Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (June 2024)
33 slides from Cynata Therapeutics's investor presentation, Jun 27, 2024
Slide 1: ASX Announcement: Investor Presentation
ASX ANNOUNCEMENT 27 June 2024 Investor Presentation Melbourne, Australia; 27 June 2024: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to invite shareholders to attend an investor webinar host
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 June 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 Cymerus manufacturing platform • Mesenchymal stem cells (MSCs)1 have shown potential to treat a wide range of illnesses,2 but standard For personal use only manufacture requires ongoing supply of new donors → challenges with consistency, potency and scale • The paten
Slide 5: FY 2024 – a year of progress
FY 2024 – a year of progress Completion of patient 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
Slide 6: Revolutionary iPSC-based Cymerus Manufacturing Platform
For personal use only Revolutionary iPSC-based Cymerus Manufacturing Platform
Slide 7: Therapeutic potential of MSCs
Therapeutic potential of MSCs Mesenchymal stem cells1 (MSCs): • Promote an immunomodulatory For personal use only environment2 • The “sensor and switcher of the immune system”3 • Promote tissue repair and regeneration • Can be used without matching donors to recipients • Can be engineered to express
Slide 8: Advantages of iPSC-based platform
Advantages of iPSC-based platform Induced pluripotent stem cells (iPSCs): For personal use only • Mature adult cells reprogrammed to become pluripotent, which means: • Effectively limitless proliferation capacity • Potential to differentiate into any adult cell type (including MSCs) • Similar proper
Slide 9: 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 from different donors For personal use only • MSCs undergo functional Substantial inter- Small number of MSCs Ex
Slide 10: 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 11: Compelling Clinical Data: CYP-001 for aGvHD
For personal use only Compelling Clinical Data: CYP-001 for aGvHD
Slide 12: CYP-001: Two Nature Medicine publications
CYP-001: Two Nature Medicine publications Phase 1 trial of CYP-001 was the first completed clinical trial worldwide with any iPSC-derived product For personal use only 11
Slide 13: aGvHD Phase 1 clinical trial - results
aGvHD | Phase 1 clinical trial - results Product: CYP-001 (Cymerus MSCs for intravenous infusion) Trial conducted in 15 patients with steroid-resistant aGvHD For personal use only • CYP-001 was shown to be Complete response 53% Overall response 87% 2yr survival 60% safe and well tolerated, with sust
Slide 14: aGvHD treatment landscape
aGvHD treatment landscape • First line treatment for aGvHD is corticosteroids – but up to 50% fail to respond – known as steroid-resistant aGvHD (SR-aGvHD) For personal use only • Numerous other therapies (e.g. immunosuppressants) have been investigated for SR-aGvHD, but most have limited efficacy a
Slide 15: Efficacy of CYP-001 vs other treatments in SR-aGvHD
Efficacy of CYP-001 vs other treatments in SR-aGvHD Overall Response Overall Response Overall Survival • Overall response rates for BAT an at Day 28 at Day 56-601 at 18 months Rux declined between D28 and D56 • Overall response rate for CYP-001 For personal use only increased between D28 and D60 • O
Slide 16: Safety of CYP-001 vs other treatments in SR-aGvHD
Safety of CYP-001 vs other treatments in SR-aGvHD • No safety concerns related to CYP-001 have been identified • Conversely, adverse reactions to ruxolitinib are common For personal use only • Grade 3-4 (serious/life-threatening) adverse reactions to ruxolitinib in aGvHD patients include:1 Adverse R
Slide 17: CYP-006TK for DFU
For personal use only CYP-006TK for DFU
Slide 18: CYP-006TK – a novel topical MSC product
CYP-006TK – a novel topical MSC product For personal use only iPSC-derived MSCs • CYP-006TK utilises a proprietary surface-coating, optimised for the delivery of MSCs directly to the wound bed • Technology exclusively licenced to Cynata by Tekcyte Limited 17
Slide 19: 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 20: Rich Clinical Pipeline – Multiple Upcoming Data Readouts
For personal use only Rich Clinical Pipeline – Multiple Upcoming Data Readouts
Slide 21: 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 (patient enrolment co
Slide 22: 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 23: 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 24: 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 25: 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 26: Strategy, Outlook and Corporate Overview
For personal use only Strategy, Outlook and Corporate Overview
Slide 27: 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 28: Commercial partnering
Commercial partnering For personal use only Several distinct products in development → potential for multiple partnerships Reinvestment of proceeds to maximise potential of the platform Platform also available to partners pursuing other indications and/or engineered MSC applications 27
Slide 29: 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 30: Board & senior management
Board & senior management Highly skilled and experienced senior leadership team with decades of experience Dr Kilian Kelly Dr Geoff Brooke Chief Executive Officer & For personal use only Independent Non-Executive Chair Managing Director • 30+ years' experience in the healthcare • 20+ years' experien
Slide 31: Upcoming catalysts
Upcoming catalysts* Results of three randomised controlled clinical trials expected between early 2025 and early 2026 Mid 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 Result
Slide 32: Summary
Summary Next generation stem • Leading platform technology in burgeoning stem cell sector cell company • Diverse and highly credentialed leadership team with proven experience For personal use only • Cymerus manufacturing technology protected by robust patent portfolio Scalable manufacturing • Enabl
Slide 33: 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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