Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (May 2024)
26 slides from Cynata Therapeutics's investor presentation, May 7, 2024
Slide 1: ASX Announcement: Investor Presentation
ASX ANNOUNCEMENT 7 May 2024 Investor Presentation Melbourne, Australia; 7 May 2024: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to release an updated investor presentation deck, which will
Slide 2: A Clinical Stage Next Generation Stem Cell Therapeutics Company
For personal use only A Clinical Stage Next Generation Stem Cell Therapeutics Company Investor Presentation May 2024
Slide 3: Important information
Important information Summary information Forward-looking statements This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries This Presentation contains certain ‘forward looking statements’, which can generally be identified by the (CYP) which is current
Slide 4: Company highlights
Company highlights Revolutionary iPSC-based Cymerus manufacturing platform • Effectively limitless quantity of consistent, high-quality mesenchymal stem cell (MSC) doses from a For personal use only single blood donation • Overcomes major obstacle to commercialisation in this highly promising field
Slide 5: FY 2024 – a year of progress
FY 2024 – a year of progress Completion of enrolment in two randomised controlled trials • Phase 3 osteoarthritis – enrolment completed November 2023 For personal use only • Phase 1 DFU – enrolment completed April 2024 Further encouraging clinical efficacy data • Promising initial data from ongoing
Slide 6: Compelling Clinical Data
For personal use only Compelling Clinical Data
Slide 7: aGvHD Phase 1 clinical trial
aGvHD | Phase 1 clinical trial Product: CYP-001 (Cymerus MSCs for intravenous infusion) First completed clinical trial worldwide with any iPSC-derived product - published in Nature Medicine1 For personal use only Complete 53% Overall 87% 2yr 60% response response survival No treatment-related seriou
Slide 8: DFU Phase 1 clinical trial – initial data
DFU | Phase 1 clinical trial – initial data Product: CYP-006TK (topical Cymerus MSC wound dressing) • Ongoing trial in non-healing diabetic foot ulcer (DFU) • Patients randomised to receive standard of care (SoC) or CYP-006TK for 4 weeks, followed by SoC For personal use only • In the first 16 patie
Slide 9: Revolutionary iPSC-based Cymerus Manufacturing Platform
For personal use only Revolutionary iPSC-based Cymerus Manufacturing Platform
Slide 10: Conventional MSC process vs Cymerus iPSC-based process
Conventional MSC process Major challenges: Ongoing need MSC isolation • Logistically challenging Culture expansion for new donors • Inter-donor variability – inconsistent activity in MSCs For personal use only from different donors • MSCs undergo functional Substantial inter- Small number of MSCs Ex
Slide 11: Therapeutic potential of MSCs
Therapeutic potential of MSCs Mesenchymal stem (or stromal) cells (MSCs): For personal use only • Promote an immunomodulatory environment via multifactorial mechanisms1 • The “sensor and switcher of the immune system”2 • Promote tissue repair and regeneration • Can be used without donor/recipient ma
Slide 12: Advantages of iPSC-based platform
Advantages of iPSC-based platform For personal use only Induced pluripotent stem cells (iPSCs): • Mature cells from adult donors, reprogrammed to become pluripotent • Effectively limitless proliferation in cell culture • Potential to differentiate into any adult cell type (including MSCs) • Avoids e
Slide 13: Strategic partnership with Fujifilm
Strategic partnership with Fujifilm • Fujifilm: one of largest healthcare conglomerates For personal use only globally, with significant assets in biotechnology sector, bolstered by recent multi-billion dollar investments • Fujifilm Cellular Dynamics Inc (FCDI: subsidiary of Fujifilm) developed the
Slide 14: Rich Clinical Pipeline – Multiple Upcoming Data Readouts
For personal use only Rich Clinical Pipeline – Multiple Upcoming Data Readouts
Slide 15: Advanced and diverse clinical pipeline
Advanced and diverse clinical pipeline Indication Trial phase Market opportunity For personal use only Acute Graft vs Host Disease (aGvHD) Cynata Sponsored CYP-001 Phase 2 underway US$600m1 (FDA Orphan Designation) Diabetic Foot Ulcers (DFU) Phase 1 underway US$9.6bn2 CYP-006TK (recruitment complete
Slide 16: aGvHD Phase 2 clinical trial
aGvHD | Phase 2 clinical trial Product CYP-001 (Cymerus iPSC-derived MSCs for intravenous infusion) For personal use only Indication High risk acute graft versus host disease (aGvHD)1 • Randomised controlled trial in ~60 adults (steroids + CYP-001 vs steroids + placebo) Study Design • Primary object
Slide 17: DFU Phase 1 clinical trial
DFU | Phase 1 clinical trial Product CYP-006TK (Novel silicone dressing seeded with Cymerus iPSC-derived MSCs) For personal use only Indication Non-healing diabetic foot ulcers (DFU) • Randomised controlled trial in ~30 adults • Patients randomised to receive either standard of care or CYP-006TK for
Slide 18: OA Phase 3 clinical trial
OA | Phase 3 clinical trial1 Product CYP-004 (Cymerus iPSC-derived MSCs for intra-articular injection) For personal use only Indication Osteoarthritis (OA) of the knee (Kellgren-Lawrence Grade 2-3) • Randomised, double-blind placebo-controlled trial in ~320 adults Study Design • Each participant rec
Slide 19: Renal transplant Phase 1 clinical trial
Renal transplant | Phase 1 clinical trial Product CYP-001 (Cymerus iPSC-derived MSCs for intravenous infusion) For personal use only Indication Prevention of kidney transplant rejection • ~16 patients to receive CYP-001 after kidney transplantation: cohort 1 (n=3); cohort 2 (n=3); cohort 3 (n=10) St
Slide 20: Strategy, Outlook and Corporate Overview
For personal use only Strategy, Outlook and Corporate Overview
Slide 21: Research partnerships
Research partnerships Large body of positive preclinical data Studies conducted in partnership with leading generated via R&D partnerships: research groups worldwide For personal use only • GvHD • Diabetic wounds • Critical limb ischaemia • Organ transplant rejection • Osteoarthritis • Respiratory d
Slide 22: Commercial partnering
Commercial partnering For personal use only Partnerships will accelerate our preclinical and clinical development programs Reinvestment of proceeds to maximise potential of the platform We will make Cymerus available to other regenerative medicine players – growth of the field in partnership is cent
Slide 23: Upcoming catalysts
Upcoming catalysts* Results of three randomised controlled clinical trials expected between early 2025 and early 2026 1H 2024 For personal use only • Renal trial – start of enrolment 2H 2024 • Renal trial – results (Cohort A) Results • aGvHD trial – completion of enrolment Completion 1H 2025 Results
Slide 24: Corporate overview
Corporate overview Cynata has been listed on the Australian Securities Exchange (ASX) since 2013 (Ticker: CYP) Shareholder distribution Substantial shareholders (>5%) For personal use only 52% Bioscience Managers 13.1% Fidelity Remaining Top 20 Bioscience Managers is an international healthcare inve
Slide 25: Board & senior management
Board & senior management Highly skilled and experienced senior leadership team with decades of experience Dr Kilian Kelly Dr Geoff Brooke For personal use only Chief Executive Officer & Independent Non-Executive Chair Managing Director • 30+ years' experience in the healthcare • 20+ years' experien
Slide 26: Contact Us
For personal use only Contact Us Cynata Therapeutics Limited Level 3, 100 Cubitt Street Cremorne Victoria 3121 Australia cynatatherapeutics info@cynata.com @cynatastemcells www.cynata.com cynata-therapeutics
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