Earnings Labs

Agenus Inc. (AGEN)

Q1 2017 Earnings Call· Thu, May 4, 2017

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Transcript

Operator

Operator

Good morning and welcome to the Agenus First Quarter 2017 Conference Call. As a reminder, we will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator instructions] Please note this event is being recorded. I would now like to turn the conference over Ms. Michelle Linn, Agenus Vice President of Corporate Communications. Please go ahead madam.

Michelle Linn

Analyst

Thank you. Welcome to the Agenus first quarter 2017 conference call. Before I continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding the company’s potential income stream, research and development, and clinical trial activities, the publication of data and potential application of the company’s technologies, and product candidates toward the prevention and treatment of diseases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Reference to these risks and uncertainties is made in today’s press release and they are disclosed in more detail in our most recent filings with the US Securities and Exchange Commission. These statements speak only as of the date of this call and Agenus undertakes no obligation to update or revise these statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties. As a reminder, this call is being recorded for audio broadcast. With me today is Dr. Garo Armen, Chairman and Chief Executive Officer, Dr. Jennifer Buell, Vice President, Research and Development Operations, Dr. Jean-Marie Cuillerot, our Chief Medical Officer and Christine Klaskin, Vice President, Finance. During this call, Garo will provide a corporate update, Jean-Marie will talk about our clinical plans and deliver both, Christine will provide a financial review and Jennifer Buell will be available for questions on our pre-clinical program, we’ll then open up the call for questions. With that, let me turn the call over to Garo.

Garo Armen

Analyst · JMP Securities

Thank you, Michelle, and thank you all for joining us this morning. We’ve had an active start to the year with notable developments both on the corporate front, in the clinic and in research. We took significant actions to focus our programs that support our path to rapid commercialization. Also and importantly in the first quarter we amended our collaboration agreement with insight that resulted in 80 million cash influx and an estimated 70 million reduction in projected cash burn over an 18 month period. This represents a favorable $150 million swing in projected cash requirements over the period. With this amendment right to the novel and differentiated antibody program targeting TIGIT reverted to Agenus. We expect that our antibody against TIGIT will have added advantages when combined with our first generation checkpoint antibodies targeting CTLA4 and/or PD-1, both of which are in clinical development today. In March, we shared news of streamlining our R&D operations with the goal of focusing our efforts on lead programs and the elimination of certain others which we regard as none core at this point. In our efforts to consolidate and streamline our operations, we announced our plan to close our Basel site this year. Key functions from Basel are being transferred to our site in Cambridge UK and to our headquarters in Lexington, Massachusetts. We anticipate that our revised agreement within Incyte and our organizational streamlining, one extends our cash runway beyond what it would have been under the prior agreement terms. Two, allows Agenus to focus on accelerating development and commercialization of assets central to our strategy. These include our PD-1 and CTLA4 antibodies and neoantigen cancer vaccine AutoSynVax and of course immuno-oncology combinations are central to our development, differentiation and pricing strategies. Three, these actions are allowing us to prioritize our…

Jean-Marie Cuillerot

Analyst · JMP Securities

Maybe an opportunity for Garo. Thanks Garo and good morning. As Garo mentioned, we are making every effort to sharpen our focus and concentrate on programs with a potential for rapid filing opportunity. One key program is our antibody, 2034. We are pleased to report that this monoclonal antibody last month. We have our first patient and we will wish dose levels that are very likely to be used throughout the program shortly. We refunded those that we will use for clinical activity determination based on safety, PK and occupancy data. This will enable two streams of activity. First, we’ll initiate our expansion cohort in cervical cancer in the second half of the year. Second, we’ll initiate a phase 1b study that will combine anti-CTLA4 and our anti-PD-1 antibodies. Of course these two upstream, we were in parallel and we expect early rate hours of safety and efficacy in the next nine to 12 months of the cervical cancer cohort and for the PD-1 and CTLA4 combination. Now let’s have a look on our anti-CTLA4. Our CTLA4 agonist 1844 is advancing to dose escalation studies with no safety concerns observed today. We present our data at ASCO next month. These two single agents are integral to our near term clinical plants. However, they are just stepping stones for mid-term strategy that is best on combinations that can be placed in two categories. The first category consists of vaccine checkpoint combination and this combination can take the form of the vaccine plus anti-CTLA4 or vaccine plus anti-PD-1 or vaccine with CTLA4 and PD-1. The second category consists of the development of antibody programs that address innovative targets such as 4-1BB and TIGIT. And of course these drugs will be evaluated in the clinic as single agents for in combinations with products…

Christine Klaskin

Analyst · JMP Securities

Thank you, Jean-Marie. Cash, cash equivalents and short-term investments were $124 million at March 31, 2017 compared to $76 million at December 31, 2016. For the first quarter ended March 31 2017, Agenus reported a net loss of $17.1 million, or $0.18 per share, compared with a net loss for the first quarter of 2016 of $31 million or $0.37 per share. The decrease in net loss for the three months ended March 31, 2017, compared to the net loss for the same period in 2016, was primarily due to the accelerated milestone payment we received from Incyte. Our operating expenses increased $6.1 million over the same period in 2016 primarily due to the later stage advancement of our programs. I now invite Garo to make any closing statements.

Garo Armen

Analyst · JMP Securities

Thank you, Christine. To summarize, we have taken deliberate measures to support the registrational trajectory of the programs at the forefront of our clinical strategy, namely CTLA-4 and PD-1. In addition to our de-risk programs, we're also prioritizing our innovative programs in our preclinical pipeline, including our next generation CTLA-4 molecule, our novel antibodies targeting TIGIT and 4-1BB and our neoantigen vaccine, AutoSynVax. We have revealed that our previously undisclosed programs include cellular therapy candidates, which we plan to advance with a framework of an independent subsidiary within externally sourced funds. Agenus is to hold majority stake in the company. We continue partnership discussions to accelerate development, further add to our cash balance and reduce our cash burn. And lastly, we continue to collaborate with our corporate partners Incyte and Merck to ensure the success of our partnered programs, in which we have a substantial financial stake. With that, I'd like to thank you for joining us on this call today. We hope our update was informative and we look forward to providing additional updates in the future. On that note, I will turn the call back to Michelle.

Michelle Linn

Analyst

Thank you, Garo. Operator, you can now open the call for question.

Operator

Operator

[Operator Instructions] The first question is from Mike King of JMP Securities.

Mike King

Analyst · JMP Securities

Good morning, guys. Thanks for taking the questions. Just quickly for Christine, on the revenue side, if we back out the one-time payment from Incyte, what were revenues for the quarter? And secondly, is this the only time we should expect any revenues from the prepayment of the royalties from Incyte?

Christine Klaskin

Analyst · JMP Securities

Yeah. So our revenues for the quarter were approximately $7 million taking out the 20 million upfront received or the 20 million in advanced milestones received from Incyte. At this time, that's all -- we're not projecting any future milestone payments in 2017.

Garo Armen

Analyst · JMP Securities

[indiscernible] is an additional proceed coming in from the approval of Shingrix expecting when GlaxoSmithKline gets approval, which is anticipated in the second half of this year and that will be in the order of about $15 million. In addition to that, there may be some milestones coming from our other collaboration between now and the year end.

Mike King

Analyst · JMP Securities

Okay. Other collaborations meaning Incyte or apart from Incyte?

Garo Armen

Analyst · JMP Securities

And/or Merck.

Mike King

Analyst · JMP Securities

And/or Merck. Okay. Great. Thanks for that. Second brief question is, maybe you could talk about how you’re thinking about the combination of 1884 and 2034 as far as how you might dose escalate. Is there any roadmap from the Ipi/Nivo combinations that might help inform how you guys might think about the combination of 1884 and 2034?

Jean-Marie Cuillerot

Analyst · JMP Securities

Hi. So yes. There is a lot of data out there about the best way to combine anti-PD-1 and anti-CTLA-4. Today, you have data from multiple fronts, not only with Ipi/Nivo that provide information on the safety profile of the pharmacodynamics and on the clinical activity of this combination. So the short response is yes. We have come to a lot of information from what has been published particularly from [indiscernible] most likely the best schedule and dose for the anti-PD-1 condition with the PD-1.

Mike King

Analyst · JMP Securities

Okay. Thanks for that. And then just finally, Garo, I don't know what you can say about the cell therapy program. Maybe just in vague general terms, can you say anything, is it like CAR T or is it like TCR, is it just as the therapy themselves. What kind of general direction can you steer us and as far as that subsidiary is concerned?

Garo Armen

Analyst · JMP Securities

Great. So clearly, we will disclose more data on this as we get closer to launch date for the company or the subsidiary. But our strategy, while we are somewhat behind the other players in terms of clinical development, we clearly have a differentiated strategy. Otherwise, we would not be pursuing it. That differentiated strategy is based on the fact that number one, the current therapies address a relatively narrow market. So our strategies involve going beyond that. Secondly, as you know, the emphasis is on CAR T-cells out there and that is not our emphasis, even though we do have a collaboration -- external collaboration that may result in some products with a CAR T approach, we ourselves are not actively pursuing that. The strategy involves both autologous approaches as well as off the shelf or allogeneic approaches, but because of competition, we're not at liberty to disclose the details of that either at this point. Of course, as we get closer to a launch date, some of these details will be disclosed. Other than that, Jen, would you like to add any other comments?

Jennifer Buell

Analyst · JMP Securities

I think that you've covered that and we're looking very forward to sharing out what our approaches are as well as our differentiate, opportunities that we have with the [indiscernible]

Mike King

Analyst · JMP Securities

Okay. If I may, the disclosure, would that be when you file an IND, when you are about to present or publish data at a conference or in a journal, peer-reviewed journal, any clues there?

Garo Armen

Analyst · JMP Securities

Well, it will be governed by legal disclosure requirements, as we get closer to launching or as we get to the point of launching the subsidiary officially.

Operator

Operator

The next question is from John Sonnier of William Blair. Please go ahead, sir.

John Sonnier

Analyst · William Blair. Please go ahead, sir

Thanks a lot for taking the question and thanks for really nice update, Garo. This is bigger picture question. You’ve really put together a very diversified collection of assets and I think it’s quite remarkable for a company of your size, you had a fairly meaningful step up in R&D over the fourth quarter and it’s really a question about your thought process in managing this now. I would love to just hear you talk about how you prioritize, where do you spend the incremental next R&D dollar? Thanks.

Garo Armen

Analyst · William Blair. Please go ahead, sir

Thank you very much John. As we indicated at the time of our realignment announcement, clearly, our company is focused in two areas. One, combinations of checkpoint antibody and that includes both combinations with first generation antibodies such as CPLA-4 and PD-1 and we are focused on literally sprinting to the finish line in terms of registration for a combination of CTLA-4 PD-1 in specific indications. Now, we’ve disclosed one indication as Jean-Marie alluded to that cervical cancer, but we have not disclosed our second target indication for competitive reasons. We do have a plan that will be unleashed near term in the form of starting clinical trials and that involves a larger target indication, but a subpopulation of that larger indication with both our agents and other complementary agents. So that's one area of focus. The second area of focus for us is clearly develop our novel antibodies, take them into the clinic and develop them in combination with the first generation checkpoints, meaning CTLA-4 and/or PD-1. And thirdly, as you heard from Jean-Marie, we initiated our AutoSynVax trial just recently and enrollment in that trial is closed. So we have enrolled patients at record time and we're very eager to start combinations of AutoSynVax along with our checkpoint antibodies, which we believe as I alluded to earlier, are key to expanding the current immunooncology market that is just responsive to checkpoint antibodies and go beyond that. So that is our focus. And we are clear on what we need to get done and as you can tell from the progress that we've made over the last two years, you cannot deliver on what we have without being focused on those issues. With regard to cell therapy, now, this is a research effort that got initiated close to two years ago and less than that 18 months actually and there have been some very important developments there in terms of getting our first candidate product that has been identified into the clinic. However, because of what you said, because of the fact that we need to remain focused in order to deliver on our key priority programs, we have decided that this effort deserves its own infrastructure, its own capabilities and its own separate financing to take it forward. And hence our decision to set it up as a separate subsidiary and fund it accordingly.

Operator

Operator

The next question is from Ramakanth Swayampakula of H.C. Wainwright. Please go ahead.

Ramakanth Swayampakula

Analyst · H.C. Wainwright. Please go ahead

Thank you. Good morning. A couple of quick questions. In the press release, you reported that TIGIT has been reverted back to Agenus from Incyte. I'm just trying to understand what are your plans with this molecule and who made Incyte decide not to pursue on their dollar, but give it back to you.

Garo Armen

Analyst · H.C. Wainwright. Please go ahead

First let me correct an erroneous statement that you have made in that Incyte decided not to pursue it. This was part of a negotiation between us and Incyte and I would not at all suggest that Incyte did not want to pursue this molecule. It was terms of the negotiation that allowed us to basically get it back. This is our discovery. It is a very important molecule, a very important target and we have the capabilities to develop it either as a single agent or and/or in combination with some of the first generation antibodies that we have. So that's one clarification. Secondly in terms of what we plan on doing it, we are literally sprinting with this molecule to take it into the clinic and once we take it into the clinic, we will disclose more specific plans in terms of how we plan on developing it.

Ramakanth Swayampakula

Analyst · H.C. Wainwright. Please go ahead

Thanks for the clarification as well. On the AutoSynVax program, I'm just trying to understand, we’re going to see some data by the year and. Is that a place for AutoSynVax to be developed as a monotherapy or you are basically going to be thinking of it as a combination program from here onwards?

Garo Armen

Analyst · H.C. Wainwright. Please go ahead

Jean-Marie.

Jean-Marie Cuillerot

Analyst · H.C. Wainwright. Please go ahead

Thanks for your question. There are plenty of data supporting that the activity or vaccine is largely amplified when they’re combined with checkpoints. The first data pretty much 10 years old and whatever the platform that is used can be vaccines or peptide [indiscernible] these drugs have to be combined with checkpoint to deliver the most activity. Here, the question will become how to manage the administration of vaccine in diseases that where checkpoints are already used as a standard of care, but we are going to evaluate that.

Operator

Operator

[Operator Instructions] This concludes our question-and-answer session. I’d like to turn the conference back over to Mr. Armen for any closing remarks.

Garo Armen

Analyst · JMP Securities

Thank you very much everybody and thank you for the very insightful questions. Of course, we are always ready to address more questions individually and we look forward to interacting with you going forward of course. And I believe Michelle, we have –

Michelle Linn

Analyst

Yeah. We just want to remind listeners that the call will be accessible from the company's website at www.agenusbio.com. Thank you.

Operator

Operator

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your telephones. Thank you.