Q1 2024 Agenus Inc Earnings Call

Operator: Thank you for standing by, and welcome to Agenus' first quarter 2024 results conference call. All lines have been placed on mute to prevent any background noise. 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 followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press Star 1 again. Thank you. I would now like to turn the call over to Zack Armen, Head of Investor Relations. Please go ahead.

Thank you for standing by and welcome to Adjourn. This first quarter 'twenty 'twenty four results conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star followed by the number.

One on your telephone keypad, if you would like to withdraw your question Press Star. One again. Thank you I would now like to turn the call over to Zac Armen head of Investor Relations. Please go ahead.

Zack Armen: Thank you, Rochelle, 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 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 the first quarter.

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

Zack Armen: 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.

Zack Armen: 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.

Zack Armen: 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 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 the first quarter.

Zack Armen: 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, Dr. Robin Taylor, Chief Commercial officer, Dr. Todd Nancy Senior strategic advisor, who will be participating in the Q&A session.

Garo: Now I'd like to turn the call over to go to highlight our progress in the first quarter.

Zack Armen: Sure.

Garo: Good morning, everyone.

Garo H. Armen: Good morning, everyone. Thank you for joining us on today's call. Three decades ago, Agenus was founded with a profound commitment to transform the landscape of cancer treatment. Ever since, we have been relentlessly pursuing this mission, leveraging the power of the immune system to develop groundbreaking therapies that could dramatically change the lives of those battling cancer. Today, as we edge closer to realizing our goals with our leading BOT/BAL program, I'm thrilled to share a significant milestone that will propel us into the next phase of our journey. This morning, we announced that we entered into a $100 million royalty financing agreement with Ligand Pharmaceuticals. It's very important to realize that this agreement allows us to keep BOT/BAL in its entirety, and also open up our options to bring in partners for this program. This [inaudible] minimally diluted capital infusion will support key development initiatives in the Bot/Bal program, including our planned confirmatory Phase III study in relapsed refractory MSS-CRC, which stands for colorectal cancer, and our commercialization readiness activities, which is currently underway.

Speaker Change: Thank you for joining us on today's call.

Speaker Change: Three decades ago again, this was founded with a profound commitment.

Speaker Change: Transform the landscape of cancer treatment.

Speaker Change: Everything we have been relentlessly pursuing this patient.

Speaker Change: Leveraging the power of the immune system to develop ground breaking therapies that could dramatically change the lives of those battling cancer.

Speaker Change: Today, as we age closer to realizing our goals.

Speaker Change: With our leading by the <unk> program.

Garo H. Armen: We announced that we entered into a $100 million royalty financing agreement with Ligand Pharmaceuticals. It's very important to realize that this agreement allows us to keep WattBowl in its entirety and also opens up our options to bring in partners for this program. This Pyrrhito minimally dilutes capital infusion, will support key development initiatives in the Bat-Bal program, including our planned confirmatory phase 3 study in relapsed refractory MSS-CRC, which stands for colorectal cancer, and our commercialization readiness activity, which is currently underway.

Speaker Change: I am thrilled to share his significant milestone that will propel us into the next phase of our journey.

Speaker Change: This morning.

Garo H. Armen: Ligand's initial commitment is for $75 million, with an option to add $25 million more. And importantly, in addition to this, we can add $100 million more in a syndicated transaction from other parties, several of whom we are already in negotiations, making the total as much as $200 million. This agreement strengthens our financial position and reinforces our commitment to bringing BOT/BAL to patients. Our cash balance as of the end of the first quarter was $52 million. With the additional cash received from this transaction, we are positioned to ensure the progress of our mission-critical work to bring BOT/BAL to patients in need. We're also in discussions for additional capital infusion mechanisms to further strengthen our balance sheet as we enter a critical phase of our effort across our BOT/BAL program. Also very importantly, over the last few quarters we have successfully reduced our cash burn rate and will continue to do so, even with our strengthened cash position. Our detailed financial scenario planning includes various partnership outcomes and a potential regulatory timelines, ensuring we are well prepared for the challenges and opportunities ahead. Our reverse stock split during Q1 was implemented to achieve three key objectives: One; to satisfy the eligibility criteria for the Russell Indices, two; regain compliance with NASDAQ listing requirements, and three; to maintain a stock price about $5 a share, enabling investments by certain institutional investors that require a minimum share price. We've confirmed regaining compliance with NASDAQ listing requirements last week, and based on our market Capex of the closure of trading on April 30th, which is Russell ramp day.

Garo H. Armen: Ligand's initial commitment is for $75 million, with an option to add $25 million more. And importantly, in addition to this, we can add $100 million more in a syndicated transaction from other parties, several of whom we are already in negotiations, making the total as much as $200 million. This agreement strengthens our financial position and reinforces our commitment to bringing BOT/BAL to patients. Our cash balance as of the end of the first quarter was $52 million. With the additional cash received from this transaction, we are positioned to ensure the progress of our mission-critical work to bring BOT/BAL to patients in need. We're also in discussions for additional capital infusion mechanisms to further strengthen our balance sheet as we enter a critical phase of our effort across our BOT/BAL program. Also very importantly, over the last few quarters we have successfully reduced our cash burn rate and will continue to do so, even with our strengthened cash position. Our detailed financial scenario planning includes various partnership outcomes and a potential regulatory timelines, ensuring we are well prepared for the challenges and opportunities ahead. Our reverse stock split during Q1 was implemented to achieve three key objectives: One; to satisfy the eligibility criteria for the Russell Indices, two; regain compliance with NASDAQ listing requirements, and three; to maintain a stock price about $5 a share, enabling investments by certain institutional investors that require a minimum share price.

Speaker Change: We announced that we entered into a $100 million.

Speaker Change: Royalty financing agreement with ligand pharmaceuticals.

Speaker Change: It's very important to realize that this agreement allows us to keep.

Speaker Change: And in its entirety and also open up our options to bring in partners for this program.

Speaker Change: This parent toe minimally dilutive capital infusion.

Speaker Change: We'll support key development initiatives in the <unk> program.

Speaker Change: Including our planned confirmatory phase III study.

Speaker Change: In relapsed refractory MSS, CRC, which stands for colorectal cancer.

Speaker Change: Our commercialization readiness activities, which are currently underway.

Speaker Change: <unk> initial commitment and days for our 75 million with an option to add $25 million more.

Speaker Change: And importantly in addition to this we can add 100 million more in extended care good transaction from other parties.

Speaker Change: Several of whom we are already in negotiations making.

Speaker Change: Making the tahoe as much as $200 million.

Speaker Change: This agreement strengthens our financial position.

Speaker Change: And reinforces our commitment to bringing back Val to Patriots.

Speaker Change: Our cash balance as of the end of the first quarter was $52 million.

Garo H. Armen: With the additional cash received from this transaction, we are positioned to ensure the progress of our mission-critical work to bring Botval to patients in need. We're also in discussions for additional capital infusion mechanisms to further strengthen our balance sheet as we enter a critical phase of our effort across our rock battle program. Also, very importantly, over the last few quarters. We have successfully reduced our cash burn rate and will continue to do so, even with our strengthened cash position. Our detailed financial scenario planning includes various partnership outcomes and a Potential Regulatory Timeline, ensuring we are well prepared for the challenges and opportunities ahead. I'll reverse that split during Q1. It was implemented to achieve three key objectives, to satisfy the eligibility criteria for the Russell Indices, to regain compliance with NASAC listing requirements, and three, to maintain a stock price about $5 a share, enabling investments by certain institutional investors that require a minimum share price. We've confirmed regaining compliance with NASDAQ listing requirements last week and based on our market cap as of the closure of trading on April 30, which is Russell rent day.

Speaker Change: With the additional cash received from this transaction.

Speaker Change: We are positioned to ensure the progress of our mission critical work.

Speaker Change: Great.

Speaker Change: To patients in need.

Speaker Change: We're also in discussions for additional capital infusion mechanisms to further strengthen our balance sheet.

Speaker Change: We enter a critical phase of our effort.

Speaker Change: Our valve program.

Speaker Change: Also very importantly.

Speaker Change: Over the last few quarters.

Garo H. Armen: We have successfully reduced our cash burn rate and will continue to do so, even with our strengthened cash position. Our detailed financial scenario planning includes various partnership outcomes and a Potential Regulatory Timeline, ensuring we are well prepared for the challenges and opportunities ahead. I'll reverse that split during Q1. It was implemented to achieve three key objectives, to satisfy the eligibility criteria for the Russell Indices, to regain compliance with NASAC listing requirements, and three, to maintain a stock price about $5 a share, enabling investments by certain institutional investors that require a minimum share price. We've confirmed regaining compliance with NASDAQ listing requirements last week and based on our market cap as of the closure of trading on April 30, which is Russell rent day.

Speaker Change: We have successfully reduced our cash burn rate and we will continue to do so.

Speaker Change: Even with our strengthened cash position.

Speaker Change: Our detailed financial scenario planning includes various partnership outcomes.

Speaker Change: And potential regulatory timelines, ensuring we are well prepared for the challenges and opportunities.

Speaker Change: A reverse stock split during Q1.

Speaker Change: It was implemented to achieve three key objectives.

Speaker Change: One.

Speaker Change: To satisfy the eligibility criteria for the rest of the industry.

Speaker Change: Okay.

Speaker Change: To regain compliance with NASDAQ listing requirements.

Speaker Change: And three to maintain a stock price about $5 a share and.

Speaker Change: Enabling investments by certain institutional investors.

Garo H. Armen: We've confirmed regaining compliance with NASDAQ listing requirements last week, and based on our market Capex of the close of trading on April 30th, which is Russell ramp day, we are more confident in our continued inclusion in the Russell 2000. Our strategic initiatives are expected to broaden our investor base and to lower our cost of capital, benefiting both our shareholders and optimizing our ability to bring valuable medicines to patients. I will now turn the call over to Dr. Steven O'Day, our Chief Medical Officer, who will provide an update on the latest developments in our BOT/BAL program. Steven will focus particularly on our progress on colorectal cancer. This focus is, in part our potential accelerated filing pathway in advanced stages of disease and also, this focus is vital as we expand treatment options in earlier lines of therapy to externally funded and global investigative sponsored trials. I might add that we have had requests for an unprecedented number of investigative responsive trials in our queue. The results from both Agenus-sponsored studies and those ISTs continue to reinforce our confidence in BOT/BAL's potential to address significant unmet needs across various solid tumor cancers. Thank you again for your continued support and commitment to Agenus. We're excited about the future and look forward to sharing more updates on our progress in the near future. Steven.

Speaker Change: And that required a minimum share price.

Speaker Change: We've confirmed regaining compliance with NASDAQ listing requirements last week.

Speaker Change: And based on our market cap as of the close of the trading on April 30, which is the Russell rent date.

Garo H. Armen: We are more confident in our continued inclusion in the Russell 2000. Our strategic initiatives are expected to broaden our investor base and to lower our cost of capital, benefiting both our shareholders and optimizing our ability to bring valuable medicines to patients. I will now turn the call over to Dr. Steven ODay, our Chief Medical Officer, who will provide an update on the latest developments in our Bob Fowl Program. Steven will focus particularly on our progress on colorectal cancer. This focus is, in part... Our Potential Accelerated Filing Pathway for Advanced Stages of Disease. And also, this focus is vital as we expand treatment options in earlier lines of therapy to externally funded and Global Investigator Sponsored Trust. I might add that we have had requests for an unprecedented number of investigative-responsive trials in our queue. The results from both Agenus-sponsored studies and those IST continue to reinforce our confidence in Botfield's potential to address significant unmet needs across various solid tumor cancers. Thank you again for your continued support and commitment to Agenus. We're excited about the future and look forward to sharing more updates on our progress in the near future. Steven.

Speaker Change: We are more confident in our continued inclusion in the Russell to taxes.

Speaker Change: Our strategic initiatives.

Speaker Change: I expect that to broaden our investor base.

Speaker Change: And to lower our cost of capital.

Speaker Change: Benefiting both our shareholders and optimizing our ability to bring valuable medicines to patients.

Speaker Change: I will now turn the call to Dr. Steve <unk>, our Chief Medical Officer, who will provide an update on the latest developments.

Steven J. ODay: In our <unk> program.

Steven J. ODay: Stephen will focus, particularly on our progress on colorectal cancer.

Garo H. Armen: This focus is, in part... Our Potential Accelerated Filing Pathway for Advanced Stages of Disease. And also, this focus is vital as we expand treatment options in earlier lines of therapy to externally funded and Global Investigator Sponsored Trust. I might add that we have had requests for an unprecedented number of investigative-responsive trials in our queue. The results from both Agenus-sponsored studies and those IST continue to reinforce our confidence in Botfield's potential to address significant unmet needs across various solid tumor cancers. Thank you again for your continued support and commitment to Agenus. We're excited about the future and look forward to sharing more updates on our progress in the near future. Steven.

Steve: This focus is in part.

Steve: Our potential accelerated filing pathway.

Steven J. ODay: In advanced stages of disease and also this focus is vital as we expand treatment options in earlier lines of therapy.

Steven J. ODay: Externally funded.

Steven J. ODay: In global investigator sponsored trials.

Speaker Change: I might add that we have had requests for it.

Speaker Change: The unprecedented number of investigator sponsored trials in our queue.

Steve: Okay.

Steve: The results of our growth agenda sponsored studies and those Isd.

Steve: Senior achieved reinforce our confidence in <unk> potential to address significant unmet needs across various solid tumor cancers.

Speaker Change: Thank you again for your continued support and commitment to address we're excited about the future and look forward to sharing more updates at our.

Speaker Change: Our progress in the near future Steve.

Speaker Change: Steven.

Steven: Thank you Garo.

Steven O'Day: Thank you, Garo. Botensilamab, in combination with balstilamab, has demonstrated deep and durable responses across a wide variety of poorly immunogenic or IO refractory solid tumors. These poorly immunogenic tumors represent the majority of adults with cancer, and this large group of patients has not previously benefited from the success of established IO therapy. Currently, our BOT/BAL program is focused on our lead indication, relapsed refractory colorectal cancer, which is not MSI-High or DMMR and is without active liver metastasis. We continue to make substantial progress. As provided in our press release of April 12th, we've seen this data set from our expanded Phase I-B cohort mature in the 77 patients in this indication, treated with a combination of botensilamab and bastilamab, there's now almost 14 months of medium follow-up. The confirmed overall response rate in all patients treated is 23%, with a median overall survival of 21.2 months. A 12-month overall survival estimate of 71%, and an 18-month overall survival estimate of 62%. The most common safety observations are immune-related diarrhea and colitis, which is managed in accordance with standard therapy. Grade 3 or greater treatment-related diarrhea and colitis occurred in approximately 16% of patients.

Steven: <unk> in combination with <unk> still a map has demonstrated deep and durable responses across a wide variety of poorly immunogenic more io refractory solid tumors.

Steve: These poorly immunogenic tumors represent the majority of adults with cancer and this large group of patients have not previously benefited from the success of established Io therapy.

Steven: Currently our Baas program is focused on our lead indication.

Steven: Relapsed refractory colorectal cancer, which is not MSI high or DMR and is without active liver metastasis.

Steven J. ODay: We continue to make substantial progress, as provided in our press release of April 12. We've seen this data set from our expanded Phase 1b cohort mature in the 77 patients in this indication who were treated with a combination of botansilamab and bastilamab. There are now almost 14 months of medium follow-up. The confirmed overall response rate in all patients treated is 23%, with a median overall survival of 21.2 months. A 12-month overall survival estimate of 71% and an 18-month overall survival estimate of 62%. The most common safety observations are immune-related diarrhea and colitis, which is managed in accordance with standard therapy. Grade 3 or greater treatment-related diarrhea and colitis occurred in approximately 16% of patients.

Steven: We continue to make substantial progress.

Steven: As provided in our press release of April 12 week.

Steven: We've seen this dataset from our expanded phase one cohort mature.

Steven: In the 77 patients in this indication treated with the combination of both film.

Steven: And Bell still a map there is now almost 14 months of median follow up.

Steven: The confirmed overall response rate in all patients treated is 23% with a median overall survival of 21 two months.

Steven: 12 month overall survival estimate of 71%.

Steven: And then 18 months overall survival estimate of 62%.

Steven: The most common safety observations are immune related diarrhea, and colitis, which is managed in accordance with standard therapies.

Steven: Great three year greater treatment related diarrhea, colitis occurred and approximately 16% of patients.

Steven: These data, which continued to mature stand in Stark contrast to standard of care therapies in this treatment setting where the overall response rates of one 6% and a median overall survival of 12 months or less.

Steven O'Day: These data, which continue to mature, stand in stark contrast to standard of care therapies in this treatment setting with overall response rates of 1% to 6% and a median overall survival of 12 months or less. In November 2023, we completed enrollment in a large, randomized, global Phase II trial with 234 metastatic colorectal cancer patients, whose tumors were not MSI-high or DMMR and were without active liver metastasis. This trial was designed to evaluate the dose and contribution of components of the BOT/BAL regimen in this indication. And importantly, also included a contemporaneous standard of care arm. Results from a March data cut from this top trial demonstrate consistency with our Phase I results at a similar stage of follow-up. We look forward to submitting more mature results from this trial to a scientific meeting in the second half of 2024. Data from this Phase II trial, along with data from the expanded Phase I cohort and a real-world evidence data set, support our anticipated BLA filing by the end of the year.

Steven: In November 2023, we completed an enrollment in a large randomized global phase III trial with 234, metastatic colorectal cancer patients, whose tumors were not MSI high or DMR and.

Steven: With that without active liver metastasis.

Steven: This trial was designed to evaluate dose and contribution of components for the Boston regimen in this indication.

Steven: Importantly, also included a contemporaneous standard of care are.

Steven: Results from our March data from this trial demonstrates consistency with our phase one results at a similar stage of follow up.

Steven J. ODay: Results from a March data cut from this top trial demonstrate consistency with our Phase 1 results at a similar stage of follow-up. We look forward to submitting more mature results from this trial to a scientific meeting in the second half of 2024. Data from this Phase 2 trial, along with data from the expanded Phase 1 cohort and a real-world evidence data set, support our anticipated BLA filing by the end of the year.

Steven: We look forward to submitting more mature results from this trial towards scientific meeting in the second half of 2024.

Steven: Data from this phase two trial, along with data from the expanded phase one cohort.

Steven: And our real world evidence data set.

Steven: Port are anticipated.

Steven: A filing by the end of the year.

Steven: We plan to gain alignment with the FDA on the filing and the design of the confirmatory phase III trial in an upcoming meeting anticipated in July 2024.

Steven O'Day: We plan to gain alignment with the FDA on the filing and the design of the confirmatory Phase III trial in an upcoming meeting anticipated in July 2024, so that the Phase III trial will commence this year and enroll in time to support an accelerated approval. We will also discuss our obligations, which include our Phase III dose and regimen, and the structure and cadence of submission. In the earlier lines of therapy for colorectal cancer, we have important investigator-sponsored trials ongoing, as Garo has referred to. These include the NEST trial with Dr. Tassi at Cornell, which showed major pathologic responses in six out of nine MS-stable colorectal patients treated in a neoadjuvant setting, including two pathologic complete responses, and three out of three complete or near complete responses in MSI-high patients. None of these patients had surgery delayed due to treatment with BOT and BAL.

Steven: So the phase III trial will commence this year and enroll in time to support an accelerated approval.

Steven: We will also discuss our obligations, which include our phase III dose and regimen and the structure and cadence of submission.

Steven: In the earlier lines of therapy for colorectal cancer, we have important investigator sponsored trials ongoing as Garo has referred to.

Steven J. ODay: These include the NESS trial with Dr. Tassi at Cornell, which showed major pathologic responses in six out of nine MS-stable colorectal patients treated in a neoadjuvant setting, including two pathologic complete responses, and three out of three complete or near complete responses in MSI high patients. None of these patients had surgery delayed due to treatment with BOT and BAL.

Steven: These include the next trial with Doctor policy at Cornell, which showed major pathological responses in six out of nine Airbus stable colorectal patients treated in a neo adjuvant setting, including two pathologic complete.

Steven: Responses.

Steven: Three out of three complete or near complete responses in MSI high patients.

Steven: None of these patients had surge or delayed due to treatment with thought about.

Steven: This next trial is continuing to rapidly expand and enroll.

Steven O'Day: This NEST trial is continuing to rapidly expand and enroll. Longer follow-up data from the original 12 NEST patients will be presented at an upcoming medical meeting. The second important early-line metastatic colorectal trial I want to highlight is the FOLFOX 3B regimen with Dr. Marwan Fakih at City of Hope. He is investigating BOT and BAL combined with standard of care FOLFOX plus bevacizumab in first-line metastatic or FOLFOX re-challenge metastatic patients. To date, the regimen has been well tolerated and continues to actively enroll patients. Going forward, FOLFOX 3B could serve as an active regimen across several different malignancies, including colorectal cancer in early line metastatic settings. For example, an upper GI malignancies. Our goal is to improve outcomes in both late-stage and earlier-stage colorectal cancer, a disease growing in prevalence and impacting younger patients. Additionally, we continue to follow maturing Agenus-sponsored Phase II trials with BOT or BOT/BAL in several important areas. The first is a refractory melanoma Phase II trial with BOT alone or BOT/BAL combination. And the second is a refractory second-line metastatic pancreas study comparing BOT to GEM-AXANE to GEM-ABRAXANE alone. We hope to provide updates on this data in the second half of 2024. Now, I'll turn the call over to Robin Taylor, who will provide more insight into our commercial strategy and operations. Robin?

Steven: Longer follow up data from the original 12 best patients will be presented at an upcoming medical meeting.

Steven: The second important early line metastatic colorectal trial I want to highlight is the full Fox three DAA regimen with Doctor model on <unk> at city of hope.

Steven: He is investigating bought about combined with standard of care full Fox plus Bevacizumab in first line metastatic.

Steven: For full Fox re challenged metastatic patients.

Steven: To date, the regimen has been well tolerated and continues to actively enroll patients.

Steven J. ODay: To date, the regimen has been well tolerated and continues to actively enroll patients. Going forward, Full Fox 3B could serve as an active regimen across several different malignancies, including colorectal cancer in early line metastatic settings. For example, an upper GI malignancy.

Steven: Going forward full Fox three b could serve as an active regimen across several different malignancies, including colorectal cancer and early line metastatic settings for example, upper Gi malignancies.

Steven: Our goal is to improve outcomes in both late stage and earlier stage colorectal cancer, a disease growing in prevalence and impacting younger patients.

Steven J. ODay: Our goal is to improve outcomes in both late-stage and earlier-stage colorectal cancer, a disease growing in prevalence and impacting younger patients. Additionally, we continue to follow maturing Agenus-sponsored phase 2 trials with BOT or BOT-BAL in several important areas. The first is a refractory melanoma phase 2 trial with BOT alone or BOT-BAL combination. And the second is a refractory second-line metastatic pancreas study comparing BOT-Jamabraxane to Jamabraxane alone. We hope to provide updates on this data in the second half of 2024. Now, I'll turn the call over to Robin Taylor, who will provide more insight into our commercial strategy and operations. Robin?

Steven: Additionally, we continue to fall or maturing agenda sponsored phase III trials with broad or bought bow in several important areas. The first is a refractory melanoma phase III trial with BARDA alone or Bob Al.

Steven: Combination.

Steven: The second is of our factory second line metastatic pancreas study comparing board, Jeremy Brock, saying to Jama Brad's, saying the low.

Steven: We hope to provide updates on these data in the second half of 2024.

Steven: Now I'll turn the call over to Rob.

Steven: Robin Taylor, who will provide more insight into our commercial strategy and operations Robert.

Rob: Thank you Steven.

Robin Taylor: Thank you, Steven. In parallel with our planned BLA submission, all of us at Agenus are focused on preparing for the launch of BOT and BAL. Our Emeryville-based CMC team is well prepared to supply BOT and BAL, both through our third-party CMO partners and subsequently, at our wholly owned and operated GMP-grade commercial facility. With respect to commercial preparations, I have hired a highly experienced and passionate leadership team across sales and marketing, market access, and commercial operations. Together, the members of the Commercial Leadership Team have successfully led or participated in over 20 launches of novel therapeutics or label expansions in colorectal cancer and other solid tumors. We are partnering closely with our global medical affairs and clinical teams to gather insights from the world's experts in GI oncology. And we've conducted market research with over 150 U.S.-based GI oncologists across academic and community settings. From both the market research and our direct discussions with GI oncologists, it is clear that there is significant anticipation for BOT and BAL, which underscores the urgency we feel to deliver this important treatment option to patients. Now, I'll turn the call over to Christine to discuss finances.

Rob: In parallel with our planned BLA submission all of US at <unk> are focused on preparing for the launch of Bud and Bell.

Rob: Our Emeryville based CMC team is well prepared to supply bought in bell both through our third party CMO partners and subsequently at our wholly owned and operated GMP grade commercial facility.

Rob: With respect to commercial preparations I had hired a highly experienced and passionate leadership team across sales and marketing market access and commercial operations.

Robin Taylor: Together, the members of the Commercial Leadership Team have successfully led or participated in over 20 launches of novel therapeutics or label expansions in colorectal cancer and other solid tumors. We are partnering closely with our global medical affairs and clinical teams to gather insights from the world's experts in GI oncology. And we've conducted market research with over 150 U.S.-based GI oncologists across academic and community settings. From both the market research and our direct discussions with GI oncologists, it is clear that there is significant anticipation for Bot and Val, which underscores the urgency we feel to deliver this important treatment option to patients. Now I'll turn the call over to Christine to discuss finances.

Rob: Together the members of the commercial leadership team have successfully led or participated in over 20 launches of novel Therapeutics, where label expansions in colorectal cancer and other solid tumors.

Rob: We are partnering closely with our global Medical affairs and clinical teams together insights from the world's experts in Gi oncology.

Rob: And we've conducted market research with over 150 U S based Gi oncologists across academic and community settings.

Rob: From both market research and our direct discussions with GI oncologists. It is clear that there is significant anticipation for button Bell, which underscores the urgency we feel to deliver this important treatment option to patients.

Christine M. Klaskin: Thank you, Robin. As Garo mentioned, we ended our first quarter of 2024 with a cash and cash equivalent balance of $52.9 million. This compares to $76.1 million at year end. Also, as Garo mentioned, this morning we announced a $100 million agreement with Ligand Pharmaceuticals consisting of an initial investment of $75 million with an option to invest an additional $25 million, thus strengthening our cash position. Our cash used in operations for this first quarter was $38 million, compared to $40 million during the fourth quarter ended December 31, 2023. For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million, which included non-cash expenses of $38 million. This compares to a net loss of $70.9 million, which includes non-cash expenses of $25 million for the same period in 2023. Our net loss per share for this first quarter is $3.04, which compares to $4.31 per share for the first quarter of 2023. I'll now turn the call back to Garo. Stephen Robin and Christine. As we conclude today's earnings call, I want to recap the pivotal developments we anticipate in the coming months of Agenus. We are on track to secure a significant cash infusion of up to $200 million by mid-year, which will strengthen our task position and support our critical research and development activities, our registration efforts, and our commercialization. Another key milestone will be our meeting with the FDA. An important step before we have their concordance in initiating our biologics license.

Christine M. Klaskin: Thank you, Robin. As Garo mentioned, we ended our first quarter of 2024 with a cash and cash equivalent balance of $52.9 million. This compares to $76.1 million at year end. Also, as Garo mentioned, this morning we announced a $100 million agreement with Ligand Pharmaceuticals consisting of an initial investment of $75 million with an option to invest an additional $25 million, thus strengthening our cash position. Our cash used in operations for this first quarter was $38 million, compared to $40 million during the fourth quarter ended December 31, 2023. For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million, which included non-cash expenses of $38 million. This compares to a net loss of $70.9 million, which includes non-cash expenses of $25 million for the same period in 2023. Our net loss per share for this first quarter is $3.04, which compares to $4.31 per share for the first quarter of 2023. I'll now turn the call back to Garo.

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

Christine: Thank you Robyn.

Christine: As Garo mentioned, we ended our first quarter of 2024, with a cash and cash equivalent balance of $52 $9 million.

Christine: This compares to $76 1 million at year end.

Christine: Also as Garo mentioned this morning, we announced a $100 million agreement with ligand pharmaceuticals, consisting of an initial investment of $75 million with an option to invest an additional $25 million, thus strengthening our cash position.

Christine M. Klaskin: Our cash used in operations for this first quarter was $38 million, compared to $40 million during the fourth quarter ended December 31, 2023. For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million, which included non-cash expenses of $38 million. This compares to a net loss of $70.9 million, which includes non-cash expenses of $25 million, for the same period in 2023. Our net loss per share for this first quarter is $3.04, which compares to $4.31 per share for the first quarter of 2023. I'll now turn the call back to Garo. Stephen Robin and Christine. As we conclude today's earnings call, I want to recap the pivotal developments we anticipate in the coming months of Agenus. We are on track to secure a significant cash infusion of up to $200 million by mid-year, which will strengthen our task position and support our critical research and development activities, our registration efforts, and our commercialization. Another key milestone will be our meeting with the FDA. An important step before we have their concordance in initiating our biologics license.

Christine: Our cash used in operations for this first quarter was $38 million compared to $40 million. During the fourth quarter ended December 31 2023.

Christine: For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63 5 million, which includes noncash expenses of $38 million.

Christine: This compares to a net loss of $70 9 million, which.

Christine: Which includes noncash expenses of $25 million for the same period in 2023.

Christine: Our net loss per share for this first quarter is $3 <unk>, which compares to $4 31 per share for the first quarter of 2023.

Christine: I'll now turn the call back to Garo.

Garo: Thank you very much.

Garo H. Armen: Thank you very much, Steven, Robin and Christine. As we conclude today's earnings call, I want to recap the pivotal developments we anticipate in the coming months of Agenus. We are on track to secure a significant cash infusion of up to $200 million by mid-year, which will strengthen our task position and support our critical research and development activities, our registration efforts, and our commercialization efforts. Another key milestone will be our meeting with the FDA. An important step before we have their concordance in initiating our biologics license application. Additionally, we will present our Phase II data for colorectal cancer, along with additional data in this indication from investigative responsive trials, which we believe will further strengthen the strong rationale of our therapies. And these data presentations are expected to be happening at major conferences.

Garo H. Armen: Stephen Robin and Christine. As we conclude today's earnings call, I want to recap the pivotal developments we anticipate in the coming months of Agenus. We are on track to secure a significant cash infusion of up to $200 million by mid-year, which will strengthen our task position and support our critical research and development activities, our registration efforts, and our commercialization. Another key milestone will be our meeting with the FDA. An important step before we have their concordance in initiating our biologics license.

Garo: Stephen rather than <unk>.

Garo: As we conclude todays earnings call I want to recap the pivotal developments, we anticipate in the coming months at Janus.

Garo: We are on track to secure a significant cash infusion of up to $200 million by mid year.

Garo: Which will strengthen our cash position and support our critical research and development activities.

Garo: Our registration efforts and our commercialization efforts.

Garo: Another key milestone will be our meeting with the FDA.

Garo: And important.

Garo: We have there concordance.

Garo: Initiating our biologics license application.

Garo H. Armen: Additionally, we will present our phase two data for colorectal cancer, along with additional data in this indication from investigator-sponsored trials, which we believe will further strengthen the strong rationale of our therapy. And these data presentations are expected to happen at major conferences.

Garo: Additionally, we will present, our phase two data for colorectal cancer.

Garo: Along with additional data in this indication from investigator sponsored trials.

Garo: We believe we will further strengthen the strong rationale a lot of therapies.

Garo: These data Presentation's I expect it to be happening at major conferences.

Garo H. Armen: Furthermore, we expect to release, as Steven said, promising Phase I and II data in melanoma, lung cancer, sarcoma, and pancreatic cancer in the second half of this year. We're very encouraged with the outcomes of these trials. These all represent cancers where there is a critical need for effective therapies. These developments underscore our dedication to innovation in oncology and also highlight our potential to make a meaningful impact on patients' lives by offering potentially chemo-free, durable benefit to patients who have limited or no treatment options left. Thank you very much once again to our shareholders for your continued support and trust in Agenus. We look forward to sharing more about our progress in these exciting endeavors as the year unfolds. Now, I believe we're ready for any questions you may have.

Garo: Furthermore, we.

Garo: We expect to release as Stephen said, promising phase, one and two data in melanoma lung cancer sarcoma.

Garo: In pancreatic cancer in the second half of this year.

Garo: We are very encouraged with the outcomes of these trials.

Garo: These all represent cancers, where there is a critical need for effective therapies.

Garo: These developments underscore our dedication.

Garo: Through innovation in oncology and also highlight our potential to make a meaningful impact on patients' lives by offering <unk>.

Garo: Surely chemo free.

Garo: Funeral benefit to patients who have limited or no treatment options left.

Garo H. Armen: Thank you very much once again to our shareholders for your continued support and trust in Agenus. We look forward to sharing more about our progress in these exciting endeavors as the year unfolds. Now, I believe we're ready for any questions.

Speaker Change: Thank you very much once again to our shareholders for your continued support and trust in <unk>, we look forward to sharing more about our progress in these exciting endeavors as the year unfolds.

Speaker Change: Now I believe we're ready for any questions you may have.

Operator: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press Star 1 on your telephone keypad. If you would like to withdraw your question, simply press Star 1 again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, press Star 1 to join the queue. Your first question comes from the line of Emily Bodnar of HC Wainwright. Your line is open.

Speaker Change: Thank you we will now begin the question and answer session.

Speaker Change: You have dialed in and we'd like to ask a question.

Operator: Please press star one on your telephone keypad, if you would like to withdraw your question.

Operator: Simply press Star one again.

Operator: You are called upon to ask your question and our listening via loud speaker on your device. Please pickup your handset and ensure that your phone is not on mute when asking your question again press star one to join the queue. Your first question comes from the line of Emily Bodnar.

Speaker Change: H C. Wainwright your line is open.

Emily Bodnar: Hi, good morning. Thanks for taking the questions and congrats on the progress. My first question, could you confirm how many patients you've treated with BOT/BAL at the recommended Phase II dose across the Phase I-B and Phase II studies, specifically for MSS-CRC patients without liver mets? And your confidence, I guess, that you have enough efficacy data to support an accelerated approval? And then, second question, if you can kind of discuss how you're thinking about strategy for BOT/BAL in melanoma and pancreatic cancer, and if you feel like these are indications that you may also seek regulatory approval for if the Phase II data are positive, or if your kind of near-term commercial focus is just on CRC? Thanks.

Emily Bodnar: Hi, good morning, Thanks for taking the questions and congrats on the progress.

Emily Bodnar: My first question could you confirm how many patients you've treated with <unk>.

Emily Bodnar: Recommended phase two dose.

Emily Bodnar: Across the phase <unk> study is specifically for MSS CRC patients without liver Mets and your confidence I guess that you have enough efficacy data to support an accelerated approval.

Emily Bodnar: And then second question, if you could kind of discuss how you're thinking about strategy for Bob.

Emily Bodnar: Del Mar in pancreatic cancer and if you feel like these are indications that you may also seek regulatory approval for the phase II data are positive or if you're in the near term.

Emily Bodnar: <unk> focus is just on CRC.

Garo H. Armen: Certainly, Emily, thank you very much for your question. I will give you some top-line answers to your questions and then I'll have Dr. O'Day get into some depth. First of all, as you may know, for the last almost six months, we have been intensively involved in pulling together the data from all the trials, including tracking the maturity of the data, as Steven alluded to, to see how we can make a compelling package in an upcoming meeting with the FDA. And our conviction, based on the data from all three cohorts, including the Phase II randomized study, as well as the durability and maturity of the data, is stronger today than ever before that we will make a compelling case. Now of course, we cannot make a definitive statement until the outcome of the FDA meeting, and we need to get their concordance on our [inaudible]. But we are in an optimal state of preparedness with where we are right now, and more developments on the progress on this will be coming forth in the next several weeks. Now, in terms of the numbers of patients from each cohort and other questions about whether melanoma, pancreatic, and lung cancer can lead to approval, those are, of course, very important questions that we are actively considering in collaboration with key opinion leaders in these fields.

Emily Bodnar: Emily Thank you very much for your question and I will give you some top line.

Garo H. Armen: Yes.

Steven J. ODay: Answer to your questions and then I'll add that the whole day.

Steven J. ODay: Andrew some debt.

Garo H. Armen: First of all as.

Garo H. Armen: You may know for the last.

Garo H. Armen: Six months, we have been intensively involved in pulling together the data from all the trials, including tracking the maturity of the data as Steve alluded to.

Garo H. Armen: To see how we can make a compelling package in an upcoming meeting with the FDA.

Garo H. Armen: And our conviction base.

Garo H. Armen: Based on the data from all three cohorts, including the.

Garo H. Armen: A phase II randomized study.

Garo H. Armen: As well as the durability and maturity of the data is.

Garo H. Armen: Is stronger today than ever before that we will make a compelling case of course, we cannot make a definitive statement until the outcome of the FDA meeting and we need to get there concordance.

Garo H. Armen: Now, of course, we cannot make a definitive statement until the outcome of the FDA meeting, and we need to get their concordance on our concordance. But we are in an optimal state of preparedness with where we are right now, and more developments on the progress on this will be coming forth in the next several weeks. Now in terms of the numbers of patients from each cohort and other questions about whether melanoma, pancreatic, and lung cancer can lead to approval, those are, of course, very important questions that we are actively considering in collaboration with key opinion leaders in these fields.

Garo H. Armen: But we are in a optimal state of preparedness.

Garo H. Armen: We are right now and.

Garo H. Armen: And more.

Garo H. Armen: Developments on the progress on this will be coming forward in the next several weeks.

Garo H. Armen: Now in terms of the numbers of patients from each cohort and other questions about whether the melanoma.

Garo H. Armen: <unk> and lung cancer can lead to approval.

Garo H. Armen: Those out of course very important questions that we are actively considering.

Garo H. Armen: In collaboration with key opinion leaders in these fields.

Garo H. Armen: And we will be alluding on the potential of this in the coming months. But, please understand that we are absolutely fixated on CRC right now, because that is our focus for our first potential approval. So, everything else is a little less of a priority, but with the additional financial resources that we expect to put into place between now and the end of the year, those other programs will come to the focus as well. Steven, if you can address some of the more specific questions that Emily asked?

Garo H. Armen: And.

Garo H. Armen: We will be alluding on the potential of this in coming months by please.

Steven: Stand today.

Steven: Absolutely fixated on CIC right now because that is our focus for our first potential approval so everything else.

Steven: A little less of a priority but.

Garo H. Armen: With the additional financial resources that we expect to put into place between now and the end of the year. Those other programs will come to the focus is wet but Stephen if you can address some of the more specific questions will be asked.

Steven O'Day: Thanks, Garo. So, we're not going to get into the specific numbers, but what I can say is that with the Phase I and the Phase II trial, we have two active doses and a significant number of patients on the combination of BOT/BAL in both the Phase I and the Phase II randomized trial that we think are supportive with safety, efficacy, and clinical pharmacology to discuss with the FDA an accelerated pathway, given the unmet need in this setting.

Steven: Thanks, Chiara, so we're not going to get into the App.

Steven J. ODay: Terrific numbers, but what I can say with the phase one and the phase II trial, we have two active doses and a significant number of patients on the combination of Bob and both the phase one and a phase II randomized trial that we think are.

Steven J. ODay: Supportive with safety efficacy and clinical pharmacology to discuss with the FDA in accelerated pathway given the unmet need in this setting.

Emily Bodnar: Okay, great, thank you.

Garo: Okay, great. Thank you.

Operator: Your next question comes from the line of Mayank Mamtani of B.Riley Securities. Your line is now open.

Emily Bodnar: Your next question comes from the line of my Askmen Bonnie.

Mayank Mamtani: B Riley Securities. Your line is now open.

Mayank Mamtani: Good morning team, thanks for taking our questions and congrats on the updates noted earlier. So, in that press release, you've mentioned that your emerging data in Phase II is encouraging, and today, I think you said it's comparable to what you noted in Phase I at a similar stage. Are you able to give a little bit more detail on what parameters we are talking about and, you know, if it's comparable to your expectation at the outset and, especially given, you know, you're enrolling slightly earlier stage patients there? And then secondly, if you are able to clarify the FDA meeting has been scheduled, and if there's a minimum follow-up from the Phase II cohort that you are trying to accomplish before you're able to submit a package that would go alongside that FDA meeting? I have a couple of follow-ups.

Mayank Mamtani: Good morning team, thanks for taking our questions and congrats on the updates noted earlier.

Garo H. Armen: Phil.

Garo H. Armen: Brad Best Police Dean you mentioned that data emerging data in phase two is encouraging and Jimmy I think you said it is comparable to what you noted in phase one at a similar stage.

Speaker Change: Allow me to give a little bit more detail on what.

Garo H. Armen: And because we are talking about.

Garo H. Armen: It's comparable to your expectation.

Garo H. Armen: Outset, then, especially given youre enrolling daily earlier stage patients.

Garo H. Armen: And then secondly, can you please clarify the FDA meeting has been scheduled and if there's a minimum follow-up from the Phase 2 cohort that you are trying to accomplish before you're able to submit a package that would go alongside that FDA meeting? I have a couple of questions. Okay. On the first question, Mayank, we have said repeatedly that we will not discuss the details of this study. And please understand, everybody, that we're not trying to be cute here.

And then secondly, can you please clarify the FDA meeting has been scheduled and if there's a minimum follow-up from the Phase 2 cohort that you are trying to accomplish before you're able to submit a package that would go alongside that FDA meeting? I have a couple of questions.

Garo H. Armen: And then secondly on the.

Speaker Change: Got it. Thank you clarify of the FDA meeting has been scheduled.

Garo H. Armen: And.

Garo H. Armen: If there is a minimum follow up from the phase II cohort that youre trying to accomplish before youre able to do.

Garo H. Armen: Submit a package that would go alongside that FDA meeting.

Garo H. Armen: Okay. On the first question, Mayank, we have said repeatedly that we will not discuss the details of this study. And please understand, everybody, that we're not trying to be cute here. It is just a courtesy call that we will not discuss the data until we have an opportunity to present it to the FDA. And subsequent  to that, our preference is, of course, to present the data, which we consider a very important set of data, that will address the selection of the dose, the contribution of the elements, and the efficacy to support the data that we have seen in earlier trials at a major conference. That would be our preference to do. So, you will get no further details on this until these steps are underway. Now, in terms of the FDA meeting, the FDA meeting request is going in as we speak. And we expect that, based on the timelines, we will be granted a meeting sometime in the second half of July. And this is data that we have not released before, so, we're not making it public until the meeting is scheduled. Of course, depending on the circumstances, we may make certain statements about it, but I believe that the outcome of this meeting will be one of the most important milestones for the company, as we potentially gear up for accelerated approval filing in the next months following the meeting. But, be rest assured that we are going on all full cylinders, as they say, on all modules are getting in a state of readiness for all modules that could potentially be submitted post the FDA meeting.

Speaker Change: And I have a couple of funds okay.

Garo H. Armen: And the first question.

Garo H. Armen: We have said repeatedly that we will not discuss the details of this study and please understand everybody that we're not trying to be cute here. It is just a courtesy call that we will not discuss the data until we have an opportunity to presented to the FDA.

Garo H. Armen: It is just a courtesy call that we will not discuss the data until we have an opportunity to present it to the FDA and subsequent regulatory authorities. Our preference is, of course, to present the data, which we consider a very important set of data, that will address the selection of the dose, the contribution of the elements, and the efficacy to support the data that we have seen in earlier trials, at a major conference. That would be our preference to do.

Garo H. Armen: And subsequent to that our.

Garo H. Armen: Our preference is of course to present, the data, which we consider a V.

Garo H. Armen: Very important set of data that will address that a selection of the dose.

Garo H. Armen: Contribution of the elements.

Garo H. Armen: And the efficacy to support the data that we have seen in earlier trials and then major conference that would be our preference to do.

Garo H. Armen: So you will get no further details on this until these steps are underway.

Garo H. Armen: So you will get no further details until these steps are underway. Now, in terms of the FDA meeting, the FDA meeting request is going in as we speak. And we expect that, based on the timeline, we will be granted a meeting sometime in the second half of July. And this is data that we have not released before, so we're not making it public until the meeting is scheduled. Of course, depending on the circumstances, we may make certain statements about it, but I believe that the outcome of this meeting will be one of the most important milestones for the company as we potentially gear up for accelerated approval filing in the next months following.

Garo H. Armen: And in terms of the FDA meeting the FDA meeting request.

Garo H. Armen: <unk> is going in.

Garo H. Armen: As we speak.

Garo H. Armen: And we expect that based on the timelines, we will be granted a meeting sometime in the second half of July.

Garo H. Armen: And this is data that we have not released Q4, and we are not making it public.

Garo H. Armen: And as soon as the meeting is scheduled.

Garo H. Armen: Of course, depending on the circumstances, we may make certain statements about it but I believe that the outcome of this meeting will be one of the most important milestones for the company as we potentially Europe or accelerated approval filing.

Garo H. Armen: In the next.

Garo H. Armen: Following the meeting.

Garo H. Armen: But rest assured that we are going on all full cylinders, as they say, on all modules or are getting in a state of readiness for all modules that could potentially be submitted post-FDA. I appreciate that color, Garo.

But rest assured that we are going on all full cylinders, as they say, on all modules or are getting in a state of readiness for all modules that could potentially be submitted post-FDA.

Garo H. Armen: <unk> be rest assured.

Garo H. Armen: Yes.

Garo H. Armen: We are going on on full cylinders as they say on.

Garo H. Armen: All modules or are getting ready in a state of readiness for all modules that could potentially be submitted post the FDA meeting.

Mayank Mamtani: I appreciate that color, Garo. Thank you. On the follow-up from Phase II, like you were at, I think, 14 months follow-up from Phase I. Is there a particular requirement or best practices in terms of how much follow-up you need to have from Phase II, or is that sort of subject to discussion?

Garo H. Armen: Yes.

Mayank Mamtani: Thank you. On the follow-up from phase 2, like you were at, I think, 14 months follow-up from phase 1. Is there a particular requirement or best practice in terms of how much follow-up you need to have from phase 2, or is that sort of subject to discussion?

Speaker Change: Appreciate that color. Thank you.

Mayank Mamtani: And a follow up from the phase II.

Mayank Mamtani: 14 months follow up and then the phase one is there.

Mayank Mamtani: Hey, good requirement.

Mayank Mamtani: Best practices in terms of how much follow up you need to have some phase two what is that.

Mayank Mamtani: Subject to discussions.

Mayank Mamtani: Yeah.

Mayank Mamtani: Okay. So and this of course, the FDA guidance that is based on.

Garo H. Armen: Okay, so on this of course, the FDA has guidance that is based on historical precedent on the minimum follow-up, but we have had significant input from our regulatory advisors on what that minimum should be. Of course, ideally, you can wait five years, but we're not going to do that. But the minimum enrollment in Phase II ended in October 2023. And based on that, you can sort of extrapolate what the follow-up period will be between now and the potential FDA meeting, and then beyond that FDA meeting, from that point to the filing of a BLA with the clinical module.

Mayank Mamtani: Make sense. Thank you. And then, on the number of ISTs that have come up on clinicaltrials.gov, are you able to comment on what sort of broad dose level you're using in most of these ISTs? And also, about CRC specifically, I believe there's one IST data that you expect in the relatively near term, in the earlier line setting. Steven, if you're able to comment on the implications of that data set in informing what the Phase III trial could look like, and then I have one last financial question after that.

Mayank Mamtani: Historical precedence on the minimum follow up.

Mayank Mamtani: We have had significant input from our regulatory advisors on what that minimum should be of course, ideally we can wait five years.

Mayank Mamtani: But the minimum.

Mayank Mamtani: <unk> in the phase III ended in October 2023.

Mayank Mamtani: And based on that.

Mayank Mamtani: And sort of extrapolate.

Mayank Mamtani: What the follow up period will be between now and the potential FDA meeting and then beyond that FDA meeting.

Mayank Mamtani: That points to the filing of a BLA with the clinical module.

Speaker Change: Makes sense. Thank you.

Mayank Mamtani: And then on the number of ISTs that have come up on clinicaltrials.gov, are you able to comment on what sort of broad dose level you're using in most of these ISTs? And also, about CRC specifically, I believe there's one IST data that you expect in the relatively near term in the earlier line setting. Steven, if you're able to comment on the implications of that data set in informing what the phase three trial could look like, and then I have one last financial question. Okay.

Mayank Mamtani: And then on the number of Isps that has come up on clinical trials Gov.

Mayank Mamtani: You alluded Colin Dunn, what sort of.

Mayank Mamtani: Blood dose level youre using in most of these isds and also about TICC, specifically I believe there's one ISP data that you expect that out of the near term.

Steven: The earlier line setting.

Mayank Mamtani: Even if you're able to comment on the implications of that data set and informing what the phase III trial could look like.

Speaker Change: And then I had one last financial question after that.

Garo H. Armen: Okay. So, as I said, thank you, Mayank, for that question. We have been confronted with an unprecedented number of ISTs. Now, what is that number? It's well over 50 IST requests. Now, clearly, given our resources, and I don't mean just financial resources because a number of the ISTs do not require much financial resources from the company but people, human resources, we cannot satisfy all of these IST requests. So, we have zeroed in on a handful of them. And these handful of ISTs are selected based on potential data generation for approval of our agents in subsequent trials. And also, of course, the rationale for generating significant clinical data that will be supporting the rationale or pursuing BOT/BAL in several different indications that are important to us. So, these will be reviewed, or are in the process of being reviewed on an ongoing basis, and we'll make prudent decisions in collaboration with some of our advisors and [inaudible], but also, be rest assured that during the time of our regulatory discussions, we are particularly sensitive to not expanding our IST programs so that we do not get caught in generating data that cannot be tabulated, cleaned up in time to be provided to the FDA for a potential BLA consideration. So, all these considerations are a critical part of our thought process now. In addition to that, I think you had another question on ISIS, about whether or not it's specific to CRC. Not, of course, a great number of the ISDs are not specific to CRC.

Garo H. Armen: Okay. So, as I said, thank you, Mayank, for that question. We have been confronted with an unprecedented number of ISTs. Now, what is that number? It's well over 50 IST requests. Now, clearly, given our resources, and I don't mean just financial resources because a number of the ISTs do not require much financial resources from the company but people, human resources, we cannot satisfy all of these IST requests. So, we have zeroed in on a handful of them. And these handful of ISTs are selected based on potential data generation for approval of our agents in subsequent trials. And also, of course, the rationale for generating significant clinical data that will be supporting the rationale or pursuing BOT/BAL in several different indications that are important to us. So, these will be reviewed, or are in the process of being reviewed on an ongoing basis, and we'll make prudent decisions in collaboration with some of our advisors and [inaudible], but also, be rest assured that during the time of our regulatory discussions, we are particularly sensitive to not expanding our IST programs so that we do not get caught in generating data that cannot be tabulated, cleaned up in time to be provided to the FDA for a potential BLA consideration.

Steven: Okay. So as I've said, thank you Mike for that question.

Steven: We have been confronted with an unprecedented number of Isps now what is that number is well over 50 Isd replaced that clearly given our resources and I don't mean, just financial resources, because a number of the Isps do not required by financial resource.

Garo H. Armen: It's well over 50 ISD requests. Now, clearly, given our resources, and I don't mean just financial resources because a number of the ISDs do not require much financial resources from the company but people, human resources, we cannot satisfy all of these ISD requests. So we have zeroed in on a handful of them. And these handful of ISPs are selected based on potential data generation for approval of our agents in subsequent trials and also, of course, the rationale for generating significant clinical data that will support the rationale for pursuing bot valley in several different indications that are important to us. So these will be reviewed or are in the process of being reviewed on an ongoing basis, and we'll make prudent decisions in collaboration with some of our advisors and cable operators, but also rest assured that during the time of our regulatory discussions.

Garo H. Armen: From the company, but people human resources, we cannot satisfy all of these ICD.

Garo H. Armen: We have zeroed in on a handful of them.

Garo H. Armen: And these handful of ISPs are selected based on potential data generation for approval of our agents in subsequent trials and also, of course, the rationale for generating significant clinical data that will support the rationale for pursuing bot valley in several different indications that are important to us. So these will be reviewed or are in the process of being reviewed on an ongoing basis, and we'll make prudent decisions in collaboration with some of our advisors and cable operators, but also rest assured that during the time of our regulatory discussions.

Garo H. Armen: These handful of Isps.

Garo H. Armen: Selected based on potential data generation for approval.

Garo H. Armen: All our agents in subsequent trials and also as far as the rationale on generating significant clinical data that will be supporting the rationale of all pursuing.

Garo H. Armen: Valley in several different indications that are important to us so.

Garo H. Armen: Yes.

Garo H. Armen: Will be reviewed or are in the process of being reviewed on an ongoing basis and we'll make prudent decisions in collaboration with some of our advisors and cable apps, but also be rest assured that during the time of our regulatory discussions.

Garo H. Armen: We are particularly sensitive to not expanding our ISD program so that we do not get caught in generating data that cannot be tabulated and cleaned up in time to be provided to the FDA for a potential BLA consideration. So all these considerations are a critical part of our thought process now. In addition to that, I think you had another question on ISIS, about whether or not it's specific to CRC. Not, of course, a great number of the ISDs are not specific to CRC.

Garo H. Armen: Particularly sensitive to not expanding our isd programs, so that we do not.

Garo H. Armen: Get caught in generating data.

Garo H. Armen: That cannot be tabulated cleaned up in time to be provided to the FDA for a potential BLA consideration. So all of these considerations are a critical part of our thought process.

Garo H. Armen: So, all these considerations are a critical part of our thought process. Now, in addition to that, I think you had another question on ISTs, whether or not it's specific to CRC, not - of course, a great number of the ISTs are not specific to CRC. They are in pancreatic, melanoma, lung, sarcomas - there's a great deal of interest in sarcomas because of the efficacy that we've seen - or I shouldn't say efficacy - I should say significant clinical activity that we've seen. The reason I'm saying I shouldn't say efficacy is because that's a term that the FDA has to bless. So, until that happens, we have to be careful how we use the terms of activity. But because of the significant activity that we have seen in sarcoma patients that have failed everything else, and they're not responding to any other treatments. There is, of course, a lot of interest in pursuing not just ISTs but also approval strategies. But as I said earlier, we are very, very cognizant of the focus that we need to have on CRC right now.

Garo H. Armen: Now.

Garo H. Armen: In addition to that I think.

Garo H. Armen: You had another question on Ics.

Garo H. Armen: Whether or not it's specific to CRC not of course, a great number of the Isps are not specific to CRC.

Garo H. Armen: They are in pancreatic, melanoma, lung, and sarcomas. There's a great deal of interest in sarcomas because of the efficacy that we've seen, or I shouldn't say efficacy; I should say significant clinical activity that we've seen. The reason I'm saying I shouldn't say efficacy is because that's a term that the FDA has to So until that happens, we have to be careful how we use the terms of activity. But because of the significant activity that we have seen in sarcoma patients who have failed everything else, and they're not responding to any other treatments. There is, of course, a lot of... pursuing not just ISDs but also approval strategies. But as I said earlier, we are very, very cognizant of

Garo H. Armen: They are in pancreatic melanoma lung.

Garo H. Armen: <unk> is a great deal of interest in Silicon Valley because of the.

Mayank Mamtani: Got it. Thank you. And then lastly, in the non-dilutive financing, the total 200 million, if you include some of the expected syndicated offering, just if you're able to comment on how much contribution BOT/BAL versus the other six partner programs in this broader deal construct, that would be helpful, just a rough range Garo. And thanks again for taking the questions.

Mayank Mamtani: Efficacy that we've seen or I should say efficacy.

Mayank Mamtani: I should say significant clinical activity that we've seen the reason I'm, saying I should say efficacy is because that's a term that the FDA has the bliss.

Mayank Mamtani: So that happens when you have capital how do we use the terms of activity, but because of the significant activity that we have seen is half of our patients.

Mayank Mamtani: Failed everything else.

Mayank Mamtani: They are not responding to any other treatments.

Mayank Mamtani: There is of course, a lot of interest in pursuing that just Ice's bank also approval strategies, but as I've said earlier, we are very very cognizant told the focus that we need to add on CIC right now.

Speaker Change: Got it. Thank you and then lost me in the non dilutive financing the total of 200 million.

Mayank Mamtani: If you include some of the expected syndicated offering just if you're able to comment on how much.

Mayank Mamtani: Contribution by value versus the other six sponsored programs in this.

Mayank Mamtani: <unk> deal.

Mayank Mamtani: That would be helpful. Just stood up trains go and thanks again for taking my question.

Garo H. Armen: So, I mean, there is - the relative contribution is articulated in that press release, the Ligand press release that was put out this morning at 7:30. So, other than that, we cannot discuss any additional details. Suffice it to say that this financing completely provides us with the freedom to pursue BOT/BAL on our own and pursue BOT/BAL in connection with partners worldwide. So, this particular transaction has absolutely no bearing, or puts any restrictions on our ability to advance BOT/BAL in collaboration with partners and by ourselves. In other words, the economics of this transaction are defined, and that was in the press release. And beyond that, I believe that we are in a superb position to exploit our commercial opportunity with BOT/BAL. And that will be, of course, for the benefit of both the company, our future potential partners, and for the benefit of Ligand.

Mayank Mamtani: So I mean, there is relative contribution is articulated in the press release.

Garo H. Armen: The ligand press release that was.

Garo H. Armen: Put out this morning at 730.

Garo H. Armen: So.

Garo H. Armen: But other than that we cannot discuss any additional details.

Garo H. Armen: I hate to say that this financing.

Garo H. Armen: Completely provides us with the freedom.

Garo H. Armen: To pursue by about an hour.

Garo H. Armen: And pursue backfile in connection with partners worldwide. So this particular transaction.

Garo H. Armen: Absolutely no Barry.

Garo H. Armen: Or put any restrictions on our ability to advanced pop out to two in collaborations with partners and by ourselves.

Garo H. Armen: In other words, the economics of this transaction are defined, and that was in the press release. And beyond that, I believe that we are in a superb position to exploit our commercial opportunity with Buckbeck. And that will be, of course, for the benefit of both the company, our future potential partners, and for the benefit of Leica.

Garo H. Armen: In other words, the economics of this transaction are defined and that was in the press release.

Garo H. Armen: And beyond that.

Garo H. Armen: I believe that we are in a.

Garo H. Armen: Third position.

Garo H. Armen: Lloyd commercial opportunity with <unk>.

Garo H. Armen: And that will be of course for the benefit of both the company our future potential partners.

Garo H. Armen: And for the benefit of it.

Mayank Mamtani: Got it. Thanks again for taking the questions.

Speaker Change: Got it.

Speaker Change: Thanks again for taking my question.

Mayank Mamtani: Your next question comes from the line of Kelly <unk> of Jefferies. Your line is open.

Operator: Your next question comes from the line of Kelly Shi of Jeffries. Your line is open.

Unknown: Hi, this is Dave, on for Kelly Shi, and thank you for taking our question. My question is about the catalyst in the second half. You said there would be a number of data in melanoma, lung, pancreatic, I think in the second half. Can you provide an expectation, what kind of data we should expect, and number of patients, and those details? Thank you.

Kelly Shee: Hi, This is Dave on for Caliche and thank you for taking the question. My question is about.

Operator: List.

Operator: And the second half you said there'll be a number of data in melanoma lung pancreatic cancer second half can you provide like expectation what kind of data we should expect in.

Operator: The number of patient and those details. Thank you.

Garo H. Armen: Okay, so clearly, if the data was expected to be not positive, we wouldn't be talking. But can I provide you with specifics on the data that will compromise our ability to present data at conferences? The answer is no. So we'll have to see as the data matures. But we're very encouraged with what we're seeing across a number of indications. As we said before, that includes melanoma, lung cancer, sarcoma, pancreatic cancer, and even others. So, please be patient and allow us to make the appropriate disclosures.

Unknown: Okay. Thank you.

Garo H. Armen: Okay, so clearly, if the data was expected to be not positive, we wouldn't be talking about it. But can I provide you with specifics on the data that will compromise our ability to present data at conferences? The answer is no. So, we'll have to see as the data matures, we're very encouraged with what we're seeing across a number of indications. As we said before, that includes melanoma, lung cancer, sarcoma, pancreatic cancer, and even others. So, please be patient and allow us to make the appropriate disclosures and have an opportunity to present the data in at a few conferences and also in publications. Okay. Thank you.

Garo H. Armen: Okay, so clearly, if the data was expected to be not positive, we wouldn't be talking about it. But can I provide you with specifics on the data that will compromise our ability to present data at conferences? The answer is no. So, we'll have to see as the data matures, we're very encouraged with what we're seeing across a number of indications. As we said before, that includes melanoma, lung cancer, sarcoma, pancreatic cancer, and even others. So, please be patient and allow us to make the appropriate disclosures and have an opportunity to present the data in at a few conferences and also in publications.

Speaker Change: Okay. So David.

Garo H. Armen: Clearly yes.

Garo H. Armen: Dave.

Garo H. Armen: What is expected to be net positive.

Garo H. Armen: We wouldn't be talking to that.

Garo H. Armen: Ken I provide you with.

Garo H. Armen: Specific time of the data that will compromise our ability to present a diet.

Speaker Change: Comprehensive answer is no.

Operator: So we'll have to see as the data matures. But we're very encouraged with what we're seeing across a number of indications. As we said before, that includes melanoma, lung cancer, sarcoma, pancreatic cancer, and even others. So, please be patient and allow us to make the appropriate disclosures.

Speaker Change: We'll have to see.

Operator: As the data matures, we're very encouraged with what we're seeing across a number of indications.

Operator: You said before that includes melanoma.

Operator: One character.

Operator: Karma pancreatic cancer and even others. So please be patient and allow us to.

Operator: Make the appropriate disclosures.

Operator: <unk>.

Operator: And have an opportunity to present the data could review comp.

Operator: <unk> also.

Operator: Obligations.

Speaker Change: Okay. Thank you.

Operator: Your next question comes from the line of Matthew Phipps of William Blair. Your line is now open.

Operator: Your next question comes from the line of Matthew Phipps of William Blair. Your line is now open.

Matthew Phipps: Hi Garo, congrats on the Ligand financing. I was wondering, the additional $25 million that can come from Ligand, is that purely based on Ligand's decision, or is there anything that can trigger that decision?

Matthew Phipps: Hi, guys. Congrats on the <unk> financing I was wondering the additional $25 million that can come from La again is that purely based on ligand decision or is there anything that can trigger that decision.

Speaker Change: Yes, it is based on luggage sooner.

Garo H. Armen: Yes, it is based on Ligand's decision.

Garo H. Armen: Great. Thanks, and then.

Matt Phipps: Great, thanks. And then, for Dr. O'Day, the melanoma on the slide that says a front-line trial - front-line registrational trial versus standard of care. I wonder if you consider that to be PD-1 monotherapy, a different PD-1 CTLA-4, or PD-1 LAG-3 at this point?

Speaker Change: Maybe for Victor.

Matthew Phipps: The melanoma on the slides until the frontline trial and register frontline Registrational trial versus standard of care.

Matthew Phipps: Wondering if you consider that to be PD, one monotherapy PD, one the different PD ones utility for or PD, one lag three at this point.

Garo H. Armen: A perfect question for one of the world's foremost experts on melanoma, and that is our Dr. Steven O'Day.

Matthew Phipps: A perfect question for one of the world's foremost experts out in melanoma that is our doctors, even though David.

Steven J. ODay: So Matt can you.

Steven O'Day: So, Matt, can you clarify the question? Again, I didn't quite understand the first line piece of it.

Speaker Change: Clarify that question again, I didnt quite get the first line piece of it.

Matt Phipps: Yeah, there's a slide you guys in your news deck that says first-line melanoma, registrational study versus first-line standard of care. Just kind of curious what you consider to be that standard of care right now, because there's maybe three different IO regimens out there.

Speaker Change: So there is a slide you guys and your newest deck that says first line melanoma Registrational study versus first line standard of care just kind of curious what you consider to be the standard of care right now because there's maybe three different io regimens out there, yes, well as.

Steven O'Day: Yeah, well, as you know, the first-line treatment is split sort of between PD-1 monotherapy, PD-1 LAG-3, or PD-1 CTLA-4. I think what we're discussing going forward and presenting later this year is our refractory setting, and obviously, we need to see that data as it fully matures in the coming weeks and months. This is in a refractory PD-1 and PD-1 CTLA-4 and BRAF refractory setting. So, depending on the strength of this data, and sort of further discussions, obviously, if there is an accelerated path, it would likely lead to a first-line confirmatory trial. Again, the FDA would have to advise on the best comparator arm in that setting.

Matthew Phipps: As you know the first line treatment.

Steven J. ODay: What sort of between PD, one monotherapy PD, one lag three or PD, one <unk> four.

Matt Phipps: Okay, thanks for taking my questions.

Matthew Phipps: I think what we're discussing going forward in.

Matthew Phipps: Presenting later this year is our here's a refractory setting and obviously, we need to see what that data as it fully matures in the coming weeks and months.

Matthew Phipps: This isn't a refractory PD, one and PD one <unk> four.

Matthew Phipps: In BRAF refractory setting so depending on the strength of this data and sort of further discussions obviously, if there is an accelerated path it would like.

Matthew Phipps: Likely lead to a first line confirmatory trial again.

Matthew Phipps: What would have to advise on the best comparator arm in that setting.

Matthew Phipps: Thanks for taking my questions.

Matthew Phipps: Once again, if you would like to ask a question. Please press star one on your telephone keypad.

Operator: Once again, if you would like to ask a question, please press star 1 on your telephone keypad. Your next question comes from the line. I think we've lost. All right. So we have the next question from Gabriel Kim. Your line is open. Hi, congratulations on the LIGAND financing.

Operator: Once again, if you would like to ask a question, please press Star 1 on your telephone keypad. Your next question comes from the line - I think we've lost - all right, so we have the next question from Gabriel Kim. Your line is open.

Gabriel Kim: Your next question comes from the line.

Operator: I think the loss alright, so we have the next question from Gabriel Kim.

Gabriel Kim: Your line is open.

Gabriel Kim: Hi, congratulations on the LIGAND financing. Um, could you just say when the anticipated closing date is? And then I had a follow-up.

Gabriel Kim: Hi, congratulations on the ligand financing.

Gabriel Kim: Hi, congratulations on the Ligand financing. Could you just say when is the anticipated closing date? And then I had a follow-up. - Hello?

Operator: Could you...

Gabriel Kim: Could you just say what is the anticipated closing date, and then I had a follow up.

Operator: Hello.

Speaker Change: Hello, Yes.

Operator: Yes, we can hear you.

Speaker Change: Yes, we can hear you.

Garo H. Armen: Hi. I think we mentioned that we expect to close the transaction this month.

Gabriel Kim: I think we mentioned that we expect to close the transaction this month.

Gabriel Kim: Okay, wonderful. And then, in terms of share count. Are you able to provide an end of quarter or current share count?

Gabriel Kim: Okay wonderful and then in terms of.

Gabriel Kim: Share count are you able to provide a end of quarter, our current share count.

Garo H. Armen: I don't have the share count with me, but I believe going into all of this, it was $20 million, something like that. Christine, do you have the exact share count? Yeah, it's just over $20 million, and we did file our 10-Q this morning, so you can see that on our file.

Garo H. Armen: I don't have the share count with me, but I believe going into all of this, it was $20 million, something like that. Christine, do you have the exact share count?

Speaker Change: I don't have the share count with me, but.

Christine: I believe going into all of this it was $20 million something like that.

Christine M. Klaskin: Yeah, it's just over $20 million, and we did file our 10-Q this morning, so you can see that on our files.

Christine M. Klaskin: Okay.

Gabriel Kim: Okay, and is that also - okay, wonderful, thank you. So, that's a current share count as well? Yes.

Gabriel Kim: Okay, and is that also - okay, wonderful, thank you. So, that's a current share count as well?

Christine M. Klaskin: Okay. Christine do you have the exact share count.

Christine M. Klaskin: Yes.

Garo H. Armen: Thank you very much.

Christine: Yes, it's just over $20 million and we did file our 10-Q. This morning, So you could see that.

Christine M. Klaskin: Okay.

Christine: Okay and is that also.

Christine: Okay wonderful. Thank you. So that's the current share count as well.

Speaker Change: Yes, thank you very much.

Gabriel Kim: Okay, thank you. Thanks a lot.

Christine M. Klaskin: Okay. Thank you thanks a lot.

Gabriel Kim: Okay.

Operator: There are no further questions at this time. I will now turn the conference back over to Garo Armen for the closing remarks.

Gabriel Kim: There are no further questions at this time I will now turn the conference back over to Garo Armen for any closing remarks.

Garo H. Armen: Thank you very much. Thank you very much for your attention and your patience. As you know, a number of our shareholders were concerned about how we would be able to get our financial conditions strengthened, our balance sheet strengthened, and what I expect is that today's announcement is the very first step in this process, and that throughout the next weeks, months, we will see additional activities that I expect will strengthen our balance sheet and allow us to be able to pursue our very important mission of getting BOT/BAL to the finish line. Thank you very much.

Garo H. Armen: Thank you very much. Thank you very much for your attention and your patience.

Garo H. Armen: As you know, a number of our shareholders were concerned about how we would be able to get our financial conditions strengthened. I hope that our financial conditions strengthen, our balance sheets strengthen, and what I expect is that today's announcement is the very first step in this process, and that throughout the next weeks and months, we will see additional activities that I expect will strengthen our balance sheet and allow us to be able to pursue our very important mission of getting bucked out to the finish line. Thank you very much.

Garo H. Armen: As you know.

Garo H. Armen: Number of our shareholders, who are concerned about how we would be able to get our financial condition and strengthen our balance sheet strengthened.

Garo H. Armen: I hope that our financial conditions strengthen, our balance sheets strengthen, and what I expect is that today's announcement is the very first step in this process, and that throughout the next weeks and months, we will see additional activities that I expect will strengthen our balance sheet and allow us to be able to pursue our very important mission of getting bucked out to the finish line. Thank you very much.

Garo H. Armen: And what I expect is that today's announcement is the very first step in this process.

Garo H. Armen: Throughout the next weeks months.

Garo H. Armen: We'll see additional activities that I expect.

Garo H. Armen: Strengthen our balance sheet and allow us to be able to pursue our very important information.

Garo H. Armen: We're getting towards the finish line. Thank you very much.

Speaker Change: Thank you that does conclude our conference for today. Thank you all for joining you may now disconnect.

Operator: Thank you. That does conclude our conference for today. Thank you all for joining us. You may now disconnect. 

Speaker Change: Please wait the conference will begin shortly.

Operator: Please wait; the conference will begin shortly. [inaudible]

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