Image source: The Motley Fool.
Lineage Cell Therapeutics, Inc. (LCTX -4.17%)
Q1 2022 Earnings Call
May 12, 2022, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
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 website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. And recordings, reproductions, 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. Good afternoon, and thank you for joining us. A press release reporting our first quarter 2022 financial results was issued earlier today, May 12, 2022, and can be found on the Investors section of our website. Please note that today's discussion will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, plans, aims, objectives, thoughts and belief, the future price of our stock, our competitive advantages with respect to competitors, our development programs, our product candidates, platform and pipeline and their potential therapeutic applications, commercial potential and potential value, the timing of our announcement of additional product candidates, clinical trials, data updates, future payments, transfer of expenditures, and activities under the collaboration with Roche Genentech.
Our ability to enter into additional collaborations or partnerships anticipated benefits and opportunities from our existing and potential future collaboration, the achievement of milestones, anticipated regulatory meetings and interactions, planned manufacturing improvements, our cash management, runway and need for capital, our anticipated growth, and our commercial opportunities. Statements made during this discussion that are not statements of historical facts should be considered forward-looking statements, which are subject to significant risks and uncertainties. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to known and unknown risks, and uncertainties. We caution you not to place undue reliance on any forward-looking statements, which speak only as of today and are qualified by the cautionary statements and Risk Factors in our filings with the SEC, including in our annual report on Form 10-K filed on March 10, 2022, and our quarterly report on Form 10-Q filed today, May 12, 2022.
With us today are Brian Culley, our chief executive officer; and Gary Hogge, our senior vice president of clinical and medical affairs. Unfortunately, our CFO, Kevin Cook, is dealing with an unexpected family emergency and won't be able to join us. Brian will provide some prepared remarks, and then he and Gary will be available for questions from analysts. With that, I'd like to turn the call over to Brian.
Brian Culley -- Chief Executive Officer
Thank you, Ioana, and good afternoon, everyone. We appreciate you joining us on the call today. As I did on our last call, I'd like to start off with some comments addressing the challenges currently facing the biotech industry. Unlike other sectors for which the supply of raw materials may become increasingly scarce for which a technological or social disruption could alter its fundamentals.
Human beings will continue to get tickled and hurt and they will continue to rely on and support the valuable innovations, which the biotech industry has delivered for decades. So we believe the current sell-off in biotech is an overreaction and that better days will return to our sector. In the meantime, each of us need to determine what steps, if any, we ought to take in response to current events. And my two aims for today are first, to review how I believe Lineage is very well-positioned to navigate the current biotech bear market; and second, to talk about some of the steps we're taking in response to this new environment, steps which we believe will help position us to be one of the companies which can outperform its peers this year and next.
With respect to Lineage being well-positioned today, several important attributes come to mind: cash on-hand, near-term milestones, and our fundamental profile. With respect to cash, we are comfortable that we have multiple years of cash on hand, and we have no need to raise money at these currently unattractive prices. Our reported cash and cash equivalents as of Q1 were approximately $78 million. And for reference, our net operating spend for each of the past two years has been less than $25 million.
While our 2022 spending is likely to be above our historic levels, given our clinical ramp and expanded pipeline, we nonetheless have multiple years of cash to support progress with each of our programs. And by the way, that runway does not include any of the milestones, which we may receive from the Roche Genentech deal over the next two years. So overall, we feel quite good about our cash position. Moving next to our program milestones.
We have a lot of important objectives we're working toward. In the near term, we're working to provide shareholders with a diverse and incremental set of clinical and regulatory events, which are not dependent on the clinical performance of just one asset, but which can still provide much-needed clarity on our developmental programs and in some cases, can help derisk or increase the value of our assets prior to their entering subsequent clinical trials. For specific goals for this year in the clinical and regulatory area, which I'd like to highlight for you today include: first, initiating a clinical safety trial of our new and improved delivery device for OPC1, which is expected to enroll between five and 10 patients and which will include, for the first time, administering OPC1 to patients with chronic spinal cord injuries, not just subacute injuries. Second, meeting with FDA to discuss improvements we've made to the OPC1 manufacturing process in areas such as purity and production scale.
Third, submitting an IND for our VAC2 program to support additional clinical testing of VAC2 in the U.S. and build upon the data generated by Cancer Research UK in non-small cell lung cancer; and fourth, generating preclinical data to support a pre-IND meeting with FDA for our new auditoring Neuron program. We, of course, have additional goals for this year, but these four, in particular, represent milestones which will provide some regulatory and spending clarity and potential derisking of our programs. And we believe execution of these goals will continue to demonstrate our ability to successfully advance novel cell therapy product candidates, which will be an important corporate message we aim to emphasize this year.
The third item, which I mentioned at the outset is our fundamental profile. We believe in this challenging environment, investors will work even harder to find the companies which they believe will outperform in an economic recovery. Being identified among those screening efforts can be enhanced by having attractive fundamentals. Now I've already discussed our cash position and planned activities, but I believe Lineage offers additional characteristics, which can help make us an attractive investment.
For example, we believe our spending levels reflect our commitment to capital efficiency, which we will continue to employ. We also have the ability to create new development programs from our platform without spending capital on external licenses and have demonstrated that capability with our new hearing loss program. We also have proven our ability to close on corporate partnering transactions through one of the largest ever licensed deals in cell therapy outside of oncology, which puts us in the envious position of working to repeat this success rather than trying to achieve it for the first time. And we have assets which we believe can form the basis of additional corporate partnerships.
So going back to my comments about the importance of being well-positioned in three categories, those categories being cash on hand, near-term milestones and events and one's fundamental profile. I feel very good about our overall situation. So turning next to the second of my two aims for today. I want to say a few things about how we're adapting to recent changes in the biotech landscape.
This also features three key principles: communications, operations, and business development. Starting with communication, we do not believe our company is well known and that it's important to be able to highlight what we can offer to shareholders. So we have adjusted our investor targeting to better align with feedback we've received about investors' mindset, and we continue to refine our key messages. I understand that sometimes it's difficult to see the fruits of those labors and current share prices, but we believe these efforts have been helpful to add new owners.
We welcome you new owners, and we will continue to engage and broaden awareness for the company and our objectives. We also have seen an increase in the number and quality of our investor meetings, which we believe reflects the team's recent performance and our future potential, particularly on the heels of the Roche Genetech Alliance and the ARVO presentation of the full set of OpRegen clinical data earlier this month. Second, we constantly review our operational plan to ensure it is appropriate for the business environment. We've all seen announcements lately from companies reducing their pipelines or reducing their headcount to achieve what they are calling operational efficiency.
Now I don't know why they weren't being efficient to begin with, but Lineage always works to be efficient. One advantage we have in this area is that our development programs share common features, in particular, our emphasis on high-quality large-scale cell manufacturing. So we're able to achieve economies of scale by allocating a single, highly trained team across all of our cell therapy programs and avoiding the expense or duplication of adding entire new teams for each new program which we launch or suffering the pain of having to choose which programs have stopped funding. In fact, while I read this week that 48 biotech companies have recently announced staff reductions this year, Lineage has been adding positions in key areas.
As one example, we recently made a new hire in business development, which is a convenient segue to my third point. Third point I wanted to make about us adapting to the new environment is that we are putting an even greater emphasis on business development this year. We obviously have had some success in this area reflected by our deals for OpRegen and VAC, but our technology platform could produce many more product candidates than what we can develop internally, and we believe there may be numerous opportunities to enter into new corporate partnerships. We also intend to explore established collaborations such as with SERM, either for existing programs or as the basis to launch Nuance.
And for example, we have already determined that manufacturing allogeneic NK cells is significantly easier than manufacturing allogeneic dendritic cells. We would be open to a partnership around an NK program or to work on the Lineage of some other exciting cell type like islet cells. And we want to ensure there is awareness about our capabilities and our interest in working with partners in areas like these. We've also seen recent evidence of well-funded cell therapy partnerships at the preclinical stage, which may open up a partnering pathway for our auditory or photoreceptor programs or for some newly developed initiatives.
To be clear, what I'm speaking about is securing funded partnerships, not creating new subsidiaries with long time lines to liquidity. The objective here, given the uncertainty facing our sector, is most easily described as utilizing more corporate alliances to advance our assets rather than our own balance sheet and in doing so, get many more shots on goal from our core technology. So going back to how Lineage is adapting to the current landscape. We're taking steps in areas of communication, operations, and business development.
Lineage has adjusted rapidly to the changing environment since the Roche Genentech deal, which we believe adds validation to our approach. We've shown we can launch new programs, which supports my frequent comments about our ability to move quickly into new areas. And by adding additional business development capabilities and imperatives, we'll seek to capitalize on unlocked areas of value in our business. Now before I move to the financial review, I do want to mention just a few specific items.
First, a few weeks ago, OpRegen clinical data was presented at the 2022 ARVO annual meeting. Notably, it was reported that a total of five patients who had OpRegen delivered to most or all of their geographic atrophy, including the fovea, showed evidence of apparent improvement of outer retinal structure, along with average games and visual function of 12.8 letters. Prior to the license deal announced with Roche and Genentech, only for such patients had been reported by lineage. And while controlled studies are needed, it is known that spontaneous restoration does not occur.
So we believe these results support OpRegen's potential to stop or reverse disease progression in geographic atrophy patients, something which, to our knowledge, no patient receiving a complement inhibitor has ever shown. Additionally, recently, we published 10-year safety data from the first OPC1 clinical trial for the treatment of acute thoracic spinal cord injury in the Journal of Neurosurgery. This is one of the longest-running clinical trials in our field, providing important first-in-human safety data with our pluripotent cell line. Ten years following treatment.
There have been no medical or neurological complications to indicate that the OPC1 cell transplant therapy is unsafe. There also have been no unexpected serious adverse events attributable to the OPC1 cell implant, and none of the patients enrolled this clinical trial had deterioration in neurologic motor function, which we believe to be significant given the severity of their injuries. Overall, these results provide additional evidence that OPC1 cell transplants can be well tolerated and that patients are willing to participate in long-term follow-up. We plan to have additional papers on OPC1 published this year, including full clinical study results from the SCiStar study of 25 cervical injury patients and an additional publication focused on the MRI findings.
So those are two additional milestones, which I didn't mention previously, -- and coincidentally, I just learned this morning that the SCiStar study results were accepted for publication, so we expect that will become available online in the coming months. Lastly, you may have seen that the Lineage team this past weekend participated in the Red Bull Wings for Life World Run to raise awareness and funds for spinal cord research. I want to again thank our employees and stockholders who supported us on this campaign. This is an annual event, it was incredibly inspirational, and I hope you'll consider taking part with us next year.
Before I dive into our financial results, I briefly want to address an item that has been on people's minds and that is concerning the supply chains. We are, of course, aware of reports of disruptions and delays due to global events such as COVID and the war in Ukraine. I am pleased to report that we aren't aware of any of these matters specifically impacting our business but we do know these issues are affecting our industry and may continue for some time. Because our in-house manufacturing is core to our value proposition, it's particularly important that we keep that operation functioning smoothly, and we have taken steps such as prepurchasing certain materials or planning for longer lead times with some of our vendors.
We ultimately have limited control over many of these matters. But for those aspects which we can control, our solution is to remain vigilant about maintaining our supplies and ensure we have backup plans in place to best meet our manufacturing and development goals and public time lines. So with that, let me turn to our results. Total revenues for the first quarter were approximately $5.2 million, an increase of $4.8 million from the same period in 2021.
The increase was primarily due to licensing fees in connection with the Roche collaboration agreement. Please recall that we received the $50 million upfront payment this quarter on a cash basis, but on a book basis, we are accruing that $50 million over the course of time as we fulfill our obligations to our partner. So the roughly $5 million is what we booked this quarter, and we'll continue to book income on a fractional basis in the quarters ahead. Total operating expenses for the quarter were approximately $11.5 million, an increase of approximately $4.2 million compared to the same period in 2021.
This increase was substantially driven by a $3.5 million nonrecurring accrual related to a potential settlement of the 2019 Asterias merger litigation and that nonrecurring item shows up in G&A. Our loss from operations for the first quarter was approximately $6.4 million, a decrease of $0.7 million as compared to the same period in 2021, resulting mainly from the two items I already mentioned, the Asterias litigation settlement accrual offset by increased revenues from our collaboration with Roche. The net loss attributable to Lineage for the fourth quarter of 2021 was $7.1 million or $0.04 per share. I think it's important to remind investors that the variance between our loss from operations and our overall net loss is impacted by changes in the value of our investments as well as changes in foreign currency rates.
Those are related, of course, to Lineage's international subsidiaries. While these nonoperational fluctuations are important, we tend to utilize loss from operations as a more relevant measure of performance with regard to moving our clinical programs forward. Turning next to the balance sheet. We reported cash and equivalents and marketable securities of approximately $80 million as of quarter end.
Accordingly, we continue to feel that our liquidity level provides us flexibility in funding to reach our value-creating objectives in the years ahead. And to put emphasis on this, I'm being purposeful by saying years instead of months or quarters, we believe this is an environment we're having at least two years of runway is an important and attractive characteristic for investors. We will likely see an increase in our net spending this year compared to last year because our plan is to create value by advancing our programs toward their next clinical trials. And we still have certain obligations under the Roche agreement such as supplying OpRegen cells for the next clinical trial, but we will maintain the same spending discipline that we hold dear to our value proposition, and we believe that spending discipline, together with our current cash balance puts us in a good position to create value during this biotech storm.
And as a reminder, we also may be successful in collecting additional cash through potential development milestones available under our Roche and/or ITI agreements, potentially also from grant awards from funding entities like CERN or from new business development deals, which we may enter into for any of our current or future programs. To conclude, I understand well that the current environment is frustrating for biotech companies and investors alike. But Lineage has performed the XBI, -- outperformed the XBI index in both good and bad markets, and we will work hard to continue that streak for a third consecutive year. Our core principle is to advance the emerging technology of cell transplants ever closer to patients and physicians by providing the product attributes and rigorous clinical testing necessary to achieve commercially successful products.
And to that end, we believe we have not only generated a market of data from our clinical programs but also made significant investments in and improvements to areas like production, scale, purity, and delivery of ourselves, which, overall, we believe, is a proven path to creating best-in-class products for the end users and strong competitive advantages to protect our and our partner sales over the long term. There's a lot to anticipate from us in the coming weeks, months, and years, and we sincerely appreciate your support as we continue to position Lineage to become a leader in cell therapy and cell transplant medicine. With that, operator, we are ready to respond to any analyst questions. Thank you.
Questions & Answers:
Operator
Thank you, sir. [Operator instructions] Our first question comes from the line of Joseph Pantginis from H.C. Wainwright. Your line is open.
Joe Pantginis -- H.C. Wainwright -- Analyst
Hey, everybody. Good afternoon. Thanks for taking the question. So a couple of questions, Brian.
Let me start on the dollar front. So I know it's just a brief comment in the prepared comments and in the press release, but I wanted to see if you could provide a little more color on the settlement of the Asterias litigation and how you would account for that because if my perception is correct, this just really appears like there was a big overhang removed from your shares.
Brian Culley -- Chief Executive Officer
Yeah. Thank you for the question, Joe. So the company has been providing disclosure on this topic for several years. And we also are being glad to be able to move on from this, as I'm sure others would be.
As a reminder for others who aren't familiar with this, we merged with Asterias in 2019, and it's not uncommon in public company mergers. We became the defendant in a shareholder class action lawsuit related to that merger. We have vigorously defended the litigation for years, but we also would like to move on with business. And so we have agreed in principle to a settlement which will have lineage contributing $3.5 million out of an overall settlement of $10.7 million.
That settlement would result in the dismissal of the lawsuit without any admission of liability or fall by Lineage. That settlement is still subject to negotiation. We still will need to execute a settlement agreement. It needs to be approved by the court.
So it's not absolutely final. However, the parties involved have agreed in principle to the key terms. So it's probable enough from an accounting perspective that we want to accrue for it in our financial statements, and that's why you see them appearing in this quarterly statement. So it's probably not a big shock for anyone who is accustomed to public company mergers.
Personally, I sometimes think of it as the final payment in connection with an acquisition, and it's somewhat the cost of doing business, which is probably something you're familiar with, but I hope it is viewed as a small clearing event for us.
Joe Pantginis -- H.C. Wainwright -- Analyst
No, that's helpful. Thanks. And then just the other dollar question that I had was, obviously, you said you have at least two years of runway, I guess, how would you reconcile that statement with -- you've been growing your pipeline recently with additional programs. So I just want to make sure how that would be portrayed to The Street with regard to any views toward increased expenses around those programs.
Brian Culley -- Chief Executive Officer
That's a multipart answer. One part is that just the nature of our technology, which is being able to manufacture specific cell types from largely common pluripotent cells gives us some economies of scale where our existing team which has available time because they might be working on one project where they have to wait, let's say, five days before they add the next growth factor or inhibitor to a process, they can be spending a lot of that time working on other programs. So we have this really nice situation with our technology where we don't have to duplicate. We can just add new programs onto existing fixed costs or fixed infrastructure.
And so that provides us some ability to keep the cost down. The other part is that these still aren't preclinical programs. We're, of course, they're excited about them, but they have not yet reached a more expensive stage of human testing. And so the cost to be able to advance these programs toward an IND is actually very modest.
And that's why you are seeing these simultaneously an expansion of our pipeline with only a marginal expansion in our spending. And I hope that is a good way of explaining it.
Joe Pantginis -- H.C. Wainwright -- Analyst
No, it certainly is. And then just my -- just to shift gears a second from a clinical standpoint regarding the upcoming OPC1 study. I wanted to focus on the device, and I'm just bringing up echoes from the paths from the original OPC1 studies. So just can you remind us, is the device ready to go to be once the study is officially ready to go? And are the docs trained? Are they being trained? And does any specific training -- is any specific training required?
Brian Culley -- Chief Executive Officer
One of the docs was the inventor. But let me invite Dr. Hogge to join the conversation and provide some response to that question.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Sure. Thanks, Brian. Thanks, Joe. So yes, we've -- as we mentioned, and we intended to do a small study to validate the device, much of that preclinical work has been done.
And some of that animal work was done with the surgeons that intend to utilize that device. So though there will be ultimately a formal training process. They have not yet completed that. They have had experience with the device, and as Brian mentioned, one of them is a coinventor.
So we are prepared to have one or two potential active sites with those physicians and surgeons ready to go.
Joe Pantginis -- H.C. Wainwright -- Analyst
Great. Thanks a lot, guys.
Brian Culley -- Chief Executive Officer
Thank you, Joe.
Operator
Your next question comes from the line of Kristen Kluska from Cantor. Your line is open.
Kristen Kluska -- Cantor Fitzgerald -- Analyst
Hi, everyone. Thanks for taking the questions. Appreciate it. The first one is just on the two newer programs, PNC1 and ANP1.
As you've mentioned, they're very broad from the perspective that they can each go after a number of different disorders, whether blindness or hearing. So I wanted to ask from a preclinical perspective, if you're planning to look at kind of like a basket of opportunities here before making the decision about what a lead program could look like or perhaps a DC effect across the board what that next direction could look like?
Brian Culley -- Chief Executive Officer
Yeah. I'm going to again invite Gary, but I will preface by saying that one of the things that was interesting in our dry AMD program was how we learned as we move through different patient types from the most severe -- most severely affected patients that had less severe disease, smaller areas of atrophy and we learned about delivery. The part of the answer is going to be that you do learn while you're doing it. But let me see if Gary would like to add to that as well.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Yes. Sure. So to that point, we know that optimizing delivery is important, whether it's from the auditory or an ophthalmic perspective. We know that both of these conditions, auditory loss, obviously, photoreceptor deficiencies do have, unlike dry AMD, well-established preclinical animal models.
So we're right now working on how best to scale up these cells to make it much more commercially viable deduct formulation as we've done with all of our other products. And to begin both the in vitro and in vivo work that would be necessary for an IND submission and some pre-IND discussion meetings with the FDA.
Brian Culley -- Chief Executive Officer
And, Kristen, I'd like to add also something that I think is not always fully appreciated. When using a cell transplant approach, you can be a little bit less concerned about what the underlying or a causative issue is because you're replacing the entire cell. So for example, in the setting of hearing loss, whether the cause is chemo or concerts or car bombs, if the problem is the dysfunction or lack of auditory neurons, perhaps we will find that we have a very broad addressable patient population, simply by the nature of the technology. But I think that some of those answers will come to us through the clinical testing itself.
Kristen Kluska -- Cantor Fitzgerald -- Analyst
OK, awesome. Thank you for that. And then just thinking about partnership opportunities like that, should we be thinking about this similar to how the OpRegen deal took place that really as a company, you're looking to at least establish some proof of concept first in-house before any deals? Or how should we be thinking about staging and things like that?
Brian Culley -- Chief Executive Officer
This is one of the most fun parts of this job because having assets that could be partnered either very early in development or very late, some of which are -- you have insight into and others which might be more conceptual or just internal to the company, provides us with a lot of different possible strategies and figuring out what the right mix of those strategies is for the best results, right, to create the most value is actually a really fun puzzle. So we don't stick to perhaps a script that says you must generate Phase 1/2b early efficacy and partner. That is largely what we did with OpRegen, and it obviously worked quite well. But we're going to really look at any partnering opportunity contextually what is our capability to advance the program further what are the capabilities the partner might bring? Is it a cell type that we have abundant experience with, and we feel that our probability of success is high? Or is it a little riskier and exploratory.
And when we run partner opportunities through that matrix, if you will, we -- I imagine, will come out the other side with some things we elect to hold on to longer and some things that we elect to partner for different reasons. And you may not always have full insight into that decision-making process. But I think if you ultimately want to get full value from a broadly applicable platform technology like differentiated cell transplants from pluripotent cell lines, you have to have some mix of partners working with you because it simply is too many opportunities for any one company to reasonably tackle on their own.
Kristen Kluska -- Cantor Fitzgerald -- Analyst
OK. And last question for me is I was actually at the ARVO conference this year. And I felt like one of the takeaways for wet AMD was a lot of focus on these newer and emerging therapies that really the goal is less frequent injections. So even though wet AMD is a more mature market than GA, I guess I'll pose the question as to how you think having some of these injectables on the market potentially first could help benefit you through physician and patient awareness and education around therapies, but then also leads to the fatigue around receiving the frequent injections.
Thanks again.
Brian Culley -- Chief Executive Officer
You bet, Kristen. I think there are two things that come to my mind. One is that our data with OpRegen indicates that this is a one-time treatment. So that's obviously an incredibly compelling advantage versus frequent injections, especially people who've got severe visual impairment even just getting to the clinic.
The other notable aspect is that we are seeing evidence of functional improvement in patients. So in terms of compliance and a patient's willingness to go and get regular injections, whether it's every one, two, three, or even six months, I think that being able to -- I hope that being able to offer those patients a stabilization or improvement of their vision is far more compelling than a patient that might have a competing therapy that is doing something biological of slowing down the condition, but the patient doesn't feel anything. I don't know that a patient can get as excited about being told that, well, your area of atrophy is five square millimeters, but we would have thought it would be 5.5 C in eight weeks. So I do think that compliance can be a problem.
I think that's very favorable for us and what we hope to offer the market. The other aspect of this, I think, is one of market conditioning. And that is that dry-AMD has no approved therapies today. So if you're a patient who receives that diagnosis you're mostly told e-vegetables and don't smoke cigarettes, but there's nothing you can really do about it.
So we have a tremendous number of individuals with the condition, but they're not organized as a patient population. So in a way, we're actually hopeful that some of the companies that are later in development that are starting to do some market awareness and market conditioning, that could be wonderful for Roche and Genentech, not that they aren't massively capable of addressing a commercial opportunity if they are able to have an approved agent in this. But I think that there is really something to be said for having someone out there ahead of you, who maybe has a less compelling package insert to detail against and then coming in behind them and taking advantage of the fact that you already have now a more educated patient population. So I love that setup -- and I hope that that's what we're able to watch occur in the coming years.
Kristen Kluska -- Cantor Fitzgerald -- Analyst
Thanks, Brian.
Brian Culley -- Chief Executive Officer
Thank you, Kristen.
Operator
Your next question comes from the line of Jason McCarthy from Maxim Group. Your line is open.
Jason McCarthy -- Maxim Group -- Analyst
Hey, Brian. Thanks for taking the question. You had mentioned potentially partnering solely for manufacturing, given your capabilities. I think I heard that right.
You'd also mentioned NK cells. Just briefly, are you actively looking for something in the NK space for the company as a space that continues to gain traction? And just more generally, from supporting another group's manufacturing, what scale can Lineage go up to? Can you go support from money all the way through Phase 3 into commercial? Or can you give us a little bit more color about the company's capabilities on the manufacturing side?
Brian Culley -- Chief Executive Officer
Yeah. I appreciate that question, Jason, because I don't want it to be not obvious that there was an advertisement in this presentation. We -- I would like other entities out there to be aware that Lineage could be a partner to other programs that are not our programs because we do have demonstrated capabilities in manufacturing that I think provide us with a compelling story with respect to being a partner. And something changed when we announced the deal with Genentech and Roche.
Clearly, there is going to be a greater sentiment or expectation of quality because we passed one of these sort of biotech hurdles, which is some measure of validation from a big pharma that people are going to assume at abundant diligence on our capabilities. So I think that is why now is the time for us to be more explicit and not passively wait for a company that might want to work in another area to say, "Hey, Lineage, can you do this? Can you do this other thing? And instead for us to actually be more active in that process for our business development folks almost at scouts to go out and say, "Hey, we have capabilities." And the reason for that, in part and in no small part is exactly what you said, other than the cost of some of the equipment and obviously, reagents and materials. I do not think that there is an obvious limit on scale one still has to keep in mind that, for example, in a setting of NK cells, I saw a few days ago, one company reported data and is talking about going up to 1.5 billion cells as a dose. That's a very large number compared to our 100,000 cells that we utilize in dry-AMD.
So it will be indication-specific, and I don't want to limit this discussion topic to NK cells. However, our phones are open, and I'm hopeful that there might be some folks who say, I'd like to understand better what Lineage is offering and what Lineage is capable of doing because if it fits, perhaps I can accelerate my own program. And I -- Brian Culley would say, I could probably find a way to make a deal that is going to benefit lineage as well. Obviously, we need to take great care to make sure that our more senior-owned assets have a priority at this time.
But again, it kind of goes back to that prior question about the mix of partnerships. So I'm excited about our ability to now go out there and point to some of our recent success and say, maybe you should go under confidentiality and learn what we do because maybe we could strike a partnership around some other area.
Jason McCarthy -- Maxim Group -- Analyst
Got it. Just briefly, can you give us a little bit of an update on the Immunomic Therapeutics collaboration and what's happening there on the GBM work?
Brian Culley -- Chief Executive Officer
Yes. That's a terrific example of how I see the VAC platform having more value than just in back to I think it potentially is much more valuable as a delivery system. One would choose an antigen. We obviously have the TERT antigen as what is the active component in our VAC2 form of the product.
However, you could use other antigens. But I want to be clear that Lineage is not really equipped to go out and select antigens as well as some companies that have machine learning, artificial intelligence tools, or more empirical ways of selecting antigens. So I would like to be able to have more programs like ITI where ITI is the company that's bringing the antigen, and we are the delivery vehicle. And the question that we hope to answer is, will using a dendritic cell -- will using natural antigen-presenting cells, the best antigen-presenting cells, will that lead to better clinical outcomes because you can get these very high levels of activated T cells, antigen-specific activated T cells.
And because oncology is a very expensive and very challenging endeavor and keeping in mind that it can be very rewarding. I think the right strategy is for us to try to find additional programs like ITI where we are more than compensated for our contribution, and we have a fractional ownership in someone else's program. And I think if we are able to perform as we have so far against the ITI collaboration and receiving some of those payments already, I think that will allow us to attract more and more valuable partnerships in the future for the VAC program.
Jason McCarthy -- Maxim Group -- Analyst
Great. Thank you.
Brian Culley -- Chief Executive Officer
Thank you, Jason.
Operator
Your next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line is open.
William Wood -- B. Riley Securities -- Analyst
Hi. This is William Wood on for Mayank Mamtani. Congratulations to the team. Really like the updates that I'm seeing here.
So just curious on your OPC1, the safety testing with the new PSD system, just assuming all things are fine with the FDA going forward. I was just curious any thoughts you could provide on what the design would be for the next phase trials? I know you also mentioned chronic patients, maybe expansion? Where do you see that going?
Brian Culley -- Chief Executive Officer
Yes. So it's a difficult question to answer right now because we haven't proposed anything to the agency or decided internally. One of the reasons for that is that our view in the setting of spinal cord injury is that the tools to -- the assessment tools are maybe not as sensitive as we would like. Some of them that are out there, even some that are frequently used are a little bit crude in terms of their ability to detect motion.
And one of the things that we have learned in talking with patients is that even very small games that they -- the patients can sometimes creatively utilize small mobility in creative ways to be able to gain higher quality of life. You wouldn't think of using necessarily the fourth finger on your left hand to manipulate your wheelchair. But if that's the only mobility you have on that hand, maybe that's good enough. So what we're trying to do in this lead-in period, while we're working on the device is we want to more closely align what is of importance to the patient with respect to quality of life and motor function and get that well collected through different assessment tools and have that aligned with FDA.
Now to get back more specifically to your question, what does that mean? I think that that's going to lead us down toward a design that has an adaptive component. There could be a lead-in phase with multiple assessment tools, all but one or two of which get dropped going into a blinded phase or a controlled phase. We don't know -- we won't be able to guide until we do some additional market research, but it's not gating at this time because, as you know, we still have to conduct the device study because we think that device when used with our Thaw-and-Inject formulation will enable us to open up many more sites because we are eliminating all of the dose preparation that used to go on in this program that we've eliminated with the creation in future introduction of the Thaw-and-Inject formulation.
William Wood -- B. Riley Securities -- Analyst
Makes sense. I appreciate it. And then also, you mentioned the recently published 10-year follow-up and safety follow-up for OPC1. I'm just curious how you see that supporting your strategy in OPC1 obviously, but then even more broadly with OpRegen and then the new progenitor lines you're developing?
Brian Culley -- Chief Executive Officer
Yeah. I think what's really exciting about the data that's being published is the durability. The durability of these graphs, the tolerability, and the safety, -- there were, as you've seen in presentations from the company, over 500 AEs recorded in the SCiSTAR study of 25 cervical patients, and only one of those AEs was potentially associated with the cells, grade 2 dysesthesia which eventually cleared on its own. So I love that favorable tolerability or safety profile.
And I think that's important because when people talk about cell therapy and think about it, there are some increasingly archaic notions about using whole sales. People will still frequently say to me, "Oh, but you have to go on lifetime image suppression." Lineage's data does not indicate that or they'll say, "Oh, you're going to have strange things go the wrong organ is going to grow in the transplant area." Lineage's data hasn't shown that. None of the clinical programs that we have, have had those kinds of experiences. So I like very much that we're able to point to five, and in some cases, 10 years of safety, tolerability, and patient compliance, i.e., reporting and continuing on study because it is just helping to derisk the conduct of a future study.
And I think further that enrollment in these studies, these later-stage or next-stage studies is enhanced by this long-term data because if I were a patient and I didn't have a background in biology, I might be scratching my head about some of these cell therapy ideas, I'm not sure how well tolerated. And if someone can say, well, here's 10 years of safety data from this set of thoracic spinal cord injury patients, and let's walk through the profile. I think that's compelling and can help with enrollment, not just in spinal cord, but in any program that we have as we continue to generate evidence that it is essentially a new therapeutic approach is looking promising.
William Wood -- B. Riley Securities -- Analyst
I appreciate that extra color there. I'll leave it there. I appreciate everything, and congratulations again to your team.
Brian Culley -- Chief Executive Officer
Thank you, William.
Operator
Your next question comes from the line of Robert LeBoyer from Noble Capital. Your line is open.
Robert LeBoyer -- Noble Capital Markets -- Analyst
Hi. I just had a question on the accounting treatment of the revenues. And I know that you got the $50 million with obligations to the collaborators. So I was wondering if you could detail how much has been paid and whether it's being amortized with the revenues or whether it was taken all at once? And if there's any expectation for the quarterly revenue recognition going forward until the unearned revenues or the entire payment is amortized.
Brian Culley -- Chief Executive Officer
Well, Rob, I first must thank you for asking a detailed financial question on a day where unexpectedly, our CFO is not available, but I'm going to do my very best. So the way that we are booking, the upfront payment from Roche is in connection with our performance obligations under that Roche agreement. So there are two major categories of performance. We are providing the clinical trial material for the next study.
And we also are continuing to follow the patients on the Phase 1/2a trial. So rather than booking all of those revenues in the first -- in that first quarter, we're going to spread them across on a fractional basis going forward. It is unlikely, although possible, that they will be equal in every quarter until exhausted. I only say that that's possible because it is, as I described, dependent on how the offset of the progress that we make is accounted for or accrued over time.
So our expectation is that there will be some variability in how much we book each quarter to reflect our performance under our obligations, but it probably will not be wildly fluctuating. And I don't think that there's any balloon at the end. I think we're going to try and spread it out in connection with our obligations under the agreement. And I hope that that stand-in response is adequate today.
Robert LeBoyer -- Noble Capital Markets -- Analyst
OK, great. That's plenty. Thank you.
Brian Culley -- Chief Executive Officer
Excellent, Rob. Thank you.
Operator
[Operator signoff]
Duration: 51 minutes
Call participants:
Ioana Hone -- Director of Investor Relations
Brian Culley -- Chief Executive Officer
Joe Pantginis -- H.C. Wainwright -- Analyst
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Kristen Kluska -- Cantor Fitzgerald -- Analyst
Jason McCarthy -- Maxim Group -- Analyst
William Wood -- B. Riley Securities -- Analyst
Robert LeBoyer -- Noble Capital Markets -- Analyst
