Agenus Inc Q2 FY2021 Earnings Call

Good morning, ladies and gentlemen. Thank you for standing by and welcome to Agenus Second Quarter 2021 Conference Call and Webcast. Please note that this event is being recorded and may be used in future Agenus promotional material. I would now like to turn the conference over to Jan Medina, Director of Investor Relations. Jan, please go ahead.

Thank you, Myra 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. As another reminder, this call is being recorded for audio broadcast. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Jennifer Buell, President and Chief Operating Officer; Andy Hurley, our Chief Commercial Officer; and Christine Klaskin, Vice President of Finance. Now, I’ll turn the call over to Garo to highlight our progress during 2021 so far. Garo?

Thank you very much, Jan, and thank you, everyone for joining us today, in addition to the named officers of the company. We also have Dr. Steven O'Day, our Chief Medical Officer to answer any questions that you may have at the end. I will start by displaying what I presented at our Shareholders Meeting approximately eight weeks ago. There, we tried to explain our business in simple terms for clarity about our key operational drivers and some of the supportive programs we have. Starting with our significant value creators, AGEN1181, which is our next generation CTLA-4 compound that does more than just what CTLA-4 does. You will hear more about that in the future as you have before. With our AGEN1181 program, we have already enrolled well over 100 patients in our clinical trials, and the results of updated clinical data will be made available in the second half of this year at at least one major clinical conference. Our second significant value driver is our AGENT-797 program, which features our iNKT cells. We can’t share much about that now since we have filed for a proposed public offering. The third major driver is our AGEN2373, a 41BB agonist, also known as CD137. This compound, which has been tested for almost a year, has shown an excellent safety profile and we’re now seeing hints of early critical activity. You will hear more about this compound in the second half of this year. Of course, we also have our QS-21 program, which has garnered significant attention due to COVID and its potential to aid other vaccines. We often receive questions about which programs to prioritize and how we fund these programs. Earlier in the quarter, we closed on a very important transaction with Bristol Myers for the licensing of our TIGIT bispecific, and while the bispecific arm hasn’t been disclosed yet, this is a highly exciting compound. We believe Bristol is one of the best candidates to advance this program, if not the best. At the time of the transaction, we disclosed that it was a competitive process. This transaction allows us to receive $200 million already, alongside over $1 billion worth of contingent milestone payments and royalties upon commercialization. Very importantly, we also have multiple potential transactions in the queue, with some possibly occurring in the second half of this year and others beyond. We talked about potential spin-out strategies as well, including our S1 filing for a proposed IPO for MiNK, which is the original AgenTus Company focused on cell therapy. We also anticipate other potential spin-outs from businesses cultivated with Agenus that are ready to stand on their own. We’ve also discussed potential project financing as a strategy to bring in extra cash, particularly for programs we intend to pursue without licensing. Our third category was supportive programs, including balstilimab, our PD-1 antibody. While our PD-1 antibody may not be a blockbuster on its own, it has the potential to be a blockbuster in conjunction with other elements within our portfolio. We’ve been discussing potential clinical collaborations for some of our earlier assets, including balstilimab and zalifrelimab, which can be highly valuable in conjunction with other entities. This will help us expand the market through combinations with our PD-1 and first-generation CTLA-4 antibodies. Our fourth pillar comprises key operational capabilities that allow us to advance our programs rapidly in the clinic, manufacture our candidates reliably, and launch our own products, which Dr. Andy Hurley will discuss shortly. With that, I will now turn the call to Dr. Jennifer Buell. Thank you, Jennifer.

Thank you very much, Garo. I’ll elaborate on what Garo mentioned regarding our research and development productivity, which has become business as usual for us. In the past six years, we’ve delivered 17 new discoveries to the clinic, which is remarkable. In addition to those filings, we have made critical advancements in these programs and have filed our first BLA application for balstilimab, which Garo mentioned has been accepted for priority review by the FDA with an action date of December 16. We're quite excited about that. As Garo shared, Andy will detail the commercial infrastructure we’re putting in place for balstilimab and future products including zalifrelimab. Our data and progress for AGEN1181 is remarkable, and the infrastructure Andy is building will support not just this launch but also AGEN1181. One of the discoveries that propelled us into the clinic is AGEN1777, a TIGIT bispecific molecule developed in collaboration with Bristol. Bristol is committed to advancing this, boasting significant experience in the space, and has an aggressive development strategy, which excites us. Importantly, this strategic partnership allows us opportunities to combine this bispecific with agents from our portfolio. Furthermore, upon approval, we have the opportunity to co-promote. Our FDA clearance for the IND of this asset has us looking forward to announcing the clinical progress. Furthermore, we expect to present data on AGEN1181 later this year based on specific cohorts we are expanding. Addressing CTLA-4 and PD-1 together, we are excited to present updates from CSC patients and their treatment journeys at ASMO. We also submitted a confidential S1 for MiNK Therapeutics, advancing invariant natural killer T cells, which have shown ability to modulate both innate and adaptive immunity. These trials target solid cancers, exploring these cells both as standalone treatments and in combination with validated checkpoint modulating antibodies. We believe these cells can enhance the benefits observed with CTLA-4 and PD-1, and we’ll present data later this year on ongoing clinical programs in patients with multiple myeloma and ARDS related to COVID-19. Lastly, we look forward to sharing updates on our VISION platform that allows us to design molecules addressing biology, identify the best approaches, and predict which patients will respond to our therapies. The combination of our biologics platform and advanced computational capabilities will enhance our ability to identify high-potential patient responses prior to therapy. I’ll now turn over to Andy Hurley to discuss our commercial strategies.

Thanks, Jen. I’m pleased to share our progress in planning the U.S. commercial launch of balstilimab for Advanced Cervical Cancer, or ACC for short. We have assembled a highly experienced leadership team across key commercial and medical functions, and I’m pleased with the collaboration and agility that team has showcased while developing a well-defined strategic and tactical launch plan. An effective launch is largely dependent on the team driving it and we have attracted top leaders from the industry to aid in building the company. Our launch strategy for balstilimab in ACC has two main goals: Firstly, ensuring that all patients who can benefit have access to it with minimal barriers. We’re leveraging innovative launch programs to alleviate typical reimbursement hurdles physicians face when trying to secure newly approved medications. Secondly, aligning a cost-efficient launch with a targeted personal and non-personal promotion approach across channels preferred by physicians based on our market research. The COVID-19 pandemic challenged every biotech firm to rethink their promotional strategies and medical education outreach. We’ll leverage those learnings to effectively present balstilimab to the ACC market. To highlight our launch planning efforts, we have secured a talented team of commercial leaders, including account directors who will engage payers pre-launch, ensuring broad formulary coverage for balstilimab at the outset. We've conducted in-depth market research with physicians and payers to shape our product positioning and messaging. Additionally, we’ve built a data management infrastructure allowing for swift insights generation, enabling real-time responses to feedback from the launch. My observation is that many launches fail due to lack of agility and responsiveness, and we’re prioritizing seamless communication and collaboration across teams to support our launch efforts. Furthermore, partnering with first-rate vendors and agencies will enhance our capabilities across crucial areas such as reimbursement hubs, marketing, medical education planning, and CRM platforms. Our overarching goal for this launch is to establish a foundational step for Agenus which will catalyze the development of a fully integrated commercial infrastructure. This will allow us to efficiently scale our teams and operational systems for future launches, maximizing the value derived from our robust pipeline of products. As Garo and Jen mentioned, we’re particularly excited about the clinical and market potential of AGEN1181 in large indications with high unmet needs. While balstilimab offers therapeutic options for a small patient subset, AGEN1181 has the potential to provide transformative outcomes for a much broader patient population. I’ve been fortunate to lead over 20 product launches in my career, and the promise of AGEN1181 is compelling and rare. It’s a significant reason I joined Agenus. Exciting times lie ahead for Agenus and for the patients we aspire to assist. I’ll now turn it over to Christine Klaskin to discuss our financial results.

Thank you, Andy. We ended the second quarter of 2021 with a cash balance of $74 million, down from $100 million at December 31, 2020. Subsequent to the quarter end, we received $200 million from our Bristol Myers partnership. For the second quarter ended June 30, 2021, our cash used in operations was $56 million, with a net loss of $84 million or $0.37 per share. This compares to cash used in operations for the same period in 2020 of $37 million, and a net loss of $48 million, or $0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021 were $30 million, compared to $18 million for the second quarter of 2020. Our cash used in operations for the six months ended June 30, 2021, was $98 million, with a net loss of $138 million or $0.65 per share, compared to cash used in operations of $72 million, and a net loss for the same period in 2020 of $94 million or $0.59 per share. We recognized revenue of $22 million and $42 million for the six months ended June 30, 2021 and 2020 respectively. This revenue includes earnings related to non-cash royalties and revenue recognized under our collaboration agreements, and $14 million from an upfront license fee we received in 2020. I’ll now turn the call back over to Garo.

Thank you very much, Christine. And thank you once again for participating in our call. I will summarize some highlights for the second half of this year to expect. As Jen mentioned, we have a PDUFA date for balstilimab monotherapy in December, and we’re diligently working in preparation for all aspects of the final phases required. As Andy mentioned, we’re preparing for the commercial launch for second-line cervical cancer and putting together an infrastructure to leverage our future launches. We will define our strategy for balzal and as Jen indicated, you can expect an exciting presentation at the upcoming ESMO conference. We will continue the development for AGEN1181 with a strategy to transition our studies to an approvable study. Additional data presentations for our pipeline of agents and partnered agents are also anticipated in the second half. We aim to advance our AGEN1777, now a Bristol Myers asset, into and through the clinics. We will be completing enrollment for various other programs, and while I can't give specifics regarding our iNKT program due to our confidential S1 filing, we are progressing commercial manufacturing capabilities for antibodies, which is critical for launching AGEN1181 upon demonstration of compelling data. Additionally, we’re working on maintaining a sustainable supply of QS-21, which we consider essential for both prophylactic and therapeutic vaccine applications. As I previously mentioned, we will anticipate additional financial and corporate transactions in the second half of this year. Thank you again for your attention. Now we’re open to any questions you may have.

Thanks, Myra, if you could open the Q&A please.

Thank you. Our first question comes from the line of Kelly Shi from Jefferies. Your line is open. Please go ahead.

Congrats on the progress. And thank you for taking my questions. I have two questions. So, the first one is, what is your marketing strategy for monotherapy in second-line cervical cancer upon approval, given that a combo is probably not too far behind? And also, when can we expect median overall survival data from the monotherapy trial? Does this data impact your commercial strategy for mono versus combo? That’s my first question. And my second question is, could you provide some color on the combo data at ESMO? Thank you.

Let me address the question top-line, and then I’ll turn it to my colleagues for specifics. However, we can't share much about the ESMO specifics as it might risk our participation in the presentation, which is not desirable. Remember that we’ve classified the data as being very exciting. Regarding your first question, generally, combinations with IO therapies tend to yield better results than monotherapy in most cases. We’re talking about improved response rates and very critically, improved durations of responses. In an ideal world, combinations should be the preferred route, but there are regulatory hurdles we need to navigate to ensure these combinations are available for appropriate patient populations. Dr. Buell and Dr. Hurley, please provide further insights.

Sure, I’ll turn it to Andy for your question, Kelly.

Yes, thank you, Kelly. I view each launch as establishing a foundation with the community we are targeting. Launching balstilimab monotherapy allows us to build relationships, understand the market, and learn the dynamics required for subsequent launches. Our strategy is to introduce a much-needed therapy to a wide range of physicians, allowing them to gain trust in balstilimab. We believe that this comfort with the monotherapy will enhance the acceptance of following combinations and their effectiveness. We’re not looking at the launches in isolation, but rather aim to develop a fully integrated commercial infrastructure allowing us to adapt to whatever products we bring to market.

Thank you. Our next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line is open. Please go ahead.

Good morning team. Thanks for taking my question and congrats on the progress. A question for Dr. O'Day regarding AGEN1181. I’m curious about updates possibly at ESMO and your different tumor types, specifically regarding the PD-1 refractory setting and combination data. Also, could you share how many patients are enrolled in the MSS colorectal cohort?

Thank you for that question. We’re excited about the AGEN1181 program. This next-generation CTLA-4 has been engineered for enhanced activity, targeting T regs and demonstrating a favorable toxicity profile. We’re advancing the Phase 1 and 1b program and have treated over 100 patients with either AGEN1181 alone or in combination. We plan to present data at a major conference by year-end, but I can’t divulge more specifics at this time. We've observed encouraging responses in tumors where traditional therapies have failed, particularly in cold solid tumors. We are indeed rapidly expanding our colorectal MS stable cohort and look forward to sharing more updates later.

Thank you for the details. For the bal monotherapy PDUFA, will you have any parallels drawn from recent FDA experiences such as with retifanlimab, and are you expecting an AdCom?

Between now and the PDUFA date, expect intensive communication with the agency and mandated inspections. Out of respect for the process, we will not disclose specific details at this point.

Understood, thanks. Regarding the patients dosed across solid tumors and ARDS, what territories have been involved in the enrollment of iNKT?

Hi Mayank, we can’t provide too much information yet due to the stage we are in. However, we'll aggressively pursue data releases throughout our portfolio.

Got it, thank you. For Garo, as you look at scaling R&D, G&A CapEx, it’s great that the Vacaville facility is coming online to expand your XOMA efforts. How should we think about this moving forward, particularly if QS-21 requires more investment?

Let me address that. We’ve managed cash expenditures versus our balance in an orderly fashion, and the Bristol transaction has significantly boosted our cash inflow. In the second half, we anticipate additional cash injections from various sources including project finance, potential sales of assets and more, reducing cash burn associated with our spin-out companies. These actions should provide us with a strong cash position by the end of each period. However, I can't give dollar guidance at this time.

Thank you for that insight.

Our next question comes from the line of Matt Phipps from William Blair. Your line is open. Please go ahead.

Good morning. Do you have updates on the timing of the bal-zal filing? Can you clarify if we need to wait for the bal PDUFA to clear?

Regarding the bal-zal filing, we plan to provide guidance in the second half of this year. This will depend on data disclosures and discussions with the FDA. As for the PDUFA date, could you remind me what was your question?

That answers my question. For AGEN1327, the TIGIT monospecific antibody, will it still move to Phase 1 this year after its transition to bispecific?

The bispecific does have clear advantages, but the monospecific antibody may still serve as an important reagent, akin to how PD-1 functions in combinations. Therefore, we’ll proceed with the development of the monospecific while keeping its broad potential in mind, though exact timing for IND filing is still to be determined.

Thank you, Garo. Just one last thought regarding your early-stage pipeline disclosures. Is there a broader move toward bispecific formats and therapies? Should we consider that direction for the evolution of your antibody-based platform?

That presumption holds truth. We indeed possess bispecifics in our portfolio with promising early activity. However, we also have strong monospecifics that we are poised to announce, including one entering clinical testing this year. The immune system operates harmoniously; while certain IO agents function independently, the most exciting activity arises from the symphonic interaction of various components. Our preclinical development using our VISION technology has showcased the exciting fusion of our own portfolio, which allows us to meticulously merge agents for optimal efficacy.

Thanks, Garo. There are no further questions at this time. You may continue.

Thank you very much for your attendance and for listening to our updates.

This concludes today’s conference call. You may now disconnect. Have a great day.