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Lineage Cell Therapeutics, Inc. (LCTX -0.93%)
Q1 2021 Earnings Call
May 13, 2021, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Welcome to the Lineage Cell Therapeutics first-quarter 2021 conference call. [Operator instructions] 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 and recordings, reproduction, or transmission of this call without the expressed 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.

Ioana Hone -- Director of Investor Relations

Thank you, Mary. Good afternoon, and thank you for joining us. A press release reporting our first-quarter 2021 financial results was issued earlier today, May 13, 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.

Any 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 of the 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, May 13, and our annual report on Form 10-K for the year ended December 31, 2020. Presenting today is Brian Culley, our chief executive officer.

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Brian will provide some prepared remarks, then take questions from analysts. With that, I'd like to turn the call over to Brian.

Brian Culley -- Chief Executive Officer

All right. Thank you, Ioana, and good afternoon, everyone. We always appreciate you joining us on these calls. It has been an extremely productive start to the year for us.

We continued to deliver positive clinical results with our lead program, OpRegen. And we entered into two strategic partnerships which expand and support our clinical pipeline programs, OPC1 and VAC. We also strengthened the overall team through the appointment of two individuals to our board of directors, both of whom possess significant medical and healthcare experience. As a reminder, Lineage is pioneering a new branch of medicine based on the transplant of whole cells and simultaneously positioning ourselves as an important leader in this rapidly growing field.

Our approach is to manufacture differentiated cell types and transplant them into the body to restore or improve function, which has been lost due to injury or disease. Simply put, we believe that if retina cells are dying, you need to transplant retina cells directly to the eye. If spinal cord cells are damaged or missing, you need to provide replacement spinal cord cells directly to the area of injury. All of our cell therapy programs are allogeneic, which means the cells are manufactured from a single common cell line instead of being removed from a patient, manipulated, and reimplanted, which is called autologous therapy.

Allogeneic approaches offer significant advantages over autologous therapies in terms of manufacturing and handling costs. In each case, the cell line we use for our therapies was established and characterized more than 20 years ago. These cell lines are pluripotent, meaning they can be directed to become any of the 200-plus cell types which comprise the human body and they provide a one-time source of starting material for all of our clinical and commercial needs. As a solution for the complexity of handling and preparing whole cells for patients, we designed thaw-and-inject formulations for what people often call off-the-shelf use so that our products can be injected into the patient just minutes after being thawed, instead of going through the lengthy complicated and costly dose preparation steps.

We believe the economic advantages of allogeneic therapies cannot be matched by autologous options in which a single unique therapy is developed for each patient or customer. Importantly, our approach avoids the risks of genetic manipulation, which has always been an area of significant potential risk. And as many of you will have noticed recently, those risks have recently impacted the field of ophthalmology. Instead of manipulating the genome and potentially causing changes, we cannot control, we rely on something called directed differentiation.

With directed differentiation, we harness the natural steps in the developmental biological pathway in order to manufacture our final cell types. We expose ourselves to various compounds under tightened regulated conditions in order to turn them into only the cell types which we desire to make. We never modify the genome as part of our manufacturing process because it simply isn't necessary. Our cells have the attributes needed to perform the job of the cells they are replacing.

As part of our quality control procedures, our cells are extensively characterized for both form and function. And because we have established large master and working cell banks and have developed protocols over the years to improve our production scale, a single cell line can be expanded from our in-house process to potentially supply the needs of any sized commercial market. These advantages help establish our belief that our technology platform has potential not only in the conditions we currently are pursuing but also may produce additional product candidates beyond dry AMD, spinal cord injury, and cancer. As we continue to generate encouraging data on both the safety and efficacy of our three current cell transplants, we will consider opportunities to investigate new applications of our technology and potentially address additional diseases either on our own or through strategic alliances.

I'll now turn to a quick review of our recent accomplishments and set some expectations for the remainder of the year. I'll begin with OpRegen, our lead product candidate intended to treat dry AMD with geographic atrophy, a disease with no FDA-approved treatments. Dry AMD is caused by the progressive loss of retina cells and is a leading cause of blindness in developed countries. Our approach to treating this disease is to transplant brand new retina cells to replace or support the ones that have died off or are dysfunctional.

Replacing the entire cell avoids risks and limitations inherent in approaches that target just a specific pathway, which may prove to be the wrong pathway or approaches which target a certain mutation which only addresses a subset of patients. We believe our approach may be able not only to slow the disease process but also even halt or reverse it. We also believe that OpRegen, which currently is contemplated as a one-time treatment performed in about 30 minutes under local anesthesia, has a substantial advantage in terms of compliance and convenience over competitors that are developing traditional drugs or biologics, which typically require monthly or semi-monthly injections. Since the beginning of the year, we have provided two interim data updates from our phase 1/2a clinical study of OpRegen, and we intend to continue providing these interim updates.

This is an open-label study, and it's our view that providing investors with frequent updates not only helps them appreciate our enthusiasm for the data we've collected but also provides clarity and transparency on how the patients are doing throughout their observation periods. We do this because the patients were treated on different dates. So we are tracking 24 separate timelines, ranging from just a few months to over five years. And the different visual assessments we perform on patients can be more or less informative depending on where they are collected along those timelines.

For example, we think changes in best-corrected visual acuity, or BCVA, are most informative during months three through six, while effects on GA growth are more likely to become detectable during the second six months post-treatment. Consistent with this view, we believe our data set has improved with each update as the amount and duration of evidence that we have provided has grown. At our most recent update, coincident with the 2021 ARVO conference, Dr. Christopher Riemann from the Cincinnati Eye Institute presented data on all 24 patients enrolled in the study with a minimum of 4.5 months of follow-up.

We were pleased that this most recent update continues to suggest to us that treatment with OpRegen can generate clinically meaningful responses in patients with dry AMD with GA. We also continue to believe that earlier intervention in less severely affected patients will increase the likelihood of detecting a clinically beneficial effect. This is why we have emphasized the data from the final 12 patients in cohort 4 who had better baseline visual acuity compared to the first 12 patients in cohorts 1 through 3 who were all legally blind at baseline. While the data are still being collected, it is notable that 83% of cohort 4 patients' treated eyes were at or above baseline visual acuity at their last assessment of at least four and a half months, while the same high percentage of the patient's untreated eyes were below pretreatment baseline values at the same time points.

Additionally, we shared for the first time at our last update that cohort 4 patients with data available from a validated quality of life questionnaire reported improvements in a majority of the vision parameters which were collected. The magnitude of these QOL improvements was also higher overall in cohort 4 than in cohorts 1 through 3, which is consistent with the larger clinical benefit we have observed among those cohort 4 patients. Previously reported structural improvements continue to be present and overall, OpRegen continued to be well tolerated with no unexpected adverse or serious adverse events. We also now have engraftment data for OpRegen extending to more than five years further supporting the potential for OpRegen to become a one-time treatment.

An additional exploratory objective in this study was the evaluation of the Orbit SDS, a third-party device designed to deliver therapeutic material to the subretinal space. We entered into an option agreement with the device manufacturer so that we can make an independent determination of the safety, performance, and ease of use of the device and its potential as an alternative way of delivering OpRegen compared to the traditional method of accessing the subretinal space via pars plana vitrectomy, or PPV. We made significant investments in this effort and even enrolled additional patients to help guide our decision, but based on the totality of clinical data that we have collected to date and other important considerations, we have elected to continue delivering OpRegen via the standard method of PPV. One of the many factors which informed this decision was the importance of delivering OpRegen cells close to or within the area of GA.

We determined that PPV provides greater flexibility and performance in this key parameter. In parallel with the Orbit cohort, we continued to treat patients via PPV and evaluate their clinical outcomes. Consequently, we have identified a number of methods by which we may be able to improve the use of PPV to deliver OpRegen further diminishing the need for a third-party device. I'm encouraged by these new opportunities to further improve the procedure, and I hope to be in a position to share some of those details as they mature.

In connection with this decision, we elected not to enter into a definitive agreement with the device manufacturer and allowed the option period to lapse. I should also point out that there are some additional financial benefits to our decision to continue with PPV, which include not having to share the economic upside of the OpRegen program with another party and not having the added regulatory, logistical, and procedural expenses and complexities that would come with having a separate device and training program to support a special surgical procedure. Overall, we will always remain open to different ways or ideas for how we might improve our treatment. Looking ahead to the OpRegen program, we continue to monitor all patients on the study.

And since the ARVO data cutoff preceded the actual ARVO update by more than one and a half months, we plan to provide another update next month, in which we will have at least six months of follow-up in all patients. In addition to longer follow-up of the promising BCVA data, this time period is important because we will be looking for indications of retinal restoration and reductions in the size and growth of the areas of GA, as I explained a moment ago. The six-month data are also important because that is the minimum amount of safety data we would want to have collected before we engage with the FDA to discuss the next steps in our development plan for OpRegen. While we wait for our next data update next month, I just want to take a moment to address something important which I believe could be a bit misunderstood.

I have sometimes been asked whether I would expect to see a greater separation of the GA curves by month four, especially in light of the large increases we've seen in visual acuity in some patients. I, first, will remind everyone that the area of atrophy grows very slowly, and changes are difficult to detect in a short time frame like three or four months, and that is why we are keen to see how the upcoming six- and nine-month measurements look. But I also want to remind everyone that our GA grafts use the patient's untreated eye as a comparison. The untreated eye is always the eye with better vision at baseline.

So it is not a balanced comparison at baseline and may even work against us because we're comparing our treated eye results with a more diseased eye in every case. But even more than those two points, it's important to understand that OpRegen RPE cells do not contain the same levels of lipofuscin found in a patient's existing RPE. So our cells are not easily seen using fundus autofluorescence, or FAF. Now FAF is a common imaging tool used to collect GA data.

But FAF is incapable of detecting the existence of or potential benefits from structural retinal restoration. In order to see restoration, you need to use high-resolution OCT imaging in conjunction with other precise imaging techniques. So in effect, we don't believe our GA graphs and tables are fully reflecting OpRegen's potential restoration benefits. I know this is a fairly technical point, but I felt it was important to note that sometimes the standard techniques are not optimized for newer technologies like ours and sometimes you need to update not only the way you treat a condition but also how you're monitoring changes in a patient.

Fortunately, OCT imaging is also a fairly common tool at clinical sites and was always part of our protocol assessments. So we have access to this powerful method of collecting anatomical data on patient retinas. And most importantly, we have OCT images for all of the cohort 4 patients treated last fall. And we're now evaluating those images using this more precise methodology, and multiple independent experts in ocular imaging technology are assisting in our review of the data.

Overall, as we continue to learn about the potential for OpRegen to drive outcomes in dry AMD, we will continue to be open to new and improved ways to handle it, deliver it or measure it. As we learn and optimize these solutions, we also will continue to share updates with you on an ongoing basis. Moving next to OPC1, our oligodendrocyte transplant program to treat cervical spinal cord injury. OPC1 is an investigational one-time surgical implantation of specialized cells directly into the area of injury in a spinal cord.

Acute spinal cord injury patients suffer from paralysis and loss of motor function, and the lifetime cost of caring for an acute spinal cord injury patient has been estimated to be as high as $5 million. But just like dry AMD with GA, there currently are no FDA-approved treatments for spinal cord injury. Over the past year, our team successfully developed a new manufacturing process leading to significant improvements in the production and quality of OPC1 and in other attributes, which are expected to enhance the commercial viability of a product. We also developed a new thaw-and-inject formulation of OPC1, enabling investigational use at a much larger number of spinal cord treatment centers, which will help to accelerate enrollment in the next clinical trial.

This new formulation will allow us to eliminate the dose preparation steps, reducing overall logistics of preparation from several hours in a lab to just a few minutes in the OR and reduce our logistics costs by approximately 90%. This new process has recently been relocated into our in-house GMP suite where we are working through the steps to increase our production scale prior to manufacturing material to support upcoming trials. In February, we announced an exclusive option and license agreement with Neurgain Technologies, a medical device company, which gives us access to a novel system that we believe will enhance delivery of OPC1 to the spinal cord. The Neurgain parenchymal spinal delivery, or PSD system, is expected to reduce a significant technical hurdle to conducting a larger scale clinical trial because it has been designed to allow for the administration of cells to the spinal cord without stopping the patient's respiration.

Our plan is to evaluate the Neurgain PSD to safely and effectively deliver OPC1 to the spinal cord in both preclinical and clinical settings. All of this groundwork is helping us to prepare OPC1 for a later-stage clinical trial, building upon the positive data from the previous Phase I/IIa clinical trial. We currently are preparing for an FDA RMAT interaction in June to assess our plans to evaluate the Neurgain PSD system for OPC1, and we look forward to providing an update following that interaction. Looking ahead, we also intend to interact with the FDA around the end of this year to discuss the improvements we've made to the OPC1 manufacturing process as well as our clinical development plans moving forward.

Following these planned meetings and interactions and assuming FDA agreement on our clinical trial design, we expect to be in a position to initiate a large-scale comparative clinical trial sometime next year. We believe the next study of OPC1 can be positioned as a registrational study, but we need to reach alignment with FDA on this path before we can commit to it as our plan. Our current efforts are focused on putting us in a position to have that discussion with the FDA and generating the data to support that path. Now I'll move to -- back to our investigational off-the-shelf dendritic cell cancer vaccine.

Dendritic cell is the most potent antigen-presenting cells in the body, and we harness their activity to deliver hand-picked antigens, an approach which is reemerging as an attractive therapeutic modality based on the consistent safety profile and increased knowledge of how to deploy dendritic cells in a clinical setting. VAC2 is comprised of mature dendritic cells, which we manufacture from proprietary established cell banks, and load with a tumor-specific target, or antigen, to instruct, enhance and deploy the body's immune system about which cells it should attack and eliminate. Last year, we exercised our option with Cancer Research UK or CRUK, to bring the VAC immuno-oncology platform in-house. And thereafter, we reported encouraging preliminary Phase I clinical results in non-small-cell lung cancer patients.

Specifically, VAC2 demonstrated potent induction of immune responses, providing us with mechanistic validation and reinforcing data obtained in the autologous VAC1 clinical trials conducted previously. Our partner, CRUK, is responsible for this study. And while enrollment has been impacted by COVID restrictions, CRUK anticipates that the final patient will be enrolled in the coming months. Following completion of enrollment, we anticipate additional data from the study would be available around the fourth quarter of this year.

Currently, our focus is on making improvements and modernizations to the manufacturing process for VAC, which will help prepare VAC2 for further trials and provide competitive advantages for any future VAC programs we may design. Our manufacturing team was directed to begin work on production enhancements, which will increase the commercial appeal and utility of the VAC platform, just like the successful improvements that we did and made with OpRegen and OPC1. As part of this manufacturing enhancement, we also aim to enhance the flexibility of the VAC platform because theoretically, we could insert any antigenic trigger into the dendritic cells, and we believe the VAC platform is capable of producing nearly a limitless number of product candidates, each one distinguished by the specific antigen which the dendritic cells are carrying to the immune system. This approach opens up a large number of potential corporate partnerships by allowing us to use our dendritic cells as carriers for other companies' antigens, while simultaneously retaining the option to advance our own selected antigens.

And as an example of implementing that strategy I just outlined, in April, we announced our first collaboration for our VAC platform. Our agreement with Immunomic will generate a novel product candidate derived from our VAC allogeneic cancer immunotherapy platform and is targeting a proprietary tumor-associated antigen construct provided by Immunomic for the treatment of glioblastoma multiforme. Lineage and Immunomic will collaborate in the manufacturing and clinical development of this novel VAC product candidate. Following the full development and delivery of GMP-backed product material, Immunomic assumes full and independent clinical and commercial responsibility and further advancement of the program.

In connection with this alliance, Lineage is entitled to payments of $2 million, which we anticipate receiving in the first year of the agreement, and up to $67 million in developmental and commercial milestones across multiple indications and territories. We also will be eligible to receive royalties up to 10% on net sales of future products. This collaboration represents the first of many partnerships we hope to enter into with our VAC platform. And we believe it helps to further validate VAC as a promising new therapeutic vaccine platform.

Our plan is to leverage our technology to generate additional VAC-derived cell therapies in collaboration with partners as well as on our own and capitalizing on Lineage's manufacturing and transplant success. These alliances can diversify our oncology pipeline and provide new opportunities for success without the financial burden of independent development. Now moving to the corporate side. We recently added two new members to our Board of Directors, Dr.

Dipti Amin and Dr. Anula Jayasuriya. Both of these women have had leadership or strategic responsibility for pharmaceutical product development and bring extensive experience in clinical research and medical affairs. These appointments reflect a commitment to ensuring that our Board can provide a broad range of expertise and perspectives as we work to position ourselves as a leader in the field of cell therapy and regenerative medicine.

Overall, I believe we've made rapid and valuable progress during the first few months of this year, advancing all three of our clinical programs and further strengthening the company's capabilities. Moving next to our financials. Our current cash and marketable securities position is expected to fund our operations well into 2023. Our operational runway, of course, could change if regulatory feedback or corporate decisions take us in different directions, but I believe we are in a very good position currently because our base case operational plan includes a lot of planning and preparation activities.

With respect to our ATM program, on March 5, 2021, we completed ATM sales totaling $25 million in gross proceeds, which was the full amount allowed under the prospectus filed in May of 2020 for that program. That same week, we filed a prospectus supplement for an additional $25 million under the ATM program. However, I would like to confirm that no sales of Lineage stock have been conducted under that new prospectus supplement dated March 5, 2021. I also want to mention that earlier this morning, we received notice informing us about the forgiveness of our $523,000 PPP loan, so elimination of that debt will be reflected in our Q2 financial statements.

I can move now into our balance sheet accounts and statement of operations for the first quarter of 2021. A more detailed view of our comparative spend for these periods can be found within our earnings announcement filed earlier today. As of March 31, 2021, we had approximately $62.4 million in cash, cash equivalents, and marketable securities, which includes our remaining ownership of approximately 1.1 million shares of OncoCyte common stock and just over 169,000 shares of common stock in Hadasit Bio-Holdings, Ltd. During the first quarter of 2021, we added to our cash position with net proceeds of $19.3 million received from sales of our common shares under our ATM program and net proceeds of $10.1 million received from selling a portion of our marketable securities.

As I referenced earlier, we have not issued or sold any shares under the ATM offering commenced on March 5, 2021. I'll turn next to the statement of operations for the first quarter of 2021. Total revenues for the first quarter of 2021 were approximately $400,000, a $100,000 decrease from the same period in 2020. That decrease was primarily related to a $200,000 decrease in grant income, which was primarily driven by the completion of NIH grant activities in a prior year and offset by a $100,000 increase in royalty-related revenues.

Operating expenses are comprised of both research and development expenses and G&A expenses. Total operating expenses for the first quarter of 2021 were approximately $7.3 million, a decrease of approximately $600,000 as compared to the same period in 2020. The decrease was primarily related to a reduction in G&A expenses. Our loss from operations for the first quarter of 2021 was approximately $7 million, a reduction of $400,000 as compared to the same period in 2020.

The net loss attributable to Lineage for the first quarter of 2021 was $1.4 million or $0.01 per share as compared to $8.4 million net loss or $0.06 per share for the same period in 2020. It's important to remind investors that the variance between our loss from operations and our overall net loss is impacted by the changes in the value of our investments in OncoCyte and Hadasit as well as foreign currency exchange rate fluctuations related to Lineage's international subsidiaries. While these 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. Overall, our first-quarter cash activity was in line with our expectations.

We anticipated the first quarter would have our highest cash expenditures for the year due to our second installment payment of roughly $700,000 to CRUK for the early exercise of our option to bring the VAC immuno-oncology platform and development of VAC2 in-house, and a $500,000 payment to Gyroscope for an extension of the option period. For the remainder of 2021, we anticipate our quarterly cash burn rate to be approximately $5.5 million. To wrap up the financials section, I'll say that I continue to be pleased with the paths we are on to maintain our financial stability while strategically driving our multiple clinical programs forward to position us to maximize shareholder value. So to conclude, Lineage and others in the field of allogeneic cell therapy are helping to demonstrate the viability and commercial potential of allogeneic cell transplants to treat or cure serious diseases or conditions, which represent major unmet medical needs and large market opportunities.

As the tools and methods used to manufacture and test these therapies in patients are reaching maturity, public policy and investor support for cell therapy has moved in a positive direction. As we advance our product candidates toward later-stage clinical trials, we are working to position Lineage to benefit from this convergence of positive factors and help accelerate the development and commercialization of this novel branch of medicine. Looking forward to the remainder of 2021, a number of key events or milestones, which we have in mind include OpRegen interim data, which, as I said, is expected next month; an RMAT interaction with FDA to assess the Neurgain PSD, which is already scheduled for June 2021. We have a plan to meet with FDA to discuss further clinical development of OpRegen, which is currently anticipated in the third quarter of 2021.

We anticipate completion of patient enrollment in the VAC2 study around the middle of this year. We are expecting completion of the improved manufacturing process and comparability testing to support a late-stage clinical trial of OPC1 to be ongoing throughout this year. We have an FDA interaction anticipated, which is to discuss manufacturing improvements for OPC1, we expect that will happen around the end of the year. We look to report results from the ongoing VAC2 study, which we expect to be around year-end.

And we will be continuing to evaluate opportunities for new VAC product candidates and new VAC alliances based on internally identified or partnered tumor antigens. At Lineage, we're proud to have the opportunity to make a profound impact on millions of people and benefiting from the technology platform which we enjoy, and the patients continue to inspire us every day. I appreciate all of you joining us this afternoon, and we particularly appreciate our shareholder support as we continue to position Lineage to be a leader in cell therapy and cell transplant medicine. And with that, operator, I am ready to respond to any analyst questions we may have.

Questions & Answers:


Thank you. [Operator instructions] Your first question comes from the line of Kristen Kluska from Cantor Fitzgerald. Your line is now open.

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Hi. Good afternoon, everybody. Thanks so much for taking the questions. The first one I had was in regards to the patient who had the retinal tissue restoration now at about three years out.

Wondering what work you might look to understand the particular effects or characteristics around this patient. And then can you discuss the importance of evaluating the long-term trends that you've observed relative to other approaches in this space?

Brian Culley -- Chief Executive Officer

Hi, Kristen, sure. I'd be happy to address each of those. What we find -- what we think is most notable about the retinal restoration patients beyond the initial observation of retinal restoration and the truly fantastic durability of that observation is that their procedure was unlike the patients which preceded them. And by that, I mean specifically, they had a fairly thorough or complete coverage of OpRegen cells right across the area of GA.

And that had never happened before. Well, we then -- one of our advisors was going through those OCT images, which I mentioned before because, again, you don't see restoration by using just FAF. And he observed in the nine-month images, these benefits that have been thoroughly discussed by us previously. So as we gained confidence in that observation and we had it vetted by additional imaging experts and experts in ophthalmology generally, we then advised or asked our investigators if they would work to try to get more aggressive delivery or more complete delivery of OpRegen across the area of GA.

And so that was different because in the early patients, we tended to stay fairly far away from the area of atrophy because we want to be careful that we didn't disrupt the patient's preferred retinal locus. We want to make sure that we didn't cause any harm or disrupt their baseline vision. But I think what we discovered with that particular patient is that it may not be the case that OpRegen's effects can work at their best at a distance. And that may -- the cells may need to be truly replacing right there in the area of the dead cells or in the diseased cells or the cells that are not functioning fully.

And so the patients which followed that extraordinary finding, they are now past four and a half months. And so they are getting into the same time frame where we think this observation of restoration can occur. And all of them, we asked the investigators to try to get more complete coverage. And in some cases, they were successful.

And in some cases, they were unsuccessful. So we have a mixture which is kind of an interesting test where we will be looking, in particular, for restoration patients that had more complete coverage of the OpRegen cells across the area of GA and we will be able to compare those with patients that did not have as complete coverage across the area of GA. So we do think that placement of cells is very important in terms of obtaining the best outcomes. With respect to your other question, the importance of trends, reaching into my background originally as a scientist, as a bench scientist, as you would work a problem, it was always very interesting if -- you couldn't get too excited about a single observation.

But as more and more observations, especially using different methodologies, as each of them sort of piled on and were directionally correct or directionally, you know, facing the right way, even if any one of them was not statistically significant, you could start to build a lot more confidence. So for example, if you're seeing BCVA benefits and GA benefits and you're seeing quality-of-life benefits, and you're seeing low-light reading speed benefits, if everything is sort of directionally going your way, it is much easier to be confident that you're having an effect even within a single assessment such as BCVA. You cannot choose just a single time point, three months, six months, nine months and say, "Aha, 25-letter gain." You really need to look at the area under the curve and say, "OK, maybe that patient was many letters at month six. How were they at month nine and three and 12?" And I think by looking not only within each assessment but across multiple assessments, you get a much more fulsome picture.

And I think that's what we're enjoying. And that is why I referenced that I feel like every time we put out an interim update, it is a more -- it is a picture of our data which can provide greater confidence and conviction that delivering the OpRegen cells to these patients is driving a benefit in them and supportive of further development.

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Great. Thank you, Brian. And then I know there are no approved therapies for dry AMD, but perhaps from what's been observed in the field of wet AMD, based on the discussions you've had with physicians and KOLs, how do you imagine both if they and their patients might rank or evaluate the importance of these different endpoints that you're observing in the trial as well as items like safety and convenience?

Brian Culley -- Chief Executive Officer

Yeah, there are several important parameters. Ultimately, the patients care most about seeing better because avoiding falling down a flight of stairs in dim light or being able to use your cellphone and watch your grandchild at their piano recital, those quality-of-life issues are – you know, there's nothing more important than those. But the burden of proof is sometimes more easily achieved with other methods. So for example, anatomical methods, improvement in the anatomy and the structure of the retina.

So the patients and the regulatory guardians of these markets are not always perfectly aligned. In our case, I'm encouraged because I think that we're able -- we're going to be able to demonstrate that we can provide both of those. But I do think that there's imperfect alignment. The overall objective of safe and effective therapies is really going to be FDA's judgment.

But the individual patients, they're going to have their own criteria in terms of their risk tolerance. Where are they in the disease? How important is it? How are they getting along, one eye or both eyes? There are many factors there. But I think that something that's notable about cell transplant approaches generally and, of course, OpRegen specifically, is I believe that, ultimately, we're going to be able to deliver both. I believe we're going to be able to demonstrate anatomical improvements to the retina, which give us a good basis for regulatory evaluation.

And I think we're also going to be able to demonstrate some degree of visual acuity improvements. So it's a complicated situation because there is no regulatory precedent, as you know. And so, you know, there is no clear path. But I do want to mention that we will remain open.

Just because one sponsor decides to pursue a certain endpoint does not set that as the bar for every other sponsor. Ultimately, you need to align your therapy and your therapy's attributes and benefits with some sort of primary efficacy endpoint. And so there is a long history, not just in ophthalmology, but more generally, for ethical pharmaceuticals, of trying to figure out what's the right way to measure the benefit that you are conferring and be able to do that in the context of a clinical trial, which is affordable and enrollable and convincing. So that's a very long answer, but I do think that -- I hope that I touched on all the points that you made there.

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Great. Thanks, Brian. Looking forward to the data next month.

Brian Culley -- Chief Executive Officer

Thank you, Kristen.


Next question comes from Joe Pantginis from H.C. Wainwright. Your line is now open.

Joe Pantginis -- H.C. Wainwright -- Analyst

Hey, Brian. Good afternoon. Thanks for taking the question. Brian, I want to go to some of your prepared comments and then also some of your commentary about the restoration patients.

So first, let me go to your comments -- prepared comments about your decision to not exercise your option for Gyroscope and then link that to a direct question about the restoration patient. Do you feel then now that the PPP -- I'm sorry, not the PPP loan, the PPV delivery is maybe more appropriate to deliver more accurately the cells to cover the area of GA?

Brian Culley -- Chief Executive Officer

Yes, Joe, thank you for the question. I think the short answer is yes. I think that we had a couple of years of data to review, and we've learned a lot of things with this new technology. And I think that we feel that having the flexibility or better placement flexibility is really important because it is ultimately going to be tied to the clinical outcome.

So I think the answer to that question is yes.

Joe Pantginis -- H.C. Wainwright -- Analyst

Got it. And then sort of going forward with that restoration patient, how are you going to be able to share some, let's call it, delivery data for the current patients to describe, you know, how and where the cells were delivered? Because like you said early on, you were avoiding the area of GA and you now have each patient, you know, subsequently been getting closer with regard to their delivery in the areas of the GA that you could be able to see restoration, you know, as time progresses? I guess it really comes down to what can you share at some point with regard to where the delivery occurred versus where the GA was?

Brian Culley -- Chief Executive Officer

Yeah. Well, it's a nice question because the company historically has been extremely transparent with its data. We have provided patient-level data at essentially every single endpoint with all of our exploratory assessments. So it will be no problem for us to provide not only the clinical outcomes, but to match those up with some sort of scale or score, plus/minus type analysis on placement of cells.

And that's the case not only for restoration but more generally for how the patients are performing. So even if what we see is that patients with the best BCVAs also had the better placement of cells, that's incredibly validating of the direction that we're going in and affirms for us that cell transplants and cell replacement is really driving this, that it's not so much trophic effects or again cells operating in a distance, which frankly has been our philosophy throughout this, and it's across all of our applications. That's not to say that maybe some factors, some biological factors that are coming from our cell line that are beneficial and contributing to clinical outcomes. We just don't think that they are sufficient for optimal outcomes.

So obviously, the home run here is being able to show restoration, and the more restoration, the better. If restoration only happens with great placement, that's fine. That's the direction we're going in any way. If we do not show restoration, if we can still show clinical benefits that can lead to an approved product and we're showing those that are happening with superior placement or more exquisite placements, then I think all of those are, you know, victory or winning scenarios.

And I should add or I can add that one of the other things that we've learned is around patient selection. So I think we're seeing some signals as to which kinds of patients might be more likely to "respond" to our therapy. And we're starting to refine our thinking there. It used to be just earlier is better.

And although I agree that earlier is still better, we're starting to even be able to think about, well, maybe we could score the Bruch's membrane health in some way and sort of have a selection criteria for patients and so forth. These are still very much a work in progress because, again, this is a new technology. And so we are learning while doing, but I also think that's incredibly encouraging because we have a lot of areas where we can get better because we have a new technology. So I hope that is responsive to your question.

Joe Pantginis -- H.C. Wainwright -- Analyst

No, it certainly is. Thank you. And actually, your statement of new technology is a great segue to my next question. And I want to ask about the regulatory topic and split it into two parts.

So first, since we're on OpRegen, you know, as you're going to go into the FDA meeting and talk about a potential registrational study, how much are you willing to disclose right now about what your wish list looks like since it is a new technology? What would you like a registrational study to look like and hope that the FDA agrees to, maybe with some tweaking or what have you? And then the second part of that is with regard to your OPC1 upcoming regulatory interactions. If I heard you correctly in your prepared comments, you said that this potential registrational study would be a comparator study, and I just wanted to verify would be, you know, compared to what?

Brian Culley -- Chief Executive Officer

So it's such a fun question that you're asking there. I think that the regulatory directions kind of fall across two parameters. There's visual acuity in all these different variations, you know, reading letters on an eye chart, reading speed, low-light reading. So there's visual acuity, and we're seeing benefits in visual acuity.

So that's on the table. Then there's GA growth or GA area, you know, some sort of GA change. And I want to keep it kind of broad because we need to keep open that it's not just the circumference of the circle that we're looking at, one of the things that we think that we can bring are changes to the depths or the health of the retina. You can think of the retinal like it's an eight-layer birthday cake.

And, you know, if you're -- if you've got all these layers that have smooshed together and they're dysfunctional if you can inflate those, I'm using really poor terminology, you know, but the little kid is going to be a lot happier with a cake that's inflated rather than one that's collapsed. And that doesn't always -- as I described, doesn't always translate easily in the aerial views that a lot of us use to look at GA. So there's a GA component here. But you asked me a different question.

You said what's my ideal. My ideal is very easy. My ideal is I want to collect, I want to have evidence of retinal restoration, and then I would like to use high-res OCT to be able to demonstrate that there are anatomical changes to the retina which never occur naturally. And I think that that would be so incredibly powerful, and it would be a really great win if we are able to have a study like that.

But, you know, there are a lot of requirements there. We need to see it. We need to be convinced of it. We need to figure out ways to measure it.

But, you know, you asked me for my wish, and so that's my answer.

Joe Pantginis -- H.C. Wainwright -- Analyst

No, great. And then the OPC1 comparator wish?

Brian Culley -- Chief Executive Officer

OPC1 comparator, yes, the office. I mean, I don't know. The challenge with OPC1 is how do you do a sham control with a surgical procedure. My opinion, and I think the opinion is shared by most neurosurgeons here, is that it is not ethical to make an incision and do a sham procedure for spinal cord injury patients.

Now a statistician is going to have a different view because they're holding on to the elephant's trunk or, let's say, the tail. But I think that there are ways of doing partial blind studies, right? Maybe the family knows if there's an incision under the bandage. But maybe the person who's doing the assessment, who's collecting the data on mobility or sensation, maybe they're blinded. So there are sort of hybrid ways or pseudo blindings that are probably capable.

We are obviously in the early days of sorting out what we think would be the most compelling and powerful way of doing that. But I do hope to avoid having to enroll a large number of semi-matched patients and essentially doubling the size of the study. But ultimately, we need to go to FDA with a compelling case and a compelling story about why that is the right way to go. And it's similar with dry AMD.

I mean I think the best comparator, in the case of dry AMD, is actually a matched patient population that you observe what happens to their GA in real time. And I was just complaining a little bit earlier that we're matching our data against the contralateral eye that we always know starts out better, and it seems a little unfair, but it's what we have. It's the only comparison which we can make. But what if we have a population, a controlled population of patients who come in at baseline with the same size of atrophy and they have similar stage of disease, but they are untreated, and we just monitor what happens.

That, for me, would be a much better comparison as to changes that occur with OpRegen compared to this contralateral eye. And I think that's the case for both GA and for BCVA.

Joe Pantginis -- H.C. Wainwright -- Analyst

Thank you very much, Brian.

Brian Culley -- Chief Executive Officer

Thank you.


Your next question comes from the line of Robert LeBoyer from NOBLE Capital. Your line is now open.

Robert LeBoyer -- NOBLE Capital Markets -- Analyst

I had a question about the presentation of the OpRegen data and the additional interim analysis that's going to be presented. I was wondering whether it was going to be presented by press release or at a scientific conference? And then when would the full data set be presented?

Brian Culley -- Chief Executive Officer

Rob, thank you for the question. A final decision hasn't been made, but we do not currently have major medical conference planned for the next update. So what I believe would be most likely is that we would provide a press release, which, in our case, typically would link out to a slide deck that we would make available so that you would be able to see more of the totality of the evidence over time. So we're too early for me to say exactly what we will do.

But looking rearward, we -- that is one way that we've been able to provide more information than you can really pack into just a press release with some top-line data.

Robert LeBoyer -- NOBLE Capital Markets -- Analyst

OK. And just in the few minutes that remain, just quickly, could you just summarize what the time frame for the OPC1 program and the milestones might be after the end of the year and assuming everything goes well?

Brian Culley -- Chief Executive Officer

Yeah, Rob. Thank you. The two major activities on OPC1 are our RMAT meetings, so where we have to talk with FDA about this new Neurgain PSD. So we have an RMAT interaction, which is scheduled for next month.

So that's not very far away. And then we want to, around the end of the year, talk about the manufacturing improvements, which I described previously or in other calls. We just want to make sure that we've got good alignment with the agency that the process that we have developed, which has much greater purity and control and scale, we want to make sure that the agency is comfortable with that process, creating cells and those cells going into patients. So those are a couple of things that you can look forward to.

And then we always keep an open line of communication going with the California stem cell agency, or CIRM. That's just -- that's always sort of a side thing that could be part of our, you know, news flow as we go forward, but there's nothing specific or imminent on that topic today.

Robert LeBoyer -- NOBLE Capital Markets -- Analyst

OK, great. Thank you very much.

Brian Culley -- Chief Executive Officer

Thank you, Rob.


Next question comes from the line of Keay Nakae from Chardan. Your line is now open.

Keay Nakae -- Chardan Capital -- Analyst

Yes. Thank you. Brian, I want to talk to you about your decision about the Orbit device. And we appreciate that you guys are finding that better coverage of the geographic atrophy area is advantageous.

So if we think about then the trade-offs of why the Orbit device was first thought to be beneficial in terms of the epiretinal membrane formation, are you comfortable that utilizing PPV is something that your surgeons can do the procedure and minimize that trade-off of the injury versus the better coverage?

Brian Culley -- Chief Executive Officer

Yeah. Hi, Keay. That is definitely an astute question. So with respect to retinal surgeon experience, PPV is widely used.

All retinal surgeons have extensive experience with it. I was told by one in particular that it is a requirement. If you want to graduate from retinal surgery in school, you need to be able to perform a PPV. So we've continued to use PPV while evaluating the Orbit device in parallel.

We didn't have very much data two years ago when we entered into the evaluation agreement. Since that time, there have been 12 more patients, which have been treated, about half PPV and half Orbit. And we've seen some interesting things. As referenced in Dr.

Riemann's ARVO presentation, the PPV procedure always only needed a single device to successfully deliver the cells. It had a high rate of success doing so. We didn't have our cells time out while using PPV. There was a single case of CNV, which arose in a PPV patient, but that occurred two years post treatment, and we don't think that was in any way associated with our cells or the procedure.

But the primary reason that we even explored alternatives a couple of years ago is that PPV is associated with a high rate of epiretinal membrane formation. But not only are the majority of the ERMs in our study clinically insignificant, but we also demonstrated that a severe ERM, which needed to be removed, could still result in an improvement in visual acuity after its removal. So we think the totality of the data, at this time, supports the continued use of PPV to deliver OpRegen. As I said, we would continue to be committed to exploring ways that we can improve our therapy.

There may be alternates or improved subretinal delivery solutions out there. But we did allow that option agreement with the manufacturer to expire in May in accordance with its terms. And we're already in the process of exploring two areas of potential improvements to the PPV procedure, which might further improve outcomes. So we think that PPV -- using PPV to deliver OpRegen is going to ultimately be a better choice for patients and for surgeons, as well as for Lineage.

Keay Nakae -- Chardan Capital -- Analyst

Great. Thank you for that answer.


And there are no further questions at this time. Brian Culley, you may proceed with your closing remarks.

Brian Culley -- Chief Executive Officer

Well, thank you, everyone. I really appreciate it. Thank you, Mary, and I appreciate everyone's participation. We will keep working hard for you, and we look forward to our upcoming events and milestones and our continued communication with all of our shareholders.

Thanks, and have a great afternoon.


[Operator signoff]

Duration: 62 minutes

Call participants:

Ioana Hone -- Director of Investor Relations

Brian Culley -- Chief Executive Officer

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Joe Pantginis -- H.C. Wainwright -- Analyst

Robert LeBoyer -- NOBLE Capital Markets -- Analyst

Keay Nakae -- Chardan Capital -- Analyst

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