Q2 2020 Genocea Biosciences Inc Earnings Call

[music] good morning, and welcome to the generic <unk> second quarter 2022 conference call. At this time all participants are in a listen.

I will need valid following the formal remarks, we will open the call for questions. Please be advised the college being recorded at the company's request at this time I'd like to sort of called over a two dogs Perry I fly Fi 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 releases available at you know show 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, That's a duvall will review the financial results.

After the prepared remarks, we'll open up the call for Q1 day.

And chip Diantha.

Tom Davis, she knows she was chief Medical Officer, and Jessica Fung. There you know she was chief Scientific Officer will then be available to answer your questions before we begin I would like to remind everyone.

Statements made during this conference call relating to it you know she is expected future performance future business prospects or future events were 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 that results could differ materially from those forecast due to the impact of many factors beyond the control of Junisha Junisha expressly disclaims any duty to provide updates to its forward looking statements.

Well there as a result of new information future events, where otherwise participants are directed to the risks factors set forth in should Osha's 2019 annual report on form 10-K.

And other periodic reports filed with the Securities Exchange Commission is now my pleasure to pass the call over to chip.

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

You know show has had an active in productive second quarter.

Demonstrating important progress across the company.

There is much to recap on todays call and we are especially excited about the path forward.

For our two differentiated clinical stage programs Gen nine Howard Neoantigen vaccine and general 11, our Neoantigen cell therapy.

First I'd like to discuss the.

10, nine vaccine program.

On July Thirtyth, we will present initial clinical data on the first five patients from part B of our ongoing phase one two way clinical trial.

With Dr. morale Gillison, a renowned professor of medicine hat, the MD Anderson cancer Center and the lead investigator of the trial.

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

To register for the event. Please visit the Investor section of our website.

We shared long term follow up data from part Hey of the same trial at NASSCO Twentytwenty is a virtual scientific program.

Evaluating the duration of immune responses and clinical outcomes for eight participants.

We are encouraged by the results seven out of eight patients treated our without disease progression at one year median follow up.

In addition, we observed that Gen nine drew broad sustain the T cell responses to neoantigens identified by our proprietary Atlas platform.

Starting after only four weeks.

And lasting for up to one year after the last vaccination.

Now, let me turn to Gen 11, our Neoantigen cell therapy that uses T cells taken from peripheral blood and expanded on Atlas identified neoantigens.

Generally hosted a virtual carrawell symposium, introducing Jay on the agenda 11, and featuring commentary about the gaps in the existing T cell therapy landscape from Dr., Eric trend assistant member at the Earl a child's research Institute in the Providence Cancer Institute.

Members of the generally management team highlighted the potential breadth of response convenient and cost advantages of Gen 11 over til therapy.

To provide additional context till therapies are the current gold standard for solid tumor cell therapy.

But challenges remain that hindered their widespread widespread use.

Till based approaches may have limited tumor specificity cannot avoid the inhibitory or pro tumor responses, we regularly finding cancer patients through our Atlas platform.

Require a surgery to extract tumor and tils.

And rely on a potentially comparatively exhausted immune cell.

By contrast agenda 11, unleashes billions of neo antigen specific T cells to an unparalleled breadth of neoantigens targeting up to 30 relevant ones.

Gentlemen, also avoids the pro tumor inhibit genes that may be detrimental to clinical response, which til therapy incidentally cannot avoid.

Does not require extra surgery or collection of viable tumor sample.

And unlike tils engages non exhausted T cell population for potentially superior activity and durability.

In sum Gen 11 may work at least as well as til therapy be accessible to more patients.

And cost less overall to the health care system.

General should filed in R&D application to begin a phase one two a clinical study of down 11.

The trial will enroll up to 24 patients.

And we'll assess gen 11 in a range of tumor types with a focus on patients who have failed standard of care checkpoint inhibitor therapy.

As we recently reported we have received verbal notification from the FDA, but they are placing a clinical hold on deion D until additional information pertaining to certain third party reagents used in the June 11 manufacturing process is received.

It should be noted that these reagents are not a component of the final cell therapy product.

That we expect to receive official written communication from the FDA regarding the hold in the near future.

And of course that we plan to work with the FDA to resolve their questions as quickly as possible.

General should also presented data at be a CR virtual annual meeting to.

That help explain how inhibitory antigens or inhibit June function.

These results validate previous research shared at 52019.

Which showed that the presence of an inhibitor and in an otherwise active immunotherapy can be detrimental to anti tumor responses.

Our latest analyses demonstrate that in preclinical models inhibit engines were found to alter the tumor microenvironment and drive tumor hyper progression and also abolish both global and tumor antigen specific T cell activity to beneficial anti tumor antigen.

The finding suggested that inhibitor and must be identified and excluded from the rational design of cancer immunotherapies to achieve more favorable patient outcomes and as a reminder.

Only Atlas can identify these divisions.

Looking beyond cancer, we know that that identifying novel antigens of T cell responses is as important another maladies such as infectious diseases.

As a potential truth in May we entered into an MTD and exclusive license option with shionogi and company to develop a novel HSV two vaccine using generics is proprietary HSV two antigen from the Gen three program, which the company discuss.

Continued in 2000.

As part of this agreement the company received $2 million for the exclusive license I am sorry option to evaluate the HSV two antigen and to negotiate a license prior to the expiration of the MTS.

[noise] upon exercise of Shionogi adoption terms of the license are expected to include an upfront payment regulatory and sales milestones as well as tiered royalties.

If license Shionogi will assume responsibility for global development and commercialization of the HSV two vaccine product.

In summary, I am pleased by our ability to remain on track during these uncertain times.

Meeting, our highest priority milestones and working to deliver on the promise of developing effective immunotherapies through our unique and differentiated approach.

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

Uh huh.

Diantha.

Yeah.

Thanks, Chad and good morning, everyone. We ended the quarter with 22.1, a cash and cash equivalents are operating results for the quarter ended June Thirtyth 2020 are as follows.

R&D expenses were 85 were 8.5 million compared to 6.8 million for the same period in 2019.

DNA expenses were 3.5 million compared to 3.2 million for the same period in 2019.

And our net loss was 11.3 million compared to 6.5 million for the same period in 2019.

Yesterday, we announced an 80 million dollar private placement consisting of common stock in warrants to purchase and warrants to purchase common stock, which was led by a leading U.S. public investment been specializing in life sciences, as well as certain existing and new investors. This important financing.

Further diversifies, our Investor day.

Stent, our cash runway into mid 22.

And enables critical clinical milestones for both Gen nine and Gen 11.

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

Ladies and gentlemen, if you have a question at this time. Please press Star then number one key on your touched down town. If your question is been answered or you registering leave yourself from to Keith. Please press the pound <unk>, Please sweet well collars key further questions.

[noise] hurt your first question comes from the line has been bring it with Stifel. You May ask your question.

Hey, good morning. Thank you so much for taking your questions I.

I wanted just ask one first on June 11, I guess can you just just wanted to can provide a little more color on the vendor that's responsible for producing this reagent and I guess, how critical is just reagent and how easy is it to switch vendors at this stage in the event that you need to.

Thanks, Ben for the question.

We can't <unk>, obviously disclose the vendor themselves and we also don't know that we need to.

Switch reagents, but it is the case that in developing our process. We gained planned and actually did development work anticipating a variety of scenarios, including the possibility of replacing such reagents and so we feel confident that if we do need to.

We could do so were quite readily.

Okay, Okay great.

Maybe just one more on the on the design of June 11 Phase. One two can you just remind us how the how that cohort a and b will be enrolled and I guess are these going to be completely staggered in other words. This discord a need to mature before moving onto the high dose and really I guess, what I'm trying to get as it is when we get the first look at data.

From this program do you anticipate being able to disclose some of this high dose data by then.

Yes, I'll I'll ask Tom to handle that question Huh.

Okay Ivan.

The you design as you suggested contains two cohorts.

Group, a and groupie, one, giving a higher dose and the other a lower doses given repeatedly.

As you, obviously can tell that basically a dose escalation.

In our initial discussions in a pre I'd with the FDA. They agreed that we would start treating two patients at the low dose.

And then could escalate.

So we actually can get to higher doses fairly quickly if we need to.

Which we think it gives us great flexibility to accrue both cohorts in parallel.

Design suggest we should be doing that and what determining whether a low dose. It is going to be less toxic to patients could be effectiveness situation or whether we need to go to the higher does I think it is a very flexible design and should sort of UBS is quite well to provide information from patients in both cohorts.

In the timeframe, we predicted which would be data the middle of next year.

Okay fantastic thanks for that color.

Sure.

Thanks for the question Ben.

I do your next question comes from the line of being a greenwash wed ask VB Lilly you May know ask your question.

Hi, Thank you for the question and you could give us some more color.

Why you chose to talk about August 1st by patients first rather than waiting for a larger cohort for gen nine.

Thanks, Dana for that question I think.

This is an important consideration here, which is that the enrollment in the clinical trial essentially took place in two waves.

And so.

For the vast majority of the patients the data will be rolling in in August and September still enabling us to deliver as previously disclosed on a larger dataset.

The end of September.

But I think that having a clear sort of discrete set of data from one group of patients.

Gives us an opportunity to provide a glimpse of what maybe or may not be happening in the clinical trial and in the context of all.

Many of the timing.

Can you maybe a little more color and why it was in two ways is there something particular like a certain site or certain tumor type that's common and if there's five patients for a broader so.

Yeah, there was nothing nothing nothing such as that either site or piece and type specific but sometimes these things just happened this way.

It would be probably a little bit too simplistic to blame it on current of Iris, but yeah. The there's nothing that we think is particularly in if you did.

Therefore, we think that.

The who the five patients for whom will present, the though would be.

In many ways broadly representative of the larger data set.

Okay, and then one more question for me instead of a holiday.

Maybe a disappointing summer for new antigen vaccine or at least some points for some competitor programs to go back and translate somewhere I Wonder if you have any thoughts of what you've learned a from maybe the genentech be on tech and grit stolen are.

The result of come out that you would think about for your own program any implication.

Yeah, So maybe I'll ask.

First to comment on some of the observations we have.

The competitive data and then after that I will have Tom comment on.

Perhaps the similarities and or differences in our clinical trials that.

Many inform what we hope to present, so first to Jeff.

Thanks, Dana for the question.

No. We we agree that the results that have been presented so far have been I'm, a little underwhelming, which is unfortunate because there is so much promise for neoantigen vaccines in cell therapy, but I think what we learned is that a what we have been saying all along is the key.

It's really that the targets matter and and I mean that in two ways. One is that with Atlas we are showing both.

At the person can make a T cell response to the neo antigens that is included in their vaccine prior to their vaccination.

And secondly, we know that the tumor has expressed that antigen.

Because otherwise they would not have made a pre existing response to it.

And you can make very high frequency T cell responses again.

Mutation, but if the tumor is not expressing that target they will have any function.

And so we're really encouraged by the fact that we approached the neoantigen vaccine in cell therapy, it's very differently that we focused on what to target the immune response on.

Oh, we chose to focus on avoiding inhibit Jim.

And we look forward to seeing the data.

Tom.

So with respect to the clinical trials that have been performance to date. There is of course a mix of approaches.

Some people in the states have you stayed delayed vaccine design.

And others have started simultaneously.

I think the data that have come from our competitors.

Have shown.

It's certainly relative data and prolonged PFS reporter from those studies, but of course, they were not specifically designed with a controlled it allows us to fully understand that.

And that's been a difficulty in the space.

For our study we are very focused not on the entirety the population, but looking for a signal of anti tumor activity.

With each patient serving as their own control and key to that is the staggered design, where the patients define their outcome on the checkpoint inhibitor based therapy and then start the vaccine I would say that this is quite a hurdle people would be skeptical that one could shrink tumors. After three to four months of a checkpoint inhibitor.

But those are the kind of read outs that we're very focused on and if we see those we would consider that to be very strong.

Great. Thank you very much.

Your next question comes from the line of my outflows with Baird. You May know ask a question.

Hi, guys. Thanks for taking the question.

Just to start maybe a quick follow up on June 11 in the partial clinical hold but I'm just curious if you guys.

I have some data available that you think might be able to address them. The f. kids questions. There and then secondly, and I realize it's maybe difficult.

Well the kind of predict but you know we think the ultimate impact is on on timelines to sort of enrolling patients in.

In the general and study.

Yeah, I think so thanks for the question, Mike I think the answer both questions is somewhat difficult to predict you asked first whether we have in hand.

The data to.

Address their concerns and every indication is that we do.

You know as Weve indicated they have contamination concerns about what could arise from one of our vendors and and so we've done extensive testing we would propose to do continue to do extensive testing and as hinted in the response to previous.

Question, Yeah, I think we've we've contemplated we prepared for and could easily implement.

Even more significant changes in order to respond to the yes.

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But we need to Steve the letter in order to confirm exactly which of those options we have to implement so.

You know, we feel very adequately prepared but the specific path that we'll take will depend on what we see him a letter which is some in some ways feeds into the response and second question about the timeline and.

I think you know in so far as we believe that we understand the issue.

Therefore have a bunch of different paths that we can implement.

You know, we think it's simply a matter of getting the latter responding to the agency with.

Measures are for which we already have data and or could read very readily implement and then given the you did there the mandated 30 days to respond. So you know somewhere in the ballpark of a couple of months.

Seems like a reasonable estimate.

And that's sort of the operating assumption, we have we're sort of very eager to get the letter and.

Forward, regardless because.

Under any circumstance, we feel very comfortable that we have put boundaries around the issue can overcome it and obviously we're excited about 10 11.

Got it that's helpful. And then maybe another question on Gen eight and.

Considering we're expecting some data next week just.

Just broadly obviously, we're in a pandemic and.

Just curious if there's been any impact on your ability to collect data from those patients.

How we should think about that.

Yeah, Tom why don't you take that question with regard to the clinical trial.

So obviously the pandemic has had impact across the board, particularly when there are very few hospital beds, our clinical sites generally tend to cut back on any of the elective procedures.

However, these patients do require their standard of care treatment.

They are having their images you know there scans taken at appropriate times, because that is part of standard of care.

There may be a few samples that don't come into we would like to see but overall, we're able to capture the critical data a pretty much on time for these patients so I'm I'm.

Certainly not saying that there's no problem, but I do think of it with the design of the study were able to capture what we need.

We need to do it.

Okay, great. Thank you for taking the questions.

Sure.

Thank you for them like.

Your last question comes from the line as Joe Plump wed need him in company you May ask your question.

Good morning, everybody and thank you for taking our questions as well.

Maybe you know the first one on.

The design of the Gen 11 study.

Could you discuss a little bit the significance of looking at a patients that are not receiving lymphoma depleting.

<unk>.

So gil thanks for the question, then obviously I have Tom answer that.

Well, it's a good question Lymphodepletion is considered standard with certain therapies, including the car cheese as well as.

The til therapy approaches and it's a lot of data, suggesting that it can be effective but it does bring with it significant toxicity.

So we were very interested to explore whether a less toxic regimen could be successful in the context of a very broad range of immune responses.

Weve noted that we can generate up to where we can use up to 30 target.

In our cell therapy, and you could almost consider that 30 different drugs in one so that we believed that this could be much more potent and by starting with.

Less toxic regimen and still substantial doses itself, we will be able to test that the key feature though is that it's built into a dose escalation and we can rapidly get to full lymphodepletion with high goes I all too in the second cohort fairly quickly if we feel that that's going to give us better results.

Does that address your question.

Yes, absolutely.

And then kind of going back to.

Yeah.

Evidence around till efficacy and.

Other.

Work that's been previously done as there is there any preclinical work looking it too.

The appearance of inhibits once in patients that failed asks til therapy.

That's a great question Troy just skill.

But so you asked if if there's any relationship with inhibit surgeon and patient to fill til therapy.

Yes, if there is so yeah, we're being done into this.

No. So the work that we're doing in terms of.

You know the profiling inhibit gen almost as a biomarker. It's currently all related to checkpoint blockade failures.

But it is a good question of whether or not.

Well this could also be used to to predict till failures, we just haven't broadened our search into that path.

But it is true that currently in the work that we had done previously that is ongoing and the gen. Nine child and collaboration that we have ongoing also from a research perspective that we think that we can.

Identify subject to May sale checkpoint blockade based on the proportion of inhibiting that we find in the screen.

Gotcha.

And kind of a last one going back to the infectious disease.

A deal that you guys announced back back in May.

Okay.

Is there any any of that maybe potential business development around other infectious.

Viruses, especially one thats pretty a pretty much everyone else everyone's mind these days.

[laughter], whether you're talking about go no.

So first of all were cancer company and our focus.

Is of course on the various ways, we can be advancing and and even doing business development around the BB applicator or around the cancer applications rather.

Of the Atlas platform.

Yes, Oh, we.

Certainly field inbound.

You know inquiries regarding other infectious diseases with regard to who did specifically.

No I think we've been taking a little bit more of a wait and see approach and just can speak a little bit to whats known about the immune responses to the that virus and why it has only to explain do why people of rushed into the clinic with their backs.

And but why it's not entirely clear that but we can be helpful. In the fight against killed it.

Once you picked us.

Right. So Ed you probably know with the majority of vaccine today are focused on one particular protein from the virus to generate neutralizing antibodies.

Which is a correct approach of course, because that is how the virus game venturing to sell.

But we also noted that it may provide incomplete protection and there are more and more papers emerging showing the importance of T cells also in protecting subjects again this virus.

And what is interesting is that in Sars the earlier respiratory virus.

Individual have published that T cell persist out to a decade for example, and may protect patient in the long term.

But antibody go away in a.

A year or two years and perhaps Wayne so there's certainly compelling arguments for exploring T cell immunity to the virus.

I think we are are looking very carefully at the field and understanding what is there and.

Let's see what happen.

Thank you very much for for that color.

<unk>.

I think your job.

At this time there no further questions into Q I will now turn to call back over to Mr. Chip Clark CEO for closing remarks.

Thanks, very much operator, I want to thank everybody for joining the call and more importantly, I want to thank everybody. Its inertia for all of the hard work that we are.

Always so privilege and grateful to have the opportunity to represent we look forward to speaking to you all again in the near future.

Thank you ladies and gentlemen, this concludes todays conference. Thank you for participation and haven't wonderful day, you may all disconnect.

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