Q3 2021 Compugen Ltd Earnings Call

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Ladies and gentlemen, thank you for standing by the conference will begin shortly.

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Ladies and gentlemen, thank you for joining us today welcome to <unk> third quarter 2021 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 <unk>.

Web site Www Dot sea Gen Dot Com as a reminder, today's call is being recorded.

I'd now like to introduce you bought naughton head of Investor Relations and corporate Communications you Vaughn. Please go ahead.

Thank you operator, and thank you all for joining us on the call today today's call is being recorded and will be available on the Investor Relations section of our website joining me to present, our prepared remarks are not Colin Dyer, President and CEO, Henry <unk>, Chief Medical Officer, and art crushing chief financial and operation.

Sir for the Q&A session. We will also be joined by Iran, O'hare Vice President research and drug discovery.

Moving to slide two before we begin I would like to remind you that during this call. The company may make projections or forward looking statements regarding future events, our business outlook, our development efforts and their outcome. Our discovery platform anticipated progress result, and timelines of our program financial and accounting related matters.

As well as statements regarding our cash position.

We wish to caution you that such statements reflect only the companys current beliefs expectations and assumptions, but actual results performance or achievements of the company may differ materially.

Statements are subject to the known and unknown risks and uncertainties I 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 on February 25 to 2021.

The company undertakes no obligation to update projections or forward looking statements in the future.

With that I'll now turn the call over to enough.

Yeah.

Slide three please.

Hey, Ron Good morning, and good afternoon, everyone and welcome to our third quarter 2021 update.

Today is an exciting day for them come to you Jim We did announcement yesterday of the expansion of our strategic collaboration with BMS and along with $20 million equity investment.

And today, we don't release or first three presentation at sea, providing clinical translational and preclinical data that demonstrate strong execution across our differentiated clinical and scientific strategy.

And to further support.

So our path forward.

Indeed to our knowledge.

The first data presentation ever of a triple blockade of PD L E ticket and PD one.

And the first time data on antitumor activity of an S. T reduced our sexual function anti <unk> antibody is presented in a scientific conference.

These dose escalation studies cleared a path to initiate multiple expansion cohort study.

Designed to broadly evaluate the inhibition of the DRAM axis in cancer immunotherapy and.

In advance they start pushing development of our two leading programs come 701 and come nine months too.

Henry will review the data from our dose escalation studies seem to call, but before that I'd like to share a high level overview of the four key pillars of our long term strategy and then overview of our clinical strategy.

Moving to slide four.

Our first pillar is to advance the field of immuno oncology research.

We just want to make goal of developing new therapies.

We have an impressive track record of driving the discovery of new new targets and pathways in the immuno oncology space with cutting edge science published in peer reviewed papers and development of our clinical stage pipeline derived from the from this time.

Clinically validated computational target discovery platform has generated a pipeline of exciting new candidates that are being evaluated in phase one clinical trials by us and our partners, including our potentially first in class anti T V already antibody com 701.

<unk>.

Our high affinity agg for FCA reduced effector function NTT, each antibody come nano too.

The patina mob and anti <unk>, two antibody, which is being developed by Bayer.

And Astrazeneca T G by specific antibody program derived from come nine O two.

I'm proud of our talented team of scientists with expertise in immuno oncology in translational medicine, and with our capabilities of driving design of new unexplored biological pathways forward as we develop first in class therapeutics targeting this pathway.

This takes us to our second pillar, which is to expand the number of patients responding to treatment.

By developing potentially first in class therapies for patients nonresponsive refractory to currently available therapies.

Specifically do unique biology, we unlocked for the P. D. R. I G pathway. Following gets discovery serves as the basis for our assessment of the different combinations of P. R. I G T G and PD one inhibitor in select biomarker informed tumor types.

Generally not responsive to checkpoint inhibitors.

What makes it differentiated beyond the discovery of this pathway and uncovering its potential role within the DRAM axis is that we are the only company evaluating combination of P. D. R. I G. T. G N PD one blocker in the clinic.

It is exciting to be the leader seem to be named axis, especially considering the recent advancements and raising interest by followers in this area.

Maximizing the value for patients is a third pillar and speaks to our goal of bringing new treatments to market as rapidly as rapidly and efficiently as possible.

To support us on our journey.

We seek collaborations and strategic partnerships with leading Biopharma companies.

With complementary capabilities worldwide to expedite our early and clinical stage programs and.

And bring them to the market.

In addition to our partnership with BMS, our partnerships with Astrazeneca and Bayer.

Also highlight the value of our strategy to broaden the opportunities of our products to reach more patients.

And finally, our fourth pillar pillar is to protect our innovations while developing drugs for patients. So we're securing IP rights.

We have developed a strong IP portfolio with potentially broad protection for drug candidate.

Now moving to slide five.

Do you have employed a comprehensive clinical strategy to assess a genome axis hypothesis.

We design multiple combination studies evaluating the simultaneous blockade of the three pathway send subset.

Or are running now in pilot in multiple tumor types selected in a biomarker informed manner.

Each of these studies include comprehensive translational data analytics in order to further support our drugs mechanism of action and discover and evaluate potential biomarker that may be a friend events for future patient selection.

Okay.

Titian.

A multiple combination studies are being pursued in some overlapping indications.

This is by itself will allow us to evaluate the contribution of each drug in this combination.

And focusing mainly on nonresponsive tumor.

<unk> test should have to differentiate the contribution of <unk> 701.

The data from these multiple studies will allow us to select the combinations and tumor types to progress our program.

Moving now to slide six.

We like to say that we delivered on all our targeted milestones for this quarter and for the year.

2021 played a major role in further solidifying our leadership position in the genome axes.

We study and impressive execution.

We've completed all our dose escalation studies, including our comps have been a one mono therapy concept in one plus the volume up.

Coming into two mono therapy, and Triple combination studies.

We have now progressed to expansion cohort across all our programs, which allows us to focus on select indications through our translational data driven approach.

Our accomplishments through 2020, one also reinforced the power of our partnering strategy in diversifying our portfolio.

With the milestone payments from Astrazeneca after the first patient dose in their phase one study of a ticket by specific derived from our continental too.

In addition, we were thrilled to announce the expansion of our collaboration with BMS.

And believe the recent $20 million strategic equity investments in competent.

For instance, our relationship and the goal of both companies to bring innovative therapies to cancer patients through the advancement of our clinical studies conducted under our collaboration.

As part of the expansion of the collaboration a joint steering Committee has been formed to facilitate strategic oversight and guidance for the programs run under the collaboration.

This committee will run alongside the existing joint Development Committee, which S at an operational level.

With that I'd like to turn the call over to Henry for him to provide an overview of our data released at sea.

Today hen.

Henry.

Thank you and us.

Can we move to slide seven please.

I am pleased to provide you with an overview of the preliminary results from our ongoing free sworn slush to study evaluating the combination of comes out of a new one potentially.

Potentially first in class antibody with the volume up on BMS is unsafe physics antibody.

Six to seven released today S IPC.

The study enrolled 13D O T evaluable patients with a variety of advanced solid tumors.

So these all comers, who had exhausted all available standard treatments were heavily pre treated with a median of two prior therapies and a maximum of 19.

The study evaluated.

It induces a considerable one in combination with fixed doses of an Ebola mob and BMS is on therapeutic antibody.

The Premier objective of this study is to evaluate the safety and Tolerability of the combination.

The study reported no dose limiting toxicities.

Combination of the favorable safety profile and was well tolerated.

Reaching this important milestone shares the path for a comprehensive evaluation of computer DRAM axis hypotheses of Triple Bock blockade of T V. Our AG features on PD, one pathway is in select biomarker informed indications.

Additionally, 70 120 milligrams per kilogram IV Q4 weeks was identified as the recommended dose for expansion.

The exposure cohorts has been initiated.

Ruling patients with platinum resistant ovarian cancer endometrial cancer and.

Head and neck squamous cell cancer.

We also reported preliminary anti tumor.

T y.

Was it stable disease in three patients with one patients with prostate cancer remain even studied beyond 100 days of treatment.

Now moving to slide eight.

We and our partner BMS phone, the translational data important or noteworthy, indicating stomach dynamic activation of the immune system following treatment across key measures, including interferon gamma induction.

T and NK cell activation, a memory T cell proliferation at all doses of <unk> hundred one.

These results are significant for several reasons.

Our consistent across measures and patients.

And the magnitude of the effect was above what has been observed immunotherapy and dwell combination settings of them suddenly one blockade as well as published results for other tissues antibodies mono and combination studies.

This supports the potent activation of the immune system following triple blockade of PD on AG.

P J on PD, one and <unk>.

Aligns with our extensive preclinical work predicting this effect.

It is also important to highlight that immune activation was achieved in all studies in.

Historically cold tumor types, including ovarian.

Hello, Russell and prostate cancer.

Together. These results further support computer or your funding for the potential of triple blockade to drive synergistic immune activation.

Look forward to the continued evaluation of our hypotheses in the ongoing biomarker informed expansion cohorts.

And staying with the theme of translational data.

Take a minute here to mention some of the preliminary findings that will be presented here.

P C in our research booster.

Following up on our observation the P. B I D is a potential unique and dominant checkpoint involved in stem doesn't like memory T. So then terrific cell interaction we evaluate the serum from the two patients who responded to a combination of conserving the one on Ebola.

Interestingly, we saw an increase in markers of dendritic cell activation in these patients when compared to non responding patients.

This may suggest that this clinical response involves enhance dendritic cell T cell interaction triggered by <unk> 71.

It is exciting to see that our research relating to <unk> potential mechanism of action translates to preliminary findings in the clinic and further supports the differentiation of PV AIG from T D on PD one.

This also suggests a differentiated profile for <unk> hundred one having a potential to address book inflamed unless inflamed tumor types, where checkpoint inhibitors have not been successful unfolded explains why one might expect a more potent immune activation.

When combining <unk> seven to one with the other inhibitors.

Moving next to slide nine and to the S. E T cell data from our phase one dose escalation study evaluating a high affinity unsafe.

Anybody commando two would reduce FC effector function.

The study enrolled 18 patients with advanced solid tumors that is all comers, who exhausted all available standard therapies.

Heavily pre treated with a median of seven prior therapies and maximum or 16.

The primary objectives of this Colorado, two monotherapy dose escalation study was to establish safety and Tolerability the recommended dose for expansion and the PK profile of <unk>.

Unknown Executive: The purpose of a therapy dose escalation study was to establish safety and tolerability, the recommended dose for expansion, and the PK profile of Com902. Overall, Combeino-2 demonstrated a favorable safety and tolerability profile. In the study, we reported two patients with dose-limiting toxicities, one patient in the single-subject dose cohort with grade 2 vomiting at 0.01 milligram per kilogram dose, and one patient with grade 3 atrial fibrillibulation at the 1 milligram per kilogram dose. These DLTs were based on assessments by the investigators.

Overall, <unk> two demonstrated a favorable safety and tolerability profile.

In this study we reported two patients with dose limiting toxicities.

One patient in the single subject dose cohort with three two vomiting at 0.01 milligram per kilogram dose.

Patients with grade three atrial fibrillation at the one milligram per kilogram dose.

These D O Ts where based on assessments by the investigator.

Unknown Executive: It is important to note that there were no DLTs reported at any other doses, including higher doses up to 10 milligram per kilogram, and the maximum tolerated dose was not high. Of note, in the Com902 repeat dose preclinical study, no ECG changes were noted. The Comdino 2, 3 milligrams per kilogram IVQ 3 week was selected as the recommended dose for expansion. Additionally, the PK of Com902 was dose proportional and supported Q3 week doses.

It is important to note that there were no DLT is reported at any other doses.

Clothing, the higher doses up to 10 milligrams per kilogram.

And the maximum tolerated dose was not reached.

Note in the coming I know to repeat dose preclinical study.

C. G changes were noted.

The commentary moved through three milligrams per kilogram IV Q3 week was selected as the recommended dose for expansion.

Additionally, the PK of <unk> 902 was dose proportional and supports Q3 week dosing.

Unknown Executive: We were encouraged by preliminary anti-tumor activity with 50% of patients or 9 of 18 achieving a best response of stable disease, with six patients, 67% with confirmed stable disease, and 3 patients, 17% with stable disease of at least six months duration or longer. And while we consider CITs to be a combination therapy, achieving a disease control rate of 50% in this heavily pre-created patient population is encouraging. These preliminary results are particularly significant for compugent and the brother Teague's space. As you may know, there is an ongoing debate regarding the role of the FC domain and its relevance for anti-tumor activity with Tididivit inhibitors. Our approach has always been to have a reduced F.C.

We were encouraged by preliminary anti tumor activity with 50% of patients or nine of 18, achieving a best response of stable disease with six patients, 6% to 7% with confirmed stable disease in three patients, 17% with stable disease of at least six months.

<unk> are longer.

And why are we consider <unk> to be a combination therapy.

The disease control rate of 50% in this heavily pre treated patient population is encouraging.

These preliminary results are particularly significant for Huntington and the brothers Egypt space as.

As you May know there is an ongoing debate regarding the rule of the FC domain and its relevance for anti tumor activity with <unk> inhibitors.

Our approach has always been to have reduce FC effector function anti <unk> antibody as we believe this reduces the risk of depleting CDA positive T cells, which are crucial for driving anti tumor activity.

Unknown Executive: Effective Function antithetic antibody as we believe this reduces the risk of depleting CD8 positive T cells, which are crucial for driving anti-tumor activity. These signals of preliminary anti-tumor activity with Com902 monotherapy are suggestive that our reduced FC approach is an appropriate strategy, and this is supported by the translational data, which I show on the next slide. Now moving to my last slide, slide 10, we see translational data from the study that further explore this.

This signals off preliminary anti tumor activity with pulmonary allergy immunotherapy.

Suggesting that a reduced F. C approach is an appropriate strategy and this is supported by the translational data, which I show on the next slide.

Now moving to my last slide Slide 10, we see translational data from the study that further explore this.

Unknown Executive: Floor stytometry analysis of peripheral blood from patients treated with Com902 shows no significant changes in T2-positive CD4 and CD8 T cells and NK cells. This is important as these results reinforce that our reduced FC approach avoids the depletion of major TG positive lymphocytes, which are critical for antitumor immunity, and as I indicated earlier, supports our rationale for choosing an IG4-FSI-reduced effective function Before I turn the call over to Annat, I'd like to thank the patients and their families, investigators, and study sites. Thank you.

Flow cytometry analyses of peripheral blood from patients treated with 902 shows no significant changes in Puget, possibly a C. D. Four on CD eight T cells and T cells.

This is important as these results reinforce that our reduced F. C approach avoids the depletion of major of major positive lymphocytes, which are critical for <unk>.

Tumor immunity and as I indicated earlier supports our rationale for choosing them agg for F C reduce effector function onsite PV antibody.

Before I turn the call over to enough.

I'd like to thank the patients and their families investigators and study sites.

And that.

Thank you Henry.

Unknown Executive: Slide 11, please. So far, 2021 has been an eventful year for CompiGEN, with strong execution across our differentiated clinical strategy, which has solidified our position as leaders in the Denham Axis. As the only company targeting PVRIG TIG and PD1 in the clinic, we are maintaining our first mover advantage for PVRIG inhibition in general, and for the three-passway hypothesis in particular. The strength of this hypothesis has grown through new translational data which supports potent immune activation, now also through triple blockade, which is consistent across tumor types and immune measures.

Slide 11 please.

So far 2021 has been an eventful year for comp again with strong execution across our differentiated clinical strategy, which has solidified our position as leaders in the <unk> axis.

And the only company targeting P. D. R. I G T G and PD one in the clinic, while maintaining our first mover advantage for P. B R. A D inhibition in general.

And for the free pathway hypothesis in particular.

The strength of these hypotheses has grown through new translational data, which supports potent immune activation.

Now also through triple blockade, which is consistent across tumor types and immune measures.

Unknown Executive: We've also strengthened our deep expertise in PVRIG biology with preclinical and translational data, which supports the differentiated profile of PVRIG as an immune checkpoint, with exciting data showing an increase in activated DC markers in serum of two patients that clinically responded to Com7.1 Placnevolumeab treatment. This new preliminary observation suggests that a unique dendritic cell, T-cell interaction triggered by Com. 701 may be driving responses in patients and, ultimately, may be capable of addressing both inflamed and less inflamed tumors.

We've also strengthened our deep expertise in P. P. R. P. B R. I G biology, with preclinical and translational data, which supports the differentiated profile of PV energy as an immune checkpoint with exciting data showing increase in activated D. C marker in Cmos to pace.

<unk>, that's clinically respondent to come 71 class me volume up treatment.

This new preliminary observation.

Suggest that a unique dendritic cell T cell interaction triggered by concept in one maybe driving responses in patients and ultimately maybe capable of addressing both inflamed and less inflamed tumor.

Unknown Executive: On the TIG front, our ultimate strategy is in combination settings, and our position is unique in evaluating PVRIG and TIG dual blockade in the clinic with our ongoing Com701 Com902 combination study. We were pleased to present translational data that support a rationale for choosing an anti-tigid antibody with a reduced FC effect of function, with results demonstrating that Com902 avoids depletion of major TG positive lymphocytes, including CD4 and CD8 T cells, as well as NK cells, while producing antitumor activity on par with other TIGs.

The ticket front, Oh tenet strategy is in combination settings, and our position is unique and evaluating Pete here anti antigen dual blockade in the clinic with our ongoing comes 71 Continental two combination study.

We were pleased to present translational data that support our rationale in choosing and NTT data antibody with reduced FC effector function with results demonstrating that come in on to avoid depletion of major teach response ticket positive lymphocytes, including city for NCD.

A T cell <unk>.

As well as NK cells, when producing antitumor activity on par with other <unk> assets.

Unknown Executive: We continue to be encouraged by the broad and growing interest in the DENAM space and our free pathway hypothesis while also maintaining our first mover advantage and strong IP protection. I'm proud of our execution with multiple key data readouts and the initiation of multiple expansion cohort studies supported by translational data and with multiple data redouts ahead, which will enable us to take our programs forward for the potential benefit of patients. I'm incredibly excited about what's to come, and I'm grateful for the amazing team at Comptogen, whose dedication has enabled our remarkable accomplishments. I'll now turn the call over to Ari to review our financials. Ari?

We continue to be encouraged by the broad and growing interest in the DRAM space and our three pathway hypotheses, while also maintaining our first mover advantage and strong IP protection.

I'm proud of our execution with multiple key data readouts.

And the initiation of multiple expansion cohort study supported by translational data and with multiple data Readouts ahead, which will enable us to take our programs forward.

Pension benefit of patients.

I'm incredibly excited about what's to come and I'm grateful for the amazing teammates Compuchem, whose dedication having neighbors our remarkable accomplishment.

I'll now turn the call over to Ari to review our financials.

Hey.

Thank you.

Ari: So moving to slide 12, our financial results for the third quarter of 2021, which we reduced this morning, continue to show our strong financial position as we execute across our expanding clinical program. The $6 million in revenues this quarter with aging to the AstraZeneca milestones triggered by the dosing of the first patient in AstraZeneca's Phase 1 study of a TIGD by specific derived from our Com 902. Cost of revenues of $.7 million are attributed mainly to royalty and milestone payment.

So moving to slide 12.

Our financial results for the third quarter of 2021 this morning.

Continue to show our financial position.

Across our expanding clinical programs.

The $6 million in revenue this quarter were they to the Astrazeneca milestone triggered by the dosing of the first patient and also then the Coke phase one two study of <unk>.

By specific derived for Wawa Ko nine okay.

Cost of revenues of $7 million, all exhibited mainly to rugby and milestone payments.

Ari: Research and Development expenses for the third quarter of 2021 were $8.7 million, compared with $5.5 million for the same period in 2020. The increase reflects the expansion and initiation of additional clinical studies in 2021, as well as increased drug manufacturing activity.

Research and development expenses for the third quarter of 2021 were $8 $7 million compared with $5 $5 million for the same period in 2020.

The increase reflects the expansion and the initiation of additional clinical studies during 2021 as well as increased drug manufacturing activities.

Unknown Executive: The net loss for the first quarter of 2021 was $6.2 million, or seven sets per basic and diluted share, compared with the net loss of $7.8 million or $0.9 per basic and diluted share for the same period in 2020. As of September 30, 2021, we had approximately $102 million in cash and cash-related accounts, compared with approximately $11 million as of June 30th, 2021. With the recent $20 million equity investment by Bristol-Myers-Web, as well as the collection of the $6 million payment from AstraZeneca expected in the fourth quarter, our year-end cash balance is expected to be in the range of $130 million to $116 million. The company has no debt.

Net loss for the third quarter of 2021 were $6 2 million or seven cents per basic and diluted share.

Compared with a net loss of $7 8 million or nine cents per basic and diluted share for the same period in 2020.

September 32021, we had approximately $102 million in.

Cash and cash related accounts.

Compared with approximately $111 million.

32021.

With the original $20 million equity investment by Bristol Myers Squibb.

What is the collection of the $6 million payment from Astrazeneca expected in the fourth quarter.

Our year end cash balance is expected to be in the range of $130 million to $116 million.

Operator: Thank you. And with that, we will now open the call for questions. Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session.

The company has no debt.

Thank you and with that we wouldn't know the clinical question.

Operator: Thank you. 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 indicate a handset before pressing the numbers. Please stand by while we poll for your questions. The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Thank you ladies and gentlemen at this time, we will begin the question and answer session. If you have a question. Please press star one if you wish to decline from the polling process. Please press star two if.

You are using speaker equipment Congress with the handset before pressing the numbers. Please standby, while we poll for your questions.

The first question is from Mark Breidenbach of.

Oppenheimer. Please go ahead.

Mark Alan Breidenbach: Hey, good morning guys, and thanks for taking the questions. I guess I wanted to start with 902, actually, and the dose you've chosen to advance into the expansion cohorts. It seems like it's a little bit below what we're seeing used for some of the other tidget antibodies, even the fixed dose that BMS 9862 is being used in your triple study. Could you maybe just comment on why you're confident that you've sufficiently dose escalated and you're confident around those 3-mig per kig doses going forward and kind of, you know, the reasons why 9-02 might be maybe more Thanks.

Hey, good morning, guys and thanks for taking the questions.

I guess I wanted to start with with nine or two actually in the dose you've chosen to advance into expansion cohorts.

It seems like it's a little bit below what we're seeing.

Used for some of the other two digit antibodies, even the fixed dose.

<unk> is being used in your in your Triple study.

Could you maybe just comment on why you're confident.

Dose escalated.

We are confident around those three meg per kg.

Dose going forward and kind of.

Reasons why it why.

902 might be.

It may be more potent than some of the other antibodies.

Advancing to late stage trials. Thanks.

Unknown Executive: Sure, thank you, Mark. Henry, would you like to start, and maybe Iran will have some additions later?

Sure. Thank you Marc Henry would you like to start and maybe Iran will have any additions later.

Henry Adewoye: Sure, I can start. Thank you, Mark, for the question. So we considered several factors when we selected, we and the investigators selected the dose that we recommended for expansion, which is 3 milligrams per kilogram body weight IVQ for 3-week. So one of the things we considered was receptor occupancy, peripheral receptor occupancy. As you know, Com9O2 is a high-affinity antibody.

Sure I can start thank you Mark for the question. So we considered several factors when we selected we and the investigators are selected the dose that we recommended for expansion, which is three milligrams per kilogram body with IV Q3 weeks. So one of the things we considered was receptor occupancy prefer receptor occupancy.

As you know come 900, Skus a high affinity to the antibody. So we observed and we've reported in the poster.

Henry Adewoye: So we observed, and we've reported in the poster, that we achieved peripheral receptor occupancy at 0.1 milligrams per kilogram body weight. We also escalated Com902 up through 10 milligrams per kilogram body weight. And the overall recommendation from a review of the data, including the PK data, was that we didn't think, in addition to the investigators and the authors of the study, that going beyond 3 milligrams per kilogram body weight dose was going to add any more clinical benefit in terms of outcomes for the patients.

We achieved peripheral receptor occupancy.

Zero points, one milligrams per kilogram body weight dose.

We also ESCO.

Escalated continental to op through 10 milligrams per kilogram body weight dose and the overall recommendation from review of the data, including the PK data was that we didn't think in addition, with the investigators and the authors of the study that's going beyond three milligrams per kilogram, but.

We dose was going to.

Add any more clinical benefit in terms of the outcomes for the patients. So that's the reason we selected three milligrams per kilogram body weight dose now when you benchmark that dose.

Henry Adewoye: So that's the reason we selected 3 milligrams per kilogram body weight. Now when you benchmark that dose, and you compare it to what the peripheral receptor occupancy is, That's at least a margin of 30. That's significant enough to have tissue penetration in the tumor microenvironment. I wouldn't want to comment on the metrics for other companies, but I think if you go back and look at the way they've demonstrated their receptor occupancy and selected their dose, it's very similar across companies. So we're actually in the main structure.

You compare it to what.

What the periphery receptor occupancy is that at least in margin.

30.

It's significant enough to have tissue penetration.

In the tumor microenvironment I wouldn't want to comment on the metrics for other.

Other companies, but I think if you go back and look at the we live.

<unk> demonstrated the receptor occupancy and selected dose it's very similar.

Across companies. So we're not really we're actually in the mainstream.

Yeah.

Unknown Executive: Yeah, maybe just to add, so indeed we compared Com 9 or 2 to the other leading TIG benchmarks, and indeed, Com 902 has better binding, better blocking, and at least as good or better functional activity in vitro.

Yeah, maybe just to add so indeed, we compared to the other leading cause you to benchmark and indeed to have better binding better blocking and at least as good or better of a functional activity in vitro. We're glad to see this translate that also into our achieving full although we're certainly keeping.

Unknown Executive: We're glad to see that this translated also into achieving full REO, or septuacupancy, at a relatively low level compared to the other published data. And, yes, as Henry mentioned, we believe that these those that we chose will be sufficient to allow full occupancy also.

In a relatively low level compared to the other published data.

Yes.

We believe that this dose that you chose this will be sufficient to allow for full year. You can see also in the tumor micro environment.

Okay.

Mark Alan Breidenbach: Okay, and just with respect to that grade three atrial fib, is this toxicity that's been seen in other studies of tidid antibodies? Is there any chance in your mind that this is a class effect, or do you think this is a one-off?

Okay, and just with respect to that one grade three atrial fib.

Is this.

Toxicity, that's been seen in other studies of ticket antibodies is there any chance in your mind that this is a class effect or do you think this is a one off.

Henry Adewoye: Yeah, so, Mark, it's a good question. We think it's a one-off for several reasons. So we've gone back to look at the preclinical data. You know, we have repeat dose toxicity studies that were conducted prior to initiating the human experiments, the human clinical trials that we have. And the repeat dose toxicity studies did not demonstrate any EKG findings, as I noted in my prepared comments. In addition, we didn't actually see any additional toxicities when we escalated through 10 milligrams per kilogram body weight, as I said in my prepared comments.

Yeah, So mark it's a good it's a good question.

We think it's a one off for several reasons. So we've gone back to look at the preclinical data.

We have a repeat dose toxicity studies that were conducted prior to initiating the human experiments with human clinical trials that we have.

And the repeat dose toxicity studies did not demonstrate any EKG findings as I alluded in my prepared comments.

In addition, we didn't actually see we didn't see any additional toxicity is when we escalated through 10 milligrams per kilogram body weight does like I said in my prepared comments that that particular Ah patients I can give a little bit of more information. So the patient came in.

Henry Adewoye: Now, that particular patient, I can give a little bit of more information. So the patient came in, was diagnosed with atrial fibrillation, and that resolved on the same day that the patient came in. This was about a week into the first dosing interval in the first cycle, so we think it's a one-off effect. Now, we do not know if the other companies that have TIG inhibitors report all the data. So you can imagine that sometimes the data that is reported might be limited to maybe three patients or two patients, and the single-digit toxicities might not be demonstrated. But we don't think, based on preclinical data, that this has any bearing or any relationship to come 902. That's our opinion.

<unk> had was that goes to the atrial fibrillation and that resolved on the same day that the patient came in so this was about a week through the first dosing interval in the first cycle. So we think it's a one off effect now we do not know if the other companies that have TD.

Inhibitors report all the data. So you can imagine that sometimes the data that is reported might be limited to maybe three patients or <unk> patients and the single digit toxicity is may not be demonstrated but we don't think based on our preclinical data that this has any bearing or any relief.

And ship to come languages, that's all.

Mark Alan Breidenbach: Okay, thanks for taking the questions. I'll jump back into the queue.

That's.

The assessment.

Okay. Thanks for taking the questions I'll jump back into the queue.

Stephen Douglas Willey: The next question is from Stephen Willie of Stifle. Please go ahead.

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

Stephen Douglas Willey: Yeah, good morning. Thank you for taking the questions. Maybe to follow up on Com 902. I think the lack of lymphocyte depletion on tigipots themselves is interesting, but can you remind us what the magnitude of decrease that you would expect to see in these cell types with those

Hey, good morning, Thank you for taking the questions maybe to follow up on Com now too.

I think the lack of.

Lymphocyte depletion on tissue call themselves is interesting, but can you remind us.

What is the magnitude of decrease that you would expect to see in these cell subtypes.

Unknown Executive: Yes, some of the companies did publish these results, and what they have shown is a dramatic reduction. It's not like a minor reduction; it's a little bit of blood. As we all know, in Q.O. Microenvironment, depletion is normally much more challenging, so we don't know if there is any kind of depletion in your microenvironment.

Those two gene antibodies that have been engineered to be pads.

Enhanced effector culture.

Yes, so some of the companies did.

Published these results and what they have shown as dramatic reduction there's not like a minor reduction in peripheral blood as we all know the tumor microenvironment. The depletion normally is much more challenging. So we don't know if there was any kind of depletion tumor microenvironment when peripheral blood they have shown the depletion.

Of CDA positive.

Unknown Executive: Okay, so that's helpful. And then on the triple combo biomarker data that you have, again, I guess it appears to kind of support the hypothesis that PBRIG is contributing something. But I know the way that the data is presented; it's a function of all doses. Is there anything that you can say with respect to there potentially being a dose dependency for some of these changes in biomarkers that you're seeing as a function of escalating?

Did you see positive cells in the peripheral blood of deduction was dramatic.

Okay. That's that's helpful and then on the on the Triple combo biomarker data that you have again.

I guess it appears to kind of support the hypothesis that <unk> is contributing something but under the way. The data is presented as a function of all doses is there anything that you can say with respect to their potentially being a dose dependency.

To some of these changes in Biomarkers that Youre seeing is a function of escalated comps over the wall.

Unknown Executive: So in this trial in the triplet study, the dose response range was not as big as we had in the past. So actually, we started on one patient in 03 and then already moved to one mic per kick, which is already for receptive occupancy. So in this specific context, we haven't seen much of a dose response. I remind you that in the past, we had a wider range of responses, concentrations; we did see a dose response for Compt 701, in combination with Nivo, etc.

Okay. So in this trial and the triplet study the dose response range was not as big as we had in the past. So actually we started in one patient and all three and then already moved to one make brocade, which is already four such that you can see.

So in this specific context, we haven't seen much of a dose response or a market in the past and we had a wider range of responses concentrations. We did see a dose response for conserving alone or in combination with naval et cetera.

Yes.

Unknown Executive: Okay, and maybe you can just lastly talk about, I guess, how the expanded Bristpo collaboration, I guess, intersects with the fact that you're now, you know, through dose escalation with common line 2, you're going to be... interrogating various combinations with that agent. How do those two things overlap with each other, if at all? And are you guys, I guess, are there guard reels in place embedded within the collaboration such that you kind of approach each day in your own way?

Okay, and then and maybe you can just lastly.

Lastly, talk about I guess, how the expanded Bristol collaboration.

I guess intersects with the fact that you're now through dose guys through dose escalation would come out of two you're going to be and.

Interrogating various combinations with without agent how do those two things overlap with each other if at all and are you.

I guess other guardrails in place.

Added within the collaboration such that you kind of each day.

Unknown Executive: Yeah, I relate to that, Steve. So, you know, this collaboration actually, this expansion of the collaboration reflects the long-term, a long-standing relationship between the two companies. Stands for itself. It is really designed in order to enhance strategic collaboration. It is designed to support the current studies that we have to support compiGent in executing these studies. At this point in time, we are on the strategy front, on the clinical strategy front, we are at the stage that we have completed all the dose escalation studies that we wanted to do.

Alright.

Yeah, Hey, Renee to that to Steve. So you know this collaboration actually this expansion of the collaboration reflects on the long term.

A long standing relationship between the two companies and it is time for a caf is really designed in order to enhance the strategic collaboration using high and it is designed to support today.

Current studies that we have to support their copy journey executing these studies at this point in time.

And we are in on the strategy front of on the clinical strategy front. We are at the stage that we completed all the dose escalation study that we wanted to do.

Unknown Executive: And we have already started the expansion cohorts, and remember that we now have two combination studies with Bristol, the Comptopon 1 Volume-Mab and the Triplat. And each of these studies is conducted in multiple, two more types. We have a broad translational program that deals with the PD markers and immunosochemistry. As we stated in the past, we're also applying advanced technologies to our patient samples. So the collaboration is actually growing and growing, and both parties feel that it will be good to have a joint strategic oversight. There is a committee that is actually working in parallel to the Joint Development Committee, that is working at the operational level. So at this point in time, having all the studies being expanded, that's the right time for us to align on the strategy of how we're interpreting the data together and what we think about next.

And we already started D expansion cohorts and remember that we have with Bristol now.

Two combination studies the consequent on volume and then the triplet and each of this study is conducted in multiple.

Two more types, we have abroad translational program the desk.

The PD markers and unions to chemistry, as we stated in the past also that work.

Playing advanced Technology Center and on the patient center. So the collaboration is actually growing and growing in both parties felt that it will be good to have a joint strategic oversight and there is a committee there is actually and working.

In parallel to the joint development Committee that is.

There is they are working at the operational level.

So at this pointing time, having all these studies are being expanded that's the right time for us to align.

One.

On the strategy of how how we are interpreting the data together and then and how we think about next steps.

Stephen Douglas Willey: All right, thanks for taking the questions.

Alright, thanks for taking the questions.

Okay.

Daina Michelle Graybosch: The next question is from Deanna Graybosch of SVB. Please go ahead. Hi.

The next question is from Deanna Gray Bosch of S. V. B. Please go ahead.

Daina Michelle Graybosch: Hi, thank you for the question and congratulations on the data guys. I wonder first about Com 902, if you could give us any more details about the nature of these stable diseases. Did you see tumor shrinkage? Was this not so much shrinkage in a lot of stable and any notable case studies that gave you a lot of confidence?

Hi, Thank you for the question and congratulations on the data guys I Wonder first on Comm nine O. Two if you could give us any more details about the nature of these stable diseases.

Did you see tumor shrinkage.

So it's not one that shrinkage and a lot of stable and in any notable case studies that gave you a lot of confidence.

Unknown Executive: Yeah, so thank you very much for the question, Dana. We did look at the metrics for the patients that were enrolled. We, with the investigators, considered that we had enough data embedded in the poster to inform on the clinical profile of the subjects, of the patients that were enrolled in this study. So the things that we were focused on, essentially, were looking at the treatment journey or the course of the patient, as illustrated in the swimer plot. We think that the swimer plot best represents how heavily pre-fitted those patients were.

Yeah. So thank you very much for the question Dana So we did.

Look at the metrics for the patients that were enrolled.

We with the investigators.

Considered that we had enough data embedded in the poster to inform the clinical.

The profile of the subjects of the patients that were enrolled in this study.

The things that we were focused on essentially.

We're looking at the treatment journey or the course of the patients So which is illustrated in the swimmer plot, we think that the swimmer plot best represents.

How heavily pre treated those patients where we also provided icons in the swimmer plot to illustrate the patients who had received prior immune checkpoints in patients who had prior treatment refractory disease.

Unknown Executive: We also provided icons in the swimer plot to illustrate the patients who had received prior immune checkpoints and patients who had prior treatment refractory disease. So one of the other things that we looked at, based on enrollment in the study, was that for patients who were induced to escalation, and it's only dose escalation that we're reporting, the assessment of measurable disease is not an eligibility criterion. So we didn't think that would inform us on whether patients had tumor reductions.

So what are the other things that we looked at as based on enrollment on the study was that for patients who are in dose escalation and its only dose escalation that we're reporting.

The assessment of measurable disease is not an eligibility criterion. So we didn't think that will inform us on whether patients had tumor reductions, yes patients could be evaluated based on receipts, but we thought that the most appropriate way to <unk>.

Unknown Executive: Yes, patients could be evaluated based on resistance, but we thought that the most appropriate and appropriate way to illustrate the anti-tumor activity of Com 9-02 was to demonstrate this using the swimmer plot. Yes, we did see a few patients with tumor regressions, but if you look carefully at the swimmer plot, I think it best answers the question of how patients were doing in the study, and that's why we decided to just go with the swimmer.

Australia, the anti tumor activity of 902 was to demonstrate this by the swimmer plot, yes, we did see a few patients with <unk>.

Tumor regressions, but if you look carefully at the swimmer plot I think the best answers the question.

Of how patients were doing on the study and that's why we decided to just go with the swimmer plot.

Daina Michelle Graybosch: So I'll follow up then. So how many of these patients, or do you note, I just thought I didn't see the notation which of these patients started with measurable disease and which ones did not?

So I'll follow up then so how many of these patients or do you know I just don't I don't see the notation, which of these patients started with measurable disease, and which ones did not.

Unknown Executive: Yeah, we decided not to include that because since it was not an eligibility criteria, not a lot of the patients had measurable disease, and we wanted to convey the finding of anti-tumor activity, including confirmed stable disease that we demonstrated in the sumer plot. So if you look at that summa plot, we have, of the 18 patients, nine of them with either the best response assessment of stable disease, and out of these nine, two-thirds, 67 percent, with confirmed stable disease, and, of course, three patients with stable disease that's been going on for six months or longer.

Yes, we decided not to include that because.

Since it was not an eligibility criteria and are not a lot of the patients had measurable disease and we wanted to convey the finding of the anti tumor activity, including confirmed stable disease that we demonstrated in the swimmer plot. So if you'll see the <unk> plus we have of the <unk>.

18 patients nine of them with either best.

Sponsor assessment of stable disease and out of this nine two thirds, 67% with confirmed stable disease and of course three patients.

With stable disease at six months or longer.

Unknown Executive: The icons that we illustrate in the swimo plot, I think they provide a surrogate assessment for how 902 as monotherapy through dose escalation has some form of clinical benefit for the patients that are enrolled. So I think it probably, if you think very carefully about it, it provides you with enough information on how patients are doing in the study.

Icons that we don't we illustrate in the swimmer plot I think provides these surrogates.

Assessment for how come 902 as monotherapy through dose escalation.

Has some form of clinical benefit for the patients that enrolled.

So I think it probably if you think very carefully about it provides you with the enough information on.

How patients are doing on this study.

Daina Michelle Graybosch: Okay, maybe one more follow-up for the patients with prior immune checkpoint inhibitors. Could, Did they follow, let's say, the SITC guidelines for washout between the periods, and confirmed progression on the checkpoint?

Okay, maybe one more follow up for the patience of prior immune checkpoint inhibitor.

Uh huh.

To date follow let's say the city guidelines for washout.

Between the period confirmed progression on the checkpoint.

Unknown Executive: Yes, we had certain benchmarks in the protocol with regard to eligibility for enrollment in this study. So of all the patients that we had, out of those 18 patients we enrolled, eight of them had received prior immune checkpoints. And if you look at the summer plot, it best illustrates those patients so that I can just go through them. So we had a patient with a codoma, adenoid cystic carcinoma, peritoneal cancer, sponsal cancer, mesotheloma, mesotheloma, prostate. cancer, adrenal cell carcinoma, and prostate cancer.

Yes.

We had certain benchmarks and the protocol when it gets to a.

Eligibility for enrollment onto the study.

So of all the patients that we had out of those 18 patients. We enrolled eight of them had had received prior immune checkpoints.

If you look at the swimmer plot it best illustrates those stations that I can just go through them. So we had a patient with a chordoma adenoid cystic carcinoma appears to allow cancer small cell lung cancer mesothelioma prostate cancer renal cell carcinoma in prostate cancer, yes, we follow the guidelines.

Unknown Executive: Yes, we follow the guidelines in terms of washout. Perfect. Okay. Thank you.

In terms of a washout.

Perfect. Okay. Thank you very much.

Daina Michelle Graybosch: Okay, thank you very much.

No worries.

The next question is from Chris Howerton of Jefferies. Please go ahead.

Chris Howerton: The next question is from Chris Howerton of Jeffrey. Please go ahead.

Chris Howerton: Hi, good morning. Congratulations on the progress and I really appreciate you taking the questions. I think a lot of really good ones have already been asked, but maybe just two for me.

Hi, good morning, congratulations on the progress and really appreciate you taking the questions I think a lot of really good ones have already been asked but maybe just two for me.

Chris Howerton: One question would be, you know, could you comment at all on any safety that you've seen with respect to the triple combination study, any notable toxicities or things that would suggest things like immune activation or things like CRS? And then the second question that I would have is this might be a little tougher to kind of think about, but, you know, one of the things that's notable about the patient populations that we have here is that, you know, they're heavily pre-treated with 10, median line of 10 pre-devious therapies.

One would be.

Could you comment at all on on any safety that you've seen with respect to the Triple combination study.

Any.

Any notable toxicities or things that would suggest things like.

Immune activation or things like Crs would be one question and then the second question that I would have is is this might be a little tougher to kind of think about but.

One of the things that's notable about the patient populations that we have here is that the.

They're heavily pre treated like 10 median line of 10 previous therapies. So how can we think about the potencies certainly of 902 in the context of patients with the healthier immune system and what are some of the things that youre going to be looking out for as you are.

Chris Howerton: So how can we think about the potency, certainly, of 902, in the context of patients with a healthier immune system and, you know, what are some of the things that you're going to be looking out for as you move forward in that? Thank you.

Move forward in that in that context. Thank you.

Yeah.

Unknown Executive: So maybe I can start. So in terms of cytokine release syndrome, we didn't observe this. None was reported in the study for the triplet and also for Com 902. This was not something preclinically that we thought we would see. And so far, with the reports that we have, we haven't reported this. Neither have the investigators, even though they ask these questions.

So maybe I can start.

In terms of cytokine.

Cytokine release syndrome.

We didn't observe this none was reported on the study for the triplet and also for <unk>.

<unk> 902.

This was not something a pre clinically that we thought we would see and so far with the reports that we have we haven't reported this neither have the investigators.

Even though the ask this questions and do the lab work when the patients are reported to observe this also.

Unknown Executive: do the lab work on the patients, reported or observe this also. We think that based on the mechanism of action of Com 902, and also as part of the triplet, that the toxicities that we've observed are not unique either to Com 902 or to the toxicities that are unique as part of the triplet. You know that we have accumulated a lot of data on Com 701.

We think that based on the mechanism of action of <unk> 902.

And also as part of the trip led that the toxicities that we've observed toxicities.

Toxicities that are not unique I'd like to come 902.

Oh, the toxicities that are unique as part of the trip lets you know that we have accumulated a lot of data on <unk> 701. So let me speak about the triplet Trust income 71 as monotherapy.

Unknown Executive: So let me speak about the triplet first on Com 701 as monotherapy, and we can say categorically that it is very well tolerated as monotherapy, and it has a favorable safety profile. We also have enough information at this time with regard to Com701 in combination with Nivolumab, which we will disclose at ASCO. It is also well tolerated and has a very good safety profile. We did not observe any of the specificities that you've mentioned. Frequent toxicity we've observed as monotherapy for Com701, in combination also with nevolumab, and also as part of the triplet, is fatigue.

And we can say categorically that it is very well tolerated as monotherapy and it has a favorable safety profile. We also have enough information at this time with regards to come 701 in combination with new volume lab, which we disclosed at <unk>.

It is also well tolerated.

As a a very good safety profile also.

We did not observe any of the toxicities that you've mentioned.

The most frequent toxicity was observed as monotherapy for <unk> 701 in combination also with with Nivola lab and also as part of the triplet is fatigue, and it's typically grade one or two fatigue.

Unknown Executive: And it's typically grade one or two fatigue that we've been able to show. The other toxicity that the other toxicities that we've seen in combination are things that are constitutional in nature and related to the cancer that the subjects have. Either they have elevated liver function test abnormalities as a result of progression in the liver, or they have obstruction of certain organ components because of the prevailing cancer itself. So there's nothing that is unusual in the studies that we've seen so far. For Com902, specifically, it's very well tolerated also.

<unk> been able to show.

The other toxicity that the other toxicities that we've seen in combination.

<unk> set a constitutional in nature and related to the cancer that the subjects have either.

They have elevated liver function test abnormalities as a result of.

Progression in the liver.

They have obstruction of certain organ components because of the prevailing cancer itself. So there is nothing that is unusual in the studies that we've seen so far for continental to specifically, it's very well tolerated also.

Chris Howerton: Mark asked about the patients with atrial fibrillation. We think it's a one-off, based on the preclinical data that we have. We didn't observe a psychoticone release syndrome in that. Also, we did note that in addition to most of the patients doing well on study treatment, only one subject came off, and that's the subject that had the treatment discontinuation that we describe. That was a patient with prostate cancer with atrial fibrillation, as I mentioned. Sounds top here.

Mark asked about the patients with atrial fibrillation, we think it's a one off where based on the preclinical data that we have we didn't observe cytokine release syndrome in that also.

We did note that in addition to most of the patients screen well on study treatment only one subject came off and that's the subject that.

Had the treatment discontinuation.

I would describe that as a patient with prostate cancer with atrial fibrillation.

That I mentioned.

So I'll stop there.

Chris Howerton: Okay, all right, then that's great. Thank you very much, Henry.

Okay Alright, that's.

That's great. Thank you very much Henry.

Unknown Executive: The next question is from Tony Butler of Roth Capital. Please go ahead.

The next question is from Tony Butler of Roth Capital. Please go ahead.

Unknown Executive: Yes, thanks very much. The question or series of questions, one is in the triple study, a small number of patients, but, What is considered a high expressor of PVRL2? That's question one. And then question two, two parts.

Yes, thanks very much.

The the question or series of questions one is on.

And the Triple study, a small number of patients but.

What is considered a high express or PV Oriel too that's question one.

And then question two parts.

Unknown Executive: Going back to the translational data, which I... have a lot of respect for. A question was actually asked about dose response, but I am curious about the pharmacokinetics of 701, and especially given the low dose versus high dose. And importantly, is there any correlation between dose level and duration, that's part A, and then B. Do you have a hypothesis as to why, if, in fact, and I realize that the translational data is all peripheral, we don't really know what goes on at the tumor site unless you have a view about that.

Going back to the translational data.

Hum.

Yeah.

I have a lot of respect for.

A question was actually answered asked about dose response Bryan.

Curious about the pharmacokinetics of 701, and especially given the low dose versus high dose and importantly is there any correlation to.

Dose level and duration.

That's part a and then B do you.

You have a hypothesis as to why if in fact and I realize the translational data is all peripheral we don't really know what goes on at the tumor site and unless you have a view about that but what what's really why don't we see greater tumor shrinkage.

Unknown Executive: But what's really interesting is that we don't see greater tumor shrinkage. And it may be simply because these are very, very sick patients who've had multiple therapies. I'm respectful of that. I'm just curious about your hypothesis on that point.

And it may be simply because these are very very sick patients.

Had multiple therapies some respectful that I'm just curious of your hypothesis on that point, thanks very much.

Unknown Executive: Thanks very much.

Unknown Executive: Okay, thanks, I think I can take it. So first of all, for the high expresser of PVRL2. So as you may remember, we published quite extensively in the past that certain tumor types had higher expression of PVRG and PVL2, and these are the indications of which we're moving forward to now. So just the indication in which PVRL2, you know, in terms of age score, if we wish, it's probably 200, 300, so this for the first one. Then for the dose and duration, Henry will probably want to take this one, and I could take the third one.

Okay. Thanks, I think I can take it so first of all for the high express or if you've heard too. So as you may remember, we published quite extensively in the past that certain tumor types has higher expression of Beaver G and fever tube and these are the indication of which we're moving forward to know so it isn't the case today, which people too.

In terms of H scores.

We wish it's probably 200 300.

So this was the first one.

Then for the dose and duration.

Yeah.

And probably you want to take this one and I can take the third one.

Henry Adewoye: Yeah, so you're correct that the duration is a reflection of the heavy treatments that the patients in the studies were on. Just as a matter of fact, we did indicate in our prepared comments and also on the poster that a median of 10 prior therapies with a range of 1 through 19. If you think of the Com 711 Nivo study, this is a median of five, so it's actually essentially a sample of the median prior therapies.

Yeah, So you're correct that the duration is a reflection.

Of the heavily heavy pre treatments that they the patients on the studies were on just as a matter of fact, we did indicate that in our prepared comments and also on the poster.

That a median of 10 prior therapies with a range of one through 19.

If you think of the comp 71 meaningful study. This was a median of five so it's actually essentially a doubling.

Ah the median prior therapies, so if patients.

Henry Adewoye: So if patients are unable to stay as long, then you probably will not be able to see this correlation that is of interest to you that is also of interest to us. So it's all based on the heterogeneity of the patient population and the length of time patients stay on. Those are the key metrics that inform the relationship with treatment outcomes.

On able to stay as long then you probably will not be able to see this correlation that is of interest to you that is also of interest to us. So it's all based on the heterogeneity of the of the of the patient population and the length of time patient.

On.

Those are the key metrics that inform on the relationship with treatment outcome.

Unknown Executive: And then for the third one, about the translation data. So, you know, we are very excited about this data and also our partner, BMS. We've been studying this pathway for over a decade, and we established the biology, and we established the preclinical data that show that if you combine these three edges together, they're all modulating the NEM axis, and they eventually are synergistic in multiple models in the preclinical setting. And now, for the first time, we see, in the patient, such a potent immune activation reflected by its potency, by its consistency, and evident by multiple rhythms.

And then for the third one so Oh bugger translational data.

You know, we're very excited about this data and also a partner BMS.

We're starting to see pathway for over a decade, and we establish the biology and established the preclinical data that shows that if you combine the three of US together the old modulating PD, one axis and they eventually synergistic in multiple models in preclinical settings and now for the first time, we see in patients.

Such a potent immune activation reflected by the potency, but the consistency and evidenced by multiple Readouts I think this is very.

Unknown Executive: And it is very exciting to see this technology now being implemented into patients. Now, in order to actually see, and maybe just to mention, again, as mentioned before, that if you compare this data to our own data with Com 7-1 on mono and N combinations, and also to all published data that we're aware of digits and mono-n combinations, the effect still seems, again, more robust and more potent, again, suggesting that the triplet is doing something different from each combination of the agents by themselves.

We're excited to see this translate now into patients.

I want to actually see and let me just you mentioned again as mentioned before the <unk>.

Comparative data to our own data with comps up in the one on the mono and in combination and also to all published data that we're aware of digits in mono and combination the fix it seems again more more robust and more potent against suggesting that the triplet is doing something different from each of the combination of the agents by themselves.

Unknown Executive: Now, what about the two microenvironments? So, you know, as mentioned, these are heavily, heavily pursued as the patient population in this specific trial, and more things need to happen in the two microenvironments in order for them to actually see tumor shrinking. So while we are falling also biopies in what we expand the trial and also look at your microenvironment, these peripheral immune effects are potent, and probably in this heavily protected patient population, we're not sufficiently in your microenvironment to modulate it enough to mediate tumor shrinkage, and we are looking forward to see what this regime will look like in our bar market-driven approach and the expansion courts. Excellent.

Now what about the tumor micro environment. So you know as mentioned these are heavily heavily pursuit of this patient population in this specific trial.

And more things need to happen in the tumor microenvironment and noticed that the actually see tumor shrinkage. So while we are falling off so biopsies and wanted to expand the trial and also look at Joel microenvironment this peripheral immune effects.

Potent and probably in this heavily pre treated patient population were not sufficient NGL macro environment two to modulate it enough to mediate tumor shrinkage and we are looking forward to see how will this regime looked like you know, we're a biomarker driven approach and that the expansion cohorts.

Okay.

Excellent.

Unknown Executive: Excellent. I'm grateful. Thank you for both very much.

Paul Thank you for both of them.

Okay.

The next question is from Ren Benjamin of JMP Securities. Please go ahead.

Ren Benjamin: The next question is from Ren Benjamin of JMP Securities. Please go ahead.

Ren Benjamin: Hey, good morning, guys. Thanks for taking the questions. I guess, just starting off with the triplet and Henry, some of the comments you have made regarding the expansion courts. Did I hear right that prostate cancer wasn't one of the ones that, you know, you'll be expanding into? And if I did hear right, I was just kind of curious, given the longstanding SD that you have here, why that is.

Hey, good morning, guys. Thanks for taking the questions.

Just starting off with the triplet and.

Henry some of the comments you made regarding the expansion cohorts did I hear right that the prostate wasn't one of the ones that.

You know you'll be expanding into and if I did hear right. I was just kind of curious given the long standing SD that you have here.

You know why that is.

Henry Adewoye: Yeah, so for the expansion cohort for the triplets, we're focused on the biomarker-informed patient population. So we're focused on ovarian cancer and endometrial cancer. We're also now focused on head and neck scrimor cell carcinoma, and we also have a basket cohort. This is of interest to us also for prostate cancer. But understandably, we think we need to prioritize the indications that are of interest to us, and that's why we're focused on what we have now as part of the expansion for the triplet.

Yeah. So for thank you Randy.

So for the expansion cohort for the triplet.

We're focused on the biomarker informed patient population. So we're focused on ovarian cancer. We are focused on endometrial cancer. We're also now focused on head and neck squamous cell carcinoma. We also have a basket cohort.

This is of interest to US also of prostate cancer.

But understandably, we think we need to prioritize the indications that are of interest to us.

That's why we're focused on what we have now currently as part of the expansion for the triplet.

Ren Benjamin: Okay. And then, you know, as you guys have looked at this data, have there been any new biomarker-based insights that you might be able to provide more color on? And, you know, have you learned anything new that you might be able to extend or you might be able to use in your expansion cohorts?

Yes.

Okay.

And then.

You guys have looked at this data.

There been any new biomarker based insights that you might.

Are you able to provide more color on and have you have you learned anything new that you might be able to expand.

Or you might be able to.

Using your expansion cohorts.

Okay.

Unknown Executive: So I would say that, again, the main observations just mentioned that the salational date and prefer blood regarding biopsies are not mandatory in this part of the trial, but obviously, this is work in progress. We are collecting samples for all the patients, especially now in the expansion course. We will follow a correlation to different bar markers we are exploring. We will also explore modulation in the two microenvironments, but this is all.

So I would say that again the mineral reserve ratios just mentioned I'll, just finish and I'll do it in peripheral blood regarding biopsies are not mandatory in these parts of the trial, but obviously this is work in progress we're collecting samples to them for all the patients, especially knowing the expression of course, it will follow a correlation to different different biomarkers we explore.

So we will explore also modulation in the tumor microenvironment, but this is all work in progress.

Unknown Executive: And Rennie has just... No, go ahead, go ahead.

So ronny.

How many.

No go ahead go ahead, sorry go ahead.

Unknown Executive: I was just going to say that, in general, and Iran was alluding to it, the fact that we were observing potent immune activation in the triplet, in the doublet, with Com 71 alone, from our perspective, it is really highly supportive of the hypothesis that we came up with for the PVRIG pathway and in combinations, and that for us was critical. In the dose escalation setting, just to get more comfortable entering the expansion cohort.

I, just I'm, just going to say that.

That in General Island around was that it was alluding to.

The fact that we were.

Observing potent immune activation in the three plant in the doublet in Wisconsin in London alone from our perspective, it is really highly supportive.

Positive did we came up we'd find a PD pathway and in combinations and that first was critical.

In the dose escalation setting just to get to.

More comfortable entering into the expansion cohort, but now there's a lot of work ahead of us.

Unknown Executive: But now there's a lot of work ahead of us pushing these studies forward and making sure that we act on all fronts on the translational approach that we're taking together with evaluating the dynomaxit hypothesis. So at this point in time, this is what we have, but we're encouraged by this.

Pushing this.

Forward and making sure that we external content led translational approach that we're taking together with the evaluating the dinner Mexico. So listen at this point in time they will react.

We're encouraged with it.

Ren Benjamin: I got it. And I guess, you know, finally, you know, given these results in the triplet and how happy you are with that. Why not evaluate 902 and 701 with, you know, an additional PD1 or PDL1 inhibitor versus the ongoing 902-701 study? And when we think about PD1 versus PDL1, right, if we look at Roche's data, you see that response rates with a PDL1 inhibitor, is there a biological rationale why stick with, let's say, a Devo, I understand from a cost perspective in the Bristol collaboration, but is there a thought process or something that you guys are thinking about now where you might want to evaluate some other combination partners?

Got it.

Just finally.

Given these results and the triplet and.

How happy you are with that one.

Why not evaluate nine O two and 701 with you know you know an additional either PD, one or PDL, one inhibitor versus the ongoing level of two seven to one study.

And when we think about PD, one versus PDL one right. So if we look at roche's data, it's you'll see that response rate with a PD lone inhibitor is there.

A biological rationale why stick with let's say opdivo.

I understand from a cost perspective, and the Bristol collaboration but is there a.

Thought process or something that you guys are thinking about now where you might want to evaluate some other combination partners.

Yeah.

Unknown Executive: So I'll start answering this, and Henry, if you have any additional thoughts, please chime in. We've now launched the studies that we wanted to do, and we're doing them in collaboration with Bristol MESQweb, and we use Nivalium. From our perspective, obviously, these studies are serving as a way for us to try and address the relevant drug combinations for the different patient populations in the different indications and try to assess which indications and combinations we should focus on for future studies.

So I'll start answering this and Henry if you have any additional thoughts.

Please.

Chinese.

We're we're now we've now launched the studies that we wanted to do and we're doing it in collaboration with Bristol Myers Squibb.

Hi, Omar.

From our perspective, obviously these studies are serving as a way for us to try and address the relevant drug combination for the different patient populations in the different indications.

And tried to to assess which indications and combinations, we should focus on for the future.

For the future study.

Unknown Executive: Having said that, we're not rolling out additional PD1, PDL1 inhibitors in the future. At this point in time, in collaboration with BMS, we're committed to pursuing this path forward and get the data that we need in order to dive more deeply into certain indications with certain combinations. Henry, do you want to add anything? Thank you.

Having said that and we're not ruling out using additional.

PD one PDL one inhibitors in the future at this point in time.

Under the collaboration with BMS.

We're committed to pursue this path forward and get the data that we need in order to dive more deeply into certain indications with certain combinations. Henry do you want to add anything.

No I think you've answered most of it just one little part of it that I think.

Henry Adewoye: No, I think you've asked most of it, just one little part of it that I think you've articulated very well before in the past and continuously do, and that's not just to look at the PD1, PDL1 axis but also to rely on the strength that Compugent has with its antibodies. So we also think strategically of a PD1 and a PDL1-free regimen, and as a consequence of that have this ongoing study with an expansion court of Com 701 and Com902 enrolling patients with non-smorcell lung cancer, head and neck, chrymersol cancer, and also colorectal cancer.

You've articulated very well before in the past and continuously and that and that's not just to look at the PD one PD L. One axis, but also to rely on the strength that comp you Didnt has with its antibodies. So we also think strategically of PD, one and PD L. One for Ray.

Demand and as a consequence.

Sequence of that we have this ongoing study with an expansion cohort of <unk> 701, and continental to enrolling patients with non small cell lung cancer head and neck squamous cell cancer and also colorectal cancer. So that's the other strategy, which I think might be of interest to you also and I know you remember these are really.

Ren Benjamin: So that's the other strategy, which I think might be of interest to you also. And I know you remember this, Remy, to not just a PD1, PDL1 combination but one that is free of those agents. Great. Thanks for taking the questions.

So not just the PD, one PD lone combination, but one that is free of those students.

Ren Benjamin: Great. Thanks for taking the question.

Great. Thanks for taking the questions.

Operator: This concludes the Q&A; there is an additional question. The next question is from Astica Gungwarden of tourist securities. Please go ahead.

Okay.

Okay.

Okay.

This concludes the Q&A.

There is off and then a general question. The next question is from.

US Deca couldn't Warden of Trust Securities. Please go ahead.

Asthika Sarith Goonewardene: Hey, guys, Asa Kupidu-a-Had, thanks for taking my question. Apologies, just any background noise where I'm on the floor at 50 here. Just want to check on the patient on the triplet combination that you did show stable disease. Were you able to get any biopsies of the tumors on progression? And maybe you could talk to us a little bit about what the signals that you might have been seeing that could have been driving the progression after the therapy? Thanks.

Hey, guys. Thank.

Thanks for taking my question I apologize for any background noise I'm at the fluid Cynthia.

Just wanted to check on the patient on the triplet combination that.

It shows stable disease, where you're able to get any biopsies of tumors.

Tumors on progression and maybe can you talk to us a little bit about what.

Where the signals that you might've been theme that could have been driving the progression.

After therapy. Thanks.

Unknown Executive: Yeah, I think that's a good question. So for patients, because the data that we are presenting is dose escalation. Biopsies are not mandatory, as opposed to patients who are enrolled in the expansion cohort where there is a pre-assessment with a biopsy and another biopsy after a certain number of periods, time on the study. So the short answer is we do not have biopsies on any of the subjects who are one subject who is either ongoing or the subjects who are stable disease or the subjects who progress. Great, thanks for picking my question, guys.

Yeah, I think that's a good question.

So for patients because it stayed at all we are presenting is a dose escalation.

Biopsies are not mandatory as opposed to patients were enrolled on the expansion cohort, where there is a pre assessment with a biopsy and another biopsy. After a certain number of period of time on this study. So the short answer is we do not have biopsies on.

Any of the subjects.

One subject to either ongoing or the subjects, who had stable disease or the subjects who progressed.

Yeah.

Great. Thanks for taking my question.

Okay.

Okay.

Asthika Sarith Goonewardene: This concludes the Q&A session. I will now turn the call back to Compugens president and CEO, Dr. Cohen-Diag. Would you like to make your concluding statement? Yes.

This concludes the Q&A session I will now turn the call back to <unk>, President and CEO. Dr. Cohen <unk> would you like to make your concluding statement.

Unknown Executive: Yes, thank you, operator. Thank you for joining us today and for your continued support. We hope to see you here at Sizi. Stay safe and healthy.

Yes, thank you operator.

Thank you for joining us today and your continued support we hope to see here at city stay safe and healthy.

Operator: Thank you. This concludes the Compugent LTD third quarter 2021 Financial Results Conference Call. Thank you for your participation. You may go ahead and disconnect.

Okay.

Thank you. This concludes the comp you Jan L. T D third quarter 2021 financial results Conference call. Thank you for your participation you May go ahead and disconnect.

Okay.

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