Christine Klaskin – Principal Financial Officer, Principal Accounting Officer, Vice President Finance Garo Armen – Chairman of the Board and Chief Executive Officer Bob Stein – Chief Scientific Officer.
Jason McCarthy – Maxim Group Reni Benjamin – HC Wainwright.
Good day, ladies and gentlemen. And welcome to the Agenus Q1 Earnings Conference Call. As a reminder, today's conference is being recorded. At this time, I would like to turn the conference over to Christine Klaskin, Vice President of Finance. Please go ahead Ms. Klaskin..
Thank you, Angel. Welcome to the Agenus conference call to discuss our first quarter 2015 financial results.
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 activity, and the publication of data and potential application of the company's technologies and product candidates and the prevention and treatment of diseases.
These forward-looking statements are subjects 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 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. 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 are Dr. Garo Armen, Chairman and Chief Executive Officer; and Dr. Robert Stein, Chief Scientific Officer.
During this call, we will review our financial results, as well as provide a corporate update. We will then open up the call for questions. With that, I will now review our first quarter 2015 financial results.
The Company’s cash burn which is defined as cash provided by operating activities excluding up-front fees received and contingent purchase price payments for the first quarter of 2015 was $10.7 million compared to $10.1 million for the same period in 2014.
For the first quarter ended March 31, 2015, Agenus reported a net loss attributable to common stockholders of $18.7 million, or $0.28 per share, basic and diluted, compared with a net loss attributable to common stockholders for the first quarter of 2014 of $409,000, or $0.01 per share, basic and diluted.
The increase in the net loss attributable to common stockholders for the quarter ended March 31, 2015, compared to the net loss attributable to common stockholders for the same period in 2014, was primarily due to non-cash, fair value adjustments of our contingent liabilities in 2015 and non-cash, non-operating income during the quarter ended March 31, 2014.
Cash and cash equivalents were $79.3 million as of March 31, 2015. This concludes the financial portion of the call. I will now turn it over to Garo, who will provide a corporate update..
So one correction on Christine’s numbers that cash and cash equivalents were $79.3 million at the end of the quarter, just a little miss out there. Okay, thank you very much Christine and thank you for all joining us this morning, we began the year building on the momentum of our achievements in 2014.
In the past few months we have executed two strategic transactions which will strengthen our efforts to develop novel immuno-therapies for patients with cancer and help us continued to build shareholder value.
In January, we announced a global alliance with Incyte, which combines Incyte’s track record of success in drug discovery, development and commercialization, with our expertise in immune-oncology biologics. More specifically, our strengths are in the development of novel checkpoint modulator antibodies.
The Incyte partnership is focused on advancing checkpoint modulating antibodies against four key immune checkpoint targets, GITR, OX40, TIM-3, and LAG-3. For the GITR and OX40 antibody programs, we will co-fund product development with Incyte equally and share profits 50-50.
While TIM-3 and LAG-3 programs are royalty bearing programs that will be funded entirely by Incyte with the potential for milestone payments for up to $155 million per product and tiered royalties on product net sales its rate ranging from 6% to 12%.
For royalty bearing programs namely TIM-3 and LAG-3, we also have the option to co-fund 30% of late stage development cost in exchange for enhanced royalties. In addition to these initial four target programs, both parties will have the option to jointly nominate and pursue additional targets within the framework of this multi-year collaboration.
Also just a few weeks ago, we announced the expansion of our antibody discovery platform, acquiring key assets from Celexion. Most importantly, we gain the SECANT yeast display platform for the generation of monoclonal antibodies.
SECANT platform is designed to produce soluble full-length monoclonal antibodies very rapidly, this yeast based platform is highly complementary to our Mammalian Retrocyte Display platform and we can use the two systems together to accelerate development of our proprietary internal programs, as well as programs that we have partnered with both Merck and Incyte.
So as I mentioned, this acquisition advances our efforts to establish world class capabilities in antibody drug discovery and developments and will also benefit our ongoing partnerships with Incyte, which we announced earlier this year and which is focused on the immune-oncology antibody therapeutics.
Also we remain untracked to file two checkpoint INDs by year end and to begin clinical trial studies early next year. In addition to our check point programs, we expect progress in our other clinical stage programs over the course of 2015. Firstly, with Prophage, as previously stated we held an end of Phase 2 meeting with the FDA late year.
At this year’s ASCO conference in June, we expect our academic collaborators to present additional Phase 2 Prophage data on patients with newly diagnosed GBM. This year we also expect our academic collaborators to submit the full Phase 2 study results for Prophage in newly diagnosed GBM to a leading peer-reviewed journal.
We have seen recent advances involving the combination of CPMs and vaccines capitalizing much greater interest in cancer vaccines both from companies who have historically shine this space as well as substantial interest from medical community.
We expect to advance Prophage into a registration study in newly diagnosed GBM later this year and we will provide you with further update as we make progress on this front.
As you are aware, GBM is the most common and the most aggressive primary adult brain cancer with limited and only modestly, very modestly effective therapy, it’s currently available. During the course of this year, we expect our GSK partner to report progress with two vaccines that contain our QS-21 Stimulon Adjuvant.
First, we expect that this full Phase 3 study results for the shingles vaccine will be presented at the Scientific Conference and submitted for publication in a peer-reviewed journal. As you remember last December, GSK announced positive findings from its Phase 3 shingles trial, showing a 97% protection rate in adults over the age of 50.
These results are unprecedent moreover shingles represents a very large market opportunity as in one out of every three adults will get shingles during their lifetime and about one third of the patients with shingles develop post-herpetic neuralgia, which is a very painful and persistent complication.
The target patient population in the U.S., Europe and Japan combined is well over 300 million people. In addition, this year we also expect the European regulatory decision on GSK’s malaria vaccine candidates RTSS or which positive Phase 3 data were also reported late last year.
As you may recall this was the first malaria vaccine ever to successfully complete Phase 3 trials, while annual royalties from this product are expected to be modest, it is a very significant advance in the fight against this deadly disease with potential to save hundreds of thousands of life annually.
As a reminder, both the shingles and the malaria vaccine contains our Adjuvant QS-21 Stimulon and we are genesis entitle to receive low single-digit royalties on potential vaccine commercial sales.
In addition to these two programs, there are additional preclinical and clinical stage QS-21 containing vaccine programs under development by our partners. We of course look forward to discussing our internal and pioneer programs in more detail at our upcoming Research and Development Day event on May 14.
At our R&D day, we will also be providing the financial community with an update on major advances and opportunities in the development of immuno-oncology therapies focused on checkpoint modulators. As many of you know checkpoint modulators has driven some of the most dramatic recent advances in the treatment of cancer.
Presenting at the event will be our management team as well as top [Indiscernible] including Dr. Charles Drake of the Johns Hopkins School of Medicine and Dr. Orin Bloch of the Northwestern University Feinberg School of Medicine. Dr. Drake is an expert on Immunology therapies targeting checkpoints and Dr.
Bloch was an investigator in the Phase 2 trial of Prophage and GBM, We will also be webcasting the R&D day event in the IR section of our website. With that, I would like to turn the call over to Dr. Robert Stein, our Chief Scientific Officer for additional comments and details.
Bob?.
Thank you, Garo.
As Garo mentioned in recent weeks we significantly strengthened our antibody discovery platform when we acquired the SECANT yeast antibody display technology from Celexion, which complements our mammalian antibody display platform Retrocyte Display, these two platforms Retrocyte Display and SECANT position us well to create best-in-class antibodies and quickly advance our candidates through IND enabling studies and into the clinic.
The acquired assets also include Celexion’s novel approaches to identify and characterize antibodies against membrane bound protein targets such as GPCRs and ion channels.
Given these novel approaches and the complementary capabilities as SECANT Retrocyte Display, we will be able to maximize the speed and flexibility with which we can achieve antibody generation and optimization. In additional the Celexion platform will help to support our ongoing collaborations with Incyte and Merck.
Our Incyte collaboration is progressing nicely, as Garo mentioned, we expect to file our first two checkpoint modulators INDs, one on an Incyte partner program and one on our own program this year this will be followed by two or more additional INDs next year, we will advance our first checkpoint modulators into the clinic in early 2016.
We’ve also made significant progress in our Merck collaboration towards our shared goal of discovering antibodies against two undisclosed Merck checkpoint targets for use in treating cancer and which are distinct from our own checkpoint modulating programs.
As Garo noted earlier, we also expect to have additional data on Prophage from the investigators sponsored Phase 2 study a newly diagnosed glioblastoma multiforme to be presented at ASCO this June. Dr.
Orin Bloch from the Feinberg School of Medicine at Northwestern University, who was the senior investigator on the Phase 2 study, will also speak about some of the landscape of potential treatments for patients infected with this devastating primary brain cancer in our fourth coming R&D day event in New York city on May 14.
As Garo noted recent data have shown that vaccines and CPMs can synergize clinically as has been reported for prospect and [Indiscernible]. These advances and our emerging data have spurred heightened interest in Prophage from potential partners.
We are pleased that these emerging results support our long held view that patient specific vaccine approaches like Prophage will have an important place in the treatment of cancer, both as monotherapy in those patients with immune systems that are responsive and up to be educated to recognize tumor antigens and in combination with checkpoint modulators and those patients whose immune systems made for example require relief from immunosuppression.
At our R&D event on May 14, we also expect Dr. Charles Drake of Johns Hopkins University School of Medicine a leader in the scientific aspects and clinical uses of CPMs to share his perspective regarding checkpoint modulators in oncology, including new approaches involving combinations of checkpoint modulators and vaccines.
In closing, I would like to remind listeners that later this year we expect our partner GSK to submit the Phase 3 data for their shingles vaccine to a peer-reviewed journal and to present the data at an appropriate medial conference.
As you may recall last December GSK announced that their prophylactic shingles vaccine had achieved an unprecedented 97% rate of protection at roughly four years in a Phase 3 trial evolving over 16,000 adults age 50 and older.
This vaccine contains a varicella protein E and also contains the Genesis QA-21 Stimulon adjuvant, we believe that this vaccine has the potential to bring truly effective shingles prevention to a much greater portion of the at risk adults.
Beyond its unprecedented 97% efficacy rate which dramatically exceeds the reported 50% to 70% protection rate of the only competitive shingles vaccine currently on the market.
Other potential advantages could include the fact that GSK’s vaccine last the potential to reactivate to spread unlike its live attenuated vaccine alternatives, genesis eligible to receive single-digit royalties from future product commercial sales of these vaccines, containing our proprietary QA-21 adjuvant. Thank you for your attention.
I’d now like to turn the discussion back over to Garo..
Thank you, Bob and Christine. We certainly look forward to providing you with continued updates on our progress with our product pipeline, as well as with our partnerships involving Incyte, Merck and GSK.
We remain committed to developing the next generation of immune based therapies that will further advance the ongoing paradigm shifts in harnessing the immune system to treat cancer and other diseases such as infections. We thank you for your continued interest and support. And with that, I will once again turn the call back to Christine..
Thank you, Garo. Angel, you can now open the call for questions..
Thank you. [Operator Instructions] And your first question will come from the line of Jason Kolbert of Maxim. Please go ahead..
Hi guys, this is actually Jason McCarthy for Jason Kolbert and congratulations.
It sounds like everything is going really well that you’ve really built a platform to start driving your pipeline forward, and I just wanted to go back to the Prophage program and wanted to ask what the company is thinking in terms of a partner even though you are attracting attention for from companies that might have checkpoint inhibitors, but you do have your own and I was wondering, if you are going to drive Prophage into a Phase 3 even in combination with your own checkpoint inhibitors as opposed to seeking out of partnership?.
No, we are clearly looking at all options, but surprises to say that there is a very high-level of commitment now to take Prophage into Phase 3 and that’s what we will hope to update you on as we progress with our strategic decisions in the next several months.
In terms of combinations as you remarked and as Bob mentioned then he can elaborate on this more, there is a very substantial growing amount of data that’s accumulating on the rationale for new vaccines with checkpoints both clinical data as well as preclinical data and that makes obviously the use of our combined tools, our combined products much more rationale, but Bob?.
I think you’ve raised a good point Jason.
We do have the main checkpoint modulators in our own portfolio that consider combining with vaccine and we have the option of doing some pilot work with some of the approved compounds, but ultimately, taking our own compounds in the registration studies the combination of Prophage, we’re looking at the ways to rapidly determine what the right combinations are and to generate the data that will allow us to make good decisions about what to progress with what status..
Great, thank you. So again it sounds like the platform is there and just looking forward to progress this year, thank you..
Thank you for your questions..
And our next question will come from the line of Reni Benjamin from H.C. Wainwright. Please go ahead..
Hi, good morning guys and thank for taking the questions as well.
Can you talk a little bit more about the SECANT platform and how it gets, either integrated into Retrocyte or how the two platforms are different enough that when combined there is synergistic benefit just any color would be helpful?.
Sure, Ren, thanks for the question.
The SECANT platform is a yeast based display platform, the nice feature of it is that it uses a full length antibodies displayed on the surface of yeast and they’re captured by coupling them to the surface of the pellets producing them with a [Indiscernible] link and by a simple shift in the sugar growth conditions for the yeast, you can either make them stay associated with the cell or have them come off in a soluble form and that allows you to do the sorting and keep the antibodies and their specificity combined to the genes of specify, their structures, but then rapidly have stable antibody.
The four antibody Retrocyte Display platform displays the antibodies on the surface of the million cells as B-cell receptors and there is a few steps to get from there to where we have soluble antibody to test and those steps are little bit more labor intensive and take more time.
The nice feature of the Retrocyte Display is that it has also selection in mammalian cell background so the antibodies that emerge have very good pharmaceutical properties that seem to be very well behave from the standpoint of expression levels and aggregation propensity, each stability and sequence corps, so the opportunity exist to quickly use display to generate a panel of antibodies against targets of interest.
Antibodies we like and then be further refined by passes to Retrocyte Display, so we can get both the rapid proving of novel target, we can build in the pharmacologic properties we want and then we have the ability to optimize readily for pharmaceutical tractability by passing through the Retrocyte Display piece, where we can also shift out or swap out, heavy change and light change very readily optimize around any particular starting point..
And so, I guess and so the focus – is it fair to say that the focus of the platform now is to not necessarily make better monoclonal antibodies to targets that are already well-known or characterized, but really to go after novel target?.
Well, I think it’s fair to say that we want the balance of high quality compounds addressing the targets that have a high degree of base value [validity], but also want to be able to explore the border zone of things that are emerging into interesting degrees of validation and we have the ability to use this to generate virtual [Indiscernible] those targets and their potential biological roles.
Our portfolio in addition to the six programs that we’ve talked about publicly includes another half dozen programs that we haven’t publicly disclosed based on targets that we’ve now develop patient belief and to activate programs around it..
Got it, and just as a – just a reminder, you’ve talked about filing INDs and being in the clinic by early next year, I had no notes that the GITR and the CTLA-4 programs were the sort of the horses at the head of this race, is that still the case or has anything changed?.
Those are still on track some other horses are closing in and may come in pretty close behind those, but GITR and CTLA-4 is still on track..
Okay.
I guess one sort of a broader, make you thought provoking question is when we think about Prophage and the checkpoint, and the potential combination with checkpoints and I think you guys had a collaboration with somebody at the New York based University, I wanted to get an update how that was going, but sort of the bigger question is, we think about either focused, I think about either focused peptide vaccines in combination with checkpoint inhibitors or something like Prophage, which supplies multiple antigens and checkpoint inhibitors and there’s probably pros and cons of both type of approaches, one con for a Prophage type of approach might be that you get a whole slough of antigens both self and new antigens that could cause problems versus the focus peptide and of course the focus peptide version you might not yet as much of a robust immune responses you want or maybe there is more escape.
Have you guys been thinking about this at all and do you kind of have any thoughts as to how you may play off both going forward?.
So let me answer the first part of your question very briefly about the collaboration, which was not in New York hospital, it’s Texas and that program with melanoma vaccine combination were checkpoints was we designed because the – at the time we had submitted the application shortly thereafter, the treatment standard change because Yervoy was introduced and then PD-1 obviously got approved, so that program is still active, but we have revised the protocol, but Bob, if you can address the other questions as well..
Sure, so Ren, I think that the general question you raised is very important. One of the things we recognizes the importance of neoepitopes occurring from passenger mutations in the course of the generation of cancers transformations.
So Prophage is very powerful and that it doesn’t require us to be smart enough to figure out exactly what the potential neoepitopes are because we harvest [Indiscernible] agnostically, that said, we build a lot of internal expertise in trying to analyse the genome of tumours and understand what the mutant proteins implied by that change in the Genome are and what the potential T-cell new epitopes that they may in gender are also being thought about carefully and we have two opportunities, one is to work with Prophage where we grind up tumours and do the agnostic sample.
And the other is to make a syntactic personalized vaccine using our heat shock protein platform and synthetic peptides which are loaded onto that heat shock protein and can be combined with our QS-21 adjuvant and we’re in the midst of studies looking at that including the beginning of a clinical study in multiple myeloma with that objective.
We know that that heat shock protein heterologously expressed and loaded up the synthetic peptides will in generally a powerful anti peptide responses because of the study that we did with the herpes simplex virus 2 genome, where we use heat shock protein 70 heterologously expressed and loaded up with 32 different, 35 peptides out of the herpes simplex virus 2 genome and that produced very robust CD4 and CD8 responses and influence viral replication.
So we are looking at both options, the algorithms for predicting the T-cell new epitopes were about 40% accurate right now based on preliminary data, but we are very deeply involved in that and one thing is very clear that if you just put selective pressure on one particular antigen, like EGF receptor variant 3, one obvious escape route is to have the cells immune eroded to reduce the expression of the target antigen.
The multivalent approaches are going to be very powerful and nevertheless the single antigen approaches are yielding some interesting early data as well..
Excellent, thank you guys very much and good luck..
Thank you, good question..
Our next question will come from the line of [Arlinda Lee] of MLV. Please go ahead..
Hi guys, thank for taking my question.
I had, I’m particularly interested in Prophage and I guess I’m curious to see if the data that you’ll be presenting at your R&D day and at ASCO will include immune response analysis and the patient stratification and if that – and then maybe a follow on about the regulatory after math?.
Okay, let me just remind that obviously at the R&D day we will present all of the data that has been articulated that is not the data that will be presented at ASCO otherwise we would be violating the ASCO rules.
So the ASCO embargo on what will present at ASCO will lift on May 13 and we will make an appropriate disclosure at that time and so the R&D day is May 14 and we’ll be able to discuss what is publicly disclosed by the lifting of the embargo, but not the entire ASCO presentation..
There will be information about the interplay between the immune status of the patient and the clinical result the same. It’s a good question and stay tuned..
Okay, and then I guess, my understanding is that at the end of Phase 2 meeting with FDA last year you have presented unstratified data at FDA and I’m wondering, if you still subsequently stratify the patients in some way if you could go back to the FDA, well we get an update on the regulatory pass forward in terms of what kind of patients and what kind of criteria using for the regulatory programs at the R&D day or would that be kind of more around the time to start the Phase 3? Thanks..
Well, we’ve got a strategy that we think will be powerful with regard to patient stratification, we haven’t chosen to share it in detail publicly and we would like to have some discussion with the FDA before wedding it more broadly, but I think that there is an approach to stratification, I think it will help us design and execute successful trials..
Okay, great. I guess then in terms of the strategy and plan, would you be – when do you plan to make with or discusses with FDA and might you start a trial, how important is having an FDA or the pivotal trial? Thanks..
Those are ongoing discussions, there is some thought about stratifying, what we’d like to do with an SPA but there are other aspects of that we can talk about later but not now..
Okay, thank you very much..
Good questions Arlinda, it’s just too early for us discuss now..
Okay, thank you..
[Operator Instructions] And we have no further questions at this time I’d like to hand it back over to Ms. Klaskin for closing remarks..
Thank you, Angel. I would like to remind listeners that a replay of this call will be available approximately two hours after the call and that the call will also be accessible from the company's website at www.agenusbio.com. On behalf of the management team at Agenus, I would like to thank everyone for joining us on today's call.
We will be available to receive any further inquiries following the conclusion of this call. With that Angel, please conclude the call..
Thank you. Ladies and gentleman, this concludes the conference call for today. We thank you for your participation. You may now disconnect your lines and have a wonderful day..