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Lineage Cell Therapeutics, Inc. (LCTX)

Q1 2016 Earnings Call· Tue, May 17, 2016

$1.57

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Transcript

Operator

Operator

Good day, ladies and gentlemen, welcome to the BioTime First Quarter 2016 Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I'll now introduce your host for today's conference call, Dan Lawrence, BioTime’s Director of Investor Relations and Corporate Communications. Dan, please go ahead.

Dan Lawrence

Analyst

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 result and key accomplishments for the first quarter of 2016 and recent corporate developments. There will be a taped 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 members of BioTime's senior management team, including Co-Chief Executive Officers Adi Mohanty and Dr. Michael West; also Chief Financial Officer, Russell Skibsted. Adi and Russell will make prepared remarks and then we will take some questions from sell-side analysts and Portfolio Managers. Before we get started, we would like to remind you that during the course of the conference call, the company will make some projections and forward-looking statements regarding future events. We encourage you to review the company's past and future 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, Co-Chief Executive Officer of BioTime.

Adi Mohanty

Analyst

Thanks, Dan, and good afternoon everyone. Thank you for joining us this afternoon. We’re off to a strong start in 2016. Since our last call six short weeks ago, we have continued to make progress on our core clinical therapeutic programs. These key programs leverage our proprietary pluripotent stem cells and our proprietary cell delivery platforms with important product candidates targeting large market opportunities in medical aesthetics and ophthalmology. On the call today, we’ll provide a brief update on our two core development programs Renevia for medical aesthetics and OpRegen in dry age related vascular degeneration or dry AMD. We will also briefly touch upon recent developments in our important non-core programs. We continue to focus on our three primary objectives designed to drive increased shareholder returns; clinical progress, simplification, and unlocking value from our non-core subsidiaries. In the area of clinical progress, BioTime and our subsidiary Asterias Biotherapeutics have a total of four therapeutic product candidates in human clinical trials. Renevia is our most advanced product candidate. It could be on the market in Europe and certain other geographies as early as the second half of next year. Renevia is a product candidate where we combine the patient’s own fat cells with our HyStem cell delivery platform which is injected into the places of the patient’s face where tissue is missing. The entire process is a single outpatient procedure that can be easily performed in the doctor’s office. Our pivotal clinical trial assessing Renevia’s efficacy in HIV-related facial lipoatrophy is ongoing and progressing as expected. The efficacy measures of the trial include change in tissue thickness measured by 3D volumetric change and aesthetic scores that include patient reported outcomes. We expect to complete patient enrolment by the second half of this year where top line efficacy data is expected…

Russell Skibsted

Analyst

Thanks, Adi. Good afternoon everyone. Our consolidated cash and cash equivalents totalled $27.1 million as of March 31, 2016, compared to $42.2 million as of December 31, 2015. The $27.1 million of cash on hand at the end of March, included $16.4 million held by Biotime and its non public subsidiaries. As of March 31, 2016, the value of the common stock we owned in Oncocyte and Asterias was approximately $170 million. Last week, Asterias announced a successful equity raise, the financed netted them a little over $16 million. This additional capital allows them to continue the development of their primary clinical programs, including the expanded OPC1 Phase 1/2a clinical trial. The financing takes our ownership percentage in Asterias to below 50%, which means that Biotime may longer to be required to consolidate Asterias financial after May 13. This is important in our objective of simplification because our financials going forward would be much easier to read and understand and in our opinion, a step closer to be more representative of BioTime’s operations. We believe with our available capital along with our grants and other non dilutive funding that we have the ability to execute our operating plans through 2016. Now, I’ll turn on the call back over to Adi. Adi?

Adi Mohanty

Analyst

Thanks, Russell. So to summarize, we’re making steady clinical progress with our dry AMD and medical aesthetic therapeutic programs. We see increasing interest from partners across all our technologies, programs and noncore assets. At the same time, we’re committed to simplifying our structure, while unlocking the value of our more mature revenue generating subsidiaries for Biotime shareholders. With that, operator we’re ready for questions.

Operator

Operator

Thank you. At this time, we’ll be conducting question and answer session. [Operator Instructions] And our first question comes from the line of Keay Nakae from Chardan Capital. Please proceed with your question.

Keay Nakae

Analyst

Hi, thanks. Yes it’s Keay. First question is for Russell, with respect to the ability to eliminate the consolidation on your subs, beyond the ownership volume below 50%, are there other considerations that have to be met before you’re able to move in that direction?

Russell Skibsted

Analyst

Good question. There are in fact, the primary issue that we look at is effective control. So that can be either control of the Board of Directors or can be some sort of voting arrangement. What I would say with Asterias is we do not need any of those. So, I would expect that we should be deconsolidated going forward.

Keay Nakae

Analyst

Okay. Very good. So that looks pretty straight-forward than at least with respect to Asterias?

Russell Skibsted

Analyst

Yes. Correct thanks.

Keay Nakae

Analyst

Okay. And then, just a second question for Adi, as it relates to the OpRegen dry AMD study, so what if anything, will you be able to say about the first patient cohort once you get the approval to move into the second patient cohort? Obviously they are evaluating safety, but will you be able to say anything about efficacy for that group around the time that you transition to the enrolment of the second cohort?

Adi Mohanty

Analyst

Hi, Keay. Yeah, thanks for the question. So, the first cohort is a safety dose. Although, the patients that we’re treating, they’re not healthy volunteers, they’re actually dry AMD patients. There might be something that we see, but the intention here is to just assess safety. What we’d like to see is we’re preparing the report right now. We’re getting ready for the DSMB meeting. What the DSMB allows us to say will be important, but maybe worth reminding people that when you look at cell therapies or these types of programs, it is so much different from a more typical biologic or small molecule program where the early safety signal doesn’t give you that much more risk reduction compared to a cell therapy program. When we’re replacing cells that are missing, what is more important to learn very early on is whether or not the cells are still there? Whether or not the body reacted and you had some immune or adverse reactions. There’s some pretty significant things that we expect to learn with this initial cohort. How much we will be allowed to say will depend on how our interaction with the DSMB goes, but anything that allows us to say that we had a successful cohort one and move on to cohort two, we think is a pretty substantial de-risking of the program unlike other typical clinical trials.

Keay Nakae

Analyst

Okay. Great. Thanks for that. And then, just maybe looking a little further ahead, as you get into the second cohort, which is kind of begetting a different dose? Again kind of similar question as you transition to approval to launch into the third cohort, what might you be able to say at that time while it’s still around the end of the year about, say second cohort efficacy?

Adi Mohanty

Analyst

Yeah, that’s a good question. So the second cohort as you know that goes up to about 200,000 cell dose and just as a reference you know, Ocata used 150,000 cell as their clinical dose. So we expect for a 200,000 cell cohort to have some clinical signal. We will be measuring more efficacy and clinical signals. How much we’ll be able to say will again depend on, this is still a clinical trial. I know its open label, but to maintain the integrity of the trial would be more important for us, but we should be seeing some signal and we should be able to say something we hope by the end of that second cohort before going into cohort three.

Keay Nakae

Analyst

Okay, very good. Thank you.

Operator

Operator

And our next question comes from the line of Rohit Vanjani of Oppenheimer. Please proceed with your question.

Rohit Vanjani

Analyst · your question.

Hi, thanks for taking my questions. Russell, I think last quarter, you were at 57% ownership of Asterias and 58% for Oncocyte. What is it for Oncocyte now and then with Asterias’ common stock and warrants offering? You said, you’re below that 50%, but what percentage is it exactly and what would it have been without that offering?

Russell Skibsted

Analyst · your question.

Without the offering, it would have been approximately 57%, which is what it was before. With the offering, as it was announced, we’re down to 49.5% of Asterias and then Oncocyte remains approximately 58%.

Rohit Vanjani

Analyst · your question.

Okay. And then Adi, for the Renevia trial, I think you said you needed 56 completers. Do you know where you are with enrolment right now? I think last quarter, you said you were two/thirds enrolled.

Adi Mohanty

Analyst · your question.

Yeah. We don’t quite talk about numbers. We’ve treated more than 40 patients already and so we don’t get into specifics of numbers, but it is tracking towards where we thought which is full enrolment in a few months. So the second half of this year, we expect to be fully enrolled and still be able to have that top line readout at the beginning of next year. I think from the last time, we have the call to now we’ve added more patients. So it’s progressing well.

Rohit Vanjani

Analyst · your question.

Okay. And then you said you’re in discussions with the FDA on facial lipoatrophy, any idea what would be involved there if you had to do a U.S. trial, would it be too well controlled studies for approval?

Adi Mohanty

Analyst · your question.

Yeah. So in this area, Rohit, I actually think we’ve got some really good news. We have yet to find the details, but let me tell you we’ve been interacting with the FDA over the last few months as I mentioned and they have told us now officially to follow the device approval pathway. So, in our interactions with them, while we were preparing the documents and going to type c meeting and they have come back and said, no we think it is a device approval pathway. There are still certain hurdles that we have to pass through with people from [indiscernible] involved the assessment, but this is a significant, I think positive for us where a device approval pathway means a single pivotal study and it also means we can leverage a significant amount of the data that we’re generating in Europe. So instead what you were just referring to, which is a typical biologics pathway of some previous study and then two confirmatory Phase 3 study just like seem to single pivotal study. Now, this is still early in the conversation as soon as we finished our meetings and have really confirm this pathway and the future of how we’re going to progress in the U.S. will be sure to share that as appropriate, but in deed over the last couple of weeks we’ve had. What I think pretty encouraging news on this front.

Rohit Vanjani

Analyst · your question.

That’s great. And then, last one from me. I think there was a stem cell article that came out earlier this month that it relates to Biotime as competitor, can you discuss the relevant of that article and then the likelihood that investors can induce the right 3d genome confirmation in IPS cells and actually what factors are involved there?

Adi Mohanty

Analyst · your question.

Rohit, maybe Mike will answer this question.

Michael West

Analyst · your question.

All right, Rohit. So you’re probably referring to induce pluripotent stem cells for all the listeners let me just very quickly recap what we were talking about. So Biotime is really relatively unique here. Our profound focus on these cells, pluripotent stem cells they are able to make all the cells of the human body. There is a different version of these cells, they are called induced pluripotent stem cells or sometimes called IPS cells. And so, in that technology and which we some years ago have reported on its possible to actually take an age cell like a skin cell. It’s sort of like a time machine take it back to beginning of life and reset the cell clock of aging [indiscernible] and we showed in that publication, I think it was back 2010 that can work, but one out of 10 attempts. Since that time, others who have study these cells embarked greater detail, the Japanese side has won a Nobel price, if some others work and it has become a big thing in the research industry, but these are sort of synthetic versions of the real normal cells, the pluripotent stem cells, the bio term works with. And so they attract a lot of study and in the last week there was a study in cell stem cell, a prestigious scientific journal, which look very carefully at the DNA of these cells and showed abnormalities. This mere some of the other papers have been published in the last few years. So, BioTime’s position is, pluripotent is the future of regent of medicine, but we rely on the goal standard normal pluripotent stem cells. We do research on IPS as we’re not using them clinically in part because of results like that just came out that you are referring to showing abnormalities and safety of products made from these cells is front and foremost of importance to the FDA and therefore biotech companies, so it highlights the strategy of BioTime and focusing on normal pluripotent stem cells, does that help answer the question or I can get into more of science if you want.

Rohit Vanjani

Analyst · your question.

No. That’s perfect. I’ll probably take it up offline with you, but thanks for that.

Michael West

Analyst · your question.

Before you - Rohit, never mind. We’ll take it offline because I was going to mention, we just made the strip all across Asia, where Japan and South Korea and other places where the IPS cells actually were being used quite a lot to a person everyone said, they’ve stopped using that and they don’t think that’s a great idea and that they actually were interested in the cells we have and it made sense to them to follow those. So I just ...

Russell Skibsted

Analyst · your question.

It’s important technology, it’s being widely used for research, for drug discovery and further things. BioTime has taken the position, the normality and safety is front and foremost and so we are focused on normal pluripotent stem cells.

Rohit Vanjani

Analyst · your question.

Great. Thanks for taking the question.

Operator

Operator

And our final question comes from line of Bruce Jackson from Lake Street Capital Markets. Please proceed with your question.

Bruce Jackson

Analyst

Hi, congratulations on all the progress.

Adi Mohanty

Analyst

Thanks, Bruce.

Bruce Jackson

Analyst

So, my first question is about the Renevia regulatory pathway in United States. So you’re already taking to the FDA, how would things play out here after the CE mark? Is this something that where you can parallel path the U.S. study or would you wait to fully complete the EU study before starting the U.S. study?

Adi Mohanty

Analyst

Well, we don’t have to wait for the EU study to be completed or registration. We do need a substantial portion of the data as you know the FDA cares a lot about safety and we’ve got a pretty large safety database already from the EU trial and it continues to grow. So there is a point at which we can get enough data from the trial without having to wait for completion of that trial and so we think, I think we previously said by the end of this year, we hope to have a protocol and a pathway and if we get approval, we’ll be ready to start this trial without having the wait for EU trial complete or the registration to complete in Europe.

Bruce Jackson

Analyst

Okay. And then, my other question was about OpRegen and with the varying dose levels in the trial. Can you just tell us a little bit about how you arrived at those dosing levels and why you think that the higher levels are going to be efficacious?

Adi Mohanty

Analyst

Well that’s a good question. I think this is a little bit of science and little bit of art. There is a significant amount of animal study that we’ve done. So I think for those who haven’t seen it, it’s a worthwhile look, several hundred animals worth of preclinical data. It was presented at ARBO last year. It’s the basis of a lot of the program that we are actually running and that combined with the experience of people like Ocata in our own experience, it indicates to us that we think that the dose is somewhere between the 200,000 and 500,000 and that Ocata was under dosing a little bit. And our animal studies showed, you know so it is an extrapolation that’s why I said a little bit of science and a little bit of an art to come up with this dose and again as you can imagine there is differences in the size of the atrophy that we’re trying to address so somewhere in the 200,000 to 500,000 range and so we’re trying both of them in our third and fourth cohort. So, we’ll get data from both those dose arms.

Bruce Jackson

Analyst

Okay. Great. Thank you very much.

Adi Mohanty

Analyst

Thanks, Bruce.

Operator

Operator

Okay. We’ve reached the end of our question and answer session. I’ll turn the conference back over to management for any closing remarks.

Adi Mohanty

Analyst

Thank you very much everyone joining us. We appreciate you taking the time and we’re look forward to coming back and reporting on further progress. Thanks.

Operator

Operator

Ladies and gentlemen, this does conclude today’s teleconference. We thank you for your time and participation today. You may disconnect your lines at this time and have a wonderful rest of your day.