Q1 2020 Earnings Call
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Ladies and gentlemen.
Operator: Ladies and gentlemen, thank you for standing by. Welcome to Compugen's first quarter 2020 results conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the investor section of Compugen's website.
Standing by welcome to topic, just first quarter 2020 results conference call. This.
This time all participants are in listen only mode. An audio webcast of this call is available.
Of course just website.
Operator: www.cgen.com As a reminder, today's call is
Probably the CE Gen <unk> as a reminder, today's call is being recorded.
Operator: I would now like to introduce Ilana Holzman, Competence Director of Investor Relations and Corporate Communications. Please go ahead.
Pinch.
Competence director of Investor Relations at corporate Communications. Please go ahead.
Unknown Executive: Thank you, Operator, and thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO, Dr. Henry Adewoye, Chief Medical Officer, and Ari Krashen, CFO and COO. Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections and other forward-looking statements regarding future events or future business outlook, our development efforts and their outcome, our discovery platform, anticipated progress and timeline for our programs, financing and accounting-related matters, as well as statements regarding our cash position. We wish to caution you that such statements reflect only the company's current expectations and that actual events or results may differ materially. You are kindly referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission, including the company's most recent annual report on Form 20-F, filed on February 24, 2020. The company undertakes no obligation to update projections and forward-looking statements in the future. I will now turn the call over to Anat.
Thank you operator, and thank you for joining us today, which makes them copy Gen, our doctor or not Cohen, Dayag, President and CEO Dr., Henry <unk> Chief Medical Officer.
And our crushing CFO and COO.
Before we begin I would like to read the following regarding forward looking statements. During the course of this conference call to company May make projections and other forward looking statements regarding future events or future business outlook, our development efforts and their outcome, our discovery platform anticipated progress at times.
Line for programs financing, an accounting related matters as well as statements regarding our cash position.
We wish to caution you that such statements reflect only the company's current expectations that actual events or results may differ materially.
You are kind of referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission, including the company's most recent annual report on form 20-F filed on February 24, 2020, the company undertakes no obligation to update projections and forward looking statements enough.
Future.
We'll now turn the call over two and not enough.
Anat Cohen: Thank you, Ilana. Good morning and good afternoon, everyone, and welcome to our first quarter 2020 corporate and financial update. As Ilana mentioned, today on the call, I have with me Dr. Henry Adewoye, our Chief Medical Officer, who will provide updates on our clinical progress. We also have Ari Krashen, our CFO and COO, who will review our financial statements and positions.
Thank you [laughter] good morning, and good afternoon, everyone and welcome to our first quarter 2020 cooperate and fashion.
In the latter mentioned down because I have we need dr. Henry otherwise, our chief Medical Officer, who will provide an update on our can you kind of progress.
We also have Ari krashin, our CFO and COO, who will review our financial statements integration.
Yes, that's too much we have experienced and urea.
Anat Cohen: In the past two months, we have experienced a new reality brought about by the COVID-19 pandemic, which has impacted every aspect of our lives, both private and professional. Our highest priority during this time has been and continues to be the safety and health of our employees while doing our best to meet our goals. Most of our employees are currently working remotely, though almost all of our lab scientists continue to work in our R&D laboratories under strict safety guidelines. We have reviewed our most critical activities and implemented mitigation plans to minimize the impact on our clinical program, which I will discuss in more detail shortly, as well as our early stage pipeline. Simultaneously with preparing for escalating scenarios nationwide or company-wide, we're now implementing measures that are intended to allow for a smooth and efficient recovery once normalization is declared.
Wrote about by the coordinating today.
We are interested in every aspect so far line, both private and professional.
Our highest priority dreams, each time has been and continues to be the shape.
Our is really.
Well, we are best to meet our goal.
Most of our employee are currently working remotely, though all of our last century continues to work in our R&D Laboratory.
History safety guideline.
We have reviewed our most recent FTD and Aegion that Didnt litigation plan to me minds to eat.
On our clinical program, which I will discuss in more detail shortly as well and our early stage by central.
She was damaging was preparing for escalating scenarios nationwide for company wise, where now implementing measures which are intended to allow for most inefficient recovery one no money Asian HD clear.
And any time, we're not experiencing finished escalate.
Anat Cohen: At this time, we're not experiencing significant delays in our plans, and despite the ongoing challenges associated with the COVID-19 global pandemic, the first quarter of 2020 has been one of significant and continued accomplishments for Compugeny. We reported additional encouraging data from our phase one COM701 dose escalation study, both as monotherapy and in combination with Odevo. These further support the potential of our overall science-driven clinical strategy. In addition, we have advanced COM902, our anti-clinical antibody, to the clinic, announcing the first patient dose in April. This marks the third target program discovered computationally by us that is now in clinical study.
[laughter] ongoing challenges associated with a combination rather than Danny.
First worked off 2021 significant and continued accomplishments from hockey.
We reported addition, encouraging data from our phase one constitutional one dose escalation study, both as monotherapy and combination we don't diesel.
D. Further supports the potential our on site recently.
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In addition, we had advanced calling on to our anti cancer.
Announcing the first patient dosing every.
Desma exercise program covers computation me by.
Now he has any kind of stuff.
During the quarter, we obviously know any for this but he said by saying our ongoing collaboration with Bristol Myers Squibb.
Anat Cohen: Earlier in the quarter, we also announced an important strategic step by expanding our ongoing collaboration with Bristol-Mares Queen to include a phase one-two-triple combination study testing COM701 with BMS Ovivo and their investigational treatment inhibitor. This study will enable us to directly test our hypothesis of an intersection between the PDRFG, PIDIT, and PD-1 pathways, in which the simultaneous blockade of these three pathways has the potential to synergistically enhance anti-tumor immune responses in selected patient populations not responsive or resistant to PD-1 blockers alone. As a brief reminder, our internal discoveries on the existence of two parallel and complementary pathways in the DNA immuno-oncology aspect lay the foundation for our current program. Our lead program, COM701, originated from our computational discovery of PBRID as a novel immune checkpoint and newly discovered inhibitory pathway in venom X. This finding adds to a prior discovery by us and by others, suggesting that STIGIT, our COLT902 target, is an additional inhibitory pathway that is part of the VINEM effort.
[laughter] phase one teacher combination study testing concept in a one lead BMS evil and their investigation on T. before.
This study will enable us to directly to our house policy.
Okay intersection between the <unk> right.
TV and PD one pathway.
We did she might tell me, okay upbeat reach pathway.
[laughter] attention.
[laughter] and human immune response, each patient population, not only philosophy or refractory to PD one locker.
As a reminder, our interest coverage on the addition of those two pilot and complimentary passionately eat ideally you know how he actually.
Laid the foundation for our current forward.
Our lead Barbara constant and a one.
Originated from our computational discovery or do you hear AG as a novel immune checkpoint and newly discovered eating joint halfway into you know.
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Suggesting that TV I will comment on two time it isn't Additionally, Detroit pathway.
Tom as you know.
Our research and preclinical data indicate that de to pathway are part of it and complementary.
Anat Cohen: Our research and preclinical data indicate that these two pathways are parallel and complementary inhibitory pathways in the xenon axis and have further strengthened our belief that in certain tumor types and patient populations where the two pathways are operative, there may be a need to block both PTRAC and TTIC in order to enhance the potent anti-tumor immune response. In addition, our preclinical data supports recent scientific findings by others, indicating a molecular intersection between the genome exit and the PD-1 pathway, thus suggesting that various drug combinations that address PDRFG, digits, and PD-1 may be required to target these three pathways in different cancer patient populations and in different cancer indications. While in some patients, blocking the PD-1 pathway will be sufficient. In others, the blockade of one or two of the other inhibitory pathways, with or without PD-1 blockade, may be required to generate a protein immunotherapy treatment response. Before Henry provides detailed clinical updates... I'd like to spend a little more time highlighting our accomplishments. And what is to come in 2020?
He just worry pathways in the you know.
And it has further strengthened our busy day session numerous times and patient population, where they do pathway operating.
Maybe I need to both P. here I can take you know what is your enhanced potent anti tumor immune response.
In addition, oh purchase any kind of data so for reasons that she findings by either.
Okay and molecular intersection between that you know [laughter] and if he wants pathway.
Yeah, suggesting that various draconian nation that address.
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Maybe required to talk with the three pathway in different cancer patient population and you cancer indication.
Why some of the patient blocking if he wants to actually will be sufficient.
The other digital cable one or two or are there any degree pathway with or without anyone's, okay, maybe required to generate colt any immunotherapy treatment response.
Before I hand, they provide de has any kind of update.
Let me spend reaches more time, highlighting our accomplishments.
Uh huh into anyway.
Last week, we presented updated data and he HCR Richard meeting, which further supports the safety and he George TDC Continental and as a monotherapy and extend our data to include also cost of in a one in combination we don't.
Anat Cohen: Last week, we presented updated data at the ACR virtual meeting that further supports the safety and anti-tumor activity of COM701 as a monotherapy and expands our data to include COM701 in combination with Opdivo. As before, we believe our results, which now include two confirmed partial responses, In addition to the high percentage of disease control rates and some durable responses of over 6 months across treatment arms, are particularly compelling as they were achieved in a dose-escalation setting in a highly refractory patient population. We have completed the monotherapy dose escalation, and we're now working on completing the combination dose escalation. And importantly, we look forward to beginning our biomarker-informed monotherapy expansion cohorts, which are expected in Q2. Our monotherapy expression cohorts will include indications we believe are most likely to respond to CON701, if these are selected based on our analysis of DNAM axis biomarker expression profiles and our clinical data. In this monotherapy expansion study, biopsies will be collected before and on COM-71 treatment to allow retrospective analysis of our xenon acid biomarker approach.
And before we believe our results, which now include two confirmed partial responses.
In addition to the high percentage of disease control rate and Sean durable responses over six months across treatment huh.
Particularly compelling.
They were she unit dose escalation setting in a highly refractory patient population.
We have completed a monotherapy dose escalation.
And were now working on completing the combination dose escalation.
Importantly, we look forward to beginning biomarker in strong well sure expansion cohorts, which are expected in Houston.
Oh, a monotherapy expansion cohort will include indication, we believe our most likely to respond to consider one.
These were selected based on our 90, Oh, Dina actually biomarker expression profile.
And our clinical data.
Indeed, one Cherokee extension study that she will be collected before and are confident on treatment to allow retrospective analysis or as you know active biomarker approach.
Additionally, we remain on track to begin our phase one to Triple combination study testing Comseven hundred one will be initial equal and their investigation of T. E store in the second half of this year.
Anat Cohen: Additionally, we remain on track to begin our Phase I-II triple combination study, testing COM701 with BNS of Devo and their investigational STIGIS inhibitor in the second half of this year. Moving to our physics program, we were pleased to announce the first patient dose in our phase one dose escalation trial of COM902 in patients with advanced malignancy. This would enable us to clinically evaluate dual blockade of PDRIG and TIGIC inhibitory pathways in the DNAM-F. We are encouraged by the biopharma industry's increasing interest in teaching. The Potential Clinical Validation of the Tickish Pathway
Moving to our TV program, we were pleased when no first patient dose.
Our phase one dose escalation trial called no two in patients with internationally.
D., we needed a clinically and finally doing okay I'll be here I'd and teaching inventories halfway into you know.
We are encouraged by the final comment he just read increasing interesting TV the potential clinical validation of the Ti pathway.
Anat Cohen: Combined with our encouraging signals of anti-tumor activity of COM701 as a monotherapy and in combination with PD-1 inhibitors, this further substantiates our hypothesis of the relevance of the genome axis and the PDRG pathway in immuno-oncology. This also serves as evidence, in our view, of the potential power and validity of our computational discovery platform. Having access to the only clinical-stage PBRID asset to our knowledge highly differentiates us in testing the clinical relevance of this asset, and we look forward to driving our three parallel clinical studies in 2020. Come to the Noir Moral Therapy.
Finally, our encouraging cigna anti tumor teachers Comseven hundred one huh.
Monotherapy and combination we didn't want to heat or.
Further substantiates, our he talked to see the Renaissance as you know assay and the P. guarantee pathway any you know.
He also served as evident in our view of this attention our inability of our computational discovery platform heavy.
The only clinical stage Pete here and he asked it to our knowledge hey differentiate.
I think the clinical recipe actually and we look forward to driving our free tirelessly 'cause studies me wage way.
Content in a while no Cherokee.
Anat Cohen: COM-701 Obdivo Antibiotic Inhibitor Triple Combination Therapy and COM-902 Dose Escalation. Furthermore, in early Q1, we provided certain anticipated milestones and data results. At this time, despite the COVID-19 pandemic, we do not expect delays in our earlier guidance. We still plan to
Constant on diesel and did you can you talk through the combination therapy and call no two dose escalation.
Furthermore, in early Q1, we provided says in anticipation my phone invasion retail.
And he time.
Finally, calling 19th Sunday, we do not expect late in our earlier Guy.
We see sent to.
Anat Cohen: Initiate and complete enrollment in our COM701 Monotherapy Expansion Cohort, with initial data expected to be disclosed in the first half of 2021; disclose initial data from our COM902 Dose Escalation Study in 2021; and initiate our triple combination study with BMS in the second half of 2020. Having said that, we're monitoring the situation on an ongoing basis, and we will share with you any material changes in our outlook While some of our sites are directing resources to COVID-19, overall, to date, we have not observed a significant impact on patient enrollment and monitoring. This could be for a number of reasons.
Initiation completed enrollment in our concept I don't want more certainty expansion cohort.
We do nation data expected to be still need to for vessels 2021.
Yeah. So initial data from our common I know two dose escalation study in 2021.
Initiate our Triple combination study and then in the second half 2020.
Having said that.
We're monitoring the situation on an ongoing manner and we share with you any measure and changes in our outlook is de Mayo IRI.
Why to sell our son are directing resources to coordinate team.
Overall today, we have no significant impact on patient enrollment anymore. So.
These could be for a number of reasons.
Anat Cohen: First, the patient population we are enrolling is comprised of patients with advanced disease who have adopted all available standards of care therapy. And second, we're still in stages in which we are recruiting a very small number of patients. In addition to these two aspects, we believe that the number of clinical science participating in our studies, our careful selection of a mix of academic and dedicated phase one clinical trial sites that see only patients with advanced cancer, and the diligence of the clinical investigators all contribute to our current position. But again, this may change.
Sure the patient population, where in Raleigh is comprised of patients with advanced disease, who have exhausted. All his name is a standard of care therapy.
And second.
We're still early stages in which we're recording a very small number of patients.
In addition to de too I think we believe there's been no clinical science.
Participating in our study.
Our carefirst election, often make a D and dedicated phase one clinical trial site that she only patients with advanced cancer.
In addition, the King investigator all contribution our current position.
But again beat me change anywhere they communication, we decide and are actively monitoring the situation.
Anat Cohen: And we're in daily communication with the site and are actively monitoring the situation. We have also continued our steady progress in strengthening our intellectual property portfolio, aiming to keep the position of our assets as strong as possible. Adding to our previously granted Composition of Matter and Use patent in the U.S. and Europe, we announce in Q1 a European patent for the use of any anti-PDRID antibody that activates T-cells and or N-cells in the treatment of cancer. An additional European Composition of Matter patent for COM701 and backup antibodies for use in the treatment of cancer, and a U.S. Patent for Methods of Screening Anti-PVRG Antibodies that Inhibit the Binding of PVRG and PVRS. We were proud to recently announce the publication of preclinical data originating from our collaboration with Bayer on Bay 1-90-5254, a first-in-class immuno-oncology therapeutic antibody targeting LDR2, which we discovered computationally and which is currently being evaluated by Bayer in a Phase I study in advanced solid tumors. We believe this also serves as important validation of the power of our platform to computationally identify untapped drug targets while also establishing ILDR2 as a new immune checkpoint and a drug target being pursued in clinical studies.
We also continued our steady progress in strengthening our intellectual property portfolio.
Just keep the position of our assets as strong as possible.
And he to our previously granted composition of matter and used staffing in the U.S. and euro.
We know you want a European passion for legal entity here and he anybody I.
I think they teach it and or education in the treatment of cancer.
In addition, the European composition of matter of patent so confident on one and that antibodies for using the treatment of cancer.
And the U.S. happen.
So message of screening and repeat here and he anybody that's easy to EBIT that binding P series D N P hearing.
We were probably two recently I know the publication on Brexit any kind of data originating from our collaboration with Bayer. They won 90 50 to 54 Fracing trucking you know how does the therapeutic antibody targeting on your two which we covered computation.
Really English is currently being violated by failure in a phase one study in advance so each or.
We believe they also serves an important validation of the power of our platform to computationally identifying.
Has dropped on it.
But also some sheet I'm here to have any checkpoint and it's rough target being pursued in clinical studies.
The recent accomplishments have contributed to compete just dramatic evolution over the past that rough waters.
Anat Cohen: The recent accomplishments have contributed to Compugen's dramatic evolution over the past several years. We transitioned to a clinical stage company with a growing body of encouraging data that support our unique approach as a target discovery and drug development biotech company, employing cutting-edge computational biology to discover new biological pathways and novel drug targets to develop first-in-class drug candidates. This quarter, and despite challenging market conditions, we were pleased to announce an approximately $79 million public offering that we believe is testament to the growing confidence in our company and the power of our approach and capability. Our strengthened cash balance empowers us to continue our strong execution, pursue our strategic clinical plans, and advance our early-stage program to propel our company forward. Before turning the call over to Henry, I would like to add that I'm very proud of our employees and grateful for their dedication.
We transition to inflation stage company with a growing Bobby encouraging data that supports our unique approach is a topic discovery in drug development that this company employing cutting edge.
Additionally, biology to discover new better because pathways and knowledge about harvest and you've got a first in class drug candidate.
Deep water and despite challenging market conditions.
We were pleased plan now in approximately 79 million dollar public offering.
As we Didnt see is testament to the growing confidence in our company and the power of our approach and capability.
Our stresses cash back and power.
To continue our strong execution.
So our strategically 'cause plan.
And it faster early stage program.
To prepare our company forward.
Before turning the part over to Henry I would like to add this I'm very proud of our employee and grateful for their syndication.
Anat Cohen: These recent accomplishments and our tremendous progress over the past several quarters were made possible due to their hard work, drive, faith, and commitment, for which I'm incredibly grateful, particularly given the extraordinary circumstances we're now facing. Nevertheless, under these circumstances, we remain focused on advancing our pipeline program and maintaining positive momentum to achieve our long-term goals. I look forward to providing updates throughout the year. And with that, I will now turn the call over to Henry. Henry?
D. mission to competition and our tremendous progress over the past several sportster were made possible uses their hard work drives sage and commitment. So we are incredibly aggressive, particularly given the extra ordinary circumstances were now facing.
Under these circumstances, we remain focused on advancing our I think for a while maintaining positive momentum to achieve our long term goal.
I look forward to providing updates throughout the year.
And we see I will now turn the call over to handling.
Great.
Henry Adewoye: Thank you, Anat, and good afternoon and good morning to everyone. As Anat mentioned, we have continued to report encouraging data from the ongoing COM701 phase 1 dose escalation study, which now includes new data from the monotherapy arm. COM 701, 20 mg per kg IVQ-4 weight. The combination arm with nivolumab or Opdivo and an update on the two patients that were ongoing study treatments in arm A. COM 701 monotherapy as our last data disclosure at SIPC 29. Last week at AACR, we presented clinical data from our ongoing Phase I clinical study designed to assess the safety and tolerability of escalating doses of COM701 immunotherapy, as well as in combination with nivolumab in patients with advanced solid tumors who have exhausted all available standard therapy. This data builds upon our prior data set presented at SITC in 2019, which included 13 patients in an A phase in the first seven dose cohorts of the immunotherapy dose escalation arm of the study.
Thank you and not a good afternoon and good morning, everyone.
As the most mentioned we have continued to reports and closing the that's when we own going come someone wants is one dose escalation study.
Which now includes new data something wouldn't sort of.
I'm still than the 120 milligrams per kilogram of did you foliage.
The communism or would you go lub or Google.
And then updates on the two difference though were ongoing literature says you know.
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Well because it is youre will present, the clinical data from our ongoing through strong clinical study designed to assess the safety and tolerability of escalating doses of come someone to one of them Serbia.
Let's go lives in combination with Nivolumab in patients with advanced solid tumors, who have exhausted or available therapies.
This do though build up on a product delisted preserved.
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Henry Adewoye: The data we reported demonstrated that COM701 was well tolerated, with no dose-limiting toxicities across all seven dose cohorts, with dosing up to 10 milligrams per kilogram IV every three weeks. In addition, the data provided initial encouraging signals of anti-tumor activity with 9 of 13 patients, or 69%, having a best time point anti-tumor activity of stable disease. These results are particularly noteworthy given the highly refractory and all-commutation population who had received a median of seven and a maximum of 15 prior lines of therapy prior to enrollment in this study. We also reported anti-tumor activity in patients with micro-satellite-steady colorectal cancer. A challenging tumor type that is typically unresponsive to checkpoint inhibitors and for which there are no approved therapies. We reported stable disease in 5 of 6 patients with MSS-CRC, or 83%. Three of the six patients with colorectal cancer had KRAS mutations.
The middle we reported demonstrates the there comes a little ones as well holds a low dose limiting toxicities across both of them do school boards would do some 10 milligrams per kilogram.
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In addition, we do know provided you should think origins signals are on schedule opportunity with nine of 13 patients for six months isn't.
You bet unborn sounds like true up to the Geo student busy.
This result, particularly moves will then give them because I knew from an old politician population. What do you didn't have someone on the maximum due prior lines of therapy brothers rumors on this but it.
We also reported a month or two to the June infusions would like was supposed to lunch in colorectal cancer.
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Henry Adewoye: All three patients had stable disease in this study. The data informed our decision to include eligible patients with microcephalic cervical erectal cancer as an indication in our upcoming expansion cohort. In our oral virtual presentation at AACR, we reported the completion of all eight dose-level cohorts in monotherapy, which now includes data from 16 patients, and the first three or four dose-level cohorts in the combination arm with 12 patients. Importantly, COM 701 was well-tolerated, with no dose-limiting toxicities, at 20 milligrams per kilogram IDQ for weeks as monotherapy and 10 milligrams per kilogram IDQ None of the patients discontinued study treatment due to the toxicity of any of the studied drugs. The most frequent adverse event observed in either arm was fatigue, reported in 39% of patients, and all between grade 1 and grade 2.
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The dealer informed decisions you include eligible do something like a surplus liquidity rectal cancer.
Indication you know upcoming exposure imports.
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In two milligrams per kilogram four weeks as monotherapy and 10 milligrams per kilogram or did you four weeks in Colombia, and she will be worried about.
None of the piece of this continues for the treatment due to the toxicity or any of the study drugs.
The most frequent other than does observed.
Was from GE reported and that's another distribution oh between grid won't encouraging.
Majority of Wisdom says this is the analysis that's important and then the sodium arms would be closer to adversely does he have other institutions.
Henry Adewoye: The majority of the adverse events in the safety analysis set reported in the study on both arms were grade 1 to 2 adverse events in 10 out of 18 patients, or 56% in arm A, and 7 out of 13 patients, or 54% in arm B, demonstrating no increased toxicity with COM701 and nivolumab. We also reported preliminary PK data that is supportive of dosing of COM701 IVQ-4 weeks at the doses evaluator. Having previously reported at SITC 2019 that the PK profile of COM-701 homotherapy permits IVQ-3 with dosing, this new data permits us flexibility with the schedule of dosing of COM-701. We continue to report encouraging anti-tumor activity of COM-701 immunotherapy and now in combination with nivolumab. We reported two patients with confirmed partial responses, a patient with microsatellite-stable, platinum-resistant primary peritoneal cancer, ongoing study treatment for 25 weeks on arm A, and another patient with microsatellite-stable colorectal cancer with a KRAS mutation on arm B Notably, these ongoing responses in microsatellites to colorectal cancer and primary peritoneal cancer, the type of ovarian cancer, are supportive of our biomarker-informed selection of indications for the immunotherapy expansion course.
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We continue to report and I was just unless you want us to feel comfortable to woman Serbia alone in combination with Nivolumab.
We reported two patients would come from partial responses.
In addition to Michael such that we will.
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Henry Adewoye: We also reported a high disease control rate in both monotherapy and combination therapy arms. 69% or 11 out of 16 patients in the monotherapy arm, and 75% or 9 out of 12 patients for the combination R. This means that 69% of patients enrolled in an A... And 75% of patients enrolled in AMBI derived some clinical benefits from the study. We are encouraged by the durability of study treatment considering the patient population enrolled in the study, patients who have exhausted all available standard therapy. Across AMA and AMB, we observed durable responses of at least stable disease for over six months in six of 28, that is 21% of patients. Of the 12 patients enrolled in AMD, 6 remain on study with a number of patients on treatment for over 200 days and some approaching the one-year mark, sticking together. These data are encouraging and support our preclinical hypothesis that inhibition of PVIID leads to enhanced activation of the anti-tumor immune response, leading to tumor growth inhibition.
We also reported because this is going to loosen well deserved.
Combination therapy arms.
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And so themselves dozens of patients enrolled in do write some clinical benefits on this but it.
We are encouraged by the durability of sort of treatment considering the patient population and move on to study.
Goossens, who have exhausted all available standard therapies.
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Henry Adewoye: The next step in our COM 701 Clinical Program is the Monotherapy Cohort Expansion. This study arm will utilize a biomarker-informed strategy to focus on tumor types based on our preclinical PVRL2 expression data and dose escalation clinical results that we believe are most likely to respond to treatment with COM7-1. Become 7-1-1 Monotherapy Cohort Expansion will enroll approximately 20 patients with advanced non-small cell lung, ovarian, breast, endometrial, and microcephalic steroid colorectal cancer, all of whom have exhausted all available standard therapy. We also will be examining our DNA axis biomarker approach in biopsies obtained from patients before and during treatment to conduct retrospective biomarker analysis to inform treatment outcomes. Operational aspects for this part of the study are underway; an important clinical milestone of the quarter was the initiation of our Phase I study of combinoids, proprietary fidget inhabitants. This study will evaluate the safety... Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antithrombol Activity of COM-902 in patients with advanced malignancies who have exhausted currently available standard of care therapies.
The next up you know comes over the one clinical program.
The mood therapy cohort expansion.
This study will utilize the bottom of the informed strategy to focus on June one page views on a preclinical PV gene expression data and do a solution clinical results that we believe almost like a Jewish sponsorships it doesn't come settlement.
The comes up a little more women, so it'll be cohort expansion will enroll approximately 20 patients with advanced non small cell lung.
In Brazil and be neutral unlikely, so, let's do a colorectal cancer.
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We also will be examined or do you know actions bottom up approach he biopsies obscene lumpier than.
Before unwilling treatment to conduct interest, but the bottom up analysis.
Forum on treatment outcomes.
Operational aspects. So there's parts of the study underway.
I mean important clinical milestone on the water.
Well the infusion of abuse ones, but do you have combined.
Oh proprietary she just consider.
The study will evaluate the Susie.
Tolerability.
From a cookie though.
From a go knowledge and preliminary Unprintable two deals come by region in patients with advanced malignancies, well exhausted corn I really do standard of care therapies.
Henry Adewoye: We believe having a wholly owned and scientific antibody is important for our overall clinical development plan and a significant differentiator in this space. Enrollment of patients into the COM 902 Dose Escalation Study is ongoing, and we look forward to initiating our Phase 1-2 triple combination study of COM701 with nivolumab and DMS986207. Bristol-Meissner-Squibb's Investigational
We believe having a wholly owned and antibody <unk> important overall clinical development plan and the significant differentiation industries.
Illumina it'll be something into the Pulmonology Boosters Commission study ongoing.
We look forward to shoot enough. This one's machine Sheeple combination study of comes up in the one with Nivolumab Mpls noted six to seven.
Just two months you squeeze investigational so you can see bigger.
Henry Adewoye: We believe this is an important step towards testing our overall hypothesis on the role of the dynamaxes and other pathways that intersect with it, such as pdrl2.org pvr slash cgenes, and pvr1 slash pv1. Our objective is to hopefully demonstrate that disabling the DNAM axis and other pathways that intersect with it will translate to clinically meaningful treatment outcomes for patients, such Progressions for Survival, duration of response, and possibly overall survival. This planned Phase 1 slash 2 open-label study will evaluate the safety, tolerability, and antitumor activity of COM701 in combination with Opdivo and DMS-986207 in selected tumor types, namely ovarian cancer, endometrial cancer, and a biomarker-driven arm of tumor types with high expression of PDRL.
We believe this is an important step towards personnel liberal purposes on do all the dealer boxes.
No the path was but it was a certain of its looks to us.
BRL two is much bigger I agree.
PVR smashed featured.
A video one last housekeeping ones.
<unk> objective is to hopefully they'll eventually.
But they certainly do them up.
And all the best wins that into such that it.
Translucent clinically meaningful treatment outcomes for patients.
So just overall response rate.
Progression free survival.
Duration of response and possibly overall survival.
This learned since one semester open label study.
Under the safety Tolerability and so what does it feel comfortable the one in combination with Opdivo dealers money six to seven in selected to what I mean liver cancer.
Individual cancer.
Biomarker, driven almost two with us with high expression of PD our culture.
The sudden will do there's going to come someone award with six doses of Nivolumab dealers money six to seven.
Henry Adewoye: The study will dose-escalate COM701 with fixed doses of nivolumab and DMS-9862. We remain on track to begin the study in the second half of this year. It is clear that these are exciting times, and we thank the patients participating in our clinical studies and their families. We also thank the investigators and study site personnel whose dedication, despite the unprecedented challenges of COVID-19, makes our studies possible. To date, the impact on our studies has been limited.
Were illegal drugs to begin the study in the second half of this year.
It is good but these are exciting tons of computers.
And with some of the patients, but this isn't about clinical studies and their families.
We also from the investigators have sort of said for Seville, whose dedication disposing unprecedented challenges of called my team. They are studies possible.
To be in Buffalo studies husband dimension.
Henry Adewoye: And, as Anat mentioned, we are in daily communication with the clinical study site and are monitoring the situation very closely. We remain committed to the advancement of all our clinical programs and are increasingly hopeful that we will help address the significant unmet needs of so many cancer patients by expanding the population that may benefit from immunotherapy from Code to Care. With that, I will turn the call over to Ari. Thank you, Henry. Good morning and good afternoon to everyone.
And I Love motion, we ideally communication with the clinical study sites are monitoring the situation very closely.
We didn't come and go to the advancement of all our clinical problems.
Increasingly hopeful that will address the significant on that means of so many cancer patients, but expanding the population by the benefit from it in Philippines.
I'm going to Joe's.
With that I was going to go over 200.
Thank you Henry.
Good morning, and good afternoon to everyone.
Ari Krashen: The first quarter of 2020 was transformational for Compugen. Today, we are better positioned financially, as reflected by our improved cash balance and linear expense structure, and are enjoying greater market recognition. We are now well-positioned to advance our pipeline, both clinical and early stage, and achieve our corporate goal. Our financial results for the first quarter of 2020, released this morning, continue to reflect the expenses associated with our ongoing Phase I study for COMP 701 and the initiation of the Phase I study for COMP 902, as well as our strong financial position derived from a recent public offering, with gross profits of approximately $79 million, including approximately $4.3 million received from the exercise of the underwriters' option, which occurred after the end of the first quarter.
The first quarter of 2020, what's that submission of a computer.
Today, we're better positioned financially.
Reflected by our improved cash balance and linear expense structure and I'm enjoying rental market recognition.
Well no well Perficient said the vessel pipeline, both clinical and early stage and achieve our corporate goals.
Our financial results for the first quarter 2020, released this morning continue to reflect the expenses associated with our ongoing phase one study for coal seven to one.
And initiation of the phase one study for coal nine to do.
As well as always Splunk for us and position the right from a recent public offerings with gross proceeds of approximately $79 million, including approximately $4.3 million received from the exercise of the underwriters option. We took care of after the end of the first quarter.
Other expenses for the first quartile 2020 were $4.7 million compared with $6.3 million for the same period or 29 kings.
Ari Krashen: R&D expenses for the first quarter of 2020 were $4.7 million, compared with $6.3 million for the same period of 2019. This decrease of over 25% is mostly attributed to the restructuring process we announced at the end of the first quarter of 2019, offset by increased clinical expenses associated with our growing clinical program. As a reminder, in the first quarter of 2019, our clinical expenses were related solely to the COM701 monotherapy dose escalation study, while today, they reflect costs associated with our expanded clinical programs, which now also include the dose escalation of COM701 in combination with Opdivo and the dose escalation study for COM902. The net loss for the first quarter of 2020 was $7.1 million, or $0.10 per basic and As of March 31, 2020, we had approximately $121 million in cash and cash-related accounts, compared with approximately $44 million as of December 31, 2019. The company had no debt in either period.
This decrease of over 25% is mostly attributed.
The restructuring process, where most of the end of the first quarter 2019, offset by increased clinical expenses associated with our going clinical programs.
As a reminder.
The first quarter of 29 thing our clinical expenses were related solely to the coast of into one monotherapy dose escalation study what today they reflect cost associated with our expanded clinical programs, which no also include the dose escalation of come seven to one in combination.
The people and the dose escalation study for coal nine of them.
Net loss for the first quarter of 20 $27.1 million or 10 cents per basic and diluted share compared with a net loss of $8.4 million or 14 cents per basic and diluted share for the same period.
2019.
There's a small set it for a 2020, where the proximately $121 million in cash and cash related accounts compared with approximately $44 million.
As of December 31st 2019.
The company had no that neither period.
Ari Krashen: The increase in our cash balances of approximately $77 million during the first quarter is mostly attributed to the approximately $70 million of net proceeds received in our recent public offering, approximately $5.2 million received from exercise of employee options, and approximately $7.2 million received from exercise of employee options offset by operating expenses and working capital. As noted earlier, an additional amount of approximately $4 million of net proceeds related to the recent public offering was received after the end of the first quarter and is not reflected Total cash expenditures on a full-year basis are still expected to be approximately $27 million. As Henry and Anat have indicated, at the moment, we are not experiencing any significant impact from COVID-19 on our operations. And as such, our cash expenditure outlook for the year has not changed at this time. It is important to note that the thoughtful approach in which we have managed our cash resources in the past will continue. At the moment, based on our current plans, we do not expect to increase our level of expenditure in a significant way going forward.
The increase you know cash balances of approximately $7 million to $7 million. During the first quarter is mostly attributed to the approximately $70 million. Net proceeds received you know recent public offering approximately $5.2 million receive form exercise of warrants and approximately.
$7.2 million received from exercise of employee option offset by operating expenses and working capital.
As noted earlier.
An additional a multiple approximately $4 million net proceeds related to the recent.
Public offering was received after the end of the first quarter and is not reflected in the cash balances as of March 31st when it 20.
Total cash expenditures or the full year basis, you still expected to be approximately $27 million.
Penryn and not have indicated at the moment, we're not experiencing insignificant impact from commenting on our operations and as such our cash expenditure outlook for the year does not change due study.
It is important to note that the focal approach and we try to manage our cash resource in the past will continue.
At the moment based although current plan, we do not expect to increase our level of expenditure in a significant way going forward.
No before opening the call for questions I would love to saying our investors for their continued support and confidence in cold kitchen.
Operator: Now, before opening the call for questions, I would like to thank our investors for the continued support and confidence in Compugen. Thank you for joining us today, and on behalf of the entire Compugen family, we hope you stay safe and healthy. Thank you. And with that, we will now open the call for questions. Thank you, ladies and gentlemen. At this time, we will begin the questionnaire. If you have a question, please press star 1. If you wish to decline the polling process, please press star 2. If you are using speaker equipment, kindly lift the headset before pressing the numbers.
Thank you for joining us today and on behalf of embark on present family. We hope you stay safe and healthy.
Thank you and without moving to open the call for questions.
Thank you ladies and gentlemen at this time will begin the question answer session. If you have a question. Please press star one if it was the clients in the public process. Please press star too. If you are using speaker equipment kind of if they had separate pressing the numbers. Please stand by only poll for questions.
Operator: Please stand by while we poll for your question. The first question is from Mark Breidenbach of Oppenheimer. Please go ahead. Hey guys. This is Matt on behalf of Mark. Thanks for taking our questions and congrats on the recent progress. Anat, I apologize if I missed this, but I just wanted to clarify whether the triplet trial will be all-comers by design or if you are going to be deploying a biomarker-guided eligibility strategy.
The first question at some Mark Freedom backup Oppenheimer. Please go ahead.
Hey, guys as a matter of for Mark Thanks for taking your questions and congrats on the recent progress I'm not I apologize if I missed it but I just wanted to clarify whether the triplet trial would be all comers by design or you are going to be deploying a biomarker guided eligibility strategy.
Anat Cohen: Yeah, hi, Matt. So obviously, dose escalation is an all-comer study, but we designed it for three arms. One is for ovarian, the other one for endometrial, and the third one is biomarker-driven PVRL-2 high patient population with different types of indications.
[noise], Yeah, Hi, Matt So obviously dose escalation isn't all comer come or study but.
As we designed for me it arm.
One is for various and the other one for endometrial and the third one is the biomarker driven PPR as to high patient population.
Different type of syndication.
Okay got it that's very helpful. And then maybe if you could just provide more detail on the development strategies for nine or two should we expect that phase one trial to really look a lot like the comps up and no. One trial did a and in the future or are you planning on using biomarker guided expansion cohorts.
Anat Cohen: Okay, got it. That's very helpful. And then maybe if you could just provide more detail on the development strategy for 902, should we expect that phase one trial to really look a lot like the COM 701 trial did? And in the future, are you planning on using biomarker-guided expansion cohorts?
So right now obviously dishes or studied said dose escalation as a monotherapy in each of them being.
Anat Cohen: So right now, obviously, this is a study, it's a dose escalation as monotherapy, and it is being designed to be tested in patients with advanced malignancies who have exhausted all available standard therapies. And going forward, I'll remind you that we developed COM902 in order to make sure that, as a complementary asset to COM701, we want to make sure that we can execute on our COM701 strategy and prove the hypothesis that we identified scientifically, first computationally, and then by experimental procedures preclinically, that TGIT and PVRIG pathways are working in parallel and in complement. And for that reason, we would like to advance COM902 to be able to test it in combination with COM701. Obviously, we are conducting a triplet study with Opdivo and the TGT inhibitor BMS, which is great. And it's advancing our timelines.
It is designed to be tested in patients with advanced malignancy equals the exhausted all available.
It's kinda therapy.
And going forward I'd remind that we develop call nine or two in order to make sure that at the <unk> as a complementary I said to come seven to one we want to make sure that we can execute on our comfort seven to one strategy.
And proved hypotheses that we and identified.
Scientifically first computationally and then by experimental procedures Preclinically debt teach NPV RMG passed with a working and in part at any complement.
And for that we would like to a advance come they need to to be able to test picking combination would come to the one.
Obviously, we are conducting a triplet study with day window eagle engage teaching he'd be door pms.
At which is great and each advancing dark timelines and he's win win for competition and BMS it, but we want to make sure that we and keep pushing our strategy forward and test come they know two class come to the no one or so independent of PD one.
Anat Cohen: And it's a win-win for Compugen and BMS. But we want to make sure that we keep pushing our strategy forward and test COM902 plus COM701 also independently of PD-1. And that's important for us.
And it and that's important for us having said that.
Anat Cohen: We have a clinical stage asset. There is an interest in the industry with respect to TGIT, and we're waiting to see the data and the efficacy of TGIT. And we will make plans as we move forward for COM 902 also independently of COM 701. So the first priority is making sure that it's complementary to COM 701. But then, we will make sure that we pursue the value of this asset as much as possible. With respect to biomarker strategy, obviously, TIGIT is part of the DINAM axis. And we as a company were looking at all these axes, at all the different pathways and our approach to looking at the different family members, sorry, at the different axis members by means of chemistry. We will probably also extend it to the TIGIT study, but it's not at this stage. And we will share our biomarker strategy for our own COM902 program when we have it ready.
We have a clinical stage asset.
And there is a interestingly in the industry it with respect to teach and we're waiting to see it did daytime and Andy if he can see for teaching and do we wouldn't make plans as we move forward for common I know two and Oh, so independent.
Just comps I don't know one so the first priority is making sure that its complement the complimentary to come seven to one but then we wouldn't make sure than we pursue the value of these assets as much as possible with respect to biomarker strategy, obviously can't Jake is part of spending on access and.
And it we as a company we were looking at all these acts to say, it's all the different attack pathway and day and our approach looking at different tasks family Menderes, sorry, a different axis member set by Immunohistochemistry, we will probably or so.
Extend due to two to date TDK study, but it's not a de stage and we will share our biomarker strategy for our own Commando two program when will it have you already.
Got it up that makes sense and then just maybe one more if I may so just in terms of data read outs are you still planning on providing data from Dublin combination dose escalation cohorts or sometime in the second house.
Anat Cohen: Got it, that makes sense. And then, just maybe, one more question, if I may. So just in terms of data readouts, are you still planning on providing data from the doublet combination dose escalation cohorts sometime in the second half?
Anat Cohen: So we actually advanced timelines and presented data at ACR. Most of the combination study, those combination, those escalation studies have already been shared with the public. Obviously, we'll have more data, but we'll find the time to present the next data readout, as I stated in the prepared remarks, starting in the first half of 2021. And we'll find the time to combine this data as well in our next disclosure.
So we actually had fun timelines and presented data at age T. R and most of the at combination study dose combination and dose escalation study it is already shared and with the public.
Obviously, it will have more data, but we'll find at times to two presented the next to data readout as I stated during their prepared remarks are is starting at <unk> in that first toughest 2021 and will find its time to combine these data as well.
Our next and disclosure.
Great. Thanks for taking my questions.
Operator: Great, thanks for taking our questions. The next question is from Asthika Goonewardene. Fund Trust, Robinson Humphrey, please go ahead. Hey there, this is Alan on behalf of Asthika Goonewardene.
The next question from opposite God Gordon not.
These of Suntrust Robinson Humphrey. Please go ahead.
And there this is Alan on the thank for taking my question. So.
Operator: Thanks for taking my question. I'll follow up on the point that you had made on the biopharma interest in Tidgit and also take a look at the potential efficacy of Tidgit with the Roche data coming up at ASCO. I guess we were curious about what you'd be looking for in a meaningful... Readout of that data. And I guess, would you be able to give us an idea of how that translates to either your triplet combination that's planned to start in the second half, or just your COM 902 program? Thanks.
Just following up on this point, but.
On the bio pharma interesting and also taking work.
The.
Control because you have to do it with the Roche coming up.
Well I guess, we were curious on what you'd be looking for her.
The meaningful.
Oh gosh I.
Hi, Good would you be able to give us an idea of how that translates to either your triplet combination but plan during the second half or or just your calmed I know two program. Thanks.
[noise]. So obviously, we're not a familiar with any of the data and.
Anat Cohen: So obviously, we're not familiar with any of the data, and we will look to see if it's only, you know, I think that the interest of the industry is mainly aroused by the actions or the announcement that Roche made, but we will wait to see. We don't put any threshold on what is an activity for the TGIT. I think that this is still, you know, it still remains to be seen what the activity of TGIT is. From our perspective, we believe that the three pathways together, blocking them in a situation where in patient populations where the three pathways are operative, and we believe, based on our data, the research, and the preclinical data, that this should enhance anti-tumor activity. And the relative contribution of TGT on this front remains to be seen. And we don't put any threshold on this. We will test it on our own.
We will look to see a already even though I think that the interest of the industry's mainly by the auction for the announcement that 10, Roche made and that would wait to see.
We don't put any threshold and to what he's an activity for the teacher.
And I seem to debt to discuss telling you know you remains to be seen what he's decks ticket you take it from our perspective, and we believe that discrete pathways to gander.
Blocking Dan in a situation where in patient populations, where the Pete three pathway so operating.
And we believe based on our data and research into preclinical data, that's a and b should enhance anti tumor activity and the relative Ti contribution of teaching based on this front it remains to be C and we don't put any any fresh.
Based on these we will pass it on their own.
At more than debt combining teach NPV Pete here right. He may generate had different outcome in a different had made patient population in different intake and indications. So we're not putting any threshold to depreciation off our studies, we restart our study.
Anat Cohen: More than that, combining TGT and PVRIG may generate a different outcome in a different patient population and different indications. So we're not putting any threshold on the initiation of our studies. We will start our studies, and we will show the relative value of each and how they're operating together as a monotherapy for COM701, COM701 in combination with COM902, so blocking PVRIG and TGT, which by the way, should also enhance DINA, and blocking the triple pathway, which may block three negative regulatory pathways and stimulate a cost-stimulatory pathway, which is DNAM. So it's really looking at the So currently, there is no specific threshold.
And we will show the relative value of each and how they're operating together as a monotherapy for come seven to one comseven wanting combination would come they know too so blocking P.I.D. and TG, which by the way should also enhanced Dino.
And blocking the treatment pathways, which may blocks, three net debt of regulatory pathways and stimulating costimulatory path, where would you see them. So.
Really looking into full perspective. So currently no specific threshold, we will be very happy to see a key any kind of TV for any kind of TV for teaching he'd be door for two reasons first equally continued to support to our hypotheses, but also remember we.
Anat Cohen: We would be very happy to see clinical activity for a TGT inhibitor for two reasons. First, it will continue to support our hypothesis. But also, remember, we discovered it computationally and published it at the time that Genentech published it in 2009. So we're very proud. If this is a clinically-validated pathway, this will be great for us. But we're not putting any limits on starting our own study.
Just covered the computation Lee and publish Teekay at the time, the genetic published kicking 2009 so.
We're very proud if you know some deals will be a clinically validated pathway. This would be great for us, but okay, and but we're not putting any need to start our own study.
Alright, Thats very helpful. And then one work by me.
Henry Adewoye: All right, that's very helpful. And then one more question, if I may, on COM 902, I guess, with the first patient dose already, how should we think about maybe the different dose cohorts that you'd be considering going forward?
On calm down to I guess.
Asian, So already how should we think about maybe the different dose cohorts that you'd be considering going forward.
I'd like Henry related, but I think that's you know we take one step at a time data driven and we'll just you know, but Henry would you like to address it.
Henry Adewoye: I'll let Henry relate to that, but I think that, you know, we take it one step at a time, data-driven, and we'll just, you know, but Henry, would you like to address it?
Yes.
Henry Adewoye: Yes, thank you so much, Anat. Yes, we'll take it one step at a time, but we're going to follow what we've typically done in dose escalation for most of these therapies. So it could be a rules-based design, meaning there's a certain number of patients that are evaluated. We'll see over a predefined number of days, that's the first cycle, typically, to see if there are any DLTs. The number of patients that we're going to enroll will depend on how long each of these DLT evaluation periods for the number of subjects that will be enrolled will be. So, for example, if we enroll one subject, it's much faster than if you enroll three subjects. So the rules-based approach that I'm talking about is something similar to maybe a 3-plus-3 design or a single-subject cohort, but essentially, the rules are based on the predefined... Items or Parameters for DLT Evaluation. It could be similar to what we have on COM 701 in-brief.
So much in that you're losing your one.
Well, we're going to four Lou.
To get it done.
Two cents dilution so most of this therapies.
<unk> based design rules based in certain number.
Ah evaluated.
See you pre defined a number of days that's the first cycle.
Really I see there any deal geez the number of patients that were going to rule will depend on how long Beach is deals you evaluation period for the number of subjects.
So for example is going to want subject much faster than three subjects. So they lose boosted I'm talking about.
Something similar to maybe three design, we see it was a good cohort, but essentially the lose based on the pre defined I, Jim So parameters for guilty about Nishu Sood <unk> similar.
Operator: All right, I got it. Thank you. And congratulations on all the progress.
What we have comes over the one in Brazil.
Right got it thank you.
Operator: Thank you, Asthika.
<unk>.
Thank you has taken.
Operator: The next question is from Colin White of Jeffries. Please go ahead. Hello, it's Colin White from Jeffreys Hill.
The next question some call in light of Jefferies. Please go ahead.
Hello, So called White from Jefferies. Your.
Anat Cohen: A couple of questions, if I may, on TIGIT. The first question I had was just about whether there is anything in any of the preclinical data or anything you have seen for your TIGIT that in any way makes you think it may be differentiated from any of the competitors' TIGITs. And then the second question I have, just to follow on from the previous questions, was: You've mentioned there that if you saw it with Roche's data, clinical activity, it would be good because it validates the TIDGET pathway. But should, in a scenario where the Roche data was to look underwhelming, would you say we should be cautious about reading too much into that about the potential of your TIDGET or your programs?
A couple of questions if I mean on and touch the first question I pod.
Just like whether there's anything and if the preclinical data told anything Gibson for your touch it.
Which in anyway makes you think it may be differentiated from any of your compared to pills touch it.
And then second question hub.
And just a follow on from the previous questions was.
I'm here to talk you just mentioned there that that's you saw it was motions day talk clinical activity it would be good because it validates the touch it possibly.
Sure and that's an audio emotionally until it was to look underwhelming did you say, we should be cautious about reading too much about.
Potential false hope you're touching or your programs.
Dipping interesting question. So so just with respect to differentiation you know our our antibody that we'll try asking me to antibodies. So.
Anat Cohen: It's an interesting question. So, just with respect to differentiation, you know, our antibody is an ultra-high affinity antibody. So, that's, you know, that's a differentiating factor, but, you know, we don't know how it will translate in the clinic. So, I wouldn't think about our TG test as completely differentiating. I think that the key differentiator for us with Compugen is the fact that we have COM701, we have a clinical-stage PVRG antibody, and we think that it is needed in specific patient populations, in specific cancer indications. So this is our key differentiator. And talking about the data being overwhelming and our own TG, as I said, I don't consider, at this stage, our TG as a key differentiator for the company.
And that's you know that took a differentiating factor, but you know, we don't know, how which would translate that into clinic. So I wouldn't think about.
I would teach because completely differentiating I think that's the key differentiation for us. It complicates. The fact that we have come to then a one we have a clinical stage PVR again to body and we think.
Deputies needed in in specific patient populations, but if you can't syndications and so these are key differentiator.
I'm talking about.
The data being overwhelming and our own teach it as I said I don't I don't consider a de stage, our TV to it as a key differentiator for the company, but I do think that and that's similar to what I was saying to us because.
Anat Cohen: But I do think that, and that's similar to what I was saying to Asthika. For us, the bar for digit activity will just serve us as a starting point to show whether we can enhance it with PVRIG and with PVRIG plus PD1 blocker. So it's really, from our perspective, it's a, um..., it's a start. So, no, I think that we still need to prove the DINAM axis hypothesis, the involvement of the three pathways, and the fact that, you know, that what we view as enhancement of anti-tumor activity is really occurring. And I'll just say that our first data with monotherapy and also with the combination in dose escalation is encouraging because it supports what we've been saying for quite some time. It's initial, but it's highly supportive.
Eight for us that bar for TG, that's TV tea and we just service at the starting point to show, where do we can enhance with PDR AG and we'd PDR AG Platts Pee Dee, plus Pee Dee Ann PD, one blocker so it's.
Really from our perspective, it's a.
It is just start so no I think that we still need to prove that dean and access hypotheses. The involvement of the free pathway and affected there. That's you know that most we view as enhancement of anti tumor activity really occurring and I'm, just saying that.
Our first data with the monotherapy is <unk> and also we the combination in the dose escalation encouraging because it supports what were saying for quite sometime if you nisha, but hey supporting.
Operator: Initial, but it's highly supported. That's great, thank you. Thank you, Carly. The next question is from Tony Butler of Roth Capital. Please go ahead. Good morning. This is Tasha speaking on behalf of Tony. Thank you for taking my question. Number one, Are there any data on PPRIG and or PIDGET mRNA in normal lymphocytes versus those found in the tumor?
That's great. Thank you.
[noise] actually calling.
The next question from Tony Butler of Roth Capital. Please go ahead.
Good morning, Cogs is cautious on all in place for Tony Thanks for taking my question number one.
Oh you.
If the data on physiology, and or if it ever runway in normal lymphocytes versus.
Those are found in the tumor.
[noise], our east specifically interested in D. MRM name or why is it specifically I'm Arnie I cannot say about the protein lever, which I think he then more important verizon over expression and determine microenvironment and and off the PDR I cant compared to no my sense.
Anat Cohen: Are you specifically interested in the mRNA, or why is it specifically mRNA? I can answer about the protein level, which I think is more important. There is an overexpression in the tumor microenvironment of PVRIG as compared to normal cells.
Anat Cohen: I mean, um... You know, in the tumor microenvironment, things change. So if there's differentiating data, whether it's your internal data or whether you would like to point me towards an existing publication, either or is good enough.
I mean.
You know in it and the tumor microenvironment things things change.
So if there's any differentiating.
Data, whether it's your internal data already whether you would like nature like what the towards an existing all publication I'd or it is good enough.
Anat Cohen: Sure. As I said, in the tumor microenvironment, the PGRID levels are overexpressed as compared to normal cells, and I just refer to the fact that it's a protein level and not the dmRNA level. I'm not sure that I know how to answer the data for the dmRNA level, but I think it's of less interest.
Sure So as I said into tumor microenvironment, and P. guarantee and never thought over expressed as compared to no my sense and I just referred to the fact that it takes a parking 11, another gamma and they level I'm not sure that I know to answer the data for the M. on all of them.
But I think its letting threat.
[noise] [noise] shore and and.
Anat Cohen: Sure. And have you observed any changes in these biomarkers in tumor cells in response to external stress, for example, let's say either radiation or the application of chemo?
Have you observed.
Any any any changes and the tumor so well and they tend to spend in these biomarkers and tumor cells in response to external club stress for example, either let's let's say other radiation or or application optimal.
Anat Cohen: So PDR-IG is expressed on the T-cells within the tumor microenvironment. And by the way, on the most exhausted CD8 plus cells, it is expressed together with TG10 and PD1. I'm not sure that I have the answer with respect to external stimuli at this moment.
So PDR AG is expressed on that he says.
Within the tumor microenvironment and by the way at the most exhausted the C. D. H class says cities expressed together would kick in and PD one [noise].
I'm not sure that I have the answer with respect to external stimuli I hand, a deep moment.
Oh, no was that before I get wouldn't talk.
Operator: No worries. Thank you for your time. Thank you.
Thank you.
This concludes our question answer session I will now from the call back to copy just president and CEO Dr. Cohen thing I'd like to make her concluding statement.
Anat Cohen: This concludes our question and answer session. I will now turn the call back to Compugen's president and CEO. Dr. Cohen-Diag, would you like to make your concluding statement?
Yes. Thank you.
Anat Cohen: Yes, thank you. Our 2020 is off to a strong start. Our ongoing COM701 phase one study is progressing well. We recently disclosed encouraging data from both the monotherapy and the combination dose escalation arms, and we are gearing up to initiate the next phase of the trial, the monotherapy expansion cohorts, during this quarter. We're also on track to begin, in the second half of 2020, the triple combination study for COM701 with BMS Obdivo and an investigational anti-TGT inhibitor, which will allow us to directly test our hypothesis on the DINAM-X. With a stronger balance sheet, we're well-positioned to continue executing on this expanded clinical development plan, invest in our early-stage programs to drive our future therapeutic pipeline, and maintain this positive momentum Thank you all for joining us today. We look forward to updating you on our progress through the year.
I were 2020 is off to a strong star.
Our ongoing Comseven hundred one phase one study is progressing well.
We recently disclosed encouraging data from both the monotherapy and it can be nation dose escalation arms and we're gearing up to initiate the next phase of the trial the monotherapy expansion cohorts during this quarter.
Well also on track to begin into second half its 2020 that treat the combination study for comps it in a one would be in essence evil and investigational anti teaching he'd be tour, which will allow us to directly test our hypotheses on that you know axes [noise].
With a stronger balance sheet, well went position to continue executing on these expanded clinical development plan investing our early stage programs to drive future therapeutic pipeline and maintain these positive momentum.
Thank you all for joining US today, we look forward to updating you on our progress through the year.
Operator: Stay safe and healthy. Thank you. Thank you. This concludes.
Hey, safe and healthy.
Thank you.
Thank you. This concludes the completion Ltd first quarter 2020 financial results Conference call. Thank you for your participation you May go ahead disconnect.
Operator: LPD First Quarter 2020 Financial Results Conference Call. Thank you for your participation. You may go ahead and disconnect.
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