Paulness
4週前
NEWS -- Lineage Cell Therapeutics to Report First Quarter 2026 Financial Results and Provide Business Update on May 12, 2026
CARLSBAD, Calif., May 05, 2026--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing "off the shelf" allogeneic cell therapies for serious medical conditions, today announced that it will report its first quarter 2026 financial and operating results on Thursday, May 12, 2026, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 12, 2026, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2026 financial and operating results and to provide a business update.
Conference Call and Webcast
Interested parties may access the conference call on May 12, 2026, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" (Conference ID: 9229676). 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 May 19, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 9229676.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy research initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "goal," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to our ability to develop new cell lines into potential differentiated cell transplant product candidates and the potential indications thereof. Forward-looking statements are based upon our current expectations, involve assumptions that may never materialize or may prove to be incorrect, and involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements, including, but not limited to, the risks that: investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges; clinical development of product candidates is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome; we may not be successful in developing new product candidates and neither we nor our collaborators may be successful in obtaining regulatory approval to market and sell any product candidates; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260505977292/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1月前
NEWS -- OpRegen® 3 Year Results in Patients With GA Presented at Foundation Fighting Blindness Retinal Innovation Summit 2026
Gains in best corrected visual acuity (BCVA) of +9 letters at 36 months among patients with extensive coverage of OpRegen cell therapy to the geographic atrophy (GA) lesion site
OCT imaging indicated partial restoration of outer retinal structure, re-appearance of an RPE layer, and features associated with recovery of photoreceptors
Anatomical and functional improvements occur following a single administration of OpRegen cell therapyLineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing “off the shelf” allogeneic cell therapies for serious medical conditions, today announced that 36-month results from patients enrolled in a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), were presented at the Foundation Fighting Blindness’ Retinal Therapeutics Innovation Summit 2026. The presentation, “Retinal Pigment Epithelium (RPE) Cell Therapy in Geographic Atrophy Secondary to Age-related Macular Degeneration: 3 Year Results from the Phase 1/2a Study,” was presented by Eyal Banin, M.D., Ph.D., Center for Retinal and Macular Degenerations, Department of Ophthalmology Hadassah-Hebrew University Medical Center and Faculty of Medicine, on behalf of Roche and Genentech, a member of the Roche Group.
“We are excited that our partners continue to collect data and highlight positive clinical results from the OpRegen RPE cell therapy phase 1/2a program,” stated Brian M. Culley, Lineage CEO. “We remain confident in the potential of OpRegen to address a significant medical need from a single administration, especially because long term clinical outcomes from RPE cell therapy are challenging the long-held view that GA is an irreversible condition, and currently available therapies have not demonstrated a visual benefit. The results presented by Dr. Banin include OCT images which indicate partial restoration of outer retinal structure, including the re-appearance of a retinal pigment epithelial layer as well as features associated with recovery of photoreceptors. It remains notable that among patients who received extensive coverage of OpRegen RPE cells across the area of atrophy (n=5), anatomical and functional benefits have lasted for at least three years, outcomes consistent with meaningful disease stabilization and even improvement. We are excited to see any additional insights which our partners, Roche and Genentech, may uncover from the ongoing GAlette study, which is a surgical optimization study intended to assess the best way to deliver OpRegen cell therapy to patients with GA secondary to age related macular degeneration.”
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
Retinal Innovation Summit 2026 Highlights
Gains in Best Corrected Visual Acuity (BCVA) in patients in Cohort 4 (less advanced GA than in other cohorts) were presented at 12 months (primary endpoint), 24 months, and have now persisted through 36 months following subretinal administration of OpRegen cell therapy
Mean change in BCVA among treated eyes for Cohort 4 patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment)
Effects were greater on average in the five (5) Cohort 4 patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery
In these patients’ treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing 3-year follow-up (compared to +7.4 ETDRS letters at 24 months) (n=5)Sustained evidence of retinal structural improvement by a quantitative Optical Coherence Tomography (OCT) analysis through 36 months was observed in treated eyes of Cohort 4 patients following a single subretinal administration of OpRegen cell therapy
At month 36, sustained evidence of retinal structure improvements in external limiting membrane (ELM) and RPE complex (RPE-C) layers on OCT was observed in the subgroup of five (5) patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery
Mean improvement of RPE-C area compared with baseline was maintained in treated eyes from 24 months (+2.6 mm2; n=4) to 36 months (+1.9 mm2; n=5)In comparison, mean change in RPE-C area decreased in untreated fellow eyes from 24 months (-2.8 mm2; n=4) to 36 months (-3.8 mm2; n=5)
Mean change in ELM area was maintained in treated eyes from 24 months (+0.8 mm2; n=4) to 36 months (+0.3 mm2; n=5)
In comparison, mean change in ELM area decreased in untreated fellow eyes from 24 months (-1.9 mm2; n=4) to 36 months (-3.4 mm2; n=5)Imaging evidence of structural benefit and greater gains in visual acuity were seen in study eyes in Cohort 4 patients at month 12, continuing through month 36
Differences as compared with fellow eyes increased over time, suggesting possible modification of the course of disease
Quantitative OCT improvements in RPE-C and ELM area and the gains in BCVA were more prominent in patients with extensive compared with limited OpRegen bleb coverage of GA
Quantitative analysis of OCT imaging revealed areas with partial restoration of outer retinal structure including re-appearance of an RPE layer as well as features associated with recovery of photoreceptors
These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to remaining retinal cells, and these effects appear durable through at least 36 months after a single administration
The Phase 2a “GAlette study” evaluating the success of subretinal delivery of OpRegen cell therapy to target areas of GA is currently enrolling (NCT05626114)
In addition to evaluating other surgical parameters, this study will test proprietary surgical devices in development for subretinal delivery of OpRegen cell therapy that have potential advantages over currently available devices and proceduresDr. Banin’s presentation is now available on the Events and Presentations section of Lineage’s website.
About the Retinal Innovation Summit 2026
The annual Retinal Therapeutics Innovation Summit 2026 is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. Members of the medical and research communities will come together with representatives from the biotech and pharma industries to discuss rapidly emerging ocular therapies and strategize how to remove barriers toward clinical utility for the most advanced retinal disease therapies. The Retinal Therapeutics Innovation Summit features presentations by leading experts on potential therapeutic approaches to treat retinal diseases and how best to deliver them to patients. In this congenial setting, summit attendees discuss progress being made in the field and how to use initial clinical successes to move toward larger scale trials. For more information, visit: https://www.fightingblindness.org/events/innovation-summit-2026-4761.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen cell therapy delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen cell therapy, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen cell therapy as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen cell therapy treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy research initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “suggest,” "confident," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to AMD, including the potential to counteract RPE cell dysfunction and cell loss, to restore or improve retinal structure and function from a single administration, to modify the course of the disease, to challenge the view that GA is an irreversible condition, and to address a significant unmet medical need; the significance and predictive value of the Phase 1/2a clinical study data reported to date, including the durability of anatomical and functional improvements observed through 36 months; expectations regarding additional insights that may be uncovered from the ongoing GAlette Phase 2a surgical optimization study, including the assessment of optimal delivery methods for OpRegen cell therapy; and the development and potential advantages of proprietary surgical devices for subretinal delivery of OpRegen cell therapy. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; that clinical data from small patient cohorts, including the Phase 1/2a study, may not be replicated in larger, controlled clinical trials; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction; that the GAlette study may not achieve its objectives, including with respect to surgical optimization and delivery of OpRegen cell therapy; that proprietary surgical devices in development may not demonstrate the anticipated advantages or may not receive regulatory clearance or approval; that the regulatory landscape for cell therapies may change in ways that adversely affect the development, approval, or commercialization of Lineage's product candidates, including changes in FDA or EMA requirements, guidelines, or policies; that competitive therapies for GA or AMD, including currently approved treatments or therapies in development by third parties, may reduce the commercial opportunity for OpRegen or render it less competitive; that market conditions, including changes in reimbursement policies, pricing pressures, or healthcare reform, may adversely affect the commercial viability of Lineage's product candidates; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice, or may experience supply chain disruptions or increased manufacturing costs; that Lineage may require additional capital to fund its operations and may not be able to obtain such capital on acceptable terms, or at all; that Lineage's collaborations with Roche, Genentech, William Demant Invest A/S, and other partners may not continue or may not yield the anticipated benefits; that Lineage's pipeline programs, including OPC1, ReSonance, PNC1, RND1, ILT1, and COR1, may not advance on anticipated timelines or may not demonstrate sufficient safety or efficacy to support further development or regulatory approval; that Lineage may not be able to adequately protect its intellectual property rights or may face challenges from third-party intellectual property claims; that key personnel may depart or Lineage may be unable to attract and retain qualified personnel necessary to execute its business strategy; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements in this press release are made as of the date hereof and are based on information available to Lineage as of such date. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260504706811/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
2月前
NEWS -- Lineage Announces Formation of Scientific Advisory Board
CARLSBAD, Calif., April 13, 2026--(BUSINESS WIRE)--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, today announced the formation of a Scientific Advisory Board (SAB) to provide strategic counsel and insights into the development of Lineage’s novel cell transplant pipeline, built on the Company’s proprietary cell differentiation and expansion platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering). The founding member of the SAB is Joachim Fruebis, Ph.D., a recognized and established executive, who brings extensive experience across ophthalmology, neurology, diabetes, and other key therapeutic areas, in addition to pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines. Additional SAB members are expected to be added throughout the remainder of the year.
"We are excited to establish a Scientific Advisory Board with Joachim as its founding member," stated Brian M. Culley, Lineage CEO. "He is a distinguished executive who brings a powerful combination of cross-therapeutic expertise and real-world development experience to our mission. His specific insights in ophthalmology, neurology, and diabetes will help guide the evolution of our cell therapy platform and help to translate our innovations into clinical and commercial success. We look forward to providing updates on further appointments to our SAB throughout the year."
"In addition, we are pleased to announce the appointment of Priyantha Herath, M.D., Ph.D., as Senior Vice President and Head of Clinical Operations for Lineage," Mr. Culley added. "Priyantha is a Board-certified specialist neurologist, with extensive experience spanning early translational development, regulatory affairs and clinical development through successful Phase 3 clinical trial execution. He brings a broad clinical perspective to Lineage, having treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes, direct patient care which has contributed to a deep understanding of disease presentation, progression, and meaningful outcomes. We welcome his expertise and leadership in this new role as we look to advance our innovative cell therapy programs through preclinical and clinical development."
Joachim Fruebis, Ph.D.
Dr. Fruebis is an accomplished scientist and leader with an extensive career driving R&D innovation in the Biotech and Pharma sectors. His in-depth expertise spans small molecules, biologics, and advanced therapies across multiple therapeutic areas including ophthalmology, neurology, diabetes and obesity, cardiovascular, metabolic, and rare diseases. His experience includes pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines. He has an established record in executive leadership functions, launching program portfolios and coordinating internal and external research initiatives. He has a recognized ability to bring together diverse teams across disciplines and modalities, providing innovative solutions and strategic leadership to advance new therapies from conception to commercialization alongside a strong track record in establishing organizations, business development, mergers and acquisitions.
Dr. Fruebis most recently served as Corporate Vice President, Cell Therapy R&D at Novo Nordisk, and before that, served as Chief Development Officer at BlueRock Therapeutics, Inc. Prior to BlueRock, he served as Senior Vice President, Clinical Development at Bioverativ (a Sanofi company), where he was responsible for developing Bioverativ’s rare disease program portfolio. Prior to Bioverativ, Dr. Fruebis served as Vice President, Senior Global Program Head for multiple disease areas, including hematology and ophthalmology at Bayer, a role in which he led cross-functional global teams responsible for the late-stage clinical development and commercialization of multiple products including the franchises for Eylea®, Kovaltry® and Jivi®. Prior to Bayer, Dr. Fruebis served as Vice President, External R&D Innovation at Pfizer, a role in which he was responsible for the rare disease, ophthalmology, and cardiovascular/metabolic therapeutic areas. Dr. Fruebis received his Ph.D. and M.S. in Biology from the University Kaiserslautern, Germany for work conducted at UC San Diego, Department of Medicine.
Priyantha Herath, M.D., Ph.D.
Senior Vice President, Head of Clinical Operations, Lineage
Dr. Herath is a U.S. Board-certified specialist neurologist, with wide-ranging expertise in clinical development from early translational, first-in-human trials through to successful completion of multiple Phase III studies. Dr. Herath has broad clinical experience in neurodegenerative disorders, including Huntington's Disease (HD), Parkinsonian Syndromes (PD, MSA, CBGD, PSP), Ataxias (SCA, FA), Alzheimer's Disease, Frontotemporal Dementia, and others. He is an expert in cognitive neuroscience, stereotaxy, multi-modal brain imaging (quantitative Positron Emission Tomography (PET), high-field Magnetic Resonance Imaging (MRI), and Magnetic Resonance Spectroscopy (MRS), and fluid biomarkers.
Most recently, he served as Clinical Group Leader for the Myasthenia Gravis (MG) disease portfolio at Argenx, where he oversaw strategic clinical and regulatory development for several late-stage development programs, including leading and executing two successful Phase III clinical studies in SeroNegative MG and Ocular MG. Prior to Argenx, he was the Neurology Clinical Lead at Alnylam Pharmaceuticals, leading the early clinical development of siRNA therapeutics programs in HD, SOD1-ALS, and other nascent central nervous system (CNS) siRNA programs. Before joining Alnylam, Dr. Herath served as Medical Director at Voyager Therapeutics, where he was clinical lead for their flagship HD program and several CNS AAV gene therapy programs in development. At Jazz Pharmaceuticals, he managed clinical trial execution of a Phase II Parkinson’s Disease program. He served as a Clinical Consultant to Alchemab, Inc., and other biotech companies, advising on the development of first in human CNS programs. Through this work, Dr. Herath has accumulated experience in clinical development and regulatory engagements with multiple national regulatory agencies across each stage of drug development.
Prior to Jazz, Dr. Herath was a Clinical Associate Professor of Neurology at the University of Kansas Medical Center, and at University of South Carolina School of Medicine, serving as an academic neurologist, combining patient care with medical research and teaching the next generation of neurologists. In his clinical capacity, Dr. Herath treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes. Because of this direct patient care, he possesses a deep understanding of disease presentation, progression, and meaningful outcomes. In his clinical career, Dr. Herath also founded and served as Director of several multidisciplinary movement and Parkinson’s Disease and deep brain stimulation clinics, including at the Kansas City Veterans Affairs Medical Center, at the University of South Carolina School Of Medicine and at Baylor, Scott & White Medical Center Round Rock TX among others.
Dr. Herath received his M.D. with honors from the Faculty of Medicine, University of Peradeniya, Sri Lanka, and his Ph.D. in Neuroscience from the Karolinska Institutet. Early in his career, he served as a civilian combat trauma surgeon at the National Hospital (SJGH) of Sri Lanka, performing surgeries for blast trauma injuries due to landmines and caring for those patients, including with spinal cord injury. He was a visiting scholar at the Weizmann Institute of Science and the All India Institute of Medical Sciences. Following his Ph.D., Dr. Herath completed residencies in Neurology and Psychiatry at the University of Pittsburgh Medical Center. Subsequently, he also completed specialized training in Movement Disorders from the National Institute of Neurological Disorders and Stroke (NINDS/NIH) under the late Mark Hallett, M.D., and an additional Advanced Movement Disorders/DBS fellowship from the University of Maryland under the late William Weiner, M.D. Dr. Herath is deeply committed to advancing meaningful and impactful treatments that address unmet medical needs and to improving the quality of life for those affected by debilitating conditions.
About the AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform
The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE "5D" describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy research initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "goal," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to the potential of the SAB to positively impact our business, provide strategic counsel and insights into the development of our pipeline, and contribute to clinical or commercial success or advance our programs through preclinical or clinical success; the anticipated benefits of the SAB members’ expertise and experience; the evolution of our cell therapy platform and our long-term business plan; our ability to translate our innovations into clinical and commercial success; the capabilities, scalability, and cost-effectiveness of our AlloSCOPE platform, including the potential for higher scale production with reduced manipulation; our ability to develop new cell lines into potential differentiated cell transplant product candidates and the potential indications thereof; and the success of our collaborations and partnerships. Forward-looking statements are based upon our current expectations, involve assumptions that may never materialize or may prove to be incorrect, and involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements, including, but not limited to, the risks that: the Scientific Advisory Board may not provide the anticipated strategic benefits or its members may have conflicts of interest or may not continue to serve; our AlloSCOPE platform may not achieve the anticipated scalability, consistency, or cost-effectiveness; our collaborators and partners may not perform as expected or may terminate their arrangements with us; investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges; clinical development of product candidates is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome; we may not be successful in developing new product candidates and neither we nor our collaborators may be successful in obtaining regulatory approval to market and sell any product candidates; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260413725758/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
2月前
NEWS -- Lineage Launches New Cell Therapy Program in Corneal Endothelial Disease
New Internally-Developed and Wholly-Owned Asset Benefits From Existing Ophthalmology and Manufacturing Expertise
Fuchs Endothelial Corneal Dystrophy (FECD) Afflicts More Than 7.3% of the Population with a Predicted 10-Year CAGR of 7.7%[/list[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, today announced the expansion of its cell transplant pipeline with the launch of COR1, a new corneal endothelial cell (CEnC) therapy program, in preclinical development for the treatment of corneal endothelial disease. Corneal endothelial disease is a progressive, often hereditary condition where cells on the inner layer of the cornea die, causing cornea swelling and vision loss. Applicable indications for COR1 are expected to include Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy. Utilizing Lineage’s proprietary cell manufacturing and expansion platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent cell Engineering), the Company has manufactured “off the shelf” corneal endothelial cells with identity, morphological, and functional characteristics which meet initial internal criteria and support further development. Lineage plans to advance this new product candidate into preclinical testing and will provide additional developmental updates on the COR1 program as they become available.
“Corneal endothelial disease is natural next application of our platform. Millions of people are candidates for corneal transplants for which today there is only one donor for every 70 diseased eyes globally. The current supply of CEnC’s from cadaveric sources is further limited by the low availability of organ donors, as well as by inconsistent yield and quality. We believe we are well positioned to produce and provide a consistent and “off-the-shelf” allogeneic source of CEnC’s by applying our proprietary AlloSCOPE platform and our development expertise from the OpRegen® program to this new ophthalmology program,” stated Brian M. Culley, Lineage CEO. “Importantly, CEnC therapy from cadaveric sources has already been approved in Japan to treat corneal endothelial disease, providing evidence for the underlying mechanism of action. Having this clinical and regulatory precedent creates a highly attractive opportunity for us to develop a more consistent and cost-effective product that could address the global shortage of donor cells. We have leveraged the capabilities of our AlloSCOPE platform and a proprietary pluripotent cell line to launch this new, internally-developed and wholly-owned initiative, and have successfully manufactured and characterized corneal endothelial cells that meet our initial attributes for identity and scale. We have elected to advance the COR1 program into preclinical testing and we also believe the recent accomplishments reported with our AlloSCOPE “5D” manufacturing process could be applied to this program to further reduce production costs through large-scale production.”
About Corneal Endothelial Disease
Fuchs endothelial corneal dystrophy (FECD) is the most common primary corneal endothelial dystrophy and the leading indication for corneal transplantation worldwide. FECD is characterized by the progressive decline of corneal endothelial cells (CEnC’s) and the formation of extracellular matrix (ECM) excrescences in the Descemet’s membrane (DM), called guttae, that lead to corneal edema and loss of vision. FECD represents one of the largest underserved populations in ophthalmology, affecting approximately 7.33% of adults over 30 years of age globally, with the patient population projected to rise from approximately 300 million in 2020 to 415 million by 2050. The current addressable market spans 2-6 million patients in the United States and approximately 16 million in Europe. Globally, there is only 1 donor cornea available for every 70 diseased eyes that need one. Over 13 million people worldwide are currently waiting for a corneal transplant, while global demand for keratoplasty reaches 12.7 million cases annually. Bullous keratopathy is caused by edema of the cornea, resulting from failure of the corneal endothelium to maintain the normally transparent, dehydrated state of the cornea. Most frequently, it is due to Fuchs corneal endothelial dystrophy or to corneal endothelial trauma which can occur during intraocular surgery or after placement of a poorly designed or mispositioned intraocular lens implant. Cell therapy treatment for FECD is minimally invasive when compared to corneal transplant surgery and is currently administered via an injection into the anterior chamber of the eye (the fluid-filled space in front of the iris). Following injection, the patient is supine for several hours to enable the cells to settle onto the back surface of the cornea (Descemet’s membrane). If successful, the new endothelial cells form a monolayer and restore the cornea’s fluid-pumping function, clearing the corneal edema.
About the AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform
The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice (“cGMP”) production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE “5D” describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative being developed for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy research initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “suggest,” or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: the potential of the COR1 preclinical program and our continuing development and planned pre-clinical activities, including our potential to produce and provide a more consistent, cost-effective and “off the shelf” product that could address the global shortage of donor cells; the application of recent advancements with our AlloSCOPE “5D” platform to the COR1 preclinical program to potentially reduce production costs through large-scale production; the potential of the AlloSCOPE platform and its ability to manufacture millions of doses of an allogeneic, cell-based product, including islets cells, derived from a single initial cell line, conferring consistent, cost-effective, and scalable cell-based production, across multiple programs, and the extent to which such ability will remain beyond the reach of many competitors. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260324374034/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
3月前
NEWS -- Lineage Cell Therapeutics Q4 Earnings Call Highlights
Lineage Cell Therapeutics (NYSEAMERICAN:LCTX) used its quarterly conference call to highlight a longer cash runway following recent warrant exercises, progress in manufacturing capabilities, and early internal validation work in a newly launched islet cell research initiative. Management also reviewed updates across its three most visible programs—OpRegen in geographic atrophy, OPC1 in spinal cord injury, and Resonance in hearing loss—while outlining how its AlloSCOPE platform underpins a strategy of building additional cell therapy assets and selectively partnering them.
Partner activity around OpRegen and GALE site expansion
Chief Executive Officer Brian Culley said the company continues to view OpRegen—its retinal pigment epithelium (RPE) cell transplant program for dry age-related macular degeneration (AMD) with geographic atrophy (GA)—as the most advanced program and a “critical case study” for its approach to cell transplantation. Culley reiterated previously discussed observations from analyses of Lineage’s Phase 1/2a work, stating Roche and Genentech analysis indicated a single dose of OpRegen could provide visual improvement lasting at least three years when delivered to the target location.
While emphasizing the company has no guidance on timing of additional trials or data disclosures from partners, Culley said Roche and Genentech have “somewhat suddenly” opened 10 new clinical sites in the GALE Phase 2a surgical optimization study over the last nine months, bringing the trial to 17 locations. He described the acceleration in site openings as a favorable sign that could support preparations for later-stage trials.
Culley also pointed to other partner actions as supportive indicators, including Genentech’s acquisition of proprietary surgical delivery devices from a competitor and the program’s RMAT designation. He noted Lineage received its first $5 million development milestone payment in December under the Roche/Genentech collaboration.
Manufacturing focus: AlloSCOPE and “better from the beginning”
Culley spent considerable time on manufacturing, describing AlloSCOPE—an acronym for “allogeneic, scalable, consistent, off-the-shelf, pluripotent cell engineering”—as a core platform designed to address challenges such as donor variability and manufacturing cost seen with autologous approaches. He said Lineage has established a GMP master cell bank and GMP working cell bank and generated clinical-grade product used in an FDA-cleared clinical trial.
Management framed this as evidence that Lineage’s cell banking system could be repeated as needed and scaled to “millions of vials” and “trillions of cells.” Culley argued early investment in scalable, reproducible processes is essential because “the process is the product” in cell therapy and early clinical manufacturing must align with eventual commercial scale.
Islet cell research initiative reaches an initial internal milestone
Lineage also provided its most detailed discussion to date of a new type 1 diabetes islet cell research initiative. Culley said the company met its initial internal go/no-go development milestone, which allowed the effort to proceed to the next phase of internal development.
He framed the primary opportunity as solving the supply and scale issues that limit the feasibility of commercial islet cell transplants. Culley said doses may require up to 1 billion cells per patient and that commercial viability may require “thousands of doses per batch,” which the company estimates could imply at least an 80-liter bioreactor scale. He argued an unresolved bottleneck is generating the billions of undifferentiated pluripotent stem cells needed to feed such a differentiation process, while maintaining pluripotency and genetic stability.
The strategy described on the call included two components:
Scaling undifferentiated cells first: Culley said Lineage is “inverting the traditional development paradigm” by focusing on scalable production of undifferentiated cells before finalizing immunosuppression strategies or other downstream elements.
Combining 2D control with 3D efficiency: Using AlloSCOPE, the company aims to merge the control of 2D culture with the volumetric efficiency of 3D systems—an approach Culley referred to as “5D engineering.” He said Lineage has reduced this to practice multiple times at half-liter scale and is now evaluating translation into multi-liter vessels.In Q&A, Culley said the company cannot predict linearity as it scales from half-liter to multi-liter and ultimately to large bioreactors, but he suggested the step from “0 to a half liter” was a larger achievement than the next incremental scaling steps. He also said the approach is intended to be capital-efficient by putting “the least expensive and most challenging step first.”
Program updates: OPC1, Resonance, and pipeline expansion
For OPC1 in spinal cord injury (SCI), Culley said the company is enrolling the DOSED study, a safety and device performance trial evaluating a proprietary delivery system designed to administer cells without stopping patient ventilation. He noted Lineage treated its “first-ever chronic SCI patient” and said the participant completed a six-month safety follow-up with no significant safety events and that the device performed as planned. The company also opened a second DOSED clinical site at Rancho Research Institute in conjunction with Rancho Los Amigos National Rehab Center.
Culley emphasized DOSED is not designed as an efficacy study, though functional assessments are being collected. He said the trial collects baseline and early functional assessments within the first 90 days, with a focus on one-year functional assessments as potentially more meaningful. He also said the first participant met criteria for ASIA impairment A and that Lineage amended the protocol to broaden enrollment after difficulty finding the originally agreed enrollment “stagger,” adding it had identified another patient who may be treated in the coming weeks.
On Resonance (ANP1), the company’s auditory neuronal cell transplant program for hearing loss, Culley said Lineage achieved its 2025 objective to secure funding partnerships by signing an agreement with William Demant Invest (WDI) expected to fund planned preclinical development through IND stage. He said the work demonstrated Lineage could generate new IP and advance a new AlloSCOPE-derived product candidate into preclinical testing within a year with a modest investment.
Management also discussed business development strategy, with Culley saying the company is mindful of cost of capital and risk and does not have a fixed objective to launch all products internally. He said Lineage seeks to create a “basket of assets” that can be partnered early to offset reliance on traditional capital markets, while retaining meaningful ownership in partnerships. Culley added Lineage expects to disclose “another new cell type” as early as the next three to six weeks, though he did not provide details.
Separately, Culley addressed a question about a hypoimmune iPSC line obtained through a Factor alliance, stating it was designed for an undisclosed neurological indication. He said Lineage is “indifferent” between iPSC and embryonic stem cell sources and follows data and line behavior, adding that Factor’s gene-editing and hypoimmunity expertise was an external capability Lineage chose not to build in-house.
Financial results: revenue lift from collaborations and extended runway
Chief Financial Officer Jill Howe said the company’s full-year net loss increased significantly versus 2024, driven mainly by non-cash charges tied to an increased warrant liability from the share price rise and a non-cash charge related to an asset acquired in 2018 that the company elected to no longer develop. She also said OpRegen costs appeared higher due to accounting treatment tied to downstream obligations after the first Roche/Genentech milestone payment; excluding that treatment, OpRegen development expenses were lower year over year.
Howe reported cash of $55.8 million as of December 31, 2025. Combined with approximately $5.4 million in warrant exercise proceeds received in March, she said Lineage expects to fund planned operations into Q2 2028. She attributed the longer runway versus prior guidance primarily to $21 million in gross proceeds from an ATM block trade in November, the March warrant exercise proceeds, and the $5 million Roche/Genentech milestone payment.
For the fourth quarter, the company reported total revenue of approximately $6.6 million, operating expenses of $13.2 million, and a loss from operations of $6.5 million. Howe said net income attributable to Lineage for the quarter was $0.9 million, or $0.004 per share, compared with a net loss of $3.3 million, or $0.02 per share, in the year-ago period.
For the full year, Howe reported revenue of $14.6 million, operating expenses of $51.2 million, loss from operations of $36.6 million, and net loss attributable to Lineage of $63.5 million, or $0.28 per share, compared with a net loss of $18.6 million, or $0.09 per share, for 2024. She said the year-over-year change reflected the non-cash warrant liability remeasurement and an impairment related to a prior acquisition.
Howe noted the runway guidance includes only the $5.4 million of warrants exercised in March and does not include the roughly $32 million of remaining underlying warrants priced at $0.91 per share. She said those warrants could be accelerated if Roche or Genentech publicly discloses intent to advance OpRegen into trials with a comparator arm.
About Lineage Cell Therapeutics (NYSEAMERICAN:LCTX)
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, allogeneic cell therapies built on pluripotent stem cell platforms. The company focuses on three primary therapeutic areas—retinal disease, neural repair and immune-effector cell oncology—leveraging its proprietary manufacturing processes to create off-the-shelf cell therapy candidates designed for broad patient populations.
Its lead candidate, OpRegen, comprises retinal pigment epithelium cells intended to slow or reverse vision loss in patients with geographic atrophy secondary to age-related macular degeneration.
The article "Lineage Cell Therapeutics Q4 Earnings Call Highlights" was originally published by MarketBeat.
Paulness
3月前
NEWS -- Lineage Cell Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results and Provide Business Update on March 5, 2026
CARLSBAD, Calif., February 26, 2026--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic, or "off the shelf", cell therapies for serious medical conditions, today announced that it will report its fourth quarter and full year 2025 financial and operating results on Thursday, March 5, 2026, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, March 5, 2026, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2025 financial and operating results and to provide a business update.
Conference Call and Webcast
Interested parties may access the conference call on March 5, 2026, 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 March 12, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 3958367.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy research initiative for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; and (vi) ILT1, a cell therapy research initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "goal," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to our ability to develop new cell lines into potential differentiated cell transplant product candidates and the potential indications thereof. Forward-looking statements are based upon our current expectations, involve assumptions that may never materialize or may prove to be incorrect, and involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements, including, but not limited to, the risks that: investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges; clinical development of product candidates is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome; we may not be successful in developing new product candidates and neither we nor our collaborators may be successful in obtaining regulatory approval to market and sell any product candidates; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at https://www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260226514909/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
5月前
NEWS -- Lineage Takes Delivery of Gene-edited Hypoimmune Cell Line Under Partnership With Factor Bioscience
CARLSBAD, Calif., January 06, 2026--(BUSINESS WIRE)--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, today announced the receipt of a novel, induced pluripotent stem cell (iPSC) line containing hypoimmunity edits, from Factor Bioscience Inc. ("Factor"). Generation of the line marks a successful milestone in the strategic collaboration between the two companies, under which Factor developed a proprietary, genetically engineered iPSC line that Lineage can utilize for differentiation into certain cell transplant product candidates. The novel cell line contains edits which are expected to support non-immune privileged and/or non-human leukocyte antigen (HLA) matched indications and includes an additional disease-specific edit with the potential to further differentiate this cell line from other cell therapies. Acceptance of the line triggered a success payment from Lineage to Factor as reimbursement for Factor’s development efforts to date. Factor remains eligible for an additional payment from Lineage subject to Lineage’s entry into an exclusive license to utilize the line. Lineage’s decision to proceed with the program will be based on further performance criteria and the outcome of additional testing, including the evaluation of the line for its ability to adapt to Lineage’s proprietary cell expansion manufacturing platform, the AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform.
"Our partnership with Factor supports our plan to create novel and superior product candidates by combining our manufacturing and process development capabilities with cutting-edge cell engineering and editing technologies," stated Brian M. Culley, Chief Executive Officer of Lineage. "This achievement under our collaboration with Factor supports our plan to broaden our cell therapy platform through the addition of new technologies and indications, as we await further updates from our lead cell therapy program, OpRegen®, for dry age-related macular degeneration with geographic atrophy. We look forward to leveraging the knowledge and expertise we have developed in retinal cell transplantation to additional cell therapy product candidates which may have the potential to transform the treatment of a wide range of diseases. We view the convergence of directed cell differentiation with modern gene editing technology as an exciting new branch of medicine, and we plan to continue to advance this emerging space."
"The cells we have delivered to Lineage embody the incredible potential of Factor’s gene-editing technology and represent a major milestone in the partnership between our companies," said Matt Angel, Ph.D., Chief Executive Officer and President of Factor. "We believe Factor’s state-of-the-art cell-engineering technologies have the potential to enable treatment of diseases in ways not previously possible. Factor and Lineage together are driving progress at the leading edge of engineered cell therapy development to benefit patients."
Lineage’s exclusive option and license agreement (the "Agreement") with Factor was announced in 2023. The novel hypoimmune iPSC line received by Lineage contains a set of specific edits selected in a development strategy vetted with subject matter experts in the U.S. and abroad, as well as under a broader competitive landscape analysis. The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent adverse NK cell responses; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell line developed by Factor in a specific field for preclinical, clinical, and commercial purposes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf," cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership; and (vi) ILT1, a cell therapy initiative focused on islet cell transplants for the treatment of Type 1 Diabetes. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
About Factor Bioscience Inc.
Founded in 2011, Factor Bioscience is a biotechnology company focused on using its patented gene-editing platform to develop life-saving cell and gene therapies. Factor is privately held and headquartered in Cambridge, MA. For more information, visit https://www.factorbio.com.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "goal," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: our plans to develop new cell lines into potential differentiated cell transplant product candidates, including those that possess hypoimmune qualities, and the potential indications thereof; our expectations regarding the utility of edited cell lines, and our ability to broaden our cell therapy platform, or create novel and superior product candidates, by combining edited cell lines with our previously developed expertise and/or manufacturing and process development capabilities, to affect the treatment of a wide range of diseases or benefit patients; our ability to differentiate a cell line from those of competitors, including through a disease-specific edit, and to develop treatments that are differentiated from our competitors, including through a disease-specific edit; the potential of Factor’s gene-editing technology, including the potential to enable treatment of diseases in ways not previously possible. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage, in its sole discretion, including based on further performance criteria and the outcome of additional testing, may elect not to exercise its license under the Agreement; that the potential development of new cell lines into new product candidates, or the success of those product candidates, may not be realized; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260106778477/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Media Relations for Lineage: Russo Partners
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Media Relations for Factor Bioscience: RF|Binder
Ted Deutsch or Armel Leslie
mailto://FactorBioscience@rfbinder.com
(609) 544-5454
Paulness
5月前
NEWS -- Lineage Cell Therapeutics Issues Letter to Stockholders
CARLSBAD, Calif., January 05, 2026--(BUSINESS WIRE)--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, today published a letter to shareholders highlighting the company’s achievements throughout 2025 and its corporate outlook for 2026.
To Our Shareholders:
As we conclude a successful 2025, I want to extend my appreciation for your continued support of Lineage Cell Therapeutics and our mission to pioneer the emerging field of allogeneic cell therapy. I also wish to provide an outline for how we plan to continue our success in 2026.
The field of cell therapy has revolutionized oncology, saving lives and creating substantial shareholder value. But opportunities to build on success in that field appear increasingly difficult or marginal. We believe the next frontier of value-creation in cell therapy resides in non-oncology indications, such as neurology, ophthalmology, and metabolic diseases. We also believe Lineage is uniquely positioned to capitalize on this opportunity, mainly by applying our proprietary cell manufacturing technology to the production and transplantation of differentiated cell types.
Lineage is helping usher in this new branch of medicine by demonstrating the value of administering mature, differentiated cells, which are intended to replace the same type of cells which the patient lost to various conditions, such as dry age-related macular degeneration (dry-AMD), spinal cord injury, hearing loss, and Type 1 Diabetes. We prefer the term cell transplant to cell therapy because we don’t administer "stem cells" to patients. Instead, we create and deliver mature, differentiated and functionally active "replacement" cells that are substantially identical to the cells which an individual has lost due to disease or trauma. Those cells have been transplanted in a one-time procedure to treat conditions caused by the loss or dysfunction of a specific cell type. We summarize our unique approach to cell therapy as "replace and restore". Each of our product candidates is allogeneic and utilizes a single, carefully selected and cultured cell line for the life of the product, which eliminates donor variability and reduces regulatory and clinical risk.
The OpRegen® cell therapy program is a suspension of allogeneic retinal pigment epithelial (RPE) cells designed to replace the RPE cells that have been lost to disease. OpRegen is being developed under a worldwide collaboration with Roche and Genentech for the treatment of geographic atrophy (GA) secondary to dry-AMD and is currently in a phase 2a trial. Our second clinical-stage program, OPC1, is an allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following a spinal cord injury. Our preclinical program, ReSonance™ (ANP1), is an allogeneic auditory neuron progenitor cell transplant for hearing loss and was recently partnered with a world-leading hearing healthcare company to advance preclinical development. We also recently launched a preclinical program in Type 1 Diabetes and have several additional indications planned for future development.
Our long-term goal is to build upon the continued success of OpRegen and create a pipeline of similar cell-based assets, some of which we might choose to develop internally and some which we might seek to partner, but all based on our core technology and platform, and which utilize our extensive expertise in the directed differentiation and scalable production of pluripotent cells into discrete cell types of the human body.
We reported many notable events in 2025, which helped broaden investor interest, including a funded research collaboration agreement for preclinical development of ReSonance, our first internally developed product candidate, and the launch of our new islet cell initiative. Alongside those accomplishments, two additional milestones were notable because they provided significant elevation in our confidence in the future of our company. The first was the continued progress made with the OpRegen cell therapy program. The second was progress made with our proprietary in-house manufacturing platform, named AlloSCOPE™.
OpRegen
OpRegen is our most advanced program to date and serves as a critical case study for our approach to cell transplantation. Dry-AMD with GA is an increasingly established indication with an educated patient population, but suffers from underwhelming treatment options. Our initial reports from our Phase 1/2a clinical study of improved anatomy, halting of atrophic progression, and improved vision in patients with dry-AMD were unprecedented, but were viewed perhaps as too preliminary to be fully appreciated by the investment community. However, we believe that Roche and Genentech leadership saw potential in our approach and provided clinical, operational and financial support to enable the program’s further development. And from their subsequent reporting of our data, it has been shown that a single dose of OpRegen cells can provide visual improvement lasting for at least 3 years among patients who receive the cells at the target location. This is an exceptionally promising finding because dry-AMD is a condition that does not self-resolve and only leads to worsening vision. Perhaps more importantly, three independent groups also pursuing RPE transplants reported similar exceptional outcomes during 2025, providing considerable evidence in support of this novel mechanism.
Although data from Roche and Genentech’s ongoing phase 2a GAlette trial of OpRegen in approximately 60 patients remains forthcoming, it is notable that during 2025, Genentech opened 9 additional clinical sites, and previously acquired novel and proprietary surgical delivery devices from a competitor, in addition to seeking and receiving RMAT designation for OpRegen. Late last year, Lineage also received its first cash milestone from among the up to $620 million of additional development and commercial milestones we are eligible for under our collaboration. Overall, we believe there is growing evidence of a commitment by our partners to OpRegen in the ongoing open-label study, so we therefore remain eager for future program updates.
The AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform
A second important achievement during 2025 was the success we demonstrated with our proprietary AlloSCOPE manufacturing platform. AlloSCOPE is a term we’re using to distinguish our methods and capabilities from our competitors. AlloSCOPE stands for Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering, which highlights the key attributes of our in-house technology and which we believe includes the "table stakes" necessary to create a commercially successful allogeneic cell therapy. From our proprietary AlloSCOPE platform, we twice successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for a final cell-based product candidate that for one of our programs, was released and used in the clinic last year. This achievement is notable because we do not need to rely on hopeful speculation regarding our ability to scale pluripotent cells with the purity, potency, and regulatory quality required for clinical use: we have reduced these steps to practice, a standard which we believe sits beyond the reach of many of our competitors and which can become a valuable differentiator for our company.
The AlloSCOPE platform describes a differentiation and production modality from which we can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial cell line, conferring consistent, cost-effective, and scalable cell-based production. Importantly, AlloSCOPE can be applied across multiple programs; and this is why we recently began to evaluate it as a solution to the massive production scale required for a commercially-viable islet cell therapy for the treatment of Type 1 Diabetes.
Together, progress with OpRegen and the AlloSCOPE platform have elevated our confidence in a successful future. With confidence in our future success as a tailwind, we have been investing further in our technology. Because our prior investments can be applied in some cases across different cell types, our cost to launch a new program can be very manageable. As a result, we now have two additional undisclosed cell types receiving initial Research & Development and/or Business Development investment, and we plan to share updates on those new initiatives during 2026.
One aspect of this expansion strategy is to help attract additional collaborations, as we demonstrated successfully with Roche/Genentech for OpRegen and William Demant Invest A/S for ReSonance. Collaborative models are central to our business, sharing development risk while maintaining disciplined capital allocation. We intend to remain selective in this regard, pursuing partnerships that amplify our advantages.
Another aspect of our strategy is pipeline diversification and expansion, which we are pursuing in a rigorous and selective way, intended to maximize the per share value of the company. That means striking a balance between capital raising and investing, and striking a second balance between partnered and internally owned assets. Our overall goal with this strategy is to pair our innovation with operational excellence in a disciplined and step-wise way, with the overall objective of enabling high-quality and effective cell therapy products to be made from our innovative platform at commercial scale for patients around the world.
To conclude, our work is grounded in the conviction that replacing lost or dysfunctional cells can restore function and fundamentally reshape many treatment paradigms. However, those cells need to be offered in a commercially viable (e.g. scalable, and off-the-shelf) format. This year, we made meaningful progress in strengthening our scientific, operational, and strategic foundations to support that vision, including:
Advancing our clinical and preclinical pipeline
Strengthening our proprietary AlloSCOPE platform and manufacturing capabilities
Maintaining cash runway, financial discipline, and organizational focusThe year ahead will be exciting as we continue advancing our therapeutic candidates and pursue opportunities that broaden our platform. The biotech sector has struggled for years, but recent forecasts from trusted investment leaders suggest that clinical-stage companies with data readouts and other major events should find enhanced interest with institutional healthcare and generalist investors in 2026. To that end, we expect continued updates this year on our lead partnered program, OpRegen, based on Roche/Genentech’s public actions to date; we have a second program, OPC1, in clinical testing; we have two externally funded development collaborations; and we have demonstrated the capability to launch brand new, in-house programs in an economically efficient way.
Our priorities in 2026 will include achieving key clinical and financial milestones, expanding our manufacturing capability, and maintaining the organizational focus necessary to execute with consistency.
Our progress is the result of the commitment and expertise of our employees, the collaboration of our partners, and the confidence of our shareholders. We remain dedicated to delivering long-term value through scientific innovation and disciplined execution, and we look forward to updating you on our achievements in the coming year.
Thank you for your continued support of Lineage Cell Therapeutics.
Sincerely,
Brian Culley
Chief Executive Officer
Lineage Cell Therapeutics
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf," cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership; and (vi) ILT1, a cell therapy initiative focused on islet cell transplants for the treatment of Type 1 Diabetes. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "goal," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: Lineage’s ability to develop additional product candidates, including two undisclosed cell types currently under development, in an economically efficient way, and that such development will capitalize on any potential opportunities for non-oncology indications, create value, or maximize the per share value of the company; the broad potential for Lineage’s regenerative medicine platform to restore function and fundamentally reshape many treatment paradigms; Lineage’s ability to enter into additional partnerships and/or collaboration agreements to support development of current or potential future product candidates; the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to AMD and the significance of the Phase 1/2a clinical study data reported to date; Roche and Genentech’s plans regarding further development of OpRegen, including their evaluation of proprietary surgical delivery devices, their commitment to the ongoing open-label study and our beliefs and expectations regarding Roche and Genentech’s provision of clinical, operational and financial support for the OpRegen program and any updates that may occur therefor; the potential of the AlloSCOPE platform and its ability to manufacture millions of doses of an allogeneic, cell-based product, including islets cells, derived from a single initial cell line, conferring consistent, cost-effective, and scalable cell-based production, across multiple programs, and the extent to which such ability will remain beyond the reach of many competitors; that the planned funding under the research collaboration agreement with WDI will fund all currently planned preclinical development of ReSonance (ANP1); and the plans and expectations with respect to OPC1. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that development activities, preclinical activities, and clinical trials of our current or potential future product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing further clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction; that competing alternative therapies, including by any independent groups also pursuing RPE transplants, may adversely impact the commercial potential of OpRegen cell therapy; that OPC1 clinical trials may not be successful; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260105645057/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
7月前
NEWS -- Lineage Cell Therapeutics to Report Third Quarter 2025 Financial Results and Provide Business Update on November 6, 2025
CARLSBAD, Calif., October 30, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic, or "off the shelf", cell therapies for serious medical conditions, today announced that it will report its third quarter 2025 financial and operating results on Thursday, November 6, 2025, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 6, 2025, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2025 financial and operating results and to provide a business update.
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.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or "off the shelf", cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership; and ILT1, a cell therapy initiative focused on islet cell transplants for the treatment of the treatment of Type 1 Diabetes. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251030250805/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
9月前
NEWS -- Lineage Cell Therapeutics Initiates Cell Transplant Program In Type 1 Diabetes
Initial Program Focus Will Be On Addressing Manufacturing Scale
CARLSBAD, Calif., September 08, 2025--(BUSINESS WIRE) -- 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, today announced the initiation of a new islet cell transplant program in Type 1 Diabetes (T1D). Specifically, the company aims to deploy its 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, potentially solving a major hurdle to commercialization of islet cell therapy product candidates.
“Recent and emerging evidence suggests that an islet cell transplant may be able to provide the equivalent of a functional cure for some people with diabetes. Several islet cell programs for T1D have reached phase 1 clinical trials, but to our knowledge, the manufacturing process required to supply sufficient material for a meaningful portion of the addressable patient population is a challenge that remains unsolved,” said Brian M. Culley, Lineage CEO. “By building upon our recent GMP manufacturing success, we believe we have a compelling opportunity to try and reduce-to-practice an islet cell production system, capable of supporting doses in the hundreds of millions of cells per eligible patient. Our initial goal for this program is to demonstrate this capability with one of our proprietary cell lines, which parenthetically is the third cell line for which we have generated a unique master cell bank at our in-house facility. If successful, we next would seek to demonstrate system compatibility with an internally- or externally-sourced hypo-immune cell line, suitable to support a clinical campaign in T1D. Importantly, we believe we can not only reach an initial feasibility decision on this initiative with a fairly modest investment, but also apply any relevant insights or improvements to our other transplant programs, including programs we may launch in the future. Overall, if we are successful in developing a commercially-viable production modality for islet cells, we believe it will create a compelling product profile, as well as provide options to license this technology to a partner or enter the diabetes field directly.”
About Type 1 Diabetes (T1D)
Type 1 diabetes (T1D) is a chronic autoimmune condition in which the body’s immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, people with T1D are unable to produce insulin, a hormone essential for regulating blood sugar levels. This leads to high blood glucose, which can cause serious health complications if not managed properly. T1D is usually diagnosed in children, teens, or young adults, but it can develop at any age. Unlike type 2 diabetes, T1D is not caused by lifestyle factors and cannot be prevented. Management requires lifelong insulin therapy through injections or a pump, along with careful monitoring of blood sugar, diet, and physical activity. According to Breakthrough T1D, the leading global type 1 diabetes research and advocacy organization, there are more than 9.5 million people living with type 1 diabetes around the world, and it is one of the fastest growing, noncommunicable, chronic health conditions on the planet.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy in development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “goal,” “suggest,” or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: Lineage’s ability to apply its manufacturing capabilities to establish a production modality that can address the issues of large-scale production of islet cells, and that such capability can produce doses of hundreds of millions of cells per patient; the potential application of any such production modality achievements to a hypo-immune cell line that is suitable to support a clinical T1D program and/or any other current or future transplant programs; the ability to reach an initial feasibility decision with a fairly modest investment; and that any islet cell product candidate that we produce will have a compelling product profile. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage’s development activities of islet cells may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early nonclinical studies of a TID product candidate may not be predictive of success in subsequent studies of that candidate; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250908617392/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
9月前
NEWS -- Lineage Announces Research Collaboration With William Demant Invest to Develop ReSonance™ (ANP1) for Hearing Loss
Three-year term intended to advance preclinical development of ReSonance
Up to $12 million of development costs to be contributed by William Demant InvestCARLSBAD, Calif., August 26, 2025--(BUSINESS WIRE)--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 neurological and ophthalmic conditions, today announced that it has entered into a research collaboration with and through an investment from William Demant Invest A/S (WDI). WDI is an evergreen investor and the holding company for William Demant Foundation’s investment activities – a majority shareholder of the world-leading hearing healthcare company, Demant A/S.
The parties will jointly advance Lineage’s auditory neuronal cell transplant, ReSonance (ANP1), for the treatment of hearing loss. The multi-year research collaboration covers preclinical development activities, including cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis, to support a potential IND/CTA filing. WDI will fund up to $12 million in research collaboration costs over the period, with development activities jointly conducted and managed by Lineage and scientists from Eriksholm Research Centre, part of Oticon A/S, which is a subsidiary of the Demant Group.
"ReSonance is our first internally-developed cell transplant program and highlights the efficiency and breadth of our technology platform. Over a short period of time and with a modest initial, incremental investment, we advanced the ANP1 product concept through successful manufacture of the desired cell type, generated new intellectual property, and advanced into initial preclinical testing. With this research contribution from WDI, which has a strong interest in hearing healthcare, we are taking the next step in the development of this exciting product candidate. This partnership will allow us to integrate the hearing loss research expertise of Eriksholm Research Centre with the manufacturing and cell transplant expertise of the Lineage team to explore the potential of a differentiated cell transplant, and position this therapy for initial clinical development," stated Brian Culley, Lineage CEO.
According to the World Health Organization (WHO), nearly 2.5 billion people are expected to experience some degree of hearing loss by 2025, ranging from mild to moderate to profound. In severe-to-profound cases, the condition may involve loss of auditory nerve cells, potentially leading to auditory neuropathy and significant hearing impairment.
Hearing relies on a series of steps that convert sound waves in the air into electrical signals, which are then relayed by auditory nerve cells to the brain. Auditory neuropathy is a challenging hearing disorder in which the auditory nerve cells are damaged or lost, meaning that the communication pathway from the ear to the brain is disrupted. Currently, auditory neuropathy remains a significant challenge in audiology, and treatment options are limited. However, one treatment approach is cell-based therapy, which aims to replace lost or damaged auditory nerve cells. By repopulating the cochlea with functional, transplanted auditory neurons, this approach may restore hearing and enhance the effectiveness of a cochlear implant in certain individuals with severe-to-profound hearing loss.
About William Demant Invest
William Demant Invest is an evergreen investor and the holding company for William Demant Foundation’s investment activities, focusing on investments in listed companies. The current market value for all companies in the portfolio is around DKK 150 billion. Founded in 2004, William Demant Invest is wholly owned by William Demant Foundation with an identical Board of Directors. The main purpose of William Demant Foundation is to secure and expand the hearing healthcare company Demant and to donate a share of its net income to charter-defined causes.
About Eriksholm Research Centre
Eriksholm Research Centre is part of Oticon A/S, a world leader in hearing healthcare and part of the Demant A/S group of companies. Eriksholm is committed to making audiological discoveries with the potential to significantly enhance end-user benefits in hearing healthcare. Eriksholm engages in close collaborations with world leading academic research institutions. By bringing experts together, Eriksholm is able to create mutually beneficial research synergies and open up new lines of inquiry in the broader research community.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf" cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the benefits of the research collaboration agreement with WDI and its impact on advancing the ReSonance (ANP1) program, including through a potential IND/CTA filing. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250826289327/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
10月前
NEWS -- Lineage Announces Dosing of First Patient in New Clinical Study of OPC1 for Subacute and Chronic Spinal Cord Injury
Successful First-In-Human Use of New Parenchymal Spinal Delivery System
First-ever Administration of OPC1 to a Chronic Injury PatientCARLSBAD, Calif., August 04, 2025--(BUSINESS WIRE)--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 neurological and ophthalmic conditions, announced today that the first-ever chronic spinal cord injury patient has been treated in the Company’s DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study at UC San Diego Health. The DOSED study is designed to evaluate the safety and utility of a new parenchymal spinal delivery system, a novel delivery device developed to deliver OPC1 directly to the site of injury in patients with spinal cord injury (SCI), and will enroll both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) SCI patients. OPC1 is an investigational, allogeneic stem cell-derived cell transplant, comprised of oligodendrocyte progenitor cells. OPC1 is designed to replace or support cells in the injured spinal cord that are absent or dysfunctional due to traumatic injury and is intended to help restore or augment functional activity in persons suffering from an SCI. Improved functional activity can lead to greater mobility and enhanced quality of life for patients and significant cost-savings for caregivers. The first patient treated in DOSED was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with a single neurological level of injury (NLI) from T1 to T10, and the novel spinal delivery system successfully administered the intended one-time injection of 10 million OPC1 cells.
"Differentiated cell transplantation is a promising therapeutic approach that is increasingly being validated in a wide range of diseases and conditions. For this reason, it is exciting to advance the OPC1 program into further clinical testing and expand the OPC1-treated population to include chronic SCI patients," stated Brian M. Culley, Lineage’s CEO. "DOSED is the third clinical study of OPC1 and is evaluating a superior delivery system, designed to deliver our proprietary cells over several minutes and without the need for stopping patient ventilation during administration. The delivery system is also compatible with a forthcoming immediate-use thaw-and-inject formulation of OPC1 that we developed for this program, which will eliminate the lengthy dose preparation steps conducted in prior studies. This is the first time OPC1 has been administered to a patient with a chronic spinal cord injury, which is an important milestone because those patients represent an additional and larger potential treatable population for this experimental therapy. In addition to evaluating the safety and performance of the new delivery device, we also will be collecting functional assessments on all patients, which gives us the opportunity to investigate any signals of efficacy that may arise in these patients. We are pleased the first-ever use of this custom delivery solution had a successful outcome with no administration issues and look forward to opening this study to additional sites."
OPC1 has extensive long-term safety data from two prior clinical trials: a five-patient Phase 1 safety trial in acute thoracic SCI, where all active subjects have been followed for at least 13 years; and a 25-patient Phase 1/2a multicenter dose-escalation trial in subacute cervical SCI, where all active subjects have been evaluated for at least 7 years. Long-term safety monitoring is ongoing for both studies, with no unexpected serious adverse events attributable to the OPC1 transplant being reported to date. Results from both studies have been published in the Journal of Neurosurgery: Spine. The Phase 1/2a publication of OPC1 in subacute cervical SCI is available here and the publication from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here. The OPC1 program was one of the first cell therapy clinical trials to be supported by the California Institute for Regenerative Medicine (CIRM) under Proposition 71. A publication focused on outlining the Magnetic Resonance Imaging (MRI) evidence from the 25-patient Phase 1/2a multicenter dose-escalation trial of OPC1 in subacute cervical SCI is also forthcoming.
Lineage founded the Annual Spinal Cord Injury Investor Symposium in 2023 and has co-sponsored the event in partnership with The Christopher & Dana Reeve Foundation in each year since then. The goals of this collaborative effort include increasing disease awareness, improving the probability of success in product development, and supporting clinical trial participation. The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Presenting companies have included AbbVie, Mitsubishi Tanabe, Neuralink, NervGen Pharma, Neuvotion, NovaGo Therapeutics, ONWARD, Paradromics and Synchron.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful recovery in, and improvements to, motor function in individuals with spinal cord injuries (SCIs). OPCs are naturally occurring precursors to the cells that provide electrical insulation for nerve axons in the form of a myelin sheath. SCI most often occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. In the U.S., there are approximately 18,000 new spinal cord injuries annually and over 300,000 patients in total living with spinal cord injuries. There currently are no FDA-approved drugs or interventions specifically for the treatment of SCI. The clinical development of OPC1 has been partially funded by a $14.3 million grant from CIRM. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
A selection of patient focused media related to the OPC1 program is available on the Media page of the Lineage website.
Lineage’s OPC1 program featured on CNN: "He was paralyzed his last day of high school. How an experimental trial is showing ‘unexpected improvement"
OPC1 patient spotlight – Chris Block’s story
OPC1 patient spotlight – Lucas Lindner’s story
About the DOSED Study
The Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) clinical study is an open label, multi-center, device safety study, in 3-5 subacute and 3-5 stable chronic subjects with complete (ASIA Impairment Scale A) or incomplete (ASIA Impairment Scale B), traumatic, focal SCI affecting either cervical (C4-C7) or thoracic (T1-T10) vertebrae (ClinicalTrials.gov Identifier: NCT06841770). The primary objective of this study is to evaluate the safety of a novel Manual Inject Parenchymal Spinal Delivery System (MI PSD System) to administer OPC1 to the spinal parenchyma. The primary endpoint is frequency and severity of the MI PSD System- or injection procedure-related adverse events (AEs) through 30 days (1 month). Secondary endpoints are frequency and severity of AEs through 90 days (3 months) following injection of OPC1 and/or the concomitant immunosuppression administered, and incidence of MRI findings indicative of deterioration or safety-related changes at 90 days post-administration of OPC1. Exploratory endpoints include measurements of neurological impairment and function, as well as pain, evaluated by changes from baseline on the following endpoints: changes in neurological function as measured by sensory and motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations; changes in post-injection pain, defined as a worsening of pain or neuropathic pain of greater than 7 days duration from baseline levels, as assessed by the International Spinal Cord Injury Pain Basic Data Set or occurrence of allodynia; changes from baseline at 30, 90 and 365 days post-injection of OPC1 in: ISNCSCI, SCIM, International Spinal Cord Injury Pain Questionnaire; patient and clinical impressions of changes in quality of life as reported by changes from baseline at 30, 90, and 365 days post-injection of OPC1 as measured by: Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Clinician Global Impression of Severity (CGI-S) and Clinician Global Impression of Change (CGI-C). Lineage also currently plans to seek approval from the FDA to introduce its new forthcoming immediate-use thaw-and-inject formulation of OPC1 into the DOSED study.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Forward-looking statements are based upon Lineage’s current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Forward-looking statements in this press release include, but are not limited to, statements relating to: the plans and expectations with respect to OPC1 and its potential benefits, including its potential to improve replace or support cells in the spinal cord that are absent or dysfunctional due to traumatic injury and help restore or augment functional activity and lead to more mobility than what could otherwise be expected and enhanced quality of life for SCI patients, including chronic SCI patients, and significant cost-savings for caregivers; the potential benefits of MI PSD System in administering OPC1; the potential approval by FDA of the introduction of an immediate-use formulation of OPC1 into clinical testing and the potential benefits of such formulation; the planned expansion of the DOSED study to multiple study sites; and the potential market opportunity for OPC1, if approved, including its potential to be the first FDA-approved intervention specifically for the treatment of SCI. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage is early in its development efforts and its investigational allogeneic cell therapies represent a novel and unproven approach to the treatment of serious and complex medical conditions; that positive findings in early clinical and/or nonclinical studies of a product candidate or delivery device may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate or device; the potential for delays in commencement, expansion, enrollment, data readouts, and completion of Lineage’s clinical studies, including due to delays in or the nature of FDA feedback or additional information requests; unexpected adverse side effects, inadequate efficacy, or other unfavorable results of Lineage’s product candidates in clinical studies that may limit their continued development, potential for regulatory approval, and/or commercial potential; Lineage’s dependence on third parties to conduct clinical studies of its product candidates and to manufacture and supply delivery systems or devices for administration of its product candidates, and the risk that such third parties or their products may not perform as expected; that Lineage may not obtain sufficient additional capital to complete the development and seek regulatory of or to commercialize its product candidates, if approved; that Lineage may not receive additional funding from CIRM to support the DOSED study which could adversely impact Lineage’s ability to expand and/or complete the study; that the ongoing Israeli regional conflict may materially and adversely impact Lineage’s manufacturing processes, including cell banking and product manufacturing for its product candidates, all of which are conducted by its subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice or at a cost-effective or commercially viable scale; that Lineage may not be able to maintain, or obtain the benefits associated with, the RMAT and orphan drug designations of OPC1 from the FDA; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at https://www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250804744293/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
11月前
NEWS -- OpRegen® (RG6501) 36-Month Visual Acuity Results Featured at Clinical Trials at the Summit 2025
Mean vision gains of +9 letters among patients with extensive coverage of OpRegen cell therapy to the Geographic Atrophy (GA) lesion site
Evidence of retinal structural improvement persisted out to 3 years
Anatomical and functional improvements occur following a single administration of OpRegen cell therapyCARLSBAD, Calif., June 23, 2025--(BUSINESS WIRE)--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 neurological and ophthalmic conditions, today announced that 36-month results from patients enrolled in a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), were presented at Clinical Trials at the Summit (CTS) 2025. The presentation, "OpRegen® Retinal Pigment Epithelium (RPE) Cell Therapy for Patients with Geographic Atrophy (GA): Month 36 Results from the Phase 1/2a Trial," was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine, on behalf of Roche and Genentech, a member of the Roche Group.
"Long term clinical outcomes following a single administration of OpRegen cell therapy is challenging the long-held view that GA causes irreversible damage. A key finding from the Lineage-run phase 1/2a trial was the importance of extensive placement of cells across the area of atrophy. Among patients who received fulsome coverage by OpRegen cell therapy, anatomical and functional benefits from a single administration have lasted for at least three years," stated Brian M. Culley, Lineage CEO. "Over this extended period, improved visual function is not a natural occurrence among patients suffering from GA, making these changes quite promising. Importantly, OpRegen-treated eyes have exhibited mean BCVA scores above baseline at each of the 12-, 24-, and 36-month timepoints, demonstrating consistency as well as durability. In short, patients who received significant coverage of OpRegen cell therapy across their GA are exhibiting long-term outcomes consistent with meaningful disease stabilization and even improvement. We are excited to see any additional insights which our partners, Roche and Genentech, may uncover from the ongoing GAlette study, which is investigating the best way to deliver OpRegen cell therapy to patients with GA secondary to age related macular degeneration (AMD)."
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
CTS 2025 Highlights
Improvement in visual acuity in Cohort 4 patients (less advanced GA than in other cohorts) was present at 12 months (primary endpoint), 24 months, and has now persisted through 36 months
Gains in Best Corrected Visual Acuity (BCVA) in patients in Cohort 4 (less advanced GA) measured at month 12 remain evident through month 36 following subretinal administration of OpRegen cell therapy
Mean change in BCVA among treated eyes for patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment)
Improvement in BCVA and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was greater than in patients with limited coverage and persisted through month 36
Effects were greater on average in the five (5) patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery
In these patients’ treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing 3-year follow-up (compared to +7.4 ETDRS letters at 24 months) (n=5)
Sustained evidence of retinal structural improvement by a quantitative Optical Coherence Tomography (OCT) analysis through 36 months was observed in treated eyes of Cohort 4 patients (less advanced GA than in other cohorts) following a single subretinal administration of OpRegen cell therapy
At month 36, sustained evidence of retinal structure improvements in external limiting membrane (ELM) and RPE drusen complex (RPEDC) layers on OCT was observed in the subgroup of five patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery
Mean improvement of RPEDC area compared with baseline was maintained in treated eyes from 24 months (+2.6 mm2; n=4) to 36 months (+1.9 mm2; n=5)
In comparison, mean change in RPEDC area decreased in untreated fellow eyes from 24 months (-2.8 mm2; n=4) to 36 months (-3.8 mm2; n=5)
Mean change in ELM area was maintained in treated eyes from 24 months (+0.8 mm2; n=4) to 36 months (+0.3 mm2; n=5)
In comparison, mean change in ELM area decreased in untreated fellow eyes from 24 months (-1.9 mm2; n=4) to 36 months (-3.4 mm2; n=5)
These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration
The Phase 2a "GAlette study" evaluating the success of subretinal delivery of OpRegen cell therapy to target areas of GA is currently enrolling (NCT05626114)
In addition to evaluating other surgical parameters, this study will test proprietary surgical devices in development for subretinal delivery of OpRegen cell therapy that have potential advantages over currently available devices and proceduresDr. Riemann’s presentation is now available on the Events and Presentations section of Lineage’s website.
About Clinical Trials at The Summit (CTS) 2025
Clinical Trials at the Summit (CTS) 2025 brings together a diverse group of experts from around the world to discuss ongoing clinical trials and the latest data, all with the goal of achieving advances in vitreoretinal care. This program will explore the partnerships and strategies required to design and execute effective clinical trials. CTS was founded by Arshad M. Khanani, MD, MA, Director of Clinical Research at Sierra Eye Associates, and is Co-Chaired by Jeffrey S. Heier, MD, Ophthalmic Consultants of Boston and Peter K. Kaiser, MD, Cole Eye Institute, Cleveland Clinic. CTS is an invitation-only, in-person meeting where participants will have the exclusive opportunity to interact with the top national and international key opinion leaders in retina at the Fontainebleau Las Vegas. For more information visit: https://www.ctsretina.org/.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen cell therapy delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen cell therapy, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen cell therapy as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen cell therapy treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "suggest," or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to AMD and the significance of the Phase 1/2a clinical study data reported to date. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen or be successful in completing clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250623206871/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
12月前
NEWS -- Lineage Cell Therapeutics Announces Updates to the 3rd Annual Spinal Cord Injury Investor Symposium
Fully Virtual Event Scheduled for June 27, 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 neurological and ophthalmic conditions, today announced additional presenters to the 3rd Annual Spinal Cord Injury Investor Symposium ("3rd SCIIS"). The 3rd SCIIS will be a fully virtual event, with interactive and on-demand sessions available starting on June 27, 2025.
“We are excited by the incredible response by presenters that have confirmed to date and believe that our third symposium will offer attendees the most comprehensive and relevant discussions related to the field of spinal cord injury we have been able to assemble to date,” stated Brian M. Culley, Lineage CEO. “We believe collaborative problem-solving is an integral component to the goal of supporting individuals living with SCI and we are proud to bring together a diverse and broad array of clinical and preclinical companies, thought leader perspectives, and most importantly, insights from persons with lived experience. This event will be open and accessible online at no cost, and we invite you to register directly through the symposium website and to join us for the virtual event on June 27th as we again assemble a unique group of forward-thinking leaders in SCI product development.”
Current confirmed thought leaders, persons with lived experience and moderating healthcare analysts (subject to change):
Armin Curt, M.D.,/b], Full Professor for Paraplegiology and Medical Director, Balgrist University Hospital, Zurich, Switzerland
Richard G. Fessler, M.D., Ph.D., Professor, Department of Neurosurgery, RUSH University Medical Center
James D. Guest, M.D., Ph.D., Clinical Professor, Department of Neurological Surgery, The Miami Project to Cure Paralysis, Professor, University of Miami Miller School of Medicine
Steven Kirshblum, M.D., Chief Medical Officer, Kessler Foundation, Professor of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School
Edelle Field-Fote, PT, Ph.D., FAPTA, FASIA, Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory, Shepherd Center
John (Kip) Kramer, B.Sc., M.Sc., Ph.D., Associate Professor, Department of Anesthesiology, Pharmacology, and Therapeutics, University of British Columbia
Monica A. Perez, PT, Ph.D., Scientific Chair, Arms + Hands Lab, Shirley Ryan AbilityLab, Professor of Physical Medicine and Rehabilitation, Northwestern University
Jeffrey C. Petruska, Ph.D., Associate Professor, University of Louisville, Department of Anatomical Sciences and Neurobiology
Jerod & Hanna Nieder, Positively Paralyzed, LLC
Robert Paylor, Motivational Speaker and Author
Marco Sorani, Executive Director, Portfolio Strategy & Governance, BeOne Medicines USA
Barry Munro B.A., LLB., Chief Development Officer, Canadian Spinal Research Organization
Jack Allen, CFA, Senior Research Analyst, Biotechnology, R.W. Baird & Co., Inc.
Joseph Pantginis, Ph.D., Director of Research, Managing Director, Equity Research, H.C. Wainwright & Co., Inc.Current corporate presenters (subject to change):
Lineage Cell Therapeutics, Inc.
NervGen Pharma Corp.
NovaGo Therapeutics AG
NurExone Biologic Inc.
ONWARD Medical N.V.
Precision Neuroscience
SCI Ventures
AmphixBioThe 3rd Annual Spinal Cord Injury Investor Symposium will be a fully virtual event open to all participants, with interactive and on-demand sessions available on June 27, 2025. This event will bring together both public and private companies developing new treatment options for people with spinal cord injury, alongside leaders in the spinal cord injury medical and advocacy communities. A number of important topics will be discussed, including but not limited to preclinical and clinical SCI treatment approaches and the drug development process; racial, ethnic, socioeconomic, geographic vulnerabilities within SCI care and outcomes; hearing the persons with lived experience voice and ensuring patient’s perspectives, needs and priorities are captured in the drug development process; and discussions of SCI clinical endpoints and the need for new and more precise assessment tools. For more information, please visit https://www.scisymposium.com or follow the event on X/Twitter @SCISymposium.
About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential effect of the 3rd SCIIS. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250605204221/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- Lineage to Present at 3rd Annual H.C. Wainwright BioConnect Investor Conference at Nasdaq NYC
CARLSBAD, Calif., May 14, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the 3rd Annual H.C. Wainwright BioConnect Investor Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Managing Director, Equity Research, on Tuesday, May 20, 2025, at 2:30pm ET. The 3rd Annual H.C. Wainwright BioConnect Investor Conference takes place on Tuesday, May 20, 2025, at the Nasdaq stock exchange headquarters in New York, NY.
Investors interested in scheduling an in-person meeting with the Lineage management team should contact their H.C. Wainwright representative or email mailto://meetings@hcwco.com. A replay of Lineage’s fireside chat will be available on the Events and Presentations section of Lineage’s website, following the conclusion of the conference.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250514299171/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Study 36 Month Results to Be Featured at Clinical Trials at the Summit 2025
CARLSBAD, Calif., May 12, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for serious neurological conditions, today announced that 36-month results from patients enrolled in a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), will be presented at Clinical Trials at the Summit (CTS) 2025. CTS will be held June 20 - 21, 2025, and brings together a diverse group of experts from around the world to discuss ongoing clinical trials and the latest data, all with the goal of achieving advances in vitreoretinal care. The presentation, "OpRegen® Retinal Pigment Epithelium (RPE) Cell Therapy for Patients with Geographic Atrophy (GA): Month 36 Results from the Phase 1/2a Trial," will be presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine, on behalf of Roche and Genentech, a member of the Roche Group.
About OpRegen
OpRegen (RG6501) is a suspension of allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in GA by supporting retinal cell health and improving retinal structure and function. OpRegen is being developed under an exclusive worldwide collaboration between Lineage, and Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
About Clinical Trials at The Summit (CTS) 2025
Clinical Trials at the Summit (CTS) 2025 brings together a diverse group of experts from around the world to discuss ongoing clinical trials and the latest data, all with the goal of achieving advances in vitreoretinal care. This program will explore the partnerships and strategies required to design and execute effective clinical trials. CTS was founded by Arshad M. Khanani, MD, MA, Director of Clinical Research at Sierra Eye Associates, and is Co-Chaired by Jeffrey S. Heier, MD, Ophthalmic Consultants of Boston and Peter K. Kaiser, MD, Cole Eye Institute, Cleveland Clinic. CTS is an invitation-only, in-person meeting where participants will have the exclusive opportunity to interact with the top national and international key opinion leaders in retina at the Fontainebleau Las Vegas. For more information visit: www. https://www.ctsretina.org/.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250512395886/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- Lineage Cell Therapeutics and the Christopher & Dana Reeve Foundation Proudly Announce the 3rd Annual Spinal Cord Injury Investor Symposium
Fully Virtual Event Scheduled for June 27, 2025
CARLSBAD, Calif., April 22, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, and the Christopher & Dana Reeve Foundation, a non-profit organization dedicated to advancing innovative research and improving quality of life for individuals impacted by paralysis, are proud to collaborate and present the 3rd Annual Spinal Cord Injury Investor Symposium ("3rd SCIIS"). This year’s event aims to bring together companies working in the development of treatments for SCI, with regulators, key opinion leaders, persons with lived experience, patient and community advocacy organizations and the investment community, in order to discuss perspectives on current and future treatments, impact and support SCI disease awareness and clinical trial participation through the implementation of patient appropriate clinical endpoints, and importantly, broaden awareness of and investment capital into SCI. The 3rd SCIIS will be a fully virtual event, with interactive and on-demand sessions available starting on June 27, 2025.
"It is a privilege to continue our collaboration with the Reeve Foundation on this event, the goals for which include increasing disease awareness, improving the probability of success in product development, and supporting clinical trial participation," stated Brian M. Culley, Lineage CEO. "For the first time, we have decided to host a fully virtual conference, as we believe it can significantly enhance participation for individuals affected by spinal cord injuries by removing barriers that can make in-person events difficult. Our aim at Lineage is to improve recovery and mobility by replacing the cells which are destroyed following a spinal cord injury and we are proud to have recently initiated a clinical study of our cell transplant candidate, OPC1. We believe that raising investor awareness can lead to greater investment, which can help to accelerate new treatments. This year’s symposium will build on prior year’s momentum and continue to foster open and collaborative dialogue among leading experts, companies, researchers, persons with lived experience, caregivers, advocacy organizations, regulators and members of the investment community."
"Driving real breakthroughs in spinal cord injury research means ensuring that those impacted have a seat at the table," said Marco Baptista, Ph.D., Chief Scientific Officer at the Reeve Foundation. "Too often, the voices of people living with SCI and other disabilities are left out of the R&D process, but their lived experience is essential to guiding innovation that truly matters. Now more than ever, we must invest in bold scientific discovery and foster collaboration between academia, industry, and the disability community. We’re committed to accelerating high potential ideas from the lab to real-life impact, and we’re proud to partner with Lineage to help unite the entire SCI community in advancing the science that could change lives."
The 3rd Annual Spinal Cord Injury Investor Symposium will be a fully virtual event open to all participants, with interactive and on-demand sessions available on June 27, 2025. This event will bring together both public and private companies developing new treatment options for people with spinal cord injury, alongside leaders in the spinal cord injury medical and advocacy communities. A number of important topics will be discussed, including but not limited to preclinical and clinical SCI treatment approaches and the drug development process; racial, ethnic, socioeconomic, geographic vulnerabilities within SCI care and outcomes; hearing the persons with lived experience voice and ensuring patient’s perspectives, needs and priorities are captured in the drug development process; and discussions of SCI clinical endpoints and the need for new and more precise assessment tools.
About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.
About the Christopher & Dana Reeve Foundation
The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation’s National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community’s voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau’s standards for charity accountability and hold the BBB’s Charity Seal. For more information, please visit https://ChristopherReeve.org or call 800-225-0292.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential effect of the 3rd SCIIS, including accelerating new treatments in SCI, broadening awareness of and investment capital into SCI, or increasing clinical trial participation; and the ability of cell transplant therapy approaches, including OPC1, to improve recovery or allow a patient to regain more mobility than what could otherwise be expected. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that engagement with patients and the advocacy community may not lead to improvements in patient outcomes; and that raising investor awareness may not lead to greater investment, nor accelerate new treatments; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250422494799/en/
Contacts
Reeve Foundation Media Contact:
Julia Leonard
(mailto://jleonard@reeve.org)
(973) 933-7222
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- Lineage to Present at 2025 Eyecelerator Meeting Sponsored by the American Academy of Ophthalmology (AAO)
Lineage Participating in Panel Discussion of Novel Retina Drug Delivery Approaches at Eyecelerator@ Park City 2025
CARLSBAD, Calif., April 21, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, has been invited to join presenters from REGENXBIO Inc., Regenerative Patch Technologies, LLC, Neurotech Pharmaceuticals, Inc., and others, as part of the "I Shall Be Released: Novel Drug Delivery Approaches for Glaucoma and Retina" panel at Eyecelerator@ Park City 2025. The panel will take place on Friday, May 2, 2025 from 12:30pm to 1:30pm MDT and is being chaired by Allen C. Ho, MD FACS FASRS, Eyecelerator Retina Program Director and Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University, Mid Atlantic Retina. Eyecelerator@ Park City 2025 is being held on May 2, 2025, at the Grand Hyatt, Deer Valley, Utah, in partnership with the American Academy of Ophthalmology (AAO).
The Eyecelerator@ Park City 2025 panel will be available on the Events and Presentations section of Lineage’s website, following the conclusion of the Eyecelerator conference.
About Eyecelerator
Eyecelerator brings the future of ophthalmology into focus. A partnership between the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS), Eyecelerator advances eye care innovation by connecting mission-driven entrepreneurs, investors, physicians, and business leaders through next-generation business conferences. Eyecelerator 2025 will provide a day of insightful, KOL-driven programs, including the latest industry advancements, investment trends, and innovative products disrupting eye care. For more information visit https://www.eyecelerator.com/ or follow the organization on Twitter: @Eyecelerator.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology (AAO) is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, the organization protects sight and empowers lives by setting the standards for ophthalmic education and advocating for our patients and the public. AAO innovates to advance the ophthalmology profession and to ensure the delivery of the highest-quality eye care. The mission of the AAO is to protect sight and empower lives by serving as an advocate for patients and the public, leading ophthalmic education, and advancing the profession of ophthalmology. For more information visit https://www.aao.org/ or follow the organization on Twitter: @AAO_ophth or @AcademyEyeSmart.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250421927098/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- Lineage Initiates Clinical Study of OPC1 for Spinal Cord Injury
Safety Study of Stem Cell-derived Transplant Includes Subacute and Chronic SCI Patients
CARLSBAD, Calif., February 11, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for serious neurological conditions, announced today that the Company has initiated the DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study. The DOSED study will evaluate the safety and utility of the Manual Inject Parenchymal Spinal Delivery System (MI PSD System), a novel delivery device developed to deliver OPC1 directly to the area of injury in patients with spinal cord injury (SCI). OPC1 is an investigational, allogeneic stem cell-derived cell transplant, comprised of oligodendrocyte progenitor and related glial cells. OPC1 is designed to replace or support cells in the spinal cord that are absent or dysfunctional due to traumatic injury and is intended to help restore or augment functional activity in persons suffering from an SCI. Improved functional activity can lead to greater mobility and enhanced quality of life for patients and significant cost-savings for caregivers. The DOSED study will enroll both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) SCI patients.
"Differentiated cell transplantation is a promising therapeutic approach, so it is a privilege that Lineage has received written clearance from FDA to launch the DOSED study as part of our continued development of OPC1," stated Brian M. Culley, Lineage’s CEO. "The DOSED study, the third clinical study of OPC1, will evaluate MI PSD, a novel delivery system designed through an external collaboration, to deliver our proprietary cells over several minutes without the need for stopping patient ventilation. The delivery system also is compatible with a forthcoming immediate-use formulation of OPC1 which we developed for this program, and which eliminates the dose preparation steps conducted in prior studies. This study will be the first time OPC1 is administered to patients with a chronic spinal cord injury, which will be a significant milestone, as it represents an additional and larger potential patient population for this experimental therapy. In addition to the safety and performance of the new device, we also will be collecting functional assessments on all patients, which gives us the opportunity to investigate any signals of efficacy that may arise. The first study site will be UC San Diego Health. We look forward to building on the promising work and clinical results observed in prior studies of OPC1."
OPC1 has an extensive long-term safety profile and has been tested in two clinical trials to date: a five-patient Phase 1 safety trial in acute thoracic SCI, where all active subjects have been followed for at least 13 years; and a 25-patient Phase 1/2a multicenter dose-escalation trial in subacute cervical SCI, where all active subjects have been evaluated for at least 7 years. Long-term safety monitoring is ongoing for both studies, with no unexpected serious adverse events attributable to the OPC1 transplant being reported to date. Results from both studies have been published in the Journal of Neurosurgery: Spine. The Phase 1/2a publication of OPC1 in subacute cervical SCI is available here and the publication from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here. The OPC1 program was one of the first cell therapy clinical trials to be supported by the California Institute for Regenerative Medicine (CIRM) under Proposition 71.
Lineage founded the Annual Spinal Cord Injury Investor Symposium in 2023 and has co-sponsored the event in partnership with The Christopher & Dana Reeve Foundation in each year since then. The goals of this collaborative effort include increasing disease awareness, improving the probability of success in product development, and supporting clinical trial participation. The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Presenting companies have included AbbVie, Mitsubishi Tanabe, Neuralink, NervGen Pharma and ONWARD.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful recovery in, and improvements to, motor function in individuals with spinal cord injuries (SCIs). OPCs are naturally occurring precursors to the cells that provide electrical insulation for nerve axons in the form of a myelin sheath. SCI most often occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. In the U.S., there are approximately 18,000 new spinal cord injuries annually and over 300,000 patients in total living with spinal cord injuries. There currently are no FDA-approved drugs or interventions specifically for the treatment of SCI. The clinical development of OPC1 has been partially funded by a $14.3 million grant from CIRM. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
A selection of patient focused media related to the OPC1 program is available on the Media page of the Lineage website.
Lineage’s OPC1 program featured on CNN: "He was paralyzed his last day of high school. How an experimental trial is showing ‘unexpected improvement"
OPC1 patient spotlight – Chris Block’s story
OPC1 patient spotlight – Lucas Lindner’s storyAbout the DOSED Study
The Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) clinical study is an open label, multi-center, device safety study, in 3-5 subacute and 3-5 stable chronic subjects with complete (ASIA Impairment Scale A) or incomplete (ASIA Impairment Scale B), traumatic, focal SCI affecting either cervical (C4-C7) or thoracic (T1-T10) vertebrae. The primary objective of this study is to evaluate the safety of a novel Manual Inject Parenchymal Spinal Delivery System (MI PSD System) to administer OPC1 to the spinal parenchyma. The primary endpoint is frequency and severity of the MI PSD System- or injection procedure-related adverse events (AEs) through 30 days (1 month). Secondary endpoints are frequency and severity of AEs through 90 days (3 months) following injection of OPC1 and/or the concomitant immunosuppression administered. Exploratory endpoints include measurements of neurological impairment and function, as well as pain, evaluated by changes from baseline on the following endpoints: changes in neurological function as measured by sensory and motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations; changes in post-injection pain, defined as a worsening of pain or neuropathic pain of greater than 7 days duration from baseline levels, as assessed by the International Spinal Cord Injury Pain Basic Data Set or occurrence of allodynia; changes from baseline at 30, 90 and 365 days post-injection of OPC1 in: ISNCSCI, SCIM, International Spinal Cord Injury Pain Questionnaire; patient and clinical impressions of changes in quality of life as reported by changes from baseline at 30, 90, and 365 days post-injection of OPC1 as measured by: Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Clinician Global Impression of Severity (CGI-S) and Clinician Global Impression of Change (CGI-C).
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the plans and expectations with respect to OPC1 and its potential benefits, and the anticipated conduct of the DOSED study for OPC1, including the ability to improve recovery, or allow a patient to regain more functional activity and/or mobility than what could otherwise be expected, or improve a patient’s quality of life; and the potential approval by FDA of the introduction of an immediate-use formulation of OPC1 into clinical testing. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage may not receive additional funding from CIRM to support the DOSED study; that the Institutional Review Board does not approve the DOSED study or requires material modifications to the study in order to approve it; that the FDA provides feedback or additional information requests related to the Investigational New Drug amendment for OPC1 or the DOSED study that adversely impacts the study’s progress; Lineage’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Lineage’s dependence on third parties to conduct clinical trials, including the UC San Diego Sanford Stem Cell Clinical Center; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; Lineage’s ability to develop, obtain FDA approval for, and commercialize its product candidates and to do so on communicated timelines, as well as OPC1’s applicability to a potential chronic SCI patient population; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250211889206/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- Lineage Cell Therapeutics Announces Closing of Second Tranche of Previously Announced Registered Direct Offering
January 27 2025 - 4:05PM Business Wire
Lineage Has Now Received $30 Million in Gross Proceeds and May Receive an Additional $36 Million in Gross Proceeds Upon the Full Exercise of OpRegen® Clinical Milestone-linked Warrants
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the closing of the second tranche of its previously announced registered direct offering of an aggregate of up to $66 million. The Company had previously received $24 million in gross proceeds at the closing of the first tranche in November 2024. Today, the Company received an additional $6 million in gross proceeds at the closing of the second tranche. In addition, the Company may receive up to an additional $36 million of gross proceeds upon the exercise in full on a cash basis of the clinical milestone-linked warrants issued in the offering.
Lineage obtained shareholder approval of the issuance of the securities at the closing of the second tranche, in satisfaction of applicable NYSE American rules. Lineage shareholders approved the issuance of 7,894,737 common shares and accompanying warrant to purchase an aggregate of up to 7,894,737 common shares, at a combined purchase price of $0.76 per common share and accompanying warrant, to Broadwood Partners, L.P., an affiliate of Neal Bradsher, a member of Lineage’s board of directors. Such warrant is exercisable for one common share at an exercise price of $0.91 per common share commencing on May 21, 2025 and will expire on the earlier of (a) May 21, 2028 and (b) the 90th day following the date of the public disclosure of the intent to advance OpRegen (also known as RG6501) into a multi-center phase 2 or 3 clinical trial which includes a control or comparator arm, or if the date of such public disclosure occurs prior to May 21, 2025, then the 90th day following May 21, 2025.
The securities described above were offered and sold by Lineage in a registered direct offering pursuant to a “shelf” registration statement on Form S-3 (File No. 333-277758) filed with the Securities and Exchange Commission (the “SEC”) on March 7, 2024, and which was declared effective by the SEC on May 14, 2024. The offering of the securities in the registered direct offering was made only by means of a base prospectus and a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at https://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC, who served as the exclusive placement agent for the offering, at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at mailto://placements@hcwco.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, “off-the-shelf,” cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to the total potential amount of proceeds from the offering, the exercise of the warrants in cash prior to their expiration, and the exercise of the warrants upon the achievements of the clinical milestone event or otherwise prior to their expiration. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that the warrants may not be exercised or, if exercised, the exercise price may not be paid in cash, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250127672835/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
NEWS -- Lineage Cell Therapeutics Issues Letter to Stockholders
CARLSBAD, Calif., January 06, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today published a letter to shareholders highlighting the company’s recent achievements and outlook for 2025.
Dear Fellow Shareholders,
We hope you had a restful holiday season and wish you a happy new year. As we look at our plans for the new year, we want to update you on our recent progress and explain why we believe 2025 will be an exciting year for our company.
As many of you know, Lineage is an emerging cell therapy company, but we more accurately should be referred to as a cell transplant company. The term cell transplant is more accurate because we do not administer "stem" cells to patients. Instead, we deliver mature, differentiated cells, which are guided along a specific lineage to become functionally identical to the cells which an individual has lost due to disease or trauma. Those cells are then transplanted in a one-time procedure to treat conditions caused by the loss or dysfunction of a specific cell type. We summarize this approach as "replace and restore". In the setting of dry-age related macular generation (dry-AMD), our manufacturing team creates new retinal pigment epithelial (RPE) cells to replace the RPE cells that have been lost by an individual after decades of use. This allogeneic cell therapy program, OpRegen®, led to a global development and commercialization partnership with Roche and Genentech, a member of the Roche Group. Our partners are currently evaluating OpRegen in a Phase 2a clinical trial. We also have established a pipeline of earlier-stage product candidates, each utilizing a single, carefully selected and cultured cell line for the life of a product, which eliminates donor variability and reduces regulatory risk. We believe we are the only publicly traded, non-oncology cell transplant company, which is one reason why we believe Lineage is the leading entity in this rapidly growing field of medicine.
Often, the most important things we do occur behind the scenes. Actions which increase our programs’ probabilities of success do not always become press releases. And discoveries that we make may be more valuable to our shareholders as trade secrets than as patents. Last year was a great example of these circumstances; we made significant progress in many areas, advancing our programs, expanding collaborations, and strengthening our balance sheet to help reach important milestones in 2025 and beyond. However, these advances were masked by significant uncertainty in the biotech sector, which has continued for years, making value-creation in biotech increasingly difficult and, unsurprisingly, frustrating many investors.
This communication is intended to provide clarity and transparency into certain areas of our business and is an opportunity to provide relevant context and expectations for our audience which aren’t normally covered in a press release. Those areas are: financing strategy, manufacturing capabilities, and our plans for long-term success. I aim to address each of those topics for both existing and future potential shareholders.
Financing – A Strong Foundation
For the past 6 years, Lineage has been funded by diverse sources of capital, including business development deals, sales of non-core assets, and an ATM facility. At their respective times, we believe each of these offered a better cost of capital than traditional investment bank-led financings. But traditional financings sometimes have advantages, and in particular, the "milestone-warrant" structure employed in our November financing was an ideal fit for our unique situation. However, the structure of that deal is complex and invites some clarity.
As many shareholders know, the company’s future is tightly linked to whether our partners, Roche and Genentech, elect to advance OpRegen into its next phase of clinical development. A forthcoming "go/no-go" decision to conduct a controlled clinical trial of OpRegen will be a major event for Lineage and for OpRegen’s probability of commercialization, so we sought not only to secure immediate capital, but also created a path to future capital, contingent in part upon the successful advancement of OpRegen by our partners into a controlled clinical trial.
In November, we closed on an initial $24 million in gross proceeds, and we expect to close on an additional $6 million later this month, subject to stockholder approval. Based on our current operational plan, we expect this capital will provide Lineage with runway into Q1 2027. In addition, we issued warrants for up to an additional $36 million at a strike price of at least $0.91, which included an acceleration (i.e. "call") of the warrants if and when the advancement of OpRegen into a controlled trial is disclosed. In a single transaction, we raised more than a year of capital and provided a path to a second year of capital if OpRegen meets the milestone defined in the warrant. We believe establishing this line-of-sight to additional capital reduces a future financial overhang and puts Lineage in greater control of its future with respect to capital raises or strategic discussions we may conduct with new or existing partners.
In the short-term, we expected the dilutive impact of this raise, because it was conducted in highly unfavorable market conditions, but it is important to run the business from a position of optionality and strength. Notably, based on our historic spending rates, we have capitalized the company potentially into mid-2028, subject to receiving the $36 million of warrant capital. And if certain alliance milestones, grants, and/or business development transactions that we are currently evaluating successfully close, Lineage could even be funded for the next four years. With this recent financing, we believe we have set Lineage on its strongest financial foundation in its history.
Manufacturing – Achieving the Unprecedented
One of the challenges of working in cell therapy is that many people restrict their scope of cell therapy to cancer, but the CAR-T field is unsustainably crowded with many poorly differentiated assets. We believe the more compelling growth opportunity in cell therapy resides in diseases and conditions outside of cancer, or what we like to call "noncology". There are only a few companies that have reached clinical testing with a "noncology" asset, including Bluerock (acquired by Bayer) for Parkinson’s Disease, and Semma (acquired by Vertex) for Type 1 Diabetes. In fact, to our knowledge, Lineage is currently the only publicly traded company in which one can invest exclusively and directly in this exciting and increasingly validated branch of medicine.
A second challenge is that a focus on clinical outcomes often overlooks the difficulty, or in some cases the feasibility, of manufacturing a product using a commercially-viable and scalable process. Autologous products are expensive because each dose is made for just one person, which precludes affordability in all but the most serious conditions (i.e. cancer). Allogeneic therapies, for which the cells are sourced from one donor but delivered to many patients, offer a theoretical solution to the problem of scale, but in our view, a truly affordable allogeneic process has not yet been reduced to practice by any company. Our view is that making 10, 100, or even 1,000 doses from a single donor fails to deliver on the intent or power of an allogeneic therapy. In fact, we call those approaches "shallow-geneic" because they lack the depth of a scalable process. They may be allogeneic by definition, but they are not sufficiently more scalable than autologous cell therapies, and therefore, do not genuinely address the issue of cost.
We believe the full vision of an off-the-shelf allogeneic therapy comes from scaling production by ten million, or even a hundred million-fold. To our knowledge, no company has yet demonstrated they can manufacture thousands of doses of their product from a stable Working Cell Bank (WCB), which itself was generated from a stable Master Cell Bank (MCB), and yet the multiplication stemming from that sequence of expansions is necessary to reach the commercially-desirable cost of goods implied from a "true" allogeneic product. Lineage aspires this year to be the first company to demonstrate this multiplicative scalable capability, using actual production lots. If we are successful, we believe it will help establish our manufacturing team as proven and capable leaders in cell therapy manufacturing.
Strategy and Future Goals – Planning for Success
The third message is how our development and financing decisions are linked to a longer-term vision of success for Lineage. We understand there are significant expectations on the ongoing OpRegen trial. While we believe our phase 1/2a results are compelling, validation and affirmation of our findings in a larger trial conducted by an international pharmaceutical company can reasonably be expected to add substantial credibility to our initial findings and future expectations. If OpRegen continues to perform as it has to date, we believe it will reflect positively on our team’s capabilities, our technology platform, and the value of the company.
Lineage is primarily known for OpRegen, but we are capable of much more than making RPE cells. A clearly articulated product portfolio, especially one that is generated from an internally-owned platform, can offer a compelling foundation for value creation. For this reason, we are establishing a pipeline of closely-related neurological cell transplant product candidates, which each employ our core technology, including: OPC1 (oligodendrocyte progenitors), to improve mobility following a severe spinal cord injury, ReSonance™ (auditory neuronal progenitors) to improve hearing in people suffering from sensorineural hearing loss, and a third, as yet undisclosed program. If OpRegen advances into a later-stage trial and our manufacturing objectives are reached, we believe our cost of capital will improve and allow us to move faster and farther with these programs. Once the power of our platform is further demonstrated and validated, we believe that the pipeline of internally-owned assets that we are advancing will make us a desirable partner for pharma and an attractive opportunity for investors.
Looking ahead, we will continue to support our partners in the development of OpRegen. In parallel, our internal focus will be on conducting the DOSED clinical study of OPC1, advancing ReSonance for the treatment of hearing loss, and other carefully chosen initiatives.
We remain committed to acting in the best interests of our shareholders and will continue to implement a thoughtful and staged approach to product development. We believe that long-term value and appreciation can be created through the advancement of our clinical and preclinical pipelines, where we intend to apply our technology and expertise to validate our unique cell transplant approach.
We appreciate your support and belief in our vision. We invite you to stay engaged with our progress through regular updates, earnings calls, and announcements.
Replace and Restore,
Brian Culley, CEO
Lineage Cell Therapeutics, Inc.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD, as well as the clinical advancement of OpRegen and its impacts on us; our ability to successfully manufacture OpRegen at scale; statements relating to the terms of the financing described herein, which do not purport to be complete and are qualified in their entirety by the full text of the financing documents, copies of which are attached as exhibits to our Current Report filed on Form 8-K on November 20, 2024, our ability to obtain stockholder approval to close on an additional $6 million in gross proceeds later this month and issue corresponding warrants, the acceleration of the expiration of the warrants in connection with the achievement of the OpRegen clinical milestone, or the exercise of the common warrants in cash prior to their expiration; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into 2027, or into 2028 assuming exercise of the warrants, or beyond 2028 assuming additional alliance milestones, grants, and/or business development transactions occur; the growth of cell therapy in diseases and conditions outside of cancer, relative to oncology cell therapy, or at all; the broad potential for Lineage’s regenerative medicine platform and our ability to develop additional product candidates, including the commencement of the DOSED clinical study for OPC1; and the potential of our pipeline, platform technology and/or manufacturing capabilities, independently and/or in connection with the clinical advancement of the OpRegen program, to validate our approach or create value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash, cash equivalents and marketable securities more quickly than expected; that we are unable to obtain shareholder approval to close on an additional $6 million in gross proceeds and issue corresponding warrants; that the warrants may not be exercised for cash, including if the price per share of our common stock never reaches or exceeds the warrant exercise price of $0.91 per share, or that we do not have an effective registration statement on file at the time of exercise, or if other conditions contained in the warrants are not met; that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that OpRegen may not clinically advance, and even if it does, that such advancement will not have a positive effect on us, our share price, our cost of capital, nor the overall success of the OpRegen program; that OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not be successful in obtaining regulatory approval for OpRegen in any particular jurisdiction; that the ongoing Israel-Hamas war and broader regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250106031795/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
2年前
NEWS -- Lineage Cell Therapeutics Announces First Closing of up to $66 Million Registered Direct Offering
$30 Million Upfront With Up to an Additional $36 Million of Aggregate Gross Proceeds Upon the Exercise in Full of Clinical Milestone-linked Common Warrants
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the first closing of its previously announced registered direct offering for the purchase and sale of up to an aggregate of 39,473,688 of Lineage’s common shares and accompanying warrants (the “common warrants”) to purchase an aggregate of up to 39,473,688 of Lineage’s common shares at a combined purchase price of $0.76 per common share and accompanying common warrant. Lineage issued an aggregate of 31,578,951 common shares and common warrants to purchase up to 31,578,951 common shares to certain healthcare focused institutional investors in the first closing. Each common warrant will be exercisable for one common share at an exercise price of $0.91 per common share and will be exercisable commencing six months following their date of issuance and will expire on the earlier of (a) the three-year anniversary of the initial exercise date, and (b) the 90th day following the date of the public disclosure of the intent to advance OpRegen® (also known as RG6501) into a multi-center phase 2 or 3 clinical trial which includes a control or comparator arm, or if the date of such public disclosure occurs prior to the initial exercise date of the common warrants, the 90th day following the initial exercise date.
H.C. Wainwright & Co. served as the exclusive placement agent for the offering.
The offering of the securities to Broadwood Partners, L.P. (“Broadwood”), an affiliate of Neal Bradsher, a member of Lineage’s board of directors, is expected to close upon obtaining shareholder approval to satisfy applicable NYSE American rules and to the satisfaction of customary closing conditions. The common warrants that may be issued to Broadwood pursuant to the definitive purchase agreement entered into between Lineage and Broadwood will not be exercisable until the later of (i) their date of issuance, which will be the date shareholder approval is obtained, and (ii) the six-month anniversary of the date of issuance of the common warrants to the unaffiliated institutional investors in the offering.
Lineage received $24 million in aggregate gross proceeds in the first closing of the offering, which was with respect to the investments by the unaffiliated institutional investors, and expects to receive approximately $6 million in additional gross proceeds from the offering with respect to the investment by Broadwood, in each case, before deducting the placement agent’s fees and other offering expenses payable by Lineage. The potential additional gross proceeds to Lineage from the common warrants, if fully exercised on a cash basis, will be approximately $36 million. No assurance can be given that Lineage will obtain the shareholder approval required to satisfy applicable NYSE American rules in order to sell the securities in the offering to Broadwood or that any of the common warrants will be exercised. Lineage currently plans to use the net proceeds from the offering for working capital and general corporate purposes, including research and development expenses and capital expenditures.
The securities described above were offered and sold by Lineage in a registered direct offering pursuant to a “shelf” registration statement on Form S-3 (File No. 333-277758) filed with the Securities and Exchange Commission (the “SEC”) on March 7, 2024, and which was declared effective by the SEC on May 14, 2024. The offering of the securities in the registered direct offering was made only by means of a base prospectus and a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, “off-the-shelf,” cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to the closing of the offering of the securities to Broadwood, the total potential amount and use of proceeds from the offering, the exercise of the common warrants in cash prior to their expiration and the exercise of the common warrants upon the achievements of such milestone events or otherwise prior to their expiration. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that the offering may not close due to the failure to satisfy the applicable closing conditions, including, with respect to the offering of securities to Broadwood, obtaining shareholder approval to satisfy applicable NYSE American rules, and that the common warrants may not be exercised or, if exercised, the exercise price may not be paid in cash, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241121738269/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
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