Lineage Cell Therapeutics, Inc. Q2 FY2020 Earnings Call

Welcome to the Lineage Cell Therapeutics Second Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. Recordings, reproduction, or transmission of this call without the express written consent of Lineage 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 Lineage. Ms. Hone, please go ahead.

Thank you, Tino. Good afternoon and thank you for joining us. A press release reporting our second quarter 2020 financial results was issued earlier today, August 6, 2020, 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, clinical trials, financings, and cost savings matters. Such statements are subject to significant risks and uncertainties including those described in our press release issued on August 6, 2020, and our most recent Form 10-K and 10-Q filings. 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 Senior Vice President of Clinical and Medical Affairs, Gary Hogge. The executives will provide prepared remarks and then take questions from analysts. With that, I'd like to turn the call over to Brian Culley, our CEO.

Thank you, Ioana, and good afternoon everyone. We appreciate you joining us on our quarterly call today. This past quarter was extremely productive for the company and on today's call, I'm going to review the most important milestones we reached with each of our three clinical-stage cell therapy programs. After I provide these program updates, Brandi will review our financials. Then we'll summarize some upcoming events which shareholders can look forward to, and then we'll open up the line for our analyst questions. I'm going to start with OpRegen, our product candidate to treat Dry AMD with geographic atrophy. Dry AMD with GA is one of the leading causes of vision loss in the world, and we estimate there are between 1 million and 2 million people in the U.S. suffering from the advanced form of the condition, which is the initial form we hope to treat. The disease is caused by the slow progressive loss of specialized retinal cells. Our approach to treating Dry AMD is to grow and transplant brand new retina cells to replace the ones which are dysfunctional, dying, or have already died off. This program is currently enrolling patients in a Phase I/IIa clinical trial at five active centers. Because there are no FDA-approved therapies to treat Dry AMD, we believe the commercial opportunity for a new treatment is incredibly attractive. We recently announced a discovery which we believe distinguishes our program substantially from the competition and positions us as the most promising Dry AMD therapeutic currently in development. I make this strong statement because in June, we reported evidence of what is potentially the first known finding of retinal tissue restoration in a patient receiving a transplant of RPE cells. This finding is unprecedented because humans lack the ability to regrow or repair retinal tissue, so most companies are simply trying to slow the rate of disease progression. Our data supports the view that Dry AMD is not an irreversible degenerative condition, which only gets worse over time. We believe we're the only company to report in a clinical setting that some portion of diseased retinal tissue may actually be recoverable in Dry AMD patients. The patient we treated with our OpRegen cells had atrophic end-stage disease yet showed substantial restoration of retinal tissue within the previous area of GA. Specifically, the area of GA assessed at nine months was approximately 25% smaller than the patient's baseline prior to treatment. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. We also recently hosted a call with renowned experts to review these results in detail. There's a replay of that call on our website, which I strongly recommend checking out. We're currently conducting a third independent review of these findings, going back to determine whether it appears in any of our previously treated patients, and we plan to submit these data in a case report manuscript for scientific peer review when these analyses are completed. One reason these data are so exciting to us is that in a clinical trial setting, you ordinarily would compare one group of treated eyes against the group of untreated eyes and determine whether the area of atrophy in the treated eyes grew more slowly because slower growth is a positive outcome in the setting. What we've shown is that it's possible to not simply slow the growth rate but actually reverse it and restore retinal structure to a normal appearance and architecture, which from a statistical perspective, makes it much easier to see differences between treated and untreated groups because the untreated group will only get worse over time. In contrast, if a few of the GAs in your treated group get smaller, then you're really pulling down the average growth rate of your experimental arm and instilling an incredible amount of statistical power into your trial. Overall, this potential may mean that we can run a smaller, faster trial while still maintaining tremendous power in our analysis. We're looking forward to seeing whether a different patient we treated just a couple of months ago becomes that valuable second example, or maybe one of the next couple of patients we treat will provide that evidence. But despite our excitement, we have to remain patient because these areas of GA do grow very slowly, and there's nothing we can do to accelerate the amount of time it takes to show differences in growth rate. We have to wait until enough time has passed to see if the GA has gotten smaller. But that certainly could be an exciting announcement if we observe it again and have it confirmed by external experts. In addition to the retinal restoration discovery, we have also observed additional benefits in some patients on this trial. Those include increases in visual acuity, reductions in the rate of growth of GA, and increases in patient reading speed. We believe the body of evidence we’re collecting will support a new paradigm for how to approach the treatment of Dry AMD and one that no other company has shown evidence for. That's our primary objective: to show that directed differentiation and transplant of RPE cells can provide clinically meaningful outcomes in this disease. By the way, I should mention that I know a lot of people are now following this emerging story. So I should explain that despite a large number of Dry AMD sufferers in this country, it is still difficult to enroll patients in clinical trials. There are many reasons for this, including the challenges of identifying what are typically elderly volunteers who still have meaningful vision—they need to sign up for elective surgery, meet the enrollment criteria, and be comfortable with a large number of doctor visits despite whatever regional COVID restrictions they may be subject to. Unfortunately, as our data set has grown and matured and the safety of the treatment is increasingly known to the physicians, enrollment might get a little bit easier going forward because these retinal specialists are able to express more confidence and enthusiasm in the potential benefits from treatment. But to be fair, COVID is still a hurdle for this study as it is for many other studies as well. To help boost the process, we have recently opened a fifth active site in the U.S. and we're hoping that we can soon get another one or two patients from our sites located in LA, Cincinnati, or Philadelphia. As a reminder about this trial, we've had three surgical experiences with the gyroscope therapeutics 510(k) approved Orbit SDS device—that's the tool we use to administer the cells into the subretinal space. We think this device can provide us with a meaningful competitive advantage in administering cells to the subretinal space. To confirm the early promising results we've seen, we would like to confirm that with another two or three patients. Once those final patients have been dosed using the device—which should occur in the next month or two—that will then conclude the Orbit portion of the study. If all goes well, we plan to conclude enrollment in the Phase I/IIa study around that time and move into a follow-up phase involving interactions with various regulatory authorities, like the FDA, and entering into more advanced partnership discussions. Overall, things are trending positively for our Dry AMD program; our focus will continue to be on collecting additional patient data, repeating the restoration finding I described, and completing the Orbit evaluation phase, which altogether will help direct our clinical, regulatory, and partnership strategies. Regarding the next data update on the OpRegen program, aside from updates or announcements we could make at any time on retinal restoration, we also plan to provide an overall update at the upcoming AAO Virtual Conference in the second week of November. In the past, we've received a very good reception from these presentations, and we will share more about our plans in our presentations as that meeting date approaches. Moving next to VAC, this is our allogeneic or off-the-shelf dendritic cell cancer vaccine. This product candidate is comprised of mature dendritic cells, which we manufacture from established cell lines and load with a tumor-specific marker to instruct the body's immune system to attack and eliminate cancer cells by educating T cells to seek out and destroy cancer cells. VAC acts like a highly trained booster for your immune system. During the second quarter, we elected to conduct an early exercise of our options to the VAC program from our development partner, Cancer Research U.K. CR U.K. has been conducting a Phase I clinical trial of VAC2 in patients with non-small cell lung cancer. After reviewing data from the first four patients treated in the study, it was clear to us that VAC2 dendritic cells could indeed provide targeted education of T cells—a signal we were seeking and which was apparent in multiple assay systems. The signal was also present in an earlier autologous version of VAC2 known as VAC1, and in an earlier investigator-sponsored study. The ongoing VAC2 trial confirmed these positive earlier findings and gave us confidence the mechanism was being preserved when moving from an autologous setting into an allogeneic setting. This is important because only an allogenic platform can provide the cost and manufacturing advantages that have limited the autologous dendritic vaccines. An additional reason for the early exercise of the VAC option was to send it to our in-house experts in cell therapy manufacturing, so that they could begin work immediately on necessary production enhancements. Although CR U.K. collected valuable clinical data, they did not have in-house expertise in pluripotent cell-guided differentiation, so they could not develop the necessary improvements to the manufacturing process. To fully exploit the potential of the VAC platform, we need to modernize it, just like we successfully did with our retina program, similar to how we are currently modernizing our spinal cord program. For example, we recently started looking into using the VAC platform to create a coronavirus vaccine. This is possible because one of the hallmarks of the VAC platform is generating high levels of CD4 positive and CD8 positive T cells in most patients, and T cells are required for the memory effects of long-term vaccines. If you've been following the literature on COVID vaccines, you've seen that while the early days focused on generating antibodies, there has recently been increased focus on the importance of engaging the adaptive immune system and specifically the patient's T cell response. Many vaccine approaches are being pursued today, but there's no way to predict what kinds and forms of immunological stimulus will work best in various genetic or professional populations. We have submitted a provisional patent application for our approach and are in the process of submitting proposals for external grant support from both U.S. and international funding organizations. We were unsuccessful with our first application, as were many other companies, but we recently received a response from BARDA inviting us to a meeting this month under what they call their Corona watch program, where we will be able to discuss our proposal and planned efforts. This is encouraging to us because BARDA reported that they received more than 3,500 meeting requests but have only granted approximately 400 of those meetings. Now, because most of these COVID funding pools didn't even exist a few months ago, there's no way for us to estimate our chances of success in obtaining a COVID-related grant from BARDA or elsewhere. But we will persist and do our best to identify external funding support for that initiative. Among our current or future VAC product candidates—which encompass both cancer and infectious diseases—the main differences are the antigen RNA sequence inserted into the dendritic cells. The dendritic cells are identical, but the sequence that we insert, which conveys the signal or message, differs and defines these products. Many of the manufacturing improvements we have begun working on are identical across the oncology and infectious disease programs. This means any funding we receive or investments we make in the VAC platform are effectively multiplied as the advanced steps are common to both oncology and infectious disease programs and all product candidates currently in or may in the future reside within them. Even though Lineage now has control of the VAC2 program, CR U.K. is still responsible for collecting data on current patients and dosing additional patients in the ongoing study. We have begun to explore additional oncology applications, which we internally call VAC3, VAC4, VAC5, as well as additional infectious disease applications that I mentioned earlier. Importantly, now that we are responsible for the VAC program, we can explore development opportunities with companies in the immuno-oncology space, where we would provide access to our dendritic cell platform as a delivery tool for someone else's antigens. This could help us generate a pipeline of different product candidates with various expression cassettes targeting many different types of cancers. We feel that the product platform nature of VAC will enable us to engage in exciting new partnership discussions and become a more prominent player in the immuno-oncology field, especially as we validate and mature the production process scale and other important commercial attributes of VAC. We are also in the process of hiring a new position that we created—a Vice President of Oncology to lead the development of VAC2, along with the expansion of our oncology pipeline, which can aid in both partnering efforts, as well as internal development programs. Lastly, I want to add that we often receive questions about the limitations of using dendritic cells for tumor therapy. It's vital to understand that first-generation efforts were largely monotherapy approaches in heavily pretreated patients, and that is not where the field has remained. We're aware of the history and are encouraged by more recent work suggesting that combination approaches with checkpoint inhibitors, chemotherapy, as well as second-generation technologies like our allogeneic dendritic cells and neoantigens may offer more promising clinical outcomes. Lineage intends to position itself as a second-generation alternative in a combination setting, with the added benefits of being allogeneic and adaptable across combinations of potential antigens. This is somewhat in the early stages, but it is something you can look forward to hearing more about from us as we continue through the year. Thirdly, moving to OPC1, this is our clinical stage program for spinal cord injury. This past quarter, we announced that manufacturing has been completely transferred to our facility in Israel, where key process improvements have been developed and implemented. We also strengthened our patent position to protect this new OPC1 process, the product, composition, and methods of use. As I described earlier, it's vital to modernize this production process to enable a later-stage clinical trial and ultimately commercialization. I'm very proud to share that my expectations have been exceeded by our CMC team working on this project. They generated new cGMP master working cell banks ensuring consistent batches are produced. They improved the production process to achieve greater efficiency and higher quality control, making it compatible with larger scale manufacturing and BLA readiness. They introduced new in-process controls and release testing, updating them to be more compatible with current and expected future regulatory guidelines. They are on track to initiate GMP production in early 2021 to support the clinical efforts. Looking ahead, they will also develop a thaw-and-inject formulation like we have for OpRegen, while in parallel, the product development team will evaluate superior delivery tools, which will enable an easier surgical procedure and faster enrollment in the next clinical trial. All this work will lead us to an arm-out meeting with the FDA, which we're planning for around the end of this year, early next year. Once all these commercially enabling improvements are in place, the manufacturing side of the OPC1 program will have caught up with the impressive clinical data side, and I believe that will open up new opportunities to evaluate and consider strategic alliances, just as we're doing with OpRegen and are planning to do with VAC. Our approach with OPC1 is intended to replicate our development strategy for OpRegen—in which we seek not only to provide cell-based regenerative benefits but also commercially relevant solutions with competitive advantages in areas like scale-up, production costs, and delivery techniques. Lastly, I want to add that I am approaching my two-year anniversary here at Lineage, and I am extremely thankful to this team for successfully implementing many changes in such a short timeframe. As you can tell from our three clinical-stage programs, we have adopted a model of taking exciting early-stage clinical data from cell therapy programs addressing high unmet needs along with low competition. Then we enhance and modernize the manufacturing processes to make them capable of supporting later-stage trials and ultimately commercialization. After modernizing the production process, we will move these products into later-stage trials, either on our own or, in most cases, in collaboration with a larger partner. The power of our directed differentiation platform is its ability to manufacture many different cell types. Through this strategy, we have an opportunity to provide our shareholders with long-term growth and sustainability—ideally while also relying on non-equity dilutive funding. On that point, I’m pleased to remind you that Lineage has not needed to conduct a traditional equity financing for almost three years, yet we have made tremendous progress with our programs and our pipeline in that same period. As Brandi will explain in just a moment, we believe we will continue to have access to capital that will permit us to continue this approach. In conclusion, if you look carefully at how we have advanced our programs and the decisions we have made, such as creating 3-dimensional RPE cell production which now counts in the billions of cells per batch, or acquiring the rights to OPC1 from Asterias, and leveraging our manufacturing expertise, or recently exercising the VAC option early, all these steps fit into a larger strategy of creating value by converting early and exciting signs into compelling and rigorous clinical data and manufacturing capabilities, which attract the attention and support of investors and major pharmaceutical companies—ideally, doing so without diluting shareholders at unattractive prices. With those program updates complete, I'll now hand things over to Brandi to review our financials and discuss additional plans we have for this year.

Thank you, Brian. I'll start off with a statement of operations for the second quarter of 2020. Total revenues for the second quarter of 2020 were $400,000, a decrease of $400,000 compared to $800,000 for the same period last year. As discussed on prior calls, we expect our revenues to be lower than historical levels as they are now generated primarily from our IAA OpRegen-related grant and royalties from the licenses of patents. Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expenses for the second quarter of 2020 were approximately $6.7 million, a decrease of $4.8 million compared to $11.5 million for the same period in 2019. R&D expenses for the second quarter of 2020 were $2.8 million, a decrease of $2.4 million compared to $5.2 million for the same period last year. This overall reduction was primarily related to a decrease of $1.7 million in OpRegen and other ophthalmic application expenses, which was primarily due to a reduced level of manufacturing activity in the second quarter of this year compared to the same period last year. Additionally, there was a $700,000 reduction in OPC1 expenses related to a decrease in development activities in 2020 compared to 2019, when technology transfer was a heavy focus with OPC1 coming in-house with the Asterias acquisition. General and administrative expenses for the second quarter of 2020 were $3.9 million, a decrease of $2.4 million compared to $6.3 million for the same period last year. The decrease was primarily attributable to the following reductions: $1.6 million in Asterias-related expenses, $200,000 in each of expenses related to compensation, accounting, and investor and public relations, and $100,000 in expenses related to travel, rent, and consulting. These decreases were offset by a $200,000 increase related to the cessation of shared services reimbursements. Our loss from operations for the second quarter of 2020 was $6.4 million, a reduction of $4.4 million compared to $10.8 million for the same period in 2019. Other expense net for the second quarter of 2020 reflected other expense net of $100,000 compared to other expense net of $20.5 million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments in marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage's international subsidiaries. The value of Lineage's OncoCyte shares decreased by $21.4 million in the second quarter of 2019, which heavily contributed to the overall balance in other expense net for that period. Our net loss attributable to Lineage for the second quarter of 2020 was $6.5 million or $0.04 per share, compared to a net loss attributable to Lineage of $30 million or $0.20 per share for the same period in 2019. Now, I'll focus on cash management. As of June 30, 2020, cash, cash equivalents, and marketable securities totaled $20.3 million. Additionally, the value of our note receivable due from Juvenescence as of this date was valued at $24.4 million. The maturity date of that note is August 30, so unless Juvenescence completes an IPO of at least $50 million in the next 24 days, the total amount of $24.6 million of principal and interest will become due and payable in cash later this month. Cash management continues to be a priority at Lineage. I'm pleased to report that net cash used in operating activities in the second quarter of 2020 was $700,000 lower than the first quarter of 2020, and net cash used in operating activities for the first six months of 2020 was $9.7 million lower than the same period in 2019. We have aimed to substantially reduce our operating expenses from historical levels while advancing our programs efficiently. As Brian discussed, operating during the COVID-19 pandemic has been challenging, but we have worked to keep our clinical programs moving forward while closely managing expenses. We continue to seek reductions in spending. For instance, we've worked to shrink our corporate footprint in the San Francisco area. Since we've reduced headcount, we don't need as much space. In the second quarter, we entered into a sublease for 10,000 square feet of our main building, which will help reduce our overall facility-related expenses. We are evaluating additional opportunities that could allow us to reduce our facility spending further. In general, our second quarter cash activity was in line with our expectations. Our original 2020 net operational spend budget was $16 million. As discussed last quarter, we anticipate a modest increase from that position during the remainder of the year, primarily related to the early exercise of our option with Cancer Research U.K., our plans for developing a vaccine against SARS-CoV-2 and other coronaviruses, and delays caused by COVID-19 in our OpRegen clinical trial. We continue to evaluate our assets and fund our operations by selling portions of our marketable securities during the second quarter. We sold about 2.4 million shares of OncoCyte common stock at an average price of $2.53 per share for gross proceeds of $6.1 million, and we continue to hold approximately 3.6 million shares of OncoCyte stock that was valued at $6.8 million as of August 4, 2020. Our ownership of OncoCyte is now about 5.4%. As Brian mentioned, it has been almost three years since this company has conducted traditional equity financing. We have successfully funded our transition into an emerging leader in the cell therapy space, not through diluted financing, but instead with a combination of smart but aggressive expense reductions and timely sales of our investments. We are committed to demonstrating the power of our cell technology to treat various diseases and conditions. As Brian discussed, we have a case of retinal restoration, which to our knowledge has never been reported before—this is extremely exciting. Over the next few months, Brian and I will expand our outreach to investors and analysts, and following our next OpRegen data release at the AAO, we expect to advance the partnering discussions we've been having with leading pharmaceutical companies and explore options for funding the next clinical trial. With only a few patients remaining to enroll in our current study, now is the time to attract more interest in our story. We are excited about the future, not only for OpRegen but also for OPC1 and the VAC platform as well.

With that, I'll turn the call back to Brandi. Moving next to things to look forward to in the remainder of this year, our goal as always will be to continue advancing our clinical programs. Specifically, there are five things we plan to emphasize, which include two data updates. First, we will meet this month with BARDA to discuss our proposal for non-dilutive funding for our coronavirus vaccine candidate. Secondly, we plan to report initial VAC2 clinical data from patients treated in the ongoing Phase I trial run by Cancer Research U.K. We expect to complete patient enrollment in the U.S. with the gyroscope orbit SDS and our new thaw-and-inject formulation in the ongoing Phase I/IIa clinical trial of OpRegen for the treatment of Dry AMD with GA. We plan to present new and accumulated OpRegen data at the AAO annual meeting in the second week of November. We expect to meet with the U.S. FDA to discuss the further development of the OPC1 program now that we have advanced manufacturing to a much more mature status. You'll also see us participating more at various events as we increase our engagement with the investment and medical communities through virtual participation in medical and healthcare conferences, along with podcasts, interviews, and similar communication channels, so that we ensure a broad audience sees our progress and achievements. With that, I again thank you for joining us on the call today. Operator, the team here is ready for any analyst questions.

We have a question in the queue from Joe Pantginis at H.C. Wainwright. You are now live.

A couple of questions, if you don't mind, Brian. First, it's nice to hear about the VAC update with regard to your upcoming BARDA meeting. I was hoping you might dive in a little more regarding your specific comments—when you look at the media today and everything focusing on antibodies, but why might a VAC approach be a little differentiated with regard to its T cell-generating properties?

Yes, thank you for that question, Joe. I think there has been an evolution in the understanding. In the early days, and it feels funny to say early days because it wasn’t long ago, everyone was focused, and rightly so, on the immediate response of generating neutralizing antibodies, and as time has passed and we’ve learned more about the virus, the preponderance of the discourse seems to have shifted towards the discussion surrounding T cells and their role in fighting viruses. While this isn’t new to an immunologist, there are now millions of amateur immunologists out there. For us, it was an interesting idea early on to use the VAC platform because it relies on the power of dendritic cells to deliver a message to the immune system. Whereas many existing vaccine approaches rely on the immune system to naturally pick up antigens and hope they are presented correctly, we skip that first step. We choose the message we think is critical. Much research has been done to determine which parts of the virus are the most important and antigenic. So we select the most essential part of the virus for the signal, package it into the dendritic cell—known as the body's best communicator of foreign material to the immune system. We can confirm from our oncology work that patients' immune systems are recognizing this packaged information and amplifying it in T cells. When creating a coronavirus vaccine, being able to select the most important antigen and bypassing that initial step to ensure fidelity in delivering the message to the immune system seems logical to us. However, there are challenges simply in mass production and distribution and testing—all paths being travelled by many companies today. We were pleased with receiving an invitation from BARDA to a meeting this month under the Corona watch program to discuss our proposal and planned efforts. This is encouraging because BARDA noted they received over 3,500 meeting requests but have only granted around 400 meetings. It's encouraging, but we can't predict who will be successful, as there could be subpopulations, such as healthcare workers, more suitable for our approach. We aim to get past step one—securing external support for our work to validate whether this approach deserves a higher investment.

Thank you for that detailed response. I have one last question. Switching back to the OpRegen data. After the striking restoration data announced, what feedback have you been receiving from the field? How has it evolved from physicians viewing that restoration data? Are they cautiously optimistic saying this is an N of one? Or are they excited and want to see more?

That's a great question. I often joke that you could present 100 cases and investors would still want to see 101 cases. There is a gap between zero and one, and we believe it's significant. However, there is still a substantial gap between one and two. People understandably want to maintain some skepticism, considering it an outlier. Typically, the people most easily convinced are the experts—those who understand what the images show and have a context to appreciate our findings from the historical evidence of what occurs in the back of the eye. A retinal expert is often more excited about our data than a generalist investor, who may find difficulty in this context. As we accumulate more evidence, whether it includes retinal restoration or not, we have been seeing positive outcomes in the eye even before announcing retinal restoration. The restoration is the frosting on an already substantial cake. We hope to build that continuum of validation, beginning with experts in imaging to retinal surgeons, ophthalmologists, and beyond as we publish and disseminate our findings. We need to generate more data to show that this restoration can happen again. As I outlined in my presentation, it does take time to see evidence of differences, often six months or more, as these lesions tend to grow slowly in the eye. But it’s noteworthy that we managed to shrink one of them and restore normal retinal architecture. We will keep generating evidence and anticipate traction as more is shared.

Next one's on the line is Dane Leone from Raymond James. You are now live.

This is Dane. Thank you for taking our question. Can you share more details on what we should expect from the AAO updates for OpRegen and how much information will be provided?

Thank you for the question. Let me invite Gary Hogge into the discussion to talk about what we think we'll be presenting at AAO.

Thanks for the question. The AAO will be the second week of November. Unfortunately, we will have a virtual meeting, but that's not necessarily a bad thing since the presentation will remain available for an extended time afterwards. The goal is to present all the Orbit patients hopefully enrolled by that point, along with three additional cord patients treated via traditional methods, and examine the safety profile for up to five years of the earliest patients. Essentially, we aim to present accumulated data for all patients and any data that we have leading up to that week before AAO.

I’m showing no further questions at this time. I would like to turn the conference back to Mr. Brian Culley for any closing remarks.

Thanks, everyone, again for joining us. I'm obviously excited about our plans, like we have a lot to look forward to this year. We appreciate the shareholder support and will continue to position Lineage to be a successful leader in cell therapy and cell transplant medicine. Thank you and have a great afternoon.

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.