Aug 2, 2019
Operator
Good day, and welcome to the ImmunoGen Second Quarter 2019 Conference Call. Today's conference is being recorded.
At this time, I would like to turn the conference over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
Courtney O'Konek
Good morning and thank you for joining. Earlier today, we issued a press release that includes a summary of our recent progress and second quarter 2019 financial results.
This press release and a recording of this call can be found under the Investors & Media section of our website at immunogen.com. On the call today are Mark Enyedy, our President and CEO; and Anna Berkenblit, our Chief Medical Officer.
Dave Foster, our Chief Accounting Officer, will also join the team for Q&A. During today's call, we will review recent progress, our second quarter financial results and highlight upcoming milestones.
During the discussion, we will use forward-looking statements and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings.
And with that, I will turn the call over to Mark.
Mark Enyedy
Thanks, Courtney. Good morning, everyone, and thank you for joining us today.
During the second quarter, we fundamentally restructured the business at ImmunoGen with a focused set of strategic objectives to prioritize portfolio of four innovative product candidates, and a strong cash position that will enable us to advance these programs through their next phases of development. We look forward to a productive second half of the year with a number of important milestones for the company.
Starting with mirvetuximab, with the benefit of the safety and efficacy data we've generated to-date, we believe mirvetuximab has the potential to displace single agent chemotherapy in ovarian cancer patients with high FRα positive platinum-resistant disease and to serve as the preferred partner for combination regimens across multiple lines of therapy. To achieve these objectives, we are pursuing a comprehensive development plan to obtain initial approval as a single agent in the platinum-resistant settings, followed by label expansion into earlier lines of treatment through combination studies.
For monotherapy, we are finalizing the design of our registration study, which we expect to review with regulators and initiate patient enrollment before the end of the year. In addition, we will share the full data from FORWARD I during an oral presentation at ESMO at the end of September.
In parallel, we continue to advance our combination cohorts with encouraging data from the Avastin combination presented at ASCO in June, which Anna will review in a moment. We will also present initial data at ESMO from our triplet combined mirvetuximab with carboplatin and Avastin in earlier line patients.
Finally, we anticipate completing enrollment in our second mirvetuximab plus Avastin cohorts in patients with recurrent ovarian cancer regardless of platinum status later this quarter. Moving to our earlier stage portfolio, we've made significant progress with IMGN632, our anti-CD123 ADC, which we are developing in AML and BPDCN under our collaboration with Jazz.
Over the last quarter, we have determined a recommended Phase 2 dose for this program, and have filed a new protocol to move forward with combination studies in relapsed/refractory AML, as well as in frontline patients with minimal residual disease following induction therapy. In addition, we will continue to enroll relapsed/refractory BPDCN patients under our existing protocol.
We will share data from both AML and BPDCN patients at ASH in December. Finally, we continue to advance IMGC936, our novel ADAM9-targeting ADC being co-developed with MacroGenics towards the clinic, as well as completing the activity needed to transition our next generation anti-folate receptor alpha ADC into preclinical development next year.
So a significant progress with the portfolio and a number of important milestones over the remainder of the year. Turning to our financial results, which we’ve detailed in the press release issued this morning.
During the second quarter, we generated $15.5 million in revenue, which include a $5 million milestone payment from Roche and $10.4 million in non-cash royalty revenues related to Kadcyla. Operating expenses were approximately $57 million, comprised of $29 million in R&D expenses, compared with $39 million for the same quarter in 2018.
The decrease was primarily driven by lower personnel expenses, as well as lower clinical trial costs, compared to the prior year when these expenses were driven by accelerating patient accrual in FORWARD I, a $19 million restructuring charge principally related to the workforce reduction in conjunction with our operational review, and $9 million in G&A expenses, which were level with the prior year. We ended the quarter with approximately $240 million in cash on the balance sheet.
We're updating our financial guidance today. For the full year, we expect revenues to be between $40 million and $45 million, our operating expenses to be between $175 million and $180 million and our cash at year-end to be between $165 million and $170 million.
With that, I'll turn the call over to Anna to review our pipeline progress in more detail. Anna?
Anna Berkenblit
Thanks Mark. Looking first at mirvetuximab monotherapy, we look forward to meeting with FDA this quarter to discuss the design of the registration trials and anticipate being able to provide additional details regarding this when we announce the full FORWARD I data at ESMO.
We also plan to seek protocol assistance from the EMA prior to initiating the Phase 3 trial which we are on track to do before the end of this year. Turning now to combinations.
As mentioned, we recently announced mature data at ASCO from the FORWARD II expansion cohorts evaluating mirvetuximab in combination with Avastin, in patients with FRα positive platinum-resistant ovarian cancer. We were pleased to see this combination in this population continues to demonstrate encouraging anti-tumor activity with durable responses and a favorable tolerability profile, particularly among patients with medium or high levels of folate receptor alpha expression, who have received up to two prior lines of therapy, as our data compare favorably to that of Avastin with chemotherapy in the AURELIA trial.
We remain focused on establishing mirvetuximab as the combination agent of choice in ovarian cancer, supporting its use in earlier lines of therapy. The mature data presented at ASCO support further exploration of this doublet in the platinum-agnostic cohort that is finishing up enrollment this quarter, as well as the ongoing expansion study evaluating a triplet combination of mirvetuximab with Avastin and carboplatin in patients with platinum-sensitive disease.
We look forward to presenting initial FORWARD II triplet safety and response rate data at ESMO in September, along with full FORWARD I data. Moving now to our early stage portfolio, IMGN632 is being evaluated for the treatment of hematological malignancies, with a focus on AML and BPDCN.
IMGN632 is a CD123-targeting ADC that deploys our most potent IGN payload. And during this quarter, patient enrollment continued in our expansion cohorts of the Phase 1 studies in patients with relapsed or refractory AML and BPDCN.
We look forward to sharing updated data from the ongoing clinical trial of IMGN632 monotherapy along with preclinical data combining IMGN632 with azacitidine or venetoclax at ASH should our abstracts to be accepted for presentation. We also advanced two additional assets that demonstrate our continued innovation in ADC.
IMGN936, which is in co-development with MacroGenics, and our next generation anti-folate receptor alpha ADC which is expected to enter development in mid 2020. With that, we'll open the call for questions.
Operator
Thank you. [Operator Instructions].
Our first question comes from the line of John Newman from Canaccord. Please go ahead.
Your line is now open.
John Newman
Just had two. So just wondering if you can give us a sense of some of the types of data analyses that we might see from mirvetuximab at ESMO obviously those data are embargoes.
But just curious if you can talk about the types of analyses that we'll see other than, obviously, the split between the high, medium and low? And then the second question I have.
Anna, so previously, you talked a little bit about some of the tweaks and changes that you can make to the second Phase 3 in ovarian cancer. And obviously you're going to be meeting with the agency.
But just wondering if you could speak in general about what some of those things could be? Thanks.
Anna Berkenblit
Sure, John. So the analyses that we will present at ESMO now for the FORWARD I study will include the key primary and secondary endpoints that were protocol specified.
And that will add color to the top-line data that we've already reported. In addition, we've done some exploratory analyses to further understand the trial and the population.
And those exploratory analyses that are informing the design of the next Phase 3 trial will be shared as well.
John Newman
Can you just remind what the key -- the primary and key secondary were?
Anna Berkenblit
Yes. So the key primary endpoint for FORWARD I was progression-free survival by blinded independent review.
And the key secondary endpoints included overall response rate and overall survival.
John Newman
The other question was around tweaks?
Anna Berkenblit
Oh! Right.
So the tweaks will be based on the analyses that we've done on FORWARD I and the additional analyses. The exploratory was, we will be designing where we’re in the process of finalizing the design of the next Phase 3 trial.
We anticipate that much of it will be the same in terms of platinum-resistant with 1 to 3 priors. Clearly, we will focus on FRα high patients because that's where we saw that strong, consistent efficacy signal from the FORWARD I study.
Operator
The next question comes from the line of Boris Peaker from Cowen. Please go ahead.
John Scott
This is John Scott on for Boris. Thank you for taking our questions.
First, previously, you indicated you may monetize some lower priority assets. I wanted to know if there's any update on that process?
And then secondary looking ahead if mirvetuximab has a label for high population based on the new study, do you anticipate the combinations that you're pursuing would also be limited for FR high? Or do you anticipate maintain a more broad strategy for all FR positive for those competitions?
Thanks.
Mark Enyedy
Sure. In terms of business development, you'll appreciate that those kinds of conversations are not generally amenable to play-by-play.
So it's an active process with outreach to multiple parties, inbound interest, and we're pursuing those conversations with all delivered speed. Right now, we're accruing patients in the combination studies, with both medium and high levels of expression.
And we're continuing to evaluate those cohorts in terms of looking for one that will provide us with a clear path to the next level beyond a monotherapy label. And so, what I would say is to be determined in terms of a registration tag.
But for the time being the cohorts that we have up and running include both high and medium patients, which are roughly 60% of the overall population.
Operator
The next question comes from the line of Kennen MacKay from RBC Capital Markets.
Kennen MacKay
I was wondering if maybe you could talk a little bit more about the potential costs of the additional FORWARD or the next FORWARD free trial and sort of what the letters are there in terms of the remaining moving parts in the trial design? Anything that could still move the needle on the estimates for the cost of this trial that hasn't been sort of completely solidified yet?
Thanks so much.
Mark Enyedy
Yes. Kennen, we have not previously sort of disclosed total trial costs, and you'll appreciate that we're in the process of working through an RFP with the various vendors, who might support that trial on a go forward basis.
And so, with that as a backdrop, I think that's about what we would say I mean the expectations for this study, we will be adjusting the hazard ratio assumptions for this study from what we used in FORWARD I to reflect the data that we have. And that will have some impact on sizing and then focusing exclusively on high patients.
So, those two things will factor into it. But at this point, we're just not in a position to comment on the costs.
Operator
We'll take the next question from Andy Hsieh from William Blair. Please go ahead, sir.
Andy Hsieh
I have two. So, obviously very intrigued about the MRD positive AML population indeed, I would assume consolidated setting.
With that, do you have an estimate in terms of duration? And also in terms of EMA, just from a scenario analysis perspective, if they are willing to review the FORWARD I study, how would that impact this ongoing effort in designing the new study?
Mark Enyedy
Sure. So I’ll let Anna, well -- and it is some importance topic so.
Anna Berkenblit
Sure. So we're really excited about the MRD positive cohort for IMGN632 monotherapy.
Because as you know, patients who get intensive frontline therapy, and then extensively do well, but still wind up having minimal residual disease is detectable by flow cytometry, for example, they don't do very well. And so, there is the potential for a well-tolerated monotherapy like ours to really benefit this population.
And it would be a way for us to get a further signal of efficacy and understand the safety profile of our drug in less heavily pretreated patients than are currently being enrolled in our Phase 1 trial. In terms of the EMA, we do plan to meet with the European regulators this fall for a protocol assistance regarding the next Phase 3 trial for mirvetuximab.
Andy Hsieh
Okay. So in terms of timing, would that occur before or after ESMO?
Anna Berkenblit
After.
Operator
The next question comes from Debjit Chattopadhyay from H.C. Wainwright.
Aaron Welch
This is Aaron Welch on for Debjit Chattopadhyay. So I just want to ask about ImmunoGen 632.
Now that you indicate you determine the recommended Phase 2 dose and presumably the dosing schedule, would you be able to disclose what that would be?
Anna Berkenblit
Yes, so -- right, so there are two schedules that we have explored, which is a Q3 week schedule, and then a weekly schedule. And we look forward to sharing data from both schedules at ASH should our abstract be accepted.
Aaron Welch
Okay, great. And for the next Phase 3 for mirvetuximab study, would you be able to tell us -- have you heard anything from physicians indicating strong interest?
Again, I know there was a lot of interest in the first trial so, but what did you heard?
Anna Berkenblit
Yes. Absolutely.
We have really heard overwhelming enthusiasm and support for the next Phase 3 trial, because this is the only way that physicians will be able to get access to mirvetuximab for their patients. And platinum-resistant ovarian cancer has a high unmet need, when you look at agents that are approved, and if you even look at the clinical trial landscape.
This is not where the PARPs show their greatest benefit. And there are not a lot of other drugs in the pipeline at this point that are being explored in platinum-resistant disease.
So the enthusiasm is really high. Investigators want this drug for their patients and they're looking forward to working with us as we are with them to execute quickly and well on the next Phase 3 trial.
Operator
We'll take the next question from Jessica Fye from JP Morgan. Please go ahead.
Unidentified Analyst
Hi, this is Daniel for Jessica. Thanks for taking our question.
When we think about the next steps for 632, do you plan to conduct a randomized Phase 3 trial as an add-on to Vidaza or venetoclax or is this going to be single arm studies?
Anna Berkenblit
Well, first thing first, we need to do a dose escalation study to basically demonstrate the safety of the combinations and doses that are combinable. Venetoclax plus azacitidine is a very effective regimen.
It's not a walk in the park. There are some adverse events associated with it.
So we will proceed as quickly as we can, as thoughtfully as we can to identify the combination that we would then move forward. And certainly a randomized trial would be involved in the development plan.
It's just too soon to say when the appropriate time would be.
Unidentified Analyst
If I can ask one more. It seems that the focus towards the future will be -- going forward will be AML.
Do you still intend to develop it for BPDCN as well?
Anna Berkenblit
Absolutely. We have an ongoing monotherapy cohort in BPDCN.
And we shared initial promising efficacy data from a very small number of patients at ASH last year. I'm glad to say that we have enrolled additional patients and we continue to see encouraging activity.
And again, we look forward to sharing those data at ASH.
Operator
We'll now take a question from Biren Amin from Jeffries. Please go ahead.
Biren Amin
What are your plans in the platinum-sensitive setting? I know you've looked at the mirv triplet combo.
Can you share what your plans are going forward with that combo?
Anna Berkenblit
Sure. So based on the tolerability profile of mirvetuximab, we aim for it to be the combination partner of choice and to displace chemotherapy.
Towards that end, in platinum-sensitive disease, patients get platinum-based combination therapy. And therefore, the initial carboplatin doublet that we explored was quite favorable, which led us to aggressively explore the triplet of carboplatin mirvetuximab and bevacizumab and we look forward to sharing initial Phase 3 data and response rate data from that cohort at ESMO.
We really have two options then for further development for mirvetuximab and that would be basically doublet therapy with carboplatin or a continued development with the triplet. And right now, we're really thinking through the options to figure out what makes the most sense for patients.
Biren Amin
And then maybe in terms of the combination with the PARP, I know that trial is on the alignment. When can we expect data from that study?
Anna Berkenblit
Yes. So you're referring to the investigator-sponsored trial with flowback as from David O'Malley at Ohio State looking at rucaparib with mirvetuximab and it's co-sponsored with Clovis.
So it's an ISP, it's in their hands. It continues to enroll and they will share data from it when they're ready to.
Operator
[Operator Instructions]. We'll take the next question from Jonathan Chang from SVB Leerink.
Please go ahead, sir.
Jonathan Chang
Hi guys, thanks for taking my questions. First question can you give us a sense of how mature the FORWARD I data will be at ESMO?
Anna Berkenblit
At ESMO you will see data from the final progression-free survival analysis which was our pre-specified protocol-based analysis. You will also see updated overall survival data.
You may recall that the median overall survival for patients with platinum-resistant ovarian cancer was somewhere between the 11 and 14 months range. And so, based on us having finished up enrollment, first quarter last year, that gives you a sense of how mature the data will be from an overall survival perspective.
Jonathan Chang
And just second question, is the IND filing for IMGC936 still on track for the second half of the year?
Mark Enyedy
So in conjunction with the restructuring, we are in the process of transferring the lion’s share of the operational responsibility for the IND to MacroGenics. And I’ve spoke with Scott last night just to talk through.
And at this point, our guidance is that the IND will go-in in the first half of 2020 to account for the need to transition a fair amount of this work and get there, in particular their clinical team up to speed and in a position to support the IND in a way that we would like.
Operator
Our last question comes from Michael Schmidt from Guggenheim Partners. Please go ahead.
Michael Schmidt
Hey, guys, thanks for taking my questions. I just had a couple on 632.
Maybe if you could give us a sense of how many patients at the potential ASH update will have been treated as the recommended Phase 2 dose? I had a question just regarding your level of confidence and actually having identified a good Phase 2 dose.
I think at the ASH presentation last year, you've seen activity at various doses, including very low doses. So I'm just curious, your confidence level in sort of having identified the right dose?
And then the last question on 632 was, if you could just touch on how you think about potential areas of differentiation from some of the bispecific antibodies that are going after the same target? Thank you.
Anna Berkenblit
Sure. So you may recall that when we presented it at ASH last year, we had already explored several dose levels and we saw activity across the dose levels.
We now have additional data across multiple dose levels that give us confidence in the recommended Phase 2 dose. We think they'll probably be around 20 patients worth of data where you can see not just safety but efficacy at ASH for that.
Moving to differentiation with the bispecifics, our drug is relatively short infusion that can be given as an outpatient once every three weeks assuming the patient is well enough. It did not have the risk of the cytokine release type of things that you can see with the bispecifics.
So potentially, a better safety profile. There's no head-to-head data comparing that.
But looking at our safety profile, we feel that it's quite well tolerated, again, over a range of doses, and has a convenience factor that patients could wind up appreciating very much.
Michael Schmidt
And then maybe just one follow-up. I guess, can you remind us as to what degree of Jazz involved in these sort of earlier development phases?
And is there an opportunity to combine this may be with Vyxeos?
Mark Enyedy
So we -- this is a highly collaborative relationship. So we have formal contract committees that meet on a quarterly basis.
But the team is engaged on a much more regular basis. So our lead physicians here at ImmunoGen came out of MD Anderson, and probably you know Stefan Faderl who is on their side.
So the two of them were colleagues at MD Anderson, and speak regularly. And so it's highly collaborative.
So as we move this program forward, it's in lockstep with them. ImmunoGen does control the development just from a contractual standpoint.
But again, it's a collaborative approach. And there is the potential to combine with Vyxeos and we're sorting through the specific indication where we would I think maximize the benefit of those two agents together.
But that's an active conversation.
Operator
It appears there are no further questions at this time. I'd now like to turn the call back to Mark Enyedy for any additional or closing remarks.
Mark Enyedy
Thank you. So very much appreciate everyone joining us on a summer Friday morning.
And we will look forward to seeing you all at ESMO at the end of September. Thanks.
Operator
Ladies and gentlemen, this concludes today's call. Thank you for your participation.
You may now disconnect.