Lineage Cell Therapeutics, Inc.
Q3 2016 Earnings Call Transcript

Published: 4 Nov 2016

[Operator:]

Welcome to the BioTime Third Quarter 2016 Results Conference Call. As a reminder, this conference call is being recorded. I will now introduce your host for today’s conference, Matt Haines of BioTime Investor Relations. Matt, please go ahead.

[Matthew Haines:]

Thank you, operator, and good afternoon, everyone. Thank you for joining us today for BioTime’s investor conference call and webcast to review the company’s results for the third quarter 2016 and recent corporate developments. There will be a tape replay of this call, which will be available approximately two hours after the call’s conclusion and will remain available for seven days. The operator will provide the replay instructions at the end of today’s call. With us today are Co-Chief Executive Officers, Adi Mohanty and Dr. Michael West; and Chief Financial Officer, Russell Skibsted. Each will make prepared remarks and then we will take questions from our covering analysts and institutional holders. Before we get started, we would like to remind you that during the course of this conference, the company will make some projections and forward-looking statements regarding future events. We encourage you to review the company’s filings with the SEC, including, without limitation to the company’s forms 10-K and 10-Q which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials, or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. And with that, I’d like to turn the call over to Adi Mohanty, Chief Executive Officer of BioTime.

[Adi Mohanty:]

Thank you, Matt. I’d like to thank everyone for joining us on the call today. During the third quarter and in recent weeks, we’ve made important clinical progress with both of our technology platforms, pluripotent stem cell technology and our HyStem three dimensional cell delivery matrix technology. We have released important positive clinical data from our OpRegen trial in dry-AMD and announced a presentation of some initial data from our Renevia pivotal trial and the medical aesthetic indication of HIV-related facial lipoatrophy. We expect these programs to generate numerous significant milestones in the coming months, which we expect will get these products closer to the patients that need them and this clinical progress should lead to increases in shareholder value. During our last conference call, we emphasized our commitment to our near-term focus on three primary objectives

[Michael West:]

Thank you, Adi. The research team at BioTime is acutely aware of the enormous potential of our company to create value for our shareholders. And simultaneously to improve the quality of life for those suffering from chronic degenerative disease. This potential is directly linked to the power of pluripotent stem cells to transform into the various cell types, they comprise the human body. This technology platform allows for the first time in history, manufacturer on an industrial scale, of all of the cellular building blocks of the heart, brain, or any other tissue that may be damaged by disease or trauma. In this respect, it is we believe a far more powerful platform than adult stem cells, which are allow the manufacturer only a limited number of potential products and generally speaking have a far more difficult time being manufactured to scale at a reasonable cost. We believe that the results, we’ve seen to date in patients by applying the technology to spinal cord injury with AST-OPC1 therapeutic candidate, and applying it to age-related macular degeneration through OpRegen are just too of numerous applications we expect to emerge in the coming years. So the goal of the research team at BioTime is to identify those additional future product opportunities with the greatest value and to advance them in preclinical studies. At the same time, we are diligently building a robust patent landscape, to ensure that we can protect our products exclusivity and increase the value to our shareholders in potential corporate partners. Most of the early stage were being performed by the BioTime research group is highly confidential, although we’ve provided from time to time a peek at some of our projects. In various scientific conferences we have for instance shown data on the production of various types of novel cartilage cell types. These may be useful in treating such disorders as low back pain and osteoarthritis. The leading complaint of an ageing population. We’ve shown data on the successful generation of what are called brown adipocytes that we and other groups believe could be important new therapeutic strategies for treating obesity and Type 2 diabetes. But this is just a tiny sampling of over 200 cell types for which we’ve created a scalable manufacturing process. I’m gratified to report that the work underway at BioTime is showing great promise in providing what we believe will be novel cost effective therapies for diseases for which drug, surgery and other current therapies are minimally effective. I’m also pleased to report that the pharmaceutical and biotechnology industries are becoming increasingly aware of the power of the technology to deliver first-in-class therapeutics and to we show results that are never before seen in medicine. We look forward to reporting on our progress in leading the field going forward and building value for our shareholders by advancing these products in the clinic and incorporate partnering. So with that, I’ll turn the discussion over to Russell Skibsted our CFO to report on the company’s financials, Russell?

[Russell Skibsted:]

Thanks, Mike. Good afternoon, everyone. Or consolidated cash and cash equivalents totaled approximately $30 million as of September 30. This compares to about $42 million on December 31, 2015. It should be noted however that the 2015 cash position did include Asterias. In addition on September 30, there was approximately $2 million in restricted cash and available for sales securities, also on September 30, BioTime owned 21.7 million shares of Asterias common stock and 14.7 million shares of OncoCyte common stock, which represented an aggregate market value of $166 million as of that date. On August 31, OncoCyte strengthened its balance sheet and completed a successful equity raise that netted them about $10 million from both new and existing investments. The additional capital allowed them to continue development of their key cancer diagnostic programs in lung, breast, and bladder cancers through meaningful milestones including the critical data that is expected soon of lung cancer. Now I’ll turn the call back over to Adi.

[Adi Mohanty:]

Thanks, Russell. As you heard from all of our members, it has been another very productive period for BioTime and our subsidiaries. With numerous value creating milestones ahead. For Renevia, we’re anticipating completing the pivotal clinical trial enrollment by the end of this year then completing the trial and reporting top line data in the first half of 2017. With these data in hand, we anticipate filing a CE mark - for a CE mark approval in Europe, and upon approval launching Renevia in Europe, and certain other countries in the second half of 2017. For OpRegen, we will report more detail data from Cohort I of our Phase 1/2a trial at ISOPT on December 2. Further, we expect to complete enrollment of patients in Cohort II, and gain approval from the DSMB to proceed to Cohort III this year. In early 2017, we expect to report complete Cohort I data and announced U.S. clinical trial site initiation. Also in the first half of 2017, we expect to report data from Cohort II and complete enrollment in Cohort III. Additionally in 2017, Asterias will be announcing data from its OPC1 trial in complete cervical cord spinal injury patients, while OncoCyte looks to launch its lung cancer diagnostic test in 2017. We look forward to updating you, as we advance our leadership position in pluripotent stem cell based therapies and our proprietary high stem delivery system, and utilize them to address major unmet needs in degenerative diseases. I would now like to open the call for questions. Operator, please go ahead.

[Operator:]

At this time we’ll be conducting question and answer session. [Operator Instructions] Our first question comes from Kevin DeGeeter with Ladenburg Thalmann. Pleased proceed with your question.

[Kevin DeGeeter:]

Hey, good afternoon, guys. Thanks so much for taking the question. Just quickly, with regard to OpRegen, as you open up some U.S. sites in the first-half of 2017, can you just give us some of your general thoughts as to how you’re thinking phase of enrollment and the number of patients per site you may be able to bring in and other metrics to help us think about the timeframe to get to some clinically relevant data on OpRegen?

[Adi Mohanty:]

Hi, Kevin, so what we’ve said is we are accelerating the initiation of U.S. trial sites. We’ve been talking to some pretty key opinion leaders, who are very engaged with us. And we expect to be able to do that early in 2017, not really even middle, but the early in 2017. We expect to complete our second cohort this year. So that leads us into Cohort 3. And Cohort 3 next year will allow us to maybe have some U.S. sites treat Cohort 3 patient, while we still have the Israel site active. I think what we’re at this point saying is, we can finish definitely Cohort 3 in the first-half of next year. We were expecting by the middle of next year to even finish Cohort 4, which is a faster pace than before. But as we get the site on board, so as we initiate that site sometime in the beginning of next year I think we’ll have a much better sense of what kind of screening and pipeline of patients we have, to give you a more precise number. At this point to be able to complete all four cohorts by the middle of next year, seems like a pretty good start for us. I hope that helps.

[Kevin DeGeeter:]

It does. That’s terrific. And then maybe just one more for me, then I’ll get back into queue, [and don’t worry, that’s my] [ph] last question. With regard to Renevia and the potential for CE mark in 2017, can you just talk about from a business development standpoint, your strategy to leverage potential CE mark for entry into other markets outside of Europe, including markets in Asia, potentially South America as well?

[Adi Mohanty:]

Yes, so I don’t know if people have - remember, just recently about a week or two ago, we made an announcement that we’ve hired a Head of Corporate Development, Jim Knight, who has spent several years at Questcor. He was there from the early days in 2010 till - I think that the sales were around $100 million till they went past $1 billion. So he was there in a large part of helping them expand the indications of the product or the drug that they had. He is very well experienced. He was at Biogen. He’s been at Elan. So this is somebody we brought on that has a lot of experience with how to take advantage of multiple indications of a single drug, as well as how to in partnering work with a large pharma in a very good. And so, Jim’s responsibilities are going to include business development and strategy related to our marketing of many of these products. This we think is an appropriate time to bring somebody like that on. This data and maybe I’ll digress just a little bit. I’m not sure everybody quite got the earlier this week news where we talked about the early data on Renevia. So our principal investigator, Ramon Llull, is presenting data from the run-in patients which are the first few patients, because of it being a device trial, these first few patients don’t go into the main trial. But they are trained at - training patients at the sites that are running the trial. So essentially they’re the first few patients of the pivotal trial. The data from this trial, which shows that those people are at one year and at one year we still have sustained volume increases in the face, along with what I find most exciting is that, we might actually have proof that we grow new tissue. So that’s the kind of data that allows us already to start having Jim put into packages that we can work with companies across Europe as well as our previous connections that we’ve already made with South Korea and Brazil, particularly South Korea. I think at the last conference call we mentioned Russell and I had been out to South Korea. We met with several significant pharma partners who are very interested and in Renevia and its application in South Korea. So our intention now is that after November 14, when the data is presented, it will allow us to use that data in more substantial conversations with partners in geographies that might have pathway that we can explore or take advantage of. So give us a couple months. This is going to evolve pretty quickly. We will be able to come back and give you a more detailed explanation of what our strategy is for Europe and for the Asian countries. I think it’s a really exciting time that we actually have data, but there’s still time. So I think this is a good time for us. We will be ready by the time where we have to make - we have to pull the trigger on some of these actions next year.

[Kevin DeGeeter:]

Terrific, thanks for all the detail.

[Operator:]

Our next question comes from Keay Nakae with Chardan Capital Markets. Please proceed with your question.

[Keay Nakae:]

Yes, thanks. First, with respect to the upcoming data presentation on the dry-AMD patients, will they be presenting any efficacy data on these three patients?

[Adi Mohanty:]

Hi, Keay. So I think that we want to be careful not to make too much of efficacy data in the 50,000 cell dose. It’s a pretty small dose. We do see some encouraging signs, but we don’t think it’s appropriate to start looking at efficacy at this stage. I think though the surrogates for efficacy are very important and we see them now. And so, it’s really important that we be able to share things like engraftment, that even after one year the cells are alive and healthy in the back of the eye that they are well-integrated grafted in the back of the eye with the rest of the RPE cells, so many things that are surrogates. We do have some efficacy data, but I don’t think the intention here is to share a lot of that information. I think we want to try and do that with the second cohort, which is coming up pretty soon, right. So we think in early next year, with the second cohort, which gets the more clinically significant 200,000 cells, we should have information that we can start sharing that will be more clinically meaningful in the early part of 2017. So just trying to make sure we don’t set too many expectations for the 50,000 cell dose and that we don’t get too far ahead of ourselves. We’re pretty excited, but trying to control ourselves from sharing early data on a small dose cohort.

[Keay Nakae:]

Okay, so then focusing on the second cohort, the 200K cells, when we get to early next year, how long does it take before you are able to measure these surrogates, such as the engraftment of the cells in a monolayer?

[Adi Mohanty:]

We think it can be pretty early. So I think a meaningful data-point would be six months and we’re pretty close to reaching that with our first patient treated in that second cohort. So we’ll have the other patients reach that point in pretty early in 2017. So that’s why we’re feeling comfortable, saying that in early 2017. We should be able to share information on that second cohort.

[Keay Nakae:]

Okay, very good. And then switching over to Renevia, with respect to the idea that you may actually be generating or growing new tissue, how do you go about advocating that?

[Adi Mohanty:]

Yes. So it is one of those I think I’ve mentioned before. I mean, that to us are the most important thing that - we are in the business of regeneration and we believe we can regenerate new tissue or help by regenerating tissue, so animal studies have been done. So we had some animal studies already, where we were able to do histology of animals, and see that - it showed in the animal we grew new tissue. We’re doing further studies in larger animals to support the clinical trials, but there were instances that our PI was able to get some human data. And that’s the part that he is sharing, because the intention is not to have histology or cut a piece of the face to check what’s under there. But he did turn out to have an opportunity to get some human data. And I believe that’s what he will be sharing in two weeks. So that’s how you know, you can look underneath and you see if there’s tissue and blood vessels and…

[Keay Nakae:]

Okay. And…

[Adi Mohanty:]

Actually, maybe I’ll add something else. Sorry. The other part is though - is that there are well-established methods of assessing externally whether or not there is neo-tissue. There are measurements of elasticity. There are measurements of the feel of the tissue that is created. So there are techniques that we are now looking at, that will help supplement the histology to help decipher the difference between neo-tissue or not.

[Keay Nakae:]

Okay. And then, just finally, with respect to that data coming up in a couple of weeks, how many patients were there in this, let’s call it the run-up cohort.

[Adi Mohanty:]

So we know that we had nine run-in patients, which is three at each of our three sites. I’m not really sure if all nine are included or if six or seven or eight are included in his presentation. We’ll have to wait for the presentation to see that. But it’s somewhere between six and nine patients.

[Keay Nakae:]

Okay, very good. Thanks.

[Operator:]

Ladies and gentlemen, we have reached the end of the question-and-answer session. I’d like to turn the call back to Adi Mohanty for closing comments.

[Adi Mohanty:]

Yes, thank you very much. Thanks for the questions. And thanks for calling in and listening. As I mentioned, it really has turned here into a very exciting time for us with very significant milestones coming up. So we look forward to sharing all that information in the coming weeks and months. Thank you.

[Operator:]

Thank you for your questions. For additional information, please feel free to contact us or visit our website at www.biotimeinc.com. This concludes today’s conference. Thank you for your participation. You may disconnect your lines at this time.