Lineage Cell Therapeutics, Inc. (LCTX) Q2 2018 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the BioTime's Second Quarter 2018 Earnings Conference Call. [Operator Instructions]. And as a reminder, today's conference is being recorded. I would now like to turn the call over to Mr. David Nakasone. Sir, 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 2018 as well as recent corporate developments. BioTime issued the second quarter earnings release earlier this afternoon. The earnings release is posted and available on our website at www.biotime.com. 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 7 days. The operator will provide the replay information at the end of today's call. With us today at corporate headquarters are Co-Chief Executive Officer, Adi Mohanty; and Chief Financial Officer, Russell Skibsted. Co-Chief Executive Officer, Dr. Michael West, will be joining us from New York. Each executive will make prepared remarks, and then we will take your questions from our covering analysts and institutional holders. Before we get started, we would like to remind you that, during the course of this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's filings with the SEC, including without limitation to the company's form 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, David. Good afternoon, everyone, and thank you for joining our call today. Let me begin by talking about the transformative agreement we announced earlier today. As part of our continued focus on unlocking value and simplification, we've reached an agreement with Juvenescence to sell 14.4 million shares of AgeX for approximately $43 million. As you may recall, just last year we formed AgeX to consolidate certain early-stage noncore assets and research programs primarily focused on the biology of aging and age-related diseases. Our goal in forming AgeX was to unlock the potential value of these assets for our existing shareholders while not taking resources away from our core clinical programs. It also helps us to further simplify our company, which is one of our key corporate objectives. In the short period of time since last year, we have demonstrated our ability to unlock value for our shareholders. Today's transaction values AgeX at over $100 million and demonstrates our ability to monetize these assets for our shareholders, providing over $43 million in non-dilutive funding to BioTime. This transaction allows our shareholders to benefit from the potential future success of AgeX and Juvenescence. We're excited to partner with a great team like Juvenescence. They're well-funded and a world-class organization with a proven and seasoned team of experts in drug development, strategy, commercialization and finance. Their key management has been on teams that have delivered over $20 billion in total shareholder value. The management team at Juvenescence has in past positions collectively taken multiple products to commercialization, with peak annual sales totaling over $70 billion. Dr. Gregory Bailey is the CEO of Juvenescence and is on the board of multiple public companies. He has co-founded and invested in multiple public and private companies. For example, he was the initial financier and an independent Director of Medivation, a company which was acquired by Pfizer for approximately $14 billion. Jim Mellon, the Chairman of Juvenescence, is a British entrepreneur, philanthropist and investor with interests in several industries. He's a controlling shareholder and Director of Manx Financial Group, an Isle of Man-based bank, and a controlling shareholder of Webis Holdings PLC. He has several other interests involving a multi-billion dollar portfolio. Now, along with this transaction, we have continued to make steady progress on our clinical development. Let me talk about our core programs now. Beginning with OpRegen, our lead cell replacement product candidate. OpRegen, which is in a Phase I/IIa multi-center clinical trial for the treatment of dry age-related macular degermation, is at a very exciting point in its development. We have successfully completed the third and final OpRegen transplant of the cohort's 3 extension arm, which brings the total number of patients treated to 12 in the first three cohorts. To date, we've not seen any unexpected serious adverse events, and OpRegen has generally been well tolerated in these patients. Data from the first three cohorts was presented earlier this year at the annual Association for Research in Vision and Ophthalmology meeting, or ARVO as it is commonly referred to. The data presented suggested positive signals with structural improvements in the retina, namely a reduction and change in drusen material, an improvement or possible restoration of the RPE layer, and the photoreceptor layer and ellipsoid zone assuming a more regular appearance. We continue to believe these data and signs of structural improvement are a prerequisite for functional improvement, and they're consistent with our preclinical animal models, which showed an improvement in actual vision. In parallel to completing the first three cohorts, we have begun treating patients in the fourth cohort of this clinical trial. Enrollment and treatment are progressing nicely. This is of particular importance, because as we have previously said, the patients in cohort 4 have much better vision than those who were treated in the first 3 cohorts. Better vision patients will likely be in an earlier stage of the disease and will allow our investigators and team the ability to perform a wide array of functional assessments. And we believe these patients in cohort 4 are representative of those that will eventually be in our target patient population. We're seeing early signs that are encouraging and similar to what we saw in the previous three cohorts. We plan to enroll and treat further patients in cohort 4 over the coming months, with the goal of enrolling 9 patients, and then the final three patients, or a total of 12, will be enrolled once we've had an opportunity to incorporate potential learnings or enhancements from the first nine patients. As announced last week, we'll present all available data, including early data from the fourth cohort, at the upcoming annual American Academy of Ophthalmology Conference that'll take place from October 27 through October 30 in Chicago. AAO, as it is commonly referred to, is the world's largest association for eye physicians and surgeons. We also announced the addition of two new U.S. clinical sites in the OpRegen trial: the Byers Eye Institute at Stanford University School of Medicine, and Retinal Consultants Medical Group in Northern California. We're very pleased to see increased interest in OpRegen, and these additional sites will expedite enrollment in cohort 4. Turning now to Renevia, which is our lead cell delivery product. In March of this year, based on the strength and quality of the data seen in our pivotal trial, we submitted Renevia for approval in the EU. This submission was filed under the CE Mark device pathway, and our expectations remain that we will receive approval before year-end. During the past quarter, we've been in discussions with the EU notifying body about our Renevia CE Mark application. Our interactions with the agency thus far are what I would characterize as routine and typical for this kind of application. They have centered mainly around the design and manufacturing of the product. And based on our submission and these interactions with the EU, we remain confident of an EU approval later this year. This CE Mark submission is an important step in BioTime's transition to becoming a commercial-ready company. But as we've said in the past, we see this as a springboard to much bigger markets, and we believe we can build upon the EU registration program to expand into new indications and new geographies. Our U.S. entry plans are progressing, and we're working with the FDA to design a study in the U.S. that we hope to have up and running by year-end. In the meantime, an investigator-led study by Dr. Joel Aronowitz, a leading Beverly Hills-based plastic surgeon, is ongoing. As announced earlier, a second investigator-initiated study led by Dr. Gordon Sasaki, also in the L.A. area, is expected to begin enrollment and treatment in the coming weeks. Dr. Sasaki is a Board-certified plastic surgeon and is considered by most to be at the forefront of plastic surgery. Some of his notable contributions include enhancing liposuction outcomes and recovery using advanced techniques such as power-assisted liposuction and SAFELipo; pioneering endoscopic techniques for brow lifts and face lifts; improving non-surgical facial rejuvenation by combining fillers, Botox, laser resurfacing and radio frequencing skin tightening. Dr. Sasaki has also been cited for his extensive work with fat. Most notably, one of his papers, where he cites that volume retention rates for fat grafting procedures alone drop off approximately 50% after the first three months following the procedure. This independent investigator-initiated study will look at the safety and volume retention of Premvia plus the patient's own fat in the hand. The study will treat a number of patients. Each subject will receive a treatment of Premvia plus their own fat in one hand, and a treatment of their own fat alone in the other hand. Along with the progress on our product development, we made great strides in getting non-dilutive funding, one of our key internal initiatives. One example, of course, is the recent transformative agreement with Juvenescence for $43 million. But in addition to this deal, we've also been successful in securing other sources of non-dilutive funding, such as grants. In May, we announced receipt of a new grant for approximately $1.9 million from the Israel Innovation Authority, or IIA. To date, the IIA has provided annual grants totaling over $13 million. We were also awarded the second half of a $1.6 million grant from the Small Business Innovation Research, or SBIR program, of the NIH to fund our next-generation retinal restoration program. We continue to look for other non-dilutive funding opportunities. For example, with the recent expansion of the OpRegen clinical trial into California, the program now qualifies for opportunities like CERM, or the California Institute for Regenerative Medicine. CERM funds promising California-based research programs that are poised to transform stem cells into cures. So to sum up, this has been a very exciting and transformative quarter for BioTime and our shareholders. We were able to reward our shareholders with the Juvenescence alliance, and we look forward to the distribution of AgeX shares later this year, which will be discussed in more detail by Russell. Now let me turn the call over to Mike West to discuss AgeX further. Mike?

Thank you, Adi. The United States, like numerous other industrialized countries around the world, is experiencing a rapid rise in the prevalence of age-related degenerative disease. Current drug-based therapeutic modalities are limited in their power to coax the body to repair itself. So the sharp rise in the number of older people with age-related diseases like Alzheimer's, Parkinson's, coronary heart disease, Type 2 diabetes, age-related macular degeneration, osteoarthritis and so on is generating enormous pent-up demand for medical solutions. Meeting that demand for select disease types, including ischemic disease and Type 2 diabetes, is a focus of AgeX. Product development within the BioTime group of companies is largely structured on pluripotency-based regenerative medicine. We harness the power of these unique cells to maintain themselves in a youthful state by means of the immortalizing gene telomerase. Since these amazing cells have the power, for the first time in history, to transform into any of the cell types of the human body, it's now possible to manufacture young cells of any kind to potentially repair tissues afflicted with specific types of age-related degenerative disease. We've transferred to AgeX a large estate of intellectual property, including patents and patent applications filed worldwide in the field of cellular immortality, or generative biology. They enable the company to commercialization numerous products in the AgeX fields. Our initial focus is on the development of young vascular cells to rebuild circulation in the context of age-related ischemic disease, a product we call AgeX VASC1. The American Heart Association predicts that cardiovascular disease will account for over $1 trillion of healthcare costs annually by the year 2035 in the U.S. alone, largely driven by the surge of aging baby boomers. Our second lead product in development is AgeX BAT1. This product is intended to reverse age-related changes in metabolism. As we age, many suffer from obesity and Type 2 diabetes. These changes can have serious health consequences, impacting not only the quality of life, but life expectancy as well. The global market associated with diabetes and obesity has been projected to rise to over $160 billion annually in the next five years. The last, and perhaps the most impactful technology under development, is called Induced Tissue Regeneration, or ITR. Some animals in nature can profoundly regenerate damaged tissues after trauma; for instance amputate the leg of a Mexican salamander, and it completely regenerates. We anticipate that the field of regenerative biology, as applied to human medicine, will be transformative. Since its founding in 2017, AgeX has received over $19 million to fund operations through the sale of equity, warrants, and the sale of nine core assets. At the start of our call, Adi described Juvenescence, our new significant partner with an investor in AgeX. In the field of gerontology, the scientific study of aging, we commonly refer to senescence, a term referring to cell aging. The term Juvenescence communicates the vision of reversing senescence in medicine. Jim Mellon, one of the founders of Juvenescence, recently compassed the world to investigate the state of the art of the science. The resulting book, also named Juvenescence, surveys the associated investment opportunities. The resulting investment thesis is exciting, and it carries with it a sense of gravity. The business opportunity is unprecedented in scope, but we sense a grave moral responsibility not only to our shareholders, but to all of the millions of patients in dire need of such lifesaving technologies. We see great chemistry in combining our science with the vision and management skills of the Juvenescence team, comprised of proven and seasoned experts in drug development, strategy, structure, commercialization and finance. We believe this results in the ingredients for a revolutionary company. As Adi mentioned, in the past two decades, key management in Juvenescence has delivered over US$20 billion in total shareholder value. We'll be working diligently with the Juvenescence team in the coming weeks and months to align our respective businesses, further advance our development plans, including those related to preclinical development, associated to-be-announced milestones, anticipated IND filings for clinical trials, and general preparations to be publicly traded as a company with the anticipated ticker symbol AGE. So in summary, we've assembled in AgeX powerful new technologies aimed at what we believe is the central biology of human aging, namely cellular immortality and regenerative biology. With our new partners at Juvenescence, we believe we're well-positioned to compete in this exciting and emerging industry. With that, I'll turn the call over to BioTime's Chief Financial Officer, Russell Skibsted, to review our financials for the second quarter. Russell?

Thanks, Mike. I will now review the financial highlights for the quarter, then touch upon the planned AgeX distribution. BioTime's consolidated cash, cash equivalents and marketable securities totaled approximately $29 million as of June 30, which compared to approximately $31 million as of the end of Q1. In addition, we own publicly traded common stock in Asterias and OncoCyte, which represent an aggregate market value of approximately $70 million based on yesterday's closing price. As announced earlier this morning, we will receive an additional $43 million from the Juvenescence transaction. This will provide us with $21.5 million in additional cash and an additional $21.5 million in securities. As we've done over the past couple of years, we've included at the end of our earnings release a non-GAAP table that details operating expenses by entity adjusting for noncash expenses. We believe this will help investors better understand BioTime's and AgeX's financials. But please keep in mind, when reviewing this table, that the table is not a cash flow by entity, because grants and other revenues are not included in the totals. During the quarter, BioTime's consolidated non-GAAP operating expenses were $9.3 million, which is comprised of about $7 million for BioTime and about $2 million for AgeX. Grant revenue of about $2 million for BioTime was recognized during the quarter. BioTime's actual cash burn during the quarter was about $5.4 million. This brings our cash burn for the first half of the year to a bit over $12 million, which is in line with our prior guidance. Based on our current plans, we continue to believe that BioTime's quarterly operating cash burn over the course of 2018 to be a little over $6 million per quarter. Provided we maintain our planned level of expenditures and receipts, we expect to have sufficient cash to get us well into 2020. Moving to the distribution of AgeX. The record date for the AgeX distribution is July 31, 2018. We are in the process of working with the SEC to finalize the AgeX registration statement. We maintain our expectation that the distribution of the AgeX shares will occur by the end of September or sooner. Because the registration statement has not yet been declared effective by the SEC, according to the New York Stock Exchange, this distribution is subject to the future fulfillment of some requirement or condition. As a result, BioTime's stock will trade with due bills attached until the actual distribution. Trading under due bills represents an assignment of the right to receive the distribution beginning on July 30, which is one business day prior to the record date of July 31, all the way through the date of distribution. What this means is, if an investor sells their BioTime stock after the record date but on or before the date of the distribution, that investor would also be selling their right to receive shares of AgeX in the upcoming distribution. Said another way, in order to receive AgeX shares through this distribution, you must be a BioTime shareholder at the close of trading on the date of the distribution. The distribution date has not yet been set because we do not have an effective registration statement. Once we do, we will make an announcement regarding the actual distribution date. Again, we expect all of this to happen within the next two months. With the completion of either the Juvenescence transaction or the AgeX distribution, BioTime will be deconsolidating the financials of AgeX from the financials of BioTime, which is just like what we did last year with OncoCyte and the year before with Asterias. The results will, again, be BioTime financial statements that will be much easier to understand. Deconsolidation will also make AgeX financials easier to understand once we complete the distribution and AgeX is a public company. In summary, BioTime shareholders will soon receive a distribution of shares of AgeX common stock which we believe is a significant unlocking of value to these BioTime shareholders. Going forward, as we near the fulfillment of our simplification strategy that we mentioned to you in early 2016, we will see a more simplified BioTime with a manageable $6 million-ish per quarter burn. I will now turn the call over to Adi.

Thanks, Russell. So our sharpened focus on the corporate imperatives of clinical progress, simplification, and unlocking value for our shareholders is paying dividends. The Juvenescence transaction and the upcoming distribution of AgeX shares are transformative transactions that provide significant, non-dilutive funding to BioTime, set up AgeX for further success, and unlock over $100 million of value that was previously not valued as part of BioTime. OpRegen development is accelerating, with encouraging data to date and expected near-term data that could be transformative for the program, the company, and for patients suffering from dry AMD. Renevia is on the verge of approval, launching the company towards a commercial product and opening the path towards much larger indications in aesthetics. BioTime is now very well-funded to deliver on important upcoming milestones: the distribution of AgeX shares to BioTime shareholders; EU approval of Renevia; data from OpRegen at AAO; data from OpRegen cohort 4 by year-end or beginning of next year. So for BioTime, we've had a great first half of the year, and the second half will build and accelerate on this progress. With that, operator, we're ready for questions.

[Operator Instructions]. Our first question comes from the line of Kevin DeGeeter of Ladenburg Thalmann.

This is James on for Kevin. Could you please talk about Juvenescence access to external drug development expertise and how that could potentially accelerate AgeX product development?

Yes, I think as we mentioned, so Greg Bailey, who is the CEO of Juvenescence, was part of founding Medivation, taking that -- early steps to form the company and take the products to the clinic, and as part of that has significant connections. Along with that, on the board is a person called Declan, who used to be the head of R&D of Merck. I can list the number of people there that have had significant success, Annalisa Jenkins. These are names that everybody in the industry would recognize as people who have delivered products through early-stage development all the way to commercialization. They are people with strong track records, but also, significantly, they have significant access to funding. So they're extremely well-funded. They've raised already about $70 million. They have access to lots of funds. And we think that combination of a well-funded, extremely -- well, shall I say, accomplished set of people, that creates a great partnership within AgeX for the products and technologies. As you know, we have some very powerful technologies. That combination of those technologies and those people we believe will accelerate development and create significant value.

And just to clarify, so potential distribution date for AgeX, it could be as soon as September?

Sure. I think I'll stick with what Russell said in his prepared remarks, which is we believe definitely that we can get all of this done within two months. Our target will be sooner than that, but that's the outside date. So on the outside it's by end of September, but we could get that done sooner, and we'll do that as soon as we can.

Our next question comes from the line of Reni Benjamin of Raymond James.

Congratulations on this, I think, pretty transformative deal and unlocking of value. A couple of questions, maybe just starting off with the OpRegen program. Adi, you mentioned that we're going to see data from a full 12 patients from the first 3 cohorts at ARVO. Can you just provide a little bit of context or color as to what will be kind of the longest follow-ups that we might see? Is there anything in the data that should materially change? Or should we be pretty happy that, if we see nothing that's changed, should we take that as a positive sign? And might we see some data from cohort 4?

So let me try to walk through that and clarify a little bit. As you know, we have three cohorts, with cohort 1 being a certain dose and a cohort 2 and 3, so there was from 500 cells per microliter to 2,000 cells per microliter. So we have cohort 1, 2 and 3. And last time we mentioned, because we had gotten so good with all the different centers coming online, and we had patients, we had an opportunity to get a few extra patients, and we did. So we got 3 extra patients enrolled, so that's how we get to the total of 12 patients. We really haven't shared a whole lot of data from those additional three patients that got treated over the last quarter, so that 12 now going to AAO in October is more meaningful than the 8 or so patients that we had shared at ARVO. So we'll have a larger number, significantly larger compared to 8. We'll have 12. And what we think is important is that continued watching or seeing the structural changes that we saw, right? Reduction of drusen we think could be pretty meaningful, and a lot of KOLs agree. The improvement of the ellipsoid zone, the RPE layer, maintaining a lot of those changes for a longer period of time is also pretty meaningful, because we saw some of them at month 4, month 5, and that was pretty good that we can already see some improvement at the month 3, 4, 5, but does that sustain for 8 or 9 months, or 12 months. Now, in either case, there is a product, right? But the idea is would this be a really long-lasting effect, or would there be a shorter effect? Those are things that we can see with some of this data that is longer-term. Some of the earlier patients, they're heading out to almost 2 years, 2-plus years. But I think more important for me is to see that the patients that are now at even 9 months that we had shown 4 months of data, are we able to see similar or continuing improvement. That's important in the first 3 cohorts. The fourth cohort, which we just started treating recently, now, we think if we have 3 or 4 months' worth of data -- I'm sorry, 3 or 4-month time point data, given that the 3 or 4-month time point data and the previous cohort was pretty meaningful, it'd be interesting to see. Whatever we have, I can't promise, and it's hard for me to now make those commitments. But we think we'll have some. Whatever we have we'll share at AAO, but, more meaningfully, the larger cohort of -- I'm sorry, larger number of patients from cohort 4, the data will be more complete end of the year, beginning of next year.

And just thinking about things a little bit longer-term and how things might unfold in 2019 and beyond, at what point do you kind of go with what you have and go to the regulatory agencies and discuss a potential commercial pathway forward? Do you already have that path pretty much planned out and ready to be conducted? And what are your thoughts regarding RMAT designations for the syndication?

So this is one of those tougher questions. Of course, we have a long-term plan, but that long-term plan -- at the very minimum, you can take the basic plan, which is when we finish IIa, we have a meeting, we do a IIb, and then you do a Phase 3 [indiscernible] more traditional plan. At the least, we think with the data we have, with safety, with starting to see some early functional -- I'm sorry, structural changes, that that path should be available at the minimum. Now, if the data from the Phase IIa becomes -- as you know, the size of the clinical signal matters -- is better than what people might get in a typical IIa, because we're seeing signs that we might get something better. But we won't know until we see the actual data. In fact, the data is better, then of course we're ready to take advantage of that and go sit with the agency and say, look, we have now 20-some patients worth of data that is really meaningful change, and based on that, is there a path to a registrationals trial right away, being that there is nothing else that works in this space? There is that opportunity. It's a little early to talk about all of those still, Ren. I think this is why we think that the data coming out within the next few months could be quite significant, because that data we think at minimum at least confirms here's the conservative pathway, and if it's really good, then it gives us that confirmation of being able to approach an accelerated pathway. We think RMAT, as you know, we're learning a lot about the RMAT designation, OPC1 having the RMAT designation within our family of companies. We know a lot about it. We're involved. And so if there's an opportunity to take advantage of that, we will. We're learning more because we are approaching the agency through that process. It's a newer process. You know that the agency wants to work with cell therapy companies, but they're learning, we're learning. So we can learn from another product within our family, and we'll apply that to OpRegen as available. As of today, I think it's still a little early for me to give you more details.

And just switching gears real quick to Renevia, you mentioned that the interactions with the agency are pretty routine. Typically, when we see people submitting for [indiscernible] approval, there's essentially a question-and-answer period, right, where essentially the clock stops, the 120-day questions and things like that. Can you tell us, is that the same case with the CE Mark and kind of where you are in that pathway? And then related to -- you mentioned expanding into new indications. You have some ISTs here in the U.S. But how do you expand into new indications in Europe? And I guess the follow-up to that question is what are the commercial activities that you're thinking about instituting as you get ready for a potential approval by the end of the year?

That's a lot of questions in one, Ren, so let me try to go through that. So it is a little different, as you know. You mentioned those things. Compared to the U.S., with the FDA, there's a -- you get this comment period, and then a Q&A period. There's a 60-day clock, 90-day clock. That is not the same for Europeans in general, but definitely for the CE Mark pathway, that is not the same. So we don't have that defined timeline, which is why previously we have said we're basing it on what has happened. So for the 40 or so approvals over the last 2 or 3 years through the CE Mark pathway, it's been that sort of 4 to 8-month timeframe it's taken, which is how we came up with we think the fall, we could get approval. But there's not a defined timeline. However, there are similar review steps. So they look at all our submissions. First they tell us if it's complete, then they tell us if they have questions, then they tell us what the label discussions look like. So we've gone through the first couple of gates, complete, and then some questions, pretty typical routine questions. It was nothing other than it took us a little bit to clarify things. So we feel pretty good about the interactions so far. We're now waiting for that next step, which would be that label conversation, and as you know, a lot for us. We have several plans in the drawer that we're ready to pull out, but a lot depends on how that label conversation goes. So we haven't finished that. That's what we think the next couple of months will be, because that's almost like the last step before they send you, like, here's what you've got. So once we have that, knowing what we have on the label tells us a lot on both fronts, which is do we have to do formal trials to do expanded indication, or did we get a larger indication in the label. And so if we have to, then we have ways that we would -- we have these KOL that are very interested in Europe for sure, that we have even trials designed and ready to go that we could initiate. And so we would be able to expand using those methodologies. In the meantime, the ones we're doing in the U.S., if you noticed -- by the way, small segue. I mean, I mentioned about Dr. Sasaki. And I don't know if everybody on the call realized -- to me, I would say he is one of the preeminent people in this space. So if you haven't seen it, we have cited his paper in the past. He has a really good paper that he's published with some 1,100 patients worth of data where he talks about how fat grafting results in about a 50% loss of the graft within the first three months. So we were quite happy and pleased that he liked what he saw. He talked to us and wanted to get involved. So what -- the trial he's doing is in hands and being able to compare fat alone, and then the fat plus Renevia or Premvia in the other hand. Wow, that's getting confusing, right, other arm of the trial of a hand. So we're ready to do those studies as needed. I think, like we had said in the past, this label discussion is important. We have several market research and other studies that we have. But we think taking the time to get that discussion complete and then activating the next steps is the most prudent thing, and we'll hopefully be back soon to share all that with all of you.

Congrats on the progress.

Our next question comes from the line of Patrick Lin of Primarius Capital.

Congrats on all the progress as well. I echo the other callers. Particularly excited about the AgeX, as well as some of the other progress. But the first question is, in terms of the distribution and the record date, I just want to make sure I heard correctly. All the people who bought stock before the record date of July 31, if they sold it since then, they do not get the AgeX spin-out when the distribution happens. Is that correct?

Patrick, this is Russell. Correct. Because the BioTime stock is -- the New York Stock Exchange is attaching the due bill, it means that the right to receive the distribution will go with the BioTime stock until the distribution date.

So if you sold it, you lost that right.

Yes, if you sold it, you lost it. On the other hand, if you buy it, you get it.

That sounds fair to me. And then, the second thing is you mentioned about the quarterly burn, roughly about $6 million a quarter. And based on what I heard about the current cash on hand, if you add in the marketable securities as well as the new cash that came in, that's well over $100 million. So would it be close to four years then of roughly at the current burn? I'm not saying that it's not [indiscernible]?

If it were all in cash.

But at the current -- no, I understand, but if you add up the cash and cash equivalents and investments, I just want to make sure I got the math right, that that's over $100 million, right?

Yes, Patrick, you're right. It is well over $100 million, and yes, that would be four years all-inclusive. But cash alone is a pretty big number now. That's why I say we're well-funded to do what we need to do.

And then the last thing is just to give us a little preview, I know you have some of these presentations coming up. But are there any investment conferences that you guys are scheduled for, and any other presentations coming up, just so we can kind of mark them on our calendar? That's it. Thank you.

Sure, Patrick. We have a number of presentations that we'll be doing in September and October, including the Rodman conference, the B. Riley conference, and Ladenberg Thalmann. And I think there are a couple other ones coming up toward the end of the year. So we will definitely keep you apprised as those conference dates approach.

Terrific progress, and look forward to future updates.

Our next question is from the line of Bruce Jackson of Benchmark.

Just a couple of more on the OpRegen trial. What is the cell concentration for cohort 4?

Yes, Bruce, so we have kept that the same as cohort 3 because we like that concentration. We've seen that now for 2 cohorts. That concentration works well. And that jives also with our preclinical data from the animal model, which also suggested that that would be likely the right dose. So 2,000 cells per microliter, that is our dose. That's what we're doing, and that's what we have in cohort 4.

And then I wanted to make sure I heard the numbers for cohort 4 correctly. So there are two arms in this cohort, correct? And then is it 9 and 3 or 6 and 3 in the 2 arms?

Well, thanks for asking that, so I know that can get confusing. So there is really just one arm where we're going to treat 12 patients. What we've been saying is what we want to do, and that's what we're trying to set up, is get the first 9 patients treated, and then take a brief -- I'm talking about like days, not a long pause -- but take a brief pause, see if we have learned things from those first nine patients that we might want to use to enhance the last three patients. So take advantage of having 12 patients, which is a pretty decent size number of patients. And so it's not separate arms. It's not -- I can see how when I'm talking, it could sound confusing, but no - one arm, 12 patients. We'll get to 9 patients, take a short breather for a couple of days, look at what we've learned from 9, and then finish the last 3 either exactly the same as the first 9 or with a small enhancement that would help us either with a procedure-related or site-related, or other small tweaks.

And then with the extra patients that were in the first 3 cohorts to get it from 9 to 12, which cohorts were they in? Were they all in one cohort, or were they in various cohorts?

Yes, good question. So it was -- we call that the cohort 3 extension arm. So they were the same as the cohort 3, which is the primary -- what I would say exciting data at ARVO came from the cohort 3 patients. So the additional 3 patients were cohort 3 extension patients.

And then finally, with the data that you're going to be showing for the first 3 cohorts, roughly what is the follow-up period just on average? I know it's going to be variable depending upon the individual patients, but what's the average follow-up period going to be?

Your comment there about being variable is very accurate. It'll be really hard for me to give you an average number. There's -- patients will be all the way from a few months to a couple of years. So I would rather not give you an average number and say, yes, we'll have patients who have been treated fairly recently to patients with really long-term follow-up.

And then a quick question for Russell. With the AgeX spin, what's the cap structure of the new company going to look like? So Juvenescence is going to have their 14 million-plus shares, and then the BioTime holders are getting 1 for every 10, right? So what's the final share count going to total up to, do you think? And what's the BioTime stake in the new spin going to be?

It might be easier to just go simple with as of today. There's about 37 million shares.

Right. There's, yes, about -- BioTime owns a little over 80% of AgeX currently, which for us represents about a little over -- almost 29 million shares. And Juvenescence is purchasing 1.4 million-plus shares of?

14, 14-point ?

We will be distributing one share of AgeX for every 10 shares of BioTime. There was 126 million BioTime shares, so we'll be distributing about 12 million-plus shares of AgeX to the BioTime shareholders.

So I think it's best right now to stay with those numbers and say, look, as of the record date, we have that many outstanding shares, 126 million or so. 1 to 10 we'll give out AgeX shares, Juvenescence bought it. As soon as we finish that, we'll give you the final remaining number for BioTime, because we'll end up with remaining shares of AgeX as well as new shares of Juvenescence.

And then last question on the AgeX pipeline. I know that Mike didn't want to give out too much information on the plans, but can you give us just maybe a little bit more on, like, the rank order of the three different programs and when we might have something begin to happen on the clinical trial front?

Right. So I see the vascular product, VASC1, and the metabolic product, BAT1, which are brown adipocytes, as roughly equivalent in their stages of development. And so we'll be developing them in parallel, and that's quite a complex task. We've developed now several products from pluripotent stem cells through preclinical development, and then to clinical trials, obviously, and have a strong sense of the tasks required, the number of animals and animal studies. But the precise timeline will depend on ongoing discussions with FDA and [indiscernible] specific indications. Obviously different indications require different types of animal models, so once we've had more definition on that front. And then, with this transaction with Juvenescence, obviously they will become a very significant partner as well as shareholder. And so there's ongoing discussions, which as you might anticipate, have preceded today's announcement about our joint collaborative efforts that they can bring to the table to help in some cases accelerate that development plan. So we thought it best not in this earning call to lay out a defined milestone time line path, but we'll be doing that as soon as possible.

Congratulations on all the progress.

And at this time, there are no further questions. I'd like to turn the conference back over to Adi for closing remarks.

Thank you. Thank you all for joining us. It is such a great, exciting time for BioTime, and we look forward to coming and sharing more of that progress over the next few months. Thank you.

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