Genocea Biosciences, Inc.

Good morning and welcome to the Genosha fourth quarter 2021 conference call. At this time, all participants are on 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 Ferry of LifeSci 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 Genosha.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 will open up the call for Q&A. And Chip, Diantha, Tom Davis, Genosha's Chief Medical Officer, Jessica Fleckner, Genosha's Chief Scientific Officer, And 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 Gen 11 and the anticipated timing of top-line results from its Phase I to A clinical trial, the planet manufacturing process, and research efforts, including with regard to ATLAS and inhibogens. 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. Genosha 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 Genosha's 2020 Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission and available on Genosha's website. It is now my pleasure to pass the call over to Chip.

Thanks, Dan, and thank you all for joining us today. I'm pleased to share Genosha's progress with you. Most notably, we recently revealed that we'll soon share initial results from our Titan clinical trial for GEN11, which is our neoantigen-targeted peripheral T-cell therapy product candidate. Let me remind the audience that GEN11 is comprised of neoantigen-specific, peripherally-derived T-cells, or NPTs, that we screen for patient-specific neoantigens with our ATLAS platform. The platform identifies through a bioassay each patient's anti-tumor neoantigens and pro-tumor inhibigens. Our PLANET process selectively expands T-cells specific to the ATLAS-identified anti-tumor neoantigens. As of March 3rd, we had completed screening 23 patient samples with ATLAS. On average across these samples, ATLAS has prioritized 12 neoantigens with an average, a range rather, of 0 to 43, and identified 16 inhibigens with a range of 1 to 82 across the patients. From there, 17 patient samples have entered the PLANET process. 100% have either successfully yielded a released drug product, 14, or continue in process, 3. Of the 14 manufactured Gen 11 drug products, six have been administered to patients across both 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 AACR. We will also present two other posters at AACR. One will provide additional color on the Gen 11 planet manufacturing process and drug product characteristics. The other will showcase the continued evolution of the inhibigent story made possible by the neoantigen selection capabilities of ATLAS. Finally, we are planning to host an investor call during AACR covering all three presentations. We will announce the exact timing shortly. I'm also pleased to welcome John Lunger, Chief Patient Supply Officer at Adaptimmune, to our Board of Directors. As the adage goes, process is product. So with successful scale-up and delivery of our drug product candidates a critical driver of long-term success, I am confident John's 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 Janssen pharmaceutical companies of Johnson & Johnson, to explore the immunogenicity of neoantigens and the impact of inhibogens in the context of vaccine therapies for cancer. So as you can see, we continue to make progress on multiple fronts. I am grateful to the Genosha 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. Diantha?

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, 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 31st, 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 11 manufacturing and clinical costs partially offset by a non-recurring payroll tax credit. The increase in R&D expenses for the year ended December 31st, 2021 is mainly due to Gen 11 manufacturing and clinical costs, headcount related costs, partially offset by facility related costs. G&A expenses for the quarter ended December 31st, 2021 were 3.1 million compared to 3.9 million for the same period in 2020. G&A expenses for the year ended December 31st, 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 a growth in our internal G&A team, partially offset by decreased facility-related costs. Other income for the quarter ended December 31, 2021 was $0.1 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 non-cash impact of the fair value adjustment for a liability classified warrant. Genosha's existing cash is sufficient to support our current operations into Q3 2022. 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'd like to ask a question, please press star then 1 on your touchtone telephone. Again, to ask a question, please press star then 1. 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 to ACR. Those six have been dosed. Is there a chance that we could see 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 will be too early to have a clinical sense of the impact on the tumor. Okay.

Understood. And I'd also just like to hear your view, like what's the bar for efficacy in these two different cohorts? I think you've talked about in the past that there's a potential for these cohorts to enroll slightly different patient populations in terms of disease severity. Do you see or view the bar for success as also being different between the two cohorts?

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

Thanks, Jeff. Obviously, a good question. As you are aware, the regimen that these patients generally receive, particularly if they're receiving TIL, is a complex combination of lymphodepletion, cell infusion, and IL-2. 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 TIL regimen. However, the TIL 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 TIL regimen, which is the intent, we would expect to see full potency in that setting, and hopefully we'll 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, understood. That's helpful. Thank you very much. Sure.

Our next question comes from Colleen Cousy of Bayard. Your line is open.

Great. Thanks for taking your questions, and congrats on all the progress. So 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, could you indicate whether there might be multiple of one tumor type?

Yeah, thanks, Colleen, for the question. We'll share all of that in more detail, of course, in about a month. But it will be multiple tumor types.

Okay, great. And how long of a follow-up can we expect from the updated AACR?

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

Well, we have been dosing patients now for some time, so there will be the durability in those patients over time. But it's really the initial response that's going to be most important. Okay. 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 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 the delta between the 23 samples that you've run for ATLAS and the 17 manufacturing runs, Can you speak to that? Have those just not started yet or is that for some other reason?

Yeah, Colleen, I'll have, excuse me, Jess handle that question, please.

Yes, 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 have 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 date? I guess, is it possible these patients could be in a different disease state, or will they all have kind of progressing tumors when they get dosed with Gen 11?

That's a question for you, Tom.

Thanks, Jeff. So we do have a manufacturing period, and the patients are selected immediately when they've defined themselves as being refractory, but we then maintain them on a 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 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 of our questions.

Thank you, Colleen.

Thank you. Our next question comes from Gil Bloom of Needham and Company. Your line is open.

Thanks for the update and exciting news coming up at AACR. Maybe another questionable 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. But considering you do have some tissue from these patients, are we going to discuss any biomarker data, you know, things like tumor infiltrating lymphocytes and original tissues, things like that. Thank you.

Gil, thanks for the question. Jess, would you characterize what we'll likely see?

Yes. So, we will be presenting some biomarker data. We have some some work ongoing looking at proliferation and persistence or phenotypes of the cells in the periphery. We have some serum biomarkers that we may be able to include. We do have work ongoing to look at TCR sequencing and tumor infiltration. I can't point you to the availability of the data for that presentation, but it is data that we are generating and we should anticipate.

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

Our next question comes from Joe Panskis of HC Waymar. Your line is open.

Hey, everybody. Good morning. Thanks for taking the question. I want 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, you call it cohort one without lymphodepletion and 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 to yield, say, an effective Th1 response while still potentially having a, you know, regulatory T cells around since you're not lymphodepleting.

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

Well, obviously, Joe, the Biology is complex, but 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 compromise in their functioning. And this regimen would provide limited toxicity and hence would be a good opportunity to test. You know, it would be a breakthrough, as I've said before, if we could provide a friendlier, less intense regimen for the patients. But also being able to show activity of the cells and showing that they are able to penetrate the tumor and induce responses is the key question. But, you know, I do recall while we had 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 TIL type regimen.

Got it. And I appreciate that color, Tom. So I guess I think the answer, Chip, is going to be we'll 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 now?

Yeah, Joe, the first two patients per protocol were in that first cohort and the next three are 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 there's a couple, a bit of a spectrum there with regard to plans, I guess. Is one able to deduce that there's maybe some potential non-dilutive types of arrangements hopefully in discussion?

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 particular transition.

Of course, of course. And then, you know, I would be remiss if I just didn't ask separately, is there any sort of, you know, other than a, you know, status quo right now as to, you know, how Gen 9 is going with sort of potential enrollment and follow-up?

Yeah, no, 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.

Thank you. I'm sure 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 for participating. You may now disconnect. Have a great day.