CYNATA THERAPEUTICS LIMITED ASX ANNOUNCEMENT8 March 2022
onlyMelbourne, Australia; 8 March 2022: Cynata Therapeutics Limited (ASX: "CYP", "Cynata", or the "Company"), a cli ical-stagebiotechnology company specialising in cell therapeutics, is pleased to release an updated Corporate Investor Presentation which will be used to update existing shareholders, potential investors, and other parties.
The presentation provides an overview of the key competitive advantages of Cynata's proprietary Cymerus™ technology. Cymerus overcomes manufacturing challenges associated with conventional mesenchymal stem cell use(MSC) manufacturing strategies, including inter-donor variability (requiring multiple donors), product
inconsistency and quantity limitations.
Cynata has a rich and diverse clinical pipeline with three active clinical trials: a Phase 3 trial in osteoarthritis, the MEND trial in respiratory distress, and a recently commenced trial in diabetic foot ulcers. The Company also recently signed a Strategic Partnership Agreement (SPA) with FUJIFILM, leading on to an agreement with Fujifilm Cellular Dynamics, Inc (a subsidiary of Fujifilm) to produce and supply Cymerus MSCs for clinical and commercial purposes. As part of the SPA, Cynata regained rights to CYP-001 (Cynata's lead product candidate) in graft-versus-host-disease (GvHD) and planning is now underway for a Phase 2 GvHD clinical trial in the USA.
personalThe presentation is attached to this announcement.
CONTACTS:
About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ ov rcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.
Cynata's lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Planning for a Phase 2 clinical Fort ial in GvHD is presently underway. Clinical trials of Cymerus products in osteoarthritis (Phase 3), respiratory failure and diabetic foot ulcers (DFU) are currently ongoing. In addition, Cynata has demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, including the clinical targets mentioned above, as well as critical limb ischaemia, idi pathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release
syndrome.
Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group.
Cynata Therapeutics Limited
Level 3, 100 Cubitt Street, Cremorne, Victoria, 3121, Australia
PO Box 7165, Hawthorn North, Victoria 3122
- +613 7067 6940 E:info@cynata.comABN - 98 104 037 372
onlyuseA Next Generation Stem Cell Therapeutics Company
ersonalI vestor Presentation (March 2022)
Investment Highlights
Cynata is a clinical stage biotech developing its proprietary CymerusTM manufacture of mesenchymal stem cell (MSC) therapeutic products to
platform technology for the scalable treat serious disorders
only | |||
Unique | Strong safety | ||
Manufacturing | and efficacy | ||
useSingle donation from a | |||
Positive pre-clinical | |||
and clinical data | |||
ersonal | single donor | supporting versatility and | |
overcomes | efficacy of Cynata's | ||
suboptimalities in | MSCs | ||
conventional MSC | |||
manufacturing | Validation through | ||
corporate partnering | |||
ARDS: Acute Respiratory Distress Syndrome, DFU: Diabetic Foot Ulcers
1. Cash as at 31 December 2021
Multiple
clinical trials
underway
Rich clinical pipeline:
- Diabetic Foot Ulcers
- Respiratory distress (ARDS)
- Osteoarthritis (Phase 3)
Phase 2 GvHD trial to
commence in 2022
Large
addressable
market
Combined market
opportunity of clinical trials underway and in planning is ~A$46bn
Significant
value upside
Multiple pathways to commercialisation,
including strategic
partnering
Well placed to fund to major catalysts with
~A$27m1 in cash
2
Why MSCs?
MSCs play a central co-ordinating role in many of the body's mechanisms of defence, repair and regeneration: the "sensor and switcher of the immune system"1
ersonal use only
- Aggarwal S, et al. Blood. 2005;105(4):1815-1822
- www.clinicaltrials.gov(as at October 2021)
Global interest in MSCs
continues to grow
>1,0002
clinical trials of MSCs have been initiated in the past decade
Source: Aldrich E.D. et al,; Stem Cells Transl Med. 2021
Nov;10(11):1500-1515
3
Conventional vs. Cynata's Cymerus MSC manufacturing process
onlyConventional Processes
use Cynata's
ersonalProcess
Cells donated | Conventional process | ||||
1 | Cells from | 2 | Limited quantity | 3 | Significant MSC |
multiple donors | of MSCs isolated | expansion required |
Cells donated | Cynata's patented process: Cymerus | ||||
1 | Cells from one | 2 | Effectively limitless | 3 | Minimal MSC |
donor | expansion | culture expansion |
CONSISTENCY | QUANTITY | QUALITY | ||
iPSC: Induced Pluripotent Stem Cells. iPSC's derived directly from adult cells and can propagate indefinitely.
MCA: Mesenchymoangioblasts. These are produced from iPSCs.
MSCs
4 Cell therapy product
MSCs
4 Cell therapy product
EFFICIENCY
4
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Cynata Therapeutics Ltd. published this content on 07 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 March 2022 22:20:08 UTC.
