Q1 2021 Compugen Ltd Earnings Call
EBIT.
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Operator: Ladies and gentlemen, thank you for standing by. The conference will begin shortly.
Ladies and gentlemen, thank you for standing by the conference will begin shortly.
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Unknown Executive: Thank you. Thank you. Thank you. Thank you. Thank you. Ladies and gentlemen, thank you for joining us today. Welcome to Compugent's first quarter 2021 results conference. At this time, all participants are in a listen-only mode.
Operator: An audio webcast of this call is available in the investor section of Compugen's website at www.cgEN.com. As a reminder, today's call is being recorded. Us from Compugin, or Dr. Anak, Cohen-Diag, Ari Kraschen, CFO and C-O-O, and Dr. Henry Adawoy, chief medical officer, who will be available for questions at the end of the call. 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 or 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, financial and accounting-related matters, as well as statements regarding our cash position.
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Ladies and gentlemen, thank you for joining us today.
Welcome to computer <unk> first quarter, 2021 result conference call.
At this time all participants are in a listen only mode on.
G. A webcast of this call is available in the investors section of computers website at Www Dot T. G N Dot com as a reminder, today's call is being recorded with us.
Some confusion or doctor on not calling day AGA Ari.
Ari crashing CFO and C O L and Dr. Henry <unk>, Chief Medical Officer, who will be available for questions at the end of the call.
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 or 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 financial and accounting related matters as well statements regarding.
Operator: We wish to caution you that such statements reflect only the company's current expectations and that actual events or results may produce differing materials. 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 20F filed on February 25, 2021. The company undertakes no obligation to update projections or forward-looking statements in the future.
Our cash position, we wish to caution you that such statements reflect on me on the company's current expectations and that actual events or results may differ materially.
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 25 2021.
The company undertakes no obligation to update projections or forward looking statements in the future I would now turn over the call to announce on that.
Anat Cohen: I would now turn over the call to anat, anath. Thank you, operator. Good morning and good afternoon, everyone, and welcome to our first quarter, 2021, corporate and financial update. We have started 2021 from a strong position building on our timely execution of our 2020 guidance and plan. We believe 2021 is going to be an important year for CompiGEN as we continue our efforts to build a robust clinical pipeline with multiple clinical studies while further deepening the scientific foundation for our differentiated programs.
Thank you operator, good morning, and good afternoon, everyone.
And welcome to our first quarter 'twenty, 'twenty, one corporate and financial update.
We have started 2021 from a strong position building on a timely execution for 'twenty 'twenty guidance on plant will.
We believe 2021 is supposed to be an important year for computing as we continue our efforts to build a robust clinical pipeline with multiple clinical studies was further deepened the scientific foundation for our differentiated programs.
We have developed a comprehensive clinical development program designed.
Anat Cohen: We have developed a comprehensive clinical development program designed to systematically elucidate the role of our internally discovered and wholly owned anti-PVRIG and TIGI assets across settings and combination regimens. With study execution, we have made great progress, both clinically and research-wise, in understanding the role of the DinaMaxis members, PVRIG and TIGIT, as potentially foundational immunotherapy checkpoint targets. Our work has identified PGRIG and TIGIT as key parallel and complementary inhibitory pathways in the DEM axis, which also intersects with a well-established PD1 pathway.
Designed to systematically elucidated the role of our internally discovered and wholly owned anti P V. Our AG and TG assets at cross checking in combination regiments.
With steady execution, we have made great progress, both clinically and research wise in understanding the role of the Dino Maxis members P. B R E G and teach it as potentially foundational immunotherapy checkpoint targets.
Our work has identified P. G R. A G and T G as key parallel and complementary inhibitory pathways in the DRAM axis.
Which also intersect with a well established PD one pathway.
Anat Cohen: Together, data suggests that these three inhibitory pathways have different dominance in different tumor types and patients, which means that in order to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. With this in mind, we have established a science-driven and data-informed clinical program that evaluates different combinations of these Axis members across indications that we believe will be most relevant in the clinic. On our last call, we shared data from the combination arm of the Phase 1 dose escalation study of Com701 in combination with Bristol-Mel scybs-Nivulimab, as well as follow-up data from our monotherapy dose escalation and cohort expansion study. For the combination arm dose escalation, we provided complete data from all five dose levels in the study.
Together, our data suggest the day three Pat inhibitory pathways have different dominance in different tumor types and patience.
Which means that in order to induce effective antitumor responses doesn't.
Certain patient populations may require the brocade of different combinations of these free pathways.
With this in mind, we have established a science driven and data informed clinical program, which evaluates different combinations of these extra members across indications that we believe will be most relevant in the clinic.
On our last call we shared data from the combination arm of the phase one dose escalation study of concept on the one in combination with Bristol Myers Squibb's, new volume up as well as follow up data from our monotherapy dose escalation and.
<unk> expansion study.
For the combination arm dose escalation.
We provided a complete data from all five dose levels seem to study.
Our encouraging results showed a disease control rate of approximately 67%.
Anat Cohen: Our encouraging results showed a disease control rate of approximately 67%, which is a significant accomplishment given the highly refractory, heavily-pretreated, and advanced disease patient population. Equally important are the observed durable responses in multiple patients and across indications, which include patients with complete and partial responses, with patients on study treatment for almost a year, or in some cases, for more than a year. An additional meaningful highlight from these updated data relates to the patient with a complete response who, prior to being enrolled in our study, had disease progression on a checkpoint inhibitor. This data suggests the dual blockade of PBRIG and PD1 may be key to driving antithrombotic immune responses in certain patient populations.
Which is a significant accomplishment given the highly refractory heavily pre treated and advance disease patient population.
Equally important are the observed durable responses in multiple patient and across indications, which include patients with complete and partial responses with patients on study treatment for almost a year or in some cases for more than a year.
And additional meaningful highlight from these updated data.
It relates to the patient with a complete response, who prior to being enrolled in our study had disease progression on a checkpoint inhibitor.
These data suggest the dual blockade of PD L. A G and PD, one may be key to driving antitumor immune responses.
In certain patient populations.
Anat Cohen: These readouts are particularly significant given our latest announcement of our expanded clinical collaboration with Bristol-Mell Squibb, to initiate a phase 1b dual combination expenses study of Com 7.01 in combination with Nivalimab, which is expected to begin in the second quarter of 2021. This study will enroll patients with ovarian, breast, endometrial, and microsatellite-stable colorectal cancer, and is an important addition to our clinical strategy, expanding the potential reach of this combination regimen, while also providing insight towards the contribution of the different components of the Denham axis across our ongoing and future Com711 studies, and specifically our ongoing triplet study of Com701 with Nivalumab and Bristlemibs, TIGIT Inhibitor.
These results are particularly significant given our latest announcement of our expanded clinical collaboration with Bristol Myers Squibb.
To initiate a phase one b dual combination expenses study of concept on a one in combination with volume up which is expected to begin in the second quarter of 2021.
This study will enroll patients with ovarian.
Breast endometrial and microsatellite stable colorectal cancer.
<unk> is an important addition to our clinical strategy.
Expanding the potential reach of this combination regimen, while also providing insight towards the contribution of the different components of the Dana on axis.
Our ongoing and future comps on a one studies.
And specifically our ongoing triplet study of <unk> 701, with any volume up and Bristol Myers Squibb's TGT inhibitor.
Anat Cohen: We also shared initial data from our Com 701 monotherapy cohort expansion, a safety and tolerability study with a biomarker-informed strategy to select two more types of cancer most likely to respond to treatment based on pre-clinical expression data and clinical results from the dose escalation arm. These indications are endometrial, breast, ovarian, colorectal, and non-small cell lung cancer. Enrollment of 20 patients in the study was completed in the fourth quarter of 2022.
We shared initial data from our comps on a one monotherapy cohort expansion.
Safety and Tolerability study with a biomarker informed strategy to select tumor types, most likely to respond to treatment.
Based on preclinical expression data and clinical results from the dose escalation arm.
These indications are endometrial.
Rest ovarian colorectal and non small cell lung cancer.
Enrollment of 20 patients in the study was completed in the first quarter of 'twenty 'twenty two.
As of the data cutoff date, we presented last quarter six out of 20 patients had the best response of stable disease.
Anat Cohen: As of the data cutoff date we presented last quarter, six out of 20 patients had the best response of stable disease across endometrial, non-smone cellang, and ovarian cancer, and two patients with durable antitumor activity continuing on treatment. These data, combined with our Com 71 dose escalation data, provide signals of antitumor activity in a monotherapy setting in two more types of cancer, typically unresponsive to immune In addition, some of these single agent signals are durable, including a patient with a confirmed partial response from the dose escalation study on treatment for over one year as of the data cutoff date presented last quarter.
Ross endometrial non small cell lung and ovarian cancer.
And two patients with durable antitumor activity continuing on treatment.
These data combined with our come sit on a one dose escalation data provides signals of antitumor activity in a monotherapy setting.
In tumor types, typically unresponsive to immune checkpoint inhibitors.
In addition.
Some of these single agent Sigma us are durable, including a patient with a confirmed partial response from the dose escalation study.
On treatment for over one year as of the data cutoff date presented last quarter.
Anat Cohen: It should be noted that these were highly refractory patients who exhausted all treatment options with tumor types that are typically non-responsive to checkpoint inhibitors, including patients with prior progression on these treatments, which together suggest that PVRIG blockade may be an important, untapped checkpoint that has the potential to drive an antitumor immune response.
It should be noted that these were highly refractory patients who have exhausted all treatment options with.
With tumor types, there are typically nonresponsive to checkpoint inhibitors, including patients with prep progression on these treatments, which together suggest that P. P. R. I G blow Kid, maybe an important untapped checkpoint that has the potential.
Of driving antitumor immune responses.
Anat Cohen: The clinical data across the combination in monotherapy arms leaves us increasingly confident in our prediction that there are certain patient populations which are likely to respond to PVRIG blockers and or PVRIG and PD1 dual blockade, including those that have progressed on immune checkpoint block. Another angle to evaluate the activity of Com701 is the data analysis in progress from the Com-701 Monotherapy cohort expansion study that will include correlative assessments based on data from patient samples, including cytokines, immune phenotyping, and immunohistochemistry analysis.
The clinical data across the combination and monotherapy arms leaves us increasingly confident in our prediction that there are certain patient populations, which are likely to respond to P. B R. E G blockers and or P. D. R. I G and PG one dual blockade.
Good.
Including does that have progressed on immune checkpoint blockers.
Another angle to evaluate the activity of constant on a one is the data analysis in progress.
From the come sit on a one monotherapy cohort expansion study.
That will include correlative assessments based on data from patient samples, including cytokine immune Phenotyping and immunohistochemistry analysis.
This data that will also be gathered from our dual and triple combination studies.
Anat Cohen: This data, which will also be gathered from our dual and triple combination studies, will enable us to gain insights relating to Com701 and PVRIG PVRL2 pathway biology, particularly in indications that are typically not responsive to PD1 blockade. Our initial assessments of patient's peripheral blood samples suggest that Com701 may enhance immune activation in cancer patients alone or in combination with Nivulum. These results provide, for the first time, an indication of the potential effect of PVRID blockade in peripheral blood of cancer patients treated with Com 701.
Will enable us to gain insights relating to come sit on a one and T V or a G. P V already two pathway biology.
Particularly in indications that are typically not responsive to PD one blockade.
Our initial assessment of patients' peripheral blood centers suggested comps on a one mean, hence immune activation in cancer patients alone or in combination with the volume up.
These results provide for the first time.
An indication for the potential effect of T V or a jeep located in peripheral blood of cancer patients treated with Com 701.
We're excited to be providing updated data from the comfort on the one monotherapy and combination with volume up studies, you know upcoming oral presentation at <unk> on June 7th 2021.
Anat Cohen: We are excited to be providing updated data from the Com-701 monotherapy and combination with Nivalumab studies in our upcoming oral presentation at ASCO on June 7, 2021, and look forward to sharing the data following our oral presentation. We continue to invest in our clinical program and have expanded our clinical strategy to include multiple clinical studies in order to maintain our leadership position in the evaluation of the DENAM axis pathway. Moving forward in 2021, we expect to continue to execute across our broad clinical strategy, which includes the ongoing triplet study of Com 701 with Nivalimab and Bristol-Mare Squib's TIGI inhibitor and the initiation of the Doublet Expansion Study of Com 701 with Nivalumab in the second quarter of 2021.
And look forward to sharing the data following our oral presentation.
We continue to invest in our clinical programs.
And have expanded our clinical strategy to include multiple clinical studies in order to maintain our leadership position in the evaluation of the Dana access pathway.
Moving forward in 2020, one we expect to continue to execute across our broad clinical strategy, which includes.
The ongoing triplet study of Com 701, with the volume up and Bristol Myers Squibb's teaching Hebei tour.
The initiation of the doublet expansion study.
<unk> 701, with the volume up in the second quarter of 2021.
Anat Cohen: The ongoing dose escalation of Com 902, our wholly owned TIGI inhibitor. Following the completion of Com902 dose escalation, and the initiation of the Doublet Study of Com701 and Com902 in the second half of this year. With these studies in place, we are positioned to rapidly generate multiple data readouts that will be key for our development of Denham Axis-based new cancer immunotherapy. Our Phase 1-2, triple combination study, evaluating the safety, tolerability, and preliminary antitumor activity of Com 701, in combination with Bristol-Mess quibs, TIG antibody, and Nivolumab, is currently enrolling patients, and we expect to share initial data from the dose escalation portion of the study in the fourth quarter of this year.
The ongoing dose escalation of come nano to our wholly owned T. G T and he'd be tour.
And.
Following the completion of the call nine O two dose escalation the initiation of the doublet study.
Seven O one income nine O two in the second half of this year.
We do studies in place we are positioned to rapidly generate multiple data readouts that will be key for our development of DRAM axis based new cancer Immunotherapies.
Our phase one two triple combination study.
<unk>, the safety Tolerability and preliminary antitumor activity of comps and no one in combination with Bristol Myers Squibb's T. G antibody and the volume on is currently enrolling patients and we expect to share initial data from the dose escalation.
One of the study in the first quarter of this year.
Anat Cohen: The purpose of this study is to allow the testing of our triple blockade hypothesis, that blocking the three intersecting PVRIG, TIG, and PD1 pathways has the potential to synergistically enhance antitumor immune responses in selected patient populations not responsive or refractory to PD1 blockade.
The purpose of this study is to allow the testing of our triple blockade hypotheses.
That's blocking the free intersecting P V R. I G T J and PD one pathway.
Has the potential to synergistically enhance antitumor immune responses in selected patient populations, not responsive or refractory to PD one blockers.
Anat Cohen: Another ongoing trial, the Com902 monotherapy dose escalation study, is an important component of Comptuance's overall strategy. We have seen the growing interest in TIGI inhibitors, which now include multiple clinical stage programs, and we're closely following the developments in this space. We firmly believe it is important to pursue the development of our own candidate to maintain our control of what we believe are two key arms of the Dinum axis and our ability to independently evaluate multiple combination approaches, which includes TIGIT in the clinic.
Another ongoing trial the come nine O. Two monotherapy dose escalation study is an important component of competence overall strategy.
We have seen the growing interest in T. G. T inhibitors, which now include multiple clinical stage programs and we're closely following the development in this space.
We firmly believe it is important to pursue the development of our own candidate to maintain our control of what we believe are two key arms of the Dean on axis.
And our ability to independently evaluate multiple combination approaches which includes T. J in the clinic.
Advancing comedy I know too through dose escalation and future combination studies is important for our position in the PV Air a G T G space.
Anat Cohen: Advancing Com902 through dose escalation and future combination studies is important for our position in the PVRIG TIG space. We expect to provide initial data from the Com-902 dose escalation study in the fourth quarter of this year and are on track to begin studies evaluating Com701 in combination with Com-902 in the second half of this year. The preclinical data we published in Cancer Immunology Immunotherapy strengthens our confidence in our clinical approach providing important information on the underlying biology of Tidit and its potential synergies with other immune checkpoints, which we can leverage in our clinical strategy.
We expect to provide initial data from the come nine O. Two dose escalation study in the fourth quarter of this year and are on track to begin studies evaluating constant on a one in combination would come in I know too.
In the second half of this year the preclinical data, we published in cancer Immunology immunotherapy.
Strengthen our confidence in our clinical approach.
<unk> important information on the underlying biology of TG and its potential synergies with other immune checkpoint, which we can leverage in our clinical strategy.
These data together with our internal PD L. A G research.
Anat Cohen: This data, together with our internal PVRIG research, allows us to focus and refine the indications we will pursue in the clinic to potentially maximize the probability of our combination strategy of Com 7-1 and Com-912. In addition, our research further demonstrates the absence of T-cell depletion activity in vitro and in vivo with Com-902 and therefore reinforces our Com-902 approach, which was designed to have reduced FC receptor engagement to avoid potential depletion of T-GITG expressing effector T cells.
It allows us to focus and refine the indications we would pursue in the clinic to potentially maximize the probability of success of our combination strategy of constant on a one income 902.
In addition, our research further demonstrates the absence of T cell depletion activity in vitro and in vivo, we'd come nine O to.
And therefore reinforces our common I know to approach, which was designed to have reduced F series scepter engagement to avoid potential depletion of T. G expressing effector T cells.
Anat Cohen: As you can see from our various scientific publications, we continue to invest in high-quality in-house research that feeds our clinical pipeline strategy in order to keep it differentiated and competitive. Our progress, from target discovery, validation, and pre-clinical development, now through to a comprehensive clinical program, has been remarkable. Our discovery of the previously unknown PVRIG pathway uncovered this immunoncology pathway, and our research and clinical work have supported our position as leaders in the Denham Axis space, which has been highlighted by our status as the only company with wholly owned clinical stage assets targeting both PVRG and TG.
As you can see from our various scientific publications, we continue to invest in high quality in house research that feed our clinical pipeline strategy.
In order to keep it differentiated and competitive.
Our progress from target discovery validation and preclinical development now through to a comprehensive clinical program has been remarkable.
Our discovery of the previously unknown P. J R. I G pathway.
Uncovered these immuno oncology pathway and our research and clinical work.
Have supported our position as leaders in the DRAM ex C space, which has been highlighted by our status as the only company with wholly owned clinical stage assets.
Getting both PV error E N T J.
Anat Cohen: And thus, the only company currently capable of evaluating in the clinic PVRIG monotherapy, dual blockade of PVRIG with PD1 or TIG, and triple blockade of PVRIG with PD1 and TIG. We're highly enthusiastic about what's to come later in the year. Most importantly, initial data from our dose escalation triple combination study. Our Phase 1-2 triple combination study, designed as a study in ovarian and endometrial cancers and additional tumor types with high PVRL2 expression is the ultimate test of our hypothesis and a true differentiator in the crowded immunoncology space.
And thus the only company currently capable of evaluating in the clinic P. B R E G monotherapy.
Dual blockade of PD argue with PD, one or ticket and triple blockade of P. Very G with PD, one and T J, where.
We're highly enthusiastic about what's to come later in the year. Most importantly initial data from our dose escalation Triple combination study.
Our phase one two triple combination study designed as a study in ovarian and endometrial cancers.
In additional tumor types with high P V already two expression is the ultimate test of our hypothesis.
And a true differentiator in the crowded immuno oncology space beyond these exciting clinical progress. We're also continually driving forward our size.
Anat Cohen: Beyond this exciting clinical progress, we're also continually driving forward our science, which has been the foundation that underlies our clinical progress. Our recent publications in cancer immunology, immunotherapy, and cancer discovery are testament to our scientific rigor and broader contributions to the fundamental biology of the Dynum Act. We will continue our efforts to drive science forward, building upon our deep scientific heritage that we believe plays an integral role in our potential success.
Which has been the foundation that underlies our clinical progress our recent publications in cancer immunology immunotherapy and cancer discovery on.
Testament to our scientific rigor.
And broader contributions to the fundamental biology of the Dean on axis.
We will continue our efforts to drive the science forward building upon our deep scientific heritage that we believe plays an integral role in our potential success.
Anat Cohen: A key factor in driving our science forward involves the advancement of our early stage pipeline with multiple programs targeting the immunosuppressive tumor microenvironment, including targeting the maloid population, which we believe will fuel long-term growth and opportunity for competent. The expansion of our fruitful research collaboration with John Hopkins University to include focused research on a competently discovered novel maloid target reinforces our ability to further discover completely new drug targets and our continued focused research and development at the early stage.
A key factor in driving our science forward involves the advancement of our early stage pipeline with multiple programs targeting the immuno suppressive tumor microenvironment, including targeting the myeloid population, which we believe will fuel long term.
Growth and opportunity for competition the expansion of our Fort fruitful research collaboration with John Hopkins University to include focused research on a competent discovered novel myeloid target reinforces our ability to further discover completely new drug targets and.
Our continued focused research and development on early stage programs.
Anat Cohen: programs along our clinical development execution. We're proud to continue this long-standing collaboration, addressing our multiple drug candidates with Dr. Drupadol, who played an important role in the pre-clinical development of Com 7-1, and look forward to collaborating with his incredible team to advance a novel immune oncology agent that has the potential to target tumor-associated macrophages in the tumor microenvironment. We're excited by this novel Malloy target, and although this is very early days, we hope that through rigorous and deep research we will build a strong foundation that can ultimately translate this very early stage program into a first-in-class clinical candidate.
Along our clinical development execution.
We're proud to continue this long standing collaboration addressing our multiple drug candidates with Brookfield Drupal doll, who played an important role in the preclinical development of <unk> 701.
And look forward to collaborating with these incredible team to advance a novel immuno oncology agent that has the potential to target tumor associated macrophages in the tumor microenvironment.
We're excited by this novel myeloid target and although this is very early days, we hope that through rigorous and deep research. We will build a strong foundation that can ultimately translate this very early stage program to a first in class clinical candidate.
And while our progress in the clinic has been a major focus we've been in pilot advancing programs like this one.
Anat Cohen: And while our progress in the clinic has been a major focus, we have been in parallel advancing programs like this one, along with additional later stage programs, to continue our science-driven approach to discover and develop novel immune oncology tags. We will continue to push the science forward and look forward to maturing these programs to a stage where we will be able to disclose more information in terms of targets and our future strategic path.
Along with additional later stage programs to continue our science driven approach to discover and develop novel immuno oncology targets. We will continue to push the science forward and look forward to maturing these programs to a stage, where we will be able to disclose more information.
And in terms of target and our future strategic path investing in our early stage programs and pipeline growth engine remains high priority for competition and we believe in the potential of our platform to uncover additional untapped novel.
Anat Cohen: Investing in our early stage programs and pipeline growth engine remains a high priority for Compugent, and we believe in the potential of our platform to uncover additional, untapped, novel immunoncology targets, just as we did with Dynum X.
Immuno oncology targets.
Just as we did with the DRAM axis.
Anat Cohen: Finally, before turning the call over to Ari, I would like to thank the team at CompuGEN, our partners, investigators, shareholders, and patients. The dedication and contributions across these groups are what have enabled us to continue our on-track execution and progress, despite the still ongoing COVID-19 pandemic. We're proud to have our prior guidance for enrollment and data across our studies unchanged.
Finally, before turning the call over to Ari.
We'd like to thank the team at the computation.
We're partners investigators shareholders and patients the dedication and contributions across these groups are what have enabled us to continue our on track execution and progress.
Fight the still ongoing COVID-19 pandemic.
We're proud to have our prior guidance for enrollment and data across our studies unchanged.
Anat Cohen: And with that, I will turn the call over to Ari to review our finances. Thank you, Anato. Good morning and good afternoon to everyone.
And with that I will turn the call over to Ari to review our financials. Thank you are not good.
Good morning, and good afternoon to everyone.
Ari Kraschen: Our financial results for the first quarter of 2021, released this morning, continue to reflect a solid financial position with, as expected, increased research and development expenses due to a growing number of clinical trials. Research and development expenses for the first quarter of 2021 were $7.3 million, compared with $4.7 million for the same period in 2020. This increase is attributed mostly to CMC-related activities, specifically manufacturing costs for additional drug supply of Com 7-1 to support the planned expansion of our various clinical trials, as well as an expanded clinical team located in the U.S., which brings additional expertise to the company to ensure the successful management and execution of our ongoing and soon-to-be initiated clinical trials.
Our financial results for the first quarter of 'twenty or 'twenty, one released this morning.
To reflect our solid financial position with as expected increased research and development expenses.
To a growing number of clinical chores.
Research and development expenses for the first quarter of 2021 were $7 $3 million compared with $4 7 million for the same period from 'twenty to 'twenty. This increase is attributed mostly to CMC related activities, specifically, many structuring costs for additional drug supply of <unk>.
And the one to support the planned expansion of our various clinical trials.
Well as extended clinical team located in the U S, which brings additional expertise to the company to ensure the successful management and execution of our ongoing and soon to be initiated clinical trials.
Ari Kraschen: As a reminder, our clinical expenses reflect costs associated with our expanded clinical programs, which will now include Com 7-01 in monotherapy, dual, and triple combination studies, as well as a dose-escalation study for Com-902. Net loss for the first quarter of 2021 was $9.9 million or 12 cents per basic and diluted chair compared with a net loss of $7.1 million or 10 cents per basic and diluted chair for the same period in
A reminder, our clinical expenses reflects costs associated with our expanded clinical programs, which will now include closer than the one in monotherapy dual and triple combination studies as well as dose escalation study for Ko 902.
Net loss for the first quarter of 2021 was $9 $9 million or 12 cents per basic and diluted share compared with a net loss of $7.1 million or 10 cents per basic and diluted share for the same period in 2020.
Operator: As of March 31st, 2021, we had approximately $19 million in cash and cash-related accounts, compared with approximately $124 million as of December 31, 2020. The company has no doubt The decrease in our cash balances of approximately $5 million net during the first quarter represents approximately $9 million of gross cash expenditures offset by a collection of $2 million from AstraZeneca related to revenues recognized in the fourth quarter of last year and $2 million of working capital.
As of March 31st 2021, we had approximately $119 million in cash and cash related accounts compared with approximately $124 million as of December 31st 2020.
The company has no debt.
The decrease in our cash balances of.
Approximately $5 million net during the first quarter represent approximately $9 million of growth cash expenditures offset by collection of $2 million from Astrazeneca related to the revenue is recognized in the fourth quarter of last year and $2 million of working capital.
Operator: As a reminder, we expect our gross cash expenditures for 2021 to be in the range between 40 to 42 million dollars without taking into consideration any potential cash inflows for the company from existing and new collaborations. Thank you, and with that, we will now open the call for questions. Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. 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.
As a reminder, we expect our gross cash expenditures for 2021 to be in the range between $40 million to $42 million without taking into consideration any potential cash inflows for the company from existing or new.
The new collaborations.
Thank you.
And with that we will now open the call for questions.
Thank you.
Ladies and gentlemen at this time, we will begin the question and answer session. If you have a question. Please press star one if you wish to decline from the polling process. Please press star two if you are using speaker equipment can be lift the headset before pressing the numbers.
Mark Alan Breidenbach: Please stand by while we poll for your questions; the first question is from Mark Brydenbach of Oppenheimer. Please go ahead. Hey, guys, congrats on all the progress, and I hope everyone is staying safe on your end. Just a couple from me.
Please stand by while we poll for your questions.
The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.
Hey, guys. Congrats on all the progress and I hope everyone is staying safe on your.
Just a couple from me.
Anat Cohen: First of all, should we be expecting any additional patients from either the monotherapy or Novolume Accommodation cohorts to be included in the analysis presented at ASCO versus what we saw in February, or will it really just be the same set with more follow-up time? And you mentioned that there might be some correlative data presented at ASCO as well. I'm wondering if you were able to track any specific markers of DEM1 activation, or will these correlates data really be more generalized indicators of immune activation and response?
First of all should we be expecting any additional patients either the mono therapy or no volume on combination cohorts to be included in the analysis presented at Ash, though versus.
This is what we saw in February or will it will really just didn't seem to state with more.
Follow up time and and.
You mentioned that there might be some from correlates data presented at our school as well I'm wondering if you were able to track.
Specific markers of activation.
Activation or will these coralloid.
Will it be more generalized indicators of immune activation on response.
Okay.
Anat Cohen: So I will take the correlative assessments and let Henry relate to the clinical data on the correlative assessments. As we stated in our last quarterly call, we were able to track with very initial data, obviously, immune activation seen by Com 71 treatment as monotherapy and also in combination with Nivalumab. So this data will be presented with respect to the DEM axis.
So I would take that the correlative assessments and I'll, let Henry relate to <expletive> to the clinical and on the correlative assessments and as we stated in our last quarterly call.
And we were able to track with very initial eh data, obviously and immune activation seen by comes to the one treatment as a monotherapy and also in combination with the volume up so and these data will be presented with respect to DRAM axis at dish.
This is really an analysis in progress and.
Henry Adewoye: This is really analysis in progress, and if we'll show some data, it will be very, very initial. We will present the data as we have it ready, probably in addition. Henry?
And if really show some day rates would be very very initial we will present the data as we would have at <unk>.
Ready M probably in additional land later conference.
Henry.
Henry Adewoye: Thank you. So, Mark, what we previously disclosed in February was a snapshot of the data. At ASCO, we'll present updated data, including all the patients who have been enrolled on the dose escalation arms of the study. So monotherapy, dose escalation, the combination dose escalation, including follow-up, will also disclose data on the patients who have been enrolled on the monotherapy, attention cohort, including follow-up on those patients' house, and particularly we will disclose data on long-term patients who have been on the study, and especially the ones that we've highlighted in the prior disclosure we had in, So it will be a summary of all the data that's been previously disclosed and new data, specifically new data in the last dose cohort.
Thank you so mark what we previously disclosed in February was a snapshot snapshot of the data.
Our school will present updated data.
Including all the patients who are enrolled on the dose escalation arms of the study so monotherapy dose escalation combination dose escalation, including follow on.
We'll also disclose data on the patients who've been enrolled on the monotherapy expansion cohorts, including follow up on those patients also.
Particularly we will disclose data on long term.
<unk>, who had been on the study.
Especially the ones that we've highlighted in the prior disclosure we had in February.
So it will be summary of all the day that as previously disclosed on new data, specifically and you do that.
The last dose cohorts of come seven day, one in combination with volume up.
Henry Adewoye: Com701 in combination with Nibolomab, both at doses of 20 milligrams per kilogram body weight and for 80 milligrams IV. So there will be a lot more safety data. All right, that's super helpful. Thanks for that.
Moving to producers of 20 milligrams per kilogram body, we dose and 43 milligrams IV Q4 weeks, so there'll be a lot more of the 60 day that day.
Cohorts.
Alright, that's super helpful. Thanks for that.
Mark Alan Breidenbach: And just also wondering if you were able to collect any post-mortem biopsies from patients in the phase one study who were on the drug at the time of death, just to be able to look for any evidence of target engagement and also do a little bit of PVRL2 expression profile in any of the phase one patients. Thanks for taking the question. Yes, as Annette mentioned in our script, there will be correlative data presented, and I'll give an opportunity to Annat to further expand the sheets.
Just also wondering if you were able to collect any postmortem biopsies from patients in phase one studies, who were on drug at the time of day.
Look for any evidence of target engagement.
And also do a little bit of a P. D. R O two expression profile.
The phase one patients thanks for taking the questions.
Yes.
As mentioned in our script.
There will be Corelogic data presented on the.
Given opportunity trend that you are further expansion on your question.
Yeah, I, we were collecting on the monotherapy expansion, we're collecting GAAP pre and on treatment I am not sure with respect to postmortem I guess, you'll need to wait for the I I'm I'm not sure that we have pushed more of them.
Mark Alan Breidenbach: Yeah, we were collecting on the monotherapy expansion; we're collecting pre and post-treatment. I am not sure with respect to post-mortem. I guess you'll need to wait for this. I'm not sure that we have post-mortem for a specific patient. Okay, fair enough.
For specific patients.
Okay fair enough alright, thanks, so much for taking the questions on and were looking for it to be asked her presentation.
Mark Alan Breidenbach: All right. Thanks so much for taking the questions, and we're looking forward to the ASCO presentation. Thank you, Mark.
Thank you Mark.
Okay.
The next question is from Stefan Willey of Stifel. Please go ahead.
Stephen Douglas Willey: The next question is from Stefan Wili of Staisel. Please go ahead. Yeah, good morning.
Yeah. Good morning, Thanks for taking the questions maybe.
Anat Cohen: Thanks for taking the questions. Maybe just to follow up on the last question. Can you maybe just kind of ballpark with respect to, I guess, how much pre and on tumor biopsy data from patients we might see at ASCO. I know you talked about some of the peripheral blood markers of immune activation, but I think there's been some increased interest in the changes in CD8 T cell fraction that are in the tumor, you know, both pre and post treatment.
Maybe just to follow up on the last question.
Can you, maybe just kind of ballpark with respect to I guess how much.
Pre and on treatment.
Tumor biopsy data from from patients we might see at <unk>.
I know you talked about some of the peripheral blood markers of immune activation.
I think there's been some increased interest in the.
The change is C D.
Fraction that are in the tumor growth.
Post treatment. So just wondering if that's an assessment that we might see at ESMO.
Anat Cohen: So just wondering if that's an assessment that we might see after. As you correctly stated, we did speak about the blood markers, and with respect to liquid biopsies, we obviously have from the dose escalation as well as from the expansion. So here we have a little bit more; the number is a little bit higher. For the tumor biopies, as you remember, we had 20 patients in the monotherapy expansion. Obviously, we couldn't get biopsy from all of them as paired pre and post treatment.
And so as you correctly stated we did speak about to the blood markers and and with respect to two liquid biopsies, we obviously have from.
From the dose escalation as well as from the expansion. So here, we have a little bit more the numbers it is a little bit higher.
On the and on the tumor biopsies and as you remember we had 20 patients in the monotherapy expansion on.
Obviously, we couldn't get biopsies from all of them is pared it pre and on treatment. So it's a it's only a portion of this end of this as a group and taking into consideration that Ann.
Anat Cohen: So it's only a portion of this group and taking into consideration that in some of them, obviously, we didn't see a response. So I think that the data will be limited. It's initial.
And that are in some of them. Obviously, we didn't see response, so I think that the data will be a limited it's in Asia.
Anat Cohen: The data that we have is, is pointing to some preliminary, as we stated, preliminary activation upon Com 71 treatment. What we're going to present will probably not be all the immunohistochemistry data because this is in progress. We will present some of the data that we have. So just to address your question, it will be limited at this point in time, but we will make sure that we present all the data when we have it, probably at a later conference. Okay, that's actually quite helpful.
The data that we have is and is pointing to some preliminary as we stated preliminary and activation of pone comes to have them on treatment.
What we're going to present, it would probably not be all day immunohistochemistry data because this is in progress we will present some of the data that are that we have so just to address your question. It will be limited at this point in time, but we will make sure that we present on.
All the data when we have it probably in a later conference.
Okay, that's actually.
Quite helpful and then.
Anat Cohen: And then Maybe just to throw a question at you that we're getting a lot, I know that there's a competitive trial readout, I think coming maybe later this quarter, one of the backbone agents in that regimen that's being evaluated as an FC silent digit. So just kind of wondering what you're maybe expecting to see out of that and how you think that data might extrapolate out to what you're pursuing with 902.
Maybe just to throw a question as you said.
We're getting a lot I know that day.
There is competitive.
Trial readout I think something maybe later this quarter.
One of the backbone agents on that.
Regimen, that's being evaluated.
She silent.
So just kind of wondering you know what you're maybe expecting to see out of that and I guess you know.
How do you think that extra.
Extrapolate out to work.
We're pursuing.
No two right now.
Yeah.
Anat Cohen: Yeah, it's a fair question that, you know, that will be the first data that is derived from an FC inactive TIG inhibitor as opposed to the rest of the data that is out there. So obviously, we're looking as well to see what the data will tell us. I guess that you are well familiar, not only in the U.S. but also in the community, with our view.
Yeah. It's a fair question that you know that it would be the first.
Data that is derived from N F C. In active teacher inhibitor as opposed to the rest of the data that is out there. So obviously, we're looking as well to see what the data will tell us I guess that U S are well familiar and not on the used day.
It also then the community with our view about the and the need or and or actually the no need for from our perspective is we see based on our data on having an F C active.
Anat Cohen: about the need or actually the no need, from our perspective, as we see it based on our data, on having an FC active. We hope this will support this view that we have this view that we have, which is based on data. We recently published a paper on Com902, a paper on Com902, which is further. There's been traveling what we're saying for quite some time.
And we hope this will the they fully support today and this view that we have which is based on which is based on data were recently published their come nano to a paper on income they know too.
Which is further strengthening what are where we're saying for quite some time.
And we have our own come nano to clean.
Anat Cohen: We have our own Com902 clinical study, and this is now in dose escalation. We promise to show data in Q4. So obviously, our data will be outside as well. So we're looking to see what the data will tell us from the other company, but we're also looking very carefully at our data as well. And we still didn't find in the public domain a reason to be concerned with our view with respect to FC inactive performance in clinical studies.
Clinical study. This is now in dose escalation, we promise to show data in Q4, So obviously, our data will be outside as well and so what we're looking to see what the data will tell us and from the other company, but also where they are.
Looking very carefully at our data as well and we still didn't find a and in the public domain a reason to be.
Concerned with our view with respect to F C in active and performance from clinical studies, So we'll see.
Stephen Douglas Willey: So we'll see. All right, I appreciate the answer, and congratulations on the progress. Thank you. The next question is from Dana Graebosch of SVB Lerink.
Alright, I appreciate the answer.
Congrats on the brothers.
Thank you.
The next question is from day, Dana Gray Bosch of S. V. B Leerink. Please go ahead.
Daina Michelle Graybosch: Please go ahead. Hi, thank you for the question. A couple of things on the science side, I think we're seeing more companies talk about targeting tactile or CD96, sort of the other member that you don't have a program against and sort of DENM access. And I wonder if the first question, and then I'll have a follow-up, but the first is, what do you think about CD-96 and its role in DNA signaling and whether you may need to target it in some patients or Yeah, it's a good question.
Alright. Thank you for the question a couple on the science side I think we're seeing more companies talk about targeting tactile or C. D 96.
The the other member that you don't have a program against instead of the day them ex us and I Wonder if the first question on on all of our follow up but the first is what do you think about <unk> 96, and its role in seeing them signaling and whether you may need to targeted in some patients or tumors as well.
Yeah. It's a good question and city 96 actually is that is a binding P V. R. B.
Anat Cohen: 3906 actually is a binding PVR, but it binds PVR with a lower affinity than TIG. So we think that the, you know, the contribution is not really clear. Definitely, PVR IG is addressing a completely different node, which is PVR, PVRL2. We believe that PVRIG and TIGPVR are the two pathways that need to be blocked in order to generate their full anti-tumor activity.
But he binds P V on with the lower affinity than than ticket.
So we think that today you know the contribution is.
And it's not really clear definitely P. V. R. I G is addressing a completely different node, which is PV air I G. P. V. R. L. Two we believe that the P V. R. I G M <unk>.
P. J R O two and T. G. P V. R. M odd two pathways that needed to be blocked in order to generate a meaningful.
Antitumor activity.
Anat Cohen: I'll say that whether CD96 is a positive cost-imulatory or a negative cost stimulator is also a question, at least in our hands and needs some papers outside. So we'll see, we'll wait and see. But it doesn't change our hypothesis.
I'll say that channel also there and where the city 96 is a positive costumer rytary on negative costumer. Tory. That's also that's also a question at least day, you know it gifting in our hands and and need some papers outside so we'll see we'll wait and see.
But it doesn't change our hypothesis.
Got it and then a follow up on the question that Steven just asked on the competitor data I Wonder if you could remind us how similar are calm nine O. Two with ARCUS is suggests that's going to have the data and any notable differences are in addition to the similarity that we should consider when looking at that data.
Anat Cohen: Got it. And then a follow-up on the question that Steven just asked about the competitor data. I wonder if you can remind us how similar our Com-902 is to Arcus's digit that's going to have the data. Any notable differences in addition to the similarity that we should consider when looking at that data?
Yeah.
Anat Cohen: So first, our antibody is IG4. I believe there's this IG1 mutated, but still FC inactive. And in general, our antibody is ultra-high affinity. That's an antibody that we've developed from day one to be complementary to Com 701, and we tested it also against other TIGI antibodies. We don't have a reason to believe that epitopes would play a role here, different epitopes like, you know, similarly to PD1. But generally, the difference is the high, ultra-high affinity with respect to our antibody.
Hum.
So first with respect our antibodies atg four I believe theres as I did you one mutated.
But still F C in active and <unk> and in general our antibodies and ultra high affinity antibody and that's an antibody that we've developed from day, one to be complementary with they would come sit on a one.
And we tested it also benchmark to other tissue antibodies. We don't have any reason to believe that to epitopes would play a role here a different epitopes like similarly to two PD one.
But generally the difference is the hires that were from high affinity with respect to our antibody. So we'll see.
Daina Michelle Graybosch: Thank you very much. The next question is from Ren Benjamin of JMP Securities. Please go ahead. Hey, good morning, guys.
Helpful. Thank you very much thank you.
The next question is from Ren Benjamin of JMP Securities. Please go ahead.
Hey, good morning, guys. Thanks for taking the questions.
Ren Benjamin: Thanks for taking the questions. Anette, you mentioned the additional data in the fourth quarter of this year. Can you give us a sense as to how many patients' worth of data we might be seeing for both studies and would it be enough to, you know, make some reasonable conclusions about a path forward? Henry, would you like to address this question?
And that you mentioned.
The additional day of my fourth quarter of this year can you give us a sense as to how many patients worth of data we might be seeing.
Seeing for both studies.
And would it be enough to.
It makes some reasonable conclusions about our path forward.
And Henry would you like to address this question.
Sure.
Henry Adewoye: Sure. So the two, Ren, so the two key projected data that will be anticipated will be for the TG antibody, like that mentioned com 902. So for that, as you know, Rennie, it's a design that has an accelerated portion. So we have a single-serve subject patient cohort, and also we have a three-plus-three. I cannot project for you now the total number of patients that we will expect. But certainly, it will be at least more than four patients I will enroll because we'll go past the single subject. We'll continue to accumulate data on that study So maybe at another presentation, we'll be able to hone in more on the absolute number of patients that were presented. Got it. And then there is the triple comment.
B G.
So the true.
G.
Directed at a low.
The anticipated will be for the antibody like Oh on that.
Mission to come true.
Sure.
So for that as you know already.
It's a design that has.
On accelerated pushing true, so where single share subject patient cohorts.
So we have a three plus three.
I cannot project for you know the total number of patients.
We expect to see.
Well certainly it would be at least one of them for patients.
Because we will pass the single subject dose level cohorts.
We're continuing to accumulate data on that study so maybe that's another presentation would be true.
Holding more on the absolute number of patients that were projected.
Okay.
Got it and then the triple combo.
Yes, so for the Triple combination.
Henry Adewoye: Yes. So for the triple combination, we also have that ongoing. It's a 3 plus 3 study design also. The projection when we started that dose escalation study was to go as high as 20 milligrams per kilogram body weight dose of Com 701 in combination with the other two agents. So the other two agents are BMS 986207, BMS TIGD, and Nivolomab.
We also have ongoing.
The three plus three study design also.
The projection when we started that a dose escalation study used to go as high as 10, two milligrams per kilogram body weight dues are with comes up on the one in combination with the other two agents. So the other two agents almost $96 seven.
The antibody.
And volume up.
Henry Adewoye: We, so far, as we keep going, we're on track. At a later teleconference, we will be able to tell you how many patients we expect. But certainly, the reason we are projecting that we'll get up to 20 milligrams per kilogram body with the dose of Com 7.01 in combination with the other two agencies is because, as you remember, the dose that we've recommended for expansion for Com 701 is 20 milligrams per kilogram body with dose IV.
We so far as you can.
Coupon we're on track I'll see you later.
The teleconference will be able to tell you how many patients with expect.
But certainly the reason we are projecting that we will get up to 20 milligrams per kilogram body would do so.
From 71 in combination with the other day agencies, because as you remember.
The dose that was.
Recommended for expansion.
So on the one is the 20 milligrams per kilogram IV Q4 weeks so.
Henry Adewoye: So as we go along, we'll be able to further refine how many patients will present at that time. And then just, you know, regarding the biomarker data that you'll be closing at ASCO as well as later on in the year. It seems to me that ultimately you are in search of a patient signature or some sort of signature that might, you know, allow you to identify patients that would respond, right, to either 701 or the combination of 71 and 9702.
As we go out loans.
Further refine how many patients that will.
<unk> presents a doctor that's on.
Got it Okay and then just you know regarding the biomarker data that you'll be disclosing at ESCO as well as you know later on in the year.
It seems to me that ultimately.
You probably are in search of a patient signature or some sort of signature that might.
Allow you identified patients.
That would respond to you know August on the water the combination of something on their lives better too.
Am I thinking about that correctly that that ultimately all these analyses will.
Anat Cohen: Am I thinking about that correctly, that ultimately all these analyses will help you to identify, you know, the patients better? Or are you looking at these data more to boost the current, you know, clinical benefit rates that you're seeing in more objective ways? Or do you kind of feel that, you know, SDs right now are pretty good?
It will help you to.
Identify the patients better or.
Are you looking at these data more to goose. The current you know.
Ah clinical benefit rates that youre seeing.
More of objective responses.
Or do you kind of feel that U S vs. Right now are pretty good and if you can get more people you know what.
Anat Cohen: And if you can get more people, you know, with stable diseases, that would be just as good, Actually, both and also for better understanding the mechanism of action of Com 71 treatment. The biomarker strategy is broad enough in order to address tumor biopsy and also information gathered from blood samples. We have the component of the retrospective analysis, and you also know that we have the component of the retrospective analysis of the patient selection basket study in the triplet.
That would be just for.
Okay.
Kelly actually booth and also for better understanding the mechanism of action effect come seven on the treatment.
The biomarker strategy is broad enough in order to address and tumor biopsies and <unk> and also information gathered from blood samples and we have the we have the component of the retrospective analysis and you also know that we have the component of patient selection.
Basket studying the triplet.
Anat Cohen: We are looking to understand what the tumors are telling us following Com71 treatment, monotherapy, or combination, and whatever we can get to better understand what's going on in a tumor macro environment, remodeling, et cetera. So both goals that you mentioned, but also better understand the mechanism of action.
We are looking to understand what debt to more circling us following comes on on treatment monotherapy or combination.
And whatever we can get to better understand what's going on in in <unk>.
In the tumor microenvironment remodeling et cetera. So both angles that you mentioned, but also better understand the mechanism affection.
Got it.
Anat Cohen: I guess just one final question for me. I'd love to just kind of get your thoughts on the Tidit landscape as you see it right now, how it's unfolded with the data that we've seen to date, and kind of, you know, how 902 might be able to sort of thread the needle in the space. I let Henry address it, but I'll just say that, you know, currently the TIG studies that are ongoing across the different indications are mostly PDL1 high. As we stated for quite some time, we believe that PVRIG will be, targeting PVRIG will be complementary, and you can see that our clinical strategy is addressing the more the PDL1 low and non-responsive patient. population.
I guess just one final question for me I'd Love to just kind of get your thoughts on the on the ticket landscape as you see it right now how it's unfolded with the data that we've seen to date.
And kind of you know how.
How.
Oh, two might be able to sort of thread the needle moving in the space.
I'll, let Henry addressed it but I'll just say that you know currently the ticket studies that are ongoing across the different indications from mostly P. D. N. One high as we stated for quite some time, we believe that P. B R. A G will be targeting PV era.
You will be complementary and you can see the talk clinical strategy is addressing the more the PDL, one low and non responsive patient population.
Henry Adewoye: With our digit, obviously, the key differentiating factor is the fact that we can combine it with Com701. But I let Henry address the landscape more, and our strategy will come later. Yeah, thank you, Alex. So, Rennie, I think what's key here is that this provides opportunities for better treatment, to have a Most of the data that's been presented prior to the release or by Roastgen and was just an escalation by Uncle Mede Merrio.
And with our digital obviously the key differentiating factor is the fact that we can combine it with comps of an old one.
And but I'll, let Henry addressing more of the landscape and our strategy would come in on too.
Yeah. Thank you on that so really I think what's key here is that this provides opportunities.
For better treatment options for patients who have advanced disease.
Most of the data that's been presented prior to the release Oh by Roche Genentech.
This escalation.
On no we have more data.
Henry Adewoye: Now we have more data from Roastien-Tec, and like Nat alluded to, this is more robust data because it's a randomized study in non-smaster lung cancer, and it appears that the activity of a combination of debt plus the PDL1 inhibitor is better enhanced in patients who have high PDL1. The data from Merck also shows that the combination appears better in combination, and it gives better results in combination with the, So that's What is currently unknown at this time, I don't think, personally speaking as an oncologist and looking at all the data that's been there, is whether there will be an impact on the kind of FC that one has.
From Roche Genentech, Unlike on that I alluded to this is more robust data because it's a randomized study in non small cell lung cancer on it appears that the activity of the combination.
That's it.
Close to a PD L. One inhibitor is better.
And hence are in patients who have high PDL one expression.
The data from Merck also shoes that the combination appears better.
Combination.
The results in combination with a PD one inhibitor <unk>.
So that's good for patients.
What is currently on voting at this time I don't think personally speaking as an oncologist and looking at all the data that's being there.
Whether they will be on in fact, where they kind of see that one has.
Henry Adewoye: We're looking forward to data disclosures by Aracres as they've iterated that they will have an internal analysis of their data, But we believe, like Anat has mentioned, that Com902 will have anti-tumor activity and that it will, as a pure blocker, that it will, which will show, based on the science, that there should be no difference in terms of whether there is an FC enhanced or non-EFAC. However, these data are all that we're collecting all ongoing and we'll see what our, I'd just like to add that Annatt, I completely aligned with what Anata said, that what actually differentiates CompuGen is that we are going to be testing a PD1 and a PDL1 free registry, where it will be the combination of Com 902 with Com 701 and we'll see what the preliminary safety, tolerability and anti-tumor activity of the combination.
We're looking forward to data disclosures by ARCUS as they've isolated that it will have on interim analysis.
But we believe like that has mentioned that.
That's true.
True.
We will have anti tumor activity and that each will see pure blocker that you probably.
Total, which will show based on the science.
There'll be should be low difference in terms of whether there is an S. G announced on non FC enhanced however, this data on all that we're collecting on ongoing I will she worked on our cost.
Also.
I'd just like to add that.
And that's completely aligned with what IMAX has said that what's actually different sheets come too. Jim is that we are going to be testing a PD one PDL, one free regimen, where it'll be the combination of continental G. We've come several new one we'll see.
The preliminary safety and Tolerability on anti tumor activity of the combination will be.
Henry Adewoye: Also remember that we have a triple combination study that's ongoing in collaboration with BMS, where we are testing the DNAM hypotheses of complete inhibition of the various aspects. So it's all incredible and exciting data that we hope to see over the next several months and before the end of the year. And hopefully, this will all lead to clinical benefit for patients who are desperately in need. Thanks very much for taking the question. The next question is from Astika Kundwarnini of Tust Securities. Please go ahead. Hi guys, thanks for taking my questions. Could I please? I want to revisit something here.
But also remember that we have the triple combination study that's ongoing in collaboration with BMS, obviously, where we are testing the DMM hypotheses.
Inhibition of the various aspects of the DRAM axis. So it's all incurred will on the X I shouldn't do that that we hope to see over the next several months before the end of the year on hopefully this will all lead to a clinical benefit for patients who are desperately.
Desperately in need of that's a true.
With options.
Perfect. Thanks, very much for taking my questions.
The next question is from a speaker could one day me of twist of tooth Securities. Please go ahead.
Hey, guys. Thanks for taking my questions today.
I want to revisit something here on the Triple can you tell me what dose level off come several one that you will gain the escalation I just want to clarify are you starting at a dose.
Asthika Sarith Goonewardene: On the triple... Can you tell me what dose level of Com 701 you will begin the escalation at? I just want to clarify, are you starting that at a dose with Com 71, dose at 20 mix for cake or something maybe around that area? And then I have another question. On the more complete IACC data that you alluded to that you'll follow up at a later conference, will that be something in the second half of 2021 as well, so that we can explain? I think so.
Similarly on those debt 20 makes the cake or something.
Maybe.
Around that area and then I have a another question on the the more complete.
Did that you looked at that you will follow up with that and a little conference well that'd be something the second half from time to anyone as well that we can expect.
So much.
Okay.
Anat Cohen: So I'll start with the IHC, and then Henry will take the triplet dose escalation question. We did not share guidance, but as I said, this is in progress. Hopefully, we can still present it this year, but we will give specific guidance when we know more. All right, thank you, Anath.
So I'll start with you I see and then Henry will take the triplet and dose escalation question, we did not share guidance, but as I said this is in progress.
Hopefully we can still presented this year, but it but we will give the specific guidance when we know more.
Okay Alright, thank you on that so yeah with regards to the triplet combination.
Henry Adewoye: So, Astica, with regard to the triplet combination, what we've disclosed is that we'll have approximately up to five dose levels of sequential dose escalation in combination with six doses of the BMS, Tidatex207, and Nivolomab. So inherently, that means that we will not be starting at 20 milligrams per kilogram body weight dose of CUM701 in combination with the other. Got it. Thanks, guys. The next question is from Roger's Song of Jeffries.
What we've disclosed is that we will have approximately up to five two level sequential dose escalation cohorts.
In combination with fixed doses of the BMS TGF antibody, United six to seven on the bottom.
So inherently that means that we will not be starting at 20 milligrams per kilogram per day with dues of Hum.
701 in combination with other agents.
Got it thanks guys.
The next question is from Roger song of Jefferies. Please go ahead.
Roger Song: Please go ahead. Great. Yeah, congrats on the progress. And most of my questions related to similar when mild truisms were raised and answered, so I won't repeat them.
Great Yeah, congrats on the progress and most of my questions are related she said all women vouchers.
Raised it on third and so I will.
Maybe just a quick question relative to that Joe Hopkins collaborations. So we know the myeloid target is one of the pillar of your competition on discovery platform. Maybe can you just provide some additional color in terms of the the nature of the day.
Roger Song: Maybe just a quick question related to the John Hopkins collaboration. So we know the myeloid target is one of the pillars of your computational discovery platform. Maybe could you just provide some additional color in terms of the nature of the collaboration, and maybe more specifically, what are the steps in the timeline for the candidate nomination and the potential kind of eye. Yeah, sure, as much as we can relate to it, we didn't disclose much, but I'll just say that the collaboration with Hopkins is very similar to how we have conducted the collaboration for a few years now. Hopkins is part of executing the research on the candidates.
The collaboration on that.
Maybe more specificity on what what are the steps and the timeline for the candidate nomination and the potential or kind of on.
Yes, sure as much as we can relate to it we didn't disclose much but I'll just say that to the collaboration with Hopkins says that.
It's very similar to how we conduct a collaboration for a few years now and Hopkins says.
And as part of executing to research on the on the candidates and as I stated there were also part on on some of the preclinical work on comes to the new one.
Anat Cohen: As I stated, they were also part of some of the preclinical work on Com 7th. So this is the nature of the collaboration. Specifically for this, for this Miloil target, this is a very early stage one. However, it still merits research in order to explore its therapeutic potential. We believe it's exciting. And as we disclosed earlier, we have, we've seen some tumor growth. of inhibition in genetic depletion animal models. The mechanism seems interesting, but it requires a lot of research.
So this is the nature of the collaboration specifically for this and for these same myeloid target. This is a very early stage one and it's still married say research in order to explore the therapeutic potential and we believe it.
And it's exciting and as we disclosed.
And we have and we've seen some tumor growth inhibition in general.
Depletion.
In animal models.
The mechanism same thing interesting, but it requires and a lot of free search.
Anat Cohen: And this is why we thought that this would be good to go hand in hand with the laboratory of Drupadol and his excellent team that we used to work with them and do the work together. That's what I can say about this specific drug target. Great, thanks for the color. Yeah, I won't leave Ari out of this conversation.
And this is why we sold the dishes that it would be good to go hand in hand with that.
Well the laboratory group, a dog and his excellent team.
That were used to work with them and and do the work together.
That's what I can say about the specific channel drug target.
Great. Thanks for the color.
Yeah, I won't leave Ari.
Out of this conversation maybe already I believe can you provide some kind of color around the opex cash maybe just remind us what is the current guidance around the cash runway.
Ari Kraschen: Maybe Ari, I believe you can provide some kind of color around the OPEX and cash. Maybe just remind us what the current guidance is around the cash room? Hey Roger Schult. So we ended the quarter with about $190 million. As we stated before, the yearly run rate for the yearly ban rate expenditures would be roughly between $40 to $42 million.
There was a short so we ended the quarter with about $190 million as we stated before the yearly run rate for the yearly run rate expenditures would be roughly between $40 million to $42 million. So having said that assuming we will not increase significantly the cash burn rate.
Roger Song: So having said that, assuming we will not significantly increase the cash burn rate, we're talking about at least cash sufficient through the end of 2023. Having said that again, if we do decide based on our clinical strategy to expand and increase the clinical trials, obviously, this estimation might change. Great. Thank you. That's all for me.
We're talking about at least cash sufficient through the end of 'twenty two 'twenty three having said that again, if we do decide based on our clinical strategy to expand.
On to increase the <unk>.
The nickel price, obviously this estimation merchant.
Great. Thank you that's all from me congrats.
Roger Song: Congratulations again. Thank you. The next question is from Tony Butler of Ross Capital. Please go ahead.
Again.
Thank you.
The next question is from Tony Butler of Roth Capital. Please go ahead.
Charles Anthony Butler: Yes, thanks very much. I appreciate you working me in here. Question Annette and Henry are around 701 and 902, the combination trial. Henry, you alluded to the fact that, for safety reasons, you would want to see that combination, but don't you actually get that with the triple? And I guess outside of dose. That is the amount that you would use optimally with 701, with the optimal dose for 902. What else might you actually define, if anything, for the two, for eliminating both co-inhibitors in the DNA axis in the absence of a PD1 antibody?
Yes, thanks, very much I appreciate Youre working me in here question on that.
On the Henry is around.
701, and non or to the combination trial Henry you alluded to the fact that for safety reasons, you would want to see that combination, but don't you actually get that with the triple and I guess outside of dosing that is the amount that you would use optimally with 701 with the.
The optimal dose for nine O two what else might you actually deploy if anything.
For.
The two book.
Eliminating both co inhibitors in the DRAM axis and the absence of a of a PD one antibody.
Henry Adewoye: Yeah, Tuning, thank you for your, Remember that in the process of doing a just escalation study, the intent is to evaluate what the safety and tolerability of that combination So if you have three study drugs that you're combining as part of a dose escalation, It is impossible to be able to extricate what the contribute to safety of either one of the components or two of the components are You can only speak to what that combination does in terms of safety and, especially within DLT window that you're assigned for the course, and also intermediate and Now, for the Dwell Company, so therefore it will not be possible to allude, completely to what a Tid inhibitor does separately as part of a triple comming, And also remember that even though we get some data from what the combination of a TITI inhibitor does, as part of that triple combination of Com-701, the Volumab, it's a different citid antithalibate. So the Tid antibody that we're using in the triplet combination, from BMS, 96-207, cannot...
Yeah, Tony Thank you for your question.
Remember that in the purchase of doing it.
Pollution study the intent is to evaluate the safety and tolerability of that combination that you're testing. So if you have free study drugs that youre, combining especially dose escalation.
It is impossible to be extra.
Extricate, what's the contribution.
The safety of either one of the compliments on two other component on.
You can only speak to what that combination does in terms of safety and Tolerability.
Especially within <unk> to be.
BLT window, that's true that you've assigned for the course from the dose escalation and also intermediate and long term toxicities right now.
No for the dwell. So therefore, it will not it will not be possible.
True.
On a completely to what the <unk> inhibitor daus are separately as part of a triple combination and also remember that even though we get some data from the combination of a <unk> inhibitor doors as part of the triplet combination of comes up on the one the volume up.
Current antibody mm antibody that we're using in the triplet combination is the true defensive.
From a P M S.
Six to seven.
It's like you cannot mystic.
Henry Adewoye: It's a separate entity itself. So it is; you cannot transfer the safety and tolerability of one antibody to the other. You can get an idea of what the relative toxicity is, but cannot transpose it to another. So therefore, there is a need since the two agents that will be combined, which are ours, Com 701, we know the safety and tolerability of Com 701. As you remember, Tony, we started at 0.01, kilogram body weight dose, and we've duced escalated through 20 milligrams per dose IVQ for a week. So we have a lot of data on ComServants. It's an unapproved agent.
It's a separate entity itself. So it is a kind of transfer the safety and Tolerability on one antibody.
To the other you can get an idea of what the relative toxicities.
Cannot to transpose it is under the antibody so therefore.
There is a need seems to be true agents that will be combining with ours comes up on the one we know the 60 on tolerability of comps up on day, one as you remember Tony we started at 0.01 milligrams per kilogram body weight does.
Escalated through 'twenty, two milligrams per kilogram dose IV Q4 weeks till we have a lot of data on comm 71, it's on them.
On approved agents.
So it's the emo is on antibody, though it still collecting data on but we really should be comfortable with what we see in terms of its preliminary anti tumor activity on safety and Tolerability.
Henry Adewoye: So it's an antibody that we're still collecting data on, but we're relatively comfortable with what we see in terms of its preliminary anti-tumor activity and safety. Com902 is another new agent. It's a ticket answer. Remember that it has never been combined with Com 701, which is another unapproved. So we have two unapproveds. And as far as the regulations go and clinical practice and conducting clinical trials, we have to be able to get the safety information of those two agents without any other 8%. Um, combination.
Culminating to ease.
Another new agent, it's a ticket antibody.
Remember that it has never been combined with comes up on the one which is on another on approved so we have two on approved agents and it sounds deregulation school in clinical practice and are.
Conducting clinical trials.
Have to be able to compile the safety information.
And separately without any other agents.
In combination. So you just you didn't dwell combination Ah.
Henry Adewoye: So just be the dual The expectation is because we know what the safety profile of come 701 is, very well tolerated. We do not expect to see anything that is out of the blue when we combine it with Com 9. At any rate, that's why we do it. So even though the triplet will inform a little bit, it will still not be sufficient to fulfill regulatory obligations with the combination of Com 7-1.1.1. I hope that It does, Henry, and thank you for the clarity, and please understand part of the rationale was, would you find other information outside of safety?
The expectation is because we know what the 60 profile of Homeserve on the one is very well tolerated.
Do not expect to see anything that is.
Out of the Blue we would combine with 92.
But anyway, that's why we're doing the clinical study so even though the triplets will inform a little bit.
It will still not be sufficient to fulfill our regulatory obligations.
With the combination of <unk> 71 on comp guidance.
I hope that answers your question.
It does Henry.
Thank you for the clarity.
I understand part of the rationale was would you find other information outside of safety, but I think you've made it very very clear what the goal is and I appreciate it.
Henry Adewoye: But I think you've made it very, very clear what the goal is, and I appreciate it. This concludes our Q&A session. I will now turn the call back to Compugent's president and CEO, Dr. Chen Dian. Would you like to make your concluding statement? Yes, thank you. Thank you all for joining the call today. 2021 is posed to be an important year for CompiGEN with meaningful milestones and multiple data readouts. We will continue to push forward as leaders in the Denham Axis space, advancing our wholly owned PVRAG and TIGA assets to potentially drive cancer immunotherapy responses in new and expanded patient populations.
This concludes our Q&A session I will now turn the call back to computers, President and CEO. Dr. Han day on would you like to make your concluding statements.
Yes. Thank you.
Thank you all for joining the call today.
2021 is supposed to be an important year for coffee, Jim with meaningful milestones in multiple data readouts.
We will continue to push forward as leaders in the Dina axis space advancing our wholly owned PV Air age antigen assets to potentially drive cash immunotherapy responses in a new and expanded patient population.
Henry Adewoye: Thank you for joining us today and your continued support. Stay safe and healthy. Thank you. This concludes the Compugens Limited First Quarter 2021 Financial Result Conference Call. Thank you for your participation. You may go ahead and disconnect.
Thank you for joining us today and your continued support.
Stay safe and healthy.
Thank you. This concludes the computer <unk> limited first quarter 2021 financial result conference call.
Thank you for your participation you May go ahead and disconnect.
Okay.
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