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Lineage Chose Animal Testing for New Corneal Cell Therapy

The biotechnology developer reported $4.8 million in quarterly research spending as its new COR1 eye-disease program cleared internal criteria for further preclinical work.

Lineage Cell Therapeutics, Inc. (LCTX), a clinical-stage biotechnology company developing off-the-shelf cell therapies, elected to advance its newly launched corneal disease program into animal testing. The decision extended its manufacturing platform’s progression into additional therapeutic programs: Lineage had reported large-scale production potential in its year-end update, launched COR1 in the first quarter and selected it for further preclinical development in the second.

The company reported that COR1 achieved bioreactor-based precursor expansion and differentiation nine months after internal laboratory work began. Chief Executive Brian Culley said the program drew on Lineage’s ophthalmology and manufacturing expertise. He said the company was prioritizing programs that it believed could generate meaningful early clinical data, alongside its manufacturing support for Roche and Genentech’s development of OpRegen.

That pipeline work carried higher research costs. Second-quarter research and development spending was $4.8 million against $3.1 million a year earlier, primarily due to preclinical and undisclosed programs. General and administrative expenses were $5.2 million; personnel costs and stock-based compensation were the principal drivers of the increase.

Revenue moved in the opposite direction, falling to $1.1 million from $2.8 million. The decline primarily reflected lower recognition of deferred Roche collaboration revenue, reflecting measured progress toward completing the first performance obligation, and lower revenue associated with the prior-year termination of its VAC-platform collaboration. Revenue from the new William Demant Invest research agreement partly offset those reductions.

Lineage nevertheless reported net income of $1.5 million against a $30.5 million loss a year earlier. The reversal primarily reflected warrant-liability remeasurement and the absence of the prior-year VAC impairment. The quarter included a $9.4 million noncash warrant gain, linked to its lower share price. Its operating loss remained $8.9 million.

The smaller operating loss also reflected the absence of the prior-year $14.8 million VAC impairment, rather than a reduction in research spending. Total quarterly operating expenses were $10.0 million. The accounting changes therefore accompanied continued spending on the broader pipeline, including programs still at the preclinical and manufacturing-development stages.

OpRegen remained in Phase 2a development under the Roche and Genentech collaboration. The GAlette study was open and active at 17 sites in the United States and Israel. An earlier study’s less-advanced-disease cohort comprised 12 patients whose treated eyes had mean visual-acuity scores above baseline through 36 months. The findings were characterized as evidence of sustained benefit, though exploratory results might not predict subsequent studies.

The spinal cord injury program, OPC1, also remained in clinical development. Its DOSED delivery-device study had completed two administrations in chronic-injury participants, with no unexpected procedural, product or device-related adverse events reported. A second study site opened at Rancho Research Institute. The study evaluated device safety and utility and provided no safety or efficacy conclusions about OPC1.

Manufacturing work extended to ReSonance, the hearing-loss program partnered with William Demant Invest. Lineage completed three engineering runs, transferred the process internally to its current Good Manufacturing Practice team and completed a manufacturing run undergoing standard release testing. It also established a deafening model for functional preclinical testing under the collaboration.

The ILT1 initiative advanced from 0.5L to multi-liter scale for undifferentiated pluripotent cells. Its goal was an integrated expansion-and-differentiation process that, if successful and applied to islet cells, could address a production hurdle for a potential Type 1 diabetes therapy.

For the six months ended June 30, operating cash use was $15.3 million against $10.4 million a year earlier. Financing activities supplied $10.0 million.

Cash, cash equivalents and marketable securities totaled $50.8 million at June 30. Those resources are expected to support planned operations into the third quarter of 2028, with initial COR1 animal-testing data expected in 2026.

More on LCTX

Lineage Cell Therapeutics, Inc. — all coverage and financials