Welcome to the BioTime, Inc. Fourth Quarter and Full Year 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 the expressed written concert of BioTime is strictly prohibited. As a reminder, today’s call is being recorded. I would now like to introduce your host for today's conference, Ioana Hone, Director of Investor Relations at BioTime. Ms. Hone, please go ahead.

Thank you, Jonathan. Good afternoon and thank you for joining us. A press release reporting our fourth quarter and full year 2018 financial results was issued earlier today March 14, 2019 and can be found on the Investors 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 and clinical trials, expected synergies and benefits of the Asterias acquisition and financing matters. Such statements are subject to significant risks and uncertainties, including those described in our press release issued on March 14, 2019 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, due to these risks and uncertainties. We caution you not to place undue reliance on any of the forward looking statement, which speak only as of today. Joining us today are our Chief Executive Officer, Brian Culley; our Chief Financial Officer, Brandi Roberts; our Chief Medical Officer, Ed Wirth; 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, our CEO.

Thank you, Ioana. And good morning, everyone. We have been extremely busy since my first earnings call just five months ago with significant advancements made on the corporate development, clinical and operational fronts. BioTime is a very different company than when I joined as CEO in September of last year and we will continue to pave the way toward our objective of becoming a leading cell therapy company. On our last call we outlined our plans to simplify BioTime’s corporate structure and focus on our most compelling clinical opportunities. We intended to accomplish this in part through targeted transactions with our affiliated companies. We have executed on these near-term promises and I would like to highlight those recent accomplishments briefly before going into greater detail on each one. First at the beginning of this week we announced that we completed our acquisition of Asterias Biotherapeutics, broadening our pipeline with the addition of two synergistic and compelling clinical stage cell therapy assets. In January, we entered into exclusive agreement with Orbit Biomedical and we will collaborate with Orbit on the use of their proprietary injection technology to deliver OpRegen for the treatment of dry age related macular degeneration in our ongoing clinical study. We also made some recent changes to our executive team. In January, we announced the appointment of Brandi Roberts as our Chief Financial Officer and Senior Vice President of Finance; and more recently, as a result of the acquisition of Asterias, we also added Dr. Ed Wirth as our Chief Medical Officer. Ed will oversee the clinical development of the OPC1 and VAC2 programs. As a reminder, BioTime owns a large portfolio of cell therapy technologies and patents. The actual and potential product candidates continued within this platform exceed our ability to fully develop them. As a result,…

Thanks, Brian. I’m very pleased to transition from the role of Chief Medical Officer of Asterias directly into the role of CMO of BioTime. Nearly my entire career over the past 25 plus years in academia and industry has focused on the translational and clinical development of cell-based therapies for neurological indications, and more recently, cancer. As a faculty member of the University of Florida I planned and conducted the first Phase I clinical study in the USA of neural tissue transplantation in the human subjects with spinal cord injuries. In 2004 I transitioned from academia to industry and served as the Medical Director of Regenerative Medicine at Geron Corporation where I planned and led the world's first clinical trial of human embryonic stems cell-derived product GRNOPC1 now known as AST-OPC1 in patients with acute SCI. Since joining Asterias Biotherapeutics at its inception in 2013 I had led the continued development of AST-OPC1 via the SCiStar trial and worked closely with my former experienced colleagues on the VAC2 program. I look forward to working with the BioTime team to continue advancing the OPC1, VAC2 and OpRegen programs into later stage clinical trials. Brandi?

Thank you, Ed. I would like to start off by saying that I’m really happy that I joined the BioTime team. I believe that my strong leadership skills in finance and operational areas such as clinical development and manufacturing will be helpful as we continue on our mission to becoming a leading cell therapy company. I bring over 20 years of experience to my position. I’m a CPA and started off my career at PricewaterhouseCoopers, so I have a strong foundation of accounting and financial knowledge. I worked at Pfizer for seven years, so I also have a strong foundation in pharmaceutical research and development. When I was a CFO at Mast, I helped to run the largest sickle-cell clinical trial ever completed. It encompassed 388 patients at 75 sites in 12 countries. I provided operational oversight including significant project management as we worked to complete data lock in a timely manner and finished our study within budget. I understand the needs of clinical stage companies and I look forward to working with the team here to create shareholder value as we work to deliver clinical data on our three cell therapy programs. I will start off the financial discussion with some balance sheet highlights. At December 31, 2018 BioTime’s cash and cash equivalents totaled $23.6 million. Our marketable securities, which include our investment in AgeX, totaled $7.2 million. Our investment in OrthoCyte was value at $20.3 million as of December 31, 2018. But as Brian mentioned previously, OrthoCyte released positive data recently and has seen a significant increase in its stock price. Accordingly, our investment in OrthoCyte was worth $55.9 million as of yesterday. Our promissory note from Juvenescence is valued at $22.1 million as of December 31, 2018. If Juvenescence completes an IPO prior to note maturity then…

Thanks, Brandi. As you can tell we’ve been rapidly transforming BioTime into a leading cell therapy company through strategic transactions on the corporate development, clinical and operational fronts and we have no plans to slow our pace of progress. We will remain focused on advancing our clinical programs in a thoughtful and cost effective manner throughout 2019 and will update investors frequently on our timelines, achievements and regulatory plans. Some things we look forward to this year include: A new corporate brand focused on clinical stage cell therapy programs which we expect to be launched in the second quarter; Updated results from our Phase I/II clinical study of OpRegen for the treatment of dry AMD at the 2019 ARVO Annual Meeting in May; Initiation of dosing with the Orbit device and the new thaw and inject formulation in our ongoing clinical study of OpRegen anticipated in the second quarter; Advancing the OPC1 program including manufacturing improvements and plans to meet with the FDA to discuss next steps in the clinical development of the program; Strengthen partnerships with CIRM and Cancer Research UK for the ongoing support of the OPC1 and VAC2 programs; Completion of the patient enrollment in our Phase I/II clinical study of OpRegen anticipated by the end of this year; Evaluating the development of OPC1 as a candidate for multiple sclerosis and ischemic stroke through ongoing research collaborations we have with major universities; And increase presence in the patient, physician and advocacy communities; And lastly, decision on BioTime’s CE Mark application for Renevia which is expected in the second half of 2019. I believe in the past six months following my hire, we have delivered on promises to take BioTime in an exciting new direction and we will continue to increase visibility of the company in our attempt to build institutional and retail support through continuous communication and engagement. Our goal is to build awareness and support for a reinvigorated and repositioned BioTime that will be this management team’s priority and focus in 2019 and beyond. And with that, operator, we are ready for questions.

[Operator Instructions] Our first question comes from the line of Jason McCarthy from Maxim Group. Your question please.

This is actually Naureen calling on behalf of Jason. Congratulations on the quarter. We were just wondering one question really with regards to the spinal cord asset that you acquired with the Asterias acquisition. You mentioned that you have a meeting coming up with the regulatory authorities later on in the year. Where do you think the path forward is with regards to this asset and is that advancing in the setting of spinal cord injury?

Hey, Naureen, thanks for joining. So because it's a new asset to BioTime, we are just going to be evaluating the existing path. At present we don't have any reason to think that the path that Asterias had discussed with the FDA has any flaws or deficiencies or problems, it's just a matter that we want to go through and make sure that we’re comfortable with it as well. If there are any changes whether those are to regulatory strategy or on CMC side or anything like that, that is something that we would update accordingly. But at that time we know that Asterias has done a lot of work and had very promising interactions with the agency on a proposed next study. And so until and unless something changes, it does grow with that program.

And just a quick question on what you could be presenting at ARVO with regards to OpRegen. Can you talk about how many patients have been enrolled and what we are missing there? Any cohorts or …?

Yes. I'll hand that question to Gary Hogge, who can provide you with some more information.

Yes, thanks for the question, Naureen. So as Brian said there are 12 patients that were involved in Cohorts 1 through 3, additional 3 patients with better vision in Cohort 4 and those data will be updated and presented at ARVO. So a total of 15 patients will be presented.

Thank you. Our next question comes from the line of Joe Pantginis from H.C. Wainwright. Your question please.

Thanks for taking the question. And congratulations on getting Asterias done. Also starting with OPC1, just curious, you did mention Brian that you will obviously be doing some internal analysis of the data, so was curious about what your public disclosure plan might be especially with regard to granularity on the patient populations in the study to-date and differences between say the AIS-A and the AIS-B populations as an example?

Yes. That’s something I think that -- I’m going to have Ed join in just a second. I think Asterias didn’t provide let’s say patient level data yet and so Ed can provide a quick review of what’s currently known. And then what are things that we will be doing as we continue to analyze this data is provide greater granularity because that will help it form our strategy, such as our inclusion-exclusion criteria in the next study.

Yes. Thanks, Brian. So yes, you may recall Asterias didn’t provide, as Brian mentioned top-line data earlier this year for the 12 month primary readout in the study and the plan as Brian mentioned is underway right now to deeply analyze this data. We believe that the data we have thus far are very informative as it relates to later stage trials with respect to patient inclusion, dosing-- dose level, dose timing and so forth. So again we’re evaluating all of those variables right now and those will factor into our plans going forward and our coming meetings release with the FDA.

But with regard to say public disclosure of any of these analysis?

Joe there is nothing on the calendar right now. But as we have summaries available whether those are in the form of peer reviewed publications or abstracts or presentations, I imagine that would be something that we would be sharing this year.

No, that’s helpful and then just one quick question hopefully. So as you are looking to get patients on the OpRegen study going under the Orbit delivery system, just curious what the outstanding punch-list might look like with regard to getting a patient to that stage?

Look, you're probably familiar just that there's a 30-day waiting period for any protocol amendment that goes in and then prior to that there is a little bit of qualification of the Orbit device that gets done. So those two things together we anticipate that our first Orbit patient will occur in the second quarter.

Thank you. Our next question comes from the line of Reni Benjamin from Raymond James. Your question please.

Can you talk a little bit about enrollments in the OpRegen program right now, are you finding any sort of difficulty in obtaining these patients and identifying the patient's? I guess where I’m going with this is I would have expected the next six patients in that study to be enrolled a lot quicker than kind of by the end of the year.

Yes, Ed please?

Hey, Reni. As we’ve gone to the better vision cohort, the Data Safety Monitoring Group as well as the FDA put in mandatory stagger periods where they wanted to evaluate the safety in those individual patients. Also as those evaluations were ongoing we began the discussions with Orbit and as Brian alluded to earlier we certainly believe that Orbit may represent a superior way to administer OpRegen. And so in a way we’re hoping now for the OpRegen to be received by the agency.

And just to clarify the nine remaining patients to be dosed in Cohort 4, they are not going to be with the Orbit injection technology, they'll be dosed the classic way and then you will have an additional x number of patients with the Orbit technology?

No, our goal would be to treat the next six patients using the Orbit device at least the next six patients.

And then I know that you guys mentioned on the call and on the press release about looking at the cell therapies as a potential treatment in multiple sclerosis and ischemic stroke. I think it was the OPC1 candidate. Can you talk a little bit about, what's driving your thought process there? Have you done work with OPC1 in these indications or is it more from work that's been done externally that makes you think that this might be a great area to go into?

Yes, I mean absolutely we're always looking for ways that existing programs may have a broader application, so rather than thinking of OPC1 as limited only to spinal cord injury, maybe it is appropriate to look at it in terms of conditions at a demyelination. So Ed if you could comment about some of the work that Asterias has done with some of the academics looking at other areas that OPC1 could potentially go into in the future?

Yes, so on the MS front we have had prior collaborations with academic institutions and also we had an ongoing collaboration with investigated obviously line actually that developed unique animal model of MS where the immune attack is directly against the myelin forming cells but it wouldn’t be necessarily reject our cells. So we’re looking at that model, potentially to help us evaluate the ability of OPC1 to re-myelinate axon in a very good MS animal model. With regard to stroke, stroke actually -- about one-third of all strokes are predominantly in the white matter which is targeting OPC1 but even major strokes have a significant white matter component to them. And so we have a collaboration in progress as we speak right now, a preclinical efficacy study in the leading animal model of stroke which is the middle surgical artery inclusion model with an investigator at University of South Florida who has done quite of few of these studies, and there the in line phase of that applicable collaboration should be completed in the second quarter and then once the data are analyzed and so forth I would imagine slightly later year we would have -- be able to provide an update from that work.

And just switching gears to Renevia real quick. Has there been any sort of back and forth with the European agency Brain? I mean typically during this phase there is both a question-and-answer period, sometimes the clock stops. Can you just give us a little bit more color there? And you mentioned a distribution agreement, what would be ideal sort of a distribution agreement look like?

So I'll do the second part of it before the first part. So we don’t currently have the infrastructure to establish a European commercial business. So I think what would be ideal for us would be to find an entity that has those capabilities and structures something where we can enjoy the potential upside, essentially shift the risk -- shift the commercial risk onto somebody else. With respect to the process, Gary, you can provide -- I mean we have been going back and forth, there’s different divisions within that group that we interact with.

Yes, so we’ve interacted with a number of other groups on the CMC side from the animal component aspect and we’re still awaiting clinical questions. So we know that they are actually reviewing it but at this time we have no deadline and to your question as to the stop clock, particularly if there is no clock and no stop clock, so it’s entirely we respond when we receive questions but thus far no positive interactions.

And one final one if you will let me. Regarding manufacturing you spent some a little bit time talking about it on the call. What are your thoughts in terms of keeping it in-house versus working with the CMO at later stages of development?

Cell therapy is not like making Aspirin as everyone knows, and I feel strongly that owning manufacturing, controlling manufacturing has tremendous value. These cells can diverge through the process and I think throwing it over the wall to a CRO, especially one that hasn’t been doing it for years and years, is a big gamble. There in some cases maybe some cost savings. Although frankly I think what we -- what our expense structure looks like is, is really attractive. So you never know what may happen in the future if a partner wants to come in and buy commercial right, some or all of the commercial rights and demand to absorb manufacturing, obviously we’re open to having that conversation. But we’re pretty happy with our very new facility there and the work that's been done. Working towards getting a close system, growing these cells in bioreactors, these are things that I think are perhaps underappreciated and meaningful differentiating characteristics for that program vis-à-vis some of the other things that are happening out there in the space.

The next question comes from the line of Keay Nakae from Chardan. Your question please.

A couple of question about the collaboration with Orbit. First of all, trying to understand how quickly a practitioner becomes [facile] using this device? Maybe to start, what kind of clinical data did Orbit have in getting the 510(K)?

Yes. Hi, Keay that’s a good question for Gary.

So the data for 510(K) clearance was granted at the end of November. They had extensive process, human developments, there was a paper published by Allen Ho out of Philadelphia area looking at some patients using the Janssen cell line. Janssen decided not to pursue that and then Orbit was an option of that. They conducted device improvement and undergone extensive human and animal testing as part of that filing with agency and so based on those data and the FDA clearance we feel comfortable beginning patients with -- OpRegen patients with Orbit.

So is it straight forward for the surgeon to utilize the device or what kind of training or even in some sort of non-human model do they need to undergo before they feel comfortable putting into a human eye, especially in somebody with less savior vision impairment.

Right. So there is training process -- physical training process, it is suprachoroidal route, so it’s not something that a typical retinal surgical specialist undergoes training and so they have an extensive training program involving online aspects, dendritic lectures and wet lab experience in preparation for that.

And our investigators undergo those before they began treating any subjects.

And in terms of the exclusivity of the collaboration, is this exclusive only to cells administer to the eye from dry-AMD or those include potentially other therapies?

Orbit’s business model if I could speak for them would be to partner with various companies in different parts of the eye and different approaches. We feel extremely satisfied that we have whole cell delivery to the back of the eye for the field that dry-AMD. It's not limited in some way. But we would imagine as that company is going to also approach some of the gene therapy companies or others that work in the eye that may have other diseases or indications, as long as we have the right to lock-up the space that we are working in that’s sort of primary interest to us.

Two more questions. One, have you explored the potential to get on that designation for dry- AMD indication?

This is something we will definitely engage with the agency when we interact with them presenting some of our Phase I/IIa data.

Okay, and just the final question on the manufacturing and moving to Israel, if you could just maybe quickly describe what it is that they are able to do much better than what you've been able to do in three months?

I wish I could, certainly components of these are proprietary illustrated part of competitive intelligence. I did allude to some of them in a general way working towards having a closed system, growing cell in bioreactor, so we think about more three-dimensional cell growth in production rather than two dimensional. The COGS improvement that you have their, the scale improvements you have there and the control improvements you have there without going any further, those are sort of the categories of advantages that we think are relevant to that program.

Thank you. This concludes the question-and-answer session. I'd like to hand the program back to you Brian Culley for any further remarks.

Alright, I appreciate everyone joining us this afternoon. I'm obviously excited about our plans and thank you for your interest in our business, and I hope we will be able to keep this positive momentum going for a long-time. Thank you very much.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.