Q1 2026 Compugen Ltd Earnings Call
Operator: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Q1 2026 Results Conference Call. An audio webcast of this call is available in the Investors section of Compugen's website at www.cgen.com. As a reminder, today's call is being recorded. I will now hand the call over to Lindsey Trickett, Head of Investor Relations and Corporate Communications, to begin. Lindsey, please go ahead.
Speaker #2: An audio webcast of this call is available in the Investors section of Compugen's website at www.cgen.com. As a reminder, today's call is being recorded.
Speaker #2: I will now hand the call over to Lindsay Trickett, Head of Investor Relations and Corporate Communications, to begin. Lindsay, please go ahead. Thank you, operator.
Lindsey Trickett: Thank you, operator. Good morning and good afternoon, everyone, and welcome to Compugen's Q1 2026 financial results conference call. With us today are Dr. Eran Ophir, President and Chief Executive Officer, and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, will join us for the Q&A portion of the call. Before we begin, I'd like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts, and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, including disclosure of clinical data, financial and accounting-related matters, as well as statements regarding our cash position and cash runway. We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, and that actual results, performance, or achievements of the company may differ materially.
Lindsey Trickett: Thank you, operator. Good morning and good afternoon, everyone, and welcome to Compugen's Q1 2026 financial results conference call. With us today are Dr. Eran Ophir, President and Chief Executive Officer, and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, will join us for the Q&A portion of the call.
Speaker #2: Good morning and good afternoon, everyone, and welcome to COMPUGEN's first quarter 2026 financial results conference call. With us today are Dr. Aaron Ophir, President and Chief Executive Officer; and David Silberman, Chief Financial Officer.
Speaker #2: Dr. Michelle Mahler, Chief Medical Officer, will join us for the Q&A portion of the call. Before we begin, I'd like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts in their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, including disclosure of clinical data, financial and accounting-related matters, as well as statements regarding our cash position and cash runway.
Lindsey Trickett: Before we begin, I'd like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts, and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, including disclosure of clinical data, financial and accounting-related matters, as well as statements regarding our cash position and cash runway. We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, and that actual results, performance, or achievements of the company may differ materially.
Speaker #2: We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, and that actual results, performance, or achievements of the company may differ materially.
Speaker #2: These statements are subject to known and unknown risks and uncertainties. And we refer you to our SEC filings for more details on these risks, including the company's most recent annual report on Form 20F, the company undertakes no obligation to update projections and forward-looking statements in the future.
Lindsey Trickett: These statements are subject to known and unknown risks and uncertainties. We refer you to our SEC filings for more details on these risks, including the company's most recent annual report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I'll now turn the call over to Dr. Eran Ophir, President and CEO.
Lindsey Trickett: These statements are subject to known and unknown risks and uncertainties. We refer you to our SEC filings for more details on these risks, including the company's most recent annual report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I'll now turn the call over to Dr. Eran Ophir, President and CEO.
Speaker #2: With that, I'll now turn the call over to Dr. Eran Ophir, President and CEO.
Speaker #3: Thank you, Lindsay. And good morning and good afternoon, everyone. Before I turn to our business updates, I want to take a moment to formally welcome Lindsay, our new Head of Investor Relations and Corporate Communications, to Compugen.
Eran Ophir: Thank you, Lindsey, good morning and good afternoon, everyone. Before I turn to our business updates, I want to take a moment to formally welcome Lindsey, our new head of Investor Relations and Corporate Communications, to Compugen. Lindsey joined us with strong experience in investor relations, we are thrilled to have her leading our communication with the investment community. Welcome, Lindsey, we are glad to have you on board. Now, let's start with our business update. 2026 is shaping up to be a significant year for Compugen, I'm pleased to share our progress in Q1 2026 as we continue executing on our strategic priorities. Starting with our fully owned clinical program, COM701, a potential first-in-class antibody targeting PVRIG, which is an immune checkpoint with unique biology, much differentiated from other PD checkpoints, including PD-1 and TIGIT.
Eran Ophir: Thank you, Lindsey, good morning and good afternoon, everyone. Before I turn to our business updates, I want to take a moment to formally welcome Lindsey, our new head of Investor Relations and Corporate Communications, to Compugen. Lindsey joined us with strong experience in investor relations, we are thrilled to have her leading our communication with the investment community.
Speaker #3: Lindsay joined us with strong experience in investor relations and we are thrilled to have her leading our communication with investor community. Welcome, Lindsay, and we are glad to have you on board.
Eran Ophir: Welcome, Lindsey, we are glad to have you on board. Now, let's start with our business update. 2026 is shaping up to be a significant year for Compugen, I'm pleased to share our progress in Q1 2026 as we continue executing on our strategic priorities. Starting with our fully owned clinical program, COM701, a potential first-in-class antibody targeting PVRIG, which is an immune checkpoint with unique biology, much differentiated from other PD checkpoints, including PD-1 and TIGIT.
Speaker #3: Now, let's start with our business update. 2026 is shaping up to be a significant year for COMPUGEN, and I'm pleased to share our progress in the first quarter of 2026.
Speaker #3: As you continue executing on our strategic priorities, starting with our fully owned clinical program, COM701, a potential first-in-class antibody targeting PVRIG, which is an immune checkpoint with unique biology, much differentiated from other checkpoints, including PD-1 and TIGIT.
Speaker #3: We believe this unique biology underlies the clinical activity demonstrated for COM701 in less inflamed indications such as ovarian cancer. As a reminder, at ESMO last year, we presented a pooled analysis of clinical data, showing that COM701 in monotherapy and combinations was well tolerated and showed consistent, durable responses in patients with heavily pre-treated, platinum-resistant ovarian cancer.
Eran Ophir: We believe this unique biology underlies the clinical activity demonstrated for COM701 in less inflamed indications such as ovarian cancer. As a reminder, at ESMO last year, we presented the pooled analysis of clinical data showing that COM701 in monotherapy and combinations was well-tolerated and showed consistent durable responses in patients with heavily pre-treated platinum-resistant ovarian cancer. Based on these results, we decided to progress the development of COM701 and test it in earlier settings of ovarian cancer as a maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer that responded to their most recent line of chemotherapy.
Eran Ophir: We believe this unique biology underlies the clinical activity demonstrated for COM701 in less inflamed indications such as ovarian cancer. As a reminder, at ESMO last year, we presented the pooled analysis of clinical data showing that COM701 in monotherapy and combinations was well-tolerated and showed consistent durable responses in patients with heavily pre-treated platinum-resistant ovarian cancer. Based on these results, we decided to progress the development of COM701 and test it in earlier settings of ovarian cancer as a maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer that responded to their most recent line of chemotherapy.
Speaker #3: Based on these results, we decided to progress the development of COM701 and test it in earlier settings of ovarian cancer as a maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer.
Speaker #3: That responded to their most recent line of chemotherapy. The rationale is to allow COM701 to induce its anti-tumor activity in earlier line patients, with lower tumor burden and a less compromised immune system, and by that increase the likelihood of these patients to benefit from COM701’s unique mode of action.
Eran Ophir: The rationale is to allow COM701 to induce its antitumor activity in early aligned patients with lower tumor burden, less compromised immune system, and by that, increase the likelihood of these patients to benefit from COM701 unique mode of action. For this purpose, we initiated the MAIA-ovarian Adaptive Platform trial. In substudy 1 of this trial, COM701 is randomized as maintenance monotherapy versus placebo in patients with relapsed platinum-sensitive ovarian cancer. We're actively enrolling patients in clinical sites across the United States, Israel, and France. Having all sites open and enrolling, spanning leading academic centers in US and Israel, as well as sites from the French cooperative group, gives us confidence in our ability to complete enrollment on schedule for having the MAIA-ovarian median PFS data at interim analysis by Q1 2027.
Eran Ophir: The rationale is to allow COM701 to induce its antitumor activity in early aligned patients with lower tumor burden, less compromised immune system, and by that, increase the likelihood of these patients to benefit from COM701 unique mode of action. For this purpose, we initiated the MAIA-ovarian Adaptive Platform trial. In substudy 1 of this trial, COM701 is randomized as maintenance monotherapy versus placebo in patients with relapsed platinum-sensitive ovarian cancer.
Speaker #3: For this purpose, we initiated the Myoviron Adapted Platform Trial. In sub-study one of this trial, COM701 is randomized as maintenance monotherapy versus placebo in patients with relapsed platinum-sensitive ovarian cancer.
Speaker #3: We're actively enrolling patients in clinical sites across the United States, Israel, and France. Having all sites open and enrolling, spanning leading academic centers in the US and Israel, as well as sites from the Akaji Gynico French Cooperative Group, gives us confidence in our ability to complete enrollment on schedule for having the myovarian median PFS data at interim analysis by Q1 2027.
Eran Ophir: We're actively enrolling patients in clinical sites across the United States, Israel, and France. Having all sites open and enrolling, spanning leading academic centers in US and Israel, as well as sites from the French cooperative group, gives us confidence in our ability to complete enrollment on schedule for having the MAIA-ovarian median PFS data at interim analysis by Q1 2027.
Speaker #3: These patient populations, comprised of those progressing post-PARP inhibitors and/or BEV, all who are not candidates for such treatments, represent a significant unmet medical need with no current standard of care.
Eran Ophir: This patient population, comprised of those progressing PARP inhibitors and/or BEV, or who are not candidates for such treatments, represent a significant unmet medical need with no current standard of care. We believe that clear prolongation of PFS in these patients could inform a registration path for COM701 and make it a potential backbone for drug combinations in this population, while also enabling a potential broader clinical development plan across earlier and later lines of ovarian cancer treatment, as well as in other indications where clinical signals previously seen for COM701. In addition, we're happy to see our partner AstraZeneca's progress on their broad rilvegostomig program. We remain confident in rilve's potential based on its differentiated In addition to its combination strategies.
Eran Ophir: This patient population, comprised of those progressing PARP inhibitors and/or BEV, or who are not candidates for such treatments, represent a significant unmet medical need with no current standard of care. We believe that clear prolongation of PFS in these patients could inform a registration path for COM701 and make it a potential backbone for drug combinations in this population, while also enabling a potential broader clinical development plan across earlier and later lines of ovarian cancer treatment, as well as in other indications where clinical signals previously seen for COM701. In addition, we're happy to see our partner AstraZeneca's progress on their broad rilvegostomig program. We remain confident in rilve's potential based on its differentiated In addition to its combination strategies.
Speaker #3: We believe that clear prolongation of PFS in these patients could inform a registration path for COM 701 and make it a potential backbone for drug combinations in this population while also enabling a potential broader clinical development plan across earlier and later lines of ovarian cancer treatment, as well as in other indications where clinical signals previously seen for COM 701.
Speaker #3: In addition, we're happy to see our partner AstraZeneca's progress on their broad relvagostomy program. We remain confident in relv's potential based on its differentiated profile.
Speaker #3: In addition, to its combination strategies. Last month, AstraZeneca presented multiple abstracts featuring relv at the ACR annual meeting in San Diego. Reinforcing our confidence in its differentiated design and growing potential.
Eran Ophir: Last month, AstraZeneca presented multiple abstracts featuring rilvegostomig at the AACR annual meeting in San Diego, reinforcing our confidence in its differentiated design and growing potential. This includes preclinical data demonstrating potential opportunities for rilvegostomig as an IO backbone for combinations, also late-breaking data from the DESTINY-Gastric03, phase II trial evaluating rilvegostomig in combination with the blockbuster ADC ENHERTU and chemotherapy as first-line treatment for HER2-positive gastric cancers. This data showed promising antitumor activity and also demonstrated combinability of rilvegostomig from safety perspective. Overall, these AACR publications continue to reinforce our confidence in rilvegostomig as AZ continue to advance it along 11 phase III trials across multiple indications, including the recently opened trial in gastric in combination with the claudin 18.2 ADC.
Eran Ophir: Last month, AstraZeneca presented multiple abstracts featuring rilvegostomig at the AACR annual meeting in San Diego, reinforcing our confidence in its differentiated design and growing potential. This includes preclinical data demonstrating potential opportunities for rilvegostomig as an IO backbone for combinations, also late-breaking data from the DESTINY-Gastric03, phase II trial evaluating rilvegostomig in combination with the blockbuster ADC ENHERTU and chemotherapy as first-line treatment for HER2-positive gastric cancers.
Speaker #3: This includes preclinical data, demonstrating potential opportunities for relv as an IO backbone for combinations, and also laybreaking data from the Destiny gastric O3 phase two trial evaluating relv in combination with the Blockbuster ADC and HERTO, and chemotherapy as first-line treatment for HER2-positive gastric cancers.
Speaker #3: This data showed promising anti-tumor activity and also demonstrated combinability of relv from safety perspective. Overall, these ACR publications continue to reinforce our confidence in relv as AZ continue to advance it along 11 phase three trials across multiple indications, including the recently opened trial in gastric in combination with the Clodin 18.2 ADC.
Eran Ophir: This data showed promising antitumor activity and also demonstrated combinability of rilvegostomig from safety perspective. Overall, these AACR publications continue to reinforce our confidence in rilvegostomig as AZ continue to advance it along 11 phase III trials across multiple indications, including the recently opened trial in gastric in combination with the claudin 18.2 ADC.
Speaker #3: With that, we are looking forward to the release of additional clinical data on RELV along the year, including at the next ASCO meeting at the end of the month.
Eran Ophir: With that, we are looking forward to the release of additional clinical data on rilvegostomig along the year, including at the next ASCO meeting at the end of the month. As a reminder, AstraZeneca has previously estimated a non-risk-adjusted peak annual revenue potential of more than $5 billion for rilvegostomig. We are eligible for additional $995 million in future regulatory and commercial milestone payments, plus mid-single digit tiered royalties on sales. Moving to GS-0321, formerly known as COM503, our potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. GS-0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing phase I dose-escalation trial continues to progress as we planned.
Eran Ophir: With that, we are looking forward to the release of additional clinical data on rilvegostomig along the year, including at the next ASCO meeting at the end of the month. As a reminder, AstraZeneca has previously estimated a non-risk-adjusted peak annual revenue potential of more than $5 billion for rilvegostomig. We are eligible for additional $995 million in future regulatory and commercial milestone payments, plus mid-single digit tiered royalties on sales.
Speaker #3: As a reminder, AstraZeneca has previously estimated a non-risk adjusted peak annual revenue potential of more than $5 billion for relv, and we're eligible for additional round of $95 million in future regulatory and commercial milestone payments plus mid-single-digit tiered royalties on sales.
Speaker #3: Moving to GS0321, formerly known as COM 503, our potential first-in-class anti-IL-18 binding protein antibody license to Gilead. GS0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer potentially overcoming the limitations of direct cytokine administration.
Eran Ophir: Moving to GS-0321, formerly known as COM503, our potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. GS-0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing phase I dose-escalation trial continues to progress as we planned.
Speaker #3: The ongoing phase one dodescalation trial continues to progress as we planned. As a reminder, we received to date $90 million from Gilead on these assets, and we're eligible to receive up to $758 million in additional milestone payment plus up to double-digit tiered royalties.
Eran Ophir: As a reminder, we received to date $90 million from Gilead of this asset, and are eligible to receive up to $758 million in additional milestone payments, plus up to double-digit tiered royalties. To the early-stage pipeline and Unigen discovery engine. Beyond our clinical assets, we continue to invest in our early-stage immune oncology pipeline. Unigen, our AI-powered computational target discovery platform, has already discovered the targets of COM701, COM902, and GS-0321. We remain committed to identifying and advancing the next wave of innovative programs grounded in novel mechanism of action designed to activate the immune system against cancer.
Eran Ophir: As a reminder, we received to date $90 million from Gilead of this asset, and are eligible to receive up to $758 million in additional milestone payments, plus up to double-digit tiered royalties. To the early-stage pipeline and Unigen discovery engine. Beyond our clinical assets, we continue to invest in our early-stage immune oncology pipeline. Unigen, our AI-powered computational target discovery platform, has already discovered the targets of COM701, COM902, and GS-0321. We remain committed to identifying and advancing the next wave of innovative programs grounded in novel mechanism of action designed to activate the immune system against cancer.
Speaker #3: Now, to the early-stage pipeline, a new gen discovery engine. Beyond our clinical assets, we continue to invest in our early-stage immuno-oncology pipeline. Unigen, our AI-powered computational target discovery platform, has already discovered the targets of COM 701, COM 902, and GS0321.
Speaker #3: We remain committed to identifying and advancing the next wave of innovative programs grounded in novel mechanisms of action designed to activate the immune system against cancer.
Speaker #3: Importantly, we have a solid financial position with a cash runway expected into 2029 following the December 2025 transaction with AZ through which we received $65 million in non-diluted capital by monetizing only a small portion of our future relv royalties.
Eran Ophir: Importantly, we have a solid financial position with a cash runway expected into 2029 following the December 2025 transaction with AZ, through which we received $65 million in non-diluted capital by monetizing only a small portion of our future Rilve royalties. Our financial stability allows us to fully focus on advancing our pipeline and reaching key value-creating milestones with both our internal and partnered programs. Throughout all of this, we continue to benefit from a deeply talented and highly committed team here at Compugen. I am proud of what we have built and energized by the opportunities ahead. With that, let me hand over to David for the financial update before we open the floor for Q&A.
Eran Ophir: Importantly, we have a solid financial position with a cash runway expected into 2029 following the December 2025 transaction with AZ, through which we received $65 million in non-diluted capital by monetizing only a small portion of our future Rilve royalties. Our financial stability allows us to fully focus on advancing our pipeline and reaching key value-creating milestones with both our internal and partnered programs. Throughout all of this, we continue to benefit from a deeply talented and highly committed team here at Compugen. I am proud of what we have built and energized by the opportunities ahead. With that, let me hand over to David for the financial update before we open the floor for Q&A.
Speaker #3: Our financial stability allows us to fully focus on advancing our pipeline and reaching key value-creating milestones with both our internal and partnered programs. And throughout all of this, we continue to benefit from a deeply talented and highly committed team here at COMPUGEN.
Speaker #3: I am proud of what we have built and energized by the opportunities ahead. With that, let me hand over to David for the financial update before we open the floor for Q&A.
Speaker #2: Thank you, Evan. And I would like to add my own warm welcome to Lindsay as well. It is a pleasure to have you join the COMPUGEN team, Lindsay, and we look forward to working together.
David Silberman: Thank you, Eran. I would like to add my own warm welcome to Lindsay as well. It is a pleasure to have you join the Compugen team, Lindsay, and we look forward to working together. I am pleased to say that we continue to advance into 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows, is expected to fund our operating plans into 2029. We anticipate using this runway to continue advancing our COM701 platinum-sensitive ovarian cancer trial, MAIA-ovarian, and to support the progression of GS-0321 in the clinic, together with continued investment in our early-stage pipeline. Going into the details, I will start with our cash balance. As of 31 March 2026, we had approximately $134.9 million in cash equivalents, short-term bank deposits, and investment in marketable securities.
David Silberman: Thank you, Eran. I would like to add my own warm welcome to Lindsay as well. It is a pleasure to have you join the Compugen team, Lindsay, and we look forward to working together. I am pleased to say that we continue to advance into 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows, is expected to fund our operating plans into 2029.
Speaker #2: I am pleased to say that we continue to advance in 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows, is expected to fund our operating plans in 2029.
Speaker #2: We anticipate using this runway to continue advancing our COM701 platinum-sensitive ovarian cancer trial, MyOvarian, and to support the progression of GS0321 in the clinic, together with continued investment in our early-stage pipeline.
David Silberman: We anticipate using this runway to continue advancing our COM701 platinum-sensitive ovarian cancer trial, MAIA-ovarian, and to support the progression of GS-0321 in the clinic, together with continued investment in our early-stage pipeline. Going into the details, I will start with our cash balance. As of 31 March 2026, we had approximately $134.9 million in cash equivalents, short-term bank deposits, and investment in marketable securities.
Speaker #2: Now going into the details, I will start with our cash balance. As of March 31, 2026, we had approximately $134.9 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities.
Speaker #2: Revenues for the first quarter of 2026 were approximately $2.2 million, compared to approximately $2.3 million of revenue for the comparable period in 2025. The revenues in the third quarters of 2026 and 2025 reflect the recognition of both the upfront payment and the IND milestone payment from the license agreement. Expenses for the first quarter of 2026 were in line with our plans.
David Silberman: Revenues for Q1 2026 were approximately $2.2 million, compared to approximately $2.3 million of revenue for the comparable period in 2025. The revenues in Q1 2026 and 2025 reflect the recognition of both the upfront payment and the IND milestone payment from the license agreement with. Expenses for Q1 2026 were in line with our plans. R&D expenses for Q1 2026 were approximately $6.9 million, compared to approximately $5.8 million in Q1 2025. The increase is mainly due to an increase in clinical expenses related to MAIA-ovarian trial, as well as higher drug supply costs supporting our trials.
David Silberman: Revenues for Q1 2026 were approximately $2.2 million, compared to approximately $2.3 million of revenue for the comparable period in 2025. The revenues in Q1 2026 and 2025 reflect the recognition of both the upfront payment and the IND milestone payment from the license agreement with. Expenses for Q1 2026 were in line with our plans. R&D expenses for Q1 2026 were approximately $6.9 million, compared to approximately $5.8 million in Q1 2025. The increase is mainly due to an increase in clinical expenses related to MAIA-ovarian trial, as well as higher drug supply costs supporting our trials.
Speaker #2: R&D expenses for the first quarter of 2026 were approximately $6.9 million, compared to approximately $5.8 million in the first quarter of 2025. The increase is mainly due to an increase in clinical expenses related to the myoovarian trial, as well as higher drug supply costs supporting our trials.
Speaker #2: Our G&A expenses for the first quarter of 2026 were approximately $2.3 million, compared to approximately $2.4 million for the comparable period in 2025. For the first quarter of 2026, our net loss was approximately $7.7 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $7.2 million, or $0.08 per basic and diluted share, in the first quarter of 2025.
David Silberman: Our G&A expenses for Q1 2026 were approximately $2.3 million, compared to approximately $2.4 million for the comparable period in 2025. For Q1 2026, our net loss was approximately $7.7 million or $0.08 per basic and diluted share, compared to a net loss of approximately $7.2 million or $0.08 per basic and diluted share in Q1 2025. With that, I will hand over to the operator to open the call for questions.
David Silberman: Our G&A expenses for Q1 2026 were approximately $2.3 million, compared to approximately $2.4 million for the comparable period in 2025. For Q1 2026, our net loss was approximately $7.7 million or $0.08 per basic and diluted share, compared to a net loss of approximately $7.2 million or $0.08 per basic and diluted share in Q1 2025. With that, I will hand over to the operator to open the call for questions.
Speaker #2: With that, I will hand over to the operator to open the call for questions.
Speaker #3: 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.
Operator 2: Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session. The first question is from Daina Graybosch of Leerink Partners. Please go ahead.
Operator: Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session. The first question is from Daina Graybosch of Leerink Partners. Please go ahead.
Speaker #3: If you are using speaker equipment, kindly lift the handset before pressing the numbers. Please stand by while we pull up your questions. The first question is from Diana Graybosch of Liring Partners.
Speaker #3: Please go ahead.
Speaker #4: Hi. Thank you for the question. Lindsay, welcome. Nice to see you here. Going into ASCO, I wonder if you could talk about more specifically the data sets ASTRA is going to present.
Daina Graybosch: Hi. Thank you for the question. Lindsey, welcome. Nice to see you here. Going into ASCO, I wonder if you could talk about more specifically the datasets Astra's gonna present with rilvegostomig and help set the context for, you know, what we should expect to see and, you know, are there benchmarks that would that we should be keeping in mind when we review the datasets?
Daina Graybosch: Hi. Thank you for the question. Lindsey, welcome. Nice to see you here. Going into ASCO, I wonder if you could talk about more specifically the datasets Astra's gonna present with rilvegostomig and help set the context for, you know, what we should expect to see and, you know, are there benchmarks that would that we should be keeping in mind when we review the datasets?
Speaker #4: We'll throw the ghost to Meg, and help set the context for what we should expect to see. Are there benchmarks that we should be keeping in mind when we review the data sets?
Speaker #2: Sure. Thanks, Dana. So we're talking about two data sets: clinical data obviously, the actual data is not released yet, and it would be cautious on setting expectations on behalf of AstraZeneca.
Eran Ophir: Sure. Thanks, Daina. We're talking about two datasets, clinical data. Obviously the actual data is not released yet, and I would be cautious on setting expectations on behalf of AstraZeneca. Overall, we talk about on the I-SPY trial in the testing rilvegostomig in our adjuvant settings with ENHERTU, which is a, by itself a blockbuster drug, which is very exciting to see these combinations. Again, I would be cautious about setting expectations, but I think looking again, and this is a, this is a platform trial, so really trying to look across, not a randomized study, but trying to look about Rilve versus other datasets. The combinability is again going to be very important to show again, how the Fc-reduced format of rilvegostomig is easier to combine with such ADCs.
Eran Ophir: Sure. Thanks, Daina. We're talking about two datasets, clinical data. Obviously the actual data is not released yet, and I would be cautious on setting expectations on behalf of AstraZeneca. Overall, we talk about on the I-SPY trial in the testing rilvegostomig in our adjuvant settings with ENHERTU, which is a, by itself a blockbuster drug, which is very exciting to see these combinations.
Speaker #2: But overall, we talk about when the I-SPY trial in the testing relv ghostomic genealogian settings with Synerto which is by itself a blockbuster drug which is very exciting to see this combinations.
Speaker #2: Again, I would be cautious about setting expectations, but I think looking again and this is a platform trial, so really trying to look across not a randomized study, but trying to look about relv versus other data sets.
Eran Ophir: Again, I would be cautious about setting expectations, but I think looking again, and this is a, this is a platform trial, so really trying to look across, not a randomized study, but trying to look about Rilve versus other datasets. The combinability is again going to be very important to show again, how the Fc-reduced format of rilvegostomig is easier to combine with such ADCs.
Speaker #2: The combinability is, again, going to be very important to show, again, how the FC-reduced format of RELV-Ghostomic is easier to combine with such ADCs.
Speaker #2: And then the second set is the GMN hepatobiliary. In combination with chemotherapy, and here again, we'll be good to see I think it's a bit of a longer follow-up from what was reported before, so it'd be interesting to see about the long-term effect, how the PFS, how the I'm not sure if there will be an always data but how the long-term effects are shaping, including the long-term safety, in combination with chemo, having in mind that there is for this trial, there's an ongoing phase three study ongoing.
Eran Ophir: The second set is the German hepatobiliary, which is in combination with chemotherapy. Here again, will be good to see. I think it's a bit of a longer follow-up from what was reported before, so it'll be interesting to see about the long-term effect, how the PFS, how the I'm not sure if there will be an OS data, but how the long-term effects are shaping, including the long-term safety in combination with chemo. Having in mind that there is a, for this trial, there's an ongoing phase III study ongoing. I guess the comparison to a single control should be with caution and still probably is gonna be made.
Eran Ophir: The second set is the German hepatobiliary, which is in combination with chemotherapy. Here again, will be good to see. I think it's a bit of a longer follow-up from what was reported before, so it'll be interesting to see about the long-term effect, how the PFS, how the I'm not sure if there will be an OS data, but how the long-term effects are shaping, including the long-term safety in combination with chemo. Having in mind that there is a, for this trial, there's an ongoing phase III study ongoing. I guess the comparison to a single control should be with caution and still probably is gonna be made.
Speaker #2: So I guess the comparison to historical control should be made with caution, but it probably is still going to be made.
Speaker #4: Great. Thank you.
Michelle Mahler: Great. Thank you.
Michelle Mahler: Great. Thank you.
Speaker #3: The next question is from Stefan Wiley of STIFO. Please go ahead.
Operator: The next question is from Stephen Willey of Stifel. Please go ahead.
Operator: The next question is from Stephen Willey of Stifel. Please go ahead.
Speaker #5: Yeah, good morning. Thanks for taking the questions. Maybe you can just talk a little bit about how you're thinking about disclosing future development candidates that are discovered off the Unigen platform.
Stephen Willey: Yeah, good morning. Thanks for taking the questions. Maybe you can just talk a little bit about how you're thinking about disclosing future development candidates that are discovered off the Unigen platform. I think the IL-18 binding protein antibody wasn't announced until it was ready for clinical development. Is that kind of how we should expect incremental assets to emerge out of the pipeline once they're ready for an IND submission? Thanks.
Stephen Willey: Yeah, good morning. Thanks for taking the questions. Maybe you can just talk a little bit about how you're thinking about disclosing future development candidates that are discovered off the Unigen platform. I think the IL-18 binding protein antibody wasn't announced until it was ready for clinical development. Is that kind of how we should expect incremental assets to emerge out of the pipeline once they're ready for an IND submission? Thanks.
Speaker #5: I think the IL-18 binding protein antibody wasn't announced until it was ready for clinical development. Is that kind of how we should expect incremental assets to emerge out of the pipeline?
Speaker #5: Once they're ready for an IND submission, thanks.
Speaker #2: Thanks, Steve. So I think it's really dependent. Eventually, definitely, the biggest group in COMPUGEN is the one which continue to work to bring additional innovative assets, like COM503, which is called today GS0321.
Eran Ophir: Thanks, Steve. I think it's really dependent. Eventually, definitely the biggest group in Compugen is the one which continue to work to bring additional innovative assets like COM503, which is called today GS-0321. Specifically for that asset, it was right for this asset and for Compugen at these times to out-license it in preclinical stage. This also influenced the stage in which we disclosed it. It was relatively early, but it doesn't mean necessarily that we have any specific guidelines that we're reporting on early assets only when it's ready for IND or only on the selection. It really depends on the actual assets, on the stage of the risking in which we want to start comment and committing.
Eran Ophir: Thanks, Steve. I think it's really dependent. Eventually, definitely the biggest group in Compugen is the one which continue to work to bring additional innovative assets like COM503, which is called today GS-0321. Specifically for that asset, it was right for this asset and for Compugen at these times to out-license it in preclinical stage. This also influenced the stage in which we disclosed it. It was relatively early, but it doesn't mean necessarily that we have any specific guidelines that we're reporting on early assets only when it's ready for IND or only on the selection. It really depends on the actual assets, on the stage of the risking in which we want to start comment and committing.
Speaker #2: Specifically for that asset, it was right for this asset, and for Compugen at these times to outlicense it in the preclinical stage. So this also influenced the stage in which we disclosed it.
Speaker #2: It was relatively early. But it doesn't necessarily mean that we have any specific guidelines that we are applying only to early assets when they're ready for IND, or only at the time of their selection.
Speaker #2: It really depends on the actual assets, on the stage of the risking in which you want to start comment and committing, so again, I wouldn't learn too much from the story of IL-10 binding protein other than the fact that it was another demonstration of how our computational platform can bring such innovative approaches—in that case, not only a first-in-class asset, but a first-in-class approach to highlight cytokine biology for the treatment of cancer.
Eran Ophir: Again, I wouldn't learn too much from the story of IL-18 binding protein other than the fact that it was another demonstration how our computational platform can bring such innovative approaches, in that case, not only first-in-class asset, but the first-in-class approach to harness cytokine biology for the treatment of cancer. We are looking into different MOAs, not necessarily similar to that, to bring again, another innovative options that could really make difference to patients.
Eran Ophir: Again, I wouldn't learn too much from the story of IL-18 binding protein other than the fact that it was another demonstration how our computational platform can bring such innovative approaches, in that case, not only first-in-class asset, but the first-in-class approach to harness cytokine biology for the treatment of cancer. We are looking into different MOAs, not necessarily similar to that, to bring again, another innovative options that could really make difference to patients.
Speaker #2: And we are looking into different MOAs, not necessarily similar to that, to bring again, another innovative options that could really make a difference to patients.
Speaker #5: All right. Thanks.
Stephen Willey: All right. Thanks.
Stephen Willey: All right. Thanks.
Speaker #3: The next question is from Leland Gersher of Oppenheimer. Please go ahead.
Operator: The next question is from Leland Gershell of Oppenheimer. Please go ahead.
Operator: The next question is from Leland Gershell of Oppenheimer. Please go ahead.
Leland Gershell: Great. Good morning. Thanks for taking our questions. Wondering if, could you remind us if the MAIA-ovarian trial, is that stratifying for patients who are PD-L1 or PD-1 expression, you know, status? Also wanted to ask when we see the interim data in Q1, given that this is an adaptive trial, would that mean that the interim data could inform some change to your design, or would you simply, you know, keep going as planned? Thank you.
Speaker #6: Great. Good morning. Thanks for taking our questions. Wondering if could you remind us if the myoovarian trial is that stratifying for patients who are PD-L1 or PD-1 expression status?
Leland Gershell: Great. Good morning. Thanks for taking our questions. Wondering if, could you remind us if the MAIA-ovarian trial, is that stratifying for patients who are PD-L1 or PD-1 expression, you know, status? Also wanted to ask when we see the interim data in Q1, given that this is an adaptive trial, would that mean that the interim data could inform some change to your design, or would you simply, you know, keep going as planned? Thank you.
Speaker #6: And also wanted to ask, when we see the interim data in the first quarter, given that this is an adaptive trial, would that mean that the interim data could inform some change to your design, or would you simply keep going as planned?
Speaker #6: Thank you. Hi.
Speaker #2: Thank you, Leland. I think Michel can take this one.
Eran Ophir: Thank you, Leland.
Eran Ophir: Thank you, Leland.
Michelle Mahler: Hi.
Michelle Mahler: Hi.
Eran Ophir: I think Michelle can take this one. Yeah.
Eran Ophir: I think Michelle can take this one. Yeah.
Speaker #6: I'm happy to take this one. Yeah. So the myoovarian trial actually is not stratified according to PD-L1 subgroup. We are stratified by second versus third line of treatment.
Michelle Mahler: I'm happy to take this one. Yeah. The MAIA-ovarian trial actually is not stratified according to PD-L1 subgroup. We are stratified by second versus third line of treatment. In Q1 2027 when it reads out, we have multiple options ahead of us in terms of adjustments to the trial. We would consider adding additional arms, and a lot of it's going to depend on the totality of the data and also plans towards engaging with the regulators and steps towards a pivotal trial.
Michelle Mahler: I'm happy to take this one. Yeah. The MAIA-ovarian trial actually is not stratified according to PD-L1 subgroup. We are stratified by second versus third line of treatment. In Q1 2027 when it reads out, we have multiple options ahead of us in terms of adjustments to the trial. We would consider adding additional arms, and a lot of it's going to depend on the totality of the data and also plans towards engaging with the regulators and steps towards a pivotal trial.
Speaker #6: And in Q1 '17, when it reads out, we have multiple options ahead of us in terms of adjustments to the trial. So we would consider adding additional arms, and a lot of it's going to depend on the totality of the data and also plans towards engaging with the regulators and steps towards a pivotal trial.
Speaker #5: Great. Thank you.
Leland Gershell: Great. Thank you.
Leland Gershell: Great. Thank you.
Speaker #2: One final additional comment, Leland, about the PD-L1 certification. I would like to remind you that PVRG, probably because it's a unique biology, we saw in other indications—and specifically in ovarian cancer—we saw responses across PD-L1 positive and PD-L1 negative patients.
Eran Ophir: One additional comment, Leland, about the PD-L1 stratification. I would like to remind you that PVRIG, probably because of its unique biology, we saw in other indication and specifically in ovarian cancer, we saw responses across PD-L1 positive and PD-L1 negative patients. For now, we didn't see, not necessarily like for other checkpoints, that the PD-L1 subset is the one responding to COM701. Again, I think this is because that unique biology very much differentiated from TIGIT to PD-1. Again, not necessarily PD-L1 stratification is the critical stratification here.
Eran Ophir: One additional comment, Leland, about the PD-L1 stratification. I would like to remind you that PVRIG, probably because of its unique biology, we saw in other indication and specifically in ovarian cancer, we saw responses across PD-L1 positive and PD-L1 negative patients. For now, we didn't see, not necessarily like for other checkpoints, that the PD-L1 subset is the one responding to COM701. Again, I think this is because that unique biology very much differentiated from TIGIT to PD-1. Again, not necessarily PD-L1 stratification is the critical stratification here.
Speaker #2: So for now, we didn't see that necessarily, like for other checkpoints, that the PD-L1 subset is the one responding to COM701. And again, I think this is because that unique biology is very much differentiated from PD-1.
Speaker #2: So again, not necessarily PD-L1 certification is the critical certification here.
Speaker #6: Thanks so much, Ron. Thank you.
Leland Gershell: Thanks so much, Ron. Thank you.
Leland Gershell: Thanks so much, Ron. Thank you.
Operator: The next question is from RK of H.C. Wainwright & Co. Please go ahead.
Operator: The next question is from RK of H.C. Wainwright & Co. Please go ahead.
Speaker #3: The next question is from RK of H.C. Wainwright. Please go ahead.
Speaker #4: Thank you. Thank you, Ron, for taking my questions. So a couple more questions. On the you have all the site what is any commentary on the enrollment status itself?
Karina Rabayeva: Thank you. Thank you, Ron, for taking my questions. A couple more questions on the, you know, you have all the, all the site. Any commentary on the enrollment status itself? Also in, because this is an event-driven trial, any commentary on the required events that needs to happen for the interim analysis? The third question is, what are you assuming, you know, for the control on PFS and what sort of an hazard ratio do you need to see to consider that as a win? Thanks, Zake. Michelle, do you want to take it?
Ramakanth Swayampakula: Thank you. Thank you, Ron, for taking my questions. A couple more questions on the, you know, you have all the, all the site. Any commentary on the enrollment status itself? Also in, because this is an event-driven trial, any commentary on the required events that needs to happen for the interim analysis? The third question is, what are you assuming, you know, for the control on PFS and what sort of an hazard ratio do you need to see to consider that as a win? Thanks, Zake. Michelle, do you want to take it?
Speaker #4: And also, because this is an event-driven trial, any commentary on the required events that need to happen for the interim analysis? And the third question is, what are you assuming for the control on PFS, and what sort of a hazard ratio do you need to see to consider that as a win?
Speaker #2: Thanks, RK. Michel, do you want to take it?
Speaker #6: Yeah, sure. So, first, with respect to our enrollment, we're not commenting at this point in time, but I will say to you that we are on track for our interim analysis as planned in the first quarter of 2027.
Michelle Mahler: Yeah, sure. Firstly, with respect to our enrollment, we're not commenting at this point in time, but I will say to you that we are on track for our interim analysis as planned in Q1 2027. Our participating investigators have a high level of engagement and are working really well with us. Regarding the events and the benchmarking, the trial is an exploratory trial, at this point in time, we don't know the full magnitude of benefit. The benchmark for the control arm from prior clinical trials in the second line and third line of maintenance, in those trials where patients did not get treatment, the same patient population had a benchmark of approximately 5.5 months, although there was a range.
Michelle Mahler: Yeah, sure. Firstly, with respect to our enrollment, we're not commenting at this point in time, but I will say to you that we are on track for our interim analysis as planned in Q1 2027. Our participating investigators have a high level of engagement and are working really well with us. Regarding the events and the benchmarking, the trial is an exploratory trial, at this point in time, we don't know the full magnitude of benefit. The benchmark for the control arm from prior clinical trials in the second line and third line of maintenance, in those trials where patients did not get treatment, the same patient population had a benchmark of approximately 5.5 months, although there was a range.
Speaker #6: And our participating investigators have a high level of engagement and are working really well with us. Regarding the events and the benchmarking, the trial is an exploratory trial, and so at this point in time, we don't know the full magnitude of benefit.
Speaker #6: But the benchmark for the control arm from prior clinical trials in the second line and third line of maintenance, in those trials, where patients did not get treatment, the same patient population had a benchmark of approximately 5.5 months.
Speaker #6: Although there was a range—in some studies, it was as low as 3.8 months, and in others as high as 5.8 months. So we're hoping to be able to show that there is meaningful single-agent clinical activity of COM701, and we've hypothesized that we would like to see a three-month or greater improvement over the benchmark PFS.
Michelle Mahler: In some studies it was as low as 3.8 months and others as high as 5.8 months. We're hoping to be able to show that there is meaningful single agent clinical activity of COM701 and we've hypothesized that we would like to see a 3-month or greater improvement over the benchmark PFS.
Michelle Mahler: In some studies it was as low as 3.8 months and others as high as 5.8 months. We're hoping to be able to show that there is meaningful single agent clinical activity of COM701 and we've hypothesized that we would like to see a 3-month or greater improvement over the benchmark PFS.
Speaker #4: Perfect. Thank you. Thanks for taking my questions.
Karina Rabayeva: Perfect. Thank you. Thanks for taking my questions.
Ramakanth Swayampakula: Perfect. Thank you. Thanks for taking my questions.
Speaker #6: Sure.
Michelle Mahler: Sure.
Michelle Mahler: Sure.
Operator: This concludes the Q&A session in Compugen's Investor Conference Call. Thank you for your participation.
Operator: This concludes the Q&A session in Compugen's Investor Conference Call. Thank you for your participation.
