Lineage Cell Therapeutics Inc (LCTX) 2020 Q2 法說會逐字稿

Welcome to the Lineage Cell Therapeutics Second Quarter 2020 Conference Call. (Operator Instructions) An audio webcast is available on the Investors section of Lineage's website at www.lineagecell.com. This call is subject to copyright as 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.

Thank you, Chino. Good afternoon, and thank you for joining us. A press release reporting our second quarter 2020 financial results was issued earlier today August 6, 2020, and can be found on the Investors section of our website. Please note that today's conference call and webcast will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, goals, product candidates, clinical trials, financing and cost savings matters. Such statements are subject to significant risks and uncertainties, including those described in our press release issued on August 6, 2020, and our most recent Form 10-K and 10-Q filings. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to those risks and uncertainties. We caution you not to place undue reliance on any of the forward-looking statements, which speak only as of today.

Joining us today are our Chief Executive Officer, Brian Culley; our Chief Financial Officer, Brandi Roberts; and our Senior Vice President of Clinical and Medical Affairs, Gary Hogge. The executives will provide prepared remarks, then take questions from analysts.

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

Thank you, Ioana, and good afternoon, everyone. We appreciate you joining us on our quarterly call today. This past quarter was extremely productive for the company. And on today's call, I'm going to review the most important milestones we reached with each of our 3 clinical stage cell therapy programs. After I provide these program updates, Brandi will review our financials then we'll summarize some upcoming events which shareholders can look forward to, and then we'll open up the line for our analyst questions.

I'm going to start with OpRegen, our product candidate to treat dry-AMD with geographic atrophy. Dry-AMD with GA is one of the leading causes of vision loss in the world, and we estimate they are between 1 million and 2 million people in the U.S. suffering from the advanced form of the condition, which is the initial form we hope to treat.

The disease is caused by the slow progressive loss of specialized retina cells and our approach to treating dry-AMD is to grow and transplant and bring new retina cells to replace the ones which are dysfunctional, dying or have already died off. This program is currently enrolling patients in a Phase I/IIa clinical trial at 5 active centers. Because there are no FDA-approved therapies to treat dry-AMD, we believe the commercial opportunity for a new treatment is incredibly attractive. And we recently announced a discovery, which we believe distinguishes our program substantially from the competition, and positions us as the most promising dry-AMD therapeutic currently in development.

I make this strong statement because in June, we reported evidence of what is potentially the first known reported finding of retinal tissue restoration in a patient receiving a transplant of RPE cells. This finding is unprecedented because humans lack the ability to regrow or repair retinal tissue. So most companies are simply trying to slow the rate of the disease progression, while our data supports the view that dry-AMD is not an irreversible degenerative condition, which only gets worse over time.

We believe we're the only company to report in a clinical setting that some portion of diseased retinal tissue may actually be recoverable in dry-AMD patients. The patient we treated with our OpRegen cells had atrophic end-stage disease, yet showed substantial restoration of retinal tissue within the previous area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient's baseline prior to treatment. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.

We also recently hosted a call with renowned experts to review these results in detail, and there is a replay of that call on our website, which I strongly recommend checking out. We are currently conducting a third independent review of these findings as well as going back to determine whether it appears in any of our previously treated patients, and we plan to submit these data in a case report manuscript for scientific peer review when these analyses are completed.

One reason these data are so exciting to us is that in a clinical trial setting, we ordinarily would compare one group of treated eyes against a group of untreated eyes, and determine whether the area of atrophy in the treated eyes grew more slowly because slower growth is a positive outcome in this setting. But what we've shown is that it's possible to not simply slow the growth rate, but actually reverse it and restore retinal structure to a normal appearance and architecture, which, from a statistical perspective, makes it much easier to see differences between treated and untreated groups, because you know the untreated group will only get worse over time.

In contrast, if a few of the GAs in your treated group get smaller, then you're really pulling down the average growth rate of your experimental arm and instilling an incredible amount of statistical power into your trial. So this is sort of like comparing 2 race cars that are headed toward a cliff, and the cliff, in this case, would be blindness. Everyone wants to find a way to make one of the cars run slower. And in our case, we have a car which went in reverse. So it's pretty easy to tell which car you want to be sitting in.

Overall, this potential may mean that we can run a smaller, faster trial while still maintaining tremendous power in our analysis. So this is why it's so important for us to try and repeat this finding and demonstrate for a second time that retinal restoration is possible and that what we are seeing is a realization of the long-held promise of cell therapy. For this reason, we're looking forward to seeing whether a different patient we treated just a couple of months ago becomes that valuable second example, or maybe one of the next couple of patients we treat will provide that evidence. But despite our excitement, we have to remain patient because these areas of GA do grow very slowly, and there's nothing we can do to accelerate the amount of time it takes to show differences in growth rates. We simply have to wait until enough time has passed to see if the GA has gotten smaller instead of getting larger. But that certainly could be an exciting announcement if we observe it and again have it confirmed by external experts.

Now in addition to the retinal restoration discovery, we also have observed additional benefits in some of our patients on this trial. Those include increases in visual acuity, reductions in the rate of growth of GA, and increases in patient reading speed. We believe the body of evidence which we are collecting will support a new paradigm for how to approach the treatment of dry-AMD, and one that no other company has shown evidence for. That's our primary objective; to show that directed differentiation and transplant of RPE cells can provide clinically meaningful outcomes in this disease.

Now by the way, I should mention that I know a lot of people are now following this emerging story so I should explain that despite a large number of dry-AMD sufferers in this country, it is still difficult to enroll patients onto clinical trials. There are many reasons for this, including the challenges of identifying what are typically elderly volunteers, who still have meaningful vision, they need to sign up for an elective surgery, meet the enrollment criteria, and be comfortable with a large number of doctor visits, despite whatever regional COVID restrictions they may be subject to. So it's asking a lot of people. But from time to time, obviously, we do find candidates who meet our criteria and then get successfully enrolled and treated on our trial.

And fortunately, as our data set has grown and matured, and the safety of the treatment is increasingly known to the physicians, enrollment might get a little bit easier going forward because these retinal specialists are able to express confidence and enthusiasm in the potential benefits from treatment. But to be fair, COVID is still a hurdle for this study, as it is for many other studies as well. But to help boost the process, we recently opened a fifth active site in the U.S., and we're hoping that we soon can get another 1 or 2 patients from our sites located in L.A., Cincinnati or Philadelphia.

As a reminder about this trial, we've had 3 surgical experiences with the Gyroscope Therapeutics 510(k) approved Orbit SDS device. That's the tool which we use to administer the cells into the subretinal space. We think this device can provide us with a meaningful competitive advantage in administering cells to the subretinal space, but we still want to confirm the early promising results that we've seen. We would like to confirm that with another 2 or 3 patients.

Once those final patients have been dosed using the device, which should occur in the next month or 2, that will conclude the Orbit portion of the study. And if everything goes well, we would plan to conclude enrollment in the Phase I/IIa study around that time and move into a follow-up phase, which would include interactions with various regulatory authorities like the FDA and entering into more advanced partnership discussions.

So overall, things are trending positively for our dry-AMD program. Our focus will continue to be on collecting additional patient data, repeating the restoration finding which I described, and completing the Orbit evaluation phase, which altogether will help direct our clinical, regulatory and partnership strategies.

In terms of the next data update on the OpRegen program, aside from updates or announcements we could make at any time on retinal restoration, we also plan to provide an overall update at the upcoming AAO virtual conference in the second week of November. In the past, we've had a very good reception from these presentations, and we will have more to say about our plans and our presentations as that meeting date approaches.

Moving next to VAC. This is our allogeneic, or off-the-shelf, dendritic cell cancer vaccine. This product candidate is comprised of mature dendritic cells, which we manufacture from established cell lines and load with a tumor-specific marker to instruct the body's immune system to attack and eliminate cancer cells. By educating your T cells to seek out and destroy cancer cells, VAC2 acts like a highly trained booster for your immune system. During the second quarter, we elected to conduct an early exercise of our option to the VAC program from our development partner, Cancer Research UK. CRUK has been [conducting] (added by company after the call), and continues to conduct, a Phase I clinical trial of VAC2 in patients with non-small cell lung cancer.

But after reviewing data from the first 4 patients treated in this study, it was clear to us that VAC2 dendritic cells could, in fact, provide targeted education of T cells, and that's a signal which we were seeking, and it was apparent in multiple assay systems. The signal was also present in an earlier autologous version of VAC2, known as VAC1, and an even earlier investigator-sponsored study. So the ongoing VAC2 trial was confirmatory of these positive earlier findings and gave us confidence that the mechanism was being preserved when moving from an autologous setting into an allogeneic setting. And this is important because only an allogeneic platform can provide the cost and manufacturing advantages which have limited the autologous dendritic vaccines.

An additional reason for the early exercise of the VAC option was to send it to our in-house experts in cell therapy manufacturing so that they could begin work immediately on necessary production enhancements. Although CRUK collected some valuable clinical data, they did not have in-house expertise in pluripotent cell guided differentiation, so they could not develop the necessary improvements to the manufacturing process. So in order to fully exploit the potential of the VAC platform, we need to modernize it, just like we did successfully with our retina program and which, as I'll explain in a moment, we're doing currently with our spinal cord program.

But to first provide an example of how we're now able to expand the VAC platform from when it was being managed by CRUK, we recently started looking into us in a VAC platform to create a coronavirus vaccine. This is possible because one of the hallmarks of the VAC platform is generating high levels of CD4 positive and CD8-positive T cells in most patients, and T cells are required for the memory effects of a long-term vaccine. If you've been following the literature on COVID vaccines, I'm sure you've seen that while the early days were focused on generating antibodies, there's more recently been an increased focus on the importance of engaging the adaptive immune system and specifically, the patient's T cell response. There clearly are many vaccine approaches being pursued today, but there's really no way to predict which kind and form of immunological stimulus will work best in various genetic or professional populations. So we have submitted a provisional patent application for our approach and are now in the process of submitting proposals for external grant support from both U.S. and international funding organizations.

We were unsuccessful with our first application to CIRM, as were many other companies, but we recently received a response from BARDA, inviting us to a meeting this month under what they call their CoronaWatch program, where we will be able to discuss our proposal and planned efforts. This is encouraging to us because BARDA reported that they received more than 3,500 meeting requests but to date, granted only approximately 400 of those meetings, so 3,500 meeting requests and 400 invitations for these meetings. Now because most of these COVID funding pools didn't even exist a few months ago, there's really no way for us to estimate our chances of success in obtaining a COVID-related grant from BARDA or from anywhere else, but we're going press on and we will do our best, obviously, to be successful with this effort in identifying some external funding support for that initiative.

I should add here that among any and all of our current or future VAC product candidates, and that's for either cancer or infectious diseases, the main differences among them are the antigen RNA sequence which we insert into the dendritic cells. The dendritic cells are identical, but the sequence that we put in there, the signal or message, that differs, and that's what defines [each of] (added by company after the call) these products.

Well, that means that many of these manufacturing improvements which we have begun working on, they are identical across the oncology and infectious disease programs, which means that any funding we receive or investments we make ourselves into the VAC platform are effectively multiplied, because they advance steps which are common to both the oncology and infectious disease platforms and all of the product candidates which currently or may in the future reside therein.

Even though Lineage now has control of the VAC2 program, CRUK is still responsible for collecting data on the current patients as well as dosing 2 additional patients in the ongoing study. So we now have begun to explore additional oncology applications, which we internally call VAC3, 4, and 5 as well as additional infectious disease applications, as I mentioned a moment ago.

And importantly, now that we are in charge and responsible for the VAC program, we also are in a position to explore business development opportunities with companies in the immuno-oncology space, where we would provide access to our dendritic cell platform as a delivery tool for someone else's antigens. This could help us generate a whole pipeline of different product candidates with various expression cassettes targeting many different types of cancers.

We feel that the product platform nature of VAC will enable us to engage in new and exciting partnering discussions and become a much more prominent player in the immuno-oncology field, especially as we validate and mature the production process, scale, and other important commercial attributes of VAC.

We also are in the process of hiring a new position that we created, Vice President of Oncology. That would be someone to lead the development of not only VAC2, but also the expanding the oncology pipeline, which, of course, can help with both partnering efforts as well as internal development programs.

Now the last thing I'd like to add on VAC program is that sometimes we get questions about limitations of using dendritic cells for tumor therapy. It's very important to understand that first generation efforts were largely monotherapy approaches in heavily pretreated patients, and that is not where the field has remained. We are, of course, aware of the history, and we're encouraged by more recent, and we believe far more relevant work, suggesting that combination approaches with checkpoint inhibitors or even chemotherapy, as well as second-generation technologies like our allogeneic DCs and neoantigens, may offer more promising clinical outcomes. And this is exactly where Lineage intends to position ourselves; as a second-generation alternative in a combination setting with the added benefit of being allogenic and adaptable across many different combinations of potential antigens. So this is still in somewhat of the early stages, but it is something you can look forward to hearing more about from us as we continue through the year.

Thirdly, moving next to OPC1. This is our clinical stage program for spinal cord injury. This past quarter, we announced that manufacturing has been completely transferred to our facility in Israel where the key process improvements have been developed and implemented. We also strengthened our patent position in order to protect this new OPC1 process, the product and composition, and methods of use. And as I described earlier, it's vital that we also modernize this production process to enable a later-stage clinical trial and ultimately, commercialization. And I'm very proud to share that my expectations have been exceeded by our CMC team working on this project. They generated new cGMP master and working cell banks, which ensures consistent batches are produced. They improved the production process, to achieve greater efficiency and higher quality control, making it compatible with larger scale manufacturing and BLA readiness. They introduced new-in-process controls and release testing, updating them to be more compatible with current and expected future regulatory guidelines, and are on track to initiate GMP production in early 2021 to support our clinical efforts.

Looking ahead, they also will be developing a Thaw-and-Inject formulation like we have for OpRegen, while in parallel, the product development team will be evaluating superior delivery tools, which altogether will enable an easier surgical procedure and faster enrollment in the next clinical trial.

All of this work will lead us then to an RMAT meeting with FDA, which we're planning for some time around the end of this year or early next year. And once all of these commercially enabling improvements which we're working on are in place, the manufacturing side of the OPC1 program will have caught up with the impressive clinical data side, and I believe that will open up new opportunities to evaluate and consider strategic alliances, just as we're doing with OpRegen and are planning to do with VAC. So overall, our approach with OPC1 is intended to replicate our development strategy for OpRegen in which we seek not only to provide cell-based regenerative benefits, but also commercially relevant solutions with competitive advantages in areas like scale-up, production costs and delivery techniques.

Lastly, I just want to add today that I'm approaching my 2-year anniversary here at Lineage and I'm extremely thankful to this team for successfully implementing so many changes in such a short time frame. As you can tell from our 3 clinical stage programs, we have adopted a model of taking exciting, early-stage clinical data, specifically from cell therapy programs which are addressing high unmet needs along with low competition, then we enhance and modernize their manufacturing processes to make them capable of supporting later stage trials and ultimately, commercialization. And then after modernizing the production process, we will move these products into later-stage trials, either on our own or in most cases, in collaboration with a larger partner.

And because the power of our directed differentiation platform is the ability to manufacture so many different cell types, we have an opportunity through this strategy to provide our shareholders with long-term growth and sustainability, ideally, while also relying on non-equity dilutive funding. And frankly, on that point, I'm pleased to remind you that Lineage has not needed to conduct a traditional equity financing for almost 3 years, yet we have made tremendous progress with our programs and our pipeline in that same period. And as Brandi will explain in just a moment, we believe we'll continue to have access to capital which will permit us to continue with this approach.

So in conclusion, if you look carefully at how we have advanced our programs and the decisions which we have made, steps that we have taken, such as creating 3-dimensional RPE cell production, which now counts in the billions of cells per batch, or acquiring the rights to OPC1 from Asterias and bringing to bear our manufacturing expertise, or more recently, exercising the VAC option early so that we could expand the cancer and infectious disease programs off of a single platform. All of these steps fit into a larger strategy of creating value by converting early and exciting science into compelling and rigorous clinical data and manufacturing capabilities, which then attract attention and support of investors and major pharmaceutical companies, and ideally doing so without diluting shareholders at unattractive prices.

So with those program updates complete, I'll hand things over to Brandi to please review our financials and discuss some additional plans that we have for this year.

Thank you, Brian. I'll start off with the statement of operations for the second quarter of 2020. Total revenues for the second quarter of 2020 were $400,000, a decrease of $400,000 as compared to $800,000 for the same period last year. As discussed on prior calls, we expect our revenues to be lower than historical levels as they are now generated primarily from our IIA OpRegen related grant and royalties from the licenses of patents.

Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expenses for the second quarter of 2020 were approximately $6.7 million, a decrease of $4.8 million as compared to $11.5 million for the same period in 2019.

R&D expenses for the second quarter of 2020 were $2.8 million, a decrease of $2.4 million as compared to $5.2 million for the same period last year. The overall reduction was primarily related to a decrease of $1.7 million in OpRegen and other ophthalmic application expenses, which was primarily related to a reduced level of manufacturing activity in the second quarter of this year as compared to the same period last year. Additionally, there was a $700,000 reduction in OPC1 expenses, primarily related to a decrease in development activities in 2020 as compared to 2019 when technology transfer was a heavy focus with OPC1 coming in-house with the Asterias acquisition.

G&A expenses for the second quarter of 2020 were $3.9 million, a decrease of $2.4 million as compared to $6.3 million for the same period last year. The decrease was primarily attributable to the following reductions: $1.6 million in Asterias-related expenses; $200,000 in each of these expenses: compensation, accounting and investor and public relations; and $100,000 in these expenses: travel, rent and consulting. These decreases were offset by a $200,000 increase related to the cessation of shared services reimbursements.

Our loss from operations for the second quarter of 2020 was $6.4 million, a reduction of $4.4 million as compared to $10.8 million for the same period in 2019.

Other expense net for the second quarter of 2020 reflected other expense net of $100,000 compared to other expense net of $20.5 million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods as well as foreign currency translation adjustments related to Lineage's international subsidiaries. The value of Lineage's OncoCyte shares decreased by $21.4 million in the second quarter of 2019, which contributed greatly to the overall balance and other expense net for that period.

Our net loss attributable to Lineage for the second quarter of 2020 was $6.5 million or $0.04 per share as compared to a net loss attributable to Lineage of $30 million or $0.20 per share for the same period in 2019.

I'll focus my next remarks around cash management. As of June 30, 2020, cash, cash equivalents and marketable securities totaled $20.3 million. Additionally, the value of our note receivable due from Juvenescence as of this date was valued at $24.4 million. The maturity date of that note is August 30. So unless Juvenescence completes an IPO of at least $50 million in the next 24 days, the total amount of $24.6 million of principal and interest will become due and payable in cash later this month.

Cash management continue to be a priority at Lineage. I'm happy to report that net cash used in operating activities in the second quarter of 2020 was $700,000 lower than the first quarter of 2020 and net cash used in operating activities for the first 6 months of 2020 was $9.7 million lower than the same period in 2019. It has been a primary goal for us to substantially reduce our operating expenses from historical levels, but do so while advancing our programs in an efficient manner. As Brian has discussed, operating during the COVID-19 pandemic has been a challenge, but we have worked to keep our clinical programs moving forward while keeping a very careful eye on expenses.

We continue to look for ways to reduce our spend. As an example, we've been working to reduce our corporate footprint in the San Francisco area. Since we've reduced headcount, we don't need as much space. In the second quarter, we entered into a sublease for 10,000 square feet of our main building, and this will help us reduce our overall facility-related expenses. We're currently evaluating additional opportunities that could reduce our facility spend further.

In general, our second quarter cash activity was in line with our expectations. Our original 2020 net operational spend budget was $16 million. And as discussed last quarter, we anticipate a modest increase from that position during the remainder of the year, primarily related to the early exercise of our option with Cancer Research UK; our plans for the development of a vaccine against SARS CoV-2 and other coronaviruses; and delays caused by COVID-19 to our OpRegen clinical trial.

We continue to evaluate our assets and fund our operations by selling portions of our marketable securities during the second quarter. We sold about 2.4 million shares of OncoCyte common stock at an average price of $2.53 a share for gross proceeds of $6.1 million, and we continue to hold approximately 3.6 million shares of OncoCyte stock that was valued at $6.8 million as of August 4, 2020. Our ownership in OncoCyte is now at about 5.4%.

As Brian mentioned, it has been almost 3 years since this company has done a traditional equity financing. We have been able to successfully fund the transition of this company into an emerging leader in the cell therapy space, not through dilutive financings, but instead with a combination of smart but aggressive expense reductions and timely sales of our investments.

We are committed to demonstrating the power of our cell technology to treat various diseases and conditions. As Brian discussed, we now have a case of retinal restoration, which, to our knowledge, has never been reported before. This is extremely exciting.

Over the course of the next few months, Brian and I will be expanding our breadth of investor and analyst outreach and following our next OpRegen data release at AAO, we expect to advance the partnering discussions we've already been having with leading pharmaceutical companies and explore options for funding the next clinical trial.

With only a few patients to enroll in our current study, now is the time to get more people interested in our story. We are excited about the future, not only for OpRegen, but for OPC1 and the VAC platform as well.

With that, I'll turn the call back to Brian.

Thanks, Brandi. So moving next to things to look forward to in the remainder of this year. Our goal, as always, will be to continue advancing our clinic programs, but specifically, there are 5 things we plan to emphasize, which include 2 data updates. So first, we will meet this month with BARDA to discuss our proposal for nondilutive funding for a coronavirus vaccine candidate. We secondly, plan to report initial VAC2 clinical data from patients treated in the ongoing Phase I trial run by Cancer Research UK. We expect to complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and our new Thaw-and-Inject formulation in the ongoing Phase I/IIa clinical trial of OpRegen for the treatment of dry-AMD with GA. We plan to present new and accumulated OpRegen data at the AAO annual meeting, the second week of November. And we expect to meet with the U.S. FDA to discuss the further development of the OPC1 program now that we have advanced the manufacturing to a much more mature status. You'll also see us participating more at various events as we increase our engagement with the investment medical communities through virtual participation at medical and health care conferences as well as participating in things like podcast and interviews and similar communication channels that we can be sure to reach a broad audience with our progress and achievements.

So with that, I again, would like to thank you for joining us on the call today. And operator, the team here is ready for any analyst questions.

(Operator Instructions) We do have a question on the queue from Joe Pantginis from H.C. Wainwright.

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

Yes. So thank you for that question, Joe. So I think there has been an evolution in the thinking from the early days, and it's funny to say early days because they're not too long ago. But everyone was focused on appropriately, I'm sure, focused on the immediate response and antibody generation, neutralizing antibodies. And then as times gone on, and we've learned a little bit more about the virus, I think the preponderance of the content that's now out there seems to have migrated more and more toward the discussion around T cells and the role of the T cells in fighting viruses.

Now none of this is new to an immunologist, but there's 300 million amateur immunologists out there now. And so for us, it was an interesting idea early on to use the VAC platform, because the VAC platform relies on the power of a dendritic cell to deliver a message to the immune system. So whereas many vaccine approaches which exist today rely on the immune system to just naturally pick up antigens and hope that they get presented the right way and the message gets delivered, we sort of skip that first step. We force the message, right? First, we get to choose the message that we think is most important, and there's been a lot of work to already determine what parts of the virus are the most important, the most antigenic. So we get to a) choose which part of the virus is the most important signal. And then b) we prepackage that into the dendritic cell, which is the body's very best communicator of foreign material to the immune system.

And so we've already picked the best antigen and then we package it into the dendritic cell, and then c) we put it into the patient. And we can tell from our efforts in oncology that the patients' immune systems are recognizing this information that we're packaging and it's making it into the T cell, and it's being amplified. So when thinking about creating a coronavirus vaccine or really any kind vaccine, being able to affirmatively select the antigen that you think is the most important and then skipping that first step to hopefully ensure that you're getting a nice fidelity of message to the immune system and then knowing a priori from experienced clinical experience in other studies that we've been able to do that with other antigens. To us, you have to try that, right? It's just -- it's so logical to us.

Now there are definitely challenges. There are challenges that all of us have with respect to mass production and distribution and testing. And these are all roads that are, to a certain degree, being traveled by many companies today. But we were very pleased that one of our applications, this one in particular, the BARDA application did at least get picked up, make it through their first pass filter and I think I'd shared that the numbers there, they've only had something north of 400 of these meetings out of 3,500 applications. So I think it's encouraging. It doesn't mean anything, but at the same time, it's quite encouraging that we were able to have enough of a proposal to make it past that first pass. And we're going to press on. And if we're fortunate with either BARDA or someone else, that we can find supporters and champions for our approach that say that, "hey, this is something that we need to do because we have no ability to predict which company's approach [will work] (added by company after the call). I don't care how big they are."

There's no real way to predict who's going to be successful. And there may be subpopulations, there may be professional populations like health care workers that are more suitable for our approach. We're not going to try and be conclusive about that. We want to see if we can get past step 1, which is to find an external support for our work so that we can validate that our approach is worth much higher levels of investment going forward. I hope that addresses the question well enough.

No, it certainly does. And then my last question is, if you don't mind, I just wanted to switch back to the OpRegen data. So after the striking restoration data that you announced, I guess I would look at it this way. What kind of feedback have you been getting from the field? And how has it evolved from physicians in looking at that restoration data?

And I guess, I would say it's semi facetiously saying, look, I mean, are doctors saying, are they looking at it cautiously right now, saying this is an N of 1? Or are they is it along the continuum that says, look, you're just not expected to see this kind of data, but we'd love to see a few more patients? Or sort of where does it stand on the continuum right now?

Yes. That's a great question because it's -- I often make some version of the joke that you could show 100 cases of this, and investors would say, well, you haven't shown me 101 cases. So there's always sort of this eagerness to have more. The difference between 0 and 1, we think, is extraordinary. But there's still a big gap between 1 and 2. People always want to have some skepticism and think it's an outlier. And I think what is typical of something like this is that the folks that are most easily convinced tend more commonly to be the experts, right? It's people who understand what the images are showing, who have a frame of reference to appreciate what you've done.

So if I sit down with a generalist investor or I sit down with a retinal expert, and I show them what we have, it is far easier to get the retina expert excited about what we have, because they have an appropriate context or framework to evaluate what we have from a large database of historical evidence of what can and cannot happen in the back of the eye. Whereas the generalist has a great difficulty with that.

So I think that there's a continuum here that has more and more evidence for our approach, whether that includes retinal restoration or not, I mean, we were doing great even before we announced retinal restoration. I mean we're seeing things happening in the eye that we're very excited about. The restoration is like 8 feet of frosting on a 6-inch cake.

So we're really happy about what we've seen. But I do think that there's going to be, hopefully, not too gradual, but somewhat of a gradual continuum through experts in imaging, out to your retinal surgeons as the publications and things get out there and are more widely disseminated. And then out to your ophthalmologists and then you kind of make your way through. And as more and more evidence is piled on, it becomes easier and easier to pass through that way. So a shorter answer to your question is, yes, everyone would like to see it happen a second time. We think we know what was special about this patient, and we think we can reproduce it. But as I described in the presentation, it's challenging because it does take maybe as early as 6, but more probably 9 or even 12 months before you can see evidence of this because these things are growing so slowly in the back of the eye. But I just want to emphasize for everyone who is listening. It's not like a cut that can heal. These are unidirectional lesions. They only get bigger. So the fact that we are able to make one of them become smaller and show normal retinal architecture was really exciting to people who understand those images. And so we're just going to keep trying to generate more and more evidence of it. And those dominoes should start falling at some point.

Next one on the line is Dane Leone from Raymond James.

This is Bin Lu on for Dane. Just one from us. On the AAO update for OpRegen, can you just give a little bit more color on what we should expect and maybe how much more fall we could see?

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

Yes, thanks the question. The -- so AAO will be in the second week of November. Unfortunately, via a virtual meeting, but that's actually not a bad thing that the presentation will live on for a long period of time afterwards. But the goal would be to present all of the Orbit patients who have hopefully been enrolled by that point as well as the 3 additional Cohort 4 patients that were treated the traditional route as well as a safety profile for up to 5 years for our earliest patients. So it will be accumulated data for all patients and any data we have up to essentially the week before AAO.

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

Well, thanks, everyone. Again, I appreciate you joining us. I'm obviously excited about our plans. I think we've got a lot to look forward to this year. We appreciate the shareholder support, and we'll continue to position Lineage to be a successful leader in cell therapy and cell transplant medicine. Thank you, and have a great afternoon, everyone.

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