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Agenus Inc. (AGEN)

Q4 2017 Earnings Call· Thu, Mar 15, 2018

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Agenus Fourth Quarter and Full Year 2017 Financial Results Conference Call. As a reminder, today's conference call is being recorded. Now, I would like to turn the conference over to Jennifer Buell, Head of External Affairs and Communications at Agenus. Please go ahead, Dr. Buell.

Jennifer Buell

Management

Thank you, and welcome to the Agenus Fourth Quarter and Full Year 2017 Financial Results Conference Call. Before I continue, I'd like to remind you that this conference call will contain forward-looking statements, including without limitation, statements regarding the Company's potential income stream, research and development and clinical trial and manufacturing plans and activities, the publication of data, the potential application of the Company's technologies and product candidates towards the prevention and treatment of diseases and the Company's plans to pursue its cell therapy portfolio through a separate business entity. 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 on our recent filing on the U.S. 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, except to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. When evaluating Agenus' business and securities, investors should give careful considerations to these risks and uncertainties. As a remainder this call is being recorded for audio broadcast. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. John Castle, Head of Translational Medicine; Christine Klaskin, our Vice President of Finance; and Bruno Lucidi, CEO of AgenTus Therapeutics, Agenus' cell therapy subsidiary. During this call, Garo will provide a corporate update and introductions to expansion of our leadership team. Christine will provide a financial review. We will then open the call for questions. With that, let me turn the call over to Garo.

Garo Armen

Chairman

Thank you, Jen. Good morning and thank you for joining us on our quarterly and annual update. We believe as a company that innovation and speed defines the presences and the future of immuno-oncology. Today, Agenus is set up to deliver on both of these. Now let me tell you some of the highlights and how we are going to do this. I will also review our accomplishments for 2017 and tell you about our plans for key developments during 2018. Firstly, last year, we launched our phase 2 combination trials of Agenus AGEN1884 which is our CTLA-4 antibody with Keytruda, Merck's PD-1 antibody. This is in patients with first-line non-small cell lung cancer. These patients are tested to have PD-L1 expression levels of over 50%. They represent a clearly defined patient population and a potentially significant commercial opportunity for us. This trial can lead us to our very first approval submission for our CTLA-4 molecule by the end of 2019. Secondly, we completed dose escalation clinical trials of our CTLA-4 and our PD-1 compounds. We reported pharmacological and biologic activity of our antibodies at major conferences last year. This year, we also launched a phase 2 combination trial of these proprietary agents in second line cervical cancer. This combination trial may also support a BLA filing as soon as 2020. Third, and very importantly, we advanced five novel immuno-oncology antibodies discovered and developed by Agenus last year. We expect to file INDs for at least three of these antibodies this year. The first IND filing will be our next-generation CTLA-4 designed to deplete Tregs and improve T cell priming. Depleting Tregs is critical to overcoming the limitations of current immuno-oncology treatments. Successfully depleting Tregs will expand the market for immuno-oncology treatments significantly by including many more patients and many…

Bruno Lucidi

CEO

Thank you, Garo and Jane. I'm actually very glad to be leading AgenTus. Cell therapy has shown life-saving potential for patients left with no option and have created significant value for shareholders. However, currently adopted cell therapy have limitations as you all know, the ability is largely restricted to hematologic tumors, they have shown a major substancities and they also have manufacturing and logistical challenges and very high cost of production. We believe AgenTus technologies and capabilities can potentially address those limitations. First, our proprietary platform has generated high-quality T cell receptor TCR libraries designed to target solid tumors. Secondly, proprietary allogeneic formats can address manufacturing and logistical challenges thereby addressing scalability and cost. Thirdly, our proprietary library of phosphorylated agents is designed to optimize efficacy and improve safety potentially with an off-the-shelf mechanism. Most compelling is our unique advantage of access to de novo discovery platform, core capabilities in bioinformatics, structural and computational biology, molecular and cell biology and also importantly the pipeline of validated checkpoint antibodies and bispecific tumor microenvironment conditioning agents to rapidly develop first-in-class combinations with potential curated benefits to patients. We are advancing our lead programs patient collaboration. I believe that AgenTus has great potential to provide substantial value to patients and for our shareholder by advancing a pipeline of highly differentiated therapies and part of huge opportunities. I'm excited to lead AgenTus and our experienced and talented team, that we call our team. Now, I will turn over to Christine Klaskin to provide the financial update.

Christine Klaskin

Management

Thank you, Bruno. Cash and cash equivalents were $60.2 million at December 31, 2017. Subsequent to the end of the year, Agenus received net proceeds of approximately $28 million from our royalty bond restructuring. For the fourth quarter, Agenus' cash used in operating activities was approximately $25.8 million compared to approximately $26.2 million during the third quarter, while our reported net loss for the quarter was $35 million or $0.35 per share compared with a net loss for the fourth quarter of 2016 of $26.1 million of $0.30 per share. Cash used in operating activities for the year ended December 31, 2017 was $94.2 million, compared to $80 million for the year-ended 2016. The company incurred a net loss of $120.7 million or $1.23 per share for the year ended December 31, 2017. This compares with a net loss of $127 million or about $0.46 per share in the same period in 2016.

Garo Armen

Chairman

Thank you, Christine. Now, I think, I will turn it back to the operator for any questions that you may have.

Operator

Operator

[Operator Instructions]. Our first question comes from Mike King with JMP Securities. Please go ahead.

Mike King

Analyst · JMP Securities. Please go ahead

Good morning and thanks for taking the questions. Sorry about the background noise. I wanted just to ask you, you know sort of how carefully you are going to be looking for the results of the CheckMate -227 study that will be coming at AACR in a couple of weeks to see if there is any requirement or maybe just prudent judgment to resize your study of AGEN1884 and pembro? That's the first question.

Garo Armen

Chairman

So, the answer to that question is, we will be looking at it very carefully as we have to – with all of the previous trials, you know we have to define our strategy, clinical strategy specifically. Jen, why don't you expand on that?

Jennifer Buell

Management

Thanks Garo. Mike, thanks very much for the question and I'll just reiterate that certainly we'll be looking out for these results. But I just wanted to remind you something we've spoken about before is we are taking our agent AGEN1884 on top of Keytruda. And an indication in first line ling where Keytruda is approved where patients are selected based on an approved diagnostic, thereby removing the regulatory and technical risk and ensuring a high probability of success. With the results that we anticipate, seeing now a host of data most recently coming out of ASCO TI, where our PD-1 is active. We see that CLTA-4 add on in lung and MSI-high colorectal cancer increases the response rate and the durability of response. We know that Keytruda has a 46% response rate in the patient population and we expect a significantly higher response rate with the add-on of our AGEN1884. So, we believe that we have the sufficient sample today, but we'll certainly be monitoring the competitive landscape as we go forward.

Mike King

Analyst · JMP Securities. Please go ahead

Maybe you could talk about how you – you know what's a win for you guys? Is it both showing superiority, non-inferiority, if let say numerically advocacy wise you are a bit lower, do you, you know if then, but provide a better tolerability profile? Is that a win? I don't know if you can sort of discuss the various potential outcomes that favor you?

Garo Armen

Chairman

So let me first take the crack at it. Let me tell you what is not a win? What is not a win is a marginal improvement on efficacy and marginal improvements on safety. That is not a win. What we are looking for in all of our trials is a significant delta with regards to efficacy. That is the foremost in our strategy, not just in the context of the first line non-small cell lung cancer trial, but in pretty much everything that we are doing today, hence, our preoccupation, our prioritization of combinations. Because with single agents, we do not believe that you will get to the kinds of outcomes that will differentiate us as a company and put us on a rapid commercialization timeline. Jen, do you want to add anything to that?

Jennifer Buell

Management

I think you covered it Garo. Mike, I hope that addresses your questions.

Mike King

Analyst · JMP Securities. Please go ahead

It does. We'll obviously look, as everyone else will be for Checkmate -227. I maybe wanted a quick follow up on the novel CTLA-4. Garo, I know you said it's going to be published in, so I don't know how much you can talk about in advance of the publication. But just in terms of the – figure out exactly what your words were as far as the improvement in activity is concerned, but should investors also be concerned about the potential for increase toxicity or adverse events.

Garo Armen

Chairman

So, I mean with a new molecule, clearly you always, have to watch for what may be a hurdle in terms of adverse events. But just a couple of things on this; one, we cannot elaborate and give you more details on this compound and its activity, for both IP reasons as well as the fact that we have an upcoming publication, and we don't want to jeopardize that certainly. Having said that, Mike, as you know our research capabilities are quite expansive. We have the ability to design very carefully properties into molecules and generate these candidates also very rapidly in a way that minimizes these potential risks. You can never eliminate them, but the design of these molecules both the next-gen CTLA-4 as well as I-O bispecific antibody are to address both optimization of efficacy and minimization of side effect. Now as I mentioned before, for example, one of our bispecifics, dose intratumoral depletion of Treg. Now, this is a very important issue, very important issue because if you deplete Treg broadly speaking, yes you may risk other safety issues, but if you do it intratumorally, it gives you a big advantage. Hence we think our molecule is the best-in-class and the first-in-class to be able to do this effectively. Jen and John, if you'd like to add any more color to this, please?

Jennifer Buell

Management

I'll just add one thing because I am really quite excited about this particular mechanism. At Agenus, we believe we'll be the first to publish on this mechanism. I think it may be something that we certainly engineered it into our antibody and it will likely change the way that antibodies are made in the future at least some of them. What we are looking for Mike, is to get to – we may be able to achieve an optimal pharmacologic dose at a lower dose than what we see with some of the current first generation CTLA-4. So again, as Garo mentioned, we will need to validate that in the clinic, but we are really quite enthusiastic about it and as soon as possible we'll make sure that you'll get visibility to that publication.

Dr. John Castle

Analyst · JMP Securities. Please go ahead

As Garo pointed out, I think just reiterating the dual effect of both looking at the Treg depletion and also to increase priming is going to be very essential and so we are looking forward to that. It's going to be in the publication as well.

Garo Armen

Chairman

Thank you, John.

Mike King

Analyst · JMP Securities. Please go ahead

Great. It sounds exciting guys. And then just one other quick question on AgenTus, and apologies if I should know this. But just wondering what sort of timing you might want to talk about revelation of your – the first target or set of targets for your cell therapy? Thank you.

Garo Armen

Chairman

I will let Bruno to address that question at his discretion.

Bruno Lucidi

CEO

For now, we are not disclosing any information about our cell therapy. We believe that we should be starting to disclose some information during the third quarter – during the second quarter this year, you know some time in May, June.

Garo Armen

Chairman

Thank you, Bruno.

Mike King

Analyst · JMP Securities. Please go ahead

Thanks for taking my question.

Jennifer Buell

Management

Thanks Mike.

Operator

Operator

[Operator Instructions] And our next question comes from Matt Phipps with William Blair. Please go ahead.

Matt Phipps

Analyst · William Blair. Please go ahead

Hi guys. Thanks for taking my question. I guess first, I was wondering if you could talk about your bispecific platform. Is this based off of single-chain variable fragments or maybe now then to whole for full size antibodies, anything you can disclose there?

Garo Armen

Chairman

Okay. So, one thing that I can tell you is that we're not using their traditional proprietary platform. So we very carefully examined where our freedom to operate lies and engineered our bispecifics based on that and based on our ability to engineer the FC regions, as well as specifically target the relevant finding domain. We have become experts at doing this, and but unfortunately because of the fact that I can't even disclosed to you, which bispecific they are for reasons of confidentiality, our partnership discussions, as well as competitive reasons.

Jennifer Buell

Management

Now I am going to add just one thing. We've had a chance to discuss this, the publicly available information on related to our approach. We have established a high throughput ability and capability to be able to identify optimal combinations. We have some research collaborations and exploiting those capabilities. And what that allows us to do is agnostically identify what are the best combinations to address an area of unmet need for a novel target development. And that's where we think the major differentiation is. We then moved to a platform that we know works and we know that has freedom to operate and it leverages parts of our own proprietary platforms that bring the molecules to life essentially if I may. But essentially, for us that critical feature is the optimal combination that actually creates that novel molecule and less so that's the bispecific platforms.

Garo Armen

Chairman

Thank you, Jen.

Matt Phipps

Analyst · William Blair. Please go ahead

Thanks. So now moving on to, I guess non-small cell. Has AGEN1884 completed dose escalation with Keytruda at this point?

Jennifer Buell

Management

Yes, it has, and completed dose escalation.

Garo Armen

Chairman

So we have picked the optimal dose and the dosing regimen.

Matt Phipps

Analyst · William Blair. Please go ahead

And so how many patients do you think will be needed to generate a margin of data set to go to the FDA in this biomarker defined patient population?

Garo Armen

Chairman

Okay. So based on our concerns about competitive reasons, and also with our assumptions for this trial, when Mike earlier asked the question of what do we consider success or what will be considered success, a significant data – delta rather in benefits which we haven't disclosed. So, if I give you the patient numbers, one can work backwards and figure out what that delta is and we don't want that to happen for competitive reason. That's one of the reasons we will be quite on this.

Matt Phipps

Analyst · William Blair. Please go ahead

Okay. So Merck recently started KEYNOTE-598 which is a 550 patient trial of pembro first Yervoy and people with PD-L1 positive or 50% non-small cell lung cancer. How that you see that playing a role in kind of the competitive landscape and regulatory discussions?

Garo Armen

Chairman

Based on public information, the maturity date for that trial is longer than ours. So, it will be contingent on how quickly they enroll versus how quickly we enroll. But with our assumptions and their assumptions, their maturity date will be somewhat later than our maturity date.

Matt Phipps

Analyst · William Blair. Please go ahead

Okay. Thanks. And then lastly, Merck also just got a priority review for single agent KEYTRUDA in advanced cervical cancer. Have you guys changed your development plans at all there for wholly-owned combination and what's the plan there? I know that was kind of one of the target indication for rapid development.

Garo Armen

Chairman

So one, let me start, and Jen will elaborate more if she like. So clearly, we believe that combinations in cervical cancer will exceed by some margin, the efficacy of a single-agent. And that's one of the reasons we've chosen the indication and we've chosen the combination strategy. So, that's key to our assumptions. And should that happen, then, we will have an important competitive advantage. Jen?

Jennifer Buell

Management

That's right. And actually we were excited to see this validation of PD-1 in second line cervical cancer. Again this is one of those tumors largely HCV induced, cervical cancer is more than 90% of cases. And what we know with those tumors of course is that you generally have higher mutational burden, you have higher response rate. We know that their response rate to PD-1, but very similar indications, HCV-induced tumors and otherwise we see where PD-1 is active, the addition of CTLA-4 increases the response and the durability of response. So we believe that this only validates our strategy and gives us an opportunity that may help to accelerate our programs.

Garo Armen

Chairman

So with that, we have some time constraints. Unfortunately, we need to end the call. And so, I will ask the operator to wrap up. And if you have any other questions, please contact us separately. Thank you very much.

Operator

Operator

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