Lineage Cell Therapeutics, Inc. (LCTX): Business Model Canvas [Apr-2026 Updated]

You're digging into the mechanics of a clinical-stage cell therapy play, trying to see past the science to the actual business engine driving Lineage Cell Therapeutics, Inc. Honestly, their model hinges on one thing: turning their proprietary, off-the-shelf cell technology into a blockbuster, starting with OpRegen for Geographic Atrophy, which is smartly partnered with Roche/Genentech for late-stage development. The Q3 2025 numbers show they burned through about $7.5 million in core operating costs (R&D plus G&A), but they banked $40.5 million in cash, giving them runway into Q2 2027, plus they just snagged a $5 million milestone payment in November 2025. So, are they building a sustainable revenue machine or just managing cash until the next data readout? Let's break down the nine blocks below to see where the real value is locked in.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that fuel Lineage Cell Therapeutics, Inc.'s pipeline progression, especially as they move OpRegen through late-stage trials. These partnerships aren't just about shared risk; they represent critical infusions of capital and specialized expertise necessary for a company at this stage.

The collaboration with Roche and Genentech for OpRegen, their retinal pigment epithelial cell therapy for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), is perhaps the most significant. This exclusive worldwide collaboration, which started back in December 2021, is structured around substantial potential payments. Lineage Cell Therapeutics, Inc. recently confirmed achieving the first development milestone on November 20, 2025, based on manufacturing and clinical advancements in the Phase 2a GAlette study. This event triggered a $5 million milestone payment, which Lineage expects to receive within 30 days. This is just the start, though; the total potential milestone payments available under this agreement stand at up to $620 million, plus the prospect of double-digit royalties upon commercialization.

Also critical for pipeline diversification is the research collaboration with William Demant Invest A/S (WDI) for ReSonance (ANP1), their auditory neuronal cell transplant for hearing loss. WDI is committed to funding up to $12 million in research collaboration costs over a multi-year period to advance the preclinical development of ANP1. This funding supports joint efforts with scientists from Eriksholm Research Centre, part of the Demant Group, covering everything from cell manufacturing to regulatory strategy to support a potential IND/CTA filing.

Here's a quick look at the financial structure of these two major external relationships:

Beyond the direct funding agreements, Lineage Cell Therapeutics, Inc. relies on a network of clinical and advisory partners to execute its trials. The execution of the Phase 2a GAlette study for OpRegen and the Phase 1/2a study for OPC1 (oligodendrocyte progenitor cell therapy for spinal cord injuries) depends on these specialized clinical trial sites. As of the Q3 2025 update, the company had expanded its clinical trial sites for the OpRegen program, with 15 unique locations now open for enrollment. Furthermore, in the OPC1 program, a significant usability milestone was met when the first chronic patient received a 10-million cell dose using a novel delivery device that avoids ventilation interruption.

Advisory and non-dilutive funding relationships also play a part in the operational structure. For instance, Lineage Cell Therapeutics, Inc. announced the 3rd Annual SCI Investor Symposium in collaboration with the Christopher & Dana Reeve Foundation, showing engagement with key advocacy groups in the spinal cord injury space. Also, remember that the recent $5 million milestone payment from Roche/Genentech isn't entirely retained by Lineage Cell Therapeutics, Inc. As per existing agreements tied to its subsidiary Cell Cure Neuroscience Ltd., approximately 24.1% of that payment is allocated to the Israel Innovation Authority (IIA), and another 21.5% goes to Hadasit Medical Research and Development Ltd. This structure reflects prior support received under Israeli law, specifically the Israeli Encouragement of Research, Development and Industrial Initiative Technology Law, 5744-1984, as amended. It's a common structure for companies with R&D operations in Israel, defintely something to track for future milestone receipts.

• Roche and Genentech collaboration covers OpRegen for GA secondary to AMD.
• WDI funding is specifically for ReSonance (ANP1) preclinical work.
• The IIA receives a portion of OpRegen milestones, such as 24.1% of the recent $5 million payment.
• OPC1 trial involved a 10-million cell dose in a chronic patient.
• OpRegen's GAlette study has 15 unique clinical sites open as of late 2025.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Key Activities

You're managing a clinical-stage biotech, so your key activities revolve around de-risking assets through clinical proof and building the infrastructure to scale-that's where the real value is created, or lost. For Lineage Cell Therapeutics, Inc. (LCTX) as of late 2025, these activities are heavily weighted toward trial execution and manufacturing validation.

Clinical-stage cell therapy development is the engine, focusing on moving three core programs forward. The OpRegen® (RG6501) program, for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), is in Phase 2a development under the GAlette Study with Genentech and Roche. The 36-month results from the Phase 1/2a trial, presented at Clinical Trials at the Summit 2025, showed durability, with treated eyes in Cohort 4 exhibiting a mean Best Corrected Visual Acuity (BCVA) change of +6.2 letters (ETDRS). Furthermore, five patients with extensive coverage showed benefits persisting through month 36. For the OPC1 program, targeting spinal cord injury (SCI), the activity involved treating the first chronic patient in the DOSED clinical study using a novel delivery system. The ReSonance™ (ANP1) program, for auditory neuropathy, is also being advanced.

The second major activity is cGMP manufacturing, which Lineage Cell Therapeutics, Inc. views as a core differentiator. They solidified their leadership here by reporting in-house Current Good Manufacturing Practice (cGMP) production for both OpRegen and OPC1, stemming from a master and working cell bank system. This validated process, derived from a single, genetically-stable pluripotent cell line, is designed to support a production capability of millions of doses of a single-administration product. This capability was demonstrated by successfully completing production runs for two different product candidates.

To fund this development and validate the platform, strategic partnering and licensing is a critical, non-dilutive activity. The OpRegen collaboration with Roche and Genentech, which offers up to $670 million in milestones plus double-digit royalties, recently yielded a milestone payment tied to manufacturing expertise. Separately, the ReSonance program entered a research collaboration with William Demant Invest (WDI), where WDI is set to contribute up to $12 million over a three-year term to cover preclinical development costs.

The internal Research and Development (R&D) activity is directed toward platform expansion. This is reflected in the Q3 2025 R&D expense, which totaled $3.3 million. A key new initiative here is ILT1, focused on islet cell transplants for Type 1 Diabetes, specifically targeting the hurdle of large-scale production for commercialization.

Finally, Intellectual property management underpins all of this. The successful establishment of the ReSonance program, advancing it into initial preclinical testing in approximately one year with a modest initial investment, demonstrated the ability to generate new intellectual property from the platform.

Here's a quick look at the pipeline programs that these key activities support:

The manufacturing scale is a direct output of these focused activities, which you need to keep an eye on as it directly impacts future cost of goods sold (COGS) and partnership attractiveness. The current in-house cGMP system is designed to support this scale:

• Production capability of millions of doses from a single master cell bank system.
• Platform successfully applied to produce two different product candidates under cGMP.
• Goal is to produce a cost-effective, scalable, and consistent supply.

Financially, these activities are sustained by a cash position of $40.5 million as of September 30, 2025, which is projected to support operations into Q2 2027. Still, the Q3 2025 net loss was $29.8 million, or $0.13 per share, reflecting the high cost of these development and manufacturing efforts. Finance: draft 13-week cash view by Friday.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Key Resources

You're looking at the core assets Lineage Cell Therapeutics, Inc. (LCTX) is relying on to drive value right now. These aren't just line items; they are the engine for their pipeline.

Financial Capital and Runway

The immediate resource is the balance sheet strength as of the last reported quarter. This dictates operational flexibility.

The runway extension into Q2 2027 is partly attributed to cash received from the William Demant Invest alliance, which is a key financial inflow supporting near-term operations.

Proprietary Technology and Manufacturing Capability

The foundation of Lineage Cell Therapeutics, Inc.'s value proposition rests on its ability to consistently create specialized human cells from a single source.

• Proprietary allogeneic cell-based technology platform for generating specialized cells.
• Scalable current Good Manufacturing Practice (cGMP) manufacturing process.
• The established two-tiered cell banking system supports production capability of millions of doses from a single cell line.
• cGMP production successfully reported for both OpRegen and OPC1 product candidates.

This manufacturing scale is designed to support an estimated 18,000 people annually in the United States for a condition like spinal cord injury, based on prior modeling for the OPC1 program.

Clinical Data Assets

The most tangible proof of concept comes from the long-term follow-up data on OpRegen (RG6501) for geographic atrophy (GA).

The data shows sustained anatomical and functional benefits persisting out to 3 years following a single administration.

Human Capital: R&D Team Expertise

The team's expertise is critical for translating the platform into clinical assets, especially in complex areas like cell differentiation and delivery.

• Expertise in directed differentiation processes from well-characterized, self-renewing pluripotent cell lines.
• Proficiency in applying advanced tools like bioinformatics and single cell RNA seek for material control.
• In-house capability to support development and manufacturing strategies for partners like Roche and Genentech.

The team is also initiating a new cell therapy initiative focused on islet cell transplants for Type 1 Diabetes, leveraging this core expertise.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Value Propositions

Lineage Cell Therapeutics, Inc. develops allogeneic, or "off the shelf", cell therapies.

One-time, allogeneic treatment: Off-the-shelf cell therapies avoiding patient-specific cell sourcing

• Developing novel allogeneic, or "off the shelf", cell therapies.
• OpRegen shows durable anatomical and functional improvements following a single administration of the therapy.

Durable functional improvement: OpRegen shows sustained visual acuity gains through 36 months

OpRegen cell therapy shows sustained improvement in visual acuity for up to 36 months in patients with geographic atrophy (GA).

Addressing unmet medical needs: Targeting degenerative conditions like Geographic Atrophy (GA) and chronic Spinal Cord Injury (SCI)

• OpRegen is in Phase 2a development for GA secondary to AMD.
• OPC1 is in Phase 1/2a development for spinal cord injuries.
• The current GA treatment landscape consists of only two therapies, Syfovre and Izervay.

Potential for functional cell replacement: Replacing cells lost due to disease or injury

• OpRegen works by restoring retinal function through targeted replacement of dysfunctional RPE cells.
• OPC1 is an oligodendrocyte progenitor cell therapy.

Reduced compliance burden: Single-administration dosing versus frequent injections for competitors

• Manufacturing capability can support a production capacity of millions of doses of a single-administration product.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Customer Relationships

You're running a clinical-stage biotech, so your 'customers' aren't just patients; they are the strategic partners funding and advancing your pipeline, the investigators executing the trials, and the investors providing the necessary capital runway. The relationships here are deep, contractual, and absolutely critical to survival.

High-touch strategic collaboration: Deep, ongoing R&D and clinical support for partners like Genentech.

The relationship with Roche and Genentech for OpRegen is the centerpiece of Lineage Cell Therapeutics, Inc.'s near-term value proposition. This isn't a simple vendor agreement; it involves deep integration of manufacturing and clinical support. Lineage Cell Therapeutics, Inc. recently achieved the first milestone under this worldwide collaboration, which has a total of up to $620 million in available milestone payments. This achievement was based on manufacturing and clinical advancements for OpRegen (RG6501). Furthermore, a separate services agreement signed in May 2024 requires ongoing support for the Phase 2a GAlette Study, including long-term follow-up activities and providing additional technical training and materials to support commercial manufacturing strategies for Genentech.

Beyond the major pharma partner, Lineage Cell Therapeutics, Inc. maintains strategic alliances for pipeline diversification. For instance, the collaboration with William Demant Invest (WDI) is structured to fund up to $12 million in research and collaboration costs for the preclinical development of ReSonance (ANP1) for hearing loss. This demonstrates a model of using non-dilutive external funding for early-stage assets.

Clinical investigator engagement: Close relationships with specialized surgeons and research centers.

The success of the OpRegen program hinges on the execution within the clinical trial sites managed by partners. The GAlette Study, run by Genentech, has shown momentum, expanding to 15 sites in six months as of late 2025. The clinical data presentation at the Clinical Trials at the Summit (CTS) 2025 was delivered by Dr. Christopher D. Riemann, a vitreoretinal surgeon affiliated with Cincinnati Eye Institute and University of Cincinnati School of Medicine, on behalf of Roche and Genentech, showing direct engagement with key opinion leaders. For the OPC1 program, the DOSED study initiated at UC San Diego Health as the first participating site in February 2025.

Investor relations: Regular financial and business updates to maintain capital access.

Maintaining the confidence of the investment community is paramount for a clinical-stage company burning cash. Lineage Cell Therapeutics, Inc. provided a business update following its Q3 2025 earnings release on November 6, 2025. The reported cash position as of September 30, 2025, was $40.5 million in cash, cash equivalents, and marketable securities, which management projected would support planned operations into Q2 2027. Total revenue for Q3 2025 was $3.7 million, though the net loss for the quarter reached $29.8 million, or -$0.13 per share. A key element of the relationship is the potential for non-dilutive capital: approximately $37 million of warrant capital could be received if Roche and Genentech publicly disclose intent to advance OpRegen into a trial with a competitor arm.

Here's a quick look at the key external relationship metrics as of late 2025:

Patient advocacy: Working with groups like the Christopher & Dana Reeve Foundation for program visibility.

Lineage Cell Therapeutics, Inc. actively engages advocacy groups to drive awareness and focus research priorities, particularly for its OPC1 spinal cord injury program. The company co-hosted the 3rd Annual Spinal Cord Injury Investor Symposium (3rd SCIIS) with the Christopher & Dana Reeve Foundation in June 2025. This event is designed to increase awareness about spinal cord injury research and drive collaboration among companies, researchers, and people with paralysis. The Reeve Foundation is dedicated to funding research and improving quality of life for individuals impacted by paralysis, including through its National Paralysis Resource Center (NPRC) which assists over 125,000 individuals and families since its launch in 2002.

• Co-hosted 3rd Annual SCI Investor Symposium in June 2025.
• Symposium goal: Increase investment capital into SCI research.
• Focus on patient-focused innovation and shared standards.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Channels

The channels Lineage Cell Therapeutics, Inc. uses to reach its customers and partners are heavily weighted toward strategic alliances and direct clinical operations.

Global Pharmaceutical Partners: Roche/Genentech for OpRegen

The collaboration and license agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. for OpRegen is a primary channel for late-stage development and commercialization efforts.

• The agreement was entered into in December 2021.
• OpRegen is currently being evaluated in a Phase 2a multicenter clinical trial, known as "GAlette".
• On November 20, 2025, the first development milestone under the Roche Agreement was achieved.
• This triggered a $5 million milestone payment to Lineage Cell Therapeutics, expected within 30 days.
• Of the $5 million payment, approximately 24.1% is allocated to the Israel Innovation Authority and 21.5% to Hadasit Medical Research and Development Ltd..
• Lineage Cell Therapeutics may receive an additional $37 million if Roche and Genentech publicly disclose intent to advance OpRegen into the next trial, contingent on the share price being above $0.91.

Specialized Clinical Trial Sites

Direct administration of product candidates and data collection occur through specialized clinical trial sites, which function as the immediate delivery channel for investigational therapies.

The GAlette Study, evaluating OpRegen, is a multicenter clinical trial. For the OPC1 program, the first chronic patient received a one-time 10-million cell dose using a novel delivery device. Lineage Cell Therapeutics also solidified its in-house facility's production capability to support a production capability of millions of doses of a single-administration product for both OpRegen and OPC1.

Research Collaborations: William Demant Invest A/S

This channel involves strategic funding and joint development for pipeline assets outside the major pharma partnerships.

Lineage Cell Therapeutics entered a research collaboration with William Demant Invest A/S (WDI) to jointly advance ReSonance (ANP1) for hearing loss.

Scientific Publications and Conferences

Dissemination of clinical data to the medical community is a key channel for establishing scientific credibility and informing future partner/investor interest.

• Positive RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month Results were featured at Clinical Trials at the Summit (CTS) 2025.
• The 36-month data update from Roche and Genentech for OpRegen was expected in June 2025.
• The presentation at CTS 2025 covered Month 36 Results.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Customer Segments

You're looking at the core groups Lineage Cell Therapeutics, Inc. (LCTX) targets with its cell therapy pipeline as of late 2025. This isn't about the stock price; it's about the patients and partners who drive the science forward.

Large pharmaceutical and biotech companies represent a key segment, primarily through strategic alliances like the worldwide collaboration with Roche and Genentech for OpRegen for geographic atrophy (GA). These partners are essential for late-stage development, such as the ongoing Phase 2a GAlette Study, and for providing the necessary infrastructure for commercialization.

The patient populations targeted by the clinical pipeline are substantial, representing significant unmet medical needs:

• The Geographic Atrophy (GA) market for OpRegen targets patients with vision impairment due to age-related macular degeneration. The Phase 1/2a trial included patients with Best Corrected Visual Acuity (BCVA) as low as 20/250.
• The Spinal Cord Injury (SCI) market for OPC1 targets a large, underserved population. In the U.S. alone, there are approximately 18,000 new SCI cases annually, with over 300,000 total patients living with SCI.
• The sensorineural hearing loss segment, targeted by ReSonance (ANP1), addresses a massive global issue, with nearly 2.5 billion people expected to experience some degree of hearing loss by 2025.

The clinical development itself defines specific patient cohorts for the OPC1 program. The DOSED study is specifically enrolling both subacute (between 21 to 42 days after injury) and chronic (between one and five years post-injury) SCI patients. This expansion into chronic injury is a major focus, as there are currently no FDA-approved drugs for SCI treatment.

The specialized medical community forms another critical segment, as they are the ones who will ultimately administer the therapies. For OpRegen, this includes specialized vitreoretinal surgeons, with Genentech evaluating proprietary surgical delivery devices in the Phase 2a GAlette Study. For OPC1, the focus is on the safety and utility of the Manual Inject Parenchymal Spinal Delivery System (MI PSD System) for direct delivery to the injury site.

Here's a quick look at the pipeline focus areas and associated scale data as of late 2025:

Financially, the company's immediate customer/partner segment is reflected in its revenue. Lineage Cell Therapeutics, Inc. reported total revenues of $2.77 million for the three months ended June 30, 2025, primarily driven by collaboration revenues under the Roche agreement. Analyst consensus projected full-year 2025 revenue at $6.83 million. The company's cash position as of September 30, 2025, was $40.5 million, which management believes is sufficient to support planned operations into the second quarter of 2027.

The segment of potential future partners is also critical, as evidenced by the $14.3 million grant from CIRM that partially funded OPC1 development. Lineage Cell Therapeutics, Inc. is positioning its platform to be a compelling partner for other cell therapy initiatives, including its internal Type 1 Diabetes (ILT1) program.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Lineage Cell Therapeutics, Inc. (LCTX) as of late 2025. For a clinical-stage biotech, the cost structure is dominated by science and trials, but non-cash items can really skew the reported bottom line. Here's how the numbers broke down for the third quarter of 2025.

The primary operational costs are split between the lab work and keeping the lights on. Total operating expenses for the third quarter of 2025 were reported at $7.5 million, which was a slight decrease from the $7.6 million in the same period in 2024. This figure is the sum of the two main buckets: Research and Development (R&D) and General and Administrative (G&A) expenses.

Research and Development (R&D) Expenses

R&D expenses remain the core investment area, totaling $3.3 million in Q3 2025. This was an increase of $0.1 million compared to Q3 2024's $3.2 million. This spending fuels the pipeline progression, which is the company's main asset.

Here's a quick look at the drivers within that R&D spend for the quarter:

• Funding for the OPC1 program accounted for $0.2 million.
• Preclinical programs absorbed $0.4 million.
• The OpRegen program saw a cost offset of $0.5 million.

General and Administrative (G&A) Expenses

General and Administrative (G&A) expenses, which cover overhead, management, and support functions, totaled $4.2 million in Q3 2025. That's a decrease of $0.2 million from the $4.4 million reported in Q3 2024. Honestly, this suggests some efficiency in the non-science side of the business.

Clinical Trial Costs and Manufacturing

Clinical trial costs are embedded within R&D but represent significant, lumpy expenditures. Lineage Cell Therapeutics, Inc. is funding ongoing studies, which you need to track closely. These costs support:

• The RG6501 (OpRegen) Phase 1/2a clinical study, which recently featured 36-month results suggesting sustained gains in visual acuity.
• Support for the ongoing Phase 2a GAlette Study for OpRegen, executed through the collaboration with Roche and Genentech.
• Initiation of a new cell therapy initiative focused on islet cell transplants for Type 1 Diabetes, which requires initial process development costs.

Manufacturing and process development costs are also a key component, especially given the company's focus on allogeneic, or "off the shelf," cell therapies. Lineage Cell Therapeutics, Inc. reported achieving cGMP (current Good Manufacturing Practice) production for both OpRegen and OPC1 using a master and working cell bank system. This system, in its current form, is designed to support a production capability of millions of doses of a single-administration product, all from their in-house facility. That scale-up capability is a major, ongoing cost driver.

Non-Cash Expenses

This is where the reported net loss can look dramatically different from the operating loss. A significant quarterly fair value remeasurement of warrant liabilities hit the books hard. For Q3 2025, this non-cash charge was $26.6 million. This change was largely attributable to a shift in the company's share price compared to the prior period, which directly impacts the valuation of those outstanding warrants.

The impact of this non-cash item is clear when you look at the bottom line. The net loss attributable to Lineage Cell Therapeutics, Inc. for the three months ended September 30, 2025, was $29.8 million, compared to a net loss of $3.0 million for the same period in 2024. The operating loss, however, was $3.8 million for Q3 2025, which was in-line with the prior year's operating loss, showing the operational burn was much lower than the net loss suggests.

Here's a quick comparison of the key cost and loss figures for Q3 2025:

To manage this burn, you should note the cash position as of September 30, 2025, was $40.5 million, which the company expected to support planned operations into Q2 of 2027. Also, there is a potential cash inflow of approximately $37 million if investors exercise warrants contingent on Roche and Genentech advancing OpRegen into a competitor arm trial. Finance: draft 13-week cash view by Friday.

Lineage Cell Therapeutics, Inc. (LCTX) - Canvas Business Model: Revenue Streams

You're looking at the core ways Lineage Cell Therapeutics, Inc. (LCTX) brings in cash right now, which is crucial for funding those long-term cell therapy dreams. Honestly, for a clinical-stage company, the revenue mix is heavily weighted toward partnerships, which is smart money management.

The primary drivers for Lineage Cell Therapeutics, Inc. (LCTX) revenue streams as of late 2025 are centered on its strategic alliances, particularly the one with Roche and Genentech for OpRegen. You see the immediate cash flow coming from recognized performance obligations and the lumpy, but significant, milestone payments.

Here's a look at the Q3 2025 revenue components:

Collaboration revenue is the big one here. It's recognized as Lineage Cell Therapeutics, Inc. (LCTX) satisfies its performance obligations under the Roche/Genentech agreement. For instance, in Q3 2025, this stream accounted for $3.54 million of the total recognized revenue.

Non-recurring, but very welcome, are the milestone payments. These are payments from partners based on hitting specific development or regulatory targets. You definitely want to track these as they provide non-dilutive funding. Lineage Cell Therapeutics, Inc. (LCTX) recently hit a key one:

• Achieved the first development milestone under the Roche/Genentech collaboration for OpRegen on November 20, 2025.
• This triggered a $5 million milestone payment.
• The total milestone payments available under the entire OpRegen collaboration are up to $620 million.

Royalties and other service revenues are minor sources right now, reflecting smaller, existing agreements. Still, you saw a year-over-year decrease of about $0.3 million in these categories compared to Q3 2024, which was offset by a slight increase in collaboration revenue for the quarter.

Beyond immediate revenue recognition, there is significant contingent capital tied to the OpRegen program's success. This isn't booked revenue yet, but it's a crucial potential cash infusion that affects the balance sheet and runway projections. Specifically, Lineage Cell Therapeutics, Inc. (LCTX) has:

• Up to approximately $37 million in warrant capital potentially available.
• This capital is contingent on OpRegen advancing into a clinical trial that includes a control or comparator arm.

That $37 million figure is important; it's a clear, near-term financial lever contingent on a specific OpRegen trial decision.