Paulness
3 weeks ago
NEWS -- Lineage Announces Appointment of Charlotte Hubbert, Ph.D., as Vice President of Corporate Development
CARLSBAD, Calif., April 01, 2024--(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 the appointment of veteran industry executive Charlotte Hubbert, Ph.D., as Vice President of Corporate Development. Dr. Hubbert has an extensive background in cell therapy research and venture investment across a broad range of therapeutic modalities and development stages, and has a proven ability to combine deep scientific expertise and business development acumen to identify innovative opportunities to drive both returns and impact. Dr. Hubbert previously served as Partner and Head of Gates Foundation Venture Capital, an initiative at the Bill and Melinda Gates Foundation Strategic Investment Fund, where she oversaw investing in innovative technologies that supported the foundation’s programs in global health and agriculture. Most recently, Dr. Hubbert served in the leadership team at NanoString Technologies. She currently serves on the Board of Directors of the Beckman Research Institute at the City of Hope, and is a Strategic Director at Madrona Venture Group.
"We are excited to add such a talented executive to our management team in the newly created position of VP Corporate Development. Dr. Hubbert’s decades of experience in cell therapy, strategic investment, and partnering make her a valuable and welcome addition to the Lineage team," stated Brian M. Culley, CEO. "Given her relevant expertise in regenerative medicine, she will be able to support multiple operational areas, including product development, market strategies, strategic partnering, and broaden awareness of the work we’re doing to create a leading cell transplant company."
Prior to joining the Bill and Melinda Gates Foundation Strategic Investment Fund, where she led investments and served on the Board of Directors of Synlogic (Nasdaq: SYBX), Sera Prognostics, Lodo Therapeutics, Agtech Accelerator, Vedanta, and Vir Biotechnology (Nasdaq: VIR), Dr. Hubbert was a vice president at H.I.G. BioVentures, investing broadly in healthcare, and began her career in early-stage biotech investing at Accelerator Corporation, where she was a part of the founding management team.
Dr. Hubbert earned a B.S. in microbiology from the University of Washington and a Ph.D. in cancer biology from Duke University for which she received the prestigious Harold Weintraub Award. She did her post-doctoral work in stem cells and regenerative medicine at the Institute for Stem Cells and Regenerative Medicine at the University of Washington. Dr. Hubbert is a member of the Kauffman Society of Fellows and is a Fierce Woman in Biopharma awardee which recognizes top executives in Biopharma. She previously served on the Board of Directors of Life Science Washington, and the steering committees of the Fred Hutch Cancer Institute’s Evergreen Fund, University of Washington Innovation Roundtable and Columbia University Lab-to-Market initiative.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "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) 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 Eterna Therapeutics Inc. 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 anticipated or implied benefits of Dr. Hubbert’s employment with Lineage. 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 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/20240401267142/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1 month ago
NEWS -- Lineage Cell Therapeutics and the Christopher & Dana Reeve Foundation Proudly Announce the 2nd Annual Spinal Cord Injury Investor Symposium
Event Scheduled for June 26 and 27, 2024
CARLSBAD, Calif., March 18, 2024--(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 again collaborate to present the 2nd Annual Spinal Cord Injury Investor Symposium ("2nd SCIIS"). The 2nd SCIIS builds upon a successful inaugural event held on June 29, 2023, and will connect a diverse set of stakeholders in the field of spinal cord injury (SCI). This year’s event aims to accelerate development in SCI research and treatments by bringing 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 treatment alternatives, 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 2nd SCIIS will be held on June 26 and 27, 2024 at the Sanford Consortium for Regenerative Medicine in La Jolla, CA.
"We are excited to continue our collaboration with the Reeve Foundation on this event, which provides an excellent opportunity to highlight the important work being done by for-profit and non-profit organizations alike and to broaden awareness and impact for those affected by this debilitating condition," stated Brian M. Culley, Lineage CEO. "Our aim at Lineage is to improve recovery and mobility by replacing the cells which are destroyed following a spinal cord injury. We are encouraged by the initial clinical testing which has been performed with our approach and look forward to continuing our work. In certain rare disease settings, we have seen that raising investor awareness can lead to greater investment, which can help to accelerate new treatments. This year’s symposium aims to build on the success of last year’s event and to 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."
"Real breakthroughs in SCI science require diverse stakeholders to start talking, sharing data and collaborating," said Marco Baptista, Ph.D, Chief Scientific Officer at the Reeve Foundation. "We are focused on propelling the field forward and incentivizing high-risk, high-reward projects that can be translated from the lab into the clinic and make a real impact on quality of life. Success necessitates more collaboration among industry and academia, informed by those with lived experience. We’re excited to again bring together all those who are impacted by SCI and paralysis to explore and learn from promising science in progress."
The 2nd Annual Spinal Cord Injury Investor Symposium will be held in-person, on June 26 and 27, 2024, in the Duane Roth Auditorium at the Sanford Consortium for Regenerative Medicine in La Jolla, CA. 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 person's with lived experience voice and ensuring patients' 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 Sanford Consortium for Regenerative Medicine
The Sanford Consortium is a multi-disciplinary and collaborative community of scientists who share the goal to harness the potential of stem cells for the treatment and cure of human diseases. The Sanford Consortium marshals the intellectual resources of five world leaders in life sciences research: La Jolla Institute for Allergy & Immunology, the Salk Institute for Biological Studies, the Sanford Burnham Prebys Medical Discovery Institute, Scripps Research, and the University of California, San Diego. Each of the Collaborating Organizations has substantive complementary research strengths that combined create a synergistic research enterprise, the whole of which is substantially greater than the sum of its parts. The Collaboratory has served as a focal point for stem cell science and has catalyzed increased collaboration among the stem cell research community. For more information, please visit https://www.sanfordconsortium.com/.
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 ChristopherReeve.org or call 800-225-0292.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "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) 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 Eterna Therapeutics Inc. 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 2nd SCIIS, including accelerating development in SCI, broadening SCI disease awareness, 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/20240318962645/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
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1 month ago
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Study 24 Month Results to Be Featured at 2024 Retinal Cell & Gene Therapy Innovation Summit
CARLSBAD, Calif., March 13, 2024--(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 24 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 the 2024 Retinal Cell & Gene Therapy Innovation Summit. The meeting will be held May 3, 2024, at the Hyatt Regency Seattle, and is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. The presentation, "OpRegen® Retinal Pigment Epithelium (RPE) Cell Therapy for Patients with Geographic Atrophy (GA): Month 24 Results from the Phase 1/2a Trial," will include anatomical and functional data from long-term follow-up in 10 of 12 patients and will be presented by David Telander, MD, PhD, Retinal Consultants Medical Group, 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 the Innovation Summit
The annual Retinal Cell and Gene Therapy Innovation Summit 2024 is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. Representatives from the biotech and pharma industries will come together with members of the medical and research communities to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal diseases therapies toward clinical utility. The Summit features presentations by leading retinal disease experts on potential gene and cell-based therapies and how best to deliver them to patients. For more information visit: https://give.fightingblindness.org/event/retinal-cell-and-gene-therapy-innovation-summit-2024/e529485.
About the Foundation Fighting Blindness
The Foundation Fighting Blindness was established in 1971 by a passionate group of families driven to find treatments and cures for inherited retinal diseases that were affecting their loved ones. At that time, little was known about these blinding retinal diseases. Very little research was being done, and there were no clinical trials for potential treatments. Today, the Foundation Fighting Blindness is the world’s leading private funder of retinal disease research. That funding has been a driving force behind the progress toward cures, including the identification of more than 270 genes linked to retinal disease, and the launch of over 40 clinical trials for potential treatments. For more information, visit: https://www.fightingblindness.org/ or follow them on X/Twitter @FightBlindness.
About OHSU Casey Eye Institute
OHSU Casey Eye Institute is a premier academic medical center providing eye care for adults and children in the Pacific Northwest and beyond. Since 1945, OHSU Casey Eye Institute doctors and vision scientists have worked side by side to discover the causes of eye disease and find new treatments. For more information, visit: https://www.ohsu.edu/casey-eye-institute or follow them on X/Twitter: @CaseyEye.
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 or "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) 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 Eterna Therapeutics Inc. 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/20240313697648/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1 month ago
NEWS -- RG6501 (OpRegen®) Preclinical Engraftment Results to Be Presented at 2024 Association for Research in Vision and Ophthalmology Meeting
CARLSBAD, Calif., March 11, 2024--(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 preclinical results as part of a surgical development study evaluating the survival and distribution of RG6501 (OpRegen) will be presented at the 2024 Association for Research in Vision and Ophthalmology Annual Meeting (2024 ARVO). The meeting will be held May 5-9, 2024, in Seattle, WA. The presentation, "OpRegen engrafts within the retinal pigmented epithelium (RPE) of Gottingen mini-pigs by 4-weeks post-administration via subretinal delivery," will be presented by Rachel N. Andrews, DVM, PhD, DACVP, Principal Scientist-Pathologist, Safety Assessment, Genentech, a member of the Roche Group, on behalf of Roche and Genentech.
About OpRegen[img][/img]
OpRegen (RG6501) is a suspension of allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (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 the 2024 ARVO Meeting
The ARVO Annual Meeting is the premiere gathering for eye and vision scientists from across the globe, at all career stages, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions. The theme of the 2024 Annual Meeting addresses how vision research is continually being transformed by new information and technologies. Exponentially expanding computing power is giving rise to improved artificial intelligence and powerful big data. Increasingly sensitive and elegant molecular techniques, including CRISPR and mRNA technologies, as well as more sophisticated imaging modalities, virtual reality, and breakthroughs in gene therapy are catalyzing our research as we aim to treat, cure and ultimately prevent blinding eye diseases. For more information, visit https://www.arvo.org/annual-meeting/meeting-info/meeting-info/ or follow the Association on X/Twitter: @ARVOInfo.
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 or "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) 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 Eterna Therapeutics Inc. 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/20240311914768/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
chrismiss_everyday
2 months ago
February 13, 2024 8:00 AM EST
Lineage Announces FDA Clearance of IND Amendment for OPC1 Cell Transplant for the Treatment of Spinal Cord Injury
The DOSED Clinical Study Will Evaluate a Novel Delivery Device in Subacute and Chronic Spinal Cord Injury Patients
CARLSBAD, Calif.--(BUSINESS WIRE)--Feb. 13, 2024-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1, an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI). Pursuant to the INDa, Lineage has initiated activities to open its first clinical site in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) study to evaluate the safety and utility of a novel spinal cord delivery device in subacute and chronic SCI patients. Initial site opening is expected to occur in the second quarter of 2024, following customary trial preparations and submission in the first quarter of a grant application to the California Institute for Regenerative Medicine (CIRM) for potential partial financial support of the DOSED clinical study.
“Lineage’s oligodendrocyte cell transplants are designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with the goal of helping to improve the quality of life and restore or augment functional activity to persons suffering from traumatic cervical or thoracic spinal cord injuries. The clearance of our INDa and the initiation of OPC1 clinical testing under our sponsorship represents a significant milestone for this program, and reflects our commitment to developing modern cell therapy product candidates,” stated Brian M. Culley, Lineage CEO. “We are excited by the opportunity to build upon the promising results achieved with OPC1 in previous trials, and to continue to seek improvements in how our therapy is prepared and administered. The DOSED clinical study in particular is intended to evaluate the safety and performance of a new delivery device, which is compatible with our forthcoming immediate-use formulation, and which does not require cessation of patient ventilation during administration. We believe these improvements can lead to a safer surgical procedure for surgeons and patients. This study also will mark the first time that OPC1 is administered to chronic SCI patients, and we will be collecting efficacy assessments in addition to the primary outcome measures of safety. Completing this regulatory step also enables us to proceed with our planned CLIN-2 grant application to CIRM to request external financial support for the OPC1 program.”
OPC1 has been tested in two clinical trials to date: a five patient Phase 1 clinical safety trial in acute thoracic SCI, where all subjects have been followed for at least 10 years; as well as a 25 patient Phase 1/2a multicenter dose-escalation clinical trial in subacute cervical SCI, where all subjects were evaluated for at least two years, one of the first cell therapy clinical trials supported by the California Institute for Regenerative Medicine under Proposition 71. Results from both studies have been published in the Journal of Neurosurgery: Spine. The data from the Phase 1/2a clinical study of OPC1 in subacute cervical SCI is available here and the data from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here.
About the DOSED Clinical 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 approximately 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 spinal cord delivery device to administer OPC1 to the spinal parenchyma. The primary endpoint is safety, as measured by the frequency and severity of adverse events (AEs) through 30 days following OPC1 injection that are related to the injection procedure. Secondary endpoints are safety and tolerability, as measured by the frequency and severity of AEs, including AEs of special interest, through 90 days following OPC1 injection, that are related to OPC1 and/or the concomitant short-term immunosuppression. Safety parameters will be evaluated by magnetic resonance imaging (MRI) data evaluating evidence of deterioration or changes in the following: intramedullary hemorrhage, cerebral spinal fluid (CSF) leak, epidural abscess, infection; evidence of an expanding cyst or mass at the injection site or elsewhere in the central nervous system (CNS); evidence of inflammatory lesion(s) at injection site or elsewhere in CNS and evidence of CSF flow obstruction. Exploratory endpoints include: (1) potential improvements in neurological impairment, function, and 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; (2) changes from baseline at 30, 90 and 365 days post-OPC1 injection in: ISNCSCI, SCIM, International Spinal Cord Injury Pain Questionnaire; and (3) patient and clinician impressions of changes in quality of life as reported by changes from baseline at 30, 90, and 365 days post-OPC1 injection.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which 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. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs or interventions specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
About the California Institute for Regenerative Medicine (CIRM)
CIRM, California's Stem Cell Agency, was created by the voters of California in 2004 with the passing of Proposition 71, which authorized $3 billion in funding for stem cell research in California. The agency funds stem cell research at institutions and companies throughout California (as well as institutions and companies outside of the state that conduct a portion of their research in California) with the goal of accelerating treatments to patients with unmet medical needs. In 2020, California voters approved to continue funding California's Stem Cell Agency through the passage of Proposition 14. CIRM’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world as well as to accelerate stem cell treatments to patients with unmet medical needs. By promoting and encouraging the growth of the stem cell biotechnology sector, the agency is also helping attract the best scientists to the state and establishing California as a global leader in stem cell research. For more information, please visit https://www.cirm.ca.gov/ and follow the agency on Twitter: @CIRMnews.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform, Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on 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 ability of cell transplant therapies, including OPC1, to improve recovery, allow a patient to regain more function than what could otherwise be expected, or improve a patient’s quality of life; the potential future achievements of our clinical, preclinical and development programs, the planned initiation of clinical trials, including the expected initial site opening for the DOSED clinical study in the second quarter of 2024; that the improvements in the delivery device for OPC1 can lead to a safer surgical procedure; and the timing and availability of clinical data updates related to our programs. 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; 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/20240213332150/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Source: Lineage Cell Therapeutics, Inc.
Paulness
2 months ago
Lineage Cell Therapeutics Announces Closing of $14.0 Million Registered Direct Offering
CARLSBAD, Calif., February 09, 2024--(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 the closing of its previously announced registered direct offering for the purchase and sale of 13,461,540 of the company’s common shares at an offering price of $1.04 per common share. The price per share was the closing price of the company’s common shares on NYSE American on February 5, 2024. Broadwood Partners, L.P., which is affiliated with Neal Bradsher, a member of the Company’s board of directors, has purchased 6,730,770 common shares in the offering, and Don M. Bailey, a member of the Company’s board of directors, has purchased approximately 100,000 common shares in the offering.
"This offering strategically strengthens our balance sheet, which can aid us in reaching important milestones in the months ahead," stated Brian M. Culley, Lineage CEO. "This deal was priced at-market, without a discount or dilutive structural elements like warrants. It featured significant insider and pre-existing shareholder participation and was executed without an investment bank. We appreciate the contributions of all parties involved in this transaction and look forward to advancing our product candidates this year."
The aggregate gross proceeds to Lineage from the offering at the closing were $14.0 million before deducting estimated offering expenses payable by Lineage. Lineage intends to use the proceeds from the offering for general corporate purposes, which may include clinical trials, research and development activities, general and administrative costs, and to meet working capital needs.
The securities described above were offered and sold by Lineage pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254167), including a base prospectus, previously filed with the Securities and Exchange Commission, or the SEC, on March 11, 2021, and declared effective by the SEC on March 19, 2021. Such securities were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to the securities was filed with the SEC. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained by visiting the SEC’s website at http://www.sec.gov.
This press release does not constitute an offer to sell or the 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 an offer, solicitation or sale would be unlawful prior to 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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the expected use of proceeds from the offering. 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 those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 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/20240209732533/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
2 months ago
NEWS -- Lineage Cell Therapeutics Announces $14.0 Million Registered Direct Offering
CARLSBAD, Calif., February 06, 2024--(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 it entered into a definitive agreement with certain investors for the purchase and sale of 13,461,540 of the company’s common shares in a registered direct offering at an offering price of $1.04 per common share. The price per share was the closing price of the company’s common shares on NYSE American on February 5, 2024. The parties entered into the definitive agreement before markets opened on February 6, 2024. The closing of the offering is expected to occur on or about February 8, 2024, subject to the satisfaction of customary closing conditions. Broadwood Partners, L.P., which is affiliated with Neal Bradsher, a member of the Company’s board of directors, agreed to purchase 6,730,770 common shares in the offering, and Don M. Bailey, a member of the Company’s board of directors, agreed to purchase approximately 100,000 common shares in the offering.
The aggregate gross proceeds to Lineage from the offering at the closing are expected to be $14.0 million before deducting estimated offering expenses payable by Lineage. Lineage intends to use the proceeds from the offering for general corporate purposes, which may include clinical trials, research and development activities, general and administrative costs, and to meet working capital needs.
The securities described above are being offered and sold by Lineage pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254167), including a base prospectus, previously filed with the Securities and Exchange Commission, or the SEC, on March 11, 2021, and declared effective by the SEC on March 19, 2021. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to the securities will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained, when available, by visiting the SEC’s website at http://www.sec.gov.
This press release does not constitute an offer to sell or the 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 an offer, solicitation or sale would be unlawful prior to 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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the offering, the completion of the offering and the expected use of proceeds from the offering. 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, without limitation, risk and uncertainties related to: the satisfaction of the closing conditions related to the offering, whether Lineage will complete the offering on the anticipated terms, or at all, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 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/20240206000006/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
3 months ago
RG6501 (OpRegen®) Phase 1/2a Results Will Be Featured at 2024 Angiogenesis Exudation and Degeneration Meeting in Presentation by Allen Ho, MD, FACS, FASRS
CARLSBAD, Calif., January 16, 2024--(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 results showing retinal structure improvements with RG6501(OpRegen) from a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) in geographic atrophy (GA) secondary to advanced age-related macular degeneration (AMD), will be presented at the 2024 Angiogenesis, Exudation, and Degeneration Meeting. The virtual meeting will be held February 3, 2024, and is sponsored by the University of Miami Health System Bascom Palmer Eye Institute. The presentation, "Retinal Structure Improvements with OpRegen RPE Cell Therapy in a Phase I/IIa Study in Geographic Atrophy," will be presented by Allen Ho, MD, FACS, FASRS, Co-Director, Wills Eye Retina Service and Director, Retina Research, Wills Eye Hospital on behalf of Roche and Genentech, a member of the Roche Group.
About OpRegen
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. OpRegen subretinal delivery 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, 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 Angiogenesis
The 21st Annual Angiogenesis meeting, entitled Angiogenesis, Exudation, and Degeneration 2024, will be held virtually on February 3, 2024. The program will feature an exceptional group of basic scientists, clinicians, and healthcare experts, all focused on understanding and treating neovascular, exudative, and degenerative diseases of the eye. The program will highlight the revolutionary pharmacotherapies now in development and clinical practice for the management of neovascular AMD, macular edema, diabetic retinopathy, retinopathy of prematurity, and inherited retinal degenerations with a special emphasis on the present and future financial impact of these drugs on clinical practices and Medicare. Angiogenesis 2024 follows the tradition of excellence established by Bascom Palmer’s widely acclaimed Angiogenesis programs between 2004 and 2023. Designed for retina specialists, general ophthalmologists and researchers, the current program will review the latest in imaging, translational research, and clinical trials with an emphasis on how these results will impact clinical ophthalmology. For more information visit: https://umiamihealth.org/bascom-palmer-eye-institute/healthcare-professionals/continuing-medical-education/angiogenesis.
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
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 and/or nonclinical 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/20240116211178/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://mailto://Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
4 months ago
NEWS -- Lineage Announces Submission of OPC1 Investigational New Drug Amendment for Treatment of Chronic and Subacute Spinal Cord Injury
CARLSBAD, Calif., December 18, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1, its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury (SCI). Receipt of FDA clearance of the INDa would enable the Company to initiate its DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, to evaluate the safety and utility of a novel spinal cord delivery device in both subacute and chronic SCI patients. The OPC1 cell transplant is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from traumatic cervical or thoracic SCIs.
"The submission of our IND amendment for OPC1 and its return to clinical testing represents a significant milestone for this program and a diligent effort by our team," stated Brian M. Culley, Lineage CEO. "With so few opportunities for SCI patients to participate in clinical trials, it is a privilege to be able to re-engage with the community as part of our efforts to improve outcomes for individuals with a debilitating condition for which there currently are no FDA-approved treatments. Our team has made a significant effort to introduce improvements to the OPC1 program, including enhancements to the production process and quality of our product candidate and an improved delivery system compatible with our immediate use, thaw-and-inject formulation. We are encouraged by the meaningful quality of life and safety results observed with OPC1 in previous trials, and we look forward to building on that promising work. We are excited by the opportunity to initiate the DOSED study and the opening of the first clinical sites in early 2024, assuming no further comments are received from the FDA in the 30 days following our INDa submission."
OPC1 has been tested in two clinical trials to date; a five patient Phase 1 clinical safety trial in acute thoracic SCI, where all subjects have been followed for at least 10 years; as well as a 25 patient Phase 1/2a multicenter dose-escalation clinical trial in subacute cervical SCI, where all subjects were evaluated for at least two years, one of the first cell therapy clinical trials supported by the California Institute for Regenerative Medicine under Proposition 71. Results from both studies have been published in the Journal of Neurosurgery: Spine: the data from the Phase 1/2a clinical study of OPC1 in subacute cervical SCI is available here and the data from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here.
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 approximately 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 spinal cord delivery device to administer OPC1 to the spinal parenchyma. The primary endpoint is safety, as measured by the frequency and severity of adverse events (AEs) through 30 days following OPC1 injection that are related to the injection procedure. Secondary endpoints are safety and tolerability, as measured by the frequency and severity of AEs, including AEs of special interest, through 90 days following OPC1 injection, that are related to OPC1 and/or the concomitant short-term immunosuppression. Safety parameters will be evaluated by magnetic resonance imaging (MRI) data evaluating evidence of deterioration or changes in the following: intramedullary hemorrhage, cerebral spinal fluid (CSF) leak, epidural abscess, infection; evidence of an expanding cyst or mass at the injection site or elsewhere in the central nervous system (CNS); evidence of inflammatory lesion(s) at injection site or elsewhere in CNS and evidence of CSF flow obstruction. Exploratory endpoints include: (1) potential improvements in neurological impairment, function, and 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; (2) changes from baseline at 30, 90 and 365 days post-OPC1 injection in: ISNCSCI, SCIM, International Spinal Cord Injury Pain Questionnaire; and (3) patient and clinician impressions of changes in quality of life as reported by changes from baseline at 30, 90, and 365 days post-OPC1 injection.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which 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. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs or interventions specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
About the California Institute for Regenerative Medicine (CIRM)
CIRM, California’s Stem Cell Agency, was created by the voters of California in 2004 with the passing of Proposition 71, which authorized $3 billion in funding for stem cell research in California. The agency funds stem cell research at institutions and companies throughout California (as well as institutions and companies outside of the state that conduct a portion of their research in California) with the goal of accelerating treatments to patients with unmet medical needs. In 2020, California voters approved to continue funding California’s Stem Cell Agency through the passage of Proposition 14. CIRM’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world as well as to accelerate stem cell treatments to patients with unmet medical needs. By promoting and encouraging the growth of the stem cell biotechnology sector, the agency is also helping attract the best scientists to the state and establishing California as a global leader in stem cell research. For more information, please visit https://www.cirm.ca.gov/ and follow the agency on Twitter: @CIRMnews.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 ability of cell transplant therapies, including OPC1, to improve recovery, allow a patient to regain more function than what could otherwise be expected, or improve a patient’s quality of life; and the potential future achievements of our clinical, preclinical and development programs, the planned initiation of clinical trials, including the DOSED study in early 2024, and the timing and availability of clinical data updates related to our programs. 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 the feedback received from the FDA for OPC1 may not enable further clinical development; 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/20231218883834/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
6 months ago
NEWS -- RG6501 (OpRegen®) Phase 1/2a Results to Be Featured at Eyecelerator at 2023 American Academy of Ophthalmology (AAO) Annual Meeting
Company Also Will Present at "Mapping the Future of Geographic Atrophy" Session at Eyecelerator@AAO 2023
CARLSBAD, Calif., October 24, 2023--(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 present as part of the "Mapping the Future of Geographic Atrophy" session at Eyecelerator 2023, on Thursday, November 2nd, 2023, at 10am PT. The session will also feature executive presenters from Apellis Pharmaceuticals, Iveric Bio, Annexon Biosciences, Aviceda Therapeutics, and ONL Therapeutics, alongside panelists, including Wiley Chambers, M.D., Director, Division of Ophthalmology, U.S. Food and Drug Administration, David Lyons, Ph.D., CFA, Janus Henderson Investors, and Namrata Saroj, OD, Principal, All Eyes Consulting.
In addition, the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure and continued clinical benefit in subjects from a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), have been accepted for presentation at Eyecelerator 2023. The presentation, "Subretinal Delivery of OpRegen, A Suspension of Allogeneic Retinal Pigment Epithelial (RPE) Cells in Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)," will be presented as part of the Presenting Company Breakout Session, between 1 – 2:45pm PDT, by Gary S. Hogge, D.V.M., M.S. Ph.D., Lineage’s Senior Vice President, Clinical and Medical Affairs. Eyecelerator will occur prior to the American Academy of Ophthalmology (AAO) 2023 Annual Meeting and will be held at the San Francisco Marriott Marquis on Thursday, November 2nd, 2023.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery 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 in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
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 2023 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 the 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 dry-form 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 are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 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/20231024732155/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
6 months ago
NEWS -- Lineage Announces Issuance of U.S. Patent Covering Proprietary Manufacturing and Differentiation Process for Retinal Pigmented Epithelial Cells
CARLSBAD, Calif., October 11, 2023--(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 the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,746,324, entitled "Large Scale Production of Retinal Pigment Epithelial Cells". The patent, which has been exclusively licensed to Lineage, has an expected expiration date of July 28, 2036. RG6501 (OpRegen®) is a suspension of human allogeneic RPE cells currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. The program is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group.
"This U.S. patent further enhances the value of our lead program, OpRegen, which is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114)," stated Brian M. Culley, CEO. "Importantly, Lineage is continuing to demonstrate its ability to benefit from decades of experience in the growth and differentiation of pluripotent cells, while simultaneously inventing and patenting new process development methods, to support long periods of exclusivity to our pipeline of cell transplant programs."
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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; and the potential value and benefits of this patent and our development capabilities, and any potential competitive advantages thereof. 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 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; that potential benefits of the Company’s intellectual property 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. 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/20231011379671/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
6 months ago
NEWS -- RG6501 (OpRegen®) Phase 1/2a Results Show Evidence of Rapid Improvement of Outer Retinal Structure in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
CARLSBAD, Calif., October 05, 2023--(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 the results of imaging analyses demonstrating rapid improvement in outer retinal structure from patients enrolled in a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), which were reviewed by multiple, independent reviewers, were presented at the 23rd EURETINA Congress. The presentation, "Time to retinal structure improvements following OpRegen subretinal delivery in patients with geographic atrophy (GA)," was presented by Adiel Barak, M.D., Professor of Ophthalmology, Vitreoretinal Unit Director, Tel Aviv Medical Center, on behalf of Roche and Genentech, a member of the Roche Group.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery 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 in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
"We are extremely pleased to see these additional observations of rapid improvements to outer retinal structure in the initial clinical study of OpRegen. These data suggest that OpRegen RPE cells may provide direct support to the patients’ remaining retinal cells within atrophic areas, and that the improvements to retinal structure can be detected within the first three months following a single administration. We look forward to additional, future clinical data updates on the OpRegen program from our partners, Roche and Genentech," stated Brian Culley, CEO of Lineage.
23rd EURETINA Congress Highlights:
All 5 patients enrolled in cohort 4 who had extensive coverage of the GA lesion with the surgical bleb containing OpRegen in suspension, demonstrated evidence of improvement in outer retinal structure as assessed by optical coherence tomography (OCT) within the first 3 months after treatment.
Retinal structural improvement in the patients described above were initially observed on day 1 (n=1), day 14 (n=1), month 1 (n=2), and month 3 (n=1).Maintenance and/or greater improvements in retinal structure were observed over time.Structural improvement (as defined below) was only observed within GA lesions with extensive coverage with the surgical bleb suggesting that OpRegen RPE cells provide support to the remaining retinal cells within atrophic areas.These 5 patients had an average of 4.4 letter BCVA gain by 3 months and 12.8 letter BCVA gain by 1 year compared to baseline.OCT images were reviewed by three independent graders from the day after surgery to the start of structural improvement and subsequent follow-up visits.Structural improvement on OCT was qualitatively defined as meeting all pre-specified criteria including: 1) reduction in outer plexiform layer (OPL) and/or inner nuclear layer (INL) subsidence; 2) reappearance of external limiting membrane (ELM); and 3) increased hyperreflectivity and/or thickness of RPE and/or Bruch’s membrane or reduction of hypertransmission on at least two non-adjacent B scans.The patient who demonstrated retinal structure improvement as early as day 1 following OpRegen subretinal delivery exhibited persistence of structural improvement as measured by OCT, with resolution of areas of complete RPE and outer retinal atrophy (cRORA) features at 24 months following treatment. Durability of retinal structure improvements beyond the 12-month primary endpoint is still being evaluated in other patients.A Phase 2a study evaluating the success of OpRegen delivery to target areas of GA is currently enrolling patients (ClinicalTrials.gov: NCT05626114).
Dr. Barak’s presentation is now available on the Events and Presentations section of Lineage’s website.
About EURETINA
EURETINA started life as the European Retina, Macula and Vitreous Society in June 2000. Since then, the organization has grown to over 4,500 members and its annual Congress attracts thousands of delegates. Its goal is to enable access to the same cutting-edge retina science worldwide. Through membership, annual Congress, Winter Meeting and always-on digital resource, the organization and its members share robust scientific and educational resources relating to retina. For more information, please visit https://euretina.org or follow the association on Twitter @EURetina.
About the 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 dry-form 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 are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 OpRegen in patients with GA secondary to AMD; the significance of clinical data reported to date from the Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration and visual function improvements; and the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen. 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 competing alternative therapies may adversely impact the commercial potential of OpRegen; 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; 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. 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/20231005306859/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
7 months ago
NEWS -- RG6501 (OpRegen®) Phase 1/2a Additional Results to Be Featured at 23rd EURETINA Congress
CARLSBAD, Calif., September 13, 2023--(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 the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure from a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), which were reviewed by multiple, independent reviewers, will be presented at the 23rd EURETINA Congress. The meeting will be held in the RAI Amsterdam, The Netherlands from October 5-8, 2023. The presentation, "Time to retinal structure improvements following OpRegen subretinal delivery in patients with geographic atrophy (GA)," will be presented by Adiel Barak, M.D., Professor of Ophthalmology, Vitreoretinal Unit Director, Tel Aviv Medical Center, on behalf of Roche and Genentech, a member of the Roche Group.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery 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 in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
About EURETINA
EURETINA started life as the European Retina, Macula and Vitreous Society in June 2000. Since then, the organization has grown to over 4,500 members and its annual Congress attracts thousands of delegates. Its goal is to enable access to the same cutting-edge retina science worldwide. Through membership, annual Congress, Winter Meeting and always-on digital resource, the organization and its members share robust scientific and educational resources relating to retina. For more information, please visit https://euretina.org or follow the association on Twitter @EURetina.
About the 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 dry-form 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 are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 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/20230913712585/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
7 months ago
NEWS -- Lineage Announces Initiation of Development Activities for Hypoimmune Pluripotent Cell Line for Neurology Indications Under Partnership With Eterna Therapeutics
CARLSBAD, Calif., September 06, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies to replace and restore specific cell types of the human body, today announced the initiation of certain development activities to generate a novel hypoimmune induced pluripotent stem cell (iPSC) line under the Company’s exclusive option and license agreement (the "Agreement") with Eterna Therapeutics Inc. ("Eterna"). This marks the next step under the strategic collaboration announced in February 2023, under which Eterna is developing innovative engineered hypoimmune iPSC lines that Lineage will evaluate for differentiation into cell transplant product candidates for central nervous system (CNS) diseases and other neurology indications. Since announcing the deal earlier this year, Lineage has evaluated its development strategy with a group of leading neurology experts in the U.S. and abroad. As a result of these and other discussions, and an assessment of the competitive landscape, Lineage finalized its selection of specific gene edits for the initial cell lines to be developed by Eterna. 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 the allogeneic NK cell response; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications. Lineage expects that these edits would expand the edited cell lines’ overall utility, including for non-immune privileged or non-human leukocyte antigen (HLA) matched indications and will further differentiate the cell line from others currently in use by competitors.
"Our partnership with Eterna reflects an important step in a corporate strategy intended to capitalize on our existing process development capabilities by combining them with cutting-edge cell engineering and editing technologies, to create novel and potentially superior product profiles," stated Brian M. Culley, Chief Executive Officer of Lineage. "This collaboration reflects our effort to broaden the application of our cell therapy platform and our plans for future success in this growing field. We look forward to leveraging our expertise to develop innovative cell transplant therapies that have the potential to transform the treatment of a wide range of diseases by capitalizing on the convergence of directed cell differentiation and manufacturing with modern gene editing technology."
"We are excited to move forward with the next phase of our partnership with Lineage," said Matt Angel, Ph.D., Chief Executive Officer and President of Eterna. "We believe that pluripotent cell therapies have the potential to significantly outperform traditional approaches in certain settings and that this milestone highlights Eterna’s capabilities for generating novel gene-edited iPSC lines using our mRNA cell engineering platform."
Under the Agreement, Eterna plans to conduct certain gene-editing activities and provide materials to Lineage for evaluation and Lineage will make payments to Eterna in connection with Eterna’s successful development and delivery to Lineage of certain materials. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell lines developed by Eterna for preclinical, clinical, and commercial purposes in the field of CNS diseases. Eterna is the exclusive licensee of the key intellectual property underlying this collaboration from its discovery partner Factor Bioscience.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
About Eterna Therapeutics Inc.
Eterna Therapeutics is a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines. Eterna has in-licensed a portfolio of over 130 patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the NoveSlice™ and UltraSlice™ gene-editing proteins, and the ToRNAdo™ mRNA delivery system from Factor Bioscience. NoveSlice™, UltraSlice™, and ToRNAdo™ are trademarks of Factor Bioscience. For more information, please visit https://www.eternatx.com.
About Factor Bioscience Inc.
Founded in 2011, Factor Bioscience develops technologies for engineering cells to advance the study and treatment of disease. Factor’s gene-editing technologies enable the precise deletion, insertion, and repair of DNA sequences in living cells to correct disease-causing mutations, make cells resistant to infection and degenerative disease, modulate the expression of immunoregulatory proteins to enable the generation of durable allogeneic cell therapies, and engineer immune cells to more effectively fight cancer. Factor’s cell-reprogramming technologies enable the generation of clonal lines of pluripotent stem cells that can be expanded and differentiated into any desired cell type for the development of regenerative cell therapies. For more information, visit https://www.factorbio.com.
Lineage Cell Therapeutics 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: our plans to develop potential new cell lines into differentiated cell transplant therapies and potential product candidates, and the potential indications thereof, and that those product candidates may be superior to alternate therapies, including as a result of the Agreement with Eterna; our expectations regarding the utility of edited cell lines, the effect of such cells lines on our overall technology, and any related clinical activities; our ability to differentiate a cell line from those of competitors, to broaden our overall capabilities, and to develop treatments that are differentiated from our competitors as a result of the Agreement. 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 or Eterna may fail to fully perform under the Agreement or that Lineage, in its sole discretion, may elect not to exercise its license under the Agreement; that the potential benefits of the Agreement, including 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. 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 subsequent 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/20230906418784/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
9 months ago
NEWS -- Lineage Cell Therapeutics and Cancer Research UK Report Topline Phase 1 Study Results With VAC2 for the Treatment of Advanced Non-small Cell Lung Cancer
Patients enrolled were diagnosed with refractory, metastatic or locally advanced, non-small cell lung cancer (NSCLC), for whom there were no other suitable treatment options
Five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease
No patients had treatment emergent serious adverse events and all patients completed per protocol vaccination
Three of eight treated patients (37.5%) reached the 2-year survival endpoint
Two patients had durable responses against segments of the tumor antigen human telomerase reverse transcriptase (hTERT) and two other patients had transient responses as assessed via enzyme-linked immunospot (ELISPOT) assays
Further analyses from immunogenicity of VAC2 in the tumor, skin punch biopsies, and peripheral responses are being conducted by Cancer Research UK
CARLSBAD, Calif., July 24, 2023--(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 Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research, today announced encouraging primary and secondary endpoint results from the recently completed clinical study of VAC2 in advanced non-small cell lung cancer (NSCLC). The Phase 1 study was a first-in-human, open label, multi-center trial designed to investigate safety, immunogenicity, and survival in patients with advanced NSCLC (defined as metastatic or locally advanced disease) when administered the allogeneic dendritic cell (DC) vaccine VAC2 (NCT03371485). VAC2 DC cells have been engineered to present hTERT, a tumor-associated antigen found almost exclusively in cancer cells, and it is postulated that VAC2 will stimulate an immunogenic anti-tumor CD4+/CD8+ T cell response toward hTERT expressed on tumor cells. All eight subjects enrolled and treated completed the full per protocol vaccination regimen, which consisted of six-consecutive weekly intradermal (ID) injections of 1 x 107 viable VAC2 cells. Overall, VAC2 was well-tolerated, there were no unexpected SAEs, and there were no dose limiting toxicities.
"The unmet medical need in refractory NSCLC is significant and results from recent clinical trials support the investigation of cancer vaccines as a promising approach to treating this disease. The antigen-loaded VAC2 product candidate appeared to be well tolerated in all treated patients and the adverse events which we did observe were modest and expected from a therapy designed to generate a robust and durable immune response to tumor antigens. The immunogenicity data reported to date are also encouraging and supportive of the clinical observations we noted in the patients," stated Professor Gary Middleton MB, BS, MD, FRCP, Professor of Medical Oncology, Institute of Immunology and Immunotherapy, The University of Birmingham, UK.
Brian Culley, Chief Executive Officer of Lineage, added: "The conclusion of this partnered study represents an important milestone for Lineage’s allogeneic cell therapy pipeline. We have completed clinical studies using three separate cell types in dramatically different diseases; geographic atrophy secondary to dry-form age-related macular degeneration, spinal cord injury, and most recently, NSCLC. The overall safety and efficacy data from these studies affirm our belief in the potential for allogeneic cell therapy to address some of the most serious medical needs, which unfortunately remain unaddressed by conventional approaches. Our goal is to determine how best to advance and expand not only the VAC platform as a delivery vehicle for tumor-associated and neoantigen vaccine delivery to resistant tumors, but also our overall approach to differentiated cell transplants as an emerging branch of medicine."
"Lung cancer is the third most common cancer in the UK and unfortunately, only 10% of patients survive their disease for 10 years or more, so we desperately need better treatment options. We are excited to see these initial VAC2 clinical data from a first-in-human application in what is the most common form of lung cancer and are hopeful that we can continue our collaborative work with Lineage on the next phase of development for this promising treatment approach," added Nigel Blackburn, PhD, Cancer Research UK’s Director of Drug Development.
On May 7th, 2020, Lineage completed an early exercise of its option to acquire data from Cancer Research UK and assumed responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK’s Centre for Drug Development completed the clinical study in NSCLC. Lineage is currently reviewing these data, as well as several tertiary and exploratory endpoint assessments, and will determine next steps to evaluate VAC2 following these analyses. Lineage, Cancer Research UK, and the participating investigators intend to present these data at future medical and scientific conferences and submit publications to relevant journals for peer review.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage's VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.
About VAC2
VAC2 is an allogeneic, or non-patient specific, off-the-shelf cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. VAC2 was studied in a Phase 1 clinical study in adult patients with NSCLC in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.
About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 150 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials. www.cruk.org.uk/cdd
About Cancer Research UK
Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research, influence, and information.
Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK wants to accelerate progress and see 3 in 4 people surviving their cancer by 2034.
Cancer Research UK supports research into the prevention and treatment of cancer through the work of over 4,000 scientists, doctors, and nurses.
Together with its partners and supporters, Cancer Research UK is working towards a world where people can live longer, better lives, free from the fear of cancer.Cancer research UK's work or to find out how to support the charity, please call +44 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.
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 effect of the SCIIS, including increasing disease awareness, the probability of success in product development, clinical trial participation, or investment and partnerships; 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 the SCIIS will effectively accelerate SCI research, clinical trials or product development; 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; 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/20230724868335/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
11 months ago
NEWS -- Lineage Cell Therapeutics Expected to Be Added to Russell 3000® Index
CARLSBAD, Calif., May 22, 2023--(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 reported that the Company is expected to be added to the broad-market Russell 3000® Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective as of the U.S. market open on June 26, 2023, according to a preliminary list of additions posted to the FTSE Russell website, following the close of the U.S. markets on May 19, 2023.
Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of April 28, 2023, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year following reconstitution, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"We are pleased that Lineage is expected to be added into the Russell 3000 Index next month. Our inclusion among larger market cap companies should help to expand investor awareness, increase institutional ownership, and provide additional liquidity in our stock," stated Brian M. Culley, Lineage CEO, "This recognition of our progress comes during an exciting time, as our partners Roche and Genentech enroll patients in a Phase 2a clinical trial of OpRegen® for the treatment of dry age-related macular degeneration, as we prepare for further clinical testing of our OPC1 treatment for spinal cord injury, and as we advance our other treatments for cancer, hearing loss, and vision loss. Overall, we believe a deeper understanding of Lineage’s strategic objectives can help increase support for our novel and exciting approach to cell transplant medicine."
About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20.1 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information on the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 expectation that Lineage will be added to the Russell 3000 Index at reconstitution and the impacts to Lineage as a result thereof; the significance of the Phase 2a clinical study of OpRegen; the timing of anticipated clinical activity related to our programs; the potential future achievements of our clinical, preclinical and development programs; our ability to broaden awareness of and increase support for our business; and the potential of our cell therapy platform. 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 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; that competing alternative therapies may adversely impact the commercial potential of OpRegen; 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. 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/20230522005300/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
11 months ago
NEWS -- Lineage Receives Grant From California Institute for Regenerative Medicine (CIRM)
Award Will Support 1st Annual Spinal Cord Injury Investor Symposium To Be Held June 29, 2023
CARLSBAD, Calif., May 09, 2023--(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 the Company has received a grant from the California Institute for Regenerative Medicine (CIRM), to support the 1st Annual Spinal Cord Injury Investor Symposium ("SCIIS"), a newly created forum to discuss the recent innovation, advancements, and challenges in the treatment of spinal cord injury (SCI). The SCIIS is being presented by Lineage and the Christopher & Dana Reeve Foundation. This event aims to bring together a diverse set of parties over the common interest of the development of new therapeutic interventions for SCI. The collaborative effort is intended to increase disease awareness, elevate the probability of success in product development, and promote clinical trial participation through a focus on patient appropriate clinical endpoints and an opportunity for investment and partnerships among and between for-profit and non-profit organizations. To support the SCIIS and these goals, CIRM has awarded Lineage an Education Conference II Grant, with a total award value of $50,000. This award recognizes the SCIIS as an important mission-specific conference, which will allow for the exchange of scientific information, create opportunities to accelerate the development of stem cell therapies to patients, increase the likelihood of successful treatments reaching patients, addresses an unmet clinical need, and can be impactful to CIRM’s overall mission.
"The approaches to and treatment of spinal cord injury are in need of innovation and modernization. This conference was created to help identify, discuss, and address gaps in the product development process and bring new options and ideas to patients in need of better solutions," stated Brian M. Culley, Lineage CEO. "At Lineage, our approach focuses on transplanting and replacing lost or damaged spinal cord cells in an effort to restore function and improve quality of life, but there are many programs in industry and academia which may help patients and we need events like the SCIIS to drive collaboration and cooperation across the field. We are proud to have the support of CIRM and other leading entities in spinal cord injury advocacy and therapeutic development, as we work to bring greater awareness to the field. The development of our OPC1 product candidate was one of the first clinical trials supported by CIRM and we are grateful to the agency for its continued commitment to SCI. This funding will help support the inaugural SCIIS and its mission to empower a diverse group of healthcare companies, key opinion leaders, patients and caregivers, policy makers, government representatives and others to connect and work together towards a common purpose: encouraging acceleration in SCI research, clinical trials and product development."
About the California Institute for Regenerative Medicine (CIRM)
CIRM, California's Stem Cell Agency, was created by the voters of California in 2004 with the passing of Proposition 71, which authorized $3 billion in funding for stem cell research in California. The agency funds stem cell research at institutions and companies throughout California (as well as institutions and companies outside of the state that conduct a portion of their research in California) with the goal of accelerating treatments to patients with unmet medical needs. In 2020, California voters approved to continue funding California's Stem Cell Agency through the passage of Proposition 14. CIRM’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world as well as to accelerate stem cell treatments to patients with unmet medical needs. By promoting and encouraging the growth of the stem cell biotechnology sector, the agency is also helping attract the best scientists to the state and establishing California as a global leader in stem cell research. For more information, please visit https://www.cirm.ca.gov/ and follow the agency on Twitter: @CIRMnews.
About the 1st Annual Spinal Cord Injury Investor Symposium
The 1st Annual Spinal Cord Injury Investor Symposium will be held in-person, on June 29, 2023, at the Sanford Consortium for Regenerative Medicine in La Jolla, CA. 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 current treatment approaches, the impact of SCI, SCI clinical trial participation and ensuring persons with lived experience perspectives, needs & priorities are appropriately captured, including with new clinical assessment tools. Advance registration is required for attendance. For more information about the conference, please visit http://scisymposium.com/ or follow the conversation on Twitter @SCISymposium, using the hashtag #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 novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage's VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 effect of the SCIIS, including increasing disease awareness, the probability of success in product development, clinical trial participation, or investment and partnerships; the ability of cell transplant therapy approaches, including OPC1, to improve recovery, allow a patient to regain more function than what could otherwise be expected, or improve a patient’s quality of life. 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 the SCIIS will not accelerate SCI research, clinical trials or product development; 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; 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/20230509005188/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
12 months ago
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration
Preliminary Evidence of Durable Anatomical and Functional Improvements Following Administration of OpRegen CellsExtensive OpRegen Surgical Bleb Coverage of Areas of GA May Be Critical for Optimizing Patient OutcomesOCT Imaging With Segmentation Analysis is Advantageous in Assessment of Retinal Integrity Post-TreatmentCARLSBAD, Calif., April 26, 2023--(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 results from imaging analyses of structural changes and visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), were presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2023). The presentation, "Exploratory optical coherence tomography (OCT) analysis in patients with geographic atrophy (GA) treated by OpRegen: Results from the Phase 1/2a trial" was presented by Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations, Department of Ophthalmology at Hadassah-Hebrew University Medical Center, on behalf of Roche and Genentech, a member of the Roche Group.
RG6501 (OpRegen) is an allogeneic retinal pigment epithelial (RPE) cell therapy currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
"We are extremely pleased to see our observations of improved retinal structure in the initial clinical study of OpRegen are being reinforced by additional external and independent analyses of the images performed by Genentech and Roche. Looking ahead, we are excited to collaborate with Genentech and Roche on the ongoing Phase 2a study of OpRegen, which is currently enrolling patients and open at multiple sites in the US, with more sites expected to come online this year," stated Brian Culley, CEO of Lineage.
Dr. Banin added, "I have been closely involved with the OpRegen program since its beginning and I continue to be excited about the potential therapeutic benefit for patients afflicted with dry AMD and geographic atrophy, a progressive and debilitating disease that significantly affects the quality of life of many. These data further highlight the potential for a single dose of OpRegen to provide significant clinical outcomes for patients in a disease with a tremendous unmet need."
2023 ARVO Presentation Highlights
Preliminary evidence of outer retinal structure and visual function improvements with OpRegen was observed in patients with GA and impaired vision (Cohort 4 [n=12]):Patients in Cohort 4 had an average 7.6 letter gain in visual acuity at 12 months in the study eye;Three patients in Cohort 4 (25%) had a 15 letter or greater gain in visual acuity at 12 months in the study eye.Long term vision preservation with outer retinal structure improvement observed in the OpRegen treated eye persisted for up to 4 years of follow-up.The extent of OpRegen bleb coverage over the area of atrophy may be important to optimize patient outcomes:In patients with extensive OpRegen bleb coverage, maintenance or improvement of outer retina structure was observed in treated eyes compared to worsening in fellow eyes:Five patients in Cohort 4 who had a surgically delivered bleb containing OpRegen that extensively covered their atrophic areas and the foveal center, experienced an average 12.8 letter gain in their study eye.Improvement in outer retinal layers also correlated with the extent of OpRegen bleb coverage:Slower rates of RPE and external limiting membrane (ELM) loss were observed in OpRegen treated eyes compared to fellow untreated eyes;Patients with extensive OpRegen bleb coverage of the atrophic area had maintenance or improvement of RPE and ELM layers compared to patients with limited OpRegen bleb coverage.Resolution of complete RPE and outer retinal atrophy (cRORA) near borders of baseline GA were observed in cases with extensive coverage:Signs of improvement in areas of cRORA included: greater hyperreflectivity at the level of RPE/ Bruch's membrane (BM); less choroidal hypertransmission; reduction of retinal subsidence, and greater continuity of outer retinal layers.OCT imaging with segmentation analysis may be advantageous in assessment of retinal integrity following OpRegen treatment:OCT enables quantitation of changes in RPE and outer retinal structure (such as ELM loss) not possible with FAF imaging following OpRegen subretinal delivery.One patient in Cohort 4 maintained improvement in visual acuity at 4 years post-treatment in the study eye (+3 letters read), compared to losing 30 letters in the untreated eye.Overall, these data suggest that OpRegen RPE cells may provide support to the remaining retinal cells within atrophic areas by counteracting host RPE cell dysfunction and loss.Further assessment of the optimal disease stage for intervention and target delivery location of OpRegen in a larger clinical study is needed to confirm these preliminary findings.A Phase 2a study evaluating the success of OpRegen delivery to target areas of GA is currently enrolling patients (ClinicalTrials.gov: NCT05626114).Dr. Banin’s presentation is now available on the Events and Presentations section of Lineage’s website.
The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC by a group of 73 ophthalmologists. ARVO is the largest and most respected eye and vision research organization in the world. ARVO members include nearly 11,000 researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For more information, please visit https://www.arvo.org/ or follow the association on Twitter @ARVOInfo.
About OpRegen®
OpRegen is a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. Following subretinal delivery, OpRegen has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal structure and function. OpRegen is being developed under a worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group.
About the 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. 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 are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on 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 OpRegen in patients with GA secondary to AMD; the significance of clinical data reported to date from the Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration and visual function improvements; and the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen. 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 competing alternative therapies may adversely impact the commercial potential of OpRegen; 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; 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. 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/20230426005108/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1 year ago
NEWS -- Q4 2022 Lineage Cell Therapeutics Inc Earnings Call
Participants
Brian M. Culley; CEO, President & Director; Lineage Cell Therapeutics, Inc.
Gary S. Hogge; SVP of Clinical & Medical Affairs; Lineage Cell Therapeutics, Inc.
Ioana C. Hone; Director of IR; Lineage Cell Therapeutics, Inc.
Jill Ann Howe; CFO & Principal Financial and Accounting Officer; Lineage Cell Therapeutics, Inc.
Jack Kilgannon Allen; Senior Research Analyst; Robert W. Baird & Co. Incorporated, Research Division
Joanne Lee
Joseph Pantginis; Director of Research & MD of Equity Research; H.C. Wainwright & Co, LLC, Research Division
Kristen Brianne Kluska; Analyst; Cantor Fitzgerald & Co., Research Division
William McKinnie Wood; Research Analyst; B. Riley Securities, Inc., Research Division
Presentation
Operator
Welcome to the Lineage Cell Therapeutics Fourth Quarter and Full Year 2022 Conference Call. (Operator Instructions) An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com.
This call is subject to copyright and is property of Lineage. And recordings, reproductions or transmission of this call without the expressed written consent of Lineage are strictly prohibited. As a reminder, today's call is being recorded.
I would now like to introduce to you your host for today's call, Ioana Hone, Head of Investor Relations at Lineage. Ms. Hone, please go ahead.
Ioana C. Hone
Thanks, Mandeep. Good afternoon, and thank you for joining us.
A press release reporting our fourth quarter and full year 2022 financial results was issued earlier today, March 9, 2023, and can be found on the Investors section of our website.
Please note that today's remarks and responses to your questions reflect management's views as of today only and will contain forward-looking statements within the meaning of federal securities laws. Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K. We caution you not to place undue reliance on any forward-looking statements which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings.
With us today are Brian Culley, our Chief Executive Officer; Jill Howe, our Chief Financial Officer; and Gary Hogge, our Senior Vice President of Clinical and Medical Affairs.
With that, I'd like to turn the call over to Brian.
Brian M. Culley
Thank you, Ioana, and good afternoon, everyone. Welcome to our full year 2022 call. We appreciate you joining us today.
2022 was another challenging year for biotech companies, but I think it was an exceptional one for Lineage. We worked successfully alongside Roche and Genentech to prepare OpRegen for its next clinical trial, and that trial is now open and enrolling new patients.
With the positive tailwinds from the OpRegen program in place, we made bold but financially responsible moves to expand our pipeline, adding a photoreceptor program, which capitalizes on our experience and success in ophthalmology and by adding an auditory neuron program, which is the first time we've shown that we can not only improve upon existing assets, but also create them from scratch in our R&D labs, vastly reducing any third-party financial obligations from these in-house product candidates.
2022 also marked a year of important and successful clinical and regulatory execution for the Lineage team as we advanced our clinical programs along their respective developmental pathways.
I realize this is a 2022 recap call, but I know a lot of investor attention is presently focused on the dry AMD landscape. So I thought that would be a better way to use my opening remarks.
Last month, FDA approved a complement inhibitor to treat dry AMD. And with this approval, the FDA has set a precedent that anatomical change in the form of photoreceptor preservation is an approvable endpoint in this condition. We believe this is an enormous regulatory decision for us because the data we have collected to date with OpRegen and its ability to improve outer retinal structure and either halt or even reverse the progression of GA is far greater than what has been demonstrated by either of the leading complement inhibitors.
Critics sometimes say that we've only shown these results in a small number of patients, but I will remind them that we are seeing changes which do not occur spontaneously, and we're reporting these via multiple independently verified analyses using objectively captured anatomical images. So on this basis, we believe these early and exceptional results are likely to be repeated in larger studies.
When I look at the error bars surrounding the point estimates on the Phase III trial for the complement inhibitor, which recently gained FDA approval for which only a small reduction in GA growth is provided, I think it's highly likely that all 5 OpRegen patients, which Roche and Genentech reported on at the ARVO Annual Meeting last year have shown greater reductions to the area of GA than all of the more than 1,200 patients treated in the clinical trials, which supported that drug's approval.
Furthermore, we have demonstrated not only anatomical changes but also functional improvements to patients' vision with an average of 7.6 letters gained among all Cohort 4 patients and increasing to 12.8 letters gained among the 5 patients who received extensive coverage of OpRegen cells across their GA and who additionally exhibited outer retinal structure improvements measured 12 months following transplant in our Phase I/IIa study.
Recently, a number of outlets have been reporting that a different complement inhibitor can provide functional benefits to vision. The evidence which that company provided was a post hoc exploratory analysis, which is something my former colleague likes to call drawing the target around the arrows after they're fired. This selective data cuts sought to make the case that patients on treatment were less likely to lose 15 letters at 12 months than patients on placebo.
Despite this data similarly being in a very small number of patients, representing only 5 to 10 patients of all patients treated on that trial, it actually was quite well received by the investment community. And for this reason, I will again draw the comparison that OpRegen data, which was reported at ARVO by Roche and Genentech showed 25% of patients in Cohort 4 gained at least 15 letters. They didn't avoid loss. They gained vision. So we're talking about comparisons, which are as large as a 30-letter delta between these approaches.
Obviously, it's a huge benefit for patients and the medical community to finally have something which may help some patients with their condition, but it appears to us that there is a tremendous amount of clinical benefit, which could still be provided. Benefits which monthly injections of complement inhibitors have not shown. It's very important for our results to continue being presented at major medical meetings and help the medical and investor communities become aware of the efficacy, safety and other attributes of our product candidate profile.
One of the additional potential advantages of the OpRegen product profile is in dosing and administration. OpRegen treatment involves a single 30-minute procedure rather than giving patients an injection every month or 2, year after year with all the compliance issues, which accompany it. For this reason, we often are asked how long our treatment lasts. But we don't yet know because we haven't reached a clear terminus or an indication of the benefit tapering.
I've mentioned on prior calls, that we have patient data going out as long as 5 years in some cases, including our very first patient with structural improvement who after 4 years has lost 30 letters in her untreated eye, which, by the way, was her better performing eye at baseline. But she was still 3 letters higher than her baseline level of visual acuity in her OpRegen-treated eye. Again, that's data coming 4 years post treatment in a disease which is widely viewed as inevitably progressive.
Long-term follow-up from the Phase I/IIa study is still ongoing, which allows us to continue to monitor evidence of the duration of treatment effect. And there may be more to come from deeper imaging analyses as well. Next month, some of that data from our Phase I/IIa trial will be made available at the 2023 ARVO Annual Meeting on April 25. That will be presented by Dr. Eyal Banin on behalf of Roche and Genentech. And as always, data updates are important disclosures, and we look forward to this next one happening in just a few weeks.
Meanwhile, we're excited about the ongoing Phase IIa study, which Roche and Genentech has launched to evaluate the safety and efficacy of OpRegen as well as certain delivery techniques. It is difficult to predict when that trial will have data available because it has an enrollment range of 30 to 60 patients. But regardless, the primary and secondary outcome measures for that study will all occur at 90 days. So the primary observation period is very brief compared to what we usually expect from dry AMD studies.
Genentech has disclosed 2 enrolling clinical sites so far in Cincinnati and Sacramento, both of whom participated in our Phase I/IIa study. Dr. Christopher Riemann, the PI from the Cincinnati Eye Institute is a former Lineage site PI who treated one of the original retinal restoration patients, and we appreciate his and Dr. Telander's continued participation in the OpRegen trial, and we expect more sites will be coming online this year.
Moving next to our spinal cord program. You'll recall that a lot of our work last year focused on activities to support regulatory interactions for OPC1, which we successfully completed as planned. Our response to an RMAT interaction with a comprehensive data package was submitted to FDA to support the use of the new delivery device, along with a clinical protocol synopsis for the small safety study we plan to conduct in sub-acute and chronic patients, and which I've discussed previously on several occasions.
We have been in active dialogue with FDA and have been responding to additional requests for information following our initial RMAT package submission. We anticipate another formal interaction to occur with FDA in the second quarter, a Type B meeting, which we hope will support submission of our planned IND amendment in the second half of this year. Assuming the necessary clearances are received, our plan is to initiate the open-label device safety clinical study known as the DOSED study in 5 to 10 patients with either subacute or chronic injuries as soon as we're able.
We also remain in frequent contact with the California Institute for Regenerative Medicine, and we continue to plan to apply for a grant to support the device safety study. As most of you are aware, CIRM guidelines state that an applicant must provide communication from FDA indicating that it's safe to proceed with a proposed clinical trial protocol. So therefore, the timing of the submission of our grant application will be contingent on and subsequent to receipt of FDA clearance to initiate the dose study.
For VAC2, we submitted our pre-IND meeting package as planned, actually a little bit earlier than we planned and have already received feedback from FDA. Our emphasis in the pre-IND package was to understand the FDA's view of our production process and the analytical methods, which we propose to use to manufacture and characterize our clinical material. Their feedback was generally positive and provided us with a clear and actionable path to an IND submission.
Any future IND filing would naturally be expected to include supporting clinical data from the Phase I study of VAC2 conducted by Cancer Research UK. We currently are still awaiting those data and were recently informed by Cancer Research UK that it's expected to be available during the second quarter of 2023. This data would be an important component of any potential IND so we will be in a better position to update you on our VAC plans at that time. In the meantime, we will continue to monitor the changing landscape of DC vaccine product candidates and their evolving clinical data.
We've also continued to engage in manufacturing and preclinical activities for our 2 new cell transplant programs in hearing loss and vision disorders, both of which were publicly launched last year. Initial preclinical studies from our photoreceptor program are currently ongoing, and we hope to be able to present top line preclinical data once the appropriate patent submissions have been made and as data become available.
Last month, we also announced the initiation of preclinical testing with our auditory neuron program in a collaboration with the University of Michigan with initial preclinical data anticipated to be available later this year. I'd like to remind everyone that Lineage's hearing loss program didn't even exist at the beginning of last year, and yet we've already started in vivo preclinical studies. Notably, we've been able to advance this program to that stage while spending less than $1 million of our R&D budget. We believe that speed and return on our R&D investment dollars are illustrative of the efficiency and versatility of the Lineage platform.
We showed the ability to advance from a little more than a product concept then develop new differentiation methods to generate intellectual property and execute on the manufacture of a specific cell type, then proceed into in vivo testing in less than 12 months and with an investment of less than $1 million. When we compare the money and time we invested to move a new program from concept into in vivo testing against the industry norms for a small molecule making the same journey, we find striking differences in the return on invested capital. And as we continue to improve our capabilities and our homegrown programs advance further, I think it will become increasingly apparent that the Lineage platform has tremendous untapped potential.
Our goal will be to unlock that value in the months and years ahead, both internally and through partnerships while still maintaining a prudent financial balance between the exciting progress occurring with OpRegen and our expansion activities with our pipeline.
This brings me next to a few comments about our most recent business development transaction. As you know from prior calls, I have said that we are emphasizing business development, and that includes in-licensing, out-licensing and joint development projects. Our most recent deal is an option agreement with Eterna Therapeutics, which gives us an affordable way to gain access to several new technologies, which fit within our overall strategic approach. These staged investments in technologies are intended to provide us with certain advantages and help set the foundation for the type of company we aim to become.
Because our confidence in the future success of OpRegen has increased upon the recent regulatory precedent set by FDA in dry AMD, we believe this is the right time to apply our technology in other areas. That is where the Eterna deal fits into our overall strategy. It provides us with an opportunity to gain experience in 3 new areas: gene editing, hypoimmunity and induced pluripotent stem cells or iPSCs. These 3 complement and are expected to bolster our in-house manufacturing and directed differentiation capabilities.
Gene editing offers us an opportunity to modify the behavior and functionality of cells and engineer new features before they are transplanted. This ex vivo editing allows us to fully characterize an edited cell line prior to it being administered to a patient. In some cases, we may look to add genes and thereby add functionality, while in other cases, we may look to delete genes, which may help with the tolerability or the durability of a transplant. Editing also gives us a competitive edge because it makes our products difficult to copy, and it may give them better clinical outcomes.
As we explained in the press release announcing the Eterna agreement, we will be utilizing a B2M deficient cell line, which is a feature associated with lower chances of transplant rejection. We don't see hypoimmunity as relevant to our existing programs because we've never received a reported rejection of our OpRegen or OPC1 cells and that's going out as long as 10 years in patients with spinal cord injury or as long as 5 years in patients with dry AMD. But the eye and spinal cord are known to be tolerant locations for cell transplants. If we want to expand our technology to other areas of the body, we need to consider whether hypoimmunity could be beneficial and ensure that all of our product candidates have an appropriate and suitable commercial product profile. We think hypoimmunity could be an interesting feature for potential new product candidates.
The third new aspect of this deal is the use of an iPSC line. We already have intellectual property for certain platform inventions and uses of iPSC cells, but exercising this option could lead to our first product candidate built from day 1 on an iPSC cell line. We know from experience that the quality and performance of iPSC lines can vary widely, and we'll be keen to see how these cells behave in our hands. Regardless, experience with both iPSC and ES lines is rare and we'll give Lineage yet another point of differentiation compared to the competition.
Overall, we're very excited about this deal because we believe it provides us with access to multiple new technologies but with a relatively modest cost structure. We anticipate providing updates under this collaboration later this year.
Overall, while many cell therapy and gene-editing companies struggled badly last year, reducing headcounts and/or deprioritizing programs, we broadened our pipeline and advanced each of our 5 programs. We made a number of key hires and expanded our research space in both California and Israel, but we did this with very responsible and stepwise investments to help ensure we have capital to reach additional milestones and important events.
I believe the company made exceptional progress in 2022 and our efforts during 2023 will remain focused on the further progression of our allogeneic cell therapy programs, making responsible investments in disease settings where we believe we can have a meaningful impact and the continued prioritization of both new and existing collaborations, all and each in support of our overarching vision of building Lineage into a leading cell therapy company.
With that, I'll now hand the call over to Jill for a discussion of our financials.
Jill Ann Howe
Thanks, Brian, and good afternoon, everyone.
Beginning with our balance sheet, I believe we continue to be efficient with our spending and are well capitalized to conduct the near-term activities, which Brian just outlined. Our reported cash, cash equivalents and marketable securities as of December 31, 2022, totaled $57.9 million, which is expected to support our planned operations into Q3 of 2024. Please note, this does not account for any of the Roche Genentech milestones, which we may receive nor for any business development or grant revenues, which we may receive during this same period.
Let me start with an overview of our fourth quarter 2022 operating results. Our revenue is generated primarily from licensing fees, collaboration revenues, royalties and research grants. Total revenues for the fourth quarter were approximately $1.9 million, a net increase of $0.7 million as compared to $1.2 million for the same period in 2021. The increase was driven by the recognition of deferred collaboration revenues in connection with the Roche agreement, which we entered into in 2021.
Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expense for the fourth quarter were $8.5 million, a decrease of $20.7 million as compared to $29.2 million for the same period in 2021. The overall decrease was almost entirely driven by a decrease in R&D expense due to the Roche collaboration. R&D expenses for the fourth quarter were $4.1 million, a decrease of $20.7 million as compared to $24.8 million for the same period in 2021. The decrease was substantially driven by the prior year $21 million accrual for financial obligations payable to the IIA and Hadasit in connection with the $50 million upfront payment received in early 2022 under the Roche collaboration. This decrease was partially offset by $0.1 million and $0.2 million in new expenses to support the development of the photoreceptor and auditory neuron cell therapy programs, respectively.
G&A expenses for the fourth quarter were $4.3 million, a decrease of $0.1 million as compared to $4.4 million for the same period in 2021. The decrease was driven by a $0.4 million in legal and litigation expenses. Loss from operations for the fourth quarter were $6.6 million. This is due to a decrease of $21.6 million as compared to $28.2 million for the same period in 2021, principally owing to Roche collaboration-related expense accruals of $21 million, as I had previously mentioned.
Other income for the fourth quarter was $0.3 million compared to other income of $0.2 million for the same period in 2021. This variance was primarily related to the change in the value of marketable equity securities as well as exchange rate fluctuations related to our international subsidiaries for the applicable period. The net loss for the fourth quarter was $6.4 million or $0.03 per share compared to a net loss of $29 million or $0.17 per share for the same period in 2021.
Now let me move on to our full year 2022 operating results. Revenues for the full year were $14.7 million. This represents an increase of $10.4 million compared to $4.3 million for the same period in 2021. Again, the increase is primarily related to revenues recognized from the $50 million upfront payment from the Roche collaboration. Total operating expense for the year was $36.5 million, a decrease of $15.6 million as compared to the $52.1 million for the same period in 2021.
Total R&D expense for the year was $14 million, a decrease of $19.9 million as compared to $33.9 million for the same period in 2021. The decrease was substantially driven by the prior year $21 million accrual for financial obligations payable to the IIA and Hadasit. This decrease was partially offset by $0.7 million and $0.5 million in R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.
Total G&A expenses for the year were $22.5 million. This is an increase of approximately $4.3 million as compared to $18.2 million for the same period in 2021. The increase was primarily attributable to $2.1 million in litigation and legal expenses, $1.3 million in salaries and related benefit fees and $0.9 million in share-based compensation expenses.
Losses from operations for the year were $22.5 million, a decrease of $26.7 million as compared to $49.2 million for the same period in 2021. Other income and expenses for the year netted an expense of $3.3 million compared to other income of $5.9 million for the same period in 2021. The net variance was primarily related to a prior year gain on sale of marketable equity securities as well as exchange rate fluctuations related to our international subsidiaries for the applicable period.
The net loss for the year was $26.3 million or $0.15 per share compared to a net loss of $43 million or $0.26 per share for 2021. Overall, we intend to maintain the same spending discipline that we have adhered to for years and which has served us well in the past. The biotech markets continue to face uncertainty, so we believe that maintaining discipline with our spending will continue to allow us to maintain our plan to reach meaningful milestones and create value for shareholders from our investments in our programs.
Now let me hand the call back to Brian.
Brian M. Culley
Great. Thanks, Jill.
Circling back to the beginning of this call, I continue to think that Lineage is doing quite well in an otherwise strained environment for the biotech industry. We have been hitting our milestones and advancing our programs in a responsible and positive way. And I expect Jill and I will continue to apply the same financial discipline to our programs this coming year.
Our approach helped us land a valuable collaboration with Roche, and I believe it will continue to be an important attribute during 2023. And further out, as our programs demonstrate success in the clinic or in preclinical testing and potentially attract additional, nondilutive support, I believe, we'll have opportunities to accelerate our work across a number of parallel paths.
Broadly speaking, a few things we'll be working on this year and which you may want to watch for updates on include additional data from the completed Phase I/IIa trial of OpRegen, which we expect next month; additional regulatory progress with OPC1, which we will conduct during the second quarter of this year and which will support OPC1 returning to clinical testing. And we'll be doing our part to support the manufacturing and Phase IIa study of OpRegen being conducted by Roche and Genentech, the results of which we believe could be a seminal event, not only for Lineage but also for the entire GA field.
In addition, we've planted a few seeds to prepare for the future, including our new preclinical programs and the Eterna option deal which gives us affordable access to new technology, which we can combine with our existing capabilities and the furtherance of our goal of using the transplant of whole cells to change the course of disease in new and exciting ways.
And with that, Mandeep, we are ready to respond to any analyst questions that there may be.
Question and Answer Session
Operator
(Operator Instructions) Our first question comes from the line of Jack Allen from Baird.
Jack Kilgannon Allen
Great. Congratulations to the team on all the progress made over the course of the quarter. Brian, you did a great job laying out some of your thoughts around the recent news in geographic atrophy, but I was wondering if you could dive a little bit more deeply into some of the conversations you have with your partner Roche on the heels of this announcement. Any sense as to how soon we could see data? I know you did make a comment as you said earlier, but I'd love to hear any more feedback from the ground there? And then I have one quick follow-up as well.
Brian M. Culley
Yes. Thanks, Jack, for the question. The shortest possible answer is no, nothing to add. The biggest challenge, I think, is the enrollment range being 30 to 60, makes it really difficult to say when, where and how the public disclosure of data will occur, whether it will come in pieces or major medical meetings and so forth. But I do suspect that as we get closer to that event for those events, that we might be in an opportunity to provide more clarity and expectation around it.
Jack Kilgannon Allen
Great. Great. And then my other question, a little bit out of the box here. I'm not sure if you've seen the news coming from some of the medical suppliers here. But it's been hard to get your hands on nonhuman primates or at least it could become more pressing to get your hands on non-human primates given some of the updates from some of the players in the space. I was wondering if you had any comment as it relates to your preclinical activities and the use of these valuable research assets and how you're factoring that into the timelines there?
Brian M. Culley
It's a great question. Part of the answer is that we do not do any nonhuman primate testing. So we haven't -- we're not susceptible to a supply challenge. But by chance, I was looking early this morning at a similar company's slide deck and noticed that they were reporting a lot of data in NHP. And it occurred to me, I wonder if that is an issue for them. It's not for us. I don't know how others are managing it, but we have, ever since COVID began, we have worked to ensure that our supply chains are in good order, and we benefit by being a multinational company in that way. But specifically to NHPs, we don't have any clinical -- excuse me, any preclinical activity utilizing that particular species.
Jack Kilgannon Allen
Great. I congratulate you again on all the progress made over the course of the quarter.
Operator
Our next question comes from the line of Mayank Mamtani from B. Riley Securities.
William McKinnie Wood
This is William Wood on Mayank Mamtani. Congratulations, Brian, to you and the team, really excited to see all the progress you've been making and looking forward to the upcoming work. A couple of questions here from us. We're excited, obviously, to see that you've got the upcoming OpRegen data at ARVO in April. Would be -- I know you've touched on this already a little bit, but it would be great to hear what we might be able to see as far as new or incremental maybe surrounding or remind us how your OTT anatomical results tend to correlate with visual acuity given pretty long follow-up that you've had now all treatment. And then also to clarify, have you or your partner Roche seen the value of cutting BCVA data in terms of a rate of vision loss by greater than 15 letters or 3 lines?
Brian M. Culley
I appreciate the questions, William. I'm going to hand off to Gary to speak to those. Thank you.
Gary S. Hogge
Yes. So obviously, there's a lot of new and buzz around the BCVA and cutting it -- looking at 3-line loss over time. The good thing is that we examine it closely throughout and in the Cohort 4, which is the optical population that is involved in those studies, we haven't had a 3-line loss in any of our Cohort 4 patients. So that's certainly something to be intrigued about. Smaller numbers we know, but it looks like we've maintained those visual improvements that we've observed over time we reported out.
And the data coming up at ARVO, we'll focus on looking at different analysis of the OCT assessment. And how quickly those changes occur and how they tie into the visual acuity improvements, particularly in those patients that showed signs of outer retinal structural improvement. And so we're very excited to have this data, again, presented by an entirely independent analysis.
William McKinnie Wood
I appreciate that extra color there. And then also just to clarify, do you know the timing of the release of ARVO abstracts and then whether you expect that the abstract presenter may comment on the Phase II enrollment status since there is a meaningful overlap in trial sites there?
Gary S. Hogge
Yes. So as per the ARVO website, it will be available sometime in early March, so perhaps in the next week or 2. With regards to Dr. Banin and his ability to comment on the future or the ongoing study that is conducted by Genentech and Roche, I don't think he'll be able to offer any additional comments at this time.
Brian M. Culley
And William, I'm going to add here. I don't think I'm putting Roche on the spot. But as a general matter, when we were running the Phase I/IIa, these were the first 24 people on the planet to ever receive this experimental therapy. Now that there is a basket of safety and efficacy data available, it makes me think that the conversation between a prospective patient on the clinical trial and their doctor might go a little differently because they could actually show some results that are available in the public domain. So I am hopeful, although I have no specific information because the trial is just underway, but I'm hopeful that enrollment will go faster than it was when we were running it.
William McKinnie Wood
Got it. That's really helpful. And then one last one, switching gears. In regard to your ANP1, there's obviously been a number of players in the hearing space, a lot of them incorporating Intratympanic administration. Just curious what your plans are on delivering the cells into the inner ear. I know you mentioned that it could be a good combo for cochlear implants, but I don't think you're going to be limiting to that. Maybe just walk us through your plans there.
Brian M. Culley
Yes. So I think what the right way for me to describe is that we have a lot of good ideas, but they need to be tested. And so we're not today in a position to say a whole lot more about an intended patient population or exactly what the right clinical application will be. There are many causes of hearing loss. We're going to follow the data that's collected. And right now, we're just at the very earliest stages of that process. So it's difficult, but I think as we reject some hypotheses, reject some options and begin to narrow down what we think is the best approach, that will be something we'll look forward to sharing when we are able to do so and feel confident in that information.
Operator
Our next question comes from the line of Kristen Kluska from Cantor Fitzgerald.
Kristen Brianne Kluska
So we've talked a lot about how a GA approval in general, could help to better educate the market. But perhaps I'll ask you the question from a different direction. How do you think that the emergence of these commercial complement inhibitors can help frame eligible patients by the time OpRegen potentially reaches the market? So I know you've shown that if patients are perhaps too far along towards legal blind status, they may not be eligible. So do you think that patients should they be compliant on these complement inhibitors could become eligible given there's at least some slowing of the progression?
Brian M. Culley
I love it. We have a market leader that is going to condition a market to accept a new therapy in an environment where there are no approved therapies today. And I think there are a couple of places where that could be beneficial. There are technologies out there that are helping people to identify this disease earlier. So I think we're going to see an increase in the prevalence through identification of patients. And I think most companies with these therapies in development are thinking that earlier patients are sort of more suited for therapy. And I also think that the aging population is going to increase the incidence of the condition.
So if you imagine that when my dad was first diagnosed with dry AMD that he would have been told, "We're sorry, there's nothing we can do for you, Mr. Culley." But now, he would be brought in. He would have a specific caregiver. Presumably he would be on therapy. And now he's a little bit of a captured population.
So if you come along with the second, third or fourth treatment in a disease setting, you benefit from the precedent and the awareness of an educated patient population. So I would not feel so positively about it if we had a MeToo therapy. But because our therapy is so wildly different, and I'm hopeful we'll continue to look so different in terms of its product profile, I think that it's actually a big positive for us.
Kristen Brianne Kluska
Okay. And given the data here and of course, the validation from Genentech and Roche, I'm wondering how you're thinking about this pathway with some of your earlier candidates as you start to do some work here? So do you like potentially establishing some proof-of-concept data in-house before potentially seeking partnerships similar to what you saw here? And then can you detail for us some of the preclinical work that you're intending to conduct near term?
Brian M. Culley
So with respect to the strategic component of your question, which has to do with partnering, I think the answer is that it very much depends on the cost of development that you're facing, your probability of success, the macroeconomic business environment you're in, your cost of capital, all of these factors are sort of fun decisions that companies with multiple assets get to make.
So we don't have a priority, a plan to either partner or not partner any of our assets. We look at them as assets that have optionality and flexibility. We just try and make them as valuable as possible so that if we do elect to enter into a partnership that we can find that partnership to be financially rewarding and strategically valuable. And that means partnering with people who have high capabilities and are going to increase the probability of success.
I do think from an approach that the success that we've had so far and we will continue with the OpRegen program does create a certain amount of a halo effect on other assets. Clearly, we are working with different cell types, and so there's not a perfect apples-to-apples comparison. But conceptually, the notion that cells are capable of doing things that are beyond the reach of small molecules is a notion that we think is being borne out in the setting of dry AMD, and we believe will be applicable in other settings.
And I could refer to this morning there was a trial that was unsuccessful in the setting of spinal cord injury utilizing a particular scaffold. There were no biologics involved. It was just pure scaffold. Unfortunately for patients, that was not a study that was successful. But again, to me, that is another reminder in the field that sometimes the standard or expected approaches just aren't quite strong enough when the condition is very severe as in the case of cells that are dying off that goes far beyond a single pathway and getting to the level of the entire cell or the cell has been destroyed through an accident or some sort of trauma such as the case of spinal cord injury.
Kristen Brianne Kluska
Thank you, Brian. Looking forward to seeing the data in a few weeks.
Operator
Our next question comes from the line of Joe Pantginis from H.C. Wainwright.
Joseph Pantginis
So Brian, I wanted to focus on your 2 leading regulatory discussions, and I'll start with VAC2 if you don't mind. So obviously, you talked about the pre-IND discussions right now are surrounding production processes as well as characterization of the cells. So I was curious how do those processes differ, if any, from what CRUK is doing?
Brian M. Culley
Thank you, Joe, for that question. I would say that the similarities in the process, they exist, but one of the reasons that we exercise the option is that we saw an opportunity to improve upon those processes. I want to be really clear for everyone listening that each cell type that we try to manufacture demands and requires its own unique set of steps. So we do not have a one-size-fits-all differentiation secret sauce that we apply to different cell types. It really is a laborious effort to figure out how to get these cells to behave in the way that we want so that we're only manufacturing the cells which we desire to be used in the clinic.
So in the setting of the DCs, which we manufacture, we've made great strides in improving the characterization of those cells and some of that data and information has been provided to FDA so that they can see what we would plan to use going forward.
So there definitely are some differences relative to what we were making -- or excuse me, what was being used by CRUK. But at the end of the day, there are release criteria and properties that are consistent across the material. So it's not like it's a different cell type that would necessarily lead to large differences in clinical behavior. We really have been satisfied with the clinical performance. We're looking more to how we can optimize it, how can we scale and get better production costs and make it more affordable and allogeneic off-the-shelf option for patients and how can we increase the potency, perhaps lower the dose. These are all things that we are working on to see if we can improve a product profile in what is otherwise very much a challenging clinical setting.
Joseph Pantginis
That's really helpful. And then just switching over to OPC1. I was hoping to get even some broad strokes at the minimum, the types of questions that have been going back and forth between you and the FDA and how that's translated into what your wish list looks like going into the Type B meeting?
Brian M. Culley
That's a great question. I would say the vast majority of the content in the materials that we've been sharing with the FDA and the questions they've been coming back with have to do with the new device. This is a device that has not been used before for this purpose. And so they have a lot of questions about how it will be used and how it will perform.
What provides us with some comfort and confidence is that the components that actually go into or touch the patient are the same. The cells that are being used are the same as before. The needle is the same type of needle. Everything that's different with the Neurgain device is actually external to the patient.
So I think from a performance perspective, I feel confident that we will have a good outcome from this study. But nevertheless, the FDA is going to be prudent and want to understand how do all these manipulators work, how do they attach, what happens in a fail situation? What's the worst case scenario? Very standard types of information-seeking questions that we've been getting. And I'll ask Gary if there's anything that he -- that comes to mind that he'd like to add to that question, Joe.
Gary S. Hogge
Yes. Just to add that there's nothing unexpected, but many of these are first time in human use when they assembled together as an entire component. And so they want a demonstration of if you pass the cell through, is it still viable and potent ones that goes through the needle and syringe. Are the components -- what's the pH of the components, what's the software look like? They are all questions that we've got to address. Many of them involve very complex detailed reports and analysis, and that's what the back-and-forth questions have been. Nothing unexpected, but many -- much of it takes time.
Operator
Our final question comes from the line of Jason McCarthy from Maxim Group.
Joanne Lee
This is Joanne Lee on the call for Jason. Just 2 around OpRegen. My first one is regarding the recent approval from Apellis, which we noticed was purely based on disease trajectory with no benefit on visual acuity. Now that we've seen a willingness from the FDA to prove based solely on structural changes in geographic atrophy, does the upcoming data at ARVO take a greater importance for OpRegen? And how does this impact the importance of also demonstrating functional benefit in patients with GA?
Brian M. Culley
Thank you for the question, Joanne. I think that the ARVO data is going to be important because there will be parts of that data that have not been shared before. And we're working with a product candidate that is being discussed as being capable of creating anatomical changes far beyond that of the leading candidate and the more recently approved complement inhibitor. So I think any new data on our approach is definitely meaningful to the field.
With respect to the second part of your question, how does it change the calculus on function? I think it's notable that the data from that recently approved asset essentially proves with statistical significance that they do not affect the visual field. So I think that the opportunity to provide a greater clinical benefit in patients is sitting there for the taking for whichever approach and whichever company can find it because the standard of care clearly has -- unquestionably has no effect on visual function. So I see that as a great opportunity, and I think that we are one of the most important contenders to grab that opportunity.
Joanne Lee
Got it. I appreciate the details. And then just given the differences in mechanism behind complement inhibition and retinal restoration, how would you expect a one-and-done treatment like OpRegen could fit in with complement targeting drugs like Empaveli and others. Would this be something patients could perhaps take and then afterwards on a follow-up receive complement inhibition to further prevent damage? Curious to see how you'd imagine OpRegen could be positioned in the treatment landscape?
Brian M. Culley
I imagine myself as a patient looking at 2 product profiles, one that requires a monthly or every other month injection in the eye. And I'm an elderly individual who has difficulty getting to a clinic 6 to 12 times a year and comparing that with a onetime procedure approximately 30 minutes, and I'm awake for it with multiple years, maybe a lifetime of benefit. So I think the product profile just screams preference, but I'm going to invite Dr. Hogge to add to my thoughts.
Gary S. Hogge
I think there's 2 ways you can look at it and both favor, hopefully, patient outcome. OpRegen potentially be used first and then follow up with a complement inhibitor. So if you take care of rest of GA (inaudible) RPE and keep the photoreceptors healthy. And then given it is an aged eye, then complement inhibition may further set up opportunities to succeed and be established for long-term benefit.
Alternately, if you keep complement inhibition first, decreased inflammatory cascade is ongoing, put in OpRegen cells, and they may be even more likely to succeed. But bottom line, the earlier intervention -- the early identification of a much larger patient pool will help both patients and physicians treating them.
Brian M. Culley
Thank you, Joanne. I'm going to actually combine your question a little bit with the question that we got from Kristen Kluska from Cantor because one of the sort of fun ways I think about the complement inhibitor is that it's sort of like one of those tower defense video games where it's slowing a process. So you can imagine there will be more patients in the hot zone, the addressable zone that could be treated by us. So in terms of the utility of OpRegen if a complement inhibitor becomes established, I think, again, you could see a greater number of patients that exist in that addressable patient population spectrum because some of the very early individuals with dry AMD who get on to complement inhibition, if, in fact, they are on for years and there's 20% or so less progression, they might still be within an addressable profile for our product at some point in the future.
Joanne Lee
Great. Appreciate the additional color. Congratulations on all the progress, and we'll be looking forward to the data at ARVO.
Operator
I would now like to turn the call over to Brian Culley for closing remarks.
Brian M. Culley
Well, thank you, everyone. We absolutely and sincerely appreciate your support of Lineage as we look to position ourselves as a leader in cell therapy and cell transplant medicine. Thank you very much for joining the call today, and have a great rest of your week.
Operator
Thank you, ladies and gentlemen. This does conclude today's call. Thank you for your participation. You may now disconnect.
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