Q4 2021 ImmunoGen Inc Earnings Call

Operator: Good morning, ladies and gentlemen, and welcome to ImmunoGen's fourth quarter and full year 2021 Financial and Operating Results Conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney Okunic, Senior Director of Corporate Communications. Please go ahead.

Good morning, ladies and gentlemen, and welcome to immune against <unk> fourth quarter and full year 2021 financial and operating results conference call.

Today's conference is being recorded at this time I'd like to turn the call over to Courtney <unk> Senior director of corporate Communications. Please go ahead.

Courtney Okunic: 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 2021 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. Kristen Harrington-Smith, our Chief Commercial Officer, will also join us for Q&A.

Good morning, and thank you for joining today's call earlier today, we issued a press release that includes a summary of our recent progress and fourth quarter and full year 2021 financial results. This press release and a recording of this call can be found under the IND.

Vectors and media section of our website at Immunogen Dot Com with me today are mark entity, our president and CEO , Anna <unk>, Our Chief Medical Officer, and Susan <unk>, Our CFO Christian Harrington Smith, our Chief Commercial Officer will also join US for Q&A. During today's call will review recent accomplishments for the business or financial results.

Courtney Okunic: During today's call, we'll review recent accomplishments for the business, our financial results, and highlight upcoming anticipated events. We will use forward-looking statements with respect to our business strategy, the development and benefit of our product candidates, the design of our clinical trials, the presentation of clinical trial data for our product candidates, the anticipated timing of clinical trials and regulatory submissions to the FDA for certain product candidates, and the anticipated commercial launch for certain product candidates. Financial Guidance and our Cash Runway Each forward-looking statement is subject to risks and uncertainties that could cause our actual results to differ materially from those expressed.

And highlight upcoming anticipated events, we will use forward looking statements with respect to our business strategy the development and benefit of our product candidates. The design of our clinical trials. The presentation of clinical trial data for our product candidates the anticipated timing of clinical trials and regulatory submissions to the FDA for certain product candidates the anticipated commercial.

Launched for certain product candidates.

Gainesville guidance and our cash runway each forward looking statement is subject to risks and uncertainties that could cause our actual results to differ materially from such statements. These risks and uncertainties include those described in our press release issued this morning and in the risk factors section of our most recent annual report on Form 10-K , and our other SEC filings which are available.

Courtney Okunic: These risks and uncertainties include those described in our press release issued this morning and in the risk factor section of our most recent annual report on Form 10-K and our other SEC filings, which are available at sec.gov and on our website at immunogen.com. All of these forward-looking statements in this presentation speak only as of the original date of this call, and we undertake no obligation to update or revise any of these statements. With that, I'll turn the call over to Mark. Good morning, everyone, and thank you for joining us today.

At SEC Gov, and on our website immunogen Dot com. This pull forward looking statements in this presentation speak only as of the original date of this call and we undertake no obligation to update or revise any of these statements with that I'll turn the call over to Mark.

Good morning, everyone and thank you for joining US today 2021 was a productive year for immunogen, but significant progress across the business as we move towards our objective of becoming a fully integrated oncology company. In particular, we delivered resoundingly positive results in Syria or pivotal study from Merck with talks a mab in ovarian cancer.

Mark Enyedy: 2021 was a productive year for ImmunoGen, with significant progress across the business as we moved towards our objective of becoming a fully integrated oncology company. In particular, we delivered resoundingly positive results in SEREA, our pivotal study for myrtoxamab and ovarian cancer, generated compelling data with IMGN 632 and AML, advanced our earlier stage programs, established a plan to reignite our research engine, laid the groundwork to support our first commercial launch, and executed the single largest financing in the history of the company. With this progress, we've generated significant momentum in the business as we enter 2022.

Generated compelling data with IMG earn 632 in AML advanced our earlier stage programs established a plan to reignite our research engine laid the groundwork to support our first commercial launch and executed the single largest financing in the history of the company with this progress we've generated significant momentum in the business as we.

We entered 2022 to expand on these points starting with our lead program <unk> maps or a fanzine in ovarian cancer are top priority. This year is to gain accelerated approval from brokered talks and bad as a monotherapy in patients with folate receptor alpha positive platinum resistant disease due to this and we believe the positive topline survey.

Mark Enyedy: To expand on these points, starting with our lead program, myrtoxamab, for sore of tanzine and ovarian cancer, our top priority this year is to gain accelerated approval for myrtoxamab as a monotherapy in patients with folate receptor alpha-positive platinum-resistant disease. To this end, we believe the positive top-line SEREA data reported in late November positioned us for initial approval in this setting with We're on track to submit the BLA for myrtoxamab by the end of this quarter and are preparing for potential accelerated approval and launch in the second half of the year.

Data reported in late November positioned us for initial approval in this setting with significant unmet need.

On track to submit the BLA for <unk> by the end of this quarter and are preparing for potential accelerated approval and launch in the second half of the year. We also expect to generate data from our confirmatory Mirasol trial in the third quarter, which is intended to support full approval.

Mark Enyedy: We also expect to generate data from our confirmatory mirosol trial in the third quarter, which is intended to support full approval. As part of our comprehensive strategy to move mervituximab into broader patient populations and become the combination agent of choice in ovarian cancer, we've designed a number of additional company-sponsored studies and, in parallel, are supporting investigator-sponsored trials for mervituximab, which Anna will discuss in further detail In step with advancing the Mervituximab program towards regulatory approval, we began building our commercial and medical affairs organizations, now led by our chief commercial officer, Kristen Harrington-Smith, and our head of medical affairs, Dr. Mimi Huizenga.

As part of our comprehensive strategy to move more of a toxin mab into broader patient populations have become the combination agent of choice in ovarian cancer. We've designed a number of additional company sponsored studies and in parallel are supporting investigator sponsored trials from Robert talks about which Andrew will discuss in further detail shortly in the call.

In step with advancing the Mervyn talks map program towards regulatory approval, we began building our commercial and medical affairs organizations now led by our Chief Commercial Officer, Kristin Harrington Smith, and our head of Medical Affairs, Dr. Mimi Hi, Zynga launch preparations for more of a toxin map are well underway and are focused on <unk>.

Mark Enyedy: Launch preparations for Mervituximab are well underway and are focused on four key priorities. Redefining expectations for positive outcomes with Mervituximab and platinum-resistant ovarian cancer. Supporting adoption of early folate receptor alpha testing and establishing standards for in-house and centralized testing. Ensuring positive physician and patient experiences through tailored education and guidance for patient management.

Our key priorities redefining expectations for positive outcomes with <unk> in platinum resistant ovarian cancer supporting adoption of early folate receptor alpha testing and establishing standards for in house and centralized testing, ensuring positive physician and patient experiences through tailored education and guidance for.

Patient management, and seeking broad payer access and reimbursement and delivering a seamless patient experience we're off to a strong start building best in class sales marketing and medical education teams and have most recently added our head of sales.

Mark Enyedy: And seeking broad payer access and reimbursement and delivering a seamless patient experience. We're off to a strong start building best-in-class sales, marketing, and medical education teams, and have most recently added our head of sales. Our second program, Paweka-Madison Nearing, formerly known as IMGN 632, is progressing nicely. We've advanced our pivotal Cadenza study in BPD-CN and expect top-line data in the front-line cohort in the second half of this year. In addition to BPD-CN, we were pleased to present data from the triplet regimen evaluating PVEC in combination with azacitidine and venetoclax and relapsed refractory AML during an oral session at ASH and are encouraged by the safety profile and efficacy observed, particularly in the higher intensity cohorts.

Our second program for Iveco Madison nearing formerly known as <unk> $6. Two is progressing nicely. We've advanced our pivotal cadenza study in D. P. D C N and expect top line data in the frontline cohort in the second half of this year. In addition to BP D C and we're pleased to present day.

<unk> from the triplet regimen in evaluating <unk> in combination with Azacitidine is in need of class in relapsed refractory AML during an oral session at ash and are encouraged by the safety profile and efficacy observed, particularly in the higher intensity cohorts based on these data we have initiated an expansion cohort for the triplet in relapsed patients.

Mark Enyedy: Based on these data, we've initiated an expansion cohort for triplet and relapsed patients and expect to move into frontline patients during the year. Regarding our earlier stage portfolio, Ghost Escalation continues in the Phase I trial of IMGC 936, our first-in-class Adam 9 targeting ADC, which we are co-developing with macrogenics and multiple solid tumor types, and it dissipates data from this program later this year We have also submitted the IND for IMGN151, our next-generation anti-folate receptor alpha ADC.

I expect to move into frontline patients during the year.

Regarding our earlier stage portfolio dose escalation continues in the phase one trial of I M. G. C 93, six our first in class Adam nine targeting ADC, which we are co developing with macrogenics in multiple solid tumor types and anticipate sharing data from this program. Later this year, we also submitted the IMD.

For IMG earn 151, our next generation anti folate receptor alpha ADC due to a delay in drug product production at our vendor F. D. A place to hold on our IMT application pending responses to some CMC related information request, we are generating the data responses in these requests and look forward to enrolling our first.

Mark Enyedy: Due to a delay in drug product production at our vendor, FDA placed a hold on our IND application pending responses to some CMC-related information requests. We are generating the data responsive to these requests and look forward to enrolling our first patient following submission of this information to the agency. Turning to business development, we were pleased to announce a multi-target global licensing deal with Eli Lilly earlier this month. This deal demonstrates the strength of our technology and leadership in ADCs and generates value from our intellectual property around our proprietary campus e-Symplex. Lastly, we completed an upsize follow-on offering that generated roughly $295 million in gross proceeds in the fourth quarter, and we ended the year with over $475 million in cash.

Patient following submission of this information to the agency.

Turning to business development, we were pleased to announce a multi target global licensing deal with Eli Lilly earlier. This month. This deal demonstrates the strength of our technology and leadership in Adcs and generate value from our intellectual property around our proprietary camptothecin platform.

Lastly, we completed an upsized follow on offering that generated roughly $295 million in gross proceeds in the fourth quarter and we ended the year with over $475 million in cash.

Anna Berkenblit: These funds, together with product and collaboration revenues, will support the business through the initial launch of Mervituximab and other material inflection points into 2024. With that, I'll turn the call over to Anna to provide some additional color on our clinical programs. Thanks, Mark.

These funds together with product and collaboration revenues will support the business through the initial launch of <unk>, a map and other material inflection points and into 2024 with that I'll turn the call over to Anna to provide some additional color on our clinical programs Anna.

Thanks Mark.

Anna Berkenblit: We are extremely pleased by the positive top-line results for our pivotal SREA trial. Recall that despite advances in the frontline and platinum-sensitive settings, most patients with ovarian cancer eventually relapse with platinum-resistant disease. Treatment options for platinum-resistant ovarian cancer are limited, consisting primarily of single-agent chemotherapy, which has limited activity, with objective response rates ranging from 4 to 13 percent and considerable toxicity.

We are extremely pleased by the positive topline results from our pivotal <unk> trial recall that despite advances in the frontline and platinum sensitive setting most patients with ovarian cancer eventually relapse with platinum resistant disease.

For treatment options for platinum resistant ovarian cancer are limited consisting primarily of single agent chemotherapy, which has limited activity with objective response rates ranging from 4% to 13% and considerable toxicity.

Anna Berkenblit: Aligning with FDA on the substantial unmet need in this population, SIREA was designed as a single-arm study of mervituximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of folate receptor alpha and who have been treated with one to three prior lines of therapy, including prior bevisuzumab. The primary endpoint of confirmed objective response rate, or ORR, as assessed by the investigator, was 32.4%, well over double the expected response with single-agent chemotherapy.

Having aligned with FDA on the substantial unmet need in this population. The rail was designed as a single arm study of <unk> in patients with platinum resistant ovarian cancer, whose tumors express high levels of folate receptor alpha and who have been treated with one to three prior lines of therapy, including prior Bevacizumab.

The primary endpoint is confirmed objective response rate or O R. As assessed by investigator was 32, 4% well over double the expected response with single agent chemotherapy.

Anna Berkenblit: Five of the responses were complete responses, which doesn't happen very often with available therapy in platinum-resistant disease. Median duration of response, or DOR, is a key secondary endpoint and was 5.9 months as of the data cutoff on November 16, 2021.

Five of the responses were complete responses, which doesn't happen very often with available therapy in platinum resistant disease.

Median duration of response or DLR as a key secondary endpoint and was five nine months as of the data cutoff on November 16th 2021.

Anna Berkenblit: With nearly half of the responders still receiving Mervituximab at that time, the duration of response continues to evolve. These results are particularly encouraging in light of the heavily pre-treated population in which 51% of patients had three prior lines of therapy. All patients received prior Bevacizumab, and 48% had received a prior PARP inhibitor. Turning to safety, the profile in psoriasis is consistent with the known safety of marvotoximab, which has now been studied in over 800 patients.

With nearly half of the responders still receiving bavituximab at that time the duration of response continues to evolve.

These results are particularly encouraging in light of the heavily pretreated population in which 51% of patients had three prior lines of therapy. All patients received prior bevacizumab and 48% had received a prior PARP inhibitor.

Turning to safety the profile of <unk> is consistent with the known safety of more of a toxin that which has now been studied in over 800 patients. The most common adverse events were low grade well first of all ocular and Gi events managed with supportive care and dose modifications if needed.

Anna Berkenblit: The most common adverse events were low-grade, reversible, ocular, and GI events, managed with supportive care and dose modifications if needed. The tolerability of mirvotuximab is demonstrated by the low 7% discontinuation rate for treatment-related adverse events, including just one patient with psoriasis discontinuing for an ocular adverse event. No corneal ulcers or perforations have been reported.

Tolerability, it's more of a toxin that is demonstrated by the low 7% discontinuation rate for treatment related adverse events, including just one patient in theory as discontinuing for an ocular adverse events.

No corneal all centers that want perforations has been reported.

Anna Berkenblit: As in prior studies, the ocular events were predictable, manageable, and reversible. Looking ahead, Dr. Ursula Matalonis will present the full SREA data set at SGO during the plenary late-breaking abstract session on Saturday, March 19. Data will include updated duration of response and key subgroup analyses, including patients with three prior lines of therapy and those who received a prior PARC inhibitor. Progression-free survival data will also be presented. As mentioned, we are on track to submit the BLA for Mervituximab before the end of the first quarter in support of potential accelerated approval later this year.

As in prior studies, the ocular events were predictable manageable and reversible.

Looking ahead, Dr. <unk> will present, the full dataset at F. G O. During the plenary late breaking abstract session on Saturday March 19th.

Data will include updated duration of response and key subgroup analyses, including patients with three prior lines of therapy, and those who received a prior PARP inhibitor.

Progression free survival data will also be presented.

I've mentioned, we are on track to submit the BLA for <unk> before the end of the first quarter in support of potential accelerated approval later this year.

Anna Berkenblit: In support of full approval, the confirmatory mirosol study of mervitoximab is expected to read out in the third quarter of 2022. We also continue to enroll patients in PICOLO, a single-arm study of myrtotoximab monotherapy in approximately 75 patients with folate receptor alpha-high recurrent platinum-sensitive ovarian cancer. Initiating label expansion, Piccolo is designed to address the increasing unmet need for an effective non-platinum option in later lines of platinum-sensitive disease.

In support a full approval the confirmatory Mirasol study of more of a toxin that is expected to read out in the third quarter of 2022.

We also continue to enroll patients in Piccolo, a single arm study of Martha talks about mono therapy, and approximately 75 patients with folate receptor Alpha high recurrent platinum sensitive ovarian cancer intended to support label expansion.

Piccolo is designed to address the increasing unmet need for an effective non platinum option in later lines of platinum sensitive disease.

Anna Berkenblit: With an overall response rate of 64%, our Phase 1 data show a potential for myrtidistimab in this patient population. We have formalized our strategy to position Mervitoximab as the combination agent of choice. With compelling data from the Mervitoximab plus Bevacizumab doublet in patients with folate receptor alpha high recurrent ovarian cancer, we expect to gain approval for this combination in close proximity to the initial monotherapy approval of Mervitoximab.

With an overall response rate of 64% our phase one data show the potential for <unk> in this patient population.

We have formalized our strategy to position <unk> as the combination agent of choice with compelling data from the <unk> plus bevacizumab doublet in patients with folate receptor Alpha high recurrent ovarian cancer, we expect to gain compendium listing for this combination in close proximity to the initial monotherapy approval.

And we're going to talk to that.

Anna Berkenblit: These data also support our design of Gloriosa, a potential label-enabling phase 3 study in the second-line platinum-sensitive maintenance setting. About a third of second-line platinum-sensitive patients receive a platinum doublet plus Bevacizumab, followed by Bevacizumab maintenance. The addition of Bevacizumab to a platinum doublet provides an overall modest improvement in PFS of approximately three to four months in this setting, highlighting the limitations of available therapies. Gloriosa is designed to evaluate the PFS benefit of mervituximab plus bevacizumab maintenance versus bevacizumab maintenance alone in all patients who have not progressed following completion of their platinum doublet plus benefit regimen.

These data also support our design to floor has a.

A potential label, enabling phase III study in the second line platinum sensitive maintenance setting about a third of second line platinum sensitive patients receive a platinum doublet plus bevacizumab, followed by debit system that maintenance.

The addition of Bevacizumab to a platinum doublet provides an overall modest improvement in PFS of approximately three to four months and the sudden highlighting the limitations of available therapy.

Gloria is designed to evaluate the PFS benefit of <unk>, plus bevacizumab maintenance versus Bevacizumab maintenance alone in all patients who have not progressed following completion of their platinum doublet plus benefit from that.

Anna Berkenblit: Approximately 440 patients will be randomized to either Mervitoximab plus Bevacizumab or Bevacizumab alone for maintenance. The primary endpoint is progression-free survival, and secondary endpoints include overall survival and overall response. We anticipate initiating Gloriosa in the second quarter of this year.

Approximately 440 patients will be randomized to either <unk>, plus bevacizumab or bevacizumab alone for maintenance.

Primary endpoint is progression free survival secondary endpoints include overall survival and overall response rate.

We anticipate initiating glory I'll say in the second quarter of this year.

Anna Berkenblit: Given the promising activity we've seen with imirvotuximab plus carboplatin development in phase one dose escalation in recurrent platinum-sensitive disease across a range of folate receptor alpha expressions, with an ORR of 80% and median duration of response of 24 months in FR-ALPHA medium and high patients, we recently announced the planned initiation of Trial 424. Trial 420 is a single-arm Phase II study of myrbituximab plus carboplatin, followed by myrbituximab continuation, in approximately 110 patients with folate receptor alpha low, medium, or high platinum-sensitive ovarian cancer. The data from this study will inform our path to registration in this setting. Moving on, to Pivecimab Sunirine, our CD123 targeting agent.

Given the promising activity, we've seen with <unk> plus carboplatin doublet in phase one dose escalation in recurrent platinum sensitive disease across a range of folate receptor alpha expression with an <unk> of 80% and median duration of response of 24 months in fr Alpha medium and high.

We recently announced the planned initiation of trials for 'twenty two.

While for 'twenty is a single arm phase two study of <unk>, plus carboplatin, followed by neurotoxin that continuation in approximately 110 patients with folate receptor alpha low medium or high platinum sensitive ovarian cancer. The data from this study will inform our path to registration in this setting.

Moving to pick that can add scenery or CD 123 targeting ADC, we presented initial safety and efficacy findings from the phase one two study up to that can add in combination with <unk> and they need a class in patients with relapsed refractory AML in an oral session at ash in December .

Anna Berkenblit: We presented initial safety and efficacy findings from the Phase 1-2 study of Povecimab in combination with azacitidine and venetoclax in patients with relapsed refractory AML at an oral session at ASH in December. Demonstrating an ORR of 48% in all relapsed refractory AML patients, these data are encouraging, particularly in higher-intensity cohorts where we observed Importantly, the Povecimab triplet demonstrated no tumor-like syndrome, veno-occlusive disease, capillary leak, or cytokine release.

Demonstrating in <unk> of 48% in all relapsed refractory AML patients. These data are encouraging, particularly in higher intensity cohorts, where we observed higher response rates.

Including an or of 59% and a 38% composite complete remission rate.

Importantly that so that the mab triplets demonstrated no tumor lysis syndrome, veno occlusive disease, capillary leak or cytokine release.

Anna Berkenblit: These data reinforce the potential of Povecimab as a new combination therapy for AML, which unfortunately is characterized by poor outcomes despite available therapy. We have opened an expansion cohort in relaxed AML patients and plan to initiate a frontline expansion cohort later this year. Also at ASH, we presented Pizecimab monotherapy data featuring vignettes from three frontline BPD-CM patients on a poster. All three patients achieved clinical complete remission, and PIVEC and ABV were associated with limited grade 3 or greater treatment-related adverse events and no capillary leaks in blood.

These data reinforce the potential that come out at the new combination therapy for AML, which unfortunately is characterized by poor outcomes despite available therapies.

We have opened an expansion cohort in relapsed AML patients and plan to initiate a frontline expansion cohort later this year.

Also at Ash, we presented Quebec in that monotherapy data featuring vignettes from three frontline <unk> patients in a poster session. All three patients achieved clinical complete remission and Quebec and that was associated with limited grade three or greater treatment related adverse events and no capillary leak syndrome.

Anna Berkenblit: We continue to enroll patients in the U.S. and Europe in CADENZA, our pivotal phase two study in frontline and relapsed refractory BPD-CN, anticipate top line data during the second half of 2022, and believe PIVECIMAP has the potential to become a best-in-class monotherapy treatment option for BPD-CN. With that, I'll turn the call over to Susan to cover the financials. Susan

We continue to enroll patients in the U S and Europe and cadenza, our pivotal phase III study in frontline and relapsed refractory B P. D. C. N anticipate top line data during the second half of 2022 and believes pit that can that has the potential to become a best in class monotherapy treatment option for B P DCM patients.

With that I'll turn the call over to Susan to cover the financials.

Susan Altshuler: Thanks, Anna. Starting with our results for the full year 2021, we generated $69.9 million in revenue, $46.8 million of which came from non-cash royalty revenues. The remainder came from license and milestone fees, which included recognition of $14.6 million of the $40 million upfront fee previously received under the company's collaboration agreement with Huadong Medicine, and $7.4 million of revenue from Partner Mile. Operating expenses were $194.9 million, comprised of $151.1 million of R&D expenses, compared with $114.6 million in 2020, and $43.8 million of G&A expenses, compared with $38.6 million in 2020.

Thanks, Anna starting with our results for the full year 2021.

We generated $69 $9 million in revenue $46 8 million of which came from noncash royalty revenues. The remainder came from license and milestone fees, which include recognition of $14 $6 million of the $40 million upfront fees previously received under the company's collaboration agreement with BARDA on medicine.

And $7 4 million of revenue from partner milestone opt.

Operating expenses were $194 $9 million comprised of 151 $1 million of R&D expenses, compared with $114 6 million in 2020, and $43 8 million of G&A expenses compared with $38 6 million in 2020, we ended 2021 with four.

Susan Altshuler: We ended 2021 with $478.8 million in cash on the balance. Turning to our financial guidance for 2020, we expect revenues to be between $75 and $85 million, operating expenses between $285 and $295 million, and cash and cash equivalents at year end between $245 and $255 million.

<unk> hundred $78 $8 million in cash on the balance sheet.

Turning to our financial guidance for 2022.

We expect revenues to be between 75, and $85 million operating expenses between $285 million to $295 million in cash and cash equivalents at year end between $245 to $255 million given.

Mark Enyedy: Given the range and timing for potential approval of Mervitoximab, revenue guidance does not yet include potential product sales from Mervitoximab. However, we expect that our current cash, combined with the anticipated product and collaboration revenues, will fund operations comfortably into 2024. With that, I will turn the call over to Mark for closing comments. Thanks, Susan.

Given the region timing for potential approval of Mervin Thompson that revenue guidance does not yet include potential product sales.

Yes.

We expect that our current cash combined with the anticipated product and collaboration revenue will fund operations comfortably into 2024 with that I'll turn the call over to Mark for closing.

Thanks, Susan we entered this year with a motivated and strong team and exciting prospects for the business between now and the end of the year, we expect to launch our first product support pivotal data for payback advance our early stage programs and further build our pipeline and research capabilities. We have the right strategy leadership and we saw.

Mark Enyedy: Between now and the end of the year, we expect to launch our first product, report pivotal data for PVAC, advance our early-stage programs, and further build our pipeline and research capabilities. We have the right strategy, leadership, and resources in place to generate significant value in the near and long term, and I look forward to more good days for our people, our business, and our patients. With that, we'll open the call for questions. Ladies and gentlemen, if you'd like to ask us a question at this time, you will need to press the star, then the one key on your touch screen. Don't tell me.

First is in place to generate significant value in the near and long term and I look forward to more good days for our people our business and our patients with that we'll open the call for questions.

Ladies and gentlemen, if you like to ask a question at this time you will need to press. The Star then the one key on your touched on telephone to withdraw. Your question you May press the pound key.

Standby, while we compile the Q&A roster.

Operator: To withdraw your question, you may press the pound. Standby while we compile the Q&A room. Now, the first question coming from the line of John Newman of Kynacorn. Your line is now open. Hi, guys. Good morning.

And our first question coming from the line of John Newman of Canaccord. Your line is now open.

John Newman: Thanks for taking my question. Congratulations on progress. Two quick questions.

Hi, guys. Good morning, Thanks for taking my question Congrats on the continued progress.

Anna Berkenblit: First one is for the progression-free survival data from SREA at SGO, just curious if we'll see both investigators assessed independently, et cetera, and then on Pivecimab, verse 632. I'm just curious as to what patient population..., potential combinations you're considering for a future pivotal study. Thanks. Hi, John.

Two quick questions.

First one is for the progression free survival data from Syria.

Just curious if we'll see both the investigator assessed and independently assessed.

And then on <unk>.

Our 632.

Curious as to what patient populations.

Potential combinations you are considering.

For our future pivotal study thanks.

Andrew.

Anna Berkenblit: Yeah, so at SGO, we will have the full data set from SREA, which will include overall response rate, duration of response, subsets, and we will include PFS data as well. I would encourage folks to come to SGO to assess the PFS data, and we will have an investor event shortly thereafter. Moving on to the PVAC questions in terms of future pivotal trials, we are thinking about the triplet, PivecaMab plus azacitidine plus Venetoclax in relapsed refractory AML based on the data that we have already generated in phase one dose escalation, and now we're exploring in an expansion cohort that potentially could support a single arm study in the relapsed setting.

Hi, John Yeah. So at <unk>, we will have the full data set from Syria, which will include overall response rate duration of response subsets and we will include PFS data as well I would encourage folks to come to S. G O to assess the PFS data and we will have them.

An investor event shortly thereafter.

Uh huh.

Moving onto the Pea that question in terms of future pivotal trials, we are thinking about the triplet tobacco ma'am plus as decided in plus vineeta clocks in relapsed refractory AML.

Just on the data that we have already generated in phase one dose escalation and now we're exploring in an expansion cohort that potentially could support a single arm study in the relapsed setting. In addition, we plan to explore a frontline setting for this triplet and should those data look promising then we could consider a frontline.

Anna Berkenblit: In addition, we plan to explore a front-line setting for this triplet, and should those data look promising, then we could consider a front-line randomized phase 3 trial to support approval for that triplet. Great, thank you. Our next question comes from the line of Michael Schmidt from Guggenheim Securities. He'll unmute. Hi, good morning.

<unk> phase III trial to support an approval for that triplet in the frontline setting.

Great. Thank you.

Yeah.

And our next question coming from the line of Michael Schmidt from Guggenheim Securities. Your line is open.

Michael Schmidt: This is EJ, Dr. Michael. Congratulations on the progress, and thanks for taking our questions. Two quick questions from us. Number one, for Mirazol. Anna, could you please help us understand the mix of patients with and without prior deficits? How are the two groups different in baseline characteristics, and how might that impact their response to MIRV? And the second question: can you really talk about your Capital Stats and ADC platform that you're licensed to? How is the payload different from other Type 1, topoisomerase-targeted ADCs?

Hi, Good morning. This is E mail from Michael Congrats on the progress and thanks for taking our questions.

Two quick questions from us number one for Mirasol.

Could you please.

Help us understand the mix of the patients with and without prior Bevacizumab.

How are the two groups different and baseline characteristics and how might that.

That impact to the response to <unk>.

And the second question can you talk about your comp to capital Thats, an ADC platform that your license to CBOE.

How is the payload different from other type one.

<unk> targeted ADC. Thank you.

Yeah.

Anna Berkenblit: Thank you. Thank you. Yes, so for Mirasol, the patient population will include both patients with and without prior Bevacizumab. Similar to Forward 1, the prior Phase 3 study where we had a mixture of, In Forward 1, about half of the patients had prior Bevacizumab, and half did not. We anticipate a similar patient mix in Mirasol. And when you think about which patients get Bevacizumab, they tend to be patients with worse prognosis and are more heavily pre-treated.

Yeah, so for Mirasol.

The patient population will include both patients with and without prior Bevacizumab.

Similar to forward one the prior phase III study, where we had a mixture of patients in forward one about half the patients had prior bevacizumab and half did not we anticipate a similar patient mix in mirasol.

And when you think about which patients get bevacizumab they tend to be patients with worst prognosis and are more heavily pretreated, let me start with a worst prognosis and then move to heavily pretreated.

Anna Berkenblit: Let me start with the worst prognosis and then move to heavily pre-treated. Bevacizumab is approved in several settings for ovarian cancer, the only one of which that has demonstrated an overall survival advantage is in the first line setting for poor risk patients, for disease, suboptimally debulked, ascites, et cetera.

Bevacizumab is approved in several settings for ovarian cancer. They only one of which that has demonstrated an overall survival advantage is in the first line setting for poor risk patients. These are patients with stage four disease sub optimally debulked ascites et cetera, So many physicians often reserve.

Anna Berkenblit: So many physicians often reserve Beficizumab for those worst patients, particularly in Europe, uh... and we can see that actually in this array of studies when you come to SGO in terms of the demographic enrolled in terms of their stage. Moving to number of prior lines of therapy, also, bevacizumab, it's hard for us in prior studies to tease apart bevacizumab versus number of prior therapies, and as a point of reference to support that, in the Forward 1 study, 65% of patients had one to two prior lines of therapy, and 35% had three priors.

Isn't that for those worst patients, particularly in Europe .

And we can see that actually are in the psoriasis study when you come to S. P. O in terms of the demographics of the patients enrolled in terms of either their stage of disease.

Moving to number of prior lines of therapy also bevacizumab, it's it's hard for us in prior studies to tease apart bevacizumab versus number of prior therapies.

As a point of reference to support that in the forward. One study 65% of patients had one to two prior lines of therapy and 35% had three priors you may recall that in survey of 51% of patients had three prior lines of therapy. So this array of population.

Anna Berkenblit: You may recall that in psoriasis, 51% of patients had three prior lines. So the psoriasis population is more heavily pretreated and potentially a worse population than what we anticipate seeing in the mirosal, based on the prior forward one. Moving to the next question on Camptothecines. So our camphyses and payloads are specifically designed to address potent anti-tumor activity and have basically unique properties from a chemical perspective that give us broad IP coverage. I think that's what I can say. I don't know, Mark, if you want to add any color.

More heavily pretreated and potentially a worst population than what we anticipate seeing in the Mirasol study based on the prior forward one study.

Moving to the next question on Camptothecin.

So our camptothecin payload or a specifically.

Designed to address the antitumor potent antitumor activity and has basically unique our properties from a chemical perspective that give a broad IP coverage for us I think that's that's what I can say at this point I don't know Mark if you want to add any color to the camptothecin payload.

Mark Enyedy: Yeah, maybe just a little broader observation here. So, you know, we take some pride in having multiple classes of payloads to apply to ADC. So, you know, we've got at least three generations of metansines. We have our indolino benzodiazepine DNA acting payloads. We're looking for additional classes.

Yeah, maybe just a little broader observation here. So you know we take some pride in having multiple classes of payloads to apply to the ADC. So you know we've got at least three generations of my Pansies. We have are in Toledo, benzodiazepine DNA acting payload.

We were looking for additional classes.

Mark Enyedy: And our team engineered this, you know, this new version of the camptothecines with the goal of broadening the therapeutic index versus what we see with some of the other camptothecines that have been deployed in the ADC context. And we've got very good preclinical data supporting that we've been able to drive activity at least in that range with better tolerability. So, we're excited about that. Lily was especially excited about it.

Our team engineered.

This new version of the campus seasons with a goal of broadening the therapeutic index versus what we see.

With some of the other camptothecin debt.

Have been deployed in the context, and we've got very good preclinical data.

Reported that we've been able to you know.

Drive activity at least in that range with better Tolerability. So we're excited about that really was excited about that and are moving forward.

Mark Enyedy: And are moving forward with the tech transfer for them to their targets while at the same time advancing internal programs that will deploy that payload. Thank you very much. And our next question, coming from the line of Etzer Darout with BMO Capital Markets, Yolanda Smith. Great, thanks for taking the question. The first one for me, you know, with respect to PFS and Seraria. I guess, how meaningful is this update from your perspective in this late-line, post-bev setting?

With the tech transfer for them for their targets, while at the same time advancing our internal programs that we'll deploy that payload.

Thank you very much.

Sure.

And our next question coming from the line up and so it starts with BMO capital markets. Your line is open.

Great. Thanks for taking my question first one for me with respect to PSS and Stuart I guess.

How meaningful is this update from your perspective in this late line.

Does setting and will we see benchmarks with this specific population as Geo and then secondly, Jim 151, given sort of the CMC submission update.

Mark Enyedy: And will we see benchmarks for this specific population at SGO? And then, secondly, on IMGM151, given the sort of CMC submission update, are you still on pace to start phase one in the first half of this year? Thank you. I'll take the PFS question, and then I'll turn it over to you, Mark, for the 151 question.

Are you still on pace to start the phase one in the first half of this year. Thank you.

Yeah.

Yeah I'll take the PFS question, and then I'll turn it over to you Mark for the 151 question. So regarding survey.

Etzer Darout: So, regarding psoriasis, you're absolutely right. The population is a late-line, post-BEV setting. And frankly, this is one of the most heavily pre-treated populations that have been studied in platinum-resistant ovarian cancer in a study this size. So there are no good benchmarks. But what I can tell you is there are...

You're absolutely right the population as a late line post Bev setting and frankly. This is one of the most heavily pretreated population that has been studied in platinum resistant ovarian cancer in a study of this size. So there are no. Good benchmarks are.

But what I can tell you is there are.

Anna Berkenblit: Multiple studies that have been published showing that in ovarian cancer, as in other solid tumors, the law of diminishing returns, if you will. With each line of therapy, the expectations for response rate, duration of response, and progression-free survival decrease. So when you get to these really late-line patients, physicians' expectations regarding efficacy are quite low given their experience. Certainly, you know, the data that we've shared with the investigators on the psoriasis study. They're quite pleased with the totality of the efficacy data that we have shared with them in terms of ORR, duration of response, and PFS because, as I said, the expectations that they have for these patients in the later-line post-dev setting are great.

Multiple studies that have been published showing in ovarian cancer as in other solid tumors.

The law of diminishing returns if you will with each line of therapy the expectations for.

Response rate duration of response and progression free survival diminishes. So when you get to the Israeli later line patients physicians expectations regarding efficacy or are quite low given their experience and certainly you know the data that we've shared with the investigators on the psoriasis study, they're quite pleased with the total.

<unk> of the efficacy data that we have shared with them in terms of or our duration of response and PFS because as I said the expectations that they have for these patients later line post fed setting is quite low.

Anna Berkenblit: What I will tell you is that we will share data at SGO to put the PFS data from psoriasis into context based on what we've known from prior studies of Myrvotuximab. As you've seen, we've replicated the overall response rate data in psoriasis that we had previously gathered in those 70 patients of foundational data that basically created the hypothesis that we have tested in So again, we'll have the data and put it into context for you. Mark, over to you for 1-5-1.

What I will tell you is that we will share data at S. G O to put the PFS data from survey it into context based on what we've known from prior studies are of them ever tucks them out as.

As you've seen we've replicated the overall response rate data in Korea that we had previously gathered in that 70 patients that foundational data that basically created the hypothesis that we have tested in Syria and now confirmed so again, we'll have the data.

And put it into context for U S. G O.

Mark over to you for 151.

Mark Enyedy: Yeah, thanks. So, just to reiterate the point that we made in the introductory comments, this is a CMC issue and not a clinical issue. So, you know, in order to issue a study may proceed letter for an IMD, the FDA requires the sponsor to submit CMC data relating to the drug, including drug product stability. Most often, those data are included in the IMD submission, and in some cases, the sponsor will make the data available to the agency during the review period.

Yeah. Thanks, So just to reiterate the point that we made in the introductory call.

Comments this is a CMC and not a clinical issue. So you know in order to issue. A study May proceed letter for an R&D. The FDA requires a sponsor to submit CMC data relating to the drug including drug product stability. Most often those data are included in the RMB submission and in some cases the spa.

Answer we will make the data available to the agency during the review period in the case of 151 plan to submit the required data during the review period. However, due to delays at our drug substance vendor, we were not able to secure a.

Mark Enyedy: In the case of 151, we plan to submit the required data during the review period. However, due to delays at our drug substance vendor, we were not able to secure a drug product production slot as we had planned, which meant that we weren't in a position to update the IMD during the review period. Thus, the agency put us on hold.

Drug product production slot as we had planned which meant that we werent in a position to update the RMB during the during the review period. So the agency put us on hold we've now secured our drug product slots for this quarter and we will generate the required data.

Mark Enyedy: We've now secured our drug product slot for this quarter, and we will generate the required data and expect to come off clinical hold in due course. It's too early to give updated guidance in terms of whether we will be delayed, but it's too early to give updated guidance on the timeline for the first patient, but we will update you when we've got a better sense following the DP run. Got it.

And expect to come off clinical hold in due course, it's too early to give updated guidance in terms of we will be delayed but it's too early to give updated guidance on the timeline for our first patients in but we will update you when we've got a better sense. Following the D. P runs.

Etzer Darout: Thank you. Congratulations on all the progress. Thank you. And our next question comes from the line-up, Boris Peaker with Colin Ylenisov.

Got it thank you and congrats on all the progress.

Thank you.

And our next question coming from the lineup Boris Becker with Cowen Your line is open.

Boris Peaker: Great, thanks. Maybe looking forward to the SGO, I think a lot of investors are going to be focused obviously on the PFS results and use that as a basis to estimate the probability of success of Mirasol. So maybe you could help us try to understand how we should be thinking of translating the PFS from Soraya to Mirasol, quantitatively. Thanks, Boris.

Great. Thanks, maybe.

Looking forward to the S. T O I think a lot of investors are going to be focused obviously on the PFS results and use that as a basis to estimate the probability of success of Mirasol. So maybe you could help us try to understand how we should be thinking of translating the PFS from Surya to mirasol.

Quantitatively.

Anna Berkenblit: You know, I think we actually have much better data to guide PFS from Forward 1 to Mirosol. What I mean by that is that PFS in a single-arm study, Suraya, is really not interpretable. You don't have a control arm to tease apart the anti-tumor activity from the underlying tempo of disease. And so that's why FDA does not use PFS when it is looking at anti-tumor activity to support accelerated approval. It's about ORR; if people want to assess the probability of technical success for mirror...

Thanks Boris.

You know I think we have actually much better data to guide a PFS from forward one to a mirror. So what I mean by that is that PFS in a single arm study like Syria is really not interpretable, you don't have a control arm to tease apart the antitumor activity.

From the underlying tempo of disease and so that's why FDA does not use a PFS when they are looking at antitumor activity to support accelerated approval, it's about or R and D. O R. If people want to assess.

The probability of technical success for Mirasol I would encourage them to review the data that we've already generated in forward. One recalled. It forward. One was the randomized phase III study of <unk> versus investigator choice chemotherapy and in the Fr Alpha high subset.

Anna Berkenblit: I would encourage them to review the data that we've already generated in forward. And called forward one was the randomized phase three study of Mervitin versus Investigator Choice Chemo and in the FR alpha high subset identified by the PS2 scoring. That is the population that we're basically replicating. And in Forward 1, we demonstrated a median PFS in that population of 5. The Hazard Ratio in Forward 1, based on either investigator or blinded independent review, was 0.6, and you may recall that in Mirosol, we designed a study to target a hazard ratio of 0.7, much more conservative. So we've already run the experiment in Forward 1.

Identified by the P S two scoring method.

That is the population that we're basically replicating in Mirasol and then forward. One we demonstrated a median PFS in that population of 5.6 months, the hazard ratio and forward one based on either investigator or independent blinded independent review was around a 0.6.

And you may recall that in Mirasol, we designed the study to target a hazard ratio of <unk> seven much more conservatively. So we've already run the experiment and forward one the population in Mirasol will be essentially the same in terms of platinum resistance, one to three priors fr Alpha high about half of them, having prior bevacizumab the one.

Anna Berkenblit: The population in Mirasol will be essentially the same in terms of platinum resistance, 1 to 3 priors, FR alpha high, about half of them having prior bevacizumab. The one difference is that we'll have a higher percentage of patients with PARP inhibitors now. And we've already demonstrated in SIREA, and you'll see the full data at FGO, that mirvotoximab has very nice activity regardless of prior PARP use or not. So from our perspective, the SIREA data increased the probability of technical success for marisol because we now have that answer about prior. I got it.

One difference is that we will have a higher percentage of patients with PARP inhibitors, now and we've already demonstrated in Syria, and you'll see the full data at F. G O that more of a toxin that has very nice activity, regardless of a prior PARP use or not so from our perspective. This array of data and increase the probability of technical.

Success for them aerosol, because we now have that that answer about what about prior apartment inhibitors. Thanks, Boris got it and Mike.

Boris Peaker: And my second question is about the Kadenza study and BPD-CN. Could you set an expectation that you need to show in the study for approval? Yeah, so the statistical design for Cadenza is really allowing us to enroll a cohort of up to 20 patients in this ultra-rare indication, somewhere between 500 and 1,000 new patients a year in the U.S. and, similarly, in Europe. And so looking at the efficacy data for the one approved agent in BPD-CN, we know that the CR-CRC rate is in the 40 to 50 percent range.

Second question is on the Cadenza study in <unk> could you just set expectations, what you need to show in the study for approval.

Yeah. So the statistical design for Cadenza is really are allowing us to enroll a cohort of up to 20 patients in this ultra rare indication there's somewhere between 501000, new patients a year in the U S and similarly in Europe .

And so looking at the efficacy data for the one approved agent.

In in a B P D C and we know that the C. R. C. C. R. Slash CRC rate is.

In the 40% to 50% range and so we would need to demonstrate a CR CRC right in that range with a nice efficacy and from a statistical perspective that based on the sample size that we're using that.

Boris Peaker: And so we would need to demonstrate a CR-CRC rate in that range with nice efficacy. And from a statistical perspective, that, based on the sample size that we're using, that rules out this 10 percent CR-CRC rate that FDA guided us. Thank you for taking my question. Our next question comes from the line of Andy Sue with William Blurry from Illinois.

Rules out there, 10% CR rate that FDA guided us to.

Got it thank you for taking my question.

Sure.

Our next question coming from the line of Andy Chu with William Blair. Your line is open.

Andy Sue: Great, thanks for taking my questions, and congratulations on all the progress last year. So, my first question has to do with the new trials. So, Anna, I'm just curious if you have, you know, kind of decided on the trial design for Gloriosa in terms of treatment duration in the maintenance phase. And also, maybe a step back, can you use this trial as a confirmatory study for piccolo? I know that sometimes, you know, FDA allows you to confirm using kind of a different patient population. And the second question is for Kristen. I'm just curious, as you prepare to launch MIRV, have you decided how the drug will be distributed? So, specifically, I'm curious about the ordering and delivery system.

Great. Thanks for taking my questions and congratulations on all the progress last year.

So first question has to do with the <unk>.

New trials.

So so and I'm just curious if you have.

We decided on the trial design for Florida gas is clearly also in terms of treatment duration.

In the maintenance phase and also maybe step back.

Can you use this trial as a confirmatory study for Piccolo.

I know that sometimes you know FDA allows you to confirm using kind of a different patient population.

And the second question is for Christian.

I'm just curious as you prepare to launch mirv.

Have you decided on how the drug will be distributed.

So specifically I'm curious about the ordering and delivery system is there.

Anna Berkenblit: Is that mostly on demand? And if that's the case, how should we think about gross demand? Thank you. Sure, so we're really excited about the GLORIOSA study, which is a study of adding mervituximab to maintenance bevacizumab versus maintenance bevacizumab in the recurrent platinum-sensitive setting. Why are we excited about this?

Mostly on demand.

And if that's the case how should we think about the question that thank you.

Sure. So we're really excited about the Glorioso study, which is a study of adding more of a toxin nab to maintenance bevacizumab versus maintenance bevacizumab in the recurrent platinum sensitive setting why are we excited about this because we've already generated beautiful data in the treatment setting.

Anna Berkenblit: Because we've already generated beautiful data in the treatment setting for the MERV BEV doublet, showing response rates of 59% in platinum-resistant disease and 69% in platinum-sensitive disease that are, you know, above the benchmarks. And so we want to move that active, well-tolerated doublet into the maintenance setting. We know that patients, once they have recurrent platinum-sensitive disease, more and more of them will have already had a PARP inhibitor in the frontline setting. And so using a triplet in the recurrent platinum-sensitive setting makes a whole lot of sense.

For the Mirv Bev doublet.

<unk> response rates of 59% in platinum resistant disease, 69% in a platinum sensitive disease that are above the benchmark and so we want to move that active well tolerated doublets into the maintenance setting we know that patients once they have recurrent platinum.

Sensitive disease more and more of them will have already had a PARP inhibitor in the frontline setting and so using a triplet in the recurrent platinum sensitive setting makes a whole lot of sense.

Anna Berkenblit: So, with that, we will take all patients who have completed their triplet, in terms of the carboplatin doublet portion of it, and as long as they haven't progressed, so they have a CR, a PR, or stable disease, they will be randomized to MIRV-BEV versus BEV alone. And you may recall that in this setting, the entire treatment path for bevacizumab only add So, adding MIRVituximab, you know, a non-cross-resistant targeted cytotoxic, we anticipate that we will have responses on the MIRV-BEV arm, and there will be a long treatment duration on the MIRV-BEV arm, really benefiting patients.

So with that we will take all patients who have completed their triplet.

In terms of the Carboplatin doublet portion of it and as long as they haven't progressed. So they have a C or a PR or stable disease. They will be randomized to mirv Bev versus Dev alone and you may recall that in this setting that entire treatment path for Bevacizumab only serve only adds about three to four months of progression free survival.

So adding more of a toxin that you know a non cross resistant targeted cytotoxic. We anticipate that we will have responses on the mirv Bev arm and there will be a long treatment duration on the mirv Bev I'm really benefiting patients. The primary endpoint is progression free survival. The study is also has sufficient power for.

Anna Berkenblit: The primary endpoint is progression-free survival. The study also has sufficient power for us to demonstrate an overall survival advantage, and that could really transform the treatment paradigm for these patients. Regarding your question about confirming whether or not Gloriosa could stand in as a confirmatory trial for Piccolo, it's a little too soon for us to work that through. Piccolo is enrolling now, and we need to engage with FDA on the exact criteria for a path toward accelerated approval, so I would stay tuned. And let me turn it over to you...

For us to demonstrate an overall survival.

Advantage and that could really transform the the treatment paradigm for these patients are regarding your question about confirming whether or not glorioso could.

Standing as a confirmatory trial for piccolo, its a little too soon for us to work that through Piccolo is enrolling now and we need to engage with FDA on a the exact criteria for a path toward accelerated approval. So I would stay tuned for that and let me turn it over to Christian now.

Kristen Harrington-Smith: Thanks, Anna. So, to respond to your question, we do plan on using a 3PL, so, like you said, an on-demand or drop-ship model. And this is to help us with our growth to net, but at this time, that's all we would like to comment on growth to net. Does that help? Yeah, okay.

Thanks Anna.

So to respond to your question, we do plan on using a three PL. So like you said a on demand or drop ship model.

And this is to help us with our gross to net but at this time.

That's all that's all we would like to comment on the gross to net.

Yes.

Does that help.

Yes, okay.

Andy Sue: So I guess the question is really, you know, how would this kind of course net differ from other, you know, other drugs or more traditional distribution? So that's kind of what I am curious about. So our goal is to avoid many of the wholesaler fees. Okay, that's UH... Andy, second order, I mean, yeah, no, no, so, I mean, when you look at the patient numbers and volumes here, there's no need to have, you know, a massive amount of inventory sitting at wholesalers, you know, awaiting to be distributed.

So I guess the question is really how how we would be kind of person that differed from.

From other other drugs or more traditional distribution, so thats kind of where I am curious yeah.

So where our goal is to avoid many of the wholesaler fees.

Alright.

Yeah.

And is that okay. Yeah. So I mean, when you look at the patient numbers in volumes here Theres no need to have you know a massive amount of inventory sitting at wholesalers. You know are waiting to be distributed so it's much more efficient from our perspective in most of the agencies.

Andy Sue: So, it's much more efficient from our perspective, and most of the ADCs use this model of setting up a 3PL and then having the orders come in and fulfilling those using the dropship model. And in doing that and setting up a very streamlined approach here, we're avoiding a lot of the fees that are associated with having inventory sitting at a wholesaler.

Or is this model.

That ended up with three PL and then having the.

The orders come in and fill.

Filling numbers using the dropship model and in doing that and setting up a very streamlined approach here, we're avoiding a lot of the fees that are attendant to having inventory sitting down at a wholesaler.

We feel like right now.

Kristen Harrington-Smith: We can't tell you right now what exactly the growth in that would be, and that probably wouldn't be a good idea in the first instance. Right, okay, that's really helpful. Thank you so much. So, Anna, is there like a fixed duration for the maintenance phase for Gloriosa? Is it like one year, you know, 18 months or two years?

We can't tell you right now what exactly the gross to net would be that probably wouldn't be a good idea in the first instance.

Andy Sue: I'm just curious if that's been set. Yeah, so in the frontline setting, when you do maintenance trials, there is a fixed duration because there's a chance that some of your patients are going to be cured. Once you have recurrent platinum-sensitive disease, The expectation is that you're not cured, so patients will be treated until progression and intolerable toxicity, or intolerable toxicity, but I have to say, I mean, across the MIRV program, we've had patients on Mervituximab for one year, two years, three years, even up to four years, and still going, so in terms of the tolerability of Mervituximab as a monotherapy, we know that it's quite well-tolerated, and with the MIRV-BEV, we've had patients on that doublet for a good long time as well, both in the platinum-resistant and the platinum-sensitive settings, so I can't tell you an estimated duration in maintenance in the recurrent platinum-sensitive setting, but it's gonna be long, because we know that the PFS... Good night. Great. Thank you so much for answering all my questions. Thanks, Andy. Our next question coming from the line of Kaylee Hsu with Jeffrey. See you later. Good morning. This is Hao calling in for Kenny Shi.

Right. Okay. That's really helpful. Thank you so much.

I'm curious so the.

Is there like a fixed duration for the maintenance.

Phase four.

Is there like one year.

18 months two years I'm just curious if that's been.

Yes.

Yeah. So in the frontline setting when you do maintenance trials, there is a fixed duration because theres a chance that some of your patients are gonna be cured. Once you have recurrent platinum sensitive disease. The expectation is that you're not cured so patients will be treated until progression and intolerable toxicity.

And tolerable toxicity, but I have to say I mean, it's across the Mirv program. We've had patients on more of a toxin them for one year two years three years, even up to four years and still going so are you now in terms of the tolerability of more of a toxin mab as a monotherapy, we know that it's quite well tolerated and with the mirv Bev we've had patients on.

Kaylee Hsu: First, thanks. First, congratulations on the great quarter. So my question is really about the MIRASO trial. Given the assumption for the medium PFS, the chemo arm is about 3.5 months. Do you see any risk that the control arm might outperform, given that more optional chemotherapy is available for the control arm? And then my second question is regarding the ECOT01 performance status.

Doublet for a good long time as well both in the platinum resistant and platinum sensitive setting. So you know I can't tell you an estimated duration and maintenance are in a recurrent platinum sensitive setting, but it's gonna be long because where you know what we know that the PFS of these patients is going to be quite long.

Great. Thank you so much for answering all my questions.

Thanks, Andy.

Our next question coming from the line of Kelly <unk> with Jefferies. Your line is open.

Good morning. This is how <unk> Falcon issue first thing first congratulation on the great quarter. So my question is really for them mirror trial, given the assumption for the medium PFS. The chemo is about three five months.

Anna Berkenblit: Do you see that may also influence the patient outcome in the control and treatment arm? And how does the patient, in terms of the consistent weight of the 01 status, if it's consistent from the Forward1 trial to Soraya and the MIRASO trial? Okay, so your question about the progression-free survival estimate on the control arm of Mirasol. We designed it for 3.5 months because that's pretty much what every study in platinum-resistant ovarian cancer has shown.

Do you see any risk that the control arm might outperform given that more optional chemo therapy is available for the control arm and then my second answer regarding to the E. C O T zero one performance status.

See that and they also influenced the patient outcome in the control and treatment treatment arm and how the patient income of the consistent and weight of the zero one status.

It's consistent from the forward one trial too sorry.

Mirror field trials.

Okay. So your question about the progression free survival estimate on the control arm of Mirasol, we have designed it for $3 five months, because that's pretty much. What every study in platinum resistant ovarian cancer has shown.

Anna Berkenblit: I would remind you that in Forward 1, for the FR alpha high subset, we actually had a median PFS of 3.2 months. You know, there are some studies out there suggesting that FR-alpha is a poor prognostic factor. So it may be that with single-agent chemotherapies, patients with high FR-alpha do worse than the overall population. So if anything, I think the control arm on Mirasol might underperform, not outperform.

I would remind you that in forward one for the Fr Alpha high subset, we actually had a median PFS of three two months.

You know there are some studies out there, suggesting that fr Alpha is a poor prognostic factor. So it maybe with single agent chemotherapy in patients with high Fr Alpha do worse than the overall population. So if anything I think the control arm on marathon might under perform not outperform I didn't understand.

Anna Berkenblit: I didn't understand your comment about it might outperform because more options are available. The options on the Mirasol control arm are topotecin, paclitaxel, and doxil, just like they were in the Forward One study. These are all drugs that were approved 20 years ago.

And your comment about it might outperform because more options are available the options on the Mirasol control arm or towboat. He can paclitaxel indoxyl just like they were in the forward. One study. These are all drugs that had been approved and you know it 20 years ago. So it's not like now there's more.

Anna Berkenblit: So it's not like now there are more better therapies. Unfortunately, we're using the same old single-agent chemotherapies that have been around for a couple of decades. So, if anything, I think the control arm on Mirasol might underperform, but we certainly didn't design it assuming that it needed to, you know, for success. Moving to ECOG performance status 0 or 1. The ECOG performance status of zero means people feel perfectly well.

More better better therapies. Unfortunately, we're using the same old single agent Chemotherapies that have been around for a couple of decades. So.

If anything I think the control arm and Mirasol might underperform, but we certainly didnt design it assuming that it needed to you now for success of the study.

Anna Berkenblit: ECOG status of one means they're a little tired. And the lower the performance status, certainly the worse patients do. And that's why we've excluded patients with poor performance status, two, three, or four, because that's when you know that the risks of whatever you're studying begin to potentially outweigh the benefits because the patients just aren't fit enough. So given the population that we've enrolled across the Mervituximab program, ECOG status is zero or one. We typically have a similar distribution across all the studies, and we do not anticipate any difference from an efficacy or a tolerability perspective for either study. Great, thank you so much; that's very helpful.

Moving to <unk> performance status zero or one.

The <unk> performance status of zero means people feel perfectly well cogs status of one means theyre a little tired.

The lower the performance status certainly the worst patients do and that's why we've excluded patients with poor performance status two three or four because that's when you you know that the the the risks of the whatever you're studying begin to potentially outweigh the benefits because the patients just aren't fit enough.

So given the population that we've enrolled across them are of a toxin that program. He called status at zero or one we typically have a similar distribution across all the studies and we do not anticipate any difference from an efficacy or tolerability perspective for either subset of patients.

Great. Thank you so much that's very helpful.

Yeah.

Kaylee Hsu: Our next question comes from the line of Kenan McKay with RBC Capital, Elana Smith. Hey, good morning, and thanks for taking the question. Just one on the psoriasis filing plans: is the data from psoriasis sufficient for the Ventana full R1 companion diagnostic and accelerated approval of the diagnostic as well, or is there additional data from Mirasol or other trials in the future that's also needed, or again, just in a confirmatory sense?

Our next question coming from the line of Kennan Mackay with RBC capital. Your line is open.

Hey, good morning, and thanks for taking my question.

Just one on those.

The Cerrado finally point.

Data from Suraj sufficient for the Ventana full our one companion diagnostic to an accelerated approval.

Agnostic as well.

Is there additional data from for Mirasol or other trials in the future. That's also needed or again, just been a confirmatory sense.

Kaylee Hsu: And then on the Mirova trial, can you maybe talk about the rationale for that trial and that carboplatin plus MIRV doublet and potentially what the next steps there could be? Thanks. Sure, I'll take the CDX question and then, Anna, you can talk about the IST with Harter.

And then on the Moreover trial can you maybe talk about the rationale for that trial and that Carboplatin plus murph.

And potentially what the next steps there could be right.

Sure I'll take the <unk> question and then.

You can talk about the ISP with harder so the answer is yes.

Kenan McKay: So the answer is yes, the data from SREA is sufficient to support the approval of the companion diagnostics. I think, as we've discussed previously on these calls, we're working with Ventana, which is Roche Tissue Diagnostics. They've actually committed the PMA in four modules.

Data from Sylvania are sufficient to support the approval of the of this of the companion diagnostic I think as we've discussed previously on these calls we are working with Ventana, which is without Roche tissue diagnostics, we've actually submitted the PMA for modules they've already submitted the first module Ah they have.

Mark Enyedy: They've already submitted the first module. They have our clinical data, which is being integrated into the subsequent modules, and they will... ... ... ... ... ... ... ... .., file in close proximity to our BLA submission, which would put them on track to have the CDX approved at the same time as the drug. And for the MIROVA study, this is a randomized phase two investigator-sponsored trial in Germany led by Dr. Philip Harder.

Political which just being integrated into the subsequent modules and they will.

File and close proximity to our BLA submission, which would put them on track to have the CTX approved at the same time as the as the drug.

And for the Neuro <unk> study. This is a randomized phase two investigator sponsor trial in Germany led by Dr. Philip harder, it's approximately 140 patients who will be randomized one to one to <unk> plus carboplatin followed by Merck Rituxan.

Mark Enyedy: It will involve approximately 140 patients who will be randomized one-to-one to mervitoximab plus carboplatin, followed by mervitoximab continuation, versus carboplatin doublet of choice, followed by maintenance of choice. And the idea here is, you know, when you talk to physicians about Mervitoximab, they want to be able to replace Paclitaxel with our drug because patients don't lose their hair, we have less neuropathy, and so this is the first opportunity for us to really combine Merv plus Carbo in a larger study for Dr. harder to do so and compare it directly to standard carboplatin doublets, which include carbopaclitaxel, carbodoxel, and carbogemcide.

Now that continuation versus Carboplatin doublet of choice followed by maintenance of choice.

And the idea here is you know when you talk to physicians about more of a toxin that they they want to be able to replace paclitaxel with our drug because patients don't lose their hair, we have less neuropathy and so this is the first opportunity for us to really combine them.

Mirv plus carbo in a larger study.

For Dr harder to do so and compare it directly to standard Carboplatin doublet, which include Carbo, Paclitaxel carbo, docile and carbo gem side have been and so this study will help us get a better sense of the tolerability profile of the doublet because at this point our databases. It you know.

Anna Berkenblit: And so this study will help us get a better sense of the tolerability profile of the doublet because, at this point, our database is limited, but also the anti-tumor activity and efficacy in the recurrent platinum-sensitive setting head-to-head against available therapies. So this data set from MIROVA will help guide further development of myrvatoximab plus carboplatin as a doublet. I should point out that it is one of three prongs that we are taking to understand the potential of myrvatoximab plus carboplatin. The second prong is a neoadjuvant study, IST, here in the U.S., led out of Ohio State.

Limited, but also the the antitumor activity of efficacy in the recurrent platinum sensitive setting head to head against available therapies. So this dataset from there over it will help guide further development of them or if it talks about plus carboplatin as a doublet I should point out is that it is one of three.

Prongs that we are taking to understand the potential of Bavituximab plus carboplatin. The second prong is a neo adjuvant study I S. T. Here in the U S led a out of Ohio State and.

Anna Berkenblit: And that study is in the neoadjuvant setting, the first time we can get myrvatoximab in untreated patients up front with tumor tissue available at the time of their debulking surgery. And then the third is trial 420, which is mervitoximab plus carboplatin in a broader population of FR-alpha-positive. So between those three, among those three data sets, we will then have sufficient data to support the registration path for Mervituximab plus carboplatin W. Got it. Thanks, Anna.

And that study is in the neo adjuvant setting. The first time, we can get more of a toxin mab in untreated patients upfront with a tumor tissue available at the time of their de Bulking study a surgery and then the third is trial for 'twenty that you heard about earlier, which is more of a tux amount plus carboplatin in a broader population of fr Alpha positive too.

So between those three among those three datasets. We will then have sufficient data to support the registration path for them or if it tucks them out plus carboplatin doublet.

Kenan McKay: Maybe, maybe just one follow-up. You mentioned that there's certainly some evidence and some publications out there to support the fact that patients with folate receptor positive disease or folate receptor high positive disease potentially have worse outcomes. Is there any other data that the team is working on or that might become available that could be used to sort of further support that fact or be added to the SORAYA accelerated approval submission? Or, if not, what data set do you see as the most supportive of that?

Got it thanks, and maybe just one.

Follow up you'd mentioned that.

There are certainly some evidence and publications out there.

To support the fact that patients with <unk>.

<unk> receptor positive disease are fully receptor high positive disease potentially.

Potentially have worse outcomes.

Outcomes.

Yes.

Other data.

The team is working on or before that it might become available.

There can be used to sort of further.

Ports about that factor will be added to be.

Two the Cri accelerated approval submission or if not what what do you see as the most supportive for that thank you.

Anna Berkenblit: Thank you. So, we do not need any data regarding FR-alpha as a prognostic factor to support our SREA study and our Path Toward Accelerated Approval. We know that FR-alpha is predictive of benefit from Mervituximab. We have a biomarker-identified population in psoriasis, FR-alpha high patients who clearly benefit from mervituximab with a near tripling of the response rate, clinically meaningful duration of response, and very nice tolerability.

So we do not need any data regarding fr alpha as a prognostic factor to support.

Our survey of study and our path toward accelerated approval.

We know that fr Alpha is predictive of benefit from or if it tucks a map we have a biomarker identified population in Syria fr Alpha high patients, who clearly benefit from or if it tucks them up with a near tripling of the response rate clinically meaningful duration of response.

And and very nice Tolerability and so fr Alpha is clearly predictive of benefit from more of a tuck for them.

Anna Berkenblit: And so, FR-alpha is clearly predictive of benefit from mervituximab. The one data set that we can point to now that is more robust in terms of answering this prognostic question, the one data set that we can point to really is the Forward 1 data set where we did the post hoc analysis looking at MIRV versus chemotherapy because, again, you need this control arm, right, because that's where you're assessing how patients do with available therapies, where we inadvertently enrolled the low, medium And you can see that the higher the FR-alpha expression, the worse patients do with investigator-choice chemotherapy, be it response rate or progression-free survival.

The one data set that we can point to now that is more robust in terms of answering this prognostic question.

The one data set that we can point to really is the forward one dataset, where we did the post hoc analysis looking at mirv versus chemotherapy, because again, you need just control arm right, because that's where you're assessing how patients do with available therapies, where we inadvertently enrolled the low medium and high patients and you can see with the <unk>.

The fr Alpha expression, the worst patients do with investigator choice chemotherapy response rate or or progression free survival and I think frankly, that's that's the only data set that we're gonna have for awhile kennan because.

Anna Berkenblit: And I think, frankly, that's the only data set that we're going to have for a while, Kenan, because now that we know we're focused on the FR-alpha-high patients, approximately 40 percent of all of the ovarian cancer patients who benefit the most from MIRV, down the road, maybe with Mervituximab plus carboplatin when we demonstrate very nice activity across a broader spectrum. F or Alpha patients, and we do a randomized trial there.

Now that we know we're focused on the fr Alpha high patients approximately you know 40% of all of the ovarian cancer patients who benefit the most from orbit Tux, a map I mean down the road, maybe with more of a tuck some app plus carboplatin when we demonstrate very nice activity across a broader spectrum of.

Fr Alpha patients and we do a randomized trial. There. Maybe then we'll have a mix of patients where we can.

Anna Berkenblit: Maybe then we'll have a mix of patients where we circle back on this question of it being a prognostic factor. But really, from a development perspective and for physicians to understand who benefits the best from Mervituximab, it's FRL for high-risk patients and that's. Thanks again and looking forward to seeing you at SGO. Our next question, coming from the line of... Jessica Fyfe with J.P. Morgan, Yolanda Salter. Hey guys, good morning. Thanks for taking my question. I need one more specific one on SGO.

Ill circle back on this question of it being a prognostic factor, but really from a development perspective and from for physicians to understand who benefits the best from murder Tucks them add it's fr Alpha high patients and that's what matters the most.

Got it thanks, again and looking forward to seeing you at SPL.

Thanks.

Yeah.

And our next question coming from the line up.

Jessica Fye with JP Morgan Your line is open.

Jessica Fyfe: Should we expect to see a swim plot, a spider plot, and a waterfall at SGO? And also, will we see a PFS Kaplan-Meier curve or just the median PFS number? Come to SGO, Jess.

Good morning, Thanks for taking my question.

I mean, one more specific one on S. G O.

Should we expect to see a swimmer plot a spider plot a waterfall spo and also will we see a PFS Kaplan Meier curve or just the median PFS number.

Come to just come to S. G O, Jeff we will have it.

Anna Berkenblit: We will have visualizations of the data for you to understand the data. Okay, great. And in the platinum-sensitive setting, can you talk about what you see at the bars, either for approval or for further development for the Phase III Evaluating Myrvotoxinab plus dev maintenance in the fully receptor-high platinum-sensitive setting, as well as for that, MERV-CARBO combo with MERV-TUXMAB continuation in the kind of broader folate receptor alpha expressing population?

Nations of the data for you to understand the data.

Okay, great and on the platinum sensitive setting can you talk about what you see as the bars either for approval or for further developments for the phase III evaluating Merck touchdown, plus does maintenance in the play with such a high platinum sensitive.

Setting as well as for that.

Mirv Carbo combo.

With love Tuck snob continuation in the kind of broader folate receptor alpha expressing population.

Jessica Fyfe: Sure, so in terms of the bar, we have designed GLORIOSA, the randomized phase 3 study to support full approval. The primary endpoint is progression-free survival. It's about 440 patients, and the hazard ratio we're aiming for is around.7. That's what it's designed for.

Sure. So in terms of the bar, we have designed glorioso the randomized phase III study to support full approval. The primary endpoint is progression free survival. It's about 440 patients are.

And the hazard ratio, we're aiming for is around <unk> seven or that's what it's designed for and so this study is designed in a robust manner to demonstrate superior efficacy from or if it tucks them at <unk>, plus bevacizumab versus Bevacizumab alone.

Anna Berkenblit: So this study is designed in a robust manner to demonstrate superior efficacy for mervitoximab plus bevacizumab versus bevacizumab. In terms of the bar for Mervituximab plus carboplatin, that doublet, we would anticipate needing a randomized phase 3 study for that doublet. So again, we would need an adequately powered randomized phase 3 study with a control arm of standard available platinum-based doublets. That should answer your question, Jess, because the strategies would be randomized trials.

In terms of the bar for <unk>, plus Carboplatin that doublet, we would anticipate needing a randomized phase III study for that doublet. So again, we would need an adequately powered randomized phase III study with a control arm of.

Standard available platinum based doublets.

That should answer your question, Jeff because these are both granted these the strategies would be randomized trials I think where the bar Ah is less clear to be honest and the unmet need is increasing in the later line platinum sensitive patients are that are we are studying.

Anna Berkenblit: I think where the bar is less clear, to be honest, and the unmet need is increasing, is in the later-line platinum-sensitive patients that we are studying in the Piccolo study. That's a population where I think the unmet need is increasing, and the bar there is not clear. We've already generated a handful of data going forward with the piccolo study, and we look forward to engaging FDA on what the bar would be in that setting to support approval from a single-arm trial. That's it.

Studying in the Piccolo study.

That's a population where I think the unmet need is increasing and the bar. There is not clear we've already generated a handful of data supporting the going forward with the Piccolo study and we look forward with engaging F. D. A on what the bar would be in that setting to support approval from a single arm trial.

For an accelerated approval.

Alright, thank you.

Yeah.

Jessica Fyfe: Thank you. And our next question comes from the line of Arthur Hay with HC Wainwright, Yelena Sokolovskaya. Hey, good morning, everyone.

And our next question coming from the line up.

With H C. Wainwright your line is open.

Hey, good morning, everyone. Thanks for taking my question. Most of my questions have been answered I, just wonder could you guys give us more color on the advantage for the.

Arthur Hay: Thanks for taking our question. Most of our questions have been answered. I just wondered, could you guys give us more color on the advantage of the cap-tosting platform?

Kept thing platform and if possible.

Mark Enyedy: And if possible, could you guys give us more color on the partnership with Eli Lilly? Sure. I mean, we covered most of what we have to say publicly about this program. So, you know, our chemists were looking for an additional payload. We noted the test that Daiichi was enjoying with their camphesins, and so the question was, as an additional chemistry exercise, could we design a better topo1 inhibitor of the Camptothecin class that would expand the therapeutic index for the payload, either by better tolerability, better efficacy, or both. What we think we have is a molecule with at least equivalent efficacy to..., with better tolerability, and we think potentially better bystander killing with this molecule.

Could you guys give us some more color on the.

Partnership with Eli Lilly.

Sherman we covered most of what we have said publicly about this program. So our chemists, we're looking for and additional payload we noted that Scott.

That daiichi was enjoying with with their camptothecin and so the question was.

But this little chemistry exercise could be designed.

A.

Better towboat, one inhibitor that.

Of the Camptothecin class.

Is that.

Expand the therapeutic index for the for the payload either by better Tolerability better efficacy or both what.

What we think we have as a molecule with at least equivalent efficacy with.

Hum.

Tolerability, and we think potentially better bystander, killing with this with this molecule. So that's been that's.

Mark Enyedy: So, you know, that's been the basis. And then I can't really comment on the financials of the deal beyond what's included in the press release that we issued last week or the week before. Thank you for the addition of color, and congratulations on the progress this quarter. Thank you. Our next question comes from the line of Zoe Consensaro with Piper Sandler from Yale. Hey guys, thanks so much for taking my question here. Maybe one, just a quick one from me.

That's the basis, and then I can't really comment on the financials of the deal beyond what's included in the press release that we issued last week or the week before.

Well. Thank you for thank you for the additional color and congrats on the progress this quarter.

Okay.

Our next question coming from the line of Silicon to Zara with Piper Sandler Your line is open.

Hey, guys. Thanks, so much for taking my question here, maybe one just quick one for me if I think back to forward. One I think it took about 10 months or so from enrollment completion to read out. So just wondering why there would be a shorter window for mirasol I know, it's not maybe apples to apples, but maybe you could help us better understand that dynamic whether it be enrollment.

Zoe Consensaro: If I think back to Forward One, I think it took about 10 months or so from enrollment completion to readout. So, just wondering why there would be a shorter window for Mirosol. I know it's not apples to apples, but maybe you could help us better understand that dynamic, whether it be enrollment kinetics, event rate, or other things. And if there's a risk that the readout could be pushed beyond 3Q.

Kinetics event rate or other things and if there is risk that the readout could be pushed beyond <unk>. Thanks.

Anna Berkenblit: Thank you; your spot on enrollment kinetics influences the timing of the readout, so progression-free survival is the primary endpoint. It's an event-driven study, right? So we will trigger the analysis for the primary endpoint when we reach the requisite number of events. And that is a function of both the enrollment as well as the timing of the event. The event rate in Mirosol is, and should be, similar to the event rate in Forward 1, given that we're enrolling very similar populations. The enrollment rate in Mirasol has been different from Forward One.

You're spot on enrollment kinetics influence Ah Ah the timing of the readout, so progression free survival as the primary endpoint. Its an event driven study right. So we will trigger the analysis for the primary endpoint when we reach the requisite number of events.

And that is a function of both the enrollment.

As well as the timing of the events the event rate in Mirasol is and should be similar to the event rate in forward one given that we're enrolling very similar populations.

The enrollment rate in Mirasol has been different from forward one with forward. One we had a very very brisk enrollment the last three months like it just shot up like Crazy.

Anna Berkenblit: With Forward One, we had a very, very brisk enrollment in the last three months, like it just shot up like crazy. So a whole bunch of patients were enrolled right at the very end, so we had to wait a good long time to get to the requisite number of progression-free survival events. Here, with Mirasol being a larger study and with the pandemic, we don't anticipate that super-duper sharp tail in enrollment, like the curve right up. And so that accounts for the differences in timing.

So a whole bunch of patients were enrolled right at the very end. So we had to wait a good long time to get to the requisite number of progression free survival events here with Mirasol will be in a larger study and with the pandemic are you know that we don't anticipate that super-duper sharp tail in enrollment.

The curve right up and so that accounts for the differences in the timing and so we're on track for top line data in Q3.

Zoe Consensaro: And so we're on track for top-line data. Okay, got it. That's really helpful.

Okay got it that's really helpful. Thanks for taking my question.

Sure.

Jonathan Chang: Thanks for taking my question. Sure. Our next question comes from the line of Jonathan Chang with SBV Leary, Key Lani Self-Defense. Hi guys, thanks for taking my questions. A couple non-merve questions for me.

And our next question coming from the line of Jonathan Chang with SBB Leerink. Your line is open.

Susan Altshuler: First question: can you provide any color on your revenue guidance of 75 to 85 million? I noted that this doesn't include potential product sales from Merva Tuxenab, so if you could provide any color on what's reflected in this guidance, that'd be helpful. And then the second question is, can you provide any additional color on how the IMGC-936 dose escalation is going, and any additional granularity on when initial data could be disclosed this year?

Hey, guys. Thanks for taking my questions a couple of non merci questions for me.

First question can you provide any color on your revenue guidance of $75 million to $85 million. While you noted that this doesn't include potential product sales from perfect toxin that so if you could provide any color as to whats reflected in this guidance that'd be helpful.

Question is can you provide any additional color on how the I M. G. C 90, threes fixed dose escalation is going and any additional granularity on when initial data could be disclosed this year. Thank you.

Susan Altshuler: Thank you. In the revenue guidance, we include our non-cash royalty revenues and the license and milestone fees, inclusive of the $75 million to $85 million. We don't include the Merck product revenues because we don't have a production-to-date yet. The timing of potential revenues would be a factor in that. That's what's included in the revenue guidance. Turning to IMGC 936, we are in dose escalation for this novel ADC with a novel ADAM9-directed Tobadi and the first DM-21 linker payload.

Great Susan.

So on the revenue guidance.

We include our noncash royalty revenues.

And.

The license and milestone fees to two inclusive of the 75 to 85 million. So we don't include them or product revenues, because we don't have a producer date of course, and so they're just the timing of potential revenue.

It may be a factor in that.

So that that's that's what's inclusive in the revenue guidance.

And turning to I M. G. C 93, six we are in dose escalation for this novel ADC with a novel Adam nine directed antibody and the first D. M 21 linker payload. So we are in dose escalation and we look forward to presenting data later this year once we've identified that.

Susan Altshuler: So we are in dose escalation, and we look forward to presenting data later this year. Once we've identified the recommended phase two dose in schedule, and then we'll also be able to share development in Adam Knight.

Commended phase two dose and schedule are and then we'll be able to also share plans for further development in Adam nine positive tumors.

Jonathan Chang: Got it, thank you. And that's all the time we have for our Q&A session. I would now like to turn the call back over to Mr. Mark Enyedy for any closing remarks. All right. Thank you everybody for joining us today. We're excited about the year ahead. We have a number of important events coming up, starting with SGO in a couple of weeks, and we look forward to talking to all of you then. So thanks very much, and we'll keep you updated on our progress.

Got it thank you.

And that's all the time, we have our Q&A session I would now like to turn the call back over to Mr. Mark <unk> for any closing remarks.

Great. Thanks, everybody for joining us today, we're excited about the year ahead, we have a number of important events of <unk>.

Starting with the Joe and a couple of weeks and we look forward to talking to all of you. There. So thanks very much and we'll keep you updated on our progress.

Okay.

Jonathan Chang: Ladies and gentlemen, that does it for our conference for today. Thank you for your participation. You may now disconnect. [music] © BF-WATCH TV 2021 © BF-WATCH TV 2021 © BF-WATCH TV 2021 © BF-WATCH TV 2021, [music]

Ladies and gentlemen that does conclude the conference for today. Thank you for your participation you may now disconnect.

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