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Operator
Thank you for holding, and welcome everyone to the Adgenis 3rd Quarter 2022 Financial Results Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you'd like to withdraw your question, again press star 1. Thank you. I'll now turn the call over to Nico Freelich from Investor Relations. Mr. Frelick, please go ahead.
Nico Freelich
Thank you, Jack, 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. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. Joining me today are Dr. Garrow Arman, Chairman and Chief Executive Officer, and Christine Klaskin, Vice President of Finance. Our Chief Medical Officer, Dr. Stephen O'Day, will be joining us for Q&A. Now, I'd like to turn the call over to Garrow to highlight our progress and speak to our outlook for the remainder of the year.
Jack
Garrow. Thank you, Nicole. Once again, good morning, and thank you for joining us today for our third quarter update and numbers discussion. It is an exciting time for agenists, and we believe also for the field of immuno-oncology. The Society for Immunotherapy of Cancer, otherwise known as FITC Conference, starts today in Boston, our home turf, during which we expect to highlight the significant unrealized potential for a new generation of IO regimens, IO being Immune Oncology, that potentially would transform the way we treat cancer. We anticipate that one of our most promising clinical assets Botansilamab, a novel adaptive innate immune activator, in addition to being a CTLA-4 binder, can provide important future therapeutic options for patients with tumors that are particularly resistant to current therapies, including, very importantly, immunotherapies. On today's call, we will provide an update on both Hansel and Matt development programs, including our participation at 60, as well as recent initiation of two Phase II ACTIVATE trials in advanced colorectal cancer for one and in melanoma for two, to be followed by trial in pancreatic cancer before the end of the year. It's important to point out that all of these trials are randomized trials. We will also highlight progress on several of our earlier stage clinical programs, including our ILT2 antagonist, AGEN1571, and our CD137 agonist, agent 2373, and provide also a financial update. Let me start with CITI. We will be sharing expanded clinical data from our phase one study on botanism map across multiple tumor-specific expansion cohorts, of heavily, and this is very important, heavily pretreated cold tumors. When we presented the data in colorectal cancer several months ago at ESMO GI in Barcelona, the experts at that time scrutinized the heavily pretreated nature of these patients, and it was the consensus that the data presented was unique in that it was both in heavily pretreated patients as well as in cold colorectal tumors. Both of them, by the way, increased the odds of non-responsiveness. And the fact that we've seen responses in that population is the impetus for enthusiasm by experts on botanical meth. Now, these data will be presented at an oral plenary session on an expended patient population, whereas we presented the data in colorectal patients at ESMO-GI, cystic presentation will encompass expended cancers. And it will be on November 12th at 10.50 a.m., The presentation is by Dr. Brie Wilkie, the Director of Sarcoma Medical Oncology and Deputy Associate Director of Clinical Research at the University of Colorado. And it is a plenary session. Agenis will also present translational data from the Phase I study. And by the way, again, this is a very large Phase I study, not a common Phase I study. Having already enrolled 250-plus patients, although the data presented will be about half of that number, given the fact that we're presenting data on patients that have had at least one scan collect data from. And so Agenis will present translational data from the phase one study and preclinical studies highlighting the mechanisms of underpinning botansilumab's differentiated enhanced anti-tumor immunity, as well as new preclinical data demonstrating superior activity in than first-generation CTLA-4 agents across multiple cold and totally immunogenic tumor models. And as we have communicated, later on November 12th, Janice will host the Road Taken conference. That's a Janice-sponsored conference. This R&D event features presentations from key opinion leaders at the forefront of immunotherapy development, including Dr. Michael Atkins, Dr. Alexander Eggermont, Dr. Brie Wilkie, the presenter of the plenary session that morning, and Dr. Larry Norton, as well as multiple presentations from our own leadership team. The agenda will center on the current and future state of I.O. treatments, as well as the unprecedented data generated to date in the Botancilla MAP program. The event will take place from 2 p.m. to 5 p.m. Eastern Standard on November 12th at the offices of Roxanne Gray in Boston. While in-person attendance is now closed due to space restrictions, institutional investors, analysts, and members of the medical community are invited to attend the live webcast of the event that can be accessed on the Investors section of our Agenis website. although I might indicate that there's a limit in the participation of that as well. Agenis made several important clinical advancements to our Botancillomab program in the third quarter. Building upon the robust responses observed in our phase one trial, we have already initiated two randomized worldwide phase two activate trials. in advanced MSS, that is microsatellite stable, or it can be also described as non-MS high CRC patients, as well as melanoma. Activate colorectal trial will evaluate botansilumab monotherapy, and in combination with bolsilimab, RPD-1 antibody, It is randomized to current standards of care in patients that have received at least one prior chemotherapy regimen. So again, these are pre-treated patients that have failed the standard of care in the prior setting. Activate melanoma will evaluate botansilumab monotherapy in patients refractory to either PD-1 or combined CTLA-4 PD-1 therapy. And this is also a very important trial design because it may achieve the approval of botansilumab as monotherapy in a continuing approvable trial. And, of course, there are benefits to going after botansilumab monotherapy indications. The primary endpoints of both studies will be overall response rates with duration of response, progression-free survival, and overall survival as primary and secondary endpoints. This is also important because all of these endpoints are considered the gold standard in clinical trial conduct. Agenis expects to launch, as I said earlier, a third phase two trial in advanced pancreatic cancer by year-end. This, too, will be a randomized trial, and it will look at botancillin map in combination with chemo versus chemo alone. Beyond these trials, Agenis continues to enroll patients in its phase one botancillin map study to evaluate expansion cohorts in additional indications. These expansion cohorts will evaluate efficacy signals as well as support dose optimization and contribution of components for the PD-1 combinations. These larger and richer data sets that will be obtained from the expansion of our Phase I trials can be used to accelerate our Phase II programs as well as support additional indications for development. And while we have not made disclosures on what additional indications we will be going after, we have a clear vision of what they are, and they include some very difficult cancers as well as some very large cancer opportunities. beyond the three indications that we've mentioned for the subject of clinical trials this year. Complementing the progress we've made on Potencilumab this quarter, we're advancing additional clinical programs developed from our antibody engineering and vision platform. It's very important also to mention that every product, other than our first-generation CTLA-4 and our PD-1, has been specifically engineered with attributes in mind. And of course, propancilumab is a clear example of that attribute, which has been designed into the molecule, which has been proven to be validated in preclinical models, and now we're seeing that to be validated in clinical trials. So getting back to our other agents, we dosed our very first patient in our phase one study, evaluating agent 1571. This is an ILT2 antagonist antibody. And we're doing the phase one trial first as monotherapy, and then it will be in combination with odansilumab and balsilumab in patients with advanced solid tumors. We continued enrollment. of our combination study evaluating agent 2373, which is our CD137 agonist. This is with potencylamab in melanoma patients who are relapsed or refractory to PD-1 therapy. We anticipate enrollment to be completed in the first half of 2023 or sooner. Agenis has a robust track record of value creation through strategic partnerships. And this quarter, multiple partner assets advance into new phase two studies. So they're advancing very nicely. For example, BMS launched a Phase 1-2 study of BMS now 986442, which is our old TIGIT by specific license to them, which was discovered by us, also known as ASIAN-1777. BMS 986442 is being evaluated in combination with Nivolumab, their own PD-1, and chemotherapy in patients with advanced solid tumors and non-small cell lung cancer. Second, Merck initiated a randomized phase two study evaluating MK4830, a candidate ILT4 antagonist also discovered by Agenis. And this is in combination with pembrolizumab, Merck's own PD-1, and chemotherapy in ovarian cancer. Additional Phase II studies of MK4830 are also ongoing in non-small cell lung cancer. Small cell lung cancer, in addition, esophageal cancer, MS high colorectal cancer, Renal cell carcinoma and melanoma were very heartened by the fact that our ILT4 antagonist antibody has indications of activity in all of these varied tumors. And lastly, INSIGHT initiated a randomized Phase II study evaluating LAG3 and TIM3 antibodies discovered by agenists in combination with PD-1 in first-line squamous cell carcinoma of the head and neck. Additional Phase II studies of these programs are ongoing in melanoma, endometrial cancer, and urothelial carcinoma. Finally, our ability to recruit top talent is critical to the development of our pipeline near-term, more specifically Botancilla Lab, into a transformative treatment for patients in need. To this end, we made some important recent additions to further bolster our clinical and regulatory leadership team. They include Dr. Todd Yancy, who was named Senior Global Clinical Development, Medical Affairs, and Commercial Advisor. He comes to us with over 40 years of combined clinical and industry experience, most recently from Beijing. We also hired Patricia Carlos as our Chief Regulatory Quality and Safety Officer. Patty has over 20 years of regulatory affairs experience, leading programs from investigational NDA to commercialization, and she was most recently at ARCIS. With that, I will now turn the call over to Christine to cover our financial reporting. Christine?
Nicole
Thank you, Garo. We ended our third quarter 2022 with a cash, cash equivalent, and short-term investment balance of $218.2 million as compared to $238.3 million and $306.9 million on June 30, 2022 and and December 31, 2021, respectively. Cash used in operations was $32.2 million for the quarter ended September 30, 2022 and $128 million for the nine months then ended. We recognized revenue of $22.8 million and incurred a net loss of $56.7 million or 19 cents per share for the third quarter ended September 30, 2022. For the nine months ended September 30, 2022, we recognized revenue of $69.6 million and incurred a net loss of $156.6 million, or 54 cents per share. Non-cash operating expenses for the third quarter and nine months ended September 30, 2022, were $22.2 million and $62.8 million, respectively. I'll now turn the call back to Garo.
Jack
Thank you very much, Christine. In closing, I just want to reiterate three things. One is the fact that we have an important pipeline of agents, a very important pipeline of agents that allows us to be able to assemble the right combinations at our own terms. And this is very important, not because only the fact that these pipeline of agents have very unique attributes that allow us to expand our horizons beyond just, let's say, a segment of cultures, but potentially to earlier stage disease, as well as hot tumors. So it's a very exciting pipeline, and we're very, very heartened by some of the data that we will be disclosing in the first half of next year that highlights the important attributes of our pipeline. Now, secondly, I should also say that there are questions, for example, about our ability and our efforts to finance our pipeline. Because as you know, we have a robust pipeline and it takes resources to advance this pipeline. And let me make a couple of comments and some historical reflections on how we have done this in the past and how we will continue to do it. For example, if you look at the past 10 years, we have funded our operations largely from two sources. One, the largest source, cash received from partners and royalty financing transactions. In combination, partnership and royalty financing transactions have netted us over $900 million over these last 10 years. In addition to that, we have also done equity offerings, primarily through our ATMs. And ATMs are an important instrument for us because they allow us to manage our cash balances quarter to quarter year to year, to make sure that cash balances do not drop below a certain level based on our anticipated uses of cash. This is very important. And this flexibility has allowed us to be able to finance our needs until the next large infusion of cash, which typically is through anticipated partnerships. So with that, I think I will conclude my remarks and we will, of course, disclose much more data that hopefully will shed light into our excitement during our weekend activities, both at the CITSE Plenary Session, CITSE Poster Sessions, as well as our road taken event on Saturday from 2 to 5. Thank you very much for your time, and I will be open to questions from the audience.
Operator
At this time, if you'd like to ask a question, please press star 1 on your telephone keypad. We'll pause for a moment to compile the Q&A roster. David Dye with SMBC, your line is open.
David Dye
Great, thanks for taking my questions, and congrats on the progress, especially on the Bolencilumab update at CICI. So first question is just around the CICI update for Bolencilumab. And we saw at the CICI abstract earlier this morning that the cutoff is in April. So I'm wondering if you can share any kind of color on the increment updates we're expecting from the update at CICI.
Jack
So a couple of comments on this, and I will turn it over to Dr. O'Day to answer the rest of it. But as you know, we provided results from our colon cancer trial with botansilumab plus bostilumab at ESMO-GI at the end of June. Now, since then, we have additional patients from CRC that will be presented also at CIDC. I cannot disclose exactly how many patients, but there will be a meaningful addition to the denominator that was disclosed at ESMO GI at the end of June. In addition to that, we will be presenting several other indications with data that is mature and data that has been cleaned up. Both are very important requirements. So it has to be mature and cleaned up. And we are reserving, of course, additional patient data to be presented at major conferences in the very early part of next year as well. So Stephen, would you like to add to that?
Garth
Yeah, good morning. Dr. Stephen O'Dea, the Chief Medical Officer of Genus. Yeah, I mean, Gero summarized it well. Obviously, the CITSE abstract went in months ago with a cutoff of April. As you can imagine, this is a large phase one trial that's rapidly accruing expansion cohorts. And we look forward to updating the data with the oral plenary session on Saturday, which will be a more mature update. of data cut and expansion of these cohorts. So looking forward to sharing that this week.
David Dye
Got it. That's really helpful. And then I just want to follow up on the 50 abstract. We saw some data from the ovarian cancer, especially from the platinum-resistant ovarian cancer, where we saw 28% ORR. This, to me, seems to be quite impressive because the historical response for PD-1 in platinum-resistant ovarian cancer is around 10%. And so I'm just wondering, can you share with us your thoughts around potentially moving into the platinum-resistant ovarian cancer as another indication? Any thoughts around that would be helpful.
Jack
Sure. Other than the fact that we have to be careful about disclosing specifics before the actual plenary session, Stephen, can you provide additional color on specifically ovarian cancer in the comment about 10% being the typical response rates for PD-1s?
Garth
Yeah, I think all of the subgroups of patients that we're expanding and getting, you know, data on are in very difficult to treat settings in which they are what we call cold tumors or already exposed to PD-1-based therapies and refractory. So certainly a refractory platinum-resistant exposed ovarian population has been a weak sort of immune opportunity in terms of PD-1 monotherapy, as you've indicated. So We're obviously excited about this as well as other diseases that are showing this kind of promise with response rates that appear substantially higher than what you would expect with PD-1 monotherapy. And we look forward again to updating this cohort and others on the plenary session on Saturday.
David Dye
Got it. That's really helpful. And then just one last question on the 1571, the ILT2 antagonist program. Maybe I missed it earlier, Garo, when you mentioned the kind of, you know, increment updates from that program. Can you share with us when should we be expecting to hear from you on the data front, you know, from that program?
Jack
So let me ask Dan Chan, who is also here, to give you a very brief rationale based on extensive preclinical data, as well as the data from a similar family of compounds that we discovered and licensed to Merck. And that clinical data, and perhaps you can draw some inferences, Dan, if Stephen has anything else to add.
Dan Chan
Yeah, thank you, Garth. So Agent 1571, which is our LT2 antagonist antibody, was designed to alleviate the myeloid suppressive function to microenvironment, in addition to enhancing the lymphoid activity as well. We discovered that patients that do not respond to PD-1 or CTLA-4 not only have an enrichment of myeloid cells, but also these myeloid cells express high levels of IL-T2, and as such, we developed an antibody to block IL-T2 inhibitory function in the 2-microenvironment. You'd have seen from our disclosures earlier this year that Agent 1571 demonstrates not only monotherapy potential, but also best-in-class activity compared to competing IL-T2 antibodies. More importantly, we show synergy with both Enfilamab in preclinical models, highlighting the importance of combining Agent 1571 with other agents in our portfolio. With respect to other family members, you have seen data from Merck on our LT4 antagonists that we licensed for them. demonstrating compelling activity in patients that did not respond or progress on PEMBRO. Again, consistent with the discoveries that we made that this family is important in extending therapy to patients that don't respond to conventional checkpoint therapy. This molecule is progressing. 1571 is progressing in the clinic quite rapidly. I'll let Stephen provide you with an update on when you can expect daisy readouts.
Garth
Yes, as Gero said and as Dan said, you know, the myeloid compartment is becoming more and more important from an immunobiology point of view. And our ILT4 that Merck has is obviously moving forward successfully in a phase two program. We're particularly excited about ILT2 for the reasons Dan described. It's first in human studies, which are going well. Obviously, we can't predict when data might be available, but certainly the studies are accruing and moving forward, and we could have as early as the end of next year data to share with the world, but certainly we'll have to just monitor the data and continue to progress these trials.
Operator
Thank you so much. Qiwen with Jefferies, your line is open.
spk10
Hi, this is Qiwen at Jefferies for Kali Xu. Congrats on the bultacinamab data. I just have two quick questions. So number one, for the response rates disclosed in the CC abstract, so may I ask how many are confirmed and unconfirmed responses for each tumor type? And also, there are different doses of bultacinamab used in this Phase I trial. So did you notice any dose-dependent response from the Phase 1 data? Thank you.
Jack
So the first question about confirmed versus unconfirmed, we only present confirmed responses at conferences. We do not. We have additional unconfirmed data that is suggestible, for example, very strong disease control rate over a long period of time, but we don't register those as responses. They may, you know, in fact, in a number of situations, these trending responses have translated to actual responses upon further scans. But in terms of the dose variances, Steven, would you like to address the fact that in the trial early on, we had used lower doses? And in fact, that lower doses, we had seen some responses as well. But most of the data that you will be seeing at CINCI is at the equivalent of one mcg and two mcg per kick.
Garth
Thank you. Yes, I mean, as Gero said, you know, the data is rapidly evolving. In terms of confirmed and unconfirmed responses, unconfirmed responses have, in a rapidly evolving trial, may just mean that they haven't had their subsequent follow-up scans. So, I would be mindful of that, and we will obviously update data on Saturday with our responses in terms of confirmed responses. In terms of doses, obviously this trial is looking at a large number of doses, initially both monotherapy and combination. We are certainly concentrating in the combination expanded cohorts with one and two milligrams every six weeks in combination with bowel. We've certainly also centered on a dose range for botansilumab also as monotherapy. So we're rapidly building databases with what we think are effective and safe doses, both for monotherapy and combinations. And I think the data speaks for itself in terms of the remarkable clinical activity in these very hard-to-treat cold or IO-resistant solid tumors. All right.
spk10
Thank you. Very helpful.
Operator
Matt Phipps with William Blair. Your line is open.
Matt Phipps
Hey everybody. Thanks for taking my questions and look forward to the event this weekend. In the CRC trial, I noticed the posting on clinicals.gov came up and maybe you can just remind us what percentage of patients you expect to be free of liver mets post chemo. And then, you know, I know liver mets are historically more difficult to treat with immunotherapies broadly. Anything in your pipeline that you guys think could target the spatial population?
Jack
Dr. O'Day, other than the fact that I just want to highlight, we are seeing responses in both liver meds and non-liver meds, although the frequency of responses in non-liver meds is higher. But further, also I'd like to draw your attention that treated liver meds, In other words, tumors that were in the liver and ablated either with chemotherapy or other surgical means also respond rather well in our trial. Stephen, please.
Garth
Yeah, Matt, it's a great question. Obviously, liver meds are a dominant feature of colorectal cancer, but there's a significant number of patients that have either never had liver mets because of the patterns of metastasis or have limited disease that is treated. And certainly we've shown clinical benefit across all comers, including tumor reductions in active liver mets, marked reductions in tumor markers like CEA and prolonged stable disease. So we think we have clinical benefit across metastatic colorectal cancer. Certainly the active The non-active liver meds, meaning never had liver meds or had limited treatment liver meds, are an enriched population that's going to be the focus of our Phase II trial as we further look at dose and contribution. But we have every intention of looking at the all-comers. In terms of, you know, our pipeline, you know, how do we address? Well, number one, clinicians, both surgeons, radiation therapists, and medical oncologists can be much more active at treating the liver mets in conjunction with systemic therapies that are very active outside the liver. And this has been a limitation of the field. So that opens up considerably. And in terms of our pipeline, you know, the myeloid compartment is a particular challenge to liver metastasis. And in fact, myeloid cells defend the tumors very well. So our ILT2 program, as Dan just said, that's both a myeloid and a lymphoid checkpoint we're particularly interested in combining that with our portfolio. And we do have plans in our phase one ILT2 trial to add both alstilumab and botansilumab to our ILT2. So more to come, but we have every intentions of going after difficult to treat cancers in both liver and non-actor liver mets with our portfolio.
Matt Phipps
Thanks, Dr. Day. One other question on that melanoma trial. Can you give us any sense of kind of what it's designed to show, any thresholds or bars, especially between the dosage arms? And, I mean, we've seen some data for, you know, Urovoi in a post-PD-1 setting, but I guess what would you even expect in a post-PD-1 plus C2LA4 setting? Just, I don't know what you can provide there, Dr. O'Day.
Garth
Matt, what disease are we talking about?
Matt Phipps
In the melanoma trial that you guys opened, the activated melanoma trial.
Garth
Yeah, so that's a great question. So we're obviously, we've talked a lot about, you know, cold tumors or PD-1 resistant tumors. Melanoma is a good example of a hot tumor where we're going to be exploring a PD-1 resistant setting, second line, both in PD-1 resistant, but CTLA-4 naive, obviously, and then PD-1 and CTLA-4 resistant setting. And we have reported responses in our monotherapy to both cohorts of patients previously. So we're looking forward to that. In terms of what we'd expect, well, the nice thing about a second-line melanoma trial with monotherapy of Botancilumab is we have clear, large databases of historic response rates. And ipilimumab is essentially a 10% to 15% response rate drug. in the second line of PD-1 resistance, but CTLA-4 naive. So we have a very clear metric of showing differentiates of botanosilumab in that setting. And in ipinevo failure, second line, obviously you'd expect a 0% response rate for a CTLA-4 agent. And obviously, so we, the bar is very low there to show differentiation. But as Gerald said early on, we think of this as a CTLA-4 blocker but as really a novel, innate, adaptive activator on the back end through FC enhancement. What we're really doing is bringing these APCs to the T cell to develop a more forceful, potent priming and memory response. And so we think this will be very active both in melanoma, pot-like tumors, but also obviously in weak neoantigens where a more potent priming response is essential. Great. Thanks, Dr. Dan.
Operator
Mayank Mamthani with B. Reilly Securities. Your line is open.
Mayank Mamthani
Good morning. Thanks for taking our questions and congrats on the progress. So, Dr. Odeh, I'm digging into the CIDC abstract here and also, you know, fortunate to compare it against the next generation CDLA-4 from one of your peers, if you consolidate format. Can you talk to the importance of duration of response that you're seeing in your overall cohort and And the fact that you're seeing, you know, complete responses, including with monotherapy, could you just touch on why that's important? And then I have a couple of follow-ups.
Garth
Thank you, Mayur. You know, it's a critical question. We're in the business of trying to cure patients with cancer. And CTLA-4, obviously, I was, you know, part of the, really, the revolution with CTLA-4. Its primary sort of contribution, in my mind, were deep, responses, particularly evidence of CRs that are durable that lead to curative therapy. And so we're, you know, we're very excited that our molecule, both single agent and in combination, is demonstrating single agent activity. I think the field is suffering tremendously from the lack of single agent activity as we look at other targets, like 3D Tidget and others. And so, you know, I think IDOs, of course, were another example of that in melanoma that fail. So we are excited to see single agent activity, but not just activity, but deep responses that are durable. They really do drive overall survival curves. And most importantly, for patients, meaningful clinical responses. Obviously, when we combine an active novel CTLA-4 with PD-1, Not only are you driving priming and memory, but you're preventing exhaustion. And our combination studies in cold tumors are particularly reassuring in that regard that we're continuing to see evolving deepening responses. So, it's critical to the field to demonstrate single agent activity that's meaningful and then use it as a combinational foundation.
Mayank Mamthani
Great. Thank you. And also would love to hear how might you be making the decision to pursue pancreatic cancer, but maybe not yet refractory lung cancer and SCLC where you do have these two responses. And I'm just curious what the profile of these patients were, the two out of three response rate that we have. Did they have dire CPI exposure or you know, if it was both CDLN4 and or DD1. And then I have one last question.
Garth
Yeah, Mayur, what diseases are you speaking of?
Mayank Mamthani
I mean, you did say that you are moving forward with pancreatic, but, you know, we don't see that data in this abstract. But what we do see is the lung cancer, the refractory lung cancer.
Garth
Yeah. So I think to Gero's earlier points, we are framing and very focused on three very important foundational experiments with our phase two programs. One is obviously single agent activity in melanoma with a reference second line that will be differentiating and powerful. We are seeing obviously this tremendous response and durability in mammoth stable colorectal, and we have a phase two program. Pancreas, we haven't shared all of our data yet in the expanded phase one, but we have preclinical models showing a really very powerful chemo botanilumab data. And we have preliminary data in the clinic that's also supportive. So that phase two trial will be looking at botanilumab in a randomized phase two trial with chemotherapy. So three separate experiments. But having said that, Our development program is very thoughtful. It's going much deeper than those three programs. And so you will see more data as we go forward in the next year and develop these plans, and we will certainly reveal those. But we clearly have a lot of opportunity in big markets that the data is showing us. So more to come on further development plans. But we do anticipate starting – these trials this year and being very focused.
Mayank Mamthani
Great. And my final question was on, just remind us what the comparator arm is in the ACTIVATE colorectal phase 2 study and any thoughts on how that may compare against, you know, there's a phase 3 LAG3 PD1 combination study also running in MSS colorectal. So, I'm just curious. if there are any design differences to be aware of.
Garth
So I'm not going to comment on differences between trials. Our trial is in the second, third line setting, obviously in patients who have failed chemotherapy and antibodies, and it will be compared, there will be a standard of care arm, which in this case is long-serve for regular affinitive options as a standard of second, third line therapy.
Mayank Mamthani
Okay, thanks for taking our questions.
Operator
Again, if you'd like to ask a question, please press star 1 on your telephone keypad. There are no further questions at this time. We do have a follow-up question from Chi-Wen with Jefferies. Your line is open.
spk10
Yeah, sorry, just one additional question. Since you have seen a strong response in the NICLC patients, could you comment on how many lung cancer patients have enrolled so far besides the three that you have disclosed? Thank you.
Jack
So we're not commenting on any specific numbers of patients until the actual presentation.
spk10
I understand. Thank you.
Operator
I would now like to turn the call back over to our presenters for closing comments.
Jack
Thank you very much, everybody. Thanks again for joining us. We look forward to providing you with some more information in a few days. And please feel free to participate through our webcast. As I said earlier, our in-person attendance is closed at this time because of space constraints and the number of inquiries we've had. But we look forward to our future interactions. Thanks again.
Operator
This concludes today's conference. We thank you for your participation. You may now disconnect.
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