Q2 2022 Compugen Ltd Earnings Call

Unknown Executive: and operating officer. For the Q&A session, we will also be joined by Dr. Henry Adewoy, Chief Medical Officer, and Dr. Iran O'Fair, Senior Vice President of Research and Drug Discovery. Before we begin, we would like to remind you that during this call, the company may make projections, our forward-looking statements regarding future events, the business outlook, development efforts and their potential outcome, the company's discovery platform, anticipated progress, results, and timelines for our programs, financial and accounting-related matters, as well as statements regarding our cash. We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions.

Unknown Executive: actual results, performance, or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainty, and we refer you to the SEC filing for more details on these risks, including the company's most recent annual report on Form 20F, filed with the SEC on February 28, 2021. The company undertakes no obligation to update projections and forward-looking statements in the future.

Unknown Executive: With this, I will now turn the call over to an hour. Thank you, Yvonne. Good morning and good afternoon, everyone, and welcome to our second quarter 2022 update. Today's call will focus on the strategic decision we have taken to move the company forward with an anticipated extended cash runway through the end of 2024. I am happy to say that we continue to execute on all fronts and have made significant progress. We now have sufficient insights to focus on two prioritized indications and wind down the existing cohort expansion studies in our current Phase 1 program.

Unknown Executive: Our focus development plan resulted in the strategic decision to wind down these studies, resulting in the conclusion of our collaboration with Bristol-Mess. I would like to thank them for our productive interaction and for supplying Mivalumab and their anti-tigyth antibodies for our Phase 1 program, enabling us to initiate the triple and dual combination studies to evaluate our dinam axis hypothesis at a time when our own differentiated anti-tigic common I would also like to thank all the investigators, support staff, and patients who participated in our studies today.

Unknown Executive: I believe that our strategic decision to move forward and prioritize two indications while ending the current Phase 1 studies is the right thing to do at this time. We at CompuGent believe that it is the optimal path forward for our company. We believe that this decision will enable faster value creation for our stakeholders and reflect better use of our current resources for the benefit of patients for the following reasons.

Unknown Executive: It gives us flexibility and allows us to be nimble and move quickly and efficiently to focus on two prioritized indications that we believe offer the highest probability of success and may support the future path to registration. Second, under these market conditions, it reduces the risk posed by a further broad assessment of three large parallel studies in hard-to-treat immune checkpoint inhibitor-insensitive indications and with patients who have exhausted all treatment options. Third, it extends our cash runway through the end of 2024.

Unknown Executive: Fourth, it enables us to leverage the combination of our own in-house clinical stage, potentially first-in-class anti-PVRIG antibody com 701 and switch to and develop our differentiated anti-tigy antibody com 911. And finally, it gives us flexibility and provides us with the greatest opportunity to advance and partner our clinical assets and support a future path to registration. I'm excited about what we have achieved and what we can achieve, and I look forward to focusing on execution and delivering value.

Unknown Executive: During today's call, I will reiterate the belief we have in our already stated, differentiated clinical strategy. Provide the rationale behind our strategic decision to conclude our current Phase 1 program early, our choice of prioritized indications and pass forward, and I will also briefly touch on progress in our preclinical pipeline. Ari will then review second quarter financials, and I will close with a few remarks. Starting with our differentiated clinical strategy, Compagent has done groundbreaking work to identify and develop two proprietary, novel, Indian checkpoint inhibitors that have the potential to be first in class and best in class. Com 701, an anti-PVRIG monocronal antibody, and Com 902, an anti-Tig monocronal antibody. As a company with vast experience on this path, our narrative remains the same.

Unknown Executive: We have a differentiated clinical strategy in uncharted territory supported by strong science. Configen is the only company studying the triple blockade of the Dinaaxis, targeting PDRIG, TIG, and PD1 in the clinic. We're leading the way, and others are following.

Unknown Executive: We recognize that targeting TIG is a competitive space, with the most advanced programs already being evaluated by pharma in phase-free studies. This is testament to the promise of modulating this pathway to enhance anti-tumor immune responses. Importantly, we believe that not all digits are the same, and we were the first company to present clinical data with an IG4 entity antibody with low FTA effect or function, and we have good reason to believe this is the right design to pursue.

Unknown Executive: And, in contrast to others, we have shown clinically that Com902 avoids depletion of CD8 plus T cells, the cells important for anti-tumor activity. We believe the IDG4 backbone may come with additional efficacy and safety benefits to be confirmed in the clinic. We have also stated that blocking only part of this act may not be enough.

Unknown Executive: Based on our groundbreaking science, demonstrating unique biology for PVRID versus other checkpoint inhibitors, and the early clinical and translational data we have presented to date, we believe targeting PVRID may be the missing piece by creating a more inflamed environment. In our Com-701 monotherapy and combination studies with Nivalum presented at ASCO in 2021, we showed partial responses or stable durable disease in patients with low expression of PDL1 tumors that are less inflamed and generally less responsive to approved checkpoints. In addition, we showed that triple combination treatment was associated with potent immune activation greater than what was seen with mono or dual therapy.

Unknown Executive: Next, moving to our strategic decision to advance two prioritized indications and end our Phase 1 cohort expansion study. Our Phase 1 cohort expansion program was designed to allow us to systematically evaluate our hypothesis that simultaneously blocking three pathways, PDRIG, digit, and PD1, in selected tumor types could extend the reach of cancer immunotherapy. We also included studies testing subsets of these three pathways by blocking only two pathways and pursuing these studies in overlapping indications with an intention to learn as much as possible about the dominance of the various pathways and the contribution of components in the hardest-to-treat tumor types.

Unknown Executive: In selected tumor types, we identified initial signals of anti-tumor activity and insights into the contribution of components in overlapping indications. In cases where part of the translational work has been performed, we were able to detect immune activation suggesting a com-701 mediated mechanism of X2.

Unknown Executive: We believe the initial signals of antitumor activity that we're seeing with Com 7-1, along with changes occurring in the tumor microenvironment in some of the hard-to-treat checkpoint non-responsive indications support further evaluation with Com 7-1. To this end, we have decided to move on independently and with more flexibility, with two prioritized indications, which we believe offer a higher probability of success and may support a future path to registry. One, in a less-infl inflamed tumor, microsatellite-stable colorectal cancer, with a low bar to beat compared to standard of care, but a tumor type that reflects a higher risk as it has so far been immunologically unresponsed.

Unknown Executive: The second is an inflane tumor, non-ferraline cancer in NTPD1 treated patients. These tumor types are more immunologically responsive and therefore may present a more permissive environment for denium access activity. Going back to Microsatellite Stable Colorexel Cancer, there is no approved therapy specifically for this patient population, and immune checkpoint inhibitors have demonstrated limited or no activity in this patient population. Treatment in a third-line or greater setting is typically regoraphineb or lawnserve, which has an overall response rate of 1%, median progression-free survival of two months, and median overall survival of 6 to 7 months.

Unknown Executive: Also note, Fembrolysmab monotherapy has shown 0% response in this population, improving only to an overall response rate of 6% in combination with antilegs. As of today, we have presented data in third-line or greater settings from 12 patients, using various doses of Com701 with or without Nivulub across studies, and we have shown encouraging preliminary antitur activity with an overall response rate of 8%, including one partial response of 44 Our clinical data from the Com-Sebanonov-Ovulomab dose escalation and court extension study in a small number of MSSCRC patients show a modestly higher response rate compared to what has been reported for standard of care.

Unknown Executive: We believe that this initial data, along with the translational package showing Com-701-driven mechanism in MSCRC patients, warrants further evaluation of Com71 triple combinations in the Single Arm Study. Next, Nothomacillin Cancer, an indication we selected as high priority due to the clinical landscape and regulatory considerations. As an inflamed tumor type, sensitive to PD1, and possibly TG checkpoint, Nontocelan cancer may have an increased probability of responding to our triplet combinations.

Unknown Executive: We specifically plan to focus on post, NTP1, Nounseline Cancer, patients, as he describes a high-hand and the patient population where positive data may allow us to more easily exemplify the uniqueness of our drugs in a single-armed triple combination study, as opposed to a first-line patient population study where the response rates and duration of response are already high with other checkpoints. In addition, a first-line setting presents significant hurdles in patients' enrollment due to competitive reasons and therefore may present a risk of delay to reach data readout marks.

Unknown Executive: In parallel to this triplet checkpoint study, we also plan to separately evaluate the blockade of PDRIG and TIG in combination with standard of care in this patient population. This will allow us to build an additional path to randomized studies and generate insights regarding Dynamaxist activity in the presence of chemotherapy. As previously communicated, we plan to share the microsatellite-stable colorectal cancer data from the Com71 Evolume Up cohort in Q4.

Unknown Executive: Given our strategic decision to end the cohort expansion studies early, a year and a half prior to projected completion of enrollment, and focus our efforts on the prioritized indications, we do not currently plan to present data from the other court. Instead, our focus will be on effective execution of our studies for these prioritized indications, continuing our track record in execution. We plan to expand the protocol of the existing Com 71 plus Com902 study and conduct the three single-arm studies. Each will consist of up to 20 patients with an aim to enrich for patients who are most likely to respond, based on the data we have, what has been reported by others, and discussions with key experts in this case.

Unknown Executive: The details of the design and the timelines will be shared once finalized in the fourth quarter of this year. We plan to share initial findings and progress of these studies during 2020. Moving on to our core research programs, competent scientists are pioneers. We continue to do groundbreaking work focusing on modulating the immune suppressive cells in the tumor microenvironment.

Unknown Executive: We are advancing several early stage programs, all predicted by our computational discovery capability, with one program entering pre-I&D enabling studies with first-in-class potential. We're very excited about this program, which is targeting a soluble immune checkpoint upregulated in the tumor microenvironment in response to interferon gamma. He developed a very high affinity antibody, Comphiphal, to block these targeted soluble immune checkpoint pathways, and we believe we're the first. We have demonstrated preclinical in vitro and in vivo activity as monotherapy and in combination across various models.

Unknown Executive: We plan to share details on this program in the fourth quarter of this year. And finally, Confident closed the quarter ended June 30 with $97 million in cash. This strong financial position should allow us to execute on our clinical plans and support our operations through the end of 2024. Before I pass over to Ari, I want to take a moment to thank the entire team for their dedication and commitment to the company during the second quarter of the year.

Unknown Executive: I also would like to thank Ari, who has agreed to continue to support Comfigen while we are in the process of identifying its success. Thank you, Anato. Our financial results for the second quarter of 2022 are in line with our forecast and working plan. As of June 30, 2022, we had approximately $97 million in cash compared with approximately $118 million of cash as of December 31st, 2021. The cash balance at the end of 2022 is expected to be in the range of $72 to $74 million. The company has no debt.

Unknown Executive: As a result of our decision to end our Phase 1 program and focus on two prioritized indications, we expect our ongoing cash expenditures starting in 2023 will be lower by approximately 20% than the current run rate, which is expected to extend the cash runway through the end of 2024. We reported a net loss for the second quarter of 2022 of $9.1 million, or 11 cents per basic and diluted share, compared with a net level of $9.5 million, or 11 cents per basic and diluted share, in the comparable period of 2021.

Unknown Executive: Research and Development expenses for the second quarter of 2022 were $6.8 million, which reflects no change from the comparable period in 2021. Our current level of R&D expenses reflect the activities associated with the various ongoing clinical studies, as well as expenses associated with our earlier stage program. Going into the second half of 2022, the reduction in expenses is expected to be limited and will reflect winding down expenses for the current ongoing studies as well as preparation for the new plan prioritized studies.

Unknown Executive: We expect that the full effect of the reduction in expenses will be reflected only in 2023. Regarding G&A. G&X expenses for the second quarter ended June 30, 2022, were $2.6 million, compared with approximately $2.7 million for the comparable period in 2021.

Unknown Executive: Now, I will turn the call back to another. In closing, Compton has done groundbreaking work on the DINAM hypothesis and is well positioned to be a leader in this new area of cancer immunotherapy. We have taken the decisive action to focus our resources on two prioritized indications, taking advantage of having two fully owned clinical assets. Results will guide our future path to registration, and we plan to share progress and initial findings from these studies during 2020.

Unknown Executive: We're making progress on our preclinical pipeline and are very excited about our lead program, which has first-in-class potential. We expect to provide more detail by the end of the year. We have a strong balance sheet with a cash balance of $97 million that will support our clinical program and our operations through the end of 2025. I firmly believe we have the right talent to be successful. We have adapted in response to the challenging market conditions, and I believe that with the potential value for us and the extension of our cash runways through the end of 2024, we are now better positioned to bring value to our shareholders. I'm enthusiastic about what is to come for CompiGEN and look forward to updating you on our progress throughout the rest of the year. Thank you all for joining us today and taking the time to follow the

Operator: Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to decline from the polling process, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers.

Operator: Please stand by while we poll for your questions. The first question is from Stephen Wiley of Stifle. Please go ahead.

Bonnie Quatch: Hi, this is Bonnie Quatch on behalf of Steve Wiley at Cefell. Was the non-small lung cancer indication previously earmarked as a tumor type of interest for any of these expansion cohort combo trials, both the doublet and the triplet? And if not, does this represent a change in the PVRL2 expression-guided selection of tumor types for DENM-1 pathway inhibition? I know the CRC indication was selected not because of PBRL2 expression but because of CBRL2 expression, but because of CERC. Signals you observed in the phase one dose expansion results.

Unknown Executive: So, non-smolecular cell and cancer was always an indication that we were stating that it's an indication where the PVRIG pathway should be active. And I will later on and share some of the data that was leading us to this. And also, we were testing the non-socellal and cancer indication in the monotherapy, small monotherapy study that we did, and we shared the data, and I will let Henry also relate to it as well

Unknown Executive: So, no, non-fone cancer is totally not a change. And the reason that we decided to move forward with this indication is really an indication, that is, an inflamed indication where we saw that TVRID from the beginning should work, and that we have some data that is encouraging. There is already some data in the public domain that makes sense for us to follow.

Unknown Executive: The fact that it is an inflammation indication is very different from the cohort studies that we were pursuing as part of the expansion cohort studies, which were focused only on how to treat patient populations and check post-insensitive. So this is an addition, but it's totally not a situation where it was not predicted to begin with. Iran, do you want to add anything about? Yeah, actually, non-small cell was definitely identified by us as one of the top indications initially from the beginning, also published in our papers that non-small cell, along with Aryan, and others, as one of the indications which has the highest expression of the pathway. And I will have to Henry describe a bit the results that you already showed for a small cell.

Henry Adewoye: Yes, thank you so much, Iran, and Annan. So we're doing those.

Henry Adewoye: So during this escalation, and we've reported this data also at ASCO in the last couple of years, we observed that we had five subjects with stable disease of the seven subjects that were enrolled into the study during this escalation. And these subjects had durable, stable disease with at least two of those subjects, which had durable stable disease for at least six months or more. The other thing that we did observe was that, and we've reported on the issues that this causes, these subjects appear to have done very well, and we've gone back to look at the therapies that they received, and all have received immune checkpoints. So those are the things that led us to confirm that there seems to be a signal also in post-I.O. Non-smorselaer lung cancer, supported by the preclinical data that Eran has assessed. Thank you.

Unknown Executive: Okay, good, thanks. And since you've indicated that you'll still be evaluating a triplet combination, does this mean that you're interested in securing another clinical collaboration to gain access to an anti-PD1 antibody? And who's to say that M.I. previously had the right to first with Gusal on any Com-7-01 partnership, so does that remain with the conclusion of the clinical collaboration?

Unknown Executive: So, yes, I mean, from the perspective of having access to PD1, not necessarily for these studies, we don't have to have a partner. We're not ruling out entering into additional collaborations in the future on this asset, obviously. But, no, these are small studies, very focused, designed well in order to maximize the effect and in order to make sure that we have the highest probability of success. And when we were stating in the prepared remarks that we can extend the cash runway, et cetera, everything is built into it, and we're taking it into consideration.

Unknown Executive: So, no, not necessarily, but as I said, we're not ruling it out. In terms of the right of first negotiation for Bristol or any other rights, know that the collaboration is over, we're independent, and we will keep the flexibility that we have in order to do the studies at the right pace and with a sense of urgency for a small company.

Unknown Executive: Okay, great. Thank you for taking my questions.

Operator: The next question is from Mark Reidenbach of Oppenheimer. Please go ahead.

Mark Alan Breidenbach: Hey, thanks for taking the questions and congrats on coming to this strategic decision.

Unknown Executive: I guess we're

Unknown Executive: helpful maybe, um, Maybe for a knot or Iran, maybe, to highlight any key mechanistic differences between Com-902 and the Bristlemaier squid-pidid antibody, both in terms of effects on immune cells.

Unknown Executive: digit antibody

Unknown Executive: Why should we expect one to behave differently from the other?

Unknown Executive: in the clinic. And then another question I had, I think I heard and not mentioned, there was an

Unknown Executive: mentioned there was an 8% overall response rate in MSCRC patients from your prior trials. I just wanted to make sure that's not inclusive of the expansion cohort that you've been running that we're expecting to see some data from in fourth court. Thank you. Correct. I'll relate first to your second question.

Unknown Executive: Correct. This is not included. Yeah, and for commonwealth two versus BMSTG. So first of all, the fact is that the BMS digit is I mutated, and commonwealth is IG4. Now relating more generally to commonwealth two without the comparison of specific to BMST for obvious reasons. But when you compare commonwealth two to most of the leading assets of other competitors, what we have seen and presented is that commonwealth has better affinity, better blocking, as good or high, as good or better functional activity in enhancing T-cell activation. So in general, we have a high-affinity antibody, so we were able to saturate, we also presented that, saturated the target at a low concentration, and we think we have the potential to be the best in class.

Operator: The next question is from Ostdicka Gunwarden of Truest Securities. Please go ahead.

Operator: Hello, this is Anj Kaner on for Ostica at Truett.

Anj Kaner: What's going to happen to the endometrial and ovarian cohorts now that CRC is a non-small seller priority? I know previously,

Unknown Executive: said that enrollment across all courts, about 20 patients each, was projected for the end

Unknown Executive: 2023, so does that still hold for endometrial and ovarian cancer? And then, secondly, how many patients' worth of data should we expect in 4?

Unknown Executive: Should we expect in 4Q, 4CRC? Is that about 20 as well? And how much fall off do those patients have?

Unknown Executive: So, yes, as we stated today, we're going to close the cohort in the expansion studies, in all the studies. It's a decision that we are taking a year and a half before the end of the study. You are correct.

Unknown Executive: The completion of enrollment was scheduled for the end of 2023. I think that, you know, I'll say to the management that the decisions that were taken are really well informed but bold and decisive, and we didn't think that, with the insights that we have and with the market conditions and the fact that we can focus on the triplet and T-indications, that's the right way to go. So this is what we do.

Unknown Executive: We will close the studies. Obviously, we'll take care not to harm any patients; the patients that are on the study or are about to be enrolled are going to be enrolled. We are working very closely with Bristol-Maskweb. In general, I'll have to say, I was saying it in my prepared remarks, but I still say that we thank them a lot. It was a fruitful collaboration, and they supported us, and we learned from each other.

Unknown Executive: But now is the time for us to move ahead and move into focus studies well-informed, and to execute, as I said, as a small biote company quickly. So this is it. And for the Q4 data, yes, we repeated the guidance that we gave, is the CRC data from the Com-701 new volume of study and into an extension cohort of 20 patients. Whatever insights that we'll have on CRC, we will share. Obviously, this will inform the design of the study that we're aiming to do, so we're on it.

Unknown Executive: Great, and then just to follow up, so for the 701 monotherapy, the ovarian, breast, and endometrial cohorts are those

Unknown Executive: Are those still going to be enrolling at some point, or are those going to be closed as well? So the monotherapy, the small monotherapy study that we did with the five indications, they already completed enrollment long ago, and we shared all the data from this study.

Unknown Executive: So, no, the studies that are currently ongoing and will be closed are the triplet and the 2W. Okay, so we can expect further development of ovarian, breast, and endometrial cancers, just to clarify, to the 7-1 level. Not at this point in time, though.

Unknown Executive: Currently, we follow the insights, and we'll focus on CRC. We want to add an inflamed indication, which makes sense for us to add. We're flexible enough to move forward on these two indications, and this is what we will do. And it doesn't mean that in the future, we're not going to open additional studies in additional indications, but for right now, this is the right decision for us. Perfect. Thank you so much. I appreciate it.

Operator: The next question is from Tony Butler of Ross Capital. Please go ahead. Thanks very much. And that just, I want to clarify the Bristol Collaborate, ending the Bristol Collaboration, still, CompuGent will still receive or be able to obtain Nevolumab; in other words, you will not need to actually pay Bristol for Nebola map in the subsequent studies in non-small cell lung cancer and ERC. That's question one; I just want to clarify. And then in question two, Iran said:

Unknown Executive: set this, but I partially said this, but I want to clarify again.

Unknown Executive: Non-smush lung cancer was a PBRL2 high-expressing tumor. What about CRC, it being a non-inflamed tumor? Is it, generally speaking, post-190, let's just call it the third and subsequent lines of therapy, also have very high levels of PBRL2, similar to that in non-small cell lung cancer.

Unknown Executive: So I will start with an Evo question. First, we will share the design. It is not given that it will be Nivo that we pick.

Unknown Executive: There are different considerations, and this is not one of them. We were concluding the collaboration with Bristol-Mare-S quibb. So we have a good relationship, definitely, but we have no additional arrangements that are following this determination, and we will buy the PD1 checkpoint that we will pick to use, that we will share, obviously. And as I said, the cost to buy the PD1 inhibitor is already calculated into the resources that we will need for these studies, and it is already calculated in what we were saying, that we were extending the cash until the end of 2024. All of it is already calculated. Thank you. Good night.

Unknown Executive: Then for your question about Piverl-2, so if I got the question right, Fiverl-2 is not expressed in relation to the inflammatory status of the tumor environment, meaning you have high or low expression across tumor types regardless of P.D1 expression. You can find PIVL2 high also in tumors which have less PD1. So we have a relatively high PIVL2 on CRC, and we also saw the clinical signals, and that's why we're following this indication, of course.

Unknown Executive: And we have also PIVL2, high expression also in PD1, higher indications like non-smolcelain. So these two indications have high expression of Piveral 2 and, in general, the PVRG pathway, and this is regardless of the PD1 pathway. I understand that, just one follow-up. It was the notion of actually...

Unknown Executive: Both being, let's just call it, you said moderately high for CRC. And so the question really is, is it as high as non-final cell lung cancer or less than that?

Unknown Executive: Just to get a relative

Unknown Executive: Relatively, I would say that CRC was not initially pre-identified initially as one of the highest priority indications, well, non-sponsor was, but it definitely had a high expression of the pathway, and when we also saw the clinical signals, it was, again, one of the indications that was not initially the top priority, but in combination with the clinical signal, it was an easy choice to move forward. Thank you very much. I

Operator: The next question is from Dana Graybosh of SVB. Please go ahead.

Daina Michelle Graybosch: Hi Guys, thank you for the questions. First, I want to clarify the information that you used to make the strategic decision. So specifically, did you review

Unknown Executive: of the ongoing cohort expansions, the CRC or any of the others, and how much did that review of the ongoing data inform this decision?

Unknown Executive: data and form this decision.

Unknown Executive: Yeah, so few things. So first, we're trying to share today some insights from the expansion cohorts that we have, and we stated that we see initial signals of anti-trumor activity, and we also have some insights with respect to the contribution of components, and also the part of the translational work that was already done, obviously the study is ongoing, and we don't have everything, in front of us, but part of the translational work is suggesting that what we see is actually Com 7.1 mediated, and that's related to the Com 7.1 mechanism of action.

Unknown Executive: So this is one driver that made us make this decision to focus and not to continue a very broad assessment of three studies, many patients in many indications. So we wanted to be faster on this and increase the probability of success. I'll also say that, obviously, at the end of the day, it is not only a cash-wise decision; not at all.

Unknown Executive: But also, we were thinking how we translate what we have in hand into some more cash-sensitive approach. So we're able, in these market conditions, to extend the cash runway, but still focus on the assets that we have and give them a high probability of success. Also, I want to mention that obviously, we did not, under these studies, we did not have started teaching, and with the pass forward for our Tidit, we saw that if we're making this change, it will just be very reasonable for us to use our own TIGs where we really believe in them. We think that it is first in class.

Unknown Executive: We have data to support our belief in it. So we saw that that could be an edge for us just to add our own Tidt and move forward. So, Dana, that's more or less the totality of the reason. So, two more follow-up questions. If we were not in this market situation and you had significantly more cash resources, how might the strategy now be different if you were? Yeah, it's a very good question, you know, because I did start the answer by telling you that it was not a cash-only decision.

Unknown Executive: It is not. It adds, but it is not. I guess that if we tried to be, we would trim the studies a little less, and we would focus maybe on more indications, in parallel, but, But with that in mind, I'll tell you that we feel very strongly that what we're doing now is not compromising on our ability to exemplify the value of Com 701, and now, by the way, also Com 902, and that we feel comfortable that this is the right decision.

Unknown Executive: Perfect. And then one last question around BMS. Was this decision and moving away from the collaboration instigated by Yukompigen, or did this come at all from BMS?

Unknown Executive: It is by Compugent. Obviously, it was done in a great, very good relationship with Bristol-Mers-Q-Q-B. We appreciate them a lot, but it is our decision, and I want to, it's a very important question. I want to elaborate on it.

Unknown Executive: It is not that we made the decision to stop the collaboration with Bristol-Mars Quib, and then we would know. Instead, we made the decision to focus the studies. We thought that with what we have, it is very reasonable for us not to wait another year and a half until we close all the studies and finish the collaboration and decision-making for BMS. We thought that this is the right time not to move ahead with this, to focus, to be nimble, to be fast, to give it the highest probability of success.

Unknown Executive: As we see now, the highest probability of success, and due to this, due to the fact that we're closing the studies, it is obviously the end of the collaboration. Yes, it was our fault. That's very helpful.

Operator: My question is from Ren Benjamin of JMP Securities. Please go ahead. Hey guys, thanks for taking the questions. Just going back to the whole BMS termination, I understand, you know, what you're saying and not, but I guess I'm kind of, you know, kind of curious a little bit more in terms of where other options were explored. So, for example, could you have restructured the current collaboration so that, you know, you could continue to get a volume map? I just wanted to know if there were any other options that were available. or, you know, terminating was the only way to go.

Ren Benjamin: So obviously, Rennie, it was a well-sought and well-informed process. It was not a decision that was taken lightly. We understand the implications, all of them, but we thought that there were advantages to compigens and getting an evil for free for the studies that we want to do is a consideration, but it is not the main consideration, obviously, because these are small studies, and we can afford it.

Unknown Executive: and at the end of the day, You know, I mentioned it as well. We have our own Com902.

Unknown Executive: We believe in our assets, and we would like to test them. And it gave us an opportunity. Probably if we had gone to much larger studies, maybe that would have been a different situation. But you know, at this point in time, we're quick to do it. We can do it. We've done all the studies up until now, right? It's our execution. And so, yes, we were internally exploring different options.

Unknown Executive: We had discussions with BMS. But, as I said, it was our decision, and we feel very comfortable to say that, at this point in time, this is the right decision. It didn't make sense for us to move forward; to continue to pursue the study.

Unknown Executive: Got it. And I jumped on the call a little late, so you may have answered this, but when you talked about Com 701, the Volumab, clinical data showing a modestly higher response rate, can you maybe provide?

Unknown Executive: color around that when I think modestly

Unknown Executive: we hire, I automatically think that the confirm

Unknown Executive: The study is going to have to be quite large in order to

Unknown Executive: That modestly higher response rate; were there any other clinical clues, if you will, that, you know, are,

Unknown Executive: That are, you know, pushing you to indication and combination, or are we kind of waiting for the full data set to come out before you make a decision regarding No, so from our perspective internally, we're at the stage of the design, and obviously, we'll share the design and pass forward in the Q4 call. I will say that, and it's a fair question, and I'll address it.

Unknown Executive: Look, at the end of the day, we have 20 patients, and MSCRC is an ultra-halt retreat. And the lines that we were treating, right, even after longsurf and regarapineb, it is ultra-high to treat, ultra-hout. So when you're looking at a patient population where the response rate for Lone Cerf and Regrophine is 1%, and you're working with small numbers, I think that it is very reasonable to define it as modest.

Unknown Executive: I will say that it is not only the response rate that we were looking at, although we were referring to the response rate in the press beliefs and in the prepared remarks, but the fact that we believe that what we see is Com 71 biology, it is driven by Com 7Biology, by its mechanism of action, gives us more confidence. Going forward, we stated that we're going to test the triplet in this indication.

Unknown Executive: So this will give us the maximum blockade of the Dinaaxis. We hope to maximize the effect, and we hope to increase confidence so it can inform our path forward. But in Q4, we'll share our path forward with a new study, which can give some insights maybe into how we're going to relate to it going forward, but it will not be a plan for the next, hopefully randomized, studies that we will

Unknown Executive: Got it. Okay.

Unknown Executive: Thanks for that clarification. And I guess, just finally, for us, you know, would love to kind of get your thoughts around Roche's disclosure at ASCO that the majority of their statistical power was allocated in their trials to OS versus PFS. You know, and kind of like a rejuvenation, I think, of, you know, the hope for the Tid assets in general. Can you maybe comment on how that disclosure may be impacting your plans or thinking going forward?

Unknown Executive: So, I think, you know, on the Roche data, I think that there is so much being said there. I think that it's paid.

Unknown Executive: I think that all of us will need to wait for the overall survival. I, you know, we think it's a big enough program at this point in time. The Tid, in general, the Tid space, we think too much. I'll tell you, look, we investigated this pathway alone and as part of the Dinaaxis and with PGRIG so much. We have so much knowledge that converges on this pathway and the science behind it. And you know that we've been speaking about it for years.

Unknown Executive: So, you know, we're optimistic with respect to TG. We don't know what the impact would be. Would it be very dominant or less dominant?

Unknown Executive: as the exact patient population, et cetera. But we believe that it's a pathway that is valid to follow, hence our decision also to focus on our own TIGs on Com 902 and do the studies with our own Com 902. So this is how it has informed our decisions. It was not the main reason why we decided to change, but it is another consideration that we were looking at.

Unknown Executive: Got it. Thanks for taking me.

Operator: This concludes our Q&A session. I will now turn the call back to Compugent's president and CEO. Dr. Cohen-Dayat, would you like to make your concluding statement?

Unknown Executive: Yes, thank you, operator. Thank you all for joining us today and your continued support. Stay safe and healthy. Thank you. This concludes the Compugent LTD second quarter 2022 Financial Results Conference call.

Operator: Thank you. This concludes the CompuGen LTD second quarter 2022 Financial Results Conference call. Thank you for your participation. You may go ahead and disconnect.

Operator: Thank you. Thank you. Thank you.

Q2 2022 Compugen Ltd Earnings Call

Demo

Compugen

Earnings

Q2 2022 Compugen Ltd Earnings Call

CGEN

Thursday, August 4th, 2022 at 12:30 PM

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