Genocea Biosciences, Inc.
Q2 2021 Earnings Call Transcript

Published: 29 Jul 2021

[Operator:]

Good day. Thank you for standing by and welcome to the Second Quarter 2021 Corporate Update Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. I would now like to hand the conference over to your speaker today Dan Ferry. Thank you. Please go ahead.

[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 Investors tab.

[Chip Clark:]

Thanks Dan and thank you all for joining us today. We are pleased to provide a few brief updates. I'll start with our two clinical programs GEN-011 and GEN-009. As a reminder GEN-011 is Genocea's neoantigen-targeted peripheral T cell therapy or NPT therapy which we're testing initially in checkpoint inhibitor refractory people with solid tumors. We believe using patient T cells taken from easily accessible peripheral blood and expanding the T cells only on tumor neoantigens prioritized by our Atlas platform may give GEN-011 efficacy, accessibility, and cost advantages over other T cell therapies. In other words, we believe that GEN-011 may stand out through better T cells seeking out better targets. The TiTAN trial is a Phase 1/2a study designed to evaluate safety, tolerability, T cell persistence and proliferation and clinical efficacy in patients with a range of tumor types across two dosing cohorts

[Diantha Duvall:]

Thank you, Chip and good morning everyone. We ended the quarter with $60.4 million of cash and cash equivalents compared with $79.8 million at December 31, 2020. Our operating results for the quarter ended June 30, 2021 are as follows. Our net loss for the three months ended June 30, 2021 was $4.3 million or $0.20 per diluted share compared to $11.3 million or $0.39 per share for the same period in 2020. Our net loss for the six months ended June 30, 2021 was $16.3 million or $0.37 diluted net loss -- $0.37 per share compared to $24.2 million or $0.84 per share for the same period in 2020. R&D expenses for the three months ended June 30, 2021 were $10.5 million, compared to $8.6 million for the same period in 2020. R&D expenses for the six months ended June 30, 2021 were $19.3 million, compared to $18.6 million for the same period in 2020. The increase in R&D expenses for the three months ended June 30, 2021 is mainly due to the growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs. The increase in R&D expenses for the six months ended June 30, 2021 is mainly due to the growth in our internal research and manufacturing teams, partially offset by the timing of GEN-011 engineering and clinical manufacturing costs.

[Operator:]

And your first question comes from the line of Ben Burnett from Stifel.

[Ben Burnett:]

Fantastic. Thank you. I wanted to just ask about the GEN-011 study. I guess now the dosing is underway, do you have a sense for the number of patients that we might get at this first update? And also just in terms of enrollment, are you seeing greater demand for one cohort over the other?

[Chip Clark:]

Hey, Ben thanks. This is Chip. Thanks for the question. I'm going to say that we're not going to give you a concrete number on the number of patients for whom we'll have the initial reporting out on just because as you can imagine, it's going to be dependent on just how things continue to progress. But suffice it to say, it's not going to be sort of one patient we want there to be a robust understanding of how GEN-011 works. As to the question about the demand for one or the other I think it might be helpful for Tom Davis our Chief Medical Officer just to help give everyone a perspective on how the investigators and patients are thinking about these cohorts to maybe better help you understand the answer. So Tom?

[Tom Davis:]

Thanks Chip. Certainly, a good question. The key design of the study here does allow for a less toxic regimen which one would think could be quite attractive to patients particularly those who are not really good candidates for high-dose lymphodepletion and IL-2. And as you might imagine we've had mixed responses definitely with investigators and patients liking the idea of a less toxic regimen and exploring how well that can work, as well as others who really want the full gusto and are prepared to take that toxicity in the hope of effectiveness.

[Ben Burnett:]

Okay. Excellent. I appreciate that context. One other question for me. Just about the manufacturing process and some of the specifications that go around like releasing the product I guess by virtue of identifying these neoantigens are you able to do like potency assays where you precisely identify like activity of the relevant T cells against their neoantigen targets? And is that something that's like being implemented at this early stage?

[Chip Clark:]

Yes. It's a really important question Ben because there's I think perhaps the perception based on some evidence in the field that there may be some challenges with release assays for these types of products. But we feel confident in our current plan and as well as our activities for the future. And Jess can -- our Chief Scientific Officer can give you some additional color on that.

[Jessica Flechtner:]

Yes. Thank you, Ben. It is true that we are able to show with the drug products that we are creating that the T cells have activity against the specific neoantigen that they were educated to respond to. And I think that gives us an opportunity to really show the strength of the drug product and how our selection directs the target to the right antigen.

[Ben Burnett:]

Excellent. Okay. That’s great. Appreciate it. Thank you.

[Chip Clark:]

Thanks for the question.

[Operator:]

And your next question comes from the line of Chad Messer from Needham.

[Chad Messer:]

Great. Thanks for taking my question. Let me say, it's great to be kicking off my earnings season with you guys yet again like so much ahead of the curve on your financial reporting. Just for the GEN-011 study one of the efficacy readouts will be T cell persistence and expansion. Just wondering if you could maybe set the stage on what we should look for in that data? Is there anything from other sort of TCR studies that might benchmark that against to see or get some sense whether the ATLAS neoantigen selection is basically doing the chop that we hope it's doing?

[Chip Clark:]

So Chad we're honored to be kicking off your earnings season in this late July time frame. I'm going to ask Jess to take over and answer the question about T cell persistence and put what we may be showing into some context. Jess?

[Jessica Flechtner:]

Yes. Thank you, Chad. I think you asked specifically about TCRs the way that they do tracking we would not be able to do since they are tracking for example a single clone in the body. But the benefit that we have and something that we will ultimately be on, is we already know the identity of the antigens against, which the T cells should respond. And so we can track those specific T cells by looking at ex vivo assays out of the body to look for continued responses against the antigens against which the T cells were educated. And so that among other assays that we're running should give us a very good picture of both how the cells engraft and how long they persist. But of course, what we are really looking forward to seeing is shrinkage of tumors and hopefully infiltration.

[Chad Messer:]

Okay. That's super helpful. Anything you can share about how much of that kinds of data we should expect with this initial release? Is that the kind of thing that comes early, or is that something that takes longer to analyze and report?

[Chip Clark:]

Jess?

[Jessica Flechtner:]

It -- the studies that we are doing are longitudinal. So, we look early but then we also have to look for how long we detect the cells in the circulation. And so I can't guide you to the number of time points that will be available at the time that we report data but we are looking over time in each of the subjects that we treat.

[Chad Messer:]

All right. Fair enough. Thank you

[Operator:]

And your next question comes from the line of Colleen Kusy from Baird.

[Colleen Kusy:]

Hi, good morning. Thanks for taking my question. Congrats on the progress. A clarifying question maybe for the endpoints that we'll be getting with the initial update of T cell persistence and expansion, will you be looking at that in the peripheral blood and in the tumor? And does the study include a pre- and post-treatment biopsy, or how else would you evaluate what's going on in the tumor?

[Chip Clark:]

I'll send that back to Jess. Thanks, Colleen for the question.

[Jessica Flechtner:]

Yes. So we -- thank you for the question. We do hope to look both in the peripheral blood and in the tumor. We do have in the schedule of the ability to have a pre- and post-treatment biopsy. I think as we learned in GEN-009 COVID may impact the ability to get biopsies depending on how the course of this pandemic goes but that is part of the plan.

[Colleen Kusy:]

Great. Thank you. And for the PLANET manufacturing when you're expanding the T cells are you aiming for a certain mix of CD8 and CD4 cells? And I guess, would you expect that mix to be fairly consistent patient to patient, or would you expect some variability?

[Chip Clark:]

Everything is coming up Jess in these questions. Jess, over to you.

[Jessica Flechtner:]

Colleen, that's a really great question. We are purposely targeting both CD4 and CD8 antigens in our product and it will vary. It won't vary because of our manufacturing process, it will vary based on the antigens and the specificities that we find in each subject. So subject one might have a dominance of CD8 antigens and therefore the product will be skewed a little bit more towards CD8 responses. And subject two may have more CD4 neoantigens and therefore the product would be steered towards CD4 more. I think what's most important for us and what we have shown in our development and engineering runs is that nearly every cell in the product is tumor specific we don't have bystanders and that we retain T cells that are specific for the breadth of neoantigens that we intended to grow them against. And we believe that breadth is a very important aspect to the product that we're developing.

[Colleen Kusy:]

Great. And then is there anything we should be looking out for the upcoming presentation you have for the PLANET process, or will that be kind of we've seen before?

[Chip Clark:]

I guess, I should say stay tuned. The idea is likely that is that we will provide maybe a little bit more color on the process and perhaps give some real-world data on how the process has worked for us.

[Colleen Kusy:]

Great. Thanks for taking my question.

[Chip Clark:]

Thank you.

[Operator:]

At this time there are no further questions. I would now like to turn the call back over to Chip Clark.

[Chip Clark:]

Thank you very much, operator and thanks again everyone for joining us today. We look forward to providing an update in the near future.

[Operator:]

This does conclude today's conference call. Thank you for your participation. You may now disconnect.