Lineage Cell Therapeutics, Inc.

CARLSBAD, Calif.--( BUSINESS WIRE )-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the International Society for Stem Cell Research (ISSCR) 2024 Copenhagen International Symposium , PSC-Derived Cell Therapies: Clinical Advances, NextGen Technologies, and the Path to Success. Mr. Culley has been invited to participate as part of a panel entitled “Clinical Trial Updates: PSC-Derived Therapies of the Eye,” on Wednesday, October 2 nd , 2024, from 10:30 am to 12 pm CEST. The panel is being chaired by Kapil Bharti, Ph.D. , Senior Investigator and Scientific Director, Ocular and Stem Cell Translational Research Section at the National Eye Institute (NEI), and will also feature executive presenters from Vision Care and Regenerative Patch Technologies, Inc. The 2024 Copenhagen International Symposium will take place October 2 – 4, 2024 at The Black Diamond, Royal Danish Library, Copenhagen, Denmark, and is being presented by the ISSCR in partnership with Novo Nordisk. 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, 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 ). The 2024 Copenhagen International Symposium presentation, “ OpRegen ®️ : A Suspension Of Allogeneic Retinal Pigment Epithelial (RPE) Cells In Patients With Geographic Atrophy (GA) Secondary To Age-Related Macular Degeneration (AMD) ,” will be available on the Events and Presentations section of Lineage’s website, following the conclusion of the ISSCR panel presentation. About The 2024 Copenhagen International Symposium: PSC-Derived Cell Therapies: Clinical Advances, NextGen Technologies, and the Path to Success Pluripotent stem cell-derived cell therapies are accelerating rapidly into clinical trials. The ISSCR, in partnership with Novo Nordisk, is pleased to invite attendees to Copenhagen, Denmark in October 2024 for an event that will gather pioneers at the forefront of ESC and iPSC-derived cell therapies. Here, world-renowned scientists and innovators will share the latest updates on ongoing clinical trials, as well as groundbreaking platforms and technologies that will revolutionize the next generation of cell therapies for devastating and intractable diseases. For more information visit https://www.isscr.org/upcoming-programs/2024-copenhagen-international-symposium/#program or follow the organization on X/Twitter: @ISSCR . About the OpRegen Phase 1/2a Study The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. About Geographic Atrophy GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, “off-the-shelf,” cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell . Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. 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 OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients, that the ongoing Israel-Hamas war may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.

→ Kristen Mulholland will take over for the retiring Peter Fasolo as chief human resources officer at J&J on Oct. 1. “Peter has led J&J’s talent strategy for the past 16 years including remarkable leadership through the global pandemic and the separation of our consumer health business,” CEO Joaquin Duato said in a statement . “He leaves a legacy of strong leaders, deep bench strength and an inclusive, caring and patient-focused culture.” Fasolo is a Bristol Myers Squibb HR vet who left J&J to become chief talent officer for KKR , only to return in 2010. Mulholland started at J&J in 2005 and has spent nearly five years as head of human resources, global total rewards & enterprise HR functions. → Just do it: Amgen technology chief David Reese said in a LinkedIn post that the pharma giant has appointed Sean Bruich as SVP of artificial intelligence and data. Bruich moves into the pharma world after an 11-year run with Nike , where he vaulted to global VP, insights, data science & analytics. This is the second high-level AI hire by a major pharma in as many weeks — Pfizer just welcomed Berta Rodriguez-Hervas as its new chief AI and analytics officer. → In its biggest personnel news since Doug Williams ’ resignation , Sana Biotechnology has poached Dhaval Patel from UCB as the Seattle biotech awaits data readouts for its CD19-targeted allogeneic CAR-T therapy in a host of indications. Patel had a 10-year career with Novartis before he held the CSO post at UCB for nearly seven years, and he’ll have the same responsibilities at Sana under CEO Steve Harr . Sana said in its second-quarter update that the goal is to reveal data for SC291 in B cell malignancies — and such autoimmune diseases as lupus nephritis, extrarenal lupus and ANCA-associated vasculitis — sometime this year. “His expertise in immunology and autoimmune diseases make[s] him ideally suited to help advance our clinical pipeline,” Harr said in a statement . → Brian Di Donato , the CFO and head of strategy at Immunocore since May 2020 , is stepping down “at the end of the year” to take the CEO job at an unnamed San Diego biotech. Di Donato was the finance leader for Achillion when Alexion scooped it up for $930 million, and he’s also a board member at Jim Wilson joint iECURE , where ex-Achillion chief Joseph Truitt is CEO. → Telix Pharmaceuticals has separated its business into four separate entities: Telix Therapeutics , Telix Precision Medicine (diagnostics), Telix Lightpoint (medtech, from its acquisition of Lightpoint Medical ) and Telix Manufacturing Solutions . With these changes in place, Telix has tapped Richard Valeix as CEO of Telix Therapeutics, Kevin Richardson as Telix Precision Medicine’s chief executive, and Raphael Ortiz as CEO of Telix International . Christian Behrenbruch ’s title has been slightly modified to group CEO. Telix had hoped to join the Nasdaq in June with an IPO around the $200 million mark, but the Melbourne biotech made a gametime decision to pull those plans . → Cambridge, MA-based neuro player Cognito Therapeutics has promoted Christian Howell to CEO. Brent Vaughan had been running Cognito since 2020 after co-founding and leading the autism diagnostic specialist Cognoa , and he hired Howell as his chief commercial officer last October. Howell had a long career with Medtronic and then joined Aetion , where he was elevated to SVP and general manager of the emerging channels group (medical device, diagnostics, digital health, and government) in April 2023. → Elsewhere, Endo is also losing its president and CEO Blaise Coleman . Board member Scott Hirsch will serve in the interim as the company searches for a permanent successor. Hirsch joined Endo’s board in April, around the same time that the company sued the FDA over its approval of a generic version of Endo’s drug Adrenalin . Hirsch is the former CEO of Solta Medical and also held the roles of president of Ortho Dermatologics and CBO of Bausch Health / Bausch + Lomb . → Thomas Bock has handed in his resignation as CEO of Notable Labs , and CSO Joseph Wagner will take over the top spot on an interim basis. This isn’t uncharted territory for Wagner: He’s the former CEO of Oncocyte (2011-15) and Canadian I/O biotech BriaCell Therapeutics (2015-16). Notable Labs merged with VBL Therapeutics in February 2023 and will start enrolling patients in its Phase 2 study of the ex- Boehringer Ingelheim drug volasertib for acute myeloid leukemia “in the coming months,” the company said in July. → Delfi Diagnostics marked the beginning of the year with a new CEO it hired away from Illumina . Now, the competitor to Grail has brought on Thomas Russo as finance chief. Russo served in the same role at Icosavax and Assembly Biosciences . During his time at Icosavax, Russo helped with the company’s growth until its $838 million upfront acquisition by AstraZeneca . → Marea Therapeutics , the Third Rock upstart led by ex- Graphite Bio CEO Josh Lehrer , has selected Ian Clements as CFO. Clements resigned from the same post at Livmarli maker Mirum Pharmaceuticals in May 2023 after four years overall with the company, and he’s the ex-VP of investor relations for Dermira . Marea launched in June with $190 million in “combined Series A and B” funding, testing an ex-Novartis monoclonal antibody that targets ANGPTL4 in adults with metabolic dysfunction. → With ex- Synlogic CEO Aoife Brennan at the controls, a seemingly rejuvenated Eliem Therapeutics has named Brett Kaplan as COO and Nishi Rampal as SVP, clinical development. Kaplan had been president and chief financial & corporate development officer for epigenetic editing upstart Chroma Medicine , and he was also the finance chief at Prevail until Eli Lilly bought the gene therapy biotech for $1 billion. An Alexion vet, Rampal also handled the role of global development and strategy lead for the neuromyelitis optica spectrum disorder (NMOSD) treatment Uplizna as an executive director with Horizon /Amgen. Eliem’s hunt for strategic alternatives ended with the acquisition of Tenet Medicines and its anti-CD19 antibody budoprutug , once known as TNT119 . → Backed by RA Capital and Forbion , Navigator Medicines disclosed its $100 million Series A this week and the recruitment of Dana McClintock as CMO. McClintock spent six years in the same position at Alladapt Immunotherapeutics and was global head of the Office of I2O Innovation for Genentech . Navigator also said that Forbion general partner Wouter Joustra and RA Capital managing director Andrew Levin have made their way to the board of directors. → Alex Bastian has been named VP, commercial strategy at Swiss-based Memo Therapeutics , reuniting with CEO Erik van den Berg . Toward the end of van den Berg’s tenure as CEO of AM-Pharma , Bastian was the Dutch biotech’s VP, commercial & patient access. He also worked for Galapagos as VP, head of value & market access. → Structure Therapeutics , one of many biotechs developing a GLP-1 drug for obesity, has elected ex- Shire CEO Angus Russell to the board of directors. The 68-year-old Russell has chaired the board at Daxxify maker Revance Therapeutics since 2014 and has a board seat at Lineage Cell Therapeutics . → Ex- Vividion CEO Jeff Hatfield has joined the board of directors at Gate Bioscience , a California drug developer that launched last November with a $60 million Series A from several blue-chip investors. Hatfield chairs the board at Vividion and Rome Therapeutics . → Opna Bio has made room for Inozyme co-founder and former CEO Axel Bolte on the board of directors. The South San Francisco biotech also announced that it had dosed the first patient in a Phase 1 trial of its multiple myeloma candidate OPN-6602 and appointed Myeloma Investment Fund managing director Stephanie Oestreich as a board observer.

Former Shire CEO brings more than 30 years of experience in building and scaling companies in the global biopharmaceutical industrySAN FRANCISCO, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and pulmonary diseases, today announced the appointment of Angus C. Russell to its board of directors. Mr. Russell previously served as Chief Executive Officer of Shire plc and brings more than 30 years of experience in building and scaling companies in the global biopharmaceutical industry. “Structure is at an important moment in its evolution as we prepare to advance our oral small molecule GLP-1 agonist, GSBR-1290, into late-stage clinical development for obesity,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “Angus is a seasoned biopharmaceutical leader with significant expertise across multiple company functions including strategy, finance, operations, and commercialization. His experience in building and scaling companies will help lead us into our next chapter of growth as we continue to progress our broad pipeline of oral small molecule therapeutics—all derived from our structure-based drug discovery platform—to make them more accessible to all.” “Structure’s GSBR-1290, 2nd and 3rd generation assets, and next-generation oral combination programs have the potential to establish a cycle of continuous innovation in the obesity market to meet the evolving needs of millions of patients while maximizing accessibility,” said Mr. Russell. “Structure’s lead program, GSBR-1290, is just the beginning in the important space of metabolism and obesity. I am thrilled to join Structure’s board of directors to help lead the company into the future.” Mr. Russell served as Chief Executive Officer of Shire plc, a biopharmaceutical company from June 2008 until April 2013, Shire’s Chief Financial Officer from 1999 to 2008, and a member of its board of directors from 1999 until 2013. While CEO at Shire, Mr. Russell was also the Chair of Shire’s Leadership Team and a lead member of the Shire Management Committee, which designed and implemented the company’s immensely successful long-term business strategy. Prior to joining Shire, Mr. Russell served at AstraZeneca plc, a pharmaceutical and biologics company, most recently as VP of Corporate Finance. Mr. Russell served on the Board of Directors of Mallinckrodt from August 2014 to June 2022 and of TherapeuticsMD, Inc. from March 2015 to December 2022. Mr. Russell currently serves as Chairman of the Board of Revance Therapeutics and is a board member of Lineage Cell Therapeutics, Inc. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the potential for the Company’s programs to establish a cycle of continuous innovation in the obesity market to meet the evolving needs of millions of patients while maximizing accessibility. In addition, when or if used in this press release, the words and phrases “expect,” “plan,” “potential,” “promising,” “to be,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, competitive products or approaches limiting the commercial value of the Company’s product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact of any global pandemics, inflation, supply chain issues, rising interest rates and future bank failures on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 8, 2024, the Quarterly Report on Form 10-Q filed with the SEC on August 8, 2024, and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company 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. Investors:Danielle KeatleyStructure Therapeutics Inc.ir@structuretx.com Media:Dan Budwick1ABDan@1abmedia.com