Q4 2023 Agenus Inc Earnings Call

March 14, 2024

Operator: Good morning, my name is Audra, and I will be your conference operator today. At this time, I would like to welcome everyone to the Agenus Inc. Fourth Quarter and Full Year 2023 Results Conference Call. Today's conference is being recorded. [Operator Instructions] At this time, I would like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.

Please wait the conference will begin shortly.

[music].

Operator: At this time, I would like to welcome everyone to the Agenus Inc. Fourth Quarter and Full Year 2023 Results Conference Call. Today's conference is being recorded. All lines have been placed on mute to prevent any background noise.

Good morning, My name is Andre and I will be your conference operator today.

At this time I would like to welcome everyone to be Edginess, Inc, fourth quarter and for the full.

Full year 2023 results Conference call. Today's conference is being recorded all lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session can he would like to ask a question. During this time simply press the star key followed by the number one on your telephone keypad.

Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 0. At this time, I would like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.

Would like to withdraw your question Press Star one again.

At this time I would like to turn the conference over to Zack Garmin head of Investor Relations. Please go ahead.

Zack Armen: Thank you, Audrey, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines, as well as timelines for data release and partnership opportunities, among other updates. These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer, Dr. Steven ODay, Chief Medical Officer, and Christine Klaskin, Vice President of Finance. Dr. Robin Taylor, Chief Commercial Officer, and Dr. Todd Yancy, Chief Strategic Advisor, will be participating in the Q&A session. Now, I'd like to turn the call over to Garo to highlight our progress in 2023 and to speak to our outlook for 2024.

Thank you Andres and thank you all for joining US today today's call is being webcast and will be available on our web site for replay.

I'd like to remind you that this call will include forward looking statements, including statements regarding our clinical development regulatory and commercial plans and timelines as well as timelines for data release and partnership opportunities. Among other updates. These statements are subject to risks and uncertainties and we refer you to our SEC filings.

These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer, Dr. Steven ODay, Chief Medical Officer, and Christine Klaskin, Vice President of Finance. Dr. Robin Taylor, Chief Commercial Officer, and Dr. Todd Yancy, Chief Strategic Advisor, will be participating in the Q&A session. Now, I'd like to turn the call over to Garo to highlight our progress in 2023 and to speak to our outlook for 2024.

These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks.

Available on our website for more details on these risks.

Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Steven O'Day, Chief Medical Officer; and Christine Klaskin, Vice President of Finance; Dr. Robin Taylor, Chief Commercial Officer; and Dr. Todd Yancey, Chief Strategic Advisor; will be participating in the Q&A session. Now, I'd like to turn the call over to Garo to highlight our progress in 2023 and to speak to our outlook for 2024. Garo?

Joining me today are Dr. Garo, Armen, Chairman and Chief Executive Officer, Dr. Stephen, Though day, Chief Medical Officer, and Christine <unk>, Vice President of Finance.

After Robin Taylor, Chief commercial officer, and Dr. Todd DMT senior strategic advisor, who will be participating in the Q&A session.

Now, I'd like to turn the call over to Garo to highlight our progress in 2023 and to speak to our outlook for 2024. Garo?

Now I'd like to turn the call over to Garo to highlight our progress in 2023 and to speak to our outlook for 2020 for apparel.

Garo H. Armen: Thank you very much. Ladies and gentlemen, today, it is with great enthusiasm that we gather to share the remarkable strides Agenus has made over the past year. Our journey has been marked by significant achievements, pivotal milestones, and a steadfast commitment to innovation in the field of oncology. In 2023, Agenus reached crucial milestones, particularly with our BOT/BAL program, and cornerstone of our operational focus.

Garo Armen: Thank you very much. Ladies and gentlemen, today, it is with great enthusiasm that we gather to share the remarkable strides Agenus has made over the past year. Our journey has been marked by significant achievements, pivotal milestones, and a steadfast commitment to innovation in the field of oncology.

Thank you very much ladies and gentlemen.

It is with great enthusiasm that we gathered to share the remarkable strides Genesis made over the past year.

Our journey has been marked by significant achievements pivotal milestones.

Thanks.

Innovation in the field of oncology.

In 2023 and generous reach crucial milestones.

In 2023, Agenus reached crucial milestones, particularly with our BOT/BAL program, and cornerstone of our operational focus. BOT/BAL therapy has undergone rigorous testing in over 900 patients, demonstrating promising activity in cancers that represent significant unmet medical needs, notably colon cancer, where we are poised for potential first approval. The impressive response rate, sustained durability, and overall clinical efficacy observed across multiple challenging cancer types have garnered attention and excitement from leading experts in the field. It is essential to note that the patients enrolled in our trials have exhausted available standard treatments, making clinical responses achieved all the more meaningful. Our achievements in the past year underscored the immune potential, immense potential of BOTENSILIMAB, both as a stand-alone therapy and in combination with BALSTILIMAB and or chemotherapy.

Particularly with our <unk> program and cornerstone of our operational publish.

Garo H. Armen: But Welltherapy has undergone rigorous testing in over 900 patients, demonstrating promising activity in cancers that represent significant unmet medical needs, notably colon cancer, where we are poised for potential first approval. The impressive response rate, sustained durability, and overall clinical efficacy observed across multiple challenging cancer types have garnered attention and excitement from leading experts in the field. It is essential to note that the patients enrolled in our trials have exhausted available standard treatment, making the clinical responses achieved all the more meaningful. Our achievements in the past year underscored the immune potential and immense potential of botanical math, both as a stand-alone therapy and in combination with vasculimab and or chemotherapy.

But rob happy is undergone rigorous testing in over 900 patients.

Demonstrating promising activity in categories that represent significant unmet medical needs.

Notably colon cancer, where we are poised for potential first approval.

The impressive response rates.

Sustained durability and overall clinical efficacy observed across multiple challenging cancer types have garnered the attention and excitement from leading experts in the field.

It is essential to note that the patients enrolled in our trials have exhausted available standard treatments, making clinical responses achieved all the more meaningful. Our achievements in the past year underscored the immune potential, immense potential of BOTENSILIMAB, both as a stand-alone therapy and in combination with BALSTILIMAB and or chemotherapy. All of these trials are currently ongoing.

It is essential to note that the patients enrolled in our trials have exhaust available.

Available standard treatments, making clinical responses achieved all the more meaningful.

Our achievements in the past the auditors for being the other potential in mass potential potentially map.

Both as a standalone therapy.

And in combination with <unk>.

And all chemotherapy.

Garo H. Armen: All of these trials are currently ongoing. The presentation of our data at six prestigious scientific forums and publication in five peer-reviewed journals is a testament to the robustness and significance of our findings. Dr. Oday will delve into the clinical data shortly, providing more detailed insights during this call. The resounding feedback from over 1,000 physicians we engaged with over the past year underscores the transformative impact of our work and the impact it could have on patient care. Furthermore, the Fast-Track Designation granted by the FDA acknowledges the urgent need for new treatments in our lead indication, which is refractory MSS-CRC in non-liver metastatic patients. As we stand on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval pilot. Our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards. In 2024, our primary objective is to pursue a global regulatory strategy for Bach-Bau through our fast-track dedication.

All of these trials are currently ongoing.

The presentation of our data at 6 prestigious scientific forums and publication in 5 peer-reviewed journals is a testament to the robustness and significance of our findings. Dr. O'Day will delve into the clinical data shortly, providing more detailed insights during this call. The resounding feedback from over 1,000 physicians we engaged with over the past year, underscores the transformative impact of our work and the impact it could have on patient care. Furthermore, the Fast-Track designation granted by the FDA acknowledges the urgent need for new treatments in our lead indication, which is refractory MSS-CRC in non-liver metastatic patients. As we stand on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval filing. Our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards. In 2024, our primary objective is to pursue a global regulatory strategy for BOT/BAL through our Fast-Track indication.

The presentation of our data six prestigious scientific forums and publication in peer reviewed journals.

As a testament to the robustness.

The significance of our findings.

Or they will delve into the clinical data shortly providing more detailed insights during this call.

Yes.

The resounding feedback from over 1000 transactions, we engaged with over the past year underscores the transformative impact of our work.

The resounding feedback from over 1,000 physicians we engaged with over the past year, underscores the transformative impact of our work and the impact it could have on patient care. Furthermore, the Fast-Track designation granted by the FDA acknowledges the urgent need for new treatments in our lead indication, which is refractory MSS-CRC in non-liver metastatic patients. As we stand on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval filing. Our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards. In 2024, our primary objective is to pursue a global regulatory strategy for BOT/BAL through our Fast-Track indication.

And the impact it could have on patient care.

Turning to Omar the fast track designation granted by the FDA acknowledges the urgent need for new treatments in our lead indications.

Which is refractory MSS CRC and non liver metastatic patients.

As we spend on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval filing. Our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards. In 2024, our primary objective is to pursue a global regulatory strategy for BOT/BAL through our Fast-Track indication. Following alignment with the FDA, we intend to initiate the submission of our biologics license application, otherwise known as a BLA, for potential accelerated approval.

As we spend on the threshold of a clinical and a critical phase in our regulatory journey.

Our focus is squarely on advancing activities for a potential accelerated approval filing.

Our immediate efforts.

Our directed towards ensuring that our development strategies align seamlessly with DSD as rig nice standards.

In 2024, our primary objective is to pursue a global regulatory strategy for Pascal.

Our fast track indication.

Garo H. Armen: Following alignment with the FDA, we intend to initiate the submission of our biologics license application, otherwise known as a BLA, for potential accelerated approval. Subsequently, pending feedback from scientific and regulatory advice in Europe. We plan to submit it to the European Medicines Agency, known as the EMA, in 2025. To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory authorities with a comprehensive data package that demonstrates the safety, efficacy, and clinical pharmacology in BOT/BAL in refractory MSS-CRC. Our Phase II study, completed in October 2023, or I should say completed enrollment in 2023, was meticulously designed to evaluate BOT/BAL dosage and the contribution of its components.

Following alignment with the FDA, we intend to initiate the submission of our biologics license application, otherwise known as a BLA, for potential accelerated approval.

Following the alignment with the SBA, we intend to initiate the submission of our biologics license application otherwise known as a BLA.

For a potential accelerated approval.

Subsequently pending feedback from scientific and regulatory advisors in Europe.

approval. Subsequently, pending feedback from scientific and regulatory advice in Europe. We plan to submit it to the European Medicines Agency, known as the EMA, in 2025. To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory authorities with a comprehensive data package that demonstrates the safety, efficacy, and clinical pharmacology in BOT/BAL in refractory MSS-CRC. Our Phase II study, completed in October 2023, or I should say completed enrollment in 2023, was meticulously designed to evaluate BOT/BAL dosage and the contribution of its components.

approval.

Subsequently, pending feedback from scientific and regulatory advice in Europe. We plan to submit it to the European Medicines Agency, known as the EMA, in 2025. To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory authorities with a comprehensive data package that demonstrates the safety, efficacy, and clinical pharmacology in BOT/BAL in refractory MSS-CRC. Our Phase II study, completed in October 2023, or I should say completed enrollment in 2023, was meticulously designed to evaluate BOT/BAL dosage and the contribution of its components.

We plan to submit to the European Medicines agency known as the EMA and 2025.

Yes.

To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory apologies with the comprehensive data package that demonstrates the safety.

Efficacy and clinical pharmacology.

And refractory MSS CRC.

Garo H. Armen: Our Phase II study, completed in October 2023, or I should say completed enrollment in 2023, was meticulously designed to evaluate BOT/BAL dosage and the contribution of its components. Additionally, by the end of 2024, we anticipate initiating a Phase III study in the patient population of our proposed indication. Our commitment to transparency and stakeholder engagement remains unwavering as we progress towards delivering these potentially life-altering treatments to patients. Looking ahead, our mission to enhance the lives of cancer patients through the power of the immune system will remain steadfast. That's been our mission from day 1, 30 years ago.

Our Phase II study, completed in October 2023, or I should say completed enrollment in 2023, was meticulously designed to evaluate BOT/BAL dosage and the contribution of its components.

Our phase II study completed in October 2023, or I should say completed enrollment in 2023 was maintained mostly designed to evaluate <unk>.

<unk> dosage and the contribution of its components.

Additionally, by the end of 2024, we anticipate initiating a Phase III study in the patient population of our proposed indication. Our commitment to transparency and stakeholder engagement remains unwavering as we progress towards delivering these potentially life-altering treatments to patients. Looking ahead, our mission to enhance the lives of cancer patients through the power of the immune system will remain steadfast. That's been our mission from day 1, 30 years ago. Of course, today with BOT/BAL leading the charge in our dynamic portfolio of agents.

By the end of 2024, we anticipate initiating a phase III study and the patient population of our proposed indication.

Our commitment to transparency and stakeholder engagement remains unwavering as we progress towards delivering these potentially life altering treatments to patients.

Looking ahead our <unk>.

Mission to enhance the lives of cancer patients sort of power of the immune system.

<unk> steadfast that's been our mission from day 130 years ago of course today with mobile leading the charge at our dynamic portfolio of agents.

Garo H. Armen: Of course, today with MacMillan leading the charge in our dynamic portfolio of agents. To expedite this transformative journey, we are actively exploring strategic partnerships. Our ongoing collaborations have already yielded significant returns, as illustrated, for example, by the recent $25 million milestone payments from BMS triggered by the commencement of a phase 2 study with BMS. 986442.

Of course, today with MacMillan leading the charge in our dynamic portfolio of agents.

Turning to me that this transformative journey, we are actively exploring strategic partnerships. Our ongoing collaborations have already yielded significant returns example hired for example by the recent $25 million milestone payment from BMS triggered by the commencement of our phase.

To expedite this transformative journey, we are actively exploring strategic partnerships. Our ongoing collaborations have already yielded significant returns, exemplified, for example, by the recent $25 million milestone payments from BMS triggered by the commencement of a Phase II study with BMS- 986442. This is a TIGIT bispecific antibody discovered, and the early development was done by Agenus, and it was licensed to BMS.

This study with BMS.

98642. This is a tangent bi specific antibody discovery and early development was done by jazz and it was licensed to BMS.

Garo H. Armen: This is a tiget by specific anybody discovered, and the early development was done by Agenus, and it was licensed to BMS. We have received a total of $250 million from this collaboration thus far. Moreover, we are progressing our efforts to monetize non-core assets and explore royalty finance and project funding opportunities, with the potential to generate an additional $100-$200 million in the relatively near term. Furthermore, we're engaged in discussions with several prospective pharmaceutical partners exploring avenues for co-marketing and Co-Development Agreement, specifically for But Now. Dr. Oday will now provide an overview of our latest clinical findings, further illuminating the groundbreaking progress we've made so far. Thank you for your continued support and confidence in Agenus. Together, we are pioneering a new era in cancer treatment, one that offers hope and healing to patients worldwide. Dr. Oday

This is a tiget by specific anybody discovered, and the early development was done by Agenus, and it was licensed to BMS.

We have received a total of $250 million from this collaboration thus far.

We have received a total of $250 million from this collaboration thus far. Moreover, we are progressing our efforts to monetize non-core assets and explore royalty financing and project funding opportunities, with the potential to generate an additional $100million to $200 million in the relatively near-term. Furthermore, we're engaged in discussions with several prospective pharmaceutical partners exploring avenues for co-marketing and co-development agreement, specifically for BOT/BAL. Dr. O'Day will now provide an overview of our latest clinical findings, further illuminating the groundbreaking progress we've made so far. Thank you for your continued support and confidence in Agenus. Together, we are pioneering a new era in cancer treatment, one that offers hope and healing to patients worldwide. Dr. O'Day?

Moreover, we are progressing our efforts to monetize non core assets and explore royalty financing and project funding opportunities with the potential to generate an additional 100 to 100 millions of dollars in the relatively near term.

Furthermore, we are engaged in discussions with several prospective pharmaceutical partners.

Flooring avenues for co marketing.

And co development agreements specifically for now.

Okay.

Dr. <unk> will now provide an overview of our latest clinical findings further eliminating the groundbreaking progress we've made so far.

Thank you for your continued support and confidence in Agenus. Together, we are pioneering a new era in cancer treatment, one that offers hope and healing to patients worldwide. Dr. O'Day?

Thanks, you for your continued support and confidence in our Janus together, we are pioneering a new era in cancer treatment and one that offers hope and healing to patients worldwide.

Hey.

Steven J. ODay: Thank you, Garo. Together with our investigators and key opinion leaders, we presented updates from BOT/BAL development program at ASCO-GI, the Society of Gynecologic Oncology. ESMO GI, CTOS and at a corporate event hosted during the ESMO Congress in October. Throughout 2023, new clinical data was presented for nearly all of our programs. And I refer you to our press release issued today that provides a comprehensive summary of our 2023 clinical development update. Today, I'd like to share a selection of our data updates from the last year, which highlight some of the compelling opportunities we have to transform care for patients. Starting with safety, we continue to observe a manageable safety profile. As of May 2023 data cut from our solid tumor Phase I/B study with doses of 1 milligram per kilo or 2 milligrams per kilo of BOTENSILIMAB in combination with BALSTILIMAB. The most common adverse events were immune-related, and the most common of these were diarrhea and colitis. Three or greater treatment-related diarrhea and colitis occurred in 14% of patients.

Steven O'Day: Thank you, Garo. Together with our investigators and key opinion leaders, we presented updates from BOT/BAL development program at ASCO-GI, the Society of Gynecologic Oncology. ESMO GI, CTOS and at a corporate event hosted during the ESMO Congress in October. Throughout 2023, new clinical data was presented for nearly all of our programs. And I refer you to our press release issued today that provides a comprehensive summary of our 2023 clinical development update.

Thank you Garo together with our investigators and key opinion leaders, we presented updates from Bob.

Development program at <unk> Gi.

<unk> of gynecologic oncology.

As <unk> Gi.

VITAS.

And at a corporate event hosted during the ESMO Congress in October.

Throughout 2023, new clinical data was presented for nearly all of our program.

I refer you to our press release issued today that provides a comprehensive summary of our 2023 clinical development update.

Today, I'd like to share a selection of our data updates from the last year, which highlight some of the compelling opportunities we have to transform care for patients. Starting with safety, we continue to observe a manageable safety profile. As of May 2023 data cut from our solid tumor Phase I/B study with doses of 1 milligram per kilo or 2 milligrams per kilo of BOTENSILIMAB in combination with BALSTILIMAB. The most common adverse events were immune-related, and the most common of these were diarrhea and colitis. Three or greater treatment-related diarrhea and colitis occurred in 14% of patients.

Today, I'd like to share a selection of our data updates from the last year, which highlight some of the compelling opportunities we have to transform care for patients. Starting with safety, we continue to observe a manageable safety profile. As of May 2023 data cut from our solid tumor Phase I/B study with doses of 1 milligram per kilo or 2 milligrams per kilo of BOTENSILIMAB in combination with BALSTILIMAB. The most common adverse events were immune-related, and the most common of these were diarrhea and colitis. Grade 3 or greater treatment-related diarrhea and colitis occurred in 14% of patients.

Today I'd like to share a selection of our data updates from the last year, which highlights some of the compelling opportunities we have to transform care for patients.

Starting with safety, we continue to observe a manageable safety profile.

As of May 2023 data from our solid tumor phase one b study with doses of one milligram per kilo or two milligrams per kilo a boat fill them up in combination with <unk> still about.

The most common adverse events were immune-related, and the most common of these were diarrhea and colitis. Grade 3 or greater treatment-related diarrhea and colitis occurred in 14% of patients. These findings are consistent with the mechanism of action of BOT and BAL as both our immuno-oncology agents. Now, turning to our CRC development program for BOT and BAL where we have made significant progress. As of our latest update during our corporate event in October 2023, our Phase I/b expanded cohort of 70 evaluable patients had a median follow-up now of 12.3 months, and RECIST confirmed an overall response rate of 24%. Based on literature review, the response rate in a similar population treated with standard of care therapies ranges from 1% to 6%. In addition, patients in our trial showed a 12-month overall survival rate of 74%. Median overall survival has not been reached.

The most common adverse events were immune related.

The most common of these.

<unk> diarrhea and colitis.

Great three or greater treatment related diarrhea colitis occurred in 14% of patients.

Grade 3 or greater treatment-related diarrhea and colitis occurred in 14% of patients.

Steven J. ODay: These findings are consistent with the mechanism of action of BOT and BAL as both are immuno-oncology agents. Now, turning to our CRC development program for Baht and Ba'al, where we have made significant progress. As of our latest update during our corporate event in October 2023, our Phase 1b Expanded Cohort of 70 Evaluable Patients had a median follow-up now of 12.3 months, and Rhesus confirmed an overall response rate of 24%. Based on literature review, the response rate in a similar population treated with standard care therapies ranges from 1 to 6%. In addition, patients in our trial showed a 12-month overall survival rate of 74%. However, median overall survival has not been reached.

These findings are consistent with the mechanism of action of button Bell as both our immuno oncology agents.

Now turning to our CRC development program for Barton.

Where we have made significant progress.

As of our latest update during our corporate event in October 2023.

Our phase one be expanded cohort of 70 Evaluable patients had a median follow up now of 12 three months.

And resist confirmed overall response rate of 24%.

Based on literature review the response rate in a similar population.

With standard of care therapies ranges from 1% to 6%.

In addition patients in our trial showed a 12 month overall survival rate of 74%.

In addition, patients in our trial showed a 12-month overall survival rate of 74%. Median overall survival has not been reached. We anticipate having top-line data from the Phase II trial publicly available in the second half of 2024 to align with our planned regulatory timeline and allow for sufficient data maturation. At ASCO GI in January of this year, data was presented from an investigator-sponsored trial being conducted by Dr. Pashtoon Kasi at Weill Cornell Medical Center, in which 12 patients with colorectal cancer were treated with 1 dose of BOT at 75 milligrams and 2 doses of BALSTILIMAB at 240 milligram. In a neoadjuvant therapy window of opportunity setting. Surgery was performed on average 4 weeks after the initiation of immunotherapy. All 3 of 3 MSI high colorectal patients had complete or near complete pathologic responses. And even more importantly, 6 out of 9 patients with MS-stable colorectal cancer had pathologic responses of 50% or greater, including 2 complete pathologic responses. None of the 12 patients had tumor growth during the treatment interval, and no surgeries were delayed due to immune-related toxicities. There were only two instances of grade 3 treatment-related adverse events, diarrhea and fatigue, which were reversed.

Median.

Overall survival has not been reached.

Steven J. ODay: We anticipate having top-line data from the Phase 2 trial publicly available in the second half of 2024 to align with our planned regulatory timeline and allow for sufficient data maturation. At ASCO GI in January of this year, data was presented from an investigator-sponsored trial being conducted by Dr. Pashtun Kasi at Weill Cornell Medical Center, in which 12 patients with colorectal cancer were treated with one dose of BOT at 75 milligrams and two doses of balstilamide at 240 milligrams in a neoadjuvant therapy window of opportunity setting. Surgery was performed on average four weeks after the initiation of immunotherapy. All three of the three MSI high colorectal patients had a complete or near complete pathologic response. And even more importantly, six out of nine patients with MS-stable colorectal cancer had pathologic responses of 50% or greater, including two complete pathologic responses. None of the 12 patients had tumor growth during the treatment interval, and no surgeries were delayed during treatment.

We anticipate having top line data from the phase III trial publicly available in the second half of 2024 to align with our planned regulatory timeline and allow for sufficient data maturation.

At <unk> Gi in January of this year data was presented from an investigator sponsored trial being conducted by Dr pass to coffee.

Ah Weill Cornell Medical Center.

In which 12 patients with colorectal cancer were treated with one dose of BOP at 75 milligrams and two doses about still about at 240 milligram.

Neo adjuvant therapy window of opportunity setting.

In a neoadjuvant therapy window of opportunity setting. Surgery was performed on average 4 weeks after the initiation of immunotherapy. All 3 of 3 MSI high colorectal patients had complete or near complete pathologic responses. And even more importantly, 6 out of 9 patients with MS-stable colorectal cancer had pathologic responses of 50% or greater, including 2 complete pathologic responses. None of the 12 patients had tumor growth during the treatment interval, and no surgeries were delayed due to immune-related toxicities. There were only two instances of grade 3 treatment-related adverse events, diarrhea and fatigue, which were reversed.

Surgery was performed on average four weeks after the initiation of immunotherapy.

All three are three MSI high colorectal patients had complete or near complete pathological responses.

And even more importantly, six out of nine patients with MF stable colorectal cancer had pathologic responses of 50% or greater in two including two complete pathological responses.

None of the 12 patients had tumor growth during the treatment interval and no surgeries were delayed during.

Steven J. ODay: Delays due to immune-related toxins. There were only two instances of grade 3 treatment-related adverse events, diarrhea and fatigue, which were reversed.

Delayed due to immune related toxicities.

There were only 2 instances of Grade 3 treatment-related adverse events, diarrhea and fatigue, which were reversible. These results represent an important opportunity to move into earlier non-metastatic lines of therapy and potentially change the treatment paradigm, particularly for early-stage MS-stable colorectal cancer. This IST is currently adding an additional 24 patients. The expansion extends the dosing of immunotherapy and the timing of surgery from 4 to 6 to 8 weeks, which is more reflective of traditional neoadjuvant therapy studies. Depending on the data, we plan to prioritize neoadjuvant development and are evaluating study designs for further pivotal studies. And lastly, in second-line pancreatic cancer, we reported data on 6 patients with the combination of BOTENSILIMAB with 2 chemotherapy agents, GEMCITABINE and ABRAXANE, as a triplet therapy. All six patients had progressed following the most aggressive first-line metastatic regimen of full furinopathy, chemotherapy, and all six had liver metastasis.

There are only two instances of grade three treatment related adverse events.

<unk> and <unk>, which were reversible.

Steven J. ODay: These results represent an important opportunity to move into earlier non-metastatic lines of therapy and potentially change the treatment paradigm, particularly for early-stage MS-stable colorectal. This IST is currently treating an additional 24 patients. The expansion extends the dosing of immunotherapy and the timing of surgery from four to six to eight weeks, which is more reflective of traditional neoadjuvant therapy studies. Depending on the data, we plan to prioritize neoadjuvantive development and are evaluating study designs for further pivotal studies. And lastly, in second-line pancreatic cancer, they reported data on six patients with the combination of botansilamab with two chemotherapy agents, gemcitabine and abraxane, as a triplet therapy. All six patients had progressed following the most aggressive first-line metastatic regimen of full furinopathy, chemotherapy, and all six had liver metastasis.

These results represented an important opportunity to move into earlier non metastatic lines of therapy.

Potentially change the treatment paradigm, particularly for early stage MF stable colorectal cancer.

This ISP is currently adding an additional 24 patients.

The expansion extends the dosing of immunotherapy and the timing of surgery from 4 to 6 to 8 weeks, which is more reflective of traditional neoadjuvant therapy studies. Depending on the data, we plan to prioritize neoadjuvant development and are evaluating study designs for further pivotal studies. And lastly, in second-line pancreatic cancer, we reported data on 6 patients with the combination of BOTENSILIMAB with 2 chemotherapy agents, GEMCITABINE and ABRAXANE, as a triplet therapy.

The expansion extend dosing of immunotherapy and the timing of surgery.

Four to six to eight weeks, which is more reflective of a traditional neo adjuvant therapy studies.

Depending on the data we plan to prioritize Neo adjuvant development and are evaluating study designs for further pivotal studies.

And lastly in second line pancreatic cancer.

We reported data on six patients with a combination of both film lab with two chemotherapy agents, Jim side of being in a Brexit as a triplet therapy.

All 6 patients had progressed following the most aggressive first-line metastatic regimen of FOLFIRINOX chemotherapy. And all 6 had liver metastasis. 4 of the patients achieved marked and sustained tumor marker reduction. We reported 2 of the 4 patients achieving a partial response at 16 weeks, with a confirmed target lesion reductions of 47% and 37%, which was pending confirmation at the time the data wa reported. Two other patients showed stable disease at their first 8-week scan, with tumor reductions of 20% and 13%, respectively. A randomized Phase II study is currently enrolling, and we anticipate preliminary data being available in the second half of this year. These results demonstrate clear activity of BOTENSILIMAB in cold tumors in both the refractory setting and in early disease, combined with either BALSTILIMAB or chemotherapy.

All six patients had progressed following the most aggressive first line metastatic regimen of both pure locks chemotherapy and all six had liver metastasis.

Steven J. ODay: Four of the patients achieved marked and sustained tumor marker reduction. We reported two of the four patients achieving a partial response at 16 weeks, with confirmed target lesion reductions of 47% and 37%, which was pending confirmation at the time the data were reported. Two other patients showed stable disease at their first eight-week scan, with tumor reductions of 20% and 13%, respectively. A randomized phase two study is currently enrolling, and we anticipate preliminary data being available in the second half of this year. These results demonstrate clear activity of botansilamab in cold tumors in both the refractory setting and in early disease, when combined with either balistilamab or chemotherapy.

Four of the patients achieved marked.

<unk> tumor marker reductions.

We reported two of the four patients achieving a partial response at 16 weeks with a confirmed target lesion reductions of 47% and 37%, which was pending confirmation of the time the data was reported.

Two other patients showed stable disease at their first 8-week scan, with tumor reductions of 20% and 13%, respectively. A randomized Phase II study is currently enrolling, and we anticipate preliminary data being available in the second half of this year. These results demonstrate clear activity of BOTENSILIMAB in cold tumors in both the refractory setting and in early disease, combined with either BALSTILIMAB or chemotherapy.

Two other patients showed stable disease at their first eight week scan with tumor reductions of 20% and 13% respectively.

Respectively.

A randomized phase II study is currently enrolling and we anticipate preliminary data being available in the second half of this year.

These results demonstrate clear activity of both the filler mab in cold tumors in both the refractory setting and in early disease, combining both film.

With either <unk> or chemotherapy and this offers hope for patients and families where current standards provide limited benefit.

Christine M. Klaskin: And this offers hope for patients and families where current standards provide limited benefit. We remain committed to improving patient outcomes and are grateful of the support of our team, trial participants, and stakeholders. Now, I'll turn the call over to Christine to discuss financials. Thank you, Steven. For the year ended December 31st, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million, or 69 cents per share. For the fourth quarter ended December 31st, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million, or 13 cents per share.

And this offers hope for patients and families where current standards provide limited benefit. We remain committed to improving patient outcomes and are grateful of the support of our team, trial participants, and stakeholders. Now, I'll turn the call over to Christine to discuss financials.

We remain committed to improving patient outcomes and are grateful in support of our team trial participants and stakeholders.

Now, I'll turn the call over to Christine to discuss financials.

Now I will turn the call over to Christine to discuss financials.

Christine Klaskin: Thank you, Steven. For the year ended December 31st, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million, or $0.69 cents per share. For the fourth quarter ended December 31st, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million, or $0.13 cents per share. Revenue primarily includes revenue under our collaboration agreements, including milestones achieved and revenue related to non-cash royalties earned.

Thank you Steven.

For the year ended December 31, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million or <unk> 69 per share.

For the fourth quarter ended December 31, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or <unk> 13 per share.

Christine M. Klaskin: Revenue primarily includes revenue under our collaboration agreements, including milestones achieved and revenue related to non-cash royalties earned. We ended the year with $76 million in cash, subsequent to which, in January 2024, we received the $25 million milestone payment from BMS, triggered by the commencement of a phase two study with BMS 986442, the Agenus-discovered tigit bispecific antibody. Additionally, we've progressed in monetizing non-strategic assets and future milestones and royalties from ongoing park operations. These efforts are expected to yield significant cash proceeds by mid-2024. Accordingly, we anticipate being funded through 2024. In parallel, we're pursuing potential partnership discussions with five biopharmaceutical parties to further expand our cash resources. I'll now turn the call back to Garo.

Revenue primarily includes revenue under our collaboration agreements, including milestones achieved and revenue related to non-cash royalties earned.

Revenue primarily includes revenue under our collaboration agreements, including milestones achieved in revenue related to noncash royalties earned.

We ended the year with $76 million in cash, subsequent to which in January 2024, we received the $25 million milestone payment from BMS, triggered by the commencement of a Phase II study with BMS-986442, the Agenus-discovered TIGIT bispecific antibody. Additionally, we've progressed in monetizing non-strategic assets and future milestones and royalties from ongoing partnerships. These efforts are expected to yield significant cash proceeds by mid-2024. Accordingly, we anticipate being funded through 2024. In parallel, we're pursuing potential partnership discussions with 5 biopharmaceutical parties to further expand our cash resources. I'll now turn the call back to Garo.

We ended the year with $76 million in cash subsequent to which in January 2024, we received the $25 million milestone payment from BMS triggered by the commencement of a phase III study with BMS 96, $4 42.

The agenda is discovered by specific antibody <unk>.

Additionally, we've progressed in monetizing non strategic assets and future milestones and royalties from ongoing partnerships. These.

These efforts are expected to yield significant cash proceeds by mid-2024. Accordingly, we anticipate being funded through 2024. In parallel, we're pursuing potential partnership discussions with 5 biopharmaceutical parties to further expand our cash resources.

These efforts are expected to yield significant cash proceeds by mid 2024.

Accordingly, we anticipate being funded through 2024.

In parallel we're pursuing potential partnership discussion with five biopharmaceutical parties to further expand our cash resources.

I'll now turn the call back to Garo.

Garo H. Armen: Thank you, Steven and Christine. As we look ahead, of course, we're excited about the opportunities that await both cancer patients and Agenus in 2024. Our steadfast dedication remains centered on providing cancer patients with enhanced treatment options, a mission that not only benefits patients but also enhances shareholder value and secures the long-term prosperity of our company through continued innovation. Innovation has been critical to our existence and our growth, and it will continue to be.

Garo Armen: Thank you, Steven and Christine. As we look ahead, of course, we're excited about the opportunities that await both cancer patients and Agenus in 2024. Our steadfast dedication remains centered on providing cancer patients with enhanced treatment options, a mission that not only benefits patients but also enhances shareholder value and secures the long-term prosperity of our company through continued innovation.

Thank you Steven and Christine.

As we look ahead.

Of course, we're excited about the opportunities that await both cancer patients and the Genesee in 2024.

Our steadfast dedication remains centered on providing cancer patients with enhanced treatment options.

Admission that not only benefits patients, but also enhance the shareholder value.

And secures the long term prosperity of our company.

Innovation has been critical to our existence and our growth, and it will continue to be. This year, a paramount objective for us is to present a compelling data package to the FDA, seeking their consent to initiate the filing of our biologics license application. At Agenus' pioneering advancement in oncology has been more than a mission for us. It's been our enduring commitment for many years. We expand our heartfelt gratitude to our shareholders, partners, and the entire Agenus team for their unwavering support.

Through continued innovation innovation has been critical to our existence.

And it will continue to be.

Garo H. Armen: This year, a paramount objective for us is to present a compelling data package to the FDA, seeking their consent to initiate the filing of our biologics license application. Agenus' pioneering advancement in oncology has been more than a mission for us. It's been our enduring commitment for many years.

This year.

Our mantra for us is to present, a compelling data package to the FDA.

Seeking their consent to initiate the filing of our biologics license application.

And then Janice pioneering advancements in oncology has been more than a mission for us.

It's been our enduring commitment over many years.

Garo H. Armen: We extend our heartfelt gratitude to our shareholders, partners, and the entire Agenus team for their unwavering support. Together, we stand at the threshold of a transformative journey, one poised to make a profound impact on the lives of patients worldwide, with the ultimate aim of delivering chemotherapy-free treatment options. Thank you very much for your time and attention, and now we welcome any questions that you may have, all dry. Thank you. At this time, I would like to remind everyone, in order to ask a question, press the star, then the number 1 on your telephone keypad. We'll take our first question from Emily Bodnar at H.C. Wayne. Hi, good morning.

We extend our heartfelt gratitude to our shareholders, partners, and the entire Agenus team for their unwavering support.

We extend our heartfelt gratitude to our shareholders partners and the entire again this team towards their unwavering support.

Together, we stand at the threshold of a transformative journey, one poised to make a profound impact on the lives of patients worldwide, with the ultimate aim of delivering chemotherapy-free treatment options. Thank you very much for your time and attention, and now we invite any questions that you may have. Audra? Thank you. At this time, I would like to remind everyone, in order to ask a question, press the star, then the number 1 on your telephone keypad. We'll take our first question from Emily Bodnar at H.C. Wayne. Hi, good morning.

Together, we stand at the threshold of a transformative journey.

One poised to make a profound impact on the lives of patients worldwide.

With the ultimate aim of delivering chemotherapy free treatment options.

Thank you very much for your time and attention, and now we invite any questions you may have. Audra?

Thank you very much for your time and attention and now we invite any questions you may have.

Thank you. At this time, I would like to remind everyone, in order to ask a question, press the star, then the number 1 on your telephone keypad. We'll take our first question from Emily Bodnar at H.C. Wayne. Hi, good morning.

Operator: Thank you. [Operator Instructions] We'll take our first question from Emily Bodnar at H.C. Wainright

Our draft.

Thank you.

This time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.

We will take our first question from Emily Bodnar at H C. Wainwright.

Hi, good morning, and thanks for taking the question.

Hi, good morning. Thanks for taking the question. My first one's on the neo-adjuvant CRC study. You mentioned that you're extending the treatment period from 4 weeks to 6 to 8 weeks. So I was curious if you could discuss how you think the longer treatment period may impact efficacy and if there are certain metrics that you think could improve with a greater treatment period? And also if you're following patients in that study post-surgery to eventually look at their surgical outcomes. And then second question on MSS CRC, could you just confirm the timing of the BLA submission? And I believe you were previously saying mid-2024. So that's the launch tracker, is that looking more like the second half now?

Emily Bodnar: Hi, good morning. Thanks for taking the question. My first one's on the neo-adjuvant CRC study. You mentioned that you're extending the treatment period from 4 weeks to 6 to 8 weeks. So I was curious if you could discuss how you think the longer treatment period may impact efficacy and if there are certain metrics that you think could improve with a greater treatment period? And also if you're following patients in that study post-surgery to eventually look at their surgical outcomes.

Garo H. Armen: Thanks for taking the questions. My first one's on the neoadjuvant CRT study. You mentioned that you're extending the treatment period from four weeks to six to eight weeks. So I was curious if you could discuss how you think the longer treatment period may impact efficacy and if there are certain metrics that you think could improve with a longer treatment period. And also if you're following patients in that study post-surgery to eventually look at their surgical outcomes. And then, on MSS CRC, could you just confirm the timing of the BLA submission? And I believe you were previously saying mid-2024. So is that still on track, or is that looking more like the second half now?

My first one's on the Neo adjuvant CRC study, you mentioned that you're extending virtually on period from four weeks to six to eight weeks just curious if you could discuss.

You think the longer treatment period may impact efficacy and if theyre.

Metrics that you think could improve with greater achievement period and also of your following patients in that study post surgery to eventually look at surgical outcomes and then second question on MSS CRC could you just confirm the timing of the BLA submission.

And your previously say mid 2024 does that thought or is that looking more like second half now. Thank you.

Sure.

The last question on the timing of the BLA submission.

And then second question on MSS CRC, could you just confirm the timing of the BLA submission? And I believe you were previously saying mid-2024. So that's the launch tracker, is that looking more like the second half now?

As we've guided.

<unk> before.

Before.

The very first step for us is to meet with the FDA, which we're planning on doing mid year.

And they're getting their specific guidance on our BLA submission. So we do not want to jump. The gun ahead of that meeting and provide different guidance than what we will get out of that FDA meeting so bear with US I think we're talking about only a few months from now.

Garo H. Armen: Thank you. So Emily, I'll start with the last question on the timing of the BLA submission. So, as we've guided investors before, the very first step for us is to meet with the FDA, which we're planning on doing mid-year, and they're giving their specific guidance on our BLA submission. So we do not want to jump the gun ahead of that meeting and provide different guidance than what we will get out of that FDA meeting. So bear with us.

Garo Armen: Thank you. So Emily, I'll start with the last question on the timing of the BLA submission. So, as we've guided investors before, the very first step for us is to meet with the FDA, which we're planning on doing mid-year, and they're giving their specific guidance on our BLA submission. So we do not want to jump the gun ahead of that meeting and provide different guidance than what we will get out of that FDA meeting. So bear with us. I think we're talking about only a few months from now, that we will be able to give you much more specific guidance on our BLA solution.

We will be able to give you a much more specific guidance on our BLA submission.

Yes.

Okay.

Darryl would you like me to.

Emily.

Neo adjuvant, the very exciting new adjuvant data is very exciting and in fact, when I was.

Talking to one of our long term advisors yesterday.

The first thing he mentioned in the conversation.

How how remarkable this new adjuvant data has been because of all the reasons you cited Emily and back to where they will elucidate trigger.

So bear with us. I think we're talking about only a few months from now, that we will be able to give you much more specific guidance on our BLA solution. Garo, would you like me to, uh, Emily, in terms of the new adjuvant, the very exciting new adjuvant data, very exciting, and in fact, when I was talking to one of our long-term advisors yesterday, the first thing he mentioned in the conversation was how, how remarkable this new adjuvant data has been for all the reasons you cited, Emily, and Dr. ODay will elucidate further. Thank you, Garo.

So bear with us. I think we're talking about only a few months from now, that we will be able to give you much more specific guidance on our BLA solution.

Steven J. ODay: I think we're talking about only a few months from now when we will be able to give you much more specific guidance on our BLA. Garo, would you like me to, uh, Emily, in terms of the new adjuvant, the very exciting new adjuvant data, very exciting, and in fact, when I was talking to one of our long-term advisors yesterday, the first thing he mentioned in the conversation was how, how remarkable this new adjuvant data has been for all the reasons you cited, Emily, and Dr. ODay will elucidate further. Thank you, Garo.

Thank you.

Emily Yes, I mean, given that MF stable colorectal cancer immune therapy has not previously been effective.

The four week window period was what surgeons, we're comfortable with allowing which was essentially no delay in the surgery and these results are remarkable in terms of the percentage of patients with the tumor.

Garo, would you like me to, uh, Emily, in terms of the new adjuvant, the very exciting new adjuvant data, very exciting, and in fact, when I was talking to one of our long-term advisors yesterday, the first thing he mentioned in the conversation was how, how remarkable this new adjuvant data has been for all the reasons you cited, Emily, and Dr. ODay will elucidate further. Thank you, Garo.

Steven O'Day: Garo, would you like me to...

Yes. Emily, in terms of the neoadjuvant, is very exciting neoadjuvant data. Very exciting. And in fact, when I was talking to one of our long-term advisors yesterday, the first thing he mentioned in the conversation was how remarkable this neoadjuvant data has been because for all the reasons you cited, Emily, and Dr. ODay will elucidate further. Thank you, Garo.

Garo Armen: Yes. Emily, in terms of the neoadjuvant, is very exciting neoadjuvant data. Very exciting. And in fact, when I was talking to one of our long-term advisors yesterday, the first thing he mentioned in the conversation was how remarkable this neoadjuvant data has been because for all the reasons you cited, Emily, and Dr. ODay will elucidate further.

Tumor regressions in four weeks. So the extension of the study will allow now a proper six to eight weeks.

<unk> period, and we do anticipate that over that time, we will see further deepening of responses. So we're looking forward to that the study is looking at surgical outcomes and obviously post surgery relapses. So this will be a comprehensive neo adjuvant study.

Thank you, Garo. Emily, yes, I mean, given that MS stable colorectal cancer immune therapy has not previously been effective, the 4-week window period was what surgeons were comfortable with allowing, which was essentially no delay in the surgery. And these results are remarkable in terms of the percentage of patients with deep tumor regressions in 4 weeks. So the extension of the study will allow a proper 6 to 8-week treatment period. And we do anticipate that over that time we will see further deepening of responses. So we're looking forward to that. The study is looking at surgical outcomes and, obviously, post-surgery relapses. So this will be a comprehensive neoadjuvant study.

Steven O'Day: Thank you, Garo. Emily, yes, I mean, given that MS stable colorectal cancer immune therapy has not previously been effective, the 4-week window period was what surgeons were comfortable with allowing, which was essentially no delay in the surgery. And these results are remarkable in terms of the percentage of patients with deep tumor regressions in 4 weeks.

Steven J. ODay: Emily, yes, I mean, given that MS stable colorectal cancer immune therapy has not previously been effective, the four week window period was what surgeons were comfortable with allowing, which was essentially no delay in the surgery. And these results are remarkable in terms of the percentage of patients with deep tumor regressions in four weeks. So the extension of the study will now allow a proper six to eight-week treatment period, and we do anticipate that over that time we will see further deepening of responses. So we're looking forward to that.

Okay, great. Thank you so much.

We will go next to me ink Ma'am Tani at B Riley Securities.

Good morning, Thanks for taking our questions and appreciate the comprehensive update so maybe just on the phase II Emmis NCIC data.

Colin Dunn, what statistically we should be focused on in.

The slight push out here. It is the leading to you one thing to have as data mature.

So the extension of the study will allow a proper 6 to 8-week treatment period. And we do anticipate that over that time we will see further deepening of responses. So we're looking forward to that. The study is looking at surgical outcomes and, obviously, post-surgery relapses. So this will be a comprehensive neoadjuvant study.

Data, which I could see makes sense, if you're thinking about it. So you see design and maybe if you can also comment on thinking and timing for launching that.

Steven J. ODay: The study is looking at surgical outcomes and, obviously, post-surgery relapses. So this will be a comprehensive neoadjuvant study. Okay, great. Thanks. We'll go next to Mayank Mamtani at B. Reilly's. Good morning.

The study is looking at surgical outcomes and, obviously, post-surgery relapses. So this will be a comprehensive neoadjuvant study.

Should we be aware of any planned regulatory meetings discussions around that and then I have a.

A couple of follow up.

Yes.

No.

As you know.

Okay, great. Thanks. We'll go next to Mayank Mamtani at B. Reilly's. Good morning.

Emily Bodnar: Okay, great. Thanks so much.

We have.

We'll go next to Mayank Mamtani at B. Riley Securities. Good morning.

Operator: We'll go next to Mayank Mamtani at B. Riley Securities.

As we said before we have completed enrollment.

In October.

Mayank Mamtani: Good morning. Thanks for taking our question. And I appreciate the comprehensive update. So maybe just on the Phase II MSS CRC data, are you able to comment on what statistically we should be focused on? And if the slide push out here is relating to you wanting to have OS data or mature durability data, which I could see makes sense if you're thinking about Phase III design. And maybe if you can also comment on thinking and timing for launching that Phase III, should we be aware of any planned regulatory meetings or discussions around that? Then I have a couple of follow-ups.

Typically 80% of the patients.

Garo H. Armen: Thanks for taking our questions and I appreciate the comprehensive update. So maybe just on the phase two MSS CRC data, are you able to comment on what we should be focused on statistically? And if the slide push out here is relating to you wanting to have OS data or mature durability data, which I could see, you know, make sense if you're thinking about phase three design. And maybe if you can also comment on your thinking and timing for launching that phase three, should we be aware of any planned regulatory meetings or discussions around that? Then I have a couple of follow-up questions, Yeah.

Bond within six months.

All of the search stores, so when we complete enrollment by the time that patients get the fair associated talking about November.

And by the time, we get to six months readout for 80% of the responses it sometime around may.

Needless to say, we have already started cleaning up the data and all of the latest review process. So that we can provide all of.

Mayank Mamtani: And maybe if you can also comment on thinking and timing for launching that Phase III, should we be aware of any planned regulatory meetings or discussions around that? Then I have a couple of follow-ups.

Outcomes as soon as possible. So it will be in the next few months and our first step is to share. This data with the FDA because of timing of the data generation and the FDA meeting will very close and then after the FDA meeting with going out and making topline data public appropriately.

Garo H. Armen: Yes. So, as you know, we have-- as we said before, we've completed enrollment in October, and typically, 80% of the patients respond within 6 months of the first dose. So when we complete enrollment, by the time the patients get their first dose, you're talking about November. And by the time we get the 6-month readout for 80% of the responses, it's sometime around May. Now, needless to say, we have already started cleaning up the data and all of the nitty-gritty processes so that we can provide all of the outcomes as soon as possible. So, it will be in the next few months, and our first step is to share this data with the FDA because the timing of the data generation and the FDA meeting will be very close. And then after the FDA meeting, we plan on making top-line data public appropriately.

Garo Armen: Yes. So, as you know, we have-- as we said before, we've completed enrollment in October, and typically, 80% of the patients respond within 6 months of the first dose. So when we complete enrollment, by the time the patients get their first dose, you're talking about November. And by the time we get the 6-month readout for 80% of the responses, it's sometime around May. Now, needless to say, we have already started cleaning up the data and all of the nitty-gritty processes so that we can provide all of the outcomes as soon as possible.

Yes.

Okay.

Phase III design timing of launch.

Comment on that.

Yes.

Stephen would you like to take that piece, yes.

Yes, I mean, our plans with the phase III trial is in the same line of therapy is the phase two and we anticipate.

Getting that trial started by the end of the year. So it can be substantially enrolled a potential producer date in 2025.

Got it and then you are being a bit more precise about it.

Biopharma strategic discussions than <unk> been before.

And could you comment on what areas are more or less alignment.

That could unlock the cocoa deal structure that it looks like you're prioritizing.

And maybe how much does the EMEA doing the CIC opportunity kind of play a role because.

So, it will be in the next few months, and our first step is to share this data with the FDA because the timing of the data generation and the FDA meeting will be very close. And then after the FDA meeting, we plan on making top-line data public appropriately.

Obviously expands the market, but it also comes with the.

Steven J. ODay: So, it will be in the next few months, and our first step is to share this data with the FDA because the timing of the data generation and the FDA meeting will be very close. And then after the FDA meeting, we plan on making top line data public appropriately. Phase 3 design timing of launch, if you could comment on that for MSHCIS. Steven, would you like to take that piece?

Commitment doing a long term study.

I think I think it's very important to address your question.

And in a way that.

Violate any confidentiality. So we have as you know talked about partnering.

Phase III, design, timing of launch, if you could comment on that [Inaudible]. for Steven, would you like to take that piece?

Mayank Mamtani: Phase III, design, timing of launch, if you could comment on that [Inaudible].

But bell.

Garo Armen: Steven, would you like to take that, please?

For the last couple of years now of course, when we started.

Garo H. Armen: Yeah, I mean, our plans for the Phase 3 trial are in the same line of therapy as the Phase 2, and we anticipate getting that trial started by the end of the year so it can be substantially enrolled at a potential fiduciary date in 2025. Okay. And then you're being a bit more precise about your biopharma strategic discussions than you've been before. Garo, could you comment on what areas of more or less alignment that could unlock the COCO deal structure that it looks like you're prioritizing? And maybe how much does the neoadjuvant CRC opportunity kind of play a role? Because, you know, it obviously expands the market, but it also comes with a commitment to doing a long-term study.

Steven O'Day: Yes. I mean, our plans for the Phase III trial is in the same line of therapy as the Phase II, and we anticipate getting that trial started by the end of the year. So it can be substantially enrolled at a potential producer date in 2025.

Our discussions with prospective partners.

We had a fraction of the data we have today.

Traction of the data.

And.

Sure.

Thanks to our enthusiastic physicians.

<unk> and of course.

Patient inquiries.

Mayank Mamtani: Got it. And then you're being a bit more precise about your biopharma strategic discussions than you've been before. Garo, could you comment on what areas are more or less alignment that could unlock the [Inaudible] deal structure that it looks like you're prioritizing? And maybe how much does the neoadjuvant CRC opportunity kind of play a role? Because it obviously expands the market, but it also comes with a commitment of doing a long-term study.

We have had an explosive growth.

Growth in our clinical trial enrollment and if you look at for example, our phase III trial enrollment.

We enrolled 230 patients in less than five months, which is a record that has surprised many people.

With all of that you would expect of course that is.

Fair amount of enthusiasm by prospective pharmaceutical companies and Mitch as we've talked about earlier all of this fascination with.

Treatments that result in weight reduction.

Garo H. Armen: I think it's very important to address your question in a way that doesn't violate any confidentiality. So, we have, as you know, talked about partnering BOT/BAL for the last couple of years. Now, of course, when we started our discussions with prospective partners, we had a fraction of the data we have today, fraction of the data. And thanks to our enthusiastic physicians, investigators, and, of course, patient inquiries. We have had an explosive growth in our clinical trial enrollment. I mean, if you look at, for example, our Phase II trial enrollment, we enrolled 230 patients in less than 5 months, which is a record that has surprised many people. Now, with all of that, you would expect, of course, that there's a fair amount of enthusiasm by prospective pharmaceutical companies amidst, as we talked about earlier, all of the fascination with treatments that result in weight reduction and radio biopharmaceuticals, as well as ADCs. But when I ask a question to experts, I say, do ADCs and biopharmaceuticals cure cancer? The answer is often not, no. Now, of course, we don't know if we're curing cancer. We don't know that. And the term curing cancer is a very dicey term because how do you demonstrate it? How do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there's a product called YERVOY that has cured, de facto, cured, a slice of melanoma patients. But it's mostly restricted to melanoma. In fact, Dr. O'Day was one of the pioneers in the clinical development of YERVOY. Now, of course, one of the attributes of the YERVOY is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T-cells.

Garo Armen: I think it's very important to address your question in a way that doesn't violate any confidentiality. So, we have, as you know, talked about partnering BOT/BAL for the last couple of years. Now, of course, when we started our discussions with prospective partners, we had a fraction of the data we have today, fraction of the data. And thanks to our enthusiastic physicians, investigators, and, of course, patient inquiries. We have had an explosive growth in our clinical trial enrollment.

<unk>.

Radio biopharmaceutical poles as well as adcs.

Can I ask a question to experts I say, two adcs and Biopharmaceuticals cure cancer the answers after lap no.

Of course, we don't know if were curing cancer, we don't know that and the term curing cancer is a very dicey term because how do you demonstrate how do you clinically demonstrate curing cancer.

And the only thing that we know for sure is that there is a product called <unk>.

That has shourd de facto cured.

Slice of melanoma patients.

I mean, if you look at, for example, our Phase II trial enrollment, we enrolled 230 patients in less than 5 months, which is a record that has surprised many people. Now, with all of that, you would expect, of course, that there's a fair amount of enthusiasm by prospective pharmaceutical companies amidst, as we talked about earlier, all of the fascination with treatments that result in weight reduction and radio biopharmaceuticals, as well as ADCs. But when I ask a question to experts, I say, do ADCs and biopharmaceuticals cure cancer? The answer is often not, no. Now, of course, we don't know if we're curing cancer. We don't know that. And the term curing cancer is a very dicey term because how do you demonstrate it? How do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there's a product called YERVOY that has cured, de facto, cured, a slice of melanoma patients. But it's mostly restricted to melanoma. In fact, Dr. O'Day was one of the pioneers in the clinical development of YERVOY. Now, of course, one of the attributes of the YERVOY is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T-cells.

But it's been mostly restricted to melanoma in fact, Dr. Jose was one of the pioneers in clinical development our Dearborn.

Now of course, one of the attributes you via voice is that it binds to <unk> four.

A very important receptor in the activation of immune system, specifically T cells. Now we also know that our potential to map <unk> four but it does so many other things. So we are hopeful hopeful that eventually what kind of <unk> activity.

We will be broader than what year voice activity has been in melanoma.

And so with that of course, we're excited about what we're going to be doing with <unk>.

And that makes the question of a.

Like minded partner that wells put in the resources to develop potential a map and Moscow amount.

Now, of course, we don't know if we're curing cancer. We don't know that. And the term curing cancer is a very dicey term because how do you demonstrate it? How do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there's a product called YERVOY that has cured, de facto, cured, a slice of melanoma patients. But it's mostly restricted to melanoma. In fact, Dr. O'Day was one of the pioneers in the clinical development of YERVOY. Now, of course, one of the attributes of the YERVOY is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T-cells.

For the kinds of cancer patients that deserve it deserve it meaning that.

Garo H. Armen: The term curing cancer is a very dicey term because how do you demonstrate that? How do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there's a product called Yervoy that has cured, de facto, cured, a slice of melanoma patients. But it's mostly restricted to melanoma. In fact, Dr. ODay was one of the pioneers in the clinical development of the airway. Now, of course, one of the attributes of the airvoy is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T-cells.

AME is that once we get the regulatory buying and we go for our first BLA filing our aim is an explosive expansion.

For the development of potential or perhaps <unk>.

Sure.

Expansion because as you know we have said.

19 different indications with varying denominators of 900 patients in total we have seen some remarkable activity. There's no two ways about it remarkable activity and that is of course.

In fact, Dr. O'Day was one of the pioneers in the clinical development of YERVOY. Now, of course, one of the attributes of the YERVOY is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T-cells. Now, we also know that our BOTENSILIMAB binds to CTLA-4, but it does so many other things. So we are hopeful that eventually, BOTENSILIMAB's activity will be broader than what YERVOY's activity has been in melanoma.

Now, of course, one of the attributes of the YERVOY is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T-cells.

The basis for why the right partner that will be.

Selected.

So in the next.

Several months would be.

Garo H. Armen: Now, we also know that our BOTENSILIMAB binds to CTLA-4, but it does so many other things. So we are hopeful that eventually, BOTENSILIMAB's activity will be broader than what YERVOY's activity has been in melanoma. And so with that, of course, we're excited about what we're going to be doing. And that makes the question of a like-minded partner that will put in the resources to develop BOTENSILIMAB and BALSTILIMAB for the kinds of cancer patients that deserve it. Deserve it, meaning that our aim is that once we get the regulatory buy-in and we go for our first BLA filing, our aim is an explosive expansion for the development of BOTENSILIMAB. Explosive expansion because, as you know, we've said across 9 different indications with varying denominators of 900 patients in total, we've seen some remarkable activity. There are no 2 ways about it, remarkable activity. And that is, of course, the basis for why the right partner that will be selected, hopefully, in the next several months, would be the partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed. So again, we have--I think Christine slipped a number of active discussions. There are a number of active discussions right now that are going on. And unfortunately, on one hand these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly 2 years. The shortest one was a year.

Now, we also know that our BOTENSILIMAB binds to CTLA-4, but it does so many other things. So we are hopeful that eventually, BOTENSILIMAB's activity will be broader than what YERVOY's activity has been in melanoma.

Partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed so again.

We have.

Christine slipped.

Number of active discussions with a number of active discussions right now.

Our growing audience.

And so with that, of course, we're excited about what we're going to be doing. And that makes the question of a like-minded partner that will put in the resources to develop BOTENSILIMAB and BALSTILIMAB for the kinds of cancer patients that deserve it. Deserve it, meaning that our aim is that once we get the regulatory buy-in and we go for our first BLA filing, our aim is an explosive expansion for the development of BOTENSILIMAB. Explosive expansion because, as you know, we've said across 9 different indications with varying denominators of 900 patients in total, we've seen some remarkable activity. There are no 2 ways about it, remarkable activity. And that is, of course, the basis for why the right partner that will be selected, hopefully, in the next several months, would be the partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed. So again, we have--I think Christine slipped a number of active discussions. There are a number of active discussions right now that are going on. And unfortunately, on one hand these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly 2 years. The shortest one was a year.

And.

Unfortunately.

On one hand, these discussions take a long time.

A long list.

Corporate discussion that has resulted in a significant partnership has taken nearly two years with shorter spot was a year, so I'm not suggesting that.

Partnership is going to be a year from now, but I just wanted to give you guidance that these things take time.

Very helpful.

And just maybe lastly on that to your marketable activity just on the pancreatic again this <unk> vaccine.

<unk> data it seems Neil could it lead to.

What patient numbers.

That thing to have.

Second half update.

Thank you Ed again, maybe lung condition that thanks again for taking the question.

Explosive expansion because, as you know, we've said across 9 different indications with varying denominators of 900 patients in total, we've seen some remarkable activity. There are no 2 ways about it, remarkable activity. And that is, of course, the basis for why the right partner that will be selected, hopefully, in the next several months, would be the partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed. So again, we have--I think Christine slipped a number of active discussions. There are a number of active discussions right now that are going on. And unfortunately, on one hand these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly 2 years. The shortest one was a year.

If I may ask either Steven or tied to address this question and if you have more specific classification for the questions. Please.

Feel free to.

To ask.

Yes.

So yes.

In terms of <unk>, we have a randomized phase III trial.

Garo H. Armen: Remarkable activity. And that is, of course, the basis for why the right partner that will be selected, hopefully, in the next several months, would be the partner, not just for us, but for the benefit of the patients, to develop this product in the way it deserves to be developed. So again, we have.

<unk> expect.

Treat 60 patients total 30 on each arm.

That trial is actively accruing.

For further proof of concept.

In terms of the lung data we have expanded the cohort as we've said to approximately 50 patients. This data is maturing we're showing you the preliminary PK data in our press release today, you can see in a very refractory PKI population of seven patients we had two patients.

So again, we have--I think Christine slipped a number of active discussions. There are a number of active discussions right now that are going on. And unfortunately, on one hand these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly 2 years. The shortest one was a year. So I'm not suggesting that the partnership is going to be a year from now. But I just want to give you guidance that these things take time.

Garo H. Armen: I think Christine slipped. We have a number of active discussions right now that are going on, and, unfortunately, these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly two years. The shortest one was a year.

The responses in both of them were complete.

The overall data continues to mature and we will have more data in the second half of the year to report.

Yes.

Great. Thanks for taking my questions. Thank.

Thank you Mike.

Okay.

Next we'll go to Colin QC at Baird.

Hi, good morning, Thanks for taking our questions can you just comment what are some of the outstanding items, you think you need FDA feedback prior to the MSS CRC filing.

Garo H. Armen: I'm not suggesting that your partnership is going to be a year from now, but I just want to give you guidance that these things take time. Well, very helpful, Garo. And maybe lastly, on that remarkable activity, just on the pancreatic and this TKI refractory lung cohort data, which seems new. Could you talk about what patient numbers you're expecting to have in your mid or second half update for pancreatic and maybe lung? If you could just comment on that,

I'm not suggesting that your partnership is going to be a year from now, but I just want to give you guidance that these things take time.

Okay.

Is the question what RSV alignment with the FDA that will prompt to potential BLA filing.

Well, very helpful, Garo. And maybe lastly, on that remarkable activity, just on the pancreatic and this TKI refractory lung cohort data, which seems new. Could you talk about what patient numbers you're expecting to have in your mid or second half update for pancreatic and maybe lung? If you could just comment on that,

Mayank Mamtani: Well, very helpful, Garo. And just maybe lastly, on that remarkable activity, just on the pancreatic and this TKI refractory lung cohort data, which seems new. Could you talk to what patient numbers you're expecting to have in your mid or second half update for pancreatic and maybe lung? If you could just comment on that. Thanks again for taking our questions.

And maybe lastly, on that remarkable activity, just on the pancreatic and this TKI refractory lung cohort data, which seems new. Could you talk about what patient numbers you're expecting to have in your mid or second half update for pancreatic and maybe lung? If you could just comment on that,

Yes.

Okay.

No.

Well first of all.

We made a strategic decision because we were moving as I said earlier, we were enrolling clinical trials rapidly for example phase.

<unk> phase II trial, and will very rapidly and it was a very important trial for us to go to the agency with because of the.

Steven J. ODay: Thanks again for taking the time. If I may ask either Steven or Todd to address this question, and if you have more specific clarification for the questions, please feel free to ask. So, yes, Lauren, in terms of Pancritz, we have a randomized phase C trial, and we expect to treat 60 patients, total 30 on each arm, and that trial is actively accruing for further proof of concept. In terms of the lung data, we have expanded the cohort, as we've said, to approximately 50 patients. This data is maturing. We're showing you the preliminary TKI data in our press release today.

Thanks again for taking the time.

Dose selection as well as the contribution of the elements and of course, we had also a small reference on now of course remind you. This trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project Optimus questions.

If I may ask either Steven or Todd to address this question, and if you have more specific clarification for the questions, please feel free to ask. So, yes, Lauren, in terms of Pancritz, we have a randomized phase C trial, and we expect to treat 60 patients, total 30 on each arm, and that trial is actively accruing for further proof of concept. In terms of the lung data, we have expanded the cohort, as we've said, to approximately 50 patients. This data is maturing. We're showing you the preliminary TKI data in our press release today.

Garo Armen: If I may ask either Steven or Todd to address this question, and if you have more specific clarification for the questions, please feel free to ask.

Steven O'Day: So yes, Mayank. In terms of pancreas, we have a randomized Phase III trial, and we expect to treat 60 patients total, 30 on each arm, and that trial is actively accruing for further proof-of-concept. In terms of the lung data, we have expanded the cohort, as we've said, to approximately 50 patients. This data is maturing. We're showing you the preliminary TKI data in our press release today. You can see in that very refractory TKI population of 7 patients. We had 2 patients have responses, and both of them were complete. The overall data continues to mature, and we'll have more data in the second half of the year to report.

Yes.

And so.

Question was for US if we go to the agency and ask them a question and an abstract form what if this what if that the answer is likely to be well. When you have the data I'll come back to us presented to us and we will give you an intelligent answer and so.

Steven J. ODay: You can see that in a very refractory TKI population of 7 patients, we had 2 patients have responses, and both of them were complete. The overall data continues to mature, and we'll have more data in the second half of the year to report. Great, thanks for taking our questions. Thank you, Mayank. Next, we'll go to Colleen Cusey at Bayer. Hi, good morning.

You can see that in a very refractory TKI population of 7 patients, we had 2 patients have responses, and both of them were complete. The overall data continues to mature, and we'll have more data in the second half of the year to report.

In order to for us to be able to get to the point, we made a strategic decision.

Call in that we would wait until all the data mature to the point, where we had a compelling package with to present to the FDA. So thats. The reason why we are waiting until the data matures, which will begin.

Great, thanks for taking our questions. Thank you, Mayank. Next, we'll go to Colleen Cusey at Bayer. Hi, good morning.

Mayank Mamtani: Great, thanks for taking our questions.

Next, we'll go to Colleen Kusey at Baird. Hi, good morning.

Operator: Next, we'll go to Colleen Kusy at Baird.

Hi, good morning. Thanks for taking our questions. Can you just comment what are some of the outstanding items, do you think you need FDA feedback prior to the MSS CRC filing? There's a question: What are the alignments with the FDA that will prompt the potential BLA filing?

Colleen Kusy: Hi, good morning. Thanks for taking our questions. Can you just comment what are some of the outstanding items, do you think you need FDA feedback prior to the MSS CRC filing?

Somewhat before the middle of this year and as you know procedure will be requesting meetings and in granted meetings to have a discussion with the comprehensive data package. It takes a little time. So we are planning on.

Garo H. Armen: Thanks for taking our questions. Can you just comment on what are some of the outstanding items you think you need FDA feedback prior to the MSS CRC? There's a question: What are the alignments with the FDA that will prompt the potential BLA filing?

Asking for to maintain very soon.

And planning on.

Having the meeting sometime around mid year, plus or minus a month.

Garo H. Armen: Is the question, what are the alignments with the FDA that will prompt potential BLA filing? Yes.

Garo H. Armen: Is the question, what are the alignments with the FDA that will prompt potential BLA filing?

Okay.

Great. Thanks, and then just one follow up on the pancreatic development program and we will have data from the phase two trial midyear what would the next steps look like in the development path towards approval there.

Colleen Kusy: Yes.

Garo H. Armen: Okay. So we want-- first of all, we've made a strategic decision because we were moving, as I said earlier, we were enrolling our clinical trials rapidly, for example, Phase II trial enrolled very rapidly, and it was a very important trial for us to go to the agency with because of the dose selection as well as the contribution of the elements. And, of course, we had also a small reference arm. Now, of course, mind you, this trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project optimist questions. And so the question was for us, if we go to the agency and asked them a question, in an abstract form, what if this, what if that? The answer is likely to be, well, when you have the data, come back to us, present it to us, and we'll give you an intelligent answer. And so in order for us to be able to get to that point, we made a strategic decision, Colleen, that we would wait until all the data matured to the point where we had a compelling package to present to the FDA. So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings to have a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month. Great, thanks.

Okay. So we want-- first of all, we've made a strategic decision because we were moving, as I said earlier, we were enrolling our clinical trials rapidly, for example, Phase II trial enrolled very rapidly, and it was a very important trial for us to go to the agency with because of the dose selection as well as the contribution of the elements. And, of course, we had also a small reference arm. Now, of course, mind you, this trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project optimist questions. And so the question was for us, if we go to the agency and asked them a question, in an abstract form, what if this, what if that? The answer is likely to be, well, when you have the data, come back to us, present it to us, and we'll give you an intelligent answer. And so in order for us to be able to get to that point, we made a strategic decision, Colleen, that we would wait until all the data matured to the point where we had a compelling package to present to the FDA. So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings to have a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month. Great,

Garo Armen: Okay. So we want-- first of all, we've made a strategic decision because we were moving, as I said earlier, we were enrolling our clinical trials rapidly, for example, Phase II trial enrolled very rapidly, and it was a very important trial for us to go to the agency with because of the dose selection as well as the contribution of the elements. And, of course, we had also a small reference arm. Now, of course, mind you, this trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project optimist questions. And so the question was for us, if we go to the agency and asked them a question, in an abstract form, what if this, what if that? The answer is likely to be, well, when you have the data, come back to us, present it to us, and we'll give you an intelligent answer. And so in order for us to be able to get to that point, we made a strategic decision, Colleen, that we would wait until all the data matured to the point where we had a compelling package to present to the FDA. So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings to have a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month.

For the pancreatic.

Yes.

So.

Just to recap the data package that we will go through the FDA with four.

For the CRC.

Acacia is.

Is approximately 150 patients in our phase one trial and.

Garo Armen: Now, of course, mind you, this trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project optimist questions. And so the question was for us, if we go to the agency and asked them a question, in an abstract form, what if this, what if that? The answer is likely to be, well, when you have the data, come back to us, present it to us, and we'll give you an intelligent answer. And so in order for us to be able to get to that point, we made a strategic decision, Colleen, that we would wait until all the data matured to the point where we had a compelling package to present to the FDA. So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings to have a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month.

And the 230 patients the amount of phase two trials now with pancreatic.

The next step for us and I will ask back to Steven.

Are they to elucidate more but the next step for US is to look at the randomized data results from the expansion cohort of the existing trial as you know.

The observed some remarkable activity in second line pancreatic cancer patients that were treated with <unk>.

Garo H. Armen: And so in order for us to be able to get to that point, we made a strategic decision, Colleen, that we would wait until all the data matured to the point where we had a compelling package to present to the FDA. So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings to have a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month. Great, thanks.

<unk> theory.

And and then relapsed and the standard of care for them is Jim a vaccine now the standard of care. Unfortunately is not curative.

And these patients relapse within a short period of time.

Garo Armen: So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings to have a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month.

Furthermore, the response rates for these patients who according to the experts in published information is in the range of 10% to 15%. So we're talking about restaurants arm being 10% to 15% with response rates.

Being very short in duration.

Now of course, the denominator of the data that we presented is small.

Got it.

The fact that all patients have seen a significant drop in.

Great, thanks. And then just one follow-up on the pancreatic development program. I know we'll have data from the Phase II trial mid-year. What would the next steps look like in the development path towards approval there? For the pancreas. Yeah.

Colleen Kusy: Great, thanks. And then just one follow-up on the pancreatic development program. I know we'll have data from the Phase II trial mid-year. What would the next steps look like in the development path towards approval there?

thanks.

Garo H. Armen: And then just one follow-up on the pancreatic development program. I know we'll have data from the phase two trial mid-year. What would the next steps look like in the development path toward approval? For the pancreas. Yeah.

Their cancer challenge.

And all patients.

Have seen a shrinkage in tumor.

Now I'll remind you that not all of them are classified as responses, but patients have seen a shrinkage in their tumor size has given us a high level of confidence that today.

For the pancreas. Yeah.

Garo Armen: For the pancreatic?

Colleen Kusy: Yes.

Garo H. Armen: Okay, so just to recap, the data package that we will go through the FDA with for the CRC indication is approximately 150 patients in our Phase I trial and 230 patients in our Phase II trial. Now, with pancreatic, the next step for us, and I will ask Dr. Steven O'Day to elucidate more. But the next step for us is to look at the randomized data results from the expansion cohort of the existing trial. As you know, we observed some remarkable activity in second-line pancreatic cancer patients that were treated with FOLFIRI and then relapsed. And the standard of care for them is GEM-ABRAXANE. Now, the standard of care, unfortunately, is not curative, and these patients relapse within a short period of time. Furthermore, the response rates for these patients, according to experts and published information, is in the range of 10% to 15%. So we're talking about reference arms being 10% to 15%, with response rates being very short in duration. Now, of course, the denominator of the data that we presented is small, but the fact that all patients have seen a significant drop in their cancer counts. And all patients have seen a shrinkage in tumor. Now, mind you, not all of them are classified as responses, but patients have seen a shrinkage in their tumor size, has given us a high level of confidence that the trial should be expanded, and this is what we're doing.

Garo Armen: Okay, so just to recap, the data package that we will go through the FDA with for the CRC indication is approximately 150 patients in our Phase I trial and 230 patients in our Phase II trial. Now, with pancreatic, the next step for us, and I will ask Dr. Steven O'Day to elucidate more. But the next step for us is to look at the randomized data results from the expansion cohort of the existing trial.

Should be expanded and this is what we're doing so we have enrolled I believe around 30 patients in a randomized trial now that data is maturing and as the data matures and we confirmed results stronger smaller denominator of the initial patients then I think we will have reason to go to the FDA.

<unk>.

Ask them for the requirements for a potential accelerated approval for this indication.

As you know, we observed some remarkable activity in second-line pancreatic cancer patients that were treated with FOLFIRI and then relapsed. And the standard of care for them is GEM-ABRAXANE. Now, the standard of care, unfortunately, is not curative, and these patients relapse within a short period of time. Furthermore, the response rates for these patients, according to experts and published information, is in the range of 10% to 15%. So we're talking about reference arms being 10% to 15%, with response rates being very short in duration. Now, of course, the denominator of the data that we presented is small, but the fact that all patients have seen a significant drop in their cancer counts. And all patients have seen a shrinkage in tumor. Now, mind you, not all of them are classified as responses, but patients have seen a shrinkage in their tumor size, has given us a high level of confidence that the trial should be expanded, and this is what we're doing.

We have also hedged our colleagues may have said before other indications that are potentially potentially indications that we will go for approval.

One.

Is again all of these will be subject to expansion.

Garo H. Armen: Now, the standard of care, unfortunately, is not curative, and these patients relapse within a short period of time. Furthermore, the response rates for these patients, according to experts and published information, are in the range of 10 to 15%. So we're talking about reference arms being 10 to 15%, with response rates being very short in duration. Now, of course, the denominator of the data that we presented is small, but the fact that all patients have seen a significant drop in their cancer counts, and all patients have seen a shrinkage of the tumor. Now, mind you, not all of them are classified as responses, but patients have seen a shrinkage in their tumor size. This has given us a high level of confidence that the trial should be expanded, and this is what we're doing.

Our trials to confirm the initial results strongest smaller denominator, but the smaller denominator.

Valves are so compelling that for example in lung cancer.

In Egfr mutant patients.

So we're talking about reference arms being 10% to 15%, with response rates being very short in duration. Now, of course, the denominator of the data that we presented is small, but the fact that all patients have seen a significant drop in their cancer counts. And all patients have seen a shrinkage in tumor. Now, mind you, not all of them are classified as responses, but patients have seen a shrinkage in their tumor size, has given us a high level of confidence that the trial should be expanded, and this is what we're doing.

We'll investigate in fact, there is a subset of a specific egfr mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen.

In our earlier trials, so that will be similar to what J&J did for a larger patient population, what thereby specifics and.

The last report that I show is for a patient population that is about.

10th of the size of what we may be pursuing.

Estimates for their product is in the billions in sales. So so there are opportunities that we will pursue that are driven by small trials.

Garo H. Armen: So we have enrolled, I believe, around 30 patients in a randomized trial now. The data is maturing, and as the data matures and we confirm the results from the smaller denominator of the initial patients, then I think we will have reason to go to the FDA and ask them for the requirements for a potential accelerated approval for this indication. Now, we have also, as our colleagues may have said before, other indications that are potentially indications that we will go for approval. One is, again, all of these will be subject to extension of our trials to confirm the initial results from a smaller denominator. But the smaller denominator results are so compelling that, for example, in lung cancer, in EGFR mutant patients, we will investigate.

So we have enrolled, I believe, around 30 patients in a randomized trial now. The data is maturing, and as the data matures and we confirm the results from the smaller denominator of the initial patients, then I think we will have reason to go to the FDA and ask them for the requirements for a potential accelerated approval for this indication. Now, we have also, as our colleagues may have said before, other indications that are potentially indications that we will go for approval.

Very specific patient populations that will yield very high response rates.

And typically de facto biomarker driven identification of these patient populations and it applies to lung cancer certain subsets of lung cancer and it applies also in a different format for the new adjuvant and in this particular case.

What we have seen in our neo adjuvant trial is a.

One is, again, all of these will be subject to extension of our trials to confirm the initial results from a smaller denominator. But the smaller denominator results are so compelling that, for example, in lung cancer, in EGFR mutant patients, we will investigate. In fact, there is a subset of a specific EGFR mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen in our earlier trials.

Sure injury, sparing and when we talk about surgery sparing we're talking about.

Surgeries that will be debilitating for the patient removal.

Rectum is a debilitating outcome, particularly in the younger patient population.

Garo H. Armen: In fact, there is a subset of a specific EGFR mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen in our earlier trials. So that will be similar to what J&J did for a larger patient population, what their bi-specific, and the last report that I saw is for a patient population that is about a tenth of the size of what we may be pursuing. The estimates for their product are in the billions of sales.

In fact, there is a subset of a specific EGFR mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen in our earlier trials.

Particularly I mean, it's debilitating for all patients, but if you're in your <unk>.

And you have a lower.

Collyn.

Lower left colon tumor that is closest to direct them.

So that will be similar to what J&J did for a larger patient population, what their bispecific. And the last report that I saw is for a patient population that is about a tenth of the size of what we may be pursuing. The estimates for their product is in the billions in sales. So there are opportunities that we will pursue that are driven by small trials, very specific patient populations that will yield very high response rates, and typically de facto biomarker-driven identification of these patient populations, and that applies to lung cancer, certain subsets of lung cancer, and that applies also in a different format for the neoadjuvant.

And thats going to yield H.

Radical surgery.

That would be horrible so if we can prevent that.

With our new adjuvant.

Strategy.

We believe that's a tremendous opportunity. So we're looking at all of these options and more of course.

Garo H. Armen: So there are opportunities that we will pursue that are driven by small trials, very specific patient populations that will yield very high response rates, and typically de facto biomarker-driven identification of these patient populations, and that applies to lung cancer, certain subsets of lung cancer, and that applies also in a different format for the neoadjuvant. In this particular case, what we have seen in our neoadjuvant trial is surgery It's debilitating for all patients, but if you're in your 20s and 30s and you have a lower left colon tumor that is closest to the rectum and that's going to yield radical surgery, that would be horrible, so if we can prevent that, with our new adjuvant strategy, we believe that's a tremendous opportunity. So we're looking at all of these options and more, of course, so stay tuned. That's very helpful; thank you.

So there are opportunities that we will pursue that are driven by small trials, very specific patient populations that will yield very high response rates, and typically de facto biomarker-driven identification of these patient populations, and that applies to lung cancer, certain subsets of lung cancer, and that applies also in a different format for the neoadjuvant.

And stay tuned.

That's very helpful. Thank you one really quick follow up if I can just on.

The Neo adjuvant. The next new adjuvant setting study will that allow for the potential to get surgery altogether or will all of those patients proceed to surgery.

Well, okay. So how's led factors are they elaborated.

No at least a one patient.

After a complete response.

Refuse Sham surgery now of course, that's a tricky situation because of ethical considerations, which we don't have an approved product in that indication yet.

In this particular case, what we have seen in our neoadjuvant trial is surgery It's debilitating for all patients, but if you're in your 20s and 30s and you have a lower left colon tumor that is closest to the rectum and that's going to yield radical surgery, that would be horrible, so if we can prevent that, with our new adjuvant strategy, we believe that's a tremendous opportunity. So we're looking at all of these options and more, of course, so stay tuned. That's very helpful; thank you.

And in this particular case, what we have seen in our neoadjuvant trial is a surgery sparing and when we talk about surgery sparing, we're talking about surgeries that would be debilitating for the patients. Removal of the rectum is a debilitating outcome, particularly in the younger patient population. Particularly, I mean, is debilitating for all patients. But if you're in your 20s and 30s and you have a lower colon-- lower left colon tumor that is closest to the rectum and that's going to yield a radical surgery, that would be horrible. So if we can prevent that, with our neoadjuvant strategy, we believe that's a tremendous opportunity. So we're looking at all of these options and more, of course, and stay tuned.

And hence.

That recommendation cannot be made by a physician for ethical reasons right now right now, but if a patient refuses to add surgeries parameters.

So, but you are seeing that.

Kind of a potential development and of course I want to stress. The fact that everything has to be done.

Rapidly with appropriate regulatory guidance.

And everything has because we got in an ethical way so that we don't jeopardize the wellbeing of patients.

so if we can prevent that, with our new adjuvant strategy, we believe that's a tremendous opportunity. So we're looking at all of these options and more, of course, so stay tuned.

Great. Thank you for taking my questions.

Yes.

We will go next to Matthew fits at William Blair.

Okay.

Hi, Thanks for taking my questions. So just curious when you as they did in the second half from the phase II colorectal study.

Colleen Kusy: That's very helpful. Thank you. One really quick follow-up, if I can, just on the neoadjuvant-- the next neoadjuvant setting study. Will that allow for the potential to get surgery altogether? Or will all of those patients proceed to surgery?

Garo H. Armen: One really quick follow-up, if I can, just on the next neoadjuvant setting study. Will that allow for the potential to skip surgery altogether, or will all of those patients proceed to surgery? Well, okay, so I'll let Dr. Oday elaborate, but I know at least one patient, after a complete response, refused to have surgery.

One really quick follow-up, if I can, just on the next neoadjuvant setting study. Will that allow for the potential to skip surgery altogether, or will all of those patients proceed to surgery?

You think youll have PFS data by that point.

Seems like given the poor prognosis patients that could be possible.

So I will refer to our regulatory experts the PFS in these patients relative to <unk> S. A.

Garo Armen: Well, okay. So I'll let Dr. O'Day elaborate, but I know at least one patient, after a complete response, refused to have surgery. Now, of course, that's a tricky situation because of ethical considerations. And we don't have an approved product in that indication yet. And hence, that recommendation cannot be made by a physician for ethical reasons right now. But, if a patient refuses to have surgery, it's their prerogative, it's their life. So, but you are seeing that kind of a potential, and of course, I want to stress the fact that everything has to be done properly with appropriate regulatory guidance. And everything has to be done in an ethical way so that we don't jeopardize the well-being of patients.

Such a short interval.

Steph I think oses.

Gold standard PFS is much less so.

Garo H. Armen: Now, of course, that's a tricky situation because of ethical considerations, and we don't have an approved product in that indication yet. And hence, that recommendation cannot be made by a physician for ethical reasons right now. But, if a patient refuses to have surgery, it's bad for them, their lives.

Steven Todd do you have any comments on that.

Yes.

Okay.

Todd.

Steve go ahead.

Yes.

Matt, Yes, I mean, obviously, we'll have response rate duration of response PFS and preliminary survival in these patients as they mature over the course of the year from there.

Garo H. Armen: So, you are seeing that kind of potential, you know, and of course, I want to stress the fact that everything has to be done properly with appropriate regulatory guidance, and everything has to be done in an ethical way so that we don't jeopardize the well-being of patients. Great, thank you for taking our We'll go next to Matthew Phipps at William Blair. Thanks for taking my questions. So just curious, when you say data in the second half from the phase two colorectal study, do you think you'll have PFS data by that point? It seems like given the poor prognosis of this patient, that could be possible.

So, you are seeing that kind of potential, you know, and of course, I want to stress the fact that everything has to be done properly with appropriate regulatory guidance, and everything has to be done in an ethical way so that we don't jeopardize the well-being of patients.

Left.

From when they were accrued so obviously, it's a composite endpoint, but to Gary's point, clearly response and duration of response is what drive and prolonged stable disease.

Drive the survival curve. So our primary endpoints are obviously response duration of response and then ultimately the gold standard survival.

Great, thank you for taking our We'll go next to Matthew Phipps at William Blair. Thanks for taking my questions. So just curious, when you say data in the second half from the phase two colorectal study, do you think you'll have PFS data by that point? It seems like given the poor prognosis of this patient, that could be possible.

Colleen Kusy: Great, thank you for taking our questions.

Okay.

We'll go next to Matthew Phipps at William Blair. Thanks for taking my questions. So just curious, when you say data in the second half from the phase two colorectal study, do you think you'll have PFS data by that point? It seems like given the poor prognosis of this patient, that could be possible.

Operator: We'll go next to Matthew Phipps at William Blair.

Yes.

Thanks, Steven and I guess just.

Matthew Phipps: Thanks for taking my questions. So just curious, when you say data in the second half from the Phase II colorectal study, do you think you'll have PFS data by that point? It seems like given the poor prognosis of this patient, that could be possible.

Curious what not disclose at least some indication of the topline results I guess.

Given the six month follow up by that point.

Why wait until after you've made with the FDA to at least I guess say whether or not.

Or at point, that's been met or something like that.

It's strictly regulatory courtesy.

It would be.

Garo H. Armen: So I will defer to our regulatory experts, but PFS in these patients relative to OS is such a short interval of difference that I think OS is the gold standard, and PFS is much less so. Steven, Todd, do you have any comments on that? Yeah, I mean Matt, John... No, Steven, go ahead, and I'll follow up with you. Okay. Matt, yeah, I mean, obviously, we'll have response rate, duration of response, PFS, and preliminary survival in these patients as they mature over the course of the year from their last treatment, from when they were accrued. So, obviously, it's a composite endpoint.

So I will refer to our regulatory experts, but PFS in these patients relative to OS is such a short interval of difference that I think OS is the gold standard, PFS is much less so. Steven, Todd, do you have any comments on that?

Not appropriate if we're ready to present this data to the FDA to make that public right before our FDA.

Sure.

Yes.

Okay, and I assume then you'll make disclosures publically after receiving the minutes from that FDA meeting so adding over time for that.

That's right.

Okay. Thank you.

Yeah.

And next we'll move to Kelly at Jefferies.

Yes, Steven, go ahead, and I'll follow up with you. Okay. Matt, yeah, I mean, obviously, we'll have response rate, duration of response, PFS, and preliminary survival in these patients as they mature over the course of the year from their last treatment, from when they were accrued. So, obviously, it's a composite endpoint.

Todd Yancey: Yes, Steven, go ahead, and I'll follow-up...

Yeah.

Hi, good morning.

Kelly.

Yes.

Matt, yes. I mean, obviously, we'll have response rate, duration of response, PFS, and preliminary survival in these patients as they mature over the course of the year from their last-- from when they were accrued. So, obviously, it's a composite endpoint. But to Garo's point, clearly, response and duration of response is what drives and prolongs stable disease and drives the survival curve. So, our primary endpoints are obviously response, duration of response, and then, ultimately, the gold standard, survival.

Steven O'Day: Matt, yes. I mean, obviously, we'll have response rate, duration of response, PFS, and preliminary survival in these patients as they mature over the course of the year from their last-- from when they were accrued. So, obviously, it's a composite endpoint.

So one quick question on our non small cell lung cancer. So for the next update.

Given you've shown 6% overall response data on patients.

Your voice is coming very faint and theres some crackling in July and if you can.

The closer to the microphone.

How about now.

Yes, better.

Okay got it.

But to Garo's point, clearly, response and duration of response is what drives and prolongs stable disease and drives the survival curve. So, our primary endpoints are obviously response, duration of response, and then, ultimately, the gold standard, survival.

So just one question on the lung cancer update.

Given you've shown 30%.

Steven J. ODay: But to Garo's point, clearly, response and duration of response is what drives and prolongs stable disease and drives the survival curve. So, our primary endpoints are obviously response, duration of response, and then, ultimately, the gold standard, survival. Thanks, Steven. And I guess just.

Overall response data in <unk> patients.

What would be the efficacy you need to see.

On the next update of that program.

The next stage of development and if so what would be the going forward plan for lung cancer.

Thanks. And I guess just curious, Garo, why not disclose at least some indication of the top-line results, I guess, in May, given the 6-month follow-up by that point? Why wait till after you meet with the FDA to at least, I guess, say whether or not or endpoint that's been met or something like that. It's strictly regulatory courtesy.

Matthew Phipps: Thanks. And I guess just curious, Garo, why not disclose at least some indication of the top-line results, I guess, in May, given the 6-month follow-up by that point? Why wait till after you meet with the FDA to at least, I guess, say whether or not or endpoint that's been met or something like that.

Garo H. Armen: Curious, Garo, why not disclose at least some indication of the top-line results, I guess, in May, given the six-month follow-up by that point? Why wait till after you meet with the FDA to at least, I guess, say whether or not... or a point that's been met. It's strictly regulatory courtesy.

And also just.

I'm wondering can you remind us.

What other data disclosure, we should expect in 2024 I believe.

Vms partner data is also expected this year S floor, just wanted to confirm thank you.

It's strictly regulatory courtesy. I think it would not be appropriate if we're ready to present this data to the FDA and make that public right before our FDA meeting. Okay, and I assume then you'll make disclosures publicly after receiving the minutes from that FDA meeting, so add. And next, we'll move to Kelly Shee at... This is Clare.

It's strictly regulatory courtesy. I think it would be not appropriate if we're ready to present this data to the FDA to make that public right before our FDA meeting. Okay, and I assume then you'll make disclosures publicly after receiving the minutes from that FDA meeting, so add.

Garo Armen: It's strictly regulatory courtesy. I think it would be not appropriate if we're ready to present this data to the FDA to make that public right before our FDA meeting.

Garo H. Armen: I think it would not be appropriate if we're ready to present this data to the FDA and make that public right before our FDA meeting. Okay, and I assume then you'll make disclosures publicly after receiving the minutes from that FDA meeting, so add. And next, we'll move to Kelly Shee at... This is Clare.

Sure.

So a couple of things here on the lung cancer as you know we slowed down overall enrollment into the trial. So what we're doing right now having dissected the data and looked at subsets of patients that have had significant responses when I say significant risks.

Matthew Phipps: Okay. And I assume then you'll make disclosures publicly after receiving the minutes from that FDA meeting. So adding a little bit of time for that. Okay. Thank you.

And next, we'll move to Kelly Shee at... This is Clare.

Operator: And next, we'll move to Kelly Shi at Jefferies.

I'm talking about complete responses rapid complete responses at a low dose level.

This is Sara on for Kelly. So one quick question on non-small cell lung cancer. So for the next update, given you've shown 56% overall response data in patients. Thank you. Thank you. Thank you. Agenus Inc. Kelly, your voice is coming in very faint, and there's some crackling in the line. If you can speak closer to the microphone, How about now? Yes. Better. Okay. I've got it. So just one question on the lung cancer update, given you've shown 50% overall response data in 9 patients, wondering what the Africa on the next update to advance the program into the next stage of development. And if so, what would be the going forward plan for lung cancer? And also, just wondering, you know, can you remind us?

Unknown Analyst: This is Sara on for Kelly. So one quick question on non-small cell lung cancer. So for the next update, given you've shown 56% overall response data in patients...

Operator: Thank you. Thank you. Thank you. Agenus Inc. Kelly, your voice is coming in very faint, and there's some crackling in the line. If you can speak closer to the microphone,

<unk> to us is a significant outcome. So we're in the process of now.

Your voice is coming in very faint, and there's some crackling in the line. If you can speak closer to the microphone, How about now? Yes. Better. Okay. I've got it. So just one question on the lung cancer update, given you've shown 50% overall response data in 9 patients, wondering what the Africa on the next update to advance the program into the next stage of development. And if so, what would be the going forward plan for lung cancer? And also, just wondering, you know, can you remind us?

Garo Armen: Your voice is coming in very faint, and there's some crackling in the line. If you can speak closer to the microphone.

Finding how we would proceed as I said earlier with those subsets of biomarker identifiable patients.

Operator: How about now? Yes. Better. Okay. I've got it.

How about now? Yes. Better. Okay. I've got it. So just one question on the lung cancer update, given you've shown 50% overall response data in 9 patients, wondering what the Africa on the next update to advance the program into the next stage of development. And if so, what would be the going forward plan for lung cancer? And also, just wondering, you know, can you remind us?

Unknown Analyst: How about now?

Garo H. Armen: So just one question on the lung cancer update, given you've shown 50% overall response data in 9 patients, wondering what the Africa on the next update to advance the program into the next stage of development. And if so, what would be the going forward plan for lung cancer? And also, just wondering, you know, can you remind us?

So that's our next step in lung cancer, but thats going to happen very quickly.

Yes. Better. Okay. I've got it. So just one question on the lung cancer update, given you've shown 50% overall response data in 9 patients, wondering what the Africa on the next update to advance the program into the next stage of development. And if so, what would be the going forward plan for lung cancer? And also, just wondering, you know, can you remind us?

Garo Armen: Yes. Better.

Unknown Analyst: Okay. I've got it. So just one question on the lung cancer update, given you've shown 50% overall response data in 9 patients. Wondering what would be the efficacy you need to see on the next update to advance the program into the next stage of development? And if so, what would be the going forward plan for lung cancer? And also, just wondering, can you remind us what other data disclosures we should expect in 2024, I believe the BMS partner TIGIT data is also expected this year as well? Just wanted to confirm.

With regard to data for the balance of this year, we have data coming mature data coming from larger cohort Charles pancreatic cancer patients in a randomized trial.

That would be some time may be preliminary data will be by mid year.

More mature data by year end.

We will have more mature data in melanoma.

Garo H. Armen: Other data disclosures we should expect in 2024, I believe the VMS partner TIGIT data is, Sure. So there are a couple of things here. On lung cancer, as you know, we slowed down overall enrollment in the trial. So what we're doing right now, having dissected the data and looked at subsets of patients that have had significant responses. When I say significant response, I'm talking about complete responses, rapid complete responses at our low-dose level; that, to us, is a significant outcome.

Other data disclosures we should expect in 2024, I believe the VMS partner TIGIT data is,

We will provide the sustainability of responses in sarcoma and.

Sure. So a couple of things here. On lung cancer, as you know, we slowed down overall enrollment in the trial. So what we're doing right now, having dissected the data and looked at subsets of patients that have had significant responses. When I say significant response, I'm talking about complete responses, rapid complete responses at our low-dose level. That, to us, is a significant outcome. So we're in the process of now defining how we would proceed, as I said earlier, with those subsets of biomarker-identifiable patients. And so that's our next step in lung cancer, but it's going to happen very quickly. With regard to data for the balance of this year, we have data coming, mature data coming from larger cohorts of pancreatic cancer patients in a randomized trial, that would be some time, maybe preliminary data will be by mid-year, but more mature data by year-end. We'll have more mature data on melanoma. We will provide the sustainability of responses in sarcoma. And, of course, you will see substantially more data in colon cancer shortly after our regulatory meeting. And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks. Thank you very much, Audrey, and thank you very much for your attentiveness and for your fantastic questions, actually. And I think we've covered a great deal here. And I just want to make sure that our stakeholders are assured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment where resources are not as abundant as they were in the past. And so maybe that's a good thing, because it forces companies, not just us, but the industry, to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch products, both from a CMC perspective as well as from a commercial perspective. We have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education, education of the system, patients, regulators, as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components.

Garo Armen: Sure. So a couple of things here. On lung cancer, as you know, we slowed down overall enrollment in the trial. So what we're doing right now, having dissected the data and looked at subsets of patients that have had significant responses. When I say significant response, I'm talking about complete responses, rapid complete responses at our low-dose level. That, to us, is a significant outcome.

And of course, you will see.

Substantially more data in colon cancer shortly after our regulatory meetings.

Okay.

Thank you Super helpful.

Okay.

Yes.

And there are no further questions at this time I would like to turn the conference over to Garo Armen for closing remarks.

So we're in the process of now defining how we would proceed, as I said earlier, with those subsets of biomarker-identifiable patients. And so that's our next step in lung cancer, but it's going to happen very quickly. With regard to data for the balance of this year, we have data coming, mature data coming from larger cohorts of pancreatic cancer patients in a randomized trial, that would be some time, maybe preliminary data will be by mid-year, but more mature data by year-end. We'll have more mature data on melanoma. We will provide the sustainability of responses in sarcoma. And, of course, you will see substantially more data in colon cancer shortly after our regulatory meetings.

Thank you very much our dry and thank you very much for your attentiveness and saw fantastic questions actually and I think we've covered a great deal here and I just want to make sure that our stakeholders are insured all of our.

Garo H. Armen: So we're in the process of now defining how we would proceed, as I said earlier, with those subsets of biomarker-identifiable patients. And so that's our next step in lung cancer, but it's gonna happen very quickly. With regard to data for the balance of this year, we have data coming, mature data coming from larger cohorts of pancreatic cancer patients in a randomized trial. That would be sometime, maybe preliminary data will be by mid-year, but more mature data by year-end. We'll have more mature data on melanoma, and we will provide the sustainability of responses in sarcoma. And, of course, you will see substantially more data in COVID-19 shortly after our regulatory meeting. And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks. Thank you very much, Audrey, and thank you very much for your attentiveness and for your fantastic questions, actually. And I think we've covered a great deal here. And I just want to make sure that our stakeholders are assured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment where resources are not as abundant as they were in the past. And so maybe that's a good thing, because it forces companies, not just us, but the industry, to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch products, both from a CMC perspective as well as from a commercial perspective. We have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education, education of the system, patients, regulators, as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components.

Commitment to make sure that we stayed folk we stay focus first of all because we are in a very unique environment, where the resources are not as abundant as they were in the past and so that.

We'll have more mature data on melanoma. We will provide the sustainability of responses in sarcoma. And, of course, you will see substantially more data in colon cancer shortly after our regulatory meetings. Super helpful.

Maybe that's a good thing because its forces companies not just us, but the industry to do things more rationally. So we intend on delivering outcomes.

Garo H. Armen: We'll have more mature data on melanoma, and we will provide the sustainability of responses in sarcoma. And, of course, you will see substantially more data in COVID-19 shortly after our regulatory meeting. And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks. Thank you very much, Audrey, and thank you very much for your attentiveness and for your fantastic questions, actually. And I think we've covered a great deal here.

Efficiency.

Unknown Analyst: Thank you. Super helpful.

And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks. Thank you very much, Audrey, and thank you very much for your attentiveness and for your fantastic questions, actually. And I think we've covered a great deal here. And I just want to make sure that our stakeholders are assured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment where resources are not as abundant as they were in the past. And so maybe that's a good thing, because it forces companies, not just us, but the industry, to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch products, both from a CMC perspective as well as from a commercial perspective. We have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education, education of the system, patients, regulators, as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components.

Operator: And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks.

We are poised to be able to potentially launch product.

From a CMC perspective, as well as from a commercial perspective, we have a terrific team in.

Thank you very much, Audrey, and thank you very much for your attentiveness and for your fantastic questions, actually. And I think we've covered a great deal here. And I just want to make sure that our stakeholders are insured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment where resources are not as abundant as they were in the past. And so maybe that's a good thing, because it forces companies, not just us, but the industry, to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch products, both from a CMC perspective as well as from a commercial perspective. We have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team. So that we can drive our processes through education, education of the system, patients, regulators, as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components.

Garo Armen: Thank you very much, Audrey, and thank you very much for your attentiveness and for your fantastic questions, actually. And I think we've covered a great deal here. And I just want to make sure that our stakeholders are insured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment where resources are not as abundant as they were in the past.

In each category.

To do this in addition to that we have assembled.

Garo H. Armen: And I just want to make sure that our stakeholders are assured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment where resources are not as abundant as they were in the past. And so maybe that's a good thing, because it forces companies, not just us, but the industry, to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch products, both from a CMC perspective as well as from a commercial perspective. We have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education, education of the system, patients, regulators, as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components.

Very very competent medical affairs team. So that we can drive our processes through education education, all of the system patients regulators as well as physicians that will eventually prescribed our medicines.

And so maybe that's a good thing, because it forces companies, not just us, but the industry, to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch products, both from a CMC perspective as well as from a commercial perspective. We have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team. So that we can drive our processes through education, education of the system, patients, regulators, as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components.

So we are pretending to all of these very important components.

We are a small large company in that sense and then all the young company in many ways, but Terry. Thank you very much for your attentiveness and we will communicate with you appropriately at the next time.

And this concludes today's conference call. Thank you for your participation you may now disconnect.

Please wait the conference will begin shortly.

So we are pretending to all of these very important components. We are a small, large company in that sense, and an old, young company in many ways. But thank you very much for your attentiveness, and we will communicate with you appropriately at the next time. And this concludes today's conference call. Thank you for your participation. You may now go.

Garo H. Armen: We are a small, large company in that sense, and an old, young company in many ways. But Peg, thank you very much for your attentiveness, and we will communicate with you appropriately at the next time. And this concludes today's conference call. Thank you for your participation. You may now go.

Okay.

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[music].

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Okay.

Operator: And this concludes today's conference call. Thank you for your participation. You may now disconnect.

Yes.

Sure.

Yes.

Okay.

Operator: Please wait; the conference will begin shortly. Please wait; the conference will begin shortly. Please wait; the conference will begin shortly. Please wait; the conference will begin shortly. Please wait; the conference will begin shortly...........................................................................................................................................................................................................................................................................................................................

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Q4 2023 Agenus Inc Earnings Call

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