will approach distribution, again with the goal of lining up vendors that we could move forward to definitive agreements with post-Saraya readout.
Our efforts at this point are concentrated more on market research to understand the physician and patient segmentation, where these patients are on payer mix of those kinds of those kinds of issues and once we have the benefit of the <unk>.
And so ray and read out we would move and Ernest in terms of recruiting.
Our sales force sales management, and the like and parallel with that we of course, there are developing of distribution plan again working with some outside support the define how we will approach distribution again with the goal of the lineup vendors that we could move forward.
The two definitive agreements with post the survey of read out so as we think about spend.
Mark Joseph Enyedy: So, you know, as we think about, you know, spending for this year, you know, we will see some, you know, some expenditures in the earlier parts of the year as we work through some of these planning exercises, and then the, you know, significant expenditure with the benefit of a positive readout, and certainly ramping heavily in the fourth quarter of this year in anticipation of the filing and approval in 2022. So, let me just pause and ask if you have any follow-up there, and if not, I'll turn it over to Anna. No, that's really helpful. I appreciate that, Colin. Thank you.
For this year, we will see some.
And some expenditures and the earlier parts of the year as we work through some of these planning exercises and then.
The significant expenditure with the benefit of a positive read out and.
And certainly ramping heavily in the fourth quarter of of this year and anticipation of the filing and.
And the approval in 2022, so let me just pause and NASA of any follow up there and if not I'll turn it over to Anna.
Yeah.
No that's really helpful. I appreciate the color. Thank you.
Anna Berkenblit: So turning to IMGN151, which is our next-generation, bi-paratopic, FR-alpha-targeted ABC, we've really designed it to address a broader population of FR-alpha-positive tumors. And we did that by targeting two separate epitopes of folate receptor alpha, which allows greater internalization events and greater cell killing. We also have a stable linker-peptide combination that allows for even greater stability in the circulation than with mervitoximab. And the payload itself, DM21, is a bit more hydrophobic, so once the ABC is internalized, you get even more bystander killing, which can help with some of the heterogeneity of FR-alpha expression.
So turning to the IMG and one last one which is our next generation five per topic.
Our alpha targeted ADC, we've really designed to address the broader population of the fr Alpha positive tumors and.
And we've done that by targeting two separate epitopes on folate receptor Alpha, which allows us greater internalization of ASP and greater cell killing.
Also have a stable linker peptide combination that allows for even greater stability and the and the circulation and then was my top of the model and the payload itself at the end of 'twenty, one is a bit more hydrophobic the once the ADC is internalized.
And you get.
Even more by standard Kilian, which can help with some of the heterogeneity of the fr Alpha expression.
Anna Berkenblit: So, with that in mind, we anticipate that IMG-M151 can address a broader population of patients. So, not just the 40% whom we know benefit from mervituximab, but with the FR-alpha high expression, but also the 40% additional FR-alpha positive tumors with lower medium expression. Because we know about 80% of ovarian cancers have FR-alpha expression, so that should really double the number And then moving to other tumor types, endometrial cancer, triple negative breast cancer, and lung cancer.
So with that in mind, and we anticipate the IMT and <unk> can address a broader population of patients.
The alpha positive.
So not just the 40% and we know benefit from or the top of the Nash, but with the fr Alpha high expression, but also the 40% additional fr alpha positive tumors with low and medium expression, because we know about 80% of fr Alpha of ovarian cancers have fr Alpha expression.
And so that should really double of the population for ovarian cancer.
Moving to other tumor types of endometrial cancer triple negative breast cancer and lung cancer.
Anna Berkenblit: You know, it's a little premature to say what the appropriate cutoff will be for those indications for patient selection, but we're confident, given the preclinical data we've generated thus far, that the potential for IMG and 151 is much broader than that of mervituximab.
So a little premature to say what the appropriate cutoff will be kind of indications for patient selection, but we're confident given the preclinical data and we generated thus far that the potential for LNG and 151 is much broader than that of America.
No.
Alright, thank you.
Anna Berkenblit: Our next question comes from Jessica Fye from J.P. Morgan. Your line is open. Good morning, this is Luke on behalf of Jess. Thanks for taking our questions. I guess to start, can you give us an idea of what sort of level of detail we can expect between the top line readout for Soraya in 3Q versus data coming later this year?
Thank you.
Next question comes from Jessica Fye from J P. Morgan Your line is open.
Good morning. This is Luke on for Jeff Thanks for taking our questions.
Just to start can you give us an idea of what sort of level of detail we can expect.
Between the top line readout for sure and.
The three Q versus data coming later this year.
Yeah.
Unknown Executive: A little hard to say right now, Lee, because we are able to pretty accurately assess when we'll have sufficient data for confirmed overall response rates by an investigator, which is our primary end point. Duration of response, as you know, needs to mature over time, and the better patients are doing on Mervituximab and Soraya, the longer their median duration of response will be.
A little a little hard to say right now the because.
We are able to pretty accurately assess when we will have sufficient data for.
First the overall response rate by the investigator, which one of our primary endpoints duration of response as you know our needs.
It needs to mature over time and the.
The better patients are doing on mirv, rituximab and for the ramp the longer the medium duration of response will be and so you know when we have material data we will share it.
Unknown Executive: Okay. And also, is there any additional color you guys can give us on the Quadong licensing fee?
Okay.
And then also is there any additional color you guys can give us on the.
Susan Altshuler: Should we expect that to be amortized, you know, sort of over the entire year? Longer than that? Shorter than that? When will we see those revenues totally recognized?
The one on the licensing fee.
Should we expect that to be amortized.
Order of over the entire year longer than that I'm sure that when the when can we see those revenues totally recognized.
Susan Altshuler: As we mentioned in our filing, the $40 million HWA-DONG upfront license fee will be recognized over time as clinical supply requirements are delivered. Therefore, our 2021 revenue guidance includes an estimated amount of the fee that will be amortized based on the current supply plan. Our estimate would be that potentially up to half of the fee could be recognized in 2021. But again, that's dependent on the supply plan, which will continue to be refined as HWA-DONG determines its regulatory strategy.
Yeah, and so you mentioned and our filing the 40 million went on upfront license fees will be recognized over time as clinical supply requirements are delivered and so our 'twenty and 'twenty. One revenue guidance includes an estimated amount of the fee that will be amortized based on the current supply plan.
Our estimate would be that potentially up to half of the fees could be recognized in 2021, but again, it's dependent on the supply plan, which will continue to be refined as we determined that the regulatory strategy.
Unknown Executive: All right. Thank you very much. Thank you. And our next question comes from Byron Amin from Jeffrey. Your line is open. Yeah, hi guys. Thanks for taking my questions. Maybe just one more on IMGN-159.
Alright, Thank you very much.
Thank you.
And our next question comes from Byron Amen from Jefferies. Your line is open.
Yeah, Hi, guys. Thanks for taking my questions, maybe just one more on the IMG and 151 I think you know with this compound Youre also seeing an increase and conjugate exposure by 40% over mirv and I think this has the also a higher half life and Merck So and maybe how do you. How are you thinking about the safety profile of one five.
Unknown Executive: And I think, you know, with this compound, you're also seeing an increase in conjugate exposure by 40% over MIRV, and I think this also has a higher half-life than MIRV. So Anna, maybe, how do you think about the safety profile of 151 as it compares to MIRV? In particular, the ocular toxins, you, you know, follow the IND by your end.
One of the comparison of Mirv and particular, the ocular tox as you file the IND by year end.
Anna Berkenblit: Yeah, so again, it's a little early to speculate, but, you know, the ocular adverse events that are seen with tubulin-directed payloads, so including Abraxane, and then ADCs with tubulin-directed payloads, including Orostatins and Macanzanoids, you know, I think it's reasonable to anticipate that there will be some ocular adverse events with IMGN 151, but it's not clear to me that it's linked in any regard to half-life specifically, so, you know, I think we're doing the pre-clinical data that we need to do to support the IMD, and we've also, you know, really figured out how to optimally manage the ocular adverse events, so we'll apply those lessons learned, you know, for when we consider patient study design in terms of lubricating eyedrops and things like that.
Yeah, so here and again until the early to speculate but.
The the ocular adverse events that are seen with tubular and directed payload.
Including Nebraska, saying, and then adcs directed payloads, including <unk>.
And they can and I think it's reasonable to anticipate the that there will be some ocular adverse events with IMG and one side, one, but it's not clear to me that it linked in any regard to halfway specifically so.
And I think we're doing the preclinical data that we need to do to support the IMT and we've also.
And really figured out how to optimally manage the ocular adverse events from the top of that so we'll apply those lessons learned.
You know for when we consider patient Ah study design in terms of lubricating eye drops and things like that.
Anna Berkenblit: And maybe just to follow up on that, are you seeing anything in your preclinical animal model studies with 151 as it relates to MRF in terms of just toxicity?
And maybe just a follow up on that are you seeing anything in your preclinical animal model studies.
With 151 as it relates and <unk>.
On Parison tumor and true.
Anna Berkenblit: Thank you.
Of just toxicity.
Unknown Executive: Great, thank you. Thank you. Our next question comes from Jonathan Chang from SVB Lyrinc.
Not at this point.
Great. Thank you.
Thank you. Our next question comes from Jonathan Chang from SBB Leerink. Your line is open.
Jonathan Chang: Your line is open. Good morning, and thanks for taking my question. Just one from me. Given the proximity of the potential psoriasis BLA filing and the mirosol data readout, can you talk about the risk, if any, that the regulators may want to see the results of mirosol before potentially approving morphotoxin?
Good morning, and thanks for taking my question just one from me.
And given the proximity of the potential serai of BLA filing and the mirror Salt data readout can you talk about the risk if any that the regulators may want to see the results of and aerosol before potentially of proofing architects of that.
Mark Joseph Enyedy: Yeah, we get this question fairly often. The answer is this: If the readout for psoriasis is positive, and the data meet the criteria for accelerated approval, which in this case would mean that the ORR and the DOR surpass that of available therapy, there is no basis for the FDA to delay regulatory action.
Yeah, we get this question fairly often the answer is this if the readout for survey is positive and the data and meet the.
Criteria for accelerated approval, which in this case of mean that the.
Or are on the DLR surpassed that of available therapy. There is no basis for the FDA to delay regulatory action.
Mark Joseph Enyedy: Got it. Thanks. Thank you. Our last question comes from Swayampakula.
Got it thank you.
Right.
Yeah.
Thank you.
Our last question comes from Swire, Coca Cola, where on the comp from H C. Wainwright. Your line is open.
Swayampakula Ramakanth: Ramakanth from H.C. Wainwright
Swayampakula Ramakanth: Your line is open.
Swayampakula Ramakanth: Thank you. Thank you for taking my question. Most of my questions have been answered, but I just have a...
Thank you and thank you for taking my question most of my questions have been answered, but just have them.
Mark Joseph Enyedy: I'm trying to understand what your commercialization strategy is in Europe for both Merva and also 632. Sure. So in both cases, again, these are highly concentrated markets, meaning the, you know, physician targets are limited. And so the commercial investments are, you know, modest and certainly something that we could undertake with our own.
And understand what you know of commercialization strategy is.
And the rope for tomorrow in the US was 62.
Sure. So in both cases again these are highly concentrated markets. Many of the physician targets of unlimited and so the commercial investments are modest and certainly something that we could undertake with our own.
Mark Joseph Enyedy: So we are evaluating those markets. We have a little bit of time as it relates to Mervituximab. We think that the EU will likely require the outcome of Mirasol as a basis for approval. We'll talk to them about this array of data, but our expectation is that they will probably want the results of a randomized controlled study to support approval. So we will revisit this over the course of the latter part of this year and into 2020. But again, both of those products could be commercialized by ImmunoGen, and we could support a robust launch in the markets in Europe.
Financing.
So we are evaluating those markets.
We have a little bit of time as it relates to more of a talks of NAV, we think that the.
You will likely require the.
The outcome of Mirasol as of <unk>.
Basis for approval and we'll talk to them about the survey of data, but our expectation is they probably will want the results of a randomized controlled study to support approval. So.
And we will revisit this over the course of the latter part of this year and into and through 2020, but again both of those products could be commercialized by us by immunogen.
And so we could support of robust launch and.
And in the markets in Europe.
Mark Joseph Enyedy: Thank you, Mark. Thanks for taking the time. Thank you. And that does conclude our question and answer session for today's conference. And I'd like to turn the conference back over to Mark Enyedy for any closing remarks. All right. Well, thank you all for the questions this morning. We're excited about the year ahead, and we'll look forward to reporting our progress in subsequent calls and during our major data presentations. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect. Everyone have a wonderful day.
Thank you Mark Thanks for taking the question.
Thank you and that does conclude our question and answer session for today's conference and I'd like to turn the conference back over to Mark entity for any closing remarks.
Great well. Thank you all for the questions. This morning, we're excited about the year ahead, and we will look forward to reporting on progress in subsequent calls and the around a major data presentations.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and you may now disconnect everyone have a wonderful day.
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