Q4 2022 Compugen Ltd Earnings Call
Ladies and gentlemen, thank you for joining us today welcome to copy fourth quarter and full year 2022 results conference call at this time all participants.
Are in a listen only mode.
The audio webcast of this call is available in the investors section of <unk> website, Www Dot Sea Gen Dotcom.
As a reminder, today's call is being recorded I would now like to introduce Ivan <unk> head of Investor Relations and corporate communications.
Ivan Please go ahead.
Thank you operator, and thank you all for joining us on the call today, joining me from comp adjourn for the prepared remarks, our doctor not Goin', Diack, President and Chief Executive Officer, and Alberto Sessa, Chief Financial Officer, Dr. Henry Otherwise, Chief Medical Officer, and Doctor, who I know their senior Vice President research and drug discovery 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 outlet development efforts and the potential outcome. The company's discovery got one anticipated progress and plans and timelines for each program financial and accounting related matters as well as statements.
Regarding the company's future cash position.
We wish to caution you that such statements reflect only the company's current beliefs expectations and assumptions, but actual results performance or achievements of the company may differ materially.
These statements are subject to known and unknown risks and uncertainties and we refer you to the SEC filings for more details on these risks, including the company's most recent annual report and form 20-F filed with the SEC on February 28 2022.
The company undertakes no obligation to update projections and forward looking statements in the future.
Now I'll turn the call over to you now.
Thank you.
Good morning, and good afternoon, everyone.
Welcome to our fourth quarter and full year wait wait to update.
Immunotherapy has been an evolution for the treatment of many patients with cancer.
2022 chess PD, one pathway inhibitor and none were great Journal $95 billion.
Thanks, Tim.
We all know that remains an urgent unmet medical need for the majority of the cancer patients who are resistant to anti PD one.
To address the needs of these patients many drug combination therapy.
Including I O I O combinations.
<unk> is the leader in the treatment I O I O combination blocking P. I G E N GT one.
What did you Duffy antibody in combination with PD, one inhibitor may function E. P. D N one high expressing patients.
Our data.
Is that just show the D edition and anti PD L. A G may sensitize, Joe Moore to respond to PD, one antibodies block K event in PDL, one low expressing patients.
As leader in the Ddos.
We believe that evaluating the triple combination of <unk>.
Our potential first in class anti <unk> 701, with our potential best in class anti TGF Continental too.
And the PD, one inhibitor has the potential to maximize clinical benefit for patients.
On this front, we have made significant progress.
I would like to share our top highlights for 2022, which we believe set us up for success in realizing our vision to transform the lives of patients by extending the reach of cancer immunotherapy to those who are resistant to <unk>.
Anti PD one therapy.
First in 2022, we took a strategic decision to.
So narrow down our broad signal seeking study.
Focused on Gi indication with high unmet medical need and less competitive landscape.
Microsatellite stable colorectal cancer.
In platinum resistant ovarian cancer.
We believe the deep Buckler provides us with a high probability of success.
For several reasons.
One <unk>.
These are indications what we have shown encouraging clinical benefit.
And by immune activation that align with a calm seven O one mechanism of action.
We did that how did you kind of Russia.
And which we believe provides the fastest route to additional meaningful data to inform the next steps in building a path to registration.
Two.
As a result of our decision to prioritize changed occasion.
We concluded our collaboration with Bristol Myers Squibb.
Thereby enabling us to focus our time and cash onto indication.
Well Ed.
Switch to evaluate our own potential best in class anti <unk> com nano too as part of our triple combination going forward.
And now there's constant or no one is no longer restricted.
We also have the opportunity to advance and partner both of our potential first in class anti <unk> 701. In addition to come now too.
And lastly did.
The decision has enabled us to extend our cash runway through at least the end of 'twenty 'twenty, four which leaves sufficient time to complete our small proof of concept study.
Aimed at strengthening the evidence and Derisked our lead asset in these two indications.
Moving now to the second highlight of 2022.
Which was the encouraging clinical data we presented in the first quarter of 2022.
June indications.
The first set of data and we presented was in patients with microsatellite stable colorectal cancer and she conference in November 2022.
And the second set of data was in patients with platinum resistant ovarian cancer, which was presented at ESMO immuno oncology conference in December 2022.
As far as we're aware, we're the only company reporting clinical benefit with an immune checkpoint inhibitor.
Supported by an underlying biologic kind of a Shan nen indeed.
In this patient population with Microsoft they like stable colorectal cancer, and liver metastases, which makes.
Roxanne at least 70% of the <unk>.
MSS CRC patients and dismiss or started shipping.
This is encouraging.
This is an indication with high unmet medical need and these patients have no approved treatment options after failure of standard of care therapies.
In these patients with platinum resistant ovarian cancer.
There was a lot of excitement from investigators reporting Europe is shrinking or stabilization of tumor in some of their patients who had previously progressed on all available treatment options.
That's all.
The clinical benefit in these patients.
Including a 20% response rate with several patients responding over nine months.
With responses also had cheat in hard to treat high grade serous adenocarcinoma patients.
Along with a favorable safety profile.
Is encouraging compared to current standards of care.
The translational work with samples taken from the patient is in progress and we expect to share the data in one of the upcoming medical conference just drain 'twenty 'twenty suite.
In both indications.
Increasing T cell numbers.
And Maggie aging antitumor immunity.
Tumor types and in patient population that could not be addressed otherwise.
And the third highlight.
Astrazeneca rapid progress and continued expansion austerity PD, one <unk> bispecific.
Or is that golf tee.
Which is derived from our common angle too.
This progress and continued investment by global leader in oncology in our opinion exam.
Exemplifies belief in the mechanism of action and more specifically.
Our differentiated N E T J com now too.
Lack cunego too, which is the highest feeney G reduced to FC effector function MTT and people in D.
Really the Augusta me, what engineers to reduce the S. T effector functionality with the potential to enhance antitumor activity.
We obviously gave me a randomized phase two data, we then actually Simon <unk> antibody.
And Astrazeneca antibody design strategy.
We believe our choice of a reduced that's the effector function NTT East West Rain Forest.
Last year Astrazeneca progressed Augusta made into phase two development in metastatic non small cell lung cancer and she then astrazeneca has extended the development for the treatment of nave non small cell lung cancer and gastric.
Cancer patients.
I suppose that account and now also plan to initiate a phase III study this year.
It has suggested that this could be one of the 10 programs with a blockbuster potential.
This is great news for us.
As we may be entitled to receive up to an aggregate of $200 million in milestones for these products as well as kids royalties on future product chest.
We look forward to the success of fridge, they've got to do it.
During our call today, I will provide an overview of the opportunity and path forward in our prioritized indication microsatellite stable colorectal cancer and platinum resistant ovarian cancer.
We'll go on to describe our next pipeline asset unfaithful suite, which is the lead asset in our early pipeline.
Why we're excited about its potential.
Alberto will take you through the financials.
I will summarize our upcoming milestones and then we will open the call up for questions.
Talking with your opportunity and path forward with our prioritize indications.
We're initiating two proof of concept studies in platinum resistant ovarian cancer and in microsatellite stable colorectal cancer.
The goal of these proof of concept studies, each district and the evidence.
Bedroom, just turned the contribution of components and bid on the extensive biomarker work we're doing.
To try and understand the patients most likely to respond with a purpose of building a path to registration in this indication.
Hello, I suppose cancer is the third most common cancer do U S.
It is estimated that in 2023.
Certainly 153000, new cases will be diagnosed in the U S and about 52000 patients will die from dish cancer in the U S.
My first thought that like stable colorectal cancer represents about 95% of the colorectal cancer patient.
With limited treatment options.
70% of the patients with metastatic colorectal cancer had metastasized to the lever and as far as we're aware.
We're the only company who has reported.
Any kind of benefit in this patient population with a checkpoint inhibitor.
Yeah.
I'm delighted to report that we have multiple sites open which are actively screening patients to enroll in our MSS CRC triplet combination proof of concept study.
Patients will be eligible if they are PD, one naive and have received up to three prior lines of therapy.
And we will be including patients with liver metastases.
We the enthusiasm of our study investigators and the lack of good treatment options for these patients we anticipate completing enrollment of up to 20 patients and plan to share initial findings D. C. Here.
With one of the data disclosure expected in the first half of 'twenty 'twenty four.
In terms of what success looks like with.
We believe that even if we repeat the 12% to offer a response rate in patients with liver metastases.
And also take into consideration other clinically relevant endpoint such as progression free survival durability of antitumor activity.
That's enough response.
Safety presence of coexistence adverse prognostic features such as K Ras mutation.
We would be for him on next steps for a potential path to registration ideally with the right partner.
Moving to platinum resistant ovarian cancer, where there is also an urgent unmet medical need as these patients have very limited treatment options.
Lacking a ridiculous ovarian cancer is a hard to treat tumor tight with limited T cell infiltration, which are required for immune checkpoint inhibitors to be effective.
Historically, most immune checkpoint inhibitors have demonstrated limited activities such as yours.
It is estimated that in 2023 in the U S alone approximately 20000, new cases will be diagnosed and so teams have their patients will die of these cancer.
We believe the T G I G unique biology.
Different than other checkpoints have the potential to generate different outcomes in these patients and delighted to say that we're on track to dose the first platinum resistant ovarian cancer patients in our triple combination proof of concept study in the <unk> in the second quarter.
A fifth year.
Immune checkpoint inhibitor nave patients will be eligible if they have received up to three prior lines of therapy and we will include patients of all histology.
Yeah.
We plan to employ a staged approach.
We will enroll up to 40 patients in total in the triplet.
We the first 20 patients on Julian J D. Here.
And the first cohort in the first half of 'twenty 'twenty four.
Once they have once we complete enrollment of the first 20 patients on triplet, we intend to evaluate the inclusion of an additional doublet arm of up to 20 patients, which is a combination of <unk> seven to one and kimberley's them up with.
<unk> nine O two.
To help us better understand the contribution of the component.
We plan to report initial findings by the end of this year.
Together with the data we have in hand. These triplet study is expected to bring us to an overall assessment of up to 60 platinum resistant ovarian cancer patient on triplet treatment, which we expect will inform us on next steps in building a potential path towards.
Station, which again ideally would be done with the right partner.
In terms of what success looks like.
We believe that easily see at least 20% overall response rate in these additional patients.
Along with the safety profile reported to date.
And taking into consideration tumor histology and other clinically relevant endpoints like your ability of anti tumor activity depth of response and progression free survival would be informed on the next steps towards a potential path to registration.
Of course in both indications.
Dang Dystrophication of a biomarker will greatly contribute to further defining our study population.
Most likely derive clinical benefit.
What identifying biomarkers in the field of checkpoint inhibition is not a given.
With our years of expertise in understanding the underlying biology of the DRAM axis.
Evidenced by the quality of the translational data, we have generated from patient biopsy using cutting edge technologies and our computational capabilities.
We believe well what fitbit to identify Biomarkers, which can help define the patients who may benefit from our concept and along the combination and we therefore allow us to better design and execute targeted well defined randomized studies.
Moving next to our leading early pipeline asset called faithful free.
We're very excited about the progress we have made with our early stage programs are originating from our computational discovery engine.
While the P. D R I G and T Beach, we're totally new targets and pathways upon with discovery.
Our next program is different.
Here, we're targeting and no pathway in a completely unique way with a potential first in class therapeutic candidate.
We didn't define a potentially dominant immuno suppressive mechanism.
Which is used by macrophages in tumors to escape immune system.
This is the eater, looking 18 binding protein and interlocking 18 complex.
Being flat or only used for inflammatory cytokine.
Interleukin 18 is present at high levels in the tumor microenvironment.
Where do you expect it to naturally activate antitumor effector cells, such as T and NK cells.
But I like Dean he's one of the rare cytokine.
That is naturally blocked by endogenous highest anything he'd be tau called interleukin 18 binding protein.
Cytokine.
So to us and our youth tariffs are ethically.
However, there is a challenge of getting them systemically and clever high enough to reach and modulate the tumor microenvironment without causing systemic side effects.
As a result of their narrow therapeutic window.
Convention overcoming a cytokine are limited in terms of efficacy.
Some recent clinical failures extended five D challenge.
Specifically <unk> has been administered.
Administered to cancer patients in the past, but felt it.
Most probably because of general limitations of recombinant cytokine, just mentioned and potentially because IL 18 is inactivated by natural blocker.
And 18 binding protein.
With that in mind, we have developed a potential first in class fully human high affinity monoclonal antibody com site for free.
Which target on.
And 18 binding protein to release endogenous naturally occurring IAG to activate T and NK cells in the tumor microenvironment.
In our preclinical models, we have shown that blocking the IL 18 binding protein can display side 18 from our 18 binding protein in the tumor microenvironment, enabling Duffy your luggage that IL 18 to have immune stimulating.
D V D any 10.
Maggie age potent antitumor efficacy.
We believe that one major advantage of using an hourly team binding protein antibody over administration of IL 18 cytokine ease.
He is a better therapeutic window.
Due to an 18 pathway upregulation confined to the tumor microenvironment.
We have shown that an antibody against an 18 binding protein.
Do you like the tumor microenvironment, so potent antitumor immunity.
Oh affecting peripheral immunity.
We believe that our KOL sites for three program represents a new and differentiated approach to harness cytokine biology.
Cancer Therapeutics.
The program is now advancing in IV, enabling studies with the goal is to find I D. In 2024.
We plan to present these new approach at a scientific conference in 2020 three.
With that I'll turn the call over to Alberto.
Thank you Ana.
To summarize our financial results.
We'll start with our cash balance.
As of December 31st 2022, we had approximately $83 $7 million in cash.
Third we had approximately $117.8 million as of December 31st 2021 affirming our focus on capital efficiency and both execution and now we're seeing them one oxy cyclone business.
During 2022, we use $41 $6 million to fund our operations and we received in the fourth quarter of $7 5 million dollar payments. Please.
<unk> of Astrazeneca phase two studies evaluating the PD one <unk> bispecific.
Bispecific derives from our common diluted.
Company has no debt.
Going into 2023, we expect our cash burn to be in the range of between $37 million to $39 million.
We understand the importance of our cash balance and we are financially disciplined we.
We are constantly constantly.
Constantly monitoring our expenses, but at the same time, we are targeting our extensive and unique knowledge in this space on specific tumor types and clinical strategies to increase the probability of success of our trucks.
<unk>.
Based on our current plans, we expect that our current cash will be sufficient to fund our operating plan at least through the end of 2024.
On the revenue front, just mentioned, we reported $7 $5 million in revenue from the fourth quarter and for the year ended December 31st strengths to 'twenty two.
Compared with no revenue and $6 million revenues, respectively for each of the comparable period of 2021.
Our revenue in 2022 are related to the milestone payment received from Astrazeneca.
Now regarding the expense trends.
R&D expenses for the fourth quarter of 2022 and for the year ended December 31st 2022 were $7 $3 million and $36 million, respectively, compared with $5 $8 million and $28 $7 million.
For the comparable period in 2021.
The increase is mainly due to higher expenses associated with our CMC activities offset by BMS participation in R&D expenses.
Research and development expenses.
Total operating expenses were 7% to 3% in 2022 compared to 71% in 2021.
Our G&A expenses for the fourth quarter of 2022 and for the year ended December 31st 2022.
$2 $5 million and $10 $3 million, respectively, compared with approximately $2 $7 million and approximately $10 $9 million for the comparable period in 2021.
For the fourth quarter of 2022, we reported a net loss of $3 $1 million or four cents per basic and diluted share.
Fair to a net loss of $8 $6 million or 10 cents per basic and diluted share in the comparable period of 2021.
Net loss for the year ended December 31st 2022 was $33 $7 million or 39 cents per basic and diluted share.
Compare with a net loss of $34 2 million or 41 cents per basic and diluted share in the comparable period of 2021.
I'm moving now to the 'twenty two 'twenty three outlook.
Going into 'twenty, two 'twenty three we expect our cash burn to be in the range of $37 million to $39 million. In 2023, we are planning to have a similar level of R&D expenses compared to 2022 mainly to support our upcoming.
MSS CRC and platinum resistant ovarian cancer proof of concept studies as well as our leading early pipeline assets column five O three.
We understand the importance of our customers.
And we believe we have sufficient cash to execute on our plans and guidance.
With that I will end there.
To summarize what you should expect from <unk> in 2023.
Thanks Alberto.
So to summarize upcoming milestones.
The net effect CRC, we're on track to dose the first patient with our triple combination as soon.
To complete enrollment of up to 20 patients and report initial findings D C. Here.
In platinum resistant ovarian cancer.
We are on track to dose the first patient with our triple combination in the second quarter after here.
We plan to complete enrollment of 20 patients and reporting nation findings this year.
And plan to complete the full enrollment in the first half of 'twenty 'twenty four.
Taking a staged approach once the enrollment of the first 20 patients in the triplet is completed we intend to evaluate the inclusion of an additional arm of Com 701, and 10 bullied him up in the absence of congonhas to to gain more insights on contribution of components.
We also continue to monitor the patients in the cohort expansion study with Bristol Myers Squibb and expect to report findings from these studies, including longer follow up and translational data from the platinum resistant ovarian cohort expansion study in 2023.
We plan to present on <unk> first rate during a medical conference in 2023 and to find an IV for qualified folks way in 'twenty 'twenty four.
Finally, this is a big year for TG to readout, and we expect to see read through to coffee Gen.
To this end I wanted to emphasize why we believe we have an edge with our differentiated clinical strategy.
Firstly, we have a combination approach with a leading N V. P V. R. I V <unk> seven O O one against a novel target, which our data suggest may sensitize tumors to respond to PD, one and possibly T. G blockade.
And were being followed by others.
P. D. R. I G is gaining traction as a relevant cancer immunology targets with more and more competitors joining these rates, including GSK, while following our triple combination approach.
Secondly, we have a differentiated F series used effector function high affinity antique T J continental to which we believe was reinforced recently.
And finally, we're targeting tumor types typically not responding to immunotherapy, where we believe the P. I G unique biology defendant other checkpoints may be exemplified and has the potential to generate better outcomes in these patients.
And we would sure initial findings from our proof of concept studies by the end of the year.
With that I will turn the call over to questions operator.
Thank you ladies and gentlemen at this time, we will begin the question and answer session.
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 kind of lift the handset before pressing the numbers.
Please standby, while we poll for your questions.
Yeah.
The first question is from Stephen Wiley with Stifel. Please go ahead.
Yes, good morning, Thanks for taking the questions I.
I guess with the decision to add a doublet cohort to platinum resistant ovarian cancer.
Would there be any attempts.
To try to enroll patients into that cohort that I guess are.
So you know typically similar to the triplet cohort and I'm just talking about perhaps.
Efforts to try to match baseline characteristics with respect to things like histology PDL one expression. So that you can get out.
Better kind of apples to apples comparison of what.
Well it is bought in New York, probably beyond doublet matched patient population.
And then I have a follow up.
Henry I guess you want to take this one.
Yes, I will take it yes, two that's a very good question.
It's the overall in tons because that provides us an opportunity as you as you rightly pointed out to be able to have an apples on apples comparison.
What the truth is it's doing and what the doublets will possibly do.
Yeah, I think I'll just add that I'm.
Taking an advantage of the amount of work that we do on biomarker in the studies that we just completed as well as being the new one.
That's also a reason to consider including a doublet and allow ourselves to get a better understanding of the patient selection.
Oh, Okay that makes sense and then.
Just quickly I guess.
Talk about how the targeting.
Jean binding probe protein gives you a wider therapeutic window versus IL 18 administration alone but.
I know that there's some literature out there kind of suggesting that the disruption of this pathway.
Can lead the pathological inflammation. So I guess just wondering if this is something that you've seen within preclinical models.
Whether or not you evaluated the asset in models of inflammatory disease to see if this all gets exacerbated.
They're on the testing goes well for you.
Yes, it like every other many of the I O assets, if you take them to the other direction. They also might play a role in inflammatory diseases.
There is the literature about the targeting IL two binding protein with the antibody or anything like that in the literature.
First due to.
So shows that if you tackle this pathway preclinical models you can actually get an answer.
Consequence of activities and yes, again, they're all literature, but I'll tee enrolled in inflammatory diseases.
It's exactly plays through the same ROI.
Protein is effectively in concert.
Okay. Thanks for taking the questions.
Yeah.
The next question is from Mark Breidenbach of Oppenheimer. Please go ahead.
Hey.
Good morning, Thanks for taking the questions and congrats on the progress just a few quick ones for me.
First of all I'm wondering if you're aware of any plans from astrazeneca to present data. This year from any of its early studies of the Bispecific antibody kind of justifying their plans to advance it into a phase III trial.
And one for Alberto is if if any of his.
Guidance on operational runway.
<unk> assumptions about additional milestone payments from astrazeneca or the guidance completely independent from that and then I have maybe one follow up.
So I'll start with the disclosure and eats at Astrazeneca decision to decide when started disclosing what so we cannot say related to weekend.
The first is you want to take them off someone.
Yeah sure. So not stayed with no control on what Astrazeneca is going to do so all our guidance do not include.
Any funds whatsoever from Astrazeneca, so it's net off.
Okay.
Super Helpful. And then just with respect to the biomarker data that you are planning to present later. This year is that is that going to be kind of actively integrated in into patient selection strategies for the two proof of concept trials or you know are those protocols kind of fixed.
Now with regards to what kind of patients and selection criteria that youre going to use.
At this point in time the protocols that.
Our intentions and plans are fixed and moving forward, but to also the studies that we're doing are designed in order to allow us to continue to collect data and to better inform and the data that we have in order to see if we can employ such as biomarker.
As it relates to tweaking in the prepared remarks. It is not a given if there's nothing easy task to identify a biomarker in the field of cancer immunotherapy.
And I do think that we're well positioned to do this work computationally experimentally with the translation that are cutting edge technologies that we're using and and do with being the first in the <unk> space, but having said that and we're designing carefully the studies and the work that we're doing.
In order to identify so at this point in time, the studies are fixed but to where it's one company and we can be opportunistic and would make sure that we act on what we have.
Okay. Thank you so much for taking the questions.
Okay.
The next question is from US they got good and Wyden of Truest Securities. Please go ahead.
Hey, guys. Good morning, and thanks for taking my question I'm. Just wondering so you did have a consumer lawn and garden.
That's my puppies in the background Squeaky voice.
With the data.
And come through in the CRC.
And nobody has to be at a medical conference and then what do you think that said it will look like and have first scan so majority of parent Ah patients.
It's sort of related to that.
You gave some thoughts on what the bar is for or odd, but what kind of duration of response do you think might be meaningful in these.
Yes.
Populations.
And then I have a quick follow up after that.
Okay. So I'll take the first one and then Henry we relate to the duration of response in both indications, but yet in the platinum resistant ovarian cancer were related to two pump two type of Fad guidance, one guidance relates to the study that is still ongoing and their debt and.
The expansion cohorts are being done with that.
And your volume up and volume up plus T J.
And that follow up data that we may disclose and later in the medical conference that's one.
The second type of Guy that's related to the new study that is being taken in a staged approach 20 patients and then additional 20 patients and treat plaque.
And we will consider and I didn't get double it to it after we'll have enrolled.
All 20 patients.
And in this case the initial findings, saying it.
Not necessarily no magical conference it depends on the rates offering walnuts et cetera, but definitely the flint data disclosure will be in a medical conference.
Yes. So thank you for the question so with respect to the duration of response in patients who have a colorectal cancer microsatellite stable and also ovarian cancer platinum resistant.
Maybe historical context will provide some information here as I provide the response.
As you remember patients who have platinum resistant ovarian cancer.
So as of approximately three to four months. So that means we think that by three to four month period of time.
301.
Most of them would have progressed.
Now for colorectal cancer. The median PFS is approximately two months also without including.
Including data from using a PD one inhibitor RASM English 317.
The median progression free survival of these vessels beyond two months also so we expect that.
There will be a substantial increase based on the data that we will probably will show and I would like to remind you that remember that oh.
Platinum resistance.
We already presented data in one subject.
Who had.
Primary peritoneal cancer and was on study treatment for two months.
And not to be on Oh, I'm, sorry treatment for.
Well look I already previously said the median PFS is approximately three to four months. So if you are seeing.
Patients who are on for six months or.
Oh more that's significant.
We've already disclosed.
Prepared statements that's all about patients on the triple net on ovarian cancer.
One for approximately nine months. So then it could be relevant for those patients.
For patients with microsatellite stable colorectal cancer.
Anything that's beyond six months also relevant.
The reason I say that is.
You'll recall the median overall survival with standard of care now whether it's a tough one to always go. Good afternoon is approximately six months, so patients who can't be on study treatment. We beyond this period of time, we will have derived so substantive clinical benefit from the study treatment.
Are they a doublet or triplet.
That answer your question I forgot.
That does Henry Thank you maybe if you can have a quick follow up.
What do you think are the next steps in colorectal cancer amongst other civil collateral cancer do you think there's a soft spot market with a single arm study. If you go up the CRC population with liver Mets I know.
About 70% of patients.
But is that a viable option for you.
They do very well there.
Yeah. So all options are on the table from the data was presented so far I think it probably would be best to pursue work the triplet will show us because they didn't have axis appears to be very active also in.
Several cancers, including as we think.
Microsatellite stable colorectal cancer and that's the reason for pursuing the triplet that's indication.
Depending on the results, we get and the triplet there of course will be a discussion with regulatory agencies.
Got to either considering the triplet regimen or trying to see if we need to sort out the contribution of components with either doublet also and then discussion with regards to where that was a therapy should be added new skus for the therapy that seems.
Enable to compare to the standard of care, which would be that's one of them, one or two or aggressively so.
At this point.
The strategy, we have is to pursue the triplet and like and that's it in our prepared comments, we will have the right disclosures.
That's okay for taking my question guys.
The next question is from Diana Gray Bosch of S. V. B Securities. Please go ahead.
Hi, guys. Thanks for the questions two for me. The first one is I would say.
Understand more if you can about your partnering conversations.
<unk> been coming to you have you been going to partner.
Which assets specifically have they been interested in which data set and have they advice at all on this front.
Yeah.
So I'll take that so first just to say partnering strategy from our perspective.
We and we are open for collaborative arrangements, we do want to make sure that we broaden the pipeline opportunities through.
Studies that will be done that and with a partner and we also view it as a way to add non dilutive funding to the company and that's our first priority. So that's just in general.
I'd say specifically on the.
The constant and Hawaiian come name the two.
Obviously, we cannot share any details or any on any possible discussion that we had for adult halfway there partners, but I would say that in general.
Come seven O one being differentiated in the fifth well leaders. We're leaving this says she is at we have a substantial amount of money.
The allergy in support of the mechanism of action that he chooses.
As to PD, one and possibly two T J.
And we have and the and the ability to do the biomarker work as I stated before that.
And and in general and there is an interesting one P. M. I G is generating that on one hand, and our intention with these new studies is to add additional two.
So as you discern besides that we have as I said in the prepared remarks to stress N D evident.
In order to able to understand it.
The passport work in a better way.
And to also solidify this difference than we're getting in tumor types that are hard to treat and mainly the P. N. One no space that is of high interest in the industry. We're differentiating ourselves not only on the P. P. R. G. I said, but also the fact that we are targeting VSAT PDL one.
No express or two more times. So that's in general so while I'm not commenting on specific tenant.
And discussions.
That's the general perspective.
Thank you and my second question is on this.
Concept studies I think he said for both MSS CRC and platinum resistant ovarian that youre enrolling patients with up to three prior lines does that mean, they could be treatment naive patients.
How early do you expect to be able to enroll patients on this study.
And can you remind us how many lines on average in the range in the past.
Now that you've done the last year, you've had so how different are these new studies in terms of lines from the last quarter.
Henry.
Yes. So so lets me would be just a question on Cresta Deanna so for ovarian cancer, what we're referring to or what that was.
I mentioned in our prepared comments are useful.
The number of up to three prior lines and platinum resistant setting. So we are considering patients who've had a platinum sensitive disease.
Keith.
We see platinum in number of times. So it is strictly.
For the platinum resistant.
Well it was just uncertain where.
Where the standard of care chemotherapy for now yes.
Yes, we have.
Ah study drug that's been conditionally approved Oh Occidental that cobalt on EDC, yes. So that's the one that's.
What we mean by up to three product lines and then for.
Colorectal cancer also this is blocking the earliest engines this is in patients.
Who have been exposed to standard of care therapies.
Most have received all of the standard of care therapies include for folks with full theory.
Three private lines also for those patients.
Okay, great. Thank you.
The next question is from Tony Butler.
F. Hutton. Please go ahead.
Hi, Good morning. This is tough one for Tony.
Yep.
The trial as it appears some clinical trials.
Today, we see the six central sites I Wonder if you could tell me how many of these trials sites.
And rolling patients for the colorectal cancer.
And then.
In turnkey.
Have most of that trial sites in more patients.
Okay great.
Yes.
So the what we have on clinical trials across Skus.
That's correct.
All the sites that we have listed for the combination study.
And all the other studies that we have currently enrolling.
Open to enrollment for colorectal.
Colorectal cancer cohort.
But that's just based on the number of patients who have this unfortunate goodness.
That.
<unk> will be brisk and we'll be on track just like our nation.
Okay.
Thank you.
What about.
Yes, yes, thank you for that and what about ovarian cancer patients, who will will that will that cohort be listed as a suffered under the same trial and the second question about traffic.
Yes, yes, it's very likely to really sit under the same.
Tayo.
Cohorts and it will be enrolling in the sites also.
I'll just add countries instead on Clinicaltrials Gov.
The necessary public disclosures.
As soon as we can.
We will also be looking for additional sites also we expect that to be on track just like in Appalachia and have prepared comments.
Let me go back to the last question because I think Sheila asked a question on the number of prior lines.
So on.
Prior disclosures at ESMO I O for example.
S ITC Dr over months presentation.
So let me start with.
Cancer faster I'd been at so.
So for the ovarian cancer cohort and Theres more Idaho, Alright, if you remember we've had two presentations one back of the vehicle from mass General Hospital. The number of this was a population of patients with platinum resistant ovarian cancer and it was the dwell combination meaning 701.
It's been going up.
Number of number of lives in that patient population of 'twenty was six.
Six.
That's the number of prior lines with a range of 229.
And then for the triplet combination that was presented by Dr. John Maloney at some risk or Chicago twice. Since also the number of median lines was for a range of one to 10, where we expect that most of the patients will be.
We will fall within this range for this new trip that triplet our expansion cohort that will be that will consist of <unk>.
701 come down too.
Awesome.
Thank you.
Okay.
Yeah.
This concludes the QA session and computer <unk> Investor Conference call. Thank you for your participation you May go ahead and disconnect.
Okay.
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Yes.
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