Lineage Cell Therapeutics reports progress in strategic goals, bolstered by $12 million WDI partnership and ongoing Operigen advancements.
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Summary
- Lineage Cell Therapeutics reported a cash position of $40.5 million as of September 30, 2025, expected to support operations into Q2 of 2027.
- The company entered a partnership with William Demant to fund up to $12 million in research for its Resonance program, targeting hearing loss.
- Lineage Cell Therapeutics is advancing its islet cell production initiative to address type 1 diabetes, focusing on overcoming production scale challenges.
- The company is awaiting a decision on a CIRM Clin II grant, which could provide up to $7 million in non-dilutive funding for its OPC1 spinal cord injury study.
- Revenues for Q3 2025 were $3.7 million, slightly down from $3.8 million in the prior year, with operating expenses reduced to $7.5 million.
- The net loss for Q3 2025 was $29.8 million, primarily due to non-cash warrant liability remeasurement.
- Lineage Cell Therapeutics plans to leverage its manufacturing capabilities and partnerships to expand its cell therapy platform, aiming for a basket of assets with some partnered and some retained internally.
Competitive advantage over companies that lack both this specialized equipment and the extensive delivery experience of our partner Roche. When you aggregate all of these publicly available actions and I did not list all of them today, but I hope you will appreciate why we are bullish on the future of OpRegen to treat G8 patients and why we are taking steps to try to repeat the success with other cell types. So, given what appears to be a steadily growing list of asymmetrically positive indicators for the successful advancement of Opregen into a controlled clinical trial, and while still noting the ultimate decision to advance the program is solely with our partners Roche and Genentech, we have increasingly been thinking about how we can create value from the clinical, technical and financial success that we're anticipating from OpRegen. With that in mind, I will turn next to some statements I made on our prior quarterly call to get a scorecard on how we've been doing last quarter. I outlined five areas of focus through the end of this year and I'm pleased to report that we have already successfully delivered on several of those strategic initiatives and we still have nearly two months to go. Our first goal was to enter into deals which partly or completely fund existing product candidates. We accomplished this goal through the partnership we announced with William Demant Invest (WDI), which is expected to fund up to $12 million in research and collaboration costs for all planned pre clinical development of Resonance, our first internally developed cell transplant program for the treatment of hearing loss. Resonance was an important test for our business model because it showed that we could conceive of and successfully manufacture a new cell based product candidate, generate new intellectual property and advance it into initial preclinical testing in approximately one year and with a modest initial investment. Soon thereafter we signed a collaboration agreement with wdi, which is a world leading hearing health care company, securing external funding leading to an IND or CTA if the data supports it, and also provides access to technology, expertise and a network of hearing health leaders. We and WDI also have preserved the right to enter into a future clinical and or commercial deal with a pharma partner if such an opportunity does arise. I believe this collaboration was an important demonstration of the speed, efficiency and return on investment that the Lineage platform can provide and provides evidence to support our strategy of replicating our OpRegen success with other cell transplant programs. In addition to funding existing assets, our second goal was creating new assets which could attract external funding or collaborations. And while we have not yet said anything publicly about what we're doing in this category, I can share this year we conducted initial wet lab work on multiple target cell types and if that work continues to go well, our expectation is that we would then disclose our next intended indication before our next quarterly call. Our third goal was to capitalize on our unique manufacturing capability, which we believe could solve issues which impede others programs from success. Our new initiative in Islet cell production is an example of how we're trying to meet this goal. Specifically, we're looking to tackle the major limitations in production scale which must be solved in order to have a commercially viable cell therapy product for type 1 diabetes. If we are successful with this initiative, our innovations could be applicable to other programs, potentially opening the door to conditions previously thought to be too big and too expensive to address. With cell therapy at scale, affordability is in fact the entire point of allogeneic off the shelf product development. So achieving this goal would mark a crucial moment for the field. Our fourth goal was to obtain a CIRM CLIN2 grant, which we applied for earlier this year. CIRM has employed a new review process and our understanding of that process is that only seven applications were advanced out of an initial larger pool of candidates. We were among those seven finalists. Since that selection to the final seven, we have answered a series of questions from the Grants Working group, but we have not received a grants score or any indication of whether we ultimately will receive a grant or not. However, we believe the finalists will be voted on at the next CIRM Independent Citizens' Oversight Committee (ICOC) meeting on December 11. Therefore, assuming CIRM maintains its plan's timing and we have interpreted their plans correctly, we should know our status toward meeting our fourth goal in about four or five weeks. And by the way, if we do receive CIRM funding, it would provide a very nice non dilutive offset of up to approximately $7 million from the ongoing dose study of OPC1 for spinal cord injury. The last of the five goals I outlined for the quarter was to complete activities leading to milestone revenues from our partnership with Roche and Genentech. As you already know, I cannot speak to our milestones or their amounts until such time as they are met, but it remains an important activity. It is a top priority and I am pleased with our progress related to this effort. As a final point, most of the goals we have focused on are tied in some way to an expansion of our business, for example, expanding the scope of the OPC1 study via a CIRM grant or expanding the output of new assets from our in house manufacturing platform. These are intentional moves by us because they reflect the convergence of three key factors. One, the reduction to practice of our high scale GMP banking system which we announced a few months ago 2 the emergence of a more favorable biotech market which has improved the cost of capital from which we can fund judicious and stepwise expansion expansion and 3 the belief that the Operigyn program will continue to advance under our Roche Genentech alliance and provide us with the credibility, confidence and capital to take our platform further than where it is today. We have been eagerly awaiting a time when this accumulation of factors would align and permit us to elevate Lineage's growth trajectory. We believe this momentum began in the second half of this year and expect it to continue during 2026. I should add at this point that while we aim in time to create a basket of cell therapy assets, some of which we might choose to develop internally and some of which we might partner, I have been asked on occasion how we as a small company, which has long demonstrated such fiscal discipline, how would we manage a larger portfolio? The answer is clear. Our core technology, our platform generates assets which share essential traits in common. Those traits occur early enough in a project that they're not dependent on us having a huge body of disease specific expertise. Our technology is based foremost on the directed differentiation of pluripotent cells into discrete and scalable cell types of the human body. And while each product candidate is of course intended for a different condition, and each cell line behaves in a unique manner, the early and necessary steps of process development, control, scale and purity are largely common features in the way we apply them, which allows us to expand the scope of our pipeline without losing the focus necessary to succeed or without requiring an excessive amount of capital investment. And by adapting or initiating each program on the same process development modality, we are generating more shots on goal per dollar invested. So with platform expansion as a convenient transition point, I'll turn lastly to an explanation of our recently revealed Islet Cell initiative. The human body is comprised of about 200 discrete cell types, and because pluripotent cells can become any of those 200 cell types, we have many choices about where to deploy our resources into new product candidates. When we were nearly 100% focused on OpRegen, this selection process was largely running in the background. Our initial pilot effort from this strategy was our program in auditory neurons, because we knew auditory neurons represented a high quality opportunity, and based on our recent collaboration with wdi, that has proven to be true. But there are many other cell types we could tackle, and as OpRegen's future brightened, we have increasingly emphasized and acted on our plans to repeat our OpRegen success. To that end, we hired a former venture capitalist who built for us a proprietary opportunity tracker. The basic idea for that tracker is that you matrix each of your product opportunities against dozens of product characteristics, such as the addressable market, the quality of translational models, and many other aspects, including, of course, our proprietary manufacturing insights. And from the thousands of data points which are generated, we can identify our best potential returns on investments. One of the top outputs from this proprietary process was the opportunity for us to enter the type 1 diabetes space. Our work identified three main obstacles preventing cell transplantation from providing a commercially feasible functional cure for type 1 diabetes patients. The first of these was the mechanism, but multiple companies have since shown that indeed an Islet cell transplant can achieve insulin independence for patients. The second obstacle is the need for lifetime immunosuppression, which is not a commercially feasible solution for the vast majority of patients. Several attempts to eliminate the need for immunosuppression have been explored, such as capsules or droplets, but we find the recent evidence from genetically edited hypoimmune cells to be the most attractive approach, one which has created a line of sight on breaching that second obstacle. That leaves only the third major hurdle, which is production scale cadavers are not a sustainable or stable source of Islet cells, but pluripotent cells are self renewing, so they can solve those deficiencies. However, while a single pluripotent cell can give rise to thousands of RPE cells, in our system you can only get a dozen or so Islet cells from each pluripotent cell that you start with, and because the anticipated dose levels are as high as a billion cells per patient, you're not really a commercially viable product. Until and unless you can overcome the biological feeling imposed by the generally accepted differentiation processes that exist today. I obviously cannot go into detail for competitive reasons, but the gist of the matter is that we have conducted some early work that suggests we may be able to increase our already large scale production process by many thousand fold. If we are successful, this could increase our relevance in the race to develop a functional cure for type 1 diabetes. Our initial goal for this program is to demonstrate our capability with one of our proprietary and best behaving cell lines. This initial work is ongoing and intended to lead to a go no go decision on further development, which we will expect to occur next quarter. If the initial work with an internal cell line is successful, we believe it could accelerate partnership conversations for this program and in parallel with any such talks we would also seek to demonstrate system compatibility with a hypoimmune cell line, either internally or externally sourced, which would be a more suitable line from which to support a clinical campaign. And depending of course on the results and feedback we collect along the way, we may elect to do this work for a partner or retain the product internally for a longer period. So to summarize, we believe we can reach an initial feasibility decision on this Type 1 Diabetes (T1D) initiative with a modest investment and just a few more months of work. And even if our overall goal isn't met, we might still discover some things which we can apply to improve the efficiency of our existing programs. So with that, I'll turn things over to Jill for a review of our financials.