Lineage Cell Therapeutics, Inc. (LCTX) Q2 2017 Earnings Report, Transcript and Summary

Greetings and welcome to the BioTime Second Quarter 2017 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Doug Sherk. Thank you may begin.

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 second quarter of 2017, as well as recent corporate development. There will be a replay of this call, which will be available approximately two hours after the call's conclusion, and will remain available for seven days. The operator will provide the replay information at the end of today's call. With us today at corporate headquarters in Alameda, California our Co-Chief Executive Officer, Adi Mohanty and Chief Financial Officer, Russell Skibsted. In addition, Co-Chief Executive Officer Dr. Michael West is joining us today from the East coast. Each executive will make prepared remarks, and then we'll take questions from our covering analysts and institutional holders. Before we get started, we'd like to remind you that during the course of this conference, 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, to the company's forms 10-K and 10-Q which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risk inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. And with that, I'd like to turn the call over to Adi Mohanty, Co-Chief Executive Officer, BioTime.

Thanks David, the second quarter of 2017 was a very productive one for BioTime. We achieved a number of important strategic goals including positive clinical data in both of our lead programs. The highlight was the successful out come of our pivotal study of Renevia in Europe. The data from the study was we believe an unqualified success, we’re now advancing Renevia towards commercialization in Europe. The next step in that process is filling for CE Mark which we expect to do by the end of this year. The results from our ongoing study of OpRegen in dry-AMD continue to be encouraging. We presented new data although from the second cohort of patients. The data showed evidence of cell survival and early signs of the biological response. Last week we announced that we received clearance from the BSMB to proceed to cohort 3 in this study. We also made progress with our subsidiary AgeX Therapeutics, which we established to consolidate certain subsidiaries early stage assets and research programs primarily focused on the biology of aging and age-related diseases. Our goal in forming AgeX is to unlock the potential value of these assets for our existing share holders while not taking resources away from our rapidly progressing clinical programs. It also helps us to further simplify our company which is one of our key corporate objectives. This afternoon, we announced AgeX raised approximately $10 million to fund its operations. The investor group includes several new investors and some existing BioTime investors. The transaction value of AgeX at approximately $68 million post money. As part of simplification strategy as well as our strategy to unlock value for our shareholders, we intend to distribute some or all of our holdings in AgeX to BioTime shareholders. Although no date have been pre-determined yet for the distribution, we are in the midst of examining various strategies and a distribution could take place as early as the end of this year. Dr. Mike West who is leading the new subsidiary is going to provide a more detailed overview on the program AgeX in a few minutes. Turning now to our aesthetics program, on June 14, we announced that Renevia had met its primary endpoint in the European pivotal trial. This was a multicenter randomized evaluated blinded controlled study. Here are some of the highlights of our call last June. The result showed there was approximately 100% retention of transplanted volume at six months where at the untreated patient had no incremental hemiataxia [ph] volume increase. The data from the running patients showed a 96% volume retention of six months and impressive 93% volume retention at 12 months. This maybe an indicator of long lasting volume retention. There was no device related adverse events, there was no serious adverse events during the transplant or during the follow up period. Currently, over 2 million procedures have done annually for fascial aesthetics purposes, they use dermal fillers and fat transfers. People prefer fat transfer as a more natural alternative to have a more healthy or youthful look. However, around 50% of fact is lost within six months of transplant. We believe that Renevia can stand out in this space given the data generated from our study. The full trial report including the other data collected during the trial is expected to be available sometime in the third quarter of 2017. Importantly, we believe the results we have reported provide sufficient clinical evidence to proceed with a CE Mark filing in Europe. We’ve time to file by the end of this year and have a solid data package demonstrating efficacy and safety from this trial which will be important for clinicians, regulators and potential commercialization patient, partners. Following CE Mark approval, Renevia could be available in Europe in 2018. We’re also starting studies to get additional data that would help support indication expansion in US entry plans. Once such trial will start shortly in Beverly Hills under the direction of Dr. Aronowitz, who is a leading plastic surgeon. We hope to be able to begin sharing data from these trials before the end of the year. All these activities are helping us prepare our data package for the discussion with the FDA. As mentioned before we have previous conversations with the FDA during which, they indicated that we’re likely to be using the device pathway for approval in the US. A device pathway is usually shorter and faster than biologic approval pathways. We expect to have further details of our plans with the FDA for Renevia before the end of this year. Now, let’s turn to ophthalmology. Earlier this month, we announced approval from the BSMB to proceed to cohort 3, which is another positive step forward in our ongoing phase 1 2A trial for OpRegen in dry-age macular degeneration also known as dry-AMD. In May we presented data at ARVO from patients in cohort 1 and 2 of this trial. The data was quite encouraging and showed evidence of cell survival as demonstrated by imaging analysis showing that the transplanted OpRegen cells remained in place and we saw early evidence suggesting biological response with some areas of the retina showing structural improvement. Cohort 3 is expected to begin enrolling patients in the coming weeks and will include patients in both Israel and the U.S. The investigators of the U.S. will be two leading ophthalmologists Dr. David Boyer of Retina-Vitreous Associates Medical Group and Dr. Richard McDonald of West Coast Retina Medical Group. On July 25, we hosted a KOL event in New York on the topic of dry-AMD. The event featured a presentation by Dr. David Boyer. Dr. Boyer addressed the broad treatment landscape explaining how there are no effective therapies available for dry-AMD despite clinical research with various modalities. Any new treatment that can demonstrate even modest benefit will likely be used at some point but would ultimately be replaced or used in combination with something like OpRegen. One advantage of a cell therapy like OpRegen is that it has the potential to provide benefit without having to completely understand the underlying biology that’s causing AMD, which in effect is more like a transplant than a drug. The event was well attended, we were pleased to see such a high level of interest from the investment community. The webcast is archived on our website. In other OpRegen news, we've been accepted for a paper presentation at AAO this November and we expect to share additional updated data there. Moving to our public affiliates they’re also making good process. Asterias presented new 9-month efficacy and safety data from its trial investigating ASC OPC 1, it’s spinal code injury. The result show that 50% of patients treated have now recovered two levels of motor function. Asterias will report second quarter results on August 14, and I encourage you to listen to their call. OncoCyte reported positive new results for its blood based lung cancer diagnostic. OncoCyte successfully completed the analytical validation study and the results again supported the data presented at the American thoracic society conference in May. OncoCyte will report second quarter results on August 14. Now I’d like to turn to call Mike West who will provide you with more details of AgeX and its expiring programs. Mike.

Thank you, Adi, today we announced funding for our subsidiary AgeX Therapeutics. I’ll summarize several aspects of this transaction in turn, first the product focus as a subsidiary then I’ll provide some detail on the current financing. And finally, I’ll describe its operational relationship to BioTime including the possible distribution of shares to BioTime shareholders and public trading of AgeX. Fist begin with the product focus. As we have discussed on prior occasions BioTime has an incredible technologic platform with which to manufacture high value therapeutics. The pluripotent cell technology unlike so many other technologies in adult stem cell companies allows us to manufacture any and all of the cell types of the human body. That in itself is pretty astonishing. Shortly after I organized the first advertised [ph] Harold Varmus Nobel Laurette and then director at the National Institute of Health testified to the US Congress that "the development of cell lines that may produce almost every tissue of the human body is in unprecedented scientific breakthrough. It is not too unrealistic to say that this research has the potential to revolutionize the practice of medicine and improve the quality and length of life". The reason he was saying that it had the potential to revolutionize medicine is that for the first time in history, biotechnology was given the means of manufacturing any kind of human cell to repair any tissue in the body. This is so critical to the practice of medicine because approximately 80% of the nearly $3 trillion annual healthcare expenditures in the United States are directed towards chronic diseases. And the chronic degenerative diseases of AgeX associated with the loss of cells and tissues is the fastest growing sector in these costs with 92% of the elderly having one chronic condition and 77% having two or more. So not only does this platform open up the possibility of a large new industry in biotechnology, it is also nicely suited to meet the needs of an aging population and improve as Varmus said, "the length of life". But the strengths of the pluripotent steam cell platform don’t end there, these cells have another amazing property, they are the first normal human cells ever isolated in a laboratory that don’t age. That is to say they replicate endlessly. Scientists call this replicative immortality. So just as babies are born young, all of the cells we make from these pluripotent cells are very young. For treating age related to genitive diseases, its ideal to provide age patients with young cells to repair the tissue affected by age related degenerative disease. And perhaps more importantly still the young cells manufacturing using pluripotent cell technology show markers consistent with them having a powerful regenerative capacity present early in development but lost later in life. With the ongoing tsunami of the genitive disease associated with the aging baby boom generation and approximately 20 years of research behind us, we believe it’s the right time to aggressively commercialize this technology through AgeX Therapeutics as its name implies, a company focused on applying the biology of regeneration and cell A mortality to aging and age-related disease. Now, as to the product development plans. Our lead products ready for development is called AgeX Path 1. Like all of the AgeX product its aimed at the vast market opportunities associated with ageing. Our product is based on pluripotent cells but it also uses our proprietary pure stem technology which we use to successfully isolate over 200 diverse purified and industrially cellular components of the human body. AgeX Path 1, is comprised of recently discovered cell types in humans known Brown Adipocytes. These cells are dramatically loss during ageing and it’s believed that their loss can disturb a youthful metabolism and lead to obesity type 2 diabetes and heart disease. Animal model suggest the restoring youthful levels of these cells can restore a useful metabolism. We planned and formulate this product in high stem, the hydro gel used in Renevia for which we’ve already obtained clinical data and safety in efficacy. We plan to begin preclinical studies leading to the first human clinical application for type 2 diabetes, a disorder of epidemic proportions with an expected one out of three Americans expected to have it by the year 2050 90% of the patients with diabetes being type 2. Another enormous unmet need in medicine is age related vascular disease. According to the American Heart Association cardiovascular diseases associated with aging are relating to rapid rise in healthcare expenditures amounting to over $1 trillion a year in United States alone by the year 2035. And of course, it’s a number one killer in the U.S. AgeX will take the lead in developing AgeX (inaudible) young cells to regenerate the vascular system in age tissues like the heart. Lastly AgeX is focused on an emerging technology called ITR or induced tissue regeneration. We believe this technology is also at the heart of human ageing and like pluripotent cells will become an entire industry in itself, let me briefly describe this amazing science. You may have noticed that some animals have a natural capacity to regrow tissues after injury, so cut the leg off of a Mexican salamander and it will simply grow back. Humans have a similar natural regenerative potential but only when the body is first being formed then that ability is turned off. Using our pluripotent cells and artificial intelligence algorithms in collaboration within silicon medicine we uncover genes that we believe underlie this important biology. The technology to unlock the body's ability to scarlessly regenerate tissues damaged from age or trauma is called ITR and we intend to lead in this important field. To fund this product development today we announced the $10 million financing in AgeX. These funds are expected to finance AgeX operations through June of 2019 thereby creating a significant savings to BioTime’s cash spend. Investors in around included new funding sources for the BioTime family including IBS Capital LLC, KIZOO Technology Capital, a fund investing in company’s turning research on molecular and cellular repair of the prepositive aging in the therapees for human application, and Jim Mellon a visionary entrepreneur known for his skills in identifying emerging global trends, other participants in the financing included founders of successful firms within the health care technology and financial fields including John Moulden, founder of Moulden Economics. Subsequent to this financing BioTime will own approximately 88% of AgeX including a post money evaluation of AgeX for approximately $68 million. BioTime contributed certain subsidiary in early stage program assets, AgeX is part of the transaction. In addition, our portfolio of patents and patent applications were signed or licensed to AgeX together with certain biological such as cell lines and laboratory equipment. AgeX will be incubated within the BioTime facilities in Alameda, California under our shared facilities agreement. I will lead AgeX's development and our near-term milestones will include certain preclinical testing of the company’s plan products and additions to the management team. In addition, as Adi mentioned we plan to distribute some or all of the BioTime ownership in AgeX. To achieve this objective, we’re examining a variety of strategies including those that led to the trading of BioTime subsidiaries, Asterias Bio Therapeutics and OncoCyte corporation on the New York Stock Exchange Market. To help drive our AgeX operations we recently announced the addition of Dr. Arbury [ph] [indiscernible] to the AgeX team as Vice President of New Technology Discovery. Arbury [ph] is one of the world’s foremost authorities on aging and the development of medical innovations that can postpone all forms of age related health ailments and we’re thrilled to have him as part of the effort. The coming months Arbury [ph] and I will be discussing AgeX's programs in a variety high profile forms. So, in summary we at BioTime folks are unlocking value for our shareholders. The funding of these clinically needed therapies through independent equity financing in AgeX, potentially accelerates their development while minimizing direct dilution to the BioTime shareholder. And let me add one final point. Throughout my nearly three-decade carrier, the folks have been building a technology to address the enormous market associated with human aging. First at Jerome from which we acquired a large portfolio of assets as well as other regenerative medicine companies my work has always been focused on gerontology. Of all the technologies, I've ever been associated with from [indiscernible] to pluripotent stem cells to semantic cell nuclear transfer, the constellation of AgeX assets is the finest and the most powerful platform I’ve ever been associated with. I’d like to thank the visionary investors behind this effort and I look forward to telling you of our progress in the coming months. I’ll now turn the call over to our CFO, Russell Skibsted to review our financials for the second quarter. Russell.

Thanks, Mike. I’d like to review some of the financial highlights from the quarter. BioTime’s consolidated cash, cash equivalence, restricted cash in escrow and available for sales securities totaled approximately $21 million as of June 30, 2017. This compared to approximately $24 million as of March 31, for the same year. As of yesterday, BioTime owned almost 22 million shares of the Asterias' common stock and almost 15 million shares of OncoCyte's common stock. Together these two ownership positions represented an aggregate market value of about $137 million based on yesterday’s closing. A little over a year ago, we introduced you to a three-point strategy of focusing our company on first clinical progress, this is where the biggest increases in value are created. Two, simplification to make it easier for people to understand our company as well as for us to run the company. And three, unlocking value for BioTime shareholders. Now, spoken with many of you over the past several months, and as we’ve discussed BioTime for the first time in over 10 years is now generating meaningful clinical results. For BioTime the next stage of our development is an exciting one of accelerated clinical development where we will generate even more human data and thereby clinical progress. These programs will require even greater focus of our attention and resources than in the past at the same time the early state programs that AgeX is pursuing as you heard from Mike extremely exciting and with the potential to profoundly change face of healthcare for millions of people. In keeping with BioTime’s core strategy we have been able to initiate AgeX operations with the investment from investors that are keenly focused on supporting these programs. Importantly the funds raised by AgeX will support its operation, operational expenses well in to 2019 and as Mike mentioned, reduce BioTime’s annual cash spend significantly. For the time being BioTime will consolidate AgeX’s financials however, as Adi and Mike both mentioned earlier we're actively exploring strategies to distribute all or part of our holdings in AgeX to the BioTime shareholders, should we end up distributing more than 50% of BioTime’s AgeX holdings we will then de-consolidate the AgeX’s financials like we did with OncoCyte earlier this year and Asterias last year. Now I’ll turn the call back over to Adi.

Thank you, Russell. So, 2017 has been a very productive year for our company. The BioTime group has six products in the clinic and the data from our clinical trials and those from our affiliates continue to be positive and encouraging. Our cell therapies have features that made them especially attractive as therapeutic candidates. We see parallels in the work we’re doing with the success that has been achieved in organ transplantation over the last 30 to 40 years. Transplants these days have a very high success rate approximately 80% to 90% in many organs and this is possible even if the disease mechanism that cause the organ failure is not completely understood. In the same way if we’re able to establish that ourselves safely in graft and remain alive in the patient then it's likely that our cell therapeutics may have a much higher probability of success in clinical development as compared to small molecule or protein therapeutics which only have a 10% to 20% success rate. Cells are the normal components of the human body and as such we believe that they have markedly better safety and efficacy profiles than conventional drugs. We continue to work on simplifying our corporate, financial and organization structure to allow us to execute our objectives more efficiently and make it easier for investors and other external stakeholders to better understand BioTime. We achieved an important step forward achieving the objective with the formation of AgeX Therapeutics. With the funding ways by AgeX we took a major step towards focusing BioTime’s resources and operations on our programs that are more clinically focused. With this funding AgeX has greater flexibility to explorer additional strategic options to grow its technology platform. We’ve also set in place the strategy to reduce BioTime’s cash utilization by several million dollars annually. I’m very excited by the opportunities in front of us as we move our programs forward. All products in development have global opportunities with multibillion dollar potential. As we move these programs forward, I believe we will build value for our shareholders whose support we deeply appreciate. We look forward to updating you as we continue to make progress. Now operator we’re ready for questions.

At this time, we will be conducting a question-and-answer session [Operator Instructions] Our first question comes from Kevin DeGeeter of Ladenburg Thalmann. Please proceed with your question.

Hi, good afternoon guys and congratulations on the progress. My first question is actually are for Dr. West. Mike can you provide us a little bit of visibility in terms of presentation of any clinical data or excuse me preclinical data around AgeX assets? When we may see some at specific forms and or programs?

Hi, Kevin. Yeah, so there is a very general description of these programs at recent keynote I gave at the World Stem Cell conference, it’s called the future of aging and its available AgeX, search YouTube for that. But it’s not preclinical data, and so as we said earlier, we plan to be disclosing more detailed preclinical and other data on these programs and in some cases high profile forms will be discussing [ph] more detail and in courses is typical in BioTime’s history and we’ll be with AgeX. And we plan to publish a lot of these results and to review scientific publications. So, later this year for flow on that information.

Great. Thank you. And with regard to expected progress by the middle of 2019. What should we look for the company, you think that there is an opportunity to identify a clinical candidate within that window or just can you set some expectations for us?

Yeah. Well the expectation should be that not just identifying the clinical candidate in terms of the product, we’ve already identified those. So, by giving the designation in AgeX Pad 1 to the [indiscernible] we’ve already isolated these cells in a scalable and a 100% pure form. And as I said we’re publishing more data on that. We have presented some of the data in the past, I believe it can be found relatively easy in post recessions with full-fledged scientific publications is yet to be published. So, the products are identified what we are somewhat vague still on let’s talk for a second about the ground aesthetics. So, these are as I mentioned recently identified cell type of the human body which is kind of hard to imagine, with all the years, we had microscopes for a long time and anatomies [ph] for a long time, it just escaped people's notice, primarily because they are present only in life and loss as we age and so the recognition that they are important in this age related metabolic dysfunction is relatively recent. And so, we have this cells in industrial cable format, as I said the high stem for the delivery and stable engraftment of the tissue as Adi pointed out in a related type of far tissues, an abdominal fat tissue performed, well frankly beyond our expectations, I mean its extraordinarily well and [Indiscernible]. And so [indiscernible] are another type of ampycyte [ph] but they are very similar in most respect. So, we think that the profit in hand the indication is our where we are not being very specific at this point. I've mentioned in my discussion this metabolic shift that occurs called metabolic syndrome with ageing leads through central obesity, we all know what that is and the redistribution of fat and coronary arteries or coronary disease and type 2 diabetes or insulin insensitivity in ageing and we will be stating probably later this year what exactly we anticipate the clinical indication will be and how we will go after it. It's very tempting to go after obesity, it's an epidemic but we will be focusing on that in the future.

And just one more housekeeping if I may before getting back in the queue. On the BioTime level how you had any discussions with tax attorneys to get a point of view as to whether any potential distribution of AgeX would be taxable or tax-free distribution to BioTime?

Mike, let me try. Kevin this is Adi. So yes, we have done quite a significant amount of analysis on the various strategies and options, so Russell and his team have looked at various ways this could be a tax-free distribution, that is certainly an option. We have looked at going public by IPO. We have looked at the learnings we've had with the OncoCyte and Asterias activities where we took those companies public and they've done fairly well and there was a lot of success and some learning, all of those have been thoroughly discussed, all of those have been assessed. We have a couple of shortlisted items but since we don’t have a final decision it's a little early for us to tell you more than that but it is really close and we expect to be able to give you more information soon.

Our next question comes from the line of Reni Benjamin of Raymond James. Please proceed with your question.

Hi guys. This is [indiscernible] and congrats on the progress for the quarter. Thanks for taking the questions. I have two set of questions. First one is our Renevia, so Adi I think you mentioned that a digital data would be presented or disclosed from the Renevia trial in the third quarter. So maybe can you provide some additional color regarding what kind of data points or data assets we would be expecting. And then regarding your CE Mark filing package, I was wondering the six months data is going to be enough or do you need to get nine months or 12 months data to support the filing? Then I'll have some follow-up on that opportunity. Thanks.

All right, thanks Ren. Yes, so you are asking about Renevia and we did report our top line data which as mentioned before was really great. I mean getting a 100% retention when comparable fat transfers that are done routinely over 300,000 fat transfers done in the U.S. alone for the face, the results are something in the range of 50% to 60% of it dies within the first six months. So, we think that getting a 100% retention was a pretty good result. The primary endpoint of the clinical trial was six months efficacy and safety. So, we believe that we have the data that would be required for doing the filing for the end of the year and that this would be sufficient. But as you know we just did the topline read out, the other data points that we’re talking about are secondary endpoints like aesthetic scores, the complete safety aboard. So, the entire completed clinical study report will think will be here within a month or six weeks to eight weeks and that we will be able to share some more information. At that point, it is likely we will also have substantial number of the patients at nine months or 12 months. So, we might be able to include nine and 12 months data in that reporting at the time for Renevia, but that is not required for our filing. So, two parts, what is required for our filing is the six-month data and the complete study report, we expect that by sometime later this quarter we’ll be able to use that for filing by the end of the year. But, just for our benefit because we are tracking these patients for 12 months and beyond, a substantial number of them will have reported out the nine or 12-month data and we hope that we will be able to share that also this quarter.

Got it. That’s very helpful. And then switching gears to OpRegen, for the cohort 3, first congrats on the clearance by the DSMB. I was wondering with the two US size on the board, do you think you can maybe get more than three patients or you think you maybe you don’t need to get more than three patients before you move to the next those cohorts. And then on the celltose [ph] do you plan to use 500,000 cells or so on the patient side and I think it appears that if you give patients with better visions with this RP cells and they actually generated better results. So, in New York in cohort 3 do you think you’re going to your old patients with better vision? Thanks.

Yeah. Hi, there are several things you asked in that question. So, let me try to get through some most of them. So, in cohort 3, absolutely you’re right we expect to be enrolling patients in both in California and in Israel and it’s a global trial, so globally competitive recruiting as we have gotten good safety data from cohort 1, cohort 2, this gives us -- allows us to keep expanding the number of trial size. But really cohort 3 is still part of that Phase 1, where what we want to be able to achieve is a more improved or a better procedure. So, even though it’s a fairly straight forward procedure, it uses cells, these retinal surgeons are used to injecting cells in the sub-retinal space. But, just making sure that the procedure is done right makes sense for us. So the main goal in cohort 3 would be to get on new sites, new physicians in a new country get the procedure perfected and make sure that we’re ready for that next cohort 4, but we think three patients is enough, we think that exactly like you said, that the real target population is less severe or earlier stage or younger geographic atrophies with better visions and that’s where we will see substantially improved functional responses, this is also what in our KOL day, Dr. Boyer was talking about the expectation that, could definitely have a better response by being in earlier stage of the disease. All of those things are things we want to make sure we get in cohort 4 so for us getting through cohort 3 is about the rest of the safety and improved procedure but focusing on cohort 4 to get to the younger patients less immunosuppression, younger patients with a more confident or comfortable procedure. We think that we have so far gotten data that gives us good reasons to believe functional data looks good, safety continues to look fine, so getting through cohort 3 makes sense for us to not add more than three patients, we think that’s going to be sufficient and we’re looking forward to getting it done and moving to cohort 4.

Just one more question on that is, [indiscernible] sales for those?

So, I think that couple things that we’ve talked about the past is, we see cell transplantation or RPE that we’re providing more like a transplant. So we’re providing RPE cells to an area that is devoid of RPE cells or the ones that have died or got injured or diseased and don’t exist and that’s why keep talking uncertainty is more like a transplant than some of the other drugs or things that people in the industry might be used to thinking out where you try to figure out what the mechanism of action is, try to intervene in that mechanism of action and modify that pathway of the disease to try and change it, it’s a more complicated endeavor and that’s why it is fraught with a much higher risk of failure. We are doing something that is more like a transplant and they’re definitely some risk and we’re learning how to perfect the transplant procedure but as we get to that we think that dose is probably not the appropriate way to talk about our transplant, so we’re going to work through what that really means is we’re trying to provide the appropriate number of cells for the appropriate size of the atrophy. So the atrophy size requires a certain number of cells and we have learned that also with cohort 1 and 2 that some people have small atrophy, some people have larger atrophies, in some cases you just need 50,000, 70,000 cells to cover the area of the atrophy, so it’s more appropriate for us to ensure that we get the right concentration of cells and the right volume of cells for the atrophy that we’re trying to address and we got enough information in the cohort 1 and 2 to make a judgment call on what we think could be an ideal concentration and in cohort 3 we’re also looking at volumes that might be less or more to make sure that we can cover the area of the atrophy, so we think that the third cohort is about refining the dose size or again I went and said dose I’m still getting used to saying this is a transplant size. So, getting used to the transplant size so that we are ready for those younger smaller atrophies in cohort 4.

Our next question comes from Keay Nakae of Chardan Capital Markets. Please proceed with your question.

Yes, thanks. First question for Adi, when do you think the investigator led studies both in Europe and California are going to start for Renevia?

Yeah. Hi, Keay so our Dr. in Beverley Hills which I find quite interesting, plastic surgeon in Beverly Hills, is ready to start. So, we think couple of weeks or so we’ll be treating first patients, so I don’t want to get back to specific. This is why I said that for sure very shortly they will be starting to treat patients that are non-HIV patients, that are doing cosmetic need implants with Renevia and any size of implant that they would like and this will start very soon and we expect hopefully even -- because it’s an open label study that before the end of the year we can start sharing some data from that study. In Europe, it is summer time but we are in the process of getting approvals, so we expect those to start after the summer sometime. I don’t quite have the dates, but they are in the process of approvals so that as soon as they are done then we’ll start those studies in Europe.

In our lease patients that have begun to evaluate are they treatment naïve or they are patients who had some sort of a fill procedure previously?

So, Keay let me also tell you before I answer that if you missed, when we were talking about the Renevia trial and the results, several of the patients in the pivotal trials for Renevia where people who had already had dermal fillers, procedures done with dermal fillers that they were not satisfied with that either had, you remember gravity calls them down, they get nodules, they had certain other issues, so they were either not long lasting enough or not natural or had some deformities. And so, we had several of those patients in the trial and we have naïve patients. So, we believe that the treatment that we’re able to do is able to help both collect for previously treated patients and helping them to improve as well as naïve patients. So, in our requirement criteria there is certainly a requirement for you couldn’t have just done it but if it’s in the past you’ve already tried it, it’s okay to treat those patients. So, we think that we might have some [Technical Difficulty].

Okay. And then a second question for Dr. West. When we’re thinking about using the Brownfield for something like a Type 2 diabetes. Where is it that you would be want these cells to in graph for a Type 2 diabetes application?

The animal studies that were done to date, that demonstrated the potential use of these fells to lower blood sugar and [indiscernible] in the animals did not try to localize the cells. But you’re quite right, this tissue is an endocrine tissue and it’s introverted. We're not going into all the fascinating science, the brain literally the sympathetic nervous system turns this tissue on and it actually generates heat, so the reason these cells cause weight loss and treat diabetes that they soak up an enormous amount of sugar out of the blood and keep the body warm and first part of the term are regulatory system of the body. So, our assumption is that will be transplying this tissue or these cells into the muscle tissue near the spine and the back, in the upper chest region where it is normally when you’re young and you’re soft, so we be putting it back to the same place. Some have speculated that the tissue could be used for cosmetic purpose, so you could break it with one stone, you could improve the contour say at the face but also treat diabetes, but we’re not thinking that’s the way it will actually perform clinically.

Okay and then just back to RE for the follow up data if we do see that in 6 to 8 weeks are you just going to issue a press release and talk about the results that way.

Yes Keay, at this point we thought we would just a press release, given our run-in beta, we hope this is our good news and great data and that we would issue it out of the press release and quickly start working towards a filling for approval.

Our next question comes from Patrick [indiscernible] of Lifestyle Capital. Please proceed with your question.

So, with Renevia, I was just curious if you would be able to remind us of your commercialization plan for this product in the EU and kind of if there is any preference for partnership at this time or development there?

Patrick, so, we have been -- I think like you said reminder right, we have been working with several potential partners and we had on the table all the different options, which is just license it out, partner it out, get a distributorship and a couple of those conversations have gone quite far long, so we expect to get the conclusion fairly soon and we want to be able to make sure that we get a partner that would help us make sure that we address the plastic surgery market that would allow us to work with them to continue to grow and develop this product because as we mentioned we think there is huge potential for Renevia not just the $7 billion facial aesthetics market, but the fact that we could possibly be growing new tissue that we construct a surgery market. There are several areas were think that this could continue to grow. I think sometimes I’d talked about something like think about Botox when it come on, it had one indication, and you kept adding indications. We think that there is a great potential for us to add several indications to expand the uses of Renevia, so allowing us to have a good amount of control but giving us the commercial skills on the ground to approach the plastic surgery market we think for Europe that is the right way, we’re making significant progress there we’ll get back to you on report on what that is for Europe for markets like the US, which we are as I mentioned starting to focus on that is something that we might do on ourselves. So, we want to keep that option open and we’ll look at how that progresses and certainly another huge market opportunity is Asia. The current attraction for regenerative medicine assets and aesthetics assets in places like South Korea and China and Japan is something that we find quite interesting and lots of people there have been interested. And what we needed to make sure that we were in a better position with was data and we have that now, we have really good data. So, we’re having those conversations about Asia, we’ll look at what the right situation is for Asia and we’ll report on that. So, Europe on deck, Asia on deck, US on deck.

Great. And moving on to AgeX, I was just curious if you could provide any more color on the implications of the formation of this subsidiary from a cash front perspective. And then kind of a similar note, any additional granularity on the company’s contribution to this financing? Thank you.

So, yes thanks. I think what I’ll do is let Russell talk about the cash and the cash burn implications and then we’ll see if we need to continue on that.

Sure. And before I answer the question Patrick, I just wanted to also correct something earlier in the prepared remarks. In my section, I spoke I said the consolidated cash as of March 2017, I misspoke when I said it was approximately $24 million. What I should have said was it was approximately $25 million. So, I think at a high end we expect the AgeX programs as they are being independently funded at this point we would estimate that the BioTime expense is related to those programs would be reduced by probably I must say roughly $5 million a year. Now, hopefully when you saw our press release if you saw at the end of the press release you saw one more step in our goal of simplicity and hopefully transparency in our financials. We provided the table that shows some GAAP and non-GAAP numbers in -- the idea is that at least within the limits that we are allowed to provide certain metrics and certain statistics that are meaningful to investors that look at development stage biotech companies as opposed to revenues and sales. So, we clarify in that table, our cash, non-cash expenses as well as breaking down those expenses by entity, so hopefully you will find that very useful. But what I do want to say is, the savings that BioTime expects to get from AgeX certainly were not included in that table, those will see in the future, but just when you look at that realize that was not taken into account, the cash savings that we would expect from AgeX going forward. Hope that answers.

Okay. Thank you.

Then he asked about the investor.

Is that good Patrick?

Yeah. I think that’s sufficient. Thank you.

Ladies and gentlemen, we have reach the end of our question-and-answer session. I would like to turn the call back to management for closing remarks.

Thank you, Darren. And thank you everyone for joining us today. We think that we’re taking great strides moving forward appreciate all your time look forward to coming back and reporting on our clinical progress, on our AgeX progress and all the other ones [indiscernible] in our pipeline. Thank you.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. And have a wonderful day.