Lineage Cell Therapeutics, Inc. (LCTX) Earnings Call Transcript & Summary

Welcome to the Lineage Cell Therapeutics conference call. [Operator Instructions] An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. Any recordings, reproductions or transmissions 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 call, Ioana Hone, Director of Investor Relations at Lineage. Ms. Hone, please go ahead.

Thank you, Shannon. Good morning, everyone, and thank you for joining us. Earlier this morning, Lineage Cell Therapeutics announced an exclusive worldwide collaboration with the Roche Group and Genentech for the OpRegen RPE Cell Therapy Program. A copy of that press release 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, goals, objectives, beliefs, views, vision, development programs, product candidates and platform and their potential therapeutic applications and commercial potential, the timing of clinical trials, future payments, transfer of expenditures and activities under the collaboration with Genentech, data announcements and updates, anticipated regulatory meetings and interactions, planned manufacturing improvements, financing, cash management and runway, anticipated benefits and opportunities from our existing and potential future collaboration, the achievement of milestones, anticipated growth and commercial opportunities. Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to known and unknown risks and uncertainties. We caution you not to place undue reliance on any forward-looking statements, which speak only as of today and are qualified by the cautionary statements and Risk Factors in our filings with the SEC including our Form 8-K filed today, December 20, 2021; our quarterly report on Form 10-Q filed on November 10, 2021; and our annual report on Form 10-K for the year ended December 31, 2020. With us today are Brian Culley, our Chief Executive Officer; and Kevin Cook, our Chief Financial Officer. Brian will provide some prepared remarks, and then all of the executives will be available for questions. With that, I'd like to turn the call over to Brian.

Thank you, Ioana, and good morning, everyone. I am incredibly proud to announce today that Lineage has entered into what we believe to be a transformative partnership with Genentech, a member of the Roche Group, for the future development of the OpRegen program for the treatment of patients with ocular disorders. For our knowledge, outside of oncology, this is the largest cell therapy licensing deal ever signed. And it provides a great sense of satisfaction for the staff, doctors, patients and many others who contributed to reaching this validating milestone. We view this collaboration as joining the outstanding product development and commercialization capabilities of Genentech with the directed differentiation, manufacturing and cell transplant expertise of Lineage. And applying those combined forces to develop therapies for ocular disorders such as dry age-related macular degeneration with geographic atrophy. When I joined Lineage 3 years ago, we established a new strategic plan to position the company as a pioneer in the allogeneic cell transplant revolution, supported by our core technology, which is the manufacturer of differentiated cell types, which are transplanted into the body to restore or improve function loss to aging, injury or disease. Our approach is simple. We believe that if a certain type of cell in the body is dying or dysfunctional, it may often be most direct, intuitive and effective to manufacture and replace that specific cell -- type of cell in order to slow or potentially reverse certain diseases. And when we manufacture and scale ourselves, we harnessed the natural developmental programming contained within each of our single-source cell lines, which means our approach does not require any gene editing or reprogramming of the cell's original DNA. We believe that avoiding the risks of genome editing, while embracing the scale and cost efficiency of off-the-shelf or allogeneic therapy, represents the most compelling clinical and commercial profile when compared to many of the competing approaches that exist today. Our core principles are to advance this emerging technology ever closer to patients and physicians by providing the product attributes and rigorous clinical testing that could lead to commercially successful cell therapy products, something which has long been promised by this field. We made significant investments in areas like production, scale, purity and delivery of our cells. And we believe we can point to the wisdom of those investments as helping to advance the OpRegen program from its academic beginnings into a clinically mature and highly promising product candidate. The market opportunity for dry age-related macular degeneration is large and patients exist throughout the world. But Genentech is a global partner with the capabilities to reach these patients in a way which the OpRegen program needed. We believe our selection of and by Genentech as the driver of the next phase of OpRegen clinical testing will be both financially and developmentally positive for the company. We also look forward to applying our directed cell differentiation expertise to additional programs, which we have under development today and others, which we plan to initiate next year. We believe Lineage's Regenerative Medicine platform is broad and powerful and can be applicable to additional cell types beyond retinal cells to potentially address many diverse therapeutic areas. Our vision for the company is to advance additional programs from our platforms and establish a pipeline of novel assets which can improve the lives of patients afflicted with a broad array of unmet medical needs. I'd like to take a moment to highlight the extraordinary capabilities of our new partners. The Roche Group and Genentech are global pioneers in personalized health care with a proven commitment to ophthalmology. They bring strong clinical and regulatory capabilities with established global development in dry-AMD with GA and have a track record of commercial success with over a decade of infrastructure to support commercialization. With Genentech's capabilities and commitment to ophthalmology, Lineage has the opportunity to accelerate and expand the development of OpRegen. We believe the results we have demonstrated with OpRegen to date represent a paradigm change many did not believe possible with cell therapy. We have shown evidence of restoration of retinal tissue and the halting or, in some cases, the reversing of the expansion of geographic atrophy. Just a few weeks ago, we announced that this retinal restoration phenomenon was observed in a fourth patient treated with OpRegen, meaning that restoration has been observed in all 4 better vision patients where surgeons successfully covered the majority of the area of atrophy with the suspension of our OpRegen cells. All 4 of these patients experienced changes, which lasted at least 12 months and as long as 3 years to date as well as increases in their visual acuity in their treated eye, which similarly have been maintained for at least 12 months in all 4 patients. These 4 patients represent the only known examples of an experimental treatment for dry-AMD that can reduce an area of atrophy in humans rather than simply slow its growth. It also supports our long-held view that in the right settings, relying on cells as therapies can deliver clinical outcomes beyond the reach of small molecules or antibodies. We believe the Genentech-Lineage partnership can provide a strong foundation for this transformative therapy and increase the probability of success with this novel approach, all in pursuit of the goal of providing a truly meaningful benefit for patients with dry-AMD and other ocular disorders. In connection with this deal, Genentech will pay Lineage a $50 million upfront payment. Lineage also is eligible to receive up to $620 million in additional developmental approval and sales milestone payments in addition to tiered double-digit royalties. In addition to these payments, Lineage expects to move the majority of its future OpRegen clinical expenses and all future commercialization expenses to Roche. In total, the value of these potential payments before royalties is approximately $670 million. As many of our investors know, the origin of the OpRegen program reaches back to work conducted at the Hadassah Medical Center in Israel, led by Professors Benjamin Rubinoff and Eyal Banin. And starting in 2007, the Israeli Innovation Authority, which is an independent agency created to address the needs of global innovation ecosystems, provided valuable financial support to the OpRegen program. Each of these parties' contributions began when OpRegen was in its earliest stages of development. And as a result, we are obligated to pay a portion of certain payments we receive under the OpRegen collaboration to both the Hadassah Medical Center and the Israeli Innovation Authority. Furthermore, under the terms of the collaboration, Genentech has agreed to lead all program activities globally from Phase II onward, including through global development, regulatory interactions and commercialization. Lineage is responsible for completing activities related to the ongoing Phase I/IIa clinical study for which enrollment is complete and may provide other support where needed. In addition, our team will be responsible for certain manufacturing activities, including supplying OpRegen material through the end of Phase II clinical development and facilitating the technology transfer of the RPE cell manufacturing process to Genentech. Genentech thereafter will assume responsibility and authority for clinical development and commercialization of OpRegen with input from a joint advisory committee. If jointly determined to be beneficial for the program at some point during the collaboration, Lineage may take on responsibility for later-stage manufacturing subject to a separate and additional economic arrangement. I'm incredibly proud of what the Lineage team has accomplished with the OpRegen program, and I wish to express our deepest gratitude to the patients who participated in our clinical study, their families, the study investigators and coordinators as well as our data safety monitoring board and external scientific and medical advisers who played an integral role in this program's preclinical and clinical development. I also want to provide a special mention of appreciation to Dr. Jordi Mones from the Institut de la Màcula and the founder of the Barcelona Macula Foundation, the investigator who identified the very first case of retinal restoration. Looking ahead, we believe this agreement with a world-class pharmaceutical partner provides an important validation of our cell therapy platform and our strategic approach to product development. With these tailwinds, our focus turns next to the clinical development of additional applications of our technology. In particular, our allogeneic cell transplant to treat spinal cord injuries called OPC1 is on track to continue clinical testing early next year to test an improved delivery system. In a Phase I/IIa study in spinal cord injury patients, OPC1 demonstrated an excellent overall safety profile, with approximately 96% of the 22 treated subjects reporting improved motor function. Motor function, which translates into the ability to feed yourself or transfer yourself from a wheelchair for meaningful improvements to quality of life and independence. And similar to the improvements we made to OpRegen, we've made tremendous gains to the purity and scale of OPC1 to prepare it for later-stage testing. We also intend to consider collaborations or partnerships for the OPC1 program, although the clinical and commercial infrastructure necessary to address that market is more reachable for a smaller company than it is for dry-AMD, which means Lineage can consider retaining OPC1 for longer and potentially even marketing it ourselves. Concurrently with these plans, we also plan to continue advancing our multiple oncology programs based on our VAC platform. VAC2 is a cell therapy comprised of mature dendritic cells, which are loaded with a tumor-specific antigen to instruct the body's immune system to attack and eliminate cancer cells. Our current focus is on making improvements in modernizations to the VAC manufacturing process, which we believe will help prepare VAC for further clinical trials and provide competitive advantages to this program. We also look forward to the completion of the ongoing Phase I clinical trial of VAC2 which is being conducted and funded by Cancer Research UK. In addition to those ongoing clinical programs I just mentioned, many of our investors have heard me say that Lineage is like an Amazon of cell therapy because just as Amazon began as a bookseller before expanding into many other areas of commerce, the Lineage platform has the potential to enable the manufacturer of many of the body's 200 different cell types and deploy those additional product candidates into an array of new disease settings, either on our own or through strategic alliances like the one we announced today. The lessons we have learned and the know-how and intellectual property we have generated, and which led to this first strategic alliance for our lead asset, are critical advantages that we will use to rapidly but responsibly drive our pipeline expansion in the future. I'm very excited about the future of Lineage and plan to hold a second conference call in January to discuss our business plans in greater detail, and I encourage everyone to watch for an announcement of that call. Returning now to our collaboration with Genentech for the OpRegen program, a collaboration which marks a significant transition point for Lineage and I believe for the entire cell transplant field, I'll conclude by saying that we believe our strengths include our manufacturing and cell biology capabilities, our extensive cell therapy patent estate and know-how -- our singular clinical evidence in disease areas with large unmet medical needs and the large commercial opportunities which we are pursuing. We believe the field of cell therapy is on the cusp of significant growth and that scalable allogeneic approaches like ours may have the ability to provide commercial and clinical advantages over autologous or other patient-derived methods. Our objective is to lead the advance of this branch of medicine by providing continued evidence that off-the-shelf cells can generate compelling safety and efficacy data, and in some cases, outcomes, which are even beyond the reach of traditional approaches like small molecules or antibodies. We're immensely proud to have the opportunity and responsibility to advance this new and exciting branch of medicine and our aim is to profoundly impact the millions of people who serve as our inspiration. We also look forward to joining forces with the teams at Roche and Genentech to advance OpRegen to patients in need of treatment. We thank you very much for joining us this morning, and we appreciate your support as we position Lineage to become a leader in cell therapy and cell transplant medicine. And with that, operator, we are ready to respond to any analyst questions which we may have.

[Operator Instructions] Our first question comes from Joe Pantginis with H.C. Wainwright.

Congratulations. This is a fantastic external validation, but even more importantly, great for the cell therapy and regenerative medicine space. So congratulations. Brian, I guess a couple of logistical questions. When you talk -- maybe first, can you talk about what other potential ocular disorders Genentech might be considering that might be a little much to ask? But -- are any of the milestones disclosed today as part of the $620 million beyond the upfront associated with indications beyond dry-AMD?

Congratulations on the question, Joe. So we're not providing a breakdown, a specific breakdown of each of the milestones today. But with respect to ocular disorders generally rather than the just dry-AMD with GA, I think mechanistically, replacing retina cells may have application in a number of different inherited retinal diseases. And those I would consider to be sort of on the table. So wherever providing a replacement retina cell might be beneficial to a patient, you could imagine that, that could be contemplated by our partners and certainly falls within the scope of the alliance. We did treat a patient with vitelliform maculopathy. So there is an example of an individual who did not have dry-AMD with GA, but for whom there was an interesting opportunity to treat them with OpRegen cells. So it is an area that we hope will be fully investigated by Genentech.

Got it. And I guess, maybe a little more color with regard to your future involvement, and you definitely threw in a little more information there with regard to manufacturing, so I guess I'll start with that. Are there any other manufacturing initiatives that you would have to do or that you have ongoing, that is beyond just providing the clinical supply through end of Phase II, I guess, to start. And then overall, being able to, I guess, opt in for later-stage manufacturing, what is your overall involvement for the program going forward?

Thanks. So the -- it's probably obvious that Lineage is the only entity that knows how to manufacture the clinical trial material. So we will need to continue to support the alliance by providing that material. But in parallel, we also will be working on a technology transfer to enable Genentech to be able to be self-sufficient in that manner. If there are challenges there, we have contemplated that Lineage may continue to be involved at a larger scale or in later stage development. And so that's sort of the scope of our obligations. Through this alliance, as it goes forward, within the agreement, there are -- what is contemplated are potential improvements. So if there are improvements made to the process, there are mechanisms by which that material can make it into the clinic and so forth. So I want to just be clear, it's not an opt-in. We don't have an option to produce commercial material. It is more of a discussion between the parties that if it makes sense for Lineage to remain in that role for longer than Phase II development that there would be a mechanism by which we would be able to do so.

Got it. And then my last question is truly logistical. So you guys were planning to or schedule an FDA meeting almost imminently or in the very near term. So I was just curious, is this something that's going to be put off for Genentech to jump on board? Or where does that stand?

Yes, essentially effective -- well, as of the effective date of the agreement, those decisions become decisions that are made by Genentech. There is a joint advisory committee. So Lineage will continue to have visibility and views, but really, those decisions are now in the hands of a very experienced and capable partner.

Our next question comes from Kristen Kluska with Cantor Fitzgerald.

And let me also add my congratulations to you on this deal. As a follow-up to one of Joe's questions for the potential of other ocular disorders, obviously, GA makes sense as an indication to evaluate given there are no current therapies in the rationale behind the mechanism. But based on the evidence that you've seen here with halting and reversing the expansion of GA, how do you even consider disorders where there are current therapies where you think the bar might be higher now based off of these findings, and then also perhaps given the convenience of OpRegen over other therapies that might require multiple ocular injections?

Yes. Thanks, Kristen, very much. With respect to convenience, just for those who aren't aware, this is -- today, it is a onetime surgical procedure. It takes about 30 minutes. It is under local anesthesia. And we have had patients who have had cells for more than 5 years and none of the patients who have been treated have rejected the cells. That's always a concern. At the same time, we've also been able to reduce the immunosuppressive regimen from 1 year down to about 90 days. So this -- I point this out because a lot of folks have somewhat older opinions or assumptions around cell therapy around things like rejection and lifetime immunosuppression. But the field is advancing, and we are learning that some of those fears are unfounded. So with respect to convenience, I mean, the greatest highlight here is that OpRegen may very well be a onetime -- once-in-a-lifetime treatment, which gives it all of the excitement around gene therapy without the risks of gene editing. Now I don't know, we have not collected enough data to say that it forever will be a onetime therapy, perhaps some people will benefit from a single dose. Perhaps some people will want to have or need to have an additional dose. And we're not -- we don't have data, but we're not aware of any reason why someone could not be retreated. Perhaps the therapy fades after 5 years or something like that, and so there could be a retreatment paradigm which is developed and investigated further by Genentech. And obviously, that could reflect recurring revenues, but that's all -- that's a large reason why we have engaged such an experienced partner to assist with those kinds of considerations and investigations. With respect to additional indications, the only other thing I might add is that there was a similar program, earlier-stage program, which looked not just at dry-AMD, but also Stargardt's disease. We have not investigated Stargardt's, and I don't have a comment as to whether Genentech will or will not investigate it, but it is just illustrative of another important unmet need for which there is a mechanistic rationale for this type of cell transplant.

And then in what ways do you believe that Roche and Genentech could leverage the success they've had with the wet-AMD franchise with dry-AMD with geographic atrophy? And then also on that side, could you discuss what specifically do you like about that, their global footprint and perhaps now to explore the opportunity in the future beyond just the U.S. and Europe?

Yes, that's a great question because it speaks to the rationale of why partner and when partner. And you sort of answered it with the word global. This is a massive global problem, and it requires a massive infrastructure. So it almost feels inevitable that this asset would have found its way into the hands of an international pharmaco at some point. The question, of course, just becomes when is the right time to do it. We felt that this is the right time because to -- in order to increase the probability of success, increase the probability that it reaches patients, it really is going to need strong development expertise, the study size, the cost, the ability to deal with potential setbacks. All of these things are important contemplations, and we think that we could not have chosen a better partner for this. The capabilities, the experience, and as you say, the ability to leverage everything from relationships to databases to the capital resources, everything that Genentech can bring to this program are things that are beyond the reach of a smaller company like Lineage. We certainly hope to be a much larger company starting today, but I think that getting a group like Genentech involved in this program and being able to leverage exactly those kinds of capabilities is exactly the strong rationale for entering into this agreement beyond the economics. This is really driven by what do we need to do to make sure the product is successful because we have data that is -- as I mentioned in the call script, it is paradigm-changing. And so that's an important thing that we need to keep in mind.

Great. And my final question, just housekeeping modeling updates. I guess, first, do you expect the deal, and the payments to take place this quarter? Or is this something we should be looking to model in the first quarter of next year? And then in respect to the upfront payment because there's multiple parties involved, about what percent of that $50 million, and I know some of this is detailed in the 8-K, do you expect to receive on your balance sheet?

Yes, this is Kevin.

There's -- thanks, Kevin. Go ahead.

Sorry. Thanks, Kristen. It's a good question. We -- the payment is due -- contractually, it's due within 30 days of execution of the agreement. So it could happen any day, but we anticipate it's probably a first quarter event, to answer your first question. And to answer your second question, if you look at the 8-K, it kind of give you some color, although it doesn't give you -- it's net of some expenses and such that we get to deduct from our obligations. But essentially, about 58%, I think, for modeling purposes of the 29 -- I mean, of the $50 million is what we get to keep, so call it, $29 million.

Our next question comes from Ed Hickman with Guggenheim Securities. Looks like Ed dropped. And our next question comes from Jason McCarthy with Maxim Group.

Congratulations on the transaction. It looks like a really nice deal. Can you talk a little bit, Brian, about maybe Roche/Genentech's want to really accelerate the OpRegen program to bolster its ophthalmic pipeline, considering that LUXTURNA was kind of less than lackluster on the gene therapy side for them after they bought Spark and Lucentis then going biosimilar. Just kind of piggybacking a little bit on the prior caller's question.

So I can't speak for them specifically. What I can say generally is that as a counterparty to the negotiations over this, what we found was a highly motivated organization that asked questions about how we can go quickly, where are areas that we can accelerate. So I think that, that is -- reflects excitement and enthusiasm about the program. I saw there was an article in The Wall Street Journal this morning about this deal, and I noticed that there was a comment by the Roche representative about this could be the tip of the spear and additional efforts in cell-based therapies. So I think that this is an interesting strategic move for that company. But I really can't get into details. What I can say is that having a corporate partner like this is really valuable when you think about the ups and downs of product development. The ability for Genentech to deal with a potential setback or a delay, just frankly, is just greater than the ability of Lineage to be able to deal with the same kinds of situations. No, we're not facing that presently. Everything is on track. We haven't had anything like that. But in thinking again about what is the long list of reasons to enter into this kind of a deal, there's certainly capital, there's certainly a validation, but capabilities is one that's really powerful. So I anticipate that we will find a partner that wants to move as quickly and responsibility -- as responsibly as they can. And I think if we had any concerns about their ability or their desire to do that, that we would not have entered into this deal.

Last question. Can you talk -- you had mentioned in your comments about the capacity to get other differentiated cell types used in your technology. Can you talk a little bit about some areas that you might consider or want to consider? We've seen some activity in the space like with Vertex around diabetes. And it seems like pure regenerative medicine and regenerating tissues is gaining more traction in those disease areas that were really thought to be just too challenging to go after?

Yes, I don't want to take away from the headline, but I think that writ-large that this transaction and what's happening in the field is about regenerative science becoming regenerative medicine. So what I mean by that is that the field of differentiated stem cells and cell transplant is maturing, and we are finally starting to deliver the things that reflect that maturation and early success beyond some of the very well-known setbacks that occurred years ago. So we want to embrace that. We feel that the field has matured and that the opportunity to be a leader in this space is just tantalizingly present. So we want to expand. The cells which we use are pluripotent, meaning they can become any of the cell types in the human body. And you are absolutely correct that there are some really interesting areas in places like type 1 diabetes or in Parkinson's disease. I mean, these are major unmet needs that may permit themselves to be further examples of whole cells being able to deliver outcomes that small molecules or other approaches cannot. We have experience in certain lineages that make us more likely to stick what we know best, right? We're not going to launch into completely foreign areas from scratch. However, we obviously have a lot of know-how in the neuroectodermal lineages and also in oncology. And I'm looking forward to being able to share more of that early next year to help everyone explain how we use this deal as a springboard, not just from a validation perspective or a capital perspective, but also from a technological perspective, to go into additional areas, and that could be done through licensing. It could be done from homegrown programs that we're already working on. It could be done through acquisition, they're -- sort of everything is on the table. I think the important message for us is that we don't want to stop. This is not the end of a chapter. This is actually the beginning of a whole new phase of the company that we internally call Lineage 2.0. So I think the sky is the limit as we continue to see the kind of data that we have seen with the OpRegen program. And I hope we see some parallels in particular with the spinal cord program. It's been doing well in our hands, and we're going to keep moving it forward.

Our next question comes from Eddie Hickman with Guggenheim Securities.

Let's try this again. Congrats on the deal. Can you talk about the scalability of these OpRegen clinical trials, given it's a really precise procedure that needs full coverage in order to get that regenerative efficacy? How difficult is it to train PIs and recruit sites worldwide and do you think this is a limiting factor for how fast development can go?

Thanks. That's a wise question, but it's got a very nice answer. The procedure which we utilized the majority -- in the majority of the patients involves vitrectomy and retinotomy, which is just a fancy way of emptying the eyeball and puncturing the retina. So those are techniques, which are routine for vitreoretinal surgeons. I sometimes only jokingly say that you can't graduate from retina surgeon school without performing those procedures. So there's minimal training required to perform a vitrectomy and a retinotomy. But we also learned in our Phase I/IIa trial that placement of the cells is highly correlated with the best outcomes, in particular, the regeneration. So there may be other methods by which cells can be delivered. We, at Lineage, did explore one of those methods, and there are others that have been developed. Ultimately, that will be decision made by Genentech. So if they elect to pursue additional routes of delivery or methods of delivery or technical improvements, that will be up to them, which we're supportive of because we ultimately want to make sure that the cell placement is as well done as possible. But I do not expect that it would be an impediment or an impairment or a restriction on enrolling larger clinical studies because it is a routine procedure. And certainly, if it becomes more complicated or the training manual gets very long, the ability of Genentech to facilitate that kind of training, I think, is in place. And I really do believe that there are great opportunities for improvement on this technology. It is a bit fanciful to think that Lineage has absolutely perfected it in 24 patients. It's a new technology and it is very likely, in my mind, to only get better with time as we learn about some new techniques and ways to deliver the cells. And I think all of that is again feeding into this common theme of working with a global leader in this space in order to get the best possible results from this asset.

Our next question comes from Dane Leone with Raymond James.

Congratulations on the deal with Genentech. Just 2 clarification questions for me, please. Firstly, could you just add more color in terms of when you expect to have a meeting with the FDA on next steps for the TAI program and what type of disclosures you would be able to make given that's now in the hands of Genentech? And then secondly, could you just clarify the accounting around the $29 million in net cash you would have received from the upfront payment?

Hey, Dane. So as I mentioned in response to a prior question, Genentech will be running the schedule with respect to FDA meetings, meeting package. We will be playing more of a supportive role, providing materials that are needed and so forth. So we don't have any disclosures or time lines or additional information, although many times updates and changes that are required to be made public by sponsors obviously do become available to the public. And so that's where certain aspects of this program will continue to be -- the visibility into this program will continue to be available through those channels or elective disclosures made by Roche or Genentech -- excuse me, made by Roche/Genentech or by Lineage, where we are able to do so. But in terms of the strategic decisions, the timing, et cetera, that will be something that will be up to Genentech in the lead role. With respect to the accounting, I think Kevin said, there's a 30-day period under which that first payment is made. So whether that occurs in calendar year 2021 or calendar year 2022 is not known to us. We just know that contractually, we expect it within 30 days.

And I'm currently showing no further questions at this time. I'd like to turn the call back over to Brian Culley for closing remarks.

Well, thanks, everybody. A great day for Lineage and I think even a great day for cell therapy writ-large. So thanks very much, and please feel free to contact the company through the usual channels if you have any additional questions. Enjoy.

This concludes today's conference call. Thank you for participating. You may now disconnect.