Cambium Bio Ltd · ASX:CMB
Cambium Bio — Corporate Update (September 2023)
16 slides from Cambium Bio's corporate update, Sep 28, 2023
Slide 1: A pioneering regenerative medicine platform in ophthalmology and tissue repair
A pioneering regenerative medicine platform in ophthalmology and tissue repair Shareholder Update Regeneus Ltd ASX:RGS September 2023
Slide 2: Disclaimer
Disclaimer Summary Information: This Presentation contains summary information about the current activities of Regeneus Ltd (“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 pu
Slide 3: Background
Background • On 28 April 2023, Regeneus announced that it had signed a non-binding term sheet to merge with Cambium Medical Technologies, LLC (“CMT”), based in Atlanta, Georgia, USA • CMT was founded in 2013 as an ophthalmology-focused spin-off from Emory University, Atlanta, GA • The Company has su
Slide 4: Cambium Bio overview
Cambium Bio overview Proforma clinical assets The merger will create a pioneering regenerative medicine platform focused on ophthalmology and tissue repair Product Elate Ocular® Progenza Sygenus Aurarix® Allogeneic adipose-derived mesenchymal AD-MSC bioactive secretome for topical Technology Fibrino
Slide 5: Cambium Bio overview
Cambium Bio overview Proforma top management and shareholding structure Top management Indicative percentage post-merger shareholding structure • Co-founder of cell therapy CDMO SingCell, Singapore • Co-founder of digital therapeutics company OME Health, London, UK Other CMT • Vice President, Health
Slide 6: Cambium's fibrinogen-depleted human platelet lysate platform technology Aurarix
Cambium’s fibrinogen-depleted human platelet lysate platform technology Aurarix ® • Platelets are anucleate cells produced in the bone marrow and found in human blood, rich in growth factors, cytokines, and other bioactive molecules • Aurarix® is pooled, enriched, fibrinogen-depleted, allogeneic hum
Slide 7: Dry Eye Disease overview
Dry Eye Disease overview Definition and clinical presentation • DED (Keratoconjunctivitis Sicca) is a multi-factor disorder of tears and ocular surface • Loss of tear film homeostasis - failure to produce high-quality or sufficient tears • May lead to visual disturbance, irritation, pain, corneal ul
Slide 8: Dry Eye Disease etiology
Dry Eye Disease etiology Contributory factors Types of DED Role of inflammation in DED • Age-related and hormonal changes • Aqueous deficient – reduced tear production • Extensive peer-reviewed literature suggests from lacrimal glands chronic inflammation of the ocular surface and • Autoimmune disor
Slide 9: Current treatment options for DED
Current treatment options for DED Low Severity of DED High Conservative Tx OTC treatments Office treatment Prescription drugs • Behaviour modification • Artificial tears • Punctal plugs • Corticosteroids • Environmental • Lubricating ointments • Thermal pulsation • Anti-inflammatories modification •
Slide 10: Cambium Bio solution – Elate Ocular biologic eye drops
Cambium Bio solution – Elate Ocular ® biologic eye drops “Off the shelf natural tear” Elate Ocular® 11 mL sterile Derived from enriched fibrinogen- Supports improved ocular surface depleted human platelet lysate health Similar pH and osmolarity to normal tears, but higher overall Administered 4 time
Slide 11: Elate Ocular is superior to validated Autologous Serum Tears concept
Elate Ocular ® is superior to validated Autologous Serum Tears concept with strong compositional, manufacturing, and commercial advantages Natural tears Autologous Serum Tears (AST) Human Platelet Lysate (HPL) Composition of AST versus natural tears Superior composition of FD-HPL versus AST ng/mL Au
Slide 12: Elate Ocular clinical data
Elate Ocular ® clinical data Demonstrated safety and efficacy in Phase 1/2 trial Safety: Overall Summary of Treatment-Emergent Adverse Events by Treatment Group • Study: “A Randomized Trial of Topical Vehicle Control (N = 22) FD hPL 10% (N = 20) FD hPL 30% (N = 22) Patients With ≥ 1: n (%) m n (%) m
Slide 13: Elate Ocular clinical development plan
Elate Ocular ® clinical development plan Two registration-enabling* Phase 3 trials in DED ✓ • Obtained Orphan Drug Designation (ODD) in Dry Eye Secondary to Chronic Graft-versus-Host Disease ✓ • Obtained two Investigation New Drug (IND) application approvals from the FDA to initiate two Phase 3 tria
Slide 14: Investment highlights
Investment highlights • Currently approved drugs provide only short-term symptom relief for dry eye disease patients with low tolerance and side Unmet need effects. Elate Ocular® can become a differentiated therapeutic with superior DED symptom relief and sign improvement Large addressable • DED is
Slide 15: Acronyms and definitions
Acronyms and definitions • AAO: American Academy of Ophthalmology • AD-MSC: adipose-derived mesenchymal stem cells • AE: adverse event • Allogeneic: derived from a healthy donor (not patient) • AST: autologous serum tears • BLA: Biologics License Application • CAM-101: Elate Ocular® investigational
Slide 16: Contact details
Contact details karolis.rosickas@regeneus.com 1 300 995 098 www.regeneus.com Regeneus Ltd 16 Goodhope Street Paddington, NSW 2021 Australia 16