Q3 2021 ImmunoGen Inc Earnings Call

Good morning, and walks to imaging third quarter 2021 financial and operating results Conference call. Today's conference is being recorded.

Operator: Good morning, and welcome to Imugent's third quarter 2021 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney O'Connick, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

At this time I'd like to turn the call over to coordinate O'connor senior director of corporate Communications and Investor Relations. Please go ahead.

unknown: and invest relations. Please go ahead.

Good morning, and thank you for joining today's call.

Unknown Executive: Good morning, and thank you for joining today's call. Today, we issued a press release that includes a summary of our recent progress and third quarter 2021 financial results. This press release and a recording of this call can be found under the Investors and Media section of our website at ImmuneGen.com. With me today are Mark Eniddy, our president and CEO; Anna Birkenblit, our chief medical officer; and Susan Al Schiller, our

We issued a press release that includes a summary of our recent progress and third quarter 2021 financial results. This press release and a recording of this call can be found under the investors and media section of our website at Immunogen Dot Com with me today are Mark Kennedy, our president and CEO.

Broken Black, our Chief Medical Officer, and Susan I'll sure our CFO.

Unknown Executive: During today's call, we will review key recent accomplishments for the business, our financial results, and anticipated upcoming events. During the discussion, we will use forward-looking statements with respect to our business strategy, the development and benefits of our product candidates, the presentation of clinical data for our product candidates, the anticipated timing of regulatory submissions to the FDA and EMA for certain product candidates, our 2021 financial outlook, and our projected cash runway. This information is subject to risks and uncertainties. Our actual results may differ materially from those described in the risk factors section of our most recent annual report on Form 10K and our other SEC filings.

During today's call. We will review key recent accomplishments for the business, our financial results and anticipated upcoming events.

During the discussion we will use forward looking statements with respect to our business strategy the development and benefits of our product candidates. The presentation of clinical data for our product candidates the anticipated timing of regulatory submissions to the FDA and EMEA for certain product candidates, our 2021 financial outlook and our projected cash runway. This information.

Subject to risks and uncertainties. Our actual results may differ materially from such statements include those described in the risk factors section of our most recent annual report on Form 10-K, and our other SEC filings with that I'll turn the call over to Mark. Thanks, Courtney and good morning, everyone and thank you for joining us today in the third quarter.

Mark Joseph Enyedy: With that, I'll turn the call over tomorrow. Thanks Courtney, good morning everyone, and thank you for joining us today. In the third quarter, we advanced our pipeline and continued our pre-launch activities as we look to transform Immunogen into a fully integrated oncology company in the coming year. Starting with our lead program, Myrvotoxymab sorovtanthanthanthin, for platinum-resistant ovarian cancer, I am pleased to say that we are on track to report top-line data from our pivotal Sierrae study this quarter. For this release, we expect to include data on the primary end point.

We advanced our pipeline and continued our prelaunch activities that you'd look to transform immunogen into a fully integrated oncology company in the coming year, starting with our lead program Merv. It talks a Bachelor of tamping in platinum resistant ovarian cancer I am pleased to say that we are on track to report topline data from our pivotal surveys.

Study this quarter for this release, we expect to include data on the primary endpoint of overall response rate as assessed by investigator the sensitivity analysis of overall response rate as assessed by blinded independent Central review the key secondary endpoint of duration of response, and the safety and Tolerability profile.

Unknown Executive: of overall response rate as assessed by the investigator, the sensitivity analysis of overall response rate as assessed by blinded independent central review, the key secondary endpoint of duration of response, and the safety and tolerability profile of Mervatuxababab. We believe these data will provide a comprehensive picture of the results of the trial. We are planning for success with Saraya, and to that end, our preparations for the BLA are well underway with the goal of submitting the application before the end of Q1.

Talks about we believe these data will provide a comprehensive picture of the results of the trial. We are planning for success with <unk> and so that in our preparations for the BLA are well underway with the goal of submitting the application before the end of Q1, along with activities in support of the potential loss of them or Rituximab and the second half of next year.

In addition to Serena, we're pursuing a broad program to establish them or rituximab as the new standard of care for patients with folate receptor Alpha positive ovarian cancer are confirmatory Mirasol trial continues to enroll and we expect topline data in the third quarter of next year. If positive these data could enable full approval.

Unknown Executive: along with activities in support of the potential launch of myrvituximab in the second half of next year. In addition to Saraya, we are pursuing a broad program to establish myrvituximab as the new standard of care for patients with folate receptor alpha-positive ovarian cancer. Our confirmatory Mirosol trial continues to enroll, and we expect top-line data in the third quarter of next year. If positive, these data could enable full approval of myrvatumab in the U.S. and importantly support an application for marketing authorization in the EU.

<unk> in the U S and importantly support an application for marketing authorization in the EU.

This past quarter, we also initiated piccolo a single arm study of merger talks about mono therapy designed to address the increasing unmet need for an effective non platinum option for fr Alpha high recurrent platinum sensitive ovarian cancer.

Or if it talks about monotherapy, we have generated encouraging data with <unk> in combination with Bevacizumab and Carboplatin. We believe Margaret talks a mab has the potential to become the combination agent of choice for ovarian cancer and we look forward to sharing our label, enabling combination strategy next quarter as we continued to expand our team we are.

Very pleased to welcome Dr. Helen factory to our board of directors for deep development and regulatory expertise will be invaluable both in the near term that you would look to bring more of it talks about the market and longer term for our full portfolio with that I'll turn the call over to Anna to provide an update on the rest of our development pipeline Anna.

Unknown Executive: This past quarter, we also initiated Piccolo, a single-arm study of Merbituxamab in the U.S. autotoxyamab monotherapy designed to address the increasing unmet need for an effective non-platinum option for FR alpha high recurrent platinum-sensitive ovarian cancer. Beyond Mervatuximab monotherapy, we have generated encouraging data with Mervatuximab in combination with Bevaci We believe Mervatuximab has the potential to become the combination agent of choice for ovarian cancer, and we look forward to sharing our label-enabling combination strategy next quarter.

Thanks Al.

I'll start with <unk>, our PD 123 targeting ADC in clinical development for Hematological malignancies as it were.

And under <unk>, two is being evaluated as a monotherapy for patients with front line and relapsed refractory <unk> and in minimal residual disease positive AML as well as in combination with either decided in and they need a class for patients with relapsed refractory AML.

<unk> uses our novel Indovina, benzodiazepine diner, or IGN payload, which is designed to alkylate DNA without cross linking.

Our IGN is a highly potent against leukemic blast, while demonstrating less toxicity to normal now progenitor.

We are excited to share initial combination data from the AML cohort at Ash in December.

Previously, we reported data that demonstrated the monotherapy activity and favorable tolerability of IMT and <unk> in heavily pretreated AML patients, including a 40% overall response rate in relapsed and refractory de Novo AML patients treated at the recommended phase two dose.

Unknown Executive: As we continue to expand our team, we are very pleased to welcome Dr. Helen Thackeray to our board of directors. Her deep development and regulatory expertise will be invaluable, both in the near term as we bring Mervituxin map to market and longer term for our full portfolio. With that, I'll turn the call over to Anna to provide an update on the rest of our development pipeline. Anna? Thanks, Mark.

The combination data for <unk> with a decided in and they need a class because we plan to share at ash include safety and anti leukemia activity from dose escalation to guide further development of the triplet.

In a separate presentation. We plan to present, then yes, frontline B P. DCM patients, who received IMT and <unk> prior to us commencing the currently enrolling pivotal cohort.

Anna Berkenblit: I'll start with IMGN 632, our CD-123 targeting ABC in clinical development for hematological malignancies. As a reminder, IMGM 6-3-2 is being evaluated as a monotherapy for patients with frontline and relaps, refractory BPDCN, and minimal residual disease positive AML, as well as in combination with asocytine and Venetoclats for patients with relapsed IMGN632 uses our novel Indolino-Benzodiazepine dimer, or IGM payload, which is designed to alolate DNA without cross-linking. Our IGMs are highly potent against leukemic blasts, while demonstrating less toxicity to normal, marrow progenitor cells. We are excited to share initial combination data from the AML cohort at Ash in December.

Abstract will be released next Thursday November 4th.

IMTT 936 hour at a nine targeting ADC is advancing through phase one dose escalation in multiple solid tumor types and <unk> and 105, one our next generation anti folate receptor Alpha ADC is on track for IND submission by year end with that I'll turn the call over to Susan to review our financials.

Susan Thanks, Anna starting with our results for the third quarter of 2021, we generated $9 $2 million in revenue, which consisted primarily of noncash royalty revenues and a $2 $5 million anticipated partner development milestone fee recall, there was a reduction in noncash royalty revenues starting in the third quarter.

And continuing forward due to the completion of the first tranche of payments under the 2015 transaction covering the sale of <unk> Tyler royalties.

Operating expenses were $43 $4 million comprised of $33 $1 million of R&D expenses, compared with $24 7 million in the third quarter of 2020, and $10 $3 million of G&A expenses compared to $10 2 million in the third quarter of 2020, we ended the third quarter with $245 $8 million.

Cash and cash equivalents on the balance sheet.

Moving to our updated financial guidance for 2021 revenue guidance is unchanged at $65 million to $75 million operating expenses are now expected to be slightly lower at $190 million to $200 million in cash and cash equivalents have increased we expect to have between $190 million to $200 million at year end with the addition of <unk>.

Anna Berkenblit: Previously, we reported data that demonstrated the monotherapy activity and favorable tolerability of IMGN632 in heavily pre-treated AML patients, including a 40% overall response rate in Relastin Refractory de novo AML patients treated at the recommended phase two dose.

Approximately $43 million through our ATM facility and the sale of a pre funded warrants to an investor during the quarter. We believe our current cash runway will be sufficient to fund operations into the fourth quarter of 2022 with that we'll open the call for questions operator.

Anna Berkenblit: The combination data for IMGM632 with azicidine and Venetoclax, which we plan to share at Ash, include safety and anti-leukemia activity from dose escalation to guide further development of the triple. In a separate presentation, we plan to present vignettes of frontline BPDCN patients who received IMGM 632 prior to us commencing the currently enrolling pivotal cohort. The abstract will be released next Thursday, November 4th. IMGC 936, our Adam 9 targeting ADC, is advancing through phase one dose escalation in multiple solid tumor types, and IMGN151, our next generation antifolate receptor alpha ADC, is on track for IMD submission by year end.

Ladies and gentlemen to ask a question. Please press Star then one.

If your question has been answered and you'd like to lose yourself from the queue press the pound key.

First question comes from John Newman with Canaccord. Your line is open.

Yeah.

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

Just one question on Korea, which is after.

After the data readout.

Is there any need for you to meet with the agency prior to BLA submission in the first quarter. Thanks.

Need is interesting.

Interesting choice of words, what I would say, it's any sponsor is very well advised to meet with the agency ahead of the filing it's called a pre BLA meeting.

Virtually all sponsors do that so yes, we will be talking to the agency between the top line in the filings.

Okay, great. Thank you sure.

Okay.

Our next question comes from Michael Schmidt with Guggenheim. Your line is open.

Michael Yeah, Hey, guys, sorry about that yeah, it's just a very quick.

Quick ones from me.

Primary endpoint of this study is obviously overall response rate per investigator assessment can you just talk about how important the independently assess response rate is in the in the approval process.

Susan Al Schiller: With that, I'll turn the call over to Susan to review our financials. Susan. Thanks, Anna. Let's start with our results for the third quarter of 2021. We generated $9.2 million in revenue, which consisted primarily of non-cash royalty revenues and a $2.5 million anticipated partner development milestone. Recall, there was a reduction in non-cash royalty revenues starting in the third quarter and continuing forward due to the completion of the first tranche of payments under the 2015 transaction covering the sale of Kedsaila Royals.

So that's question number one and then the second question was just on the regulatory hurdles with duration of response I think you've spoken about six months before summer.

Some of your peers.

In ovarian cancer have spoken about a potential school months Dr. Hurdle, just wondering what your updated thoughts on that.

Sure Michael So.

As you know our primary endpoint is overall response rate by investigator and in the protocol. We have overall response rate by blinded independent Central review as a sensitivity analysis.

<unk> fit with Pryor.

Approvals in ovarian cancer FDA will have both datasets available to them.

Susan Al Schiller: Operating expenses were $43.4 million, comprised of $33.1 million of R&D expenses compared with $24.7 million in the third quarter of 2020, and $10.3 million of GNA expenses compared to $10.2 million in the third quarter of 2020. We ended the third quarter with $245.8 million in cash and cash equivalence on the balance. Moving to our updated financial guidance for 2021, revenue guidance is unchanged at $65 to $75 million. Operating expenses are now expected to be slightly lower at $190,000 to $200 million.

To inform the overall benefit risk.

Regarding duration of response.

For this population, there's not a lot of great data out there, but the study that has associated the 12% response rate is or really and in are really at the control arm of single agent chemotherapy that had a 12% response rates that was associated with a median duration of response of five points.

That being said I can certainly understand other folks.

Describing a meaningful duration of response of four months because as you may recall in our really is these are patients with platinum resistant disease with just one or two prior lines of therapy, it's essentially a bev naive population and we're going after a frankly, a higher unmet need group with including patients with three prior lines of therapy and they are all risk.

Aestheticism App.

That being said you may recall that in our foundational 70 patients worth of data. We had a median duration of response of seven eight months and we believe that based on the $5 four months from the really a study anything around six months or greater would certainly be clinically meaningful.

Susan Al Schiller: And cash and cash equivalents have increased. We expect to have between $190 to $200 million in euros. With the addition of approximately $43 million through our ATM facility and the sale of a pre-funded warrant to an investor during the quarter, we believe our current cash runway will be sufficient to fund operations into the fourth quarter of 2020.

Great. Thank you.

Our next question comes from Andy <unk> with William Blair. Your line is open.

Great. Good morning, Thanks for taking my question and congratulations on all the progress.

Mark I think you mentioned.

Something after the comments about Avastin and Carboplatin combination that labeling in April in combination strategies will be disclosed next quarter can you give us a little more color on that comment.

Operator: With that, we'll open the call for questions. Ladies and gentlemen, to ask a question, please press one more than one. If your question has been answered and you'd like to remove yourself from the queue, press the pound keys. Our first question comes from John Newman with Cantercourt. Your line is open. Hi, guys. Good morning. Thanks for taking my question. Congratulations on all the progress.

Sure. So as you know we didn't have.

The number of early stage studies looking at various.

Robert talks about combinations have been very pleased with both the activity and the Tolerability.

Those combination so you know what we've typically seen is response rates and measures of progression free survival duration of response would exceed the relevant benchmarks for the combination partners. So for example, if you look at our early data with <unk>.

Cargo in Mirv, what we saw was.

Response rates to 70% to 80%, 80% in the Fr Alpha high patients.

Gretchen free survival of about 15 months and that contrasted nicely with other cargo doublets that have been reported where.

unknown: Just one question on Seria, which is it?

You see response rates in the mid fifties and progression free survival in the range of eight 510 five months so.

With the benefit of those.

Those data out along with what we've seen with Mirv Bev.

Unknown Executive: Which is after the data readout, is there any need for you to meet with the agency prior to the BLA submission in the first instance? Need is an interesting choice of words. What I would say is that any sponsor is very well advised to meet with the agency ahead of the filing. It's called a pre-BLA meeting. Virtually all sponsors do that, so yes, we will be talking to the agency between the top line and the filing. Okay, great.

Working through as we speak a comprehensive strategy.

That will include.

Studies that would support formal label expansion with respect to these combinations.

Some of that requires conversations with the agencies with our investigators and so on we are taking the fourth quarter to work through those those points with them and look forward to talking to you in the first quarter about where we'd come out in the studies that we're initiating.

Got it okay. That's very clear thank you Mark and then.

I guess looking back at ESMO I think they referred to as one of the like.

unknown: Okay, great. Thank you. Sure.

Coffers winners in terms of compelling datasets I'm just curious about your take on the optimization is done there.

Michael Werner Schmidt: Our next question comes from Michael Schmidt with Guggenheim. Your line is open. Michael? Yeah, hey guys, how about that? Yeah, just two quick ones from me.

Kind of any read through too.

<unk> IMG and 151, the next generation asset.

So Andy if you could clarify what youre thinking so youre talking about in her two daiichi her two ADC with a camptothecin.

Michael Werner Schmidt: Overall response rate per investigator assessment. Can you just talk about how important the independently assessed response rate is in the approval process? And so that's question number one. And then the second question was just on the regulatory hurdle for duration of response. I think you've spoken about six months before. Some of your peers in ovarian cancer have spoken about a potential four months DoR.

Youre thinking about how that is built upon the success of <unk> silos, and you're asking an analog for how my IMG and 151 build on the success of <unk> is that what youre driving at.

Yes that and also I guess for her.

Hershey was basically two sites of optimization right. So.

Basically the linker and the payload.

And I believe $1 51.

All different components were optimized just curious about kind of that leads to do that the clinical benefit derived from two <unk>.

<unk> versus theoretically the rebalance it and one yeah sure so.

unknown: four months DOR hurdle, just wondering what your updated thoughts are on that. Sure, Michael.

Always innovating and so the innovations that we've built into 151 includes the antibody is a by parent topics. So you're buying two separate epitopes on folate receptor Alpha, which we've shown leads to more internalization events and more cell, killing and that translates into being able to target.

Unknown Executive: So, as you know, our primary endpoint is overall response rate by investigator, and in the protocol, we have overall response rate by blinded independent central review as a sensitivity analysis. Consistent with prior approvals in ovarian cancer, FDA will have both data sets available to them to inform the overall benefit. Regarding duration of response for this population, there's not a lot of great data out there, but the study that has associated the 12% response rate is Orrelia.

Hi.

Tumors with broader expression of fr Alpha so.

So that we see activity very nice activity for IMT and 151 in low and medium levels of Fr Alpha.

Depression in vitro and in vivo and so IMT and 151 is really designed to address a broad range of fr alpha positive tumors, including.

Essentially almost all of ovarian cancer as well as then moving into endometrial cancer triple negative breast and lung cancer and Youre right. The linker payload has also been innovated on in terms of.

More stable linker payload, that's even more stable in circulation and Margaret talked about.

The payload itself is a bit more hydro pulled back a bit more potent and has it been more bystander, killing so we're really excited to be on track to file the IND before the end of the year from 151 and get that into the clinic early next year.

Unknown Executive: And in Orrelia, the control arm of single-agent chemotherapy that had a 12% response rate, that was associated with a median duration of response of 5.4 months. That being said, I can certainly understand other folks describing a meaningful duration of response of four months because, as you may recall from Orrelia, these are patients with platinum-resistant disease with just one to two prior lines of therapy. It's essentially a Bev naive population.

Okay. That's very helpful. Thank you.

Our next question comes from Keenan Mckay with RBC capital markets. Your line is open.

Hi, Thanks for taking the question and looking forward to this right data maybe.

The cerrado data really looming.

Looming, perhaps you're just wanted to get your current perspective on sort of the bar for accelerated approval again as it relates to <unk>.

Overall response rates.

As well as the confidence intervals associated with.

unknown: And we're going after, frankly, a higher unmet need group, including patients with three prior lines of therapy, and they have all received Bevacism and that. That being said, you may recall that in our foundational 70 patients' worth of data, we had a median duration of response of 7.8 months, and we believe that based on the 5.4 months from the Aurellia study, anything around six months or greater would certainly be clinically Correct. Thank you. Our next question comes from Andy Hussai with William Blair. Your line is open.

The overall response rate.

Whether that overall response rate itself is more important.

Non overlapping confidence intervals, there with them were extended to Tara.

Secondarily I just wanted to.

Housekeeping question here just wanted to see if the folate receptor alpha diagnostic would be ready to be filed along alongside merger.

Successful already in Q1, there. Thank you.

Sure Ken So the guidance that we got from FDA is that we need to exclude 12%. So what that means is the lower bound of the 95% confidence interval needs to be above 12% to be considered a statistically positive study.

Andy Hussai: Great, good morning, thanks for taking my question, and congratulations on all the progress. Mark, I think you mentioned something after the comments about the Abbasin and Corporate Plan combination that labeling and enabling combination strategies will be disclosed next quarter. Can you give us a little more color on that comment?

And certainly the larger the simplifies the narrow or the confidence interval.

And so as a reminder, we have.

70 patients, where we demonstrated a confirmed overall response rate of 31, 4% the lower bound of that confidence interval was 29% and the <unk> study was actually a bit bigger right. It was designed to be about 100 105 patients. So again.

He is a confidence interval will be appropriate for that study. So again, that's in terms of statistical significance in terms of what's clinically meaningful to physicians and patients would be a doubling of response rate from what you get expected with standard of care single agent chemotherapy, which again is 12%.

Mark Joseph Enyedy: Sure, so as you know, we have pursued a number of early stage studies looking at various Myrotoxamab combinations and been very pleased with both the activity and the tolerability of those combinations. So, you know, what we've typically seen are response rates and, you know, measures of progression-free survival or duration of response that exceed the relevant benchmarks for the combination partners. So, for example, if you look at our early data with Carvo and MIRV, you know, what we saw was, you know, a response rate of 80%, 80% in the FR alpha high patients and progression-free survival of about 15 months.

Turning to your second question regarding the companion diagnostic we've been working with Ventana since the inception of the market parts of that program and we anticipate that the <unk> will be.

Available contemporaneously with the drug we've already.

<unk> has already filed some of the components of the PMA. So we're on track there.

Yeah.

Our next question comes from Kelly <unk> with Jefferies. Your line is open.

Congrats on the progress. Thank you for taking my questions.

So far so Ah trial.

Trial.

The protocol allowed amongst PARP inhibitor trade Memphis, I Wonder if I estimate of what percentage of the patients actually had a pop inhibitor treatment and also a follow up question is you.

Mark Joseph Enyedy: And that contrasts nicely with other Carbo doublets that have been reported, where you see response rates in the big 50s and progression-free survival in the range of 8.5 to 10 and a half months. So, you know, with the benefit of those, you know, you know, I think, those data, along with what we've seen with Merv Beth, we are working through, as we speak, a comprehensive strategy that will include studies that will support formal label expansion with respect to these combinations. You know, some of that requires conversations with the agencies, with our investigators, and so on. We are taking the fourth quarter to work through those problems.

Dave and difference of prior treatment Augustine and bedrock.

Compared to a forward one what do you think.

The impact of the boat space agents in the background.

Uh huh.

Merv treatment efficacy. Thank you.

So over the past several years parks had been adopted and incorporated into the treatment of ovarian cancer and the forward. One study, which was performed at the time that the initial approval for the treatment setting were being done and just the maintenance trials were ongoing about 10% of patients had had a prior PARP inhibitor with each.

Each subsequent cohort that we have enrolled since then with all of our combination studies the percent of patients who have had a prior PARP inhibitor has increased to about 35% to 40% over time with the most recent publicly reported cohort and what we've seen is a consistent and continued efficacy.

unknown: those points with them and look forward to talking to you in the first quarter about where we go from here and the studies that we're initiating. Got it, okay, that's very clear. Thank you, Mark. And then I guess, you know, looking back at ESMO, I think they were heard to be one of the conference winners in terms of compelling data sets. I'm just curious about your take on the optimizations done there and kind of any re-through to IMGN-151, the next generation asset.

Now regardless of prior PARP use or not.

You may recall that the mechanism of action for PARP inhibitors, they interfere with the tumor cells ability to repair DNA damage.

And our drug is a tubular directed inhibitor. So theres no reason after reorient to anticipate crop resistance between these mechanisms.

Great. Thank you.

As a reminder to ask a question. Please press Star then one.

Our next question comes from Jessica Fye with Jpmorgan. Your line is open.

unknown: So, Andy, if you could clarify what you're thinking. So you're talking about Her 2, Diichu's Her 2, ABC with Campathesan, and you think about how that's built upon the success of Cad Scyla, and you're asking an analog for how might IMGN151 build on the success of Myrbituximab? Is that what you're driving at?

Good morning, everyone. This is Daniel for Jessica Fye. Thank you for taking my question.

Mr. Ryan and David that you rule out the 12% overall response rate with chemo and the analysis using the blinded independent Central review, but it comes in below the doubling of chemo. You've just suggested will be clinically meaningful maybe can you talk about what that scenario would mean for approval and for the commercial opportunity for <unk>.

unknown: Yeah, that and also, I guess for and her two sites of optimization, right? So, you know, basically, you link around the payload. And I believe 151, all different components were optimized. You're just curious about kind of that lead through the clinical benefit derived from two optimizations versus, you know, theoretically, three from 151. Yeah, sure. So, you know, we're always innovating.

Excellent.

So again, we believe that a doubling of response rate would be considered clinically meaningful in that 12% benchmark is based on investigator assessment from Australia.

So you know we will have both datasets FDA will review, both datasets and it's really about the overall benefit risk. So one is the benefit. So you know what is the response rate and what's the duration of those responses compared to available therapy and also turning to risks you may recall from the forward. One study <unk> has a very nice.

<unk> ability profile with fewer dose reductions due to drug related adverse events and fewer discontinuation. So again FDA will have both datasets to assess the overall benefit risk, but from a study perspective, it's about ruling out a 12% overall response rate for the primary endpoint.

Unknown Executive: And so the innovations that we've built into 151 include the antibody being bi-paratopic. So it binds to two separate epitopes on folate receptor alpha, which we've shown leads to more internalization events and more cell killing. And that translates into being able to target tumors with broader expression of FR alpha so that we see activity, very nice activity, for IMGN151 at low and medium levels of FR alpha expression in vitro and in vivo.

Then as it relates to the commercial opportunity.

And as said.

Something clinically meaningful here would be to double the response rate versus.

<unk> care have somewhat longer duration of response, and what we'd see reported and I think when you look at the real world evidence.

In these patients.

<unk> percent actually is an optimistic response rate.

As we think about additional studies that had been done here. So we think with this profile that bavituximab will displace single agent chemotherapy and you know as you think about the market opportunity here. When we look at second through fourth line platinum resistant disease here in the U S.

Unknown Executive: And so IMGN151 is really designed to address a broad range of fR alpha positive tumors, including essentially almost all of ovarian cancer, as well as then moving into endometrial cancer, triple negative breast, and lung cancer. And you're right, the linker payload has also been innovated on in terms of having a more stable linker payload that's even more stable in circulation. than Murgotoxinin acid. The payload itself is a bit more hydrophobic, a bit more potent, and has a bit more bystander killing.

Each year, there are roughly 22000 patients.

Who are available for treatment.

Just.

Just under 50% of those patients get single agent chemotherapy, so that'll be our target indication of course with the cut for patients who express folate receptor alpha at high levels, which is about 40% of the patient population.

Population, so we think that between <unk>.

<unk> and Mirasol, we're looking at about 4200 patients per year.

Okay. Thank you and then maybe a quick follow up.

It might be a little bit early but in terms of.

The overall response rate that will be shown in the label is it will it be based on investigator or assessment or will it be based on the Baker assessment.

unknown: So we're really excited to be on track to file the I&D before the end of the year for 151 and get that into the clinic early next year. Okay, that's very helpful. Thank you. Our next question comes from Keenan McKay with RBC Capital Markets. Your line is open.

So investigator assessment is the primary endpoint for our study if you look at labels for other drugs that are approved in ovarian cancer. Some of them have investigator assessment and some of them have.

Independent assessment and some labels have bulk so we look forward to discussing with the FDA during label negotiations.

Great. Thank you very much.

Our next question comes from Jonathan Chang with SVP Leerink. Your line is open.

Keenan McKay: Hi, thanks for taking the question and looking forward to the Saraya data. Maybe, with the Saraya data really looming ahead here, just wanted to get your current perspective on sort of the bar for accelerated approval again as it relates to overall response rates as well as the confidence intervals associated with the overall response rate, whether that overall response rate itself is more important or non-overrength. overlapping confidence intervals there with the standard of care.

Good morning, and thanks for taking my questions. First question can you discuss your views regarding Merv Rituxan map into earlier line ovarian treatment settings, specifically what are your thoughts on the maintenance setting.

Yeah. So maintenance has certainly become a part of ovarian cancer treatment and it's really.

Change the paradigm for patients now as <unk> inhibitors are being adopted as well as with Bevacizumab, that's been around a little bit longer both in the restaurant platinum sensitive setting in the frontline setting and then most recently with a payroll of study where the combination of elaborate plus bevacizumab.

Keenan McKay: And then secondarily, I just wanted to ask some housekeeping questions here, just wanted to see if the foliate receptor alpha diagnostic would be ready to be filed alongside Murph if Soraya is accessible in Q1 there. Thank you.

Is really quite.

Quite helpful for patients, particularly.

The HRD patients.

So we're really excited about the potential for mirv atop the Nab as a maintenance option.

Knowing the safety profile of <unk> mono therapy, we have had some patients on for well over a year two years even three.

And also the combination former Rituximab plus Bevacizumab you may recall, our really nice data in over 120 patients now.

Unknown Executive: So the guidance that we got from FDA is that we need to exclude 12%. So what that means is the lower bound of the 95% confidence interval needs to be above 12% to be considered a statistically positive study. And certainly, you know, the larger the sample size, the narrower the confidence interval. And so, as a reminder, we had 70 patients where we demonstrated a confirmed overall response rate of 31.4%. The lower bound of that confidence interval was 20.9%.

Very nice progression free survival duration of response data.

And having patients on for many many cycles. So we believe that Murphy toxin that absolutely has potential to be incorporated into the maintenance treatment paradigm and as you've heard from Marc we look forward to sharing our label expansion strategies for combinations that next quarter.

Maybe just to add one point there I mean, there's two elements to this the first is continuation of therapy. So for example, when we think about Carboplatin.

The first patients we enrolled got the normal six to eight cycles in cargo and then they simply continued on Marvin talks about therapy.

Unknown Executive: And the Suraya study is actually a bit bigger, right? It was designed to be about 100, or 105%. So again, the confidence interval will be appropriate for that side study. And again, that's in terms of statistical significance. In terms of what's clinically meaningful to physicians and patients, a doubling of response rate from what you get expected with standard of care, single agent chemotherapy, which again, Turning to your second question regarding the companion diagnostic, we've been working with Ventana since the inception of the Mervitoxam program, and we anticipate that the CDX will be available contemporaneously with the drugs. We've already filed some of the components of the PM Our next question comes from Kelly Shee with Jeffries. Your line is open.

As we said we reported out small numbers, but progression free survival of about 15 months separately, you could imagine combining merv it talks a map with avastin.

And the maintenance protocol that we're having to see something else as an induction.

Therapy to generate a response and then adding rituximab to that so we're working through those.

Those points as we speak and will be part of the discussion that we have a next quarter.

Yeah.

Understood. Thank you.

And second question can provide any color on how the IMG see 936 dose escalation has progressed and should we expect data in the early part of next year.

Yes, so I am do you see 93 fixes are Adam <unk> targeting ADC and it has our next generation may tanzanite payload beyond 'twenty one Adam nine is widely expressed across a variety of solid tumors and so we're doing.

Dose escalation study three plus three.

In those tumors that we now express Adam nine, including Triple negative breast cancer colorectal.

unknown: Congratulations on all the progress, and thank you for taking the time to answer my questions.

unknown: So for a Suraya trial, the protocol allows parlor inhibitor treatment. So I wonder, like, if they are estimated what percentage of the patient actually had a pop inhibitor treatment. And also, a follow-up question is, given the difference in prior treatment, I was seeing an inhibitor, compared to Forward 1. What do you think the impact of both this agent in the background is?

Cancer, pancreatic and gastroesophageal, so I would say that that phase one dose escalation is going as anticipated and we look forward to sharing data in 2022, I don't think I can give more timing at the moment, but we will update it certainly as we get closer.

Yeah.

Got it thanks for taking my questions.

Our next question comes from RK Romack Huh.

H C. Wainwright your line is open.

Thank you good morning folks.

So let me add my question on that.

It'll take some lab as well.

Unknown Executive: Merv treatment advocacy. Thank you. So, over the past several years, PARPS have been adopted and incorporated into the treatment of ovarian cancer. In the Forward One study, which was performed at the time that the initial approvals in the treatment setting were being done and the maintenance trials were ongoing, about 10% of patients had had a prior PARP inhibitor. With each subsequent cohort that we have enrolled since then, with all of our combination studies, the percent of patients who have had a prior PARP inhibitor has increased to about 35 to 40% over time with the most recent publicly reported cohort.

In terms of Mirasol.

Enrollment can you give us any color as to where it is at this point.

So mirasol is enrolling and we're on track to have data Q3 next year.

Okay, and then on on 632.

What sort of data expectations should be for the call.

Combination in terms of like.

You know what sort of.

Efficacy endpoints are safety that you would be putting out.

Thank you for asking RK, we're quite excited about ash <unk> two is our CD 123 targeted ADC that we are in.

In combination with a decided dean and many of the class and where.

Looking forward to our presentation, where we will share initial safety and anti leukemia activity for the triplet.

Unknown Executive: And what we've seen is a consistent and continued efficacy of Mervidoxinem, regardless of prior PARP use or not. And you may recall that the mechanism of action for PARP inhibitors is they interfere with the tumor cells ability to repair DNA damage, and our drug is a tubular directed inhibitor, so there's no reason a priori to anticipate cross-resistance. Great, thank you.

So.

Stay tuned.

Okay.

November 4th it yes.

Yes, yes.

And then on to them.

Hum.

Again.

I know you do you'll have it in your slides as to when the data is expected but.

How should we think about that data.

On top of what we're going to see at Ash.

How are you planning to build that up.

Operator: As a reminder, to ask a question, please press star than one. Our next question comes from Jessica Five with J.P. Morgan. Your line is open. Good morning, everyone. This is Daniel from Jessica Fai.

So that.

You can get we can try to understand how this drug is working not only as a monotherapy, but also as a combination therapy.

Okay.

So IMT and 632 is being studied in <unk>.

unknown: Thank you for taking your question. For Soraya, in the event that you rule out the 12% overall response rate with chemo and the analysis using the Blind and Independent Central Review, but it comes in below the doubling of chemo you've just suggested would be clinically meaningful. Maybe you could talk about what that scenario would mean for approval and for the commercial opportunity for Mark Texema? So again, we believe that a doubling of response rate would be considered clinically meaningful, and that 12% benchmark is based on investigator assessments from Orrelia.

D C N. Both relapsed refractory B P D C and and and and enrolling pivotal frontline B P. D. C. N cohort. After we've received breakthrough therapy designation from FDA in the relapsed refractory setting. We're also exploring <unk> two as monotherapy in <unk> positive cohort that cohort is open to.

Any AML patient, who is NRG positive after their prior therapy. So it could be after frontline induction or it could be later line.

And so we look forward to sharing data at ash for BT DCM.

Sure.

I would say a handful of patients who are frontline we've talked about them in the past there are three frontline patients who we are.

Who received <unk> six three to prior to us commencing the official pivotal cohort in the frontline setting and we've shared in the past that each of those patients who've had a CRC and we look forward to sharing additional details around those three patients.

unknown: So, you know, we will have both data sets. FDA will review both datasets, and it's really about the overall benefit and risk. So one is the benefit. So, you know, what is the response rate and what's the duration of those responses compared to available therapy? And also, turning to risk.

Okay. Thank you. Thank you very much folks and I talked to you guys.

Thanks.

Yeah.

Our next question comes from Joe Kattan Zero with Piper Sandler Your line is open.

Hey, guys. Thanks, so much for taking my question, maybe one quick one for me just following up on <unk>.

So just wondering how we should think about how this area.

Unknown Executive: You may recall from the forward that one study, Mervitoxinab, has a very nice tolerability profile with fewer dose reductions due to drug-related adverse events and fewer discontinuations. So again, FDA will have both data sets to assess the overall benefit risk.

Response rate and Dor translates to Mirasol, and maybe just sort of Directionally, where you think it would head in Mirasol based on this survey data. Thanks.

Yeah.

So surya and Mirasol.

Quite similar patient populations, Joe the difference is that in Mirasol patients may or may not have had prior bevacizumab, whereas in survey of every patient has had prior bevacizumab. However, it's the same number of lines of therapy, one to three prior lines of therapy and you may recall in the forward one study about half of the page.

Unknown Executive: But from a study perspective, it's about ruling out a 12% overall response rate for the primary. Then, as it relates to the commercial opportunity, you know, Anna has said, something clinically meaningful here would be to double the response rate versus standard of care and have, you know, a somewhat longer duration of response than what we see reported. And, you know, I think when you look at the real-world evidence in these patients, 12% actually is, you know, an optimistic response rate, as we think about additional studies that have been done here.

<unk> had prior Bevacizumab, we anticipate a similar percentage of patients are in mirasol, having prior bevacizumab, but remember in Mirasol. The primary endpoint is progression free survival of course, we will be looking at overall response rate in the Mirasol study as well so.

I think that gives you a sense of the patient populations and.

Thank you will you will be able to.

Think about how Mirasol may play out taking into consideration both the survey data that we will share this quarter as well as the prior forward one dataset.

Unknown Executive: So we think with this profile that, you know, Robert's a person, touch from that will displace single agent chemotherapy. And, you know, as you think about the market opportunity here, when we look at second through fourth-line platinum-resistant disease here in the U.S., each year, there are roughly 22,000 patients who are available for treatment, and just under 50% of those patients get single agent chemotherapy.

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

Yes.

Our next question comes from Boris <unk> with Cowen Your line is open.

Great.

Sorry, I joined a few minutes late if you may have addressed this but for the AML data update later at Ash.

You consider successful data and considering the competitive dynamics in the AML space.

Yeah, So let's see our cri rates are really important in AML in relapsed refractory AML and for a combination we think.

Unknown Executive: So that'll be our target indication, of course, with the cut for patients who express fully receptor alpha at high levels, which is about 40% of the patient population. So we think that between Saraya and Mirosol, we're looking at about 4,200 patients per year. Thank you.

Uh huh.

CR cri rate something in the rate up.

30% to 40% would be quite clinically meaningful and would support further development.

Got it and so my last question is for 632, if the data achieved that threshold.

Is the timeline for future development or would you have to do a randomized study and if so how long would something like that take.

unknown: And then maybe a quick follow-up. I know it might be a little bit early, but in terms of the overall response rate that will be shown in the label, will it be based on the investigator's or assessment, or will it be based on the Bicker assessment? So investigator assessment is the primary endpoint for our study. If you look at labels for other drugs that are approved in ovarian cancer, some of them have investigator assessment, some of them have independent assessment, and some labels have both. So we look forward to discussing this with the FDA during label negotiations. Thank you very much. Our next question comes from Jonathan Chang with SB Lyrink. Your line is open.

Well given the high unmet need in relapsed refractory AML many.

Combinations and single agents are used and none of them are really outstanding.

There is the potential for a single arm study to support accelerated approval.

And ultimately there's also a potential.

For a frontline randomized study.

I think it's a little early for us to really start getting into timing of what the.

The pivotal registration trial or trials would be for the combination. We really are looking forward. However to sharing the initial combination data for the triplet of ash.

Great. Thanks for taking my question.

There are no further questions at this time I'd like to turn the call back over to the team for any closing remarks.

Great. Thanks, very much very much appreciate you joining us. This morning, obviously, we have a big quarter yet ahead of us. So like you. We await this array of data with great anticipation and we're on track to deliver that data this quarter and then separately with.

Unknown Executive: Good morning, and thanks for taking my questions. First question: can you discuss your views regarding Mervetuxmeb in earlier line ovarian treatment settings? Specifically, what are your thoughts on the maintenance settings? Yeah, so maintenance has certainly become a part of ovarian cancer treatment, and it's really changed the paradigm for patients now as PARC inhibitors are being adopted, as well as with Bavisimab, a little bit longer, both in the recurrent flatum-sensitive setting and the frontline setting.

With 632 important data at.

At Ash and then finally 151, we expect to file the IND.

For that program before the end of the year. So stay tuned and we will look forward to sharing additional data with you over the course of the quarter.

This does conclude the conference you may now disconnect everyone have a great day.

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Unknown Executive: And then most recently with the Paola study where the combination of Elaborate plus deacizumabasimabst is really quite helpful for patients, particularly HRD patients. So we're really excited about the potential for Mervatuximab as a maintenance option, knowing the safety profile of Mervatuximab monotherapy. We have had some patients on it for well over a year, two years, even three.

Okay.

Okay.

Okay.

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Sure.

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Unknown Executive: And also, the combination of Mervituximab plus Bevacizumab. You may recall our really nice data in over 120 patients now with very nice progression-free survival, duration of response data, and having patients on for many, many cycles. So we believe that my ketoxinab absolutely has the potential to be incorporated into the maintenance treatment paradigm. And, you know, as you heard from Mark, we look forward to sharing our label expansion strategies for combinations next quarter. Yeah, maybe just to add one point there. I mean, there are two elements to this.

Mark Joseph Enyedy: The first is continuation of therapy. So, for example, when we think about carboplattened, the first patients we enrolled got the normal 6 to 8 cycles of cargo, and then they simply continued on myrotoxamab therapy. And as we said, you know, we reported small numbers but progression-free survival for about 15 months. Separately, you could imagine combining marmitoxymab with Avastin in a maintenance protocol. So having received something else as an induction therapy to generate a response, and then adding Myrbitoxamabic to that.

Mark Joseph Enyedy: So we're working through those points as we speak, and they will be part of the discussion that we have next quarter. Understand? Thank you. And second question, can you please provide any color on how the IMGC 936 dose escalation has progressed? Should we expect data in the early part of next year? Yeah, so IMGC 9-9 targets ABC, and it has our next generation metaninoid payload, DN21. Adam 9 is widely expressed across a variety of solid tumors, and so we're doing a dose escalation study 3 plus 3 in those tumors that we know express atom 9, including triple negative breast cancer, colorectal, lung cancer, pancreatic, and gastroesophageal.

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Anna Berkenblit: So I would say that phase one dose escalation is going as anticipated, and we look forward to sharing data in 2022. I don't think I can give you any more timing at the moment, but we'll update it certainly as we get closer. Got it. Thanks for taking the question. Our next question comes from RK Romicon with H.C. Waywright. Your line is open.

Operator: Your line is open. Thank you. Good morning, folks. So, let me add my question on Merew TextMab as well. In terms of Marisol enrollment, can you give us any color as to where it is at this point?

Unknown Executive: So Mirosol is enrolling, and we're on track to have data in Q3 next year.

unknown: Okay, and then on 632. What sort of data expectations should we have for the combination in terms of like, you know, what sort of efficacy endpoints or safety that you would be putting out?

Anna Berkenblit: Thank you for asking RK. We're quite excited about Ash. GM632 is our CD-123 targeted ADC that we are in combination with Aza-Sidididine and Benetoclax, and we're looking forward to our presentation where we will share initial safety and anti-leukemia activity for the triplet.

unknown: Okay. Thanks for that. I think the abstract came out on November 4th. Yes, yes, I'm aware of that. And then on Cadenza, Again, you know, not, I know you have it in your slides as to when the data is expected, but how should we think about that data, on top of what we're going to see at Ash, how are you planning to build that up? so that we can try to understand how this drug is working not only as a monotherapy but also as a combination therapy.

Anna Berkenblit: So IMGN 632 is being studied in BPDCN, both in relapse-refractory BPDCN and in an enrolling pivotal frontline BPDCN cohort after we've received breakthrough therapy designation from FDA in the relapse-refractory setting. We're also exploring 632 as monotherapy in an MRD positive cohort. That cohort is open to any AML patient who is MRD positive after their prior therapy. So it could be after frontline induction, or it could be later on. And so we look forward to sharing data at Ash for BPDCN for, I would say, a handful of patients who are frontline.

Anna Berkenblit: We've talked about them in the past. There are three frontline patients who received IMGN 632 prior to us commencing the official pivotal cohort in the frontline setting, and we've shared in the past that each of those patients has had a CRC, and we look forward to sharing additional details about those three patients. Thank you, Anna.

Anna Berkenblit: Thank you, Anna. Thank you very much, folks. And I'll talk to you guys later.

Operator: Our next question comes from Joe Katanzaro with Piper Sandler. Your line is open. Hey guys.

Joseph Michael Catanzaro: Hey guys, thanks so much for taking my question. Maybe one quick one for me, just following up on Mirosol. Just wondering how we should think about how the Saraya response rate and DOR translates to Mirosol and maybe just sort of directionally where you think it would head in Mirosol based on the seraya data.

Unknown Executive: So, Syrea and Mirosol are quite similar patient populations, Joe. The difference is that in Mirosol, patients may or may not have had prior Bevacizumab, whereas in Syraha, every patient has had prior Bevacizumab. However, it's the same number of lines of therapy, one to three prior lines of therapy.

unknown: And you may recall in the Forward One study, about half of the patients had prior Bevacizumab. We anticipate a similar percentage of patients in Mirosol having prior Bepidivisimab.

Unknown Executive: But remember, in Mirosol, the primary endpoint is progression-free survival. Of course, we will be looking at overall response rate in the Mirosol study as well. So I think that gives you a sense of the patient populations, and I think, you know, you will be able to think about how Mirosol may play out, taking into consideration both the Saraya data that we will share this quarter, as well as the prior Forward One data set.

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unknown: Okay, thanks, that's helpful. Thanks for taking my question.

Boris Peaker: Our next question comes from Boris Peaker on Cowan. Your line is open. Great, sorry, I joined a few minutes late, if you may have addressed this, but for the AML data update later at ASH, what do you consider successful data and considering the competitive dynamics in the AML Yeah, so CRRI rates are really important in AML, in Relast Refractory AML, and for a combination, we think, you know, CRCRI rates, something in the rate of 30 to 40% would be quite clinically I got it.

unknown: And so my last question is, for 632, if the data achieves that threshold, what is the timeline for future development? And would you have to do a randomized study, and if so, how long would that take? Well, given the high unmet need in relapse refractory AML, many combinations and single agents are used, and none of them are really outstanding, there is the potential for a single-arm study to support accelerated approval, you know, and ultimately, there's also the potential for a frontline randomized study.

unknown: But I think it's a little early for us to really start getting into timing of what the pivotal registration trial or trials would be for that. We really are looking forward, however, to sharing the initial combination data for the triplet at Asch. Great, thanks, take my question. There are no further questions at this time. I like to turn the call back over to the team for any closing remarks.

Unknown Executive: Great, thanks very much. I very much appreciate you joining us this morning.

Unknown Executive: joining us this morning. Obviously, we have a big quarter yet ahead of us. So like you, we await the serrated data with great anticipation, and we're on track to deliver that data this quarter and then, you know, separately with 632 important data at Ash. And then, finally, 151; we expect to file the I&D for that program before the end of the year. So stay tuned, and we will look forward to sharing additional data with you over the course of the quarter. Thanks. This does include the conference. You may now disconnect. Everyone, have a great day!

unknown: Bhopin'n't, Theean, and the Ande, Thank you, and and and Thank you, and Thank you, and Thank you, and Thank you. Thank you, thank you, thank you, and so on the Thank you, Thank you.

unknown: Thank you. Thank you. Thank you. Thank you. Thank you, and thank you. Thank you. Thank you. Thank you.

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