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Lineage Cell Therapeutics, Inc. (LCTX -3.51%)
Q4 2020 Earnings Call
Mar 11, 2021, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Ladies and gentlemen, welcome to the Lineage Cell Therapeutics fourth-quarter and year-end 2020 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 property of Lineage. And recordings, reproduction or transmission of this call without 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, Jeff. Good afternoon, and thank you for joining us. A press release reporting our fourth-quarter and full-year 2020 financial results was issued earlier today, March 11, 2021, 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, data updates, product candidates, planned regulatory meetings, clinical trials, planned manufacturing improvements, financing and cash management matters.

Such statements are subject to significant risks and uncertainties, including those described in our press release issued on March 11, 2021, and our most recent Form 10-K filing. 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. 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

Well, thank you, Ioana. And good afternoon, everyone. We really appreciate you joining us on the call today. Before I summarize some recent highlights and our financials, I first just want to remind everyone of three ways in which Lineage differs among the growing number of cell therapy companies you may hear about.

I sometimes say that we are pioneering a new branch of medicine, which is one of the many exciting things you've probably heard about the stem cell industry. But Lineage isn't a stem cell company. We don't put stem cells in people. We grow stem cells into great numbers, and then we convert those cells into these specific cell types which your body uses.

We then transplant those differentiated cells into your body to restore or improve function, which has been lost due to injury or disease. That means we're more of a self transplant company than a stem cell company. I wanted to begin with that important point today because there are significant biological differences between using our differentiated cells compared to the undifferentiated stem cells, which some companies and clinics work with. As one example of this, I'm often asked how our approach compares to adult stem cells or mesenchymal cells, which are usually harvested from places like bone marrow, fat or umbilical cords.

And the answer is that we aren't like them at all. Those are undifferentiated cells. Which in some cases might be enriched to create certain proteins or survive in certain environmental conditions, but that's not how we approach the diseases we're working on. We believe that if retina cells are dying, you need to replace and transplant retina cells directly to the eye.

If spinal cord cells are missing, you need to transplant replacement cells directly to the spinal cord. For this reason, Lineage resembles transplant medicine more than cell therapy. And that's an important point to keep in mind when evaluating what we believe are the lower risks and the potential advantages of our approach. The second thing to keep in mind is that all of our programs are allogeneic or off-the-shelf therapies.

We never remove cells from a patient, manipulate those cells and then inject them back into the patient's body. Those are autologous approaches and in some special settings, those indeed could be helpful, but they also are unavoidably expensive and difficult to scale because you're literally making a custom therapy for that one person. The Lineage product candidates are manufactured from a single common cell line, which was established and characterized more than two decades ago. Our therapies are designed to be pulled off the shelf, or in this case, from out of freezer and thawed and injected into the patient just minutes later.

The economics of an allogeneic therapy compared to an autologous therapy really speak for themselves. But as I like to say, unless you're working in a disease with unlimited pricing power, if you are not off the shelf, then you're going to be left on the shelf. The third thing is, I want to remind everyone that our platform and with it, much of our patent estate, relies on something called directed differentiation. That means that we harness natural steps in the developmental pathway in order to manufacture ourselves.

We never manipulate or edit the genomes of ourselves as part of the manufacturing process. While the risks of gene editing are still being assessed, it's clear they do exist. But fortunately, that's not something Lineage has to worry about. Our cells are extensively characterized for both form and function, and in all cases, a single cell line can be expanded to supply the commercial needs of any size market.

These advantages help establish our belief that our platform technology has a lot of potential, not only in these conditions, but also may be able to produce additional product candidates beyond dry-AMD, spinal cord injury and cancer. Pluripotent cells can become any of the cells, which comprise the human body. So we have a large variety of conditions to which our cell therapy technology could be applied and clinically evaluated. And as we continue to generate encouraging data, on both the safety and efficacy of our three current cell transplants, we'll also look for opportunities to investigate new applications of our technology and potentially address additional diseases, either on our own or through strategic alliances.

Our belief is that our approach will prove increasingly compelling so that Lineage can emerge from the background of cell therapy companies to become an important pioneer in what we might more accurately call the cell transplant revolution. Of course, that plan only works if we first establish some success with our initial endeavors. So I now turn to a quick review of last year's accomplishments and set some expectations for you in the year ahead. I'll begin with OpRegen, our product candidate intended to treat dry age-related macular degeneration with geographic atrophy.

This disease is caused by the progressive loss of retina cells and is a leading cause of blindness in developed countries. Approved therapies do exist for wet-AMD, and they generate billions of dollars in annual revenue. But despite dry-AMD being eight or nine times more common than wet-AMD, there are no FDA-approved therapies for the dry form. This paucity of treatments may be due to the fact that by the time a patient is experiencing retinal cell death, the extent of damage may be beyond what small molecules or antibodies can provide.

Our approach is to transplant brand-new retina cells to replace or support the ones that have died off or are dysfunctional. And by doing so, we believe we may be able not only to slow the disease process, but also potentially 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 over competitors developing traditional drugs or biologics because those require monthly or semi monthly injections directly into the eye. In November of last year, we completed enrollment in our Phase 1/2a clinical trial of OpRegen and reported updated results from this study.

At that time, new data were presented on 20 patients, including eight patients in Cohort 4 of the study. We're especially interested in the Cohort 4 patients because they have better baseline vision and smaller areas of GA, which is a profile consistent with the patient profile we believe will lead to better outcomes from our treatment. The data we reported showed improvements in visual acuity in the majority of Cohort 4 patients when compared to their untreated eyes. But with the duration of benefit extending to as long as 24 months, which is the longest period for which data was available for those patients, a trend toward slower GA growth also was observed as was previously reported structural improvements in the retina and decreases in drusen density.

And overall, OpRegen continued to be well tolerated in all patients treated to date. Last year, we also made the first known clinical report of retinal tissue restoration, which had persisted to 23 months and with durable improvement in the patient's visual acuity. This is an unprecedented finding because humans lack the ability to regrow or repair retinal tissue. Most of our competitors are attempting to slow the rate of disease progression.

But data from our transplant approach supports the hypothesis that OpRegen may be able to actually reverse dry-AMD and rescue tissue, especially in an earlier stage patient. We've taken steps to see if we can replicate this finding in patients which were treated last fall. Those patients recently had their three months follow-up visit. So we will be monitoring them closely because of the time frame for which we potentially would see this restoration phenomenon is now coming into range.

Our plan is to evaluate these patients for changes before the ARVO conference in May. And if at that time, there's something notable to report on retinal restoration, we would plan to do so in connection with that event in order to maximize awareness and evaluation of any findings. We also intend to provide another interim data update around ARVO, which we expect will be informative because, although it's wonderful to see benefits as early as two or three months in, we really want to have four to six months of data before we consider a patient to be benefiting from our treatment. This means you can look forward to two separate and near-term updates from Lineage on the OpRegen clinical study.

The first one toward the end of this month and then the second one in May or June. Thereafter, in the third quarter of this year, we plan to speak with FDA about next steps for development. So overall, there will be a lot to watch for with respect to the OpRegen program. Moving next to OPC1, our oligodendrocyte transplant program to treat cervical spinal cord injury.

You may have seen mention of this program in the Wall Street Journal today, and I'm expecting this program will receive additional publicity as we continue to make progress with it. OPC1 is a one-time surgical implantation of specialized cells plays 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 run as high as $5 million.

But just like dry-AMD, there currently are no FDA-approved treatments for spinal cord injury. Over the past year, the Lineage team successfully deployed a new manufacturing process, which led to significant improvements in the production and quality of OPC1, including to areas like scale, purity, reproducibility and other attributes, which enhance the commercial viability of this product candidate. Our team also developed a new thaw-and-inject formulation of OPC1, enabling its use at a much larger number of spinal core treatment centers, which will help accelerate enrollment in the next clinical trial. Along the way, we were able to eliminate the dose preparation steps, reducing overall logistics of preparation at a qualified cell prep lab from several hours to just a few minutes in the OR, and in doing so, reduce the logistics costs by approximately 90%.

With these manufacturing improvements in place, we next announced an exclusive option and license agreement with Neurgain Technologies, a medical device company, which gives us access to a novel and convenient delivery system. 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. We plan to collaborate with Neurgain and the affiliate Maracugina at UC San Diego on the preclinical and clinical testing of this novel system. The Neurgain PSD is expected to be a much better option than the complicated gantry, which was utilized in the first clinical trial, and it will allow us to incorporate our new than on inject formulation described before as enabling faster patient enrollment by access to a larger number of clinical trial sites.

Most importantly, since the PSD system could eliminate the need for a patient's respirator to be turned off during the procedure, this should facilitate a measured and targeted transplantation of cells to the affected area, which may reduce procedural risk and improve patient outcomes. Our plan is to evaluate the Neurgain PSD to safely and effectively deliver OPC1 cells to the spinal cord throughout this year. These manufacturing and delivery steps have helped us to lay the groundwork to prepare OPC1 for a later-stage clinical trial and building upon the positive data from the previous Phase 1/2a clinical trial. Looking ahead, we plan to request an RMAT meeting with the FDA during the second quarter of this year, at which we will discuss our plans to evaluate the new delivery device.

We also intend to request to meet with the FDA in the fourth quarter of this year to discuss improvements we've made to the OPC1 manufacturing process, as well as our clinical development plans moving forward. Once these meetings are complete and assuming GMP manufacturing has been successfully completed as well, we expect to be in a position to initiate a large-scale comparative clinical trial next year. We believe the next study of OPC1 can be positioned as a registrational study, and we will seek to gain agreement with the FDA on this path. Next, I'll move to back to VAC2, our off-the-shelf dendritic cell cancer vaccine.

Dendritic cells are the most potent antigen-presenting cells in the body, and we harness their activity to deliver handpicked antigens, an approach which is reemerging as 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 to deploy the body's immune system about which cells it should attack and eliminate. Last year, we exercised our option with Cancer Research UK to bring the VAC immuno-oncology platform in-house. And thereafter, we reported encouraging preliminary Phase 1 clinical results in non-small cell lung cancer patients.

Specifically, VAC2 demonstrated potent induction of immune responses in all four patients tested to date, providing us with mechanistic validation and reinforcing data obtained in autologous VAC1 clinical trials conducted by Asterias and Duke University. Antigen reactive pentamer staining induced by VAC2 and further supported by ELISPOT data, suggested that VAC2 is highly potent, inducing significantly higher levels of antigen-specific T cells compared with the levels invoked by alternative approaches such as the DNA and RNA-based vaccines. Our partner Cancer Research UK is responsible for this study and enrollment of the last few patients has unfortunately been impacted by COVID restrictions across the U.K. However, I'm pleased to share today that the seventh patient in the study was recently and successfully enrolled and CR-UK anticipates that the final patient will be enrolled in the coming months.

Following completion of enrollment, we anticipate additional data from this study will be available around the fourth quarter of this year. We believe the best path ahead for VAC2 may be to evaluate in combination with therapies considered biologically synergistic with a dendritic cell vaccine, such as chemotherapy or the immune cell protected properties offered by checkpoint inhibitors. That path could also involve a potential partner that has already commercialized such a synergistic therapy. But first, we have a number of improvements and modernizations we'd like to make on the manufacturing side which will help prepare VAC for further trials and provide competitive advantages for future programs we may design.

Our manufacturing team was recently directed to begin work on production enhancements which we believe will increase the commercial appeal and utility of the back platform, just like we did to create value and competitive carriers with OpRegen and OPC1. As part of this manufacturing enhancement, we also aim to enhance the flexibility of the back platform because you could theoretically insert any antigenic trigger into the dendritic cells, that means that the VAC platform is capable of producing nearly a limitless number of product candidates, each one being distinguished by the specific antigen, which the dendritic cells are carrying to the patient's 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 carefully selected antigens. An improved back platform could permit us in the coming years to generate a deep pipeline of unique product candidates, each targeting a different type of cancer.

And we feel this product platform nature of VAC will enable us to become a more prominent player in the immuno-oncology field, especially as we validate and mature the production process, scale and other attributes of the VAC platform. Overall, I believe we've made rapid and valuable progress with all three of our programs, increasingly converting what began as interesting science projects into rigorous clinical data packages for product candidates with attractive commercial profiles. As we further advance these programs and prepare them to enter later-stage clinical trials, we believe Lineage is on the right path to create significant value for patients and shareholders. And in addition to the product development strategy I just described, we also have conducted a series of business and financial transactions which are designed to help build value over the longer term.

As one example, we incubated and funded the early product development of OncoCyte, which today is a revenue-generating cancer diagnostic company with a market cap of over $300 million. Over time, we have been able to convert our ownership position in companies like OncoCyte and another public company we spun; out, AgeX, and convert those ownership positions into cash to fund our clinical programs without the need for traditional financings. With our broad technology platform, we may find additional opportunities to do this in the future. More recently, we announced sales from our ATM program.

And when combined with sales of marketable securities we own, this has provided us, as of March 5, with approximately $57 million of cash and cash equivalents. That capital is expected to fund our operations well into 2023, which will allow us to deliver multiple significant milestones and provide us with flexibility with respect to our partnership discussions. I'll highlight next, our balance sheet accounts and statement of operations for the fourth quarter of 2020 and full-year 2020, a more detailed view of our comparative spending for these periods can be found within our earnings announcement filed earlier today. We ended 2020 with $32.6 million in cash and cash equivalents.

During 2020, we funded our operations primarily by receiving $24.6 million from juvenescence, and by selling a portion of our positions in OncoCyte, AgeX and Hadasit Bio-Holdings, the latter of which collectively provided us with an additional $13.1 million. We also raised more than $5 million in gross proceeds in 2020 from sales on our ATM. Between January 1, 2021, through March 5, 2021, we continue to opportunistically utilize our ATM, adding nearly $20 million in additional gross proceeds, as well as $10.1 million in additional gross proceeds from sales of OncoCyte shares. As of March 5, 2021, we continue to hold approximately 1.1 million shares of OncoCyte stock valued at $4.2 million on that date and just over 169,000 shares of Hadasit stock valued at $330,000 on that date.

Consistent with our prior cash management strategies, we were able to make timely decisions about when to conduct sales of our marketable securities or the ATM in order to help fund our business. Next, I'll turn to the statement of operations for the fourth quarter of 2020. Total revenues for the fourth quarter of 2020 were $400,000, a $900,000 decrease from the same period in 2019. This was primarily due to the absence of a $600,000 upfront payment from a new license agreement in 2019, as well as the completion of NIH grant activities in 2020.

Operating expenses are comprised of both research and development expenses and general administrative expenses. And total operating expenses for the fourth quarter of 2020 were approximately $6.1 million, a decrease of $1.9 million as compared to the same period in 2019. The decrease was comprised of a $900,000 decrease in R&D expenses and a $1.0 million decrease in G&A expenses. Our loss from operations for the fourth quarter of 2020 was $5.9 million, a reduction of $1.0 million as compared to the same period in 2019.

Our net income attributable to Lineage for the fourth quarter of 2020 was $2.0 million or $0.01 per share, as compared to $4.5 million net loss or $0.03 per share for the same period in 2019. The position of net income was driven by unrealized gains on our marketable securities, as well as due to foreign currency exchange rate fluctuations, which are largely impacted by the remeasurement of U.S. dollar-denominated notes payable by self-care neurosciences to Lineage. I'll now take a brief recap of the full-year 2020.

Total revenues for 2020 were $1.8 million, a decrease of $1.7 million as compared to 2019. The decrease was primarily due to decreases of $1.0 million in grant revenue, $400,000 in royalties from product sales and license fees, and $300,000 in the sale of research products and services due to the cessation of such sales. Total operating expenses for 2020 were $27.9 million, a decrease of $14.1 million compared to the same period in 2019. The decrease was comprised of a $5.6 million decrease in R&D expenses and an $8.5 million decrease in G&A expenses.

Part of our goal from the Asterias merger was to implement significant cost reductions and achieved synergies from putting the two companies together. And we obviously were pleased to see this plan pay off in terms of significant expense reductions year over year. Our loss from operations for 2020 was $26.4 million, a reduction of $12.4 million as compared to 2019. And our net loss attributable to Lineage for 2020 was $20.6 million or $0.14 per share, as compared to $11.7 million or $0.08 per share in 2019.

The variance in our net loss numbers year over year are significantly impacted by changes in the value of our marketable securities and equity investments for the applicable periods. While these fluctuations are important, we tend to utilize loss from operations as a more relevant measure of performance in regard to moving our clinical programs forward while effectively managing our expenses. Overall, our fourth-quarter cash activity was in line with our expectations, and we were able to maintain our 2020 quarterly burn of approximately $5 million due to our sustained cost reduction efforts throughout the last year. We also expect our first quarter burn for 2021 to be in a similar range, excluding the three following additional expense items.

Our second installment payment of roughly $700,000 to Cancer Research UK for the early exercise of VAC2, a $500,000 payment to Gyroscope for an extension of the period during which we have an exclusive right to negotiate a definitive agreement, and the payout of our annual bonus compensation. These expenditures will be offset by the 2021 fundraising activities I mentioned earlier when discussing our balance sheet highlights. So to wrap up the financial section. I can say I'm very happy with the progress we have made in 2020 because heading into 2021, we're equipped with a healthy balance sheet, which helps us fund our operations well into 2023, and drive our clinical programs forward.

So to conclude, Lineage and others in the field of allogeneic cell therapy are helping to demonstrate the viability and commercial potential of using allogeneic cell transplants to treat or cure serious diseases or conditions that represent major unmet medical needs and large market opportunities. And as the tools and methods used to manufacture and test these therapies and patients are reaching maturity, public policy and investor support for cell therapy has moved in a positive direction. As we prepare to advance our product candidates into later-stage trials, we're working to position Lineage to benefit from this convergence of positive factors and help to accelerate the development and commercialization of this novel branch of medicine. Specifically, some of the events and milestones that our shareholders can look forward to include presenting OpRegen data from the ongoing Phase 1/2a clinical study, as I said, toward the end of this month, and again in the second quarter of 2021, planning to meet with FDA to discuss further clinical development of the OpRegen program, which is anticipated in the third quarter of 2021, completing patient enrollment in the ongoing Phase 1 study of VAC2, which is anticipated in the 2021, evaluating the near gain parenchymal spinal delivery system, which has already begun and will continue throughout 2021, completing the OPC1 manufacturing to support a late-stage clinical trial, introducing manufacturing enhancements to the VAC2 program, which is already under way and will continue throughout this year, reporting results from the ongoing Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer, which is anticipated around the fourth quarter of 2021, and evaluating partnership opportunities and the expansion of existing collaborations for OpRegen, OPC1 and VAC2.

At Lineage, we have an opportunity to make a profound impact on millions of people, and the patient serves our inspiration every day. I appreciate all of you joining us this afternoon. And we appreciate our shareholders' support as we position Lineage to become a leader in cell therapy and cell transplant medicine. And with that, operator, I am ready to respond to any analyst questions, which we may have.

Questions & Answers:


Understood. [Operator instructions] Your first question comes from the line of Joe Pantginis from H.C. Wainwright. Your line is open.

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

Hi, Brian and Ioana. Thanks for taking my question. Hope the two of you are doing well. Brian, I have three questions.

The first one might be a simple yes or no, but I just want to make sure. Regarding your prepared comments on VAC2, you also talked about manufacturing improvements around that as well. But is it safe to assume, I don't want to put words in your mouth, that any manufacturing improvements would really impact the entire VAC platform, as you said, you can have almost a limitless amount of potential assets?

Brian Culley -- Chief Executive Officer

Yeah. Thanks for the question, Joe. I think our expectation is the answer is a simple, yes. The dendritic cells are carriers.

You can think of them as just being just the messengers, the important part is -- and the specific part is the message which they carry. So if we are able to improve things like scale, purity, reproduction, efficiency of introducing the antigen into the cells, all of those should be applicable to all of the programs, which we might imagine, whether our own or partnered so it is -- that's where we see a lot of value in that program is that we can conduct a series of steps that are going to be applicable to everything that we do in oncology rather than having to go through all of those steps for each and every program. So I think the answer is yes. We don't have a reason to think that we would have to do that and make each production or each cell line unique, we think that we can capitalize on the commonality.

And then the only variable becomes the antigen. And so what we need to sort out is how does that look to the regulators? Certainly, with autologous approaches, there appears to be a lot of flexibility, considering that you've got essentially a different product every single time. So we would hope to capitalize on some of those economies of scale in our production system.

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

No, that's helpful. Thanks. And I realized the way I asked the question might have come across as if it was a congressional hearing. I was like, a yes or no will suffice.

So sorry about that. So my next question is just switching to your finances. You've been very active lately, obviously, with different raises, selling some of your OncoCyte, etc. And you also just filed a new S-3 shelf filing.

So obviously, the fact that you're well funded well into 2023 is a good thing to protect investors in my belief. But I guess, maybe can you comment on sort of the big picture of your overall financing strategy based on your recent moves and maybe looking toward the future?

Brian Culley -- Chief Executive Officer

Yeah. Sure. I'm happy to, Joe. And you probably know I'm largely incapable of providing just a yes or no answer.

So we did provide a lot of detail in the press release recently, but I realized that most of that content is focused on the actual transactions and doesn't really speak to our strategy and the success that I think we've had with it. I would say there are three big takeaways from recent financing news and events. The first and foremost is that we now have more than two years of runway. And when you look at what we have done in the past two years, you can imagine there are a lot of milestones we expect this capital will help us reach in the next two years, including having two separate programs in late-stage clinical trials.

The second point is that rather than doing a traditional financing with the higher fees and the discounted pricing that's often associated with that option. We were able to take advantage of our rising share price and higher trading volume to raise a fairly meaningful amount of money, and that can create leverage, which we can use to oppose talk of financing overhangs or of getting pushed around in partnership negotiations. And third, I'd say is that a large amount of the capital that we have raised has come from selling equity in public companies we originally created like OncoCyte and AgeX. And we've been able to create value from noncore assets that way and use that to fund our main business.

So it might be forgotten, but I think it's worth mentioning that we haven't had to do a traditional financing in more than three years. And I don't know how many biotech companies can say that, but I imagine it's a small number. And with our large patent portfolio, we may have additional opportunities to spin out new regenerative medicine businesses. So from time to time, you're going to see things like the registration statement, which we filed today, because it gives us the flexibility to raise capital and management thinks it's prudent housekeeping to have the ability to access the capital markets quickly if and when it makes sense for us to do so.

But that -- we'll invest the money in the right way. And I think, overall, we take a creative and diversified approach to funding the business and try to do so in a minimally dilutive way, which obviously helps to protect share price and create value for shareholders.

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

Got it. That's really helpful. And then my last question is around OpRegen. Obviously -- well, not obviously, but since it's your lead asset in the upcoming data.

So you gave a nice teaser, I think, about the upcoming ARVO data, but I was hoping to get more color, not only around that, but about what kind of expectations we might have for the data update by the end of this month with, ultimately, I think you said we might be starting to get to the point with some of these patients getting to the time part where we might see additional regeneration. So I guess that's like, a, the highest anticipation factor which we might be getting to. But what kind of expectations we have around data this month and in May?

Brian Culley -- Chief Executive Officer

Yeah, I'm not surprised for that question. So I guess, a two-part answer. One is that we have for some time now, said that we plan to provide a three-month update. So we enrolled a bunch of patients in the fall, and that's going to nearly double the number of Cohort 4 patient data that we have through three months.

So people are going to want to be looking for continued trends with these additional patients. Three months is early, but if we see any patients starting off well, I think that's a good sign. We also will report on not one, but two patients. That's new.

I don't want to give away everything. But we have not one but two patients that had a modified immunosuppression regimen. We'll have updates on the Orbit device, overall safety. But restoration, I understand was what everyone is really keen to hear something about.

You're correct that we first saw restoration fairly late. It was at a nine-month visit. But we don't know when it became detectable only that it was after three months. So we didn't see it in three months, and we did see it in nine months.

So the reason that there's such a big window there is that in our protocol, we don't do every form of imaging at every appointment. Too many visits can be onerous for the patients, the sites, and frankly, the GA doesn't change that much month-to-month. And then no one expected that retinal restoration was going to occur. So there was no reason to put a whole bunch of atypical assessments in place.

So what that means is that any new evidence of restoration could become visible at month four or month six or month eight, but we wouldn't necessarily see it as soon as it's evident. We have to wait until it gets picked up in one of these routine imaging visits. However, we do know that the time frame was between three and nine months, and that's the same time frame we're now in with the additional five patients who were treated in a similar way to the prior patients. So we have to wait and see.

And if we do see more restoration evidence, we certainly will report it shortly after it's validated by third parties. So we're entering the zone of highest interest right now.

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

No. That's really encouraging. Looking forward to it. And thanks for all the color, Brian.

Brian Culley -- Chief Executive Officer

You bet. Thank you, Joe, for the questions.


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

Jason McCarthy -- Maxim Group -- Analyst

Hi, Brian. Thanks for taking the questions. A couple of questions. First, on the OPC1 program.

We've seen positive data, signals of efficacy. Thus far, you had mentioned that potentially moving toward a Phase 2, which could be a registrational trial in 2022. What do you think the size of that trial and the parameters around that trial could look like. And I'm asking because we're watching AbbVie with lampalizumab, right there in the Phase 2 50 some-odd patient trial.

I'm not sure if that's for registration or not, but they did get fast track and orphaned. And we could see that data while you guys are working up toward your Phase 2 clinical registration trial. Can you give us a little bit more color on how you think about that?

Brian Culley -- Chief Executive Officer

Yeah, certainly, Jason. It's a very nice question because there is no precedent, right? We don't have anything approved with cell therapy or act on growing molecules. So it's an unknown. However, there are some, I would say, reasonable boundary conditions.

So one rule of thumb is that FDA likes to see at least 100 exposures to a therapy in order to get a good sense of safety in particular. But we also do have examples of various treatments, especially in orphan indications, where a smaller number of patients can provide the basis for an approval. So I don't know the answer because we haven't been able to go to the agency and have that discussion. But I think that it is probably capped at 100 and I think it's going to be driven in part by your one's expectations as to the clinical benefit.

Now there are some things that we might think about doing in terms of the balance across the arms and how we build a statistical plan and which assessments that we use. So different assessments can, of course, give you different kinds of statistical power. If you're looking at a responder's analysis, if you're looking at a certain event compared to if you're looking at continuous variable, you might have more statistical power because you're looking at the area under the curve. So it's really difficult for me to say it's likely to be x number of patients.

But what I can say is that I think 100 is probably a reasonable ceiling that one might expect. But the details of that, really, that's going to be known to us later than today. We can just project it for now.

Jason McCarthy -- Maxim Group -- Analyst

And then on the cell therapy side, just in general, you had mentioned in your opening remarks about -- or very specifically about what Lineage does with differentiated cells that integrate and go in and actually correct the tissue that's there versus something like MSCs. And we've been seeing this tremendous shift in the cell therapy space. And you could look at groups like Sana and Bear, and Vertex actually just moved into a type 1 diabetes study today or yesterday, how important is it that bigger players are now moving into a space that Lineage is in already? And then similarly with the most advanced clinically asset relative to everybody else in the space, even these bigger players. How does that bode for Lineage going forward?

Brian Culley -- Chief Executive Officer

I love it. There's a little bit of the curse of the front runner here. When you're a little bit ahead of everyone, people who are looking for parallels or comparables, they simply don't have as much data or evidence or reference points to evaluate you. So on one hand, you say, oh, there's a paucity of competition.

That's great. But on the other hand, how do you value a company like ours because there aren't a lot of examples. So I would say that I am delighted to see companies like Blue Rock and Sema and Sana being recognized and rewarded with high valuations because I think now we have greater reference points. And the fact that those companies and maybe some others that we could add to the list, aren't operating in our specific space means that we get all the benefits of technological corollary without the penalty of direct commercial competition.

So I think it's a good thing for Lineage. And I think that it is ultimately going to be good for the space because it's going to draw more attention and recognition that there are places and settings and diseases for which cell therapy is probably a better choice than the traditional small molecules and antibodies.

Jason McCarthy -- Maxim Group -- Analyst

It's a great answer. We couldn't agree more. Thanks, Brian.

Brian Culley -- Chief Executive Officer

Thank you, Dr. McCarthy.


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

Keay Nakae -- Chardan -- Analyst

Thanks, Brian. Let me just talk about the new delivery device for spinal cord injury. First of all, in terms of its ability to allow the practitioner to lay down both geographically with more accuracy and the amount of sales, can you talk about those capabilities?

Brian Culley -- Chief Executive Officer

Yeah, the -- yes and no. And the no part is that we haven't tried it in a human yet, so we don't know. But from a design consideration, there are a number of advantages to the new device. So the assembly itself is smaller and it uses fewer components.

It can provide single hand operation for the XYZ positioning. So if you think of three axis, the needle depth which is a really integral component here, has greater accuracy. And the connections between the component parts, there are fewer of them. They're all little tighter.

So you've got less, let's say, wiggle to the device. Now really, the big advantage here is being able to administer cells more slowly. But one of the things that is often underappreciated with cell therapy is it's not just the cells. It's the delivery and the placement is nearly as important as the active agent.

So having a tool that we think can do a better job of placing the cells into the area injury will be beneficial. But the cells do have the ability to migrate a little bit. So it's not like landing a rover on Mars, and you got to have it on the bottom of the crater where it's really flat. You do have a little bit of flexibility but we think that the improvement here reflects the normal evolution of a new technology and that ultimately, clinical outcomes will be improved as you get better at not only the quality of the cells that you're putting in, but also how and where you place them.

I think we're seeing that with OpRegen, and I think we're going to see that with OPC1.

Keay Nakae -- Chardan -- Analyst

And then just in terms of, I guess, the ability or how quickly the practitioner can be fast on with the device, are you able to at least start on to davers? And what does that experience like in terms of how quickly the practitioner can get up to speed and feel comfortable using the device?

Brian Culley -- Chief Executive Officer

There's a high degree of familiarity with the device. You've got your XYZ manipulator. And the differences sometimes just come down to how big is the knob, but directionally, the positioning of the syringe and the micro drive assembly, which holds the syringe is very familiar. Ultimately, what you're talking about is your angle of insert and your depth.

Those are the two most significant components. So I think the learning curve for this will be relatively low, but that is one of the things that we are going to be investigating. There's probably a good case to be made to do extensive first animal and then could daver testing to demonstrate and get specific answers to your question. And we will be doing exactly that in cooperation, not only with Neurgain, but also the neurosurgeon team at UCSD, which helped to design and develop this new PDI system.

Keay Nakae -- Chardan -- Analyst

So just a final question to wrap that up. Any sense of what the FDA is going to want to know, understand about these types of issues before they let you go forward in humans?

Brian Culley -- Chief Executive Officer

Nothing specific. It's different than what we have with, for example, the OpRegen program because there, we know that the device has already been 510(k) cleared. So we don't have that same status. So when we think about approaching FDA.

One of the things that we are going to want to do in meeting packages is to provide the sort of comfort and experiential data to say that this is a good tool and that it can be well adapted. We don't yet know exactly what the testing expectations or criteria are going to be, which is why we're planning next quarter, which really isn't too far away now, to request an RMAT meeting to have a conversation about the device and to see what kind of learnings we need to provide to support its use and part of that is almost certainly going to include some of the expert, call it, testimony that the device can be readily adapted to this patient population and that for the delivery of our cells, that it would be an official to be using something like this as opposed to the original scaffolding equipment, which potentially could lead to errors because it's a little bit more complicated.

Keay Nakae -- Chardan -- Analyst

OK. Thanks.

Brian Culley -- Chief Executive Officer

You bet. You bet. Thank you, Keay.


[Operator signoff]

Duration: 51 minutes

Call participants:

Ioana Hone -- Director of Investor Relations

Brian Culley -- Chief Executive Officer

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

Jason McCarthy -- Maxim Group -- Analyst

Keay Nakae -- Chardan -- Analyst

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