Q3 2021 Genocea Biosciences Inc Earnings Call

Okay.

Good morning, and welcome to the Genocea third quarter 2021 conference call. At this time all participants are in listen only mode. Following the formal remarks, we'll open the call up for your questions. Please be advised that todays call is being recorded by the company's request.

At this time I would like to turn the call over to Mr. Dan Ferry of Life's Advisors. Please go ahead Sir.

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 <unk> dot 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, <unk> Chief Medical Officer.

And Jessica Flak, there she gnosis 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 <unk> 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 1095.

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 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 <unk> 2020 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.

Thanks, Dan and thank you all for joining us today.

I am pleased to share Genocea this progress with you today.

Notably we are excited about our Titan clinical trial for Gen 11, our lead clinical program.

As a reminder, gen 11 is generally shows.

Antigen targeted peripheral blood T cell therapy or M. P T 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 their C D E and CD four T cells preferentially for the patients tumor neo antigens prioritized by our proprietary Atlas platform.

They give jen 11 efficacy accessibility and cost advantages over other adoptive T cell therapies.

In other words, we believe that better T cells to better targets may hold the key to success.

I will also remind you that the tightened trial as a phase <unk> study designed to evaluate the <unk>.

Safety and Tolerability.

Cell persistence proliferation, and clinical efficacy of Gen 11th as mono therapy.

Patients receive either Gen 11, as a single dose preceded by a conventional T cell therapy limbo depletion regimen and followed by daily high dose IL two.

Or Gen 11 split into multiple doses with no lymphoid depletion and followed by intermediate IL two doses.

We continue to make substantive progress with five clinical sites now active and three more to come online imminently.

And with our proprietary planet process reliably yielding drug product.

Based on this progress we now expect to have initial data from a small subset of patients in the first or early second quarter next year.

We're also pleased that we have multiple poster presentations at next months since the 2021 annual meeting.

These presentations will continue to showcase the neo antigen selection capabilities of our Atlas platform.

Through differentiated long term immunogenicity and clinical response data for Gen nine.

Our adjuvant it peptide neo antigen vaccine candidate.

And through additional research with inhibitors and their potential application to novel autoimmune disease treatments.

I am also pleased to welcome Jennifer Herron, Senior Vice President and Chief Commercial Officer at 80 C Therapeutics to our board of directors.

Her extensive oncology experiences nicely complement those of our other board members.

I'll close my part of this brief update by saying that I am so proud of the Genocea team for the agility and tenacity. They demonstrate as we continue these research and clinical development.

Efforts.

I'm now going to pass the call over to Diantha to summarize our financials from this quarter before opening the call up to questions.

Panther.

Thank you chip and good morning, everyone. We ended the quarter with $48 9 million of cash and cash equivalents compared with $79 8 million at December 31, 2020.

Our operating results for the quarter ended September 32021 are as follows.

Our net loss for the three months ended September 32021 was $3 6 million.

Compared to $4 6 million for the same period in 2020.

Our net loss for the nine months ended September 32021 was 19.

<unk> 9 million compared to $28 7 million for the same period in 2020.

R&D expenses for the three months ended September 30 of 2021.

$9 5 million compared to $7 5 million for the same period in 2020.

R&D expenses for the nine months ended.

For the nine months ended September 32021 were $28 7 million compared to $26 1 million for the same period in 2020.

The increase in R&D expenses for both periods is primarily due to growth in our internal research and manufacturing teams.

And our general Evan manufacturing and clinical costs.

G&A expenses for the quarter ended September 32021 were $3 9 million compared to $3 6 million for the same period in 2020.

G&A expenses for the nine months ended September 32021 were $11 6 million compared to $10 5 million for the same period in 2020.

The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.

Other income for the quarter ended September 32021 was $8 1 million compared to $6 2 million for the same period in 2020.

Other income for the nine months ended September 32021 was $18 8 million compared to about $6 5 million for the same period in 2020.

The increase in our other income for both periods is mainly due to the noncash impact of the fair value adjustment for the $33 6 million liability classified warrants issued in connection with our July 2020 private placement.

Our current operating plan extends our cash runway into the third quarter of 2022.

With that let's now open the call.

Let's now open the call up for questions operator.

Thank you very much.

Your first question is from Ben Burnett from Stifel. Your line is open.

Alright, Thank you very much for taking my questions.

I guess I was wondering if you could just maybe provide a little bit more color as to what's behind the shift in timing for general oven.

Hey, Ben it's chip thanks for the question.

It's a very marginal shift and I'm actually proud of how small it is given that we set this guidance.

Really at the beginning of the trial when we were operating with a.

Our novel.

Reduction plan in the novel drug more broadly so there's nothing I think substantive to read into this shift of about one month in the window.

Okay understood.

I guess, maybe if I could ask one other question just curious if you could offer more color on what we'll get at could see just in terms of additional gen nine data.

Yeah, No Ben what Tom why don't you and then just speak to the clinical and biomarker.

Biomarker data that we'll have here.

Sure. Thanks Chip and thanks for the question Dan.

We're excited to go into city with a good amount of data of course, you get nine program. We started several years ago and the data has already matured to a certain degree but to key questions. In that program were first where are we able to generate immune responses and where are they going to be durable.

Additionally, how long will any clinical effect seen last and I think those are the two key elements from the clinical perspective for that program and we will be able to update that at 50.

If we're seeing persistent immune responses and prolonged disease control will be very pleased.

And this is jessica but the additional immunology that we will provide in the posters include immuno phenotyping data, where we can give.

Give a little bit more color on the types of T cells that we are generating and some monitoring of biomarkers like cell free DNA.

And as we said in the script and I think we're really pleased with the degree to which these data will continue to differentiate them.

Okay Super interesting, we're looking forward to it thank you.

Thank you.

Okay participants if you need to ask a question press Star then the number one on your telephone keypad Thats star one to ask Chris.

Your next question for.

Dan Your line is open.

Hello, and good morning, everyone and thanks for the update.

Just a question on the pilot study should we have any expectation of a biopsy data.

Some points or is that not part of the protocol and I'm gonna have a follow up.

Joe just to clarify I assume you mean this is chip obviously.

You mean post dosing biopsies, presumably to measure for example, T cell infiltration into the tumor.

Exactly okay.

Okay, Yeah, Tom why don't you handle that question. Please.

Sure of course.

Endpoint is is a key one in til therapies, and we are certainly going to be looking for tumor.

Duplication of the tumor by our tightened cells.

Protocol does require a biopsy post infusions as you probably know we can't guarantee that patients will be able to have biopsies done.

But certainly we are capturing that data along with a lot of the other data around the activity themselves.

Alright.

And maybe a different question are there any business development opportunity with the Atlas platform potentially inhibit chances are you guys pursuing them.

That pathway as well.

Yes, Gil it's an important question and the answer is yes, we continue to demonstrate that.

We are finding both the right antigens for inclusion in therapies as well as these inhibits <unk>.

In the context of cancer appear to be pro tumor and therefore are certainly things you would not want T cells to be preferentially reacting too in the context of our oncology treatment. So we are pursuing business development opportunities in this area and hope to be able to demonstrate.

Great progress on this.

Excellent. Thank you for taking our questions and I will be staying in tune with it.

Great. Thank you.

Again, that's a reminder to ask a question press Star then the number one and your telephone keypad.

We have a question from calling Coffey from Baird. Your line is open.

Hi, good morning, Thanks for taking my question.

Or that the initial tightened upbeat.

Hi.

Are you able to comment on how many patients you expect to have any initial update.

But the follow up would it be.

Yeah.

Thank you for the question, calling we're not going to provide specific numbers here, but obviously the goal is to make sure that our initial update provides excuse me.

As much as it is realistically possible a true sense of the activity that Gen 11 may be able to afford these very very sick patients and so I think we may be able to provide a little bit more guidance, specifically on that as we get into the window.

That makes sense. Thank you.

Got it.

I know you said, you're enrolling a broad range of solid tumors are there any indicators and the initial readout what sort of tumor types will be included if there's any that are enrolling faster.

Hum.

Tom why don't you handle Collyns question. Please.

Sure, calling as you pointed out it is a basket study.

But we have selected sites with particular strength in certain tumor types.

And as this is coming into this space. We're focused on those that have been known to be responsive to checkpoint inhibitors the tumor categories.

The patients are refractory.

Right now, we're not pointing to a specific indication that we would prioritize down the line, but the study does allow for expansion cohorts, where we will be focusing in specific histology.

Great. Thank you and then one last one.

On the data that you'll have it fits the on some of the potential pathogens and autoimmune diseases. Just wondering if you had any comments you can share on that now and thoughts on.

On development not any dizziness.

Yeah, Yeah, it's really interesting Jess why don't you take that question. Please.

Yes. Thank you for the question, we as you know since we showed that inhibiting or deleterious in cancer. We wondered if they could also be beneficial in cases of autoimmunity, where you would want to drive that kind of immune response and so the.

Data that we will be presenting at Citi is very early but it shows April perhaps that these inhibitors may play in dampening auto immunity and so we're really excited about these very early data.

Great. Thanks, so much for taking my question.

Thank you Colin.

There are no further question at this time I would now like to turn the conference back to Mr. <unk>.

Thank you operator, and thanks again, everyone for joining us today.

This concludes today's conference call. Thank you for all participating you may now disconnect.

[music].

Yeah.

Yes.

Yes.

Sure.

Yeah.

[music].

Yes.

[music].

Yeah.

[music].

Yes.

Yes.

Okay.

Yeah.

[music].

Yeah.

Okay.

Yes.

[music].

Hum.

[music].

Okay.

Yes.

Yes.

Okay.

Okay.

Yes.

Okay.

Yes.

Yes.

Okay.

[music].

Yes.

Okay.

Yes.

[music].

Yes.

[music].

Sure.

Yes.

Yes.

[music].

[music].

[music].

[music].