Yahoo Finance Agenus Inc. (NASDAQ:AGEN) Q1 2024 Earnings Call Transcript
Agenus Inc. (NASDAQ:AGEN) Q1 2024 Earnings Call Transcript May 7, 2024
Agenus Inc. beats earnings expectations. Reported EPS is $-3.04104, expectations were $-3.1. AGEN isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Thank you for standing by, and welcome to Agenus 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. [Operator Instructions] Thank you. I would now like to turn the call over to Zack Armen, Head of Investor Relations. Please go ahead.
Zack Armen: Thank you, Michelle [ph], and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities among other updates. These statements are subjects to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Steven O’Day, Chief Medical Officer; and Christine Klaskin, Vice President of Finance. Dr. Robin Taylor, Chief Commercial Officer; and Dr. Todd Yancy, 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 in the first quarter. Garo?
Garo Armen: Good morning, everyone. Thank you for joining us on today's call. 3 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 ground-breaking 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 am 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 $100 million loyalty financing agreement with Ligand Pharmaceuticals. It is 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 clinical minimally diluted 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 stem-cell [ph] 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 agreements 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 our efforts across our BOT/BAL program. Also very importantly, over the last few quarters, we have successfully reduced our cash burn rate and we'll 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 3 key objectives.
One, to satisfy the eligibility criteria for the Russell Indexes [ph]. Two, to regain compliance with NASDAQ listing requirements. And three, to maintain a stock price of above $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 at the close of the trading on April 30, which is the Russell Days [ph], 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 to 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 focuses in part our potential exhilarated filling [ph] 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 investigators sponsored trials. And I might add that we have had requests for an unprecedented number of investigators 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 tumour 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: 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 a 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 indications, 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 12, we've seen this datasets from our expanded Phase 1b cohorts mature in the 77 patients in this indication treated with a combination of Botensilimab and Balstilimab; there's now almost 14 months of medium follow-up.
The confirmed overall response rates in all patients treated was 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 diarrhoea and colitis, which is managed in accordance with standard therapies. Grade 3 or greater treatment related diarrhoea colitis occurred in approximately 16% of patients. These data which continued to mature stated stark contrast to standard-of-care therapies in this treatment settings with overall response rate of 1% to 6%, and a median overall survival of 12 months or less. In November 2023, we completed enrollment in our large randomized global Phase 2 trial with 234 metastatic colorectal cancer patients whose tumors were not MSI high or FMMR, and were without active liver metastasis.
This trial was designed to evaluate dose and contribution of components for the BOT/BAL regimen in this syndication [ph]. And importantly, also included a contemporaneous standard-of-care arm. Results from our March data cut from this top trial demonstrates consistency with our Phase 1 results at a similar stage of follow-up. We look forward to so many more mature results from this trial to our scientific meeting in the second half of 2024. Data from this Phase 2 trial along with data from expanded Phase 1 cohort, and a real world evidence dataset support our anticipated BAL8 [ph] 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 3 trial in an upcoming meeting anticipated in July 2024.
So if the Phase 3 trial will commence this year and enrol in time to support an accelerated approval. We will also discuss our obligations, which include our Phase 3 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. Tasi at Cornell, which showed major pathologic responses in 6 out of 9 MS-stable colorectal patients treated in a neoadjuvant setting including 2 pathologic complete responses, and 3 out of 3 complete or near complete responses in MSI high patients. None of these patients had surgery delayed due to treatment with BOT and BAL. This NEST trial is continuing to rapidly expand and enrol.
Longer follow-up data from the original 12 NEST patients will be presented at 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 was investigating BOT and BAL combined with standard-of-care FOLFOX plus Bevacizumab in first-line metastatic or FOLFOX re-challenged metastatic patients. To-date the regimen has been well tolerated and continues to actively enroll patients. Going forward, FOLFOX 3B could serve 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 a second is a refractory second-line metastatic pancreas study comparing BOT gem-Abraxane to gem-Abraxane 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: Thank you, Steven. In parallel with our scientific BLA submission, all of us at Agenus are focused on preparing for the launch of BOT and BAL. Our Emeryville based CMC Team is well prepared to supply BOT and BAL, both to 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, marketing 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 on GI oncology and we’ve conducted market research with over 150 US based GI oncologists across academic and community settings.
From both, to 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: 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 Armen: 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 upto $200 million by mid-year. We will strengthened our cash position and support our clinical research and development activities, our registration efforts and our commercialization efforts. Another key milestone will be our meeting with the FDA, an important [indiscernible] before we have their concordance in initiating our biologics license application. Additionally, we will present our Phase 2 for colorectal cancer along with additional data in this indication from investigator sponsored trials, which we believe will further strengthen the strong rational 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 1 and 2 data in melanoma, lung cancer, sarcoma and pancreatic cancer in the second half of this year. We are very encouraged with the outcomes of these trials. These all represent cancers where there is a clinical need for effective therapies. These developments underscore our dedication through innovation and oncology and also highlight our potential to make a meaningful impact on patients’ lives by offering potentially chemo-free durable benefit [ph] to patients who had limited 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 endavours as the year unfolds. Now, I believe we're ready for any questions you may have.
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