Earnings Labs

Lineage Cell Therapeutics, Inc. (LCTX)

Q2 2016 Earnings Call· Tue, Aug 9, 2016

$1.57

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Transcript

Operator

Operator

Good day, ladies and gentlemen. Welcome to the BioTime 2016 Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I will now introduce your host for today's conference, 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 results and key accomplishments for the second 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; also 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 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 right. 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. I'd like to thank everyone for joining us on the call today. During the second quarter, we once again made meaningful clinical progress on our key therapeutic programs, Renevia in medical aesthetics and OpRegen in dry AMD. These therapeutic candidates represent our two technology platforms, our industry-leading Pluripotent stem cell technology and our HyStem proprietary delivery technology. Our early-stage work and additional product candidates based on our two platform technologies is also progressing well with the goal to build our future therapeutic pipeline. We also strengthened our cash position during the quarter by completing a successful equity raise on attractive terms involving high quality new and existing investors. All-in-all, the past few months have been very productive. Our stated near-term strategy is to focus on three primary objectives that are designed to drive products to patients while increasing shareholder returns. First and foremost is advancing Renevia and OpRegen through the clinical study process. Biotechnology companies build shareholder value by moving product candidates successfully through the clinical trial process. Every stage of clinical progress adds value. Moving a product candidate from Phase 1 to Phase 2 adds a good deal of value. Moving a product candidate from Phase 2 to Phase 3 is even more important, because not only does it add significant value for shareholders, but also gets the product closer to the patients that need them. Even stepping from discovery to preclinical often increases valuation. There are many recent examples of clinical progress translating into significant shareholder value. Acadia more than doubled this market cap when it released positive Phase 3 data for NUPLAZID. Kythera was acquired by Allergan for 2.2 billion once KYBELLA the drug that destroys fat cells under the chin was approved by the FDA. Our goal is that Renevia and OpRegen to join…

Michael West

Analyst

Thank you, Adi. While the biotechnology industry is increasingly recognizing the power of pluripotent stem cell technology and in particular BioTime's leadership in the space, we believe this is due to the power of the platform itself and frankly to the disappointing outcomes from multiple adult stem cell derived products and development. Of course those stem cell therapeutic candidates don't use pluripotent stem cells which are our focus. We believe that there are three important criteria to recognize about our technology to understand these trends first, pluripotent stem cells are infinitely renewable. This allows indefinite scalability of product potentially lower cost to goods dramatically improve generic infirmity and the quality of the products. Second, pluripotent stem cells can make all of the cell types in the human body. This allows us to carefully choose from thousands of potential cell types to prioritize product development and choosing those with the greatest market potential and the lowest risk profile and therefore potentially the greatest reward for patients and our shareholders. Third, cellular products made from our master cell banks for pluripotent stem cells have a very young profile, this strong scientific support for the contention that these cells maybe able generate disease tissues more powerfully then ever seen in the past with adultery cells. This last property of our technology was the subject of an announcement we've made in June regarding a launch of an unlined resource called Embryonic AI had the met annual gathering I describing for the first time by collaboration underway between BioTime and in silica medicine to use deep learning, supercomputer algorithms to identify previously unknown biology in our cells. Discoveries made to potential use to trigger in humans the profound scarless regeneration seen in animals that can re-grow even suffered limb, damaged hearts or brain. We call…

Russell Skibsted

Analyst

Thanks, Mike. Good afternoon everyone. As we've been saying we are focused on simplifying our business and increasing transparency. One important example of this occurred this past quarter when Asterias Biotherapeutics completed its most recent financing. With our ownership at about 49% we now are no longer required to consolidate the operating results for Asterias into our financial statements. We believe this change helps investors better understand the financial performance and condition of BioTime's operation. GAAP and therefore the SEC require us to show a 100% of a majority owned subsidiaries numbers even if we own only a little over 50%. This means that by the time is required to show on its financial statements 100% of the subs numbers including assets liabilities revenue expenses and cash burn when we own over 50%. In fact, even when we are not funding a company merely because we own more than 50%, we are required to reflect cash burn in our published financial statements. We believe this is a very confusing to investors. We recently strengthened our balance sheet, and completed a successful equity raise admitted $18.9 million from high quality new and existing investors. The additional capital allows us to continue the development of our key therapeutic programs Renevia and OpRegen through meaningful milestones. I'll now provide a brief preview of some key financial metrics. Our consolidate cash and cash equivalents totaled $27.7 million as of June 30, 2016 which does not include Asterias cash. This compares to $27.1 million on March 31, 2016 which did include the cash from Asterias. The $27.7 million last quarter included $16.4 million from the financing. Another $2.5 million from the underwriters exercise of its over allotment option was received by us on July 5, which was after the close of the quarter and are not reflected on the recently filed quarterly financials. As of June 30, 2016 BioTime owned $21.7 million shares of Asterias common stock and $14.7 million shares of onsite common stock, which represented an aggregate market value of about one $104 million as of that date. Now I'll turn it back over to Adi.

Adi Mohanty

Analyst

Thanks, Russell. So to summarize, we're making steady clinical progress with our dry AMD and Medical Aesthetic Therapeutics programs and expect additional milestones of the second half of 2016. As we build the preeminent biotech company based on our pluripotent stem cell and proprietary delivery technologies, we are also committed to simplifying our structure and unlocking the value from our non course subsidiaries. With that, operator, we're ready for questions.

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from Rohit Vanjani from Oppenheimer and Company.

Unidentified Analyst

Analyst

This is Marcus [ph] for Rohit. Thanks for the questions, just a few from me. I might have missed this, but what's the current BioTime ownership for OncoCyte? I know you previously mentioned that was at 58%, is that still the case?

Adi Mohanty

Analyst

It is the case, we're still at 58% of OncoCyte.

Unidentified Analyst

Analyst

Okay, great. And you mentioned on maybe on the last call that FDA followed by approval halfway for facial like for atrophy, has that since changed, and if not, can you talk a little bit about the hypothetic timeframe it will have in terms of approval?

Michael West

Analyst

Thanks, Marcus. You're right. We did mention that the FDA indicated the device pathway which is very encouraging. We continue to have very encouraging interactions with the FDA. It is a little premature for us to be giving out a timeline. Our intentions are that very soon once we finish all the interactions with the FDA, we're preparing protocols and those kinds of conversations. As soon as we have that we will be able to share with everybody our plans that progressing well. We'll share with you more precise plans once we know more about the trial and that should be coming in the coming months.

Adi Mohanty

Analyst

The things are going well.

Unidentified Analyst

Analyst

Okay, great. And just in terms of I know you mentioned a few times for Renevia and potential other applications and some other indications in the market opportunity. Can you maybe just give us little bit more colors in terms of what you view specifically a potential target indications and maybe it was estimated market size of those markets especially have right some sense of how large opportunity is?

Adi Mohanty

Analyst

Sure, that's a big question, and I think what the way I would answer it is we looked at Renevia essentially being a way to create that regenerate the fat tissue loss that happens whether it's with HIV related facial lipoatrophy or age related or trauma related. And when you think about age related it quickly becomes more in that medical aesthetics sometimes cosmetic use. So facial aesthetics in general is a pretty large people have talked about numbers in the range of $5 billion a year market and a substantial portion of that is what we believe clearly the market that we can target. Many of those people who are using alternative therapies in facial aesthetics have issues with the fact that they are synthetic, they don't feel natural. They are not very consistent because overtime they seem to begin to drift or gravity pulls them down. They are also not very long lasting. So if we can create a natural longer lasting more consistent procedure which is what we think we could do which is Renevia essentially growing new tissue. We think that there is a substantial part of that market that we can target. So that's our thinking and focus going forward. Of course as a clinical trial design develops, as a clinical trial develops and as we are able to do other studies which we plan to do in the coming months to supplement or to add to the data that we collect from the Renevia trial, we think that the Renevia trial will create a great foundation for expanded uses in the future. There are -- they are getting me -- maybe I am going to go too long because there are several other ways that Renevia could be used in many other applications. But we're going to start by staying focused on the facial part and there are other parts and other lesions people have need for creating fat tissue that we think we can target in the future. That was two block, but that's a summary of where we think it could go.

Unidentified Analyst

Analyst

Got it. Thanks. Just last one for me; as you mentioned, cash burn for the quarter, I might have missed that, and do you guys have enough cash on hand to get through the cohort three for option?

Michael West

Analyst

It's good question. We didn't say that but we typically if you look at our cash burn in the quarter it's about $5 million. Actually in the second quarter it was actually little bit under $4 million. So in terms of the cash that we have, we did mentioned that we are $27.7 million that with the burn. We've got I think plenty of cash to get through that cohort and completely through the first half of 2017.

Adi Mohanty

Analyst

Marcus, this is Adi. I'll add to that so when you asked specifically about cohort three, I'm sure we can get through cohort three. We can probably get through a few others too. It just we don't want to reach out too far. I am positive we can get to a cohort three.

Unidentified Analyst

Analyst

Got it. Thanks, guys.

Michael West

Analyst

You bet. Thank you.

Operator

Operator

Thank you. Our next question comes from Keay Nakae from Chardan Capital Markets.

Keay Nakae

Analyst

Hi, thanks. Adi, with respect to your Renevia trial, was there EU -- can you just give us any qualitative comments on how that's progressing even in terms of interest in people's wanting to enroll so that you can hit the timeline that you have stated and also it just any other anecdotal promise about how it's going?

Adi Mohanty

Analyst

Sure. Keay. I think last time we mentioned that trials been going well and we continue to add more patients since the last time. I think through June we have great accrual of July and August that's the summer time in Europe, so that's slow down a bit, but we've got a few patients lined up already scheduled for towards the end of the August. So we feel very comfortable that we will get enrolment done in the second half of this year. The trial we mentioned the thing that we can easily say without violating any clinical trial rules is that the safety profile just continues to be absolutely fantastic which is very encouraging for us. And the patients are happy, the physicians are happy. I think in one of the calls before I mentioned we get the see these patients, because there is untreated arm and treated arm. So we continue to feel pretty encouraged, but we have started to do is these conversations with the FDA. I mentioned that because I think the data we are collecting with not just ultrasound but even with 3D. It becomes even more important as we create these packages for the FDA. So our path forward continues to be get the trial further along, get it fully recruited, get the data out early next year, get the U.S. trial conversation with the FDA completed and trial that we can share with all of you and get that started. All of them we still are on track I believe with everything that we planned.

Keay Nakae

Analyst

Great. And then just with respect to the discussions with the FDA, is your takeaway that what they maybe suggesting is readily doable, so it's not such a high hurdle that it becomes a difficult trial to enroll and actually it's something that you can executed in a reasonable straight forward manner?

Adi Mohanty

Analyst

So I want to caution, right. So we have very -- these are early conservation I don't think I can tell you exactly what they are thinking until we sat down with our protocol. So we haven't presented the protocol and discuss with them, but we've got guidance, we had conversations. They were very encouraging. We think encouraging -- the indication we got was probably a device single trial will be acceptable to them. So that was very encouraging. Now we got to finish the design, we got to presented to them. I have no doubt the recruitment and approval will be much faster or easier than the HIV related trial because now we are going to for the broader indication so we expect that, that should be easier. We've already talked to several KOLs in the U.S. who are very interested and if you want more color we can have hospital or clinical head to talk about it. But we talked to several KOLs in the U.S. who are ready to get started on it. So I think we are doing the right thing to prepare ourselves to have a quick enrolment and good trial. But I don't want to get ahead of ourselves. We have not yet had the real protocol design and trial design conversation with the FDA.

Keay Nakae

Analyst

Okay. And I know you said that -- you informed us of those details once you have and is that like an end of the year Q1 or perhaps sooner.

Adi Mohanty

Analyst

Well, I think I'll careful because this is we are talking about regulatory agency interactions, so how do you predict that now. I know for sure it's in the coming months. Now is that three months, six months it would be unfair for me to give you a exact timing on that.

Keay Nakae

Analyst

Okay. So that's fine for now. I appreciate the answers. Thanks.

Adi Mohanty

Analyst

Thanks, Keay.

Michael West

Analyst

Thanks, Keay.

Operator

Operator

Thank you. We run over our allotted time. I'll turn the call back over to our speakers for closing comments.

Adi Mohanty

Analyst

So, this is Adi. Thank you all very much for joining us today in the middle of summer its' a big tough. We appreciate everybody taking the time and look forward to talking to you soon. Thanks

Operator

Operator

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.