On November 6, 2025 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions, reported its third quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update.
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"It has been a productive third quarter for the Lineage team," stated Brian M. Culley, Lineage CEO. "Last quarter, I outlined five areas of focus through the end of this year, and I am pleased to report that we delivered on several of these during the third quarter, as outlined below.
We entered into a research collaboration with William Demant Invest A/S, which is designed to fund all currently planned preclinical development of our ReSonance program, demonstrating the ability of our technology platform to produce a partnered program with limited investment and in a short amount of time.
We solidified our position as a leader in allogeneic cell process development by reporting cGMP production for each of OpRegen and OPC1, from a master and working cell bank system which, in its current form, can support a production capability of millions of doses of a single-administration product, all from our in-house facility.
We launched a new cell therapy initiative, focused on islet cell transplants for the treatment of Type 1 Diabetes, with an initial focus on addressing the unsolved issue of large-scale production of islet cells, which if successful could potentially solve a major hurdle to commercialization of islet cell therapy product candidates."
"Looking ahead, we will continue to work on the other strategic initiatives I outlined, including activities designed to drive milestone revenue from our alliance with Roche and Genentech and pursuing grant funding from the California Institute for Regenerative Medicine (CIRM) for our OPC1 program. We also continue to plan for a successful future by seeking to capitalize on our investments in our cell transplant platform and to utilize our manufacturing achievements as a foundation from which additional programs can be strategically advanced via funded collaborations or independently," added Mr. Culley.
Select Business Highlights
RG6501 (OpRegen Cell Therapy)
Positive RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month Results featured at Clinical Trials at the Summit (CTS) 2025, suggesting evidence of sustained gains in visual acuity and structural support of the retina.
Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech, including support for the ongoing Phase 2a GAlette Study.
In addition to testing of other surgical parameters, Genentech currently plans to evaluate two proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the Phase 2a GAlette Study.
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.
ReSonance (ANP1)
Announced research collaboration with William Demant Invest A/S (WDI) to jointly advance development of ReSonance (ANP1) over a term of three years; up to $12 million of development costs to be contributed by WDI in a collaboration which covers preclinical development activities, including cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis.
Manufacturing Capability
Successfully completed a production run for each of OpRegen and OPC1, two of our product candidates, each produced from a customized, two-tiered current Good Manufacturing Practice ("cGMP") cell banking system, highlighting the application of the Lineage platform across multiple programs.
This production process utilizes a genetically-stable master cell bank created from a single, well-characterized pluripotent cell line, to generate a working cell bank, which then provides the source material for a final cell-based product candidate.
This demonstrated cGMP production process 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.
ILT1
Launched new cell therapy initiative, focused on islet cell transplants for the treatment of Type 1 Diabetes; plans are to deploy the company’s manufacturing capability to address the issue of large-scale production of islet cells, with the initial goal of establishing a production modality that can support the entire production process in a dynamic culturing system, which if successful could potentially solve a major hurdle to commercialization of islet cell therapy product candidates.
OPC1
First chronic spinal cord injury participant treated in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study.
First treated participant was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with a single neurological level of injury (NLI) from levels T1 to T10, and the novel delivery system successfully administered a one-time injection of OPC1.
No significant safety events have been reported sixty days following treatment in the first chronic SCI participant.
The California Institute for Regenerative Medicine (CIRM) continues to review Lineage’s application for a CLIN2 clinical grant to support our DOSED study of OPC1.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities of $40.5 million as of September 30, 2025, is expected to support planned operations into Q2 2027.
Third Quarter Operating Results
Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended September 30, 2025 were $3.7 million, a decrease of approximately $0.1 million as compared to $3.8 million for the same period in 2024. The decrease was primarily driven by lower royalty revenue and other service revenues recognized of $0.3 million, partially offset by more collaboration revenues of $0.2 million.
Operating Expenses: Operating expenses are primarily comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended September 30, 2025 were $7.5 million, a decrease of $0.1 million as compared to $7.6 million for the same period in 2024.
R&D Expenses: R&D expenses for the three months ended September 30, 2025 were $3.3 million, an increase of $0.1 million as compared to $3.2 million for the same period in 2024. The net increase was primarily driven by $0.2 million for our OPC1 program, $0.4 million for our preclinical programs and other undisclosed programs, partially offset by $0.5 million for our OpRegen program.
G&A Expenses: G&A expenses for the three months ended September 30, 2025 were $4.2 million, a decrease of $0.2 million as compared to $4.4 million for the same period in 2024. The decrease was primarily attributable stock-based compensation and services provided by third parties.
Loss from Operations: Loss from operations for the three months ended September 30, 2025 was $3.8 million, which was in-line with the comparative prior year period’s loss.
Other Income/(Expenses): Other income/(expenses) for the three months ended September 30, 2025 reflected other expense of $26.0 million, compared to other income of $0.8 million for the same period in 2024. The change was largely attributable to the non-cash quarterly fair value remeasurement of the warrant liabilities of $26.6 million primarily due to a change in our share price as compared to the prior year period, and $0.2 million for exchange rate fluctuations related to Lineage’s international subsidiaries.
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2025 was $29.8 million, or $0.13 per share (basic and diluted), compared to a net loss of $3.0 million, or $0.02 per share (basic and diluted), for the same period in 2024. The change was primarily driven by the non-cash quarterly fair value remeasurement of the warrant liabilities due to a change in our share price as compared to the prior quarter.
Conference Call and Webcast
Interested parties may access the conference call on November 6, 2025, by dialing (888) 596-4144 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". 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 November 14, 2025, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 3958367.
(Press release, Lineage Cell Therapeutics, NOV 6, 2025, View Source [SID1234659578])