Compugen Q1 2024 Earnings Call Transcript

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Provided by Quartr
May 20, 2024

There are 9 speakers on the call.

Operator

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's First Quarter 20 4 Results Conference Call. At this time, all participants are in a listen only mode. An audio webcast of this call is available in the Investors section of Compugen's website, www.seagen.com. As a reminder, today's call is being recorded.

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 from Compugen for the prepared remarks are Doctor. Anat Cohen Diag, President and Chief Executive Officer and Alberto Sessa, Chief Financial Officer. Doctor. Michel Malher, Chief Medical Officer and Doctor.

Speaker 1

Ivan Ophir, 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, development efforts and the potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, financial and accounting related matters as well as statements regarding our cash position. We wish to caution you that such statements 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, 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. The company undertakes no obligation to update projections and forward looking statements in the future.

Speaker 1

With that, I now turn the call over to Anat.

Speaker 2

Thank you, Yvonne, and thank you, everyone, for joining us on our Q1 2024 call. Today, I will cover the significant progress we have made across our pipeline in the Q1 of this year and I will then move to our planned catalyst through the rest of 2024. But before I go there, I thought I would start with a question which we frequently get asked. Is Compugen an AI company? And the answer is yes.

Speaker 2

Compugen is a pioneer in computational discovery of novel drug targets and not just in theory, but in practice, which is a significant differentiator. We successfully moved our newly discovered drug target from computer prediction to drug discovery to preclinical and clinical trials, continuously feeding our own pipeline with potential significant opportunities to address cancer immunotherapy resistance. The Gilead deal on COM-five forty three highlights the most recent asset discovered through our computational discovery capability. Our discovery platform is a validated AI ML Powered platform. This platform is the engine fueling our competitive advantage and pipeline and has already delivered multiple fully owned clinical programs, multiple validating strategic partnerships and multiple early stage undisclosed assets, which are expected to feed our future pipeline and the opportunity to deliver long term value creation.

Speaker 2

We plan to speak more on our discovery platform at future events. So now I will move to the focus of today's call. In the Q1 of the year, we again executed on our promises. Firstly, at the annual ASCO conference in June, we will present preliminary antitumor activity of COM701 in combination with COM902 and pembrolizumab in patients with MSS CRC and liver metastasis from our ongoing proof of concept study. Secondly, we completed enrollment of more than 20 patients in our platinum resistant ovarian cancer study and we're on track to report initial findings in the Q4 of year.

Speaker 2

Thirdly, the progress we have made unlocking novel biology of new drug targets and in diversifying our approach to address cancer immunotherapy resistance was reflected by our presentation at the Keystone Symposium and the American Association of Cancer Research Conference in March April this year, along with the publication of our COM-five forty three and PVRIG papers in cancer immunology research. At both conferences, we presented data supporting the unique biology of PVRIG suggesting its role in sensitizing tumors to the other immune checkpoints KGIT and PD-one. And additionally, data supporting the therapeutic potential of our high affinity potential 1st in class anti allylating binding protein antibody COM-five forty three showing its activity localized to the tumor macro environment with a potential advantage of a wider therapeutic window than systemically delivered cytokines. Finally, in the Q1 of 2024, our partner AstraZeneca continued to rapidly advance the development of risagastomid. We're delighted that initiating a second Phase 3 trial TROPION LUNG10 in non squamous non small cell lung cancer.

Speaker 2

The study will assess with zagastomig as monotherapy and in combination with DATO DXD, a TROP-two directed ADC being developed in collaboration with Daiichi Sankyo. Compared to pembrolizumab as first line treatment for patients with advanced or metastatic non squamous line cancer with high PD L1 expression. As a reminder, we recently received a $10,000,000 milestone payment upon dosing of the first patient in the Phase 3 study of the first indication, biliary tract cancer. Under this agreement, we're eligible to receive development milestone payments for the first and second indication. The progress into a second Phase 3 trial addressing a major indication such as non squamous non small cell lung cancer reinforces our partnering strategy to broaden opportunities for our pipeline and brings us closer to realizing additional future milestone payments and royalties.

Speaker 2

As a reminder, the TIGIT component of rivagasumig is derived from our potential best in class anti TIGIT COM902 and both rilvagastomig and COM902 fall in the FcReduced inactive function camp. Moving on now to what's planned for the rest of the year. 2024 is planned to be a catalyst rich year for us with multiple data readouts and updates expected from our diversified portfolio. At ASCO in June, we plan to prevent data from our ongoing proof of concept study in NSF CRC patients, including those with liver metastasis, who have been treated with the the II combination of COM701, COM902 and pembrolizumab. NSX CRC and in particular such patients with liver metastasis represents significant unmet medical need and the hard to treat patient population.

Speaker 2

As stated in 2022, we presented data from our first cohort of 22 patients treated with a dual combination of COM701 and nivolumab and we were the 1st and only company to report responses to IO in this population of patients with liver metastasis, reporting a 12% overall response rate and stable disease in addition to immune activation supporting PVRIG biology and COM701 mechanism of action. Although this indication was not initially selected based on dominant PVRIG pathway expression levels, following this encouraging clinical data and with an aim to assess the strength of our findings in liver metastasis patients in a larger cohort, we initiated our ongoing study in 20 patients with MSS CRC and added our anti TIGIT COM902 to the drug combination to see if we could improve on the responses seen with the drug combination. Recruitment was rapid, reflecting the significant unmet need and we enrolled the last patient in September 23. The data will be presented at the upcoming ASCO on June 1 with a data cutoff date of April 5, 24 and remains supportive of COM701 mediated activity and safety with some patients continuing treatment as the data cut off date. However, with the totality of the data we have in hand, we believe that an IO approach is not the way forward in this notoriously IO resistant patient population of MSR CSC with liver metastases.

Speaker 2

Yet, the total clinical activity observed to date in the 2 evaluated cohorts suggest the effects are COM701 mediated and due to the unique biology of PVRIG may warrant further evaluation of COM701 with other agents in MSS CRC. Therefore, the door remains open for other COM701 combinations in this patient population. However, this will not be the focus of our internal resources at this time. It is important to note that observations made in tumors, which are biologically distinct from each other, such as NSF CRC and platinum resistant ovarian cancer are not considered indicative of each other. With this, I will remind you that we have reported more dominant PVRIG pathway expression levels in ovarian cancer.

Speaker 2

This brings us to our next catalyst. The next catalyst for our triple combination will be the presentation of our data in platinum resistant ovarian cancer for which we have completed enrollment. Data presentation is on track for the Q4 of 2020 4 and our plan is to present this data at a medical conference. We believe the totality of the data we have reported to date in platinum resistant ovarian cancer patients is encouraging compared to the current standard of care. Based on the data we reported at SMIO in December 2022, from the first cohort of 20 platinum resistant ovarian cancer patients treated with triple combination, investigators were excited to report durable shrinking or stabilization of tumors in some of their patients who had previously progressed on all available treatment options.

Speaker 2

We presented a 20% overall response rate with some patients responding for over 16 months, which is favorable considering median duration of response for single agent chemotherapy is around 3 to 4 months and in ADCs is around 6.9 months. Responses were achieved in the hard to treat high grade serous adenocarcinoma patients along with a favorable safety profile. We also presented preliminary biomarker data showing an association between PVRL2 expression and clinical benefit. Of note, we also previously presented data showing COM701 monotherapy activity in a patient with ovarian cancer whose tumor microenvironment was immune desert. This patient has a partial response of more than 18 months.

Speaker 2

For the ongoing study, we plan to present data in the Q4 of the year, including the baseline characteristics, safety, overall response rate, disease control rate, preliminary data on duration of responses and potentially biomarker data. Data showing clinical benefit in platinum resistant ovarian cancer is expected to allow us to pursue the next study towards a path to registration, which depending on data may employ a predictive biomarker enrichment strategy. In addition, we're also on track to submit the IND for COM-five forty three in the second half of this year and expect that IND clearance for which we're eligible for $30,000,000 maximum payments from Gilead will be achieved in 2024. With that expectation, we're in advanced stages of planning the Phase 1 study. Finally, in the second half of this year, AstraZeneca expects data from their Phase onetwo ARTEMIDE 1 trial in non small cell lung cancer in the frontline setting.

Speaker 2

Before passing over to Alberto to go through the financials, I would like to take this opportunity to warmly thank him for his commitment and leadership since he joined us in 2022. Alberto has been a great partner to me and the rest of the team here at Compugen. David Silverman will take over the reins from Alberto as Chief Financial Officer effective August 15. David has experience in the healthcare industry as Chief Financial Officer of a biotech company traded on the NASDAQ and I'm looking forward to introducing you to David when he joins. I also want to emphasize that while benefiting from our solid cash position to enhance and advance competent to additional milestones, we're also financially disciplined.

Speaker 2

We have 2 potential the significant unmet need in immuno oncology. In addition, we have 2 strong validating strategic pharma partners, Gilead and AstraZeneca, on rilbogastimig and COMFACT for 3 respectively and from whom we're eligible to receive future milestone and royalty payments. With that, I will hand over to Alberto for the financial update.

Speaker 3

Thank you, Anat. I'm happy to summarize our financial results. I will start with our cash balance. As of March 31, 2024, we had approximately $101,300,000 in cash compared with approximately $51,100,000 as of December 31, 2023. This cash balance includes $60,000,000 upfront payment from Gilead related to the licensing of COM503 $10,000,000 milestone payment from AstraZeneca on dosing the first patient in the Phase 3 trial in biliary, track cancer.

Speaker 3

We recognize the importance of cash efficiency

Speaker 4

and

Speaker 3

we are disciplined in how we deploy our cash reserves, while making sure we focus on reaching game milestones. We have a cash runway into 2027, taking into account the expected milestones payment of $30,000,000 from Gilead for COM503 IND clearance expected in the second half of twenty twenty four. It is important to emphasize that this does not include any additional potential cash inflow from our partners. I remind you that the company has no debt. Revenue for Q1 2024 were approximately 2.6 $1,000,000 compared to no revenue for the comparable period in 2023.

Speaker 3

The revenue reflects recognition of a portion of the upfront payment from the license agreement with Gilead. Expenses for Q1 of 2024 were in line with our plans. R and D expenses for the Q1 of 2020 4 were $6,400,000 reduced from $7,400,000 in the Q1 of 2023. Our G and A expenses for the Q1 of 2024 were $2,400,000 compared to $2,600,000 in the Q1 of 2023. For the Q1 of 2024, net loss was $7,300,000 or $0.08 per basic and diluted share, compared to a net loss of $9,300,000 or $0.11 per basic and diluted share in the Q1 of 2023.

Speaker 3

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

Speaker 2

Thank you, Alberto. To summarize, COMPIDENCE turns out as a clinical stage immune oncology target discovery pioneer. We're differentiated by our validated discovery platform, which is powered by the mix of human expertise with AI and machine learning to fuel our 1st in class pipeline. We're on track to deliver a catalyst rich 2024 across our diversified pipeline and planning to present data for our COM701, COM902 treatment combination at ASCO in NSF CRC as well as data from our platinum resistant ovarian cancer at the end of the year. We're planning to submit COM-five forty three for IND in the second half of this year and are advancing our planning for the initiation of Phase 1 for this program.

Speaker 2

With the pipeline that is being advanced internally and by our partners, this is an exciting time for Compugen and we believe that we have the fundamentals in place to bring value to our shareholders and cancer patients. I am proud of what we are achieving here at Compugen. I would like to thank all our Compugen colleagues for their collaborative spirit and daily dedication, resulting in a well executed Q1 of the year and setting us up for future success. With that, I will turn the call over for questions. Operator?

Speaker 4

Thank

Operator

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

Speaker 2

Hi, guys. This is Julie on for Steve. Thank you for taking my question and congrats on the progress. We just have two questions on our end. The first one is related to colorectal trial.

Speaker 2

So I know that ASCO abstracts will be available this week, but when it comes to the actual presentation, how much additional incremental details should we expect in the actual presentation versus abstract? And following this presentation, what would be a path forward for this study? And the second question would be related to IND submission for this asset? Thank you.

Operator

[

Speaker 2

IND submission for this alpha? Thank you. So maybe thank you. And maybe I'll start with a second question for COM-five forty three. This decision of disclosing clinical data from a Phase I study will be taken in collaboration with Gilead.

Speaker 2

This is an asset that was licensed to Gilead. And I cannot commit on their behalf and we'll give some guidance when we'll know. But obviously before that we'll need to file the IND and initiate the study, which filing is expected the second half of this year. And for the CRC data, yes, the abstract is going to be out this week and the presentation of data will be June 1 for Compugen. It will be a data worth 20 patients enrolled and we share the antigen or activity, durability, translational data, safety, etcetera, and obviously patient baseline characteristics.

Speaker 2

And as we've already stated, the data is supportive of anti tumor activity of COM701, is supportive of COM701 mechanism of action, PVRIT biology. But we believe based on the data and this is the guidance that we shared today, it was important for us to share the guidance at the time that we know what is the decision that we've already took is that we believe that IOIO only combinations would not be the right way to target MSF CRC with liver mass population, which as you know in line consists of 70% of the patient population. We believe that that's not the right path and we decide that while there could be a path forward for COM701 in NSF CRC with liver, MET, maybe in other combinations or maybe even in earlier lines, we're not taking this path forward at this point in time.

Operator

The next question is from Asthika Gurdwajan of Truist Securities. Please go ahead.

Speaker 5

Hi, guys. Good morning and thanks for taking my questions. So maybe wanted to just dig in a little bit more here on colorectal and I'd like maybe you and Niran to comment on what do you think is missing here? It sounds like you're resilient that 701 biology is active, but maybe if you can help us understand what did you need more immune activation and less maybe less checkpoint blockade, but maybe more debulking? What exactly was the missing moment here given the encouraging activity we saw earlier for this approach?

Speaker 5

And then beyond ovarian for 701, 902, how should we think about the other avenues that you're going to pursue this combination? Is there a next priority to maybe revive efforts in CRC, but with a different combination to maybe address what's missing? Or have you identified another tumor type that you would like to take into? Thanks.

Speaker 2

Okay. Thanks, Asthita. I'll start by saying that, look, we can't get really to the specifics of the data and maybe this discussion will be worth to be taken following the presentation in June 1. Maybe Eran wants to add, but I'll just say that with ILO only, we believe that what we see is not enough in order to pursue. But maybe Eran, do you want to say anything about it more than that?

Speaker 6

Yes. So with the unique biology of PVRIG and what you have seen previously, definitely we see activity in places where normally checkpoints are not working in MSS CRC, liver metastases, immune modulation, increase in T cells. But we've seen it in part with the patients, right? And eventually, move forward, you need to have sufficient activity and sufficient amount of the patients to really consider to go towards approval. And as you understand what we see in the pure IO combination of the triplet, in this very difficult and not immunogenic indication, what you have seen is not enough to convince ourselves to move forward as is.

Speaker 6

And yes, as discussed, maybe not at this point in time, but there are other rational based combinations that could be employed to increase IO activity in this kind of difficult indication and this is something to consider for the future, but again, not

Speaker 2

at this point in time. And then actually takes me to your second question about additional tumor types. I think that with the data that we have in hand on COM701 activity in non inflamed tumor types across indications where PD-one is really not the populations are not responsive to the PD-one inhibition or very or responsive to a very low extent. We have data across indications and COM701 is active. And other than putting the resources and focusing now on platinum resistant ovarian cancer, which we really have a package of data and additional 20 or more than 20 patients worth of data will really help us make decision about how to move forward there.

Speaker 2

I think that the field is open for us for different type of path in the non inflamed indications. Also in the inflamed indications, obviously, we've never tested inflamed indications and we had a reason why we didn't do it. PVRIG Biology gave us an edge in this non inflamed indications and we could prove COM701 activity in combination in single arm studies without asking the question, is it PD-one inhibition that is generating this activity? And we could do all the work and show in batches that this is concentrated on mechanism of action. And also another path is to combine with the non IO combinations.

Speaker 2

But really, we are now at the step that we're focusing in platinum resistant ovarian cancer, and we will make the decisions during the year how we move forward in this indication.

Speaker 6

And maybe I would add that maybe I would just add that in addition to what we're focusing on at the moment, we pre identify few indications with dominant p. Verdipathy. Ovarian is one of those, there are other indications, for example, like non small cell lung cancer, as Anat mentioned, more inflamed settings. So definitely there are multiple opportunities. And combining this with safety profile of COM701 that really will enable us safe combinations maybe in other indication, maybe in early line.

Speaker 6

So again, the opportunities are there and there are quite a few, but we are focusing now on the ovarian cancer, which we have seen in our quite promising data.

Speaker 5

Thanks guys.

Operator

The next question is from Dana Graybosch of Leerink. Please go ahead.

Speaker 7

Hi, thank you for the question. I'm going to continue this line of discussion on your strategy for PVRIG going forward. And in ovarian, in particular, I wonder how you're considering combining with other standard of care agents like chemotherapy or VEGF, sevacizumab? And just reflecting on the path in colorectal, there's one path that is seeing if you can get a pure IO therapy to work, and there's another path others have taken in these difficult tumors to do combination and of course to get that signal that takes a different kind of study. And I wonder how you're considering that.

Speaker 7

And it reminds me that at one point, you had planned a chemo combination I think in lung cancer, and I'm not sure you ever started enrolling that. So again, remind us why you didn't start enrolling that and what a path a specific path you would see in lung cancer should we get to that point? Thank you.

Speaker 2

Thank you, Dana. I'll start and Niran and Michel, feel free to chime in. I'll start with the ovarian. First, I'll say that you've asked us about combinations. And first, I'll say that we're focused on this IO combination that we're pursuing now.

Speaker 2

And with the package of data that we have, with the initial biomarker correlation, we feel that if data will repeat itself, we see clinical benefits and there is a path forward for us targeting different type of patient population, those that are progressing on ADCs and those that are or standard of care and those that are ineligible. Having said that, it is true that combination with chemo, VEGF, ABCs may be relevant. And this is really from based on the mechanism of action of PVRIG being combined with the cytotoxic agent. And also from the safety profile as Arain mentioned to Stika. So this is on the ovarian front and while we will focus on ovarian and get the data from this study, we can decide how we move forward taking into consideration the competitive landscape, obviously, ovarian cancer.

Speaker 2

With CRC, and as I said, I'll let Ron and Michel as he wants on each of the indications. But in CRC, I think that while we see a possibility of moving forward in this indication in combination with standard of care, again, here mechanistically and safety wise or in earlier lines, I think that the risk profile and this is for this stage of the company, the risk profile in MSS CRC, we deliver met and is a profile that we saw that at this time, we shouldn't focus and put our resources, but still this door is open to being pursued in the future. So that's for CRC.

Speaker 7

And I didn't ask about CRC. I asked about non small cell lung cancer. What would be

Speaker 1

potential going forward there?

Speaker 2

That's okay. Sorry. Yes. And this is correct that we plan at a certain point in time to move based on the data that we have that Taran mentioned, data in patients that already experienced checkpoint blockade. We had very nice data, 7 patients though, but very nice data.

Speaker 2

And we thought of pursuing non small cell lung cancer with the therapy as a small study. The reason that we decided to focus on the non inflamed indications at the end of the day was the fact that we were with the cash indications that we had at that time, we decided to focus on indications where we will not need large studies in order to prove the activity of COM701 combinations, single arm small studies that we can tease out the contribution of COM701 quickly and move forward. This is still on the table. And as I said, as a company in general, we're thinking about indications that we can pursue internally by ourselves. An indication that we may pursue, as I was saying all the time, partnering is also a priority for us and larger indications that could be pursued in partnerships.

Speaker 2

And Eran, Michel, anything to add in ovarian and non small cell lung cancer combinations?

Speaker 4

Go ahead. I was just going to emphasis again what you were saying, Anant, because when we look across the indications that we've presented data in, we definitely do see a effect driven by COM701. So I think that there are opportunities, even within other indications like endometrial breath where we've presented data before and we are considering a lot of different options to have a more robust sort of strategy moving forward.

Speaker 6

And I think at this point in time, we're focusing on the pure IO. We have strong data from preclinical to clinical. This is really strong immune modulating regime that have an excellent safety profile. It's chemo free, it's really attractive and the data we've seen in the now in ovarian and some of the other indications really pushes us to continue and explore this IO pure definitely an approach and there's a definitely an approach and there's a rationale for that. I mean, with the unique biology of PVRIG, the ability to prime new T cells is there is a rush to combine with ADCs of chemotherapy with the enhanced immunogenicity that can enhance the rationale to combine with bev with the effects of T cell infiltration.

Speaker 6

So moving forward, we definitely consider the data, the indication and other rationale based indication that we may consider in the future.

Operator

The next question is from Tony Butler of Rodman and Renshaw.

Speaker 8

Annette, with respect to the ovarian cancer, data set that's forthcoming, will data also patients who are actually segmented by positivity with PVR L2? That's part A of that question. Number 2 is, you mentioned a biomarker strategy, I believe, for moving forward with a larger potentially registrational trial. Have you settled on and this may be far on, have you settled on an H scores? I recall, those individuals who had clinical benefit had age scores that were, I guess, relatively high, 300 or so.

Speaker 8

And then the 3rd point is, while I assume all ovarian cancer patients will have had bev, is there a reason why you wouldn't they would not want to stay on bev, even if in fact it has marginal activity, certainly at single agent. Thank you very much. And one last point, is 20% the hurdle rate that for which we should be looking toward or forward toward the Q4 for that data set? Thanks.

Speaker 2

Thank you, Tommy. So I'll let Michel answer the best question. I'll start with what you asked about the biomarker and later on relate to the h score. First, I'll say that in terms of the data, yes, we presented data that relates to the activity, to the efficacy, the durability, translational, the data that we'll have in hand. We also anticipate to share PVRL2 biomarker data, obviously, I will say before I let the run relate to the 8 score, And we'll say before I let around relate to the 8 score, I will say that we will look at the data and different bars of data will allow us to make a decision.

Speaker 2

Do we go with or without the biomarker? We're not limiting ourselves to a biomarker. This is an enrichment strategy that may help. It will depend on the data that we have in hand, but we are not ruling out a study that will not be biomarker driven, maybe a study that we still continue to assess the biomarker finding. It really depends on the data that we'll have in hand.

Speaker 2

Eran, do you want to take the ASCO one? Yes.

Speaker 6

So yes, Tony, remember correctly. This is a very important observation for our previous study, in which we showed that the patient who responded had clinical benefit from the treatment of the COM701 combination had higher age score of pvL2, and this opened the door for a potential biomarker, yes, to enrich for these patients who have long durable responses and then, of course, to move to registration faster and all the benefits of having a biomarker. So this work is ongoing also in this study. To define the cutoff, obviously, we need to show also in this study that the phenomena of PC cells, we need to really define looking and now we'll have much more patients combining the studies together. We can really look at the totality of the data, the response rate, the correlation to the ACE score and then to define the actual cutoff if and when we will move forward with the biomarker selected study.

Speaker 6

So this is ongoing, yes.

Speaker 4

Do you want me to comment on the best? Yes. Go ahead. Yes. So in the initial lines of treatment in these patients, they do get bevacizumab together with platinum.

Speaker 4

Platinums are basically mainstay of therapy in the ovarian cancer population. Generally, if a patient does relapse following a full regimen, which includes bevacizumab maintenance, they may get put on to the PARP inhibitors as second line or sometimes they'll do it in the other way around. They generally are not repeated they might repeat this, but it's really more repeating the platinum agents until the patient becomes resistant. So that's defined by a platinum free interval of 6 months or less. And the patients that have been enrolled on our studies so far are the platinum resistant patient population.

Speaker 8

Thank you very much.

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