Q3 2020 ImmunoGen Inc Earnings Call

November 6, 2020

[music].

Good morning, and welcome to Immunogen third quarter 2020 financial and operating results Conference call. Today's conference is being recorded now I'd like to turn the call over to Courtney Okonedo Senior director of corporate Communications and Investor Relations. Please go ahead.

Operator: Good morning, and welcome to ImmunoGen's 3rd Quarter 2020 Financial and Operating Results Conference Call. Today's conference is being recorded. Now I'd like to turn the call over to Courtney Okonick, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Good morning, and thank you for joining todays call earlier today, we issued a press release that includes a summary of our recent progress in third quarter 2020 financial results.

Courtney Okonick: 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 third quarter 2020 financial results. This press release and a web stream of this call can be found in the Investor and Media section of ImmunoGen.com. With me today are Mark Enyedy, our President and CEO; Susan Altshuler, our Chief Financial Officer; and Anna Berkenblit, our Chief Medical Officer. Stacey Cohen, our Chief Business Officer, will also join us for Q&A. During today's call, we will review key accomplishments for the business over the last three months, our financial results, and upcoming milestones. During the discussion, we will use forward-looking statements, and our actual results may differ materially from those statements.

This press release and web stream of this call can be found under the Investor and media section of 'em you'd mentioned dotcom with.

With me today are mark entity, our president and CEO, Susan Altshuler, our Chief Financial Officer, and Anna Perkins, Let our Chief Medical Officer, Stacy Cohen, our Chief business Officer will also join us for Q and a.

During today's call, we will review key accomplishments for the business over the last three months, our financial results and upcoming milestones during the discussion we will use forward looking statements and our actual results may differ materially from such statements descriptions of the risks and uncertainties associated with an investment in immunogen are included in our SEC filings.

Courtney Okonick: Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings. And with that, I'll turn the call over to Mark. Thanks, Courtney. Good morning, everyone.

With that I'll turn the call over to Mark.

Thanks, Courtney good morning, everyone and thank you for joining us today Weve generated significant momentum in the business over the last several months achieving a number of important milestones across the company, while managing the challenges of operating in the current environment.

Mark Joseph Enyedy: And thank you for joining us today. We've generated significant momentum in the business over the last several months, achieving a number of important milestones across the company while managing the challenges of operating in the COVID environment. Starting with our lead program, we were pleased to announce our strategic collaboration with Huadong Medicine to develop and commercialize Mervituximab in Greater China. This is the second largest pharmaceutical market in the world, and Huadong's extensive research, development, and regulatory capabilities, along with its access to a large network of local hospitals, will allow us to realize Mervituximab's potential to improve outcomes and bring more good days to women living This partnership further strengthens our balance sheet with an upfront payment of $40 million, additional milestone payments of up to $265 million, and tiered royalties on commercial sales.

Starting with our lead program, we were pleased to announce our strategic collaboration with Quad on medicine to develop and commercialize mirvetuximab in greater China. This is the second largest pharmaceutical market in the world and markdowns extensive research development and regulatory capabilities, along with its access to a large network of local hospitals.

This will allow us to realize mirvetuximab potential to improve outcomes and bring more good days to women living with ovarian cancer in the region.

As partnership further strengthens our balance sheet with an upfront payment of $40 million additional milestone payments of up to $265 million and tiered royalties on commercial sales. We look forward to working with Martin to bring mirvetuximab to the market in greater China and I. Thank the teams at Lazard and ropes and gray for their support and bringing.

Mark Joseph Enyedy: We look forward to working with Huadong to bring Mervituximab to the market in Greater China, and I thank the teams at Lazard and Ropes & Gray for their support in bringing this deal to fruition. Beyond Greater China, we are working with a sense of urgency to execute on our pivotal trials and prepare for the first potential launch of mirvotoximab in 2022 in the U.S. To this end, we continue to advance site activation and patient enrollment for both psoriasis and mirosal and are on track to report top-line data from psoriasis in Q3 next year. In addition to a potential monotherapy label, we are committed to moving into earlier lines of therapy by combining it with other agents. With the benefit of the encouraging data we shared at ASCO and ESMO earlier this year, we are working to define the best path to label expansion with our combination regimens and look forward to sharing our approach on a future call.

Steel to fruition.

Beyond greater China, we are working with a sense of urgency to execute on our pivotal trials and prepare for the first potential launch of Mirvetuximab in 2022 in the US to this end, we continue to advance site activation and patient enrollment for both server and Marisol and are on track to report topline data from Serbia.

In Q3 next year. In addition to a potential monotherapy label, we are committed to moving into earlier lines of therapy by combining with other agents with the benefit of the encouraging data we shared at ASCO and ESMO earlier. This year, we are working to define the best path to label expansion with our combination regimen and look for.

Or to sharing our approach and a future call moving to our earlier stage programs. We were delighted to receive breakthrough therapy designation from FDA for I am Gn Sixthree two for the treatment of relapsed or refractory BBCN underscoring the need for safe and effective treatments for this rare and aggressive cancer. We are engaged with the FDA to further.

Mark Joseph Enyedy: Moving to our earlier stage programs, we were delighted to receive breakthrough therapy designation from FDA for IMGN 632 for the treatment of relapsed or refractory BPDCN, underscoring the need for safe and effective treatments for this rare and aggressive cancer. We are engaged with FDA to further define the development path for BPDCN while continuing to evaluate IMGN 632 and AML and other hematological malignancies. Finally, through effective execution and business development and the deployment of our ATM facility, we have further strengthened our balance sheet and now expect our existing cash, together with future payments from our partners, to fund our operations into the second half of 2022. With that, I'll turn the call over to Anna to review our clinical programs in more detail. Anna?

Define the development path for BP DCN, while continuing to evaluate 632 in AML and other hematological malignancies, finally through effective execution and business development and deployment of our ATM facility. We have further strengthened our balance sheet and now expect our existing cash together with future payments from our partners to fund our.

Operations into the second half of 2022 with that I will turn the call over to Ana to review, our clinical programs in more detail Ana.

Thanks, Mark we are pleased with the progress of Mirvetuximab and our earlier stage pipeline as we enroll patients in our ceria Mirasol I am Gn, Sixthree too and I am JC 936 trials.

We are on track with Mirvetuximab monotherapy for Serbia, We expect top line data during the third quarter of 2021 and to be Olay submission before the end of 2021 to support approval in 2022.

Anna Berkenblit: Thanks, Mark. We are pleased with the progress of Mervituxinab and our earlier stage pipeline as we enroll patients in our SREA, Mirasol, IMGN-632, and IMG-C936 trials. We are on track with mirvotoximab monotherapy. For psoriasis, we expect top-line data during the third quarter of 2021 and a BLA submission before the end of the year.

For mirror. So we expect to report top line data for this study in the first half of 2022.

Moving to our Mirvetuximab combination regimens, we presented final data from our forward to triplet cohort evaluating mirvetuximab in combination with Carboplatin and Bevacizumab at ESMO in September.

The platinum sensitive triplet cohort evaluated 41 patients with recurrent platinum sensitive ovarian cancer with medium or high levels of folate receptor Alpha who have received up to two prior lines of therapy.

Anna Berkenblit: For Mirosol, we expect to report top-line data for this study in the first half of 2020, moving to our Mervituximab combination regimen. We presented final data from our Forward 2 triplet cohort evaluating mervituximab in combination with carboplatin and bevacizumab at ESMO in September. The Platinum Sensitive Triplet Cohort evaluated 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of folate receptor alpha who have received up to two prior lines of therapy.

We observed a confirmed overall response rate of 83% with a median duration of response of 10.9 months and median progression free survival of 12.8 months.

I also remind you of the Mirvetuximab and Bevacizumab doublet data presented at ASCO in May where we observed an overall response rate of 64% in patients with high fr Alpha expression, regardless of platinum status.

The mirth beds data generated to date could support compendia listing and given the observed responses and favorable tolerability profile. We are working quickly to define a formal path to registration for mirvetuximab in combination and seek to expand into earlier lines of therapy.

Anna Berkenblit: We observed a confirmed overall response rate of 83% with a median duration of response of 10.9 months and median progression-free survival of 12.8 months. I will also remind you of the Mervituximab and Bevacizumab doublet data presented at ASCO in May, where we observed an overall response rate of 64% in patients with high FR-alpha expression, regardless of platinum status. The MIRV-BEV data generated to date could support compendia listing, and, given the observed responses and favorable tolerability profile, we are working quickly to define a formal path to registration for mirvotuximab in combination, to expand into earlier lines of therapy.

Moving to our earlier stage portfolio, we advanced our programs targeting both hematological malignancies and solid tumors.

We continue to progress multiple cohorts with I.M.G. and 632, our anti CD 123, AIDC, including monotherapy expansions in B.P.D.C.N. and minimal residual disease positive AML following frontline induction therapy, as well as combinations with decitabine and they need a KLAX in relapsed refractory.

Three A.M.L.

We look forward to presenting updated data from the I.M.G.N. 632, monotherapy bpd see an expansion cohort in an oral presentation and a trials in progress poster on the A.M.L. monotherapy and combination cohorts at Ash in December.

In the Ashby P.D.C.N. abstract released earlier. This week 23 patients are included comprising the largest prospective study with a single agent in patients with relapsed refractory B P. D C N.

Anna Berkenblit: Moving to our earlier stage portfolio, we advanced our programs targeting both hematological malignancies and solid tumors. We will continue to progress multiple cohorts with IMGN 632, our anti-CD123 agent, including monotherapy expansions in BPD-CN and minimal residual disease positive AML following frontline induction therapy, as well as combinations with azacitidine and venetoclax in relapsed refractory AML. We look forward to presenting updated data from the IMGN 632 Monotherapy BPD-CN Expansion Cohort in an oral presentation and a Trials in Progress poster on the AML Monotherapy and Combination Cohorts at ASH in December. In the ASH BPD-CN abstract released earlier this week, 23 patients are included, comprising the largest prospective study with a single agent in patients with relapsed refractory BPD-CN. We are pleased with the activity in these heavily pre-treated patients with high unmet needs, including those with prior intensive chemotherapy, prior transplant, and prior Alzheimer's, with an overall response rate of 30% and Clinically Meaningful Durations of Response, ranging from over 3 months to 9 days. IMGN 632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration.

We are pleased with the activity in these heavily pretreated patients with high unmet need including those with prior intensive chemotherapy prior transplant and prior L. sonorous with an overall response rate of 30% and clinically meaningful durations of response ranging from over three months to 9.2 months.

I am GE and 632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration.

We look forward to Dr. Pepper Rogers presentation on Saturday December 5th.

Finally, we are pleased to have enrolled our first patient in a phase one dose escalation study evaluating I am GE Si 936 hour, Adam nine targeting 80, C, which is being co developed with macrogenics in solid tumors, including non small cell lung colorectal pancreatic gastric and triple negative breast.

Cancer and look forward to further advancing this trial.

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

Thanks, Anna for the third quarter of 2020, we generated $18.2 million in revenue nearly all of which came from non cash royalty revenue.

Operating expenses were $34.9 million compared with $31.2 million for the third quarter of 2019. This.

This increase was driven by increased R&D expenses from greater clinical trial costs related to advancing our mirasol, Syria, and 632 studies, partially offset by lower restructuring expenses GM.

<unk> expenses were $10.2 million compared to $9.2 million in the third quarter of 2019, primarily due to increased professional fees at the end of the third quarter, we had $188.2 million in cash.

Anna Berkenblit: We look forward to Dr. Pemiraju's presentation on Saturday, December 5th. Finally, we are pleased to have enrolled our first patient in a Phase I dose-escalation study evaluating IMGC 932. Our ADAM9-targeting ADC, which is being co-developed with macrogenics in solid tumors, including non-small cell lung, colorectal, pancreatic, gastric, and triple negative breast; we look forward to further advancing this trial.

Certainly subsequent to quarter end, we brought in $54 million and net proceeds from our aftermarket financing received $40 million in upfront payments from one on medicine related to our partnership for the rights to Mirvetuximab and greater China received an upfront payment from a newly executed license agreement with Meridian.

We will receive a $5 million payment from Novartis for a development milestone achieved in September.

Updating our 2020 financial guidance, we now expect revenues to be between 60 and $65 million operating expense expenses to be between 150 and $165 million.

Susan Altshuler: With that, I'll turn the call back over to Susan to review the findings. Thanks, Anna. For the third quarter of 2020, we generated $18.2 million in revenue, nearly all of which came from non-cash royalty revenues. Operating expenses were $34.9 million, compared with $31.2 million for the third quarter of 2019. This increase was driven by increased R&D expenses from greater clinical trial costs related to advancing our Mirasol, SIREA, and 632 studies, partially offset by lower restructuring expenses. DNA expenses were $10.2 million compared to $9.2 million in the third quarter of 2019, primarily due to increased professional fees. At the end of the third quarter, we had $188.2 million in cash.

And our cash at the year end to be between 245 and $250 million.

Please note that our revenue guidance does not include any potential impact from the agreement with what on medicine.

We are preparing for the potential accelerated approval for Mirvetuximab in platinum resistant ovarian cancer and are planning for increased investment in 2021 related to manufacturing and support of commercial launch with the addition of these investments we expect that current cash and anticipated cash receipts from partners will fund operations into the second half of 2022.

With that I will turn the call back over to Mark.

Thanks, Susan just a few closing remarks, we've made significant progress with the business over the course of 2020 and look forward to a strong finish to the year. We're excited about the future with the benefit of a strong cash position and an experienced management team we've positioned the business to execute on a number of important milestones in 2021 includes.

In pivotal data in a BLA submission for our lead program defining the path to registration for 632, and BBCN as well as label expansion for Mirvetuximab generating initial data from GE Si 936, and finally, an R&D for MGM 151, So I look forward to keeping you apprised of our progress and what our exciting time.

Susan Altshuler: And importantly, subsequent to quarter end, we brought in $54 million in net proceeds from our at-the-market financing, received $40 million in upfront payments from Huadong Medicine related to our partnership for the rights to Mervituximab in Greater China, received an upfront payment from a newly executed license agreement with Viridian, and will receive a $5 million payment from Novartis for a development milestone achieved in September. Updating our 2020 financial guidance, we now expect revenues to be between $60 and $65 million, operating expenses to be between $160 and $165 million, and our cash at the year-end to be between $245 and $250 million. Please note that our revenue guidance does not include any potential impact from the agreement with Huadong Medicine.

As for the company with that we'll open the call for questions operator.

As a reminder, classical question, we'll need to press star one on your telephone to withdraw your question press the pound key please stand by while we compile the culinary roster.

Our first question comes from the line of John Newman from Canaccord. Your line is now open.

Hey, good morning, guys. Thanks for taking my question.

Just had a question on IMS yen 62, you know the SASSA has become really interesting.

With the data that you presented for BBCN as follows the breakthrough status.

Just curious about how you're thinking about the registration pathway.

Especially because if you look at your CR rates.

You're basically neck and neck with where stemline was in the relapse refractory population. So just curious as to how you're thinking about.

Helping this asset in terms of registration thanks.

Thanks, John Yeah, we're very pleased with the activity were seeing in relapse refractory T.D.C.N. and we look forward to sharing updated data at.

Susan Altshuler: We are preparing for the potential accelerated approval for Mervitoxibab in platinum-resistant ovarian cancer and are planning for increased investment in 2021 related to manufacturing in support of commercial launch. With the addition of these investments, we expect that current cash and anticipated cash receipts from partners will fund operations into the second half of 2022. With that, I will turn the call back over to Mark. Thanks, Susan.

And around the time of actually also we'll be sharing plans in terms of our registration path forward you know as we've discussed previously our goal this year was to.

Meet with that FDA to define the path forward and we look forward to sharing that around the time of that.

Great. Thank you.

Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim. Your line is now open.

Hey, guys. Good morning, and congrats on the progress from me as well on I am GE and six to be too can.

Mark Joseph Enyedy: Just a few closing remarks. We've made significant progress with the business over the course of 2020 and look forward to a strong finish to the year. We're excited about the future.

Can you maybe provide a little bit more color on how much additional data we might expect here at the Ash conference and I did note that some of the Prs later converted to CRC just wondering if that's a general phenomenon, but sub it's eighty's fees in this indication.

Mark Joseph Enyedy: With the benefit of a strong cash position and an experienced management team, we've positioned the business to execute on a number of important milestones in 2021, including pivotal data and a BLA submission for our lead program, defining the path to registration for 632 and BPDCN, as well as label expansion for Mervituximab, generating initial data for IMGC 936, and filing an IND for IMGN 151 So I look forward to keeping you apprised of our progress and what are exciting times for the company. With that, we'll open the call for questions. Operator?

Thanks, Michael So you may recall at Ash last year, we had TNBC DCM patients enrolled nine at home, where a valuable and at the time of the data cut off for the abstract for Ash, we had enrolled 23 patients where do you see we have a 30% response rate and now we do have duration of response information that.

We saw over three months to 9.2 months ago duration of response data is quite nice in this relapse refractory population as we continue to enroll and we will present updated data on the entire data set.

Cash.

Okay, Great and then.

An operational question I guess, you know should you decide to file a B.L.A. based on these data how how might this affect the jazz pharma opt in rights. My understanding was that they may need to opt in prior to being a submission just wondering how that might.

Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Newman from Pianacord.

Workout structurally speaking.

Yes, thanks, Michael so the.

Where does the agreement works is there are essentially two adopting purity is the first runs from the time, we signed the agreement up and fill the initiation of pivotal development in am now.

John Lawrence Newman: Your line is now open. Hey, good morning, guys. Thanks for taking my question. I just had a question on IMGN 632. You know, this asset has become really interesting with the data that you presented for BPD-CN as well as the breakthrough status. Just curious about how you're thinking about the registration pathway, especially because if you look at your CR rate, you're basically neck and neck with where Stemline was in the relapser factory population. So I'm just curious as to how you're thinking about developing this asset in terms of registration. Thanks, John.

And the second opt in period runs from that they are through the BRL eight filing for Annabel on there's a little bit of nuances related to an interim filing for BBCN, which is probably beyond the scope of this call. So the way I would characterize it is simply that they.

Opt in early Uptil, the initiation of pivotal development for for and now and as I said, there's there's some nuance around BBCN, where if they have not opted in there's a deferral period huh.

Okay. Thank you and then on a I know, but when you think about market size.

Duration of treatment makes a big difference can you maybe comment on how duration of therapy. In your study may compare to that that has been seen with as Andreas.

Unknown Executive: Yeah, we're very pleased with the activity we're seeing in Relapse for Fractured TPD-CN, and we look forward to sharing updated data at ASH. At the time of ASH, we will also be sharing plans in terms of our registration path forward. You know, as we've discussed previously, our goal this year was to meet with FDA to define a path forward, and we look forward to sharing that around the time of ASH. Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim. Your line is now open.

So Michael it's a little early for us to start you know talking about comparing or.

In terms of duration of response, but I would just remind you that with wells on the duration of response and the absence of transplants is actually rather brief sales onto you develop anti drug antibodies a at the median duration of response tends to be a in a three month range again in the absence of transplant. So you know what.

Please with the patients that we enrolled thus far heavily pre treated a you know post intensive chemotherapy, some post transplant and some hotels arent and we've had a duration of response north of nine months.

Great Thanks, and congrats on all the progress.

Michael Werner Schmidt: Hey guys, good morning, and congratulations on all the progress from me as well. On IMGN 632, can you maybe provide a little bit more color on how much additional data we might expect here at the ASH conference? And I did note that some of the PRs later converted to CRC. Just wondering if that's a general phenomenon with ADCs in this indication.

Thank you.

Thank you. Our next question comes from the line of Andy Sigh of William Blair. Your line is now open.

Oh, great. Thanks for taking my question and congrats on all the progress just a quick one for me. So so I guess.

Speaking not familiar.

Familiar with the type of regulatory pathway. So I'm just wondering.

And what needs to be done there in order to gain some sort of.

Anna Berkenblit: Thanks, Michael. So, you may recall at ASH last year, we had 10 BPDCN patients enrolled, nine of whom were evaluable. And at the time of the data cutoff for the abstract for ASH, we had enrolled 23 patients, where you see we have a 30% response rate. And now, we do have duration of response information, as you saw, over three months to 9.2 months.

Regulatory approval or or or marketing authorization.

It is a full blown phase.

Trial lead aid or just basically a bridging study a complementary.

I guess, both the forward one.

Their cell and then that's the right decision.

So any sort of color on that would be super helpful. Thank you.

Sure Andy so the the one of the reasons, we chose $5 because of their expertise in developing drugs in China and so we look forward to it really clarifying the regulatory path for Mirvetuximab in China, a we are confident that we will need to generate data indication.

Anna Berkenblit: So, the duration of response data is quite nice in this relapsed refractory population. We continue to enroll, and we will present updated data on the entire data set at ASH. Okay, great. And then an operational question, I guess, you know, should you decide to file a BLA based on these data?

In China, and we're working with what I'm trying to figure out the most expedient path to doing so and we will get regulatory ER alignment with the Chinese regulators.

To do so.

Got it thank you very much.

Thank you. Our next question comes from the line number in Amin from Jefferies. Your line is now open.

Unknown Executive: Yeah, thanks, Michael. The way the agreement works is that there are essentially two opt-in periods. The first runs from the time we sign the agreement up until the initiation of pivotal development in AML, and the second opt-in period runs from that day through the BLA filing for AML. There's a little bit of nuance related to an interim filing for BPDCN, which is probably beyond the scope of this call. So the way I would characterize it is simply that they can opt-in early up until the initiation of pivotal development for AML. And as I said, there are some nuanced rules around BPDCN where if they have not opted in, there's a deferral period. Okay, thank you. And then, Anna, I know when we think about market size, duration of treatment makes a big difference. Can you maybe comment on how the duration of therapy in your study may compare to that that has been seen with Alzheimer's?

Hi, guys. Thanks for taking my questions maybe on on Mirvetuximab, but do you think F.D.A. will want to wait for the Marisol data before it considers the BLE that's supported by Soraya.

Well, that's certainly a possibility or that is not our base case assumption you know the survey data are really on track to be delivered a year ahead to allow us to have a filing before the end of next year and so you know we don't think.

Unless they have some concern we don't think there will be any rationale for them to wait for the Myris ALLDATA, yes.

The American Spirit I'd point, you to the true Delvina situation you know obviously they had a delay in the sense that you have you know manufacturing issues.

The delay Dan, but ultimately you know they gained approval on the.

On the it's a single arm study, while the <unk> and the the phase three study read out shortly thereafter, and so I think you know I think after todays prepared to take action, particularly where you have a significant unmet need on the basis of the data that are in front of them.

Anna Berkenblit: So, Michael, it's a little early for us to start, you know, talking about comparing ourselves to Aldonra's in terms of duration of response. But I would just remind you that with Aldonra's, the duration of response in the absence of transplant is actually rather brief. With Aldonra's, you do develop anti-drug antibodies, and the median duration of response tends to be in the three-month range, again, in the absence of transplant.

Got it and then your strategy for combination I know in the past you've talked about potential companion lift thing, but youve thinking on this call. Today, you mentioned that you would disclose some plants and a future call are you I guess is how many reconsidering that strategy and would you potentially move.

Forward with them or a registrational study in this setting.

Yeah. So the way to think about it is additive. So we've generated a lot of good combination data and it would be those data that are the basis for submitting to the compendia supportive lifting and correspondingly reimbursement in the U.S. as you know that you know in the absence.

Andy Tsai: So, you know, we're pleased with the patients that we've enrolled thus far, heavily pre-treated, you know, post-intensive chemotherapy, some post-transplant, and some post-Aldonra, and we've had durations of response north of nine months. Great, thanks, and congratulations on all the progress. Thank you. Thank you. Our next question comes from Andy Tsai from William Blair.

So the label, we would be constrained in terms of the ability to promote those data and so the goal really is ultimately to gain a.

Label and label expansion in earlier lines stations, and we think the best approach there likely will be some combinations, either with a vast and or or carbon plant. So that's what we're working through as we speak.

Andy Tsai: Your line is now open. Oh, great. Thanks for taking my question and congrats on all the progress. Just a quick one for me.

Okay, and then maybe just a question on the BBCN program with Sixthree to are there any plans in evaluating listen frontline because you know if I look at your safety profile, you're not seeing any capillary leak syndrome or is I think we saw this with Amazon Ross and then they.

Unknown Executive: So I guess, you know, the street is not familiar with the China regulatory pathway. So I'm just wondering, what needs to be done there in order to gain some sort of, you know, regulatory approval or, or marketing authorization? Is a full-blown phase 3 trial needed, or just basically a bridging study complementing, I guess, both the Forward I, Nercel, and Soraya would be sufficient? So any sort of color on that would be super helpful.

I guess, you know, what's driving that because it seems that we've seen this with other CB 123 program. So just want to kind of understand.

But what's driving that safety profile.

Yes so.

Certainly we're excited about further development of eye injury, and 632 in both relapse refractory and the front line setting a and actually the protocol is currently open we recently amended or it is enrolling in front line patients. We just started that so you know I think for the safety profile perspective, it's very clear.

Unknown Executive: Thank you. Sure, Andy. So, one of the reasons we chose Huadong is because of their expertise in developing drugs in China, and so we look forward to really clarifying the regulatory task for myrbitoxinab in China. We are confident that we will need to generate data in patients in China, and we're working with Huadong to figure out the most expedient path to doing so, and we will get regulatory alignment with the Chinese regulators to do so. I got it.

With that I haven't had a 632 has a very favorable safety and Tolerability profile. You know, we're not required to be hospitalized and we have not had a capillary leak syndrome that has really been seen in can be fatal, but els Andreas.

And that's in large part due to the good theory, a toxin conjugate immunogens stopped.

Stop working on the theory of how often times against many years ago in terms of PD 123, and other ways of targeting it you know with bi specific there's certainly a cytokine release syndrome that can be problematic for those by specific so I think at this point, we're quite pleased with the safety profile that we're seeing.

Burin Amin: Thank you very much. Thank you. Our next question comes from Burin Amin from Jeffreys. Your line is now open. Yeah, hi guys.

Great. Thank you.

Thank you. Our next question comes on the line of Jessica Fye from JP Morgan. Your line is now open.

Mark Joseph Enyedy: Thanks for taking my questions. Maybe on Mervituximab, but do you think FDA will want to wait for the Mirasol data before it considers a BLA that's supported by Soraya? Well, that's certainly a possibility, but that is not our base case assumption.

Hey, guys. Good morning, Thanks for taking my question one focused on a million for money I know some of your supply and you talk about the number of platinum resistant ovarian patients, but maybe just drilling into that more specifically what do you see as the annual incidence of post that this isn't a platinum or just.

Mark Joseph Enyedy: You know, the Saraya data is really on track to be delivered a year ahead to allow us to have a filing before the end of next year. And so, you know, we don't think, unless they have some concerns, we don't think there will be any rationale for them to wait for the Mirasol data. In that case, I'd point you to the Tredelby situation. Obviously, they had a delay in the sense that they had, you know, manufacturing issues that delayed them, but ultimately, they gained approval in the single-arm study while the Phase 3 study read out shortly thereafter. And so I think, you know, I think the FDA is prepared to take action, particularly where you have a significant unmet need on the basis of the data that are in front I got it.

In ovarian cancer with one of the three prior lines of therapy.

Yeah and to add one more.

Criteria into that those that are fully receptor alpha positive you know that at a high level. We think the annual incidence of the market for our proposed label would be 2500 patients.

Okay.

And do you think it is going and we think it Jackson did the if you take away the previously treated with a vast and criterion. It jumps to 505000. So when we look at the data from forward, one, which we think is a reasonably representative sample about half the pace.

He's had prior avastin and half did not.

[noise] garner and is that U.S. or U.S. and you're out yeah. Those are U.S. numbers.

So what we think we have yeah, we use a combination of data. So we buy data from D.R.G.. We also have a an agreement with flat iron where we're looking at a longitudinal cohort and then we supplement that with the physician survey through a if sales to get those numbers. The DRG is just starting.

Mark Joseph Enyedy: And then your strategy for combination, I know in the past you've talked about potential compendia list things, but I think on this call today, you mentioned that you would disclose some plans on a future call. Are you, I guess, as a company, reconsidering that strategy, and would you potentially move forward with a registrational study in this setting? Yes, the way to think about it is additive.

Starting point.

Got it and.

[laughter] possibility that the Serrano trial could support European approval for another tax number you anticipate needing controlled data like from an aerosol.

Yeah. So we will go talk to the M&A about the result was to re are for sure.

Their appetite for a single arm studies to support approval.

So historically has been limited in oncology I've seen it doesn't have done it with Ah things in my past life or at a genzyme.

Mark Joseph Enyedy: So we've generated a lot of good combination data, and it would be those data that are the basis for submitting to the compendia to support a listing and, correspondingly, reimbursement in the U.S. As you know, in the absence of a label, we would be constrained in terms of the ability to promote those data. And so the goal really is ultimately to gain approval and label expansion in earlier Lyme patients, and we think the best approach there likely will be through combinations either with Avastin or Carboplatin. So that's what we're working through as we speak. Okay.

So we will go out the conversation and if that doesn't you know et cetera.

Bear fruit and you know it would be mirasol that we support full approval in the EU.

Okay, and then it sounds like you're kind of thinking about the.

Ah path forward from tax man in combination. So what are the most kind of interesting possibilities there in your view and which of those would best maximize the commercial opportunity.

Yeah, you know if you look at.

Ovarian cancer today, you know most patients on individual diagnosis following surgical debulking I mean, there is a fair amount of Neoadjuvant use and we're actually looking at that and then I S T.

Anna Berkenblit: And then maybe just a question on the BPD-CN program with 6.3.2. Are there any plans for evaluating this on the front line? Because, you know, if I look at your safety profile, you're not seeing any capillary leak syndrome, whereas I think we saw this with Ilizandras. And then I guess, you know, what's driving that? Because it seems that we've seen this with other CD123 programs. So I just want to kind of understand, you know, what's driving that safety profile.

But you know the patients get a either a you know a platinum based doublet or about or triplet with the 30 agent being a vast and so you know we generate some very nice trip with data and that we shared at a mature data at a at ESMO, but you know for a market opportunity perspective, I think obviously.

Thirdly, substituting mirvetuximab for Paclitaxel in the you know the doublet or the triplet would be the highest market opportunity. The challenge. There is that that's going to be a very large a large study and so what we're looking at are opportunities or to move into earlier lines.

Anna Berkenblit: Yeah, certainly we're excited about further development of IMGN-632 in both relapsed refractory and the frontline setting. And actually, the protocol is currently open, we recently amended it, and it is enrolling frontline patients. We've just started that. So, you know, I think from a safety perspective, it's very clear that IMGN-632 has a very favorable safety and tolerability profile. You know, we're not required to be hospitalized, and we have not had the capillary leak syndrome that has really been seen and can be fatal with Alzheimer's, and that's in large part due to the diphtheria toxin.

Therapy.

Either you know using a strategy similar to the data that we shared pad ASKO, where the patients were platinum agnostic that is it was a mix of patients who were at our the resistance.

Or or sensitive, but later line patients and you know the data we saw there in terms of response rate.

We are quite compelling and we had a 64% response rate in those patients with high levels of fully receptor alpha expression. So looking at that sort of you know third line later platinum agnostic population or separately going after you know a non platinum based regimen in plan.

Sensitive patients patients who remain platinum sensitive because what happens is after a couple on the platinum a there are a lot of reasons why positions are not giving platinum to those patients, they're hypersensitivity tired bone marrow et cetera.

Jessica Fye: In terms of CD123 and other ways of targeting it, you know, with bi-specifics, there's certainly cytokine release syndrome that can be problematic for those bi-specifics. So I think at this point, we're quite pleased with the safety profile that we have. Great, thank you. Thank you. Our next question comes from Jessica Five from JP Morgan. Your line is now open. Hey guys, good morning. Thanks for taking my questions. I want to focus on ovarian cancer for a minute.

So what we see in our data is a growing population of those patients where you know a combination regimen and that doesn't include platinum. So for example, mirvetuximab plus the vast and could be a very nice alternative for them. So those are the those are that our thoughts are in terms of.

Have a label expansion.

Got it thank you.

Sure.

Thank you. Our next question comes from the line of Boris Peaker from Cowen. Your line is now open.

Great. Thanks for taking my question I'm, just curious for the nurse so as long as the Cerenia trial, a as you are enrolling at what fraction of patients are you finding to fall into the Polish up the positive category based on your new lets say.

Mark Joseph Enyedy: I know in some of your slides you talk about the number of platinum-resistant ovarian patients, but maybe just drilling into that more specifically, what is the annual incidence of post-bevacizumab platinum-resistant ovarian cancer with one of the three prior lines of therapy? Yeah, and to add one more criterion to that, those that are folate receptor alpha positive, you know, at a high level. We think the annual incidence of the market for our proposed label would be 2,500 patients. And we think, Jeff, that if you take away the previously treated with Avastin criterion, it jumps to 5,000. So when we looked at the data from Forward One, which we think is a reasonably representative sample, about half the patients had prior Avastin treatment, and half did not. And is that U.S. or U.S. and Europe? Yeah, those are U.S. numbers.

So for us it's not a new assay is the asset that we have used up from the beginning of the program the tier two plus assay and we're tracking exactly as we would expect we know from passing over 2000 patients that about 40% are fr Alpha high.

Great. Thanks for taking my question.

Sure.

Thank you. Our next question comes in the line of Joe had 10 barrels from Piper Sandler. Your line is now open.

Hey, guys. Thanks, so much for taking my question here, maybe just one quick one I guess now with a a nice greater China deal under your belt for Mirvetuximab. How do you think about the potential for additional X.U.S. partnerships around that asset I guess, namely Europe and is that largely consistent on how you view.

Mark Joseph Enyedy: So we use a combination of data. So we buy data from DRG. We also have an agreement with Flatiron where we're looking at a longitudinal cohort. And then we supplement that with a physician survey through Ipsos to get at those numbers. But DRG is the starting date, the starting point.

Your cash needs moving forward and whether maybe you could potentially create more value as psoriasis and mirror solid read out in the near future. Thanks.

Yeah, Joe I mean, I think you said it well, which is you know this is a multi variable equation here and we're looking at you know what resources, we would need to bring to bear to launch the product versus you know what the value would be bringing on a partner for in particular Europe.

Mark Joseph Enyedy: And is there a possibility that the SORAYA trial could support European approval for Roboteximab, or do you anticipate needing controlled data like from Mirafol? Yeah, so we will talk to the EMA about the results of SREA for sure. Their appetite for single-arm studies to support approval has historically been limited in oncology. I've seen it done.

Yeah, Weve done the analysis in Europe, and it's a fairly concentrated market in terms of physician targets, you know treatment patterns and so it actually more concentrated than the U.S., that's offset to some degree by the need for national level, you know commercial infrastructure. So you know what you end up.

Mark Joseph Enyedy: I've done it with things in my past life at Genzyme. So we will go out for the conversation, and if that doesn't bear fruit, then it would be Mirosol that would support full approval in the EU. And then it sounds like you're kind of thinking about the Path Forward for MIRV-TuxMab in combination. So what are the most interesting possibilities there, in your view, and which of those would best maximize the commercial? Yeah, you know, if you look at ovarian cancer today, most patients on initial diagnosis following surgical debulking, I mean, there is a fair amount of neoadjuvant use. And we're actually looking at that in an IST.

With their estimates of you know commercial and medical Affairs, you know infrastructure similar to what you have in the Europe. When you look at a sort of region to region comparison, but certainly within the ambit of a of a company like immunogen, particularly you know being able to finance on the back of a pause.

Live pivotal data. So that said you know there are a lot of advantages to partnering as well and so that's something that we are we will evaluate in particular with with ER positive pivotal data in here one thing I would add and I am with the Chinese deal at 40 million upfront licenses.

Proceeds from the ATM, we've now yeah.

Guidance for cash outlay until the second half were pleased to meet you really feel that we're in a position of strength. So we want to do the right strategic decision on partnerships because we.

Mark Joseph Enyedy: But, you know, patients get either a platinum-based doublet or a triplet with the third agent being Avastin. And so, you know, we generated some very nice triplet data that we shared at – mature data at ESMO. But, you know, from a market opportunity perspective, I think, obviously, substituting mervituximab for paclitaxel in the doublet or the triplet would be the highest market opportunity.

Have that Optionality now that we bring to the balance sheet this quarter.

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

Sure.

Thank you. Our next question comes from the line of Jonathan Chang from SVB Leerink. Your line is now open.

Hey, Good morning, guys. This is David Russo on for Jonathan Thanks for taking our questions.

Mark Joseph Enyedy: The challenge there is that that's going to be a very large study. And so what we're looking at are opportunities to move into earlier line therapy, either using a strategy similar to the data that we shared at ASCO, where the patients were platinum-agnostic. That is, it was a mix of patients who were either resistant or sensitive, but later-line patients. And, you know, the data we saw there, in terms of response rates, were quite compelling. We had a 64% response rate in those patients with high levels of folate receptor alpha expression. So looking at that sort of, you know, third line and later platinum-agnostic population are separately going after, you know, a non-platinum-based regimen in platinum-sensitive patients who remain platinum-sensitive. Because what happens is, after a couple of lines of platinum, there are a lot of reasons why physicians are not giving platinum to those patients, their hypersensitivity, tired bone marrow, et cetera.

First question for 632 have you guys presented or do you have plans to present any duration of response data from the 71 patients treated with monotherapy at ash of last year and.

And then second could you provide any color on the enrollment progress and the combination cohorts and when we might see initial data from the phase the Ben combo didn't pan out please.

So for the M.L. monotherapy data that we presented at Ash last year four I'm GM 632.

We anticipate that when we write a manuscript for that we will provide duration of response data.

Moving to the combination we look forward to weren't going into planning and Investor Conference call event around the time of that and that would be the appropriate time for us to provide a progress update on the combinations for I.M.G.N. Sixthree too we do on the trials in progress poster at Ash, describing the study design.

Combining with a decidedly with Citi to class and as the triplet and we are in the midst of a that dose escalation.

Got it. Thank you and then just second I noticed on the idea of when our collaboration with Bridion slashed marriage and.

Mark Joseph Enyedy: And so what we see in our data is a growing population of those patients where, you know, a combination regimen that doesn't include platinum, so for example, mervituximab plus Avastin, could be a very nice alternative for them. So those are our thoughts in terms of label expansion. Thank you. Thank you.

We've seen some impressive sales figures already this year from two pads and I was just wondering if you could provide any further specificity on your economics within the thyroid eye disease opportunity and timing of potential regulatory filing and I guess anything else here that you'd highlight about the the promise of this this opportunity. Thanks a lot.

Sure So we're not Tiffany.

Boris Peaker: Your line is now open. Great, thanks for taking my question. I'm just curious for the MIRASOL as well as the SERREA trial, as you are enrolling patients, what fraction of patients are you finding to fall into the folate receptor positive category based on your new assay? So Boris, it's not a new assay, it's the assay that we have used from the beginning of the program, the PF2 Plus assay, and we're tracking exactly as we would expect We know from testing over 2,000 patients that about 40% are FR alpha high. Great

Promoting upfront numbers on that deal, but just the structure as you know upfront milestones in royalties in traditional type of fashion and we do have the opportunity to recognize approximately $50 million in development milestones and ups and $95 million in sales.

Wow sounds on that program.

We do think it is well placed with meridian and they're in a position to move that forward. As you know we're focused on cancer here in immunogen, and we think that its complimentary to have them pursuing this asset in the third eye disease indication.

Which has a very promising.

Anna Berkenblit: Thanks for taking my question. Thank you. Our next question comes in the line from Joe Catanzaro from Piper Sandler.

Potential.

Great. Thanks, a lot and congrats on the progress.

Thanks.

Thank you. Our next question comes from the line of Kennen Mackay from RBC. Your line is now open.

Joseph Michael Catanzaro: Your line is now open. Hey guys, thanks so much for taking my question here. Maybe just one quick one.

Hi, Thanks, so much for taking my question and congrats on what's been a really remarkable deal here at another good question Mark I was wondering where you're building the most common.

Joseph Michael Catanzaro: I guess now with a nice bigger China deal under your belt for Mervyn Tuck's Mab, how do you think about the potential for additional ex-US partnerships around that asset, I guess, namely, Europe? And is that largely consistent with how you view your cash needs moving forward and whether maybe you could potentially create more value as Soraya and Mirosol read out in the near future? Thanks. Yeah, Joe, I mean, I think you say it well, which is, you know, this is a multivariable equation here.

From an interest these days is it from strategic assets relating to the Mirvetuximab or.

Potential combination therapies.

There were people.

For Mirvetuximab and additional trials or cohorts that can be done there or you know earlier pipeline at a mine are more sort of platform interest looking to accessing linker in paymode tech or similar.

Similar to the burgeoning deal that we recently heard about.

Yeah. So what I would say is we get to the two ends of the spectrum and what I mean by that is you know there's inbound interest in Mirvetuximab, obviously, weve signed a deal for greater China, but you know, it's a late stage oncology asset and as you can imagine that tends to attract a lot of a lot of attention.

Mark Joseph Enyedy: And we're looking at, you know, what resources we would need to bring to bear to launch a product versus, you know, what the value would be of bringing on a partner for, in particular, Europe. You know, we've done the analysis in Europe, and it's a fairly concentrated market. In terms of physician targets, you know, treatment patterns, and so on, actually more concentrated than the U.S., that's offset to some degree by the need for national level commercial infrastructure. So you end up with estimates of, you know, commercial and medical affairs, you know, infrastructure, similar to what you have in Europe when you look at a sort of region-to-region comparison.

At the other end of the spectrum. It is around the platform you know that with the recent success in terms of approvals and the AIDC space. You know there is a lot of interest.

And the underlying technology. So we are fielding or you know inbound or similar to what you know catalyze the discussion with the wood for Radian and so those are the kinds of things, we're entertaining and you know I think.

As as we see the progress for example, with 936, which really integrates a number of important innovations that came out of our labs over the last you know half decade, or so in terms of payloads Linkers and also some antibody engineering you know people see that and I think if those that program progresses.

Mark Joseph Enyedy: Certainly within the ambit of a company like ImmunoGen, particularly being able to finance on the back of positive pivotal data. So that said, there are a lot of advantages to partnering as well. And so that's something that we will evaluate in particular with positive pivotal data in hand. One thing I would add is, you know, with the China deal and the $40 million upfront plus the proceeds from the ATM, we've now updated guidance for cash outlay until the second half of 2022, and we feel that we're in a position of strength. So we want to make the right strategic decision on partnerships because we... And we have that optionality now that we bring to the balance sheet this quarter. Okay, got it.

You know probably that will engender, even greater interest and so we're excited about those things and being able.

To deploy the technology platform more broadly so that's where it is in the middle of both the 632 and Adam nine or our partner and so you know, we're we're not getting any interest there, but what those programs do have as you know innovation that has intrigued others to come knocking.

Got it and I'm not maybe just oh elaborating on that a little bit obviously, there's been a lot of strategic interest in agencies after the.

You remember listening or competitive immunomedics acquisition and there are some of the deals every day in Oh, a theater and brother now.

Anything relating to no interest in combination of Bdcs with the checkpoints, maybe in ovarian cancer and I'm wondering are you know if.

Joseph Michael Catanzaro: That's helpful. Thanks. Thanks for taking my question. Thank you. Our next question comes from the line of Jonathan Chang from SVB Larynx.

If there are specific.

Secondly could stand out as.

The better sort of combination partners or really you know spend any evolution in thinking or around the field or.

Jonathan Chang: Your line is now open. Hey, good morning, guys. This is David Ruchon on behalf of Jonathan.

Unknown Executive: Thanks for taking our questions. First question, for 632, have you guys presented, or do you have plans to present, any duration of response data from the 71 patients treated with monotherapy at ASH last year? And then second, could you provide any color on the enrollment progress in the combination cohorts and when we might see initial data from the AZE event combos in AML? So, for the AML monotherapy data that we presented at ASH last year for IMGM 632, we anticipate that when we write a manuscript for that, we will provide duration of response data. Moving to the combinations, we look forward to, we're in the midst of planning an investor conference call event around the time of ASH, and that would be the appropriate time for us to provide a progress update on the combinations for IMGN 632.

Central immuno oncology partner in barely temper.

Partner in a combination drugs I'm not not Oh, yeah, yeah. So Karen you may remember that we are moving forward with Merck combining with the keytruda in the ovarian cancer setting in platinum resistant patients and the initial responses were quite encouraged.

As you know when we expanded out the the cohort we didn't see a significant contribution in terms of efficacy beyond what weve typically seen in that population with with single agent Mirvetuximab and so we have not pursued that further.

There have been some really interesting preclinical or.

Data I was pointing to a paper by offerings. The paleo to the lab I think based in Switzerland, and you know what they showed was synergy in particular between these you know tubulin acting agents and the checkpoint inhibitors and say do it sort of encouraging early data, which.

Didn't pan out, but what I would say is we're not averse.

Averse to its business and it has a few other words add here yeah, I think unfortunately ovarian cancer is unlike many other tumor somewhere.

Checkpoint inhibitors have revolutionized the treatment paradigm there have been several phase three failures for checkpoint inhibitors at this point in ovarian cancer with Allomap in the javelin studies and with the type of listen that most recently in the imagine 15 study. So you know they tend to be not very patiently direct consumer I would.

Unknown Executive: We do have a trials in progress poster at ASH describing the study design for combining azacitidine with venetoclax and as a triplet, and we are in the midst of that. Got it. Thank you. And then, just second, I noticed on the IGF-1R collaboration with Viridian slash Miragen, we've seen some impressive sales figures already this year from Topeza, and I was just wondering if you could provide any further specificity on your economics within the thyroid eye disease opportunity and timing of potential regulatory filing, and I guess anything else here that you'd highlight about the promise of this opportunity. Thanks a lot. Sure. But we're not...

Go so far as to say checkpoint inhibitors have not really achieve proof of concept in ovarian cancer. So I think it would be unlikely unless there's a new targets identified in the biology, it's wrong for us to pursue a combinations with the currently available checkpoint inhibitor.

Right. So look if we look at the earlier part of the portfolio for example, with the IMS you see 96, the Adam nine program, where we are moving into tumor types that have shown activity with checkpoint inhibitors I think that creates the opportunity. So we're absolutely open to it I says is that we.

We ran experiment with Mirvetuximab in ovarian cancer and for the reasons and identified.

You know didn't see anything that they are you know.

Needless to say this is a place we want to bet heavily.

Got it thank you very much.

Sure.

Thank you. Our next question comes from the line of Swine online a cool run line comes from H.C. Wainwright. Your line is now open.

Unknown Executive: Transcripts provided by Transcription Outsourcing, LLC. We do have the opportunity to recognize approximately $50 million in development milestones and up to $95 million in sales milestones on that program. We do think it's well-placed with Viridian.

Thank you. This is OK from had C ran but most of my questions have been asked I'm just trying to.

A question on 96. This is Adam nine are targeting NDC.

Unknown Executive: They're in a position to move that forward. As you know, we're focused on cancer here at ImmunoGen, and we think that it's complementary to have them pursuing this asset in the thyroid eye disease indication, which has very promising potential. Great. Thanks a lot and congratulations on the progress. Thank you. Our next question comes from the line of Kenan McKay from RBC. Your line is now open.

That's your partner, but Macrogenics <unk>.

Could you just give us some color as to the progress of the trial and also anything regarding timing for data.

Data release.

Yeah, our take we're delighted to have announced on our earnings call that we dose the first patient and so the trial is on its way you know, it's a standard three plus three dose escalation study and the beauty of Adam nine is that it is highly expressed a multitude of sales.

Kenan McKay: Hey, thanks so much for taking the question, and congrats on what's been a really remarkable year here. I had another BD question. Mark, I was wondering where you're fielding the most incoming interest these days? Is it from strategics relating to Mervituxmab or potential combination therapies for Mervituxmab and additional trials or cohorts that could be run there, or, you know, earlier pipeline out of nine, or more sort of platform interest looking to access linker and payload tech, similar to the Verdean deal that we recently heard about? Yeah, so what I would say is we get it at the two ends of the spectrum.

All in tumors and not on normal tissue. So there's a nice.

Ah differential there that is allowing us to go after non small cell lung cancer colorectal pancreatic gastric in triple negative breast cancer. So we anticipate that the three plus three design should as well well and when we have sufficient data we look forward to sharing it.

Thank you thanks for taking my question.

Thank you. Our next question comes on the line of John Newman from Canaccord. Your line is now open.

Mark Joseph Enyedy: What I mean by that is, you know, there is inbound interest in myotoxin. Obviously, we've signed a deal for greater China, but, you know, it's a late-stage oncology asset, and as you can imagine, that tends to attract a lot of attention. At the other end of the spectrum, it is around the platform.

Hi, guys. Thanks for taking the follow up so I just wondered if you could maybe.

Elaborate a bit on how we should think about.

Use of Mirvetuximab longer term.

It's in the front line the combination.

Very and I know, obviously, that's down the road that will be a bigger study, but just curious as to how you might get there if that would be a study that.

Mark Joseph Enyedy: You know, with the recent success in terms of approvals in the ADC space, you know, there is a lot of interest in the underlying technology, so we are fielding, you know, inbound similar to what, you know, catalyzed the discussion with Viridian, and so those are the kinds of things we're entertaining, and, you know, I think... As we see the progress, for example, with 936, which really integrates a number of important innovations that came out of our labs over the last half-decade or so in terms of payload linkers and also some antibody engineering, people see that, and I think as that program progresses that will engender even greater interest, and so we're excited about those things and being able to deploy the technology platform more broadly, so that's where it is. In the middle, both 632 and ADAM9 are partnered, so we're not getting any interest there, but what those programs do have is innovation that has intrigued others to come knock. That's it. And Mark, maybe just elaborating on that a little bit.

You know down the line immunogen to put together and run.

So it would maybe be a study to look at with Caulks groups I'm just curious given the activity that you're seeing in combination with not just platinum, but also also with the best thanks.

Yeah, So just to revisit the conversation we have with jazz we.

We are looking at.

ER combination regimens to expand the label.

That could include recurrent.

Platinum sensitive patients where are these platinum agnostic patients that I described and so I think that is the likely next step to get to a front line indication I think would likely involve.

A cooperative group study given the scale of a of that effort. So you know what we really want to do in the you know for the next step in and label expansion is to move into earlier lines and address some of these recurrent platinum sensitive and platinum agnostic patients and also you know going right to visit.

Mark Joseph Enyedy: Obviously, there's been a lot of strategic interest in ABCs after the Immunometics Acquisition, Competitive Immunometics Acquisition, and some of the deals that we've seen, Seattle Ciagen, or now, Inking, relating to an interesting combination of ADCs with checkpoints. Maybe in ovarian cancer, I'm wondering if there are specific checkpoints that stand out as maybe the better sort of combination partners, or really, you know, if there's been any evolution in thinking around the field of a potential immuno-oncology partner in ovarian cancer. Partnering in a combination drug sense, not a... Yeah, yeah. So, Kenneth, you may remember that we moved forward with Merck combining with Keytruda in the ovarian cancer setting in platinum-resistant patients. And the initial responses were quite encouraging. However, when we expanded out the cohort, we didn't see a significant contribution in terms of efficacy beyond what we typically see in that population with single-agent myrmitoximab. And so we have not pursued that further.

Top of accuse also started this I S T a neoadjuvant ER and see what the impact is there I can't tell you sitting here today, what the exact path to registration would be for a neoadjuvant study and that's something we need to think through so I think in terms of near term or from US you know look for.

That patient segment, where we're in a later line platinum sensitive platinum agnostic patients and stay tuned.

Yes.

Great. Thank you.

Thank you at this time I'm showing no further questions I would like to turn the call back over to the team for closing remarks.

Great. Thanks, very much we appreciate the interest today and look forward to seeing you all at a at ash and in the new year and as we make further progress with the business. So thanks very much.

Ladies and gentlemen, this concludes today's conference call. Thanks for participating you may now disconnect.

[music].

Mark Joseph Enyedy: There have been some really interesting preclinical data. I was pointing to a paper by Alfred Zepelius, which is a lab, I think, based in Switzerland. And what they showed was synergy in particular between these tubulin-acting agents and the checkpoint inhibitors. And as I say, it's encouraging early data that didn't pan out. But what I would say is we're not opposed to it, but Anna has a few other words to add here. Yeah.

Anna Berkenblit: I think, unfortunately, ovarian cancer is unlike many other tumors where checkpoint inhibitors have revolutionized the treatment paradigm. There have been several Phase III failures for checkpoint inhibitors at this point in ovarian cancer, with Avelamab in the JAVALIN studies and with teslizumab most recently in the IMAGINE50 study. So, you know, these tend to be not very mutationally driven tumors.

Anna Berkenblit: I wouldn't even go so far as to say that checkpoint inhibitors have not really achieved proof of concept in ovarian cancer. So I think it would be unlikely unless there's a new target that's identified and the biology is strong enough for us to pursue combinations with the currently available checkpoint inhibitors.

Mark Joseph Enyedy: But if we look at the earlier part of the portfolio, for example, with the IMGC 936 and the ADAM9 program, where we are moving into tumor types that have shown activity with checkpoint inhibitors, I think that creates an opportunity. And we're absolutely open to it. As I said, we ran the experiment with myrvotoximab in ovarian cancer and, for the reasons that Anna identified, didn't see anything that, you know, you've made us say this is a place we want to bet heavily on. Got it.

[music].

Kenan McKay: Thank you very much. Thank you. Our next question comes from the line of Swayampakula Ramakanth from HC Wayne Wright.

Swayampakula Ramakanth: Your line is now open. Thank you. This is RK from HC Wainwright.

Unknown Executive: Most of my questions have already been asked. A question on 936, this is the item 9 targeting ADC that you have partnered with MacroGenX. Could you just give us some color as to the progress of the trial and also anything regarding timing for data release? Yeah, R.K., we're delighted to have announced on our earnings call that we've dosed the first patient, and so the trial is on its way. You know, it's a standard 3 plus 3 dose escalation study, and the beauty of ADAM9 is that it is highly expressed in a multitude of solid tumors and not in normal tissue, so there's a nice differential there that is allowing us to go after non-small cell lung cancer, colorectal, pancreatic, gastric, and triple negative breast cancer.

Unknown Executive: So we anticipate that the 3 plus 3 design should enroll well, and when we have sufficient data, we look forward to sharing it. Thank you. Thank you. Our next question comes from the line of John Newman from Canaccord. Your line is now open.

John Lawrence Newman: Hi guys, thanks for taking the follow up. So I just wondered if you could maybe elaborate a bit on how we should think about using Mervituximab longer term in the front line. Unknown Executive, Swayampakula Ramakanth, Dingding Shi, Boris Peaker, Etzer Darout, Anna Berkenblit, Renee Lentini, Anabel Chan, Isabel Kalofonos, Lauren White, ImmunoGen Inc. Down the line, ImmunoGen can put together and run. That would maybe be a study to look at with co-op groups.

Mark Joseph Enyedy: Just curious, given the activity that you're seeing in combination with not just platinum but also with the vaccine. Yeah, so to revisit the conversation we had with Jess. We are looking at combination regimens to expand the label that could include recurrent platinum sensitive patients or these platinum agnostic patients that I described. And so I think that is the likely next step. To get to a frontline indication, I think it would likely involve a cooperative group study given the scale of that effort.

Mark Joseph Enyedy: So what we really wanna do for the next step in label expansion is to move into earlier lines and address some of these recurrent platinum sensitive or platinum agnostic patients. And also, going right up to the top of the queue, we have started this IST in neoadjuvant and see what the impact is there. I can't tell you sitting here today what the exact path to registration would be for a neoadjuvant study. That's something we would need to think through.

Mark Joseph Enyedy: So I think in terms of near-term from us, look for that patient segment where we're in later line platinum sensitive or platinum agnostic patients and stay tuned. Great, thank you. Thank you. At this time, I am showing no further questions.

Operator: I would like to turn the call back over to the team for closing remarks. Great, thanks very much. We appreciate the interest today and look forward to seeing you all at ASH and in the new year and as we make further progress with the business. So, thanks very much. Ladies and gentlemen, this concludes today's conference call. Thanks for participating. You may now disconnect.

Courtney Okonick: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? www.microsoft.com.ca ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Good morning, and welcome to ImmunoGen's third quarter 2020 financial and operating results conference call. Today's conference is being recorded. Now, I'd like to turn the call over to Courtney Okonick, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Mark Joseph Enyedy: Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings. And with that, I'll turn the call over to Mark. Thanks, Courtney. Good morning, everyone.

[music].

Mark Joseph Enyedy: And thank you for joining us today. We've generated significant momentum in the business over the last several months, achieving a number of important milestones across the company while managing the challenges of operating in the COVID environment. Starting with our lead program, we were pleased to announce our strategic collaboration with Huadong Medicine to develop and commercialize Mervitoximab in Greater China. This is the second largest pharmaceutical market in the world, and Huadong's extensive research, development, and regulatory capabilities, along with its access to a large network of local hospitals, will allow us to realize Mervitoximab's potential to improve outcomes and bring more good days to women living This partnership further strengthens our balance sheet with an upfront payment of $40 million, additional milestone payments of up to $265 million, and tiered royalties on commercial sales.

Mark Joseph Enyedy: We look forward to working with Huadong to bring Mervituximab to the market in Greater China, and I thank the teams at Lazard and Ropes & Gray for their support in bringing this deal to fruition. Beyond Greater China, we are working with a sense of urgency to execute on our pivotal trials and prepare for the first potential launch of mirtuximab in 2022 in the U.S. To this end, we continue to advance site activation and patient enrollment for both Sirea and Mirasol and are on track to report top-line data from Sirea in Q3 next year. In addition to a potential monotherapy label, we are committed to moving into earlier lines of therapy by combining it with other agents. With the benefit of the encouraging data we shared at ASCO and ESMO earlier this year, we are working to define the best path to label expansion with our combination regimens and look forward to sharing our approach on a future call.

Anna Berkenblit: Thanks, Mark. We are pleased with the progress of Mervituxinab and our earlier stage pipeline as we enroll patients in our SREA, Mirasol, IMGN 632, and IMGC 936 trials. We are on track with mirvotoximab monotherapy. For psoriasis, we expect top-line data during the third quarter of 2021 and a BLA submission before the end of the year. Report

[music].

Anna Berkenblit: For Mirasol, we expect to report top-line data for this study in the first half of 2020, moving to our Mervituximab combination regimen. We presented final data from our Forward II triplet cohort, evaluating mervituximab in combination with carboplatin and bevacizumab at ESMO in September. The platinum-sensitive triplet cohort evaluated 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of folate receptor alpha who have received up to two prior lines of therapy.

Good morning, and welcome to Immunogen third quarter 2014 financial and operating results Conference call. Today's conference is being recorded now I'd like to turn the call over to coordinate our <unk> senior director of corporate Communications and Investor Relations. Please go ahead.

Good morning, and thank you for joining todays call earlier today, we issued a press release that includes a summary of our recent progress and third quarter 2020 financial result.

Anna Berkenblit: We observed a confirmed overall response rate of 83% with a median duration of response of 10.9 months and median progression-free survival of 12.8. I will also remind you of the Mervituximab and Bevacizumab doublet data presented at ASCO in May, where we observed an overall response rate of 64% in patients with high FR-alpha expression, regardless of platinum status. The MIRV-BEV data generated to date could support compendia listing, and, given the observed responses and favorable tolerability profile, we are working quickly to define a formal path to registration for mirvotuximab in combination, to expand into earlier lines of therapy. Moving to our earlier stage portfolio, we advanced our programs targeting both hematological malignancies and solid tumors. We will continue to progress multiple cohorts with IMGN 632, our anti-CD123 AD. Monotherapy Expansions in BPD-CN and Minimal Residual Disease Positive AML following frontline induction therapy, as well as combinations with azacitidine and venetoclax in relapsed refractory AML

This press release and web stream of this call can be found under the Investor and media section of you mentioned dot com with.

With me today are mark entity, our president and CEO, Susan offshore, our Chief Financial Officer, and Adam <unk>, Our Chief Medical Officer, Stacy Cohen, our Chief business Officer will also join us for Q1 <unk>.

With that I'll turn the call over to Mark.

Thanks, Courtney good morning, everyone and thank you for joining US today, we have generated significant momentum in the business over the last several months achieving a number of important milestones across the company, while managing the challenges of operating in the code environment.

Starting with our lead program, we were pleased to announce our strategic collaboration with Qualcomm medicine to develop and commercialize mirvetuximab in greater China. This is the second largest pharmaceutical market in the world and watch dogs extensive research and development and regulatory capabilities, along with its access to a large network local hospitals.

This will allow us to realize merger talks about potential to improve outcomes and bring more good days to women living with ovarian cancer in the region is.

Anna Berkenblit: We look forward to presenting updated data from the IMGN 632 Monotherapy BPD-CN Expansion Cohort in an oral presentation and a Trials in Progress poster on the AML Monotherapy and Combination Cohorts at ASH in December. In the ASH BPD-CN abstract released earlier this week, 23 patients are included, comprising the largest prospective study with a single agent in patients with relapsed refractory BPD- We are pleased with the activity in these heavily pre-treated patients with high unmet needs. Prior Intensive Chemotherapy, Prior Transplant, and Prior Alzheimer's, with an overall response rate of 30% and Clinically Meaningful Durations of Response, ranging from over three months to nine. IMGN 632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration.

This partnership further strengthens our balance sheet with an upfront payment of $40 million additional milestone payments of up to $265 million in tiered royalties on commercial sales. We look forward to working with watchdog to bring more of a talk some after the market in greater China and I. Thank the teams at Lazard and ropes and gray for their support and bringing this.

Deal to fruition.

Beyond the greater China, we are working with a sense of urgency to execute on our pivotal trials and prepare for the first potential launch of Mirvetuximab and 2022 and the U.S. to this end, we continue to advance site activation and patient enrollment for both survey a mirror so and are on track to report topline data from Serbia.

In Q3 next year. In addition to a potential monotherapy label, we are committed to moving into earlier lines of therapy by combined with other agents with the benefit of the encouraging data we shared at ASKO at ESMO earlier. This year, we are working to define the best path the label expansion with our combination regimens and look for.

Anna Berkenblit: We look forward to Dr. Pemiraju's presentation on Saturday, December 5th. Finally, we are pleased to have enrolled our first patient in a Phase I dose-escalation study evaluating IMGc9. Our ADAM9-targeting ADC, which is being co-developed with macrogenics in solid tumors including non-small cell lung, colorectal, pancreatic, gastric, and triple negative breast; we look forward to further advancing this trial.

And to sharing our approach in a future call moving to our earlier stage programs. We were delighted to receive breakthrough therapy designation from F.D.A. Fry M.G.N. 632 for the treatment of relapsed or refractory B BBCN underscoring the need for safe and effective treatments for this rare and aggressive cancer, we are engaged with hefty Ada for that.

Anna Berkenblit: With that, I'll turn the call back over to Susan to review the findings. Thanks, Anna. For the third quarter of 2020, we generated $18.2 million in revenue, nearly all of which came from non-cash royalty revenues. Operating expenses were $34.9 million, compared with $31.2 million for the third quarter of 2019.

Find the development path for BP DCN, while continuing to evaluate 632 in AML and other hematological malignancies filing through effective execution and business development and deployment of our ATM facility. We have further strengthened our balance sheet and now expect our existing cash together with future payments from our partners to fund our.

Operations into the second half of 2022 with that I will turn the call over to Ana to review, our clinical programs in more detail and huh.

Susan Altshuler: This increase was driven by increased R&D expenses from greater clinical trial costs related to advancing our Mirasol, SIREA, and 632 studies, partially offset by lower restructuring expenses. GNA expenses were $10.2 million compared to $9.2 million in the third quarter of 2019, primarily due to increased professional fees. At the end of the third quarter, we had $188.2 million in cash.

Thanks, Mark we are pleased with the progress of Mirvetuximab and our earlier stage pipeline as we enroll patients in our ceria Mirasol I.M.G.N. sixthree too and I am J.C. 936 trials.

We are on track with Mirvetuximab monotherapy for psoriasis, we expect top line data during the third quarter of 2021 and to be Olay submission before the end of 2021 to support approval in 2022.

Susan Altshuler: And importantly, subsequent to quarter end, we brought in $54 million in net proceeds from our at the market financing, received $40 million in upfront payments from Huadong Medicine related to our partnership for the rights to Mervituximab in Greater China, received an upfront payment from a newly executed license agreement with Viridian, and will receive a $5 million payment from Novartis for a development milestone achieved in September. Updating our 2020 financial guidance, we now expect revenues to be between $60 and $65 million, operating expenses to be between $160 and $165 million, and our cash at year end to be between $245 and $250 million. Please note that our revenue guidance does not include any potential impact from the agreement with Huadong Medicine.

For Mirasol, we expect to report top line data for this study in the first half of 2022.

We observed a confirmed overall response rate of 83% with a median duration of response of 10.9 months and median progression free survival of 12.8 months.

The mirth bad data generated to date could support Compendia listing and given the observed responses and favorable tolerability profile. We are working quickly to define a formal path to registration for mirvetuximab in combination and seek to expand into earlier lines of therapy.

Moving to our earlier stage portfolio, we advanced our programs targeting both hematological malignancies and solid tumors.

Mark Joseph Enyedy: With the benefit of a strong cash position and an experienced management team, we've positioned the business to execute on a number of important milestones in 2021, including pivotal data and a BLA submission for our lead program, defining the path to registration for 632 and BPDCN, as well as label expansion for MRFATUXIMAB, generating initial data for IMGC 936, and filing an IND for IMGN So I look forward to keeping you apprised of our progress and what are exciting times for the company. With that, we'll open the call for questions. Operator?

We continue to progress multiple cohorts with I.M.G. and 632, our anti CD 123, AIDC, including monotherapy expansions in B.P.D.C.N. and minimal residual disease positive AML following frontline induction therapy as well as combinations with decitabine and then either KLAX in relapsed refractory.

Three A.M.L.

In the Ashby PDC, an abstract released earlier. This week 23 patients are included comprising the largest prospective study with a single agent in patients with relapsed refractory B P. D C N.

John Lawrence Newman: Your line is now open. Hey, good morning, guys. Thanks for taking my question. I just had a question on IMGN-632. You know, this asset has become really interesting with the data that you presented for BPD-CN as well as the breakthrough status. Just curious about how you're thinking about the registration pathway, especially because if you look at your CR rate, you're basically neck and neck with where Stemline was in the relapse refractory population. So I'm just curious as to how you're thinking about developing this asset in terms of registration. Thanks, John.

We are pleased with the activity in these heavily pretreated patients with high unmet need including those with prior intensive chemotherapy prior transplant and prior else on risk with an overall response rate of 30% and clinically meaningful durations of response ranging from over three months to 9.2 months.

I am GE and 632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration.

Unknown Executive: Yeah, we're very pleased with the activity we're seeing in relapsed refractory dPDCN, and we look forward to sharing updated data at ASH. At the time of ASH, we will also be sharing plans in terms of our registration path forward. You know, as we've discussed previously, our goal this year was to meet with FDA to define a path forward, and we look forward to sharing that around the time of ASH. Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim. Your line is now open. Hey guys.

We look forward to Dr. Pepper Rogers presentation on Saturday December 5th.

Finally, we are pleased to have enrolled our first patient in a phase one dose escalation study evaluating I am GC 936 hour, Adam nine targeting 80, C, which is being co developed with macrogenics in solid tumors, including non small cell lung colorectal pancreatic gastric and triple negative breast.

Cancer and look forward to further advancing this trial.

Michael Werner Schmidt: Good morning, and congratulations on all the progress from me as well. On IMGN 632, can you maybe provide a little bit more color on how much additional data we might expect here at the ASH conference? And I did note that some of the PRs later converted to CRC. Just wondering if that's a general phenomenon with ADCs in this indication. Thanks, Michael.

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

Thanks, Anna for the third quarter of 2020, we generated $18.2 million in revenue nearly all of which came from non cash royalty revenue.

Operating expenses were $34.9 million compared with $31.2 million for the third quarter of 2019.

This increase was driven by increased R&D expenses from greater clinical trial costs related to advancing our mirasol, Syria and fixed rate two studies, partially offset by lower restructuring expenses.

Anna Berkenblit: So, you may recall at ASH last year, we had 10 BPDCN patients enrolled, nine of whom were evaluable. And at the time of the data cutoff for the abstract for ASH, we had enrolled 23 patients, where you see we have a 30% response rate. And now, we do have duration of response information, as you saw, over three months to 9.2 months.

Gn expenses were $10.2 million compared to $9.2 million in the third quarter of 2019, primarily due to increased professional fees at the end of the third quarter, we had $188.2 million in cash.

Importantly, subsequent to quarter end, we brought in $54 million and net proceeds from our aftermarket financing received $40 million in upfront payments from one on medicine related to our partnership for the rights to Mirvetuximab in greater China received an upfront payment from a newly executed license agreement with Meridian.

And will receive a 5 million dollar payment from Novartis for a development milestone achieved in September.

Updating our 2020 financial guidance, we now expect revenues to be between 60 and $65 million.

Operating expense expenses to be between 160 and $165 million.

Unknown Executive: How might this affect the Jazz Pharma opt-in rights? My understanding was that they may need to opt in prior to BLA submission. Just wondering how that might work out, structurally speaking. Yeah, thanks, Michael. So the way the agreement works is there are essentially two opt-in periods. The first runs from the time we sign the agreement up until the initiation of pivotal development in AML. And the second opt-in period runs from that date through the BLA filing for AML.

And our cash at the year end to be between 245 and $250 million.

Please note that our revenue guidance does not include any potential impact from the agreement with lot of medicine.

With that I will turn the call back over to Mark.

Anna Berkenblit: There's a little bit of nuance related to an interim filing for BPDCN, which is probably beyond the scope of this call. So the way I would characterize it is simply that they can opt-in early up until the initiation of pivotal development for AML. And as I said, there are some nuanced rules around BPDCN where if they have not opted in, there's a deferral period. Okay, thank you. And then, Anna, I know when we think about market size, duration of treatment makes a big difference. Can you maybe comment on how the duration of therapy in your study may compare to that that has been seen with Alzheimer's?

In pivotal data in a BLA submission for our lead program define the path to registration for 632, and BBCN as well as label expansion for Mirvetuximab generating initial data from GC 936, and finally denying the Ferrari MTN 151, So I look forward to keeping you apprised of our progress and what our exciting.

Times for the company with that we'll open the call for questions operator.

Anna Berkenblit: So, Michael, it's a little early for us to start, you know, talking about comparing ourselves to aldonras in terms of duration of response. But I would just remind you that with aldonras, duration of response in the absence of transplant is actually rather brief. With aldonras, you do develop anti-drug antibodies, and the median duration of response tends to be in the three-month range, again, in the absence of transplant.

As a reminder, classical question want to press Star one on your telephone to withdraw your question about came.

Yes, Bob while we compile the culinary roster.

Our first question comes from the line of John Newman from Canaccord. Your line is now open.

Hey, good morning, guys. Thanks for taking my question.

Just had a question on IMS Gen. Six due to you know this asset is becoming really interesting.

With the data that you presented for BBCN as follows the breakthrough status.

Anna Berkenblit: So, you know, we're pleased with the patients that we've enrolled thus far, heavily pretreated, you know, post-intensive chemotherapy, some post-transplant, and some post-aldonras. And we've had durations of response north of nine months. Great, thanks, and congratulations on all the progress. Thank you. Thank you. Our next question comes from Andy Tsai from William Blair. Your line is now open.

Just curious about how you're thinking about the registration pathway.

Especially because if you look at your CR rate.

Youre basically neck and neck with where stemline was in the relapse refractory population. So just curious as to how you're thinking about device.

Developing this asset in terms of registration thanks.

Thanks, John Yeah, we're very pleased with the activity were seeing in relapse refractory PTCL and we look forward to sharing updated data at.

Andy Tsai: Oh, great. Thanks for taking my question. And congrats on all the progress. Just a quick one for me. So I guess, you know, the street is not familiar with the China regulatory pathway. So I'm just wondering what needs to be done there in order to gain some sort of, you know, regulatory approval or, or marketing authorization? Is a full-blown phase 3 trial needed, or just basically a bridging study complementing, I guess, both the SporeWord1, Nercel, and Soraya would be sufficient? So any sort of color on that would be super helpful.

And around the time of apps. We also will be sharing plans in terms of our registration path forward you know as we've discussed previously our goal this year was to.

Meet with the FDA to define the path forward and we look forward to sharing that around the time of that.

Great. Thank you.

Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim. Your line is now open.

Hey, guys. Good morning, and congrats on the progress from me as well on I M G and six to be too can.

Can you maybe provide a little bit more color on how much additional data we might expect here at the Ash conference and I did note that.

Unknown Executive: Thank you. Sure, Andy. So, one of the reasons we chose Huadong is because of their expertise in developing drugs in China, and so we look forward to really clarifying the regulatory task for Myrvotoxinab in China. We are confident that we will need to generate data in patients in China, and we're working with Huadong to figure out the most expedient path to doing so, and we will get regulatory alignment with the Chinese regulators to do so. I got it.

Some of the Prs later converted to CRC, just wondering if that's a general phenomenon, but sublets eightys fees in this indication.

Thanks, Michael So you may recall at Ash last year, we had TNBC DCM patients enroll nine at home, where a valuable and at the time of the data cut off for the abstract for Ash, we have enrolled 23 patients where you see we have a 30% response rate and now we do have duration of response information that.

He saw over three months to 9.2 lots of those duration of response data is quite nice in the relapse refractory population.

We continue to enroll and we will present updated data on the entire data center.

Unknown Executive: Thank you very much. Thank you. Our next question comes from Burin Amin from Jefferies. Your line is now open. Yeah, hi guys.

Cash.

Okay, Great and then.

An operational question I guess, you know should.

Should you decide to file at DNA based on these data.

Burin Amin: Thanks for taking my questions. Maybe on Mervituximab, but do you think FDA will want to wait for the Mirosol data before it considers a BLA that's supported by Soraya? Well, that's certainly a possibility, but that is not our base case assumption.

How how might this affect the jazz pharma opt in rights my understanding was that they may need to opt in prior to being a submission just wondering how that might work out structurally speaking.

Yeah. Thanks, Michael So the way the agreement works is there are essentially two opt in period. The first runs from the time, we signed the agreement up until the initiation of pivotal development and am now.

And the second option period runs from that they got through the BRL eight filing for Annabel on there's a little bit of nuance related to an interim filing for BP DCN, which is probably beyond the scope of this call. So the way I would characterize it is simply that they care about.

Mark Joseph Enyedy: You know, obviously, they had a delay in the sense that they had, you know, manufacturing issues that delayed them, but ultimately, they gained approval in the SINGLES-ARM study, and the Phase 3 study read out shortly thereafter. And so I think the FDA is prepared to take action, particularly where you have a significant unmet need on the basis of the data that are in front of them.

Opt in early Uptil, the initiation of pivotal development for for animal and as I said, there's there's some nuance around BBCN, where if they have not opted in there's a deferral period.

Okay. Thank you and then I know I know, but when you think about market size.

Duration of treatment makes a big difference can you maybe comment on how duration of therapy. In your study may compare to that that has been seen with Amazon rose.

Mark Joseph Enyedy: And then your strategy for combination, I know in the past you've talked about potential compendia listing, but I think on this call today, you mentioned that you would disclose some plans on a future call. Are you, I guess, as a company, reconsidering that strategy, and would you potentially move forward with a registrational study in the setting? Yeah, so the way to think about it is additive.

So Michael it's a little early for us.

Are you talking about comparing.

In terms of duration of response, but I would just remind you that with all the duration of response in the absence of transplant is actually rather brief you.

You develop anti drug antibodies and the median duration of response and see a in a three month range I guess in the absence of transplant. So.

We're pleased with the patients that we have enrolled thus far heavily pre treated.

Post intensive chemotherapy, some post transplant and sometimes sales office and we've had a duration of response north of nine months.

Great Thanks, and congrats on all the progress.

Thank you.

Thank you. Our next question comes from the line up and be side by William Blair. Your line is now open.

Mark Joseph Enyedy: So we've generated a lot of good combination data, and it would be those data that are the basis for submitting to the compendia to support a listing and, correspondingly, reimbursement in the U.S. As you know, in the absence of a label, we would be constrained in terms of the ability to promote those data. And so the goal really is ultimately to gain label expansion in earlier Lyme patients, and we think the best approach there likely will be through combinations either with Avastin or Carboplatin. So that's what we're working through as we... Okay.

Oh, great. Thanks for taking my question and congrats on all the progress just a quick one for me.

So I guess.

We could not familiar.

Familiar with the type of regulatory pathway. So I'm just wondering.

What needs to be done there in order to gain some sort of.

Regulatory approval for our marketing authorization.

Is that more broad based.

Trial, the data or just basically a bridging study a complementary.

I guess, both the forward one.

Nerve cell and.

Yeah, that's right.

Any color on that would be super helpful. Thank you [noise].

Sure Andy so the the one of the reasons, we chose cloud because of their expertise in developing products in China and so we look forward to really clarifying the regulatory path for a toxin that in China. We are confident that we will need to generate data indication.

In China, and we're working with what amounts to figure out the most expedient path to doing so and we will get regulatory ER alignment with the Chinese regulators to.

To do so.

Got it thank you very much.

Thank you. Our next question comes from the line of varying Amin from Jefferies. Your line is now open.

Anna Berkenblit: Yeah, certainly we're excited about further development of IMGN-632 in both the relapsed refractory setting and the frontline setting. And actually, the protocol is currently open, although we recently amended it.

Hi, guys. Thanks for taking my questions, maybe on Mirvetuximab, but do you think ft, Jay will want to wait for the Marisol data before it considers the BLE that's supported by Soraya.

Well, that's certainly a possibility that is not our base case assumption.

Anna Berkenblit: It is enrolling in frontline patients that we just started out with. So, you know, I think from a safety perspective, it's very clear that IMGN-632 has a very favorable safety and tolerability profile. You know, we're not required to be hospitalized, and we have not had the capillary leak syndrome that has really been seen and can be fatal with Alzheimer's.

The survey data are really on track to be delivered a year ahead to.

Who allow us up.

You have a filing before the end of next year and so.

We don't think.

Unless they have some concern we don't think there will be any rationale for that to wait for.

For the Mirasol data.

American Spirit I'd point, you to the sort of Delhi situation, you know obviously they have a delay in the sense that they had manufacturing issues are the.

Anna Berkenblit: And that's in large part due to the diphtheria toxin conjugate. ImmunoGen stopped working on diphtheria toxin conjugates many years ago. In terms of CD123 and other ways of targeting it, you know, with bispecifics, there's certainly cytokine release syndrome that can be problematic for those bispecifics. So I think at this point, we're quite pleased with the safety profile that we're seeing. Great, thank you. Thank you. Our next question comes from the line of Jessica Fye from JP Morgan. Your line is now open. Hey guys, good morning.

The delay Dan, but ultimately they gained approval on the.

On the single arm study, while the <unk> and the the phase three studies read out shortly thereafter, and so I think you know I think that FDA is prepared to take action, particularly where you have a significant unmet need on the basis of the data that are in front of them.

Got it and then your strategy for a combination I know in the past you've talked about potential compendia listing, but you're thinking on this call. Today, you mentioned that you would disclose some plants.

And a future call are you I guess as a company reconsidering that strategy and would you potentially.

Move forward with them.

Jessica Fye: Thanks for taking my questions. I want to focus on ovarian cancer for a minute. I know in some of your slides you talk about the number of platinum-resistant ovarian patients, but maybe just drilling into that more specifically, what is the annual incidence of post-bevacizumab platinum-resistant ovarian cancer with one to three prior lines of therapy? Yeah, and to add one more... Criterion to that, those that are folate receptor alpha positive, you know, at a high level. We think the annual incidence of the market for our proposed label would be 2,500 patients. And we think, Jeff, that if you take away the previously treated with Avastin criterion, it jumps to 5,000. So when we looked at the data from Forward One, which we think is a reasonably representative sample, about half the patients had prior Avastin treatment, and half did not. And is that U.S. or U.S. and Europe? Yeah, those are U.S. numbers.

Just rational study in this setting.

Yeah, that's the way to think about it is additive. So we've generated a lot of good combination data and it would be those data that are the basis for submitting to the compendia supportive lifting and correspondingly reimbursement in the U.S.

As you know that in the absence of a label we would be constrained in terms of the ability to promote those data and so the goal really is to ultimately to gain a.

Label the label expansion earlier line patients and we think the best approach there likely will be.

Combinations, either with a vast and or or car build plans. So that's what we're working through as we speak.

Okay, and then maybe just a question on the BBCN program with fixed three two.

Are there any plans and evaluating this and frontline because if I look at your safety profile.

You're not seeing any capillary leak syndrome or is I think we saw this with sales on Ross and then I guess, what's driving that because it seems that we've seen this with other CB 123.

Program. So just wanted to kind of understand that.

Mark Joseph Enyedy: So we use a combination of data. So we buy data from DRG, and we also have an agreement with Flatiron where we're looking at a longitudinal cohort, and then we supplement that with a physician survey through Ipsos to get at those numbers. But DRG is the starting point.

Thats whats driving that safety profile.

Yeah. So.

Certainly we're excited about further development of AI and dancing three two in both relapse refractory and the frontline setting ER and actually the protocol is currently open. We recently amended it is enrolling in front line patients that we just started that so you know I think for the safety profile perspective is very clear.

Mark Joseph Enyedy: And is there a possibility that the SORAYA trial could support European approval for ribotexamab, or do you anticipate needing controlled data like from Mirafol? Yeah, so we will go talk to the EMA about the results of SREA for sure. Their appetite for single-arm studies to support approval has historically been limited in oncology. I've seen it done.

That I am GM Sixthree too has been very favorable safety and Tolerability profile.

You know were not required to be hospitalized and we have not had a capillary leak syndrome. This is real.

We didn't see that can be sales or else August.

Thats in large part due to the theory, a toxin conjugate immunity.

Inogen stops working on the theory of toxin conjugates many years ago.

In terms of PD 123, and other ways of targeting it was by specific there's certainly a cytokine release syndrome that can be problematic for those by specific so I think at this point, we're quite pleased with the safety profile that we're seeing.

Mark Joseph Enyedy: I've done it with things in my past life at Genzyme. So we will go out for the conversation, and if that doesn't bear fruit, then it would be Mirosol that would support full approval in the EU. And then it sounds like you're kind of thinking about the, So what are the most interesting possibilities there in your view, and which of those would best maximize commercialization? Yeah, you know, if you look at ovarian cancer today, most patients on initial diagnosis following surgical debulking, I mean, there's a fair amount of neoadjuvant use. And we're actually looking at that in an IST.

Great. Thank you.

Thank you. Our next question comes on the line of Jessica Fye from JP Morgan. Your line is now open.

Hey, guys. Good morning, Thanks for taking my question.

One focused on a million on many I know some of your slides you talk about the number of platinum resistant ovarian patients, but maybe just drilling into that more specifically what do you see as the annual incidence of post that this isn't a platinum resistant ovarian cancer with one of the three prior lines of therapy.

Yeah, absolutely one more.

Mark Joseph Enyedy: But, you know, patients get either a platinum-based doublet or a triplet with the third agent being avastin. And so, you know, we generated some very nice triplet data that we shared at the mature data session at ESMO. But, you know, from a market opportunity perspective, I think, obviously, substituting myrmituximab for paclitaxel in the doublet or the triplet would be the highest market opportunity. The challenge there is that that's going to be a very large study. And so what we're looking at are opportunities to move into earlier line therapy, either using a strategy similar to the data that we shared at ASCO where the patients were platinum agnostic. That is, it was a mix of patients who were either resistant or sensitive, but later line patients.

Criteria into that.

Those that are full late receptor alpha positive.

At a high level, we think the annual incidence of the market for our proposed label would be 2500 patients.

Okay.

And.

Okay, Great and we think Jack this is the if you take away that previously treated with a vast and criterion jumps to 505000. So when we looked at the data from forward, one, which we think is a reasonably representative sample.

Yeah about half the patients had prior avastin and half is not.

Got it and is that you asked sorry, you asked and you haven't yet does the U.S. numbers.

So what we yeah we.

A combination of data. So we bought data from DRG. We also have a an agreement with flat iron where we're looking at a longitudinal cohort.

And then when we supplement that with the physician survey through if sales to get those numbers. The DRG is starting to starting point.

Got it.

Is there a possibility that the saran trial could support European approval from the tax number do you anticipate needing controlled data like a marathon.

Mark Joseph Enyedy: And, you know, the data we saw there in terms of response rates were quite compelling. We had a 64% response rate in those patients with high levels of full-weight receptor alpha expression. So looking at that sort of, you know, third line and later platinum agnostic population are separately going after, you know, a non-platinum-based regimen in platinum-sensitive patients who remain platinum sensitive. Because what happens is after a couple of lines of platinum, there are a lot of reasons why physicians are not giving platinum to those patients, their hypersensitivity, tired bone marrow, et cetera.

Yeah. So we will go talk to the M&A about the result was array for sure.

Their appetite for a single arm studies to support approval historically has been limited in oncology I've seen it Don Don It with things in my past life.

The genzyme.

So we will go out the conversation.

And if that doesn't that doesn't bear fruit than it would be mirasol that would support full approval in the EU.

Okay, and then it sounds like you're kind of thinking about the.

Ah path forward from Texas in combination so what are the most kind of interesting possibilities there in your view and what's your husband best maximize the commercial opportunity.

Yeah.

No if you look at.

Ovarian cancer today, you know most patients on initial diagnosis following surgical debulking I mean, there's a fair amount of Neoadjuvant use.

Mark Joseph Enyedy: And so what we see in our data is a growing population of those patients where, you know, a combination regimen that doesn't include platinum, so for example, Mervituximab plus Avastin could be a very nice alternative for them. So those are our thoughts in terms of label expansion. Thank you. Sure. Thank you. Our next question comes from the line of Boris Peaker from Cowen.

Actually looking at that and then I S T.

But you know patients get a either a platinum based doubling or.

Triplet with the Thirtys and being a vast and so you know we generate some very nice trip with data and has that we shared at a mature data at ESMO, but.

Our market opportunity perspective, I think obviously substituting mirvetuximab for paclitaxel in the doubling or tripling would be the highest market opportunity, which out there that's going to be a very large a.

Large study and so what we're looking at our opportunities are.

He move into earlier lines.

RFP.

Hi, there you know using a strategy similar to the data that we shared at ASCO, where the patients were platinum agnostic that is it was a mix of patients who were either resistance.

Or or sensitive, but later line patients and the data we saw there.

In terms of response rate.

We're quite compelling and we had a 64% response rate in those patients with high levels of folate receptor alpha expression, so looking at that sort of third.

Third line later platinum agnostic population or separately going after.

A non platinum based regimen in platinum sensitive patients patients who remain platinum sensitive because what happens is after a couple on platinum there are a lot of reasons why physicians are not giving platinum to those.

Patients there.

Anna Berkenblit: Great. Thanks for taking my question. Thank you. Our next question comes in the line from Joe Catanzaro from Piper Sandler.

Hypersensitivity tired bone marrow et cetera.

And so what we see in our data is a growing population of those patients where.

Combination regimen and that doesn't include platform. So for example, mirvetuximab plus the vast and could be a very nice alternative for them. So those are the those are that our thoughts in terms of a label expansion.

Joseph Michael Catanzaro: Your line is now open. Hey guys, thanks so much for taking my question here. Maybe just one quick one.

Got it thank you.

Sure.

Thank you. Our next question comes from the line of Boris Peaker from Cowen. Your line is now open.

All right. Thanks for taking my question I'm, just curious for the nurse, so as well as a ceria trial.

Joseph Michael Catanzaro: I guess now with a nice bigger China deal under your belt for Mervyn Tuxenmab, how do you think about the potential for additional ex-U.S. partnerships around that asset, I guess, namely Europe? And is that largely consistent with how you view your cash needs moving forward and whether maybe you could potentially create more value as Soraya and Mirosol read out in the near future? Yeah, Joe, I think you say it well, which is, you know, this is a multivariable equation here, and we're looking at, you know, what resources we would need to bring to bear to launch a product versus, you know, what the value would be of bringing on a partner for, in particular, Europe. You know, we've done the analysis in Europe, and it's a fairly concentrated market in terms of physician targets, treatment patterns, and so on, actually more concentrated than the U.S. But that's offset to some degree by the need for national level, you know, commercial infrastructure.

As you are enrolling at what fraction of patients are you finding to fall into the folate receptor positive category based on your new assay.

So for us, it's not a new assets the assets that we have used from the beginning of the program the tier two plus assay and we're tracking exactly as we would expect we know from passing over 2000 patients that about 40% our ally.

Great. Thanks for taking my question.

Sure.

Thank you. Our next question comes from the line of Joe had 10 barrels from Piper Sandler. Your line is now open.

Hey, guys. Thanks, so much for taking my question here, maybe just one quick one I guess now with a nice greater China deal under your belt for Mirvetuximab. How do you think about the potential for additional ex us partnerships around that asset I guess, mainly Europe and is that largely consistent on how you view your cash needs.

Moving forward and whether maybe you could potentially create more value as psoriasis and your salt read out in the near future. Thanks.

Mark Joseph Enyedy: So, you know, what you end up with are estimates of, you know, commercial and medical affairs, and infrastructure similar to what you have in Europe when you look at a sort of region-to-region comparison, but certainly within the ambit of a company like ImmunoGen, particularly being able to finance on the back of positive pivotal data. So that said, you know, there are a lot of advantages to partnering as well, and so that's something that we will evaluate, in particular, with positive pivotal data in hand, have that optionality now that we think is well-achieved this quarter. Okay, I got it.

Yeah. So I mean, I think you said it well, which is you know this is a multi variable equation here and we're looking at you know what resources, we would need to bring to bear to launch the product versus what the value would be bringing on a partner for in particular Europe.

Weve done the analysis in Europe, and it's a fairly concentrated market.

In terms of physician targets, you know treatment patterns and so it actually more concentrated than the U.S., that's offset to some degree by the need for national level.

Commercial infrastructure. So you know what you end up with their estimates of commercial and medical affairs.

You know.

Infrastructure similar to what you have in the Europe. When you look at us or region to region comparison, but certainly within the ambit of a of a company like immunogens, particularly being able to finance on the back of positive pivotal data so that.

That said there are a lot of advantages to partnering as well and so that's something that we are we will evaluate.

In particular with some with ER positive pivotal data in hand.

Joseph Michael Catanzaro: That's helpful. Thanks. Thanks for taking my question. Thank you. Our next question comes from the line of Jonathan Chang from SVB Larynx. Your line is now open. Hey, good morning, guys. This is David Ruchon on behalf of Jonathan Chang.

Adam.

The China deal at 40 million upfront plus the proceeds from the ATM we've now.

Guidance for cash outlay engine on the second half will easily here and we feel that we're in a position of strength. So we want to do the right strategic decision on partnerships because we have.

Have that Optionality now.

She is water.

Jonathan Chang: Thanks for taking our questions. First question, for 632, have you guys presented, or do you have plans to present, any duration of response data from the 71 patients treated with monotherapy at ASH last year? And then second, could you provide any color on the enrollment progress in the combination cohorts and when we might see initial data from the AZE event combos in AML? So, for the AML monotherapy data that we presented at ASH last year for IMGM 632, we anticipate that when we write a manuscript for that, we will provide duration of response data. Moving to the combinations, we look forward to, we're in the midst of planning an investor conference call event around the time of ASH, and that would be the appropriate time for us to provide a progress update on the combinations for IMGN 632.

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

Sure.

Thank you. Our next question comes from the line of Jonathan Chang from ethylene be Leerink. Your line is now open.

Hey, Good morning, guys. This is David Rouge on for Jonathan Thanks for taking our questions.

First question for 632 have you guys presented or do you have plans to present any duration of response data from the 71 patients treated with monotherapy at ash of last year and.

And then second could you provide any color on the enrollment progress and the combination cohorts and when we might see initial data from the phase of Ben combo didn't add up please.

So for the ammo monotherapy data that we presented at Ash last year for GM Sixthree too.

We anticipate that when we write a manuscript for that we will provide duration of response data.

Moving to the combination we look forward to where in the midst of planning and Investor Conference call event around the time of that and that would be the appropriate time for us to provide a progress update on the combinations for I am Gn Sixthree too we do on the trials in progress poster at Ash, describing the study design.

Combining with agent signing with that need a class and as the triplet and we are in the midst of that that dose escalation.

Got it. Thank you and then just second I noticed on the idea of when our collaboration with Brady and slash marriage and.

We've seen some impressive sales figures already this year from some pads and I was just wondering if you could provide any further specificity on your economics within the thyroid eye disease opportunity and timing of potential regulatory filing and I guess anything else here that you'd highlight about the the promise of this this opportunity. Thanks a lot.

Unknown Executive: Swayampakula Ramakanth, Dingding Shi, Boris Peaker, Etzer Darout, Anna Berkenblit, Renee, We do have the opportunity to recognize approximately $50 million in development milestones and up to $95 million in sales milestones on that program. We do think it's well-placed with Viridian. They're in a position to move that forward. As you know, we're focused on cancer here at ImmunoGen, and we think that it's complementary to have them pursuing this asset in the thyroid eye disease indication, which has very promising potential. Great. Thanks a lot and congrats on the progress. Thank you. Our next question comes from the line of Kenan McKay from RBC. Your line is now open.

Sure so weren't.

Were not.

To promoting upfront numbers on that deal, but the structure as you know upfront milestones and royalties in its traditional type of fashion and we.

We do have the opportunity to recognize approximately $50 million in development milestones and ups and $95 million and sales milestones on that program.

We do think it's well placed with meridian, they're in a position to move that forward. As you know we're focused on cancer here in immunogen, and we think that its complimentary to have them pursuing this asset in these disease indication how.

Which has a very promising.

Potential.

Great. Thanks, a lot and congrats on the progress.

Thanks.

Thank you. Our next question comes from the line of Kennen Mackay from RBC. Your line is now open.

Kenan McKay: Hey, thanks so much for taking the question, and congrats on what's been a really remarkable year here. I had another BD question. Mark, I was wondering where you're fielding the most incoming interest these days? Is it from strategics relating to Mervituximab or potential combination therapies for Mervituximab and additional trials or cohorts that could be run there, or, you know, earlier pipeline out of nine or more sort of platform interest looking to access linker and payload tech similar to the Verdean deal that we recently heard about? Yeah, so what I would say is we get it at the two ends of the spectrum.

Hi, Thanks, a lot for taking my question and congrats on what's been a really remarkable deal here or there another.

Good question Mark.

Mark I was wondering where are you building the most.

Become an interest these days is it from.

From switches, it's relating to the mirvetuximab or central.

Central combination therapy.

Therapies.

For Mirvetuximab and additional trials or cohorts, but can be run there or earlier pipeline alamein or more sort of platform interest working to accessing linker and paymode cut off similar to the dirty and deal that we recently heard about.

Yeah. So what I would say is we get to the two ends of the spectrum. What I mean by that is you know there's inbound interest in Mirvetuximab, obviously, weve signed a deal for greater China, but you know, it's a late stage oncology asset and as you can imagine that tends to attract a lot of a lot of attention.

Mark Joseph Enyedy: What I mean by that is, you know, there is inbound interest in myrtoxamab. Obviously, we've signed a deal for greater China, but, you know, it's a late-stage oncology asset, and as you can imagine, that tends to attract a lot of attention. At the other end of the spectrum, it is around the platform.

At the other end of the spectrum. It is around the platform I'm you know that with the recent success in terms of approval and the AIDC space. You know there is a lot of interest in.

Mark Joseph Enyedy: You know, with the recent success in terms of approvals in the ADC space, there is a lot of interest in the underlying technology. So we are fielding, you know, inbound similar to what catalyzed the discussion with Viridian, and so those are the kinds of things we're entertaining, and, you know, I think... As we see the progress, for example, with 936, which really integrates a number of important innovations that came out of our labs over the last half decade or so in terms of payload linkers and also some antibody engineering, people see In the middle, both 632 and ADAM9 are partnered, so we're not getting any interest there, but what those programs do have is innovation that has intrigued others to come knocking. That's it. And Mark, maybe just elaborating on that a little bit.

And the underlying technology. So we are fielding inbound similar to but.

But you know catalyze the discussion with the with for Radian and so those are the kinds of things, we're entertaining and you know I think.

Yes, we see the progress for example, with 936, which really integrates a number of important innovations that came out of our labs over the last half decade, or so in terms of payloads Linkers and also some antibody engineering you know people see that and I think if those that program progresses.

You know, we'll probably that will engender, even greater interest and so we're excited about those things and being able to.

To deploy the technology platform more broadly so that's where it is in the middle on both the 632 and Adam nine or our partner. So we're not getting any interest there, but what those programs do have it is.

Innovation that has intrigued others to come knocking.

Gotcha, and Mark maybe just Oh elaborating on that a little bit obviously, there's been a lot of strategic interesting.

Mark Joseph Enyedy: Obviously, there's been a lot of strategic interest in ABCs after the Competitive Immunomedics Acquisition, and some of the deals that we've seen, Seattle Ciagen, rather now, inking, relating interest in the combination of ADCs with checkpoints. Maybe in ovarian cancer, I'm wondering if there are specific checkpoints that stand out as maybe the better sort of combination partners, or really, you know, if there's been any evolution in thinking around the field of a potential immuno-oncology partner in ovarian cancer. Partnering in a combination drug sense, not a... Yeah, yeah. So, Kenneth, you may remember that we moved forward with Merck combining with Keytruda in the ovarian cancer setting in platinum-resistant patients. And the initial responses were quite encouraging. However, when we expanded out the cohort, we didn't see a significant contribution in terms of efficacy beyond what we typically see in that population with single-agent myrmitoximab. And so we have not pursued that further. There have been some really interesting preclinical data. I was pointing to a paper by Alfred Zepelius.

Exactly.

You remember listening competitive immunomedics acquisition.

All of the deals that region.

Yes, we will see a gym rather now.

Anything relating.

Interest in combination.

He is with checkpoints maybe you.

You know Barry I'm wondering.

If there are specific supports that standout as maybe the better sort of combination partners or really good also.

Evolution in thinking or.

Around the field.

That's where immuno oncology partner in barely temper.

Partnering our combination drugs I'm not not Oh, yeah, yeah. So Karen you may remember that we are moving forward with Merck, combining with keytruda and the ovarian cancer setting and platinum resistant patients and.

The initial response was were quite encouraging however, when we expanded out the the cohort we didn't see a significant contribution in terms of efficacy beyond what weve typically seen in that population with with single agent Mirvetuximab and so.

We have not pursued that further or how does a really interesting preclinical a data I would point into a paper by offerings. The paleo to the lab based in Switzerland, and you know what they showed with synergy in particular between these you know to me.

Anna Berkenblit: It's a lab, I think, based in Switzerland. And, you know, what they showed was synergy, in particular, between these tubulin-acting agents and the checkpoint inhibitors. And they had some encouraging early data, which didn't pan out.

Good acting agents and the checkpoint inhibitors, and say that it's sort of encouraging early data, which didn't pan out.

Anna Berkenblit: But what I would say is we're not opposed to it, but Anna has a few other words to add here. Yeah, I think, unfortunately, ovarian cancer is unlike many other tumors where checkpoint inhibitors have revolutionized the treatment paradigm. There have been several Phase III failures for checkpoint inhibitors at this point in ovarian cancer with Avellumab in the Javelin studies and with Tezolizumab most recently in the Imagine 50 study. So, you know, these tend to be not very mutationally driven tumors.

What I would say is were not adverse.

Adverse to us.

It has a few other words add here yeah, I think unfortunately ovarian cancer is unlike many other tumors bear a checkpoint inhibitors have revolutionized the treatment paradigm there've been several phase III failures for checkpoint inhibitors at this point in ovarian cancer with Allomap in the javelin studies.

And with the type of listen that most recently in the imagine 15 study. So you know the Tencent not very patiently direct consumer I wouldn't go so far as the sales checkpoint inhibitors have not really achieve proof of concept in ovarian cancer cells.

Anna Berkenblit: I wouldn't even go so far as to say that checkpoint inhibitors have not really achieved proof of concept in ovarian cancer. So, I think it would be unlikely unless there's a new target that's identified and the biology is strong for us to pursue combinations with the currently available checkpoint inhibitors. Right, but if we look at the earlier part of the portfolio, for example, with the IMGC9360 ADAM9 program, where we are moving into tumor types that have shown activity with checkpoint inhibitors, I think that creates an opportunity. So we're absolutely open to it. We ran the experiment with Mervituximab in ovarian cancer and, for the reasons that Anna identified, didn't see anything that you've made us say this is a place we want to bet heavily on. Got it.

I think it would be unlikely unless there's a new target that's identified and the biology wrong for us to pursue a combinations with the currently available checkpoint inhibitor.

Right, so, but if we look at the earlier part of the portfolio for example, with the IMS you see 96 to Adam nine program, where we are moving into tumor types that have shown activity with checkpoint inhibitors I think that creates the opportunity. So we're absolutely open to it I says is that we.

We ran the experiment with Mirvetuximab in ovarian cancer and for the reasons and identified.

You know, we didn't see anything that that.

Let me just say this is a place we want to bet heavily.

Got it thank you very much.

Mark Joseph Enyedy: Thank you very much. Thank you. Our next question comes from the line of Swayampakula Ramakanth from HC Wainwright.

Sure.

Thank you. Our next question comes from the line of Swine online Cool Ranch line comes from H.C. Wainwright. Your line is now open.

Swayampakula Ramakanth: Your line is now open. Thank you. This is RK from HC Wainwright.

Thank you. This is OK from had C ran but most of my questions have been asked I'm just trying to.

Unknown Executive: Most of my questions have been asked. Just have a question on 936. This is the ADAM9 targeting ADC that you have partnered with MacroGenX.

A question on 96.

This is Adam nine targeting NDC.

Do you have a partner with the macroeconomics.

Unknown Executive: Could you just give us some color as to the progress of the trial and also anything regarding timing for data release? Yeah, R.K., we're delighted to have announced on our earnings call that we've dosed the first patient, and so the trial is on its way. You know, it's a standard 3 plus 3 dose escalation study, and the beauty of ADAM9 is that it is highly expressed in a multitude of solid tumors and not on normal tissue, so there's a nice differential there that is allowing us to go after non-small cell lung cancer, colorectal, pancreatic, gastric, and triple negative breast cancer, so we anticipate that the 3 plus 3 design should enroll well, and when we have sufficient data, we look forward to sharing it.

Could you just give us some color as to.

The progress of the trial and also anything regarding timing for data data release.

Yeah, Hey, we're delighted to have announced on our earnings call that we dose the first patient and so.

So the trial is on its way you know, it's a standard three plus three dose escalation study and the beauty about nine is that it is highly expressed a multitude of solid tumor and not on normal tissue for the night a differential there that is allowing us to go after non small cell lung cancer.

Our colorectal pancreatic gastric in triple negative breast cancer. So we anticipate that the three plus three design should as well.

Well and when we have sufficient data and we look forward to sharing it.

Unknown Executive: Thank you. Thanks for taking my question. Thank you. Our next question comes from the line of John Newman from Canaccord. Your line is now open.

Thank you thanks for taking my question.

Thank you. Our next question comes on the line of John Newman from Canaccord. Your line is now open.

Hi, guys. Thanks for taking the follow up so.

Just wondered if you could maybe.

Elaborate a bit on how we should think about.

Use of Mirvetuximab longer term.

On the front line.

Nomination.

In ovarian I know, obviously, that's down the road that will be a bigger study, but just curious as to how you might get there if that would be a study that.

You know down the line Immunogens and put together and Ron.

That would maybe be a study to look at with Cowen groups I'm, just curious given the activity that you're seeing in combination with not just platinum, but also also with the best thanks.

Yeah, So just to revisit the conversation we had with jazz.

Mark Joseph Enyedy: We are looking at combination regimens to expand the label that could include recurrent platinum sensitive patients or these platinum agnostic patients that I described. And so I think that is the likely next step. To get to a frontline indication, I think it would likely involve a cooperative group study given the scale of that effort.

We are looking back.

ER combination regimens to expand the label that could include recurrent platinum.

Platinum sensitive patients or are these platinum agnostic patients that I described and so I think that is the likely next step to get to a front line indication I think would likely involve a cooperative group study given the scale of that effort. So what we really want to do.

Mark Joseph Enyedy: So what we really want to do for the next step in label expansion is to move into earlier lines and address some of these recurrent platinum sensitive or platinum agnostic patients. And also, you know, going right up to the top of the queue, we have also started this IST in neoadjuvant and see what the impact is there. I can't tell you sitting here today what the exact path to registration would be for a neoadjuvant study. That's something we would need to think through. So I think in terms of near-term from us, look for that patient segment where we're in, you know, later line platinum sensitive or platinum agnostic patients, and stay tuned.

New and the you know for the next step in and label expansion is to move into earlier lines and address some of these recurrent platinum sensitive or platinum agnostic patients and also going right at the top of the queues also started this iced tea in Neoadjuvant and see what the impact is there I can't tell you.

Sitting here today, what the exact path to registration would be.

For a neoadjuvant study and that's something we would need to think through so I think in terms of near term from US you know look for that patient segment, where we're in a later line platinum sensitive platinum agnostic patients and stay tuned.

Mark Joseph Enyedy: Great, thank you. Thank you. At this time, I am showing no further questions. I would like to turn the call back over to the team for closing remarks. Great, thanks very much. We appreciate the interest today and look forward to seeing you all at ASH in the new year and as we make further progress with the business. So, thanks very much. Ladies and gentlemen, this concludes today's conference call. Thanks for participating. You may now disconnect.

[music].

Great. Thank you.

Thank you at this time I'm showing no further questions I would like to turn the call back over to the team for closing remarks.

Great. Thanks, very much we appreciate the interest today and look forward to seeing you all at a at ash and in the new year and as we make further progress with the business. So thanks very much.

Ladies and gentlemen, this concludes today's conference call. Thanks for participating you may now disconnect.

Q3 2020 ImmunoGen Inc Earnings Call

Request a DemoDemo

IMGN

ImmunoGen

Earnings