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Participants

Zack Armen; Head of Investor Relations; Agenus Inc

Garo Armen; Chairman of the Board, Chief Executive Officer, Co-Founder; Agenus Inc

Steven O’Day; Chief Medical Officer; Agenus Inc

Robin Taylor; Chief Commercial Officer; Agenus Inc

Christine Klaskin; Vice President, Finance and Principal Financial and Accounting Officer; Agenus Inc

Emily Bodnar; Analyst; H.C. Wainwright & Co., LLC

Mayank Mamtani; Analyst; B. Riley Securities, Inc.

Matthew Phipps; Analyst; William Blair & Company, L.L.C. (Research)

Presentation

Operator

Thank you for standing by, and welcome to agendas First Quarter 2024 Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you queue. I would now like to turn the call over to Zach Armin, Head of Investor Relations. Please go ahead.

Zack Armen

Thank you, Michelle, and thank you all for joining us today. Today’s call is being webcast and will be available on our 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 time lines 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 class, Kent, Vice President of Finance, Dr. Robin Taylor, Chief Commercial Officer, and Dr. Todd Yancey, two strategic adviser will be participating in the Q&A session.
Now I’d like to turn the call over to Gary to highlight our progress in the first quarter.

Story continues

Garo Armen

Good morning, everyone. Thank you for joining us on today’s call. Three decades ago, Agennix was founded with a profound commitment to transform the landscape of cancer treatment ever. Since we have been relentlessly pursuing this pressure, leveraging the power of the immune system to develop groundbreaking therapies that could dramatically change the lives of those battling cancer today as we age closer to realizing our goals with our leading bus powered program. I’m thrilled to share a significant milestone that will propel us enter 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 both Val and in its entirety and also all open up our options to bring in partners for this program. This parent’s home minimally dilutive capital infusion. We’ll support key development initiatives in the buyback program, including our planned confirmatory Phase three study in relapse refractory MSS CRC, which span 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 them 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 back value.
Okay. 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 back value 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 barbell 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 time lines, ensuring we are well prepared for the challenges and opportunities.
Okay. Our reverse stock split during Q1 was implemented to achieve three key objectives, one, to satisfy the eligibility criteria for the Russell indices to regain compliance with NASDAQ listing requirements and three to maintain a stock price of about $5 a share and enabling investments by certain institutional investors that require and 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 trading on April 30th, which is the Russell Reynolds say, we are more confident in our continued inclusion in the Russell 2000 of our strategic initiatives and efforts 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, will provide an update on the latest developments in our buyback program. Stephen will focus, particularly on our progress on colorectal cancer This focuses in part, our potential accelerated filing pathway in advanced stages of disease. And also this focus is vital as we expand treatment options in earlier lines of therapy to externally funded and global investigator-sponsored trials.
I might add that we have had requests for an unprecedented number of investigator-sponsored trials in our Q, the results of our growth agenda sponsor studies and those IST. continue to reinforce our confidence in BioCloud potential to address significant unmet needs across various solid tumor cancers. Thank you again for your continued support and commitment to agendas were excitement about the future and look forward to sharing more updates on our progress in the near future. Stephen?

Steven O’Day

Thank you, Garo. Potent civil I-Mab in combination with balstilimab has demonstrated deep and durable responses across a wide variety of poorly immunogenic or I-O 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 I-O therapies. Currently, our Boswell program is focused on our lead indication, relapsed refractory colorectal cancer, which is non MSI high or DMMR. And as without active liver metastases, we continue to make substantial progress as provided in our press release from April 12th. We’ve seen this dataset from our expanded Phase Ib cohort mature in the 77 patients in this indication treated with the combination of both silicon and balstilimab. There’s 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 at 12 months.
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 three or greater treatment related diarrhea. Colitis occurred in approximately 16% of patients. These data, which continued to mature stented stark contrast to standard of care therapies in this treatment setting with overall response rates of 1% to 6% and a median overall survival of 12 months or less. In November 2023, we completed enrollment in a large randomized global Phase two trial with 234 metastatic colorectal cancer patients whose tumors were not MSI high or DMMR. and were back with our active liver metastases.
This trial was designed to evaluate dose and contribution of components for the barbell regimen in this indication and importantly, also included a contemporaneous standard of care. Our results from a March data cut from this top trial demonstrates consistency with our Phase one 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 two trial, along with data from the expanded Phase one cohort and our real-world evidence data set 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 three trial in an upcoming meeting anticipated in July of 2024. So the Phase three trial will commence this year and enroll in time to support an accelerated approval. We will also discuss our obligations, which include our Phase three dose and regimen, and this 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 NASH trial with Dr. Pasi at Cornell, which showed major pathologic responses in six out of nine MS stable colorectal patients treated in a neoadjuvant setting, including two pathologic complete responses and three out of three complete or near-complete responses in MSI high patients. None of these patients had surgery delayed due to treatment with Bob and about this next trial is continuing to rapidly expand and enroll longer follow-up data from the original 12 MS patients, we’ll be presented at an upcoming medical meeting.
The second important early line metastatic colorectal trial. I want to highlight is the full Fox three b. regimen with Dr. Marwan for team at City of Hope he is investigating bar and bound combined with standard of care, full Fox plus bevacizumab in first-line metastatic for full Fox rechallenge metastatic patients. To date, the regimen has been well tolerated and continues to actively enroll patients going forward, full Fox 3B could serve as an active regimen across several different malignancies, including colorectal cancer and 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 and prevalence, it is impacting younger patients.
Additionally, we continue to follow and maturing agenda sponsored Phase two trials with Bob or Bob Bell in several important areas. The first is a refractory melanoma Phase two trial. We’ve bought a loan or Bob, our combination. And the second is a refractory second-line metastatic pancreas study comparing bought gem Abraxane gem Abraxane alone. We hope to provide updates on these data in the second half of 2020.
For now, I’ll turn the call over to work with Robin Taylor, who will provide more insight into our commercial strategy and operations rather than just even in parallel with our planned BLA submission.

Robin Taylor

All of us at Genesis are focused on preparing for the launch of Bud and bells. Our EM rebuild based CMC team is well prepared to supply, bought and Bell 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 buy-and-bill, 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

Thank you, Robyn. As Gary 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 Gary 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 31st, 2023. For the first quarter ended March 31st, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million, which includes noncash 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 $3.4, which compares to $4.31 per share for the first quarter of 2023. I’ll now turn the call back to Gary.

Garo Armen

Thank you very much, Steve and Robyn and this team as we conclude today’s earnings call, I want to recap the pivotal developments we anticipate in the coming months agendas. We are on track to secure a significant cash infusion of up to $200 million by midyear, 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 concordance in initiating our biologics license application. Additionally, we will present our Phase two data for colorectal cancer along with additional data in this indication from investigator-sponsored trials, we fully believe will further strengthen the strong rationale of our therapy and these data presentations. I expect that 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 through 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 there. Thank you very much once again to our shareholders for your continued support and interest in agents. 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.

Question and Answer Session

Operator

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, 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 loud speaker on your device, please pick up your handset and ensure that your phone is not unmute.
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

Hi, good morning. Thanks for taking the questions and congrats on the progress. On my first question, could you confirm how many patients you’ve treated would fall foul of the recommended Phase two dose across the Phase Ib 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 Bob Bell 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 you’re kind of near term income commercial focus is just on CRC things.

Garo Armen

Certainly, Henry, thank you very much for your question. And I will give you some top line answer to your questions. And then I’ll have Dr. O’Day get into some debt. First of all, as you may know, for the last almost six months, we had really intensively involved in pulling together the data from all the trials, including tracking the maturity of the data, as Steven alluded to, and to see how we can make a compelling package in an upcoming meeting with the FDA and our conviction based on the data from all three cohorts, including the Phase two 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. Of course, we cannot make a definitive statement until the outcome of the FDA meeting, and we need to get their concordance on and attentive. But we are in a optimal state of preparedness where we are right now and more developments on the progress. And this will be coming forward in the next several weeks.
Now in terms of the numbers of patients from this 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 and 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 of worked. But Stephen, if you can address some more specific questions.

Steven O’Day

Thanks, Joe. So we’re not going to get into the app the specific numbers, but we can have what I can say with the Phase one and Phase two trial. We have two active doses and a significant number of patients on the combination of Bob Bauer in both the Phase one and Phase two randomized trial that we think are supported with safety, efficacy and clinical pharmacology to discuss with the FDA an accelerated pathway given the unmet need in this setting.

Emily Bodnar

Okay, great. Thank you.

Operator

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

Mayank Mamtani

Good morning. Thanks for taking our questions and congrats on the updates noted earlier. So in prior press release, I think you’ve mentioned that there are emerging data and Phase two is encouraging. And today, I think is that comparable to what you noted in Phase one at a similar stage.
Could I could are you able to give a little bit more detail on what for us, what parameters we are talking about and it’s comparable to your expectation at the outset and especially given you are 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 two cohort that you’re trying to accomplish before, you’re able to submit a package that would go alongside that and see anything and I have a couple of buckets.

Garo Armen

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

Mayank Mamtani

I appreciate that color, guys. Thank you. Under under follow up from the Phase two, like you are at, I think 14 months follow up in the from the Phase one is there a particular requirement or best practices in terms of how much follow-up you need to have on Phase two? Or is that is that a subject of discussion?

Garo Armen

Okay. So and this of course, the year has guidance that is based on some historical precedence on the minimum follow-up. But we have had significant input from our regulatory advisors on what that minimum should be, of course, ideally we can wait five years, but we’re not going to do. But the minimum enrollment in the Phase two 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

It may make sense that. 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 what dose level you’re using in most of these ISTs and 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.
Stephen, if you’re able to comment on the implications of that data set and informing what the Phase three trial could look like. And then I have one last financial question after that.

Steven O’Day

Okay. So that said, thank you, Mike, for that question. We have been confronted with an unprecedented number of licensees now what is that number is well over 50 SD. We expect clearly, given our resources and I don’t mean just financial resources because a number of the ICs do not require my financial resource from the company, but people, human resources, we cannot satisfy all of these eyes the requests. So we have zeroed in on a handful of them. And these handful of ICs 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 all pursuing them, but Valley in several different indications that are important to us. So and 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 advisers and KOLs, but also the rest assured that during that time, all our regulatory discussions, we are particularly sensitive, not expanding our ISD. 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 on.
In addition to that, I think you had another question analyzes that of whether or not it’s specific to CRC, not, of course, a great number of the IOCs, and that’s specific to CRC. They are in pancreatic melanoma, lung start call as a great deal of interest in sarcoma because of the efficacy that we’ve seen are intrinsic seats, I should say the significant clinical activity there and see the reason I’m saying I should say efficacies because that’s a term that the FDA has blessed until that happens. We have to be careful in how we use the terms of activity, but because of the significant activity that we have seen in sarcoma patients that have failed everything else and they’re not responding to any other treatments. Now there is, of course, a lot of interest in pursuing, not just those The Bank also approval strategy. But as I said earlier, we are very, very cognizant of the focus that we need to have on GRCB.

Mayank Mamtani

Got it. Thank you. And then lastly, in the non-dilutive financing, the total of $200 million, if you include some of the expected syndicated offering, just if you’re able to comment on how much down contribution by value versus the other six partnered programs in this broader deal gone. So that would be helpful. Just a rough range go and thanks again for taking the question.

Garo Armen

So I mean, there is the relative contribution is articulated in the press release or the Laggan press release that was put out this morning at seven 30. So but other than that we cannot discuss any additional details. But suffice it to say that this financing completely provided us with the Freedom pursue by about an outline and tissue by file in connection with partners worldwide. So this particular transaction has absolutely no bearing or put any restrictions on our ability to advance by about two, two 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.
So ex Lloyd, our commercial up opportunity with my background, and that will be, of course, for the benefit of both the company, our future potential partners. And for the benefit of Vegas, are you getting insulin, particularly.

Operator

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

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

Garo Armen

Okay. So then clearly, it’s the data was expected to be not positive. We wouldn’t be talking about, but can I provide you with specifics on the data that will compromise our ability to present data at a conference? And there’s 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 and have an opportunity to present the data at peer review conferences and also in publications.

Okay. Thank you.

Operator

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

Matthew Phipps

Again, congrats on the ligand financing. So 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 Armen

Yes, it is based on logins to the suite.

Matthew Phipps

Great. Thanks. And then come back to the melanoma on the slide to the front-line trial and register a 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, it’s perfect questions for one of the world’s foremost experts on melanoma, and that is our Dr. Steven O’Day. So back to you and clarify the question again. I didn’t quite get the first line piece of it.
Yes, there’s a slide you guys use deck that says the first-line melanoma registrational study versus first-line standard of care. Just kind of curious, would you consider to be the standard of care right now because there’s maybe three different I-O regimens out there?

Steven O’Day

Yes. 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 at 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 of this is in our refractory PD-1 and PD-1 CTLA-4 and BRAC. 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 would would have to advise on the best comparator arm in that setting.

Matthew Phipps

Well, thanks for the question.

Operator

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 — so we have the next question from Gabriel. Kim, your line is open.

Hi. Congratulations on the ligand financing. Could you just say one is the anticipated closing date? And then I had a follow-up.

Garo Armen

Well, well, yes, we can hear you hired? I think I think we mentioned that we expect to close the transaction this month, but.

Okay, wonderful. And then some in terms of bomb share count are you able to provide a bump in the quarter or current share count.

Garo Armen

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

Okay.

Garo Armen

Christine, do you have the exact share count up?

Christine Klaskin

Yes, it’s just over 20 million and we did file our 10 Q this morning. So you could see that on ample evidence.

Okay. And is that also some Okay, wonderful. Thank you. So about the current share count as well. Yes. Thank you very much.

Steven O’Day

Okay. Thank you. Thanks a lot.

Operator

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

Garo Armen

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

Operator

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