Oncothyreon, Inc. (ONTY) Q2 2014 Results Earnings Conference Call August 11, 2014 4:30 PM ET
Julie Rathbun – Investor Relations
Dr. Robert Kirkman – Oncothyreon's President and CEO
Dr. Jay Venkatesan – Oncothyreon’s Executive Vice President and General Manager
Julie Eastland – Oncothyreon's Chief Financial Officer and Vice President, Corporate Development
Yatin Suneja – Cowen and Company
David Nierengarten – Wedbush Securities
Good day, ladies and gentlemen, and welcome to the Oncothyreon Second Quarter 2014 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded.
I would now like to turn the conference over to Ms. Julie Rathbun of Investor Relations. Ms Rathbun, you may begin.
Thank you. Good afternoon, and welcome to Oncothyreon's conference call to discuss the acquisition of Alpine Biosciences as well as our financial results for the second quarter of 2014. With us this afternoon are Dr. Robert Kirkman, Oncothyreon's President and CEO; Dr. Jay Venkatesan, Oncothyreon’s Executive Vice President and General Manage and Julie Eastland, Oncothyreon's Chief Financial Officer and Vice President, Corporate Development.
In the first part of the call, Dr. Kirkman, and Dr. Venkatesan will discuss the acquisition by Oncothyreon of Alpine Biosciences. Dr. Kirkman will then briefly review the status of Oncothyreon's clinical pipeline, after that Ms. Eastland will review Oncotheyreon’s financial results for the [first] quarter of 2014. We’ll then open up the call to questions.
Before I turn the call over to Dr. Kirkman, let me first remind you that during this call, we will be making a number of forward-looking statements. These forward-looking statements include Oncothyreon's expectations regarding the use and adequacy of cash resources, future expenses, the clinical development of tecemotide, the commercial outlook for tecemotide, clinical development activities for ONT-380, and ONT-10. Potential development of products using Protocell technology acquired in the Alpine Biosciences acquisition and potential partnerships for expansion of Protocell technology in tradition fields.
Forward-looking statements involve risks and uncertainties related to Oncothyreon's business and the general economic environment, many beyond the company's control. Those risks, uncertainties and other factors could cause Oncothyreon's actual results to differ materially from those projected in forward-looking statements.
For a detailed description of these risks and uncertainties, you are encouraged to review our annual report on Form 10-K filed with the SEC and other official corporate documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR.
I would now like to introduce Bob Kirkman, Oncothyreon's President and CEO. Bob?
Thanks very much, Julie. As Julie just indicated, we are going to depart from our usual format for our quarterly conference call this afternoon to discuss our announcement today that we will be joining with Alpine Biosciences. We believe this transaction brings a very exciting new technology into the company, one with the potential to significantly transform a number of therapeutic modalities and in the process potentially create significant value for our shareholders.
I want to begin this afternoon by describing our strategic rationale for this transaction. I will then introduce Jay Venkatesan, Alpine’s CEO who will be joining Oncothyreon. Jay will give you a brief overview of the technology which involves a nano particle called the Protocell and talk about some of its potential applications. And together we will then outline our near term plans.
In our excitement today about the acquisition, I don’t want to neglect updating our pipeline. There’s a lot happening there as well which I will review a little bit later. And Julie will also review the financials and update our financial guidance. So why Alpine and why now?
First and foremost, because the science and its potential clinical applications are extremely interesting. Protocells are nano particles capable of the targeted delivery of a wide variety of molecules, including nucleic acids, proteins, toxins and small molecules. But as importantly from my perspective, the technology is more than the delivery system. It’s a way to create unique products both for ourselves and partners to develop.
Oncothyreon has a solid clinical pipeline and we’ve been successful in in-licensing or acquiring -- promising molecules to develop. But we’ve also wanted an internal discovery capability in order to develop our own product candidates, with the acquisition of Alpine’s technology we now have that. This is an important step towards the creation of a more valuable and more fully integrated bio technology company. There are of course limits on what we can do ourselves and there are many product opportunities that may be created which we will need partners to develop. That’s another important reason for this transaction as it has the potential to create significant business development opportunities. We believe these business development opportunities have the potential to bring significant resources to support the company’s core programs.
Ultimately the transaction is about creating shareholder value. We believe that the combination of cutting edge science, new product opportunities and the possibility for significant business development activities has the potential to do just that. That’s why Alpine and why now.
I would now like to introduce Jay, to tell you about the Alpine technology and what he sees as some of the potential opportunities. Jay will be joining Oncothyreon as Executive Vice President and General Manager with responsibility for a business unit devoted to this technology. As some of you will know Jay’s been a friend of Oncothyreon for sometime. In his prior role at Ayer Capital, he was a significant investor and he’s very familiar with what we do. I am delighted by his vote of confidence in deciding to join our team and we very much look forward to working with him going forward. Jay?
Thank you, Bob. We are very excited about the acquisition of Alpine Biosciences by Oncothyreon. And as Bob just mentioned, I’m very familiar with the Oncothyreon team and its development program and believe the company has great opportunities going forward. When Oncothyreon approached us with the opportunities to develop Protocells within their organization, we thought it was an ideal fit. First, Oncothyreon understood the broad applicability of technology and patent interest in developing Protocell for both Oncology and rare disease applications.
Second Oncothyreon has substantial experience in Lipid chemistry and manufacturing as a result of their experience with tecemotide and ONT-10, which convinced us that they have accelerated their timelines IND filing and clinical applications for technology. Third, Oncothyreon has direct expertise and experience in target therapeutics in oncology which is where there are fastest and more obviously applications in the technology.
As such, both Alpine and Oncothyreon thought there were numerous opportunities for us to advance the platform quickly and into a number of therapeutic categories. For areas that are not of primary interest to the two companies, we felt that there were opportunities to partner out the platform in the near term. As a result of this shared vision and complimentary skill set, we both talked about Oncothyreon acquisition about and we demonstrate meaningful synergies.
Now let me tell you about Alpine and Protocells. Alpine Bioscience was formed in 2012 to find and develop and enabling technology for delivering a variety of small and large molecules in a targeted ways. In recent years a number of exciting developments in gene editing, RNAi integrating and non-integrating gene therapy and protein therapeutics have been developed.
However, all of these fundamental therapeutics vitalities have suffered from an inadequate ability to deliver the activation to the right cells indeed though and to generate a robust clinical response. Our belief is that delivery is the fundamental challenge holding back many of these technologies.
The technology we have been developing at Alpine was first developed by multi disciplinary team of scientists of the University of New Mexico. The UNM Cancer Center and Sandia National Laboratories, the University of New Mexico is the world’s leading in nanoscience through its nanoscience and micro systems program.
The UNM Cancer Center is one of just 68 premier cancer centers in the nation recognized by the National Cancer Institute for its scientific excellence contributions to cancer research and delivery of innovative treatment to patients in New Mexico.
Sandia National Laboratories is a national lab owned by the U.S. Department of Energy’s National Nuclear Security Administration. Sandia’s mission is to be the premier science and engineering laboratory for national security and technology innovation.
Protocells’ are comprised of mesoporous silica nano-particle. Mesoporous refers to the size of the porous in the particle, in the core and surrounded by a lipid -- supported lipid bilayer. The surface bilayer can be functionalized for targeting ligands, PEG and other features that provide for long-lasting, stable, systematic distribution.
A key feature of the technology is that the silica core has an enormous surface area, approximately a 1,000 square meters per gram of silica, which allows for dramatically improved loading capacities. The silica serves the second purpose which is to support the lipid bilayer. This greatly improves the stability of the lipid layer and allows us to use fluid lipids on the surface.
Fluid lipids allow for diffusion of the targeting ligands on the surface significantly enhancing the binding capabilities of protocells versus other technologies where the targeting agents are actually fixed to a rigid structure.
As a result of these key features protocells embodies the four essential elements of the disruptive delivery system. One, loading capacity, protocells can encapsulate 40 to a 1000 times greater quantities of molecules in current technology. Two, superior targeting, as a result of use of targeting ligands on a fluid lipid surface, protocells offer approximately 100-fold improvement in binding affinities versus targeted liposome and are able to achieve monoclonal antibody like affinities with very few targeting ligands on a protocell surface.
Third, safety and lack of immunogenicity, protocell have been shown to be safe and biodegradable in animal testing with minimal immunogenicity. And fourth, diversity and delivered payloads. Protocells are able to deliver cargos including small molecules, siRNA, proteins and toxins and DNA.
The results of this is that protocells have been shown to have unique capabilities in delivery both large and small molecules. For instance protocells can be loaded with a cocktail of chemotherapies in a single protocell has been shown to be adequate to kill a single multi drug resistant tumor cell in vitro.
Comparably loaded liposomes are one million four plus potent than protocells in the same experiment. Protocells have also been shown to deliver toxins with high specificity and a comparable improvement five or more orders of magnitude versus liposome toxin combinations.
The potentially bigger opportunity though is in delivering proteins and nucleic acid. This is where we think protocells have the potential to be transformative. Currently protein replacement in particular enzyme replacement has been limited in its application due to issues with delivering adequate quantities of protein to the desired cells and organelles.
With enzyme replacement virtually every product on the market are being developed uses nanophosphate to drive non-specific uptick by deliver [insulin] and deliver the enzymes to the liposome.
Protocells because of their unique attributes they are able to deliver proteins or nucleic acids including proteins in a targeted fashion thus allowing us to get the cells of interest. Using targeting more of these on the enzymes itself, we can then deliver the enzyme to the organelles interest whether the liposome or elsewhere. We are currently investigating protocells for applications including delivery of Minicircle DNA and mRNA proteins intracellular and to deliver proteins to other organelles such as the proteasomes.
A key advantage of protocells is that they do not generate immune response unlike viral factors and so can be used for repeat dosing and application. Our goal of these programs is to allow for protein replacement on an infrequent basis while avoiding the risks of integrating gene therapy approaches.
In summary, we believe that the platform has the potential to be transformative in a number of therapeutic areas. Oncothyreon will now have additional drug discovery capabilities on oncology and rare diseases which will help us become a more fully integrated biotechnology company. We believe that the current pipeline of products at Oncothyreon is under appreciated and we’re happy to become part of the company both for their current assets and for the protocell potential. As such we wanted to receive equity in the company so that we can participate in Oncothyreon’s potential upside for the long term.
We are excited about the business combination and I am personally excited to be joining the team and working to develop protocells within Oncothyreon to realize the value of this exciting technology. With that I’ll turn it back over to Bob.
Thanks, Jay. I think you can see why we were excited about the Protocell technology and the opportunity it brings to Oncothyreon. Let me conclude this portion of the call with a brief explanation of our plans for the technology. We currently plan to conduct a protocell portion of our business and a business unit devoted to this technology under Jay’s direction. The technology resides in a wholly owned subsidiary of Oncothyreon we’ve renamed Protocell Therapeutics. The Alpine name and related domain names were assigned to [indiscernible] the co-founder of Alpine as part of this transaction.
We look forward to continuing to collaborate with the inventors of the Protocell technology at the University of New Mexico and at Sandia. We expect to add a small number of employees reporting to Jay over the next few months with specific expertise needed to most rapidly develop protocells. We don’t intend to duplicate skill sets we already have, and will all be working together to move this forward as quickly as possible.
With regard to protocells our immediate goal will be to complete a variety of activities necessary to move protocell product into our IND-enabling studies sometimes next year. There are a number of product candidates under consideration and we will provide more clarity on those programs in the future.
And now I want to turn to our pipeline, our focus during today’s call has obviously been on today’s announcement about which we are very excited, but I do think its important to give you an update on the status of our clinical stage pipeline. None of what we’ve announced today is meant to change in anywhere our enthusiasm for our existing product candidates.
Let me start with ONT-380, the small molecule inhibitor of HER2 we are developing under a collaboration agreement with Array BioPharma. Our development program ONT-390 is design to take advantage about the potential for an improved tolerability profile based on the lack of binding to EGFR and the potential activity in the CNS based on demonstrated preclinical data.
We are currently conducting two Phase 1b trials of ONT-380 both in combination with other agents. The first trial is a combination trial with antibody toxin conjugate Kadcyla also known as T-DM1.
The second trial, it’s a combination trial Xeloda and/or Herceptin. Both trials are dose escalation trials design to determine the recommended dose of ONT-380 in the combination. Both trials are also design to help us obtain preliminary evidence with respect to the activity ONT-380 in the central nervous system.
Patients with either asymptomatic and untreated or treated and stable central nervous system metastases from HER2 positive breast cancer are eligible for the dose escalation portions of both trials, while patients with CNS metastases, which are either asymptomatic and untreated or progressive following local therapy, may be included in expansion cohorts in each trial once the recommended dose is determined.
We’re making very good progress in rolling both of these trials. In the T-DM1 combination trial we’ve completed the initial dose escalation portion of the trial, one expansion cohort and our currently enrolling the CNS expansion cohort.
In the second trial, we have completed dose escalation with each Xeloda and Herceptin separately and are now opening the triplet for enrolment. We’ve also initiated the CNS expansion cohort with Herceptin and ONT-380 combination. As previously indicated we expect to have initial data from these trials late this year.
Let me turn now to our immunotherapy pipeline. A highlight of the second quarter was our presentation at ASCO of the data from our Phase 1 of ONT-10 and patients with advanced cancers expressing MUC1.
Those data demonstrated that the vaccine was well tolerated resulted in a humoral immune response in the vast majority of patients and lead to encouraging disease control in advance stage patients with a variety of cancer types.
Based on these data, we selected the dose for further trials and initiated enrollment of two expansion cohorts in patient with either breast or ovarian cancer. That enrollment also going well and we’ve passed the half way mark in both cohorts.
We are also excited to announce in May our collaboration with Celldex on the plan combination trial with ONT-10 and varlilumab or CDX-1127. They are T-cell stimulating antibody. It seems likely that combination immunotherapy will become increasingly important as more agents become available. And we believe the combination of an immunogenic vaccine like ONT-10 and then immune stimulating agent like varlilumab may prove particularly interesting.
We’ve been hard with Celldex to prepare the IND which is required for this combination trial, which we currently expect to file before the end of the month. Finally enrollment is continuing in START2 Merck Serono’s Phase 3 randomize trial of Tecemotide to 1,000 patients with unresectable stage III non-small cell lung cancer who have received concurrent chemo-radiation .
This trial is design to confirm data from an exploratory analyze of a large predefined subgroup of patients from their original START trial. We received Tecemotide after concurrent chemo-radiotherapy, which shows that these patients achieved a median overall survival of 30.8 months versus 20.6 in those patients treated with placebo.
Let me now turn the call over to our CFO, Julie Eastland, who will review our second quarter financial results. Julie.
Thank you, Bob. As reported in our press release today, Oncothyreon's loss from operations decreased to $7.8 million for the three months ended June 30, 2014 compared with $18 million for the comparable period in 2013, and decrease to $50 million for the six months ended June 30, 2014, compared with $26 million for the comparable period in 2013.
The decrease in loss from operations from both the three and six months periods was due to lower research and development expenses primarily attributable to a $10 million upfront payment to Array BioPharma in June of 2013.
The net loss for the three months ended June 30, 2014 was $6 million, or [$0.909] per basic and diluted share, compared with a net loss of $16.4 million or $0.28 per basic and diluted share for the comparable period in 2013.
And the net loss for the six months ended June 30, 2014 was $15.6 million or $0.22 per basic and diluted share compared with a net loss of $24.7 million or $0.43 per basic and diluted share for the comparable period in 2013.
Again the primarily reason for the decrease in net loss for both the three and six-month periods was the upfront payment to Array in 2013. And for the six months this was partially offset by changes in the fair value of the warrant liabilities.
As of June 30, 2014, Oncothyreon's cash, cash equivalents, and investments were $58.5 million, compared to $72.6 million at December 31, 2013, a decrease of $14.1 million. The decrease was primarily attributable to $13.7 million of cash used in operations during the six months ended June 30, 2014.
And before I turn the call over to Bob, I’d like to provide financial guidance for the remainder of 2014. Please note that we believe this guidance to be correct as of today, but that circumstances may change, and we assume no obligation to update this guidance.
Oncothyreon currently expects operating expenses in 2014 to be lower than in 2013, which included the one-time upfront payment to Array. Also we currently expect cash used in operations in 2014 to be approximately $30 million to $33 million.
Please note that this guidance is unchanged from last quarter as we currently expect this guidance to include the additional expenses associated with the acquisition of Alpine. As a result Oncothyreon estimates that its existing cash, cash equivalents and investments will be sufficient to fund operations for at least the next 12 months.
This concludes the financial update. Now let me now turn the presentation back over to Oncothyreon’s President and CEO, Bob Kirkman for concluding remarks. Bob?
Thanks, Julie. I think you can see we’ve had a busy and productive summer. Our pipeline has been making good progress. I’m particularly pleased with the rapid enrolment in the ONT-380 trials and the opening of the expansion cohorts and patient with CNS disease.
I’m also looking forward to the initiation of our combination trial of ONT-10 and varlilumab. And of course I’m very excited about the protocell opportunity and looking forward to working with Jay to bring this to the clinic as rapidly as possible.
As always, we very much appreciate the support of our shareholders. And operator, we’d now be pleased to answer questions.
Thank you. (Operator Instructions) Our first question is from Eric Schmidt with Cowen and Company. Your line is open.
Yatin Suneja- Cowen and Company
Hi, guys. This Yatin call in for Eric. Congratulations on the acquisition and thank you for taking my question. Actually I have a couple. So with regard to Alpine’s protocell technology, what was most intriguing about this technology and maybe if you can comment how this platform differentiated from other nanoparticle or liposome platforms?
Maybe I’ll answer the first part of that question and let Jay answer the second part of that question. I think that what was most intriguing to us was the ability to create what we think will truly be unique and product opportunities that we can add to our pipeline that are really at the cutting edge in a variety of therapeutic fields.
Obviously, our particular interest is in oncology and in immunotherapy and we think there are obvious places that we can take this technology there. We’re also very excited about the breadth of this opportunity and believe that we will be able to develop some significantly business development activities that help support the core activities as we go forward. I’ll let Jay address the question about differentiating this technology from other forms of nanoparticles. Jay?
There are couples of key areas where we think protocells are differentiated from what is being developed today and that comes down to the two key elements of protocells. The fact that it starts with mesoporous silica core and then the lipid bilayer, and it’s that interaction between the silica core and the lipid bilayer that is so fundamental to the technology.
As mentioned, the silica core allows you to hold large quantities of both small and large molecules as mentioned up to 1,000 fold as much as comparably size liposome can hold. Additional is that diversity of payloads we can carry both hydrophobic or hydrophilic molecules. We can carry molecules of various charges and we can certainly carry different sizes which allows us lower everything from the small molecules to Minicircle DNA, MRNA and protein.
And then finally the lipid bilayer on the surface is important for both the biocompatibility of the molecule, but also because of the fluidity on the surface it allows for targeting. And is that combination of thing, the ability to target delivery to multiple different organs or cell types of almost any type of payload that’s so valuable.
As you’ve seen with most technologies out there, typically people have been limited to deliver and limited in terms of the size of payload they can carry and I think that’s where this technology is going to shine, it is moving to other tissue types and moving to larger payloads.
Yatin Suneja- Cowen and Company
Good. That sounds exciting. And then in terms of future development, could you maybe talk about how are you planning to integrate this technology with your internal capabilities?
Sure. This is Bob, I’ll start with that. Obviously, our skill sets here have been in oncology and that’s obviously on the primary areas where we believe this can be developed. We also think we’re bringing to the table some skill sets that we have here that will be particularly important for this technology not the least of which is a an existence expertise in lipid chemistry based on our therapeutic vaccines both of which employ that kind of technology.
So, we believe that the combination of our existing clinical development skills, our existing chemistry skills and our regulatory skills with respect to preclinical development are all going to be very important as this technology moves forward. It’s going to be a little while before we are prepared to tell you exactly what the first product we’re going to develop will be as we move forward, but that will be coming sometime in the next few months.
Yatin Suneja- Cowen and Company
Great. Thanks Bob maybe just one more question and I’ll jump back into the queue. This is with regard ONT-380, is there any change in development plans after neratinib success in adjuvant setting? Thank you very much.
Our development plans for ONT-380 have been very much focused on two areas, one is that’s -- its based on its preclinical activity and CNS models obviously we’re very focused on development strategy there and we think that has the potential – should we demonstrate activity in the current trials that we have potentially more rapid path to regulatory approval. So we’re very interested in that. We also are – we believe that because of the characteristics of this molecule particularly its tolerability that we’ll be able to combine effectively with other agents. It’s likely that our first – our next registration strategy after the CNS strategy will be based in first line metastatic disease.
We’re obviously excited by the demonstration that small molecule that targets. HER2 has demonstrated activity. We know ONT-380 is equipotent against HER2 with neratinib. We also believe based on our clinical data to-date that it will have an improved tolerability profile. So we’re glad for that demonstration of efficacy and looking forward to continuing our development with 380.
Yatin Suneja- Cowen and Company
Thank you very much and congrats on all the progress, guys.
Thank you. And our next question is from David Nierengarten with Wedbush Securities. Your line is open.
David Nierengarten - Wedbush Securities
Hi. Sorry, going to follow-up with – I mean, it’s any kind of speculation or the ideas on your part as to which molecules would be best delivered by the protocell technology? I understand if you don’t want to name an indication or anything, but it services a particular macromolecule that [indiscernible] that is not addressed currently by other delivery technology that I’d loved to hear? Thanks.
Sure. And this not – David this will be the first development program that we’ll pursue, but I think from a conceptual perspective one of the most exciting opportunities is the delivery of non-integrating gene therapy with something like Minicircle DNA where the potential for delivering a Minicircle DNA that can then encode protein and what we’ve seen in animal studies is not that we’ve done, but broadly speaking Minicircle DNA has been shown in rat and mice studies to deliver proteins for up to three to six months. The potential to have a long effect for a protein therapeutic on an infrequent dosing basis is obviously a compelling theoretical possibility.
And the fact that protocells don’t general immune response that would lead to neutralization allows us to have the potential to have repeat dosing which is obviously limitation of most of the viral bacterial approaches that people are taking for gene therapy. So I think that’s an interesting conceptual opportunity for the technology.
David Nierengarten - Wedbush Securities
And I know you refer to larger size macromolecules, I mean, is there a limit to the size of the gene which you can potentially deliver in liposomal DNA or circular DNA?
That’s a great question. I think right now Dave; we’ve been seeing data with up to 4,000 or 5,000 base pair plasmid DNA and their multiple copies in there without any trouble. I don’t think we’ve pushed the limit to how large those molecules can be. I think that’s one of the things we’re looking at. We have not yet found anything that would be sufficient -- would be too large but we haven’t been [exhaustive] in our efforts there either.
David Nierengarten - Wedbush Securities
Thanks, Jay, that’s really interesting. Thanks.
Thank you. And I’m not showing any further questions. I’d now like to turn conference back over to Mr. Robert Kirkman.
Thank you very much. Well, I think you can say it’s been an exciting quarter for us. We’re very much looking forward to the ongoing progress with both ONT-380 and ONT-10. Jay and I will be on the road for a couple of days introducing and what we are attempting to accomplish with us joining the other of our two companies. I think it’s going to be an exciting rest of the year for us and I look forward as I know both Jay and Julie to meeting with you over the course of the next couple of months and having a chance to discuss all of this in lot more detail.
And with that I thank you very much for your attention this afternoon and operator that concludes our call.
Thank you. Ladies and gentlemen, thank you for participating in today conference. This does conclude the program and you may all disconnect. Everyone have a great evening.
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