Lineage Cell Therapeutics, Inc. Q1 FY2022 Earnings Call

Welcome to the Lineage Cell Therapeutics, First Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investor's section of Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage and recordings, reproductions, or transmissions 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. Good afternoon and thank you for joining us. A press release reporting our first quarter 2022 financial results was issued earlier today, May 12th, 2022, and can be found on the Investors section of our website. Please note that today's discussion will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, plans, aims, objectives, thoughts and beliefs, the future price of our stock, our competitive advantages with respect to competitors, our development programs, our product candidates platform and pipeline, and their potential therapeutic applications, commercial potential and potential value, the timing of our announcement of additional product candidates, clinical trials, data updates, future payments, transfer of expenditures, and activities under the collaboration with Roche-Genentech, our ability to enter into additional collaborations or partnerships, anticipated benefits and opportunities from our existing and potential future collaborations, the achievements of milestones, anticipated regulatory meetings and interactions, planned manufacturing improvements, our cash management runway and need for capital, our anticipated growth and our commercial opportunities. Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to known and unknown risks and uncertainties. We caution you not to place undue reliance on any forward-looking statements which speak only as of today and are qualified by the cautionary statements and risk factors in our filings with the SEC, including in our annual report on Form 10-K, filed on March 10th, 2022, and our quarterly report on Form 10-Q filed today, May 12th, 2022. With us today are Brian Culley, our Chief Executive Officer, and Gary Hogge, our Senior Vice President of Clinical and Medical Affairs. Unfortunately, our CFO, Kevin Cook, is dealing with an unexpected family emergency and won't be able to join us. Brian will provide some prepared remarks and then he and Gary will be available for questions from analysts. With that, I'd like to turn the call over to Brian.

Thank you, Ioana, and good afternoon, everyone. We appreciate you joining us on the call today. As I did on our last call, I'd like to start off with some comments addressing the challenges currently facing the biotech industry. Unlike other sectors for which the supply of raw materials may become increasingly scarce or for which a technological or social disruption could alter its fundamentals, human beings will continue to get sick and hurt, and they will continue to rely on and support valuable innovations which the biotech industry has delivered for decades. So we believe the current sell-off in biotech is an overreaction and that better days will return to our sector. In the meantime, each of us needs to determine what steps, if any, we ought to take in response to current events. My two aims for today are, first, to review how I believe Lineage is very well-positioned to navigate the current biotech bear market. And second, to talk about some of the steps we're taking in response to this new environment. Steps which we believe will help position us to be one of the companies which can outperform its peers this year and next. With respect to Lineage being well-positioned today, several important attributes come to mind: cash on hand, near-term milestones, and our fundamental profile. With respect to cash, we are comfortable that we have multiple years of cash on hand and we have no need to raise money at these currently unattractive prices. Our reported cash and cash equivalents as of Q1 were approximately $78 million. For reference, our net operating spends for each of the past two years has been less than $25 million. While our 2022 spending is likely to be above our historic levels given our clinical ramp and expanded pipeline, we nonetheless have multiple years of cash to support progress with each of our programs. And by the way, that runway does not include any of the milestones which we may receive from the Roche-Genentech deal over the next two years. So overall, we feel quite good about our cash position. Moving next to our program milestones, we have a lot of important objectives we're working toward. In the near term, we're working to provide shareholders with a diverse and incremental set of clinical and regulatory events that are not dependent on the clinical performance of just one asset, but which can still provide much-needed clarity on our developmental programs. In some cases, these can help de-risk or increase the value of our assets prior to their entering subsequent clinical trials. Specific goals for this year in the clinical and regulatory area which I'd like to highlight include, first, initiating a clinical safety trial of our new improved delivery device for OPC1 which is expected to enroll between five and ten patients and which will include for the first time, administering OPC1 to patients with chronic spinal cord injuries, not just acute injuries. Second, meeting with the FDA to discuss improvements we've made to the OPC1 manufacturing process in areas such as purity and production scale. Third, submitting an IND for our VAC2 program to support additional clinical testing of VAC2 in the U.S. and build upon the data generated by Cancer Research UK in non-small cell lung cancer. And fourth, generating pre-clinical data to support a pre-IND meeting with the FDA for our new auditorium RON program. We, of course, have additional goals for this year, but these four in particular represent milestones which will provide some regulatory and spending clarity and potential de-risking of our programs. We believe execution of these goals will continue to demonstrate our ability to successfully advance novel cell therapy product candidates, which will be an important corporate message we aim to emphasize this year. The third item, which I mentioned at the outset, is our fundamental profile. We believe in this challenging environment, investors will work even harder to find the companies which they believe will outperform in an economic recovery. Being identified among those screening efforts can be enhanced by having attractive fundamentals. I have already discussed our cash position and planned activities, but I believe Lineage offers additional characteristics which can help make us an attractive investment. For example, we believe our spending levels reflect our commitment to capital efficiency, which we will continue to employ. We also have the ability to create new development programs from our platform without spending capital on external licenses and have demonstrated that capability with our new hearing loss program. We also have proven our ability to close on corporate partnering transactions through one of the largest ever license deals in cell therapy outside of oncology, which puts us in the advantageous position of working to repeat the success rather than trying to achieve it for the first time. We have assets which we believe confirm the basis of additional corporate partnerships. So going back to my comments about the importance of being well-positioned in three categories: cash on hand, near-term milestones and events, and one's fundamental profile, I feel very good about our overall situation. Turning next to the second of my two aims for today, I want to say a few things about how we're adapting to recent changes in the biotech landscape. This also features three key principles: communications, operations, and business development. Starting with communication, we do not believe our company is well-known and that it's important to be able to highlight what we can offer to shareholders. We have adjusted our investor targeting to better align with feedback we've received about investors' mindsets, and we continue to refine our key messages. We understand that sometimes it's difficult to see the fruits of those labors in current share prices, but we believe these efforts have been helpful to add new owners. We welcome our new owners and we will continue to engage and broaden awareness for the company and our objectives. We have also seen an increase in the number and quality of our investor meetings, which we believe reflects the team's recent performance and our future potential, particularly on the heels of the Roche-Genentech alliance and the ARVO presentation of the full set of opportune clinical data earlier this month. Second, we constantly review our operational plan to ensure it is appropriate for the business environment. With all seen announcements lately from companies reducing their pipelines or reducing their headcount to achieve what they are calling operational efficiency. I don't know why they weren't being efficient to begin with, but Lineage always works to be efficient. One advantage we have in this area is that our development programs share common features, in particular, our emphasis on high-quality, large-scale cell manufacturing. This allows us to achieve economies of scale by allocating a single, highly trained team across all of our cell therapy programs, avoiding the expense or duplication of adding entirely new teams for each new program we launch or suffering the pain of having to choose which programs to stop funding. In fact, while I read this week that 48 biotech companies have recently announced staff reductions this year, Lineage has been adding positions in key areas. One example is we recently hired new business development personnel, which conveniently leads to my third point. The third principle I wanted to discuss regarding how we are adapting to the new environment is that we're putting an even greater emphasis on business development this year. We have had some success in this area, reflected by our deals for OpRegen and VAC, but our technology platform could produce many more product candidates than what we can develop internally. We see numerous opportunities to enter into new corporate partnerships and intend to explore established collaborations such as with CIRM, either for existing programs or as a basis to launch new ones. For example, we have already identified that manufacturing allogeneic NK cells is significantly easier than manufacturing allogeneic dendritic cells. We would be open to a partnership around an NK program or to work on Lineage in a program involving some other exciting cell type such as islet cells. We want to ensure there is awareness about our capabilities and interest in working with partners in areas like these. We've also seen recent evidence of well-funded cell therapy partnerships at the preclinical stage, which may open a partnering pathway for auditory or photoreceptor programs, or for some newly developed initiatives. To be clear, what I'm speaking about is securing funded partnerships, not creating new subsidiaries with long timelines to liquidity. The objective here, given the uncertainty facing our sector, is most easily described as utilizing more corporate alliances to advance our assets rather than our own balance sheet. In doing so, we can get many more shots on goal from our core technology. Going back to how Lineage is adapting to the current landscape, we're taking steps in areas of communication, operations, and business development. Lineage has adjusted rapidly to the changing environment since the Roche-Genentech deal, which we believe adds validation to our approach. We've shown we can launch new programs, which supports my frequent comments about our ability to move quickly into new areas. By adding additional business development capabilities and imperatives, we aim to capitalize on unlocked areas of value in our business. Before I move through the financial review, I want to mention just a few specific items. First, a few weeks ago, opportune clinical data was presented at the 2022 ARVO Annual Meeting. Notably, it was reported that a total of five patients who had OpRegen delivered to most or all of their geographic atrophy, including the phobia, showed evidence of apparent improvement of outer retinal structure, along with average gains in visual function of 12.8 letters. Prior to the license deal announced with Roche and Genentech, only four such patients had been reported by Lineage. While controlled studies are needed, it is known that spontaneous restoration does not occur. We believe these results support operations' potential to stop or reverse disease progression in geographic atrophy patients, something which to our knowledge, no patient receiving a complement inhibitor has ever shown. Additionally, we recently published 10-year safety data from the first OPC1 clinical trial for the treatment of acute thoracic spinal cord injury in the Journal of Neurosurgery. This is one of the longest-running clinical trials in our field, providing important first-in-human safety data with our pluripotent cell line. Ten years following treatment, there have been no medical or neurological complications to indicate that the OPC1 cell transplant therapy is unsafe. There have also been no unexpected serious adverse events attributable to the OPC1 cell implant. None of the patients enrolled in this clinical trial had deterioration in neurologic motor function, which we believe is significant, given the severity of their injuries. Overall, these results provide additional evidence that OPC1 cell transplants can be well-tolerated and that patients are willing to participate in long-term follow-up. We plan to have additional papers on OPC1 published this year, including full clinical study results from the SCiSTAR study of 25 cervical injury patients, and an additional publication focused on the MRI findings. So those are two additional milestones I didn't mention previously. Coincidentally, I found out this morning that the SCiSTAR study results were accepted for publication, so we expect that to become available online in the coming months. Lastly, you may have seen that the Lineage team this past weekend participated in the Red Bull Wings for Life World Run to raise awareness and funds for Spinal Cord Research. I want to again thank our employees and stockholders who supported us in this campaign. This is an annual event, it was incredibly inspirational, and I hope you'll consider taking part with us next year. Before I dive into our financial results, I briefly want to address an item that has been on people's minds, and that is concerning the supply chains. We are, of course, aware of reports of disruptions and delays due to global events such as COVID and the war in Ukraine. I'm pleased to report that we aren't aware of any of these matters specifically impacting our business, but we do know these issues are affecting our industry and may continue for some time. Because our in-house manufacturing is core to our value proposition, it's particularly important that we keep that operation functioning smoothly. We have taken steps such as pre-purchasing certain materials or planning for longer lead times with some of our vendors. We ultimately have limited control over many of these matters, but for those aspects we can control, our solution is to remain vigilant about maintaining our supplies and ensure we have backup plans in place to best meet our manufacturing and development goals and public timelines. With that, let me turn to our results. Total revenues for the first quarter were approximately $5.2 million, an increase of $4.8 million from the same period in 2021. The increase was primarily due to licensing fees in connection with the Roche collaboration agreement. Please recall that we received the $50 million upfront payment this quarter on a cash basis, but on a book basis, we are accruing that $50 million over the course of time as we fulfill our obligations to our partner. The roughly $5 million is what we booked this quarter and will continue to book income on a fractional basis in the quarters ahead. Total operating expenses for the quarter were approximately $11.5 million, an increase of approximately $4.2 million compared to the same period in 2021. This increase was substantially driven by a $3.5 million non-recurring accrual related to a potential settlement of the 2019 Asterias merger litigation, and that nonrecurring item shows up in G&A. Our loss from operations for the first quarter was approximately $6.4 million, a decrease of $0.7 million as compared to the same period in 2021, resulting mainly from the two items I already mentioned—the Asterias litigation settlement accrual offset by increased revenues from our collaboration with Roche. The net loss attributable to Lineage for the fourth quarter of 2021 was $7.1 million or $0.04 per share. I think it's important to remind investors that the variance between our loss from operations and our overall net loss is impacted by changes in the value of our investments, as well as changes in foreign currency rates. Those are related, of course, to Lineage's international subsidiaries. While these non-operational fluctuations are important, we tend to utilize loss from operations as a more relevant measure of performance with regard to moving our clinical programs forward. Turning next to the balance sheet, we've reported cash and equivalents and marketable securities of approximately $80 million as of quarter-end. Accordingly, we continue to feel that our liquidity level provides us flexibility and funding to reach our value-creating objectives in the years ahead. To put emphasis on this, I'm being purposeful by saying years instead of months or quarters. We believe this is an environment where having at least two years of runway is an important and attractive characteristic for investors. We will likely see an increase in our net spending this year compared to last year because our plan is to create value by advancing our programs toward the next clinical trials. We still have certain obligations under the Roche agreement, such as supplying OpRegen cells for the next clinical trial, but we will maintain the same spending discipline that we hold dear to our value proposition. We believe that spending discipline, together with our current cash balance, puts us in a good position to create value during this biotech storm. As a reminder, we also may be successful in collecting additional cash through potential development milestones available under our Roche and/or ITI agreements, potentially also from grant awards from funding entities like CIRM or from new business development deals which we may enter into for any of our current or future programs. To conclude, I understand well that the current environment is frustrating for biotech companies and investors alike, but Lineage has outperformed the XBI index in both good and bad markets, and we will work hard to continue that streak for a third consecutive year. Our core principle is to advance the emerging technology of cell transplants ever closer to patients and physicians by providing the product attributes and rigorous clinical testing necessary to achieve commercially successful products. To that end, we believe we have not only generated significant market data from our clinical programs but also made significant investments and improvements in areas like production scale, purity, and delivery of our cells, which overall we believe is a proven path to creating best-in-class products for the end users and strong competitive advantages to protect our and our partners' sales over the long-term. There's a lot to anticipate from us in the coming weeks, months, and years. We sincerely appreciate your support as we continue to position Lineage to become a leader in cell therapy and cell transplant medicine. With that, Operator, we are ready to respond to any analyst questions. Thank you.

Thank you, sir. Our first question comes from the line of Joe Pantginis from H.C. Wainwright. Your line is open.

Hey, everybody. Good afternoon. Thanks for taking the question. So, a couple of questions, Brian. Let me start on the dollar front. So, I know it was just a brief comment in the prepared comments and in the press release, but I wanted to see if you could provide a little more color on the settlement of the Asturias litigation and how you would account for that? Because if my perception is correct, this really appears like there was a big overhang removed from your shares.

Yes. Thank you for the question, Joe. The company has been providing disclosure on this topic for several years, and we are glad to move on from this, as I'm sure others would be. As a reminder for those who aren't familiar with this, we merged with Aserias in 2019, and it's not uncommon in public company mergers to become the defendant in a shareholder class action lawsuit related to a merger. We have vigorously defended the litigation for years, but we also would like to move on with business. So, we have agreed in principle to a settlement, which will have Lineage contributing $3.5 million out of an overall settlement of $10.7 million. That settlement would result in the dismissal of the lawsuit without any admission of liability or fault by Lineage. This settlement is still subject to negotiation. We still need to execute a settlement agreement. It needs to be approved by the court, so it's not absolutely final.

No, that's helpful. Thanks. And then just the other dollar question that I had was obviously you said you have at least two years of runway. How would you reconcile that statement with the fact that you've been growing your pipeline recently with additional programs? I just want to make sure how that would be portrayed to the street with regard to any views towards increased expenses around those programs?

That's a multipart answer. One part is that just the nature of our technology, which is being able to manufacture specific cell types from largely common pluripotent cells, gives us some economies of scale. Our existing team, which has available time, can work on one project while waiting for five days before they add the next growth factor or inhibitor to a process. They can spend a lot of that time working on other programs. So, we have a nice situation with our technology where we don't have to duplicate efforts. We can add new programs onto existing fixed costs or infrastructure. This allows us to keep costs down. The other part of your question is that these are still pre-clinical programs. Of course, they are exciting but they have not reached the more expensive stage of human testing. The cost to advance these programs toward an IND is actually very modest, and that's why you are seeing a simultaneous expansion of our pipeline with only a marginal increase in our spending.

No, it certainly is. Shifting gears to the clinical aspect of the upcoming OPC1 study, I wanted to focus on the device and recall the original OPC1 studies. Can you remind us if the device is ready to go once the study is officially ready, and whether the doctors are trained, or if any specific training is required?

I heard one of the docs was an inventor, but let me invite Dr. Hogge to join the conversation and provide some response to that question.

Sure. Thanks, Brian. Thanks, Joe. Yes, we intend to conduct a small study to validate the device. Much of that pre-clinical work has been done and some of that animal work was completed. There are surgeons that intend to utilize that device, but while there will ultimately be a formal training process, it has not yet been completed. They have had experience with the device, and as Brian mentioned, one of them is a co-inventor. We are prepared to have one or two potential active sites with those physicians and surgeons ready to go.

Great, thanks a lot, guys.

Thank you, Joe.

Your next question comes from the line of Kristen Kluska from Cantor. Your line is open.

Hi, everyone. Thanks for taking the questions. Appreciate it. The first one is just on the two newer programs, OPC1 and ANP1. As you've mentioned, they're very broad from the perspective that they can each go after a number of different disorders. I wanted to ask from a pre-clinical perspective, if you're planning to look at a basket of opportunity here before making the decision about what a lead program could look like or perhaps, if you see effects across the board, what that next direction could look like?

Yeah. I'm going to invite Gary, but I'll preface by saying that one of the things that was interesting in our dry AMD program was how we learned as we progressed with different patient types from the most severely affected to patients that had less severe disease or smaller areas of atrophy. We learned about delivery. Part of the answer will be that we do learn while we're doing it. Let me see if Gary would like to add to that.

Yes. To that point, we know that optimizing delivery is important, whether it's from an auditory or an ophthalmic perspective. We know that both of these conditions, auditory loss and photoreceptor deficiencies, have well-established pre-clinical animal models. We are currently working on how best to scale up these cells to make them commercially viable, utilizing a thaw-and-inject formulation as we've done with our other products alongside the in vitro and in vivo work necessary for an IND submission and some pre-IND discussions with the FDA.

Kristen, I would also like to add something that I think is not always fully appreciated. When using a cell transplant approach, one can be less concerned about the underlying or causative issue because you're replacing the entire cell. For example, in the setting of hearing loss, whether the cause is chemotherapy, concerts, or other noise exposure, if the problem is the dysfunction or lack of auditory neurons, we may find that we have a very broad addressable patient population due to the nature of the technology. Some of these answers will emerge through clinical testing itself.

Okay. Awesome. Thank you for that. Thinking about partnership opportunities like that, should we be thinking about them as similar to how the opportune deal was structured, meaning that you are looking to establish proof-of-concept first before any deals, or how should we be thinking about staging and strategy?

This is one of the most rewarding aspects of this job. Having assets that could be partnered either very early in development or very late provides us with a range of strategies and figuring out the right mix of those strategies for the best results is indeed a puzzle. We don't adhere to a script that mandates generating Phase 1-2b efficacy before partnering. That was largely our approach with OpRegen, which worked quite well. We will evaluate any partnership opportunity contextually. We will consider our capability to advance the program, what the partner may bring, our experience with the cell type, and the associated risks. This evaluation process may not always be transparent, but ultimately, for full value creation from a broadly applicable platform like differentiated cell transplants from pluripotent cell lines, we need a mix of partners because there are too many opportunities for any one company to tackle alone.

Okay. Lastly, I was at the ARVO conference this year and felt like one of the takeaways for wet AMD was the focus on newer therapies aimed at reducing the frequency of injections. Given that wet AMD has a more mature market than GA, how do you think having injectables on the market could help benefit you through physician and patient awareness and education around therapies, but also in mitigating fatigue around frequent injections?

I think there are two important points. One is that our data with OpRegen indicates this is a one-time treatment, which is an incredibly compelling advantage over the frequent injections. Patients with severe visual impairment often struggle even making it to the clinic. The second aspect is that we are seeing evidence of functional improvement in patients. Compliance and willingness to undergo regular treatments, whether it's every month, three months, or even six months can become problematic. We hope being able to offer patients stabilization or improvement in their vision is more compelling than a competitor's therapy that only slows down the condition without visible effects. I also want to discuss market conditioning. As dry AMD currently has no approved therapies, patients diagnosed with this condition typically receive advice to eat well and avoid smoking, but have no real treatment options. There’s a large patient population that isn't organized as advocates. It’s our hope that companies ahead of us in development will help educate the market about treatment options, which could be advantageous for Roche and Genentech. Patients will be better informed when we present a more effective solution, and thus I see that as very favorable for us as we move forward.

Thanks, Brian.

Thank you, Kristen.

Your next question comes from the line of Jason McCarthy from Maxim Group. Your line is open.

Okay, Brian, thanks for taking the question. You had mentioned essentially partnering solely for manufacturing given your capabilities, and you had mentioned NK cells briefly. Are you actively looking into NK cells as a space that continues to gain traction, and more generally, how does Lineage support other groups manufacturing efforts? What scale can you reach? Can you support through Phase 3 and commercial, or can you give us a little more color about the company's capabilities on the manufacturing side?

I appreciate that question, Jason, because I want to clarify that there is an advertisement embedded in this presentation. We want other entities to be aware that Lineage could potentially be a partner for their programs. Our demonstrated manufacturing capabilities should present us with opportunities as we highlighted with the recent Genentech and Roche deal, which ideally enhances our reputation for quality and diligence. This is the right time for us to actively promote our capabilities rather than waiting passively for inquiries. There is no clear limit on scale for our manufacturing, apart from the costs associated with equipment, reagents, and materials. However, there are higher dosage requirements in specific indications like NK cells, where doses might reach 1.5 billion cells, which is significantly higher than the 100,000 cells we utilize in dry AMD. While I don’t want to limit our discussion just to NK cells, we are open to partnerships. I encourage potential partners to explore what we offer, as it might accelerate their programs while also benefiting Lineage. We need to focus on ensuring our core assets take priority, but we want to explore how we can support other programs through our recent successes.

Got it. Can you provide a brief update on the Immunomic Therapeutics collaboration? What is happening with that project in relation to GBM work?

That's a terrific example of how I see the VAC platform having more value beyond just VAC2. It has great potential as a delivery system. One would choose an antigen, such as the turret antigen, the active component in our VAC2. However, Lineage isn’t ideally equipped to select antigens as some companies effectively employ machine learning or empirical techniques for that purpose. I’d like more programs like that with ITI, where they contribute the antigen and we serve as a delivery vehicle. We hope to discover whether using a dendritic cell, the gold standard for antigen presenting cells, results in better clinical outcomes through the activation of T-cells. Oncology is a challenging and expensive endeavor, but if we can partner effectively as we do with ITI and receive adequate compensation for our contributions, it will enable us to attract even more valuable partnerships for the VAC program in the future.

Great, thank you.

Thank you, Jason.

Your next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line is open.

Hi, this is William Wood on behalf of Mayank Mamtani today. Congratulations to the team. I really appreciate the updates I'm seeing here. I have a question about your OPC1 and the safety testing with the new PSD system. Assuming everything goes well with the FDA, could you share your thoughts on the design for the next phase of trials? You've also mentioned chronic patients, possibly regarding an expansion. Where do you see that heading?

It's a difficult question to answer right now, as we haven't proposed anything to the agency or decided internally. One reason for this is our view that assessment tools in spinal cord injuries are perhaps not as sensitive as we'd like. Some of the assessments currently used may be quite basic. We've learned from talking with patients that small gains in motion can significantly enhance quality of life. Even if a patient can use just one finger to manipulate their wheelchair, that's a notable improvement. As we prepare for the device study, we want to align what is important for patients regarding quality of life and motor function. We aim to collect this data through various assessment tools and ensure it aligns with FDA requirements. More specifically regarding your question, the design may feature an adaptive component. We could have a leading phase with multiple assessment tools, of which one or two become focused in a subsequent controlled phase. We won't be gated at this time, as we still need to conduct the device study to determine the advantages of the thaw-and-inject formulation.

Makes sense. I appreciate it. You also mentioned the recently published 10-year follow-up and safety information for OPC1. I'm curious how this data supports your strategy for OPC1 and also more broadly with OpRegen and the new progenitor lines you’re developing.

I find the durability of this published data really exciting, particularly regarding tolerability and safety. As you've seen in presentations from the company, over 500 adverse events were recorded in the SCiSTAR study of 25 cervical patients, and only one of those adverse events potentially associated with the cells was grade 2 dysesthesia, which cleared on its own. I love that we have this favorable tolerability and safety profile. This is crucial because there are often outdated concerns regarding the use of whole cells in therapies. People frequently ask about lifelong immune suppression or abnormal growth patterns post-transplant, which our data does not suggest. Our clinical programs have not illustrated those kinds of outcomes. We can confidently point to up to five or even 10 years of safety data from thoracic spinal cord injury patients, helping to de-risk future study conduct and potentially enhance enrollment in later stage studies. This comprehensive long-term data would be particularly compelling for patients considering participation in our studies as they weigh their options.

Appreciate the extra color there. I'll leave it there. Thank you again and congratulations to the team.

Thank you, William.

...0 00000000..We have now concluded our Q&A. Thank you for joining us.