Q4 2023 Compugen Ltd Earnings Call

Operator: Bye Guys. Thanks for watching!

It will be difficult.

Sure.

Operator: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's fourth quarter and full year 2023 results conference. At this time, all participants are in a listen-only mode.

Okay.

[music].

Ladies and gentlemen, thank you for joining us today welcome to Compuchem, what quarter and full year 2023 results conference call. 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, www.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

An audio webcast of this call is available in the investors section of copy of Jim's website Www Dot Sea Gen Dot Com as a reminder, today's call is being recorded I would now like to introduce Yvonne Naughton head of Investor Relations and corporate Communications you Vaughn. Please.

Go ahead.

Yvonne Naughton: Thank you, Operator, and thank you all for joining us on the call today. Joining me from Compugen for the prepared remarks are Dr. Anat Cohen-Diag, President and Chief Executive Officer, and Alberto Sessa, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, and Dr. Eran Ophir, Chief Scientific Officer, will join us for the Q&A. Before we begin, we would like to remind you that during this call, the company will make projections or forward-looking statements regarding future events, the business outlook, development efforts and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, financial and accounting-related matters, as We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, but actual results, performance, or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties, and we refer you to the SEC filings for more details on these risks, including the company's most recent annual report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future.

Thank you operator, and thank you all for joining us on the call today, joining me from comp adjourn for the prepared remarks are Dr. <unk> Cohen, <unk>, President and Chief Executive Officer, and Bruce <unk>, Chief Financial Officer, After Michelle Moore, Chief Medical Officer, and Dr. Iran Nuclear Chief Scientific officer will join us for the Q&A.

Before we begin we would like to remind you that during this call. The company can make projections or forward looking statements regarding future events business and.

Development efforts and the potential outcome the company's discovery platform anticipated progress on plans results in timeline for our programs and onshore and accounting related matters as well as statements regarding our cash position.

We wish to caution you that such statements reflect only the company's current beliefs expectations and assumptions and actual results performance or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties and we refer you to the SEC filings for more details on these measures, including the company's most recent annual report.

And form 20-F.

Company undertakes no obligation to update projections and forward looking statements in the future and with that I'll turn the call over to announce.

Anat Cohen: And with that, I'll turn the call over to Anat. Thank you, Yvonne, and thanks to everyone for joining our call today. Before we discuss the full year and fourth quarter highlights, I want to start by welcoming the new addition to our management team, Michelle Mahler, who took over the role of Chief Medical Officer on March 1st, 2024. I'm really excited to welcome Michel, an oncologist by training with extensive experience in leading clinical development in both biotech and pharma companies in and outside of the U.S. Michel is an excellent fit for Compugen and will be a I would like to take this opportunity to thank Henry for his major contributions and commitment to Compugen and his leadership. Henry has been instrumental in the successful transition of Compugen from a preclinical to a clinical-stage company and in creating the growth opportunities in front of us. Moving now to the highlights of 2023.

Thanks, Bob and thanks to everyone for joining our call today.

Before we discuss the full year and fourth quarter highlights.

I want to start by welcoming the New addition to our management team Michelle mother, who took over the role of Chief Medical Officer on March 1st 2024.

I'm really excited to welcome Michelle and oncologist by training with extensive experience in leading clinical development in both biotech and pharma companies in and outside of the U S.

Michelle is an excellent fit for coffee can and will be a great partner to me and a collaborator to the whole team as we work together on executing our programs to accelerate value creation.

I would like to take this opportunity to thank Henry for his major contributions and commitment to coffee Jan and he's very Joshi.

Henry has been instrumental in the successful transition of coffee Jang from preclinical to clinical stage company and creating the growth opportunities in front of us.

Moving now to the highlights of 2023.

Anat Cohen: Our successes in 2023, and in the last quarter in particular, position us well as we advance into 2024 and are expected to play an important role in the exciting future I envision for Compugen. Firstly, at the end of the year, we executed a preclinical licensing deal with Gilead for a total deal value of up to $848 million, including a $60 million upfront payment and $30 million near-term milestone payment, plus additional single-digit to low double-digit royalties on future net sales. Delighted by Gilead of COM503, for which we are expected to lead phase one development, further validates our computational discovery, research, and development capabilities. It is also testament to the differentiation of our antibody program targeting the IL-18 binding protein.

Our successes in 2023 and in the last quarter in particular position us well as we advance into 'twenty 'twenty four and.

Our expected to play an important role in the exciting future I envision for coffee.

Firstly at the end of the year, we executed a preclinical licensing deal with Gilead for a total value of up to $848 million, including a $16 million upfront payment and $30 million near term milestone payment.

And we additionally single digit to low double digit royalties on future net sales.

They liked this by Gilead of qualified school suite for which were expected to lead phase one development.

Further validates our computational discovery research and development capabilities.

It is also a testament to the differentiation of our antibody program targeting the <unk> binding protein.

Anat Cohen: The deal process was competitive, which reflects the significant interest in the IL-18 space and highlights the potential of our CONFIRM-3 differentiated antibody approach. As a reminder, COM543, a potential first-in-class anti-IL-18 binding protein antibody, represents a novel way to harness IL-18 pathway biology for the treatment of cancer by using an antibody against IL-18 binding protein, and therefore, potentially avoiding the challenges presented by the administration of therapeutic

The deal process was compassion T, which reflect the significant interest in the on 18th space.

Highlights the potential of our qualified first with differentiated antibody approach.

As a reminder, call faithful three a potential first in class anti all 18 binding protein antibody.

Represents another way to harness IL 18 pathway biology.

The treatment of cancer by using an antibody against an 18 binding protein and therefore potentially avoiding the challenges presented by administration of therapeutics type of Guy.

Anat Cohen: Secondly, Focusing on execution and advancing the development of our clinical stage assets, we initiated two proof-of-concept clinical studies with our differentiated COM701 combinations in platinum-resistant ovarian cancer and metastatic microsatellite stable colorectal cancer. We completed enrollment in the ongoing MSF CRC study, and we significantly ramped up enrollment in our ongoing PROC study, with enrollment of at least 20 patients expected by the end of the first quarter of 2024. In addition, we presented new data at scientific conferences throughout 2023, including preliminary evidence supporting the association between the biomarker PVR-L2 and clinical benefits intended to guide the next step in our development path for COM701 combination therapy. Thirdly, in the fourth quarter of 2023, our partner AstraZeneca advanced revagostamine, their PD-1-tigid bispecific, the tigid component of which is derived from Compugen's COM902, into phase three development for biliary tract cancer.

Secondly, focusing on execution and advancing the development of our clinical stage assets we.

We initiated two proof of concept clinical studies with our differentiated concept in one combination.

In platinum resistant ovarian cancer.

And metastatic microsatellite stable colorectal cancer.

We completed enrollment in the ongoing MSS CRC study and we significantly ramped up the enrollment of our ongoing Brook study.

With enrollment of at least 20 patients expected by the end of the first quarter of 'twenty 'twenty four.

In addition, we presented new data at scientific conferences throughout 2023, including preliminary evidence supporting decile CH in between the biomarker PD out end to end clinical benefit.

Intended to guide the next step in our development path for <unk> 701 combination.

Okay.

Thirdly in.

In the fourth quarter of 2023, our partner Astrazeneca advanced rates of Augusta me their PD, one teaching bispecific the <unk>.

Ticket component of which is derived from competence co mingled to into.

Into phase III development in biliary tract cancer.

Anat Cohen: Dosing of the first patient in these phase three trials entitled us to a milestone payment and brings Compugen one step closer to a potentially marketed drug. AstraZeneca's broad clinical investigation of this asset across multiple indications and across various lines of treatment and combinations increases our probability of realizing future milestone payments and drugs.

Dosing of the first patient in this phase III trial in type of death to a milestone payment and brings comping, Jay one step closer to a potentially marketed drugs.

I suppose that it caused broad clinical investigation of this outfit across multiple indications and across various lines of treatment and combination.

Increases our probability of realizing future milestone payments and royalties.

Finally.

Anat Cohen: The cash received from our licensing deal with Gilead and the milestone met by AstraZeneca in 2023 allows us to move into 2024 with a solid balance. The additional cash we received and the cash we expect to receive upon IND clearance of COM 543 is expected to extend our cash runway from the end of 2024 into 2027 and potentially accelerate value creation by enabling us to invest in enhancing our discovery capabilities and advancing our diversified portfolio This is an exciting time for Compugen. This is a good segue for me to move to what to expect from us in 2024.

The cash received from our licensing deal with Gilead and.

And milestone met by Astrazeneca in 2020 three.

Allow us to move into 'twenty 'twenty, four with a solid balance sheet.

The additional cash we received and the cash we expect tourists team at bone IV clearance of Col. Five full suite.

He is expected to extend our cash runway from the end of 'twenty 'twenty four into 'twenty 'twenty seven.

And potentially accelerate value creation by enabling us to invest in enhancing our discovery capabilities.

And advancing our diversified portfolio, including our differentiated concept under one common I know too I O combination strategy.

The phase one development of called FIFO suite.

And our early stage innovative pipeline.

This is an exciting time for coffee yet.

This is a good segue for me to move to what to expect from us in 'twenty 'twenty four.

Anat Cohen: 2024 is planned to be a catalyst-rich year for us, with multiple data readouts and updates expected from our diversified portfolio. In 2024, we plan to share data from our ongoing proof-of-concept studies, NSSCRC, and platinum-resistant ovarian cancer. These are particularly challenging indications to treat and have historically failed to respond to immunotherapy.

'twenty 'twenty four is planned to be a catalyst rich year for us with multiple data readouts and update expected from our diversified portfolio.

In 'twenty 'twenty four we plan to share data from our ongoing proof of concept study and assess your C and platinum resistant ovarian cancer.

These are particularly challenging indications to treat and has historically St George Paul Junior off therapy.

Anat Cohen: While we believe that these indications represent a very high bar, we have previously presented encouraging clinical data, supported by immune activation, suggesting that the unique biology of PVRIG enables anti-PD-1 activity in this challenging indication. The goal of these studies is to further substantiate our clinical findings, including our initial biomarker results, to potentially enable us to move forward with a biomarker-enriched development strategy. Regarding emesis CRC, In the first cohort of 22 patients treated with COM701 in combination with nivolumab, we showed an encouraging overall response rate of 12% in stable diseases in patients with liver metastasis, a patient population which historically has not responded to other drugs. For the ongoing proof-of-concept study, our objective is to understand if there could be an additional benefit of adding an antigen to the dual combination and further evaluate the combination in the liver metastasis patient population, which represents approximately 70% of the patient population in the evaluated line of treatment.

While we believe that these indications represent a very high bar.

We have previously presented encouraging clinical data.

Supported by immune activation, suggesting that the unique biology of P. D. R. I G in Nabors anti PD one activity in this challenging indication.

The goal of these studies is to further substantiate our clinical findings, including our initial biomarker read does too.

To potentially enable us to move forward with a biomarker enriched development strategy.

Regarding banister CRC.

The first cohort of 22 patients treated with comps up in the one in combination with need volume up.

We showed an encouraging overall response rate of 12% and stable diseases in patients with liver metastases and patient population, which historically has not responded to other drugs.

For the ongoing proof of concept study.

Our objective is to understand if there could be an additional benefit of adding an antique teachers to the dual combination.

And further evaluate the combination in the liver metastases patient population, which represents approximately 70% of the patient population.

Devaluated line of treatment.

Anat Cohen: The ongoing study, fully recruited in 2023, at a speed which we believe reflects the significant unmet need. Data presentation from this ongoing study is planned for the first half of 2024 with the aim to be presented at a medical conference. You can expect to see baseline characteristics, including safety, overall response rate, disease control rate, duration of response, and translational data. In patients with platinum-resistant ovarian cancer, based on the data from the first cohorts of 20 patients treated with triple combinations, there was a lot of excitement from investigators reporting durable shrinking or stabilization of tumors in some of their patients who had previously progressed on all available treatment options.

The ongoing study fully recruited in 2020 three.

Pete, which we believe reflects the significant unmet needs.

Data presentation from this ongoing study is planned for the first half of 'twenty 'twenty four would you aim to be presented at a medical conference.

You can expect to see baseline characteristics, including safety overall response rate disease control rate duration of response and frustration on the data.

In patients with platinum resistant ovarian cancer.

Just on the data from the first cohort of 20 patients treated with triple combination.

There was a loss of excitement from investigators reporting durable shrinking or stabilization of storm work in some of their patients who had previously progressed on all available treatment options.

We believe the totality of the data reported in these patients is encouraging compared to the current standard of care.

Anat Cohen: We believe the totality of the data reported in these patients is encouraging compared to the current standard of care; we presented a 20% overall response rate with patients responding for over 16 months, which is favorable, considering the median duration of response for single-agent chemotherapy is around three to four months, and for ADCs is around 6.9 months. Responses were also achieved in hard-to-treat high-grade serous adenocarcinoma patients, along with a favorable safety profile for the ongoing study in platinum-resistant ovarian cancer. We're delighted to report that our investigators are active in recruitment, and we expect to complete recruitment of at least 20 patients this quarter and plan to present in the fourth quarter of 2024. Again, our preference will be to present it at a medical conference. For this ongoing study, you can expect to see baseline characteristics and data for at least 20 patients, including safety, overall response rate, disease control rate, duration of responses, and preliminary biomarker data. Moving now to Comp 5-4-3.

We presented a 20% overall response rate with patients responding for over 16 months, which is favorable.

Considering median duration of response for single agent chemotherapy is around three to four months and in a D. C is around six nine months.

Responses were also achieved in the hard to treat high grade serous adenocarcinoma patients.

Along with a favorable safety profile.

For the ongoing study in platinum resistant ovarian cancer.

We're delighted to report that our investigators are active on recruitment and we expect to complete recruitment of at least 20 patients this quarter.

And plan to present in the fourth quarter of 'twenty 'twenty four.

Again, our preference would be to present at a medical conference.

So they started going study you can expect to see based on characteristics and data for at least 20 patients, including safety over response rate disease control rate duration of responses and preliminary biomarker data.

Moving now to qualify for St.

Anat Cohen: Rapid execution on both COMP503 IMD clearance and phase one development is a priority for us, and we were incentivized by Gilead on this priority. We greatly value the partnership with Gilead, and together, we're well advanced on the design of the Phase I trial and feel confident that we can initiate Phase I shortly after we gain R&D clearance. We are on track for R&D submission in the second half of 2024 with subsequent initiation of the Phase I study following R&D clearance. Finally, in the second half of 2024, AstraZeneca expects data from their Phase I-II Artemide I trials in non-procellant cancer in front-line settings and their Phase 2 Gemini trial in Hepatobiliary cancer. Before handing over to Alberto, I go through our financials.

Rapid execution on both coasts I supposed to wait I'm declaring it phase one development is a priority for us.

And we're incentivized by Gilead on this priority.

We greatly value the partnership with Gilead and together, we're well advanced on the phase one trial design and feel confident that we can initiate phase one shortly after we gain <unk> clearance.

We're on track for submission in the second half of 'twenty 'twenty four we subsequent initiation of the phase one study following R&D clearance.

Finally in the second half of 'twenty 'twenty four astrazeneca expects data from their phase one to optimize one trials in non small cell lung cancer in the frontline setting.

And their phase two Gemini trial and Hepatobiliary cancer.

Before handing over to Alberto to go through our financials I.

Anat Cohen: I want to emphasize that we will continue to be financially disciplined while benefiting from our solid cash provision to enhance and advance our company. We are strategic with how we deploy our resources, and this will include two main priorities. One, advancing our clinical stage programs, COM 701 and COM 902 combinations, and COM 503 upon initiation of its clinical study, and two, Investing in competence, our core competitive advantage, the integration of our computational discovery platform with innovative research and drug development capabilities. In terms of COM 701 combinations, advancing our ongoing studies will be data and biology-driven. In PROC, we believe data showing durable responses and additional biomarker correlations are expected to allow us to move ahead employing a predictive biomarker enrichment strategy. As a result of the evolving platinum-resistant ovarian cancer treatment landscape, we see the opportunity for COM-71 combinations to be used as a treatment option in two patient populations, those progressing on ADCs and those ineligible for ADCs.

Want to emphasize.

That's what we'll continue to be financially disciplined while benefiting from our solid cash position to enhance and advance our company.

Were strategic with how we deploy our resources and this will include two main priorities.

One.

Advancing our clinical stage programs concept and the one in Colorado to combinations.

And qualify for three upon initiation of its clinical study.

And to <unk>.

Investing in competence core competitive advantage the integration of our computational discovery platform, we do not give research and drug development capabilities.

In terms of concept in a lot of combination.

Advancing our ongoing studies will be data and the LNG driven.

In park, we believe data showing durable responses and additional biomarker correlations are expected to allow us to move ahead, employing a predictive biomarker enrichment strategy.

As a result of the Vulcan platinum resistant ovarian cancer treatment landscape.

We see the opportunity for concept into one combinations to be used as a treatment option in two patient populations.

Don progressing on the agencies and those ineligible for ABC.

Anat Cohen: In MSS CRC, the bar is very high due to the many failures and the non-responsive nature of the liver metastasis patient population. We believe data showing an overall survival advantage over standard of care would be encouraging. Our study in MSS CRC is still ongoing as some of the patients enrolled only on September 23. And based on data from the overall end-delivery metastasis patient populations, we will determine the next step. Based on the encouraging safety and efficacy data generated to date with our COM701 combinations across indications, we believe there is an opportunity to collaborate with potential partners to bring COM701 combinations to patients across a broad range of indications, generating a potentially large opportunity. For the second main priority,

In NSE or see the bar is very high due to the many failures and the nonresponsive nature of the liver metastases patient population.

We believe the data showing an overall survival advantage over standard of care would be encouraging.

Our study in NFS. Your C is still ongoing and some of the patients enrolled only in September 23.

Based on data from the overall and the liver metastasis patient population.

We will determine the next steps.

Based on the encouraging safety and efficacy data generated to date with our concept and on combinations across indications.

We believe there is an opportunity to collaborate with potential partners to bring call 701 combination to patients across a broad range of indications generating a potentially large opportunity.

For the second main priority.

Anat Cohen: We will continue to invest in the engine powering our core competitive advantage; we are skilled and highly experienced in integrating cutting-edge computational capabilities with groundbreaking immuno-oncology research and drug development expertise to discover novel drug types. Investing to enhance our computational discovery platform from computer prediction to early stage programs, we believe will enable us to progress the generation of novel drug candidates. The next step, come find folks free. And finally, our focus remains on non-dilutive funding, which we have demonstrated in 2023 we can successfully execute on. With that, I turn the call over to Alberto.

We will continue to invest in the engine powering our core competitive advantage, where skilled and highly experienced in integrating cutting edge computational capability with groundbreaking immuno oncology research and drug development expertise.

To discover novel drug targets.

Investing to enhance our computational discovery platform from computer prediction to early stage programs, we believe will enable us to progress the generation of novel drug candidates.

The next column fivefold asleep.

And finally, our focus remains on non dilutive funding for which we have demonstrated in 'twenty two 'twenty three we can successfully execute on.

With that I'll turn the call over to Alberto.

Alberto Sessa: Thank you, Anna. I'm delighted to say that we will advance into 2024 with a solid balance. This is a result of Compugen's accomplishments on the collaboration front in 2023, securing non-delusive funding, which was always our priority, with cash, end-to-date. And with the milestone payment we expect to receive upon IND clearance of COM503, we expect to extend our cash runway to support our operating plans into 2027. Going into the details, I will start with our cash balance. As of December 31, 2023, we had approximately $51.1 million in cash, cash equivalents, restricted cash, and cash investments compared with approximately $83.7 million as of December 31, 2020.

Thank you you all know.

I'm delighted to see.

Into 2024 with a solid balance sheet.

This is a result of cultigen accomplishments on the collaboration front in 'twenty 'twenty cute securing non dilutive funding, which was always our priority.

Cash.

And to date.

We expect to receive upon.

And so.

We expect to extend our cash runway to support our operating plan into 'twenty lunch Jimmy.

Going into the details I will start with our cash balance.

As of December <unk>.

We had approximately $51 $1 million in cash cash equivalents restricted cash and cash and investments compared with approximately $83 $7 million.

I'm there since you finish 'twenty to 'twenty two.

Alberto Sessa: The cash balance at the end of 2023 does not include the receipt of $60 million from payments from Gilead for our COM503 preclinical license and $10 million from my son's payments from AstraZeneca on dosing the first patient in the phase 3 trial. In addition, in 2024, we expect to receive from Gilead an additional $30 million MySon payments upon the COMP503 IND claim. I would like to remind you that all payments from GILAD are subject to a 15% discount with Olding. The company has no debt.

The cash balance.

Thank you <unk>.

The receipt of $60 million upfront payment from Gilead.

Sure.

Great. Thank you.

And $10 million.

Payments from Astrazeneca on dosing the first patients in the phase III trial.

In addition in 'twenty to 'twenty four we expect to receive.

An additional $15 million milestone payment upon all five years.

<unk>.

I would like to remind you all payments.

Subject to a 15%.

We don't think decks.

The company has no debt.

Alberto Sessa: As Anat mentioned, we understand the importance of our cash balance, and we are financially disciplined. Based on our current plans, we expect that our current cash, together with a milestone payment payable upon COM503 IND clearance, will be sufficient to fund our operating plans into 2027. The cash rate reflects the planned development of our clinical assets and continued investment in our early innovative pipeline. On the revenue front, we reported approximately $33.5 million in revenues for the fourth quarter of 2023 and for the year ended December 31st, 2021, compared to $7.5 million in revenues for each of the comparable periods in 2022.

As <unk> mentioned, we understand the importance of our cash balance and we are financially disciplined.

Based on our current plans, we expect that our current cash together with the Muslims payments.

A poll cofinal tree.

<unk> will be sufficient to fund our operating plan into 'twenty 'twenty Sidney.

Cassia rates reflects the planned development of our clinical assets and continued investment in our early nobody is likely.

On the revenues, we reported approximately $35 million in revenues for the fourth quarter of 2023 and for the year ended December 31st 2023.

<unk> to $7 5 million revenues for each of the comparable periods in 2022.

Alberto Sessa: The revenues for the year ended December 31, 2023 include the portion of the upfront payment from the license agreement with Gilead allocated to the license, and the clinical milestones from the license agreement with AstraZeneca in the amount of $10 million. Now, moving to expenses. R&D expenses for the fourth quarter of 2023 and for the year ended December 31st, 2023, were $10.9 million and $34.5 million, respectively, compared with $7.3 million and $30.6 million for the comparable period in 2020.

The revenues for the year ended December 31st 2020 to include the portion of the upfront payment from <unk>.

License agreement with Gilead allocated to the license and the clinical milestones from the license agreement with Astrazeneca in the amount of $10 million.

Now moving to expenses.

<unk> expenses for the fourth quarter of 2022 and for the year ended December 31st 2022.

We're 10 $49 million and $34 $5 million respectively.

With $7 million and $36 million for the comparable period in 2022.

Alberto Sessa: The increase in 2023 is mainly due to lower amortization of the deferred participation in R&D expenses following the termination of the agreement with BMS, offset by decreasing ad counter returns. Research and development expenses as a percentage of the total operating expenses were approximately 78% in 2023 compared to 73% in 2022. Our G&A expenses for the fourth quarter of 2023 and for the year ended December 31st, 2023, were $2.5 million and $9.7 million, respectively, compared with approximately $2.5 million and approximately $10.3 million for the comparable period in 2020.

The increase in 'twenty to 'twenty three is mainly due to lower amortization of the deferred participation in R&D expenses. Following the termination of the agreement with BMS offset by decreases come through as to expenses research and development expenses.

Vintage of the total operating expenses were approximately 278% in 2023 compared to 73% in 2022.

Our G&A expenses for the fourth quarter of 2022 and for the year.

And the December 31st 2020, key were $2 $5 million and $9 $7 million, respectively, compared with approximately $2 5 million and approximately $10 3 million for the comparable period in 2022.

Alberto Sessa: Finally, on Netlock. For the fourth quarter of 2023, we report a net profit of $9.7 million, or $0.11 per basic and diluted share, compared to a net loss of $3.1 million, or $0.04 per basic and diluted share, in the comparable period of 2022. The net loss for the year ended December 31st, 2023, was $18.8 million, or $0.21 per basic and diluted share, compared with a net loss of $33.7 million, or $0.39 per basic and diluted share, in the comparable period of 2022.

Finally.

Our net loss for the fourth quarter of 'twenty to 'twenty. Two we report a net profit of $9 $7 million or 11 sensitive basic and diluted share compared to a net loss of $1 million or four cents per basic and diluted share in the comparable period of time.

'twenty two.

Net loss for the year ended December 31st 2023.

$18 $8 million or 21.

Basic and diluted share.

Compared with a net loss of $33 $7 million or searching nine sensitive basic and diluted share in the comparable period of 2022 with that I will hand back to enough to summarize.

Anat Cohen: With that, I will hand it back to Anas to summarize. Thanks for watching! To summarize, 2023 was a very successful year for Compugen, both on the execution front and the validation of our computational discovery and development capabilities, including the exciting preclinical license deal with Gilead for our IL18BP immunology program, the initiation of two proof-of-concept studies and presentation of preliminary predictive biomarker data with our unique and innovative triple-IO combination, and progress by our partner AstraZeneca initiating Partnering remains an important part of our strategy, and we'll continue to focus on collaborating to extend the reach of our potentially first-in-class medicines to cancer patients and to accelerate value creation. I would like to thank all our colleagues here at Compugen for their passion and commitment to our success in 2023 and their dedication and readiness to drive for success in 2024. With that, I will turn the call over to questions. Operator.

Thanks Alberto.

To summarize 2023 was a very successful year for cockpit yeah.

Both on the execution front and the validation of our computational discovery and development capabilities.

Including the exciting preclinical license deal with Gilead for our ILEC 10, BP Immunology program.

<unk> off to a proof of concept studies.

Presentation of preliminary predictive biomarker data with our unique and innovative throughput I O combination.

And progress by our partner Astrazeneca, initiating a phase III trial with weird So got somebody.

Our accomplishments in 2023 position us well for a catalyst rich 'twenty 'twenty four and we then extended cash runway expected into 'twenty 'twenty seven.

Which we've been knee, we support the development of our clinical assets and novel early stage pipeline.

Partnering remains an important part of our strategy and we'll continue to focus on collaborating to extend the reach of our potentially first in class medicines to cancer patients and to accelerate value creation.

I would like to thank all of our colleagues here at comp again.

Their passion and commitment to our success in 2023.

And there's education and readiness to drive for success in 2024.

With that I will turn the call over to questions operator.

Thank you ladies and gentlemen at this time, we will begin the question and answer session. 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 congruent with the handset before pressing the numbers. Please standby, while we poll for your questions.

The first question is from.

<unk> got good warden of Truest. Please go ahead.

Hey, guys.

Operator: 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, kindly lift the handset before pressing the numbers.

Good morning, and thank.

Thanks for taking my questions and congrats on all the progress that have been made.

Looking forward to seeing how the cutlass play out that you just spoke to you a very interesting year for the company.

Just wanted to check in on the colorectal cancer data, which.

Operator: Please stand by while we poll for your questions. The first question is from Asthika Goonewardene of Truist. Please go ahead. Hey, guys. Good morning.

I'm sure I think everyone on the call is probably assuming that we could see that Ron nasco.

Perhaps I missed this but do you have biomarker data in that presentation. I know you said you have sometimes some special data, but I just wanted to.

Asthika Sarith Goonewardene: And thanks for taking my questions. And congrats on all the progress that has been made. Totally agree. Looking forward to seeing how the catalysts play out this year.

Clarify that'd be biomarker data a broker.

That's been tied to response.

So it's a very good question and we did say that will relate to translation I want to remind you that and with the prior year cohort of 22 patients where we disclose the data already in 'twenty three we did not.

Anat Cohen: This will be a very interesting year for the company. And I just wanted to check in on the colorectal cancer data, which I'm sure everyone on the call is probably assuming that we could see that around ASCO. Perhaps I missed this, but will you have biomarker data in that presentation? I know you said you'll have some translational data, but I just want to specifically clarify if there will be biomarker data that you can tie to response. So, it's a very good question, and we did say that we'll relate to translation. Now, I want to remind you that with the prior cohort of 22 patients where we disclosed the data already in 23, we did not share biomarker correlations. We did not see biomarker correlations in the CRC with the prior cohort.

And sure biomarker correlations, we did not see biomarker correlation scene.

Yes, even with the prior cohort if you will have anything to report them.

And we the next cohorts, we'll do that but I think that it's fair to say to mention that up until now we did not have seen the power of cohort biomarker correlations, Iran is there anything that he wants to add on this front.

As always we're doing a lot of reports on all fronts to analyze both correlation to response and the Pharmacodynamic markers and then whatever it would be relevant by the time of the presentation would be ships.

Got it thanks and then.

Eran Ophir: If we have anything to report with the next cohort, we'll do that. But I think that it's fair to mention that, up until now, we did not see biomarker correlations in the prior cohorts. Eran, is there anything that you want to add on this front? Now, as always, we're making a lot of efforts on all fronts to analyze both correlation-to-response and pharmacodynamic markers, and then whatever will be relevant by the time of the presentation will be shared. I got it.

Oh, and everybody with the platinum resistant ovarian cancer.

When we presented our bid run this.

This year.

At the time of the presentation I know you will have some preliminary biomarker work, but can you talk about what maybe your plans off of next steps then in terms of developing a potential companion diagnostics.

I think that it's fair to say that we're now at the stage that we're looking and as we said last time, we're optimizing DSA, while we're while we're testing the samples that we have in place.

Anat Cohen: And then with the platinum-resistant ovarian cancer data that will be presented later on this... and, At the time of the presentation, I know you will have some preliminary biomarker work, but can you please talk about what maybe your plans are for next steps in terms of developing a potential companion diagnosis? I think that it's fair to say that we're now at the stage where we're looking, as we said last time, at optimizing the assay while we're testing the samples that we have in place, those that we have already tested, and new ones. The aim is to be able to set a cutoff and to have an assay that we can use. It does not necessarily need to be a companion diagnostic level in terms of the assay itself, in order to be used in clinical trials.

And those that we already tested and in new ones.

The aim is to be able to set a cutoff and to have a nice day that we can use he does not necessarily need to be a companion diagnostic 11 in terms of the <unk>.

The S itself. It S. A in order to be used in clinical trials. So so we will if the data will repeat itself and we'll see correlations will make sure that we have an assay that can be used to select patients in a clinical trial.

Not necessarily this will be the assay that will be used eventually if everything goes well as a companion diagnostics in the market just to make sure that this is clear, but if data looks good we'll make sure that we have the SA two eh to select patients ready.

Anat Cohen: So we will, if the data repeats itself and we see correlations, we'll make sure that we have an essay that can be used to select patients in a clinical trial. Not necessarily, but this will be the essay that will be used eventually if everything goes well as a companion diagnostic in the market, just to make sure that this is clear. But if the data looks good, we'll make sure that we have the essay to select patients ready. Great. Thanks so much, guys. Thanks for taking my questions. I'll hop back in the queue.

Great. Thanks, so much guys. Thanks for taking my questions I'll hop back in queue. Thank you Jacob.

The next question is from Dr. Gray boss of Leerink. Please go ahead.

Hi.

I have a follow up can I sneak up there in that.

My ear it sounds like you're not you're emphasizing the biomarker enrollment strategy much more in this earnings call than you have in any quarter, So what changed.

<unk> data our strategy wise, that's leading to that change in emphasis.

Operator: Thank you, Chico. The next question is from Daina Graybosch of Lierink. Please go ahead. I kind of have a follow-up to Asthika there in that, Sounds like Anat, you're emphasizing the biomarker enrollment strategy much more in this earnings call than you have in the past. So what changed?

And so I think first and I don't know the banks are size more but to but at least I'll say, how we see.

And our path forward in light of potential data and in light of the competitive landscape I think that we we all recognize how the competitive landscape competitive treatment landscape is changing over time.

Daina Michelle Graybosch: Data or strategy wise, that's leading to that change in empathy, and so I think first, I don't know that we emphasize more, but at least I'll say how we see things passed forward in light of potential data and in light of the competitive landscape. I think that we all recognize how the competitive landscape, the competitive treatment landscape, is changing over time. We never took them up, and also maybe additional ADCs, and we understand that with the biomarker, we may have an end. And having a biomarker assay in place will allow us to go into a study that is well designed, gives us a higher probability of success, maybe a smaller study. And we believe that a biomarker will give us an edge, so we're not implying anything with respect to potential data outcomes. And as you know, we're still enrolling patients. We're only anticipating to complete enrollment by the end of the quarter.

We'd never took them up and also maybe additional a D CS and and we we understand.

Debt and with the biomarker, we may have an edge.

And having good and biomarker ethane place and will allow us to go into a study that is well designed gives us a higher probability of success, maybe a smaller study.

And we believe that a biomarker will give us an edge so not implying anything with respect to potential data outcomes and as you know we're still enrolling patients we're only anticipating to complete enrollment by the end of the quarter.

And I think that's it it's natural for US looking at the competitive landscape to try to look for places, where we can see an edge to ourself and I will also add.

And other than the biomarker. We also understand that there are now two population. So we may target. This is the those that are progressing or 90 season. Those that are not eligible for a b C. And we're also looking to see and where we may have an Ed just on these two populations. So maybe that would give some more color on.

Anat Cohen: I think that it's natural for us looking at the competitive landscape to try to look for places where we can see an edge for ourselves. I will also add that, other than the biomarker, we also understand that there are now two populations that we may target. This is those that are progressing on ADCs and those that are not eligible for ADCs. And we're also looking to see where we may have an edge in these two populations. So maybe that would give some more color on the focus of this call. And then, maybe, one follow-up.

And on the focus of this call.

Yeah.

And then maybe one follow up I think I heard you say at the end and you wrap up that you're looking to partner comps up in Taiwan.

With other company potentially in other novel combinations are you thinking any specific novel combinations or can you talk more about that strategy.

I think look pottery and get comfort in a one M and culminating with two n's or come come they know too well, it's always sad and something that we took into consideration and that's because we're not intending to take the program alone to the market.

Daina Michelle Graybosch: I think I heard you say at the end of your wrap-up that you're looking to partner COM701 with other companies, potentially in other novel combinations. Are you thinking any specific novel combinations, or can you talk more about that strategy? Look, partnering COM701 and COM902 and or COM902 was always something that we took into consideration. And that's because we're not intending to take the program alone to the market.

And it and I think that today.

We did that.

You have in place, which is the kind of broad across indications. So all of these indications. There. We showed data is really hard to treat two more times. The way we were able to show durable responses at the patients on the patients with the patients that responded.

Anat Cohen: And I think that today, with the data that we have in place, which is kind of broad across indications, all of these indications that we show data on are really how to treat two more types where we were able to show durable responses to the patients on the patients with the patients that responded, a good tolerability that allows for combinations. We're thinking not only about what we're doing internally, but we're also thinking about how to broaden the opportunities for our drugs. And we recognize the fact that there is, obviously, as a small biotech company, a limit to what we can do. And for us, broadening the opportunities for collaboration is a priority. So that's it.

Good Tolerability.

That allows for combinations, we're thinking not only on what we're doing internally, but we're also thinking about how.

To broaden the opportunities for our drugs and we recognize the fact that there is oh.

Obviously as a small biotech company there is a limit to what we can do.

And for US pardon me the opportunities through collaborations is there is it is.

He is a priority so that Pete and I will let to Iran relate more to the mechanism of faction potential collaborate a potential combination strategy based on decent mechanism affection and the toll over but.

Safety profile around maybe you want to add few thinks about it.

Eran Ophir: I will let Eran relate more to the mechanism of action, potential combination strategy based on this mechanism of action in the tolerable safety profile. Eran, maybe you want to add a few things about that. Yeah, so we've shown quite extensively that PVRG is a unique checkpoint and that blocking PVRG indeed can synthesize tumors to TGT and PD-1. So, and this is what we're testing, right? The triplet combination, which is an IO, pure combination, extremely safe, very good tolerance profile, and we hope to see the signals mature, and we'll share them later this year. But of course, the potential is out there.

Yeah. So we've showed quite extensively the technology's unique checkpoints.

Then that blocking <unk> tumors to two did you did you want so and this is what we're testing right. The triplet combination, which is an annual fuel combination extremely safe and very good tolerability profile and in and we hope to see the cigna's mature when we share with you later this year, but of course the potential is out there it would be combined with skin with Europe.

We combine early lines of therapy I mean, this mechanism of action of people that you couldnt available.

Other aspects.

Providing a relatively safe approach that could drive T cells into the tumor.

This could be combined also.

Regardless of the triplet combination we are pursuing.

Great. Thank you.

The next question is from Stephen Wiley of Stifel. Please go ahead.

Daina Michelle Graybosch: It could be combined with chemotherapy; it could be combined in earlier lines of therapy. I mean, this mechanism of action of PVRG could be relevant also in many other aspects, providing a relatively safe approach that could drive T-cells into the tumor, and we believe this could be combined also in regardless of the triplet combination we are pursuing. Great, thank you. The next question is from Stephen Wiley of Stiefel. Please go ahead. Yeah, I can. I think you may have mentioned it on the call. Speak a little bit about the historical, and I guess there's obviously a lot of bio-based. That's it. Look at us.

Yeah.

Yeah. Good morning, Thanks for taking the questions.

Thank you you may have mentioned it on the call, but can you just maybe speak to I guess.

The efficacy metrics I know, there's a lot of talk about the biomarker directed strategy.

Can you speak a little bit to that.

Efficacy data that you're going to be.

Using out of the colorectal trial.

Decision.

Asked the question because.

Historical disconnect here that tends to exist between response rates.

And eventually the data.

Schumer toys.

And then I guess, there's obviously a lot of different.

I O based regimens that are pursuing and Don liver met population is.

Is that something that is of interest to you to look at that as a potential.

Development opportunity or do you think that that landscape has kind of become a bit too crowded.

So I think that it's fair to say that are when we're looking at what to do you know how we will judge our data it really with respect to the benchmarks and what would.

Stephen Douglas Willey: So I think that it's fair to say that when we're looking at how we will judge our data, it's really with respect to the benchmarks and what would be relevant based on standard of care, but also based on, you know, other clinical trials. I think that, and I'll let Michelle comment on it, but I think that it's a fair point that you raised. The data that we were seeing in the data that was disclosed already is really data within the liver met population that was intriguing for us because, really, this is a very hard-to-treat patient population. Really, there are no agents there that are really targeting this patient population. And I think that when we have our data in front of us, we will look at the overall population, but we will also take a close look at the liver mets where we believe that we have an edge. So I'll let Michelle speak about, you know, how we may look at our data as compared to benchmarks. Great, thank you.

Well it would be.

A relevant based on the standards based on standard of care, but also based on you know other clinical trials.

And I think that and I'll, let michelle relate to it but I think that it's a fair point that you raised and the data that we were seeing.

Is it in the data that we've disclosed already is really data we didn't deliver unmatched population.

There was intriguing for us because really really this is a very hard to treat patient population really there are no agents there that are really targeting.

Targeting this patient population.

And I think that to when we will have our data in front of US we will look at the overall population, but we will also take a close look at the lever of match it.

Well, we believe.

Then we have an edge so I left hand, Michelle and speaking about our you know how we how we may look at the data as compared to benchmarks Brent. Thank you. Thanks for the question I think that you made a very good point and we think about the data quite similarly so.

Unknown Executive: Thanks for the question. I think that you made a very good point, and we think about the data quite similarly. So in early stage clinical trials, as you know, we often look at overall response rates as a way to test whether there is a proof of concept. And it's often seen as a surrogate for other endpoints that are related to progression-free survival and overall survival. But I think also in these hard-to-treat populations, we cannot ignore the sustained, Stable Disease Responders, keeping in mind that once a lot of these drugs go on to phase three registration studies, the primary endpoints are no longer overall response rates, and many times they're reporting out a primary endpoint of overall survival. So when we look at single-arm studies, we have to interpret survival endpoints with the limitations that we have, knowing that our data sets are small, single-arm studies, but we also have to keep in mind the big picture in terms of what the registration endpoints are.

In early stage clinical trials as you know is we often look at overall response rates as a way to test whether theres a proof of concept and it's often seen as a surrogate for other endpoints that are related to progression free survival and overall survival, but I think.

Also in these hard to treat populations, we cannot ignore the sustained.

Stable disease responder.

Ping in mind that once a lot of these are drugs go onto phase III registration studies. The primary endpoints are no longer overall response rate and many times, they're reporting alturas.

Every endpoint of overall survival. So when we look at the single arm studies, we have to interpret survival endpoints with the limitations that we have knowing that our datasets are small single arm studies, but we also have to keep in mind. The big picture in terms of what are the registration end points and so I think.

Unknown Executive: And so I think it's important not to ignore the patients that have sustained responses of stable disease, and that's where the disease control rate becomes relevant in looking at the data. We will look at the totality of the data to be able to make these go, no-go decisions, and we will also look at it with an eye towards what will be the survival benchmarks as the landscape evolves.

It's important not to ignore the patients that have sustained responses or stable disease, and that's where the disease control rate becomes relevant.

In looking at the data. So we will look at the totality of the data to be able to make these go no go decisions.

And we will also look at it with an eye towards what will be the survival benchmarks as the landscape is evolving.

Unknown Executive: And with that, I think I'd be happy to elaborate if you have additional questions. Let me just get, any interest specifically in, So I just want to clarify that you're talking about patients without liver metastases, because our data is actually targeted at the most difficult-to-treat patient populations. So in the data that was previously presented, 75% of the patient population had liver metastases. Yeah, which is obviously a subgroup of non-liver med patients that are now. Okay, so given what we're seeing and what we've presented in our patients with levomets, it still remains an area of focus for us. Yeah, I think I'll just, Steve, I'll just add that we recognize the fact that there's not a lot of data there for liver mass at all. I think that there is some data, maybe by genus, that is relating to overall survival, median overall survival of 8.7 months, etc.

And with that I think happy to elaborate if you have additional questions.

And then it just gets.

Any interest specifically and maybe.

Looking at the popular.

Population and a bit more.

The detail I know you probably only.

These patients represented in there.

I just want to clarify that you were talking about the patients without little metastases, because that data is actually targeted to the most difficult to treat patient population. So in the data that was previously presented 75% of the patient population had liver metastases.

What he says.

Which is E G E.

Ah subgroups.

<unk>.

Pursued by a variety of companies.

The number of <unk>.

Based regimens.

Okay. So given given what we're seeing and what we've presented in all patients with liver Mets. It still remains an area of focus for us.

Okay.

Yeah, I think I'll, just add Steve I'll, just add that we recognize the fact.

That there's not a lot of data there for live in that at all and I think that there is some there is some data maybe bye bye agena studies relating to and two of her survival median over survival of fat eight seven months et cetera, we're taking all of this into consideration I mean over.

Anat Cohen: We're taking all of this into consideration. I mean, overall response rate is not there at all for liver mass, and we will look at overall response rate. We do expect that in our patient population, we'll have the same representation of the population in terms of liver mass. Most of the time, more than 70% of the patients in this line of treatment that we're enrolling have liver mass.

The response rate is not their tons four lever them up and we will look at all of our response rate and we do expect it in a patient population will have the same representation.

The population in terms of the liver met most of the more than 70% of the patients.

In this line of treatment that we're enrolling are having liver Mets.

Anat Cohen: So we expect that we'll have the same representation in this, and we will take a careful look at this patient population because we do think that we may have an edge there. And then, I guess just on the partnering. Nationality Front, remind us, are you exclusive with Astra?

So we expect it will have the same representation in this N M and it and then we will take a careful look at this patient population because we do think that that we may have an edge there.

Okay.

Okay, and then I guess just on the partnering Optionality front can you just remind us are you exclusive with Astro on coal mine are too.

Stephen Douglas Willey: Thank you very much. Thank you. I guess I just asked. So totally the latter.

Or is that just specific to the use of our specific antibodies incorporating attach a domain and I guess I just asked the question because.

I mean, obviously gilead just made it.

A fairly strong vote of confidence in a nutshell silent.

There's probably some scarcity value around that.

So totally the latter.

The latter so astrazeneca and has the rights to use.

Operator: So AstraZeneca has the right to use the COM 902 segment in their bi-specific. So they got the rights to develop bi-specifics based on our COM 902. We own COM 902. We have also kept to ourselves rights for certain bi-specifics that we have an interest in.

The cum 902 segment and in a in their bispecific. So they got the rights to develop Bispecific based on our come 902, we own call 902.

We also kept ourselves right for sudden bi specifics did we have an interesting. So for example, the T. G. P. B R. E D O D. G P very astute with I work on I know too.

Anat Cohen: So, for example, the TGP-VRIG or TGP-VRL2 with our COM 902 is ours. We totally relate to COM 902 as an asset. It's nice to see that you mentioned the FC question, which we were always saying, always that it either does not matter or that if it matters, then it should be a silent one. And we're happy to see that there is data now supporting it. We own COM701 and COM902.

Worse.

We do we totally relate to come nine months to as an asset and it's nice to see that you know Ted did you mentioned that that S. C question, which we were always saying always studied I did do not met there it does not matter or debt if it <unk>.

Terrorists, then it you'd be silent one.

And we're happy to see that there is a they don't know supporting it.

We own and Com 701 and call 902.

Anat Cohen: We believe that these are good partnering opportunities. We have our own plans to move ahead with these assets internally, obviously in a data-driven manner, and in a biology-driven manner. But we do think that these are drug assets that can generate collaboration opportunities for us, and we will intend to proceed because we believe that, with partners, we can broadly test them. And as you know, I answered Daina, but I think that one of the key things that should be mentioned is that we tested COM701, COM902 combinations in the most hard-to-treat patient populations. It gives us an edge. You can test it in single-arm studies, but one cannot ignore that these assets have potential in the inflamed tumor type.

We believe that these are good partnering and Gulfport unique Ts, we have our own plans to move ahead with these assets internally, obviously in a data driven manner and biology, driven manner, but we do think that.

These are and drug assets that can generate a collaboration opportunities for us.

And we will do we will intend to pursue it because we believe that with partners. We can broadly testing and as you know I I answered to Dana.

And I think that's one of the key he thinks that you'd be mentioned, we tested concept and no one called 902 combinations.

Most hard to treat patient population.

It gave it gives us an edge you can definitely think single arm studies, but but one cannot ignore the beach asset has a potential in the inflamed tumor types.

Anat Cohen: And this is a great opportunity based on the data that we have, and the data that we have is supporting COMP 701 driven effects. We believe that they could serve as good partnering opportunities, and hopefully, the TG data that is out there and that will be out there by the companies that are leading this field will allow us to clear the air for TG at least to understand that there is a benefit by adding TG to PD-1 and that there is a third component that is needed. And I think that the world is starting to see that there is the third component that is needed, and we believe that it's PVRIG. So yes, on the partnering front, that's how we think about it. Thank you. This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect. Thank-you for watching.

This is a great opportunity it based on the data that we have and the data that we have supporting comps are the ones we've in effect.

We believe that it could serve as a good partnering opportunities and hopefully at the T. G Tech data that is out there and that will be out there and buy the companies that are leading these fields.

Will.

All of us to clear the air for T. G at least to understand that there is a benefit by adding T. G. Two PD one and that there is a third component that is needed and I think that the words touch to see that there is a third component that is needed.

And we believe that it's P V. I G. So yes, I'm partnering front, that's that's how we think about it.

Okay. Thanks for taking questions.

Thank you.

This concludes the Q&A session and Comping Jones Investor Conference call. Thank you for your participation you May go ahead and disconnect.

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