Q4 2021 Genocea Biosciences Inc Earnings Call

Okay.

Okay.

Good morning, and welcome to the Genocea fourth quarter 2021 conference call. At this time all participants are in a listen only mode. Following the formal remarks, we will open the call for your questions.

Please be advised that this call is being recorded at the company's request.

At this time I'd like to turn the call over to Daniel theory of lifestyle Advisors. Please proceed.

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 you know should I 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, Dan Duvall will review the financial results.

After the prepared remarks, we will open up the call for Q&A.

And chip Diantha Tom.

Tom Davis.

She knows she was chief Medical Officer, Jessica Faulkner, She knows as Chief Scientific Officer.

Ray Stapleton Chief Technology Officer will then be available to answer your questions.

Before we begin this presentation contains forward looking statements as defined under the private Securities Litigation Reform Act of 1995.

Including statements related to channel 11, and the anticipated timing of topline results from its phase one two clinical trial.

The planet manufacturing process and.

And research efforts, including with regard to Atlas and inhibit chance.

All such forward looking statements are intended to be subject to the safe Harbor protection provided by the Reform Act. Each forward looking statement is subject to risks and uncertainties and actual outcomes and results could differ materially from those projected in such statements.

The forward looking statements in this presentation speak only as of the original date of this presentation.

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> 'twenty 'twenty annual report on Form 10-K , and other periodic reports filed with the Securities and Exchange Commission.

And available on <unk> website.

It is now my pleasure to pass the call over to chip.

Okay.

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

I'm pleased to share geneticists progress with you.

Most notably we recently revealed that will soon share initial results from our Titan clinical trial for <unk> 11.

Which is our neo antigen targeted peripheral T cell therapy product candidate.

Let me remind the audience that general Evan is comprised of new antigen specific peripherally derived T cells or N P Ts that.

That we screen for patients specific neo antigens with our Atlas platform.

The platform identifies through a bio SA each patients anti tumor neo antigens and pro tumor inhibitor <unk>.

Our planet process.

Selectively expand T cells specific to the Atlas identified anti tumor neo antigens.

As of March 3rd we had completed screening twenty-three patient samples with Atlas.

On average across the samples Atlas has prioritized 12, neo antigens with an average a range rather of zero to 43 and identified 16 inhibit gins with a range of one to 82 across the patients.

From their 17 patient samples have entered the planning process.

100% have either successfully yielded a release drug product 14 or continue in process three.

Of the 14 manufactured Gen 11 drug products.

<unk> had been administered to patients across both of the multi dose and single dose cohorts with the remaining eight available for dosing upon patient need.

We expect to share initial data principally from the first five patients in the poster presentation at ACR.

We will also present two other posters at ACR.

One will provide additional color on the Gen 11.

Janet manufacturing process and drug product characterized characteristics.

The other will showcase the continued evolution of the inhibitor and story made possible by the neo antigen selection capabilities.

Of Atlas.

Finally, we are planning to host an investor call during ACR covering all three presentations.

We will.

The exact timing shortly.

I'm also pleased to welcome John Monger, Chief patient supply officer added afternoon.

Two our board of directors.

As the adage goes processes product.

So with successful scale up and delivery of our drug product candidates a critical driver of long term success.

Am competent johns experiences and expertise will prove invaluable to us and our board.

I also would like to remind you that in January we entered into an R&D collaboration and option agreement with Janssen biotech incorporated one of the answer and pharmaceutical companies of Johnson <unk> Johnson to explore the immunogenicity of neo antigens and the impact of inhibiting <unk> in the context of vaccine <unk>.

<unk> for cancer.

So as you can see we continue to make progress on multiple fronts.

I am grateful to the Genocea team for many things, including their heart tenacity and agility.

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.

Tampa.

Thank you chip and good morning, everyone.

We ended the quarter with $37 1 million of cash and cash equivalents compared with $79 8 million at December 31, 2020.

Our operating results for the quarter ended December 31, 2021 are as follows.

Our net loss for the three months ended December 31st was 13.

The December 31, 2021 was $13 3 million compared to 15 million for the same period in 2020.

Our net loss for the year ended December 31st 2021 was $33 2 million compared to $43 7 million for the same period in 2020.

R&D expenses for the three months ended December 31, 2021 were $10 3 million compared to $7 8 million for the same period in 2020.

R&D expenses for the year ended December 31, 2021 were $39 million compared to 34 million for the same period in 2020.

The increases in R&D expenses for the quarter ended December 31, 2021 is mainly due to gen. Two Gen 11 manufacturing and clinical costs, partially upset by a nonrecurring payroll tax credit.

The increase in R&D expenses for the year ended December 31, 2021 is mainly due to gen 11 manufacturing and clinical costs headcount related.

Costs, partially upset by facility related costs.

G&A expenses for the quarter ended December 31, 2021 were $3 1 million compared to $3 9 million for the same period in 2020.

G&A expenses for the year ended December 31, 2021 were $14 7 million compared to $14 4 million for the same period in 2020.

The decrease in G&A expenses for the quarter ended December 31, 2021 is mainly due to a decrease in professional services. The increase in G&A expenses for the year ended December 31, 2021 is mainly due to our growth and our internal G&A team.

Partially offset by decreased facility related costs.

Other income for the quarter ended December 31, 2021 was <unk> 1 million compared to other expense of $3 3 million for the same period in 2020.

Other income for the year ended December 31, 2021 was $18 9 million compared to $3 3 million for the same period in 2020.

The increase in other income for both periods is mainly due to the noncash impact of the fair value adjustment for our liability classified warrants.

<unk> existing cash is sufficient to support our current operations into Q3 'twenty.

However, we have strategic plans to extend our operations.

Into 2023.

With that let's now open up the call for questions operator.

Thank you again, ladies and gentlemen, if you like to ask a question. Please press Star then one on your Touchstone telephone again to ask a question. Please press Star then one.

Our first question comes from Ben Burnett of Stifel. Your line is open.

Hey, Thank you very much I guess first question you mentioned five patients of data could be expected ACR. There's six have been dosed is there.

Is there a chance that we could see some an update for the six patients as well.

Hi, Ben Thanks for the question I think we may have safety and Tolerability data, but it would be too early to have a clinical sense of the impact on the tumor.

Okay understood and I would also just like to hear your view like like what's the bar for efficacy in these two different cohorts I think I think you've talked about in the past that there is a potential for these cohorts to enroll a slightly different patient populations in terms of disease severity.

Do you see your view the bar for success is also being different between the two cohorts.

Yeah. Thanks for the question Ben I'll ask Tom to frame the the rationale for the two dosing cohorts and then and then how we think about a potential success.

Thanks, Jeff.

Obviously, a good question.

As you are aware the regimen that these patients generally receive particularly if they're receiving kiln is a complex combination of <unk> depletion.

Cell infusion and IL too many patients are unable to tolerate that regimen and knowing in the design of our study that some of these patients may not be eligible for the full course.

We allowed for a less intense regimen, which is the multi low dose arm. If we see any activity in that multi low dose arm I think it will be very exciting essentially because there are many patients again, who don't have the capacity to tolerate the full tilt regimen. However.

However, the kill regimen and any adjustments in dosing along the way.

Should all give us a sense of the potential for this treatment and as we give the full killed regimen, which is the intent we would expect to see.

Full potency in that setting and hopefully we will see a good range of tumor responses.

This is an early data set of course, so you are going to be seeing just the initial patients who were treated.

Okay.

Okay understood. That's helpful. Thank you very much.

Sure.

Our next question comes from Colin Cuzzi of Baird. Your line is open.

Great. Thanks for taking my questions and congrats on all the progress so far.

For the.

Five patients that you'll have data on are you able to say at this point what tumor types. They have and if you can't say that it could you indicate whether there might be multiple up one tumor type.

Yeah. Thanks, Colin for the question well, we'll share all of that in more detail of course.

About a month.

But it will be it will be multiple tumor types.

And how long of a follow up can we expect from the updated ACR.

Yeah, Tom why don't you handle that please.

Well, we have been dosing patients now for some time, so there will be a good durability in those patients over time.

But it's really the initial response, that's going to be most important.

And remember that the key hurdles with these cell therapies.

Stretches across the spectrum from safe infusion to proliferation and persistence of the cells in patients, which really can define in the future. So there's a good amount of data that we'll be able to share that will give you a sense of the potential for gen 11.

Okay, Great that's helpful and then.

The Delta between the 23 samples that you Brian for Atlas in the 17 manufacturing runs I guess can you can you speak to that are there have there is just not started yet or it.

Is that for some other reason.

Yeah, I'll comment I'll have excuse me Jeff.

Well that question please.

Yes, there are there it's it's all of the above so your question is very astute. We have several that have been screened and are in process and going forward into manufacturing we had some.

Where the screens have happened, but the patients have either.

Chosen to withdraw consent or did not move forward in the study and.

So it's a combination of factors.

Okay. That's helpful. Thank you and last question can you just remind us what the protocol is for when these patients are dosed in terms of their disease State I guess is it possible. These patients could be in different disease state or will they all have.

Progressing tumors when they get dosed with general on it.

That's a question for you Tom.

Thanks Chip.

So we do have a manufacturing period and the patients are selected.

When they've defined themselves as being refractory.

But we then maintain them on bridging regimen or some other chemotherapy if necessary before we ultimately dose. So the short answer is it will be a mixture of patients with a different state.

Stage of disease. Some of these patients will have received multiple prior therapies and others will be newly refractory.

Okay, great. Thank you so much for taking all my questions.

Yeah.

Thank you Colin.

Thank you. Our next question comes from Gil Blum with Needham and company. Your line is open.

Thanks for the update and exciting news coming up with C. R.

Yeah.

There are no crystal ball question.

So.

I mean, we're going to see data from five patients I'm, assuming we're going to look at some tumor responses with considering you do have some tissue from these patients or weaken a bit.

Discuss any biomarker data.

Seems like tumor infiltrating lymphocytes, when the original tissue and things like that.

No.

Gil Thanks for the question just would you characterize what we'll likely see.

Yes, so we will be presenting some biomarker data we have.

Some work ongoing looking at proliferation and persistence phenotypes of the cells in the periphery.

We have some serum biomarkers that we may be able to increase we do have work ongoing to look at TCR sequencing and tumor infiltration I can point you to the availability of the data for that presentation, but it is data that we're generating and we should.

We anticipate.

Alright, Thank you for taking our questions and congrats on the progress.

Our next question comes from Joe Pascal of H C. Wainwright Your line is open.

Hey, everybody. Good morning, Thanks for taking the question I wanted to see if I can frame. This question the right way a little more about the rationale about the two dosing cohorts. So I guess when you look at what you call at cohort one without lymph a depletion in the multiple fractional doses.

I guess your internal rationale or data to support you know these lower doses over time that you can get sort of an efficient antigenic load.

Yields say, an effective th one response, while still potentially having a.

Regulatory T cells around since Youre not limp depleting.

Yeah, Thanks, Joe I'm going to speak have Tom rather speak to that.

Yes.

Obviously, Joe the biology is complex.

We certainly know that you can generate effective immune responses and with more circulating cells in the periphery, you should be able to control disease, but the main message as I emphasized before is that we would like to have some way, where we could dose patients who perhaps have more advanced disease or otherwise compromising their functioning and this regimen.

Would provide.

Limited toxicity, and hence would be a good opportunity to test.

It would be a breakthrough as I've said before if we could provide a friendlier less intense regimen for patients.

Also being able to show activity of the cells and showing that they are able to penetrate the tumor and induce responses. It's a key question.

But I do recall, while we have the two cohorts that lower dose the multi low dose arm really is intended for the patients who simply can't take the high dose and our goal ultimately would be to dose as many patients as we can with the full kill type regimen.

Got it and I appreciate that color Tom.

Uh huh.

I think the answer chips going to be you will see it next month, but of the five patients and even additional patients for safety and Tolerability well can you share the breakdown of these five patients now as to which cohorts they are in.

Yeah, Joe the first two patients per protocol.

In that first cohort in the next three.

In the second cohort.

Got it got it and I guess, just briefly sort of two parts, but separate independent though.

A little bit of a teaser with regard to the operational update that diantha provided and strategic plans to potentially extend the runway. So obviously theres a couple a bit of a spectrum there with regard to you know plans I guess.

It is one able to deduce that theres, maybe some potential non dilutive types of arrangements hopefully in discussion.

[laughter] there there are lots of discussions on a variety of fronts and so we're not going to specifically tip. Our hand in this conversation about the ways in which we might.

Address that that particular transition.

Of course of course, and then you know I'd be remiss, if I just didnt asked separately.

Is there any sort of.

Other than a status quo right now as to how <unk> is going what sort of potential enrollment and follow up.

Yeah, no. That's a it's a we continue with long term follow up and hope to be able to share.

An update on that in the near future.

Okay, Great I appreciate it thanks guys.

Yeah.

Thank you. Thank you I'm showing no further questions at this time I'd like to turn the call back over to chip Clark for any closing remarks.

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

Thank you ladies and gentlemen, this does conclude today's conference. Thank you all participating you may now disconnect have a great day.

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