Q2 2024 Agenus Inc Earnings Call

Zack Armen: Thank you, Leonardo, 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 subjects 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 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 second quarter. Garo?

Operator: 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, 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 second quarter.

Garo H. Armen: Good morning, everyone and thank you for joining us on today’s call. On the merits of our circumstances and on matters within our control, with a strong emphasis on impacting patient lives, we have made significant progress in the development of botensilamab, which we call BOT, and balstilimab, which we call BAL. And these are for the treatment of colorectal cancer, even though the combination has been used for many other cancers. Recently, Agenus disclosed top-line data from its global Phase II trial, evaluating the BOT/BAL combination in patients with relapsed refractory microsatellite stable, which is called MSS colorectal cancer. These patients constitute about 95% of the diagnosed colorectal cancer patients globally, and as you know, colorectal cancer has been on a significant rise as of late. The results from our second trial, the Phase II trial, are consistent with those observed in our Phase I trial, demonstrating a confirmed overall response rate of approximately 20% in the cohorts receiving 75 mg of BOT plus 240 mg of BAL combination. This dosage has been identified as the active dose during a recent meeting with the U.S. FDA, allowing Agenus to proceed with further development, including our planned confirmatory Phase III trial. BOT/BAL is demonstrating unprecedented activity in treating challenging cancers across various stages, both as a chemotherapy-free, IO-IO only combination, as well as in combination with standard chemotherapy in first-line metastatic patients where chemotherapy is the standard of care. It is important to recognize that key opinion leaders and clinical investigators globally, including significant numbers in the U.S. who have seen our data and/or have experienced the outcomes in their patients, strongly advocate making BOT/BAL available to their patients.

Garo H. Armen: Good morning, everyone and thank you for joining us on today’s call. On the merits of our circumstances and on matters within our control, with a strong emphasis on impacting patient lives, we have made significant progress in the development of botensilamab, which we call BOT, and balstilimab, which we call BAL. And these are for the treatment of colorectal cancer, even though the combination has been used for many other cancers. Recently, Agenus disclosed top-line data from its global Phase II trial, evaluating the BOT/BAL combination in patients with relapsed refractory microsatellite stable, which is called MSS colorectal cancer. These patients constitute about 95% of the diagnosed colorectal cancer patients globally, and as you know, colorectal cancer has been on a significant rise as of late. The results from our second trial, the Phase II trial, are consistent with those observed in our Phase I trial, demonstrating a confirmed overall response rate of approximately 20% in the cohorts receiving 75 mg of BOT plus 240 mg of BAL combination. This dosage has been identified as the active dose during a recent meeting with the U.S. FDA, allowing Agenus to proceed with further development, including our planned confirmatory Phase III trial.

Garo Armen: Evaluating the blood-blood combination in patients with relapsed refractory micro-satellite stable, which is called NSS colorectal. These patients constitute about 95% of the diagnosed colorectal cancer patients. Lonely, and as you know, colorectal cancer has been on a significant rise as of late. The results from our second trial, the Phase 2 trial, are consistent with those observed in our Phase 1 trial, demonstrating a considerable response rate of approximately 20 percent in the cohorts receiving 75 milligrams of butt plus 240 milligrams of bobcomb. This dosage has been identified as the active dose during their recent meeting with the U.S. FDA, allowing Agenus to proceed with further development, including our planned confirmatory phase three trial. Bach-Bow is demonstrating unprecedented activity in treating challenging cancers across various stages, both as a chemotherapy-free, IO-IO only combination, as well as in combination with standard chemotherapy in first-line metastatic patients. It is the standard of care. It is important to recognize that opinion leaders and clinical investigators globally, including significant numbers in the U.S., who have seen our data and or have experienced the outcomes in their patients strongly advocate making BotBow available to their patients.

Garo Armen: The results from our second trial, the Phase 2 trial, are consistent with those observed in our Phase 1 trial, demonstrating a considerable response rate of approximately 20 percent in the cohorts receiving 75 milligrams of butt plus 240 milligrams of bobcomb. This dosage has been identified as the active dose during their recent meeting with the U.S. FDA, allowing Agenus to proceed with further development, including our planned confirmatory phase three trial. Bach-Bow is demonstrating unprecedented activity in treating challenging cancers across various stages, both as a chemotherapy-free, IO-IO only combination, as well as in combination with standard chemotherapy in first-line metastatic patients. It is the standard of care. It is important to recognize that opinion leaders and clinical investigators globally, including significant numbers in the U.S., who have seen our data and or have experienced the outcomes in their patients strongly advocate making BotBow available to their patients.

Garo H. Armen: BOT/BAL is demonstrating unprecedented activity in treating challenging cancers across various stages, both as a chemotherapy-free, IO-IO only combination, as well as in combination with standard chemotherapy in first-line metastatic patients where chemotherapy is the standard of care. It is important to recognize that key opinion leaders and clinical investigators globally, including significant numbers in the U.S. who have seen our data and/or have experienced the outcomes in their patients, strongly advocate making BOT/BAL available to their patients. In our trials of significant numbers of patients suffering more than 350 in colorectal cancer and over 1,000 patients across 10 different cancer types, we are seeing deep, durable responses in patients who otherwise face grim prognosis with current standard treatment. We believe, along with the experts in the field, that these durable responses translate to long-term patient benefit. While the FDA has not yet concurred with this view, and the urgency to make BOT/BAL widely available to patients and their treating physicians, we are optimistic that our mature data will influence their thinking. On the other hand, we’re very encouraged with the initial feedback from other regulatory agencies, which has been notably much more positive thus far.

Garo Armen: It is important to recognize that opinion leaders and clinical investigators globally, including significant numbers in the U.S., who have seen our data and or have experienced the outcomes in their patients strongly advocate making BotBow available to their patients. In our trials with significant numbers of patients covering more than 315 colorectal cancers and over 1,000 patients across 10 different cancers. We are seeing deep, Turbo response patients who otherwise face real problems with current standard treatment.

It is important to recognize that opinion leaders and clinical investigators globally, including significant numbers in the U.S., who have seen our data and or have experienced the outcomes in their patients strongly advocate making BotBow available to their patients.

In our trials with significant numbers of patients covering more than 315 colorectal cancers and over 1,000 patients across 10 different cancers. We are seeing deep, Turbo response patients who otherwise face real problems with current standard treatment. We believe, along with the experts in the field, that these durable responses translate to long-term patient benefit. However, the FDA has not yet concurred with this view and the urgency to make QATAR widely available to patients and their treating physicians. We are optimistic that our mature data will influence their thinking. On the other hand... We're very encouraged by the initial feedback from other regulatory agencies, which has been notably much more positive stuff.

Garo Armen: We believe, along with the experts in the field, that these durable responses translate to long-term patient benefit. However, the FDA has not yet concurred with this view and the urgency to make QATAR widely available to patients and their treating physicians. We are optimistic that our mature data will influence their thinking. On the other hand... We're very encouraged by the initial feedback from other regulatory agencies, which has been notably much more positive stuff.

Garo Armen: We are optimistic that our mature data will influence their thinking. On the other hand... We're very encouraged by the initial feedback from other regulatory agencies, which has been notably much more positive stuff. On this note... We started engaging with regulatory bodies outside of the U.S., including the European Agency, in order to explore rapid approval pathways for black baths. In Europe, this could mean conditional approval, to bring these potentially life-saving agents to patients as soon as possible. I need to separate myself from all of this.

We are optimistic that our mature data will influence their thinking. On the other hand... We're very encouraged by the initial feedback from other regulatory agencies, which has been notably much more positive stuff.

Garo H. Armen: On this note, we started engaging with regulatory bodies outside of the U.S., including the European Agency, in order to explore rapid approval pathways for BOT/BAL. In Europe, this could mean conditional approval to bring these potentially life-saving agents to patients as soon as possible. Separately from all of this, we are very excited to share that important and very exciting data from a multi-cancer, neoadjuvant study, which is being conducted at a major European cancer center, will be presented at a major cancer conference in upcoming months. Our clinical data, as you know, has generated strong support from medical and scientific communities. Recent publications in Nature Medicine and Cancer Discovery, along with a peer-reviewed journal article that came in from Dana-Farber Cancer Institute here in Boston, emphasize the importance of bringing BOT/BAL to patients with MSS colorectal cancer.

Garo Armen: We are very excited to share that important and very exciting data from a multi-cancer neoadjuvant study, which is being conducted at a major European cancer center, will be presented at a major cancer conference in the coming months. Our clinical data, as you know, has generated strong support from medical and scientific communities. Recent publications in Nature Medicine and Cancer Discovery, along with a peer-reviewed journal article that came in from Dana-Farber Cancer Institute here in Boston, emphasize the importance of bringing muck down to patients with MSS Polaroid.

Garo H. Armen: By the way, MSS colorectal cancer is one of the most difficult cancers to treat, not just within the colorectal realm, but across the board. We’ve also seen an unprecedented number of compassionate use requests, driven by the deep and durable responses in a cancer where patients have no acceptable options among many approved drugs, highlighting the urgent demand for BOT/BAL in the colorectal cancer community. Dr. O’Day will describe this reality in more detail during our call. On the business side, we’re actively exploring global partnerships for BOT/BAL and other assets in our pipeline. We’ve regained full rights to AGEN1777 and AGEN2373 from BMS and Gilead, respectively, and are evaluating new partnerships for these programs among the biopharma industry players.

Garo Armen: Dr. O'Day will describe this reality in more detail during our call. On the business side, we're actively exploring global partnerships for Babel and other assets in our pipeline. We've regained full rights to Agent 177 and Agent 2373 from BMS and Gilead respectively, and are evaluating new partnerships for these programs among the biopharma industry players. As you know, many companies out there are scrambling to cut costs, and I'm talking about large companies, medium-sized companies, and small. But there are still pockets of brilliance.

Dr. O'Day will describe this reality in more detail during our call. On the business side, we're actively exploring global partnerships for Babel and other assets in our pipeline. We've regained full rights to Agent 177 and Agent 2373 from BMS and Gilead respectively, and are evaluating new partnerships for these programs among the biopharma industry players.

Garo H. Armen: As you know, many companies out there are scrambling to cut costs, and I’m talking about large companies, medium-sized companies, and small companies. But there are still pockets of brilliance amongst them. Interestingly, we’ve been having increased interest from some of these innovative companies following our announcement about the FDA guidance discouraging accelerated filing. We’ve strengthened our cash position in the second quarter with the first transfer of the $75 million royalty financing led by Ligand Pharmaceuticals, and we’re in talks with investors for a second closing. We’re encouraged by the fact that we have received inquiries to potentially invest at premium prices to our current stock price. Additionally, I’d like to let you know ahead of time, because the filing will be this afternoon, that we will be expanding our ATM filing facility to be in a state of readiness, in spite of the fact that we have no current plans to issuing stock at these prices.

Garo Armen: Interestingly, we've been having increased interest in some of these innovative companies following our announcement about the FDA guidance discouraging accelerated fire. We've strengthened our cash position in the second quarter with the first transfer of the $75 million royalty financing led by Ligand Pharmaceuticals, and we're in talks with investors for a second quarter. We're encouraged by the fact that we have received inquiries to potentially invest at premium prices to our current stock. Additionally, I'd like to let you know, ahead of time, because the filing will be this afternoon, that we will be expending our ATM filing facility to be in a state of readiness, in spite of the fact that we have no current plan to issue stock at these prices.

Garo Armen: Additionally, I'd like to let you know, ahead of time, because the filing will be this afternoon, that we will be expending our ATM filing facility to be in a state of readiness, in spite of the fact that we have no current plan to issue stock at these prices. And you will see in this filing that we've had some minor sales in the first half of the year, but the average price has been approximately $15 a month.

Additionally, I'd like to let you know, ahead of time, because the filing will be this afternoon, that we will be expending our ATM filing facility to be in a state of readiness, in spite of the fact that we have no current plan to issue stock at these prices.

Garo H. Armen: And you will see in this filing that we’ve done some minor sales in the first half of the year, but the average price has been approximately $15 a share. Given the uniquely active nature of our agents, our commitment to advancing BOT/BAL is stronger than ever before. We’re dedicated to ensuring that patients get access to these lifesaving therapies as quickly as possible. And you will hear about some of the plans that we’re contemplating on putting into place as soon as possible from my colleagues later on. Before we hear from Dr. O’Day about more details on our patient-centric, exciting and life-altering outcomes, I’m delighted to announce that Tom Harrison has joined our Board of Directors. A few words about Tom before I introduce him. Tom is one of the true transformative leaders in the healthcare industry, having grown diversified agency services into Omnicom Group’s largest division with over 5,000 clients and annual revenues exceeding $6 billion.

Garo Armen: Given the uniquely active nature of our agents, our commitment to advancing bus balance is stronger than ever before. We're dedicated to ensuring that patients get access to these life-saving therapies as quickly as possible, and you will hear about some of the plans that we're contemplating on putting into place as soon as possible from my colleague, Greg Robinson. Before we hear from Dr. O'Day about more details that are patient-centric, exciting, and life altering, I'm delighted to announce that Tom Harrison has joined our board of directors. A few words about Tom before I introduce him. Tom is one of the true transformative leaders in the healthcare industry, having grown diversified agency service into Omnicom Group's largest division with over 5,000 clients and annual revenues exceeding $6 billion.

Tom Harrison: Before we hear from Dr. O'Day about more details that are patient-centric, exciting, and life altering, I'm delighted to announce that Tom Harrison has joined our board of directors. A few words about Tom before I introduce him. Tom is one of the true transformative leaders in the healthcare industry, having grown diversified agency service into Omnicom Group's largest division with over 5,000 clients and annual revenues exceeding $6 billion. His deep experience in healthcare communications and branding combined with a strong scientific background from his early days at Pfizer.

Before we hear from Dr. O'Day about more details that are patient-centric, exciting, and life altering, I'm delighted to announce that Tom Harrison has joined our board of directors. A few words about Tom before I introduce him. Tom is one of the true transformative leaders in the healthcare industry, having grown diversified agency service into Omnicom Group's largest division with over 5,000 clients and annual revenues exceeding $6 billion.

Garo H. Armen: His deep experience in healthcare communications and branding, combined with a strong scientific background from his early days at Pfizer, makes him very uniquely equipped to guide Agenus in our next phase of growth. Tom’s innovative approach in merging high science with creative marketing will be key in our ability to educate the global community about the critical benefits of our therapy. I want to emphasize educating. His strategic vision and operational experience is key in our efforts to bring groundbreaking cancer treatments to patients worldwide, not just the U.S. Please join me in welcoming Tom Harrison to say a few words on this call. Tom?

Tom Harrison: Mason, Kim, and Mamtani are very uniquely equipped to guide Agenus in our next phase of growth. Tom's Innovative Approach to Merging High Science with Creative Market will be key in our ability to educate the global community about the critical benefits of our care. I want to emphasize his Strategic Vision. And operational experience is key in our efforts to bring groundbreaking cancer treatments to patients worldwide, not just in the U.S. Please join me in welcoming Tom Harrison to say a few words on this call. Tom said,

Tom Harrison: Thank you so much for that most, most kind introduction. Hopefully, I’m worthy of those wonderful words. I’m truly honored to join the Board of Directors of Agenus, a company that is at the forefront of innovation in the field of immuno-oncology. The work that is being done here at Agenus is not only groundbreaking, but it’s also life changing for patients battling some of the most challenging cancers that Garo has already outlined on the call. As someone who has spent a significant portion of my career in healthcare advertising and strategic advising of CEOs across the healthcare industry, I’m excited to bring my experience to Agenus. The opportunity to help elevate the awareness of our innovative pipeline and to communicate the significant advances that we are making in cancer treatment is something that I am really deeply passionate about.

Tom Harrison: I'm truly honored to join the board of directors of Agenus, a company that is at the forefront of innovation in the field of immuno-oncology. The work that is being done here at Agenus is not only groundbreaking, but it's also life-changing for patients battling some of the most challenging cancers that Garo has already outlined on the call. As someone who has spent a significant portion of my career in healthcare advertising and strategic advice to CEOs across the healthcare industry, I'm excited to bring my experience to Agenus. The opportunity to help elevate the awareness of our innovative pipeline and to communicate the significant advances that we are making in cancer treatment is something that I am really, deeply passionate about.

Tom Harrison: The opportunity to help elevate the awareness of our innovative pipeline and to communicate the significant advances that we are making in cancer treatment is something that I am really, deeply passionate about. My career, as Garo said, has always been driven by a commitment to excellence and innovation founded on a foundation of science, from co-founding Harrison Star Business Group to my current role as Senior Operating Partner at Emerita Capital Partners. I have been fortunate to work throughout my career with very talented teams, such as the one here at Agenus, to drive growth and deliver impactful results.

The opportunity to help elevate the awareness of our innovative pipeline and to communicate the significant advances that we are making in cancer treatment is something that I am really, deeply passionate about.

Tom Harrison: My career, as Garo said, has always been driven by a commitment to excellence and innovation founded on a basis of science. From co-founding Harrison and Star Business Group to my current role as Senior Operating Partner at Merida Capital Partners, I have been fortunate to work throughout my career with very talented teams, such as the one here at Agenus, and to drive growth and deliver impactful results. I see a similar spirit of innovation and dedication here at Agenus, and I am eager to contribute to our shared mission. One of my key priorities, as Garo said, will be to enhance our strategic communications efforts to ensure that our scientific advancements and our therapeutic potential are clearly understood by healthcare providers, by patients, by investors, and regulatory bodies around the world.

Tom Harrison: I see a similar spirit of innovation and dedication here at Agenus, and I am eager to contribute to our shared mission. One of my key priorities, as Garo said, will be to enhance our strategic communications effort, to ensure that our scientific advancements and our therapeutic potential are clearly understood by healthcare providers, patients, investors, and regulatory bodies around the world. By doing so, we can not only elevate Agenus's visibility and reputation but also help accelerate the delivery of our life-saving therapies to those who are in dire need.

I see a similar spirit of innovation and dedication here at Agenus, and I am eager to contribute to our shared mission. One of my key priorities, as Garo said, will be to enhance our strategic communications effort, to ensure that our scientific advancements and our therapeutic potential are clearly understood by healthcare providers, patients, investors, and regulatory bodies around the world.

Tom Harrison: By doing so, we can not only elevate the visibility and reputation of Agenus, but also help accelerate the delivery of our lifesaving therapies to those who are in dire need. I am particularly excited about the progress we are making with our BOT/BAL program and the potential it holds to address unmet medical needs across multiple cancer indications. The robust data that we have generated, coupled with our active engagements with global regulatory authorities, positions us well to bring these innovative treatments to market. I look forward to working closely with Garo, with the full Board of Directors, and the entire senior Agenus team to drive our mission forward. Together, we will continue to push our boundaries of what is possible in cancer immunotherapy and improve patient outcomes. Thank you again, Garo, for the warm welcome, and everyone for the warm welcome with whom I’ve spoken, and I’m excited about the journey that we have ahead. So now I’m going to turn the call over to Steven to go over our updates of our clinical progress to date.

Tom Harrison: I am particularly excited about the progress we are making with our BotVal program and the potential it holds to address unmet medical needs across multiple cancer indications. The robust data that we have generated, coupled with our active engagements with global regulatory authorities, positions us well, pardon me, to bring these innovative treatments to market. I look forward to working closely with Garo, the full board of directors, and the entire senior Agenus team to drive our mission forward. Together, we will continue to push the boundaries of what is possible in cancer immunotherapy and improve patient outcomes. Thank you again, Garo, for the warm welcome and everyone for the warm welcome with whom I've spoken, and I'm excited about the journey that we have ahead. So now I'm going to turn the call over to Stephen to go over our update on our clinical progress to date.

Tom Harrison: Together, we will continue to push the boundaries of what is possible in cancer immunotherapy and improve patient outcomes. Thank you again, Garo, for the warm welcome and everyone for the warm welcome with whom I've spoken, and I'm excited about the journey that we have ahead. So now I'm going to turn the call over to Stephen to go over our update on our clinical progress to date.

Steven O'Day: Thank you, Tom and Garo. I’m pleased to provide an update on our clinical progress across the BOT/BAL program now, as Garo said, spanning over 1,100 patients treated in refractory advanced cancers, as well as earlier stages of metastatic disease, and most recently in the neoadjuvant setting. BOT/BAL is demonstrating remarkable activity, with a manageable safety profile in patients with relapsed refractory MS-stable colorectal cancer and non-active liver metastatic disease. Our data remains consistent between the Phase I expanded cohort and our Phase II randomized trials, particularly in terms of RECIST-confirmed overall response rates, duration of response, and importantly, overall survival. [inaudible] the MS-stable colorectal cancer patient population of 23% in the Phase I trial, and now 19.4% in a [inaudible] Phase II trial, is roughly three times the low single-digit overall response rate of any available standard of care therapy in this setting.

Dr. Steven O'Day: I'm out, a very unstable colorectal cancer patient population of 23% in the phase one trial and now 19.4% in a phase 2 trial is roughly three times the low single-digit overall response rate of any available standard of care therapy in this setting. Our median overall survival for the Phase 1 trial of 21.2 months, with a remarkable 18-month estimated overall survival of 63%, stands in marked contrast to approximately, at best, 12 months with the best standard of care therapy.

I'm out, a very unstable colorectal cancer patient population of 23% in the phase one trial and now 19.4% in a phase 2 trial is roughly three times the low single-digit overall response rate of any available standard of care therapy in this setting.

Steven O'Day: Our median overall survival for the Phase I trial of 21.2 months, with a remarkable 18-month estimated overall survival of 63%, stands in marked contrast to approximately, at best, 12 months with the best standard of care therapies. While survival with the Phase II dataset is early and maturing, we see consistency in the six-month survival rate of 90% in our selected combination BOT/BAL arm in the Phase II trial, as compared with the 88% in the Phase I BOT/BAL arms, and this is very reassuring to us. We plan to submit the Phase II data after a later maturity data cut later this year to a major medical congress in the early part of 2025. We are confident that as these data mature, they will continue to demonstrate differentiation in overall response, duration response, and survival compared to standard of care therapies in this late-line refractory MS-stable colorectal cancer.

Dr. Steven O'Day: While survival with the Phase II data set is early and maturing, we see consistency in the six-month survival rate of 90% in our selected combination bot bowel arm in the Phase II trial, as compared with 88% in the Phase I bot bowel arms. And this is very reassuring. We plan to submit the phase two data after a later maturity data cut later this year to a major medical congress in the early part of 2025. We are confident that as these data mature, they will continue to demonstrate differentiation, in overall response, duration of response and survival compared to standard of care therapies in this late line refractory MS stable colorectal,

Dr. Steven O'Day: We plan to submit the phase two data after a later maturity data cut later this year to a major medical congress in the early part of 2025. We are confident that as these data mature, they will continue to demonstrate differentiation, in overall response, duration of response and survival compared to standard of care therapies in this late line refractory MS stable colorectal, In addition, we're seeing remarkable activity of Bofal in earlier stages of CRC treatment lines, which is highlighted by our data in the NEF neoadjuvance trial, which was updated with an oral presentation at ESMO GI in Munich in this past June.

We plan to submit the phase two data after a later maturity data cut later this year to a major medical congress in the early part of 2025. We are confident that as these data mature, they will continue to demonstrate differentiation, in overall response, duration of response and survival compared to standard of care therapies in this late line refractory MS stable colorectal,

Steven O'Day: In addition, we are seeing remarkable activity of BOT/BAL in earlier stages of CRC treatment lines, which is highlighted by our data in the NEST neoadjuvants trial, which was updated with an oral presentation at ESMO GI in Munich in this past June. This trial evaluated one dose of BOT with two to four doses of BAL before surgery. In the updated NEST-2 cohort, which provided longer time between the first dose of BOT/BAL and surgery of up to eight weeks, remarkably seven of nine MS-stable colorectal patients, or 78%, achieved at least a 50% tumor regression at the time of surgery, with five out of nine or 56% achieving complete pathologic regressions of their tumors. Importantly, no surgeries were delayed due to adverse events. This data stands in stark contrast to historical data with attempts at neoadjuvant IO therapy in poorly immunogenic MS-stable colorectal cancer where pathologic response rates have been poor.

Dr. Steven O'Day: This trial evaluated one dose of BOTS with two to four doses of BAL before surgery. In the updated NAS2 cohort, which provided a longer time between the first dose of bot valence and surgery of up to eight weeks, Remarkably, seven of nine MS-stable colorectal patients, or 78%, achieved at least a 50% tumor regression at the time of surgery, with five out of nine, or 56%, achieving complete path Importantly, no surgeries were delayed due to adverse events. This data stands in stark contrast to historical data, with attempts at neoadjuvant IO therapy in poorly immunogenic MS-stable colorectal cancer, where pathologic response rates have been poor.

Dr. Steven O'Day: This data stands in stark contrast to historical data, with attempts at neoadjuvant IO therapy in poorly immunogenic MS-stable colorectal cancer, where pathologic response rates have been poor. We plan to continue to build on these groundbreaking data in the neoadjuvant setting with additional studies. And, as Garo alluded to, additional IST studies are ongoing. Data in our Phase II bot-bound melanoma and pancreas trials continue to mature, and we look forward to updating these data in the coming months.

This data stands in stark contrast to historical data, with attempts at neoadjuvant IO therapy in poorly immunogenic MS-stable colorectal cancer, where pathologic response rates have been poor.

Steven O'Day: We plan to continue to build on these groundbreaking data in the neoadjuvant setting with additional studies, as Garo alluded to, and additional IST studies are ongoing. Data in our Phase II BOT/BAL melanoma and pancreas trials continue to mature, and we look forward to updating these data in the coming months. Finally, we will be presenting updated data with BOT and BAL in a relapsed/refractory sarcoma population in an oral presentation at the ESMO conference in Barcelona in September. Now I’ll turn the call over to Christine to review our financials.

Dr. Steven O'Day: Finally, we will be presenting updated data with bot and bow in a relapsed refractory sarcoma population in an oral presentation at the ESMO conference in Barcelona in September. Now, I'll turn the call over to Christine to review our financials.

Christine M. Klaskin: Thank you, Steven. We ended the second quarter 2024 with a consolidated cash balance of $93.7 million, compared to $76.1 million on December 31, 2023. For the three and six-months ended June 30, 2024, we recognized revenues which includes [inaudible] revenue of $23.5 million and $51.5 million respectively. This compares to $25.3 million and $48.2 million for the same period in 2023. Our cash used in operations for the first half of 2024 was $76.4 million, a reduction from $118.6 million for the first half of 2023. Our net loss for the three and six-month ended June 30, 2024, it’s $54.8 million and $118.3 million. These include non-cash operating expenses of $33.5 million and $71.8 million respectively. I will now turn the call back to closing remarks.

Christine Klaskin: Our net loss for the three and six months ended June 30, 2024 is $54.8 million and $118.3 million, respectively. These include non-cash operating expenses of $33.5 million and $71.8 million, respectively. I will now take a call back for closing remarks.

Garo H. Armen: Thank you very much, Tom, Steven, and Christine. I’d like to extend my gratitude to everyone for joining us today to review our second quarter progress. Our unwavering focus remains on delivering BOT/BAL to individuals living with advanced MSS colorectal cancer and many other cancers where we have shown activity. We are steadfastly exploring innovative and expedited methods to make these treatment options available worldwide. Remember, amongst the importance of these treatment options is that they represent IO-IO, that is immuno-oncology, immuno-oncology combo treatments, without chemotherapy, with an extended life extension potential. This is very important for patients that have absolutely no options going forward with limited benefit and horrible toxicity. Patients are counting on us, and we are deeply committed to fulfilling our mission to provide therapies with curative intent, not only for colorectal cancer, but as I said, for many other cancer types where we have seen some profound activity. Thank you very much for your continued support and trust in Agenus. I will now turn the call back to the operator to facilitate any questions you may have. Operator?

Garo Armen: Our unwavering focus remains on delivering Botval to individuals living with advanced MSS polorenthal cancer and many other cancers where we have a trauma. We are steadfastly exploring innovative and expedited methods to make these treatment options available worldwide. Remember, amongst the importance of these treatment options is that they represent IOIO, that is, immuno-oncology, and immuno-oncology combo treatments without chemotherapy, with an extended life extension potential This is very important for patients that have absolutely no options going forward with limited benefits and Cora Vukovic. Patients are counting on us, and we are deeply committed to fulfilling our mission to provide therapies with curative intent, not only for colorectal cancer but, as I said, for many other cancer types, where we have seen some profound results. Thank you very much for your continued support and trust in Agenus. I will now turn the call back to the operator to facilitate any questions you may have. Operator.

Garo Armen: Patients are counting on us, and we are deeply committed to fulfilling our mission to provide therapies with curative intent, not only for colorectal cancer but, as I said, for many other cancer types, where we have seen some profound results. Thank you very much for your continued support and trust in Agenus. I will now turn the call back to the operator to facilitate any questions you may have. Operator.

Operator: Thank you very much for your continued support and trust in Agenus. I will now turn the call back to the operator to facilitate any questions you may have. Operator.

Operator: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone that in order to ask a question, press the star and then the number one on your telephone keypad. If you are called upon to ask your question and are listening by a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking a question. We do request for today's session that you please limit to one and one follow-up only. We will pause for a moment to compile the question and answer roster. Again, if you would like to ask a question, press the star 1 on your telephone keypad. The first question comes from the line of Emily Bodnar, of HC Wainwright. Please go ahead.

Operator: We will pause for a moment to compile the question and answer also. Again, if you would like to ask a question, press the star 1 on your telephone keypad. The first question comes from the line of Emily Bodnar, of HC Wayans. Please go ahead.

Emily Bodnar: Thank you for taking my question. My first one is can you again discuss the FDA’s guidance for the Phase III design in terms of the number of patients that you might need per arm, including the center of care arm and specific end points that you plan to look at? And then maybe if you can give any guidance to how soon you believe you could initiate a Phase III study and whether you believe the resources you have financially could support you running one along? Thanks.

Garo H. Armen: So Emily, among the options that we’re considering right now is a Phase III trial that can commence as early as the next four months and enroll inside of a year. And the reason I say enroll inside of a year is because there is such outcry of patient demand out there that we’re getting, and this has been at an increasing pace before the FDA guidance was issued, which we announced a couple weeks ago, and particularly after the FDA guidance, because now patients are very concerned that they’re not going to be able to get this drug in a commercial setting. And so there is a huge interest of patients coming to us for drugs globally. So that’s why we believe that once we initiate a Phase III trial, we’ll be able to enroll very rapidly. That’s why I feel confident that enrolling patients inside of a year post-commencement is something that is highly possible. Now, among the options that we are considering for Phase III trial we’ve been approached by certain groups that has significant subsidies offered to bring innovative medicines to patients as soon as possible. Among these groups is an outfit that has proposed to do a randomized Phase III trial that will satisfy the needs of regulatory agencies globally, not just the FDA, for as little as $10 million. So that’s what we’re really exploring now amongst other options, and stay tuned, the decision will be made in the couple of months.

Garo H. Armen: So Emily, among the options that we’re considering right now is a Phase III trial that can commence as early as the next four months and enroll inside of a year. And the reason I say enroll inside of a year is because there is such outcry of patient demand out there that we’re getting, and this has been at an increasing pace before the FDA guidance was issued, which we announced a couple weeks ago, and particularly after the FDA guidance, because now patients are very concerned that they’re not going to be able to get this drug in a commercial setting. And so there is a huge interest of patients coming to us for drugs globally. So that’s why we believe that once we initiate a Phase III trial, we’ll be able to enroll very rapidly. That’s why I feel confident that enrolling patients inside of a year post-commencement is something that is highly possible. Now, among the options that we are considering for Phase III trial we’ve been approached by certain groups that has significant subsidies offered to bring innovative medicines to patients as soon as possible.

Garo Armen: There is such a craft, all patient demand out there that we're getting, and this has been at an increasing pace before the FDA guidance was issued, which we announced a couple of weeks ago, and particularly after the FDA guidance, because now patients are very concerned that they're not going to be able to get this drug in a commercial setting. And so there is a huge interest in patients coming to us from Drawk Global. So that's why we believe that once we initiate a phase three trial, we will be able to enroll patients very rapidly.

Garo Armen: So that's why we believe that once we initiate a phase three trial, we will be able to enroll patients very rapidly. That's why I feel confident that enrolling patients inside of a year, of course, when it begins, is something that is highly possible. Now, among the options that we are considering for phase 3 trials, we've been approached by certain groups that have significant subsidies offered to bring innovative medicine to patients as soon as possible. Among these groups is an outfit that has proposed to do a randomized phase 3 trial that will satisfy the needs of regulatory agencies globally, not just the FDA, for as little as $10 million. So that's what we're exploring now, amongst other options, and stay tuned; the decision will be made in the next couple of weeks.

So that's why we believe that once we initiate a phase three trial, we will be able to enroll patients very rapidly.

Garo H. Armen: That’s why I feel confident that enrolling patients inside of a year post-commencement is something that is highly possible. Now, among the options that we are considering for Phase III trial we’ve been approached by certain groups that has significant subsidies offered to bring innovative medicines to patients as soon as possible. Among these groups is an outfit that has proposed to do a randomized Phase III trial that will satisfy the needs of regulatory agencies globally, not just the FDA, for as little as $10 million. So that’s what we’re really exploring now amongst other options, and stay tuned, the decision will be made in the couple of months.

Garo H. Armen: Among these groups is an outfit that has proposed to do a randomized Phase III trial that will satisfy the needs of regulatory agencies globally, not just the FDA, for as little as $10 million. So that’s what we’re really exploring now amongst other options, and stay tuned, the decision will be made in the couple of months.

Emily Bodnar: Okay, great. Thank you. And I believe you mentioned that you’re expecting to have data in pancreatic and melanoma cancers in the coming months. Could you just confirm it as expected for the year and, if so, how much data should really be expecting?

Garo H. Armen: So we are expecting maturing data to be disclosed in pancreatic cancer and melanoma, in lung cancer and neoadjuvant cancer patients of all comers, which is a trial that I spoke about which is being conducted at a major cancer center in Europe by very, very difficult investigator who’s had experience with other neoadjuvant trials. So these are amongst the most important data outputs that you will see in coming months.

Emily Bodnar: Okay, thanks for taking the questions.

Operator: Your next question comes from the line of Kelly Shi of Jefferies. Please go ahead.

Kelly Shi: [inaudible]. It's very difficult to hear you. Please give your readout. Yes, better. Okay, great. This is Claire on for Kelly.

Kelly Shi: [inaudible].

Garo H. Armen: It's very difficult to hear you. Please give your readout. Yes, better. Okay, great. This is Claire on for Kelly.

Garo H. Armen: It's very difficult to hear you.

Kelly Shi: Can you hear me now? Yes, better. Okay, great. This is Claire on for Kelly.

Kelly Shi: Can you hear me now?

Kelly Shi: Yes, better. Okay, great. This is Claire on for Kelly.

Garo H. Armen: Yes, better.

Kelly Shi: Okay, great. This is Claire on for Kelly. Thanks for taking our question. So wondering if you could provide more color on the initial meeting you had with the European agency. What kind of data did you show them and whether that’s the same data package as what you provided to the FDA? And for the subsequent meetings could you let us know what would the key discussion points with them? Thank you.

Claire: Thanks for taking our question. So I'm wondering if you could provide more color on the initial meeting you had with the European agency, like what kind of data you showed them and whether that was the same data package as what you provided to FDA. And for the subsequent meetings, could you let us know what the key discussion points were with them? Thank you.

Garo H. Armen: Okay. So we’re not going to disclose much detail other than the following. And the reason we’re not going to disclose much details is because we do not want background efforts to basically stop another agency from doing what they think is the right thing to do. And if you can read between the lines of what I’m saying, I think it will be very clear in the future to know that all these interactions are confidential. We’ve had the very initial interaction with one of the major agencies. And I will tell you their stance on this is diametrically opposite to the U.S. FDA, diametrically opposite. What do I mean by that? They have done their homework, they understand the data, they have had slightly more mature data than what we had presented with to the FDA, because as you know, the FDA has very strict rules on not considering data post-submission of the package, and between the submission of the package and the meeting could be several months.

Garo Armen: What do I mean by that? They have done their homework. They understand the data. They have had slightly more mature data than what we had presented to the FDA because, as you know, the FDA has very strict rules about not considering data post-submission of the patent. And between the submission of the package and the meeting could be several months. So even though we had more mature data, by the time we had the actual meeting, this data wasn't being formally considered in their guidance.

What do I mean by that? They have done their homework. They understand the data. They have had slightly more mature data than what we had presented to the FDA because, as you know, the FDA has very strict rules about not considering data post-submission of the patent. And between the submission of the package and the meeting could be several months.

Garo H. Armen: So even though we had more mature data by the time we had the actual meeting, this data wasn’t being formally considered in their consideration of their guidance to us. But the European agency has seen this more mature data, and their guidance to us is very simple, that they have indicated several pointers that will be helpful to us in making sure that we meet all the requirements, but they’ve also said to us that they hope that these requirements, which are important box-checking elements, will not get in the way of our rapid exploration of submission.

Garo Armen: But the European Agency has seen this more mature data and has given us guidance. It is very simple: they have indicated several pointers that will be helpful to us in making sure that we meet all the requirements. But they've also said to us that they hope that these requirements, which are important box-checking elements, will not get in the way of our rapid exploration of submissions.

Kelly Shi: Okay, got it. Thank you.

Operator: Your next question comes from the line of Madison El-Saadi of B. Riley Financial. Please go ahead.

Madison El-Saadi: Hey, guys, thanks for taking the question. A couple for me. Just as we look at this November dataset, kind of just wondering what the expectations on survival and durability are, if we’re looking for specifically just kind of maintain that 19.5%-20% ORR. And then could you also confirm, I’m sorry if I missed it, could you confirm that the two patients that had not had their confirmatory scan if they did have those scans? And then lastly, on the Phase II design, just wondering thoughts on the control arm, if it’ll look like the Phase II, or if it could be different things? Thanks.

Garo H. Armen: Okay. So number one, all of the data that we reported are strictly confirmed ORR, okay? Which means that there is still some upside to that, but there is no downside to it. In other words, we will not have any downside revision to what we have already reported as overall response rates in the second trial, the Phase II trial, multi-arm Phase II trial. Now, of course, from the Phase I trial, we almost have 24 months of follow-up. And as we said earlier, the follow-up in the Phase II trial will be at a point of about 12-month maturity. And the trends that we’re seeing in the Phase II trial are almost identical to the trends that we have seen in our Phase I trial. And so, with all of that, we are confident about the integrity of our data.

Garo Armen: In other words, we will not have any downside revision to what we have already reported as overall response rates in the second trial, the phase two trial, the multi-arm phase two trial. Now, of course, from the phase one trial, we almost had 24 months of power. And as we said earlier, the Pow wow in the Facebook chat will be at a point of about 12 months maturity, and the trends that we're seeing in the phase two trial are almost identical to the trends that we have seen in our faith one far. And so, with all of that... We are confident about the integrity of our data.

Garo Armen: And as we said earlier, the Pow wow in the Facebook chat will be at a point of about 12 months maturity, and the trends that we're seeing in the phase two trial are almost identical to the trends that we have seen in our faith one far. And so, with all of that... We are confident about the integrity of our data. We're confident about the patient selection. In other words, there's no cheating.

And as we said earlier, the Pow wow in the Facebook chat will be at a point of about 12 months maturity, and the trends that we're seeing in the phase two trial are almost identical to the trends that we have seen in our faith one far. And so, with all of that... We are confident about the integrity of our data.

Garo H. Armen: We’re confident about the patient selection. In other words, there’s no cheating here. All patients that are enrolled in this trial fall into the category of either third or fourth line patients in the metastatic study. So, that has been confirmed. And of course, that adds to the validity of the data. And as Dr. O’Day would say, deep, underlining deep, and durable, underlining durable responses in immune oncology trials that are particularly mediated with a CTLA-4 binding antibody, as you know, BOT doesn’t just bind to CTLA-4, it is a multifunctional antibody, but one of the things that it does is bind to CTLA-4. We are confident that in an immuno-oncology treatment setting, any trial that is an IO-IO trial that binds to CTLA-4 and shows significant overall response rates always translates to survival benefit. I think this is a point that certain agencies understand, and other agencies like the FDA, I think, need to be schooled in this phenomenon. And it is, frankly, our responsibility, not the FDA’s responsibility, for us to present the data to convince them of the reality of the power of immuno-oncology with IO-IO agents that are mediated with CTLA-4 binding in addition to PD-1. Next question.

Garo Armen: All patients that are enrolled in this trial fall into the category of either third or fourth blind patients in the metastatic setting. So that has been confirmed, and of course, that adds to the validity of the data. And, as Dr. O'Day would say, deep... underlining deep and durable responsibility. Endemic Oncology trial that is particularly mediated by a CTLA-4 binding antibody. But as you know, BUP doesn't just bind to CTLA-4. It is a multifunctional antibody, but one of the things that it does is bind to CTLA-4. We are confident that in an immuno-oncology treatment setting, any trial that is an IO-IO trial that binds to CTLA-4 and shows a significant overall response rate always translates to survival.

Garo Armen: Endemic Oncology trial that is particularly mediated by a CTLA-4 binding antibody. But as you know, BUP doesn't just bind to CTLA-4. It is a multifunctional antibody, but one of the things that it does is bind to CTLA-4. We are confident that in an immuno-oncology treatment setting, any trial that is an IO-IO trial that binds to CTLA-4 and shows a significant overall response rate always translates to survival. I think this is a point that certain agencies understand, and other agencies, like the FDA, I think, need to be schooled in this phenomenon.

Endemic Oncology trial that is particularly mediated by a CTLA-4 binding antibody. But as you know, BUP doesn't just bind to CTLA-4. It is a multifunctional antibody, but one of the things that it does is bind to CTLA-4. We are confident that in an immuno-oncology treatment setting, any trial that is an IO-IO trial that binds to CTLA-4 and shows a significant overall response rate always translates to survival.

Garo H. Armen: I think this is a point that certain agencies understand, and other agencies, like the FDA, I think, need to be schooled in this phenomenon. And it is, frankly, our responsibility, not the FDA's responsibility, for us to present the data to convince them of the reality of the power of immuno-oncology with IO-IOAG, which is mediated by CTLA-4 binding in addition to PD-1.

Garo Armen: And it is, frankly, our responsibility, not the FDA's responsibility, for us to present the data to convince them of the reality of the power of immuno-oncology with IO-IOAG, which is mediated by CTLA-4 binding in addition to PD-1.

Operator: Your next question comes from the line of Madeleine Stone on behalf of William Blair. Please go ahead. Great. Hi, this is Madeline on behalf of Matt Phipps.

Operator: Your next question comes from the line of Madeleine Stone of William Blair. Please go ahead.

Madeleine Stone: Great. Hi. This is Madeline on for Matt Phipps. Thanks for taking our question. So, for future discussions planned with the FDA, how much additional follow-up from the Phase II trial will you need in that more mature dataset?

Garo H. Armen: Approximately six more months of follow-up versus what we had presented to them in a submitted document. Great, thank you.

Garo H. Armen: Approximately six more months of follow-up versus what we had presented to them in a submitted document.

Madeleine Stone: Great, thank you.

Operator: That concludes our question-and-answer session. I will now turn the conference back over to Garo Armen for closing remarks.

Garo H. Armen: Thank you very much, Leonardo. And, once again, thank you for your attention. I appreciate the questions that we’ve gotten. And the basic conclusion that I had is that I know we’ve made reference to the fact that we will be having more follow-up on patients before we engage with regulatory agencies, including the FDA. But I’d like to further indicate to you that we feel confident in the follow-up data from this trial because we have the data, by and large, and it will be only a question of cleaning up the data and presenting it in a format with the appropriate arguments, that will hopefully align our way of thinking, our KOLs’ way of thinking, our investigators who have significant experience in the field with our agents, their way of thinking with the regulatory. So this is what we hope to accomplish in the next few months. Stay tuned, and we always welcome your engagement in the form of offline additional questions that you may have. Thank you again.

Garo Armen: Our KOLs, we are... our investigators who have significant experience in the field with our agents, their way with regular. So this is what we hope to accomplish in the next few months, stay tuned, and we always welcome your engagement in the form of

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining us. You may now disconnect.

Great.

Oh.

Thanks.

[music].

Speaker Change: Good morning, and welcome to agonist second quarter 'twenty 'twenty four conference call and webcast all participants will be in a listen only mode until the question and answer session. Please note. This event is being recorded if anyone has any objections you may disconnect at this time.

Zac Imet: I would now like to turn the conference over to Zac I met head up Investor Relations agonist.

Speaker Change: Please go ahead.

Speaker Change: Thank you Leonardo and thank you all for joining us today.

Speaker Change: Today's call is being webcast and will be available on our web site for replay.

Operator: 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. Dr. Robin Taylor, Chief Commercial Officer, will be participating in the Q&A session. Good morning, everyone, and thank you for joining us today, with a strong emphasis on impacting patient lives. These are for the treatment of colorectal cancer, even though the combination has been used for many other cancers, demonstrating a considerable response rate.

Speaker Change: 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 amongst other updates.

Operator: 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 FTC 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, 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 second quarter.

These statements are subject to risks and uncertainties.

Speaker Change: Or are you to our SEC filings available on our website for more details on these risks.

Speaker Change: Joining me today are Dr. Garo, Armen, Chairman and Chief Executive Officer, Dr. Steve <unk>, Chief Medical Officer, and Christine <unk>, Vice President of Finance.

Speaker Change: After Robin Taylor, Chief commercial officer, who will be participating in the Q&A session.

Speaker Change: Now I'd like to turn the call over to Garo to highlight our progress in the second quarter.

Garo Armen: Good morning, everyone, and thank you for joining us today and for The Merits of Our Circumstances and on matters within our control, with a strong emphasis on impacting patient lives. We have made significant progress in the development of botansilamab, which we call BOT, and bostilamab, which we call BAP. And these are for the treatment of colorectal cancer, even though the combination has been used for many other cancers. Recently, Agenus disclosed top-line data from its global phase 2 trial.

Garo: Good morning, everyone and thank you for joining us today.

Speaker Change: And the merits of our circumstances.

Speaker Change: And on matters within our control.

Speaker Change: With a strong emphasis on impacting patient lives.

Garo: We have made significant progress in the development of cobalt, so the map, which we call bot.

Speaker Change: And basket of a map, which we called back.

Speaker Change: And these are for the treatment of colorectal cancer, even though the combination has been used for many applications.

Speaker Change: Recently at Genesis disclosed top line data from its global Phase II trial evaluating the combination in patients with relapsed refractory microsatellite stable, which is called and.

Garo Armen: Evaluating the butthole combination in patients with relapsed refractory microsatellite staples, which is called NSS, colorectal These patients constitute about 95% of the diagnosed colorectal cancer patients. Lonely, and as you know, colorectal cancer has been on a significant rise as of late.

Speaker Change: Well the rectal cancer.

Speaker Change: These patients.

Speaker Change: About 95%.

Speaker Change: Colorectal.

Speaker Change: Cancer patients.

Speaker Change: And as you know colorectal cancer.

Speaker Change: I'm a significant rise in salt Lake.

Garo Armen: The results from our second trial, the phase 2 trial, are consistent with those observed in our phase 1 trial, demonstrating a confirmable response rate of approximately 20 percent in the cohorts receiving 75 milligrams of butt plus 240 milligrams of bobcomb. This dosage has been identified as the active dose. During their recent meeting with the U.S. FDA, allowing Agenus to proceed with further development, including our planned confirmatory phase three trial, Bach-Bow is demonstrating unprecedented activity in treating challenging cancers across various stages, both as a chemotherapy-free, IO-IO only combination, as well as in combination with standard chemotherapy in first-line metastatic patients. It is the standard of care.

Speaker Change: The results from a second trial the phase II trials are consistent with those observed in our phase one trial.

Speaker Change: Demonstrating.

Speaker Change: The overall response rate.

Speaker Change: Approximately 20% in the cohort receiving.

Operator: In the cohorts receiving this dosage, it has been identified as the active dose. It is important to recognize that opinion leaders, including significant numbers in the U.S., who have seen our data and or have experienced the outcomes in their patients strongly advocate for and over 1,000 patients across 10 different cancer patients who otherwise would have paid from other regulatory agencies. In Europe, this could mean conditional...

Speaker Change: 75 milligrams of <unk>, plus 240 milligram vial combination.

Speaker Change: This dosage has been identified as the active dose.

Speaker Change: During our recent meeting with the U S FDA.

Speaker Change: Allowing us to proceed with further development, including our planned confirmatory phase III trial.

Speaker Change: <unk> Valley is demonstrating.

Speaker Change: Precedented activity increasing challenging cancers.

Speaker Change: Various agents.

Speaker Change: All right.

Speaker Change: As a chemotherapy free Io Io only combination.

Speaker Change: As well as in combination with standard chemotherapy.

Speaker Change: In first line metastatic patients for chemotherapy.

Speaker Change: It is the standard of care.

Garo Armen: It is important to recognize that opinion leaders and clinical investigators globally, including significant numbers in the U.S., who have seen our data and or have experienced the outcomes in their patients strongly advocate making BotBow available to their patients. In our trials of significant numbers of patients, covering more than 350 in colorectal cancer and over 1,000 patients across 10 different cancers, we are seeing deep, Turbo Response, patients who otherwise would have paid for Current Standard Treatment.

Speaker Change: It is important to recognize that key opinion leaders.

Speaker Change: And clinical investigators globally.

Speaker Change: Including significant numbers in the U S who have seen our data.

Speaker Change: And or have experienced the outcomes in their patients.

Speaker Change: Strongly advocate and making it.

Speaker Change: Available to their patients.

Speaker Change: In our trials are significant numbers of patients totaling more than 350 in colorectal cancer.

Speaker Change: And over 1000 patients across 10 different cancer types.

Speaker Change: We are seeing deep.

Speaker Change: Global responses in patients who are otherwise pretty green products.

Speaker Change: With current standard treatments.

Garo Armen: We believe, along with the experts in the field, that these durable responses translate to long-term patient benefit. While the FDA has not yet concurred with this view and the urgency to make Quattro widely available to patients and their treating physicians, we are optimistic that our mature data will influence their thinking. On the airplane hand.

Speaker Change: We believe along with the experts in the field.

Speaker Change: That these durable responses translate to long term patient benefit.

Speaker Change: While the FDA has not yet concurred with this view.

Speaker Change: And the urgency to make quite widely available for patients.

Speaker Change: And their treating physicians.

Speaker Change: We are optimistic that our mature data.

Speaker Change: <unk> influence their thinking.

Speaker Change: On the other hand.

Garo Armen: We're very encouraged by the initial feedback from other regulatory agencies, which has been notably much more positive. On this note, we've started engaging with regulatory bodies outside of the U.S., including the European Agency, in order to explore rapid approval pathways for BAP. In Europe, this could mean conditional approval, to bring these potentially life-saving agents to patients as soon as possible. Apart from all of this,

Speaker Change: We're very encouraged with the initial feedback.

Speaker Change: From other regulatory agencies, which has been notably much more positive thus far.

Speaker Change: On this note.

Speaker Change: We started engaging with regulatory bodies outside of the U S, including the European agency in order to explore rapid approval pathways or bought back.

Speaker Change: In Europe this could mean for <unk>.

Speaker Change: Alright cool to bring these potentially life saving behavior as the patients.

Speaker Change: As soon as possible.

Operator: Separate me from all of this. We are very excited to share that important and very exciting data from a multi-cancer neoadjuvant study emphasize the importance of bringing Buc-Bal to patients. Dr. O'Day will describe this reality in more detail. Additionally...

Speaker Change: Separately from all of this.

Garo Armen: We are very excited to share that important and very exciting data from a multi-cancer neoadjuvant study, which is being conducted at a major European cancer center, will be presented at a major cancer conference in the coming months. Our clinical data..., as you know, has generated strong support from medical and scientific communities. Recent publications in major medicine and cancer discovery, along with a peer-reviewed journal article that came in from Dana-Farber Cancer Institute here in Boston, emphasize the importance of bringing mouth-to-mouth to patients with MSS Polaroid.

Speaker Change: We are very excited to share that importantly, and very exciting data from a multi cancer Neo adjuvant study.

Speaker Change: Which is being conducted at a major European cancer Center.

Will be presented at a major cancer conference.

Speaker Change: In upcoming months.

Speaker Change: Our clinical data as you know.

Speaker Change: No. It has generated strong support from medical and scientific communities.

Speaker Change: Recent publications in nature medicine in cancer discovery.

Speaker Change: Along with a peer reviewed journal.

Speaker Change: He called it the came out from Dana Farber Cancer Institute here in Boston.

Emphasized the importance of bringing <unk> to patients.

Speaker Change: MSS colorectal cancer.

Garo Armen: By the way, MSS colorectal cancer is one of the most difficult cancers to treat, not just within the colorectal realm, but across the board. We won't have seen an unprecedented number of compassionate use requests, driven by a deep and durable response, in a cancer where patients have no acceptable options among any approved drugs, highlighting the urgent demand for valve in the colorectal cancer community.

Speaker Change: MSS colorectal cancer is one of the most difficult cancers to treat that just went into Colorado ground, but across the board.

We've also seen.

Speaker Change: And unprecedented number of compassionate use requests.

Speaker Change: Driven by the deep and durable responses.

In cancer, where patients have no acceptable options upon.

Speaker Change: Any approved drugs.

Speaker Change: Highlighting the urgent demand pull back vowels.

Speaker Change: In colorectal cancer community.

Garo Armen: Dr. O'Day will describe this reality in more detail during our call. On the business side, we're actively exploring global partnerships for Babel and other assets in our pipeline. We've regained full rights to Agent 177 and Agen 2373 from BMS and Gilead, respectively, and are evaluating new partnerships for these programs among the biopharma industry players. As you know, many companies out there are scrambling to cut costs. And I'm talking about large companies, medium-sized companies, and small. But there are still pockets of brilliance.

Dr. Jose: Dr. Jose will describe this reality in more detail during our call.

Yeah.

Speaker Change: On the business side.

Speaker Change: Absolutely exploring global partnership for <unk> and other assets in our pipeline.

Speaker Change: We've regained full rights to a gen one triple set it.

And age and $23 73 from BMS and Gilead, respectively.

And are evaluating new partnerships.

Speaker Change: For these programs.

Speaker Change: Among the Biopharma industry players as you know.

Many companies out there are scrambling to cut cost and I'm talking about large companies medium sized companies and small companies.

Speaker Change: But there are still pockets, so greg against amongst them.

Garo Armen: Interestingly, we've been having increased interest in some of these innovative companies following our announcement about the FDA guidance discouraging accelerated fire. We've strengthened our cash position in the second quarter with the first transfer of the $75 million royalty financing led by Ligon Pharmaceuticals, and Wayne Cox would invest those funds for a second quarter. We're encouraged by the fact that we have received inquiries to potentially invest at premium prices to our current stock.

Interestingly, we've been having increased interest from some of the innovative companies.

Following our announcement about the FDA guidance discouraging.

Speaker Change: Salaries at fiery.

Speaker Change: We've strengthened our cash position in the second quarter with the first tranche of the 75 million royalty financing led by ligand pharmaceuticals.

And we're in talks with investors for a second closing.

We're encouraged by the fact that we have received inquiries to potentially invest at premium prices to our current stock price.

Garo Armen: Additionally, I'd like to let you know, ahead of time, because the filing will be this afternoon, that we will be expending our ATM filing facility to be in a state of readiness, in spite of the fact that we have no current plan to issue stock at these prices. And you will see in this filing that we've done some minor sales in the first half of the year, but the average price has been approximately $15 a year.

Additionally.

Operator: I'd like to let you know, because the filing will be this afternoon. And you will see in this filing that we've done some minor sales, and about more details that are patient-centric, exciting, and life-altering... I'm delighted to announce that Tom Harrison has joined our board of directors.

I'd like to let you know.

Speaker Change: Ahead of time.

Because the pilot will be this afternoon that.

Speaker Change: We will be expanding our ATM filing facility to be in a state of readiness.

Despite of the fact that we have no current.

Two issuing stock at these prices and you will see in this filing does that we've got some minor sales.

In the first half of the year, but the average price has been approximately $16 a share.

Garo Armen: Given the uniquely active nature of our agents, our commitment to advancing bus balance is stronger than ever before. We're dedicated to ensuring that patients get access to these life-saving therapies as quickly as possible. And you will hear about some of the plans that we're contemplating on putting into place as soon as possible from my colleague, Greg Ramos, before we hear from Dr. O'Day about more details that are patient-centric, exciting, and life-altering outcomes.

Given the uniquely active nature or by agents, our commitment to advancing back Val.

Is stronger than ever before.

We're dedicated to ensuring that patients get access to these lifesaving therapy as quickly as possible.

You will hear about some of the planes that we're contemplating on putting into place as soon as possible for my colleague Greg Roth.

We hope to hear something back all day.

About more details about our patient centric exciting and life altering outcome.

Garo Armen: I'm delighted to announce that Tom Harrison has joined our board of directors. A few words about Tom before I introduce him... Tom is one of the true transformative leaders in the healthcare industry, having grown diversified agency service into Omnicom Group's largest division with over 5,000 clients and annual revenues exceeding $6 billion. His deep experience in healthcare communications and branding, combined with a strong scientific background from his early days at Pfizer, makes Mason very uniquely equipped to guide Agenus in its next phase of growth.

I'm delighted to announce that comparison has joined our board of directors.

A few words about Tom <expletive> Ryan to address it.

Tom is one of the true transformative leaders in the healthcare industry.

Having grown diversified agency services.

I'm, Nick come groups largest division with over 5000 clients.

<unk> annual revenues exceeding $6 billion.

Garo Armen: His deep experience in healthcare communications and branding combined with a strong scientific background from his early days at Pfizer make them, I want to emphasize. And operational experience is key in our efforts to bring groundbreaking cancer treatments to patients worldwide, not just in the U.S. From co-founding Harrison and Starr Business Group to my current role as Senior Operating Partner at Emerita Capital Partners. Our data remains consistent between the Phase I expanded cohort and our Phase II randomized trials, particularly in terms of leases confirmed overall response rates, duration of response, and importantly, overall survival.

His deep experience in healthcare communications and branding combined with a strong scientific background or probably early days at Pfizer.

Makes sense.

Very uniquely equipped to guide the Genesis in our next phase of growth.

Garo Armen: Tom's innovative approach to merging high science with the Creative Market will be key in our ability to educate the global community about the critical benefits of our care. I want to emphasize his Strategic Vision and operational experience is key in our efforts to bring groundbreaking cancer treatments to patients worldwide, not just the U.S. Please join me in welcoming Tom Harrison to say a few words on this call.

<unk> innovative approach in emerging high science.

With creative marketing will be key.

And our ability to educate the global community about the critical benefits of our therapy.

I want to emphasize educating.

His strategic vision and.

And operational experience is key in our efforts to bring groundbreaking cancer treatments for patients worldwide not just the U S.

Please join me in welcoming Tom Harrison to say a few words on this call to Tom.

Tom Harrison: Thank you so much for that most, most kind introduction. Hopefully, I'm worthy of those wonderful words.

Thank you so much for that most most kind introduction.

Hopefully unworthy of them wonderful words.

Tom Harrison: I'm truly honored to join the board of directors of Agenus, a company that is at the forefront of innovation in the field of immuno-oncology. The work that is being done here at Agenus is not only groundbreaking, but it's also life-changing for patients battling some of the most challenging cancers that Garo has already outlined on the call. As someone who has spent a significant portion of my career in healthcare advertising and strategic advice to CEOs across the healthcare industry, I'm excited to bring my experience to Agenus. The opportunity to help elevate the awareness of our innovative pipeline and to communicate the significant advances that we are making in cancer treatment is something that I am really, deeply passionate about.

I'm truly honored to join the board of directors of Jeans, a company that is at the forefront of innovation in the field of immuno oncology.

Work is being done here that gene. This is another groundbreaking but it's also life changing for patients.

Some of the most challenging cancers Carol has already outlined on the call.

As someone who has a significant portion of my career in healthcare advertising and strategic advising.

It was across the healthcare industry.

I'm excited to bring my experience to Chinas.

Attuned to help elevate the awareness of our innovative pipeline.

Communicate the significant advances we are making in cancer treatment is something that I am really deeply passionate about.

Tom Harrison: My career, as Garo said, has always been driven by a commitment to excellence and innovation founded on a foundation of science, from co-founding Harrison Star Business Group to my current role as Senior Operating Partner at Emerita Capital Partners. I have been fortunate to work throughout my career with very talented teams, such as the one here at Agenus, to drive growth and deliver impactful results. I see a similar spirit of innovation and dedication here at Agenus, and I am eager to contribute to our shared mission.

My career as it.

It has always been driven by our commitment to excellence.

Innovation.

On a basis of science.

Founding Harrison Historic business group to my current role.

Operating partner at narrowed a capital partners.

I'm fortunate to work throughout my career with very talented teams such as the one here a genius.

We can deliver impactful results.

A similar spirit of innovation and dedication here the genes.

And I am eager to contribute to our shared mission.

Tom Harrison: One of my key priorities, as Garo said, will be to enhance our strategic communications effort to ensure that our scientific advancements and our therapeutic potential are clearly understood by healthcare providers, patients, investors, and regulatory bodies around the world. By doing so, we can not only elevate the visibility and reputation of Agenus but also help accelerate the delivery of our life-saving therapies to those who are in dire need. I am particularly excited about the progress we are making with our BotVal program and the potential it holds to address unmet medical needs across multiple cancer indications.

One of my key priorities.

So it will be to enhance our strategic communications efforts to.

To ensure that our scientific advancements in our therapeutic potential and clearly understood by healthcare providers and patients.

Testers regulatory bodies around the world are.

Doing so we can not only elevate.

<unk> ability and reputation of edginess.

So help accelerate the delivery of our life saving therapies to those who are in dire need.

I am, particularly excited about the progress, we're making with our but bell program and the potential it holds to address unmet medical needs across multiple cancer indications.

Tom Harrison: The robust data that we have generated, coupled with our active engagements with global regulatory authorities, positions us as well, pardon me, to bring these innovative treatments to market. I look forward to working closely with Garo, with the full board of directors, and the entire senior Agenus team to drive our mission forward. Together, we will continue to push the boundaries of what is possible in cancer immunotherapy and improve patient outcomes. Thank you again, Garo, for the warm welcome and everyone for the warm welcome with whom I've spoken, and I'm excited about the journey that we have ahead. So now I'm going to turn the call over to Stephen to go over our progress so far.

A robust data that we had generated coupled with our active engagements with global regulatory authorities position positions us well.

Pardon me to bring these innovative treatments to market.

I'll look forward to working closely with Garo.

Our board of directors and the entire senior Ademas team to drive our initiatives forward together, we will continue to push our boundaries.

It is possible and cancer immunotherapy and <unk>.

<unk> patient outcomes.

Again for the warm welcome and everyone for the warm welcome to Cmos smoking.

I'm excited about the journey that we have ahead.

So now I'm going to turn the call over to Steven.

Update.

Clinical progress to date.

Dr. Steven O'Day: Thank you, Tom and Garo. I'm pleased to provide an update on our clinical progress across the Bonta Health program. As Garo said, spanning over 1100 patients treated in refractory advanced cancers, as well as earlier stages of metastatic disease, and most recently in the neoadjuvant setting, BotVal is demonstrating remarkable activity with a manageable safety profile in patients with relapsed, refractory, MS-stable colorectal, and non-active liver metastatic disease. Our data remains consistent between the Phase 1 expanded cohort and our Phase 2 randomized trials, particularly in terms of leases confirmed overall response rates, duration of response, and importantly, overall survival.

Thank you Garo.

To provide an update on our clinical progress across the board.

Program.

As garo spanning over 100 patients treated.

<unk> advanced cancers, as well as earlier stages of Madison cardiac disease, and most recently in the Neo adjuvant setting.

Potbound determine Australia remarkable activity.

A manageable safety profile in patients with relapsed refractory <unk> stable colorectal cancer.

Non actor liver metastatic disease.

R&D remains consistent between the phase one expanded cohort in our phase two randomized trials.

In terms of obesity confirmed overall response rate duration of response and it corporately overall survival.

Uh huh.

Dr. Steven O'Day: Call me if you don't, an unstable colorectal cancer patient population of 23% in the phase one trial and now 19.4% in a year. The phase two trial is roughly three times the low single-digit overall response rate of any available standard of care therapy in this setting.

Okay.

Great.

Stable colorectal cancer patient population of 23% in the phase one trial now.

94%.

Right.

The phase two trial is roughly three times the low single digit overall response rate of any available standard of care therapy in this setting.

Garo Armen: Our median overall survival for the Phase 1 trial of 21.2 months, with a remarkable 18-month estimated overall survival of 63%, stands in marked contrast to approximately, at best, 12 months with the best standard of care therapy before surgery. We ended the second quarter 2024 with a consolidated cash balance of $93.7 million compared to $76.1 million on December 31, 2023. For the three and six months ended June 30, 2024, we recognized revenue of $23.5 million and $51.5 million, respectively. Our cash used in operations for the first half of 2024 was $76.4 million, a reduction from $118.6 million for the first half of 2023.

Dr. Steven O'Day: Our median overall survival for the Phase 1 trial of 21.2 months, with a remarkable 18-month estimated overall survival of 63%, stands in marked contrast to approximately, at best, 12 months with the best standard of care therapy. While survival with the Phase II data set is early and maturing, we see consistency in the six-month survival rate of 90% in our selected combination Botfowl arm in the Phase II trial as compared with 88% in the Phase I Botfowl arms, and this is very reassuring.

Our median overall survival for the phase one trial of 21, two months with a remarkable 18 months estimated overall survival of 63% stands in marked contrast to approximately at best.

With the best standard of care therapies.

While survival with the phase two data centers currently are maturing we see consistency in the six month survival rate of 90% are selected combination arm.

The phase III trial.

Compared with the 88%.

<unk>. So this is very reassuring to us.

Dr. Steven O'Day: We plan to submit the phase two data after a later maturity data cut later this year to a major medical congress in the early part of 2025. We are confident that as these data mature, they will continue to demonstrate differentiation, in overall response, duration response and survival compared to standard of care therapies in this late line refractory MS stable colorectal, In addition, we're seeing remarkable activity of Bofal in earlier stages of CRC treatment lines, which is highlighted by our data in the NEF neoadjuvance trial, which was updated with an oral presentation at ESMO GI in Munich this past June.

We plan to submit the phase II data. After a later maturity data later this year to a major medical Congress in the early part of 2025, we are accounting for that as these data mature they will continue to demonstrate differentiation.

And overall response duration of response and survival compared to standard of care therapies. In this late line refractory MF stable colorectal cancer.

In addition, we're seeing remarkable activity are bought out at earlier stages of CRC treatment lives, which is highlighted by our data in the Nash Neo adjuvant trial, which was updated with an oral presentation at ESMO Gi in Munich.

This past year.

Dr. Steven O'Day: This trial evaluated one dose of BOT with two to four doses of BAL before surgery. In the updated NAS2 cohort, which provided a longer time between the first dose of bot val and surgery of up to eight weeks, Remarkably, 7 of 9 MS-stable colorectal patients, or 78%, achieved at least a 50% tumor regression at the time of surgery, with 5 out of 9, or 56%, achieving complete pathologic regression Importantly, no surgeries were delayed due to adverse events.

This trial evaluated one dose of bonds with two to four doses of <unk>.

For surgery.

In the updated Ness, two cohort, which provided a longer time between the first dose of barbell in surgery.

Weeks.

Marketplace Southern.

MFS stable colorectal patients or 78% achieved at least a 50% tumor regression at the time of surgery with five out of 956% achieving complete pathologic regressions or tumors and importantly, no surgeries were delayed.

Two adverse events, but.

Christine Klaskin: This data stands in stark contrast to historical data, with attempts at neoadjuvant IO therapy in poorly immunogenic MS-stable colorectal cancer, where pathologic response rates have been poor. We plan to continue to build on these groundbreaking data in the neoadjuvant setting with additional studies. And, as Garo alluded to, additional IST studies are ongoing. Data in our Phase 2 BotBow melanoma and pancreas trials continue to mature, and we look forward to updating these data in the coming months.

This data stands in Stark contrast to historical data with attempts at Neo adjuvant Io therapy, and poorly immunogenic MF stable colorectal cancer, where pathologic response rates have been poor.

We plan to continue to build on these groundbreaking data in the neo adjuvant setting with additional studies.

And as.

Garo alluded to an additional ISP studies are ongoing.

Data in our phase two markdown melanoma pancreas trials continue to mature and we look forward to updating these data in the coming months timely renewal presenting updated data with Barton valid a relapse refractory <unk>.

Christine Klaskin: Finally, we will be presenting updated data with Bot and Bow in a relapsed refractory sarcoma population in an oral presentation at the ESMO conference in Barcelona in September. Now, I'll turn the call over to Christine to review our financials.

Comer population.

An oral presentation at the ESMO conference in Barcelona.

September.

Christine Klaskin: We ended the second quarter 2024 with a consolidated cash balance of $93.7 million, compared to $76.1 million on December 31, 2023. For the three and six months ended June 30, 2024, we recognized revenue, which included $23.5 million and $51.5 million, respectively. This compares to $25.3 million and $48.2 million for the same period in 2023. Our cash used in operations for the first half of 2024 was $76.4 million, a reduction from $118.6 million for the first half of 2023.

Now I will turn the call over to Christine to review our financials.

Okay.

Thank you Steven.

We ended the second quarter 2024, with a consolidated cash balance of $93 7 million.

Compared to $76 1 million on December 31, 2023.

For the three and six months ended June 32024, we recognized revenue which include Neil.

Yeah.

$23 $5 million and $51 $5 million respectively.

This compares to $25 $3 million and $48 2 million for the same periods in 2023.

Our cash used in operations for the first half of 2024 with $76 4 million.

And reduction from $118 6 million for the first half of 2023.

Christine Klaskin: Our net loss for the three and six months ended June 30, 2024, is $54.8 million and $118.3 million, respectively. These include non-cash operating expenses of $33.5 million and $71.8 million, respectively. I will now turn the call back to the CEO for closing remarks.

Our net loss for the three and six months ended June 32024.

$54 $8 million and $118 $3 million. These include noncash operating expenses of $33 5 million and $71 8 million respectively.

I will now turn the call back for closing remarks.

Yeah.

Garo Armen: Thank you very much, Tom, Stephen, and Christine. I'd like to extend my gratitude to everyone for joining us today to review our second quarter progress.

Thank you very much John Stephen and Christine I'd.

I'd like to extend my gratitude to everyone for joining us today to review our second quarter progress.

Operator: Our unwavering focus remains on delivering Botfowl to individuals living with advanced MSS polorenthal cancer and many other cancers where we have a trial. Patients are counting on it. We do request for today's session that you please limit your questions to one and one follow-up only. Again, if you would like to ask a question, press the star 1 on your telephone keypad. The first question comes from the line of Emily Bodnar, of H.C. Wayne.

Garo Armen: Our unwavering focus remains on delivering Botfowl to individuals living with advanced MSS polorenthal cancer and many other cancers where we have a breakthrough. We are steadfastly exploring innovative and expedited methods to make these treatment options available worldwide. Remember amongst the importance of these treatment options is that they represent IOIO, that is, immuno-oncology, and immuno-oncology combo treatments without chemotherapy, with an extended life extension potential. This is very important for patients that have absolutely no options going forward with limited benefits, and Cora Vukovic.

Our unwavering focus remains on delivering by Val d'or individuals living with advanced MSS colorectal cancer and many other cancers, where we have shown activity.

We are <unk>.

First we exploring innovative and expedited methods to make these treatment options available worldwide.

Remember amongst the important so these treatment options is that they represent I O I O immuno oncology immuno oncology combo treatment.

Without chemotherapy with an extended life.

Life extension.

Potentially.

Is very important for patients that have absolutely no options.

Going forward with.

With limited benefit.

And horrible taxes.

Garo Armen: Patients are counting on us, and we are deeply committed to fulfilling our mission to provide therapies with curative intent, not only for colorectal cancer but, as I said, for many other cancer types, where we have seen some profound results.

Patients are counting on us.

And we are deeply committed to fulfilling our mission to provide therapy with curative intent not only for colorectal cancer.

I've said for many other cancer types, where we have seen some profound activity.

Garo Armen: Thank you very much for your continued support and trust in Agenus. I will now turn the call back to the operator to facilitate any questions you may have. Operator.

Thanks, you very high score your continued support and trust in identities.

I'll now turn the call back to the operator to facilitate any questions you may have.

Operator.

Hi.

Operator: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone that in order to ask a question, press the star and then the number one on your telephone keypad. If you are called upon to ask your question and are listening through a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking a question. We do request for today's session that you please limit to one question and one follow-up only.

Thank you.

Begin the question answer session at this time I would like to remind everyone in order to ask a question.

And then the number one on your telephone keypad.

I'd call it that to ask your question and then ideally sending biologic device.

Pick up your handset and ensure that your phone is not on mute when asking a question.

We do request for today's session that you. Please limit to one question and one follow up on the.

Operator: We will pause for a moment to compile the question and answer your questions. Again, if you would like to ask a question, press the star 1 on your telephone keypad. The first question comes from the line of Emily Bodnar, of H.C. Weyland-Weyand. Please go ahead.

We will pause for a moment to compile the question and answer roster.

Again, if you would like to ask a question press the star one.

On your telephone keypad.

Your first question comes from the line of Emily Bodnar.

H C wain.

Please go ahead.

Emily Bodnar: Thank you for taking the questions. My first one is, if you can discuss the FDA's guidance for the Phase 3 design in terms of the number of patients that you might need per arm, including the center of care arm, and the specific endpoints that you plan to look at. And then maybe you could give any guidance on how soon you believe you could initiate a Phase 3 study and whether you believe the resources you have financially could support you running one alone.

Continuing the question my first one.

If you can discuss the updated guidance for the phase III design in terms of the.

Number of patients that you might need army, including the standard of care arm.

Specific endpoint that you plan to look at.

And then maybe if you can give any guidance as to how soon you believe you could initiate a phase III study whether you believe.

Wow.

Financially.

New running one alone.

Garo Armen: So Emily, among the options that we're considering right now is a retrial that can command as early as the next four months and enroll within a year. And the reason I say about Tag of the Year is because...

So Emily among the options that we're considering right now is <unk>.

<unk> trial.

That can commence as early as the next four months.

And then Raul inside of a year.

And the reason I ask and rolling CAGR over years because.

Garo Armen: There is a touch of Christ in all the patient demand out there that we're getting, and this has been at an increasing pace before the FDA guidance was issued, which we announced a couple of weeks ago, and particularly after the FDA guidance, because now patients are very concerned that they're not going to be able to get this drug in a commercial setting. And so there is a huge interest from patients coming to us. Poor drugs.

There is touch outcry.

Patient demand out there.

Operator: Please go ahead, that we're getting, and this has been at an increasing pace before the FDA guidance was issued, which we announced a couple of weeks ago, and particularly after the FDA guidance because now patients are very concerned that they're not going to be able to get this drug in a commercial that has significant subsidies offered to bring innovative medicine. So, that's what we're exploring now, amongst other opportunities, and stay tuned; the decision will be made in the next couple of weeks.

Were getting and as has been the case at an increasing pace.

The FDA guidance was issued which we announced a couple of weeks ago.

And particularly after the FDA guidance, because now patients are very concerned that they're not going to be able to get this drug.

Commercial setting.

So there is a huge.

Interest paid.

Patients coming to us for drug.

Garo Armen: Global. So that's why we believe that once we initiate a phase three trial, we will be able to enroll very rapidly. That's why I feel confident that enrolling patients inside of a year, post-convention, is something that is highly possible. Now, among the options that we are considering for phase 3 trials, we've been approached by certain groups that have significant subsidies offered to bring innovative medicine to patients as soon as possible. Among these groups is Hartaj, which has proposed to do a randomized phase 3 trial that will satisfy the needs of regulatory agencies globally, not just the FDA, for as little as $10 million. So that's what we're exploring now, amongst other options, and stay tuned; the decision will be made in the next couple of weeks.

Globally.

Emily Bodnar: Okay, great. Thank you.

So that's why we believe that once we initiate a phase III trial.

We will be able to enroll very rapidly that's why I feel confident that enrolling patients inside of a year post commencement.

Is something that is highly possible.

Among the options that we're considering for our phase III trials, we've been approached by certain groups.

That has significant subsidies offered to bring innovative medicines to.

Patients as soon as possible.

These groups is an outfit export bonus to do a randomized phase III trial that will satisfy the needs of regulatory agencies globally not just for SBA.

Or as little as and millions of dollars.

So that's what we're exploring now amongst other options and stay tune the decision will be made in that next couple of months.

Emily Bodnar: I believe you mentioned that you're expecting to have data on pancreatic and melanoma cancers in the coming months. Could you just confirm if that's expected for this year? And if so, how much data should we be expecting?

Okay, great. Thank you.

And I believe you.

Mentioned that you're expecting to have data in pancreatic and melanoma cancers in the coming months.

Just confirming that.

For this year and if so.

How much data actually be expecting.

Garo Armen: So, we are expecting maturing data to be disclosed in pancreatic cancer, in melanoma, in lung cancer, and neoadjuvant cancer patients of all kinds, which is a trial that I spoke about, which is being conducted at a major cancer center in Europe by a very, very visible investigator who has had experience with other neoadjuvant trials. So these are amongst the most important data outputs that you will see in the coming weeks.

Operator: So we are expecting maturing data to be disclosed in pancreatic cancer. So these are amongst the most important data outputs that you will see in the coming days. Okay, thanks for taking the question. It's very difficult to hear you. Can you hear me now?

So we are.

Thing maturing data to be disclosed in pancreatic cancer.

In melanoma and lung cancer.

And Neil Adjuvant cancer patients of all Commerce, which is a trial that I spoke about which is being conducted at a major cancer centers in Europe.

Buying very very visible investigator, who has had experience with other adjuvant trials.

So these are amongst the most importantly data outputs that you will see in coming months.

Emily Bodnar: Okay, thanks for taking the question.

Okay. Thanks for taking the question.

Okay.

Operator: Your next question comes from the line of Kailashi of Jaipur East. Please go ahead.

Your next question comes from the line of <unk> of Jefferies. Please go ahead.

Okay.

Hi, Good morning. This is clarke on for Kelly, Thank you for taking our questions.

Operator: It's very difficult to hear you. Can you hear me now? Yes, better. Okay, great. This is Claire on behalf of Kelly.

Very difficult to hear you.

Very difficult to hear.

Can you hear me now.

Yes, better.

Operator: Thanks for taking our question. So I'm wondering if you could provide more color on the initial meeting you had with the European agency, like what kind of data you showed them and whether that was the same data package as what you provided to FDA. And for the subsequent meetings, could you let us know what the key discussion points were with them? Thank you.

Okay great.

This is clara on for Kelly.

And our question. So I wonder if you could provide more color on the initial meeting you how is the European agency.

What kind of data that you Sheldon and whether that same data package has provided to FDA and for yourself.

<unk> could you, let us know what would be the key discussion points listen thank you.

Garo Armen: Okay, so we're not going to disclose much detail other than the following, and the reason we're not going to disclose much detail is that we do not want background efforts to basically stop another agency from doing what they think is the right thing to do. And if you can read between the lines of what I'm saying, I think it will be very clear in the future to know that all these interactions are confidential. We've had the very initial interaction with one of the major agencies, major agencies, and I will tell you their stance on this is diametrically opposite to the U.S.'s. Absolutely diametrically opposite.

Okay. So we're not going to disclose much detail other than the following and the reason, we're not going to disclose details of that because we do not want background.

Our efforts to basically stopped and other agency from doing what they think is the right thing to do and if you can read between the lines and what I am saying I think it will.

We are very clear in.

In the future to know that all of these.

Interactions that confidential.

We've had the very initial interaction with one of the agencies major agencies.

And I will tell you their stance on this is diametrically opposite to the USDA diametrically opposite right.

Garo Armen: What do I mean by that? They have done their homework. They understand the data. They have had slightly more mature data than what we had presented to the FDA because, as you know, the FDA has very strict rules about not considering data post-submission of the patent. And between the submission of the package and the meeting could be several months. So even though we had more mature data, by the time we had the actual meeting, this data wasn't being formally considered in their guidance.

Do I mean by that they have done their homework.

Understand the data.

They have had more of a slightly more mature data than what we had presented to the FDA because as you know it.

Very strict rules.

Not considering data cost submission of the package and between the submission package and a meeting could be several months. So we even though we had more of a mature mature data by the time, we had the actual me hey, let's say that wasn't being four already considered in their consideration.

Sure.

Our guidance to us.

Garo Armen: But the European Agency has seen this more mature data, and its guidance to us is very simple: they have indicated several pointers that will be helpful to us in making sure that we meet all the requirements. But they've also said to us that they hope that these requirements, which are important box-checking elements, will not get in the way of our rapid exploration of submissions.

The European Agency has seen this more mature data.

And their guidance to us it is very simple.

Indicated several client chairs that would be helpful to us and making sure that we meet all the requirements, but they are also set to us that.

Operator: Yes, better. But they've also said to us that they hope that these requirements, of Be Riley Financial. Please go ahead; in the Facebook chat, we will be at a point of about 12 months maturity, and the trend that we're seeing in the phase two trial is almost identical. We are confident about the integrity of our data. In other words, there's no cheating, not the FDA's responsibility, for us to present the data to convince them of the reality of the power of immuno-oncology with IO-IOH.

They have hope that these requirements, which are of a box checking important box checking the elements will not get in the way of a rapid exploration of submission.

Operator: Okay, I got it. Thank you.

Okay got it thank you.

Operator: Your next question comes from the line of Madison L. Saadman, of B. Reilly Financial. Please go ahead.

Your next question comes from the line of Madison outside.

<unk> please.

Please go ahead.

Operator: Hey guys, thanks for taking the question. A couple from me, just as we look at this November data cut, kind of just wonder what the expectations on survival and durability, are if we're looking if you're looking to just kind of maintain that 19.5 slash 20 percent or are and then could you also confirm sorry if i missed it could you confirm that the two patients that had not had their confirmatory scan if they did have those scans And then lastly, on the Phase 3 design, just wondering thoughts on the control arm, if it'll look like the Phase 2 or if it could be different things.

Hey, guys. Thanks for taking the question.

A couple from me just as we looked at this November data I was just wondering what the expectation is all survival and durability.

Or if we're looking at if you.

Just kind of maintain that $19 five slide 20%.

And then could you also confirm and sorry, if I missed it but could you confirm that the two patients that have had their confirmatory scan if they did have those scans.

And then lastly on the phase III design, just wondering thoughts on the control arm will look once the phase III or if it could be different.

Garo Armen: Okay, so number one... All of the data they will be reporting is strictly confirmed ORR. Okay, which means that there is still some upside to that, but there is no downside.

Yeah.

Okay. So.

Number one.

All of the data that we reported are strictly confirmed <unk>.

Okay.

Which means that there is still some upside to that.

There is no downside.

Garo Armen: In other words, we will not have any downside revision to what we have already reported as overall response rates in the second trial, the phase two trial, the multi-arm phase two trial. Now, of course, from the phase one trial, we almost had 24 months of power.

In other words, we will not have any downside as revisions to Washington.

Already reported as overall response rates in the second trial, the phase II trial, multi arm phase II trial.

Now of course from the phase one trial.

Almost half.

24 months of follow up.

Garo Armen: And as we said earlier, Allure, in the Facebook chat, will be at a point of about 12 months maturity, and the trends that we're seeing in the phase two trial are almost identical to the trends that we have seen in our faith lifestyle. And so, with all of that... We are confident about the integrity of our data. We're confident about the patient selection. In other words, there's no cheating.

And as we said earlier.

The.

Follow up.

In the.

Our phase III trial.

We'll be at a point of about 12 months maturity.

And the trends that we're seeing in the phase II trial.

Almost identical.

So the trends that we've seen in our phase one trial.

And so with all of that.

We are confident about the integrity of our data.

We're confident in the back of patient selection in other words, there is no cheating here.

Garo Armen: Old Page, those that are enrolled in this trial fall into the category of either third or fourth blind patients in the metastatic setting. So, that has been confirmed, and of course, that adds to the validity of the data. And, as Dr. O'Day would say, deep, underlining deep and durable, underlining durable responsibility.

All patients that are enrolled in this trial fall into the category of <unk>.

Third or fourth line patients in the metastatic space.

So that has been quite firm.

And that adds to the validity or backfill.

They would say.

Deep.

Underlining deep.

And durable.

They're lining durable responses.

Garo Armen: Ending the oncology trial that is particularly mediated by a CTLA-4 binding antibody. As you know, BUP doesn't just bind to CTLA-4. It is a multifunctional antibody. But one of the things that it does is bind to CTLA-4. We are confident that in an immuno-oncology treatment setting, any trial that is an IO-IO trial that binds to CTLA-4 and shows a significant overall response rate always translates to survival. I think this is a point that certain agencies understand, and other agencies like the FDA, I think, need to be schooled in this phenomenon. It is not the FDA's responsibility for us to present the data to convince them of the reality of the power of immuno-oncology with IO-IOA, which is mediated with CTLA-4 binding in addition to PD-1.

Immuno oncology trials.

That are protected leave <unk> with a <unk> four binding antibody as you know.

Doesn't just mindlessly GLA for it as a multi functional antibody, but one of the things that it does is buying two four.

We are confident.

And in immuno oncology.

<unk> treatment.

<unk>.

Any trial that is an Io io and try it.

That binds to <unk> four.

And shows significant overall response rates.

Always translate to survival.

I think this is a point there.

Certain agencies to understand and other agencies like the FDA I think need to be schooled in this.

This phenomenon and it is frankly, our responses might.

That the FDA had responsibility for us to present, the data to convince them of the reality of the power of immuno oncology with Io Io agents that are mediated with DLA for binding in addition to PD one.

Next question.

Operator: Your next question comes from the line of Madeleine Stone to William Blair. Please go ahead.

Your next question comes from the line of Madeleine Stone of William Blair. Please go ahead.

Okay.

Great Hi, this is Matt <unk> on for Matt Thanks for taking our question.

So for future discussions plans with the FDA how much additional follow up from the phase two trial will you need more mature dataset.

Operator: Approximately six more months of follow-up compared to what we had

Operator: Approximately six more months of follow-up versus what we had presented to them in a submitted document. That concludes our question and answer session. I will now turn the conference back over to Garo Armen for closing remarks.

Approximately six more months of follow up versus what we had presented to them.

Submitted documents.

Okay.

Great. Thank you.

Okay.

That concludes our question and answer session I will now turn the conference back over to Garo Armen for closing remarks.

Thank you very much easier in Idaho and.

Once again, thank you for your attention.

I appreciate the questions that we've gotten.

And the basic.

Inclusion.

Is that.

I know we've made reference to the fact that we will be heading more follow up on patients.

Before we engage with regulatory agencies, including the FDA.

But I'd like to further indicate to you.

We feel confident.

And the follow up data from this trial, because we have a good day that by and large and it will be only a question of cleaning up the data and presenting it in a format with the appropriate.

Arguments.

That will hopefully.

Align our way of thinking.

Our kols way of thinking.

Our investigators who have significant experience in the field with our agents there way of thinking.

With the regulatory.

So this is what we hope.

Hope to accomplish in the next few months.

Stay tuned and we.

We always welcome your engagement and the four models offline additional questions that you may have thank you again.

Yes.

Yes.

Ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.

Okay.

Okay.

Okay.

Ladies.