Cambium Bio Ltd · ASX:CMB
Cambium Bio — Corporate Update (March 2021)
26 slides from Cambium Bio's corporate update, Mar 3, 2021
Slide 1: Regeneus Company Update Investor Webcast Presentation
ASX Announcement 3 March 2021 Regeneus Company Update Investor Webcast Presentation Regeneus Ltd (ASX: RGS) (Regeneus or the Company), a clinical-stage regenerative medicine company, today advises it has released an updated investor presentation. The presentation will be delivered to investors by CE
Slide 2: Company update presentation
Company update presentation Developing next generation pain management and inflammation therapeutics Regeneus Ltd (ASX:RGS) 03 March 2021
Slide 3: Disclaimer
Disclaimer Summary Information: This Presentation contains summary information about the current activities of Regeneus as at the date of this Presentation. The information in this Presentation is of a general nature and does not purport to be complete. This Presentation does not purport to contain
Slide 4: Company overview
Company overview Background Financial information • Regeneus (“RGS”) is a pioneer cell therapy company founded in Sydney in 2007 Share price (02 Mar 2021) A$ 0.115 • The company went public (ASX:RGS) on the Australian Stock Exchange in 2013 Shares issued 300.3m • Two platform technologies leveraging
Slide 5: Technology and products
Technology and products SIG IEINS Se
Slide 6: Proprietary allogeneic mesenchymal stem cells and secretome platform
Proprietary allogeneic mesenchymal stem cells and secretome platform Mesenchymal stem cells Bioactive Secretome • Multipotent stem cells, which perform multiple functions in human body including • Bioactive molecules (cytokines, chemokines, growth factors, extracellular vesicles) direct differentiat
Slide 7: How Regeneus platform technology is different?
How Regeneus platform technology is different? MSCs / iPSCs only Extracellular vesicles (EVs) • Generation 1.0 therapies • Novel, early-stage modality Provide only limited functionality through Expensive isolation and purification process differentiation and engraftment Manufacturing scalabili
Slide 8: Established mechanism of action
Established mechanism of action PROGENZA ✓ Promotes endogenous ✓ Tissue repair ad-MSCs + Bioactive secretome cartilage repair Soluble factors: Cytokines Chemokines Growth factors Differentiation EVs: ↑ ECM protein secretion Exosomes ↑ chondrocytes Micro vesicles Cell-cell contact Macrophages NK cell
Slide 9: Scalable product platforms
Scalable product platforms Multiple opportunities in pain and inflammation focused indications Orphan diseases Wound healing United States Osteoarthritis Progenza Sygenus MSCs and Cell free Secretome Neuropathic Secretome pain Inflammatory skin conditions The product platforms are protected by a por
Slide 10: Strong nonclinical and clinical data
Strong nonclinical and clinical data • Confirmed the Primary Endpoints of safety and tolerability at both low and high doses with a single injection Progenza • Confirmed the Secondary Endpoints of efficacy: Osteoarthritis • Pain: significant, rapid and sustained pain relief achieved via VAS and Phas
Slide 11: Established chemistry, manufacturing and controls (CMC) process
Established chemistry, manufacturing and controls (CMC) process • Adipose-derived: adipose contains 500-1000 times more MSCs than bone marrow • Allogeneic: multiple patients from a single donor. Improved product safety, potency, and consistency Source material • Rigorous donor screening process • No
Slide 12: Pain and osteoarthritis market opportunity
Pain and osteoarthritis market opportunity 11
Slide 13: Pain – large and growing problem
Pain – large and growing problem Prevalence of chronic pain (1) Large addressable market Lower back pain 28.1% 1.5bn Knee pain 19.5% people worldwide suffering from pain (2) Severe headache or migraine 16.1% Neck pain 15.1% 50% Shoulder pain 9.0% of patients report inadequate relief (2) Finger pain
Slide 14: Opportunity in knee osteoarthritis
Opportunity in knee osteoarthritis Large addressable market Worldwide United States Japan 5EU: DE, FR, GB, IT, ES Patients 240m(1) 33m(2) 25m (3) 52m (4) Market size(4) $3.5bn $2.6bn $330m $520m Attractive market characteristics Ageing population Increasing prevalence Dissatisfaction with No disease
Slide 15: Current osteoarthritis treatment market
Current osteoarthritis treatment market Current treatments only provide pain relief – not disease modification less severe OA more severe OA 50% of diagnosed and prevalent knee OA is moderate-severe ~5% cartilage loss per year as disease progresses less invasive therapies more invasive therapies Lif
Slide 16: Where Progenza fits in current osteoarthritis treatment market
Where Progenza™ fits in current osteoarthritis treatment market Progenza addresses an unmet need in the current treatment market by providing disease modification and pain relief to address patient symptoms without having to undergo surgery and invasive procedures less severe OA more severe OA 50% o
Slide 17: Competitive landscape
Competitive landscape Progenza is well positioned to become the first in class disease modifying therapy in knee osteoarthritis Product Progenza Tanezumab Fasinumab AlloJoin Cymerus PPS Invossa Stage P2 BLA P3 P2 P3 P3 P3 (tbc) Treats symptoms (pain) ✓ ✓ ✓ ✓ unknown ✓/ ✓ Potentially disease modifyi
Slide 18: Value creation plan
Value creation plan SIG IEINS Se
Slide 19: Value drivers for Regeneus
Value drivers for Regeneus Multiple levers to create shareholder value Licensing Independent Strategic and development M&A partnerships • Launch Progenza OA in partnership with • Prepare for Progenza OA Phase 2 trial in • Consider strategic exit to a large pharma or Kyocera in Japan the US a large c
Slide 20: Development pipeline
Development pipeline Platform Technology Indication Geography Stage Current status Preclinical Phase 1 Phase 2 Phase 3 Approval • Collaboration with Kyocera signed in 2020 Allogeneic adipose-derived MSCs Japan 2015 2017 2022 2024 • PMDA Conditional Approval expected in 2024 with bioactive secretome
Slide 21: Collaboration and licensing agreement with Kyocera for osteoarthritis in Japan
Collaboration and licensing agreement with Kyocera for osteoarthritis in Japan Expedited path to market in Japan Background Deal • Japan headquartered global diversified conglomerate • The Collaboration and License Agreement was signed in August 2020 • Revenue $15.5bn, market capitalisation $23.6bn
Slide 22: Progenza osteoarthritis opportunity in United States
Progenza™ osteoarthritis opportunity in United States Regeneus plans to initiate a Phase 2 trial in the US in 2022 Market opportunity US osteoarthritis therapeutics market (USD bn) US osteoarthritis patients 75% of global OA market 33 million CAGR: 9.1% 2.6 1 in 7 1.1 adults 2016 2026 Source: Global
Slide 23: Expected Progenza osteoarthritis US Phase 2 trial timeline
Expected Progenza™ osteoarthritis US Phase 2 trial timeline 2021 2022 2023 month 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 Regulatory GAP analysis FDA Pre-IND Meeting NIH grant funding process Non-GMP product Nonclinical study GMP product available IND submission
Slide 24: Other near term value accreting opportunities
Other near term value accreting opportunities Product Geography Stage Indication Status Timing • Similar clinical trial design to the Progenza OA Phase 2 trial in the US Progenza Australia Phase 2 Knee osteoarthritis • Ability to use the same Progenza cGMP product as in the US Q2 2021 • A grant appl
Slide 25: Regeneus investment highlights
Regeneus investment highlights • A unique combination of stem cells and their bioactive secretome exerts superior therapeutic effect Leading, differentiated • Applicable in a broad range of pain and inflammation indications technology platform • A scalable and cost effective manufacturing process •
Slide 26: Contact details
Contact details karolis.rosickas@regeneus.com www.regeneus.com Regeneus Ltd 2 Paddington Street Paddington, NSW 2021 Australia /regeneus-ltd @regeneus /regeneus 25