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Edited Transcript of BTX earnings conference call or presentation 8-Aug-19 8:30pm GMT

Q2 2019 BioTime Inc Earnings Call

ALAMEDA Sep 18, 2019 (Thomson StreetEvents) -- Edited Transcript of Lineage Cell Therapeutics Inc earnings conference call or presentation Thursday, August 8, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Brandi L. Roberts

Lineage Cell Therapeutics, Inc. - CFO

* Brian M. Culley

Lineage Cell Therapeutics, Inc. - CEO, President & Director

* Ioana C. Hone

Lineage Cell Therapeutics, Inc. - Director of IR

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Conference Call Participants

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* Jason Wesly McCarthy

Maxim Group LLC, Research Division - Senior MD

* Kevin Michael DeGeeter

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

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Presentation

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Operator [1]

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Welcome to the BioTime Incorporated Second Quarter 2019 Conference Call. (Operator Instructions) An audio webcast of this call is available on the Investors section of BioTime's website at www.biotime.inc.com. This call is subject to copyright and is the property of BioTime. Any recordings, reproduction and transmission of this call without the expressed written consent of BioTime are strictly prohibited. As a reminder, today's call is being recorded. I would now like to introduce your host for today's conference.

Ioana Hone, Director of Investor Relations at BioTime. Ms. Hone, please go ahead.

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Ioana C. Hone, Lineage Cell Therapeutics, Inc. - Director of IR [2]

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Thank you, Chris. Good afternoon, and thank you for joining us. A press release reporting our second quarter 2019 financial results was issued earlier today, August 8, 2019, and can be found on the Investors section of our website.

Please note that today's conference call and webcast will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, goals, product candidates and clinical trials, expected synergies and benefits of these various acquisition and financing matters. Such statements are subject to significant risks and uncertainties, including those described in our press release issued on August 8, 2019, and our recent SEC filings on Form 8-K, Form 10-K and Form 10-Q. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to those risks and uncertainties. We caution you not to place undue reliance on any of the forward-looking statements, which speak only as of today.

Joining us today are our Chief Executive Officer; Brian Culley; our Chief Financial Officer, Brandi Roberts; and our Chief Medical Officer, Ed Wirth, who is joining us telephonically from our manufacturing facility in Israel, where he is overseeing the final steps of the tech transfer of OPC1 to our facility. The executives will provide prepared remarks, then take questions from analysts and institutional holders.

With that, I'd like to turn the call over to Brian Culley, our CEO.

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [3]

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Thank you, Iona, and good afternoon, everyone. As most of you know, on my first quarterly call last year, I outlined our plan to reposition BioTime as an indisputable leader in the field of cell therapy. That meant reducing the complexity of our business, particularly of our affiliate companies and focusing on our clinical stage pipeline.

In connection with this plan, we also made a large number of changes to our management team, including hiring a new Chief Financial Officer, Chief Medical Officer, General Counsel and, just this week, a new Vice President of Business Development. We are also relocating our corporate headquarters to Carlsbad, California, just north of San Diego. With these changes to our structure and team now in place, we felt the company was so profoundly different from 1 year ago, that it also would make sense to update our name. We chose Lineage Cell Therapeutics because it not only does a better job of describing what we do, but also gives investors and other important audiences a reason to take a fresh look at our business.

We further elected to relocate our office and management functions to Carlsbad, but we plan to retain our R&D space in the Bay Area and our GMP manufacturing facility in Israel. You can read more about the reasons for the name change and the relocation in a letter to shareholders, which I provided last week, and which is available on our website. Please also note that in connection with the name change, trading under our new ticker LCTX or lima, charlie, tango, x-ray, will be effective as of Monday, August 12, 2019.

With these organizational steps largely complete, these quarterly calls will increasingly focus on the progress we make with our therapeutic assets and, of course, our financials. We believe that communicating not only the progress we make with our clinical assets but also doing a better job of highlighting the value of our manufacturing expertise and our intellectual property positions as well as our position as a leader in the development of treatments for dry-AMD and spinal cord injury for which there are no FDA-approved treatments, will transform Lineage into a highly valuable company.

I'll now move in to the clinical program update. As a reminder, we have now centralized all clinical operations in our California offices. Beginning first with our dry-AMD program. Last month, we successfully administered OpRegen, our suspension of RPE cells to a dry-AMD patient using the orbit subretinal delivery system, which uses a suprachoroidal route to gain access to the subretinal space without the need for a vitrectomy or retinotomy. This was the world's first case of RPE cells being administered this way, and I'm pleased to announce that the procedure was a success. There were no unexpected complications, the patient recovered well, the retina looks as good as it did at baseline with no tears or punctures.

In the coming weeks and months, we'll be collecting anatomical and visual data from the subject to assess whether our cells have successfully engrafted and whether they are providing any clinical benefit in terms of GA growth and visual acuity. After a 30-day follow-up and review by the Independent Safety Committee, we'll be eligible to enroll another patient and we'll continue enrolling patients until we have dosed and assessed at least 6 subjects with the Orbit device. All these patients will be dosed in the United States, and we expect this enrollment to be complete by year-end.

At the same time that we dosed the Orbit patient, we also introduced a new off-the-shelf thaw-and-inject formulation of OpRegen, which we developed. This sounds like a minor improvement, but it now allows a surgeon to literally thaw a vial of OpRegen cells immediately before treatment and avoid a full day of dose preparation and transport of those cells via third-party to the surgical site within a narrow time window. Clearly, thaw-and-inject is a far more commercially desirable characteristic for our therapy and another important improvement to this program, reflecting our attention to both clinical and commercial aspects of this promising new therapeutic candidate.

In May, we announced the award of a new R&D grant of approximately $2.5 million from the Israel Innovation Authority. This grant provides additional funding for the development of OpRegen. We appreciate the IIA's continued financial support and believe that this grant is indicative of their confidence in our OpRegen program. Our vision restoration program, which is a separate initiative from OpRegen, also received a meaningful endorsement in the form of a $670,000 third year award to our SBIR grant for a total of $2.3 million to date. This grant tells us the NIH believes that we made substantial progress in our Direct To Phase II award and is supporting us to generate additional animal data from our Vision Restoration program. Our work in Vision Restoration was recently accepted for publication and more recent advances will be presented as a podium talk at the Society for Neuroscience Meeting in Chicago this fall.

As a reminder, despite millions of affected individuals, there is no FDA-approved therapy for dry-AMD. One of the main challenges in developing a treatment for dry-AMD is that the scientific community doesn't yet know what the target. Is it inflammation, oxidative stress, genetic deficiencies and which of the hundreds of potential targets or even combinations of targets is responsible for the loss of RPE cells and the resulting damage to photoreceptors. Our approach supercedes these questions and potential dead ends by replacing the entire cell with a brand-new one. Our indifference to the original cause of AMD also means we expect to be subjected to less market segmentation, thus increasing the potential commercial value of our approach. And lastly, there are only a handful of companies competing with us in this way. Our data are early, but they're quite encouraging, and we look forward to providing you with further updates, most notably at the AAA -- excuse me, the AAO meeting coming up this October.

Moving next to our OPC1 program for spinal cord injury. We have successfully transferred this program from Asterias to our manufacturing facility in Israel and we will be fully exited from the Asterias facility in Fremont by the end of this month. I'm not sure there's a broad awareness of this next point, so I just want to explain that because we had significant overlapping capabilities with Asterias, we only needed to retain a single full-time employee from that company without noticeably slowing the pace of our progress. We essentially stepped in to the shoes of their entire business, while shedding 95% of their ongoing employee-related costs.

And because the OPC1 program needed a number of enhancements to its process development before it can return to the clinic and because this is an area where we have had success with our AMD program, it made complete sense to deploy our Israeli manufacturing team onto this project. To be more specific, we believe there are improvements we can bring to both the purity and scale of OPC1 manufacturing, which will greatly increase the commercial value and partnerability of this program. And our plan is to introduce these improvements over the course of this year. Then, because this program has received RMAT designation, which means we have preliminary clinical evidence indicating that it has the potential to address an unmet medical need, we plan to approach the FDA to discuss the process improvements we're making in preparation for a comparative clinical trial, which we expect will begin next year. In the meantime, we will take this period to conduct additional readiness activities related to protocol design, statistics, site identification, the delivery process and other key components of the study, so that to the extent possible, the next study will be set up for another successful outcome.

Moving on to VAC2, our dendritic cell cancer vaccine. I suspect everyone on this call is aware that Cancer Research U.K. is currently conducting a clinical trial of our VAC2 asset in non-small cell lung cancer patients. This is a study we're using largely to demonstrate safety and tolerability of our treatment, but also to measure whether the patients develop an immune response to our antigen. If in fact, we're able to instruct T cells to mount an elevated response to our antigen, we believe we will have a compelling argument to combine our dendritic cell vaccine with a checkpoint inhibitor and observe superior outcomes compared to either treatment alone. Published data suggest that it may be best to attack cancer from 2 sides. So the immune checkpoint inhibitor makes cancer cells more susceptible to destruction, while our dendritic vaccine enhances T-cell activity against those tumor cells. And while we do not have data from our oncology program to share on today's call, we are actively screening subjects at the Birmingham site, and in the meantime, we would invite folks to take note of the emerging literature which we believe increasingly supports the use of dendritic cells to stimulate CDA positive and CD4 positive immune responses. We also expect to have more to say about this program around the end of the year after we've received the data from the immunogenicity assay. So please stay tuned.

As a final item for this clinical update, you will of course recall that we submitted our CE Mark application for Renevia last year and its review is still ongoing. We have answered every question promptly, and we're told to the satisfaction of our notified body, BSI, and all open items for review were closed many weeks ago. Since that time, we have persistently inquired as to when we can expect an outcome without receiving definitive guidance back except to hear that a substantial backlog exists at BSI. Unfortunately, as unsatisfying as this is for all of us, there is little more we can do other than to wait for the process to be completed. We, of course, will promptly inform you of any decisions or substantive updates from BSI, but it's clear that we can't provide any additional guidance on this because we have no meaningful control over it.

I now will hand things over to Brandi to review our financials and discuss some additional plans we have for this year.

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Brandi L. Roberts, Lineage Cell Therapeutics, Inc. - CFO [4]

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Thank you, Brian. I'd like to start the financial discussion off with an update on our cash position. We ended the second quarter with $16.7 million in cash, cash equivalents and marketable securities. In early July, we converted about 15% of our OncoCyte Holdings for gross proceeds of $4.5 million.

Also in July, we sold about 647,000 shares of our Hadasit Holdings for gross proceeds of $1.2 million. I'm also happy to report that just today, we received proceeds of approximately $2 million in our OpRegen grant funding from the IIA. The transactions involving OncoCyte and Hadasit are part of an intentional strategy to raise operating capital for BioTime through sources other than BioTime common stock. And where it makes sense to do so, we will continue to leverage our equity investments or the $21.6 million face value promissory note due to us next August from Juvenescence to further support our business. We believe that OncoCyte, Hadasit and AgeX have promising technologies, but it's important to balance that promise with the need to advance our internal programs. It is also important to note that in parallel, we will continue to assess other funding and strategic alliance opportunities, which may be available through our existing or future potential partners. I'd also like to note that we may raise capital in small amounts from quarter-to-quarter. We don't necessarily believe that we need to have 1 to 2 years of cash on hand, like many other biotech companies because we have these investments that we can leverage as necessary.

We are also actively working on cost reductions. As Brian mentioned, we were able to just about observe the activities of Asterias into existing BioTime employees' responsibilities. We were also able to further reduce head count by realigning priorities and ensuring focus on our clinical development programs and reducing or eliminating noncore or unprofitable activities. Additionally, we're looking forward to cost savings related to our move from Northern California to Southern California. After implementing these cost savings initiatives, we are looking at a cost structure for 2020, ranging from $24 million to $28 million. This was lower than our expected spend for 2019 of $32 million to $34 million, and it's significantly reduced from the spend of the combined companies for 2018 of $43 million. I think that this is a really important aspect of the company that people often overlook. We have successfully integrated 2 companies, and within 1 year, we are looking to realize reduced spend of approximately 35% to 45%.

Now I'd like to switch gears and talk a little bit about the statement of operations for the second quarter of 2019. I'll start by reminding everyone that beginning on August 30, 2018, BioTime fees recognizing revenues and expenses related to AgeX and its subsidiaries due to the AgeX deconsolidation on that date. Accordingly, our 2019 results do not include AgeX activity, while the second quarter of 2018 does.

Total revenues for the second quarter of 2019 were $800,000, a decrease of $1.8 million as compared to the same period in 2018. The decrease was primarily related to a $1.4 million decrease in grant revenues and a $300,000 reduction in subscription and advertisement revenues attributable to the AgeX deconsolidation. I want to address the variance in grant revenue as sometimes this is difficult to understand.

In the second quarter of 2018, we received approvals from the IIA for prior year expenses. Therefore, the grant revenue recognized in that quarter was quite high. Since that period, we recognized revenue more consistently quarter-over-quarter. It's important to note that we've actually been approved by the IIA for more grants in 2019 versus 2018. Operating expenses include R&D expenses as well as G&A expenses. Total operating expenses for the second quarter of 2019 were $11.5 million as reported, a decrease of $100,000 compared to the same period in 2018, and $9 million as adjusted, a decrease of $400,000 compared to the same period in 2018. In addition to stock-based compensation and depreciation and amortization expense, there were also $900,000 of a serious merger transaction-related costs that were excluded from total operating expenses for the second quarter of 2019, as adjusted. The full reconciliation between GAAP and non-GAAP operating expenses by entity is provided in the financial tables included with our earnings release.

R&D expenses for the second quarter of 2019 were $5.2 million, a decrease of $1.1 million compared to the same period in 2018. The decrease was primarily related to a $1.4 million decrease from the AgeX deconsolidation, offset by a net increase of $300,000 in BioTime programs, primarily related to an increase of $1.7 million in OPC1 and VAC2 expenses and a reduction of $1.4 million in Renevia, HyStem and PureStem expenses. G&A expenses for the second quarter of 2019 were $6.3 million, an increase of $1 million as compared to the same period in 2018. The increase was primarily attributable to increases of $1.9 million in severance, legal and related costs related to the Asterias merger, which was offset by a decrease of $1.1 million from the AgeX deconsolidation.

Other income or expenses net for the second quarter of 2019 reflected other expense net of $20.5 million compared to other income net of $4.5 million for the same period in 2018. The variance was primarily related to changes in the value of equity investments in OncoCyte and Asterias for the applicable period. The net loss attributable to BioTime for the second quarter of 2019 was $30 million or $0.20 per share, basic and diluted, compared to a net loss attributable to BioTime of $4.2 million or $0.03 per share, basic and diluted, for the same period in 2018.

I'd like to take a moment to talk about the $30 million loss, as I know it sounds like a big number. We have 2 components to our net loss. Our loss from operations, which directly correlates with our business and other expenses, which largely reflects the changes in the market values of our investments and other public companies. Of the $30 million loss in the second quarter, $20 million was related to these other expenses. Our loss from operations was roughly $10 million and only $1.7 million larger than the loss from operations from the same period in 2018. That fluctuation is almost entirely due to the accounting for the lower grant revenues, which was solely related to the timing of grant approval. We are very focused on reducing operating expenses and as we continue to implement our cost savings initiative, we expect to see ongoing reductions throughout the remainder of the year and into 2020. We remain committed to developing our 3 clinical stage assets with the most reasonable and efficient spend as possible.

With that, I will turn the call back to Brian.

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [5]

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Thanks, Brandi. It's been almost 1 year since I joined the company, and I'm glad to have largely completed the process of simplifying the business and redefining our brand. I think we now have the right pieces in place to achieve our goals, and we have a number of additional steps planned, which are intended to improve our visibility in the investor community and ensure our work is being noticed.

I also want to add that cell therapy is becoming a mainstream technology. The subcategories of CAR-T and gene therapy have already enjoyed an explosion of growth, and we think that our area of cell therapy, specifically transplanting differentiated cells into the body to replace lost function, also will grow exponentially in the coming years. We saw this happen years ago with the sudden and tremendous interest in developing drugs for orphan diseases, and we think deals like the $600 million transaction that was announced this morning between Bayer and Blue Rock are just the tip of the iceberg for cell therapy.

To be ready for this growth, we will focus on further collection and maturation of our OpRegen data in dry-AMD, improving the manufacturing of OPC1 cells in a consistent and scalable manner and determining whether VAC2 engenders an immune response in cancer patients, each of which are key advancements for our business, expected to happen in the second half of this year and into the beginning of next year.

Specifically, 3 clinical milestones our investors can look forward to this year include completing patient enrollment in the United States in the Orbit SDS portion of the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD. Presenting new OpRegen data from the ongoing Phase I/IIa clinical study at the 2019 American Academy of Ophthalmology Annual Meeting in October and announcing a decision on BioTime's CE Mark application for Renevia.

Lastly, we look forward to launching this new corporate brand, website and social media presence next week as Lineage Cell Therapeutics. Thank you very much for listening today. And with that, operator, the team is ready for any questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from the line of Kevin DeGeeter with Oppenheimer.

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Kevin Michael DeGeeter, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [2]

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Congratulations on really a tremendous amount of progress here. Brian, can you just comment as to how we should frame expectations with regard to data presentation at AAO? Should we look for data -- clinical data from newly dosed patients, including those with the new device? Or should we anticipate this being mostly longer term follow-up on patients dosed in earlier cohorts?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [3]

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Yes, Kevin, I think the answer is, you'll get some of both. So certainly, it's important to see a maturation of the original set of patients that were dosed, seeing how someone's area of geographic atrophy or even their visual acuity, how that performs at 12 months versus 3 months. I think 12 months is much more interesting. So for the patients or the subjects who have already been treated, seeing an aging or a maturation of that data to maybe get a sense for how long a benefit sticks around, I think that's part of what you should look for. And then the other part is, it may be even more important, which is how are the administrations with the new device going. Is it living up to expectations? The expectations are high, but the first subject as a stand-alone piece of evidence seems extremely encouraging, where there's a lot of risk going in with the new device for the first time, but everything seem to have gone well. So you can expect in October that there will be additional Orbit subjects that you'll be able to have, let's say, AE information on or hopefully lack of AE, rather. And then you'll also see an aging or a maturation of the initial subjects. And so you'll get a little bit of each.

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Kevin Michael DeGeeter, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [4]

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Terrific. Now that's very helpful. And then just secondly, then I'll get back in the queue. You did point out and highlight the addition of a new member of the team, the head of Business Development. Can you just comment on your current priorities with regard to business development? And how one thinks about that in terms of breakdown by geography versus certain products, for example, OpRegen versus others?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [5]

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Of course. I think, first and foremost, what business development does for an organization is provide optionality, partnerships principally bring one of 2 things or a combination, and that is money and capabilities. And so if you are actively out there having conversations, making sure you've got options on the table to be able to enter into an agreement and it makes sense to do so or not enter into an agreement if it's not beneficial for your company. So the top level strategy is really about optionality. The next level strategy gets into things like regional partnerships versus global partnerships, front loading, backloading economics. That gets into a level of detail that we won't cover on this call. But I do think that adding an experienced Business Development Vice President will be helpful for getting us some greater awareness and bring some options to us that we might not have had over the last few months.

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Operator [6]

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And our next question comes from the line of Jason McCarthy with Maxim Group.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [7]

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Brian, 2 questions. I just want to touch on the Orbit device and the Cohort 4 first. Assuming that all goes well, you get the first patient in, no safety issues, then you move up to the sixth patient, we still have to wait some time to start to see the BCMA data and other measures. Would you consider either expanding to more patients in that fourth cohort or would you look to start another -- second study, a Phase II study, almost in parallel before we see the data from those last 6 or 7 patients in the Phase I/IIa?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [8]

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Jason, it's a good question. And we can't say definitively what the answer will be right now. When we entered into the agreement with Orbit, we said, "Okay, well, we agree with them. We will look at 6 patients." When we introduced Orbit into the trial, there were 9 subjects left to be enrolled. So I can't even promise you that we will do the last 3 without Orbit, with Orbit or at all. So I think what we want to do, because we have a new device and it's a relatively small number, is just collect the data and see how it's looking for us. If there's a strong argument to expand enrollment in the current study and the current protocol, we're of course going to consider that. But if the counter argument is that we've learned what we needed to learn and we're ready to go into a larger and differently designed study, we'll be very excited about doing that, because that presumably means that things have gone well. So we need to collect the data before we can make the decision, but we do want to keep the flexibility of collecting additional data, if needed, as something that is on the table. But the current plan is 6 subjects with Orbit and then we'll have to make a decision as to the final 3. And if the data look good, we would want to close this study and start a new larger study thereafter, either alone or, to bring Kevin's point back in, potentially with a partner on board.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [9]

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Got you. And just a second question, because with all the focus on spinal cord and AMD, you did mention VAC2, and you could see potentially some early data showing immunogenicity, in which case you would consider possibly doing a combination trial with a checkpoint. Given that it is a cell-based vaccine, I'm not sure if there's cryo preservation involved that could save costs, but it looks like a trial that could be rather costly. Would you seek a partner? Or would you look to expand BioTime or now Lineage's role in oncology?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [10]

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Yes. So as you know, we do have a really nice partnership with Cancer Research U.K. for the current protocol if we -- one thing that we have said that we would like to do is talk to Cancer Research U.K. to find out if it makes sense for us to continue and expand that involvement into a different protocol that I think would include checkpoint inhibitor and combination or perhaps some other design. One of the things that we are going through right now is to find out where we can best operate in that space. So I don't think that non-small cell lung cancer is necessarily the best place for this technology today. There are probably better places that we might have a chance of succeeding, not due to any one specific characteristic, but rather to the overall constellation of where checkpoint inhibitors are used, what the competitive landscape looks like and so forth.

So it's true that we haven't said historically a whole lot about VAC2, but we are increasingly encouraged by the idea that educating T cells the way that we do it and using not an autologous source, which you'll recall from some other companies, can be extremely expensive and onerous from an operational and handling standpoint, but rather having an off-the-shelf solution of dendritic cells loaded with an antigen that can prime the T cells to engender a response and then using the checkpoint inhibitor to basically make that response and that amplification permissive. We think that, that's probably the best probability of success. And so the first place we would start is with our existing partner, and if they're not interested or not willing, then we of course would go to a table of other ideas that we have, which of course can include continuing on our own. So we still probably have quite a number of months before the current study is completed, but we definitely want to find out as soon as we're practically possible and prepared to do so, what the bright next clinical study with VAC2 should look like.

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Operator [11]

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And our next question comes from the line of Joseph Pantginis with H.C. Wainwright.

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Unidentified Analyst, [12]

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This is [Pascual] (inaudible) from the line of Joe. Can you hear me okay?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [13]

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Yes, Pascual.

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Unidentified Analyst, [14]

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Okay. Few questions for me. So for the Orbit device, how do you view the uptake and physician interest of the Orbit device? And can you remind us about the logistics of any special training before patient treatment?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [15]

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Yes, certainly. The Orbit device, in light of the fact that it received its 510(k) clearance just last November, is largely unfamiliar to surgeons. So there is a training procedure that they go through. It's about a half day training procedure that could be on cadaver eyes or it could be on a large mammal eye. That training is pretty straightforward. The response to that training and the first experiences that physicians have had with the device, they say it's been overwhelmingly favorable. The physician who did the first procedure in the human setting was very happy that it performed exactly as it did in training. And others who have been trained, whether part of our study or whether part of the work that was done by Orbit in the past, has been very favorable. So we think that eventually, this is going to become the standard of care to deliver cells to the back of the eye. We just happen to be the pioneers of it. But all of the evidence that we have to date would suggest to us that this will be the way of the future.

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Unidentified Analyst, [16]

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All right. Very good. Another question for me, please. Can you tell us where you are in complying all these OPC data now that this is announced? And what are the views toward a potential publication or improvements of manufacturing progress? And also what about regulatory discussions?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [17]

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Yes, of course. So with respect to OPC1, the study enrollment is complete and has been completed for more than a year. So there has been a presentation of the 12-month follow-up data. The full publication, the full manuscript, is in preparation, but you can expect that later this year. With respect to improvements that we're introducing, this is part of our total development strategy, we approach these programs with a comprehensive attitude, meaning if we have an opportunity to introduce an improvement, there may be a short-term delay, but if it has a long-term benefit with respect to our competition or increases our probability of success, obviously we run those numbers to make sure it makes sense to conduct that. So that is part of what we're doing right now with OPC1. And with respect to the, I think, the third part, you asked about regulatory. Some of the data that we're collecting, which will support our regulatory strategy, that will be packaged up, put into a meeting package and used as the basis to get some back and forth with FDA. So we'll go to them mostly for an RMAT manufacturing meeting, first. We will presumably do a clinical meeting, second. But we also benefit from the fact that Asterias had already had a very productive clinical meeting prior to their acquisition by us. So we know kind of where the FDA's head is at with respect to the clinical side of things. So I think that meeting would be mostly refinement, but we do want to make sure we have clarity with respect to FDA's attitude on the improvements that we're looking to introduce to the process over the course of this year.

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Operator [18]

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And our last question comes from the line of Jason Kolbert with Dawson James

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Unidentified Analyst, [19]

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This is [Tucker] on behalf of Jason. And my first question is for Brandi. And could you review with me how you carry the value, exactly how you value BioTime's ownership with its affiliated companies? And talk about any plans to continue to monetize said holdings?

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Brandi L. Roberts, Lineage Cell Therapeutics, Inc. - CFO [20]

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Sure. So right now, we have about 5% ownership in AgeX. We have about an 8% ownership in Hadasit and our remaining ownership in OncoCyte is about 24%. So we look at all of those investments as opportunities to help fund our operations. But we really balance out what our needs are and when it makes sense to potentially use those investments. So we look at them from time to time. We're obviously excited about the technologies that those companies are working on. But we balance that with meeting to fund our own operations as well.

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Unidentified Analyst, [21]

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That's great. And I just have one more question. Can you opine on what's clinically next for OpRegen? And what I mean is it seems like we've been here before with early but promising data that didn't pan out in longer trials such as (inaudible)? And what signals are you seeing that suggests this time may be different?

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [22]

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So the -- I don't know if this is the brass ring in dry-AMD, but there are 2 attributes that I think people are very interested in. One is the size of the area of geographic atrophy. So essentially, how many cells have died off and what does the dead area look like? And how quickly does it expand and grow because as it grows over the area of your macula, that's how you're losing your fine vision. And then the other one, which is connected, but not in a perfectly linear way, is visual acuity. And visual acuity is usually measured with whatever corrective measures you have, your glasses or contacts. There has been some efforts in the past. There was a company in particular that seem to have a benefit in vision, but they saw no change in geographic atrophy. And so it caused them to investigate this and they felt that patients were learning how to improve their reading ability, while they were losing their vision to AMD. So they're getting better at taking the test basically, not unlike a high school kid who learns how to do better at SAT test taking, even if they don't have any more knowledge. So what we are excited about and encouraged by is that we have evidence, early as it is currently, but we can point to at least some case studies, where an individual has had an improvement in vision, which has been what we think is clinically relevant and durable over a long number of months and counting. And we've had a case study where over the period of about a year, it appears to us that the area of GA is not expanding in the area where cells were administered. So again, that is -- it's an early study. It's largely a safety study, but we're seeing these signs of efficacy that give us some encouragement. I think it's really important to keep in mind that there are essentially 3 levels of benefit in dry-AMD. So the lowest hurdle is to slow the rate of growth, the growth of GA. The next higher benefit would be to stop the rate of growth of GA. And of course, the greatest benefit would be to reverse the rate of growth in GA and then to bring back site. It's an open question with the FDA as to what an applicable endpoint will be in this disease. Everyone gets excited about improving vision, and we all know why. But there certainly is a precedent from some other companies that just working on the area of GA and the rate of growth isn't a provable endpoint. So what we will do is that we are a data-driven company, so what we will do is we will look at the data, we will try to assess what our cells are capable of doing. And then we will go to the agency with a clinical study that seeks to highlight the benefit of our cells and whether that's on vision or GA area or some combination thereof, remains to be seen. But we'd like to essentially stack the deck in our favor. Does that provide the information you were looking for?

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Unidentified Analyst, [23]

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Yes, absolutely. Congratulations on the progress.

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Operator [24]

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I'm not showing any further questions at this time. So I would now like to turn the call back to Brian Culley for any further remarks.

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Brian M. Culley, Lineage Cell Therapeutics, Inc. - CEO, President & Director [25]

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I know -- I have no further remarks. I appreciate everyone joining us this afternoon. We're obviously excited about our plans, and we want to keep the momentum going. So thank you so much.

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Operator [26]

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Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone, have a great day.