Lineage Cell Therapeutics announces cGMP production success

Published 01/05/2025, 14:16
Lineage Cell Therapeutics announces cGMP production success

Lineage Cell Therapeutics, Inc. (NYSE:LCTX), with a market capitalization of $114 million, reported today that it has successfully completed a production run for two different product candidates using a current Good Manufacturing Practice (cGMP) cell banking system. This system employs a genetically-stable master cell bank derived from a single pluripotent cell line to create a working cell bank, which in turn produces the final cell-based product candidate.

This achievement is significant as it demonstrates the company’s capability to manufacture millions of doses of a cost-effective, scalable, and consistent supply of an allogeneic, cell-based product from a single cell line. This process can potentially be applied across multiple Lineage programs. According to InvestingPro data, while the company maintains strong liquidity with a current ratio of 3.65 and holds more cash than debt, it faces challenges with rapid cash burn and weak gross profit margins.

However, Lineage cautions that there is no guarantee that they will be able to continue producing clinical quantities of their product candidates using this system consistently, cost-effectively, or on a commercially viable scale. The manufacturing process for cell therapy candidates is complex and subject to various risks. Establishing a cell line that can proliferate without differentiating and remain well characterized is challenging and resource-intensive. With last twelve months revenue of $9.5 million and negative earnings, InvestingPro’s comprehensive analysis reveals 8 additional key insights about LCTX’s financial health and future prospects, available in the Pro Research Report.

The company’s recent success was announced in May 2025, but Lineage emphasizes the need for caution regarding forward-looking statements. They highlight that these statements are based on assumptions that may not materialize and are subject to risks and uncertainties, including those related to the manufacturing process of cell therapy product candidates. With the next earnings report due on May 8, 2025, investors can access detailed financial analysis and Fair Value estimates through InvestingPro, which currently indicates the stock is fairly valued.

This information is based on a press release statement filed with the SEC. Lineage Cell Therapeutics, Inc. is incorporated in California and is listed on the NYSE American LLC under the trading symbol LCTX. The company’s business address is 2173 Salk Avenue, Suite 200, Carlsbad, California, 92008, and it operates under the SIC code for Biological Products, except Diagnostic Substances.

In other recent news, Lineage Cell Therapeutics reported a notable increase in revenue for the fourth quarter of 2024, reaching $2.9 million, up from $2.1 million in the same period the previous year. Despite the revenue growth, the company continues to operate at a loss, with a full-year net loss of $18.6 million, an improvement from the $21.5 million loss in 2023. Craig-Hallum analyst Albert Lowe adjusted the price target for Lineage Cell Therapeutics to $3.00, down from $4.00, while maintaining a Buy rating, following the company’s financial results and product pipeline updates. The company’s cash position has strengthened, with reserves expected to sustain operations into the first quarter of 2027. Lineage Cell Therapeutics is advancing its clinical programs, including the Phase IIa study of OpRegen in Geographic Atrophy, conducted by partner Roche/Genentech, and the newly launched DOSED trial for spinal cord injuries. The company’s strategic focus on cell therapy innovation continues, with CEO Brian Culley expressing confidence in the potential of OpRegen to drive positive clinical outcomes. The company also aims to expand its manufacturing capabilities and secure additional funding as part of its strategic efforts.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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