Welcome to the BioTime’s Fourth Quarter and Full Year 2017 Results Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host for today’s conference, David Nakasone of BioTime Investor Relations. David, please go ahead.

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 fourth quarter and full year 2017 as well as recent corporate developments. There will be a replay of this call, which will be available approximately 2 hours after the call’s conclusion and will remain available for 7 days. The operator will provide the replay information at the end of today’s call. With us today at corporate headquarters in Alameda, California are: Co-Chief Executive Officer, Adi Mohanty; and Chief Financial Officer, Russell Skibsted; Co-Chief Executive Officer, Dr. West, is joining us from Europe. Each executive 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 call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company’s filings with the SEC, including, without limitation, 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 on intellectual property rights. And with that, I’d like to turn the call over to Adi Mohanty, Co-Chief Executive Officer of BioTime.

Thanks, David. Good afternoon, everyone, and thank you for joining our call today. Since we talked last with you in early November, we have continued to focus on our three main objectives: clinical progress, simplification and unlocking value. During the past few months, we had meaningful accomplishments like the recent submission of Renevia for CE Mark in Europe, the DSMB approval for initiation of cohort 4 of the ongoing OpRegen clinical trial. Our 2017 accomplishments, along with the recent accomplishments, capped an important year for BioTime as we transition from a clinical stage to a commercial-ready company. With an expected approval of Renevia in Europe and functional data in OpRegen trial, we expect 2018 will be a transformational year for BioTime. Our 2017 accomplishments include: Renevia meeting its primary endpoint in a European pivotal trial of HIV-associated lipoatrophy; additional Renevia data presented at the International Federation for Adipose Therapeutics and Science conference where we reported that treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. We completed enrollment for the third cohort of the ongoing OpRegen clinical trial in dry-AMD and received DSMB approval to proceed to cohort 4. Positive data from the OpRegen clinical trial was presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology, or ARVO for short. Images presented at the conference appeared to indicate that the transplanted OpRegen cells engrafted in an area of the scar. This is the area that was depleted of RPE cells. Additionally, some areas appeared to show structural improvement suggesting possible evidence of a biological response without any signs of retinal edema, which is a fluid buildup that can further compromise vision. OpRegen has shown that it is generally well tolerated, and there were no device-related serious…

Thank you, Adi. AgeX Therapeutics is leading in the application of our pluripotent stem cell platform for novel targets in age-related degenerative disease. So as with the aging retina, the concept is very simple: transplanting young cells into old tissues in the body to restore or regenerate youthful function. Our initial cell therapy product focus is AgeX-VASC1 and AgeX-BAT1 for age-related cardiovascular and metabolic disease, respectively, some of the largest and fastest-growing markets in medicine today. An additional program underway at AgeX is induced Tissue Regeneration, or iTR. While discovered through the use of pluripotent stem cells, iTR really represents a new paradigm. As we all know, adult humans have only limited capacity to repair tissues in the body resulting from trauma or degenerative disease. In some animal species, such as Mexican salamander, there exists a profound capacity to regenerate injured tissues, even amputated limbs. Recent studies suggest that this power reflects the capacity present early in life and then largely lost by the time we are born. Using the company’s proprietary pluripotent stem cell platform, AgeX and BioTime scientists compared cells with the potential to regenerate tissues in humans, similar to that occurring naturally in regenerating animals, with adult cells lacking that capacity. The transition from an early capacity to regenerate tissue to subsequent loss in adults is one of the most complex processes studied in biology today. Therefore, AgeX scientists collaborated with Insilico Medicine to apply artificial intelligence to better understand the process. We published the results of the collaboration in January in the peer-reviewed scientific publication, Oncotarget. This study resulted in the identification of genes differently expressed during the time tissues can regenerate compared to later in life when that capacity is impaired. One gene highlighted in this study is designated COX7A1. It is thought to play…

Thank you, Mike. I’d now like to review some financial highlights from the quarter and full year. BioTime’s consolidated cash and cash equivalents totaled approximately $37 million as of December 31, which compared to approximately $17 million as of September 30. The increase in cash is directly attributable to the $27 million public offering we closed during the fourth quarter. BioTime further benefited on a non-GAAP – or a nonconsolidated basis by the reduced cash spend in the second half due to the reduced spending on the programs that went to AgeX. In addition, we have marketable securities with our affiliate ownership positions, which currently represent an aggregate market value of approximately $75 million. As Adi previously mentioned, 2017 was a very successful year for BioTime. We continue to make significant progress on our three-point strategy of focusing on clinical progress, simplification and unlocking value for our shareholders. As Mike mentioned, our plans to take AgeX public are progressing well. We continue to work with investment banks and other financial institutions and the lawyers, a lot of lawyers, to complete and implement the strategy and activities for taking AgeX public, which may include tax redistribution of BioTime’s AgeX shares to BioTime shareholders. As I’ll remind you on every call, GAAP requires us to consolidate the financials of entities where we own over 50% of the stock, even when those entities are stand-alone companies. We have included, at the end of our earnings press release, a non-GAAP table that details non-cash expenses and operating expenses by entity. We believe this will help investors better understand BioTime’s actual operating expenses and cash burn. Please keep in mind when reviewing this table that you also have to take into consideration grants that are recognized in our financial statements but that are not included in the operating expenses in the table in order to obtain an estimate of our true cash burn. As noted above, BioTime’s consolidated cash and cash equivalents totaled approximately $37 million as of December 31. During the fourth quarter, BioTime’s non-GAAP operating expenses were approximately $6.2 million, and for the full year, BioTime’s non-GAAP operating expenses were approximately $24.4 million. Based on our current 2018 plans, we expect our quarterly operating burn rate over the course of 2018 to be a little over $6 million per quarter. Provided we maintain this level of spending, we expect to have sufficient cash to get us well into 2019. And with that, I will turn the call back to Adi.

Thank you, Russell. As you can see, we are a diversified company with products that span many geographies rather than being dependent on a single product, country and/or region. Our products target specific parts of the body that are locally administered, which, compared to many systemic drugs or therapies, reduces the potential likelihood of side effects, increases the potential for success. Many drugs or therapies fail because of their side effects. BioTime’s products are likely to have a much lower risk profile. And we have successfully unlocked value for our shareholders through the creation and distribution of companies like Asterias and OncoCyte and plan to unlock further value with the pending distribution of AgeX. 2017 was a very good year for BioTime. 2018 is shaping up to be even better with Renevia being potentially approved later this year; confirmation from the FDA on U.S. entry plans for Renevia and facial anesthetics; data presentation from the OpRegen trial at ARVO; and then potentially, transformational data from the patients treated in cohort 4 of the OpRegen trial. We will also unlock value with the potential distribution or public float of AgeX shares to BioTime shareholders. So BioTime is poised to have a breakout year. With that, operator, we’re ready for questions.

[Operator Instructions] Our first question comes from the line of Kevin DeGeeter with Ladenburg. Your line is now open.

Hey guys, thanks for the call and a lot of additional information here. With regard to the expanded patient enrollment in cohort 3, Adi, can you just clarify, are those patients going to be under the same protocols in terms of immunosuppression and other characteristics? Or if you just can comment on whether there’ll be any deviation from the protocol as the initial three patients received.

Yes. Hi, Kevin. Yes, thanks for the question. The additional three patients in cohort 3, if you remember, in terms of the immunosuppression, we used to have 12 months, but we’re now doing three months. And so these three patients will be done with three months immunosuppression. What this does for us really is allows us to have more sites in the U.S. come online, have more practice from physicians in the U.S. because the first few patients are done in Israel, now the patients are being treated in the U.S. It improves the overall package of data that we have. Nine patients is good, but adding three patients to that initial nine-patient cohort is even better. It also allows us to start testing some of these functional test that we intend to carry out with cohort 4. So a substantial amount of benefit with patients that are already ready to go. This recruiting and execution that we have gotten so much better out of the last couple of four months, we have these patients already. So the patients are already scheduled, and we’ll be able to knock them off very quickly.

Okay. Two more quick housekeeping questions for me. With regard to this expansion of cohort 3, are these 20/200 patients? Or there are some of these 20/70 patients as well?

No, we can’t do 20/70 in cohort 3. So we are concurrently recruiting for 20/70, so they’re in parallel. We already have people who were on the better side of the 20/200, so we can have somewhat selected patients, but they do have to meet the criteria of cohort 3 just that we can be selective in terms of a better – within those ranges. But the cohort 4 is also beginning work now. So cohort 3 was already done. Cohort 4 recruitment is already beginning. So hopefully, we’ll be able to do that fairly soon. That will be 20/70.

Terrific. And then just one last one for me, and then I’ll get back in the queue. With regard to the planned study of Renevia in Europe looking at aesthetic applications, will that be used the same dose that you filed within the context of HIV-associated lipoatrophy? Or will you be able to explore higher doses in that study? Higher volumes, I guess, I should say.

Yes. No, that’s a good question. It’s – definitely, we think of this as an ability to explore in much broader range of applications and certainly much different volumes. In fact, the investigator-initiated trial that we started in the U.S. has already gone to closer to 20 ccs per cheek in terms of volume compared to 5. And that’s significant in the cosmetic or aesthetic use, right? Large volume fillers are in the range of 10 to 20 ccs per cheek rather than 5. And we’ve already treated some patients in the U.S. with about 20 ccs. And so the European trial is anticipated to have larger volume, completely unconstrained in terms of patients that we can take into the trial and test more of the aesthetic and cosmetic requirements.

Great. Thanks for taking my questions.

Thank you. And our next question comes from the line of Ren Benjamin with Raymond James. Your line is now open.

Hey, good afternoon, guys. Thanks for taking the questions. Maybe just starting off with Renevia. Adi, can you talk a little bit about the timing after submission? When do you expect to hear from the European regulators? And is there a back-and-forth dialogue? And kind of based on that timing, I guess, give us a sense as to how partnering discussions may be going.

Yes. Hi, Ren. Thanks for the question. Yes, that’s – there’s quite a few pieces on that question. So we just, as we announced, filed. The filing is a design dossier for a CE Mark filing, which is a device pathway. And typically, what runs with the device approvals is current what we have seen in the market in the regulatory agencies, it’s taking about six months. So we think that about six months sounds right. We will start discussions and interactions with the agencies over the next few weeks. So the next two to three months, we’ll have interactions with the agency. We’ll talk about what’s in the file, what potential labels we could have because really, often the devices are approved based on performance of the device and not the therapeutic indication, which is great because this allows us an opportunity to have a conversation about the potential label. And so that is a important input into our commercial thinking. So we’ve been doing a lot of work on commercial, right? We continue to work with partners that we’re discussing, with distributors. We also have a go-it-alone strategy that we’re continuing to work on, but since this label discussion over the next few months is pretty important, the potential label could be quite beneficial. And as these discussions evolve and we know more about what that label is going to look like, you can imagine that our commercial thinking will evolve. So we – as these conversations get firmer, we know more. I think that will be the time for us to give you a lot more specifics of our commercial plans, but it’s an exciting time, so we’re pretty excited. We’re working on all of these options, and we’ll get back on the details.

Got it. And then in regards to sort of the Premvia status right now. I think on the call, you mentioned it’s progressing nicely, and then in answer to Kevin’s question, you talked about how some individuals have gone up as far as 20 ccs in a cheek. Can you give us a sense as to how many patients have been enrolled? Or how many do you need before you maybe begin discussions with the FDA to talk about next steps?

Yes, Ren, so let me take that question a couple of parts because we think that the data that comes from these investigator-initiated trials has multiple uses. It has use in terms of being proof that we can do larger volumes in non-HIV patients. It has use in our ability to work on a expanded label. It has use in commercialization. It has use as support data in our discussion to the FDA. However, it is still disconnected from our discussion to the FDA. So we have made a premeeting submission with the FDA. We’ve had a phone call. We’re going to continue that conversation with the FDA. So over the next few months, we’ll get a good firm answer from the FDA. We’ll be able to come back to you. We still expect that, that will happen this year, that we’ll have a idea of what the FDA wants, and then we’ll be able to start a trial for U.S. entry this year. But the investigator-initiated trial is still different. We’re doing all of these to be prepared for broader labels. So the current trial with Dr. Aronowitz, we don’t quite have a fixed number. As you know, it’s a IIS, investigator-initiated study. What we think is if we get in the range of five to seven or eight patients, it is a data set that we could publish or share at a conference. So that’s kind of what we think is a minimum. I mean, we will continue to recruit patients. But once we get to that number of patients, we think we’ll be able to share the data, which is where we have said that we think this year or in the next few months, we should be able to come out with a data set from this investigator-initiated trial and possibly other investigator-initiated trials because we have had significant interest from other physicians over the last couple of months, and hopefully, we’ll be able to share more of the – who else is coming onboard. That’s the data set we’ll be able to share over the next – in the coming months.

Got it. And then just switching gears to OpRegen. Can you talk a little bit in regards to the timing of enrollment for cohort 4? And when we might be able to see the initial data?

Yes. So the cohort 4 has been approved, and we have started now prescreening work, and we’re going to get into getting the patients lined up. Instead of being at this point really specific month or week, our intention is to have enough patients in cohort 4, such that in – towards the end of the year, Q4, maybe AAO potentially, which happens in the fall, have data from cohort 4 presented at one of those major scientific conferences. That’s our goal with the cohort 4, and we think that’s very achievable given that we have more sites coming online. We’ve had significant interest from very big centers in the U.S. who are interested in signing on and are signing on. And so we think we won’t have a problem. We have a pipeline of patients. We’ve got lots of patients prescreened. We think, though, that the early functional data that we’re talking about, even with these three additional cohort 3 patients, we might be able to get an early peak, I don’t want to promise yet, at ARVO, which is, I think, April 30 and May 1. So in pretty short order, we think we might have some interesting exciting data to share on OpRegen. And so that’s our step one, and then – yes, in the fall or Q4 data from cohort 4.

Got it, thanks very much.

Thank you. And our next question comes from the line of Keay Nakae with Chardan Capital Markets. Your line is now open.

Yes, thanks. Adi, just to follow-up on your last statement about what we might expect to see at this year’s ARVO at the end of April.

Yes. And so I want to be – certainly, we think that we’ll have nine patients worth of data, maybe more than nine patients worth of data, in terms of safety engraftment, other kinds of biological activity. So we – what I cannot tell you, as we build in this data set over the next month, is for sure if we’ll have some of that early functional data, but we have seen some encouraging data, and we’re trying to see if we can put that together in time to get it in the ARVO submission for – it’s not very far from now. But we think we’ll have some data there that will be actually quite exciting, and that’s our push. We think we’ll be able to share some.

So functional data from the cohort 3 patients?

Early – the functional data, again, I want to be careful with cohort 3. If you remember, we keep saying functional data is still a lot more difficult than cohort 3 than in cohort 4, but yes, some early functional data.

Okay. And then for Renevia, again, the U.S. investigator-led study, the change in the protocol from the stromal vascular fraction to what sounded like maybe more generic fat, can you give us a little more detail on that?

Yes, Keay. I think I’ve talked about this before, but I think it’s worth mentioning. So as you all know, fat grafting or fat transfer is a pretty common aesthetic procedure with several hundred thousand procedures done in the U.S. It’s routinely done by plastic surgeons and we’ve cited publications, many publications that talk about how these fat grafts, within three to six months, they dropped about 50%. So you’ve got patients paying $8,000, $10,000, and a few months later, they’re down 50% of the fat, but it’s still a pretty typical procedure for large-volume dermal fillers – I’m sorry, instead of large-volume dermal fillers because those synthetic fillers at large volumes are a bigger problem than at smaller volumes. They cost a lot. They have all the issues of being not natural. So fat graft is a well-established procedure. And for us to be able to have Renevia with fat, which is a very small difference in procedure, so you do everything that you normally do for a fat transfer but just add the step of mixing it with Renevia and potentially change the outcome to a 12, 16, 18, 24-month outcome, that’s where the big opportunities. Because our pivotal trial, which was in very severe patients, as you saw, we had data that showed 70% at 12 months and 18% at – I mean, 64% at 18 months. We think that doing Renevia with fat is the broader application that is easily done by most of these people who are already doing fat graft. So that was our goal is to quickly move the fat. The fact that we were able to quickly move to fat we think is very encouraging, and so we’re pretty excited that we’re going to start treating patients with Renevia and fat and get some of that data. That’s what gets to that broad use and broad application and broad label.

Okay, thanks for that. Okay. And then, just finally, with respect to the most recent grant from Israel for dry-AMD, is that also a grant that is essentially exhausted over a one year period?

I’m sorry, essentially, there – Keay, this is Russell. Essentially, they’re annual grants that get paid as the items in the grant as the expenses take place. So yes, it’s for expenditures during that period of time for the plan – the development plan, but the cash flows can be over the course of the year or a little fast, so yes, one to one and half years.

Okay, thanks for that.

Thank you. And our next question comes from the line of Bruce Jackson with Lake Street Capital. Your line is now open.

Hi. Most of my questions have been answered, but I just wanted to get your current thinking on the AgeX spin. So what are the critical checkpoints on that, if you will? And where do you stand right now on that?

Yes. Thanks, Bruce. I think Russell, you’re going to take that one.

Sure. Hi, Bruce. We remain really committed to continuing the work towards the goal of the second quarter distribution. We’re working with investment banks and other financial institutions and the lawyers, a lot of lawyers, to complete and implement the strategy and activities for taking AgeX public, which, we’ve said before, may include a tax-free distribution of AgeX shares – BioTime’s AgeX shares to the BioTime shareholders. We have already completed many of the major activities that are involved in this process, but there’s plenty more to go. As an example, we’re waiting to receive the final ruling from the IRS regarding the potential tax-free distribution. We’re working with the SEC on the registration statement as well as the number of other accounting issues that are being clarified. As an example of that, we need two years’ worth of audited financials for AgeX, which is a compilation of the financials of entities that we contributed to the AgeX entity. So there’s a lot of work in that, as you can imagine, and we’re making sure that we do it right because we believe AgeX has tremendous value. In fact, if you noticed that at the end of January, a company that is in the similar space and stage, Restore Bio, completed an $85 million IPO. Restore is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of aging-related diseases. Their current market cap is over $400 million. So there’s a lot of interest in the space, and we have very high hopes that AgeX is going to be one of the main players in that space. Hope that answers your question.

It does. And then just one quick one. Do you have an operating expense target for 2018?

I think, what you could do is repeat what you said.

Yes. I think what we’ve said was we think that for 2018, we’re looking at roughly a little over $6 million a quarter based on our current – the current plans. And I would – if you take a look at the last – the non-GAAP table that’s in the back of our earnings release, then I think that gives you a really good starting point of looking at BioTime’s cash expenditures. So in that table, you’ll see that the BioTime operating expenses were about $24 million in 2017. But as I mentioned on the call, the operating expenses, they’re a good proxy, but they do not include revenue from grants and other sources, which, for 2017, we’re about close to $2 million. So I think that gives a good sense.

Okay. That’s it for me. Thank you.

Thank you. And our next question comes from the line of Patrick Dolezal with LifeSci Capital. Your line is now open.

Hi, thanks for taking my questions. Just have a few here on OpRegen. So for cohort 4, I was curious what the plans are for the cell dosage and how this change relative to your cohort 3 might affect the balance between safety and efficacy, just kind of curious where the tipping point is there in terms of driving functional improvements.

So I’ll try to answer. Tell me if I did, Patrick. So cohort 1 and 2, we have different doses than cohort 3. We perfected the dose on what we think is the right dose. So we have the appropriate concentration of cells, we believe, to move forward. And so that of dose concentration of cells is what we’re going to use in cohort 4 in the first six patients. So our plan is the first six patients of cohort 4, get 20/70. I mean that we’ve better vision patients at earlier stages with the dose that we like and get the data, so that we can have data from these patients before the end of the year. That’s what we’re trying to achieve, and we think it was a pretty important step that we had the kind of data on our first few cohorts that our independent Data Safety Monitoring Board allowed us to go, essentially, from legally blind patients to what would be the more – eventually, the target population of patients that would be using a – somewhere in the 20/70, 20/80 range is where people look for a treatment.

Got it. Okay, that’s helpful. And so it sounds like the arm 1 and 2 of cohort 4 are going to be in series kind of starting with arm 1?

I think for us, in terms of cohort 4, we see that as six patients, and that we want to get those done as quickly as possible. And we can – other than doing a single stagger at the beginning just to try out the better vision patients, we have no stagger requirements, so we should be able to get all of these patients in the next couple of months.

Got it. And then in terms of moving to the second arm with the 20/80 patients, I was just curious if the difference in acuity at baseline between arms 1 and 2, if you think that ultimately would kind of change how these patients might respond. So kind of if you have even higher expectations for the second arm or what you guys are currently thinking.

So Patrick, maybe – from what you just mentioned, maybe there is something that we should clarify. So there’s not a separate 20/70 and a 20/80 arm to us. It’s 20/70 is the target. And so which means there’s obviously a range, right? You can’t be that precise. So it could be 20/80. It could be 20/90. It could be a 20/65. So 20/70 is the target, and that’s what we’re trying to get done, and we don’t have two separate arms. And so maybe that’s where it got confusing is that the arm 1, we’re going to do all of these patients in better vision 20/70, 20/80, in that range, and get six patients done. And then think about what the additional patients, the best use of the additional patients in the remaining arm of the cohort is.

Understood, okay. That’s helpful. Thanks a lot.

And our final question comes from the line of Patrick Lin with Primarius Capital. Your line is now open.

Hi, guys. Thanks for doing this call. I just have a quick question in terms of just hearing your thoughts, Adi, on what your experience and journey has been like since you joined BioTime, and what your thoughts are now looking at all of the programs, where they’re at today, in terms of the inflection point and where you think the momentum is actually now at the point where you feel like this is really going to be able to take off in terms of news, catalysts and so on.

Yes. So Patrick, it’s – thinking even think from 1.5 years or 2 ago. I think we’ve done a lot of the foundational work. We have got BioTime to where we would like it to be. We’ve talked about our core pillars of clinical progress, simplification, unlocking value. And using those as guideposts, if you see where we are – I think I talked about it at the end of my script, and I believe that. Renevia is about ready to be approved this year. We have discussions ongoing with the FDA for Renevia. We have OpRegen data coming up in a couple of months and then probably maybe transformational OpRegen data later this year. We have AgeX spinout, which is an unlocking event next quarter. So where I’m standing now, it looks like significant events happening over the next couple of three, four months, that is what sets up BioTime to have a breakout year. So I think we’re in great shape. We have these programs with good data progressing well. They’re at stages that are important inflections. And we have the cash. So we have money to do all of this, this year. And all of this over the next few months, to me, it was worthwhile setting up the company the way we did. We’re here today, about to make some significant milestones that change the company. So I would say that, of course, I could go on for a while, but I hope that kind of encapsulates what feels like what a good place. We’ve done a lot of hard work and now lots of stuff happening over the next few months.

Terrific. Thank you for that update and look forward to hearing more news ahead.

Thanks, Patrick.

Thank you. And that does conclude today’s Q&A session. I’d like to return the call to Mr. Adi Mohanty for any closing remarks.

Yes. I just want to thank everybody for joining us today. It’s been a great year, and it’s going to be a fantastic year ahead. So I look forward to coming information. Thank you.

Ladies and gentlemen, a replay for this call will be available approximately two hours after the call end. Dial-in for the replay is dial-in for the replay is 855-859-2056 with the conference code of 5878807. Once again, a dial-in for the replay is 855-859-2056 with the conference code of 5878807. This does conclude today’s program, and you may all disconnect. Everyone, have a great day.