Lineage Cell Therapeutics, Inc.

At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investors section of Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of lineage and recordings, reproductions, or transmissions of this call without the express 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, Iwona Hone, Head of Investor Relations of Lineage. Ms. Hone, please go ahead.

Thank you, Desiree. Good afternoon, and thank you for joining us. A press release reporting our second quarter 2025 financial results was issued earlier today, August 12, 2025, 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 statement sections in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K and in subsequent SEC filings. 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, and Jill Howe, our Chief Financial Officer. I'll now hand the call over to Brian.

Thank you, Ivana. Good afternoon, everyone. We appreciate you taking the time to join us on the call today. I will begin with some recent updates on the Oprigen program, then say a few words about how Oprigen's progress is driving a new strategic direction for the company. Then I will review details around the first participant we treated in our spinal cord program before handing off to Jill for financials and then Q&A. As a reminder, OpriGen is an off-the-shelf RPE transplant for patients suffering from dry AMD with geographic atrophy. Last quarter, our partners, Roche and Genentech, provided an update on patients treated in Lineage's Phase I-IIa clinical trial, which showed that the anatomical and functional benefits which we first reported have lasted for three years. Notably, the five patients who received fulsome coverage of Oprigen across their area of atrophy had a mean gain of vision of nine letters. In contrast, these patients' untreated eyes lost 11 letters, which means that at three years, there is a 20-letter difference in mean visual acuity between Oprigen-treated and untreated eyes in individuals who received Oprigen cells across their GA. These effects were also reported at one year and two years, reflecting a consistent as well as durable treatment effect. And because vision gains are not known to occur spontaneously in the natural course of this disease, we believe these effects are increasingly validated with each analysis, especially as the untreated eyes continue to worsen. Importantly, the loss of 11 letters in the untreated eyes on this trial matches recent results reported in the journal Retina, which showed data on more than 18,000 dry AMD patients' eyes for as long as three years. Human beings have not shown themselves capable of regrowing retinal tissue or reversing the damage from dry AMD on their own, so with each passing year, the maintenance of vision gains and the growing delta between treated and untreated eye seems to be adding support the operogen having the potential in some patients to be a one-time functional cure, and challenging the long-held view that GA is an irreversible condition. In addition to these exciting results, we can now point to three other companies with RPE suspensions in clinical development, which this year followed lineage and reported that they, too, have observed gains of vision in GA patients following an RPE transplant. Notably, one of those companies is Astellas, a global leader in regenerative medicine. So while this is admittedly an entirely new therapeutic approach, there are now four independent groups reporting vision gains from an RPE transplant, which in the aggregate reflect more than 20 individuals exhibiting an effect which is known to not occur naturally. From our perspective, these new reports of positive outcomes using RPE cell transplants are welcome because they provide independent validation of this mechanism, but they do not create a lot of concern for us because not only is lineage the farthest along in clinical development, we also believe we are in the best overall position to capture the large commercial opportunity offered by GA, an opportunity which does not appear to be being satisfied by the currently available anti-complement drugs. In particular, we expect that our alliance with Roche and Genentech will provide the clinical and development expertise and the financial backing to conduct the trials necessary for approval and, if approved, the commercial infrastructure to launch an ophthalmology product on a global basis. To support our partner, Our recently reported accomplishments in cell manufacturing have produced a GMP banking and production platform capable of generating millions of doses of our product candidates in a xeno-free 3D culturing system. And as a fourth competitive advantage, we believe the ongoing Phase IIa clinical trial being run by Genentech will provide insights into surgical procedure and delivery methods, which may further extend our existing leadership position. While there is still much to be done and no guarantee of positive results continuing, we do note, in addition to the data and positioning I just described, that there is a growing list of events which seem consistent with things moving in a positive direction for Oprogen. This list consists of our partners seeking and obtaining RMAT designation, adding additional sites to the ongoing Phase 2A trial, acquiring proprietary delivery technology and engineering expertise from a third party, and continuing to highlight OPERGEN results at major medical meetings. All this activity has occurred against a rigorous pipeline prioritization, which Roche conducted last year, leading to the termination of multiple programs and alliances, but which to our knowledge has not impacted the OPERGEN program. We are, of course, encouraged by what these data and events may indicate, But I will remind everyone that we do not have access to the data from the ongoing Phase 2A trial, and we do not know the timing for any such updates or other development decisions which may get announced. But given what appears to be a growing list of asymmetrically positive indicators for the successful continuation of the Oprigen program, we are increasingly thinking about how we can continue to grow and capitalize on the clinical, technical, and financial success that we're anticipating from Oprogen. To that end, we have taken preliminary steps into several new therapeutic areas, which we think can capitalize on our directed differentiation expertise and recent manufacturing accomplishments. As we demonstrated with the Resonance Program for hearing loss, we were able to generate an entirely new cell type and advance it into preclinical testing in about one year and with an approximate R&D investment of just $1 million. That program continues to advance in the preclinical setting, and we think we can leverage that experience to work on additional cell types and have those programs built from the start on our preferred proprietary platform. If we're successful, this strategy may be able to create additional opportunities for early-stage funded partnerships, while at the same time expanding and diversifying our pipeline beyond Oprogen. There are three main reasons why we plan to move in this direction. The first is that if Oprygen continues to advance, we believe we will not only receive the approximately $37 million in proceeds from the exercise of issued warrants, but also we'll be transitioning our manufacturing and quality activities to Genentech, which frees up capacity and capital for us to do other things. The second reason to launch new programs is that Lineage has reduced to practice a platform capability consisting of both manufacturing and directed differentiation. And that platform is not limited to just RPE cells. We have invested in technology and innovation using RPE cells as the prototype, but our platform technology resides above the generation and administration of RPE cells. So we can take the discoveries that have already been funded by our prior investments and apply them to new programs, thereafter potentially attracting additional funded partnerships. Third, because the biotech markets remain challenging, we want to be mindful of our cost of capital. Over the past few years, we have invested only about $30 million per year, which is lower than the total annual burn of many of our peers, but we remain in a prolonged period of sector underperformance. So we want to be considerate of the dilution of traditional capital raises and be more aggressive about funding our progress through non-equity dilutive transactions. That means we'll be focusing on five things. We want to enter into deals which partly or completely fund existing product candidates. We want to create new assets which can attract such funding. We want to capitalize on our unique manufacturing capability to solve issues which impede others' programs. We want to obtain grants like the CIRM CLIN II grant we applied for in June And finally, we want to complete activities required to collect milestone revenues from our partnership with Roche and Genentech. These are all strategies we are evaluating or employing to help us reduce our dependency on the equity capital markets while still advancing our programs through significant milestones. Overall, while we will always remain open to all sources of capital, we believe successfully employing this strategy is the best path toward increasing the value of the company's shares. Moving on, I next will provide an update on OPC1, our off-the-shelf cell transplant program designed to increase mobility for people who have suffered from a spinal cord injury. To date, OPC1 has been administered to 31 individuals with acute severe spinal cord injuries in Phase 1-2 clinical trials, and the long-term safety and efficacy data we have collected so far is both promising and worthy of further investigation. However, We had two areas of improvement we wanted to complete before we would feel ready that OPC-1 could successfully complete a later stage trial. The first area of improvement is delivery and the second is manufacturing. Regarding delivery, last week it was a privilege to announce that we had administered OPC-1 for the first time to a chronic injury participant. This is an important milestone because chronic injuries represent an additional and larger potential addressable population for this experimental therapy. Treatment occurred in what we call the DOST study, which is the third clinical study of OPC1 and is evaluating the safety of a novel system designed to deliver our proprietary cells without stopping ventilation during treatment. The first participant in DOST was neurologically complete SCI injury AIS grade A, with a single neurological level of injury between T1 and T10, and the novel delivery system successfully administered the intended one-time injection of 10 million OPC1 cells. In addition to the safety and performance of the new device, we also will be collecting functional assessments, which gives us the opportunity to investigate any signals of efficacy that may arise. We believe the device we are testing in the dose study will be superior to the original delivery system in two ways. First, it's easier to use and deploy to clinical sites. But more importantly, the new device is intended to allow a dose of cells to be administered over four to five minutes without stopping the participant's respiration. Previously, it was necessary to stop ventilation when you deliver the cells. So if this device is proven to be safe and effective, this would be a significant enhancement to the safety of the procedure. In addition, this delivery system is compatible with a forthcoming immediate use formulation of OPC1 that we developed, and which eliminates the complex dose preparation steps required with the original clinical material. Importantly, The first time we used this device in a clinical setting, it successfully delivered the cells to the target locus, which was an important risk-reducing event for this new device. We still need to conduct this procedure in a range of injury types, but having the first administration be a success was a great milestone for the team. And with some increased confidence, we next look forward to opening the study at additional sites and building on the promising work and results observed in prior studies of OPC1. The second area of OPC1 improvement I mentioned is our new manufacturing process, for which we have increased the scale, purity, and control of the cells we make, and we developed a new immediate use formulation, which eliminates the lengthy dose preparation steps that were required with the original clinical material. Subject to clearance from FDA, our plan is to introduce the cells from this new and improved process into the open enrollment phase of the ongoing DOST trial. In parallel with DOST, we also are working on the design of a larger clinical trial with a focus on collecting specific and clinically relevant endpoints, which would help address the well-documented challenges of data collection in this patient population. When all three of these activities have been concluded, the design, the device, and the We believe we, either alone or with a partner, will be in a position to conduct a larger clinical trial of OPC-1. And finally, at the end of June, we also submitted a clinical grant application to CIRM to request support of the ongoing dose study and are currently awaiting updates from the CIRM review process. With that, I'll turn things over to Jill for a review of our financials.