Q1 2021 Genocea Biosciences Inc Earnings Call
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Hum.
Thank you for calling me I have your conference I D number please.
Some of them it's 2191366.
Thank you may I have the spelling of of your first and last name. Please.
Yes first name is of Rachel or a C. H E. L. Last name is Smith S. M I T H.
Thank you and your company.
I'm of the ore that's AI E R. A.
Thank you and I will be on I'll turn your length of the conference.
Thanks, Dan and thank you all for joining us today.
We are pleased to provide updates on several important efforts.
Start with our two clinical programs Gen nine and Gen 11.
As a reminder, gen 11 is genocea as neo antigen targeted peripheral T cell therapy or N P T therapy.
Which we're testing initially in checkpoint inhibitor refractory people with solid tumors.
We believe using patients T cells taken from easily accessible peripheral blood and expanding the T cells only on tumor neo antigens prioritized by our proprietary antigen discovery platform Atlas.
They give jen 11 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 tightened study.
Phase <unk> study designed to evaluate safety biomarkers of activity and the anti tumor efficacy in patients with a range of tumor types across two dosing cohorts.
One with a single Gen 11 dose and the other with Gen <unk> administered as multiple low doses.
We continue to add clinical sites.
Excuse me 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.
Now, let me turn to Gen nine hour adjuvant, the peptide neo antigen vaccine.
In our last update we reported initial evidence of Gen non clinical activity on top of checkpoint inhibitors.
Of nine CPI sensitive patients dosed with Gen nine.
Three patients experienced a novel reduction in tumor volume and achieved independent resist responses post Gen nine dosing, including two Prs and one CR.
Five of additional CPI sensitive patients had shown disease control post vaccination.
Within the CPI resistant population.
Five of seven patients appear to have stabilized disease.
Gen nine of elicited broad and strong anti tumor before and see the T cell responses to vaccine neo antigens.
We are continuing to monitor these patients and expect to provide long term follow up clinical and Immunogenicity data from this study at the ESCO 2021 annual meeting from June Force to June 98th.
We also continue to explore and develop insights from our Atlas platform.
We have been the first to identify what we call inhibitory antigens of pro tumor T cell responses.
At the recent the ACR conference, we presented new data highlighting the presence of the single inhibitor <unk> and otherwise.
Protective of immunotherapy can completely reverse the therapies intended anti tumor responses.
And the inhibitory effect can be seen as early as four days post dosing.
We also continue our Sars COVID-19 two research efforts to identify conserved antigens of protective T cell responses that may enable a next generation vaccine protecting against a wide range of strength.
We look forward to providing additional updates on all of our clinical and research activities throughout the year.
In addition to this operational progress we recently strengthened our executive leadership team appointing.
Jacqueline Sumer summer, rather as chief legal and compliance officer.
Jacqui brings over 15 years of legal experience, including roles at several biopharmaceutical companies with a focus on oncology and cell therapy development and commercialization.
I have no doubt that her leadership and expertise will be a significant contributor to our progress.
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.
Thank you chip and good morning, everyone. We ended the quarter with $66 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 1 million for the same period in 2020.
Other income was <unk> 4 million compared to <unk> 5 million for the same period in 2020, and our net loss was 12 million compared to $13 million for the same period in 2020.
In February of 'twenty, one, we repaid a portion of our existing debt and refinance the remainder of the $10 million of term loan debt refinancing along with our cash operating plan extends our cash runway to the end of 2022.
With that let's now open up the call for questions operator.
Ladies and gentlemen at this time, if you would like to ask a question. Please press star followed by the number one of your telephone keypad.
Leasehold Ravi cure the raw.
Foster.
You have a question from the line of Ben Burnett with Stifel.
Hey, good morning. Thank you for taking my questions I wanted to ask you provided some interesting data at ACR recently.
Kind of expounding on on some of the data around inhibitor <unk> showing that inhibitor and the <unk>.
<unk> of inhibitor and diminished and otherwise affect the vaccine in an animal model I wanted to ask it is based on your work is it none of that inhibitory effect. If it's I guess, there's the rather binary or do you see a range of sort of inhibition.
Depending on the specific inhibitor <unk> included.
Yeah, Ben Thanks for the question.
Ask Jeff to handle that.
Good morning, Dennis the Great question, we reported I believe a year ago at city, so not the last one but the one before that there is indeed, a spectrum of impacts that the inhibitor can have from being completely dominant as we have shown.
Repeatedly with the most recent data at ACR, but also to be.
Subdominant 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're studying.
Okay.
Okay interesting I guess it was it is it surprising that adding a checkpoint inhibitor.
I guess by Arctic didn't seem to have much of a of an impact I guess is that is that consistent with this notion that theres just a.
A defect in and accessing the tumor microenvironment.
We thought that the addition of the checkpoint inhibitor could.
The health and maybe recover some of the deleterious effect of the presence of the inhibitors 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.
Yes.
Yeah, Okay, Okay totally agree and I appreciate the.
Answering these nuanced questions. So thank you.
Thank you Ben.
You have a question from the line of Chad Messer with Needham.
Okay.
Great.
Good morning, and thanks Chip Jessica desk with the catch up.
Obviously very excited for the one one.
A dataset.
Just wondering I advance the recently ran into some some issues with the FDA on.
Some sort of CMC stuff and release criteria.
I know youre sort of different your peripheral blood just wondering whether there's anything to be learned there that you are paying attention to and any reason to believe.
You would would or would not have any kind of similar issues.
Chad it's an important question and it's one that we have some confidence that we've addressed based on the fact that.
Release was part of our IND package, but I'll ask Jess to.
Be more specific about the reasons why we think we at least today have reason to believe we should not face this issue in the same way.
Yes, good morning, Chad.
We as chip said, we have written our plans for our release testing of the potency test into our I N D 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 11 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 til therapies, where.
Excuse me the specificity.
<unk> is a little bit indeterminate because of the non specific expansion of sales from the tumors and the presence of non tumor specific by stand ourselves.
So.
I think by virtue of our product being well characterized from the beginning and some of the tests that we've put in place we are poised to.
Perhaps have no less issues I don't want to say no issues in terms of release and and potency.
Yes.
Alright, great Yeah. Thank you. Thank you for that.
Maybe just the probing one of.
On the the COVID-19 work that you're doing Youre looking for.
Conserved are common.
Antigens, obviously, we're all.
Paying a lot of attention to the variance with COVID-19 right now of the big question for the future.
Just wondering how many what's your access to the sort of current variants that are out there. How much are you able to look at it now and how do you feel you'll be able to sort of keep up with debt over time, what's the.
What's the availability how good of a job.
John do you think you're going to be able to do the are based on information you guys can get access to.
[laughter] yeah. It certainly partly an access issue, but it's also.
The case that a lot of information is available about the variance, but I'll have Jess will give you more color on sort of why we think focusing on.
Antigens of T cell response should.
Should be important here.
Right the variance of emerging fast and furiously as you know and it is true that antibodies can drive these types of mutations.
Because they're all essentially targeting the same protein and in the same region of the same protein.
We have published in the past that a T cell antigen or the targets of T cells don't tend to mutate in the same way because they of diversity.
Different people have different responses to different.
Pieces of the same protein.
We also know that antigen the city does not equal protective immunity. So just because you can measure of T cell response.
It doesn't mean that that T cell responses productive and so the way our debt. We are looking is to understand what people who are exposed to this virus and protect themselves from it are doing correctly with their T cell responses as opposed to those who are exposed and perhaps have severe disease.
We have the opportunity with Atlas to screen.
Large protium, our large libraries and so what we have done and are doing is as mutants and marriage, we are adding them to our library and we are screening subjects against the meeting in addition to the the parent the strain that was originally identified.
Right in China.
The the benefit of this is we can understand both how existing amenity changes because of the mutations as well as if there are regions that arent changing that are associated with protective immunity. So it's an exciting project I will be giving an update at the world vaccine Congress next week and of talk.
And that's it.
Alright, great no that's very impressive.
All of the work that's been done on COVID-19 and glad to see you guys, taking and adding your cutting edge.
Antigen based science to all of that so thank you.
Thank you Chad.
Once again, ladies and gentlemen, if you have a question. Please press star one.
You have of course, you from the line of Kelly Coffey with Baird.
Hi, good morning, Thanks, so much for taking our questions.
I guess one of the channel 11 ahead of the efficacy readout in sports you or <unk> 22, what sort of update do you expect to provide throughout the year kind of thing.
I know part of that.
Thanks, Colin I think there are a couple of different types of updates that we'll be providing one certainly is just progress on enrollment and dosing.
And the other could be.
Progress on manufacturing successes.
And so.
I think giving.
The people the confidence that.
We are successfully proceeding toward.
Clinical data.
Processes very much of the product here I think.
There's going to be important.
Great. That's very helpful. Thank you and if I could ask a couple of net uninhibited in Manhattan.
Just curious if you have any longitudinal data on the uninhibited and I guess the is there any data that would suggest that targets the evolved over time to become more or less inhibitory.
That's interesting.
It's definitely for Jeff.
[laughter].
So I think in our human studies, we are tracking them what happens if we'd have inhibitor <unk> prior to treating patients.
What happens after we treat them to the same inhibit genic profiles and so that is something that we will continue to follow as we continue to develop our programs clinically.
In the animal models, we have not yet.
Done that work in the way that you ask I think it is of good question and.
And it and it really pertains boats to the tumor itself.
You know the expression of that particular antigen or those antigens as well as to the immune response to those antigens and so it is something that I can assure you we will look at in the future.
Great. Thank you and I guess another one of them inhibiting is there any difference that you've seen in the amount of heavy tens of percentage of Havent had been that you find in the peripheral blood person when you walk in the tumors specifically.
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.
Great. Thanks for taking my question.
Thanks, Paul there are no additional questions in queue at this time.
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.
Ladies and gentlemen, this does conclude today's conference you may now disconnect.
Yes.
Okay.