Agenus - Q1 2024

Executive Summary

• Agenus reported Q1 2024 revenue of $28.0M and a net loss of $63.5M (-$3.04 per share), with cash used in operations of $38.2M and cash/cash equivalents of $52.9M; the quarter included announcement of a $100M royalty financing from Ligand to support BOT/BAL development and launch readiness.
• Clinical momentum in r/r MSS CRC (non-active liver metastases) remained strong: confirmed ORR 23% (n=77), median OS 21.2 months, 12‑month OS 71%, 18‑month OS 62%, with grade ≥3 diarrhea/colitis ~16%.
• Management plans an FDA meeting in July 2024 to align on an accelerated approval BLA for BOT/BAL in r/r MSS CRC NLM and to commence the confirmatory Phase III trial this year; commercial readiness (CMC supply, leadership hires) is underway.
• Prior quarter (Q4 2023) delivered $84.0M revenue and a net loss of $49.0M (-$0.13 per share) as the company secured Fast Track for BOT/BAL in MSS CRC NLM and guided to being funded through 2024; Q3 2023 revenue was $24.3M with a net loss of $64.5M.
• Notable stock catalysts: finalized Ligand royalty financing, FDA July meeting outcome, Phase II CRC data disclosure in 2H 2024, and initiation of confirmatory Phase III; reverse split achieved Russell eligibility and restored Nasdaq compliance, broadening investor access.

What Went Well and What Went Wrong

• What Went Well

  • Secured minimally dilutive $100M royalty financing (initial $75M, optional $25M) from Ligand to fund BOT/BAL development and launch readiness. “This capital infusion is pivotal for advancing the development and market readiness of our BOT/BAL treatment.” – CEO Garo Armen.
  • Robust efficacy signals in r/r MSS CRC NLM: 23% confirmed ORR (n=77), mOS 21.2 months, 12‑mo OS 71%, 18‑mo OS 62%; safety manageable with ~16% grade ≥3 diarrhea/colitis.
  • Commercial buildout: seasoned leadership across sales, marketing, access, and operations; dual CMO/wholly owned GMP facility readiness; strong market research (~150 U.S. GI oncologists) indicating significant anticipation for BOT/BAL.

• What Went Wrong

  • Ongoing operating losses and high cash burn: Q1 2024 net loss $63.5M (-$3.04/share) with cash from operations of -$38.2M, increasing capital dependency despite reductions vs Q4.
  • Limited disclosure on Phase II CRC topline prior to FDA meeting; analysts flagged desire for more detail, but management held data to preserve regulatory process timing.
  • Adverse events remain a watch item: immune‑related diarrhea/colitis at grade ≥3 levels in ~16% of CRC patients; increases vs ~14% reported previously, though managed per standard therapies.

Transcript

Operator (participant)

Thank you. I would now like to turn the call over to Zach Armen, Head of Investor Relations. Please go ahead.

Zack Armen (Head of Investor Relations)

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

Now, I'd like to turn the call over to Garo to highlight our progress for the first quarter. Garo?

Garo H. Armen (Chairman and CEO)

Good morning, everyone. Thank you for joining us on today's call. Three decades ago, Agenus was founded with a profound commitment to transform the landscape of cancer treatment. Ever since, we have been relentlessly pursuing this mission, leveraging the power of the immune system to develop groundbreaking therapies that could dramatically change the lives of those battling cancer. Today, as we edge closer to realizing our goals with our leading Bot/Bal program, I'm thrilled to share a significant milestone that will propel us into the next phase of our journey. This morning, we announced that we entered into a $100 million royalty financing agreement with Ligand Pharmaceuticals. It's very important to realize that this agreement allows us to keep Bot/Bal in its entirety and also open up our options to bring in partners for this program.

This pivotal, minimally dilutive capital infusion will support key development initiatives in the Bot/Bal program, including our planned confirmatory phase 3 study in relapsed refractory MSS-CRC, which stands for colorectal cancer, and our commercialization readiness activities, which are currently underway. Ligand's initial commitment is for $75 million, with an option to add $25 million more, and importantly, in addition to this, we can add $100 million more in a syndicated transaction from other parties, several of whom we are already in negotiations, making the total as much as $200 million. This agreement strengthens our financial position and reinforces our commitment to bringing Bot/Bal to patients. Our cash balance as of the end of the first quarter was $52 million.

With the additional cash received from this transaction, we are positioned to ensure the progress of our mission-critical work to bring Bot/Bal to patients in need. We're also in discussions for additional capital infusion mechanisms to further strengthen our balance sheet as we enter a critical phase of our effort across our Bot/Bal program. Also, very importantly, over the last few quarters, we have successfully reduced our cash burn rate and will continue to do so even with our strengthened cash position. Our detailed financial scenario planning includes various partnership outcomes and potential regulatory timelines, ensuring we are well prepared for the challenges and opportunities ahead. Our reverse stock split during Q1 was implemented to achieve three key objectives. One, to satisfy the eligibility criteria for the Russell Indices. Two, to regain compliance with Nasdaq listing requirements.

Three, to maintain a stock price about $5 a share, enabling investments by certain institutional investors that require a minimum share price. We've confirmed regaining compliance with Nasdaq listing requirements last week, and based on our market cap as of the close of the trading on April thirtieth, which is the Russell re-rank day, we are more confident in our continued inclusion in the Russell 2000. Our strategic initiatives are expected to broaden our investor base and to lower our cost of capital, benefiting both our shareholders and optimizing our ability to bring valuable medicines to patients. I will now turn the call to Dr. Steven O'Day, our Chief Medical Officer, who will provide an update on the latest developments in our Bot/Bal program. Steven will focus particularly on our progress on colorectal cancer....

This focus is in part our potential accelerated filing pathway in advanced stages of disease, and also this focus is vital as we expand treatment options in earlier lines of therapy through externally funded and global investigator-sponsored trials. I might add that we have had requests for an unprecedented number of investigator-sponsored trials in our queue. The results from both Agenus-sponsored studies and those ISTs continue to reinforce our confidence in Bot/Bal's potential to address significant unmet needs across various solid tumor cancers. Thank you again for your continued support and commitment to Agenus. We're excited about the future and look forward to sharing more updates on our progress in the near future. Steven?

Steven O'Day (CMO)

Thank you, Garo. Botensilimab, in combination with balstilimab, has demonstrated deep and durable responses across a wide variety of poorly immunogenic or IO-refractory solid tumors. These poorly immunogenic tumors represent the majority of adults with cancer, and this large group of patients have not previously benefited from the success of established IO therapies. Currently, our Bot/Bal program is focused on our lead indication, relapsed refractory colorectal cancer, which is not MSI-high or dMMR, and is without active liver metastasis. We continue to make substantial progress. As provided in our press release of April twelfth, we've seen this data set from our expanded phase Ib cohort mature. In the 77 patients in this indication, treated with a combination of botensilimab and balstilimab, there is now almost 14 months of median follow-up.

The confirmed overall response rate in all patients treated is 23%, with a median overall survival of 21.2 months, a 12-month overall survival estimate of 71%, and an 18-month overall survival estimate of 62%. The most common safety observations are immune-related diarrhea and colitis, which is managed in accordance with standard therapies. Grade 3 or greater treatment-related diarrhea colitis occurred in approximately 16% of patients. These data, which continue to mature, stand in stark contrast to standard of care therapies in this treatment setting, with overall response rates of 1%-6% and a median overall survival of 12 months or less. In November 2023, we completed enrollment in a large, randomized, global phase II trial with 234 metastatic colorectal cancer patients whose tumors were not MSI-H or dMMR, and were without active liver metastasis.

This trial was designed to evaluate dose and contribution of components for the Bot/Bal regimen in this indication, and importantly, also included a contemporaneous standard of care arm. Results from a March data cut from this top trial demonstrate consistency with our phase I results at a similar stage of follow-up. We look forward to submitting more mature results from this trial to a scientific meeting in the second half of 2024. Data from this phase II trial, along with data from the expanded phase I cohort and a real-world evidence dataset, support our anticipated BLA filing by the end of the year.

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

This NEST trial is continuing to rapidly expand and enroll. Longer follow-up data from the original 12 NEST patients will be presented at an upcoming medical meeting. The second important early line metastatic colorectal trial I want to highlight is the FOLFOX 3B regimen with Dr. Marwan Fakih at City of Hope. He is investigating botensilimab and balstilimab combined with standard of care FOLFOX plus bevacizumab in first-line metastatic or FOLFOX rechallenged metastatic patients. To date, the regimen has been well tolerated and continues to actively enroll patients. Going forward, FOLFOX/Bev could serve as an active regimen across several different malignancies, including colorectal cancer, in early-line metastatic settings. For example, upper GI malignancies. Our goal is to improve outcomes in both late stage and earlier stage colorectal cancer, a disease growing in prevalence and impacting younger patients.

Additionally, we continue to follow maturing Agenus-sponsored phase 2 trials with BOT or BOT/BAL in several important areas. The first is a refractory melanoma phase 2 trial with BOT alone or BOT/BAL combination, and the second is a refractory second-line metastatic pancreas study comparing BOT gemcitabine to gemcitabine alone. We hope to provide updates on these data in the second half of 2024. Now I'll turn the call over to Robin Taylor, who will provide more insight into our commercial strategy and operations. Robin?

Robin Taylor (Chief Commercial Officer)

Thank you, Steven. In parallel with our planned BLA submission, all of us at Agenus are focused on preparing for the launch of botensilimab and balstilimab. Our Emeryville-based CMC team is well prepared to supply botensilimab and balstilimab, both through our third-party CMO partners and subsequently at our wholly owned and operated GMP grade commercial facility. With respect to commercial preparations, I have hired a highly experienced and passionate leadership team across sales and marketing, market access, and commercial operations. Together, the members of the commercial leadership team have successfully led or participated in over 20 launches of novel therapeutics or label expansions in colorectal cancer and other solid tumors.

We are partnering closely with our global medical affairs and clinical teams to gather insights from the world's experts in GI oncology, and we've conducted market research with over 150 US-based GI oncologists across academic and community settings. From both the market research and our direct discussions with GI oncologists, it is clear that there is significant anticipation for Bot and Bal, which underscores the urgency we feel to deliver this important treatment option to patients. Now I'll turn the call over to Christine to discuss financials.

Christine Klaskin (VP of Finance)

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

This compares to a net loss of $70.9 million, which includes non-cash expenses of $25 million for the same period in 2023. Our net loss per share for this first quarter is $3.04, which compares to $4.31 per share for the first quarter of 2023. I'll now turn the call back to Garo.

Garo H. Armen (Chairman and CEO)

Thank you very much, Steven, Robin, and Christine. As we conclude today's earnings call, I want to recap the pivotal developments we anticipate in the coming months at Agenus. We are on track to secure a significant cash infusion of up to $200 million by mid-year, which will strengthen our cash position and support our critical research and development activities, our registration efforts, and our commercialization efforts. Another key milestone will be our meeting with the FDA and importance before we have their concurrence in initiating our biologics license application. Additionally, we will present our phase 2 data for colorectal cancer, along with additional data in this indication from investigator-sponsored trials, which we believe will further strengthen the strong rationale of our therapies, and these data presentations are expected to be happening at major conferences.

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

Operator (participant)

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

Emily Bodnar (Equity Research Analyst)

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

Garo H. Armen (Chairman and CEO)

Certainly, Emily. Thank you very much for your question. I will give you some top-line answers to your questions, and then I'll have Dr. O'Day get into some depth. First of all, as you may know, for the last almost 6 months, we have been intensively involved in pulling together the data from all the trials, including tracking the maturity of the data, as Steven alluded to, to see how we can make a compelling package in an upcoming meeting with the FDA. And our conviction, based on the data from all 3 cohorts, including the phase 2 randomized study, as well as the durability and maturity of the data, is stronger today than ever before that we will make a compelling case.

Now, of course, we cannot make a definitive statement until the outcome of the FDA meeting, and we need to get their concordance on our conviction. But we are in a optimal state of preparedness with where we are right now, and more developments on the progress on this will be coming forth in the next several weeks. Now, in terms of the numbers of patients from each cohort and other questions about whether melanoma, pancreatic, and lung cancer can lead to approval, those are, of course, very important questions that we are actively considering in collaboration with key opinion leaders in these fields. And we will be alluding on the potential of this in coming months. But please understand that we are absolutely fixated on CRC right now, because that is our focus for our first potential approval.

So everything else is a little less of a priority, but with the additional financial resources that we expect to put into place between now and the end of the year, those other programs will come to the focus as well. But Steven, if you can address some of the more specific questions Emily asked.

Steven O'Day (CMO)

Thanks, Garo. So we're not gonna get into the specific numbers, but what I can say is with the phase 1 and the phase 2 trial, we have 2 active doses and a significant number of patients on the combination of Bot/Bal in both the phase 1 and the phase 2 randomized trial.

that we think are supportive with safety, efficacy, and clinical pharmacology to discuss with the FDA an accelerated pathway, given the unmet need in this setting.

Operator (participant)

Okay, great. Thank you. Your next question comes from the line of Mayank Mamtani of B. Riley Securities. Your line is now open.

Mayank Mamtani (Equity Research Analyst)

Good morning, team. Thanks for taking my questions, and congrats on the updates noted earlier. So, in prior press releases, you've mentioned that your emerging data in phase 2 is encouraging, and today, I think you said, it's comparable to what you noted in phase 1 at a similar stage. Are you able to give a little bit more detail on what parameters we are talking about? And, you know, if it's comparable to your expectation at the outset, and especially given, you know, you're enrolling slightly earlier stage patients there.

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

Garo H. Armen (Chairman and CEO)

Okay. On the first question, Mayank, we have said repeatedly that we will not discuss the details of this study. Please understand, everybody, that we're not trying to be cute here. It is just a courtesy call that we will not discuss the data until we have an opportunity to present it to the FDA. Subsequent to that, our preference is, of course, to present the data, which we consider a very important set of data, that will address the selection of the dose, contribution of the elements, and the efficacy to support the data that we have seen in earlier trials, at a major conference. That would be our preference to do. You will get no further details on this until these steps are underway.

Now, in terms of the FDA meeting, the FDA meeting request, is going in as we speak, and we expect that based on the timelines, we will be granted a meeting sometime in the second half of July. This is data that we have not released before, so we're now making it public. As soon as the meeting is scheduled, of course, depending on the circumstances, we may make certain statements about it, but I believe that the outcome of this meeting will be one of the most important milestones for the company as we potentially gear up for accelerated approval filing, in the next, months following the meeting.

Rest assured that we are firing on all cylinders, as they say, on all modules, and are getting ready, in a state of readiness for all modules that could potentially be submitted post the FDA meeting.

Mayank Mamtani (Equity Research Analyst)

Appreciate that color, Garo. Thank you. On the follow-up from the phase 2, like you're at, I think 14 months follow-up in the from the phase 1, is there a particular requirement or best practices in terms of how much follow-up you need to have from phase 2, or is that sort of subject to discussion?

Garo H. Armen (Chairman and CEO)

Okay. So on this, of course, the FDA has guidance that is based on historical precedent on the minimum follow-up, but we have had significant input from our regulatory advisors on what that minimum should be. Of course, ideally, you can wait five years, but we're not gonna do that. But the minimum enrollment in the phase 2 ended in October 2023. And based on that, you can sort of extrapolate what the follow-up period will be between now and the potential FDA meeting, and then beyond that FDA meeting, from that point to the filing of a BLA with the clinical module.

Mayank Mamtani (Equity Research Analyst)

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

Garo H. Armen (Chairman and CEO)

Okay. As I've said, thank you, Mayank, for that question. We have been confronted with an unprecedented number of ISTs. Now, what is that number? It's well over 50 IST requests. Now, clearly, given our resources, and I don't mean just financial resources, because a number of the ISTs do not require much financial resource from the company, but people, human resources. We cannot satisfy all of these IST requests. So we have zeroed in on a handful of them, and these handful of ISTs are selected based on potential data generation for approval of our agents in subsequent trials. And also, of course, the rationale of generating significant clinical data that will be supporting the rationale of pursuing Bot/Bal in several different indications that are important to us.

So, these will be reviewed or are in the process of being reviewed on an ongoing basis, and we'll make prudent decisions in collaboration with some of our advisors and KOLs. But also, be rest assured that during the time of our regulatory discussions, we are particularly sensitive to not expanding our IST programs so that we do not get caught in generating data that cannot be tabulated, cleaned up in time to be provided to the FDA for a potential BLA consideration. So all of these considerations are a critical part of our thought process. Now, in addition to that, I think you had another question on ISTs that if whether or not it's specific to CRC. Not, of course, a great number of the ISTs are not specific to CRC. They are in pancreatic, melanoma, lung, sarcomas.

There's a great deal of interest in sarcomas because of the efficacy that we've seen, or I shouldn't say efficacy, I should say significant clinical activity that we've seen. The reason I'm saying I shouldn't say efficacy is because that's a term that the FDA has to bless. So until that happens, we have to be very careful in how we use the terms of activity. But because of the significant activity that we have seen in sarcoma patients, they have failed everything else, and they're not responding to any other treatments, there is, of course, a lot of interest in pursuing not just ISTs, but also approval strategies. But as I said earlier, we are very, very cognizant of the focus that we need to have on CRC right now.

Mayank Mamtani (Equity Research Analyst)

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

Garo H. Armen (Chairman and CEO)

So I mean, there is the relative contribution is articulated in our press release, or the Ligand press release that was put out this morning at 7:30 A.M. So, but other than that, we cannot discuss any additional details. Suffice it to say that this financing completely provides us with the freedom to pursue botval on our own and pursue botval in connection with partners worldwide. So this particular transaction has absolutely no bearing or puts any restrictions on our ability to advance botval to in collaboration with partners and by ourselves. In other words, the economics of this transaction are defined, and that was in the press release.

And beyond that, I believe that we are in a superb position to exploit our commercial opportunity with botval, and that will be, of course, for the benefit of both the company, our future potential partners, and for the benefit of Ligand.

Mayank Mamtani (Equity Research Analyst)

Got it. Thanks again for taking the question.

Operator (participant)

Your next question comes from the line of Kelly Shi of Jefferies. Your line is open.

Kelly Shi (Equity Research Analyst)

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

Garo H. Armen (Chairman and CEO)

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

Steven O'Day (CMO)

Okay. Thank you.

Operator (participant)

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

Matthew Phipps (Equity Research Analyst)

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

Garo H. Armen (Chairman and CEO)

Yes, it is based on Ligand's decision.

Matthew Phipps (Equity Research Analyst)

Great, thanks. And then, maybe for Dr. O'Day, the melanoma on the slide that says the frontline trial and frontline registrational trial versus standard of care, wondering if you consider that to be PD-1 monotherapy, PD-1, a different PD-1 CTLA-4, or PD-1 LAG-3 at this point?

Garo H. Armen (Chairman and CEO)

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

Steven O'Day (CMO)

Matt, can you clarify the question? Again, I didn't quite get the first line piece of it.

Matthew Phipps (Equity Research Analyst)

Yeah, sure. There's a slide, you guys, in your news deck that says, "First line melanoma registrational study versus first line standard of care." Just kind of curious what you consider to be that standard of care right now, 'cause there's maybe 3 different IO regimens out there.

Steven O'Day (CMO)

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

Matthew Phipps (Equity Research Analyst)

Got it. Okay, thanks. That's my questions.

Operator (participant)

Once again, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from the line. Oh, I think we lost. Oh, all right. So we have the next question from Gabriel Kim. Your line is open.

Speaker 10

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

Operator (participant)

Yes, we can hear you.

Garo H. Armen (Chairman and CEO)

Hi. I think, I think we mentioned that we expect to close the transaction this month.

Speaker 10

Oh, okay. Wonderful. And then, in terms of share count, are you able to provide an end of quarter or current share count?

Garo H. Armen (Chairman and CEO)

I don't have the share count with me, but I believe going into all of this, it was 20 million, something like that.

Speaker 10

Okay, so-

Garo H. Armen (Chairman and CEO)

Christine, do you have the exact share count?

Christine Klaskin (VP of Finance)

Yeah, it's just over $20 million, and we did file our 10-Q this morning, so you could see that on our file.

Speaker 10

Okay. Okay, and is that also... Okay, wonderful. Thank you. So that's a current share count as well?

Christine Klaskin (VP of Finance)

Yes.

Garo H. Armen (Chairman and CEO)

Thank you very much.

Speaker 10

Okay, thank you. Thanks a lot.

Operator (participant)

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

Garo H. Armen (Chairman and CEO)

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

Operator (participant)

Thank you. That does conclude our conference-