Company: LCTX
Filing Date: 2025-03-10
Form Type: 10-K
Source: 0000950170-25-036309
Chunk: 11

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1
Chunk 11
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 Foundation with additional support from CIRM.

•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 preclinical hearing loss models.

Business Strategy

Our initial goal is to address serious neurological and ophthalmic disorders by developing and advancing allogeneic, or “off-the-shelf,” treatments comprised of functional cells transplanted to the body. Our biological therapies are derived from the differentiation of pluripotent stem cells from established and self-renewing cell lines. We direct these pluripotent cells to become specific cell types, or combinations of the desired cell types, and use those differentiated cells as the treatment to restore diseased or diminished functions, such as impaired vision, loss of movement, sensation, or hearing.

To support the furtherance of our product candidates, we aim to generate or have generated in vitro and in vivo functional data to support human testing. In some cases, we may collaborate with strategic partners, external advisors, or consultants to support the development of our cell therapy technology.

A key area of focus is our continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a multicenter clinical study of OpRegen in patients with GA secondary to AMD, as well as in the follow-up portion of our 24-patient Phase 1/2a multicenter clinical study of OpRegen, in patients with dry AMD.

We recently announced the initiation of the DOSED clinical study at our first contracted clinical site, UC San Diego Health, which will evaluate the safety and utility of a novel spinal cord delivery device to deliver OPC1, to the spinal parenchyma, in both subacute and chronic spinal cord injuries.

Our preclinical and research product candidates, ANP1 for hearing loss and PNC1 for vision loss due to photoreceptor dysfunction or damage, will continue to be evaluated for their scientific and commercial merit to determine the suitability of each program to advance into initial human testing.

Our efforts to broaden the application of our cell therapy platform and support long-term growth also include a strategic collaboration with Factor Biosciences for the development of a novel hypoimmune iPSC line, which will be evaluated for differentiation into cell transplant product candidates for CNS diseases and certain neurology indications. Through this collaboration