Genocea Biosciences, Inc.
Q1 2019 Earnings Call Transcript

Published: 1 May 2019

[Operator:]

Good day, ladies and gentlemen. Thank you for standing by and welcome to the Genocea First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference may be recorded. At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. You may begin.

[Dan 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 Investor's 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 will open up the call for Q&A; and Chip, Diantha and Tom Davis, Genocea's Chief Medical 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 forecast due to the impact of many factors beyond the control of Genocea. Genocea expressly disclaims any duty to provide updates to it's 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.

[Chip Clark:]

Thanks, Dan, and good morning, everyone. Thanks for joining us today. We continue to advance our vaccine and cell therapy programs highlighted by GEN-009, our Neoantigen Vaccine Candidate and GEN-011, our Neoantigen Adoptive Cell Therapy Candidate. As we say here at Genocea, targets matter and we continue to believe that target or antigen selection plays a large and under-appreciated role in driving immunotherapy efficacy. The body of work we have amassed over the past 18 months demonstrates two things

[Diantha Duvall:]

Thanks, Chip, and good morning, everyone. It's really a pleasure to be here and be part of the Genocea team. Our operating results for the first quarter ended March 31, 2019 are as follows

[Operator:]

Thank you. [Operator Instructions] Our first question is coming from the line of Chad Messer with Needham. Your line is open.

[Chad Messer:]

Good morning, and thanks for taking my question. Obviously, very anxiously awaiting the date at ASCO but wanted to check-in on the timelines for the next part of that study, the checkpoint inhibitor combination; when is that getting underway and any idea when that data might be available?

[Chip Clark:]

Yes, Chad, thanks for the question, and let's obviously assume that we're reporting positive data at ASCO. In such a case, we would proceed into the rest of the trial and I'll have Tom, our Chief Medical Officer, feel the questions specifically.

[Tom Davis:]

Sure. By current plans, we of course are eager to start Part B of the study as quickly as we can. We're currently predicting that we'll start to roll in the middle of this year and should have preliminary data available in the middle of next year. It's a fairly large effort on our part, and I think the team is doing a great job and we should be able to meet those timelines.

[Operator:]

And our next question is coming from the line of Gil Blum from Needham. Your line is open.

[Gil Blum:]

Thanks for taking my question. So, this is a little bit about the data coming out of AACR. Is using Atlas as a diagnostic tool commercially feasible in any way? Thanks.

[Chip Clark:]

Gil, thanks for your question. I would first say that the data that we presented at AACR is of a different nature than the data we'll be reporting at ASCO. ASCO is about Atlas, potentially identifying the right neoantigens, and also potentially excluding the wrong, the inhibitory neoantigens from a vaccine in order to make a vaccine that is more immunogenic. I think the question that we raised and the data that we presented at AACR also in a complementary way suggests that understanding this ratio of stimulatory to inhibitory antigens could play a diagnostic role but it would take more investment in order to convert this into an actual sort of in-practice diagnostic. Is that your question, Gil?

[Gil Blum:]

Yes. My question was more about whether this is an interesting avenue to pursue further.

[Chip Clark:]

I'm going to have Tom feel that.

[Tom Davis:]

Well, I'm sure you're aware, many people have been trying to find a way to predict responses in patients which is very useful from a clinical perspective. But more importantly, it can tell us why patients are responding and give us a whole new realm of possibilities for future therapeutics. So from my perspective, I think Atlas is critically important in understanding antigens and how to select them. And along the way we'll be learning a great deal about potential correlative markers that could both, predict response and could be much easier to use as a diagnostic. So, I think the potential here is huge and we will be learning much more within this next stage of the study. That said, we're obviously looking for a therapeutic for these patients and we'll use Atlas to focus there, for the most part.

[Chip Clark:]

I think what's intriguing about your question, Gil, is that it in a way acknowledges the difference between our platform and that of everybody else as a real biological answer that we are coming up with by profiling the immune responses patients make to their own tumor, that's fundamentally different than some prediction-based approach. And so there is, as you're rightly speculating, a wide-range of applications for our platform.

[Operator:]

Our next question coming from the line of Mike Ulz with Baird. Your line is open.

[Mike Ulz:]

Great, thanks and good morning. Just a quick question for me, and -- with the data coming up at the ASCO meeting, just curious if you can comment what type of data we should expect in the abstract? Our understanding is it was probably submitted earlier this year, so we may not have a much data in abstract but we just wanted to get your thoughts there.

[Chip Clark:]

Yes. The abstract as you have rightly characterized is not likely to have -- it will not have post-vaccination data. Tom can speak to what we put in there.

[Tom Davis:]

So it's something insightful, you're aware that there is a delay between when patients are put on a study and when we initiate the vaccination; and due to that we did not have any immunogenicity data at the time the abstract was submitted. And you can assume that that may well reflect on the positioning of the abstract at ASCO. However, we do intend to have preliminary immuno-response data on patients from the trial at the presentation at the poster [ph]. And just for the record, those of you who don't know, the poster is going to be hanged at 8

[Mike Ulz:]

And just as a quick follow-up at the presentation at ASCO; should we assume that you'll have immunogenicity data across all nine patients or there will be a subset?

[Tom Davis:]

It will be subset. We won't have complete data here but there are other opportunities to present a more complete data set further on the year; so we are planning to make the data available as soon as possible.

[Operator:]

Our next question is coming from the line of Joe Pantginis with H.C. Wainwright. Your line is open.

[Joseph Pantginis:]

Good morning, everyone, thanks for taking the question. While all the focus is currently on the GEN-009 immunogenicity data and you certainly touched upon this; can you share some additional details even if it's just broad strokes about the work going on in the background, on the science front even, to further leverage your ability to identify these inhibitory antigens and show differentiation versus other technologies? And of course and related to that, can you potentially apply these inhibitory antigens therapeutically in the future? Thanks.

[Chip Clark:]

Thanks, Joe. I will hand this question over to Jessica Flechtner, our CSO.

[Jessica Flechtner:]

I think the question -- we are really carefully examining what the mechanism of these inhibitory antigens are. As we have reported previously, we had developed a mass model where we have shown that they are tumor-promoting and we continue to work to develop the mechanism in our research laboratory. Whether or not these can be deployed as a therapeutic would require more time and study, so I really can't comment on that now. But what we know is that they are existing in both, humans and mice; that by driving cells that are responsive to these inhibitory antigens, the mice at least get worse, and in our human subjects we find that proportion of inhibitory to stimulatory peptide seems to predict outcome after checkpoint blockade.

[Operator:]

[Operator Instructions] And at this time, I'm showing no further questions. I would like to turn the call back over to Chip Clark for closing remarks.

[Chip Clark:]

Thank you, Olivia [ph]. We expect the next few months will be very exciting here at Genocea, and we remain optimistic that our efforts over the past year and a half, especially, will have positioned us to bring potentially life-saving therapies to patients. We look forward to updating you further in the coming weeks. And thanks again for joining us today.

[Operator:]

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program and you may now disconnect. Good day.