Compugen Q2 2023 Earnings Call Transcript

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August 7, 2023

There are 10 speakers on the call.

Operator

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Second Quarter 2023 Results Conference Call. At this time, all participants are in a listen only mode. As a reminder, today's call is being recorded. An audio webcast This call will be made available on the Investors section of Compugen's website, www.cgen.com.

Operator

I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

Speaker 1

Thank you, operator, and thank you all for joining us on the call today. Joining me for Compugen for the prepared remarks are Doctor. Anatko Ndiag, President and Chief Executive Officer and Alberto Sessa, Chief Financial Officer. Doctor. Henry Adewoye, Chief Medical Officer and Doctor.

Speaker 1

Ran O'Fir, Chief Scientific Officer will join us for the Q and A. Before we begin, we would like to remind you that during this call, the company may make projections or Forward looking statements regarding future events, business outlook, research and development efforts and the potential outcome, the capabilities of the company's Discovery platform anticipated progress and plans results and time lines for its programs financial and accounting related matters, including projected financial information as well as statements regarding the company's future cash position and other results and the company's future initiatives. We wish to caution you that such statements to reflect only the company's current beliefs, expectations and assumptions, but actual results, performance or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties, which could cause the company's actual results to differ materially from those projected in such forward looking statements, and we refer you to the SEC filings for more details on these risks, including the company's most recent annual report on Form 20 F filed with the SEC on February 28, 2023. The company undertakes no obligation to update projections and forward looking statements in the future.

Speaker 1

And now I'll turn the

Speaker 2

call over to Anant. Thank you, Yvonne. Good morning and good afternoon, everyone, and welcome to our Q2 2023 update. At Compugen, Our goal is to transform the treatment of cancer patients who have no effective treatment option by discovering novel drug targets and developing potential 1st in class drugs. On this front, we were efficiently executing on our differentiated clinical approach to evaluate the benefit of our Monotherapy free, triple cancer immunotherapy combination of COM701, COM902 and pembrolizumab blocking 3 pathways of the genome access, PVRIG, TIGIT and PD-one.

Speaker 2

At ASCO this year, we were excited to see the positive momentum and interest of the industry and the scientific community in targeting the DNAM1 axis as a potential novel approach in treating cancer reflected by our own data and data presented by others including AstraZeneca, Roche and Arcus Looking at the totality of the data we have presented to date in how to treat cancer patients, There was enthusiasm among those we spoke with regarding responses demonstrated with our triple combination approach in patients with microsatellite stable endometrial cancer who had failed standard of care including prior pembro and lenvatinib treatment. For these patients, there were no other treatment options. In 9 patients, we showed an overall response rate of 22% and a disease control rate of 44%. The responses were durable and supported by immune activation better than what one would for COM701 based combinations in patients with other hard to treat tumors, including Microsatellite stable colorectal cancer, platinum resistant ovarian cancer and checkpoint inhibitor Experienced non small cell lung cancer patients. Reflecting on the totality of the data to date In patients typically not responsive to standard of care including immunotherapy, our data suggests that our COM701 based combination has the potential to offer a treatment option with a favorable safety profile for how to treat patients across the spectrum of PD L1 expression levels in patients who are anti PD-one treatment refractory pointing to a potential COM701 mediated mechanism of action.

Speaker 2

Our immediate focus is on expanding our data in 2 indications, platinum resistant ovarian cancer and MSS colorectal cancer while continuing to invest in biomarker discovery which is important efficiently setting our development path forward. However, we believe that the therapeutic potential of COM701 as part of the DNOM-one axis maybe much broader than these two indications. As mentioned earlier, AstraZeneca presented clinical results at ASCO on rilvigostomy, a PD-one digit by Specific antibody derived from our COM902 establishing its safety and pharmacokinetic profile and showing anti tumor activity in patients previously exposed to checkpoint inhibitors and usually not responsive to immunotherapy. AstraZeneca continues to advance risagostimic development In multiple studies, including a Phase II trial in jackpot inhibitor naive non small cell lung cancer patients and a Phase 2 trial in hepatobiliary cancer and previously announced plans to initiate a Phase 3 trial this year. We know that not all anti TIGITs are designed the same and like COM902 which is an anti piggy with reduced assay effect of function, rilzagastomig was engineered to have an inactive assay domain to enhanced anti tumor activity.

Speaker 2

Another program in this FT inactive or reduced effect of function chem is ARQUS anti TIGIT. At ATCO, ARQUS Gilead showed continued improvement in progression free survival First is blocking PD-one alone with a potentially better safety profile to what has been shown to date with Fc Active Anti TIGIT. Another session that gained great interest at ASCO was Roche TIGIT liver cancer data. This is the 3rd randomized trial showing and doubling the progression free survival on top of standard of care and Roche has initiated a Phase III trial in first line hepatocellular cancer based on these results. We were pleased that the discussions of Roche presentation highlighted the potential significance of adding PVRIG blockade in hepatocellular cancer.

Speaker 2

This is another hard to treat indication which may serve as a fit for COM701 treatment. The important role of PVRIG was also called out in another ASCO session on novel approaches to checkpoint inhibitors in which the presenter was intrigued by our data presented by Doctor. Mike Uwemann from MD Anderson at SITC last year showing that blocking PVRIG in combination with PD-one led to responses In unexpected diseases like microsatellite stable colorectal cancer, it is great to see and increased awareness of PVRIG role in cancer immunotherapy. It is important to highlight Compugen's differentiated approach and how we stand out among all the players. Firstly, we have always said that blocking TIGIT may not be enough and that PVRIG may be needed.

Speaker 2

Our discovery of PVRIG and the extensive research we have conducted to test the effect of unlocking its Biological function as a new drug target in the context of the DNAM access supports the need to block it. This belief is consistently being reinforced as we roll out our clinical data across multiple indications. Secondly, we believe we have a potentially best in class reduced Fc effect of function anti TIGIT. The data available today suggest that Fc design of the TIGIT antibody may either not matter or it may be better to have a reduced or inactive Fc domain as we have. And finally, with COM701 and COM902, our 2 wholly owned PVRIG and TIGIT programs, We're the leader in the unique chemotherapy free treatment combination approach of blocking 3 genome access immune checkpoint PVRIG, TIGIT and PD-one with initial clinical data to support our hypothesis.

Speaker 2

Along with a very successful ASCO, I would like to refer to additional progress we have made in the first half of the year. We're advancing patient enrollment in our 2 follow on proof of concept studies. Enrollment in the NSF CRC study is on track to be completed by the end of the year. Enrollment is Slower than planned in the platinum resistant ovarian cancer study, but we believe we can catch up on enrollment with the planned activation of additional sites. As a reminder, the goal of these studies is to obtain more data, help us better understand the contribution of components and build on extensive biomarker work to identify the patients most likely to respond.

Speaker 2

We believe that this strategy provides the fastest way to efficiently set our development path forward and to potentially derisk Our lead assets COM701 and COM902 in these two indications. In May of this year, we presented data on our potential 1st in class anti IL-eighteen binding protein antibody COM-five forty 3, at the CIMT conference, Europe's Annual Immunology Conference. We believe there is excitement around our innovative approach leading to the development of this COM-five forty three program and its potential in addressing immunotherapy resistance. Finally, on the progress in the first half of twenty twenty three, We were delighted with the favorable ruling of the European Patent Office to uphold the broad claims in our PVRIG patent. This ruling of the European Patent Office is a win for our innovation.

Speaker 2

The discovery of PVRIG's role as a novel immune checkpoint and a drug target for cancer. As a company that excels in the discovery of new drug targets, we harnessed a broad patent strategy that takes advantage of our novel target discovery capability. Now moving on to what you should expect to see from us over the second half of the year. First, we plan to report initial findings from our ongoing proof of concept studies by the end of the year and final data at a medical conference in 2024. 2nd, we're expecting to present new translational and initial biomarker data and long term patient follow-up from our platinum resistant ovarian cancer studies presented at EDMARIO last year as well as additional data from our COM-five forty three preclinical program all by the end of the year.

Speaker 2

We also plan to present new data from the metastatic breast cancer study of 17 patients treated with COM701 and nivolumab. Patients were enrolled into this cohort regardless of their ER, PR and HER2 status. These patients were heavily pretreated and has exhausted all available standard treatments, which could include immune checkpoint inhibitors and ABCs. Before handing over to Alberto, I will touch briefly on our finances and then Alberto will go into the details. We have an expected cash run rate for at least the end of 2024, which we believe is sufficient to support all planned operations and reach milestones to potentially de risk our lead assets COM701 701 and COM902.

Speaker 2

In terms of future funding, non dilutive funding of our pipeline assets is our priority. On this front, it is worth noting that the trend in immunotherapy is to combine and treat earlier and we believe the profile of FALID assets COM701 and COM902 make them ideal combination candidates to be used in earlier treatment settings. Additionally, There is increasing excitement around the potential of IL-eighteen pathway modulation in immuno oncology. And with COM-five forty three, we're happy that we have a differentiated approach to potentially harness this cytokine biology for optimal use in treating cancer. Finally, through our partnership with AstraZeneca, we may become eligible for future milestone payments.

Speaker 2

And with that, I will hand over to Alberto for the financial update.

Speaker 3

Thank you, Anat. I'm happy now to summarize our financial results. I will start with our cash balance. As of June 30, 2023, cash, cash equivalents and cash investments were approximately $66,500,000 compared with approximately $83,700,000 as of December 31, 2022, affirming our focus on capital efficiency, while continuing our execution on our DNAM 1 axis hypothesis. The company has no debt.

Speaker 3

We recognize the importance of cash efficiency and we are disciplined in how we deploy our cash resources ensuring we will focus on reaching key milestones with our available cash runway through at least the end of 2020 Expenses for the Q2 of 2023 were in line with our plans. R and D expenses for the Q2 of 2023 were $7,800,000 up from $6,800,000 in the Q2 of 2022. The increase is mainly due to the end of the amortization of deferred participation in R and D expenses on March 31, 2023 and an increase in preclinical NCMC activities associated with planned COM-five zero three activities offset by a decrease in clinical trial expenses, headcount and currency exchange effects. Our G and A expenses for the Q2 of 2023 were $2,400,000 compared to $2,600,000 in the Q2 of 2022. For the Q2 of 2023, net loss was $9,300,000 or $0.11 per basic and diluted share compared to a net loss of $9,100,000 or $0.11 per basic and diluted share in the Q2 of 2022.

Speaker 3

With that, I will hand back to Annette to summarize.

Speaker 2

Thank you, Alberto. To summarize, we continue to execute and deliver on our goals. With our most recent data in For satellite stable endometrial cancer, we continue to provide evidence supporting the potential COM701 mediated clinical benefit in how to treat patients who are not responding to standard of care and failed prior IO therapy. We're looking forward to presenting new translational and initial biomarker data and long term patient follow-up from COM701 combination in ovarian cancer. First data in metastatic breast cancer as well as additional data from our COMFIGHT for 3 preclinical program all by the end of the year.

Speaker 2

We also plan to share initial findings from our 2 ongoing studies in microsatellite stable colorectal cancer and platinum resistant ovarian cancer evaluating our leading triple combination blockade of PVRIG, CG and PD-one with COM701, COM902 and pembrolizumab by the end of the year. The opportunity we have to positively impact the lives of so many motivates every single employee within Compugen every day. With that, I will turn the call over for questions. Operator?

Operator

Thank The first question is from Stephen Willey of Stifel. Please go ahead.

Speaker 4

Hi, good morning. Thanks for taking the questions. I guess just with respect to the Phase II platinum resistant ovarian Cancer study, you talked about enrollment, I guess, going a little bit slower than expected. Are you is that just a function of The kinetics of site activation or do you now need to bring more sites than originally planned online in order to meet The target enrollment goal, which I believe was about 50% before the end of this year.

Speaker 2

Henry, would you like to address this question?

Speaker 5

Yes, Anat. Thank you very much, Steven. So, first, let me say that there's a strong interest by the sites and investigators to participate on this study. There's Strong belief in the hypothesis in inhibiting the DNAM1 axis with the triple combination of pembrolizumab COM701 and COM902. 2, at least based on the results we previously disclosed with the triplets that consisted of COM701, COM701, the BMS digit antibody, nivolumab, 20% response rate as represented at ESMO IO.

Speaker 5

What we've observed is that there is a delay as a result of restricted resources Other sites, resources meaning personnel mainly, change in timing of IRB and ethics coming to review cycles And a few competing studies in the platinum resistant ovarian population also. We are in close contact to the sites And several additional sites are being considered who are more likely to recruit platinum resistant ovarian cancer patients And the other choice to open now, which should get us back on track.

Speaker 4

Okay. And I guess when you think about the year end update, is there some threshold number of patients, specifically in ovarian that you want to have enrolled before you try to communicate Something incremental?

Speaker 2

So maybe I'll take this one. So in general, we're still guiding To the same guidance that we shared that we hope to enroll up to 20 patients by the end of the year. And that's when Henry is saying that We can catch up that what we mean. So we cannot at this point in time estimate Any deviation from the guidance. But obviously, if there will be any, obviously, we'll share that.

Speaker 2

And we believe that We'll be able to share data as planned by the end of the year. I just want to remind that in In any case, we indicated that for the 2 studies, this will be initial data from the study and that As we'll enroll additional patients in the ovarian study in 2024, we'll share the full data disclosure.

Speaker 4

Okay. And then maybe just lastly, I guess, you talked about having, I guess, these 2 data sets To present at a medical conference in 'twenty four. And just kind of wondering internally, Is the goal at this point to be able to make some kind of registrational go forward decision before the end of 2024 On the basis of these two studies, I'm just trying to think about what's kind of the next step here once we get The proof of concept data. Thanks. Yes.

Speaker 2

So maybe I'll start and Henry if you would like to add Please chime in. But basically, the goal of the study from the get go for these two studies was to add more data to the data that we already have in these two indications, which seems promising to us and to assess some of the contribution of components And to build the path towards building a study that will take us to eventually to build the registration path. So that's the goal, yes. And we'll need to see as we go with these studies, what is the data, how it looks like. And as we said previously, it's more than the overall response rate.

Speaker 2

It is the additional A parameters that we're evaluating, the durability, the safety profile, etcetera, this will allow us To gain the understanding how we move forward. Henri, anything to add on this front?

Speaker 5

No. Thank you, Annette. You've covered it all.

Operator

The next question is from Ashthika Gunwarden of Truist Securities. Please go ahead.

Speaker 6

Hey, guys. Good morning. Thanks for taking my questions. I'm going to build on The questions that Steven asked here. So for the update that we're getting for enzyme resistant ovarian cancer by Year end, I know the expectation is the initial data.

Speaker 6

Can you just clarify what kind of I think that the data will be seen in that presentation. And is it still right to assume that this is going to be kind of more as Investor update and not a medical meeting update for the presentation update this year.

Speaker 2

It will be an investor update and not a medical conference update from the 2 new proof of concept studies that we do, yes. We tend to present data in medical conferences from studies that are more completed where we have And more insights.

Speaker 6

Yes. Okay. And And then I've got a question about what efficacy data will be in these 2 updates. Just wanted to try and tease out if you can if there's going to be confirmed scan Or is it just a delivery scan or should we set different expectations?

Speaker 2

Henry, would you like To assist

Speaker 5

you? Yes, Anant. Thank you. The earliest readouts one can get For this, the patient population will be response rates. We obviously will be interested Also in looking at other important clinical endpoints such as duration of response or possibly progression free survival.

Speaker 5

Now that being said, this will depend on enrollment and our ability to catch up like we think we will be able to we project we'll be able To do, but those are the key endpoints, the most important being response rates.

Speaker 6

Got it. And then on the issue with the delays, I totally appreciate that there's some personal restrictions and I'm just wondering, is there any impact of the ADC launch And platinum business in ovarian cancer is also maybe causing any delays here. And then It relates to that, have you seen any delays in recruitments to the colorectal study?

Speaker 5

Henry? Thank you, Asthika. In speaking with the investigators and all the sites that we have, We haven't observed or we haven't reported back to us that the ADCs have contributed meaningfully to the delay that we've just highlighted. Now as you recall last year, the ADC that we're talking about here is mavetuximab, which is Actually, which has accelerated approval in platinum resistant ovarian cancer, that has not been the communication we received back. And that's accelerated approval is also in the restricted biomarker limited population followed receptor alpha positive patient population.

Speaker 5

So that has not been a part of the reason for the minimal delay that we've discussed.

Speaker 6

Got it. And so and just also just want to double check, that's been no delays on the colorectal side, Right. There's no competing product there, but is that recruiting well as well, Dife?

Speaker 5

The sites that we have are Well with colorectal cancer, as you know the patient population with microsatellite stable colorectal cancer is a very underserved one. There are lots of patients unfortunately that are in need of newer therapies for microsatellite stevo colorectal cancer And we haven't experienced that much of a significant delay with that population.

Speaker 7

Hi. This is Jeff LaRosa on for Dana. Thanks for taking our question. Yes. The first is, what do you hope to show the breast cancer update that will be supportive of your plans and strategy in ovarian cancer in MSS CRC?

Speaker 7

And for the initial I mean, the updated translational initial biomarker data in PROC with Bristol's TIGIT, How comparable is this data set to your own study with your TIGIT? Any differences there you could point to? And Regarding the ASCO data in HCC, was that a tumor type that you sort of predicted would be Amenable to PVRG blockade and what's your interest in that indication? Thank you.

Speaker 2

So Henry

Speaker 5

That the patient population that we've enrolled, a patient population that's heterogeneous, with respect to whether they're ERPR positive or ERPR This is a patient population that have exhausted all available standard of care therapies, including therapies that are approved such as TRUDELSI. Now The anti tumor activity and that will confirm to us that There is activity with the combination that we're pursuing with COM701 plus nivolumab. So that's What would be of interest to us, especially in these hard to treat patient population that have possibly received Several lines of therapy.

Speaker 8

Yes. Then for the question about the biomarker. So Yes, we anticipate that the same biomarkers that would inform or that we learn from in the study of the using the BMS digit Should be relevant also for the other studies that we are doing. Both BMS TIGIT and our COM902 are FCON active. And in general, This that was a study of blocking triple blockade of TIGIT PD-one and PVRIG.

Speaker 8

So biologically, it should be very similar to the And if you will identify some new translational or potential predictive biomarkers in that study, we We definitely think it could be and should be relevant also to the follow-up study that we're currently doing. Now about the HCC. So we identified ovarian endometrial as one of the top indication with dominance of the pathway. And that's why we went To these indications also breast, but ATC is definitely one of the top expressers of the pathway. We couldn't start with all of them and PVR2 It's quite broadly expressed in many indications.

Speaker 8

So ATC is definitely an indication in which the pathway is dominant and it's the target indication that definitely see a potential in.

Speaker 2

And just in terms of the whether we're going to test the indication to your specific question. I think that it is being shown by now that the PVRIT blockade potential, the COM701 therapeutic potential is much broader than the 2 indications that we're focusing right now. We took to focus on these 2 indications where we have data and where we Believe that additional data that we will expand with these studies may allow us to better design the path forward. But I want to stress that again and again that there are potential of COM701 is much beyond these two indications and it includes endometrial cancer and non small cell lung cancer And HCC and as we said, we'll present data in breast towards the end of the year. That's very encouraging to us.

Speaker 5

Yes. I think one of the other questions you asked was, if there was any substantive difference between the Triplets that we're currently exploring in the ovarian cancer space, which is the triplets I'm referring to now is COM902 plus COM701 plus pembrolizumab versus the earlier triplets, which is the triplet with the BMS antibody BMS-nine thousand Q7 and nivolumab. We did if you as a reminder, we did have a press release Where we enrolled the 1st patient in to the current triplets of COM902, COM701 and pembrolizumab. And as part of What one of the what we said was that we did not this is one of the investigators on that study. The initial observation is that this combination, which is the pembrolizumab containing triplet of COM902, COM701 Pembrol is very well tolerated as observed at least in the patient population with microsatellite sevaculotrectal cancer In the initial study that we enrolled.

Speaker 5

So there are no differences observed so far. And this is Earlier on, as we enrolled colorectal patients, microsatellite tumor colorectal cancer patients, we do not expect There to be any substantive differences in terms of safety and tolerability. I hope that answers your question.

Speaker 7

It does. Thank you all.

Operator

The next question is from Tony Butler of E. S. Hutton. Please go ahead.

Speaker 9

Good morning. I would like to go back to this notion of PVR 2 dominance at least over PBR, which seems to be a recurring theme in some of the cohorts in which you're Attempting to move forward with the triple combination and in particular of course 701. And that's back to ASCO where you had Some really good data in endometrial cancer. The cutoff, if I recall, was in April. The 2 responses And then to patients who had stable disease.

Speaker 9

And I wondered if there was any additional information on follow-up. That is, were patients actually able to show an additional reduction in tumor size of those responses and or Of those patients who had stable disease. Thank you.

Speaker 2

Eran, would you like to address the PVRL2 portion?

Speaker 8

So the PVRL2 portion, I think that it's not only PVRL2, I mean, in general, it's the PVRG pathway dominance, PVR2 obviously is important part of it. And this is again a measure that we looked at in both endometrial, which have a dominance and also another indication, As mentioned before.

Speaker 2

Henry, anything more to add?

Speaker 5

Nothing more to add to what Elena mentioned.

Speaker 9

But anything more on the patients for additional follow-up that were presented at that time?

Speaker 2

So we are going to present follow-up data on these patients. Remember that When we shared the data in December at that module, December 2022, we had patients that were Still on study treatment, responsive patients, some of them had durability of more than 9 months. We are going to present data by year end, a follow-up data for these patients. So I guess that you will

Speaker 9

And that will and one more thing, I just want to be sure that The endometrial patients, that's what I'm focusing

Speaker 2

on. No, it will relate to the ovarian. Sorry, I misheard your question. It will relate to the ovarian. No, we didn't plan yet to have any follow-up on the ovarian cancer on the endometrial cancer patients.

Operator

This concludes the Q and A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and

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