Doug Sherk - IR Adi Mohanty - Co-CEO Michael West - Co-CEO Russell Skibsted - CFO Oscar Cuzzani - VP of Clinical Development

Kevin DeGeeter - Ladenburg Thalmann Keay Nakae - Chardan Capital Markets

Welcome to the BioTime First Quarter Results Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, 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 first 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 are Co-Chief Executive Officers, Adi Mohanty and Dr. Michael West; and Chief Financial Officer, Russell Skibsted. In addition, Dr. Oscar Cuzzani, Vice President of Clinical Development is joining us today from the ARVO Conference, and will be available for questions on the exciting new data we released yesterday. Adi, Russell, and Dr. West 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, Doug. It's been just a short few weeks since our last earnings call, but the BioTime group of companies has made good progress in our core strategic objectives, clinical progress, simplification, and unlocking value. We presented additional clinical data, and announced the formation of AgeX Therapeutics. I'll begin the call with a review of our clinical progress. I will then turn the call over to Russell and Mike for some additional comments before we open the line for questions. BioTime continues to make progress with our core therapeutic programs in the areas of ophthalmology, aesthetics, and delivery. In ophthalmology, we presented positive new data earlier this week the ARVO's Annual Meeting, on May 8th. ARVO is the Association for Research in Vision and Ophthalmology. Their annual meeting is currently being held in Baltimore, and is the largest gathering of high-end vision researchers in the world. More than 11,000 are attending from more than 75 countries. At this important meeting, new data from both of our ophthalmic programs is being presented. On Monday, data from cohorts 1 and 2 of our lead ophthalmic therapeutic, OpRegen, our RPE replacement therapy being developed for dry-AMD was presented, and tomorrow, data from our preclinical retinal restoration program will be presented. We're in a Phase I/IIa trial for OpRegen. The safety data to date is extremely encouraging as we have not seen any serious adverse events. I recently mentioned in our annual shareholder letter the importance of early safety data in our cell therapies, including OpRegen. We also suggest in the letter that OpRegen is more like a transplant than a therapeutic. When you have a failing kidney, liver, or other organ, if you're lucky to receive an organ for transplantation, we know you have a high likelihood of success. Transplants work even when we don't understand the detailed mechanism of how the original disease occurred. Nowadays, transplants have a pretty high success rate, approximately 80% to 90%. Therefore, if we're able to establish that our cells safely engraft and remain alive in the patient then it is likely that our cell therapeutic may have a much higher possibility of success as compared to small or large-molecule therapeutics. As OpRegen progresses we expect the additional data to illuminate the understanding of our pluripotent cell-based technology. Then we believe our cell therapies should be valued higher at earlier stages when compared to other molecular approaches that have much higher failure rates. On average, only about one in 10 molecular drugs that enter clinical studies make it to commercialization. That means nine out of 10 drugs fail or are abandoned in development and are never approved. There's an old saying in drug development, every drug does two things in the body, the thing you expect it to do, and the thing you don't. Most drugs fail because they have unexpected side effects elsewhere in the body than their intended area of effect. Our products do not fit that model. As I just said, transplant science has improved to the point where success rates are in the 90% range. While we do not know what the success rate of our therapies will be, we do know that many aspects of our cell replacement therapies are more similar to transplants than they are to systemically-administered molecular drugs. I mention this information in the hope of better explaining why we are encouraged by the safety data that we see so far with no serious adverse events in the trial. We have also seen very encouraging early signals of biological activity in OpRegen. We have to be careful about drawing any conclusions at this early stage of development, but we are seeing signs that suggest our product could be well differentiated from others that have attempted RPE transplant. Monday's presentation at ARVO reported new clinical data from both cohort 1 in patients who received 50,000 cells, and cohort 2 patients who received a dose of 200,000 cells. Imaging analysis suggests the OpRegen cells engrafted in the back of the eye, including an area of the scar that was completely depleted of RPE cells. There was also possible evidence of a biological response with some treated areas of the retina. Imaging assessment suggest that the thinned area of retina above the scare increased in thickness, indicating possible evidence of a biological response in some areas appearing to show structural improvement without any signs of retinal edema. The positive increase in retinal thickness suggests that our transplanted cells not only engraft, but are likely functioning as we intended. As a result, they may help with remodeling of the other layers below. Thus corrected visual acuity also remains stable in all treated eyes, and importantly, showed no signs of deterioration which could be expected if no treatment was given. Remember, the patients enrolling in our clinical trials are steadily losing their RPE cells and the ability to see with that part of their retina. We plan to have an OpRegen KOL event in the coming weeks to share our progress. At that venue, we and the KOLs will present a more detailed clinical perspective of the data that we have seen so far, and the encouraging implications going forward. Our next step with OpRegen is to seek approval from the Data and Safety Monitoring Board for cohort 2. We plan to do this by the end of the second quarter, and then begin dosing cohort 3 at the study. The U.S. sites announced recently will be able to enroll patients along with the Israel side for cohort 3. We have fewer requirements to stagger patients as we progress through the cohorts, while we have to wait for more than a month between patients in past cohorts. In the next cohort, cohort 3, this requirement is reduced by half. The reduction is based on the continued good safety that we have generated so far in the trial. It is possible that we'll have a zero staggering requirement in future cohorts beyond cohort 3. Also at ARVO, we're presenting data related to our second ophthalmic program, which is an exciting, although earlier state pipeline therapeutic intended for retinal restoration. The data will be presented at ARVO tomorrow, and be related to our three-dimensional human retinal tissue. Efficiently manufactured in a lab from our pluripotent cell technology, our 3D tissue is designed to be used as a retinal implant. Our tissue may solve the primary gating factor to retinal restoration, which is the limited availability of natural or manufactured tissue that is mutation-free and highly similar to young natural human tissue. The presentation at ARVO focuses on the structural similarity of BioTime's lab-manufactured tissue to young natural human tissue. BioTime's manufactured tissue contains all the cell types that comprise the human retina's, including RPE cells, photoreceptors, and ganglion cells. Highly similar to young natural tissue, our tissue may ultimately help restore vision to the patients suffering from severe forms of retinal diseases that are associated with vision loss and blindness. Turning now to Aesthetics, Renevia is our lead program in this area. Renevia is a potential treatment for facial lipoatrophy, also known as facial fat loss. It is currently in a pivotal clinical trial in Europe to assess safety and effectiveness for patients who have lost facial fat due to HIV therapy. We previously mentioned that we expect the top line data from the current European trial mid-year. The trial has continued to progress well. We have seen no safety related issue, and we now expect to read out top line results of this study next month, in June. We're also making good progress on our plan to expand indication for Renevia; our objective to develop new indications as to enter the $7 billion facial aesthetics market. People are looking for natural long-lasting option in aesthetics. Initial data from our ongoing Renevia trial suggest that achieving volumetric improvements maybe sustainable for more than a year. Right now, fat transfer has become common and lasts only six to eight months, and many dermal fillers are indicated for six to 12 months, yet, several hundred thousand patients pay out of their own pocket $8,000 to $10,000 for a facial fat transfer. We're pursuing facial aesthetics indication for Renevia for two reasons, first the patients we think Renevia has a potential to offer more consistent natural lasting results, second we see this consumer discretionary market as a prudent diversification strategy for BioTime as we look to build the company with a balance of reimbursed and self-pay therapeutics. Companies with this type of diversification have done well in the last few decades, as an example Allergen has done a great job of managing a portfolio of self-pay and reimbursed products and we believe this diversity of payment helps minimize economic pressure felt by many pharmaceutical companies due to reimbursement rates. We remain engaged in several conversations with potential corporate partners in Asia, and Europe about Renevia, but also have engaged with many U.S. physicians, we anticipate sharing information soon about a possible U.S. investigator initiated trial that would pursue facial aesthetics indication. Turning now to delivery, we've mentioned some of our delivery programs before. These are earlier stage programs that includes drug delivery in osteoarthritis, delivery of BDNA [ph] or stroke and delivery of other molecules we have an orthopaedics bone grafting product which we previously announced was in collaboration with Heraeus, a multi-billion dollar German conglomerate, they sell orthopaedic products in the U.S. through Zimmer. BioTime is developing an innovative bone grafting product for Heraeus as part of this collaboration. A part pays for the development and we're able to receive milestone payments and other economics. We hope to share more progress on this collaboration in the next couple of months. The BioTime group affiliated subsidiary companies are also making good progress. Experiences made continued progress in clinical trials since our last call for OPC1 a therapeutic for acute spinal cord injury, the data safety monitoring committee of the study recommended continuation of enrollment for cohort 3 and four as planned. As a reminder, a serious previously about important functional improvement in spinal cord injury patients at lower Cellulose doses of OPC1. The strides expect to report additional safety and efficacy data for cohort 2 as well as for the currently enrolled in cohort 3 and 4 later this year. OPC1 is also a cell therapy based pluripotent style as OpRegen. There is now seven years worth of safety data on OPC1 in many patients. We are encouraged to see that safety data across different products in the platform continue to look good which adds to our confidence in our technology and approach. Our second public affiliate OncoCyte remains on track to commercialize its lung cancer diagnostic in the second half of this year. The company has created a medical advisory committee a full lung cancer specialist to facilitate a goto market strategy and help shape future pipeline products. In addition key performance metrics up its 300 patient lung diagnostic clinical study will be presented at the American Thoracic Society meeting on May 22. We invite you to listen to this Asterias's Investor call tomorrow on May 11 and the OncoCyte Investor call after the date of presentation on May 22. Let me now turn the call over to Russell who will discuss our balance sheet and the significant value that BioTime's holdings in these public affiliates represents for our shareholders.

Thanks, Adi. BioTime's consolidated cash and cash equivalents total $23.8 million as of March 31, 2017, this compared to $22 million on December 31, 2016. The December number included $10.2 million of OncoCyte's cash. Remember, prior to the consolidation of OncoCyte's financials which occurred on February 17 of this year, BioTime included OncoCyte's cash it is reported numbers whereas the March 31 cash number did not. Over the past several years, we unlocked some value for our shareholders with the formation of Asterias and OncoCyte. These companies initially operated as separately traded public subsidiary. During this time, we consolidated their financials, which made it difficult for people to readout the effects of the Asterias and OncoCyte, and fully understand BioTime's operation. As both Asterias and OncoCyte have now progressed to the point where they now operate as separately traded independent affiliate companies, we were able to deconsolidate their financial. This is a significant step forward in our efforts of simplifying the structure and transparency of biota. As of yesterday, BioTime owned 21.7 million shares of Asterias common stock, and 14.7 million shares of OncoCyte common stock. Together, these too ownership positions represented an aggregate market value of about $154 million based on yesterday's closing prices. Now, I'll turn it back over to Adi.

Thanks, Russell. Russell has made very clear how real the value of our simplification unlocking strategies can be. Let me now touch on the formation of AgeX. An additional simplification and value unlocking strategy we announced last month, AgeX consolidates certain early stage assets and research outside of BioTime's three core areas of ophthalmology, aesthetics, and delivery. Our objective in forming AgeX is to find a way to unlock the potential value of these non-core assets for our existing shareholders, while at the same time further simplifying the BioTime structure. To share more on AgeX, I'd like to now turn this call over to Mike.

Thank you, Adi. Steve Jobs once said, "Innovation distinguishes between a leader and a follower," and that's why we often refer to the BioTime group of companies as technology leaders and regenerative medicine. We innovate, and we innovate a lot. Some of the scientists now associated with our group of companies were among those who were the first to unravel the mechanisms of cell aging in the late 1990s. In 2010, some of it showed that it was possible to reverse the aging of human cells in a laboratory dish; both being provocative assertions at the time, now well-established in the scientific literature. We organized the first efforts to create the pluripotent cell technology platform, which for the first time in human history allows us to manufacture young cells of all types for the treatment of age-related degenerative disease. Again, provocative at the time, now a well-established field called Regenerative Medicine. But we didn't stop there. Scientists in the BioTime group also know that in the translation of these discoveries into the human clinical trial the pluripotent cell derived therapy, or we've only begun to innovate at BioTime. For some time we've been quietly innovating an entirely new class of therapies directly targeting some of the largest market opportunities associated with human aging. In our minds, these new technologies are the most powerful we have ever invented. In this regard, we have three new programs slated for development, one is for Type 2 diabetes, another for age-related ischemic disease, and one for scarless tissue regeneration; all based in part on an exciting new understanding of how and why we age. Induced Tissue Regeneration or ITR is we believe a means of unlocking the body's ability to regenerate, and therefore repair tissues, and do so scarlessly; something that was never possible before. We plan to develop these products to our subsidiary AgeX Therapeutics, and we plan to use the subsidiary to consolidate and continue to simplify our corporate structure. In addition to the new products like ITR, we plan to transfer BioTime subsidiaries, LifeMap Sciences, ReCyte Therapeutics, and potentially others into AgeX. These and other planned events may not only turn AgeX into a leader in the biotechnology of aging, but may also unlock value for our shareholders. We'll be discussing more details on these programs in the plans for AgeX in the coming weeks and months. And with that, I will turn the call back over to Adi.

Thank you, Mike. So, the data we're presenting keeps us on track to achieve several important milestones in 2017 as we execute our core objective. For OpRegen, we expect to complete DSMB for cohort 2 by the end of the quarter, and begin cohort 3. We expect to complete enrollment of cohort 3, and begin cohort 4 by the end of the year. We also expect to report further data from these cohorts before the end of the year. Our Renevia trial will report top line data next month, and if that data is positive then we'll work towards filing for CE Mark by the end of the year, and look forward to a commercial launch of Renevia in Europe next year. We also expect to share data from other U.S.-based studies on Renevia before the end of the year. Asterias will be reporting data on the OPC1 study later this year, and be sharing information on their cancer vaccine trial VAC2 before the end of the year. OncoCyte remains on track to report data on their lung cancer diagnostic very soon and then commercially launch the cancer diagnostic before year-end. They also expect to report data on breast cancer diagnostic later this year. We also expect to report data from early stage programs in delivery later this year. So 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 VAC2's initial trial will be in the United Kingdom. And all of our products have potential in most parts of the world rather than being restricted to one geography for various reasons. We expect to have a balance among various types of payers and therefore are not solely dependant on a single country or reimbursement regime. For example, Renevia primarily addresses private or self-pay market such as aesthetics, while OncoCyte's lung cancer diagnostic is not likely to be affected by possible changes to drug reimbursement policies in the U.S. We are eager to get our therapies to patients, and we believe that our core strategies, along with the rich pipeline of data will help us deliver increased value to our shareholders. Along the way, we believe we will help evolve the evaluation or valuation methods used by everyone since many of our products are likely to have higher success rates if we successfully cross the initial hurdle. And we look forward to updating you as we continue to make progress. Now, operator, we're ready for questions.

Thank you. [Operator Instructions] Our first question comes from the line of Reni Benjamin with Raymond James. Please state your question.

Hi guys, this is [indiscernible] stepping in for Reni. Thank you so much for taking my questions, and also congrats on the progress made for the quarter. Maybe can we first start on the data you presented at ARVO meeting two days ago; I was wondering what feedback you got from physicians attending the conference, especially on the data that suggest those RPE cells were able to get into the scar areas. And also, their opinions on the stable BCVA you saw among these patients. And then I have a couple of follow-ups. Thanks.

Hi, Dan [ph], this is Adi. And so, Oscar is on the line, but he's at ARVO, so if there's any technical difficulties I'm going to try and jump in. I can start by saying that he was there, significant number of people from our team were at ARVO. And absolutely what we heard was the data was remarkable. So Oscar, maybe I'll give you a minute to say what you heard from people about what the data we presented.

Okay. I hope you can hear me. The response from key opinion leaders that we're seeing in the poster or that I had the chance to discuss with them the results in different settings outside the poster were all very positive. Some of them, they were saying, I have never seen stem cells -- sorry, embryonic RPE cells attached to the atrophy area so well, and I haven't seen this in other trials. The other thing is the monolayer that was obtained, and as you see, the monolayer is a requisite for these RPE cells to be able to function. And several other things in the response of the upper retina that was in many ways giving some signs of recovery. We cannot say that the recovery is visual at this time because we didn't test it, but the structural recovery give us significant hope that this will be a very positive thing when we keep starting and including more endpoints in the trial.

Thanks, Oscar.

Got it, that's perfect. Maybe then besides the reduced patient staggering requirements, do you also think that the reduction of immunosuppression time, I believe, is from 12 months to, right now, three months, can this actually also accelerate enrollment going forward?

Yes, -- I think -- sorry, didn't mean to cut you off. Please go ahead and finish.

The answer is, yes.

Okay. So, Oscar -- I was going to just help, Dan [ph] -- I think I mentioned last time, and I'll just try to help explain that. We think it's a substantial difference because, think about it, we're trying to do -- this is age-related macular degeneration. These are old patients that we're recruiting. And in the early parts of the trial just all regulatory agencies require you to take sort of the extreme cases. So we're taking patients that are pretty far along in their disease. So overall, we're talking about much older patients in later stages of the disease, and doing 12 months of immunosuppression is a significant burden. And you can imagine that. And so going to three months is a substantial difference. I mean, 12 to three months is not a small difference. That is a dramatic difference. I know Oscar very quietly says, it does, but for sure we think that that will have an impact. And we'll continue to work towards either making it three months or even less, if possible. So think it'll have a significant benefit, yes.

Got it. Maybe the last question from me is if I remember correctly, the U.S. patients will be treated under an amended protocol as compared to that being used in the Israeli trial right now. So maybe first, correct me if I'm wrong, if that's the case can you talk about what changes have been made for the U.S. sides? Thank you.

So I'll let Oscar correct me, but…

I'll answer that.

Okay.

There were three main changes. One is actually to ease the enrollment, but the amendment has been done globally. That means all the sites in Israel and in U.S. will be effecting these particular change. The three main changes has been that we allow now patients that have controlled glaucoma. The second is that patients that have more than five years of resolution of a cancer that has a criteria of the investigator is minor or not important and with a letter of the oncology can allow the patient to enter the study. And the third one is actually for the eligibility of the [indiscernible] the eye that will not be treated. It was a very steep requirement of the size of the lesion that was present there. What we require now is that diagnosis of geographic atrophy in the [indiscernible] eye.

Got it. Thank you so much.

U.S. was then removal of the need for hospitalization. As you know, in U.S., we treat most patients as an outpatient basis. And in Israel there is a mandatory hospitalization of the patient for one day.

Okay, well -- Dan, is that -- okay. Perfect, keep going.

Yes, your next question comes from the line of Kevin DeGeeter with Ladenburg Thalmann. Please state your question.

Hi, good afternoon guys. Thank you for taking my questions. They focus mostly on Renevia today. Adi, you mentioned in your prepared comments that among the next steps for Renevia may include an investigator-sponsored in the U.S. or definitely looking at facial aesthetics, but can you talk a little bit more about the global regulatory strategy for Renevia assuming a positive outcome from the ongoing study in the EU, and specifically with regard to the U.S. market timeline and next steps in the context of a regulatory process?

Thanks Kevin. So, yes, actually that is very exciting. I think, hopefully, this is one of those we're really excited about OpRegen that we were presenting data -- actually currently presenting at ARVO. But Renevia, if you remember, we had mentioned that sometime around the middle of this year we might be able to do top line readout. It's been going so well that we actually are now sure that we will be able to do something next month. So that to us is great. We're going to have a full dataset that we can read out next month for Renevia. And that top line data is important. We know so far that the safety has been very good. So we've got no reason to worry about safety. But still, we got to get the top line, get the safety, get the efficacy data. That package is important for many reasons. That helps us figure out that size of the signal, the size of what other trials might be required. So, in terms of regulatory strategy, we have taken some of the initial positive data that we had from run-in patients and gone and talked to the FDA. But getting a full data package will make it a much more robust conversation. So we expect to go back and discuss that with the FDA. If you remember the last time, they had indicated to us that they think it's a device pathway; it could be a single confirmatory trial. We want to go back with a nice robust data package. But in order to make that data package even more robust is where we've mentioned that we've started to look at non-HIV patients. That's what the investigator-initiated trial in the U.S. is about, is trying to come up with data in the U.S. in non-HIV patients in an aesthetics indication where sometimes the volumes that are used are larger. We're going to try and cover all of that. I said we'll talk about it fairly soon. We have made significant progress with many physicians in the U.S., and pretty shortly we should be able to tell you about that trial. And we expect, this year, to be able to share some data from that trial. I mention all of this because data from the EU, the data from some of these investigator-initiated trials that are non-HIV, all put together as you can imagine will create in our minds a really good package to take for the expanded aesthetics indication. So, we have this plan for the U.S. with this whole bigger data package. But in Asia and Latin America we're already engaging with them. I think we're not ready to give you a lot more detail yet, but know that soon after Europe, Asia and U.S. are in our plans. And we're going to build it out as quick as we can, and provide as much data as we can to you when we have it.

Terrific. And then maybe one more staying on Renevia today, with regard to how we think about how to characterize a win for the ongoing study in Europe, which does include this focus on those HIV patients, you mentioned up to 12 months duration, is that a realistic bar to shoot for in the context of this patient population in terms of an average of medium duration of benefit? Or should we look for something somewhat more modest in this patient population?

Kevin, so not many people have asked that, so thank you for that. Because I think a while back we had mentioned that the reason we feel so encouraged by the data is it's in HIV patients. These are compromised patients. So if it does well in these patients it's likely to do better in others that don't have HIV. And we have some preclinical or lab data to suggest that's possible. Let me go back to -- the trial itself requires six months of readout. So if we can maintain volume in about three months. And I'll give you an example, several other, say, double fillers went in with something like a five cc injection and came with something like two cc or so of retention at the end of six to nine months. So we believe that if we can get something better than the 50%-60% retention of volume from the time you started till the six-month time point that would be a win. But then we have some patients, like I said, we already have longer-term data for nine months or 12 months. So a subset of them that have been on the trial longer, we'll look at those also. So if we can get volume retention at the end of six months in a HIV patient population that is somewhat compromised, we think that would be a win. If we have anything more in terms of slightly longer duration or slightly better volume retention, all of those would give us confidence in this path forward of going to the expanded indication.

Great. Thank you for taking my question.

Thank you. Our last question comes from the line of Keay Nakae with Chardan Capital Markets. Please state your question.

Thank you. With respect to OpRegen, as you move forward into cohort 3, what's the status of the U.S. factor? Are they ready to go once you get DSMB approval?

Yes. Keay, hi, I think I mentioned this last time right about what was about six weeks ago when we talked to, our expectation is that end of June they will be ready for treating patients. So, the timing sort of coincides with hopefully the DSMB approval. All the contracts and all of those things have been already done with these sites. So we're just doing all the prep work on dose prep and all those other things that are required to get them ready, and they are on track. So, we expect that in that June-July timeframe the confluence of DSMB approval, U.S. sites, all of those to be matching in that timeframe.

Okay, very good. And then with respect to presenting additional data from the dry-AMD study later this year, do you have an idea yet what the form for that might be?

So, we are still assessing what the form might be. I think that we have opportunities, for example, there's another big conference later this year or -- so, it's a little early for me to tell you exactly what that form might look like, but very -- in the next couple of months we should be able to tell you exactly where or what form it's going to take, but we're sure that we will have more data longer time points, more patients before the end of the year. So we will find a way to share that information.

Okay. And then, similarly with the Renevia data, if you could give us the top line data results in June, is there a conference in the late summer-early fall, that you're perhaps targeting to do deeper reveal of the data?

That's a good point. A deeper review of the data and discussion is absolutely something we'd like to do. So, at this point, we haven't finished planning, you know, that event. We're pretty focused on making sure that we get this particular top line data, the readout, and all of that done. And sooner that has done around that time we should be able to share with you because we'd love to have a few [indiscernible] from the U.S involved in some sort of way of getting into deeper dive of that data. Our Principal Investigator, Ramon in Spain, he's done a lot more work on the side with samples and data that are very informative as to what's really going on with the way our product is behaving. So, we'd love to get all of them here. We're working on that. I can't quite give you a exact date, time yet, but absolutely, we will plan on having a place where you can have a good deep dive on that fairly soon. So, let me not lock down into a date yet, but promise that there will be one.

Okay, and then -- yes, yes, for Mike, with respect to the three opportunities within AgeX, what's the timeframe to have either of these go into first demand study?

We're deepening the planning on the capitalization of AgeX, and of course that drives the timelines. And so, it would be premature at this point to lay that out, but as soon as we have all the planning done on that, we should be rolling out timelines, you know, some milestones, and it'll be largely milestones related to all the completion of preclinical studies and targeting dates for an IND.

Okay, that's all I have. Thanks.

Thank you, Keay.

Thank you. That is this time we have allotted for question-and-answer session. I will now turn it back to Adi Mohanty for closing comments.

Thank you. I appreciate everybody's time today. We are in a very exciting time. There's a rich pipeline of data coming out, and lots of stuff for us to talk about. I think the company is really returning the corner along with all the clinical progress we are making, the simplification, I want people to know that we are not forgetting about unlocking value, we are focused on doing the unlocking of the value including at this very time we have been an active strategic review of our ways of making sure that we can reward our shareholders, and that includes value creation, distribution of some of our holdings; all of those options are on the table and we are looking at them very closely. So, please stay tuned. Thank you.

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