Genocea Biosciences, Inc.
Q1 2021 Earnings Call Transcript

Published: 29 Apr 2021

[Operator:]

Good day and thank you for standing by. Welcome to the First Quarter 2021 Financial Results Conference 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. 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 updates on several important efforts. I will start with our two clinical programs GEN-009 and GEN-011. As a reminder, GEN-011 is Genocea’s Neoantigen Targeted Peripheral T-Cell therapy, or NPT therapy, which we are testing initially in checkpoints inhibitor refractory people with solid tumors. We believe using patient’s T-Cells, taken from easily accessible peripheral blood and expanding the T-Cells only on tumor neoantigens prioritized by our proprietary antigen discovery platform ATLAS may give GEN-011, efficacy, accessibility and cost advantages over other T-Cell therapies. In other words, better T-Cells and better targets may hold the key to success. We are currently conducting the TITAN study, a Phase 1/2a study designed to evaluate safety, biomarkers of activity and antitumor efficacy in patients with a range of tumor types across two dosing cohorts, one with a single GEN-011 dose, and the other with GEN-011 administered as multiple low doses. We continue to add clinical sites and accrue patients into the trial. We will provide updates throughout the year and expect to report initial efficacy from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.

[Diantha Duvall:]

Thank you, Jess, and good morning, everyone. We ended the quarter with 56 million of cash and cash equivalents compared with 79.8 million at December 31 2020. Our operating results for the quarter ended March 31 2021 are as follows. R&D expenses were 8.8 million, compared to 10 million for the same period in 2020. G&A expenses were 3.7 million compared to 3.4 million for the same period in 2020. Other income was 0.4 million compared to 0.5 million for the same period is 2020. And our net loss was 12 million compared to 13 million for the same period in 2020.

[Operator:]

You have a question from the line of Ben Burnet with Stifel.

[Benjamin Burnett:]

Hey good morning. Thank you for taking our questions. I wanted to ask you provided some interesting data AACR recently kind of expounding on some of the data around inhibiting showing that is inhibiting - the inclusion of inhabitant diminished and otherwise effective vaccine and an animal model. I wanted to ask based on your work, is it known if that inhibitory effect if it is a rather binary or do you see a range of sort of inhibition like depending on the specific Inhibigen included?

[Chip Clark:]

Yes, Ben, thanks for the question. I will ask Jess to handle that.

[Jessica Flechtner:]

Good morning, Ben. It is a great question. We reported, I believe, a year ago, it is not the last one, but the one before that there is indeed a spectrum of impacts that the Inhibigens can have from being completely dominant, as we have shown repeatedly with the most recent data at AACR, but also to be sub dominant and have an impact, but it isn’t completely reversing the phenotype. And I think it depends both on the antigen itself and on the disease that we are studying.

[Benjamin Burnett:]

Okay, interesting. I guess, is it surprising that adding a checkpoint inhibitor I guess, by , didn’t seem to have much of an impact, I guess is that consistent with this notion that there is just a defect and in accessing the tumor microenvironment?

[Jess Flechtner:]

We too thought that the addition of a checkpoint inhibitor could help and maybe recover some of the deleterious effects of the presence of the Inhibigen on the response. So we were surprised. I think it helps us understand or maybe it points us to different directions on the mechanism for these particular responses. But I think it also helps us really solidify the case that we currently need to avoid these in our therapies, because we still don’t know how to overcome them.

[Benjamin Burnett:]

Okay, totally agree and I appreciate the answer to these nuance questions. So, thank you.

[Chip Clark:]

Thank you, Ben.

[Operator:]

You have a question from the line of Chad Messer with Needham.

[Chad Messer:]

Great. Good morning and thanks Chip, Jess, good to catch up. I’m obviously very excited for the one/one, a data set. Just wondering IO bands recently ran into some issues with the FDA on unison sort of CMC stuff and release criteria. I know yours are different, your peripheral blood, just wondering whether there is anything to be learned there that you are paying attention to and any reason to believe you know would or would not have any kind of similar issues?

[Chip Clark:]

Chad it is important question. And it is one that we have some confidence that we have addressed based on the fact that release was part of our IND package, but I will ask Jess to be more specific about the reasons why we think we - at least today have reasonably we should not face this issue in the same way.

[Jessica Flechtner:]

Yes, good morning Chad. As Chip said, we have written our plans for our release test and our potency test into our IND and we are in or have had conversations with the agency in order to make sure we are doing the right thing. I can assure you that what is good about the GEN-011 product itself, is that it is very well characterized. We understand the specificity in the product and we understand that the T-Cells are poised to do their job appropriately. And this is a little bit different than some of the standard therapies where the specificity is a little bit indeterminant because of the non-specific expansion of cells from the tumors and the presence of non-tumor specific bystander cells. So, I think by virtue of our product being well characterized from the beginning, and some of the tests that we have put in place we are poised to perhaps have less issues. I don’t want to say no issues in terms of release and potency.

[Chad Messer:]

Alright, great. Yes thank you for that. Maybe just a probing one on the COVID work that you are doing. You are looking for conserved or common antigens obviously; we are all paying a lot of attention to variants with Covid right now, a big, big question for the future. Just wondering how many - what is your access to the sort of current bearings that are out there? How much are you able to look at this now? And how do you feel you will be able to sort of keep up with it overtime? What is the w availability? How good of a job do you think you are going to be able to do there based on information you guys can get access to?

[Chip Clark:]

Yes, it is certainly partly an access issue. But it is also a case that a lot of information is available about the variants, but I will have Jess to give you more color on sort of why we think focusing on antigens to T-Cell response should be important here.

[Jessica Flechtner:]

Right, the variants are emerging fast and furiously, as you know and it is true that antibodies can drive these types of mutations, because they are all essentially targeting the same protein - and the same region and the same protein. We have published in the past that T-Cell antigen, or the targets of T-Cells don’t tend to mutate in the same way, because of diversity, different people have different responses to different pieces of the same protein.

[Chad Messer:]

Alright, great, nice, very impressive. All the work that is being done on COVID and glad to see you guys taking and adding your cutting edge antigen based science to all that. Thank you.

[Chip Clark:]

Thank you Chad.

[Operator:]

You have a question from the line of Colleen Kusy with Baird.

[Colleen Kusy:]

Hi good morning. Thanks so much for taking our questions. I guess one of GEN-011 ahead of the efficacy 4Q or 1Q 2022, what sort of updates do expect to provide throughout the year in terms of clinical progress?

[Chip Clark:]

Thanks Colleen. I think there are a couple of different types of updates that we will be providing. One certainly is just progress on enrollment and dosing. Another could be progress on manufacturing successes. And so, I think giving people the confidence that we are successfully proceeding toward clinical data, since process is very much the product here, I think is going to be important.

[Colleen Kusy:]

Great, that is really helpful, thank you. And if I can ask a couple of on Inhibigens. Just curious if you have any longitudinal data on Inhibigens I guess, is there any data that would suggest that targets evolved over time to become more or less inhibitory?

[Chip Clark:]

That is interesting and definitely for Jess.

[Jessica Flechtner:]

So I think, in our human studies, we are tracking what happens if we have Inhibigens prior to treating patients? What happens after we treat them to those same Inhibigenic profile? And so that is something that we will continue to follow as we continue to develop our programs clinically.

[Colleen Kusy:]

Great. Thank you. And I guess another one on Inhibigen. Is there any difference that you have seen in the amount of Inhibigens or percentage Inhibigens that you find in the peripheral blood versus when you look in the tumor specifically?

[Jessica Flechtner:]

That is also a good question. We haven’t been able to do that kind of work yet. We are looking in the mouse model to be able to answer that question, but I don’t have the information.

[Colleen Kusy:]

Okay. Thanks for taking my question.

[Chip Clark:]

Thanks Colleen.

[Operator:]

There are no additional questions in queue at this time.

[Chip Clark:]

With that, then I will thank everybody for their attention to this call and look forward to providing you with updates throughout the year. Thank you very much.

[Operator:]

Ladies and gentlemen, this does conclude today’s conference. You may now disconnect.