Cambium Bio Ltd · ASX:CMB
Cambium Bio — Shareholder Meeting (November 2017)
35 slides from Cambium Bio's shareholder meeting presentation, Nov 2, 2017
Slide 1: AGM Presentation: Highlights and Business Update for FY17
AGM Presentation Highlights and Business Update for FY17 John Martin CEO Sydney 2 November 2017
Slide 2: Important Notice
Important Notice Forward-Looking Statements This Presentation contains certain statements which constitute forward-looking statements or information ("forward-looking statements”). These forward-looking statements are based on certain key expectations and assumptions, including assumptions regarding
Slide 3: Agenda
Agenda • Overview • Business Highlights and Update for FY17 • Financial Highlights for FY17 • Outlook for FY18
Slide 4: Overview
STeEGeneus living regenera tive medicine Overview
Slide 5: Overview
Overview 3 world-class Diversified portfolio of clinical- Driven by innovation technology platforms stage products and collaboration • Allogeneic adult stem • Human and animal health markets • Track record of technology cells (MSCs) from innovation and rapid adipose tissue for • Multiple product opp
Slide 6: Development Pipeline
Development Pipeline Human Health Development Pipeline TECHNOLOGY PROGRAM PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVAL PLATFORM Osteoarthri?s Allogeneic Adipose Progenza MSCs & Secre5ons Pain Immunotherapy RGSH4K Solid Tumours for oncology Dermatology Allogeneic Adipose Sygenus MSC Secre5ons Pain A
Slide 7: Business Highlights and Update for FY17
Business Highlights and Update for FY17
Slide 8: Landmark Collaboration with AGC on Progenza in Japan
Landmark Collaboration with AGC on Progenza in Japan
Slide 9: Landmark Collaboration with AGC for Progenza in Japan
Landmark Collaboration with AGC for Progenza in Japan In December ‘16, Regeneus and AGC, a leading Japanese manufacturer of biopharmaceutical products, entered into collaboration and licence agreement for the manufacture and licensing of the clinical development of its off-the-shelf stem cell therap
Slide 10: AGC - Japan's leading bio-CMO
AGC - Japan’s leading bio-CMO • AGC is Japan’s leading biopharmaceutical contract manufacturing organization – 2016 net sales of JPY1,283 billion (US$12.8 billion) – Existing CMO relationships with many major pharmaceutical businesses • In AGC’s recent “Vision 2025”, Life Sciences was designated a s
Slide 11: Benefits of Collaboration with AGC
Benefits of Collaboration with AGC + • Leading Japanese biopharma manufacturer with global capability and aligned goals – Leading biopharmaceutical contract manufacturer in Japan – expanded global capability with recent acquisitions of Biomeva in Germany and CMC Biologics in EU and USA – Strategic c
Slide 12: Japan First Strategy for Progenza
Japan First Strategy for Progenza • Japan First Strategy for Progenza takes advantage of Japan as global capital of regenerative medicine – fast-track regulatory environment for RM products • shorter phase 2 trial – “probable efficacy” • Conditional Approval 5-7 years - no requirement for phase 3 tr
Slide 13: Regenerative Medicine Markets are Large and Growing Rapidly
Regenerative Medicine Markets are Large and Growing Rapidly • Japan is 2nd largest healthcare market in the world • Forefront of Accelerated Approval for Regenerative Medicines • Leading market for Regenerative Medicine licensing activities *Japan’s Ministry of Educa5on Trade & Industry es5mates
Slide 14: Successful Progenza STEP Trial Results for Knee Osteoarthritis
Successful Progenza STEP Trial Results for Knee Osteoarthritis
Slide 15: Progenza Phase 1 Trial for Knee OA - Primary Endpoints Met
Progenza - Ph 1 Trial for Knee OA - Primary Endpoints Met Primary Endpoints Met • Progenza at both doses was found to be safe and tolerable • No serious adverse events occurred • The majority of adverse events (AEs) were of mild severity • No trends or findings of concern were identified Trial Desig
Slide 16: Progenza Phase 1 Trial for Knee OA - Significant Secondary Endpoints
Progenza - Ph 1 Trial for Knee OA - Significant Secondary Endpoints Significant Secondary Endpoints • Significant reduction in knee pain in Progenza groups - rapid and sustained • Significant improvement in cartilage volume compared to placebo in target dose • Positive signs of disease modification
Slide 17: Progenza STEP Data Aligns with Preclinical Results
Progenza STEP Data Aligns with Preclinical Results Safe and tolerable Rabbit Osteoarthri5s Model - par5al meniscetomy • No Progenza-related systemic or • Single Progenza intra-ar5cular injec5on 21 days post-surgery local toxicities or dose related adverse effects Cartilage Degeneration Scores- Later
Slide 18: Progenza – MSCs + Secretions Creates Competitive Advantage
Progenza – MSCs + Secretions Creates Competitive Advantage
Slide 19: Progenza – Patented and Scalable Allogeneic Stem Cell Platform
Progenza – Patented and Scalable Allogeneic Stem Cell Platform • Progenza - patented, scalable, off-the-shelf stem cell technology platform to treat a wide range of inflammatory conditions • Progenza mesenchymal stem cells (MSCs) are sourced from a healthy adult donor – high safety and tolerability
Slide 20: Progenza – Secretions Create Competitive Advantage
Progenza – Secretions Create Competitive Advantage MSCs secrete a diverse variety of bioactive factors including cytokines, growth factors, extracellular vesicles and exosomes Secretions respond to the local environment and are the driving force for reducing inflammation, promoting tissue repair and
Slide 21: Secretions Show Promise in Pain Model v Morphine
Secretions Show Promise in Pain Model v Morphine • Secretions administered in a post- operative pain model show significantly greater and longer lasting analgesic effect than a standardised dose of morphine • Initial pain reduction in OA from Progenza is believed to be due to the fast acting secreti
Slide 22: Positive Outlook for Progenza in Japan
Positive Outlook for Progenza in Japan • Tech transfer of Progenza to AGC on track • AGC well positioned to establish global cGMP manufacturing hub for Progenza – industrialisation of product manufacturing with world class biopharma manufacturer – confidence in product manufacturer assists with regu
Slide 23: Progress on ACTIVATE Cancer Vaccine Trial
Progress on ACTIVATE Cancer Vaccine Trial
Slide 24: RGSH4K Cancer Immunotherapy Platform
RGSH4K Cancer Immunotherapy Platform • Autologous cancer immunotherapy which uses a patient’s own tumour as source coupled with a bacterial adjuvant • Addresses tumour heterogeneity as all relevant tumour associated antigens are included • Immune memory may be effective in reducing risk of tumour re
Slide 25: RGSH4K Update on Phase 1
RGSH4K Update on Phase 1 • Phase 1 Study for solid cancers (ACTIVATE Trial) – Multiple solid tumour types accepted – Patients with terminal cancer for which no other therapy exists – Varying levels of streptavidin to identify biologically active dose Activity / Milestone ACTIVATE trial open for recr
Slide 26: Progress on Animal Health Trials
Progress on Animal Health Trials
Slide 27: Kvax Canine Cancer Vaccine
Kvax Canine Cancer Vaccine • Safety Study results – >100 dogs treated & 17 different tumour types – No safety concerns – At census (25 dogs) - 71% exceeded survival time up to 22 months • Osteosarcoma study results – Completed canine clinical trial with Dr Bergman of VCA, largest US vet services gro
Slide 28: CryoShot - Allogeneic Stem Cell Platform
CryoShot - Allogeneic Stem Cell Platform • Leading in-field, practical experience with allogeneic MSCs in the veterinary field globally with >90 vet practices involved and 5,000+ field trial treatments • Better pain relief than NSAIDs in uncontrolled studies for osteoarthritis in dogs • Improved int
Slide 29: Key Patents Granted
STeEGeneus living regenera tive medicine Key Patents Granted
Slide 30: Patent Portfolio Update
Patent Portfolio Update Overview • 58 patents or patent applications across 14 patent families • 12 patents granted in Australia; 3 in NZ; 2 in Japan • Patents cover: methods of manufacture; compositions and delivery; use of products for treatment of a broad range of indications Key patents granted
Slide 31: Financial Highlights for FY17
Financial Highlights for FY17
Slide 32: FY17 Financial Results Overview
FY17 Financial Results Overview $’000’s 2017 2016 Change Rev enue 10,169 1,878 8,291 • Revenue includes $8.9m from AGC Cost of Sales (55) (292) 237 licence fees Gross Profit 10,114 1,586 8,528 Other income 2,608 2,747 (139) • R&D tax incentive of $2.6m included in other R & D expenses (4,456) (4,309
Slide 33: Forecast Operating Cashflows
Forecast Operating Cashflows $’000’s • Prior year quarterly cash outflow from operations was maintained at Cash at 30/06/2017 4,135 $1.7 million up from 2016 $1.5 million Material cash inflows • Future quarterly cash burn to progressively increase to up to $2 • R&D incentive receipt million per quar
Slide 34: Outlook for FY18
Outlook for FY18 Progenza • Convert clinical partnering discussions for Progenza for OA and other indications in Japan and other territories Sygenus • Report on studies for topical application of MSC secretions technology RGSH4K • Complete recruitment of ACTIVATE Phase 1 clinical trial CryoShot • Re
Slide 35: Further Information
Further Information ASX: RGS Sandra McIntosh Company Secretary & Investor Relations M: +61 450 253059 P:+61 2 9499 8010 E: investors@regeneus.com.au