Lineage Cell Therapeutics, Inc. · AMEX:LCTX
Lineage Cell Therapeutics — Investor Presentation (January 2021)
42 slides from Lineage Cell Therapeutics's investor presentation, Jan 6, 2021
Slide 1: Corporate Overview
Corporate Overview January 5, 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer to buy any securities of Lineage Cell Therapeutics, Inc. (“Lineage”). This presentation includes certain information obtained from trade and statistical services,
Slide 3: Management biographies: CEO and CFO
Mr. Culley joined Lineage as CEO in September 2018. Prior to joining Lineage, Mr. Culley served from August 2017 to September 17, 2018 as Interim Chief Executive Officer at Artemis Therapeutics, Inc., where he was responsible for the management of the company. Mr. Culley previously served as Chief E
Slide 4: Lineage Cell Therapeutics — Investor's Overview
Lineage Cell Therapeutics — Investor’s Overview Innovative Approa - Transplanting “off the shelf” cells to treat serious medical conditions Uniduerscvantace - World-class manufacturing and IP; can manufacture an unlimited supply q 8 of specialized cell types from established pluripotent cell lines -
Slide 5: Technology Overview
== LIN ew CELL THERAPEUTICS “We aim to pioneer a new branch of medicine, based on transplanting specific cell types into the body” Technology Overview
Slide 6: Lineage Technology Platform — Allogeneic Cell Transplants
Lineage Technology Platform — Allogeneic Cell Transplants * The Lineage Platform starts =a - with a frozen vial of ( < Bianca i ste Il self-renewing stem cells stem cells * These pluripotent cells can <= oUNEAGE = Ee “= TECHNOLOGY =~ become any cell type in the mat Ge => Liver Cells Vascular / Smoot
Slide 7: Competitive Advantage: In-House Manufacturing and Know-How
Competitive Advantage: In-House Manufacturing and Know-How Lineage’s competitive advantage is the differentiation of an unlimited supply of pluripotent stem cells into specialized cell types Capabilities Facilities * Cell banking and handling Process development Manufacture of clinical trial materia
Slide 8: Pipeline and Validating Partnerships
Pipeline and Validating Partnerships Financial Clinical Programs Support Phase 1 Phase 2a Next Steps Received OpRegen® (RPE Cells) SES Gnlimoveton Enrollment Dry AMD with we (Gian) a, completed Nov 10; Geographic Atrophy (GA) data in Q1 and Q2 over (otgodendroeres) — CIRM > |: Spinal Cord Injury (SC
Slide 9: OpRegen: RPE Cell Transplants to Treat Dry AMD
== LIN ew CELL THERAPEUTICS AMD is the leading cause of irreversible vision loss in the US — rT Source: aao.org OpRegen : RPE Cell Transplants to Treat Dry AMD
Slide 10: Dry AMD Can Lead Rapidly to Blindness
Dry AMD Can Lead Rapidly to Blindness Visual acuity over time... The area of geographic 20/20 atrophy or “GA” grows (normal) larger as retinal cells die 2012 2013 2014 2015 2017 2019 » 20/200 (legally blind in 3 years) Dry AMD involves the progressive loss of retina cells, which can lead rapidly 20/
Slide 11: Multi-Billion Dollar Market Opportunity in the U.S.
Multi-Billion Dollar Market Opportunity in the U.S. Age-related Macular Degeneration (AMD) (all forms) afflicts ~11 million people in the United States Type of AMD % of AMD Cases FDA Approved Therapies Wet AMD 10-15% Lucentis & Eylea (S10 Billion in annual sales) Dry AMD 85 - 90% None No Approved 10
Slide 12: Lineage Approach — OpRegen, an RPE Cell Transplant
Lineage Approach — OpRegen, an RPE Cell Transplant * Dry AMD involves the loss of retina cells, * OpRegen is an injection of RPE cells creating an area of geographic atrophy (GA), _ directly to the retina, to replace lost retinal which causes impaired vision and blindness cells and preserve or impro
Slide 13: Ongoing Phase 1/2a Clinical Trial of OpRegen for Dry AMD
Ongoing Phase 1/2a Clinical Trial of OpRegen for Dry AMD Cohorts 1-3 Cohort 4 Safety Portion / Legally Blind Efficacy Portion / Impaired Vision h -—————________, f \ 123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 COMPLETED ENROLLMENT COMPLETED 11/10/2020
Slide 14: Promising Results
Promising Results (As of AAO 2020 Update) The transplanted OpRegen cells have been well tolerated with no cases of rejection Cohort 4 patients (the intended commercial population) have better vision at 9 & 12 months, with improvements lasting >24 months in some patients A trend towards slower GA gro
Slide 15: Improved Visual Acuity in Treated vs. Fellow Eye
Improved Visual Acuity in Treated vs. Fellow Eye Statistical Significance at 9 & 12 Months Mean Change in Cohort 4 BCVA — Treated & Fellow Eye 30 n=7 n=5 n=4 n=2 2 a o P=0.0148, P=0.0180, c ‘sa 15 28 | a 2 Ee € | ao ze 4 | 5 ov 2s ° es £ oO “15 01234 6 9 12 15 24 —Treated Eye —FellowEye Time Post-Im
Slide 16: Real-World "Letters of Improvement"
Real-World “Letters of Improvement” -RNOV S—Si Zz Cc R D H Initial Visual NV S co} K —— “cuity Example (20/125) “———DRZKO SoNeHee (V———- +10 letters (20/s0) “se cRVSZ VK CNH oe SVKON ° +15 letters (20/63) ETDRS Visual Acuity Chart #3 “=E LANES yy.
Slide 17: Slower Growth of GA Observed in Pooled Cohort Patients
Slower Growth of GA Observed in Pooled Cohort 4 Patients Mean Change in Cohort 4 GA (mm?) — Treated and Fellow Eye n=6 n=5 n=4 me from baseline Mean Change in size of GA (mm?) —TreatedEye —=FellowEye Time Post-Implantation (months) L (As Presented at rV:Xe)) Ceru THERAPEUTICS y.
Slide 18: Retinal Restoration — Smaller Area of GA, Maintained for Years
Retinal Restoration — Smaller Area of GA, Maintained for 2 Years Date Time in Study Colored areaon | Areamm?(SQRT) | Changes in rate of Changes in rate Figure below progression from of progression previous from baseline May 2017 Minus 1 year Orange 4.21 mm? (2.05) | N/A N/A 7.90 mm? (2.8) +0.64 mm s
Slide 19: Dry AMD Competitive Landscape
Dry AMD Competitive Landscape Only cell therapy has the potential to restore tissue with infrequent dosing Only Lineage has shown evidence of retinal restoration Only Lineage has access to the Gyroscope delivery system to deliver cells Cell Therapy Complement Inhibitors * Lineage Cell (Ph1/2) le * A
Slide 20: Proprietary Delivery System — The Gyroscope SDS
Proprietary Delivery System — The Gyroscope SDS Lineage has an exclusive option to a delivery device which overcomes issues with the traditional method of delivering cells to the retina Traditional Method (safety issues) Gyroscope SDS (Lineage method) 4 cannula Stable bleb Enlarged retinotomy (no re
Slide 21: Commercial-Scale Manufacturing Capabilities
Commercial-Scale Manufacturing Capabilities * OpRegen consists of >99% pure RPE cells - Uses NIH-approved line was established >20 years ago - Extensive characterization and karyotyping performed on each batch - No genetic modifications are made to the cells * Immediate-use “thaw and inject” formula
Slide 22: OpRegen — Positioned for Commercial Success
OpRegen — Positioned for Commercial Success OpRegen has been designed to capture a multi-billion dollar opportunity: * Transplanting RPE cells may provide benefits other approaches cannot ¢ Market opportunity is not limited to monogenic deficiencies (e.g. gene therapy) * Treatment to date has been w
Slide 23: OPC1: A Cell Therapy for Spinal Cord Injuries
== Lifetime care for an SCI patient can cost nearly = $5 million Source: christopherreeve.org OPC1: A Cell Therapy for Spinal Cord Injuries
Slide 24: Lucas' Story
Lucas’ Story Lucas Linder, an OPC1 clinical trial participant, was paralyzed from the neck down. The next year, he threw out the first pitch at a Major League Baseball game.
Slide 25: About Spinal Cord Injury
About Spinal Cord Injury * Loss of movement is the primary feature of a spinal cord injury * The goal of treatment is to provide additional upper extremity function (limb, hand & fingers) * Greater mobility leads to improved quality of life and independence for patients ¢ Approx 18,000 persons per y
Slide 26: Spinal Cord Injuries are Measured by Motor Levels
Spinal Cord Injuries are Measured by Motor Levels Higher-level injuries are associated with less mobility Function — Cervical Injury Level C1-C3 cS 7-8 Bowel | Bladder i | Bed Mobility | Transfers Pressure Relief Eating Dressing Grooming Bathing Wheelchair Car transport il Daily Home Care | 24 hr at
Slide 27: Lineage OPC1 cells for Spinal Cord Injury
Lineage OPC1 cells for Spinal Cord Injury Healthy oligodendrocytes, which support and myelinate neurons, can be damaged and lost due to inflammatory response following an injury OPC1 is a cellular therapy comprised of oligodendrocyte progenitor cells (OPCs) which are derived from a pluripotent cell
Slide 28: OPC1 Mechanisms of Action
OPC1 Mechanisms of Action 1. Prevention of Cavitation Control OPC1 2. Myelination of axons 3. Secretion of neurotrophic factors Control Media OPC1 shiverer mouse shi mouse + OPC1 i ed ee
Slide 29: Clinical Trial Design (enrollment complete)
Clinical Trial Design (enrollment complete) * Open Label (n=25) * Primary Assessment: Safety * Traumatic cervical SCI (C4-C7) | * Secondary Assessment: Neurological Function (Isncsci) ° AIS-A and AIS-B Enrolled * Exploratory Functional Assessments: (ScIM, GRASSP) * Dosed 21-42 days post injury 3 pat
Slide 30: Clinical Trial Results - Safety and Efficacy in Patients
Clinical Trial Results - Safety and Efficacy in 22 Patients Cell Engraftment Motor Function Gain (at 12 months) (at 12 months) 32% Two or More 96% Levels 96% Successful of Subjects Engraftment Reported 9% Improved Motor ee Function One Level No Improvement (4%) No Improvement (4 To date, there have
Slide 31: Real-World Benefit from a Motor Level Improvement
Real-World Benefit from a 2 Motor Level Improvement Motor level gains translate into clinically meaningful improvements in self-care and reductions in cost of care Function Cervical Injury Level C1-C3 cS C6 C7-C8 Bowel (s) Bladder Bed Mobility Transfers Pressure Relief Eating Dressing Grooming Bathi
Slide 32: Clinical Trial — Year Results (from Nov 2019 Update)
Clinical Trial — 2 Year Results (from Nov 2019 Update) * Promising overall safety profile (21 subjects evaluated) - No evidence of adverse changes via MRI - No unexpected serious adverse events related to the OPC1 cells - No study subjects had worsening of neurological function ¢ Motor Level Improve
Slide 33: OPC1 Manufacturing Update (December 8, 2020)
OPC1 Manufacturing Update (December 8, 2020) Major improvements in production and quality of OPC1 product ¢ Anew ready-to-inject formulation ¢ Elimination of dose preparation ¢ A10to 20-fold increase in production scale ¢ Asignificant reduction in product impurities (next slide) ¢ Improvements in fu
Slide 34: OPC1 Manufacturing Improvements: Lower Impurities
OPC1 Manufacturing Improvements: Lower Impurities % Positive 30 25 20 15 10 OPC-1 Impurity/non-targeted cell population profile by flow cytometry GPOR OPC-1 LCT OPC-1 ares d ie a x ane aie a Marker 2 Marker 3 Marker 4 Marker 5 Marker 6 Marker 7
Slide 35: OPC1 Program: Next Steps
OPC1 Program: Next Steps Key Considerations: Compelling clinical data supports later-stage comparative clinical trial Manufacturing deficiencies of prior sponsor have been addressed Delivery device enhancements can enable a greater number of sites Planning to meet with FDA to discuss manufacturing i
Slide 36: VAC: A Cell Therapy Platform for Cancer and Infectious Diseases
Immunotherapy is "poised to revolutionize treatment for all types of cancer" Source: cancerresearch.org VAC: A Cell Therapy Platform for Cancer and Infectious Diseases
Slide 37: The VAC Platform: Allogeneic Solutions for Autologous Problems
The VAC Platform: Allogeneic Solutions for Autologous Problems ¢ The VAC platform consists of large-scale “off the shelf” production of mature immune cells called dendritic cells (DCs) * DCs are manufactured and loaded with either a tumor antigen (to treat cancer) or a viral antigen (as a vaccine fo
Slide 38: VAC Development — Many Programs from a Single Platform
VAC Development — Many Programs from a Single Platform VAC1 and VAC2 Highlights © * Positive phase 1 data in AML Pd * Positive ongoing phase 1 trial in lung cancer (NSCLC) Lineage - * Cancer Research UK alliance Manufacturing Dendritic * High T cell responses seen Platform Cells VAC3, VAC4, VACS...O
Slide 39: VAC Platform Next Steps
VAC Platform Next Steps Upcoming Events and Key Considerations: * Complete dosing in ongoing clinical trial (2 patients remain) ¢ Evaluate options for VAC2 with a checkpoint inhibitor * Design new products (i.e. VAC3, 4, 5, 6...) with newly discovered antigens ¢ Identify potential partnership and gr
Slide 40: Upcoming Milestones
Upcoming Milestones PROGRAM OpRegen VAC OPC1 NE LL THER TIMIN Qi 2021 Q2 2021 2H 2021 Ongoing Qi 2021 Q3 2021 Ongoing Qi 2021 1H 2021 1H 2021 Ongoing Ongoing AGE AP E uTICS INITIATIVES Present interim OpRegen data (3-month Cohort 4 update) Present interim OpRegen data (6-month Cohort 4 update, ARVO)
Slide 41: Our Goal is to Provide Life-Changing Cell Therapies to Patients
Our Goal is to Provide Life-Changing Cell Therapies to Patients Lineage Cell Therapeutics: Bringing the Promises of Cell Therapy into Clinical Reality 3 clinical-stage World class One of the Funded well Leader in the programs with in-house GMP largest patent into 2022 with emerging field billion-dol
Slide 42: lineagecell.com/media/#patients
lineagecell.com/media/#patients
Lineage Cell Therapeutics — Investor Presentation (January 2021) on 6ix