Earnings Labs

Lineage Cell Therapeutics, Inc. (LCTX)

Q3 2018 Earnings Call· Thu, Nov 8, 2018

$1.57

+0.97%

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Transcript

Operator

Operator

Welcome to the BioTime, Inc. Third Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investors Section of BioTime's website at www.biotimeinc.com. This call is subject to copyright property of BioTime, Inc. and recording, reproduction or transmission of this call without expressed written concert of BioTime is strictly prohibited. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Ioana Hone of BioTime Investor Relations. Ms. Hone, please go ahead.

Ioana Hone

Management

Thank you, Tiffany. Good morning and thank you for joining us. My name is Ioana Hone and I am responsible for Investor Relations at BioTime. And it is a pleasure to be with you today. A press release reporting our third quarter 2018 was issued earlier today Nov 8th, 2018 and can be found on the Investor Section of our website. Please note that today's conference call and webcast will contain forward-looking statements within the meaning of federal securities laws including statements regarding our strategy, goals, product candidates, clinical trials, synergies and benefits of the acquisition and financing matters, such statements are subject to significant risks and uncertainties including those described in our press release issued on November 8th, 2018 and our recent SEC filings on Form 8-K, Form 10-K, and Form 10-Q. Actual results or performance may differ materially from the expectations indicated by our forward looking statements, those risks and uncertainties described in the BioTime and Asterias reports filed with the SEC including the following factors, whether our respective shareholders will approve the merger, the ability to meet closing conditions to the merger on a timely basis or at all, delay in closing the merger, the ultimate outcome and result of integrating the operations of BioTime and Asterias and the ultimate ability to realize synergies and other benefits, business disruption following the merger, the availability and access in general to fund operations and necessary capital expenditures. We caution you not to place under reliance on any of the forward-looking statements which speak only as of today. Joining us today our are newly appointed Chief Executive Officer, Brian Culley; our Chief Financial Officer, Russell Skibsted; and our Senior Vice President of Clinical and Medical Affairs, Gary Hogge. The executives will provide prepared remarks, then take questions from analysts and institutional holders. With that I'd like to turn the call over to Brian Culley, who joined BioTime as new CEO on September 17th.

Brian Culley

Management

Thank you, Ioana, good morning, everyone. We have a lot of important items to update for you today, so thank you for joining in the call. To start off, I'm extremely pleased to have been selected by the BioTime Board of Directors to lead the next phase of our growth. I've joined what I believe is a transformational period for this company. We aim to become the premier cell therapy company. And I believe we have the opportunity to do this by being one of the first cell therapy companies to turn ambitious research ideas into treatment realities. I want BioTime to lead this mission and I believe I can help drive the process through my experience building the teams, infrastructure and institutional awareness necessary to advance the pipeline of treatments through clinical development. I also have a successful history of engagement with patients and advocacy groups, which can further increase our visibility and significance with the medical investment communities by ensuring awareness and appreciation of our clinical accomplishments. Some of you are aware of my background, so I'll just mention briefly that I have more than 25 years of technical and business experience across diverse operational areas, including strategy, finance, product licensing and product development. Early in my career, I worked at the bench running experiments at both academic and for profit research laboratories. So I understand the process and the potential of basic research. But I also spent time in the regulatory world and know what it takes to successfully file a new drug application with the FDA. I have a strong business development background and bought and sold not only individual drug programs, but also several companies. To give you a sense for my management style, as a former scientist, I believe making decisions based on reliable…

Russell Skibsted

Management

Thanks Brian. BioTime's consolidated cash, cash equivalents and marketable securities totaled approximately $21.4 million as of September 30th, which compared to approximately $29 million at the end of the second quarter at which time we consolidated AgeX's financial. As Brian noted a moment ago, we received the second installment of the $10.8 million from the Juvenescence transaction. In addition, we own publicly traded common stock in Asterias and OncoCyte which represent an aggregate market value of approximately $53 million as of yesterday. Once the planned distribution of AgeX is completed later this month, we will own over 1.7 million shares. In upcoming financials, the value of the shares will be included on our balance sheet as marketable securities. We also have a $21.6 million convertible note from the Juvenescence transaction, which we received during the third quarter. If the note is converted to Juvenescence's common stock prior to its maturity date, due to a Juvenescence IPO, the value of the common stock may be categorized as a marketable security that BioTime may use to supplement its liquidity. If the Juvenescence note is not converted, it is payable in cash plus interest at 7% per year at maturity. As a reminder, as a result of the sale of 50% of our interest in AgeX to Juvenescence, we deconsolidated AgeX's financials from ours on August 30th, 2018. So going forward, our operating results will no longer include AgeX's operating results. In the meantime, to provide additional clarity as to BioTime and AgeX's financials, we've included a non-GAAP table at the end of our earnings release the details operating expenses by entity, adjusted for non-cash expenses. We believe this will help investors better understand both BioTime's and AgeX's financials which we believe will make our story more straightforward for investors. Please keep in…

Brian Culley

Management

Alright. Thanks Russell. So clearly the overall biotech markets have been volatile recently. We believe are focused on the fundamentals and in particular the steps we've taken to provide a positive future for BioTime has provided us with the ability today to report on an exciting and transformative quarter. We have supplemented and strengthened our pipeline with two additional and synergistic assets, which will help us become a premier cell therapy company. We have strategically converted earlier stage non-core research programs into cash and equity, which can be utilized to fund our more clinically advanced value drivers without diluting our shareholders' equity. And we have advanced the clinical development of our lead program which continues to generate encouraging results in the disease with no currently approved therapies and comparatively modest competition. This quarter was packed with news but we have no plans to slow our pace of progress. We plan to complete the Asterias transaction early next year and will integrate the companies in a thoughtful and productive manner. We will remain focused on advancing our clinical programs throughout 2019 and we will update investors often on our new timelines and regulatory plans. As a final topic for today, I'm confident in our future because I previously transformed companies not only through strategic transactions like those we've discussed today, but also by building institutional and retail relationships through productive and continuous engagement. I have long standing relationships with the buy side sell side from my prior CEO roles and I intend to bring a similar approach to BioTime in order to increase awareness and visibility of the company in our programs. Awareness is vital to our growth. To highlight that point, we recently restructured our Investor Relations function by engaging the Hone Group and Solebury Trout, a global investor relations firm specifically serving the life sciences industry. We will work with these professionals to increase our exposure to the capital markets and accelerate interest in BioTime from the institutional investment community. Our goal is to build awareness and support for a reinvigorated and repositioned BioTime and have BTX on every investor's radar screen next year. We will achieve this through numerous specific initiatives including a targeted investor outreach to build that institutional following, investor in sell-side elements to educate people about our promising science, conferences and roadshows in major cities and an aggressive rollout of our recent progress and future plans at J.P. Morgan, the largest Healthcare Conference of the year. Most importantly, I believe that stating and then delivering on our milestones across the spectrum of corporate and clinical development activities ultimately will drive the company forward on both the fundamental and equity basis and that will be this management team's priority and focus. With that operator, we are ready for questions.

Operator

Operator

[Operator Instructions] And our first question comes from Reni Benjamin with Raymond James. Please proceed.

Reni Benjamin

Analyst

Hey, thanks for taking the questions. Congratulations Brian on the new role and it seems like you're already beginning to transform the company. So good luck with that. Have a couple of questions, maybe starting off with OpRegen. You did have some updated data, you mentioned during the prepared remarks that enrollment is progressing, you hope to complete enrollment by next year, but just kind of looking out into 2019, can you talk a little bit more about your vision in terms of advancing the OpRegen asset into more pivotal studies, or do you think that you know longer term follow ups from the given - from the current cohorts are what are more likely in that only after discussion with the FDA and possibly in 2020 or so is when the next sort of pivotal studies will be conducted?

Brian Culley

Management

Hey Reni. Thank you very much for the warm welcome. And with respect to OpRegen, I'll let Gary follow-up, but what I would say is that the more data that you bring to the agency obviously the more helpful that is and the more informative it is. I do not believe it is the case that we need to wait 12 months after the last patient dosed to have the clarity and develop our plans and so forth. But let me give Gary an opportunity to provide some more detail around that.

Gary Hogge

Analyst

Thanks Reni. So, basically as we said recently as at AAO, we enrolled the first 12 patients in cohorts 1, 2, 3 and the first 3 patients in the fourth that are receiving better vision cohort. There is a total target of 12 for that cohort. So as at the day we presented at AAO, we are certainly encouraged by the early data showing the potential size of efficacy and certainly well tolerate at this point. And so as we progress with that better seeing, better vision, this cohorts will feel to better assess how to move forward after that.

Reni Benjamin

Analyst

Got it. Okay. And then just switching gears to Renevia, can you provide some color a little bit of context regarding the kind of questions that you're getting, you know if you believe that this is likely going to result in approval by the first quarter of 2019, I've seen that there is nothing all that onerous or complicated, but any sort of color regarding that process?

Gary Hogge

Analyst

Yes, so the question that we received today have been unremarkable standard around CMC that we've been able to easily address what we've been waiting for our questions around the clinical aspect and BSI has new process, they've instituted which has delayed their questions to us. So as soon as those are received, we'll have a better idea of when we might deal with that forward, but I think that is a good assessment if you take Q1 of next year.

Reni Benjamin

Analyst

Got it. And just regarding the ongoing activities, I think Brian you mentioned that there will be a reduction of the ongoing activities. I assume you mean here in the U.S. and the IS, investigator sponsored studies. Am I correct in that or is there something else?

Brian Culley

Management

No, that's correct. The work is substantially complete and European study and as just was discussed, the regulatory work with respect to the CE Mark is ongoing. So yeah, the wait and see approach the slowdown of activity, that's really looking exclusively at the U.S.

Reni Benjamin

Analyst

Got it. Okay. And then just finally for me. It seems like just my back to the angle of calculation for the acquisition of the remaining shares of BioTime, I guess total is about $82 million or so is what the company is being valued at, is that correct or did I miss something?

Brian Culley

Management

With respect to the valuation of the company, I mean you're right and of course that's going to change daily as we trade because we have a fixed conversion ratio. But yeah, they have about 55 little over 55 million shares outstanding. Remember, we own about 30% or about close to 40% of those, so if you look at a net basis, it ends up being you know roughly 16% that the shareholders will own at BioTime once all of this gets completed. But I think you're back to the envelope calculations today are correct.

Reni Benjamin

Analyst

Excellent. Thanks very much guys and good luck on going forward.

Brian Culley

Management

Thank you, Reni.

Operator

Operator

Thank you. And our next question comes from Keay Nakae with Chardan. Please proceed.

Keay Nakae

Analyst · Chardan. Please proceed.

Yes, thank you. I am wondering if you can comment on the upcoming meeting with the FDA. And number one, do you have some firm objectives that you're looking to come out of the meeting having gain clarity on and just maybe a more general statement since you've had receive the RMAT designation, do you believe that that's been helpful in your interactions with the agency?

Brian Culley

Management

So, for the U.S. what we're interested in finding out because it has a very significant impact on our future plans is how the agency will categorize or view the product. So, because of the use of cells, because some of the components of Renevia, it may be deemed to be more drug like than device like. And as you are well aware - sorry.

Keay Nakae

Analyst · Chardan. Please proceed.

Brian, I was referring to OPC1, I'm sorry.

Brian Culley

Management

Pardon me, Keavy. Well here let me - I'll just send it right to Gary.

Gary Hogge

Analyst · Chardan. Please proceed.

Well, with regards to OPC, so the agency doesn't have to give us response our questions more than 24 hours since we have answered the meeting, so we don't know what the responses are, start inquiries at this time. So once we receive them, we'll have a better idea of whether or not our initial believes based on the data are consistent with what the FDA is.

Keay Nakae

Analyst · Chardan. Please proceed.

And have you been finding the interaction easier since you've got the RMAT designation?

Brian Culley

Management

That's really a question for Asterias. We have - we're in that period between signing and closing, so it really is something that we can't answer, but obviously we're directed to them until the deal closes and then we can provide abundant information.

Keay Nakae

Analyst · Chardan. Please proceed.

Okay. And then just moving on to the acquisition. Is there - I know you said a number of reasons for doing it, but would you say there's a primary one, obviously you have the current equity ownership you'd like to protect, you've talked about the synergies and the operation the assets themselves have their own compelling values. But is there a primary driver especially when we consider that they are earlier stage and would require an investor as we have with the serious investors to have you know that longer term investment horizon for those assets?

Brian Culley

Management

Yeah, that's a good question. We didn't apportion a let's say percent contribution of each of the factors that we considered, it's really a constellation of things. But that constellation together is intended to help create a premier cell therapy company. So we think that all the items I won't repeat them because you've already heard them from me, but all of them have a purpose and the purpose is to establish BioTime as that preeminent company. I think we've all been waiting a very long time for the promises of cell therapy to become reality. And so having the critical mass to having multiple shots on target, going after programs that I believe are more suitable with respect to wholesale approaches. All of these things together are intended to achieve that objective and each of them contribute an important way.

Keay Nakae

Analyst · Chardan. Please proceed.

Okay, thanks. That's all I have.

Brian Culley

Management

Great, thanks Keay.

Operator

Operator

Thank you. And our next question comes from Jason McCarthy with Maxim Group. Please proceed.

Jason McCarthy

Analyst · Maxim Group. Please proceed.

Hey guys and I'd also say congratulations Brian on your new role, looking forward to where BioTime is going to go over the next year, very exciting in cell therapy. Question around manufacturing, you did mention that you have that GMP facility in Israel and I was wondering you know what's the capacity of that facility, manufacturing become a bit of a hot topic around things like gene therapy and now that you have the Asterias assets coming under the BioTime. Will you look to transfer that manufacturing in-house to your own facility?

Brian Culley

Management

Yeah, that's an excellent point. I think people occasionally lose sight of the fact that cell therapy manufacturing is a little bit different and very difficult and reproducibility and control have tripped up some companies. I've only been on the job 7 weeks, I'm actually headed to go see, I'm going to go to Israel and see our facility leaving on Sunday. So I'm going to get a sense for that. We haven't made any final decisions about where any assets are going to be manufactured, we have ideas and plans. Certainly we will update you on a full some way after closing. But with respect to sort of faction figures around that facility, I invite Gary if he has anything to add to it. We have been able to manufacture plenty of OpRegen more than is necessary for our next study. So I think we're in good shape there but expect to additional capacity in the potential to move other assets there.

Gary Hogge

Analyst · Maxim Group. Please proceed.

I will echo Brian's comments. So certainly we are comfortable with production for OpRegen and remains, we've seen what we do with other assets.

Jason McCarthy

Analyst · Maxim Group. Please proceed.

Okay. And in terms of OPC1, you mentioned some features of the SCi-STAR study, can you tell us when the next update from that program is going to be, is that would assume that with spinal cord injury that this is going to need or require long term looks at efficacy even without having a randomized trial, this initial just to see if those effects are maintained?

Brian Culley

Management

I wish I could. Again I could only refer you to the comments I made already on the call. We're not allowed to provide guidance with respect to the proposed merger. So I'm going to have to defer that redirect you to Asterias themselves until at such time the deal is closed.

Jason McCarthy

Analyst · Maxim Group. Please proceed.

Okay, great. Thanks for taking the question. Congratulations again.

Brian Culley

Management

Thank you very much Jason.

Operator

Operator

Thank you. And at this time I'm showing no questions in queue. I like to turn the call back over to Brian Culley for further remarks.

Brian Culley

Management

All right, so in just the past two weeks, we've announced the acquisition of one public company and the distribution date for another. We've announced the receipt of $10 million of non-dilutive capital and encouraging clinical data in a disease with no treatment options. So I'm feeling pretty good about my first conference call at BioTime. I appreciate everyone joining us this morning. I'm excited about our plans. And I hope we'll be able to keep this positive momentum going for a long time. Thanks very much.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program, you may now disconnect. Everyone have a great day.