Q2 2023 Compugen Ltd Earnings Call
Thank you David.
Sure.
[music].
Ladies and gentlemen, thank you for joining us today welcome to <unk> second quarter 2023 results conference call. At this time all participants are in a listen only mode. As a reminder, today's.
Call is being recorded on an audio webcast of this call will be made available on the investors section of <unk> website, Www Dot <unk> dot com.
I would now like to introduce <unk> head of Investor Relations and corporate communications. Please.
Please go ahead. Thank you operator, and thank you all for joining us on the call today, joining me for cartridges for the prepared remarks are Dr. <unk> Cohen dialogue, President and Chief Executive Officer, and Alberto Sessa, Chief Financial Officer, Dr. Henry <unk>, Chief Medical Officer, and Dr. Ronald Fisher, Chief Scientific Officer will join us for the Q&A.
Before we begin we would like to remind you that during this call. The company may make projections or forward looking statements regarding future events business outlook research and development efforts and the potential outcome. They came at those he's led the company's discovery platform anticipated progress and plans resolved some timelines rich programs financial and accounting related matters.
Projected financial information as well as statements regarding the company's future cash position and all the results and the company's future initiatives.
We wish to caution you that such statements reflect only the company's current beliefs expectations and assumptions, but actual results performance or achievements of the company may differ materially.
Statements subject to known and unknown risks and uncertainties, which could cause the company's actual results to differ materially from those projected in such forward looking statements and we refer you to the SEC filings for more details on these risks, including the company's most recent annual report on form 20-F filed with the SEC on February 28 2023.
Right.
The company undertakes no obligation to update our projections and forward looking statements in the future.
And now I'll turn the call over to <unk>.
Thank you Yvonne.
Good morning, and good afternoon, everyone and welcome to our second quarter 2023 update.
As coffee Jan our goal is to transform the treatment of cancer patients who have no effective treatment option.
Discovering novel drug target and developing potential first in class drugs.
On the strong we were efficiently executing on our differentiated clinical approach to evaluate the benefits of our chemotherapy free cheapest catching in all therapy combination of content and alarm Com now too and then believe him up block.
King Street pathways after dinner at E. P. B R E T G S PD one.
And I've called this year, we were excited to see the positive momentum and interest of the industry understand if your community in targeting to do number one axis as a potential novel approach intriguing cancer.
And by our own data.
And data presented by other including Astrazeneca Roche and ARCUS Gilead.
Looking at the totality of the data we have presented to date in hard to treat cancer patients.
There was enthusiasm among adults we stopped with regarding responses demonstrated with our triple combination approach in patients with microsatellite stable endometrial cancer, who had failed standard of care.
Any prior Pan bra and blended factor needs treatment.
Well Dee patient there were no other treatment options.
Okay.
In nine patients we showed an overall response rate of 22% and a disease control rate of 44%.
The responses were durable.
Supported by immune activation that said than what one would expect for an anti PD one alone.
This is dmitry as data is consistent with the antitumor activity, we reported 471 based combination.
In patients with other hard to treat tumor.
Including microsatellite stable colorectal cancer Latino worthy central variant cancer, and checkpoint inhibitor experienced non small cell lung cancer patient.
Reflecting on the totality of the data to date in patient cheaper cutting not responsive to standard of care, including immunotherapy.
Our data suggest.
Our content in a land based combination has the potential to offer a treatment option. We just favorable safety profile for hard to treat patients across the spectrum of PDL one expression levels.
Patients who are anti PD, one treatment refractory pointing to a potential concept and along Maggie aged mechanism of action.
Our immediate focus is on expanding our data entry indication.
Platinum resistant ovarian cancer and.
Colorectal cancer.
While continuing to invest in biomarker discovery, which is an important inefficiently checking our development path forward.
However, we believe that the temperature protection of concert and one is part of the genome one axis may be much broader than these two indications.
As mentioned earlier Astrazeneca presented clinical results at Agco on rid of Augusta me and PD, one bispecific antibody derived from our culinary know too.
Establishing its safety and pharmacokinetic profile.
And showing antitumor activity in patients previously exposed to checkpoint inhibitors, and usually not responsive to immunotherapy.
Yeah.
Astrazeneca continues to advance the <unk> development in multiple studies, including a phase two trial in checkpoint inhibitor naive non small cell lung cancer patients and the phase two trial in a patio biliary cancer and privilege and now plan to initiate a phase III trial.
D C here.
We know that not all N P. T. G. R. Designed this thing.
And I call nano too, which is an N P. T G with reduced FC effector function really of Augusta me was engineered to have an inactive FC domain to enhance antitumor activity.
Another program in the U S D E F G or reduced effector function can you.
Our crews and GTT.
And I call August Gilead showed continued improvement in progression free survival.
First is blocking PD one alone.
With a potentially better safety profile to what has been shown to date with F. E. F E N E T G.
And that obsession that gained great interest of Casco was Roche did you to lever cancer data.
This is disturbed randomized trials.
The benefit of adding an anti T G G.
Hundreds of care.
Blocking T gauge rejected in its four times greater overall response rate and a doubling of progression free survival.
On top of standard of care.
And Roche has initiated a phase III trial in first line had a bunch of setting that cant cancer based on these results.
We were pleased that the discussions of Roche presentation highlighted the potential to be significant.
P. J R O G blockade in a patch of cellular cancer.
This is another hard to treat indications, which may serve as a seat for com 701 treatment.
The important role of P. M. At Gee was also called out in another as co session on novel approaches to checkpoint inhibitors.
In which the presenter was intrigued by our data presented by jokes on my Vermont from M D Anderson and she'd be last year.
Knowing that blocking P V R. G in combination with PD one lateral responses.
Unexpected diseases like microsatellite stable colorectal cancer.
It is great to see an increased awareness of PV I liked your role in cancer immunotherapy.
Yeah.
It is important to highlight comprehensive differentiated approach and how we stand out among all the players.
Firstly, we have always said that blocking <unk> may not be enough and the P. B R. E G may be needed.
Our discovery of P. P. R. I G and extensive research we've conducted to test the effect of unlocking geeks biological function as a new drug targets in the context of the Dina Ashley's supports the need to block it.
This belief is consistently being reinforced as we roll out our clinical data across multiple indications.
Secondly, we believe we have a potentially best in class reduced FC effector function anti T G.
The data available today suggests it's S. T d's done of the D. G antibody may I did not matter.
Or it may be better to have a reduced or inc. A U S. T domain as we have.
And finally, Wisconsin into one and come now to our two wholly owned <unk> programs, we're the leader and a unique chemotherapy free treatment combination approach of blocking three axes immune checkpoint P. I G.
D G to N PD, one we did initial clinical data to support our hypothesis.
Along with a very successful ethical I would like to refer to additional progress we have made in the first half of the year.
We're advancing patient enrollment in our two photo one proof of concept studies.
And Raul 19 D. Anisette CRC study is on track to be completed by the end of the year.
Enrollment is slower than planned in the platinum resistant ovarian cancer study.
But we believe we can catch up one enrollment with a planned activation of additional sites.
As a reminder, the goal of these studies is to obtain more data help us better understand the contribution of components and bid on extensive biomarker work to identify the patients most likely to respond.
We believe that this strategy provides the fastest way to efficiently serve our development path forward.
And to potentially Derisk, our elite athletes comps are going to want and calm nano too in these two indications.
In May of this year, we presented data on our potential first in class anti on 18 binding protein antibody called FIFO Shri.
And the C I N T conference.
Europe's annually Immunology conference.
We believe there is excitement around our innovative approach.
Leading to the development of these complex was week program and its potential in addressing immunotherapy repletion.
Finally.
On the progress in the first half of 2023.
We're delighted with the favorable ruling of the European patent office too.
To uphold the broad claims in our P. D R. I G patent.
This ruling of the European patent office is a win for our innovation the discovery of Pea <unk> role as a novel immune checkpoint and a drug target for cancer.
As a company that accessing the discovery of new drug targets.
We harnessed our broad patent strategy that takes advantage of a novel target discovery capability.
Now moving on to what you should expect to see from us over the second half of year.
First we plan to report initial findings from our ongoing proof of concept studies by the end of the year.
And finally data and a magical conference in 'twenty 'twenty four.
Second we're expecting to present, new translational and initial biomarker data.
And long term patient follow up from our platinum resistant ovarian cancer studies presented at <unk> last year.
As well as additional data from our coffee first three preclinical programs all by the end of the year.
We also plan to present, new data from the metastatic breast cancer study all 17 patients treated with <unk> 701, any volume up.
Patients were enrolled into this cohort regardless of their E. R. P R and heritage statues.
These patients were heavily pre treated and had exhausted all available standard treatments, which could include immune checkpoints you need huge doors and a D C.
Before I hand over to Alberto I will touch briefly on our finances, and then Alberto will go into the details.
We have an expected cash runway through at least the end of 'twenty 'twenty four which we believe is sufficient to support our planned operations and reach milestones to potentially derisk, our lead assets come sit in one and comm 902.
In terms of future funding.
Non dilutive funding of our pipeline as it is our priority.
On this front it is worth noting that the trend in immunotherapy is to combine and treat earlier.
And we believe the profile of our lead assets come to the new one and calling on them to make them ideal combination candidates to be used in earlier treatment settings.
Additionally, there is increasing excitement around the potential of IGF pathway modulation in immuno oncology.
And we'd content for free we're happy that we have a differentiated approach to potentially harnessed. This type of kind of biology.
For optimal use in treating cancer.
Finally for.
Our partnership with Astrazeneca, we may become eligible for future milestone payments and with that I will hand over to Alberto for the financial update.
Thank you.
Thanks Happy now.
Our financial results.
I've always said with our fish Bobby.
Joe do you want to take your free cash.
And cash investments with Brookfield.
66, <unk> fog medium dania compared with approximately $83 7 million.
The subjects are Q1, 2022.
Our focus on capital efficiency.
Right.
Our execution and know what the number one offs and so forth.
The company has no debt.
We recognize the importance of cash efficiency and we are disciplined in how we deploy our crusher servicers, ensuring we will focus on reaching came.
We thought were available touch all week.
And just watch it went to court.
Expenses for the second quarter of 'twenty, two 'twenty three where he lives we've got work plans.
R&D expenses for the second quarter of 2023 or $7.8 million up.
$648 million in the second quarter as much as Waikiki.
The increase is mainly due to the amortization of deferred participation in R&D expenses.
The first one to 'twenty three.
And then increase it.
Clinical and CMC activities also.
With plant coal fired electricity meters.
Offsets the cruising clinical trial expenses headcount and currency exchange effects.
Our G&A expenses for the second quarter of 'twenty to 'twenty, three with $2 $4 million compared to $46 million in the second quarter of 2022.
For the second quarter of 2023, net loss was $9 million or 11 cents per basic and diluted share compared to a net loss of $9 $1 million or 11 cents per basic and diluted share in the second quarter of two ex U.
'twenty two.
With that I will hand back to him nuts to summarize.
Thank you Alberto.
To summarize we continue to execute and deliver on our goals.
With our most recent data in microsatellite stable endometrial cancer.
We continue to provide evidence supporting a potential concept and alignment needs of clinical benefit in hard to treat patients who are not responding to standard of care and says prior I O therapy.
We're looking forward to presenting new translation at an initial biomarker data and long term patient follow up how concept in one combination in ovarian cancer.
First data in metastatic breast cancer as well as additional data from our call cycle three preclinical programs all by the end of the year.
We also plan to share initial findings from our two ongoing studies in microsatellite stable colorectal cancer and platinum resistant ovarian cancer.
<unk>, a leading triple combination blockade of PD L. E. T. G N P D. One, Wisconsin, one continental to temporary lease them up by the end of the year.
The opportunity we have.
To positively impact the lives of so many more.
Motivates every single employee, we deem com P J everyday.
With that I return the call over for questions.
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 one if you wish to decline from the polling process. Please press star two if you are using speaker equipment currently what's the handset before pressing the numbers. Please stand by while we poll for your questions.
The first question is from Stephen Wiley of Stifel. Please go ahead.
Hi, good morning, Thanks for taking my questions.
I guess, just with respect to the fees to platinum resistant ovarian cancer study you talked about enrollment I guess going a little bit slower than expected or are you is that just a function of.
Hum.
Ex of site activation or do you now need to bring more sites than originally planned online in order to meet our target enrollment goal, which I believe was about 50% before the end of this year.
And I agree with you Mike Henry would you like to address this question.
Yes. Thank.
Thank you very much doing so first let me say that there's a strong interest by the sites and investigators to participate in this study.
There's a strong belief.
The hypotheses and people seem to do that.
Axes.
Triple combination of Pembina.
Southern Nevada, Colorado to at least based on the results we previously disclosed.
The triplets that consisted of continental come seven to one.
Most of this antibody undergo lula, 20% response rate, but also presented at ESMO.
What we've observed is.
Is that are there is it really as a result of restricted resources other sites resources moving personnel really changing.
Change in timing of IRB Ethics Committee review cycles.
And if you come to do studies in the platinum resistant ovarian population also.
We're in close contact with the sites and several additional sites are being considered.
And more likely to recruit a platinum resistant ovarian cancer patients.
Okay, no, which should get us back on track.
Okay.
Okay, and I guess when you think about the year end update is there some threshold number of patients specifically in ovarian, but you want to have enrolled before you try to communicate something incremental.
So maybe I'll take the fun.
And so in general we're still guiding to the same guidance that we shared that we hope to enroll up to 20 patients by the end of the year.
And that's why Henry saying that we believe we can catch up to that is that what we mean.
And so we we cannot at this pointing time estimate any deviation from the Guy who does and but obviously if there will be any obviously, we would share that and we believe that we will be able to share data as planned by the end of the year.
Just want to remind that in and in any case, we indicated that for the two studies. These would be initial data from this study.
And that's it and will enroll additional patients in.
And in the ovarian study in 'twenty 'twenty four was shared there there's some data disclosure.
Okay, and then maybe just lastly, I guess.
You talked about having I guess these two data sets to present at a medical conference in 'twenty four and.
Just kind of wondering internally is is the goal at this point to be able to make some kind of registrational go forward decision before the end of 2024 on the basis of these two studies. So I'm just trying to think about.
What's kind of the next step here once we get the proof of concept data. Thanks.
Yeah, So maybe I start I'm hungry if you if you would like to add to it. Please chime in but basically the goal of the study from the get go for these two studies was to add more data to the data that we already have in these two indications, which seems promising to us.
And to affect some of the contribution of components.
And to be able to pass to work at building a study that would take us to eventually to get the registration path. So that's the goal yes.
And and we need to we need to see as we go we do studies what is that data how it looks at penney's and as he said it previously it's more than that of a response rate, which is the addition of any projects that were evaluating.
And did your ability the safety profile. That's why this will allow us to to gain an understanding of how we move forward Henry anything to add on these fronts.
No I think you've covered it all.
Okay. Thank you.
Okay.
The next question is from a sticker couldn't warden of Truest Securities. Please go ahead.
Hey, guys. Good morning, Thanks for taking my questions I'm going to build them.
I think your question Steven asked here so far.
Okay.
Awesome.
So.
Yeah Ryan.
I know the expectation is for initial data can you.
Just quantify what kind of efficacy data will be key is that our presentation and and they can still right to assume that this is going to be more I think as an investor update.
Meeting update for that study.
After the presentation of that this year.
It will be any investor update in North America Conference update from the two new proof of concept studies definitely doing it yet.
We tend to present data at medical conferences from studies that are entering a more complete and where we have it and he said yes.
Okay.
Yeah.
Okay.
And then I've got a question about what efficacy data will be an update.
Try to keep at it and if that's going to be confirmed scans or if it's just a preliminary scan or TV.
Expectations.
Henry would you like.
To address this.
Oh, yes. Thank you.
The earliest ddos one can get.
For this patient.
Patient population will be response rates.
We also obviously will be interested also in looking at our other important clinical endpoints such as duration of response or possibly a progression free survival now all that being said this will depend on enrollment and our ability to catch up like we think we will be able to repurchase.
We'll be able to do but those are the key endpoints are the most important being our response rates.
Got it.
And then on the.
It should be.
With the delay totally appreciate that first of all restrictions and there's some chance that that would be et cetera happening I'm. Just wondering is there any impact.
The ADC launch and platinum resistant ovarian cancer is also.
Maybe causing any delays here.
And then related to that have you seen any delays in recruitment for the colorectal.
Eddie.
Henry.
In speaking with the investigators and all of the sites that we have we haven't observed though they havent reported back to us that the E. D. CS contributed meaningfully to the tea leaves I would just highlight it.
As you recall, our speaker E D C.
But we're talking about here is liver tox coming up.
Which is.
Absolutely because ex loops that approval in September 2000, and cancer that has not been a communication issue.
I mean, that's a solicit approval is also in the restricted a biomarker population.
Populations are fully receptor alpha positive patient population, so that has not been.
Or what's the reason for the delay that we've disclosed.
Got it.
And just also just want to double check that I.
I didn't no delays on the colorectal side right.
No competing products.
Exactly.
Well guys.
Uh huh.
Well with colorectal cancer as you know the patient population.
Microsoft for civil colorectal cancer.
The first one.
Lots of patients Unfortunately.
Need of more therapies for Microsoft lets people colorectal cancer.
And we haven't experienced that much of a significant delay with that population.
Excellent. Thanks, so much for taking my questions guys I'll jump back in queue.
Yeah.
The next question is from Dana Gray box of Leerink partners. Please go ahead.
Hi, This is Jeff Lewis on for Dana Thanks for taking our question.
Just the first is what do you hope to show the breast cancer update that'll be supportive of your plans and strategy in ovarian cancer and MSS CRC.
And for the initial update.
Up in translation on the show biomarker data.
And profit Bristol's ticket, how comparable the status of your own study with your ticket.
Any differences there you could point to.
And regarding the Apple stayed out of it.
H D C was that a tumor type.
That you sort of predicted would be amenable.
Inedible to PDR G blockade and what's your interests in that indication. Thank you.
So Henry your stock at Jack Henry just stocking the breath, and then theyre wrong, we'd take the biomarker and HTC expression.
Yes. Thank you for the question with regards to the breast cancer data Oh I can see at this point is that the patient population that was enrolled.
The petition that's heterogeneous.
Respect you, whether the ERP are positive or.
Maybe if you were her junior Omega threes.
This is a patient population that have exhausted all available standard of care therapies, including therapies that are approved.
So Josh.
No.
The important thing that we do.
Looking for in this patient population.
You used to see these signals of anti tumor.
We've achieved that.
You confirm to us that there is activity.
A combination.
We are pursuing it comes up in the one person doing that so.
So that's what would be of interest to us, especially in these hard to treat.
Patient population.
Possibly received silver.
Several lines of therapy.
Okay.
Yes, Ben for the questions about the biomarker. So yes, we anticipate that the same biomarkers that we didn't form or that we learn form in the study of the using the BMS did you should be relevant will support the other studies that we're doing both of them are studios and all incremental to all of you know.
Not to leave them in general this that wasn't started blocking typical carried the did you didn't want him to give you a a G. So but as you can be should be very similar to the study through the poly conducting and if you're if you will there. Despite some of the newer translational or potential predictive biomarkers in that study, we definitely think that could be and should be relevant.
Also to the follow up study that we're currently doing.
No about HCC, so we identified the pollyanna dmitry.
What are the top indications dominates the pathway and that's why we win.
These indications also brisk, but HSA is definitely one of the topics bristles of the pathway.
We couldnt start with all of them and people are quite broadly expressed in many indications.
So you can see is different.
Acacia and wished them both ways dummy mountain photographer vacation that we definitely see it potentially.
Okay.
And just think tariffs themselves.
And whenever we're going to attack the indication to your specific question I.
I think that that is being shown by now that the T V. I E blockade potential that constantly go one therapeutic potential is much broader than that two indications that we're focusing right now.
We took to focus on these two indications we have data and where we believe that additional data.
And would you say and studies may allow us to better design in the past for Boston, but I want to stress that again and again that's happening potential of continental one is much beyond these two indications anything close endometrial cancer and non small cell lung cancer.
And as you can see and as we said would prevent anything breath. It towards the end of the year, that's very encouraging to us.
Yeah, I think one of the other questions. You asked was if there was any substantive difference.
And the triplets that we're currently exploring a new grant Kansas fish.
We choose the Tripathi I'm, referring to now is continental Trucost comes up and the one for somebody Who's a lab visibly Elliot triplets, which is the triplet with the BNS.
And you Gotta do almost 96 to seven and roll them up.
We did if you as a reminder, we do have the press release, where we enrolled the first patient scheme to the current triplet of continental to comes up on the one October newsletter.
And that's part of what's going to be what we said was that you did not a this is one of the investigators on that study.
The Michelle's submission is that this combination which is the program is about continuing our triplet of commonalities to consume a little one.
Is very well tolerated.
<unk> actually seen the patient population with microsatellite stable colorectal cancer and the initial study that we are enrolled so there are no differences observed so far Oh this is elliot.
On us.
Colorectal patients.
That's super colorectal cancer patients, we do not expect there to be any substantive differences in terms of safety.
That answers your question.
It does thank you all.
Okay.
The next question is from Tony Butler of E. F. Hutton. Please go ahead.
Good morning.
We'd like to go back to this notion of.
PV oral two dominant reached over P V or.
Which seems to be a recurring fee and some of the cohorts and what you're attempting to move forward with.
The triple combinations and in particular of course 701.
And that's back to US go where you had some really good data in endometrial cancer. The total.
So I recall was in April .
The two responses to.
Two patients with stable disease, and I wondered if there was any additional information or follow up.
That is where patients actually able to show an additional reduction.
Size of those responses and or all of those.
Patients who had stable disease.
Sure.
Yeah.
Ron would you like to address a few cameras to portion.
Well so the deferred portion of things that you put on it people do them in a generality people would you, possibly dominant Stephen too, which is important part of it and this is again a measure that we looked at in both endometrial Vishal dominance and also in other indications.
Before.
Right.
And anything more to add.
Nothing more to add to what our.
Sure.
But anything more on the patients for additional follow up.
Pursuant to the settlement.
So we so we are going to present, a photo of staying down on these patients remember that we used when we shared the data in December at the small young December 'twenty two.
And we had patients that were still on study treatment responsive patients and some of them had durability of more than nine months.
We are going to present data and by year end and follow up data for these patients. So I guess that you will have answers to some of your questions then.
And that won't.
Just wanted to be sure that will include the endometrial patients that's what our focus.
Oh, no it will relate to D to the ovarian sorry, I misheard. Your question. It will relate to do vary and no. We didn't plan and yet to have any fall off on the ovarian and endometrial.
And Dmitry had cancer patient.
Okay. Thank you.
Okay.
This concludes the Q&A session and Compu Jens Investor Conference call. Thank you for your participation you May go ahead and disconnect.
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