LCTX

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Head of Investor Relations - Ioana Hone Chief Executive Officer - Brian Culley Chief Financial Officer - Jill Howe Senior Vice President and Head of Clinical - Dr. Priyantha Herath Operator: Welcome to the Lineage Cell Therapeutics Second Quarter 2026 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 the copyright and is the property of Lineage and 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 call, Ioana Hone, Head of Investor Relations at Lineage. Ms. Hone, please go ahead. Ioana Hone: Thank you, Jericho. Good afternoon and thank you for joining us. A press release reporting our second quarter 2026 financial results was issued earlier today, August 6, 2026, and can be found on the Investors section of our website. Please note that today's remarks and responses to your questions reflect management's views as of today only and will contain forward-looking statements within the meaning of federal securities laws. 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. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K and in the Form 10-Q filed today. 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 described in our SEC filings. With us today are Brian Culley, our Chief Executive Officer; Jill Howe, our Chief Financial Officer; and Dr. Priyantha Herath, our Senior Vice President and Head of Clinical. I'll now hand the call over to Brian. Brian Culley: Thank you, Ioana. Good afternoon, everyone. We appreciate you taking the time to join us today. As some of you know, from time to time, I like to use these calls to bring investors behind the scenes to better understand how we are advancing our programs and business. Probably everyone on this call knows how important OpRegen is. But based on progress we've made elsewhere, we think this is an opportune time to explain what we've been focusing on while Roche and Genentech continue to conduct optimization activities on our lead program. Insights and milestones from the OpRegen program have allowed us to fuel the growth of a new and significantly more internally owned pipeline of cell therapy assets. And I'm not sure that side of our company is as appreciated as it could be. So I plan to discuss that today. Our history of creating multiple new assets from our platform while maintaining a consistent level of annual investment is due to the success we have enjoyed with the AlloSCOPE manufacturing platform. From AlloSCOPE, we believe we will be able to generate off-the-shelf products with commercial scale production costs in the hundreds of dollars per dose versus the hundreds of thousands of dollars you might expect from autologous products. Purity, potency and control are all critical parts of a successful cell therapy product, but we believe the highest value proposition for allogeneic programs is found on the supply side and specifically the ability to establish low-cost production of consistent and potent material. It's quite easy to make prophetic claims about production costs or process control, but it's quite difficult to do these things in practice. For many reasons, cell therapy manufacturing is materially more difficult than it is for small molecules. But unlike some of our peers, Lineage does not need to engage in speculation about our manufacturing capabilities. We have already successfully employed the AlloSCOPE platform to generate a 2-tier GMP banking and GMP production system, which we believe is credibly capable of generating millions of vials of a product candidate. The material from those banks has been cleared by FDA and used in the OpRegen clinical trial. We think having demonstrated this necessary regulatory manufacturing milestone distinguishes us from those who have not. And moreover, we have successfully made cell banks and GMP clinical material for other cell types and from other cell lines, demonstrating the application of our technology in the service of several different indications. We highlight our manufacturing achievements because we know how difficult these things are and we want to invite comparisons to others working in the cell therapy field. Our success to date with OpRegen means that we have an amazing opportunity to apply the experience, know-how and intellectual property that we have generated to create new assets. This is a core strategic objective for Lineage, which we internally refer to as Lineage 3.0. And we want to broaden awareness of these assets because we believe they highlight potential additional value residing in our company. Importantly, these pipeline assets each possess 3 key criteria, which I will outline for you now. First, we have and will continue to choose programs for which we believe the AlloSCOPE platform offers a significant competitive advantage, meaning there is a quality and/or a supply issue that we can seek to address through our consistency and scale solutions. Second, we identify programs that may be capable of generating meaningful signals in a relatively small single-arm trial. OpRegen is a great example of this. At the completion of a first-in-human trial, we secured a collaboration with a $50 million upfront fee and an additional $620 million in potential milestones, which we believe was driven by the fact that GA patients are not known to spontaneously replenish their retinas or durably retain vision gains, yet we showed this outcome in 5 clinical cases. This evidence was compelling even from a small number of patients because the change deviated from the expected natural course of disease. Similar outcomes can be predicted from diabetes and corneal endothelial cell therapy programs because outcomes such as corneal clarity and insulin independence are not known to occur naturally, making these clinical signals easier to identify, even in relatively small trials. And then third, we want the assets that make up Lineage 3.0 to provide us with superior overall economics, which doesn't mean we won't still consider partnering an asset early. It just means that the economics for any deals we strike should reflect the value of us mitigating some of the risks associated with scale-up and for the potential or actual generation of convincing data from a first-in-human trial. I'm next going to briefly discuss how we believe the 3 components of Lineage 3.0 that I just discussed will generate value for us in each of our pipeline programs. I'll start with COR1, our corneal endothelial cell, or CEnC, therapy program, which is designed for the treatment of Fuchs or other corneal endothelial dystrophies. COR1 is a wholly owned preclinical asset, which benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our technology platform because it focuses on what we do best, large-scale, high-quality cell manufacturing. We began exploring CEnC as a potential new program in the second quarter of 2025 and we started doing wet lab work in the third quarter of 2025. And just 9 months later, we successfully employed our AlloSCOPE 5D technology to this program. That means we achieved seamless bioreactor-based 5D precursor expansion and differentiation to support CEnC production, which we believe, together with our proprietary thaw and inject formulation, supports a potentially best-in-class product profile. This work, unsurprisingly, also met our internal criteria for continued advancement into preclinical testing, which is beginning imminently. And thanks to the development precedent that is available for this indication, we are targeting to have initial in vivo data generated by the end of the year. We think this will be an important data point because we want to show that the cells which we make can perform at least as well as cadaver cells in the applicable and previously established models of efficacy. As to how we see ourselves fixing a supply side issue with COR1, millions of people are potential candidates for corneal transplants and yet today there is only 1 donor for every 70 diseased eyes globally. The current supply of CEnCs from cadavers is limited by the low availability of donors as well as by inconsistent yield and quality. But cadaver-sourced transplants have also been demonstrated to be highly effective. Cadaveric sources of CEnCs have been approved in Japan to treat corneal endothelial disease, providing strong evidence for cell replacement as an effective mechanism of action. And as an added benefit, unlike the OpRegen program, we don't expect to have any need for delivery optimization because the cornea is a relatively accessible site with a simple injection-based delivery method, supporting a long clinical track record of positive outcomes. The COR1 program aims to solve the double deficiencies of supply and shelf life of the current therapy because not only do cadaver-derived cells have variable yield and quality, donor-harvested material is not currently cryopreserved and needs to be used promptly. These deficits highlight the benefits of having a reliable, consistent and scalable source of these cells that can also be frozen, shipped and thawed before use. For these reasons, COR1 fits ideally into our ongoing paradigm for rapid pipeline development and we look forward to providing additional updates on this program as it continues to advance. As I mentioned, we recently elected to advance COR1 into in vivo animal testing and initial internal preclinical data is expected to be generated later this year. Moving next to type 1 diabetes. This is our second case study for Lineage 3.0. As with CEnCs, the clinical data shows that islet cell transplants can be an effective and powerful treatment option. Each year, dozens of patients become insulin independent, thanks to islet cells sourced from cadavers. However, islet supply is a major unsolved problem. Expansion of islets from cadaver sources cannot currently meet the commercial needs for these cells. Immunosuppression, patient eligibility and hypoimmunity are all additional hurdles that need to be overcome and several companies are making great strides on those problems. But we believe the hurdle with the least amount of progress to date and also the best fit for our technology is making islets at the scale required to address the large unmet need. And we believe significant value in the islet cell transplant community should accrue to whomever solves the scale problem. One reason for this supply gap is that the required dose of islet cells may be as high as 1 billion cells per patient. In comparison, the dose of OpRegen is up to 200,000 cells, which is 5,000x smaller. On top of that, the proliferative capacity of RPE cells in our hands is at least 50x greater than the published capacity of islets, meaning there is an approximately 250,000-fold gap between current technology and what we believe will be needed for commercial scale islets. This gap will need to be filled somehow. Therein lies the fundamental problem. Islet cells do not readily expand during differentiation or in mature form. So the scale problem needs to be solved prior to differentiation into these cells. Our proposed solution to this problem is employing a modification of our AlloSCOPE platform in what we call AlloSCOPE 5D, which has the goal of generating large-scale production of predifferentiated cells with reduced manipulation and passaging so that you're capturing both 2D synchronization and control of differentiation with 3D environmental control and scalability. We are employing AlloSCOPE 5D to support the ILT1 program because the 5D technology is aimed at not only generating massive numbers of pluripotent cells prior to differentiation, but also ensuring those cells retain their pluripotency and synchronized response to the factors that are needed for efficient differentiation. Yes, it's true that pluripotent cells can maintain long telomeres and self-replicate, but they can still lose genomic integrity and synchrony with every cell cycle or passage, meaning it is necessary, yet very difficult, to maintain homogeneity and control of differentiation as you expand into large numbers of cells. ILT1 is our plan for a cell therapy product candidate that is initially focused on producing a homogenous population of undifferentiated pluripotent cells ready for synchronized differentiation and which could serve as the high feed source material to an islet cell differentiation process for large-scale production. If we can develop a modality that supports an islet cell production process from expansion through differentiation in a dynamic culturing system, we can potentially solve a major hurdle to commercial scale production of an islet cell therapy. This manufacturing-first approach underlies our view of the islet transplant competitive landscape. If we can solve the manufacturing problem, we might have a very successful product with large margins. And even if others are present, we can be nicely positioned against anyone else trying to solve the scale-up problem through less efficient brute force approaches. And with this initiative, we are inverting a traditional development paradigm by focusing on the scale-up of undifferentiated cells first, because as I explained just a moment ago, we believe that once you've shown that you can actually produce your material while maintaining its quality at scale, you may be materially reducing the risk profile for the remainder of the development project. Multiple independent groups have already shown that islets can clear preclinical and clinical testing and be an effective intervention for people with type 1 diabetes. But no one, to our knowledge, has shown that they can scale islets to levels that meaningfully meet the unmet need. For this reason, we think it's appropriate to focus on the unresolved scale problem before performing expensive preclinical and clinical studies. We believe advancing into clinical testing without a robust manufacturing process may prove to be a significant setback for some of the current companies in this space and that there is value in establishing from the beginning a process that can support downstream development, especially when such development has a credible clinical and regulatory precedent. I previously reported that we met our first internal manufacturing milestone for this initiative by demonstrating a fully suspension-based process for undifferentiated pluripotent cells from one of our proprietary cell lines at a 0.5 liter scale. We have since then successfully demonstrated this process in a larger multi-tier format. In parallel, we have applied AlloSCOPE 5D to our COR1 program, showing that we could successfully apply 5D expansion protocols to support the generation of a fully differentiated and specific cell type. Looking ahead, our next goal is to show that cells we expand from the 5D platform can also differentiate into islet precursors, which could demonstrate their ability to be further differentiated into islet cells. I'm hopeful that demonstration will bring more attention to this program and I'm pleased at how quickly this work has progressed. As I said on a prior call, we're happy to take you on this development journey because if it continues to pan out, we believe it could become a very valuable component of our business. Next, I'll spend a few moments on ReSonance. ReSonance is a preclinical auditory neuronal cell transplant to treat hearing loss and is the first internal program built from the beginning on our AlloSCOPE platform. ReSonance is being developed under a partnership with William Demant Invest, or just Demant, where Demant has agreed to fund up to $12 million toward a preclinical development plan, which is intended to support an IND and/or CTA filing. This 3-year alliance is approaching its 1-year anniversary and we are pleased with the progress made to date by the parties. ReSonance is an example of 2 important features of our platform. The first is that we showed we could conceive of and successfully manufacture a completely new cell-based product candidate in a rapid and efficient way. We generated new intellectual property and advanced ReSonance into preclinical testing in about 1 year. The speed and success of that project then led to a partnership with Demant, a world-leading health care -- hearing health care company, which brought us access to specialized technology, auditory expertise and a network of hearing health leaders. The second key feature of ReSonance is it is aligned with our Lineage 3.0 ideals. We believe that if a signal of a treatment effect in hearing loss patients is observed, it would be an important finding in this population, even if it occurs in a small number of patients. That is because, like in dry AMD, patients who suffer from hearing loss from the destruction of a particular type of cell have not been shown to improve spontaneously. If we do see signs of a treatment effect in even a small number of patients with sensorineural hearing loss, we think that could drive value even long before the results of a randomized trial. ReSonance continues to advance in preclinical testing and the goal of our partnership, as I said, is to advance it to an IND. So I look forward to keeping you informed of our progress. In the meantime, I can share an update that we have successfully completed 3 engineering runs of ReSonance and we also recently completed our first GMP run, which is now undergoing release testing. We've also been establishing a novel model of deafening, which will enable us to conduct functional animal testing using the cells we produced under this important partnership. ReSonance represents a novel approach to treating a large underserved market. It doesn't include the cadaver-based treatment precedent of cornea or islet cells, but that's partly why we elected to partner it early and share risk. But at the same time, ReSonance has only one comparable competitor that we can identify and is targeting a very large potential market. So it fits nicely with our Lineage 3.0 strategy. For this reason and more, we're hoping to see ReSonance make it into a clinical trial. Next, as a hybrid to the first 3 examples I've given today, I'm pleased to share some new ideas we have been evaluating for OPC1 development. Implementing these new ideas would more closely align OPC1 into the Lineage 3.0 paradigm. As you likely know, the early efforts with OPC1 were conducted by a different sponsor and focused solely on a subacute patient population. We haven't needed to evaluate the merits of this approach because we've been focused on the more immediate and necessary goals of manufacturing the cells on what we believe will be a commercially viable platform and developing a new delivery device. In the past year, we've more fully evaluated our new manufacturing process and collected some encouraging initial data with the new device. As a result, we've gotten increasingly comfortable that both of those aspects will be successful, which means we can now turn more earnestly to the topic of patient selection. We also recently hired a new Head of Clinical, Dr. Herath, who's on the call today and brings the appropriate resources to evaluate the various possible development paths for OPC1. As a result of that work, which remains ongoing, we anticipate we may decide to prioritize a chronic patient population for future OPC1 development. There are many reasons to consider this adjustment, but I'll review 3 of them for you today. First, and probably the most compelling reason of them all, is that chronic patients have a much more stable neurological baseline compared to subacute patients. The neurological and functional status of chronic patients is typically well established, can be reliably and repeatedly measured and is not likely to change meaningfully without intervention. That means these patients can serve as their own internal treatment control, something that is not possible with a subacute patient population. We think this can help overcome the heterogeneous nature of these injuries and the resulting clinical picture because, as you know, subacute patients experience a great deal of spontaneous improvements during the first 9 months or so. SCI experts we've consulted with acknowledge that it's extremely difficult to tell whether a change in function in a subacute patient is attributable to treatment or to spontaneous improvement, even if you have a well-matched natural historical cohort as a comparison. This issue is mitigated in chronic patients, which is why they fit better into our translational evidence paradigm. Chronic patients are also significantly easier to enroll than subacute patients because they're approximately 10x more prevalent than the subacute population and because the window of eligibility for chronic is measured in months or years, not in just a few weeks. But that is not the only reason to consider focusing on chronic injuries. The change in demographics, the published evidence and the standard of care for subacute patients has advanced and we need to advance with it. Over the years, the average age of an SCI injury has risen from people in their 20s into their 40s. Patients are older, more medically complex and bring different challenges regarding consent and stabilization. Thanks to improved care, the acute and subacute rehab phase, which subacute patients experience in the hospital, has shortened to just a few weeks and AIS conversion rates have risen, which is great for patients. But makes clinical trial data collection and database comparisons in the subacute population more difficult than before. Meanwhile, recent data from various groups have shown that chronic patients, especially those with preserved midsagittal tissue bridges at their injury site, are the ones most likely to show evidence of recovery from cell therapy, especially when the intervention is combined with a rehabilitation protocol. For years, this was not the conventional wisdom. Animal studies from years ago suggested chronic SCI would be a less responsive population. But those studies were conducted, in some cases, 20 years ago, had some design flaws and were never replicated by us or others. We find the recent and modern bodies of work done by both clinical or industrial groups and preclinical and academic groups to be much more convincing and reliable. We appreciate the dedication of these groups to advancing the field because it allows us to proceed into the chronic population with not only a product candidate with the longest published safety profile in the field, but also preexisting evidence of potential activity for this mechanism. Overall, we are excited that chronic patients, a direction and population we have long considered attractive, have been increasingly validated by us and others, giving us a more promising clinical path and the opportunity to adapt the OPC1 program into our model of early trials that can potentially generate meaningful evidence. And so while we continue to enroll the ongoing DOSED study and assess our new way of delivering OPC1 cells to patients, we are simultaneously refining our view of how to best focus on the chronic patient population. Dr. Herath has been collaborating with SCI thought leaders and I expect we will be able to discuss some of our specific plans on a future call. In the meantime, I'll add that the DOSED study, which is designed to demonstrate the safety and performance of the novel spinal cord cell therapy delivery device, to date, has performed as expected with no unexpected procedural, product or device-related adverse events nor does it require any significant design changes. So we are looking forward to enrolling additional patients on that study this year. And now saving the first for last, I will provide a few words on our lead program, OpRegen. I think everyone is well versed on where we stand with this program. Data we initially reported from our OpRegen Phase I/IIa clinical study included improved anatomy of the retina, halting or reversal of atrophic progression and improved vision in patients with dry AMD. These are outcomes not known to occur naturally in human beings. And since we made these initial reports, 3 other companies have reported similar outcomes with their own version of an RPE transplant, providing supporting evidence for this mechanism of action. But importantly, our data indicate that such outcomes are achieved only when the cells are delivered right to the target lesion and there are choices you can make regarding how to conduct delivery to this area. For example, you can access the subretinal space from the front of the eye, transvitreally, or around the back of the eye, suprachoroidally. Like many surgical choices, there are trade-offs. So our partners have undertaken a campaign to evaluate a number of surgical devices and methods, which we believe are intended to improve and simplify clinical outcomes. We believe that this approach may ultimately support a more valuable asset through 3 prongs, a stronger risk-benefit profile, a dominant position over competitors and presumably translating into more revenues attributable to wider adoption by surgeons. This kind of work takes time, but we're encouraged by the progress, for example, reported by the clinical research team at Duke University, which published recently on a novel single-step subretinal injection device that significantly outperformed the current off-the-shelf device in calibrated volume delivery to the subretinal space in a relevant animal model. Overall, as we look at how actively Roche has been culling their pipeline in favor of first and best-in-disease assets and alongside the supportive comments they have made about OpRegen and their commitment to ophthalmology, we remain confident that the OpRegen program is receiving abundant care and attention from our partners and we continue to anticipate a positive future for the program. This, by the way, is aligned with what the Genentech speaker at the ARVO Eyecelerator Conference said a couple of months ago. He noted that transformational outcomes in cell therapies should be defined by a metric of visual function and preserving vision and went on to say that Genentech was investing in surgical development because safe and reliable delivery of OpRegen was key to the outcome that they're looking to achieve for their patients. He also highlighted the 3-year clinical data with OpRegen as evidence of what was possible for the field. We support all of those statements and more. So while we await completion of the ongoing surgical optimization work in the GAlette study, we will continue to closely monitor any relevant activity. As one example, OpRegen was recently registered in the EMA IRIS database, which is something that sponsors need to do before they conduct product-related activities like obtaining scientific advice or running clinical studies in Europe. As a second example, we were very happy to see that Roche expanded the GAlette study from 6 sites to 17 starting last year. And as a third example, Roche dedicated approximately half of its exhibit hall space at the most recent ARVO conference to the OpRegen mechanism of action, which we think is intended to raise awareness of this novel approach to treating dry AMD with an RPE cell transplant. These kinds of actions, along with their continued efforts to discuss the OpRegen program from the podium at medical and scientific conferences, continues to provide us with encouragement that OpRegen is being well supported within the Roche organization. To wrap up, I believe it's important to highlight that we have in the past year demonstrated the ability to rapidly generate additional novel assets with what we believe are differentiated and compelling profiles to create a growing pipeline of cell transplants that we can develop internally or seek to partner where we think it makes sense to do so. Our overall strategy aims to efficiently leverage our AlloSCOPE platform to create, support and manage a broad pipeline of cell-based assets. I'll invite you to keep in mind that our platform assets share certain essential traits so that each dollar we invest in innovation may have impact across multiple programs. We believe this allows us to expand our pipeline without losing the focus required to succeed in each indication and still maintain a manageable and efficient level of capital investment compared to our cell therapy peers. Most of all, we appreciate that the innovative and successful work that created the OpRegen program is giving us the opportunity to generate a portfolio of similar cell-based transplant therapies for many millions of patients around the world and hopefully build a very successful and important company. With that, I will turn things over to Jill for a review of our financials. Jill Howe: Thanks, Brian. I'll begin with an update on our cash runway. As of June 30, 2026, we had $50.8 million in cash, cash equivalents and marketable securities, which we expect will fund planned operations into the third quarter of 2028 and that is 1 quarter longer than the runway we reported on our last call. This extension of our runway reflects our use of the ATM on a single day, June 26, commonly known as Russell Reconstitution Day. By taking advantage of the unusually high trading volume associated with Lineage being added to the Russell 3000 Index, we raised approximately $4.6 million at a weighted average price of $1.28 per share. We were pleased that even with these sales, our stock still closed above its opening price on that day. Beyond our cash currently on hand, we also remain eligible for several other sources of capital. First, we are eligible to receive approximately $32 million from the cash exercise of warrants issued in November 2024, which has a strike price of $0.91. Importantly, those warrants, which have a 3-year maturity date, will accelerate to 90 days if Roche and Genentech publicly disclose their intent to advance OpRegen into a multicenter trial that includes the control or comparator arm. Second, we also remain eligible for up to $615 million in development and commercial milestone payments under the Roche and Genentech collaboration agreement. And third, we continue to evaluate potential partnerships similar to our Roche and Demant collaborations, which we could enter into, into the future. Before reviewing our second quarter results, I'd like to highlight a change from prior periods. We are reporting net income this quarter rather than a net loss. This result primarily reflects a noncash gain from the quarterly remeasurement of our warrant liabilities at fair value. Because our share price declined compared to the prior quarter, the estimated value of these obligations decreased, which creates an accounting gain. This gain was also partially supported by foreign currency effects associated with our international subsidiaries. But I will note that these adjustments affect our reported earnings and reflected normal accounting policies, but do not represent cash received or used during the quarter. Now I will review our second quarter results. Our revenue is generated primarily from collaboration revenues, royalties and other revenues. Total revenues were $1.1 million, a net decrease of $1.7 million as compared to $2.8 million for the same period in 2025. Decrease was primarily driven by lower collaboration revenue recognized under the Roche Agreement, reflective of measured progress towards completion of the first performance obligation as well as lower revenues recognized associated with the prior year termination of the VAC Collaboration Agreement which was partially offset by an increase in revenues related to our research collaboration with WDI. Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expenses were $10 million, a decrease of $12.5 million as compared to $22.5 million for the same period in 2025. And the overall decrease was primarily driven by the $14.8 million expense recognized in the prior year for the noncash loss on impairment for an intangible asset related to the VAC platform. R&D expenses were $4.8 million, an increase of $1.7 million compared to $3.1 million for the same period in 2025. The net increase was primarily driven by our preclinical programs and other undisclosed programs. G&A expenses were $5.2 million, an increase of $0.7 million as compared to approximately $4.5 million for the same period in 2025. The net increase was primarily driven by personnel costs and stock-based compensation expenses. Loss from operations were $8.9 million, a decrease of $10.9 million as compared to $19.8 million for the same period in 2025. The decrease was primarily driven by the prior year noncash impairment expense related to the VAC platform of $14.8 million, which is a nonrecurring transaction. Other income and expenses reflected other income of $10.5 million compared to other expense of $10.6 million for the same period in 2025. The net change was primarily attributable to the quarterly fair value noncash remeasurement of the warrant liabilities, driven by a decrease in our share price as compared to an increased share price in the prior year's quarter, which is partially offset by exchange rate fluctuations related to our international subsidiaries. The net income and loss attributable to Lineage was $1.5 million or $0.01 per share for basic and $0.03 loss per diluted compared to a net loss of $30.5 million or $0.13 per share for both basic and diluted for the same period in 2025. The change was primarily driven by the prior year noncash loss on impairment expense related to the 2019 acquisition for the quarterly fair value remeasurement of the warrant liabilities. Overall, our second quarter results reflected our continued focus on disciplined fiscal management and prudent capital allocation. We remain committed to managing expenses carefully while directing resources towards strategic investments that strengthen and advance our pipeline. We believe this balanced approach supports our near-term operating priorities and our long-term growth objectives. With that, I'll turn the call back to Brian for closing remarks. Brian Culley: Thanks, Jill. This will continue to be an exciting year for Lineage. I'll just repeat some key points. First, we continue to remain confident in the potential for OpRegen to advance into a multicenter controlled trial. Second, with that confidence, we have made investments in our AlloSCOPE platform, demonstrating the ability to rapidly and strategically generate additional novel cell transplant assets, all based on our platform technology and utilizing our AlloSCOPE capabilities. And then looking ahead, our approach to product development will seek to take advantage of the power of cell transplantation to swiftly, effectively and strategically develop assets with the potential to generate signals from early clinical trials. We're very proud of our progress to date and also believe there's much more to look forward to from our platform in the months ahead. We appreciate your support and belief in our vision. With that, operator, we are ready for any analyst questions. Operator: [Operator Instructions] Your first question comes from Mayank Mamtani with B. Riley Securities. Mayank Mamtani: Appreciate a lot of detail here. So maybe just first on the islet cell program. If you could comment a little bit on what the multiliter scale you are at right now with working volumes? And if you could maybe talk about your process and protocol, how that contrasts with peers, including, I think, a couple that are in clinical stage and have mentioned recently their excitement about having more patients be exposed to this modality. And then my second question was on the chronic DOSED study where you've had, I believe, a couple of SCI patients on study. And I was just wondering if there's been any update, including a 1-year update, I think you had mentioned before. And maybe just comment on what sort of things to look out for as you advance your regulatory dialogue here, including some clinical data we can get from here. Brian Culley: Thanks, Mayank. So as to your first question, there are many component parts that go into AlloSCOPE 5D. There are biological inputs, physical inputs, engineering inputs. There's know-how. And while one might think that something as simple as the vessel size you're using for any particular stage might not be in and of itself revealing and think that is true, there are a finite number of providers in the space. And so even something as simple as saying what scale we're at will probably not be shared by us anytime in the future because we want to maintain protection across every aspect of what we're doing. It is that important to us. So we're being intentionally unclear about exactly what vessel size, because if there were only one company in the world that makes a 4.4-liter vessel, you would know one of the many component parts and we're just not going to do that. So for now, you're going to have to be satisfied with multiliter. But perhaps Dr. Herath can give you a more satisfying answer to your other question about where we are in the DOSED study. Priyantha Herath: Mayank, good to meet you here. So as you know, the DOSED study was not designed to assess functional changes in our patients. And therefore, we shouldn't be actually looking for clinical improvements or any such thing in this particular study. What we can tell you, however, is that the patients, both of them -- one of them completed a year, the other one, 90 days. They have both remained adverse events free and completely stable as expected, given they are chronic patients. What we can also tell you is that there has been some anecdotal information that has come through from the family members, which we can't really assess formally, but we can tell you that the patient has reported some improvement, improved breathing and core strength, et cetera. But again, as I said, we are not going to comment on formal neurological changes in these patients until we advance to a proper efficacy study. Operator: Your next question comes from Jack Allen with Baird. Jack Allen: I apologize, I wasn't able to listen to all the prepared remarks. So I'm not sure if some of these have been covered. But I wanted to start off with the COR1 program, which it's great to see is moving forward. I guess I wanted to ask about what your time is as it relates to potentially getting this asset into the clinic and how you think about the partnership opportunity with COR1. I believe some of these indications are fairly high in the number of patients that you could potentially treat. Would you look to bring a partner on ahead of moving into the clinic? Or would you like to provide clinical proof of concept and really derisk the program and then partner the program? And I have a quick follow-up as well. Brian Culley: Thank you for the question, Jack. Always, these are options for us. So there are scenarios that are driven by capabilities where sometimes partnering makes sense. But COR1 probably doesn't rate high on that particular criteria because we can execute a plan. What's really beneficial about COR1 is that others have already established the appropriate animal models, human study designs have been done, leading ultimately to an approved product, in this case, only in Japan to date. So there's a lot of imitation or copycat that we don't have to innovate a whole lot, which I think will allow us to go faster. Ironically, we did a call dedicated solely to COR1, where my main message was that value for a program like this perhaps should be rewarded or granted even as early as just developing the right product profile. Because we know that the way that this works today is that many thousands of individuals provide donor material. We are just another source of donor material. So I think that the risk profile for our corneal endothelial cells is probably very different than if you are pursuing an entirely different approach. A small molecule hitting a target that's not validated is very different than if 40,000 people have already had this procedure and you show up with the [ forty thousand and first ] source of cells. I think that's a very different product profile. So we will be, I think, benefiting in terms of getting into the clinic from the fact that there's a precedent. It probably allows us to do a number of things in parallel. And I think the risk profile would allow us to go confidently down some of those paths in parallel. What we said today is that one of our goals is to generate initial animal model data. If we are in a position to share it before the end of the year, that's even better. That would certainly be a goal for us. But I do want to remind, for everyone who's listening to that question, this program scarcely existed a year ago. And now here I am talking about how quickly we might be able to get into clinical trials. And so that more than anything else, ought to be a good indication because if you tried to do the same thing with a small molecule approach, you could be spending 4 or 5 years screening compounds and working your way through SAR, doing hit-to-lead activities. So the power of this platform is exactly that, that we can generate programs with differentiated risk profiles and differentiated products and features very rapidly without breaking the bank along the way. Jack Allen: Yes, I know. It's been great to see the rapid progress there. And then if I may, just one brief follow-up. You mentioned a regulatory filing around OpRegen in Ireland. I was hoping you could just elaborate a little bit more on what that filing was and what it could mean as it relates to Roche's appetite to starting studies in that geography. Brian Culley: Yes. Thank you for the question. Not Ireland. I did go there for the first time last year, a lovely place, but I was referring to the IRIS database. So the EMA maintains the IRIS database. And so you need to register any material before you talk with the regulatory bodies in Europe about that material. So it's nothing more than an administrative step, but it's an administrative step that's been done 2, 2.5 years, 3 years after licensing the program. So it is nothing more than another tea leaf. But I invite the listeners to consider how many tea leaves start to make you feel that there's some asymmetry in a possible positive outcome here. So it doesn't commit -- to my knowledge, it doesn't commit Roche or Genentech to doing anything in Europe, but it does invite the question why they bother doing that. And I think that's what a lot of the questions are that we have regarding the OpRegen program and all the different activities that seem to point to us that things are going well. Jack Allen: Thanks for the correction on IRIS versus Irish. That's great progress to hear. Operator: Your next question comes from John Newman with Canaccord Genuity. John Newman: Congrats on the continued progress. So I'm just wondering, Brian, if you could just remind us on the OpRegen program, what are the commercial -- or sorry, what are the milestones that you're eligible for in that program? And do you maintain commercial rights or maybe some sort of right to opt in? Or is it more of a royalty on the commercialization side? Brian Culley: Yes. Thanks for the question, John. So we remain eligible for $615 million of developmental and commercial milestones. Those are not broken out publicly. There was one milestone that we already met that was in connection with a manufacturing and clinical achievement that we met. So that was obviously another positive indicator that we're doing some good things for our partner. And then it's not a co-promote agreement. It is a plain vanilla royalty agreement. It's a double-digit royalty that has tiers that increase the rate as certain thresholds are met. As with any license, there are also certain conditions where those royalty rates can be going in the opposite direction. But the base case is that is pretty attractive to us, a double-digit base case for that license agreement with Roche and Genentech on a worldwide basis. And I will note that while it is for any eye disorder, it is limited to the RPE cells. So any other cell type that we're working on represents more opportunities for potential partnerships, but the Roche/Genentech one could be deployed into any number of different ophthalmological disorders. They do have the right to do that if they so elect. John Newman: One additional question on a different program. Should we expect additional updates this year from your work in diabetes? Brian Culley: I hope so. It's more likely than not. I do tend to provide a lot of in-depth information about what we're doing. And I can frankly tell you that I've been surprised at the rate of progress by the team. So I think the answer is yes, but I'll reserve the right to be wrong in my prediction there. But I have provided an update, I think, 3 consecutive quarters. So I would certainly hope that I would have something interesting to say before year-end. Operator: Your next question comes from Joe Pantginis with H.C. Wainwright. Joseph Pantginis: Two questions, please. So Brian, you started the call by saying you're going to provide some background information behind the scenes and what have you. So I'm really happy that you provided all of the manufacturing types of details. But I want to go even deeper there and that is to get to the final cell that gets into the vial and that's based on all of your expertise and the proprietary nature of what I guess I would call the recipe for these cells where once it makes the vial, like I guess you could provide a little more detail here. It's like you just can't go back into the recipe and say, okay, I'm going to add another tablespoon of sugar. So I was hoping you could just sort of talk about the proprietary nature there that could impact the competitive profile in the future. That's number one. Number two, I'm going to ask, I guess, the 47th version of a proxy question regarding OpRegen. And that is based on your services agreement can you point to anything in your agreement with them with regards to increasing of services, sending them more products or anything of that nature? Brian Culley: Thank you, Joe. I'll answer the second question first. It's shorter. No. There's internal information that we have that is nonpublic. And so of course, we have greater insights and beliefs relative to our investor audience. But all of the service agreement information is, and continues to be confidential. Regarding the recipe, so making a specific cell type, and I should be really clear again here, not just making it, because there's a lot of labs that can make a cell that you choose, but being able to make it reproducibly, have the right control, the purity, the quality, being able to do it on a scalable platform, right, these are all the table stakes to play for a commercial pot. And as soon as you layer in those criteria, it becomes more difficult. So a lot of our intellectual property is in the methods that we utilize in order to make these specific cells with all of these additional criteria. But more than that, and the reason why I continue to figuratively pound the table on how difficult this is and why it's important to do it correct from the beginning, is the regulatory component. If you are making cells, and let's say it takes you randomly 45 days to run a batch of a certain kind of cell and that's good enough to do a Phase I clinical trial, but you know that it's not a commercially viable process and you just say to yourself, well, I'm going to put some steroids in here. I'm going to throw some sugar in here and I'm going to make the process, spit out more cells, I'm going to, i.e., scale it, you are changing your product in the view of the FDA. In a worst-case scenario, your product is different enough that you must start over. So we believe that it is a flawed approach, an unnecessarily risky approach to develop a program that doesn't already, at the beginning, demonstrate the ability to have a high probability of scalability with your process. Build a process that scales on day 1 because none of us want to get into a situation where we celebrate Phase I clinical data and then have to go out to the world and explain and apologize why we can't actually make enough of this product that we're touting as being successful. That sounds like a terrible strategy. So we take more time. We probably invest more money, but we retain in-house the technology so that we feel a very different sense of our ability to scale these products so that if we do show evidence in a clinical trial, we don't have to go back and change anything. We may have some comparability across batches, but we're not changing anything in our methods. And it is a fundamental principle among those who exist within cell therapy manufacturing, not even the cognoscenti, like just general people who are really wise in cell manufacturing, are going to appreciate how important it is to not make any changes to your process. But I think that, that is so different from how we look at small molecules where we just say, look, throw more raw materials in, do some quality control, run your analytics and you're going to have the same stuff. That's true for small molecules. It is violently untrue for cell therapy manufacturing. So we continue to perhaps look and feel a little bit differently. A reason to run a call like the one we're doing today, which is sort of a behind the scenes, get to know us, understand our strategy, is in part specifically because there are principles of cell therapy manufacturing that are not applied to small molecules and not applied to antibodies, but are critical to understand in order to understand how Lineage is building itself to be a successful company in the future. So I thank you for that question because it gives me an opportunity to stand on a soapbox and shout it again. Operator: Your next question comes from Sean McCutcheon with Raymond James. Sean McCutcheon: Brian, just one from us. On OPC1, can you speak to the requisite safety waiting period and challenges identifying and getting patients into the DOSED study? What are your expectations for cadence of new patients enrolled and being treated moving forward now that the second patient has been dosed, that they were dosed about 90 days ago. And should we anticipate only chronic patients being enrolled into the DOSED study moving forward? Brian Culley: Yes. And I'll let Dr. Herath in just a minute answer that. We didn't expect to -- we didn't expect the need to be urgent around chronic because we figured chronic would come in before subacute because subacute, of course, requires an accident or an event. And so we thought that the subacute patients, of which 3 to 5 are planned, would be the lagging population. But now we're starting to have some different thoughts. And so yes, we do retain the optionality of potentially changing the protocol. And maybe instead of those subacute patients, perhaps we'll use those patients as bridging to our new cells. But let me invite Dr. Herath to provide his views on that. Priyantha Herath: Sean, good to meet you again. So the first 4 patients in the protocol, each will have a 1-month DSMB break before the next patient can be enrolled. So there's that. So until we are done with the fourth patient, we cannot rapidly expand the recruitment. And so that's where things are for the time being. Third patient is currently being assessed. We have several candidates. What I can tell you is that they are all chronic patients right now, just for the reason that Brian mentioned. So then the fourth patient will come. Beyond that, further expansion and how rapidly we can go depends on a number of factors such as finding the patients, initiating more sites and so on and so forth. But I think the anticipation is to try to get the remaining patients relatively quickly, hopefully, within the next 12 months or so overall. Operator: There are no further questions at this time. I will now turn the call back to Brian Culley for closing remarks. Brian Culley: Excellent. Thanks, everyone. Our focus on replacing cells that have become dysfunctional or destroyed might reshape many treatment paradigms in the future and we really thank you for joining us on this mission. Have a great day. Operator: This concludes today's call. Thank you for attending. You may now disconnect. Before you buy stock in Lineage Cell Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Lineage Cell Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Lineage Cell Therapeutics. The Motley Fool has a disclosure policy. Lineage Cell Therapeutics (LCTX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Interested in Lineage Cell Therapeutics, Inc.? Here are five stocks we like better. Pipeline progress: Lineage advanced preclinical programs in corneal disease, Type 1 diabetes and hearing loss, while Roche and Genentech continued optimizing surgical delivery for the lead OpRegen retinal therapy. Clinical developments: The OPC1 DOSED study has treated two chronic spinal-cord-injury patients without unexpected safety issues, though the study is not designed to measure efficacy. OpRegen remains eligible for up to $615 million in development and commercial milestones plus tiered double-digit royalties. Financial position: Lineage ended the quarter with $50.8 million in cash and marketable securities, extending its expected runway into Q3 2028. Revenue fell to $1.1 million, but net income reached $1.5 million, primarily due to a non-cash warrant-liability gain. Lineage Cell Therapeutics (NYSEAMERICAN:LCTX) outlined progress across its cell-therapy pipeline during its second-quarter 2026 earnings call, highlighting preclinical advances in corneal disease, Type 1 diabetes and hearing loss programs while Roche and Genentech continue surgical-delivery optimization work for its lead OpRegen program. Chief Executive Officer Brian Culley said the company’s strategy, which it calls “Lineage 3.0,” centers on using its AlloSCOPE manufacturing platform to develop allogeneic, or off-the-shelf, cell therapies that can be produced consistently at scale. Culley said the company aims to target indications where small initial trials could generate meaningful treatment signals and where Lineage can retain improved economics through internal development or partnerships. → No Hangover: Revisiting Microsoft One Week After Earnings Culley said Lineage has established a two-tier current good manufacturing practice banking and production system that it believes can produce millions of vials of a product candidate. Material from those banks has been cleared by the FDA and used in the OpRegen clinical trial, he said. The company believes the platform can support production costs in the hundreds of dollars per dose, compared with potentially much higher costs for autologous therapies. Culley emphasized that cell-therapy manufacturing requires reproducibility, purity, potency and scalability, and said changes to a production process after early clinical trials can create regulatory and comparability risks. → MarketBeat Week in Review – 08/03 - 08/07 During the question-and-answer session, Culley declined to provide more detailed information on the vessel sizes used in the company’s Type 1 diabetes manufacturing work, citing the proprietary nature of the process. He said Lineage’s approach is to establish a scalable manufacturing process early rather than modify it later after clinical data are obtained. Lineage’s wholly owned COR1 program is being developed as a corneal endothelial cell therapy for Fuchs’ dystrophy and other corneal endothelial diseases. The company began evaluating the program in the second quarter of 2025 and initiated laboratory work in the third quarter of that year. → Why the Landlord of the AI Boom Could Outlast the Chipmakers According to Culley, Lineage has applied its AlloSCOPE 5D technology to expand precursor cells in bioreactors and differentiate them into corneal endothelial cells. Preclinical in vivo testing is expected to begin imminently, with initial internal animal data targeted by year-end. The company plans to evaluate whether its cells perform at least as well as cadaver-derived cells in established efficacy models. Culley said the program addresses supply and shelf-life limitations in donor-derived corneal transplants. He cited an estimate of one donor for every 70 diseased eyes globally and noted that donor-derived material must be used promptly rather than cryopreserved. In response to an analyst question, Culley said the existing clinical and regulatory precedent for corneal endothelial cell replacement could allow Lineage to move relatively quickly, although he did not provide a timetable for a clinical filing. For Type 1 diabetes, Lineage is pursuing ILT1, a manufacturing-focused initiative intended to produce homogeneous populations of undifferentiated pluripotent cells that can serve as source material for islet-cell differentiation. Culley said islet-cell doses may require as many as 1 billion cells per patient and that islet cells do not readily expand during differentiation or in mature form. The company previously demonstrated a suspension-based process for undifferentiated pluripotent cells at a half-liter scale and has since shown the process in a larger multi-tier format. Its next objective is to demonstrate that cells expanded through the 5D platform can differentiate into islet precursors. Culley said Lineage may provide another diabetes-program update before year-end. Lineage also reported progress in ReSonance, its auditory neuronal cell-transplant program for hearing loss. The program is being developed with William Demant Invest, which has agreed to fund up to $12 million toward a preclinical plan intended to support an investigational new drug application or clinical trial application filing. The company has completed three engineering runs and its first GMP run, which is undergoing release testing. It is also establishing a deafening model for functional animal testing. For OPC1, Lineage is considering prioritizing chronic spinal cord injury patients for future development. Culley said chronic patients have more stable neurological baselines than subacute patients, who can experience spontaneous improvements during the months following injury. He also said chronic patients are more prevalent and have longer eligibility windows for enrollment. The ongoing DOSED study is designed to evaluate the safety and performance of a new delivery device for OPC1. Culley said no unexpected procedural, product-related or device-related adverse events have occurred and no significant device design changes have been required. Priyantha Herath, senior vice president and head of clinical, said two chronic patients have been treated, with one having completed one year of follow-up and the other reaching 90 days. He said both remained stable and adverse-event-free. Herath cautioned that DOSED was not designed to assess functional efficacy. While he noted anecdotal reports from family members involving breathing and core-strength improvements, he said Lineage would not formally assess neurological changes until an efficacy-focused study. The first four patients in the protocol require a one-month data safety monitoring board pause between enrollments, and the company is assessing candidates for a third patient. OpRegen, Lineage’s retinal pigment epithelial cell therapy for geographic atrophy associated with dry age-related macular degeneration, remains under development by Roche and Genentech. Culley said the partners are evaluating surgical methods and devices intended to improve safe, reliable delivery to the target lesion in the subretinal space. He cited expansion of the GAlette study from six to 17 sites beginning last year and OpRegen’s registration in the European Medicines Agency’s IRIS database. Culley characterized the latter as an administrative step required before certain Europe-related product activities, rather than a commitment to conduct studies there. Lineage remains eligible for up to $615 million in development and commercial milestones under its Roche and Genentech agreement, as well as tiered double-digit royalties. Culley said the agreement is not a co-promotion arrangement. Chief Financial Officer Jill Howe said Lineage ended the second quarter with $50.8 million in cash equivalents and marketable securities, which the company expects will fund planned operations into the third quarter of 2028. The projection is one quarter longer than its prior estimate. The extension reflected approximately $4.6 million raised through the company’s at-the-market facility on June 26, when Lineage was added to the Russell 3000 Index. The shares were sold at a weighted average price of $1.28 each, Howe said. Total revenue was $1.1 million, down from $2.8 million in the prior-year quarter, primarily due to lower collaboration revenue under the Roche agreement and lower revenue following the prior-year termination of the VAC collaboration agreement. Research and development expense increased to $4.8 million from $3.1 million, driven by preclinical and undisclosed programs. General and administrative expense rose to $5.2 million from about $4.5 million, reflecting personnel costs and stock-based compensation. Operating loss narrowed to $8.9 million from $19.8 million a year earlier, largely because the prior-year period included a $14.8 million non-cash impairment charge related to the VAC platform. Net income was $1.5 million, or $0.01 per basic share, compared with a net loss of $30.5 million, or $0.13 per share, a year earlier. Howe said the quarterly net-income result primarily reflected a non-cash gain from the fair-value remeasurement of warrant liabilities as Lineage’s share price declined from the prior quarter. She said the accounting adjustment did not represent cash received or used during the quarter. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, allogeneic cell therapies built on pluripotent stem cell platforms. The company focuses on three primary therapeutic areas—retinal disease, neural repair and immune-effector cell oncology—leveraging its proprietary manufacturing processes to create off-the-shelf cell therapy candidates designed for broad patient populations. Its lead candidate, OpRegen, comprises retinal pigment epithelium cells intended to slow or reverse vision loss in patients with geographic atrophy secondary to age-related macular degeneration. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Lineage Cell Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management introduced 'Lineage 3.0', a strategic pivot focusing on wholly owned assets where the AlloSCOPE platform provides a distinct competitive advantage in manufacturing scale and quality. The company is prioritizing programs capable of generating meaningful clinical signals in small, single-arm trials, citing OpRegen's success as the blueprint for this translational evidence paradigm. A core strategic pillar is solving the 'supply-side' crisis in cell therapy by achieving commercial-scale production costs in the hundreds of dollars per dose, contrasting with the high costs of autologous products. Management emphasized that cell therapy manufacturing must be established at scale from 'day one' to avoid regulatory setbacks and product comparability issues that often plague peers transitioning from Phase I to commercialization. The company is leveraging its experience with Roche and Genentech to fuel a new pipeline, including corneal endothelial cells (COR1) and islet cells for diabetes (ILT1), while maintaining a consistent annual investment level. Strategic positioning now favors indications where outcomes like corneal clarity or insulin independence do not occur naturally, allowing for faster validation of efficacy. Lineage anticipates generating initial in vivo animal data for the COR1 corneal program by the end of 2026 to demonstrate performance parity with cadaver-sourced cells. The company plans to prioritize chronic patient populations for future OPC1 development, assuming these patients provide a more stable neurological baseline for measuring treatment effects compared to subacute patients. Management expects to demonstrate that cells expanded via the AlloSCOPE 5D platform can differentiate into islet precursors, potentially solving the massive scale-up hurdle for type 1 diabetes treatments. The current cash runway is projected to fund operations into the third quarter of 2028, supported by disciplined fiscal management and potential milestone payments from the Roche collaboration. Future clinical trials for OPC1 will likely incorporate rehabilitation protocols, following modern evidence suggesting chronic patients with preserved tissue bridges are most responsive to cell therapy. The company reported a net income for the quarter, primarily due to a non-cash accounting gain from the remeasurement of warrant liabilities following a decline in share price. A $14.8 million non-cash impairment charge related to the VAC platform from the prior year did not recur, significantly improving the year-over-year operating loss comparison. Management flagged the inherent difficulty of maintaining genomic integrity and synchrony during the massive expansion of pluripotent cells required for the ILT1 program. The OpRegen program was recently registered in the EMA IRIS database, a necessary administrative step for future regulatory advice or clinical studies in Europe. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management declined to specify exact vessel sizes for the ILT1 program to protect proprietary engineering and biological inputs, describing the current scale only as 'multi-liter'. The strategy focuses on solving the 'scale problem' before expensive clinical trials, noting a 250,000-fold gap between current technology and commercial needs for islet cells. Dr. Herath clarified that the DOSED study is designed for safety and device performance, not functional changes, though anecdotal reports of improved core strength were noted. The study requires a one-month safety waiting period between the first four patients, which dictates the current enrollment cadence. Management believes COR1 has a lower risk profile because cadaver-cell efficacy is already clinically validated; Lineage is simply providing a superior, scalable source. The company may seek to provide clinical proof-of-concept before partnering to maximize economics, though they remain open to earlier deals if the product profile is sufficiently derisked. Lineage remains eligible for $615 million in milestones and a tiered double-digit royalty on worldwide sales. The Roche/Genentech agreement is limited to RPE cells but covers any eye disorder, leaving other cell types available for independent development by Lineage.

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lineage Cell Therapeutics Inc (LCTX) extended its cash runway into the third quarter of 2028, one quarter longer than previously guided, providing greater financial stability. The company successfully raised approximately $4.6 million through an ATM offering on Russell Reconstitution Day without negatively impacting its stock price, demonstrating prudent capital management. Lineage Cell Therapeutics Inc (LCTX) reported net income of $1.5 million for Q2 2026, a significant improvement from a net loss of $30.5 million in the same period last year, driven by non-cash gains. The Alascope manufacturing platform has demonstrated the ability to rapidly generate new pipeline assets, with the Core 1 corneal program advancing to preclinical testing just nine months after starting wet lab work. Lineage Cell Therapeutics Inc (LCTX) remains eligible for up to $615 million in development and commercial milestones from the Roche/Genentech collaboration, alongside a double-digit tiered royalty on worldwide sales. The company's OPC1 program is pivoting to a chronic spinal cord injury patient population, which offers a more stable neurological baseline, easier enrollment, and a larger patient pool compared to subacute patients. Lineage Cell Therapeutics Inc (LCTX) successfully completed its first GMP run for the Resonance hearing loss program and established a novel deafening model for functional testing, advancing the partnership with Demant. The company's ILT1 diabetes program is progressing well, having successfully demonstrated a fully suspension-based process for undifferentiated pluripotent cells at a multi-liter scale, addressing a key manufacturing hurdle. Management highlighted that the Operigen program has received continued support from Roche, including expansion of the GALET study to 17 sites and registration in the EMA IRIS database, signaling ongoing commitment. Lineage Cell Therapeutics Inc (LCTX) reported a decrease in total revenue to $1.1 million for Q2 2026, down from $2.8 million in the prior year, primarily due to lower collaboration revenue recognized under the Roche agreement. R&D expenses increased by $1.7 million to $4.8 million in Q2 2026, driven by investments in preclinical programs, which could pressure future cash flows if not offset by partnership revenues. The company's reported net income was primarily due to a non-cash gain from the remeasurement of warrant liabilities, which is not indicative of operational profitability and could reverse if the share price rises. The OPC1 dose study is progressing slowly, with only two patients dosed to date and a mandatory one-month DSMB break between the first four patients, limiting the pace of enrollment and data generation. Management remains intentionally vague about the scale and details of its Alloscope 5D manufacturing process, which may frustrate investors seeking clarity on the ILT1 program's competitive positioning. The Operigen program's advancement into a multi-center controlled trial remains uncertain, with no definitive timeline provided, and the company relies on 'tea leaves' such as the EMA IRIS registration as indirect signals of progress. Lineage Cell Therapeutics Inc (LCTX) faces significant manufacturing challenges in scaling islet cells for diabetes, with a 250,000-fold gap between current technology and commercial-scale needs, which may not be easily overcome. The company's reliance on partnerships, such as the Demant collaboration for Resonance, introduces dependency on external funding and expertise, which could limit control over program development timelines. General and administrative expenses increased by $0.7 million to $5.2 million in Q2 2026, driven by personnel and stock-based compensation, indicating rising overhead costs that could impact efficiency. Warning! GuruFocus has detected 4 Warning Signs with LCTX. Is LCTX fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more detail on the proprietary nature of your cell manufacturing "recipe" and how it impacts your competitive profile? Also, can you point to anything in your services agreement with Roche regarding increased services or product supply for the Oprogen program?A: Brian Culley, CEO: Regarding the recipe, making a specific cell type reproducibly with the right control, purity, and quality on a scalable platform is the table stakes for a commercial product. Our intellectual property lies in the methods we use to make these cells with these additional criteria. The critical point is the regulatory component: if you change your process after Phase 1, the FDA may view it as a different product, potentially forcing you to start over. We build a process that scales from day one to avoid celebrating clinical data and then being unable to manufacture enough product. Regarding the Roche agreement, all service agreement information remains confidential, but we have greater internal insights and beliefs relative to our investor audience. Q: On the islet cell program, what working volume scale are you at with the multi-tier format, and how does your process contrast with peers? Also, on the chronic dose study, can you provide an update on the patients, including any one-year data?A: Brian Culley, CEO: We are being intentionally unclear about the exact vessel size to protect our intellectual property, as there are a finite number of providers in the space. You will have to be satisfied with "multi-liter" for now. Dr. Priyantha Harath, SVP and Head of Clinical: The DOSE study was not designed to assess functional changes. Both patientsone completed a year, the other 90 dayshave remained adverse event-free and stable as expected for chronic patients. There has been anecdotal information from family members about improved breathing and core strength, but we will not comment on formal neurological changes until we advance to a proper efficacy study. Q: On the Core One program, what is your timeline for potentially getting this asset into the clinic, and how do you think about partnership opportunities? Would you partner before the clinic or de-risk the program first?A: Brian Culley, CEO: These are always options for us. Core 1 doesn't rate high on the criteria for early partnering because we can execute the plan ourselves. The benefit is that others have already established animal models and human study designs, leading to an approved product in Japan. We don't have to innovate a lot, which allows us to go faster. The risk profile is different because we are just another source of donor material, with 40,000 people already having had this procedure. We aim to generate initial animal model data by the end of the year. The program scarcely existed a year ago, and now we are talking about clinical trials, demonstrating the power of our platform to generate programs rapidly. Q: Can you remind us of the milestones you are eligible for in the Oprogen program, and do you maintain commercial rights or is it a royalty arrangement?A: Brian Culley, CEO: We remain eligible for $615 million in development and commercial milestones, which are not broken out publicly. We already met one milestone related to manufacturing and clinical achievement. It is not a co-promote agreement; it is a plain vanilla royalty agreement with a double-digit royalty that has tiers increasing as thresholds are met. There are conditions where royalty rates could decrease, but the base case is attractive. The license is for any eye disorder but limited to RPE cells. Any other cell type we work on represents more opportunities for potential partnerships. Q: On OPC-1, can you speak to the requisite safety waiting period and challenges identifying and enrolling patients into the dose study? What is the expected cadence of new patients, and should we anticipate only chronic patients being enrolled moving forward?A: Brian Culley, CEO: We didn't expect to need to be urgent around chronic patients, but we are starting to have different thoughts. We retain the optionality of potentially changing the protocol, perhaps using subacute patients as a bridge to our new cells. Dr. Priyantha Harath, SVP and Head of Clinical: The first four patients in the protocol each have a one-month DSMB break before the next patient can be enrolled. Until we finish the fourth patient, we cannot rapidly expand recruitment. The third patient is currently being assessed, and we have several candidates, all chronic patients. We anticipate getting the remaining patients enrolled relatively quickly, hopefully within the next dozen months or so. Q: You mentioned a regulatory filing around Oprogen in Ireland. Can you elaborate on what that filing was and what it could mean for Roche's appetite to start studies in that geography?A: Brian Culley, CEO: Not IrelandI was referring to the IRIS database, which is maintained by the EMA. You need to register any material before talking with regulatory bodies in Europe. It is an administrative step, but it was done two and a half to three years after licensing the program. It doesn't commit Roche or Genentech to doing anything in Europe, but it invites the question of why they bothered. It is another "tea leaf" that points to a possible positive outcome for the program. Q: Should we expect additional updates this year from your work in diabetes?A: Brian Culley, CEO: I hope so; it's more likely than not. I have been surprised at the rate of progress by the team. I have provided an update for three consecutive quarters, so I would certainly hope to have something interesting to say before year-end. Q: Can you provide more detail on the proprietary nature of your cell manufacturing "recipe" and how it impacts your competitive profile? Also, can you point to anything in your services agreement with Roche regarding increased services or product supply for the Oprogen program?A: Brian Culley, CEO: Regarding the recipe, making a specific cell type reproducibly with the right control, purity, and quality on a scalable platform is the table stakes for a commercial product. Our intellectual property lies in the methods we use to make these cells with these additional criteria. The critical point is the regulatory component: if you change your process after Phase 1, the FDA may view it as a different product, potentially forcing you to start over. We build a process that scales from day one to avoid celebrating clinical data and then being unable to manufacture enough product. Regarding the Roche agreement, all service agreement information remains confidential, but we have greater internal insights and beliefs relative to our investor audience. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive 3 Year Phase 1/2a Clinical Data of RG6501 (OpRegen®) Featured at Retinal Therapeutics Innovation Summit 2026 Announced Progress with Wholly-Owned Corneal Endothelial Disease Cell Therapy Program (COR1) Established Scientific Advisory Board With Cell Therapy Executive Joachim Fruebis, PhD As Founding Member Cash, cash equivalents, and marketable securities as of June 30, 2026 expected to support planned operations into Q3 2028. CARLSBAD, Calif., August 06, 2026--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel, allogeneic, "off the shelf", cell therapies for serious medical conditions, today reported its second quarter 2026 financial and operating results. The Company will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update. "As we continue to support our collaboration with Roche and Genentech for their clinical development of OpRegen, Lineage remains focused on building out our allogeneic cell transplant pipeline. Our most recent advancement is COR1, our wholly-owned corneal endothelial cell (CEnC) therapy preclinical program, which we believe highlights the value of our pluripotent cell-based therapeutic platform to be able to generate novel assets with differentiated and potentially superior characteristics," stated Brian M. Culley, Lineage CEO. "COR1 benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our platform. Notably, only nine months after internal lab work began, we successfully utilized our proprietary AlloSCOPETM 5D technology to achieve seamless bioreactor-based precursor expansion and differentiation to support large-scale CEnC production. We believe this expansion and differentiation capability, together with a thaw-and-inject formulation, can support the development of an exciting and potentially disruptive asset in corneal disease." "The COR1 program, together with others in our pipeline, reflects Lineage’s balanced business strategy: to provide manufacturing support for Roche and Genentech’s clinical development of RG6501 while also prioritizing programs that we believe can potentially generate meaningful data from early clinical trials, which could allow us to evaluate clinical potential earlier, optimize capital allocation, and accelerate value creation," added Mr. Culley. Select Business Highlights - RG6501 (OpRegen Cell Therapy) Positive RG6501 (OpRegen cell therapy) Phase 1/2a clinical study 3 year results encore featured at Foundation Fighting Blindness’ Retinal Therapeutics Innovation Summit 2026, suggest evidence of sustained gains in best corrected visual acuity (BCVA) and partial structural restoration of the retina, including regions with re-appearance of an RPE layer and features associated with recovery of photoreceptors. Positive long-term clinical outcomes reported following a single administration of OpRegen cell therapy. Ongoing execution of Lineage’s contributions to Roche and Genentech's development of OpRegen. The ongoing Phase 2a GAlette Study is currently open and active at 17 clinical sites in the U.S. and Israel. Ongoing efforts to further support development of OpRegen cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies. - COR1 Program (Corneal Endothelial Disease) Reported positive development progress with COR1, our corneal endothelial cell therapy (CEnC) program, a wholly-owned preclinical asset which benefits from our existing ophthalmology and manufacturing expertise and which represents a natural next application of our technology platform. Utilizing Lineage’s proprietary cell manufacturing and expansion platform, AlloSCOPE, the Company successfully achieved seamless bioreactor-based precursor expansion and differentiation to support CEnC production which, together with a thaw-and-inject formulation, may demonstrate a potentially superior product profile, and which meets Lineage’s internal criteria for continued preclinical advancement. Lineage has also elected to advance the COR1 program into in-vivo animal testing with initial preclinical data expected to be generated in 2026. Applicable indications for COR1 are expected to include Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy. - OPC1 Program (Spinal Cord Injury) Currently enrolling participants in the DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study. The DOSED study is evaluating the safety and utility of a novel delivery device developed to deliver OPC1 directly to the area of injury and will enroll both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) SCI participants. Two successful administrations using the novel delivery system have been completed in chronic SCI participants. Participants experienced no unexpected procedural, product, or device-related adverse events and no significant design changes are required for continuation of the DOSED study. Opened second clinical site in the DOSED study, Rancho Research Institute, in conjunction with Rancho Los Amigos National Rehabilitation Center. - ILT1 Manufacturing Initiative Successfully continued to meet our internal milestones for our ILT1 manufacturing initiative, advancing from 0.5L to multi-liter scale using a fully suspension-based process for generating undifferentiated pluripotent cells using one of our proprietary cell lines, which supports further and continued development. The goal of ILT1 is to establish a production modality that can support an expansion through differentiation process, entirely in a dynamic culturing system, which if successful and applied to islet cell differentiation, could potentially solve a major hurdle to production and commercialization of an islet cell therapy product candidate for the potential treatment of Type 1 Diabetes. - ReSonance (ANP1) Program (Hearing Loss) First internally-developed program, an auditory neuron cell transplant to treat hearing loss built on our AlloSCOPE platform. Research collaboration was established in 2025 with William Demant Invest A/S (WDI) to jointly advance preclinical development of ReSonance over a term of three years. Successfully completed 3 engineering manufacturing runs, completed the internal technology transfer to our current Good Manufacturing (cGMP) team, as well as completed one cGMP manufacturing run, which is currently the subject of standard release testing. Established a novel model of deafening to support ReSonance functional preclinical testing under the collaboration. - Scientific Advisory Board (SAB) Established SAB to provide strategic counsel and insights into the development of Lineage’s novel cell transplant pipeline with founding member Joachim Fruebis, Ph.D., an accomplished scientist and leader with an extensive career driving R&D innovation in biotechnology and pharma. Balance Sheet Highlights Cash, cash equivalents, and marketable securities of $50.8 million as of June 30, 2026 is expected to support planned operations into Q3 2028. Second Quarter Operating Results Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended June 30, 2026 were $1.1 million, a net decrease of $1.7 million as compared to $2.8 million for the same period in 2025. The decrease was primarily driven by lower collaboration revenue recognized from deferred revenues under the Roche Agreement reflective of measured progress toward completion of the first performance obligation, as well as lower revenues recognized associated with the prior year termination of the VAC platform-related collaboration agreement, partially offset by an increase in revenue related to our new research collaboration agreement with WDI. Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended June 30, 2026 were $10.0 million, a decrease of $12.5 million as compared to $22.5 million for the same period in 2025. The overall decrease was primarily driven by the $14.8 million expense recognized in the prior year for the loss on impairment for the intangible asset related to the VAC platform. R&D Expenses: R&D expenses for the three months ended June 30, 2026 were $4.8 million, an increase of $1.7 million as compared to $3.1 million for the same period in 2025. The net increase was primarily driven by our preclinical programs and other undisclosed programs. G&A Expenses: G&A expenses for the three months ended June 30, 2026 were $5.2 million, an increase of $0.7 million as compared to approximately $4.5 million for the same period in 2025. The net increase was primarily driven by personnel costs and stock-based compensation expense. Loss from Operations: Loss from operations for the three months ended June 30, 2026 were $8.9 million, a decrease of $10.9 million as compared to $19.8 million for the same period in 2025. This decrease was primarily driven by the prior year non-cash impairment expense related to the VAC platform of $14.8 million, which was a non-recurring transaction. Other Income/(Expenses): Other income/(expenses) for the three months ended June 30, 2026 reflected other income of $10.5 million, compared to other expense of ($10.6) million for the same period in 2025. The net change was primarily attributable to the quarterly fair value non-cash remeasurement of the warrant liabilities driven by a decrease in our share price as compared to an increase in the prior year’s quarter, partially offset by exchange rate fluctuations related to Lineage’s international subsidiaries. Net Income/(Loss) Attributable to Lineage: The net income/(loss) attributable to Lineage for the three months ended June 30, 2026 was net income of $1.5 million, or $0.01 earnings per share (basic) and ($0.03) loss per share (diluted), compared to a net loss of ($30.5) million, or ($0.13) loss per share (basic and diluted), for the same period in 2025. The change was primarily driven by the prior year non-cash loss on impairment expense related to a 2019 acquisition and the quarterly fair value remeasurement of the warrant liabilities. Conference Call and Webcast Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" (Conference ID: 2355043). A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 13, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2355043. About the AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE "5D" describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy manufacturing initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell. Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: plans and timing for development of COR1, including expected timing of initial data from in-vivo animal testing; the potential safety and therapeutic benefits of COR1 for patients suffering from corneal endothelial disease, including FECD and bullous keratopathy; the benefits of a thaw-and-inject formulation; the potential for COR1 to demonstrate a superior product profile and expectations regarding market opportunity and competitive positioning for COR1; the potential for Lineage’s AlloSCOPE manufacturing platform to enable large-scale production of COR1 in accordance with cGMP and other applicable manufacturing standards and requirements and reduce production costs; the ability of Lineage’s two-tiered cell banking system to generate millions of doses of final product; the potential of the AlloSCOPE platform, including based on our prior success in completing a production run for two product candidates, to manufacture millions of doses of a cost-effective, scalable, and consistent supply of an allogeneic, cell-based product derived from a single initial cell line, that can be applied across multiple programs; Lineage’s development strategy of prioritizing programs that it believes can generate meaningful data in early clinical trials, thereby allowing the Company to evaluate clinical potential earlier, optimize capital allocation, and accelerate value creation; Lineage's plans to, and its ability to, apply its manufacturing capabilities to establish a production modality that, if successful, and if paired with an islet-cell differentiation protocol, could potentially address manufacturing scale considerations relevant to potential future islet cell therapy product candidates and potentially solve a major hurdle to commercialization of islet cell therapy product candidates through its ILT1 manufacturing initiative; the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to age-related macular degeneration and the significance of the Phase 1/2a clinical study data reported to date, including the expectation that findings from the open-label, single-arm Phase 1/2a study may support continued evaluation; Genentech’s plans to evaluate proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the Phase 2a GAlette Study; the ongoing open and active status of the Phase 2a GAlette Study at clinical sites in the U.S. and Israel and ongoing patient enrollment at such sites; the benefits of Lineage’s services agreement with Genentech and its impact on advancing the OpRegen cell therapy program; the plans and expectations with respect to OPC1, including the ongoing DOSED clinical study and enrollment of additional participants; the expected funding under the research collaboration agreement with WDI and the activities it is intended to support to advance the development of ReSonance (ANP1), including the characterization of the WDI collaboration as a demonstration of the speed, efficiency, and value creation of the AlloSCOPE platform, and the expectation that the completed cGMP manufacturing run will satisfy standard release testing requirements; the anticipated contributions of the Scientific Advisory Board to Lineage’s development strategy; Lineage’s expectation that its cash, cash equivalents and marketable securities are sufficient to support its planned operations into the third quarter of 2028; and Lineage’s plans to advance its pipeline of allogeneic cell therapy candidates in 2026 and beyond, including its long-term strategy of creating a leading pipeline of cell-based transplant programs based on its core technology and AlloSCOPE manufacturing platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to expend our cash, cash equivalents and marketable securities more quickly than expected; that cash runway projections are based on current operating assumptions and are subject to change based on business conditions, development activities, and other factors outside Lineage’s control, and that Lineage may need to raise additional capital before that time; that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that Lineage's development strategy of prioritizing programs based on the potential for early meaningful data may not result in the generation of meaningful data, nor ultimately successful product candidates, and that the ability to generate meaningful data in early clinical trials is uncertain and may not be predictive of clinical success in later-stage studies; that early, exploratory, or interim findings in clinical and/or nonclinical studies of a product candidate may not be predictive of results in controlled, subsequent, or later-stage clinical and/or nonclinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing further clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction, and Genentech retains discretion over the advancement of OpRegen and Lineage cannot control Genentech's decisions; that competing alternative therapies may adversely impact the commercial potential of OpRegen cell therapy; that OPC1 clinical trials, including the DOSED study, may not be successful; that the DOSED study is evaluating device safety and utility and no safety or efficacy conclusions regarding OPC1 are available at this time; that COR1 is a preclinical asset and there is no assurance that preclinical data expected to be generated in 2026 will be positive or generated on the anticipated timeline, that COR1 will advance into clinical development, or that COR1 will demonstrate the same or superior efficacy, a superior product profile or disruptive potential relative to existing or competing therapies for corneal endothelial disease; that Lineage’s ILT1 development is in its early stages, and even if our AlloSCOPE 5D manufacturing initiative is successful in producing large scale production of undifferentiated pluripotent stem cells, that we may not be able to successfully or feasibly differentiate those cells into islet cells, and further, we may not successfully establish a production modality for large-scale islet cell production, and there is no assurance that undifferentiated pluripotent stem cell manufacturing milestones will translate to clinical or commercial development or result in a viable product candidate for the treatment of Type 1 Diabetes; that the AlloSCOPE platform may not generate new programs with the speed, efficiency, or value creation potential that Lineage anticipates, and past development timelines may not be indicative of future results; that the WDI collaboration may not achieve its intended objectives, that WDI may not contribute the full amount of anticipated funding, that the WDI anticipated funding may not be sufficient to complete the planned activities under the WDI collaboration and that additional funding may be required, and that the completed cGMP manufacturing run may not satisfy release testing requirements; that the ongoing 2026 Iran War and broader Israeli regional conflict may materially and adversely impact clinical activities at Israel trial sites participating in the GAlette study and/or our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806053201/en/ Contacts Lineage Cell Therapeutics, Inc. IR Ioana C. Hone([email protected])(442) 287-8963 Russo Partners – Media Relations Nic Johnson or David Schull([email protected])([email protected])(212) 845-4242

CARLSBAD, Calif., July 30, 2026--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel, allogeneic, "off the shelf", cell therapies for serious medical conditions, today announced that it will report its second quarter 2026 financial and operating results on August 6, 2026, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on August 6, 2026, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2026 financial and operating results and to provide a business update. Conference Call and Webcast Interested parties may access the conference call on August 6, 2026, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" (Conference ID: 2355043). A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 13, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2355043. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy manufacturing initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell. Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "goal," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to our ability to develop new cell lines into potential differentiated cell transplant product candidates and the potential indications thereof. Forward-looking statements are based upon our current expectations, involve assumptions that may never materialize or may prove to be incorrect, and involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements, including, but not limited to, the risks that: investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges; clinical development of product candidates is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome; we may not be successful in developing new product candidates and neither we nor our collaborators may be successful in obtaining regulatory approval to market and sell any product candidates; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260730404175/en/ Contacts Lineage Cell Therapeutics, Inc. IRIoana C. Hone([email protected])(442) 287-8963 Russo Partners – Media RelationsNic Johnson or David Schull([email protected])([email protected])(212) 845-4242

Interested in Lineage Cell Therapeutics, Inc.? Here are five stocks we like better. OpRegen remains the company’s top priority, with Lineage saying Roche and Genentech continue to view the geographic atrophy program as potentially disease-modifying. Management said it still lacks access to GAlette data and has no firm timeline for a controlled trial decision, though the study has expanded to 17 sites. Lineage is pushing its AlloSCOPE manufacturing platform into new programs, including the newly announced COR1 corneal endothelial cell transplant candidate for Fuchs dystrophy and other corneal diseases. The company said the platform could support scalable, lower-cost off-the-shelf cell therapy production. The company ended Q1 with $53.4 million in cash and said that should fund operations into Q2 2028. Lineage also expects more updates later this year on OPC1, ReSonance, ILT1 scale-up, and other development milestones. Lineage Cell Therapeutics (NYSEAMERICAN:LCTX) reported first-quarter 2026 results and used its earnings call to highlight progress across its cell therapy pipeline, including its lead OpRegen program in geographic atrophy, a newly launched corneal endothelial cell program called COR1, and ongoing manufacturing initiatives built around its AlloSCOPE platform. Chief Executive Officer Brian Culley said the company remains confident in the potential for OpRegen, its retinal pigment epithelium cell transplant program partnered with Roche and Genentech, to advance into a multi-center controlled trial. He noted that Roche and Genentech recently described OpRegen as a potentially disease-modifying treatment, language he characterized as notable because geographic atrophy in dry age-related macular degeneration is a progressive condition. → Micron Investors Face a High-Stakes Moment After the Latest Rally Culley said Lineage does not have access to data from the ongoing GAlette study and does not have a timeline to share for a potential data reveal or public commitment to a controlled trial. However, he pointed to the expansion of the GAlette study to 17 sites, including 11 new clinical sites opened beginning in late 2025, as an indicator that Lineage views positively. Culley said earlier data from the OpRegen Phase 1/2a study showed improved retinal anatomy, halting or reversal of atrophic progression, and improved vision in patients with dry AMD. He also said long-term analysis by Roche and Genentech showed vision gains persisted for at least three years after a single administration of cells among patients who received the cells in the target location. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? During the question-and-answer portion of the call, Culley said the company’s comments on disease modification were based on public presentations by Roche and Genentech, not on non-public GAlette study data. He said Lineage interprets the updated language as “positive,” while emphasizing that investors must evaluate public information for themselves. Culley also discussed the competitive landscape in retinal cell therapy and complement inhibitors. He said Lineage views multiple independent reports of RPE transplant-related vision improvements as supportive of the overall treatment approach. By contrast, he said complement inhibitors appear to have a “very small treatment effect” and said he would like to see evidence from prospective studies showing an effect on visual function. → How Berkshire’s New York Times Bet Looks Today A major focus of the call was Lineage’s AlloSCOPE manufacturing platform, which Culley described as central to the company’s strategy for developing allogeneic, off-the-shelf cell therapy candidates. He said the platform uses a two-tiered banking system, with a master cell bank generating a working cell bank, which then generates clinical material. Culley said Lineage believes this structure could support large-scale manufacturing and potentially lower cost of goods for certain programs. He emphasized that, in cell therapy, “the process is the product,” and said Lineage is choosing to invest in commercially viable manufacturing processes before advancing programs into clinical testing. The company announced COR1, a wholly owned preclinical corneal endothelial cell transplant program intended to treat Fuchs corneal dystrophy and other corneal endothelial diseases. Culley said the program is designed to provide a consistent and affordable supply of corneal cells for procedures that currently rely on cadaveric donor tissue. According to Culley, Lineage has manufactured off-the-shelf corneal endothelial cells on its AlloSCOPE platform with identity, morphological and functional characteristics that met the company’s initial internal criteria. He said the program is expected to move into translational models and then initial human testing, and said he hopes to provide a timeline for a clinical trial on the next quarterly call. Lineage also provided updates on OPC1, its oligodendrocyte progenitor cell program for spinal cord injury. Culley said OPC1 has been administered to 30 individuals across two Phase 1/2 safety trials and that the company expects to present an in vivo comparability package to the FDA later this year, with the intention of introducing newly manufactured cells into the ongoing DOSED trial. The DOSED trial is evaluating a novel delivery system for OPC1. Culley said the device has performed as expected so far, with no unexpected procedure-, product- or device-related adverse events and no significant design changes required. The study has also expanded to a second site, the Rancho Research Institute in Downey, California, in conjunction with Rancho Los Amigos National Rehab Center. Culley said the first chronic spinal cord injury participant in the DOSED study is nearing a one-year follow-up visit, and the company expects to provide an update on the next earnings call. In response to an analyst question, he said enrollment of chronic patients may be easier than subacute patients because chronic patients can be identified in the community, while subacute enrollment depends on a qualifying recent injury near a study site. For ReSonance, Lineage’s auditory neuronal cell transplant program for hearing loss, Culley said the company has completed three engineering runs and is preparing to perform the process in its GMP suite. The program is partnered with William Demant Invest, which agreed to fund up to $12 million of preclinical activities leading to a first-in-human regulatory filing. Culley said an annual continuation decision is approaching and that Lineage expects the program to continue based on work completed to date. Lineage also discussed ILT1, a manufacturing initiative aimed at addressing scale in type 1 diabetes cell therapy. Culley said the company met its first internal milestone by demonstrating what it believes is a scalable, fully suspension-based process for generating undifferentiated pluripotent cells using a proprietary cell line. Work has moved from a half-liter scale to a larger multi-liter format, he said. Chief Financial Officer Jill Howe said Lineage ended the quarter with $53.4 million in cash as of March 31, 2026, which the company expects will support planned operations into the second quarter of 2028. She said Lineage may also receive approximately $32 million from the exercise of existing warrants if the intent to advance OpRegen into a multi-center trial with a control comparator arm is publicly disclosed. Howe said Lineage remains eligible for up to $615 million in developmental and commercial milestone payments under its Roche and Genentech collaboration agreement. She also said the company continues to evaluate additional partnership opportunities similar to its Roche and Demant collaborations. Total revenue was approximately $1.7 million, up from $1.5 million in the prior-year period, primarily due to collaboration revenue under the Demant agreement. Total operating expenses were $9.3 million, compared with $8 million in the same period of 2025. Research and development expenses increased to $4.2 million from $3.1 million, driven by spending on OPC1, ReSonance, and preclinical and undisclosed programs. General and administrative expenses were approximately $5.1 million, compared with $4.9 million a year earlier. Net loss attributable to Lineage was $4.8 million, or $0.02 per basic share and $0.03 per diluted share, compared with a net loss of $4.1 million, or $0.02 per basic and diluted share, in the prior-year period. Culley said Lineage expects to provide additional updates in the second half of the year, including initial OPC1 data, the ReSonance continuation decision, COR1 development plans, ILT1 scale-up progress, additional Scientific Advisory Board appointments and patent-related updates. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, allogeneic cell therapies built on pluripotent stem cell platforms. The company focuses on three primary therapeutic areas—retinal disease, neural repair and immune-effector cell oncology—leveraging its proprietary manufacturing processes to create off-the-shelf cell therapy candidates designed for broad patient populations. Its lead candidate, OpRegen, comprises retinal pigment epithelium cells intended to slow or reverse vision loss in patients with geographic atrophy secondary to age-related macular degeneration. 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This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lineage Cell Therapeutics Inc (LCTX) successfully expanded its Alloscope manufacturing platform, leading to the launch of the CORE1 corneal endothelial cell transplant program. The company met its first internal milestone with the ILT1 manufacturing initiative, showcasing progress in its manufacturing capabilities. Lineage Cell Therapeutics Inc (LCTX) established a new scientific advisory board, attracting an established cell therapy executive as its founding member. The OPERGEN program showed promising long-term vision gains in patients with dry AMD, with data indicating potential disease-modifying effects. The company has a strong cash position of $53.4 million, expected to support operations into Q2 of 2028, with potential additional funding from existing warrants and milestone payments. The OPERGEN program's future remains uncertain as the company awaits a decision on advancing into a multicenter controlled trial. Lineage Cell Therapeutics Inc (LCTX) reported a net loss of $4.8 million for the first quarter of 2026, an increase from the previous year. The company faces challenges in scaling up the production of islet cells for type 1 diabetes, with significant hurdles in achieving commercial viability. Enrollment in the OPC1 dose study is challenging, particularly for subacute patients, due to the need for tragic incidents to occur near clinical sites. The company is still in the early stages of developing its CORE1 and ILT1 programs, with significant work needed before reaching clinical trials. Warning! GuruFocus has detected 3 Warning Signs with LCTX. Is LCTX fairly valued? Test your thesis with our free DCF calculator. Q: On OPERGEN, your understanding of it being characterized as disease-modifying relates to what data was presented at the recent Foundation Fighting Blindness Summit. How do you think of the photoreceptor recovery and some of the stratifying web coverage data that you have integrated as part of the GALET trial? A: With regard to disease modification, we do not have access to the data in the ongoing GALET study. However, the opening of 11 sites after initially having six is a clear indicator of planning for a larger campaign. The recent presentation included language about potentially modifying disease, which is a positive change. Our insights regarding bleb coverage and photoreceptor recovery come from our own Phase I/EBITDA and other companies' data, not from the ongoing GALET study. Q: On the corneal endothelial cell program, what's the internal criteria you may have met here, and what sort of work is underway preclinically? What should we watch for as you proceed with manufacturing and IND filing? A: For the corneal program, we focus on achieving a high-quality manufacturing process that is reproducible and doesn't need changes during development. This approach reduces risk, especially in indications with a cadaver-sourced precedent for efficacy. We invite scrutiny on the reproducibility, scalability, and potency assays of our material, as these are integral to a product's survival. Q: Can you provide thoughts on the competitive data in the RPE cell space and geographic atrophy space, particularly regarding Astellas and ISTEM's updates? A: Astellas' data update is an important clearing event for us. We haven't seen much information about their manufacturing, delivery, or safety, and the data is limited. We feel comforted that we remain in a leading position. Regarding complement inhibitors, they show a small treatment effect, but there's no evidence of impact on visual function. RPE transplants, however, have shown to increase patients' vision. Q: Regarding the dose study of OPC-1, are there any updates on the CIRM grant application? A: We reapplied for a CIRM grant in January, and a decision is expected later this summer. If we receive the grant, it would be beneficial, but not receiving it won't materially impact the program. We are moving forward with the dose study and plan to introduce our internally-made cells into the ongoing trial. Q: On the ILT1 program, what are the risks when differentiating baseline pluripotent cells into ILT cells, and how might this impact scale-up? A: Differentiating pluripotent cells into specific cell types like islets is challenging. While we can expand RPE cells post-differentiation, islet cells don't expand once differentiated. The focus is on pre-differentiation, but risks exist at every step. We've had success in GMP environments and are confident in our team's ability. The approach is stepwise and risk-reducing, with go-no-go decision points to manage investment prudently. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive 3 Year Phase 1/2a Clinical Data of RG6501 (OpRegen®) Featured at Retinal Therapeutics Innovation Summit 2026 Launched New Corneal Endothelial Disease Cell Therapy Program Met First Milestone with AlloSCOPE™ 5D Manufacturing Initiative Treated Second Chronic SCI Patient in OPC1 DOSED Device Safety Study Established Scientific Advisory Board With Cell Therapy Executive Joachim Fruebis, PhD, as its Founding Member Appointed Priyantha Herath, MD, PhD, as Senior Vice President & Head of Clinical CARLSBAD, Calif., May 12, 2026--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing "off the shelf" allogeneic cell therapies for serious medical conditions, today reported its first quarter 2026 financial and operating results. The Company will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update. "This quarter, we continued to build on our developmental and clinical accomplishments. Most notably, we applied our proprietary cell manufacturing technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), to launch COR1, our new, wholly-owned corneal endothelial cell therapy program. COR1 is a preclinical asset which we believe benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our platform. We also achieved our first milestone with our AlloSCOPE 5D manufacturing initiative, aimed at addressing the challenges of large scale production of undifferentiated pluripotent stem cells. If successful at a larger scale, the overall goal is to leverage this initiative, together with a differentiation protocol, to address the insufficient supply of islet cells needed to support a potential treatment of Type 1 Diabetes," stated Brian M. Culley, Lineage CEO. "In parallel, we advanced our DOSED study, successfully administering OPC1 to a second chronic SCI participant using a novel delivery system. We also established a new Scientific Advisory Board with recognized and established cell therapy executive Joachim Fruebis, PhD, as its founding member. Dr. Fruebis’ extensive experience across ophthalmology, neurology, diabetes, and other key therapeutic areas will help drive the evolution of our cell therapy platform and help to translate our innovations into clinical and commercial success. We look forward to additional updates on further appointments to our SAB throughout the year." "This will be an exciting year for Lineage. Our current cell therapy pipeline features seven separate cell types, two of which are in the clinic, and each of which is in development for a discrete indication addressing a significant unmet need. We remain focused on advancing our innovative pipeline through disciplined internal spending and support from external partners, in line with our long-term strategy of creating a leading portfolio of cell-based transplant programs, all based on our core technology and our AlloSCOPE manufacturing platform," concluded Mr. Culley. Select Business Highlights RG6501 (OpRegen Cell Therapy) Positive RG6501 (OpRegen cell therapy) Phase 1/2a clinical study 3 year results encore featured at Foundation Fighting Blindness’ Retinal Therapeutics Innovation Summit 2026, suggest evidence of sustained gains in best corrected visual acuity (BCVA) and partial structural restoration of the retina, including re-appearance of an RPE layer and features associated with recovery of photoreceptors. Positive long-term clinical outcomes reported following a single administration of OpRegen cell therapy. Clinical data reported at 12-, 24-, and 36-months for Cohort 4 (less advanced disease) of the Phase 1/2a study (12 patients) has continued to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients. Notably, five patients who received extensive coverage of OpRegen cell therapy across their geographic atrophy (GA) lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement through 36 months. Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech. The ongoing Phase 2a GAlette Study is currently enrolling at 17 clinical sites in the U.S. and Israel. In addition to testing other surgical parameters, Genentech currently plans to evaluate proprietary surgical delivery devices in the Phase 2a GAlette study that have potential advantages over available off-the-shelf devices. Ongoing efforts to further support development of OpRegen cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies. OPC1 Program (Spinal Cord Injury) Second chronic SCI participant treated in the Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) study. Second treated participant was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with single neurological levels of injury (NLI) at level T4 to T5, and the novel delivery system successfully administered a one-time injection of OPC1. Opened second clinical site in the DOSED study, Rancho Research Institute, in conjunction with Rancho Los Amigos National Rehabilitation Center. COR1 Program (Corneal Endothelial Disease) Launched COR1, our corneal endothelial cell therapy (CEnC) program, a wholly-owned preclinical asset which we believe benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our technology platform. Applicable indications for COR1 are expected to include Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy. Utilizing Lineage’s proprietary cell manufacturing and expansion platform, AlloSCOPE™, the Company is manufacturing "off the shelf" corneal endothelial cells with identity, morphological, and functional characteristics which meet initial internal criteria and support further development. Lineage plans to advance this new product candidate into translational models to support potential clinical testing. ILT1 Manufacturing Initiative Successfully met our first milestone for our ILT1 manufacturing initiative, demonstrating a highly scalable and fully suspension-based process for generating undifferentiated pluripotent cells using one of our proprietary cell lines. Initial work accomplished at 0.5 liter scale and supports further development into a larger multi-liter format. If successful at larger scale, Lineage may seek to demonstrate AlloSCOPE 5D scalability with one or more internal or partner-sourced hypo-immune or non hypo-immune cell lines, suitable to support potential islet cell differentiation and preclinical testing. This initiative inverts traditional cell therapy product development by focusing on the challenge of large-scale production of a potential cell-based product candidate prior to conducting preclinical and clinical testing. The goal of ILT1 is to establish a production modality that can support an expansion through differentiation process, entirely in a dynamic culturing system, which if successful, could potentially solve a major hurdle to production and commercialization of an islet cell therapy product candidate for the potential treatment of Type 1 Diabetes. ReSonance (ANP1) Program (Hearing Loss) First internally-developed program, an auditory neuron cell transplant to treat hearing loss built on our AlloSCOPE platform. Research collaboration established in 2025 with William Demant Invest A/S (WDI) to jointly advance preclinical development of ReSonance over a term of three years. WDI collaboration represents an important demonstration of the speed, efficiency, and value creation of the AlloSCOPE platform. Up to $12 million of development costs was agreed to be contributed by WDI in 2025, which was intended to cover activities including, cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis. Successfully completed 3 engineering manufacturing runs, with preparations underway for internal technology transfer to current Good Manufacturing (cGMP) team. Established novel model of deafening to support ReSonance functional preclinical testing under the collaboration. Scientific Advisory Board (SAB) Established SAB to provide strategic counsel and insights into the development of Lineage’s novel cell transplant pipeline. Founding member Joachim Fruebis, Ph.D., is an accomplished scientist and leader with an extensive career driving R&D innovation in biotechnology and pharma. His in-depth expertise spans small molecules, biologics, and advanced therapies across multiple therapeutic areas including ophthalmology, neurology, diabetes and obesity, cardiovascular, metabolic, and rare diseases. Dr. Fruebis’ experience includes pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines, including at Novo Nordisk, BlueRock Therapeutics, Bioverativ and Bayer. Additional SAB members are expected to be added throughout the remainder of the year. Appointment of Priyantha Herath, M.D., Ph.D., as Senior Vice President & Head of Clinical Priyantha is a Board-certified specialist neurologist, with extensive experience spanning early translational development, regulatory affairs and clinical development through successful Phase 3 clinical trial execution. He brings a broad clinical perspective to Lineage, having treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes, direct patient care which has contributed to a deep understanding of disease presentation, progression, and meaningful outcomes and we welcome his expertise and leadership in this new role. Balance Sheet Highlights Cash, cash equivalents, and marketable securities of $53.4 million as of March 31, 2026 is expected to support planned operations into Q2 2028. First Quarter Operating Results Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended March 31, 2026 were approximately $1.7 million, a net increase of $0.2 million as compared to $1.5 million for the same period in 2025. The increase was primarily driven by collaboration revenue recognized under our new research collaboration agreement with WDI. Operating Expenses: Operating expenses are composed of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended March 31, 2026 were $9.3 million, an increase of $1.3 million as compared to $8.0 million for the same period in 2025. R&D Expenses: R&D expenses for the three months ended March 31, 2026 were $4.2 million, an increase of $1.1 million as compared to $3.1 million for the same period in 2025. The net increase was primarily driven by $0.3 million for our OPC1 program, $0.2 million for our ReSonance program, and approximately $0.7 million for our preclinical and other undisclosed programs. G&A Expenses: G&A expenses for the three months ended March 31, 2026 were approximately $5.1 million, an increase of $0.2 million as compared to $4.9 million for the same period in 2025. The net increase was primarily driven by personnel costs, partially offset by services provided by third parties. Loss from Operations: Loss from operations for the three months ended March 31, 2026 was $7.6 million, an increase of $1.1 million as compared to $6.5 million for the same period in 2025. Other Income/(Expenses): Other income/(expenses) for the three months ended March 31, 2026 reflected other income of $2.8 million, compared to other income of approximately $2.4 million for the same period in 2025. The net increase was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries and no warrant-related financing transaction costs incurred as compared to the prior year’s quarter. Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2026 was $4.8 million, or $0.02 per share (basic) and $0.03 per share (diluted), compared to a net loss of $4.1 million, or $0.02 per share (basic and diluted), for the same period in 2025. Conference Call and Webcast Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" (Conference ID: 9229676). A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 19, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 9229676. About the AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE "5D" describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy manufacturing initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell. Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: that our prior success in completing a production run for two product candidates using our AlloSCOPE platform should enable the ability to produce millions of doses of a cost-effective, scalable and consistent supply of an allogeneic, cell-based product derived from a single initial cell line, that can be applied across multiple programs; Lineage’s plans to, and its ability to, apply its manufacturing capabilities to establish a production modality that, if successful, and if paired with an islet-cell differentiation protocol, could potentially address manufacturing scale considerations relevant to potential future islet cell therapy product candidates and potentially solve a major hurdle to commercialization of islet cell therapy product candidates through its ILT1 manufacturing initiative; the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to age-related macular degeneration and the significance of the Phase 1/2a clinical study data reported to date, including the expectation that findings from the open-label, single-arm Phase 1/2a study may support continued evaluation; Genentech’s plans to evaluate proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the Phase 2a GAlette Study; the ongoing enrollment of the Phase 2a GAlette Study at clinical sites in the U.S. and Israel; the benefits of Lineage’s services agreement with Genentech and its impact on advancing the OpRegen cell therapy program; the plans and expectations with respect to OPC1, including the ongoing DOSED clinical study and enrollment of additional participants; Lineage’s plans to advance COR1 into preclinical testing, expectations regarding the development of its corneal endothelial cell therapy program, and the expectation that applicable indications for COR1 will include Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy; the expected funding under the research collaboration agreement with WDI and the activities it is intended to support to advance the development of ReSonance (ANP1); the anticipated contributions of the Scientific Advisory Board to Lineage’s development strategy; the anticipated contributions of Priyantha Herath, M.D., Ph.D. in his role as Senior Vice President & Head of Clinical; Lineage’s expectation that its cash, cash equivalents and marketable securities are sufficient to support its planned operations into the second quarter of 2028; and Lineage’s plans to advance its pipeline of allogeneic cell therapy candidates in 2026 and beyond, including its long-term strategy of creating a leading pipeline of cell-based transplant programs based on its core technology and AlloSCOPE manufacturing platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to expend our cash, cash equivalents and marketable securities more quickly than expected; that cash runway projections are based on current operating assumptions and are subject to change based on business conditions, development activities, and other factors outside Lineage’s control, and that Lineage may need to raise additional capital before that time; that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that early, exploratory, or interim clinical findings may not be predictive of results in controlled or later-stage studies; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing further clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction, and Genentech retains discretion over the advancement of OpRegen and Lineage cannot control Genentech's decisions; that competing alternative therapies may adversely impact the commercial potential of OpRegen cell therapy; that OPC1 clinical trials, including the DOSED study, may not be successful; that the DOSED study is evaluating device safety and utility and no safety or efficacy conclusions regarding OPC1 are available at this time; that Lineage’s resubmission of its CLIN2 clinical grant application to CIRM may not be approved, which could adversely impact funding for the ongoing DOSED study; that Lineage’s ILT1 development is in its early stages, and even if our AlloSCOPE 5D manufacturing initiative is successful in producing large scale production of undifferentiated pluripotent stem cells, that we may not be able to successfully or feasibly differentiate those cells into islet cells, and further, we may not successfully establish a production modality for large-scale islet cell production, and there is no assurance that undifferentiated pluripotent stem cell manufacturing milestones will translate to clinical or commercial development or result in a viable product candidate for the treatment of Type 1 Diabetes; that the ongoing Israeli regional conflict may materially and adversely impact clinical activities at Israel trial sites participating in the GAlette study and our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512098382/en/ Contacts Lineage Cell Therapeutics, Inc. IR Ioana C. Hone ([email protected]) (442) 287-8963 Russo Partners – Media Relations Nic Johnson or David Schull ([email protected]) ([email protected]) (212) 845-4242