Genocea Biosciences, Inc.
Q2 2019 Earnings Call Transcript

Published: 25 Jul 2019

[Operator:]

Good morning, ladies and gentlemen, and welcome to the Genocea Biosciences Second Quarter 2019 Financial Results. [Operator Instructions].And without further delay, I would like to hand over the program to Mr. Dan Ferry. Sir, you may begin.

[Daniel Ferry:]

Thank you, operator, and good morning, everyone. Earlier today, we issued a press release that outlines the topics we plan to discuss today. This release is available at genocea.com, under the Investors tab. During the call today, Chip Clark, President and CEO, will provide a brief corporate update. And the company's Chief Financial Officer, Diantha Duvall, will review the financial results. After the prepared remarks, we'll open up the call for Q&A., and Chip; Diantha; Tom Davis; Genocea's Chief Medical Officer; and Jess Flechtner, Genocea's Chief Scientific Officer, will then be available to answer your questions.Before we begin, I would like to remind everyone that statements made during this conference call relating to Genocea's expected future performance, future business prospects or future events or plans may include forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. Actual outcomes and results could differ materially from those forecasts due to the impact of many factors beyond the control of Genocea. Genocea expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events or otherwise. Participants are directed to the Risk Factors set forth in Genocea's 2018 annual report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission.It is now my pleasure to pass the call over to Chip.

[William Clark:]

Thanks, Dan. And thank you all for joining us today. The second quarter was huge for Genocea, highlighted by our ASCO Data Presentation in June, where we were selected as one of the top 10 immuno-oncology abstracts by ASCO's Journal of Clinical Oncology. Just as critically, we've seen in shift in perception since then in two ways

[Diantha Duvall:]

Thanks, Chip, and good morning, everyone. Our operating results for the quarter ended June 30, 2019, are as follows. R&D expenses were $6.8 million compared to $5.3 million for the same period in 2018. G&A expenses were $3.2 million compared to $4.5 million for the same period in 2018. And our net loss was $6.5 million compared to a net loss of $4.4 million for the quarter ended June 30, 2018.During the quarter, we also raised more than $42 million in gross proceeds from a public equity financing. We ended the second quarter with $58.7 million in cash and cash equivalents, extending our cash runway into 2021.With that, let's now open up the call for questions. Operator?

[Operator:]

[Operator Instructions]. And our first question is from Ben Burnett from Stifel.

[Benjamin Burnett:]

I have just two questions. First question, I guess in the Phase I update later this year at ESMO regarding Cohort A, how many patients do you expect to be included in that update? And I guess can we expect the same type of immunogenicity data that we saw at ASCO?

[William Clark:]

Yes. Ben, this is Chip. I'm going to have Tom, our Chief Medical Officer, answer that question.

[Thomas Davis:]

Ben, as you know, we were able to present the immunogenicity data on five patients at ASCO. And since then, we've had an additional three patients who'll be giving us data, which will be available in time for the ESMO presentation. So, you can look for fairly complete data on eight patients.

[Benjamin Burnett:]

Okay. Okay. Great. I also had a question about the Part B readout expected next year. I guess, is that still expected mid-next year? Apologize if I missed that. And I was also wondering, if you could just speak to kind of the design of the study? I guess, specifically, when we do get data, how well the design of the study enables us to differentiate efficacy from the vaccine versus background therapy, such as checkpoint inhibitors?

[William Clark:]

Yes. Ben, I'll reiterate our guidance that we expect data in the middle of next year. When exactly will, of course, depend upon both the pace with which we enroll patients and the speed with which we manufacture the vaccine, and we'll provide ongoing updates as we progress? I will have Tom answer the question of the Part B readout and, specifically, how we would intend to differentiate between the vaccine effect and checkpoint inhibitor effect. Tom?

[Thomas Davis:]

So obviously, that's one of the challenges in the field and the question, the issue comes up constantly as you can imagine. But I think what we're seeing with data so far is that there's not a clear signal of activity, which makes it difficult to separate from the innate activity of the checkpoint inhibitor regimens. So, people should recognize that if there is a clear treatment effect, you'll be able to see it in the data. But what's most important is to clearly define what has happened before a vaccine is given and what happens after, and determine whether that changes. When you look at it as a group phenomenon, you have to look at the statistics, the totality of responses, and it requires comparison to really tell if there's a benefit. But if instead you look at individual patients and carefully assess their prognostic factors, what happens to them in the months before they received the vaccine and then what changes thereafter, you can better identify if there is a treatment effect for each individual and then, of course, add them cumulative to see what the overall effect is. So, our focus rather than typically looking at overall response rates, perhaps, identifying which were due to the checkpoint inhibitor and which were not, we'll be focused on individuals and attempting to identify which specific ones appear to have both immunologic and clinical shrinkage that happens in parallel.

[Operator:]

And the next question is from Chad Messer from Needham & Company.

[Gil Blum:]

This is Gil, on for Chad. And congrats on the progress. Just a bit of a follow-on, on Ben's question here. So, at ESMO we'll get more immunogenicity data. Are we going to see at some point some progression-related data?

[William Clark:]

Gil, just to clarify you're asking if we're going to have progression data from those Part A patients, I assume?

[Gil Blum:]

Yes. Not that, that helped clearly, but in...

[William Clark:]

Right. No, sure. I got it. Thanks, Gil. I'll have Tom answer that question.

[Thomas Davis:]

Sure. At the presentation, we'll be able to update on the status of the patients at the time we give the presentation. I would remind everybody that these patients are in remission after having had adjuvant therapy for their disease. So, it's very hard to predict who will progress, who won't and how rapidly that will happen. But certainly, as a strong trend for patients to not relapse will be very interested in those outcomes.

[Gil Blum:]

Excellent. And another question is, these are pretty impressive immunogenicity results for the kind of adjuvant that you guys have been using. Any thoughts on using other adjuvants or other delivery systems for your vaccine?

[William Clark:]

Yes. Thanks, Gil. I'll handle that. As I think most people on the call understand we have, in addition to GEN-009, the current vaccine in development as well as GEN-011, our neoantigen cell therapy, for which we intend to file an IND in the first half of next year, we also have our GEN-010 program in which we are exploring alternate delivery and/or adjuvant program technologies. We obviously have not yet disclosed the specifics therein. I think the thinking behind this is that we want to have a second program to build on any particular opportunities for improvement that may arise from the GEN-009 program. I think, generally speaking, what we want from a cancer vaccine is to have broad and strong immune responses that lead to strong clinical benefit. We want to be able to deliver the vaccine as quickly and as cheaply as possible in addition to that. Thus far, we're really quite pleased with the performance of GEN-009 using, as you've said, synthetic long peptides plus poly ICLC. We think the breadth; the nature and the magnitude of the response has been quite compelling. And so, I think it's going to take the clinical readout from the ongoing clinical study to determine the degree to which we would want to emphasize of our investment on GEN-010. So, we're very excited about GEN-009, we're very excited about GEN-011, and GEN-010 is potentially waiting in the wings as needed.

[Operator:]

The next question is from Mike Ulz from Baird.

[Michael Ulz:]

Congrats as well on starting Part B. So maybe just a quick follow-up on Part B here. Just in terms of the protocol, are you guys restricting the use of the checkpoint inhibitor to say, for example, KEYTRUDA, or is it more flexible?

[William Clark:]

Yes. Thanks, Mike, for the question. Tom?

[Thomas Davis:]

Yes. Our goal is really to see what the vaccine can add to standard-of-care, which, of course, gives you the easiest path forward and the best data that you can identify to compare to for the readout. So, the trial was designed to incorporate five different tumor types, and those patients will have access to the current standard-of-care PD-1-based regimens that would be appropriate in their particular situation. And then we will be able to add the vaccine at an appropriate time in the disease course. In some ways, we should be able to leapfrog to what others have done in the states rather than simply combining simply with PD-1 to see what happens. We're basically now building on what is standard-of-care somewhat similar to trials that others are progressing to. Results of these, of course, will need to take into account the differences between the standard-of-care regimens. But we think with the continuum of data that come from these patients, we'll be able to tease out what the benefits are and identify clinical benefits when they come through.

[Michael Ulz:]

Got you. And maybe if you can just comment on the -- you've mentioned in multiple cohorts; can you give us a sense of a patient numbers you're targeting there?

[William Clark:]

Thanks, Mike. Tom?

[Thomas Davis:]

Yes. The trial is designed to have five cohorts, which include lung cancer, head and neck, melanoma, urothelial and renal carcinomas. Those groups are designed to identify initial signals taking up to 15 patients each. And there will be a separate group of patients who have proven themselves refractory to checkpoint inhibitors who will similarly receive vaccination in order to determine what the impacts can be in those patients.

[Operator:]

[Operator Instructions]. I am showing no further question at this time. I would like to turn the conference back to Mr. Chip Clark.

[William Clark:]

Thank you, Operator. And thanks, again, everyone, for joining us today.

[Operator:]

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.