ImmunoGen, Inc.
Q2 2017 Earnings Call Transcript

Published: 28 Jul 2017

[Operator:]

Good day, everyone, and welcome to today’s ImmunoGen Second Quarter 2017 Financial Results Conference Call. Just as a reminder, today’s call is being recorded. At this time for opening remarks and introductions, I would like to turn the call over to Ms. Sarah Kiely. Please go ahead, ma’am.

[Sarah Kiely:]

Thank you. Good morning and thank you for joining today’s call. Earlier today we issued a press release that includes a summary of our recent progress and our financial results for the quarter ended June 30, 2017. This press release and a recording of this call can be found under the Investor section of our website at immunogen.com. With me today are our CEO, Mark Enyedy; our Chief Medical Officer, Anna Berkenblit; and our CFO, Dave Johnston. Rich Gregory, our Chief Scientific Officer will also join us for the Q&A. During this call, 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. With that, I’ll now turn the call over to Mark.

[Mark Enyedy:]

Thank you, Sarah. Good morning, everyone, and thank you for joining us. For the call this morning, I’ll start with a brief overview of our progress over what was a strong second quarter for the business and highlight upcoming milestones for the back-half of the year. Anna will then provide an update on our clinical portfolio and Dave will cover our second quarter financial results. By way of an overview, we continue to build significant momentum with the business with focused execution of our strategic priorities of advancing our lead program, accelerating our early-stage portfolio and strengthening our balance sheet. During the second quarter, we reported single agent and combination therapy data with mirvetuximab in over 150 patients at ASCO. These data strengthened our confidence in the design and outcome of our pivotal study from mirvetuximab and as we move the drug into earlier lines of treatment for ovarian cancer. In addition, we presented encouraging initial clinical results for 779 in acute myeloid leukemia, which Anna will cover in a minute. Lastly, we significantly improved our cash position through the transactions with Sanofi and Debiopharm, which enable us to increase our focus on the development of mirvetuximab and our IGN programs. Taking together the results of our efforts in the second quarter have better positioned the company for long-term success and delivering value to patients and investors. With that, Anna will update you on our recent progress with mrvetuximab and our novel ADC assets.

[Anna Berkenblit:]

Thanks, Mark. We continue to make significant progress advancing our lead program mirvetuximab. mirvetuximab represents a broad opportunity across multiple treatment settings and it’s the first ADC to enter pivotal development for ovarian cancer. Mirvetuximab has a distinct mechanism of action targeting folate receptor alpha and offers the potential to replace chemotherapy and serve as a preferred agent for combination therapy, including pairings with immune-oncology drugs and PARP inhibitor. As part of our speed to market strategy, we’re enrolling patients in our first randomized Phase III trial, which we call FORWARD I. This study is designed to compare mirvetuximab as monotherapy with the current standard of care in 333 women with platinum-resistant ovarian cancer, whose tumors express FR-alpha at medium or higher level and who has been treated with up to three prior regimens. Patients meeting these criteria represents roughly 12,000 to 14,000 women in the United States and a similar size population in Europe. Since enrolling our first patient in January, we have opened enrollment at more than 60 sites in North America and Europe and are on track to have at least 100 sites in these geographies before the end of the year. In June at ASCO, we presented pooled data on mirvetuximab from three separate ovarian cancer expansion cohorts from the Phase I study, reinforcing the initial data used to define the Phase III population and affirming our confidence in the design of the trial. In the subset of patients, who would have met key eligibility criteria for FORWARD I, the confirmed overall response rate was 47% and the median progression-free survival was 6.7 months. These results compare favorably to what would have been expected with the current standard of care options in this settings, which generally yield response rates in the range of 15% to 20%, and a progression-free survival of less than four months. Importantly, mirvetuximab was well tolerated across all ovarian cancer cohorts with manageable predominantly grade I and grade II adverse events. Building on the monotherapy data, our comprehensive development program levers the favorable tolerability profile of mirvetuximab to use it in combination regimens moving it into earlier lines of therapy. We initiated the FORWARD II trial last year to look at a number of combinations, including Avastin, carboplatin, pegylated liposomal doxorubicin or Doxil and Keytruda, which Merck is supplying through a collaborative agreement. The FORWARD II study is progressing well. And as presented at ASCO, we’ve reached the recommended Phase II dose for each of these four combinations with the full dose of mirvetuximab combining with full doses of each of these agents. The safety profile for these combinations were manageable and as expected based on the known profiles of each agents with no new safety signals identified. We also absorbed anti-tumor activity in dose escalations that compares favorably to publish benchmarks for combination regimens with these agents and support continued development of mirvetuximab combination therapy. We have advanced expansion cohorts in Avastin and naive and Avastin pretreated patients similarly encouraging carboplatin combination data that prompted us to assess option for acceleration of further development in platinum sensitive disease. We have also advanced the Keytruda combination to an expansion cohort and we expect to present initial activity related findings from these cohorts at a meeting in the first-half of 2018. Additional opportunities with mirvetuximab are being explored in three NCCN trials open for enrollment. One in combination with gemcitabine and two neoadjuvant trials in triple negative breast cancer. We have also co-funded with Clovis, an investigated sponsored trial combining mirvetuximab with the PARP inhibitor, Rubraca. The findings we’ve reported and the ongoing trial supports the broad potential of mirvetuximab across multiple treatment settings. Moving to our earlier-stage pipelines, we recently presented the first-in human data from our ongoing Phase I study evaluating single agent IMGN779 in patients with relapsed or refractory acute myeloid leukemia, whose tumors express CD33. As a reminder, IMGN779 combines a high affinity humanized anti-CD33 antibody with one of ImmunoGen’s novel payload called IGN, which alkylates DNA without cross-linking. We have specifically designed these payloads for potent anti-tumor activity, while providing the tolerability necessary for ongoing retreatment. The data were reported at the EAJ Congress in Madrid and described the safety pharmacokinetic and pharmacodynamic profile of 779, as well as initial anti-leukemia activity through dose level 7. No dose limiting toxicities were observed not was there any accumulative toxicity observed with repeated doing. At the higher dose levels, prolonged exposure and CD33 saturation were observed along with anti-leukemia activity in patients whose disease have progressed following intensive front-line therapy. These data suggests favorable tolerability and encouraging activity in patients with AML. We look forward to determining the recommended dose for 779 and moving quickly into later-stage development. Lastly, we are on track to file an IND in the third quarter for IMGN632, our novel CD123 targeting ADC for hematologic malignancies. We look forward to continuing to share progress with you on mirvetuximab and our earlier-stage pipeline. Now, I’ll turn it back over to Mark.

[Mark Enyedy:]

Thanks, Anna. In addition to the significant progress we made with our clinical programs, we also took important steps to strengthen our balance sheet and realize additional value through two business development transactions in the second quarter. First, we amended our longstanding agreements with Sanofi. Under the amended terms, ImmunoGen received a $30 million payment in exchange for a fully paid exclusive license to manufacturing commercialized several experimental agents in development by Sanofi. Second, Debiopharm acquired I IMGN529, our clinical stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphoma. Under the terms of the agreement, ImmunoGen received a $25 million upfront payment for 529, and is entitled to $5 million milestone payment after the completion of the transfer of certain technology related to 529, which is expected to occur by the end of 2017, and we’re eligible for an additional $25 million milestone payments upon 529 entering a Phase 3 clinical trial. These transactions strengthened our cash position and demonstrates the inherent value of our technology, while supporting our stated objectives to prioritize the development of mirvetuximab and our other novel ADC assets. With both companies having established strong legacies in developing oncology products, Sanofi and Debiopharm bring the right resources and commitment to complete the development of these candidates and deliver them to patients around the globe. Just a couple of additional items from our partners. First, CytomX announced the treatment of the first patient in a Phase ½ trial evaluating CX-2009 in advanced solid tumors. CX-2009 is a drug conjugate that combine CytomX Probody technology with a proprietary ImmunoGen linker and payload. We earned $1 million milestone payment for the start of the first study with this candidate. And second, our partner Bayer recently announced that the pivotal Phase 2 trial assessing anetumab ravtansine in patients with recurrent malignant pleural mesothelioma did not meet the study’s primary endpoint of progression-free survival. The safety and tolerability of anetumab were consistent with earlier clinical findings and Bayer is continuing to follow patients in the study for the secondary endpoint of overall survival, as well as pursuing development and additional trials in multiple solid tumors. While it’s disappointing that the study did not meet its primary endpoint, we remain encouraged by Bayer’s commitment to further evaluating anetumab for multiple tumor types with significant unmet need. So we’ve completed a strong first-half of the year. Looking ahead, we expect several key events with our portfolio. As Anna mentioned, in the third quarter, we plan to file an IND for 632 and ADC targeting CD123, which we intend to develop from multiple hematological malignancies. We also plan to present additional data from our Phase 1 trial 779 in patients with relapsed refractory and now at a medical meeting later this year, together with preclinical combination data for 779. And we expect to publish results from the 40 patient Phase 1 mirvetuximab expansion cohort evaluating the use of prophylactic steroid eye drops in combination with mirvetuximab. I look forward to updating you on our progress of these programs and those of our partners. And with that, I’ll hand the call over to Dave to review our financials.

[David Johnston:]

Thanks, Mark. Our financials were discussed in some detail in our press release that was issued earlier this morning. So I’m just going to review the highlights and talk about our updated guidance for 2017. Revenues for the second quarter ending June 30, 2017 were approximately $39 million, which includes a $30 million paid up license fee from Sanofi related to the recent transaction. A $1 million milestone payment from CytomX and approximately $6.5 million in non-GAAP royalty revenue. Just as a note, the $25 million we received from Debiopharm in this quarter will be recognized as revenue likely later this year, as we complete the tech transfer. Operating expenses in the second quarter were approximately $44 million, driven by $35 million of research and development expenses. For the second quarter, ImmunoGen reported a net loss of about $9 million, or $0.10 a share. We ended the second quarter with approximately $150 million of cash and cash equivalents and $100 million of convertible debt outstanding. Based on the revenue generating transactions with Sanofi and Debiopharm in the second quarter, we are updating our revenue and cash guidance for 2017. Projected revenues are expected to be between $115 million and $120 million compared to our previous guidance of between $70 million and $75 million. Our guidance for operating expenses is unchanged and we expect to end 2017 with between $90 million and $95 million in cash, compared to previous guidance of between $35 million and $40 million. We expect this will allow ImmunoGen to fund our operations into the second-half of 2018. So with that, we’ll open up the line for any questions, operator.

[Operator:]

Thank you. [Operator Instructions] We’ll go first today to Michael Schmidt of Leerink Partners. Please go ahead.

[Michael Schmidt:]

Hey, guys, good morning, and thanks for taking my questions. I had one on mirvetuximab. You mentioned the – an ongoing process to assess options to develop the drug in platinum sensitive disease, and I was just wondering what are your sort of the pushes and pulls are here to make this decision?

[Anna Berkenblit:]

Yes. So, Michael, as you know, the data from the combination with carboplatin were quite encouraging. In dose escalations, we had a response rate 55%, again, small numbers of patients with that and coupled with the progression-free survival of about 12 months in patients with a median of three prior lines of therapy, was really quite encouraging. So we are considering options to move mirvetuximab as a doublet with carboplatin or potentially as a triplet with Avastin or even Keytruda into earlier lines of therapy. We’re currently assessing the options and we’ll keep you posted as we solidify our development plans.

[Michael Schmidt:]

Great, thanks. And then on the 779, you mentioned the next update here probably by year-end at the ASH conference. And so I was wondering, how you think about development path for this product? Thanks.

[Anna Berkenblit:]

Thank you for that question. With recent events, the landscape for AML has changed considerably from our perspective. Two key events have occurred that are allowing us to, again, reassess our plans for 779. So first is that, Seattle’s CD33 directed ADC, which cross-links DNA and causes significant DNA damage stopped development. They had a Phase 3 trial in first line unfit patients in combination with hypomethylating agents that was stopped early because of excess deaths on the experimental arm, and they’ve halted development. Our prior plan had been to develop 779 around them assuming success. Since they’re no longer developing it, that provides additional opportunities for our ages, which alkylates DNA and does not cause double-stranded DNA damage. The other event that occurred is the positive ODAC for Mylotarg. The questions that the Oncology Drug Advisory Committee was asked was whether or not event free-survival was a meaningful endpoint in AML? And the answer was, yes. The vote was 6 to 1 in favor of a death free-survival. What that means for us is, it may open up the potential for event free-survival being the primary endpoint for our first line AML trial for approval, which could allow us to develop the drug with a smaller and shorter Phase 3 trial. So we’re taking these two events into consideration as we’re thinking about moving 779 up into earlier lines of therapy.

[Michael Schmidt:]

Great. Thanks so much.

[Operator:]

Up next from William Blair, we’ll go to Andy Hsieh. Please go ahead.

[Andy Hsieh:]

Hey, good morning. Thanks for taking my question and congratulations on a very productive quarter. Another question on 779, from the initial clinical experience, AML is very diverse. You can kind of segment into very – various segments. From the initial experience, is there any particular population that you’re looking for treatment naive, treatment experience, high intensity chemotherapy eligible or not. Just wondering, Anna could comment on that? Thank you.

[Anna Berkenblit:]

Sure, Andy. So CD33 is expressed on most AML blast somewhere between 85% and 90% of patients have CD33 positive AML. So we view our agent to be really potentially beneficial for almost all AML patients as opposed to the other drugs that are making significant progress in AML that are targeted for flip 3 or IVH mutations. The other point I was going to make on blanking on at the moment. Can you repeat your question, Andy, because you had a couple of different questions embedded in there?

[Andy Hsieh:]

Oh, yes absolutely. So this is about…

[Anna Berkenblit:]

Intensive therapy. Yes, intensive therapy…

[Andy Hsieh:]

Exactly.

[Anna Berkenblit:]

So the other point is that, our CD33-directed agent, at this point, we have seen the ability to repeat dose. And again, we think we have a better tolerability profile that will allow us to combine with intensive therapy like seven plus three for other intensive regimens. So right now we’re still focused on identifying the correct dosing schedule for 779 as monotherapy.

[Andy Hsieh:]

Thanks for the additional color.

[Operator:]

Moving onto Matthew Harrison of Morgan Stanley.

[Cyrus Amoozegar:]

Hi, yes, thinks for taking my question. This is Cyrus on for Matt. So you’ve mentioned the Seattle Genetic CD33 compound. What differentiates your compound from there? And what indications do we have that – this is not a CD33 issue, but a drug specific issue?

[Richard Gregory:]

So this is Rich Gregory, CSO. A few data that I think informed that question. First, you have to remember that we started the development of IMGN779 in the other IGN payload containing ADCs. The primary differentiator behind the construction of those drugs was to eliminate some of the toxicities that we would absorb with cross-linking ADCs. And we knew the cross-linking ADCs were excessively potent and we had very good data in our own hands with him. But we actually detected two different kinds of toxicity in our preclinical studies, one of which was what we call a delayed toxicity, which is primarily associated, we believe with a vascular defect that occurs over time. And the other of course is significant repression of the bone marrow. And probably the best data that I can refer you to from our company that directly addresses this data is what we presented at ASH last year. But we actually directly compared a across-linking compound, which is similar mechanism of action to what you see from Seattle and other companies using PBDs through our technology, which is chemically you would look at it and say very, very similar, but it has some very distinct changes that allow it to only address and modify one trend of the DNA. And the key bit of data that we showed was that, if you look at the ability they kill tumor cells either approach was pretty much equivalent. But if you look to the toxicity to the normal bone marrow like normal bone marrow per gender is and we’ve extended this data quite a bit since. The alkylator has a much better tolerability profile, meaning, it does not – it take a much larger dose, the alkylator to kill the bone marrow. Now we believe that this will manifest and the difference in what you see with Seattle in its most recent data is an imbalance of death in the study, which is primarily likely result of that bone marrow repression and the subsequent infections that occur. So mechanistically, we have a strong reason to be optimistic that our drug will differentiate in that space.

[Cyrus Amoozegar:]

As of target?

[Richard Gregory:]

So the target is a second question, which was CD33. And there, I would say, our preclinical data support that it’s a solid target and we have good tolerability data in our preclinical studies. But more than that I would refer you to the recent discussion around Mylotarg. And I think with appropriate dosing Mylotarg is demonstrated CD33 as a viable target, and the key is to have a compound with appropriate tolerability that voids the toxicity is seen with either calicheamicin or PBDs, which are primarily these significant bone marrow or vascular toxicities.

[Cyrus Amoozegar:]

Got it. Thanks for taking my questions.

[Operator:]

We’ll move next to Canaccord’s, John Newman. Please go ahead.

[John Newman:]

Hi, there. Good morning, guys. Thanks for taking my question. I just had a follow-up question on 779. When you look at the toxicity profile that you saw in your model versus the alkylators, did you see any difference in terms of the timing where the mylo especially showed up. I’m just curious if with the alkylating compound, you would get any sort of delayed or prolonged bone marrows question whereas with your compound, or excuse me the cross-linking compound if you do that whereas with the alkylator you don’t see that? Thanks.

[Mark Enyedy:]

Yes, I actually don’t believe we haven’t updated directly address your question. What I can say is, when we look at the alkylators versus the cross-linkers with cross-linkers, for example, if you treat mice with equivalent doses, what you see with the cross-linkers is 10 to 20 days after administration as you start seeing a rapid decline in weight. And this is associated with repression of bone marrow, but also vascular defects and you don’t see that with the alkylator. So I do believe that some of these toxicities do take time to manifest and it will be differentiated at later time points. Early on, of course, they both have very similar direct toxicity against target cells. So any target-related toxicity that would occur early in administration would probably be similar between the two platforms.

[John Newman:]

Okay, great. Thank you.

[Operator:]

We’ll go next to Biren Amin of Jefferies.

[Biren Amin:]

Yes, thanks for taking my question. So maybe if I could just start on FORWARD I, I think, you’re expecting futility analysis in the first-half of 2018. If that’s still on track, given all of your sites will be up and running by the end of the year, and what’s the threshold that you would need to hit where the futility would be triggered?

[Anna Berkenblit:]

So we are on track for a futility analysis, first-half of next year and the futility analysis will be performed after 80 PSS event. We have set the threshold such that if the hazard ratio is greater than one in both the intent to treat population and the subset of patients with high FR-alpha expression, which we anticipate will be about two-thirds of the patients enrolled then we would stop.

[Biren Amin:]

Great. And then just a follow-up on merv. Are the two trials in the triple negative setting that are being run by NCCN, what’s the rationale to evaluating the setting? And can you just talk about the inclusion criteria? Is it based on FR expression? And then I guess the combination of the Clovis PARP, how many patients will that trial enroll, and again will that trial enroll based on FR status and BRCA mutation status?

[Anna Berkenblit:]

So the triple negative breast cancer trials, there are two of them in the neoadjuvants settings. The rationale is that, triple negative breast cancer is one of the tumor type that expresses FR-alpha by IST. The percent of triple negative breast cancers that express FR-alpha is lower than ovarian, which is why we have focused on ovarian cancer. But we believe there is potential for mirvetuximab to benefit triple negative breast cancer patients. So these two NCCN trials will be selecting triple negative breast cancer patients for FR-alpha expression. And as they are neoadjuvants trials, the bleed out from the surgery will be quite informative. For your question regarding the combination trial with Rubraca, that is an IST that is currently in the final stages. So we don’t have the final protocol yet. And certainly, when we’re thinking about that combination, there is the potential to benefit both BRCA wild type patients and BRCA mutant patients, and we are going to select for FR-alpha.

[Biren Amin:]

Great. Thank you.

[Operator:]

Up next we have Boris Peaker of Cowen. Your line is open. Please go ahead.

[Boris Peaker:]

Thanks. Good morning. So my first question is on CD33, or your 779 compound?

[Anna Berkenblit:]

Boris, can you speak up, please?

[Boris Peaker:]

Sure. With mylotarg returning back to the market, I’m just curious how that would impact your development for 779?

[Anna Berkenblit:]

So we’ll have to see what the ultimate label is for mylotarg. The data that they presented were in combination with seven plus three in the front-line setting. The other point is that mylotarg seems particularly to benefit the good risk patients. So there are opportunities for us to develop our CD33 directed ADC in other areas of AML, specifically the first-line unfit patients. Right now, they really have an unmet need, because the standard of care is single agent hypomethylating agent. So that’s an area we’re very interested in exploring, especially based on recent events with Seattle Genetics. And then we’re going to have to see where mylotarg does land. My understanding is, they also included their data in the relapse refractory setting as part of their submission even though that wasn’t a discussion point at the ODAC.

[Boris Peaker:]

Gotcha. And then maybe a financial question, you’ve been very successful in out-licensing some non-core assets. I’m just curious what other assets you have that you still see as a potential for rising capital and in the same funnel like any thoughts on mirvetuximab ex-U.S. out-licensing thing?

[Mark Enyedy:]

Hey, Boris, this is Mark. Just to start, we look at the portfolio and we had significant inbound interest in the IGN programs in part based on the data that we’ve presented some of which we reviewed on this call. And so we think that creates an opportunity for us to partner those assets. To be clear, we’re moving in a different direction than the company has historically taken with the platform deals, where we see the later-stage development and commercialization to our partners. Here we would be looking for co-development and co-commercialization relationships for those assets in order to generate longer-term value or higher longer-term value for the company. With respect to mirvetuximab, I think at this juncture, it would need to be a pretty compelling offer for the program. We would, for sure, want to retain the U.S. rights. And in terms of the ex-U.S. rights, what we would need to see is a partner that would allow us to substantially expand the breadth of the program that where you are pursuing there to increase the overall value of the asset. So that’s how we’re thinking about it right now.

[Boris Peaker:]

Great. Thank you very much for taking my questions.

[Mark Enyedy:]

Sure.

[Operator:]

We’ll hear next from Cantor Fitzgerald with Mara Goldstein.

[Cantor Fitzgerald:]

Oh, thanks very much for taking the question. Just on the Bayer collaboration and with the discontinuation of the anetumab program in recurrent mesothelioma, I’m just wondering what are the other, if any potential milestones to the company based on the current clinical program?

[Mark Enyedy:]

Yes. So a couple points of clarification there. So in the mesothelioma process, they are continuing to follow patients for the secondary endpoint of overall survival in the study. In addition, there are currently ongoing Phase 1b studies in multiple tumor types, including a study in platinum-resistant ovarian cancer in combination with doxorubicin. So there are multiple ongoing clinical studies for that program. And the next development milestone that we would have would be the commencement of pivotal testing in a second indication. So that’s the situation. So, active program there, you may have listened to the Bayer earnings call yesterday, they are committed to this program. They’re excited about this program. I think they’re disappointed with the results in mesothelioma. And as they noted that notoriously difficult to treat tumor types. But what they have seen in their earlier studies is, patients on – lag after after a number of years, which is a remarkable result, which I think led to some surprise at the outcome here. But they continue to pursue it, and let’s say, we’ve got an active agreement there and we’ll be expecting additional milestone payments as they progress.

[Cantor Fitzgerald:]

Okay. Thank you.

[Mark Enyedy:]

Sure.

[Operator:]

[Operator Instructions] We’ll go next Jessica Fye with JPMorgan.

[Jessica Fye:]

Hey, guys. God morning. Thanks for taking my question. I just was hoping that you could walk through how we should think about timing for the next data readouts of mirvetuximab in combination with some of these other agents. So we can kind of see more patient numbers and kind of get a better sense of the profound combination of those other products? Thank you.

[Anna Berkenblit:]

Yes Sure, Jessica. So at ASCO, we presented basically full data from dose escalation for three of the combinations. The Keytruda one got a late start. So we were only able to present initial safety data. So we anticipate in the first-half of next year presenting initial efficacy data for the Keytruda combination. And as you know, the vast and expansion cohorts are enrolling and we are now enrolling the Keytruda expansion cohort. So we – we expect to present data in the first-half of next year there as well.

[Jessica Fye:]

Got it. Thank you.

[Operator:]

[Operator Instructions] We’ll go next to Matthew Eckler of RBC Capital Markets.

[Matthew Eckler:]

Hey, guys, good morning and thanks for taking the question. So I wanted to ask about the primary endpoints for FORWARD 1. I know the trial is designed such that you can take a concurrent look at both the ITT and high FR-alpha expressing population. So could you just talk a little bit about what percentage of the trial each population are, as well as your confidence for hitting on the ITT versus high expresser groups?

[Anna Berkenblit:]

So taking a step back, about 80% of ovarian cancers are FR-alpha positive. When we break it down by low medium and high expression, about 40% are high, 20% are medium, and 20% are low. So we expect that the patient population in our Phase 3 trial will cover about 60% of ovarian cancer patients overall. Then looking specifically at the patients we are enrolling in the Phase 3 trial, about two-thirds of them will be high and about one-third of them will be medium, okay. So we are going to be able to test in the ITT population, which consist of the medium and high patients, as well as a subset of high patients, which is about two-thirds of the patients enrolled. Given the activity that we’ve seen throughout the mirvetuximab program now, over 200 patients have been treated. There is definitely a correlation, the higher the FR-alpha expression, the deeper and more durable the tumor shrinkage. So that’s why we are looking at the mediums and highs, because there is a trend. It may turn out that the greatest benefit is for the highs. And the way we’ve designed the analysis for the primary endpoint, it will allow us climb success on either the ITT population and the highs or just the highs, because we’re using the [indiscernible], it’s not a sequential procedure, so we didn’t have to pre-specify that we would do one test first and then the other, so it gives us a little flexibility yet allows us to retain power in the Phase 3 setting.

[Matthew Eckler:]

Okay, great. Thank you. And then for the the upcoming 779 data later this year, what should we expect there in terms of patient numbers, follow-up times, possibly additional dosing cohorts to be included? And then separately, will there be Phase 1 eye drop data at ESMO?

[Anna Berkenblit:]

So first for 779, we are in the process of finalizing an abstract for submission and we will present whatever data we have. We are still in dose escalation and we have not seen any dose-limiting toxicities yet. So we are going as quickly as we can. There’s a lot of investigator enthusiasm and these cohorts open and close within a day pretty much because of the investigator enthusiasm. So we will present the data that we have. One of the focuses of our program is really making sure we understand the pharmacokinetics and pharmacodynamics to get the dose right. There are a lot of lessons that we have learned from the Mylotarg experience, where they had five different Phase 3 trials with different doses and schedules of Mylotarg. We want to make sure we get the dose right when we get into pivotal Phase. Turning to the eye drop cohort. We had submitted data for the eye drop cohort. It’s a very important cohort for us, as a company, because we recognize the importance of managing the blurred vision that is observed with ADCs like ours. And primary prophylactic corticosteroid eye drops appear to help us maintain dose intensity. That’s why we’ve included it in our Phase 3 trial. That being said, it was not selected for presentation at ESMO, I think, in part, because the data from oncologist’s perspective have already been out there at ASCO as that was part of the pooled analysis.

[Matthew Eckler:]

Okay, gotcha.

[Anna Berkenblit:]

So we’ll we’re working on a manuscript and are really focusing on educating ophthalmologist.

[Matthew Eckler:]

Okay. Okay, great. Make sense. Thank you. And then one last question here, in terms of the increased revenue guidance for the full-year, I guess, I was wondering if you could elaborate what went into that, is this really just a result of the two recent asset divestitures?

[Mark Enyedy:]

Hey, Matt, the increase in the guidance is directly related to the two transactions that we have this quarter, the $25 million and $30 million within an anticipated additional milestone tied to the tech transfer, which will be anticipated before year-end. So that’s pretty much what is related to.

[Matthew Eckler:]

Got it. Okay, great. Thank you so much.

[Operator:]

And it appears there are no further questions at this time. I would like to turn the conference back over to Mr. Mark Enyedy for any additional or closing remarks.

[Mark Enyedy:]

Thank you. So just to wrap up, we’re headed into the second-half of the year, with increased momentum following a strong second quarter. We presented encouraging data supporting our lead program and highlighting the differentiation of 779 and our DNA operating payload, as well as strengthening our balance with transactions to provide financing for these programs. And we look forward to updating you as we make further progress with the business over the next quarter. So thanks for your interest this morning, and we look forward to catching up.

[Operator:]

Thank you. And again, that does conclude today’s conference. We thank you all for joining