Q3 2021 Iteos Therapeutics Inc Earnings Call

Speaker 3: We have led to our deep understanding of cancer immunology and immunosuppressive pathway to build our pipeline and attract a partnership we will provide us with additional reporting.

Speaker 3: We are now focused on the expectation of our working trials, delivering on the commit we have met who are patient with advanced cancer.

Speaker 3: With that, I will have it covered to do later our chief living telephoto to provide shorter details on the symptoms process that we have made and where we are headed with this exciting programs.

Good afternoon, and welcome to the H S Therapeutics third quarter 2021 financial results conference call.

Speaker 4: I'll begin with key updates on our anti-tuget antibody, Theos448.

At this time, all participants are in listen only mode.

Speaker 4: ELS 448 has the potential to achieve significant anti-tumor immune response through a multi-faceted mechanism.

Following the formal remarks, we will open the call up for your questions.

Before this call is being recorded at the company's request.

Speaker 4: The antibody blocks the binding of chitit to its ligand, resulting in the immune mediated killing of tumor cells by T cells and end-case cells.

This time I'd like to turn it over to Ryan Baker head of Investor Relations at just Brian. Please proceed.

Thank you operator, and thank you everyone on the call for joining US today, joining me from Ics with prepared remarks are Michelle did to President and Chief Executive Officer, Joe Lager, Chief Medical Officer, and Matthew Gall Chief Financial Officer.

Speaker 4: It also engages the Fc gamma receptor, further promoting anti-tumor immune response.

Speaker 4: through the release of pro-inflammatory cytokines and chemokines and the activation of antigen presenting cells.

Before we begin the team will be making forward looking statements in the prepared remarks, Andrew in the Q&A session.

Speaker 4: Also, the antibody causes depletion of immunosuppressive T-regs and exhausted T-cells, cells that are known to dampen the immune response.

Any statements made during this call that are not statements of historical or current facts are intended to be forward looking statements pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act.

Speaker 4: We are pursuing a clinical development plan based on this multifaceted mechanism of action of EOS 448, which is focused on the indications and combinations where we see the greatest potential to benefit patients.

Of 1995.

We want to emphasize that such forward looking statements reflect our current expectations and assumptions regarding timing progress and success of our clinical trials therapeutic potential thereof expected milestones or our financial condition, including cash runway our business operation development efforts and the potential benefits of other collaborations.

Speaker 4: Given the encouraging monotherapy data we presented earlier this year, we are progressing the next set of trials for this program.

Neither predictions nor guarantees of future events or performance.

Speaker 4: We are pleased to share that we have initiated dosing in two combination cohorts in patients with solid tumors in our phase 1-2 clinical trial of ES448.

Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with our business.

Speaker 4: the first in combination with pembrolizumab, and the second in combination with inopadamid.

Including those under the heading entitled Risk factors in our quarterly report on Form 10-Q for the quarter ended September 32021, which was filed with the SEC as well as in subsequent reports, including our current reports on form 8-K.

The company disclaims any obligation to update or revise any forward looking statements, except as required by law Michelle we'll start today's call by sharing with you the significant progress our team here at <unk> has made the past quarter.

Speaker 4: Over the next several months, we will initiate additional studies exploring the safety and efficacy of EOS 448.

A recap of our corporate strategy and provide more robust clinical development plans for our pipeline programs.

And then our Chief Medical Officer, Joe Lager will provide a more detailed update on our clinical programs.

Speaker 4: This will include the combination with GSK's approved anti-PD1 to Starlimeth.

SAP up our comments with our CFO, Matthew Gall, who will provide an update on our financial status.

Speaker 4: We will also evaluate EOS 448 in monotherapy and in combination with Bristol-Myers squids, Iberdomide and multiple myeloma.

Led by Michels closing remarks.

We'll then open the lines for the Q&A session with that I will hand, it over to Michelle.

Speaker 4: We look forward to providing updates on the Clinical Development Plan for ES448 as we progress.

Thank you Ryan Hello, everyone. Thanks for joining us far below third quarter 2021 court.

Speaker 4: Turning to independence, we have a unique drug candidate in three ways.

At <unk>, our team is dedicated to understanding the biology of the tumor microenvironment.

Speaker 4: First, unlike the other adenosine receptor antagonist, in the pettinant was designed to inhibit the HWA receptor in the high concentrations of adenosine found within tumors.

We used a deep understanding to design, what we believe are best in class assets to the immune system to help patients with cancer live longer.

And EBITDA.

Speaker 4: Second, Inipadinate was designed to be highly selected for the A2A receptor, which plays a key role in regulating adenosines in the suppressive effects within the tumor. And third, Inipadinate does not penetrate the central nervous system, reducing the potential for off-target safety effects and improving its therapeutic index.

We are continuing to progress our clinical programs.

And then two digit antibody, which we partner with Glaxosmithkline to jointly develop and commercialize.

<unk> EBIT demand I will maybe one selective <unk> inhibitor.

Both of these therapies have demonstrated single agent efficacy and excellent safety profile.

Speaker 4: We continue to make significant progress in our clinical development and have several updates to share.

And both target.

We do risk through our own data as well as external Amanda.

Speaker 4: We have completed enrollment in the initial evaluation of in-appadement in combination with team of therapy and with Pemperelismab and a founded profile that supports future development.

Okay.

We are excited by Qualcomm and the potential to significantly impact.

Patients lives.

What drives us.

Speaker 4: We have also completed enrollment in the cohort exploring in-appedement in monotherapy and castrate resistant prostate cancer and have initiated an expansion of the combination of in-appedement with PemberlizMab in PD1 resistant melanoma.

If we did.

Let's start by discussing our strategic collaboration with Glaxosmithkline.

NTT <unk> U S Gulf Coast.

This collaboration.

Can you do to accelerate.

Speaker 4: Finally, as we mentioned earlier while discussing the updates on ES448, we have initiated the evaluation of the combination of independent with ES448, and we'll also be evaluating the triple combination of ES448 with independent and GSK's?? driver might be able to?? ES 448, what about the Al fireplace?

The development of U S.

In the third quarter of 2021, we closed the co development and co commenced edition collaboration agreement and we see those take some time.

In a containment.

Beyond the upfront payment.

<unk> to receive up to 140.

Speaker 4: In addition, we are building on the identification of potential patient selection biomarkers identified in our Monotherapy Study and plan to open a new cohort in our ongoing Phase 1-2A trial in patients with high biomarker expressions.

<unk> 45 billion in additional development and commercial milestone payments.

<unk> achieved a milestone.

This partnership validates our view that did you is the most prudent.

Anything new target in the coming generation of new Io therapies.

Speaker 4: Our initial trial is a rich source of translational data that we continue to use to optimize the in-appadement clinical development program to evaluate in-appadement in the patient and tumor types most likely to benefit from treatment.

U S.

<unk> potentially to be differentiated in the teeth.

Okay.

The GSK partnership is broad numbers about Youtube.

Menu.

To highlight a coupon.

This partnership brings together the best in class.

Speaker 4: With the data we already have in hand and that we are generating an ongoing study and validation from other approaches in the Adenosine Pathway, we are initiating the next phase of development.

Capability could you of the two companies and ended bodes us well.

<unk> combination including combination.

TB.

Speaker 4: We will have data in several indications and combinations that we expect will provide many attractive options as we move into the Randomize Control setting.

Anyway.

Okay.

As an example.

Evaluating the combination of GSE approved anti PD, one Jim early Paul.

Speaker 4: I will now hand the call over to Matthew Gal, our chief financial officer.

The map with both of our highly differentiated clinical stage candidate.

Speaker 5: Thanks, Joe. I'd like to provide an update on our financial results for the third quarter of 2021. The company's cash and cash equivalent position was $899.8 million as of September 30th, 2021, as compared to $340 million as of September 30th, 2020.

Okay.

Got it.

This is just one of the many unique combination we are available to export.

Also the structure of this partnership provides.

Disability.

We aim to become an industry leader in the immuno oncology Paul to seize upon cash.

Speaker 5: IJOS is well capitalized to support the programs we just detailed. Following receipts of the upfront payment from GSK, pursuant to our collaboration and license agreement in August of 2021, we believe that our existing cash and cash equivalents would enable us to fund our operating expenses and capital expenditure requirements into 2020.

Before T surely update them close.

On the <unk> quota share.

Co commercialization rights in the U.

Now turning to EBIT man hour can equal.

I think really driven in the supply chain.

Speaker 5: Revenues, nearly all of which were associated with recognition of a portion of the upfront payment received from GSK, were $104.3 million for the quarter, while we recorded no revenue in the third quarter of 2020.

We won't we seem to it.

Dave.

We think keeping reporting.

73.

These data continue to validate our enthusiasm for this possible market.

Speaker 5: We expect to recognize the full upfront payment through revenue over the next few years. Additional information regarding revenue recognition related to the collaboration agreement will be included in our Form 10Q for the quarter ended September 30, 2020.

Based on our unique understanding of the specific condition within the tumor microenvironment.

You can see.

So design and get back to them.

<unk> <unk> inhibitor equally.

Speaker 5: Research and development expenses were $16.1 million for the quarter ended September 30, 2021, as compared to $8.7 million for the third quarter of 2021.

The specific conditions of the genome.

Hum.

These two adjustments.

Adjusted EBIT of one one walking.

Yes, our sense.

Speaker 5: This increase was primarily due to an increase in activities related to clinical trials for EOS 448 and Inupiatent, our preclinical pipeline, and the expansion of our...

Continued to undergo.

Our immediate launch of data exciting program cookies on Florida are missing the point system.

Two quick questions.

Speaker 5: General administrative expenses were $8.8 million for the quarter ended September 30th, 2021, as compared to $4.8 million for the third quarter of 2020. This increase was primarily due to more hires, professional fees, and other costs associated with becoming a public company.

Could you see gigabit with limited edition bed property candidate targeting the new mechanism.

In busway.

In that instance.

This is important qualcomm against the new target.

I think.

Well.

Speaker 5: The net income attributable to common shareholders was $69.6 million, or a net income of $1.98 per basic share and $1.86 per diluted share for the quarter ended September 30, 2021, as compared to a net loss of $11.6 million, or a net loss of $0.48 per basic and diluted share for the third quarter of 2020. I'll now turn the call back over to Michelle for closing.

Thank you.

Demonstrating a couple of DVT in high yield this quarter.

We will continue to capitalize on our demand.

Recall for sickle and building a differentiated immuno oncology pipeline.

In summary, our Covid, who 2021.

The golf ball Paul.

Hello, I'm, a robust import dependent.

With expansion underway for both <unk> and <unk>.

We are demonstrating our ability to cultivate.

Speaker 3: As we have shared on this goal, we are executing on our accelerated clinical department plans for both of our highly differentiated unit.

<unk> innovation into clinical programs with the potential to improve outcomes for people with cancer.

Speaker 3: our potent high affinity anti-tetra antibody, US44A, and even, by demand, our A2A receptor antagonist that is being optimized for the tumor myocardium.

Our deep understanding of cancer immunology on municipal bonds.

To build our pipeline on that front the partnership we will provide us with additional opportunities.

We are now focused on the execution of our Watsonville poems delivery on the Combi, we admit patients.

Speaker 3: We remind for use on scientific innovation to improve clinical outcomes for patients. With our deep understanding of tumor immunology, we will continue to advance our cure on pipeline and accelerate our primary efforts to discover new targets and strategies to advance cancer in the data.

Okay.

With that I will hub.

<unk>, our chief Medical officer to provide further details on this digital portal.

Meg on where we are with.

Speaker 3: With our current science, research, pipeline and the team we assemble, we are in a better position than ever to be among the front runners to develop this new generation of IoT rapese and the remains of use on our ambition to be a leader in bringing this therapy to patients.

With this exciting compound thanks Michelle.

I'll begin with key updates on our anti <unk> antibody.

Four eight.

It's four four age has the potential to achieve significant anti tumor immune response through a multi faceted mechanism.

Antibody block the binding of <unk> to its ligand.

Speaker 3: Thank you very much for joining today's call. I'd like to know how to call back to the operator to open up the line for questions.

Nothing in the immune mediated killing of tumor cells by T cells and NK cells.

It also engages the FC gamma receptor further promoting anti tumor immune response through their release of pro inflammatory cytokines and hemoglobin and the activation of antigen presenting cells.

Speaker 1: Thank you. If you'd like to ask a question, please press star by one on your telephone keypad now.

Speaker 1: If there's any reason you'd like to remove that question, please press star Follow by 2. And when preparing to answer your question, please ensure your phone is unmuted locally.

Also the antibody causes depletion of the immunosuppressive T regs and exhausted T cells cells that are known to dampen the immune response.

Speaker 1: We've got the first question from Diana. So, Diana, push from SDB, the link. Please go ahead.

We are pursuing a clinical development plan based on this multi faceted mechanism of action of <unk>.

Speaker 6: Thank you. I think it's true for Joe. Joe, you talked about completing enrollment for the Enupaduit combination of chemo and pangro. Two questions on that. One, I think he said there is a profile supported for the development. Can you better fully characterize what you mean by profile support?

Which is focused on the indications and combinations, where we see the greatest potential to benefit patients.

Given the encouraging monotherapy data will be presented earlier. This year. We are progressing the next set of trials for this program.

Speaker 7: And then you also mentioned expansion in melanoma PD-1 pre-treated. Have you made a go-no-go decision on expanding prostate in CNBC?

We are pleased to share that we have initiated dosing in two combination cohorts in patients with solid tumors and our phase <unk> clinical trial of <unk> for four eight.

First in combination with Pembina loosen up and the second in combination with <unk>.

Speaker 4: Yes, thanks, Dana. So in terms of the first question, yes, for an appointment, we've completed the safety evaluation or the dose evaluation for the combination with both Pembrolyzenab and with chemotherapy.

As a reminder, we had planned to initiate this combination study with <unk> now prior to entering into the collaboration with GSK and both parties agreed that it made sense to generate data on the combination this will inform our clinical strategy with dose Charlotte map.

Speaker 4: For pembrolizumab, we have a dose where, you know, what are our criteria for saying that the profile is...

Over the next several months, we will initiate additional studies exploring the safety and efficacy of <unk> for four eight.

Speaker 4: suitable for moving forage. We have a dose that is safe. We have the TA is expected for the drug and we have initial evidence of efficacy in that cohort that's

This will include the combination with Gsk's approved anti PD, one does Darling man.

We will also evaluate it was 448 in monotherapy and in combination with Bristol Myers Squibb, I Bergen lied in multiple myeloma.

Speaker 4: makes us interested in moving forward with. And as we said, we are moving forward with the Pembalism app combo in melanoma.

We look forward to providing updates on the clinical development plan for <unk>.

Speaker 4: The same is true for chemotherapy, that we have selected a dose where we have good safety and we have preliminary evidence of activity.

448, as we progressed.

Turning to in the patents, we have a unique drug candidate in three ways.

First unlike the other adenosine receptor antagonist and the patent inch was designed to inhibit the HOA receptor in the high concentration of adenosine found within tumors.

Speaker 4: In terms of the other cohorts for prostate cancer, we've completed the

Speaker 4: Monotherapy evaluation in prostate cancer. And we have decided not at this time to open the cohort in prostate cancer in combination with pemberless math. We think that there are better options for development of the drug at this time.

Second in the patent it was designed to be highly selective for the HOA receptor, which plays a key role in regulating adenosine in their suppressive effects within the tumor.

And third in the patent does not penetrate the central nervous system, reducing the potential for off target safety effects and improving its therapeutic index.

Speaker 4: And in terms of the combination with chemotherapy, we are moving that forward. We have evaluated different indications, including triple negative breast cancer, and have chosen the indication to move forward, and we'll be giving an update on that as that study begins, ready to start. Great, thank you very much. Thank you.

We continued to make significant progress in our clinical development and have several updates to share.

We have completed enrollment in the initial evaluation of independent in combination with chemotherapy and with temporal has not and it sounded profile that supports future development.

We have also completed enrollment in the cohort exploring independent in monotherapy in castrate resistant prostate cancer.

And have initiated an expansion of the combination of independent with timberlands Mad and PD one resistant melanoma.

Finally, as we mentioned earlier, while discussing the updates on the S. Four for age we have initiated the evaluation of the combination of independent with EOG for four eight and well also be evaluating the triple combination of yes, four four H and new cabinets and GSK, it's still sterling.

Speaker 8: Yes. Can you go ahead? Oh, great. Thank you.

Speaker 8: Hey, thanks guys for taking the question. Just a, I'm sorry, a strategic question here on Inupatnet. Yeah, I know you're taking the first agent, the first generation agent here into randomized trials, and you talked about this next generation. I know you kind of, I think you've addressed this before, but maybe just remind us, how do these two agents coexist? What's the strategy there in terms of bringing both of them forward? Um...

In addition, we are building on the identification of potential patient selection Biomarkers identified in our monotherapy study and plan to open a new cohort in our ongoing phase one two trial in patients with high biomarker expression.

Our initial trial is a rich source of translational data that we continue to use to optimize the independent clinical development program to evaluate in the continent in the patients and tumor types, most likely to benefit from treatment.

Speaker 8: And then I also, I don't think I heard you guys before talk about this triplet combo, a 448, the GSK PD-1 in your padnet. Can you maybe talk a little bit about the...

With the data we already have in hand, and that we are generating and ongoing studies.

Speaker 8: You know what led you to begin that trial and what data to prompted that. Thanks.

Validation from other approaches and the adenosine pathway.

We're initiating the next phase of development.

We'll have data in several indications and combinations that we expect will provide many attractive options as we move into the randomized controlled study.

Speaker 4: Yeah, Chris. So on your first question about our drugs targeting the identity pathway, you know, independent is our lead there. It is the A2A receptor antagonist that we think is optimized for use in the tumor micro environment to really optimize the anti-tumor response of the immune system.

I will now hand, the call over to Matthew Golf, our Chief Financial Officer.

Thanks, Joe.

Like to provide an update on our financial results for the third quarter of 2021, the company's cash and cash equivalent position was $899 8 million as of September 32021, as compared to $340 million as of September 30 of 2020, I, Joe says well capitalized to support the pro.

Speaker 4: And as you mentioned, we have selected a candidate for a new mechanism of action that is also in the Adenosine Pathway. Our preclinical data has shown that these two targets are both...

Graham So we just detailed following receipt of the upfront payment from GSK pursuant to our collaboration and license agreement in August of 2021, we believe that our existing cash and cash equivalents, what enabled us to fund our operating expenses and capital expenditure requirements into 2026.

Speaker 4: effective ways to restore the immune system and also may well work well together. So that is why, you know, both they should work independently and should also work well together. So that's why we're progressing both of these drugs. So independent, which is in clinic and the new drug candidate that we've recently saw.

Revenues nearly all of which were associated with the recognition of a portion of the upfront payment received from GSK, where $104 3 million for the quarter, while we recorded no revenue in the third quarter of 2020.

Speaker 4: In terms of your second question around the triplet of PD-1 plus TIGIT plus A2A, this is something we've been interested in for a while. As we previously disclosed, we were moving forward with the doublet of TIGIT and in the patternment. And it makes sense to also evaluate the triplet of combination of PD-1 plus TIGIT plus in the patternment. This is something we've been interested in for a while.

We expect to recognize the full upfront payment through revenue over the next few years additional information regarding revenue recognition related to the collaboration agreement will be included in our Form 10-Q for the quarter ended September 32021.

Research and development expenses were $16 1 million for the quarter ended September 32021, as compared to $8 7 million for the third quarter of 2020.

Speaker 4: You know, there also has been some recent data or not data, but some information from the ongoing artist trial and non-small-small-tensor where they have suggested that they have interesting data on a triplet, including a PV1 digit and a dancing receptor antideist, and that also increased our interest in moving forward with that combat.

This increase was primarily due to an increase in activities related to clinical trials for U S for four rate and any patent our preclinical pipeline and the expansion of our team.

General and administrative expenses were $8 $8 million for the quarter ended September 32021, as compared to $4 8 million for the third quarter of 2020. This increase was primarily due to more hires professional fees and other costs associated with becoming a public company.

Speaker 8: Okay. And I'm sorry. I want to make sure that I understand the answer that you had to the first question. Did I hear you say that you're not taking 850 forward in prostate cancer? Is that correct? Or did I mishear that?

The net income attributable to common shareholders was $69 6 million or net income of $1 98 per basic share and $1 86 per diluted share for the quarter ended September 32021, as compared to a net loss of $11 6 million or a net loss of 48.

Speaker 4: That is correct. We're not moving forward in prostate cancer into the combination. We're not going to evaluate the combination with pembrolizumab.

Speaker 4: in prostate cancer at this time, we've decided to prioritize other development of that drug.

Per basic and diluted share for the third quarter of 2020.

I'll now turn the call back over to Michel for closing remarks.

Speaker 1: The next question comes from Anupam Ramas of AP Morgan. Please go ahead.

Thank you Matt.

As we have shared from the schools, we are executing on our accelerated clinical development plans for both of our highly differentiated.

Speaker 9: Hey, guys. Hope you're all well, and thanks so much for taking the question. On EOS 448, so what do you, along the lines of some of the prior questions, what are you trying to learn specifically from the PEMBRO combination study that you might be able to apply to your DorspolarMAD combination study? Thanks so much.

I will put them on <unk>.

T anti digital antibody U S portfolio.

And do you think about the man hour each wounds have done.

That has been optimized for the genomics on them.

We humans for Qs.

Thanks for taking innovation to improve clinical outcomes for patients.

Speaker 4: We had plans, you know, had...

Our deep understanding of tumor immunology, we will continue to advance our pipeline and exited that that will be.

Speaker 4: started initiating that trial of ES448 with Pembellism app prior to entering into the partnership with GSK. And when we looked at the timelines, we realized that we could initiate that study.

The efforts to discover new targets <unk>, Ken certain that that piece.

We talk to them.

<unk> pipeline and the team we have assembled.

Speaker 4: sooner than we could initiate the study with Dostarlamab. We think having the data from that study in combination with Pembrolizumab will, you know, help us as we are initiating the combination trial with Dostarlamab.

We are in a better position than ever to be amongst the Holdco notes could you got this new generation of I used to have.

Yes.

Human cookies on our ambition to be a leader in green.

Turning to Asia.

Thank you very much for joining today's call I'd like to know town called back to deal pivotal to open up the line for questions.

Speaker 4: to collect the dose and perhaps move a bit faster in that combination based on having data already with anti-PD1.

Thank you if you'd like to ask a question. Please press star one on your telephone keypad now.

Speaker 4: So it mainly was about seed. You know what, I think as we move forward, we also think it could be valuable to have data on how the drug performs with different anti-PD1 partners.

If any reason you'd like to when they thought question. Please press star followed by <unk>.

I'm prepared to ask a question. Please ensure your line is muted locally.

First question from Diana Diana.

Bush from SVP Leerink. Please go ahead.

Thank you.

Two for Charlie So you talked about completing enrollment or there any tie to what combination of chemo in tango two.

Speaker 1: Our next question comes from David Nearingarth from Web Brush Securities. Please go.

Questions on that one I think he said there was a profile supported a further development can you.

Speaker 10: Hey, thanks for taking my questions first.

Speaker 10: Regarding the combination with Pembro and GSK's work with the Starlimab.

There are no fully characterize what you mean by profile supportable.

And then you also mentioned expansion and melanoma PD. One pretreated have you made a go no go decision on expanding in prostate and T. M. D. C S.

Speaker 10: I'm assuming, but correct me if I'm wrong, that there's no gating mechanism. So they're not going to wait for data from your PEMBO study in order to begin the combination studies with the Starlam lab. And then the second question that I had was, do you plan or is there a plan for incorporating the adenosine assay that you have been working on from the monotherapy study into the combination studies and maybe time to

Yeah.

Yeah. Thanks, Dana CRO in terms of your first question, yes for independents, we've completed the safety evaluation or the dose evaluation for the combination with both timberlands mab and with chemotherapy.

Speaker 10: look at having an arm or two where you stratify according to expression. I think.

No.

For member listen I have we have you know a dose a where are.

You know what are our criteria for saying that the profile is.

Speaker 4: Thanks, David. So, yes, on the combination with Pembrolizumab and combination with Dostarlamab that we are doing with US448, we are going full speed ahead with initiating the combination with Dostarlamab. And the initial data from the combination with Pembrolizumab will not be dating.

Suitable for moving forward, we have a dose that is safe.

Okay as expected for the drug.

And we have initial evidence of efficacy.

And that cohort that's at.

It makes us interested in moving forward with and as we said we are moving.

Speaker 4: And on the second question on the assay that we've identified that may help to predict the patients that benefits from an epidemic, we are incorporating that in our future studies. So we are planning to do cohorts with monotherapy to

Moving forward with the Kimberly not combo in melanoma.

The same is true for chemotherapy that we have selected a dose where we have good safety and we have preliminary evidence of activity and.

Speaker 4: enroll patients who are biomarker high to better define the benefit that we see in that population. And we are including those assays in our study in melanoma, and we'll also include it in the planned randomized trial for next year.

In terms of the other cohorts are for prostate cancer, we've completed the.

Monotherapy evaluation and prostate cancer.

We have decided is not at this time to opened a cohort.

Prostate cancer in combination with timberlands NAV, we think that there are better options for development of the drug at this time and in terms of the combination with chemotherapy. We are moving that forward. So we are have evaluated different indications, including triple negative breast cancer.

Speaker 1: As a reminder, if you'd like to ask a question, please press star, fill out by one on your telekipad now.

Speaker 1: Please go ahead.

And have chosen the indications to move forward and we'll be giving you an update on that.

Speaker 11: Thank you. Thanks for taking my questions. Just trying to understand the rationale behind combining 448 with Bristol's Iberdomide for multiple myeloma. If you could please comment on it.

The study began ready to start.

Great. Thank you very much.

Thank you.

Yeah.

Speaker 4: Yeah, so we are planning to do a study of ES448 as monotherapy and in combination with bi-buremite and relapse for factory multiple myeloma.

Chris Your line is open season show you on mute locally.

Speaker 4: We have had a collaboration with Jeff Hill at Fred Hutch in Seattle where we've demonstrated that there does seem to be a significant benefit of the combination of S448 or EPC-engaging PIGIT antibody with an image.

Sorry can you guys hear me.

Hello.

Yes can you guys hear me go ahead.

Great. Thank you.

Hey, Thanks, guys for taking the question just now I'm sorry, a strategic question here on your patent.

Yeah, I know you you're taking the first agent the first generation agent here into random randomized trials and you talked about this this next generation I know you're kind of I think you've addressed this before but maybe just remind us.

Speaker 4: And, you know, I, I, I birdabied is a potent drug. It has data in, um,

Speaker 4: Relucture fracturing myeloma that serves as a useful historic control. And it's an attractive study to do because it's giving patients an image that they haven't already seen before in that late-line setting where regulatory agencies require to start the development in myeloma.

How do these two agents.

Coexist, what's the strategy there and in terms of bringing both of them forward.

And then I also I don't think I heard you guys before talk about this triplet combo.

448, the GSK PD, one and your pad and then can you maybe talk a little bit about the.

Speaker 11: Thank you. And then regarding the biomarkers that you're looking for,

You know what led you to begin that trial and you know what data.

Speaker 11: especially in the independent study. What sort of biomarkers are you looking for?

To that.

<unk>.

Yeah, Chris So on your first question about our drugs targeting the adenosine pathway.

Speaker 4: So we disclosed at ASCO the data that we had from our initial study in monotherapy where we found that the adenosine receptor, A2A receptor itself, the levels of that, the number of cells expressing A2AR in the tumor.

Independence is our lead there. It is the HOA receptor antagonist that we think is optimized for use in the tumor microenvironment to really.

<unk> optimized the anti tumor response of the immune system.

And as you mentioned, we have selected the candidates are.

Speaker 4: was correlated with clinical benefits in the patients in that study.

For a new mechanism of action that is also in the adenosine pathway and our preclinical data has shown that these two targets are both.

Speaker 4: That is an IHC marker. We have also looked at other markers, both by IHC and by Nanostring, looking at the mRNA markers.

Effective ways. It restores the immune system and also may well worked well together. So that is why you know.

Both they they should work independently and should also have worked well together. So that's why we are progressing both of these drugs the independent which is in clinic and a new drug candidates that we've recently collected.

Speaker 4: We have identified other markers that also potentially identify the patients that benefit using those methods as well.

In terms of your second question around the tripling of the PD, one plus <unk> plus a two way. This is something we've been interested in for a while as we previously disclosed we were moving forward with the doublet of ticket on an apartment and it makes sense to also evaluate the triplets.

Speaker 1: As a final reminder to register a question, please press star followed by one on your telephone You

Combination of PD, one plus <unk>, plus a little part of it.

Right.

Speaker 1: I can confirm we have no further questions currently registered, so I'll hand it back to the CIT team for any closing remarks. Thank you.

You know there also has been some recent data are or not data, but oh, some information from the ongoing ARCUS trial in non small cell lung cancer, where they have suggested that they have interesting data on a triplet recruiting PD one ticket and another thing.

Speaker 1: Okay, this now concludes today's call. Thank you all for joining. You may now disconnect your line.

Receptor antagonist and that also.

Grades are interested in moving forward with that company.

Okay, and I'm, sorry, I I I wanted to make sure that I understand the answer that you had to the first question did I hear you say that you're not taking 854 and and prostate cancer is that correct or did I mishear that.

Speaker 12: The.

Okay.

That is correct, we're not moving forward in prostate cancer into the company, we're not going to evaluate the combination with timberlands in the mab.

In prostate cancer at the time, we decided to prioritize other development of that drug.

Okay.

Okay.

The next Gen. It comes from.

On <unk> Rama from Jpmorgan. Please go ahead.

Hey, guys hope, you're all well and thanks, so much for taking the question.

On a full four eight so what are you along those lines with some of the prior questions, but what are you trying to learn specifically from the Pembroke combination study that you might be able to apply to your door solar Mab combination study. Thanks, so much.

And kind of.

No.

We had plans are.

Hi.

Started initiating that trial, yes, forthright with timberlands not prior to entering into the partnership with GSK.

And when we looked at the timelines, we realized that we could initiate that study.

Sooner than we could initiate the study with the Darla man, we think having the data from that study in combination with Tempur wasn't up well you know help us as we are initiating a combination trial with the trial on that.

Yeah.

To select the dose and perhaps move a bit faster.

And that combination based on having data already.

Anti PD one.

So, but mainly it was about seed.

As we move forward.

We also.

It could be valuable to have data on how the drugs performance with different contact PD one partners.

Okay, well, thanks, so much for taking our question.

Thanks, Jonathan.

Our next question comes.

David and Eric got from Wedbush Securities. Please go ahead.

Oh.

Hi, Thanks for taking my questions.

<unk>.

Regarding the combination with Penn Bro, and Gsk's work with to start on that.

I'm I'm, assuming but correct me if I'm wrong that there is no gating mechanism, so that theyre not going to wait for data from your <unk> study in order to begin a combination studies to start on that.

And then the second question that I had was do you plan or or is there a plan for incorporating the adenosine assay that you had been working on.

From the monotherapy study into the combination studies and maybe time to look at having an arm or two where you stratify according to <unk>.

Expression.

<unk>.

Thanks, David So, yes on the combination with timberlands and that in combination with the Sterling Mab that we are doing with your corporate we're going full speed ahead with initiating the combination with just startling up and the initial data from the combination with timberlands the map will not.

Be gating.

And then the second question on the assay that we've identified that may help to predict the patients that benefit from any pattern. We are incorporating that in our future studies. So we are.

Plenty to do a cohort.

With monotherapy.

To.

Enroll patients who are biomarker high to better define the benefit that we see in that population.

We are including that those assays in our study and melanoma and will also include it in our planned randomized trial for next year.

In relapsed refractory multiple myeloma.

We have had a collaboration with Jeff Hill at Fred Hutch in Seattle.

Well you know we've.

Demonstrated that there does seem to be a significant benefits of the combination of you know sport more eights or FTE are engaging pigeon antibody with an image.

And you know I I bird of bi is a potent drug.

It has data in them.

Relapsed refractory myeloma that serves as a useful historic control and it's a new attractive studies to do because it's giving patients and image that they haven't already seen before in that late line setting where you know regulatory agencies require us to start the development in myeloma.

Thank you and then regarding the the Biomarkers without your top two looking for.

Specially in the.

And studies watchful of Biomarkers, you're looking for.

So we are disclosed at <unk> the data that we had from our initial study in monotherapy, where we found that the adenosine receptor HOA receptor itself.

Low levels of that the fresh number of cells expressing HOA are in the tumor.

Was correlated with clinical benefit.

In the patients in that study.

That is our IHT marker. We have also looked at other markers both by I H D and by Nanosphere I'm looking at M Army markers.

And.

So.

We have identified other markers that also are potentially identify the patients that benefit using those methods as well.

Country Central debate at this point, we're not.

Thank you.

As a final reminder to register a question. Please press star followed by one on no telephone keypad now.

Yeah.

I can confirm we have nice other questions current you've registered so I hand, it back so you could team for any closing remarks. Thank you.

Thank you very much everyone that'd be great.

This now concludes today's call. Thank you all for joining you may now disconnect your lines.

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