Agenus Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 7, 2023

There are 9 speakers on the call.

Operator

Good morning. My name is Jeannie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Agenus Q3 2023 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Operator

Thank you. Zach Arman, you may begin your conference.

Speaker 1

Thank you, operator, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities among other updates. These statements are subject to risks uncertainties and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Doctor.

Speaker 1

Garo Armen, Chairman and Chief Executive Officer Doctor. Stephen O'Dea, Chief Medical Officer Doctor. Tad Yancey, Chief Strategic Advisor and Christine Klasky, Vice President of Finance. Doctor. Robin Taylor, Chief Commercial Officer, We will be participating in the Q and A session.

Speaker 1

Now, I'd like to turn the call over to Garo to highlight our progress and speak to our outlook for the remainder of the year. Daryl?

Speaker 2

Thank you, Zach. Ladies and gentlemen, as we gather today for the earnings call, Let's reflect on the remarkable patient outcomes from our botanselinab trials. As underscored by our leading experts and researchers, we're witnessing sustained benefits in treating some of the most challenging cancers. Based on these observations and for the sake of cancer patients, Our urgent mission is to set a new benchmark in cancer care, providing patients with longer term potentially period benefit with some patients experiencing treatable toxicities. Our BAW therapy is showing promise across various cancer stages and types with benefits seen in some of the most treatment resistant so called cold tumors.

Speaker 2

In addition, recent data presented at our corporate event in Madrid during ESMO reveal but potential in earlier stages of cancer where remarkable rapid responses were observed with the possibility to prevent significant treatment related morbidities, including The potential need for colostomy. Moving forward, we're concentrating on 3 key priorities, Submitting our 1st Biologics license application for colorectal cancer, prioritizing other clinical programs with the potential for rapid approval and importantly, smart reallocating resources to achieve our goals. Accordingly, we're gearing up our first bulk BLA submission In mid-twenty 24, with a focus on late stage colorectal cancer, Doctor. Yancy will delve deeper into this topic shortly. The cancer community's enthusiasm and rapid enrollment in our Phase 2 clinical trial in MSS CRC highlights and urgent unmet need.

Speaker 2

To address this, we have started A compassionate use program with the AMOL broadening it into an expanded access program next year. With very limited options to treat patients with advanced colorectal cancer, The positive trends and lasting responses in our studies strengthen our conviction in BotVal's potential. Our top priority is obtaining balanced approval in MSS CRC In order to allow patients access to this important IO treatment, offering them new hope, which does not exist today. Our second area of focus is advancing our prioritized clinical programs, which includes refractory pancreatic cancer and new adjuvant setting in CRC. Doctor.

Speaker 2

O'Day will detail the exciting data that showcases BOTS potential in these cold solid tumors. In addressing our financial capabilities to drive our objectives, We're already taking and continue to take steps to contain costs. These steps are important, particularly given the current challenging environment in the biotech sector. Our immediate prospects for additional cash infusion that does not involve stock issuance Including milestone payments from 1 of our partnered programs expected by the end of December 2023, that's this year. In addition to this expected milestone, We are in the process of the sale of 2 non strategic assets and pursuing the partial sale of milestones and royalties Due to Agenus from our partner programs, these 3 sales are expected to close by the end of the first quarter half of 2024.

Speaker 2

The potential proceeds from these 4 transactions I estimated that approximately $200,000,000 in total. With our cash balance at the end of Q3, Along with these 4 claim transactions, we believe we are sufficiently funded through the end of 2024. In addition to these planned transactions, we're also in advanced discussions for a potential structured financing for Bob Powell as well as a potential corporate collaboration with a large pharma or biotech company. That ends my formal remarks introductory remarks. And now I'll be Handing it over to Doctor.

Speaker 2

O'Dea to shed light on our latest findings and data updates. Stephen?

Speaker 3

Thank you, Garo. Together with our investigators and key opinion leaders, we presented updates from the Bot Bowel Development Program at a corporate event hosted during the Madrid ESMO Congress in October. I'll now briefly describe these data updates beginning with colorectal cancer. We updated our Phase 1b cohort of 70 evaluable patients with BAWT and DAL in refractory MS Stable colorectal cancer without active liver metastasis. This is the target population for our fully enrolled Phase 2 study and the population in which we've received fast track designation from the FDA.

Speaker 3

The RECES confirmed overall response rate was 24%. The duration of response was not reached with 59% of responses ongoing and now a median follow-up updated to 12.3 months. These patients showed a 12 month overall survival rate of 74%, approximately twice that reported for standard of care. With longer follow-up, the median OS previously reported at 20.9 months Is now no longer reached. Importantly, the OS curve plateau continues to emerge and strengthen as the data matures with the longest patient now alive at 3.5 years and 3 other patients who are alive beyond 21 months.

Speaker 3

We plan to file our initial BLA in this indication in mid-twenty 24. Next, we presented data from an investigator sponsored trial window of opportunity setting. Surgery was performed on average only 4 weeks after the initiation of immunotherapy. All 3 MSI high colorectal patients Had complete or near complete pathologic responses. And even more importantly, 6 out of 9 patients with MS stable colorectal cancer had pathologic responses of 50% or greater, including 2 complete pathologic responses.

Speaker 3

None of the 12 patients had tumor growth during the treatment interval and no surgeries were delayed due to immune related toxicities. These results represent an important opportunity to move into earlier lines of therapy with curative intent and change the treatment paradigm for MS stable colorectal cancer, potentially avoiding the morbidity of late line therapies. In second line pancreatic cancer, We have treated 6 patients with the combination of bodensilinab, GEMZAR and Abraxane triplet. All six patients had progressed following first line metastaticfulfuronox therapy And all 6 had liver metastasis. 4 of the 6 patients have achieved marked and sustained tumor marker reductions.

Speaker 3

2 of the 4 patients have already achieved partial responses at 16 weeks with target lesion reduction of minus 47%, which has been confirmed and minus 37% which is pending confirmation scans and both responses are ongoing. 2 other patients showed stable disease at their first 8 week scans with tumor reduction of minus 20 and minus 13% and they remain on study awaiting 16 week scan. A randomized Phase 2 study is currently enrolling and a data update is anticipated in the first half of 2024. Our other Phase 2 trial is in refractory metastatic melanoma, including PD-one refractory as well as PD-one CTLA-four refractory disease. In a Phase 1b expansion cohort of 10 patients, bonesilumab alone showed a 30% objective response rate and 60% disease control rate in these refractory patients.

Speaker 3

In the Phase II study, The bodensilumab monotherapy cohort is now fully enrolled and the bodensilumabbalsilumab combination cohort is enrolled with approximately 30 patients. A data update is anticipated in the second half of twenty twenty four. In PD L1 refractory and non small cell lung cancer, we've reported on 9 patients who were treated with the combination of BOTT and bowel. 5 of the 9 patients in the combination achieved Rhesus confirmed partial responses for ORR of 56% and a disease control rate of 89%. Approximately 50 patients have now been enrolled in 2 expansion cohorts, including PD-one refractory as well as TKI driver mutation refractory disease.

Speaker 3

A data update is anticipated in mid-twenty 24. Doctor. Brie Wilke, Director of the Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research The University of Colorado Cancer Center presented an update of botancilliamab program in sarcomas at ESMO 2023. In 41 evaluable heavily pretreated sarcoma patients, the combination of BAWT and BAW demonstrated an overall response rate of 20%, a median duration of response of 19.4 months and a 6 month progression free survival of 40%. There were differential responses observed by dose level with 29% response rate in the 2 milligram per kilo BOT cohort compared to 15% in the 1 milligram per kilo BOD cohort.

Speaker 3

In addition, we observed promising activity in difficult to treat subtypes of sarcoma such as leiomyosarcoma and visceral angiosarcoma. The results we've achieved in cold tumors in both the refractory setting and more recently in early disease offers hope for patients and families where current standards of care are inadequate or limited in benefit. The robustness of our data broadly across tumor types resulting in deep and durable responses showcases a potential groundbreaking advancement in oncology for botanilumab. We remain committed to improving patient outcomes and are grateful for the support of our team, trial participants and stakeholders. I am confident in the positive impact we are making and I'm excited about the future.

Speaker 3

Now I'll turn the call over to Todd to discuss our regulatory strategy.

Speaker 4

Thank you, Stephen. The landscape for MSS CRC patients who receive 1 to 2 prior lines of therapy is challenging. There are limited effective options available. So our focus in our development and regulatory path is to bridge that gap. At present, the available therapies in this setting, including monotherapy with rigorafenib, monotherapy with ONSURF and the newly introduced combination of Avastin and ONSURF offer only reported improvements in survival and response rates are low with survival curves going to 0.

Speaker 4

Recognizing this, we've developed a differentiated investigational agent with reported results for these standard of care therapies with survival curve plateaus consistent with substantial long term benefit. In our studies, patients with a median of 4 prior lines of therapy, a quarter of whom had received prior immunotherapy experienced a 24% resist response rate compared to the standard of care's reported rate of only 3%. Importantly, our median overall survival is currently exceeding 21 months, a significant bleep from standard of care at 12.9 months as reported in the RCAD database. Our regulatory process is well underway And we as we have stated plan to submit our first BLA as characterized in our fast track designation in the middle of 2024. This application is robust.

Speaker 4

It's targeted to include data from approximately 400 patients at 2 different doses, both 1 milligram per kilogram and 2 milligrams per kilogram and will be supported by safety data from several 100 additional patients across multiple indications where we have observed broad activity. And in this process, we're not leaving any stone unturned. We're conducting a comprehensive and full exploration of dose and schedule ranging from the lowest dose of 0.1 milligrams per kilogram to 3 milligrams per kilogram in our Phase 1 and Phase 2 studies. Additionally, we're investigating the contribution of components of to experimental agents, bot and bow in a randomized fashion within our now fully enrolled Phase 2 study. As we move forward, we are and we'll continue to proactively engage with regulatory authorities.

Speaker 4

While we await complete feedback from the FDA and EMEA, We have taken scientific advice from key European countries and are in the process of scheduling meetings with the CHMP and FDA representatives. These discussions are crucial as they will guard our path forward toward approval. Our goal is clear. We aim to submit this package for potential approval by 2024 mid year and we're optimistic about the opportunity for an accelerated review, which would allow us to bring this innovative solution to patients in need as soon as we can. Now I'd like to turn the call over to Christine to discuss the financials.

Speaker 5

Thank you, Todd. We ended our Q3 of 2023 with a consolidated cash, cash equivalent and short term investment balance of $100,630,000 This compares to $193,400,000 at the end of last year. For the 3 9 months ended September 30, 2023, we recognized revenue, which includes non cash revenue of $24,300,000 $72,500,000 respectively, Including non cash expenses of $28,100,000 we incurred a net loss of $64,500,000 for the 3rd quarter. For the 9 months of 2023, we incurred a net loss of $208,900,000 which includes non cash expenses of $82,000,000 I'll now turn the call back to Garo.

Speaker 2

Thank you, Christine. I want to express my gratitude for your support during this pivotal phase of Agenus. Our strides in cancer research highlighted by vodenselimab signify a potential new era in cancer care. I also want to express my gratitude to our employees. I am confident in our team's dedication and our ability to achieve our milestones.

Speaker 2

The success of potential in that remains our top priority And I assure you that our diligently managed finances will ensure the necessity We expect to meet and exceed our goals with the prospect of bringing hope and healing to those affected by cancer. Thank you for your support once again. Together, we are destined for remarkable achievements for the benefit of cancer patients, which will in

Speaker 5

turn

Speaker 2

create significant value for all of our stakeholders. With that, I will now open the phone call for questions. Thank you very much.

Operator

Your first question comes from the line of Emily Bodner with H. C. Wainwright. Your line is open.

Speaker 6

Hi, good morning. Thanks for taking the questions. First one, just briefly, if you can comment on when we may expect to see initial Phase 2 data for the MSS CRC study. And then secondly, if you could talk about how you're thinking about strategy in neoadjuvant CRC. Are you kind of looking to evaluate broadly in CRC or just focus on MSS patients and maybe just discuss the regulatory pathway to potentially getting BOPAL approved in that setting?

Speaker 5

Thank you.

Speaker 2

Thank you, Valerie. So let me answer the question broadly and I'll ask if Doctor. O'Day has any additional comments. But So what I've said publicly is the fact that we have clearly disclosed the data on the first 70 patients, not because The rest of the data isn't satisfactory, but the rest of the data needs to be cleaned up and we need a little bit of work to do. But Our look at the data both in the second cohort and in our Phase 2 studies indicate that we should have a sustainable response rate, perhaps even an improving response rate as we disclose and analyze these data for regulatory and beyond purposes.

Speaker 2

So That is going to be more of a regulatory decision when to disclose it. And the ideal circumstance for us will be Certainly to publish data at around the time of a potential BLA submission to publish the data in the PPP journal. That would be quite a lot of plan. Now with regard to the neoadjuvant plans. We haven't quite crystallized it yet.

Speaker 2

Of course, the typical response for new adjuvant studies is the fact that large studies, they take time. But we believe that depending on What patient populations we go after, we may be able to look at a subset of patients That would be the subject of high morbidity with standards of care. And as you know, In these patients, even though the treatments are largely curative, they're not 100% curative, standard of care, not 100 percent cure to, but they cure a quite substantial number of patients. But those cures come at a very high cost to the patients. And that includes the potential use of colostomy bags.

Speaker 2

It involves sexual dysfunction and also involves the loss of muscle function in the area of the abdomen. And particularly if you are a patient in your 30s, 40s. You don't want to be subject to these morbidities. So We're going to take a little bit of time, not too much time to determine exactly what the patient population and trial design would be with the aim of a very rapid trial execution and potentially rapid filing and approval. So I think We'll disclose some of these details in the first half of next year.

Speaker 6

Okay, great. Thank you.

Operator

Your next question comes from the line of Colleen Cusi from Baird. Your line is open.

Speaker 7

Great. Good morning.

Speaker 5

Thanks for taking our questions and congrats on the progress. For the randomized CRC study that's fully enrolled, Can you just give us a sense of the regulatory bar there? Does the combination need to be better than the individual drug arms and standard of care and by what margin?

Speaker 2

If I may ask Todd to answer that question. Thank you.

Speaker 4

Hi, Colleen. I think there are really 2 questions One is what do we expect in terms of performance versus standard of care and the second is really what do we expect to see in terms of incremental contribution in the doublet. So just to remind everybody about the design of the trial, there are 5 arms of which 1 is standard of care and of course patients are randomized across these arms. The other four arms all have botanilimab, which as monotherapy we know to be active from the Phase 1 dose escalation. And 2 of those arms have bonelimab in combination with balsilimab.

Speaker 4

And as we've been observing in the data set that we've been presenting for the MSS CRC patients on active liverimets since well for the last almost 18 months, There is a substantial benefit in the combination. And so as it relates to the first question versus standard of care, standard of care for patients with 1 to 2 prior lives of therapy is offering a 3% overall response rate and An expected median overall survival of 12.9 months that's coming from the RCAD database of over 18,000 patients. And currently we're showing 24% versus 3% for response and over 21 months for median overall survival. So We need to be obviously meaningfully better than currently available standards of care. So looking at 3% versus 24% or 12.9 months versus over 21 months, I think it's clear to everyone that you could drive a truck through that.

Speaker 4

Now as it relates to the incremental contribution of balustilumab to votintilumab given our mechanism of action, Which is really multifactorial. First of all, we have obviously our optimized engagement with CTLA-four in a receptor ligand interaction, But the back end engineering that's resulting in suddenly an activation of both innate and adaptive immune response It's created a hot meal here and we have we expect to see a substantial improvement in the combination certainly at least a doubling of response when we add balsilumab. And so I think that's what we want to be able to discern. Just for comprehensiveness, we'll also remind everyone that in that same clinical trial. We are looking at 2 active doses, 1 milligram per kilogram and 2 milligram per kilogram.

Speaker 4

And at time of regulatory submission, we anticipate having approximately 175 patients in each of those two doses. So we'll be able to have a robust perspective on the activity of the doses 12 and also on the tolerability of those 2.

Speaker 5

That's super helpful. Thank you. And at the time of BLA submission, would you expect to have any sort of overall survival early data from this study.

Speaker 4

I think we would have certainly evident trends for patient benefit. What we've observed pretty consistently in the Phase 1 database, which is not small, remembering we've got 101 patients in total there For safety and we have 70 patients in the MSS CRC non active liver metastatic patient population for efficacy adjudication. We are obviously seeing that responses for patients And that response can be stable disease or better is translating to not only durable response, but Very substantial overall survival. As I certainly expect that we'd be able to demonstrate a point that's been for response, durability of response For patients with stable disease or better and that that is trending toward a survival benefit. Remember also that the time of submission is not a moment in time that's frozen because we will be required to provide updates on safety and efficacy During agency review and that will allow time for additional maturation of the data set.

Speaker 4

And again, it's been consistent since we began to show data in June of 2022, the longer the study goes, The more mature the observations have been around the durability of response and its translation to survival. So I think we have a very, very robust set of data to present to the agencies for their review.

Speaker 5

Got it. That makes sense. And on the cash guidance, you maybe just provide a little bit more color on what's included in that in terms of the ongoing and planned studies?

Speaker 2

Say the if you can repeat the question on the latter part of your question.

Speaker 5

Yes. Just on the updated cash guidance.

Speaker 2

I got it, I think. Okay. So As you know, we finished the quarter with a little over $100,000,000 My guidance for the 4th quarter burn is approximately $40,000,000 Now Beyond that, as we've said earlier, we will have a milestone payment That is due to us by the end of this year. And we will sell 2 assets that are non strategic assets. We expect that to be completed in the first half of this next year.

Speaker 2

And then a third party order of the transaction. Now of course, the first two are entirely in our control, meaning the milestone payment in the asset sales. And the royalty transaction will require external investors for that kind of a transaction. We have done that before, some years ago, in fact, about 5 years ago. We consummated a transaction for 3rd party royalties when we had a much skinnier loyalty portfolio at the time.

Speaker 2

And we did this with Zoma Corporation. We're talking about a transaction that will be multiples of that transaction for a much larger and much more attractive portfolio that has had some very encouraging comments from our partners. So with those, we expect to bring in approximately $200,000,000 of cash between now and the middle of next year. That is through non stock issuance transactions. Without any stock issuance, we expect to bring in approximately $200,000,000 And with that, it will take us well beyond the end of next year.

Speaker 5

Got it. Thank you.

Speaker 2

Any other questions?

Operator

Mayank Mamtani, your line is open.

Speaker 8

Good morning. Thanks for taking our questions and helpful recap of the ESMO event data. So maybe just to clarify on the 2nd line plus CRC Actuate approval. Are you able to talk to the specific guidance you may have On the design of the Phase 3 confirmatory study and maybe timing of initiation to just kind of round out the Other updates you provided and then I will follow-up.

Speaker 2

So I'll just make a broad comment on the confirmatory studies and then I'll ask Todd to provide additional color. But with regard to confirmatory studies, We have 2 choices. 1 is to do a confirmatory study in the 2nd or 3rd line setting. The other one is to do a confirmatory study in the first line. We have not made that decision yet.

Speaker 2

We've had discussions with the FDA on the latter line confirmatory study. We have not yet had discussions on the first line because we're awaiting data from an ISD study, which is ongoing right now, which studies PacBio on top of Pofax. And we expect that data to be available in the Q1 of next year and that will inform us better which way to go, whether we go with first line or third line. Todd, would you like to add any additional color on this?

Speaker 4

Yes. I'd just add a couple of points to that. We already, Mayank, now that we have a clear understanding of how to preemptively manage or to intervene early on GI toxicity. We already have a higher level of comfort with regard to our ability to combine in the frontline with 5FU and Oxaliplatin based regimens, Of course, we have associated GI toxicity. So that level of comfort is rising.

Speaker 4

But at City of Hope, we are conducting a study to determine what the best management paradigm would be for the combination. In addition to that, I think we have greater strength of evidence for incremental benefit in earlier lines of therapy derived from the preliminary data set we're seeing in the neoadjuvant setting. So I think our objective will be to optimize the development program to accelerate access for patients to a broader patient population. And so There's a lot of regulatory precedent for doing a confirmatory trial in either a broader patient population than the accelerated approval indication and or in an earlier line. And again, at the end of the day, the decision with regard to the design of the confirmatory trial We'll require alignment with both the U.

Speaker 4

S. And the European authorities and we're basically looking at 2 potential options at least That we would present for their review.

Speaker 8

Very helpful. Thank you. And then on the new pancreatic cancer bought chemo data, could you just clarify what number of patients you are targeting in the randomized control cohort? And If you are seeing any uptick in enrollment similar to what occurred in other colorectal cancer expansion cohort last year And for the relatively warmer tumors in lung and melanoma, it seems like you have both mono and what Gal combination data. There is a team here of mono bot data and combination bot valid data.

Speaker 8

So how are you sort of thinking across hematite Where you may pursue both standalone versus maybe combination, if there's a view on that you could share. And I have one more financial question after this.

Speaker 2

Thank you. Doctor. O'Dea, would you like to take that first part, first multi part question?

Speaker 3

Yes. Mayank, can you repeat the very first part of it? I have the melanoma part, but

Speaker 8

The pancreatic cancer bought chemo data number of patients that you're targeting in the randomized control And if you've seen any uptick in enrollment, like what happened with the rig?

Speaker 3

So we have a lot of enthusiasm around the data so far with both our PIs on the pancreas study, but more broadly KOLs. So we are expanding that and it is accruing and we plan on treating another 60 In terms of melanoma, obviously, we have single agent activity in melanoma in a PD-one and PD-one CTLA-four refractory that we've reported in our 1b trial. We've now accrued A large number of patients to monotherapy in both the PD-one refractory and PD-one CTLA-four refractory at 2 different doses. And as I said today, we're combining it with BAW and that data will be maturing and we look forward to presenting it in 2024.

Speaker 8

Got it. And maybe for Garo, this concept of structured financing or even corporate partnerships. I was just curious if there's any sort of segmentation you're thinking by indication or geographies, Are there any sort of constructs and deal down sheets that are more preferred versus less? If you could provide some color there, that would be helpful. And thanks all for taking my questions.

Speaker 2

So the kinds of discussions we're having and some of them are in advanced stages as I said before, really encompass both a global collaboration across all indications as well as specific indication collaboration for which infrastructure exists at some companies to be able to segregate product by indication. That's new technology and we've been proposed the potential option of segregating certain indications That are of greater interest to shareholders. So we're looking at all of these options simultaneously and I think a good deal for us would be driven by several things. Number 1, The appropriateness of the collaborator, their conviction that our product could be a significant player in the immuno oncology and broader oncology fields. So that's number 1 because we believe that that we have not seen at any immuno oncology and oncology treatment setting.

Speaker 2

So for example, when we talk about patients that have either failed all other therapies Or do not respond to other therapies, not just immunotherapy, but beyond immunotherapy, is that patients that are in dire need of a product that offers them a potentially curative option With toxicity that is transient, I think that there is an enormous need in the field for such a product. I think motensilumab offers that treatment option for patients. Now so given this, The partner must have high conviction that this product could be a huge win for patients And a huge win commercially as a result. That's number 1. Number 2, the partner needs to make the appropriate financial commitments, Not just for compensating us in terms of upfront and milestones, but also a substantial financial commitment And development has to be rapid because as we've said before, we have seen Clear clinical activity in so far 9 different cancers.

Speaker 2

You can't lie about that. It's real. It's been presented at major conferences. And so, of course, there are regulatory and other questions about Do overall response rates translate to longer term benefit? We know they do.

Speaker 2

We need to demonstrate that with numbers, But with CTLA-four binding antibodies and ours is a multifunctional broad functioning molecule that binds the CTLA-four as one of its 5 different activities, Not just the center stage activity, but 1 of 5 different activities. So all of that means that this product needs to be rapidly developed across all indications. And if you pay attention to my quadrant slide, you will see That the opportunity for cancer patients is enormous. So the partnership has Based on a commitment, financial commitment for rapid development. And of course, other cultural compatibility that will allow our A team to work with and partners A team to bring this into a harmonious conclusion.

Speaker 8

Yes, that makes a lot of sense. Thanks for taking our questions.

Operator

Your last question comes from the line of Kelly Hsieh with Jefferies. Your line is open.

Speaker 7

Hi, this is Claire on for Kelly. Thanks for taking our questions. So just one question for the plan for CRC. So can you remind us what's your plan for those CRC patients with liver mets? Is the Phase 3 confirmatory studies Specifically in patients without liver mAbs or is there an option to look at all comer patients as well?

Speaker 7

Thank you.

Speaker 2

So I will take a little crack at it and then I'll ask Doctor. O'Day to also Coming on this. So as you know, LiverMeds is a Sort of a black box right now for everybody. There's no clear answer as to why Liberumet patients don't response. There is speculation about why they may not respond.

Speaker 2

And of course, liver is a privileged organ with a lot of immunosuppressive components. Now we are looking at a number of ways of overcoming it. For example, if you look at our pancreatic data, All patients in small number of patients that have been treated had liver mets. And all patients that have responded have had liver meds response. We don't know if any of the other chemotherapy components are Contributing to this, for example, there's some speculation that gemcitabine may play a role in this.

Speaker 2

We don't know that. But I think in the next coming months, we will have a very deliberate action plan and trying to answer this question with small trials, possibly ISDs that will be undertaken to see if we can translate some of what we have observed in pancreatic cancer can be also actualized in CRC. But right now, we're working with limited knowledge. But I think as you said, this is an area that needs to be explored very diligently. Doctor.

Speaker 2

O'Day?

Speaker 3

Yes. So obviously in the refractory colorectal patient population, The IO combination of BOPPAL has its most profound signal to date in the non active liver met patients. These are patients who've never had liver metastases or have had treated liver metastases. But depending on the alignment of the Phase III trial, as Todd said, If we do move to first line, obviously, we would treat all comers. And so we will be aligning our Phase 3 trial with in the coming weeks months.

Speaker 7

Thank you.

Operator

There are no further questions at this time. Garo Armen, I turn the call back over to you.

Speaker 2

Thank you very much everyone for your attentiveness to our developments. This is a very exciting time, I believe, for cancer patients. Certainly, patients that are in desperate need of effective therapies, but not just therapies that extend their life by a month or 2, in a very high cost of quality of life, but potentially expand life much longer With potential curative outcomes in some patients and with a much, much more acceptable, more dignified quality of life with some gastrointestinal side effects that are typical to over activation of the immune system, But they are reversible. And I think if you look at our record, our physicians Have learned that reversibility is a function of rapid intervention. And as our trials Congrats from earlier stage Phase I trials for extended cohorts of patients to Phase II trials.

Speaker 2

We will be seeing A significant improvement in the way our transient toxicities are managed. So it's a very exciting time for patients. And other than the obligations that we need to fulfill in order to bring these products to patients very rapidly. I think the future looks brighter than it has ever looked in our company's history and in my career as an observer and an operator in this business. So thank you very much.

Operator

This concludes today's conference call. You may now disconnect.

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Key Takeaways

  • In refractory MSS colorectal cancer, bodensilimab plus balstilimab achieved a 24% ORR, 74% 12-month OS, and median OS not reached after 12.3 months’ follow-up, with the longest patient alive at 3.5 years.
  • A first BLA submission for late-stage colorectal cancer is planned for mid-2024 under Fast Track, supported by data from ~400 patients at two dose levels and additional safety data.
  • Across other “cold” solid tumors, promising results include pancreatic triplet therapy with 2 confirmed partial responses (–47%/–37% lesion reduction), melanoma monotherapy ORR of 30% in PD-1/CTLA-4 refractory patients, NSCLC combo ORR of 56%, and sarcoma ORR of 20%.
  • Financially, the company ended Q3 with $100.6 M in cash and investments, and expects ~$200 M in non-dilutive proceeds from milestones and asset/royalty sales by mid-2024, funding operations through YE 2024.
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Earnings Conference Call
Agenus Q3 2023
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