On March 10, 2025 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for serious neurological conditions, reported its fourth quarter and full year 2024 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 (Press release, Lineage Cell Therapeutics, MAR 10, 2025, View Source [SID1234651041]).

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"Throughout 2024, we made substantial progress across multiple fronts, advancing our programs, expanding collaborations, and strengthening our balance sheet to support significant anticipated milestones," stated Brian M. Culley, Lineage’s CEO. "Our lead asset OpRegen continues to make progress in the ongoing GAlette Study, and we are encouraged by Roche and Genentech’s commitment to the OpRegen program. Our partner’s efforts to advance OpRegen for the treatment of dry AMD with GA include adding clinical sites and seeking and obtaining RMAT designation. We view these actions as positive indicators for this pioneering cell transplant and look forward to further updates on the program."

"We anticipate our internal programs will similarly advance through important milestones during 2025," added Mr. Culley. "We will focus on conducting the recently-initiated DOSED clinical study of a novel OPC1 delivery system, advancing ReSonance for the treatment of sensorineural hearing loss, and advancing other carefully selected early-stage initiatives. In parallel, we will continue our efforts to demonstrate an in-house manufacturing capability that supports Lineage having an industry-leading position in allogeneic cell banking and production. As the power of our cell differentiation and manufacturing platforms are further demonstrated and validated, we believe that our pipeline of internally-owned assets and cell-based know-how will make us a desirable development partner and an attractive opportunity for investors."

Select Business Highlights

– RG6501 (OpRegen)

Ongoing execution of Lineage’s contributions to our collaboration with Roche and Genentech, a member of the Roche Group, across multiple functional areas, including support for the ongoing Phase 2a clinical study (the "GAlette Study") in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), and expansion of the clinical study to sites in Israel.
Roche announced receipt of RMAT designation from the U.S. FDA for OpRegen, for the treatment of GA secondary to AMD.
Entered into a separate services agreement with Genentech to further support development of OpRegen, including: (i) activities to support the ongoing Phase 1/2a study and currently enrolling GAlette Study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.
Positive clinical data from long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen featured at the 2024 Retinal Cell & Gene Therapy Innovation Summit.
– OPC1

Submitted an Investigational New Drug Amendment (INDa) for OPC1 to enable initiation of DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study in subacute and chronic spinal cord patients.
DOSED study initiated in February 2025; UC San Diego Health named as the first participating study site.
Lineage and OPC1 program featured on CNN: "He was paralyzed his last day of high school. How an experimental trial is showing ‘unexpected improvement."
Created and hosted the 2nd Annual Spinal Cord Injury Investor Symposium in partnership with the Christopher & Dana Reeve Foundation, with additional grant support from CIRM.
The goals of this collaborative effort include increasing disease awareness, improving the probability of success in product development, and supporting clinical trial participation. Presenting companies have included AbbVie, Mitsubishi Tanabe, Neuralink, NervGen Pharma and ONWARD.
– ReSonance (ANP1)

Preclinical results presented at 59th Annual Inner Ear Biology Workshop.
ReSonance manufactured by a proprietary process, developed in-house, at clinical scale, with relevant in-vitro functional activity.
Immediate-use, thaw-and-inject formulation durably engrafted in multiple preclinical hearing loss models.
ReSonance is currently being evaluated in a functional model of hearing loss through a collaboration with the University of Michigan Kresge Hearing Research Institute.
– Corporate

Closed two financings totaling $44 million in gross proceeds; potential to receive an additional $36 million in gross proceeds upon the full cash exercise of OpRegen clinical milestone-linked warrants.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $47.8 million as of December 31, 2024, together with the approximate $5.5 million in net proceeds from the second closing under our November 2024 registered direct offering completed in January 2025, is expected to support planned operations into Q1 2027.

Fourth Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended December 31, 2024 were approximately $2.9 million, a net increase of $0.8 million as compared to $2.1 million for the same period in 2023. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the collaboration and license agreement with Roche.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended December 31, 2024 were $7.8 million, a decrease of $0.4 million as compared to $8.2 million for the same period in 2023.

R&D Expenses: R&D expenses for the three months ended December 31, 2024 were $3.4 million, a decrease of $0.5 million as compared to $3.9 million for the same period in 2023. The net decrease was primarily driven by $1.2 million for our OPC1 program expenses and $0.2 million for other research and development expense programs, partially offset by $0.4 million for our OpRegen program expenses and $0.5 million for our preclinical programs.

G&A Expenses: G&A expenses for the three months ended December 31, 2024 of $4.4 million were primarily in line with expenses for the same period in 2023.

Loss from Operations: Loss from operations for the three months ended December 31, 2024 was $5.1 million, a decrease of $1.3 million as compared to $6.4 million for the same period in 2023.

Other Income/(Expenses): Other income/(expenses) for the three months ended December 31, 2024 reflected other income of $1.8 million, compared to other income of $1.6 million for the same period in 2023. The net increase was primarily driven by changes in fair value of warrant liability, largely offset by exchange rate fluctuations related to Lineage’s international subsidiaries and certain warrant-related transaction costs incurred as part of the November 2024 financing.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2024 was $3.3 million, or $0.02 per share (basic and diluted), compared to a net loss of $4.8 million, or $0.03 per share (basic and diluted), for the same period in 2023.

Full Year Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the year ended December 31, 2024 were $9.5 million, a net increase of $0.6 million as compared to $8.9 million for the same period in 2023. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the collaboration and license agreement with Roche.

Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2024 were $31.0 million, a decrease of $2.7 million as compared to $33.7 million for the same period in 2023.

R&D Expenses: R&D expenses for the year ended December 31, 2024 were $12.5 million, a decrease of $3.2 million as compared to $15.7 million for the same period in 2023. The decrease was primarily driven by $2.7 million for our OPC1 program expenses, $1.1 million for our preclinical and other research and development programs. These decreases were partially offset by $0.6 million for our OpRegen program.

G&A Expenses: G&A expenses for the year ended December 31, 2024 were $18.2 million, an increase of approximately $0.9 million as compared to $17.3 million for the same period in 2023. The net increase was primarily driven by $0.6 million for stock-based compensation expense and $0.4 million for personnel costs, partially offset by an overall decrease in costs incurred for services provided by third parties.

Loss from Operations: Loss from operations for the year ended December 31, 2024 was $21.5 million, a decrease of $3.2 million as compared to $24.7 million for the same period in 2023.

Other Income/(Expenses): Other income (expenses) for the year ended December 31, 2024 reflected other income of $2.9 million, compared to other income of $1.5 million for the same period in 2023. The net increase of $1.4 million was primarily driven by changes in the fair value of warrant liability, exchange rate fluctuations related to Lineage’s international subsidiaries, and fair market value changes in marketable equity securities. This increase in other income was partially offset by certain warrant-related transaction costs incurred as part of the November 2024 financing, as well as the non-recurring prior year employee retention credit.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2024 was $18.6 million, or $0.09 per share (basic and diluted), compared to a net loss of $21.5 million, or $0.12 per share (basic and diluted), for 2023.

Conference Call and Webcast

Interested parties may access the conference call on March 10, 2025, by dialing (800) 715-9871 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 March 17th, 2025, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6707203.