Welcome to the Lineage Cell Therapeutics Third Quarter 2019 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 Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. Recordings, reproduction or transmission of this call without the express written consent of Lineage are strictly prohibited.As a reminder, today's call is being recorded. I'd like to introduce your host for today's conference, Ioana Hone, Director of Investor Relations at Lineage. Ms. Hone, please go ahead.

Thank you, Sara. Good afternoon, and thank you for joining us. A press release reporting our third quarter 2019 financial results was issued earlier today, November 12, 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 and financings and cost savings matters. Such statements are subject to significant risks and uncertainties including those described in our press release issued on November 12, 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 those risks and uncertainties. We caution you not to place undue reliance on any of the forward-looking statements 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.

Thanks Ioana and good afternoon everyone. Thanks to a productive quarter, we have a good call planned for you today. I'm mostly going to speak about Renevia and OpRegen followed by some brief remarks on OPC1 and VAC2 before handing things off to Brandi. Brandi will review our financing activities for the third quarter and discuss our plans for further significant reductions in our cash spending, which will occur in 2020 and which will strengthen our financial position even as we advance multiple product candidates with large commercial potential.Starting off, we recently announced that our facial aesthetics product, Renevia was granted CE Mark, very proud with the Lineage team successfully developed this product, conducted a controlled multicenter clinical trial, produced excellent safety and efficacy results and now has received approval of that product in a major market territory.Many small companies have never achieved these milestones, so I believe it reflects well upon the team skills and performance.Importantly, this regulatory clearance for commercial sale comes with an intended use of Renevia for the delivery of autologous adipose tissue or fat to restore or augment facial volume for the treatment of facial lipoatrophy. And if you follow this program for a while, you already know that facial lipoatrophy is often associated with treatment of chronic diseases like HIV, which is the patient population from which our clinical data was generated. But lipoatrophy has many causes, and it's actually a feature of the normal aging process. So we believe Renevia may address a much broader population than just HIV patients, and therefore represents an attractive market opportunity.In particular, we believe using Renevia in combination with the patient's own fat to augment facial volume may be a more appealing option for medium or even large volume procedures. The reason we believe this is facial…

Thank you, Brian. I'd like to start the financial discussion off with an update on our cash position. We ended the third quarter with $35.7 million in cash, cash equivalents and marketable securities. We've previously outlined a larger corporate financial plan to raise operating capital from time to time to support our clinical stage programs through sources other than Lineage common stock and we have continued to execute against this strategy.In the third quarter, we sold 6.25 million shares of OncoCyte common stock for net proceeds of $10.7 million. Additionally, we sold a little over 650,000 shares of AgeX common stock for net proceeds of $1.6 million and a little less than 650,000 shares of Hadasit stock for net proceeds of $1.2 million. Accordingly, all of our remaining investment positions are now less than 20% of those companies outstanding shares, and therefore are accounted for in our financial statements as marketable equity securities.Remember, all of these positions are the result of the value created by our research programs over the years. Recently, we have been effectively monetizing that value as we focus our own spending on developing our clinical programs, including Renevia, OpRegen, OPC1 and VAC2. Now I will talk a bit about the statement of operations for the third quarter of 2019.I will start by reminding everyone that beginning on August 30, 2018 Lineage recognizing revenues and expenses related to AgeX and its subsidiaries due to the AgeX deconsolidation on that date. Accordingly, our 2019 results do not include AgeX activity, while a portion of the third quarter of 2018 does. Total revenues for the third quarter of 2019 were $600,000, a decrease of $400,000 as compared to the same period in 2018.The decrease was primarily related to a decrease in grant revenue, which is based on the timing…

All right, thank you, Brandi. We've taken steps in the past year to restructure the business substantially reduce our expenses and focus on our brand in cell therapy and our most promising near-term assets. Our inspiration of course comes from the patients we aim to serve and we continue to be very excited about our cell therapy programs and how they may benefit those affected by the serious medical conditions we focus on.We also are excited to receive a new product approval and will be moving towards commercialization of our first product in Europe and will continue to focus on the efficient use of resources to support the optimal clinical development of our cell therapy programs, which we believe will help maximize near-term stockholder value.Some of the near-term milestones which our investors can expect to see include the completion of patient enrollment in the U.S. using the Thaw-and-Inject and the Orbit SDS device in the OpRegen study. That's expected in Q1 2020. VAC2 initial immunogenicity data from the ongoing Phase I study of non-small cell lung cancer which is expected around year-end. New OpRegen data from the ongoing study which will be presented at ARVO in May 2020.Continued advancements of the OPC1 program with those manufacturing improvements, I explained which will be ongoing throughout 2020. We plan to meet with the FDA to discuss the clinical development of OPC1 which is planned for the middle of 2020. We said a lot about identifying an external partner for commercialization of Renevia in Europe that work has already begun and is targeted for the first half of 2020 and as always, we aim to maintain a high level of engagement with the investment in medical communities through participation in industry conferences, and the strengthening of existing partnerships with entities such as the…

Thank you. [Operator Instructions] Our first question comes from the line of Joe Pantginis with H.C. Wainwright. Your line is now open.

Hi guys, this is Pasquale Sansone from the line of Joe, thank you for all the updates, congrats on the progress. So a few question in my hand, so the first one for your Renevia program, are you looking for specific geographies to start with?

So thank you for the question. Send our regards to Joe, with respect to the geography, the CE Mark covers a broad number of regions essentially it overlaps with European Union. So, nowadays, it's less important where a potential partners domiciled is more important that they have the capabilities to be able to reach prospective subjects. And there are differential levels of enthusiasm for products like this. Some regions have great interest and excitement in aesthetics, others less so.So we envision this process as being one in which we evaluate a constellation of different factors, the capabilities of potential partner and the perspective revenues ultimately, that they believe that they can reach and that will help us define whether a greater emphasis is in one area within the European Union or another area of the European Union. But in all cases, our focus will be in territories where the CE Mark is applicable and recognized.

All right, thank you so much for the answer. A few other questions from me. So what kind of OPC1 manufacturing enhancements are you focusing on?

So I think it's premature to prescribe what the future press release would be. But generally speaking, our objective here is to enhance the overall characteristics, we want the product to be easier to make, easier to use. I used an example of with OpRegen, we were able to introduce a simple Thaw-and-Inject formulation. Currently, we do not have a simple Thaw-and-Inject formulation for OPC1. So it requires extensive dose preparation the day before. So that's one example that we would look to as being indicative of the kind of features that we want to have in place and locked before we initiate a larger comparative and randomized trial.

That’s helpful. What kind of clinical and or business update should we expect for the VAC2 program?

So for VAC2, I make the caveat a second time that we don't actually have the right at this time to disclose the data, we have to get the permission from CR U.K. But the data that we are most interested in obtaining, and then hopefully soon after sharing would be on the immunogenicity. Dendritic cancer vaccines generally speaking are well tolerated. So I don't think we're expecting to see issues with respect to the tolerance, although because you’re engendering an immune response it wouldn't be that unusual to see side effects such as flu like symptoms, or injections-site reactions, those would be consistent with a mechanism of action for a dendritic cell vaccine.But our interest is really on being able to identify a specific immune response to our antigen, we need to tie together the stimulus we put in and how the body responds to that. Now at the same time, if we also enjoy any sort of indications of response, whether it's complete or partial, we certainly want to report on that, the numbers are still quite small, so there wouldn't be statistical significance. But it would be additive to an overall story that we would want to see unfolding, that a patient that has some sort of a response to our therapy would also have evidence that they have a high level of immune reactivity to our antigen. So it's not so much around safety. I would say the priority is the immunogenicity, because if you don't, if you don't have evidence that mechanistically, it makes sense than anything else that your reporting can be called into question. So the primary interest, like primary response for us would be around the immunogenicity data.

That’s very helpful. And do you have any guidance for when you're going to release this data?

With respect to the VAC2 program?

Yes.

So we believe that we will be able to have the initial immunogenicity data collected at the end of this year, we would hope to be able to be afforded the ability to share that but again, that will be CR U.K.’s decision, and we would just hope that they would like us feel compelled to share information if it's promising and of interest. Naturally being the entity that they are, they are principally concerned with developing new therapies but also their publication and wanting to not undermine any publication. So it's a negotiation, it's a discussion, but hopefully they understand that if there's something encouraging that the world wants to know about that.

Okay. My last question, so for the OpRegen program, how many additional patients that you’re dosing in Cohort number 4?

So we have an additional five subjects that are planned to be dosed with the Orbit SDS. The protocol has room for eight additional subjects. The protocol has drafted is in anticipation of 24 subjects. One of the questions that we will take up later in the year and earlier next year is whether we would want to end the protocol after the six Orbit subjects are dosed and the reason for that consideration is that if the Orbit SDS is performing very well, that would be the route of administration that we would anticipate, we would go forward with. And there wouldn't be a reasonable, there wouldn't be a reason for us to go back to the old way of administering the cells. So it's possible that we would end the study a little early after the Orbit section.We could also think about maybe adding additional patients if we needed to or wanted to, but I can tell you that the protocol calls for eight additional subjects, but the Orbit portion of it calls only for the next five additional subjects.

Thank you so much Brian for all the updates.

I appreciate your questions. Thank you.

Thank you. Our next question comes from the line of Keay Nakae with Chardan. Your line is now open.

Well, thank you, Brian. With respect to OpRegen, the ability to move from the staggered to parallel enrollment. Is that conditioned on just a quick review of safety for the second patient?

Hi Keay, you know what I'll do, I'll just throw that to Gary Hogge, who runs the program and he can tell you about the staggered and how we hope to remove it.

Yes, Keay. So yes two questions, yes. It’s been on the second patient is going well. Certainly the GSMB is obviously keenly interested in the better vision patients being safely treated. And so they want to make sure that those goes well. So assuming the second surgery goes well, it’s our anticipation that they'll remove all staggered from the patients.

And I know you’re optimistic about the first patient using Orbit but was there anything else you've learned from that patient that would be helpful going forward?

Well, it was the first two, first in humans, first Thaw-and-Inject formulation of OpRegen, it was the first used at the Orbit 2.0 devices, it was the 510(k) device is approved. So it was a learning experience to do that procedure alone. And so the subsequent procedures will build on that. So we anticipate that each subsequent procedure will go better than the previous one.

Keay, I'm going to add also that, I don't think we were lucky that the first Orbit subject went well, I think that the device was very well designed. Maybe the primary area of risk is that because it's a new device, anytime a surgeon is using it, it's typically their first time using it in an active surgical environment. They are able to practice on animal eyes or cadaver eyes. But there is risk associated with a new set of hands using it for the first time in a clinical setting.

Okay, great. Then on Brandi, thinking about the cost of injections for next year, how should we think about the split between R&D and G&A?

Yes, so I think, we've obviously been working to reduce our expenses in both of those areas. I would say, for 2020, I would think, if you looked at our quarter-to-date for this period, we were roughly half and half that probably makes sense going forward as well.

Okay, very well. Thanks.

Thank you.

Keay, thank you for the question about cash projections. I hope people don't miss the very significant reduction in our budget for 2020. I mean, that is a really major point that I think we made and it’s just the way these things are structured, it ends up coming in the middle of a presentation. But our anticipated cash needs next year compared to what we had previously guided is a massive reduction. And we're very proud of that without any meaningful slowdown in our rate of progress. So thanks for the question about cash projections.

Thank you. Our next question comes from the line of Jason Kolbert with Dawson James. Your line is now open.

Hi, guys. Thank you. Let's just stay on the topic of cash projection. So if I look at what the anticipated burn rate for the full-year 2019 is, it was pretty high. On a percentage basis, how much lower do you think it's really going to be in 2020? Is it 25% lower? Is it 40% lower?

Yes, it's actually it’s pretty big Jason. So when you look at what we’ve already spent to-date in 2019 and what we forecast for the fourth quarter, that's roughly about $34 million. And we're saying we expect our net operational spend to be about 16. So that's less than half of what we spent in 2019. And of course, we had the merger with Asterias this year. So we had lots of expenses related to bringing that company in, and getting the synergies completed so that we can run the company on a much lower burn going forward.

Yes, I'm willing to bet to that most analysts like me have not caught up with these changes. So there are pretty significant changes.

Yes, I appreciate you taking a look at that and making sure those are updated.

Yes, exactly. And the other part though, is how much cash is locked up in all your holdings just without kind of holding you to a specific number, and I'm going to go through the balance sheet and go through the quarter and kind of come to my own conclusions. But when you look at your holdings today, how much cash is kind of locked in there?

Yes, so not a problem. So we just filed the 10-Q as well. So you'll be able to see all the information there. But we showed a bit cash of about $14.4 million, as of the end of the third quarter, and a little over $21 million of marketable securities. So that's how you get to the total of $35.7 million. So you can see how that cash will flow. So we don't really need to make any decisions in the near-term about whether we're going to sell any of those marketable securities.And as you also know, we have that Juvenescence note coming due to us in just about 10 months. So by reducing our expenses, it really gives us a lot more flexibility in terms of when we need to sell those assets or look at that.

Right, so remind me of the value of that note and also the value of your remaining equity holdings in the other companies?

Sure. So as of 9/30, the equity securities was about $21.3 million.

Okay.

And then in terms of sorry, remind me of your first question?

I was just trying to get a handle on what is the value of the Juvenescence note in addition?

Sure. Sure, sure, sure. Yes, the face value of the Juvenescence note is $21.6 million on the balance sheet to date is $23.2 million with the accrued interest and debt maturity, we would expect that to be $24.6 million.

Nice, okay, yes. So you have plenty of cash. It's really you guys are in a great spot. So now I'm going to ask you, to me it’s just a very obvious question. But I think it will be helpful to a lot of people having lived through this before with other companies like StemCells, Inc. some of the parallels are striking. But some of the differences are striking to like the emphasis on manufacturing. So Brian, can you talk just a little bit about what's involved in the tech transfer to make manufacturing happen in Israel. And then help me understand when you look at macular degeneration versus spine, how you're going to prioritize their programs and how you're going to avoid some of the pitfalls that may be undid stem cell thing, which fair enough, it's a different product. But they were going after the same things with the same concepts, right?

Yes, certainly. So I think one thing that is perhaps not well understood across the investment community at large, right, so outside of your specialist is that growing and manufacturing cells is completely different than making small chemicals. If you do a nucleophilic acyl substitution reaction in the chemistry lab, your results are going to look essentially the same every single time because it's physics.It's bounded by the laws of physics. Cells behave with a lot more variability, when you grow cells, if you can imagine that almost any variable you can dream-up could be demonstrated as having an effect on the Lineage of a population of cells. And to give you a real nice specific example, the rate at which a bunch of cells are moved up and down a pipette, or whether cells are growing on the edge of a flask versus the middle of the flask, everything you can imagine, can cause variability.And you're talking about a process that may be, it varies from company to company, but it could be four weeks, it could be six weeks, it could be eight weeks of cell growth. So you have this countless number of areas of potential variability. And of course, what the FDA cares greatly about is control. They want to make sure that you're making the same thing every time so that if you test yourself in a patient population and they grant you approval, you're not administering something different later on.So the tech transfer is really a massive undertaking, because you're changing the operators, you're changing the equipment, you're changing the air pressure, because you could be at a different altitude, everything you can think of has to be reconciled and explained and controlled. So it's just simply a long process, it’s a laborious process.…

It does and it's amazing how much you've transformed this company just in the short period of time, you've been there. My last question is really on Renevia, my nickname in Japan was Tanuki. That means Raccoon because I always have black eyes, so what I want to know is, it seems to me that the aesthetic marketplace for a filler is huge, it’s enormous, the amount of money that's spent on this country, just on when you're, as you get older, a natural feature of aging is kind of a thinking outlook. So I would think that the BD potential here could be quite significant. What's your early read?

My early read is that there's little that attracts more attention these days than people wanting to look and feel good. So I concur that the aesthetics market represents a huge opportunity. Admittedly, it is competitive, you really I think need to find your niche, you need to find where you stand out. If you are a smaller product or you're a smaller company, you need a foothold, you need a beachhead, you need a place to start and to build from, I think we have that inherently built in with Renevia because the data in HIV lipoatrophy was quite convincing.So I think that can afford a potential partner a beachhead, so to speak. And then additional work and a lot of market research, you start to sort of emerge from there and figure out where other appropriate uses could be based on collection of additional data and market research, as I say. So I think the really short answer is it's unknown to us.It's unknown to us, in part because we're not a European based aesthetics company. That's why we're looking for a partner who brings those capabilities. But I think that we are quietly optimistic about the short, medium and long-term future.

Yes, I am too. Thank you so much, great job today.

Thank you, Jason.

Thank you. Our next question comes from the line of Jason McCarthy was Maxim Group. Your line is now open.

Hi, this is Joanne Lee on the line for Jason McCarthy. Congratulations on the progress and thanks for taking the question. So my first question is more clinically related, as we seen in wet AMD an improvement of 15 letters or more typically represents a clinically meaningful improvement. And since wet and dry-AMD are similar, but distinct diseases.Could you shed a bit more color on what are some of the provable end points that we might be seeing in dry-AMD and then could you explain the importance of focusing on treating patients who are legally blind versus patients with less severe disease, why is it easier for the second group of patients? Thank you.

Certainly, Joanna and thanks for joining. I'm going to pass the question again to Gary Hogge, who can talk to you about similarities and differences with wet and dry as well as the importance of now treating the better vision subjects.

Yes, so the three line difference is typically associated with the wet-AMD therapies. So Eylea and Lucentis and difference between treatment and sham treatment groups. It's not necessarily an improvement, it’s just a three-line difference at the one-year assessment time point. Typically, with the GA therapy, it's a 50% reduction in the progression of the area of GA. And that was done for the lampalizumab study is the primary end point also for the CAPELLA study. So it would be up to discussions with the agency to see whether it's geographic atrophy or best visual acuity which might be more important but both play a role. And so that would ultimately steer what the next study might look like.With regards to why we think the less severely affected patients are likely to benefit from therapy. In all likelihood, the photoreceptors are much more preserved, and were much more likely to preserve those that are still in the transition area. Those are kind of sick but not dead yet and the thought is the cell replacement therapy with the RPE from OpRegen enables those cells to become healthy again. And that's thought then to potentially halt the progression of disease.

Okay, great, thanks. That was helpful, thanks again for taking the question and we look forward to an update from the KOL event.

Thanks Joanne.

Thank you. This concludes today's question-and-answer session. I would now like to turn the call back to Brian Culley, CEO for closing remarks.

Thank you, Sarah, I appreciate everyone joining us this afternoon. I'm obviously excited about our plans. And as a final reminder, our focus going ahead will be on three items, collecting and maturing our OpRegen data in dry-AMD, finding the right commercialization partner for Renevia and as always ensuring we meet our milestones while keeping our expenses low as possible. Thank you so much. I look forward to speaking with some of you after the event.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.