Q3 2020 Genocea Biosciences Inc Earnings Call

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Good morning, and welcome to you know should third quarter 2020 conference call. At this time, all participants are listen only mode.

On the phone remarks, we'll open the call up for questions. Please be advised that todays call is being recorded at the company's request.

At this time I'd like to turn the call over to Dan very of Lifesize Advisors. Please proceed.

Thank you operator, and good morning, everyone earlier.

Earlier today, we issued a press release that outlines the topics we plan to discuss today.

This release is available at you know should dot com under the investors tab.

During the call today Chip Clark President and CEO will provide a brief corporate update and the Companys Chief Financial Officer, Diantha Duvall will review the financial results.

After the prepared remarks, we will open up the call for acuity and chip Diantha.

Tom Davis, Judicious, Chief Medical Officer, and Jessica Flattener Genesis 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 notions Expedia 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 forecasts due to the impact of many factors beyond the control Junisha.

She knows expressly disclaims any duty to provide updates to its forward looking statements, whether as a result of new information future events or otherwise participants.

Participants are just directed to the risk factors set forth in judicious 2019 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.

Generally I had an eventful third quarter, So let me jump right in.

I'll start with Gen 11, our adoptive T cell therapy designed to improve upon the limitations.

Thank you and your team therapies.

We think of Gen 11, as they are.

Third category of Neoantigen T cell therapies.

We called the category in Ptcs or Neoantigen targeted peripheral T cells.

Jen 11 includes CVA and city for positive T cells only for the Atlas identified meal antigens, driving anti tumor responses and excludes T cells to pro tumor inhibitions.

With these T cells, we will target up to 30, Neil antigens per patient, ensuring a broad anti tumor attack.

There are two accessibility advantages.

Hurst by using T cells taken from peripheral blood, we avoid the challenges of extracting sufficient pills from tumors, which may make some patients ineligible for till therapy.

Second Gen 11 is HLA agnostic, meaning it should work in any patient regardless of their genetic makeup.

The cost advantages also derive in part from our use of peripheral T cells.

Using such cells, we do not need the extra time or cost associated with the sterile tumor resection necessary for till extraction.

Also our planet T cell expansion process does not engineer the T cells and is robust and highly scalable.

We of course aimed to begin to demonstrate these benefits in the ongoing clinical trial.

Next style turn to Jen nine hours, Neil antigen vaccine program.

In July we presented initial clinical data for the first five patients from part D of our ongoing phase one to a clinical trial.

With Doctor Mora, Gillison and renowned professor of medicine at the M. D. Anderson cancer Center and the lead investigator of the trial.

Part B of the study is exploring the combination of Gen nine and checkpoint inhibitor based regimens in advance solid tumors.

Juno shared follow up clinical response, and Immunogenicity data from the same five patients.

At the European Society for medical oncology are asthma virtual Congress 2020.

The incremental findings demonstrated tumor reductions or stable outcomes for all five patients.

Suggesting gen nine vaccination could be used in combination with CPI based therapies to augment their effects.

In addition, 100 per cent of patients demonstrated immune responses to Atlas identified new antigens.

We look forward to reporting additional clinical and Immunogenicity data from bees ended the remaining part be patients. During the 2020 virtual society for immunotherapy of cancer or <unk> annual meeting from November 9th to 14th as.

As well as during a conference call on November 9th at 830 am.

Details for this call will be provided in the coming days.

Also at city will provide a detailed technical introduction to channel 11.

<unk>, new insights on the utility or inhibit gins as identified by Atlas.

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 Diantha.

Thanks Chip in the morning, everyone in July we close to private placement with a combination of new and existing investors for net proceeds at $74.5 million.

Proceeds will be used for continued advancement of Gen. Nine Gen 11 investment Atlas in general corporate purposes.

Are operating result.

And a quarter ended September 30th 2020 Orange sauce.

R&D expenses for seven $5 million compared to six $8 million for the same period in 2019. The increase in R&D is primarily due to an increase in costs associated channel 11, and Alice partially offset by a decreasing costs associated with Jenna.

G&A expenses were three $6 million compared to $2.8 million for the same period in 2019. The increase in DNA is primarily due to increase in rent legal consulting and other professional fees.

Other income and expense includes a fair value adjustment for liability classified warrants issued in connection with the 2018 and 2020 private placement, partially offset by issuance costs associated with the 2020 private placement.

And our net loss was four $6 million compared to $7.5 million for the same period in 2019, a decrease in our net loss is primarily due to the fair value adjustment that I just mentioned.

And the issuance costs.

And the partially offset by the issues costs in that same private placement.

Are diluted earnings per share reflect an adjustment to both the numerator and and Uhm dominator attributable to the warrant issued in the 2020 private placement.

Our financial position for the quarter ended September 30th includes 87 6 million of cash and cash equivalents and we believe this cash will be sufficient to fund our operations tended 22.

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

Ladies and gentlemen, if you have a question or comment at this time, Please press thigh and one on your Touchtone telephone if you'd like to Australia question. Please press the pound cake.

Sam I only compounded Q&A last day.

Okay Great question.

Kind of common Bang Bang it kind of painful you may proceed.

<unk>.

Just a quick one first on on Jen Jen nine I guess, what's been your experience with the manufacturing of Genian RP and is this I just spent a relatively consistent with with the party experience just in terms of the time frame that success rate.

Hi, Ben.

Chip and thanks for the question. The short answer is yes, it's been quite consistent with part of a.

We've made vaccine for every patient we've reliably been able to make.

Most of the peptides that we wanted for the vaccine and the needle needle time, which we previously reported to be in the neighborhood of 16 weeks has been consistent for part B and of course, we anticipate that with further investment in that scale, we can make that could go much faster.

Okay very helpful. Thank you.

And maybe just one more on on general loaded.

So I think <unk> stated that the phase the phase want to it just in terms of endpoints you've talked about measuring clinical activity alright in terms of a sponsor a duration response and so forth, but you've also talked about assessing the degree of tumor penetration I was just wondering if you could provide a little color around that just in terms of how you measure this.

Just curious if you have like an expectation for what you want to see here.

In terms of tumor penetration just based on other cell therapy studies.

Yeah, I've been so I'm going to turn that question over to Jeff.

Sure. Thanks for the question then we will be looking.

Tumors in tumor I should pay by any means to chemistry and buy some TCR sequencing too.

<unk>.

<unk> infiltration into the tumors may or may not have changed after treatment and looking to see if there are tcr's that are consistent with those in the tread correct.

So as for what we expect we can't say until we see but if we are successful we anticipate that there will be an increasing infiltration to the tumor is relative to the baseline biopsy.

Okay.

And if I could just clarify these are from a from a biopsy of the target Legion.

Presentation, where we can get a biopsy cause treatment yet.

Okay.

Okay, great. Thank you very much.

Thanks, Bye and our next question comes from Cats.

My favorite neater uncomfortable.

Hi, Chrissie.

Great. Good morning, Thanks for taking my question.

Just interested for the Titans study on the rationale for the two different dosing alarms.

Data, you or or others are generated yet.

Have you interested in looking at multi low versus a single high doses in there.

And then just any any sort of guidance, even if it's big on what we should be expected about timing on hearing something from that trial.

The chat thanks for the questions I'll take the second question and then hand, it over to Tom to tackle the first.

It's just a little bit too early for us to begin to give guidance on the clinical trial and when to expect data we want to really see it get off the ground a little bit longer before we make any.

You know concrete predictions about the the time to data.

But I will say that the clinical trial as far as we can tell so far.

Is getting off to a nice start.

So I'll know ask Tom to handle the question of the rationale for the two different dosing cohorts Tom.

Hi, Jeff.

So the the trial design.

Why do you keep in mind that this is a first in human trial with a novel technology.

And it certainly is always a a question about the safety of a new cell product just targeting a novel group of targets Redistrict H. So of course the phase one is looking at a dose escalation with one cohort receiving a lower dose and then the second basically receiving.

Ah regimen very similar to what's used in the till process.

Kill process has been shown to be active so we are expecting a lot from that particular arm.

But I will add it to process includes.

Chemotherapy blimp depletion as well as high docile to in order to drive cell growth.

And the local ladies cohort for US is also intended to determine whether or not we might have activity.

In patients who cannot tolerate that intense till therapy.

So I certainly look at both arms as being a potential treatment for different patient populations. The lower dose for those who are more sensitive to the toxicity and then the high dose for those who can tolerate it.

I've said the safety will be a key part of any bazelon, but we're very much looking to see what kind of tumor reductions. We can achieve with these treatments. So I think we'll get a lot of very useful information from both arms.

Great. Thanks, So that's very helpful in terms of setting.

Setting my expectations for the for the two dosing on so thank you.

Sure.

Thanks, John.

And our next question constantly Joe patterns with a seemingly.

My first name.

Taking the question one of the focus on General 11 also specifically on manufacturing I guess first what is the general time of the process relative to Jen nine and then.

Currently and your future needs with regard to manufacturing what are your current capabilities to be able to manual manufacturer. This highly scalable acid as you've described and what are your future needs for manufacturing. Thanks a lot.

Yeah. Thanks, Thanks, Joe I'll have just.

Take the both questions.

The the time for manufacturing is.

Actually a little bit shorter than what we have done for the vaccine. So we're looking forward to continuing to deliver very quickly and in fact, we actually have a past for how to continue to make it faster and commercialized. So we're really excited to get this going.

With respect to what we have right now we are working with.

With contact manufacturing organization, we are working in a scalable system that is closed so that we can really rapidly scale up when we need to and so we're confident that we have watson, what we need in place to successfully execute on this child and we are planning for success.

And we.

We will be ready to capitalize on success Wednesday Heaven.

And with regard to your future needs like do you think how long do you think you'll be in the hands of a CMO versus wanting to bring things in house.

Okay. So as you can imagine we're working on those scenarios right now so I'm not ready to make any statements about when that could happen, but we are planning for success in planning for how we will scale out.

Absolutely Fair fair answer thanks Jess.

Thanks, Joe.

And our next question comes from Diana Ross T V. Leerink you May proceed.

Beyond Cat is also presenting a poster under legacy Neon program.

Similar to Jenny 11.

Wonder what you think are what you'll be looking for in their poster and how we should think about comparing the early data we'll see.

<unk> company.

We didn't hear the first part of the question but.

How are the of the question was what we're expecting to see from the biotech poster.

<unk>, yeah, and and how we should think about comparing it to Jenny 11 Yep.

Yep.

Jim 11.

They they're going to have data aircell therapy got a neon legacy sales there understood understood well, we don't know what they're going to be presenting of course, but I think.

In some ways there are similarities to their between the two programs and that we are both using peripheral blood.

To expand on antigen for dosing and I outlined their potential advantages such an approach has over.

Till therapy and or TCR therapy.

I think we remain confident based on the comparative data regenerated in our respective vaccine programs that are antigen selection platform Atlas should make a decisive difference we've we've shown comparatively.

Kurier breath of immune response and magnitude of immune response, and we think that that augurs well for Gen 11, as well and so.

We would we would expect to be able to include more of the right antigens to X T cells to the more of the right antigens and to exclude two sales to the wrong answered and therefore, we should expect superior clinical activity going forward February of course look forward to see whatever progress. They may have achieved I believe they started there.

Clinical trial maybe.

Maybe a quarter before us.

That's great and very helpful. Maybe one more follow up on it the other sort of thinking about the therapy that we've been doing it.

<unk>.

<unk> I guess that the company of Kelly that has Kono Neil antigen approach of course, you can kills and not peripheral T cells and I Wonder how we should think about outlet.

And clone, all new Int Jones, or what you think about that approach.

Yeah, So I'll ask to speak to how we think about <unk>, new antigens and their relevance in this context.

Sure.

Hi, Thanks for the question Dana we think that it is true that clennell antigens are important because they are thought to be necessary and.

Present in all of the tumors because they were responsible for probably the cancer forming to begin with.

We believe that we are finding T cell responses to these chunk, all new antigens as well as to.

Either your antigen that may be unique to each patient tumor and so by definition, we will be addressing both.

And what we know from our research studies and from a clinical.

Child patients to date, when we look at what makes an antigen an engineer what the targets are we actually don't see any enrichment for these types of targets in terms of what the patients who are making responses to naturally.

And so by having a.

A breath of responses that we won't have in general 11, as well as we haven't done nine is going to target those chemical and passenger mutation and really we think have an all out assault on the tumor.

Helpful. Thank you.

Ladies and gentlemen, either for clothes ask you any questions today.

Ladies and gentlemen is concluded actually and a question of today's conference I would now like it turning to call back over it to check like for any closing remarks.

Thank you very much operator, and thanks to everyone for joining us today.

Ladies and gentlemen, today's conference call. Thank you for participating and you may now disconnect anyone have a great day.

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