There was additional info shared via email for those on the...

There was additional info shared via email for those on the mailing list:

Cynata continues to make significant development progress, underpinned by our focused clinical development and commercialisation strategy.

In particular, we are advancing clinical development plans in diabetic foot ulcer (DFU), with a Memorandum of Understanding signed with TekCyte in anticipation of a license agreement for the use of their advanced wound dressing technology to deliver Cynata’s Cymerus™ MSCs. Cynata’s planned trial to treat DFU patients is based on a solid pre-clinical data, and we look forward to completing the license agreement and commencing the clinical trial. Diabetic foot ulcers represent a significant unmet medical need – in Australia alone, diabetic foot disease results in >27,000 hospitalisations, >4,400 amputations and >1,700 deaths annually and is expected to represent a global treatment market of around US$10bn.

In parallel, our Phase 3 osteoarthritis clinical trial is currently recruiting patients following the successful assessment of initial subjects treated in November 2020. The trial is led by the University of Sydney and funded by an NHMRC grant; it is designed to evaluate the important clinical endpoint of modifying the outcome of the underlying disease. Given current osteoarthritis treatment options largely focus on alleviating pain and that there are no cures available, this is a landmark trial which potentially addresses a market opportunity of approximately US$12bn p.a..

Cynata’s broad clinical pipeline is underpinned by the Cymerus platform technology that has been demonstrated to produce consistent and highly potent MSCs. The Company has recently initiated a new pre-clinical study at Monash University in a model of lung disease to investigate the observed high potency of our MSCs and to provide a valuable understanding of the molecular processes in their potentially useful clinical effects. This is being conducted in parallel with planning for a clinical trial in idiopathic pulmonary fibrosis.

Cynata is now in a very strong position to advance clinical development across multiple indications and to achieve further value catalysts with a proforma cash balance of ~A$30m (based on A$25m cash as at 31 December 2020, and additional A$3.55m raised under the Entitlement Offer and Shortfall Placement in January 2021 and A$1.4m R&D Tax Incentive Rebate received in February 2021). I look forward to providing you with further updates in due course.