Lineage Cell Therapeutics, Inc. Q3 FY2021 Earnings Call

Welcome to the Lineage Cell Therapeutics Third 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 Investors section of Lineage's website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. 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, Kris. Good afternoon, and thank you for joining us. A press release reporting our third quarter 2021 financial results was issued earlier today, November 10th, 2021, 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, goals, product candidates, clinical trials, data announcements and updates, anticipated regulatory meetings and interactions, planned manufacturing improvements, financing, cash management and runway, anticipated collaboration opportunities and benefits, and commercial potential. 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 quarterly report on Form 10-Q filed today, November 10th, and our annual report on Form 10-K for the year ended December 31, 2020. With us today are Brian Culley, our Chief Executive Officer; Kevin Cook, our Chief Financial Officer; and Gary Ho, our Senior Vice President of Clinical and Medical Affairs. Brian and Kevin will provide some prepared remarks, and then all of the executives will be available for questions from analysts. With that, I would 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 you have seen in today's press release, the Lineage team had another productive quarter. Most notably, we delivered additional positive clinical data from our lead asset OpRegen, which is intended to treat dry age-related macular degeneration with geographic atrophy. We also took important strides to advance our OPC1 program to treat spinal cord injury. Additionally, we continue to grow our executive team with the appointment of Mr. George Samuel as our General Counsel. Lastly, we continue to generate awareness for the Company, our data, and our mission through various investor and medical events, presentations, and other engagements. As I say in every call, Lineage is pioneering a new branch of medicine. Our approach for each of our product candidates is to manufacture and differentiate cell types, with all batches forever produced from a single-cell line, and transplant those differentiated cells into the body in order to restore and improve function, which has been lost due to aging, injury, or disease. Simply put, we believe that if a certain type of cell in your body is dying or dysfunctional, you need to replace that specific type of cell. As a reminder, our approach does not require any gene editing or reprogramming of the cell's original DNA. We are involved in the debate over which editing approach or platform is best because we avoid these risks entirely. When we manufacture ourselves, we harness the natural developmental programming contained within each of our single-source cell lines. This regenerative medicine platform, which we own, is broad and powerful, not only for the value of our three current indications, but also because our cell transplant approach might someday be applicable to a large number of additional cell types and address many different unmet needs. We view our approach as the path to reaching our long-term goal of becoming the leading cell therapy company. With that, I will turn to a brief review of our recent accomplishments and set some expectations for the remainder of this year and early 2022. I will, as usual, begin with OpRegen, our lead product candidate intended to treat dry AMD with GA, a disease with no FDA-approved treatments. Our approach to treating this disease is the transplanting of healthy new retina cells to replace or support those that have died or are dysfunctional. Replacing the entire cell avoids risks and limitations inherent with approaches that target just a single pathway, which may be insufficient to drive a clear clinical benefit, or gene therapy approaches that target a specific mutation relevant to only a small subset of patients. Importantly, we now have evidence that our approach can not only slow the disease process—which is the objective of the leading companies in this space—but also even halt or reverse an area of atrophy, which obviously would have a far greater impact on disease progression. We feel we have evidence of this reversal of GA in three patients so far, particularly those who received a comprehensive covering of our OpRegen cells across their atrophic area. This phenomenon is something we refer to as retinal restoration, identifiable by the new appearance of critical layers of the retina, specifically, the presence of new areas of RPE model layer with overlying ellipsoid zone, external limiting membrane, and outer loop nuclear layer, all of which were absent in previously confirmed atrophic areas at the time of baseline assessment. This is a remarkable clinical observation, achievable with just a single administration of RPE cells performed in about 30 minutes under local anesthesia. We believe our approach may have an enormous advantage in terms of compliance, convenience, and benefit over traditional drugs being developed by competitors that require monthly or semi-monthly injections. We also have seen Phase 3 data from one of the leading complement inhibition companies, and it is unclear whether that data will support approval. But if we assume that it does, given that that product's clinical benefit was somewhat modest, it clearly leaves abundant room for improvement and opportunity. That, along with the restoration data we have previously presented, is something which has never been shown with any complement inhibitors or oxidative stress reducers. In addition to that anatomical observation, we have reported functional improvements in the majority of our patients' treated eyes. In contrast, we have noted visual acuity declines in the majority of our patients' untreated eyes. Seeing these benefits, even though it's a small population, is exciting, but visual acuity can be a difficult assessment to rely on in clinical trials because the size and location of atrophy only broadly correlate with vision. For this reason, we expect our primary efficacy endpoint in a registrational trial will be the change in the rate of growth of atrophy over time, which is similar to what is being pursued by companies like Apellis and Iveric. Overall, the data set we are collecting includes both functional and anatomical evidence, reinforcing our belief that the suspension of OpRegen RPE cells can generate clinically meaningful outcomes in patients with dry AMD with GA, particularly in those with earlier-stage atrophic disease. Looking ahead, we will provide an important clinical update at the 2021 Academy of Ophthalmology annual meeting, which takes place this week and through this weekend. Dr. Michael Ip, a retinal imaging expert from UCLA's Doheny Eye Institute, will present new imaging data generated from our cohort four patients. You're already aware that we have recorded retinal restoration using high-resolution OCT imaging, which is necessary because older FAF technology cannot detect our healthy RPE cells. More recently, we have performed a sub-study analysis of that same data using a separate technology known as 3D Okta. 3D Okta is a validated Part 11 compliant imaging grading software, which can provide quantitative information on the thickness and area of key layers of the retina. Using this approach, we can interrogate not just the boundary of GA, as defined by the formation of new layers, but now we can report individual measurements of thickness and volume of areas such as the outer nuclear layer or the RPE-drusen complex. We will provide a general clinical study update, but what we are most excited about in the coming days is the ability to provide a second independent method of measuring retinal restoration. These data, presented at the largest ophthalmology meeting in the world, will hopefully foster greater professional awareness of our program. Additionally, we are working with our advisors to prepare for multiple engagements with the FDA to discuss aspects of OpRegen designation, our manufacturing plans, and the design of a late-stage clinical trial. We anticipate the first of these events to occur this quarter, continuing into the first quarter of 2022. Throughout this year, we have provided a cascade of positive event updates from the use of OpRegen, with increasing evidence of benefit and the durability of those benefits rising as more time has passed since treatment. With our minimum of 12 months of data on all patients available later this quarter, we are excited to move this program forward and unlock its potential. Overall, we believe we are seeing the validation of our cell transplant approach with each passing day, and that the manufacture and delivery of replacement RPE cells will eventually be proven to be the most powerful and effective method of treating this degenerative condition. Now we'll move to OPC1, our cell transplant for treating spinal cord injury patients. OPC1 is a single administration of oligodendrocyte progenitor cells, delivered directly into the area of spinal cord injury. Like dry AMD, there are currently no FDA-approved treatments for spinal cord injury despite many attempts. Our view of this indication is very similar to dry AMD, as we may be able to demonstrate that transplanting a whole functional cell into a damaged area can accomplish things that are beyond the reach of traditional small molecules or other biologic approaches. Those efforts have not yet led to any approvals, so it's clearly time for some new approaches. Over the past two years, we have worked on a new manufacturing process for OPC1. Our attention to this area has led to tremendous advances in the purity, scale, and reproducibility of our OPC1 batches. This new process was recently moved into our in-house GMP facility, with a batch size that can support a registrational clinical trial. We expect to complete GMP production via this new process and with a new thaw-and-inject formulation in the first quarter of next year, ensuring ample supplies of clinical material for the controlled study we wish to conduct in this indication. While we are completing steps to introduce our newly manufactured lots into clinical development, we also plan to initiate an interim clinical safety study of a new delivery device through our collaboration with Neogame technologies. This new device was developed to help avoid complications and risks which might occur with an earlier delivery system, as delivering materials to the spinal cord is a delicate procedure. Anything we can do to reduce patient risk is important to us. We have learned from the OpRegen program that careful placement of cells correlates with better outcomes, so it made sense for us to invest in superior delivery options. Two notable advantages of this new device are easier manipulation of the XYZ axis and the ability to deliver cells much more slowly, as the patient can remain connected to a respirator during delivery. This is a significant advancement over the prior method, and we are excited to be pioneering this approach. Over the past quarter, we completed the manufacture of clinical device prototypes and continue the required verification and validation work based on FDA input. We expect to complete this evaluation this quarter and, immediately thereafter, initiate human clinical performance and safety testing with the new delivery device. An amendment through our open IND is planned for the first quarter of 2022. We are also preparing for an FDA interaction to discuss our cell manufacturing improvements, which we anticipate will occur in the first quarter of 2022. Interestingly, because this performance trial focuses on safety and delivery, we have expanded the eligible patient criteria beyond the sub-acute population treated to date. We have received feedback from the FDA indicating their openness to include patients with chronic injuries in this trial. This is notable because it's generally easier to identify and enroll patients with chronic injuries. Any hint of improvement in patients who have functionally plateaued for years would be an incredible finding. To be clear, showing an improvement in mobility in chronic injury patients is not the intent of the study, but something we want to keep in mind. We didn't expect to see retinal restoration in the OpRegen program, so it is essential to collect data across a variety of parameters because sometimes you find unexpected surprises. Overall, I am pleased with the progress we've made in getting all of these pieces to fall into place in a coordinated manner. We have the GMP clinical material, the new delivery device testing, and some new ideas on regulatory strategy converging next year to support further testing of OPC1. I will conclude the OPC1 section by adding that our work on this program reflects our commitment to advancing nascent cell therapy technologies into commercially viable product candidates. I've said many times that cell therapy is on the cusp of a breakout, but that breakout will require a maturation from early or academic programs through manufacturing and delivery enhancements, ultimately leading to the generation of controlled clinical data. The Lineage model is to serve as that bridge and facilitate the adoption of this new branch of medicine. Now thirdly, I will move to VAC2, our investigational off-the-shelf dendritic cell cancer vaccine. VAC2, as many of you will recall, is comprised of mature dendritic cells we manufacture from proprietary established cell banks, which are then loaded with a tumor-specific target or antigen to instruct the body's immune system to attack and eliminate cancer cells. Our partner Cancer Research UK continues to be responsible for this study, but enrollment has been impacted by COVID restrictions across the UK. CRUK is still working on enrolling the final patients into the study, and once that is completed, we anticipate additional clinical data will become available. Since the trial is operationally out of our hands, we cannot accurately predict when the final patient will be treated. But I will share that I am increasingly frustrated by the pace of enrollment in this trial. We have initiated steps to address this situation so that the VAC2 program can advance in a more predictable fashion under our direction and control. Meanwhile, we are focused on making improvements and modernizations to the VAC manufacturing process, which will help prepare VAC2 for future trials and provide competitive advantages for any future VAC programs we may design and advance. If the manufacturing-focused investment is similar to what we successfully did for both OpRegen and OPC1, it is core to our competitive advantage in cell therapy. As part of the manufacturing enhancement process, we aim to increase the flexibility of the VAC platform because theoretically, any antigen could be added to our dendritic cells. We believe the VAC platform is capable of producing a large number of product candidates, each distinguished by the specific antigen the dendritic cells present to the patient's immune system. This opens up many potential corporate partnerships, allowing us to use our dendritic cells as carriers for other companies' antigens while simultaneously retaining the option to advance our own programs. These partnerships can diversify our oncology pipeline across more programs and provide new opportunities for success without the financial burden of independent development. As you're aware, we already have the first instance of this with our glioblastoma program, which we have partnered. Overall, I believe we have continued to execute our plans and generate valuable progress by advancing all three of our clinical programs and further strengthening the Company's capabilities. With that, I'm happy to turn the financial update over to Kevin.

Thank you, Brian, and good afternoon, everyone. Let's briefly review our recent financial results. Total revenues for the third quarter were approximately $2.3 million, a $1.7 million increase from the same period in 2020. This increase was due primarily to increased royalty revenue from a certain partner based on an updated communication to us regarding the royalties owed. Total operating expenses for the third quarter of 2021 were approximately $8.1 million, an increase of approximately $900,000 compared to the same period in 2020. That increase was primarily related to increased litigation expenses related to the hysteria steel as well as share-based compensation expense. As a result of these items, our loss from operations for the third quarter was approximately $6.8 million, an increase of $100,000 compared to the same period in 2020. The net loss attributable to Lineage for the third quarter of 2021 was $7.8 million or $0.05 per share compared to a $7.8 million net loss last year, or $0.05 per share for the same period. Turning to the Balance Sheet, the Company ended the quarter with approximately $65 million in cash, cash equivalents, and marketable securities. That wraps up the financial section. So, I thank you for your time and will now turn the call back over to Brian.

Thanks, Kevin. I want to spend the last minute or two here just being really clear about some of the events and milestones that we anticipate. So first, just three days from now, additional interim data from the OpRegen clinical study will be featured at the 2021 American Academy of Ophthalmology Annual Meeting in the presentation I described by Dr. Michael Ip. Before year-end, we plan to provide an additional data update, which will be able to include a minimum of 12 months on all treated patients in the OpRegen study, and as a reminder, that is the primary endpoint for that study— a 12-month observation period. We also have multiple interactions with the FDA planned, where we will discuss OpRegen product designation or manufacturing plans and later stage clinical development. Those steps are anticipated to begin this quarter and continue into the first quarter of next year. For the OPC1 program, we aim to complete the evaluation of the spinal delivery system in non-clinical testing, anticipated in this quarter. We also expect to complete GMP production of OPC1 via our improved and larger scale manufacturing process using our new thaw and inject formulation, which is expected to occur in the first quarter of next year. We have an FDA interaction planned to discuss recent manufacturing improvements we've made to OPC1 that's anticipated in the first quarter of the next year. We are looking forward to initiating clinical performance and safety testing of the new delivery device with an IND amendment submission planned for the first quarter of next year. Regarding the VAC programs, completion of enrollment by Cancer Research UK and the ongoing VAC2 Phase 1 in non-small cell lung cancer is something we hope will occur in the first quarter of 2022. The continued development of the new VAC-based therapeutics with our strategic partner will be ongoing throughout next year. We will also be evaluating opportunities for new VAC product candidates based on internally identified or partnered tumor antigens, which will be ongoing throughout next year. At Lineage, we believe the field of cell therapy is poised for explosive growth, and that scalable allogeneic off-the-shelf approaches, prepared in formulations optimal for clinical settings, can provide substantial commercial advantages over autologous or patient-derived sources and methods. Our objective is to usher in a new branch of medicine using our proprietary differentiation protocols, and I believe the data we have been generating are supportive of that goal. With that, I would like to thank you very much for joining us this afternoon and Operator, we are ready to respond to any analyst questions that you may have.

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

This is actually William on for Mayank. I really appreciate you taking our questions today, and great overview of your third quarter—really, really a lot of good events that went on. I was just curious regarding your upcoming FDA interactions for OpRegen, if you'd be discussing the—might have the strong 3D Okta that you mentioned you would be highlighting at the AAO coming up this weekend, and then the possibility of incorporating this into later studies. At a high level in your discussions with the FDA, will you be communicating these conversations broadly to the public and what might we expect overall?

Let's get Gary Ho involved in that question. Gary, are you on track for that?

Sure. So thanks for the question, William. Yes. We will certainly incorporate the Dohainee data in any discussions we have with the agency because they have provided supporting evidence of retinal restoration and treatment effect. It's done independently, using OCT images obtained as part of the study. They review those independently, compiling that data over time, and producing heat maps to show improvement from baseline to the one-year primary endpoint. We will definitely incorporate that into discussions with the agency about potential designation changes or inclusion in a subsequent clinical study to show a treatment effect not only on the area of geographic atrophy, but also throughout the layers of the retinal structure of interest.

And then I guess just high level with those, because there are, I believe you mentioned there will be multiple FDA; will you be communicating those findings an ongoing process?

We won't be previewing our regulatory strategy or discussions for competitive reasons. But after we hold the FDA meetings and receive specific feedback on the plan that we will pursue, we will share that with the public. Typically for how Lineage does things, we would share that in an abundant at the tail. I have said several times that there are many designs which might fit well for our situation, including various adaptive or continuous phase 2, 3 designs. The work is currently ongoing to determine the clinical plan we will present to the FDA as our first and best choice. We completed enrollment on November 10th of last year, literally one year ago, and those patients have now just finally reached today the primary endpoint of one year post-treatment. We think we're on track and moving quickly, and any discussions on the next study design will depend on collected and analyzed data, which is why we expect that interaction related to study design to occur in Q1 of next year rather than Q4 of this year.

Right. Makes sense. And then one about OPC1, you mentioned that you have a new cell inject formulation. I was wondering if you can give any information on how that might be improved over your current formulation, sorry, maybe on a higher level, but I am also curious about cell viability or just any extra benefits that the patients might expect.

The key advantages here are that we are trying to accomplish a ready-to-use formulation. One of the headaches of most cell therapy approaches is dose preparation. In the case of OPC1, the prior study required preparation of the cells that had to be washed out and placed, then counted. This work had to begin the day before. We have the technology and the experience successfully deploying similar approaches from OpRegen. Our goal is a thaw-and-inject formulation that can go from a frozen state directly into the delivery needle and into the patient without delays. This results in a significant reduction in handling and manipulation costs and complexity and helps reduce the possibility of a dosing error. Additionally, we will be able to administer cells more slowly by using this formulation with the new device, as we will not have to take the patient off the respirator during the administration of the cells. This is a significant advancement over the previous method, and we think it will greatly facilitate the clinical activity while possibly opening additional sites.

That's fine. I really appreciate that extra color and thank you for answering our questions today. I look forward to everything. Thanks. Bye.

Appreciate that, William. Thank you.

Your next question comes from the line of Joe Pantginis from H.C.W. Your line is open.

Hey everybody. Good afternoon, thanks for taking the question. Brian, I want to ask a specific question then I am going to get a little more macro. During your prepared comments, you gave us a little bit of a tease with regard to OPC1 saying that you're toying with new ideas regarding regulatory strategy. I'm just wondering if you could provide a little more color on that comment.

You're really putting me on the spot. Not yet. Here's what I can say, I’m comfortable saying that there are clinical settings—there are disease settings where endpoints are difficult, and dry AMD is one of them. We all would love to think that visual acuity is easy to rely on, but it's challenging. Similar situations exist in spinal cord injury. It's tough to demonstrate improvements in mobility, given the crude tools and assessments generally collected. I talked to a patient on the study who received OPC1 cells. He said, 'I didn’t score as high on one of the scales because the movement I gained didn’t register,' but for him, it was beneficial for independence—he could hold a mug. This disconnect is essential to address. There are other tools available, and I'm interested in how we might re-approach this to increase our probability of success by aligning the therapy with what is being measured. I look forward to exploring this further.

That’s really helpful, thanks. I look forward to FDA visibility on their feedback. On a more macro front, you have a lot of logistical things going on at the Company with the manufacturing of yourselves and your device initiatives with OPC1. Given those logistics, have you had to change your plans regarding all the global supply chain issues everyone is experiencing right now?

That is a very clever question. I'm proud of our manufacturing folks for being proactive about supply chain issues. We've conducted a lot of pre-purchasing of critical materials and have been able to leverage our international presence. We've purchased equipment or materials in one country and shifted to another, identifying cost savings while ensuring availability. I’ve heard stories about issues with simple supplies, but we are more concerned with reagents, as running a long production campaign without a key ingredient can halt progress. Our manufacturing team has been good about advanced purchasing and stockpiling materials that don’t have expiration dates. I hope that every company can avoid these challenges.

That's really helpful; thanks for that. It’s obviously an ongoing issue, and it’s nice to hear that you planned ahead and are dealing with it. My last question is somewhat macro-focused, but on the VAC program. Beyond VAC2 and the lung cancer program, how would you characterize your ongoing discussions for additional antigens that might be of interest?

It's a fair question, but as a rule, I try not to comment on business development activity. I've experienced large partnerships that fell apart unexpectedly, so I’m uncomfortable placing any sort of potential around it. However, we maintain a high level of interest in engaging various entities regardless of their type. I feel more comfortable announcing partnerships as they are signed rather than providing guidance on the number of deals we might expect.

That's a very fair answer, Brian. I had to ask, considering the potential around the VAC Cell platform. Thank you for the color.

Great stuff, Joe. Thank you.

Your next question is from the line of Kristen Kluska from Kantar Fitzgerald. Your line is open.

Good afternoon. This is Rick on for Kristen. Thank you for taking our questions. To follow up on an earlier question regarding the multiple FDA interactions in upcoming quarters around OpRegen, how are you thinking about priorities and potential cadence of regulatory discussions as you think about moving the program forward?

I'll invite Gary to provide more details than we have in the past.

As we've announced previously, we have already received fast-track designation, which affords us certain interactions with the agency and guidance opportunities. We can consider other designations that we believe we may fulfill obligations for, like RMAT—Regenerative Medicine Advanced Therapy designation. As the FDA reviews data, they may suggest that certain data meet their expectations. In addition to our fast track, we are considering those two options as well. Our data from the study is currently being analyzed and compiled, and we will participate in a meeting with the agency to discuss the profile endpoints, size, and scope of the next study, following the designation meeting.

Thank you for that answer, and one more perhaps. For OPC1, you've guided that you could move from non-clinical testing with the PSD system in 4Q this year to potential clinical safety testing with OPC1, with a potential IND amendment in the first quarter of next year. Could you please discuss how rapidly you believe you could move from the IND amendment stage into clinical testing?

Gary, do you have thoughts on the gap between the IND amendment stage and clinical testing readiness?

The agency will review our supporting documents. We hope to have the first date in hand as quickly as possible. We haven’t set a date yet but expect to move as quickly as the agency allows us.

Okay. Thank you very much.

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

Hey Brian, this is Michael Okunewitch on the line for Jason. Thanks for taking my question.

Hi Michael.

Could you talk a bit about the importance of achieving statistical significance after the nine-month data on the OpRegen study, and if it gives you a clear idea of the expected effect size and what kind of trial size you'd need for later stage studies? Are there any comparable trials you can look at to get an idea?

It's important to clarify that we have statistical differences, which is wonderful. But we are observing differences between treated and untreated eyes, so the data points are diverse over time. The details regarding trial size and endpoints will largely depend on our engagements with the FDA. There are precedents in the field that can be informative. The trial size is a function of the end-point required for statistical significance based on the clinical benefit. If we can show that we are reversing the growth of GA, that’s a colossal clinical effect observable in a smaller patient population. As registrational studies must feature enough patient exposures for safety assurance, I suspect we will need somewhere between 200 and 300 patients for meaningful data. We can’t clear this until our meeting with the FDA.

Thank you. Can you provide more granularity on when you're expecting to hear the output from those upcoming meetings, both for OpRegen and OPC1?

We have a series of events lined up and I’ve mentioned them in the call. The most notable meeting about the design of the OpRegen clinical study is expected in Q1 next year. We anticipate multiple interactions in Q1, but the form of those engagements can vary from writing to calls or in-person discussions. We are gearing up for a crucial quarter because the number and substance of regulatory interactions are high during this time.

Right. Thank you very much. Can you touch on your earlier comments about the 3D measurement of geographic atrophy? Is there a possibility that you could detect additional signs of retinal restoration beyond those original three patients where you've already determined it because you previously lacked the measuring tools?

Yes, I would say yes. I didn’t expect to see retinal restoration at the beginning, so is it possible? Absolutely. Gary, do you want to elaborate on how that technology can work in identifying potential additional restorations?

Absolutely. This analysis is performed independently and in a blinded manner. The team that identifies these areas ofiRORA or incomplete retinal atrophy, and cRORA repair do not know which patients received treatment. There’s every chance they could find additional patients exhibiting signs of retinal restoration, and it is up to them to validate which additional patients may show clear benefits.

Thank you very much.

Your next question comes from the line of Dane Leone from Raymond James. Your line is open.

Thanks for taking the questions. When you meet with the FDA, what is the primary endpoint that you hope to establish for running a pivotal study with OpRegen?

We plan to align with what leading companies are doing, which is observing the change in GA area over time via three assessments. There has been some misconception in the past that our compelling visual acuity data could serve as the main focus, but we prioritize reversing the size of GA. We intend to monitor the change of GA over time, with the further presumption of proposing OCT as the imaging assessment tool, as it captures our cells better than the FAF imaging technology does. The FDA’s preference may evolve, but we believe that the acceptance of OCT is a practical expectation. Gary, did I miss anything?

No, you captured it well. Everyone recognizes that OCT is a superior method. Together with microperimetry, visual acuity, and other functional data, the FDA has deemed these as approvable endpoints, making a compelling case for OpRegen.

Got it. Thanks.

Sure.

Great.

I am showing no further questions at this time. I would now like to turn the conference back to Mr. Brian Culley for his concluding remarks.

Thank you everyone. As always, we appreciate your support as we position Lineage to become a leader in cell therapy and cell transplant medicine. We still have more to accomplish this year, and I believe 2022 and even 2023 will be even better as we continue exhibiting our progress and growing awareness of our accomplishments. Thank you very much, and have a great afternoon or evening.

This concludes today's conference call. Thank you for your participation and have a wonderful day. You may now disconnect.