Doug Sherk - IR Adi Mohanty - Co-CEO Michael West - Co-CEO Russell Skibsted - CFO

Keay Nakae - Chardan Capital Markets Kevin DeGeeter - Ladenburg Thalmann Patrick Dolezal - LifeSci Capital Patrick Lin - Primarius Capital

Welcome to the BioTime Fourth Quarter and Full Year 2016 Results Conference Call. As a reminder, this conference is being recorded. I will now introduce today's host, Doug Sherk of BioTime Investor Relations. Doug, 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 2016 and recent corporate developments. 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 instructions at the end of today's call. With us today are Co-Chief Executive Officers, Adi Mohanty and Dr. Michael West; as well as Chief Financial Officer, Russell Skibsted. Each 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, the company will make some 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, 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 of intellectual property rights. And with that, I'd like to turn the call over to Adi Mohanty, Co-Chief Executive Officer of BioTime.

Thanks, Doug. Early in 2016 we laid out our core strategy objectives clinical progress, simplification and unlocking value. We have made good progress with all three, but we are not nearly done and expect to make more progress in 2017. On the clinical progress front, we have announced encouraging clinical data from both of our lead therapeutic development programs Renevia and OpRegen. For Renevia, data from the patients enrolled in the ongoing pivotal trial in lipoatrophy suggested that the volumetric improvement we achieved maybe sustainable for at least one year and maybe longer. This outcome is encouraging for potential application in the broader aesthetic segment and not merely the initial HIV related lipoatrophy indication. Initial data from our OpRegen cell therapy clinical trial in dry-AMD suggests that the RPE cells we are transplanting into patients both engraft and survive. Again for at least one year and maybe longer. There are also some early signs of biological activity which is; what we are looking for in this trial, late last year, we organized a third core therapeutic development area that we're calling delivery. I'll provide some more information on this development area in a few moments. In addition, our public affiliates of Asterias and OncoCyte both reported positive clinical data during the year and are making considerable progress in their clinical programs. The exciting data that Asterias has reported from its OPC1 cell therapy clinical trial in the treatment of spinal cord injury. Along with the initial data from our OpRegen cell therapy trial is demonstrating that very large potential of our core technology in the manufacture of pure cells for the treatment of serious medical conditions for which molecular therapies have not been successful. Meanwhile, OncoCyte is on track to possibly to launch a commercial product later this year. That product addresses a high unmet need that represents a multibillion dollar potential market opportunity. We continue to be successful in appropriately funding the company, as evidenced by our $20 million raise last month. The financing was done on very good terms and Russell will provide more detail on our capital raising a little later. As we progress in our clinical programs and continue to expand our capabilities we are prudently building our management team. In October Jim Knight was appointed as Head of Corporate Development. Jim is overseeing business development, portfolio strategy and strategic marketing. Jim will lead our commercial preparation and partnership strategies that are critical to our plans for Renevia, OpRegen, and other pipeline products. He brings more than 20 years of experience including Questcor Pharmaceutical, Biogen and Elan. We brought Jim to our team, because we are generating substantial clinical proof and the time was right for someone with the skills. We have experienced increasing interest from potential partners, because our products address large market opportunities in areas in which some bio-pharma companies see significant long-term potential. Dr. Oscar Cuzzani, joined us as VP of clinical development last year. Oscar's industry experience includes AbbVie and Allergen, where he gained experience in products in ophthalmology, aesthetics and immunotherapy. Oscar was a practicing Retinal Surgeon and has held senior level positions at the National Eye Institute and the Bascom Palmer Eye Institute. Oscar has already made significant contributions to our clinical trials with his background in aesthetics and ophthalmology. For example, the Renevia trial is now fully enrolled and we have developed a strategy to seek broader indications for other large aesthetic opportunities. Also the current OpRegen trial is expanding into the U.S. and we are preparing to read out very important data this year. In February of this year, Dr. Stephana Patton joined us as our General Counsel. Stephana has more than 17 years of experience in the biotech and pharma industry, including positions at Bio-Delivery Sciences and Salix Pharmaceuticals with particular expertise in IP licensing and business development transactions. Stephana is impacting the overall operational discipline of our company, but also her particular skills are already helping us refine and accelerate our plans to unlock value from BioTime's powerful technologies. We also added GMP product capabilities at our facility in Israel where we plan to manufacture some of our cell therapy products. As they move through the clinic and in the future into commercial production. So now let's review our clinical progress. Renevia is our product candidate that's closest to the market. It is in a pivotal study in Europe, top-line data from which is expected around mid-year, if the data are positive, we plan to file for a CE Mark before the end of year. Renevia is based on our proprietary cell delivery metrics that we called HyStem, which is designed to allow for the stable engraftment of transplanted cells. Renevia is combined with the patient's own cells before it's administered. Importantly, the entire procedure is done in a single office visit. The initial indication and the subject of the current clinical trial is lipoatrophy associated with HIV treatment. However, we think Renevia may be suitable to treat much broader and larger indications in patient lipoatrophy. Lipoatrophy is a term for fat loss. Facial fat loss also happens when we age. It leads to wrinkles, laugh lines and other effects that create visible reminders that we're all getting older. According to GBI Research, the global facial aesthetics market is a multibillion dollar market. The current Renevia trial is a pivotal, randomized, evaluator blinded study which is fully enrolled. Dr. Ramon Llull, the Principal Investigator in our Renevia trial gave an all presentation last November at the annual IFATS Meeting. At that meeting he discussed some of the data from the patients who have been enrolled in the initial running portion of the trial. Dr. Llull showed that Renevia was successfully administered in a manner that was reproducible and safe with no adverse events. Furthermore, he presented 3D imaging data showing that the volume increase was maintained in patients even in those that were one year after the procedure. This is particularly encouraging because we believe that the incremental volume is likely the result of Renevia promoting new tissue generation, which could be a single of a long-lasting effect. If the study is successful, we would be in a position to file for a CE Mark in Europe by the end of 2017. I want to emphasis that we see the HIV study as a gateway study supporting the development of much larger opportunities for Renevia in facial aesthetic indication. The value of the work we're doing now is important to our registration and commercialization strategy for Renevia globally. We've established a thoughtful development plan to seek broader indications for Renevia to address larger market segments in aesthetics. We look forward to sharing more details in the coming months. Our goal with this trial is to show that Renevia achieve a sustained increase in tissue thickness as measured by 3D imaging. If this occurs in the trial as the early data suggest, we believe Renevia has a potential to become a market leading alternative to synthetics and other existing techniques used in reconstruction of tissue today. The facial aesthetics market is a self-pay market. There are a very large number of people in the U.S. today that pay $8,000 to $10,000 for fat transfer procedures, which don't last very long. With success in the clinic, we see a very significant opportunity for Renevia. As we think about commercializing Renevia, we're exploring potential partnerships with companies that have the resources and local market expertise in a number of global aesthetics markets. We're confidentially sharing our data with various parties and have received serious interest from in Asia, Latin America and Europe. We're actively assessing these along with other communization options. Now moving to OpRegen, our clinical stage cell therapy candidate targeting the major unmet medical need of dry-AMD. Age-related macular degeneration or AMD is the leading cause of blindness in people over the age of 60. Wet AMD products generate over $5 billion in annual revenues, but the number of people suffering with dry-AMD is estimated to be nine times the number for wet AMD. However there are currently no approved products for dry-AMD. OpRegen is currently being evaluated in a Phase I/IIa clinical trial that is assessing different dose regiments in the advance form of dry-AMD. Our Principal Investigator Dr. Eyal Banin presented positive data from the first cohort of patient in December at the International Symposium on Ocular Pharmacology and Therapeutics. The primary focus of this initial cohort was safety. Patients received a target dose of 50,000 cells. Dr. Banin reported that OpRegen was successfully administered and there were no serious adverse events. Retinal imaging data showed that the RPE cells that were administered and grafted in the patients and settled into a monolayer, which is good. Importantly, for at least the first patient the RPE cells continue to be present after one year. The second patient showed similar results at the six month time point. These results appear to confirm the data we saw with OpRegen in animal models. Last June, we received DSMB approval to continue the trial and move to the second cohort where we began treating patients with a higher more clinically relevant dose of 200,000 cells. It is in these higher dose cohorts where we believe OpRegen has the potential to demonstrate greater efficacy signals. We anticipate completing the second cohort and then approaching the DSMB in the second quarter of this year to get approval to begin administering the next higher 500,000 cell dosage to the third patient cohort. If approved by the DSMB, we expect to begin cohort 4 before year end. We continue to learn more from the patient we have treated so far in this study. Dr. Banin made a follow-up presentation on the cohort 1 patients in February at the Bascom Palmer Institute. The data showed stable vision and FAF [ph] readings that may indicate biological activity in patients that have completed 9 and 12 month time point readings. We continue to be encouraged by these results. We are particularly pleased with the continued favorable safety profile seen with patient from both cohort 1 and 2 so far. As we continue to collect this encouraging data, we are learning a lot about the product and its possibilities in the long-term. We are also learning something's that we're beginning to take advantage of now. As an example, we have identified protocol enhancements that were recently filed with the regulators. These would allow us to reduce the required duration of immunosuppression from 12 months to 3 months. This is significant for our patients. The trial and the long-term prospects of the product also. If the trend of data continues, it is our hope; we may eventually be able to administer OpRegen without any immunosuppression. We plan to use the enhance protocol as we expand the trial into the U.S. Just this week we announced that two of the top retinal surgeons in the country Dr. Boyer and Dr. McDonald will be enrolling patients at their respective centers of excellence. We are pleased that these two world renowned physicians find up with us after seeing all the data in OpRegen and the patient trial data generated to-date. Getting FDA approval for the protocol improvements and bringing on the U.S. sites this year, will help accelerate patient enrollment, both due to the larger population in the U.S. as well as the enhanced trial protocol that'll be used by these U.S. sites. We will be sharing data from our ongoing OpRegen trial at this year's annual meeting of the Association for Research and Vision in Ophthalmology, known as ARVO, which will take place in Baltimore in early May. This is a major ocular meeting, is the largest gathering of Eye and vision researches in the world. We plan to share data from both cohorts 1 and 2. Now let's shift gears a bit, talk about our business development activities. We announced in February that we are expanding our ophthalmology portfolio through an in-licensing agreement we signed with the University of Pittsburgh, for the next-generation retinal disease therapy. This leverages our growing capabilities in ophthalmology and cell therapy. This potential therapy, which was developed in part through collaboration with BioTime's scientists is based around the concept that we could use our pluripotent cells to generate three dimensional laminated human retinal tissue that would be implanted into patients. Our plan is to explore the use of this technology as a restoration treatment for a variety of blinding retinal degenerative diseases including retinitis pigmentosa, macular degeneration and diabetic retinopathy. We look forward to sharing more on this program with you later this year. Earlier, I mentioned that we now have three therapeutic areas that we're focusing on aesthetics, ophthalmology and delivery. While Renevia is an example of a cell delivery therapeutic, the product has been developed far enough in the clinic that we consider it an aesthetic product. But we are leveraging our HyStem technology platform and are experience with developing delivery products like Renevia to work on additional therapeutic programs. For instance, Reglide is in preclinical development as a device for viscosupplementation and a combination product for drug delivery in osteoarthritis or OA. The viscosupplementation program aims to administer Reglide directly into OA affective joints as a means to provide joint lubrication to reduce pain. The drug delivery program seeks to enable the sustained release of therapeutics in affected OA joints to slow or reverse disease progression. In addition to improving pain and joint function. This product is expected to go through a device approval pathway, which is often a short approval process. We have other similar programs like HyStem with BDMS and I look forward to sharing more about these delivery programs in the coming quarters. Turning briefly to our public affiliates and we continue to hold major positions in. Asterias reported very encouraging data from the SCiStar clinical study, showing meaningful clinical improvement in motor function in patients with complete surgical spinal cord injuries. If you haven't already seen the video of patients enrolled in this program, I encourage you go to Asterias's website. It's impressive and inspiring. Asterias has continued to execute on their plans and is providing an update to investors at their quarterly call on Tuesday March 28th. With regard to OncoCyte, last week the company reported positive data from its lung cancer confirmatory test. The data from the study exceed levels OncoCyte believes necessary for a commercially successful test. And the company is moving forward with its plans to launch the lung cancer diagnostic during the second half of 2017. This is a very significant development as OncoCyte could be the first company to launch a blood test based confirmatory lung cancer diagnostic. This will transform OncoCyte from a clinical stage company to a commercial stage company in a very short few months. As you may know, lung cancer has the higher mortality rate among all cancers. And the single most important thing we could do to help is to have better and faster detection. We are encouraged by the progress of OncoCyte, their management conducted a conference call March 6th, to update investors and we encourage you to get more information on their progress. Let me talk about our progress on the other two core strategic objectives, simplification and unlocking value. One of our corporate goals as we said is to help investors better understand the company and one of the ways we have been doing this is by simplifying our financials. During the past year, we were required to report consolidated financials that included both Asterias and OncoCyte. In May of 2016 we deconsolidated Asterias from our financial statements and we just went through a similar exercise with OncoCyte last month. Going forward, our financial statements will more clearly reflect BioTime's operations and cash utilization. Russell will expand on this a bit later. We've made great strides towards achieving simplification, but we believe we can further simplify BioTime, we are actively working to assess the best ways to leverage our technology and assets to unlock the inherent value. Our efforts may include partnerships, asset sales and other strategic initiatives. One option we are considering is a consolidation of many of our exciting early stage assets and technologies into a single subsidiary, one such technology will describe by Dr. West in a very impactful presentation, which I recommend you watch, you can find the links to this presentation on our website's homepage there have been over a quarter of a million views of this presentation on YouTube. Our objective with these early stage assets is to find ways to unlock their potential value for our existing shareholders, while at the same time further simplifying the BioTime's structure. If we could replicate the spin-off on OncoCyte in terms of value created for the shareholder, that would be a great achievement. We plan to share more on this with you in the near future. And now to give you some more inside on some of the exciting early stage assets I mentioned, I like to turn the call over to Dr. Mike West.

Thank you, Adi. As we reported on numerous occasions in the past, our pluripotent cell platform has a spectacularly broad range of potential applications in medicine. Many of the first of these will likely be age-related to generative diseases, where the loss or dysfunction of cells is the primary cause of the disease. For the first time in the history of medicine, pluripotent cells allow a means of manufacturing all of the cell types of the human body on an industrial scale for potentially millions of patients. While the company and its affiliates Asterias Biotherapeutics have chosen retinal, spinal cord and cancer immune therapy as their first therapeutic programs, there are dozens of potentially high value of therapeutics in the BioTime pipeline. Reviewing the data from our research group, we believe that regenerative therapies for applications in the cardiovascular and Type 2 diabetes markets are among the highest value applications next in our pipeline. Let's look at cardiovascular disease for example. It has been the number one killer in the United States since 1920. In 2011, the American Heart Association predicted that by the year 2030, approximately 40% of Americans would have cardiovascular disease. Sadly, that number was reached 15 years early. In 2015, over 100 million Americans had at least one major disease of the cardiovascular system. Recently updated numbers anticipate that by 2035 over 130 million Americans will suffer cardiovascular disease and will costs our nation over $1 trillion a year. We have isolated the cells that when properly administered have the potential to rebuild the vascular tree feeding age tissues like the heart with abundant circulation. These cells known as vascular endothelial cells when manufactured using our pluripotent cell technology have the potential to be used off the shelf as a cost effective therapy for this large and growing marketing opportunity. In regard to the other example, I gave of diabetes The Center for Disease Control estimates that over 25% of people 65 year of age and over have diabetes and over 50% have pre-diabetes. Total direct and indirect cause associated with the disease exceeds $250 billion annually in the U.S. alone. Impart this is such as serious challenge for medicine because the epidemiology has been driven by an ageing demographic and the search in obesity. Recent data suggest that an exciting new strategy to address the problem of type 2 diabetes and obesity is possible through the transplantation of brown adipocytes. This recently discovered type of cell in humans is lost dramatically with age. Brown adipose tissue cells when injected into obese and diabetic animals have been reported to cause weight loss and reversal of the symptoms of diabetes. If reproduced in human clinical trials such a therapy could provide a novel and potentially important strategy for managing this important health crisis. BioTime scientists have invented protocols for the manufacture of highly terrified vascular pregeneratives for the treatment of cardiovascular diseases and brown adipocytes for the treatment of type 2 diabetes. We're pursuing strategies that may allow us to accelerate the pace of preclinical and potentially human clinical studies to determine whether these therapeutic show sufficient safety and efficiency to be used in clinical practice. As important as these products are I must take a moment to speak of a technology called induced tissue regeneration or ITR. Pluripotent cells continue to excite scientific world impart because of their profound capacity to generate tissues in a laboratory dish. As a result, there is a continuing stream of the scientific publications reporting this or that tissue like human brain or heart tissue has been created in a laboratory. BioTime scientists have study this biology and search for answers to one of the most important questions in medicine. Why can't the human body repair tissues after their damage? And why do injured tissues scar instead of regenerating? In studying which genes are turned off or on when the human body forms BioTime scientists believe they have covered molecular pathways in this important new field. These discoveries may provide a technology platform every bit is powerful as pluripotent with applications in aging and even cancer. Our most important technology platform, the ability to generate cells of any type in the human body now has growing clinical proof from both OPC1 and OpRegen. We're pleased to report that BioTime and its subsidiaries continue to lead the world in this technology, which has the potential to transform medicine as we know it today. And on that optimistic note, I'll turn the call over to Russell Skibsted our CFO, who will discuss our financial results and the recent offering. Russell?

Thanks, Mike. Our consolidated cash and cash equivalent totaled $22.1 million as of December 31, 2016, which does not include Asterias cash, but it does include OncoCyte's cash. This compares to $42.2 million on December 31, 2015, which did include the cash from Asterias and OncoCyte. Recall that we deconsolidated Asterias in May of last year. About one month ago, in February, we strengthened our balance sheet by completing a successful equity raise with gross proceeds of about $20.1 million. The raise was completed on attractive terms involving modest discounts and no warrants. It included both new and existing long-term fundamental investors. This compares quite well to many of the recent financings done by small and medium size companies in the bio pharma area. We think the continued interest by top tier investors speaks to the quality of our programs and our company. The additional capital also allows us to continue the development of our key therapeutic programs Renevia and OpRegen through important and meaningful milestones. Additionally, as of yesterday BioTime owned 21.7 million shares of Asterias common stock and 14.7 million shares of OncoCyte common stock, which represented an aggregate market value of about $150 million. As we have been saying, we are focused on simplifying our business and increasing transparency. One important example of this occurred in the second quarter of 2016 when as a result of an equity raise by Asterias, we deconsolidated their financials from BioTime's financials. Similarly, on February 17th of this year, as a result of the exercise of some warrants, our ownership of OncoCyte dropped below 50%, which allowed us to deconsolidate OncoCyte's financials from BioTime's financial statements on a go forward basis. We strongly believe this change helps investors to better understand the financial performance and condition of BioTime's operations. GAAP and therefore the SEC requires us to show 100% of a majority owned subsidiaries numbers even if we own only a little over 50%. This means for example, that BioTime is required to show on its financial statements 100% of the subsidiaries numbers including assets, liabilities, revenue, expenses and cash burn, even if we only owned a little over 50% of the company. In fact, even if the company is completely independent merely because we own more than 50% we are required to reflect all of that company's cash burn in our published financial statements. We believe this is very confusing to investors. Keep in mind that the recent 10-K filed this one reporting in 2016 numbers that OncoCyte is still consolidated in the financials, but beginning in the reporting period of Q1 2017 we will no longer consolidate OncoCyte when BTX reports its financials. So, now I will turn it back to over Adi.

Thanks, Russell. So I wanted to summarize with a few things, I think differentiate BioTime from many other small biotech companies. You may want to consider these as you look at our company. We have seven programs in various stage of clinical development at BioTime and our affiliates and eight programs likely to enter the clinic in the next few months. So unlike many other companies we are not heavily dependent on a single clinical program or product. Two of these programs have the potential to be commercialized by the end of the year. So we are not just an early stage company. As mentioned earlier, OncoCyte hopes to begin the commercialization of its lung cancer diagnostic later this year. And also as mentioned earlier Renevia may receive a CE Mark in Europe and therefore be able to be commercialized soon. We have a balance among programs in the U.S. and in various global geographies. OpRegen is currently in a clinical trial in Israel that is being expanded to the U.S. While that too its initial trial will be in the UK and all of our products have potential in most parts of the world rather than being restricted to one geography for various reasons. As it's true for some other companies' products. We expect to have a balance among various types of payers and therefore are not solely dependent on a single country or reimbursement regime. For example, Renevia primarily addresses private or self-paying markets such as aesthetics. While OncoCyte's lung cancer diagnostic is also not likely to be affected by possible changes to drug reimbursement policies in the U.S. Our core cell therapy technology is showing proof of working in multiple indications and has a large body of safety data. So, keep in mind whereas most drugs developed deal with safety problems because of off target effects early on, our cell therapies have so far demonstrated strong safety. This fact has significant implications for the odds success of our clinical programs, which contrast to the 90% failure rate of small molecule drugs in clinical trials, 80% failure rate of large molecules in clinical trials. As we work towards building a large successful biotech company, we made solid progress in 2016, which has continued in 2017. We remained focused on our three stated objectives of clinical progress, simplification and unlocking value. We believe these are still the right areas to focus the company, while we also strengthened our skills in the areas of partnerships and commercialization. We anticipate reporting several milestones this year, could very well be the year of the data for us. These milestones include the presentation of OpRegen data for cohort 1 and 2 at ARVO in May. The completion of OpRegen cohort 3 and beginning cohort 4 by year end. Top-line data for our pivotal trial in Renevia by midyear with the submission for CE Mark by year end. Sharing our market entry plans for Renevia by the end of the year. We also expect to report initial, but important data from delivery therapeutic products. And finally don't forget we have other programs that have the potential to generate a great deal of value overtime. Mike West comments earlier should make clear that the very large potential of some of these technology platforms, we are working to create at least one additional value unlocking event this year. We look forward to updating you on all of these events. Now operator, we are ready for questions.

Thank you. At this time we'll be conducting a question-and-answer session. [Operator Instructions] And our first question comes from Keay Nakae from Chardan. Please go ahead.

Yes, thank you. Adi I wanted to start with Renevia. I know that previously you had been talking about targeting a range of patients for enrollment you stated earlier on the call, you have completed enrollment. So if you can update what the actual number is and what status excite you that within that range that's the right number?

Hi, Keay. Yes, I think in the past I have been talking about we are looking for approximately 50 completers and the idea there is to get a certain power of the study. So this was all turned into the agency last year or a year before, I forgot exactly, but in that timeframe. And so the European regulators had agreed with our assessment of the approximate number of people it would take to get the study powered. And it was in the wing 20 and 25 patients in each arm, one arm being the treated arm, one arm the other arm being the control or the late treated arm. And so we have approximately over 60 plus patients in the trial and given the dropout rates that we have seen for the untreated arm, we are fairly comfortable that we will have well over 40 completers in a couple of months and over 50 completers couple of months after that. So, we are quite confident that we have all the patients that we need to power the study appropriately and have a strong data readout middle of this year.

Okay, very good. And then let's assume that that data midyear is positive such that your confident in filing the CE Mark. As you then think about the U.S. opportunities can you talk about timing for completing discussions with FDA and maybe starting a U.S. study?

So, I think you have heard me say in the past that U.S. is absolutely something that we are focused on doing. We have had a couple of conversations with the FDA that have been very encouraging likely to go through a device pathway in the U.S. And then we decided that we would take advantage of the data coming out of the European trial so that we could have a really well constructed protocol that we would take to the U.S. agency. We are still expecting to do that. So some time, in the next few months I'll give you more specifics of exactly when we go to the agency. But I can tell you that along with the data that's been generated here, we are starting to add other data. We've done a couple of additional animal studies to generate data, but also we expect to be able to share very shortly maybe a month or two with you that we're starting to do a small study to generate non-HIV patient based data. So, we have a couple of physicians who are very interested. And we think all of that is important helpful and will inform us as we go to the FDA or allow the commercial opportunity to expand in other geographies as we get more data from some of these additional studies.

Okay, great. And then over to dry-AMD and OpRegen. So with effect to brining on the U.S. investigators, do you expect to have the protocol changes and the sites ready to go in order to be able to enroll cohorts 3 patients?

That's a good question. I think what I mentioned, maybe I'll just repeat this Keay, I think I was really excited when Dr. Boyer and McDonald decided to sign up with us. If you look up Dr. Boyer resume, he has been involved in several innovative technology. He is very, very well known in this space and he has looked at the data from all our patients. It was during these discussions that we starting looking at all our safety information that we have so far. So we've got more than cohort 1 patients worth of safety data. And with his input we were able to already look at immunosuppression being something that is a critical item. Right, so currently the current protocol has immunosuppression for 12 months. But the safety data look good enough to recommend that maybe three months is going to be enough. And why is this important, we are looking at really old patients, who are getting enrolled in the studies and telling them ahead of time that there will be an immunosuppression for a year is often quite a hurdle in recruiting them into the trial. So, we have actually already made these changes and submitted to the FDA. So our expectation is that very shortly when we get into the U.S. sites it will be with this enhanced protocol. And whether it's cohort 3 or not I don't want to say and I mean I think we'll continue to enroll patients anywhere in any geography that we can to keep the trial going.

Okay. And then just a final question I'll get back in queue for Russell, you gave us some nice break out of the spending, allocations for R&D and G&A and with the deconsolidation of OncoCyte at least qualitatively, can we comment on what G&A and R&D spending in '17 relative to '16 would look like?

It's a good question Keay. At this time we are not giving guidance as you can appreciate given all the actions that we're doing in accelerating the clinical progress simplifying and trying to unlock value from the core program that we have undertaken last year and that we are planning for this year is these huge efforts makes it very difficult to forecast exactly what those burns would be. Saying that we don't see any significant changes in cash spend in the near-term. So the fact helps I understand you're model it.

Okay. Good enough for now. Thanks, I'll get back in queue.

You bet.

Thanks, Keay.

Our next question is from Kevin DeGeeter from Ladenburg Thalmann. Please go ahead.

Hi, good afternoon, guys. Thanks for taking my question. As we prepare for [indiscernible] and seeing the first clinical data on OpRegen, can you still better classify for us, how we should think about the target profile of OpRegen compared to some of the earlier generation cell therapies that [indiscernible] RPE cells. And just the general characterization if we could think of these first two cohorts is providing a meaningful initial read of clinical efficacy or should we really be looking to the third cohort or beyond that type of differential?

Hi, Kevin. There is quite a few things in that question you asked. So let me try to answer and let me know if I got this. So, we believe that we have a very differentiated product, because if you remember I have been saying that OpRegen is 99% plus pure RPE cells, we have a biological test that shows that before we administer it that's what we have. It is made with what we call it's xeno-free process meaning no animal products, in fact some cell therapy manufacturers use mouse feeder cells as their foundational starting point and we don't we use human. So we're human all the way through, so no animal products. And so we think it's that and the fact that we have full certification of where these cells came from a substantially larger preclinical package than anyway else has ever had that really gets into understanding what could happen with these when we administer them. There is several other similar things that to us differentiate our product from anyone else and we think that that will have meaningful impact definitely on safety, definitely on approvability with the regulatory agencies and likely in efficacy. So the test with the trial we have been doing so far, what we have seen which is very encouraging and similar what we saw in preclinical data is that very safe. And now we have got patients well over a year, we have got quite a few to me there is several patients in both cohort 1 and 2 that we have been looking at the safety data on. We are starting to I think I mentioned, see a little bit of a clinical signal and I mentioned that Dr. Benin was making a presentation in front of a whole bunch of retinal surgeons in Florida and I think I mentioned you know FAF readings indicating biological activity and maybe a resident retinal surgeon Oscar Cuzzani would be way better at explaining this. But the simple way of looking at it is that that's the fundus autofluorescence and that's the way that you can help which cells are completely alive and which cells are dying. And those pictures are available they were represented and they start to indicate some pretty encouraging signs of what might be happening, along with the visual acuity and other test. So, that to us encourages us extremely, so I feel like the ARVO presentation, which will include not just the cohort 1 but cohort 2 patients. We should have some pretty meaningful data including biological activity, visual acuity some other things. So, I don't know what that data is and as you know when you sign up for ARVO you got to wait for ARVO before you can talk about it. Does that answer it?

Is does, it gives me a nice profile to how to think about expectation for the upcoming data set. I guess just one more question kind of along the OpRegen line. I know we have talked previously that a lot of thought process went into the thought of how to changes as the right way to inject the cells. But now that you have had a chance to work with a couple cohorts any learning that's resulted in to any revisions to how you think about the right way to deliver cells for these patients or what are your expectations going into this study? It's been validated and you are going to continue along similar type of injection plus dosing protocols?

So that one I will have to say right look, like any other trial we expect to keep learning and getting better, we have not seen any significant change from what we have planned. But of course we are learning a lot as we do each individual procedure and as we get more experts involved. Before we had a couple of doctors in Israel, now we have a couple of doctors in the U.S. This is all great, this is exactly what we wanted to get done in this stage of the trial. Nothing major what we have learned in small tweaks that we can improve the procedure itself seems to be simple, easy and so not much to be change. And so I think 10 minutes or less for a procedure like this is pretty good compared to what other people have done. So, we don't have any major learnings which is good, that it means what we started out what is working, but yes of course we have some several small things we are learning and that's the intention and we will be able to make it better.

Okay terrific. And then just maybe one last one for me then I'll get back into queue. As we think about next steps to simplifying the company's business structure. Is the limiting factor there to executing those steps are they operationally within BioTime, is it involve getting business development partnerships in place. I am trying to appreciate as we think about the entire execution, what are the inputs that are going to most impactful to the final decision?

Okay. I think it's actually pretty simple. This is one areas where I feel we have internal control of many of the options we are considering. So I think it's just execution making sure we are thoughtful, looking at all the different options, making sure that we are picking the one that is most beneficial to investors, most beneficial to us internally. Now I like where we are, we don't need a lot of external things to happen, this is something we're actively working on and we'll be able to share more really soon.

Thanks so much.

Our next question comes from Patrick Dolezal from Life Science Capital. Please go ahead.

Hi, thanks for taking my questions. Just a couple on Renevia here, how does the length of time that you have seen facial volume improvements with Renevia compared to that as facial fat transfer procedures? And also what are the pros and cons as compared to some of these synthetic options out there?

Hi, Patrick. Well that's a great question, because I keep trying to tell people you know I think if you have seen synthetics, if you haven't you should look at them, when you get these synthetic pillars, quite often they have a different feel to the person that has got those implants or injections as well as to others. So, it feels different to the touch its grainy, but also has the gravity pool, I mean a lot of them end up with 30%, 40% of them which is a big number end up with nodules, that collections because of gravity or other movement. So there is a certain non-natural feel to a lot of those synthetics. Fat transfers feel more natural and they look more natural. However fat transfers what we have seen from data in papers as well as talking to plastic surgeons they typically last six to seven month, eight month certainly they are not much longer than that. And think about this, these patients are paying $8,000 to $10,000 for a fat transfer for a facial procedure that lasting them somewhere in the six to eight months' timeframe, they are happy for that first part of it and then pretty unhappy because they paid a pretty decent price. So, the difference for us that we believe is given the data we have seen it appears also I can't be completely confident yet, but absolutely we have seen some data now, Dr. Llull has presented data that says, we might be growing new tissue. And if the sustained volume increase that we have seen up to a year is because of growth of new tissue, we think it could last longer. Certainly it is more natural and so the more natural your own tissue feel longer lasting Renevia we believe has a significant opportunity to be a market leader in the aesthetics area. Does that answer your question?

Yes, definitely. Thanks for that. And so in the event of positive data and subsequent approval with the plan B to commercialize in-house at the moment.

So, that's a good question. So I think what we have said is for Europe, which is our first target and then Asia, which is actually pretty close behind because lots of people from there have been talking to us, as we get more and more data. We are actively assessing both of those options. I think for sure, we think that a place like Europe may be conducive to a partner that has presence in many countries, is calling on plastic surgeons as understands the call point really well and has some understanding of aesthetics products. It might be a good opportunity for us to take advantage or something like that, learn with a partner. For sure, we believe that in the U.S. we could do these ourselves. There is about 5,000 or so plastic surgeons in the U.S. that do more than 80% of these procedures. So, that's a pretty small number, that's smaller than a rare disease sale force in my mind. So, given my background with the rare diseases. So, that is absolutely something that we think that we could do. So, that's the choice we can a little bit latter. Very soon though you'll hear about our final decision on our assessment of go with loan or partner. We've got great interest, we are talking to a couple people now actively on Europe. So, we should be able to share that soon. No, decision has been made yet.

Great, looking forward to those developments. Thanks a lot.

Thanks, Patrick.

Our next question comes from Patrick Lin from Primarius Capital. Please go ahead.

Hi, guys. Thanks for taking my call. My first question is looking at back of the envelop excluding the Asterias and also the OncoCyte holdings as well as the cash, we're looking at maybe $150 million, $200 million market cap. Wondering if you could just refresh my memory on what are the market sizes of what you're addressing with OpRegen, Renevia and others? And then I have a follow-up.

Hi, Patrick. Yes, so it's pretty interesting right if you look at the opportunities we are going after Renevia is targeted toward aesthetics market, which was estimated to be $5.4 billion in 2016. So, any portion of that is a pretty large market opportunity already. For OpRegen, well, as I mentioned there is nobody has been able to give a great dollar number, but what they have said clearly because there is already products out for wet AMD. Wet AMD sales are well over $5 billion and nine times more dry-AMD patients, which is what OpRegen is targeted towards. So, there is lots of studies by lots of big companies who talk about what could that be. Well, definitely it's a multiple of that $5 billion. So targeted toward something that is a double-digit billion dollar market. And as just Renevia and OpRegen if you can go down, we talked about OncoCyte is targeting a multibillion dollar market, some of our other products would be. So almost all of these are multibillion dollar market opportunities.

Great. And on the OpRegen side can you just share how economics might work if you were you either address this yourself or partner with somebody in the future?

Patrick, I think you might remember in terms of economics for something like OpRegen, we had a competitor Ochada [ph] who I think I have explain we feel were differentiated against and we might have a better product, but we differently differentiate and we have done several things that make me believe that we have a better path to approval. But they had absolutely done a few more patients than where we are today. And so they were bought by Astellas for about $400 million last year. So, somewhere in the next few months, we'll be about the same place as they were. So, that is one deal that you could look at. The other thing I can tell you is with a cohort 3 data or cohort 2, cohort 3 data, significant value could be got by just individual geographies. Just Japan alone, just Europe alone each of these is I would say triple digit like 100 million plus in terms of value that you could have if you were going to do something at those stages. But, holding on to that could also be great and that something we can assess, if it's a $10 billion, $12 billion, $15 billion, $18 billion opportunity at the end, getting value for that is not going to be the issue.

Great. And if I can do a quick follow-up with this question is for both you and Mike. It seems like the stem cell technology has really come a long way and wondering in terms of its pretty safe, I think the recent data suggest. But in terms of the development and the inflection point, do you have any idea where are we today, are we near the inflection point and why all of a sudden the technology for stem cell really taking off?

Hey, Mike you want to…

Hi, Patrick. The as many people have observed there is a similarity here with this field that we're leading of regenerative medicine with pluripotency to recombinant DNA revolution some time ago with Genentech and Amgen and monoclonal antibodies both were very broad technology platforms. And both were - they were first discovered and generated enormous amount of public interest and scientific interest. But took 20 years from the lab bench discovery, which everyone heard about to the point of real significant increase in market capitalization of the company's leading defray and in commercialization. And if you track the similarities we're right at about the 19 year mark now with pluripotency the first published papers on human pluripotent cells was 1998 and with similar to those parallels we are seeing just internally really significant increase in a number, not only in scientific publications I feel some 10,000 plus publications, but the commercial interest as well. So in the past where a lot of larger pharma companies said look let's take some time and watch this field, they're really getting involved in the field now and showing really considerable interest. And a lot of that to has been spirit by the progress we've heard about in immunotherapy CAR T technology and so on. And demonstration itself can deeply exciting the new category of therapeutics cells, white monoclonal antibodies and recombinant proteins can be manufactures biologics and treat previously untreatable diseases. And in fact even the CAR T technology increasingly people working in that field they were saying the pluripotent platform which BioTime is we believe the leader of is likely the best way of manufacturing those cells. Adi do you have additional points.

No, I think it's a question that it's that I've had not recently because I believe more and more this is getting more accepted by big pharma and other people. So I think this has become about we have taken the technology to the point where we have now human data, clinical data keeps coming out. We will have a pivotal trial data this year with Renevia, that's going to be a commercial product. We have data from - human data from OpRegen that is starting to prove that this is working. We have OPC1 data from Asterias that is showing that it's working. So there is multiple cell therapy products in the clinical and we are, I think we're definitely the leaders, but others too where the poor technology is falling to the way side and the ones like ours that have done the real work are starting to show data. And I think that's what is starting to change everybody's believe in the technology, in what is possible. So, I don't think there is a lot more question about when is this technology going to be ready, it is, I think people accept, is it ready now it's getting the word out enough people saying looking it is, it's ready, it's here, it's being accepted, we're going to have commercial products now, not many years from now.

Thank you very much.

Thanks, Patrick.

Thank you. Due to time constrains, we have reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any closing comments.

Yes, hi. So, thank you all very much, for taking the time, joining us, we are very excited with where we are going. We appreciate your time and effort and look forward to coming back very soon with some exciting news to share. Thank you.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.