The clinical-stage stem cell and regenerative medicine firm, Cynata Therapeutics (ASX:CYP) has recently released its annual report for the financial year ended June 2021 (FY21).
During the period, the Company achieved several clinical milestones and continued to advance its position in the regenerative medicine sector, while prudently managing through unforeseeable circumstances with the pandemic. Moreover, the Company strengthened its Board and bolstered its financial position to provide the financial strength needed to advance product development plans with confidence.
Cynata’s success during the year was reinforced by the addition of new indications to the clinical pipeline and the introduction of cornerstone healthcare investor BioScience Managers.
The latest annual report underlines Cynata’s strong position as a leader in the regenerative medicine space with advanced clinical trials. Here are some of the key operational developments that shaped a remarkable financial year for the Company:
- Cynata commenced the SCUlpTOR Phase 3 clinical trial of CYP-004 for osteoarthritis in FY21. SCUlpTOR stands for Stem Cells as a symptom and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis. The trial, funded by an Australian Government grant, is the world’s first Phase 3 clinical study for an iPSC-based cell therapy and one of the largest mesenchymal stem cell (MSC) trials in osteoarthritis.
- During the period, Cynata also expanded the recruitment criteria and began enrolment of patients with respiratory failure in the MEND (MEseNchymal coviD-19) clinical trial. The Company initially commenced the MEND trial in COVID-19 patients admitted to an ICU with respiratory failure, then later expanded the recruitment criteria to include patients with respiratory distress from any cause, in a bid to capture more applicable participants and accelerate trial completion.
- In June, Cynata received ethics committee approval to initiate a clinical trial in Diabetic Foot Ulcers (DFU). This achievement represents a significant milestone towards initiating patient recruitment into the trial. The clinical trial is expected to commence in 4Q CY21.
- Cynata signed a worldwide exclusive agreement with TekCyte to utilise advanced wound dressing technology for the planned trial in DFU. TekCyte is a leading manufacturer in advanced biomedical coatings, which has developed a unique and scalable wound dressing technology that can facilitate the delivery of MSCs directly to DFUs.
- The Company’s proprietary Cymerus MSC technology was the subject of an article featured on the front cover of, and published in, the prestigious Nature Medicine journal, in November last year. It provided further recognition of Cynata’s technology platform.
- Cynata progressed towards expanding the clinical pipeline in potential therapeutic targets, including renal transplantation and IPF (idiopathic pulmonary fibrosis). The clinical trial planning for IPF is currently underway, supported by promising preclinical results which show the efficacy of Cymerus MSCs in rodent models of idiopathic pulmonary fibrosis.
Cynata strengthened its board in FY21, with the appointment of Dr Geoff Brooke as Independent Chairman to support the Company’s advancing clinical development and commercialisation pathways.
Moreover, the Company raised AU$18.3 million (gross) in an entitlement offer, institutional placement, and shortfall placement, led by an AU$10 million investment by BioScience Managers – a cornerstone healthcare investor. This successful transaction provided robust validation of the Company’s technology and clinical pipeline, allowing it to be well-placed to advance existing and new therapeutic targets.
Supported by the capital raising, the Company’s cash balance stood at AU$26.7 million as of 30 June 2021.
Cynata has planned the following clinical activities for FY22 and beyond:
- Cynata signed a new Strategic Partnership Agreement (SPA) with Fujifilm in September 2021, for Fujifilm to manufacture Cynata’s Cymerus MSC products for clinical and commercial purposes. As part of the agreement, Cynata has all development and commercialisation rights to CYP-001 for GvHD and will look to immediately implement a US development strategy. The Company received US$5m in October from Fujifilm under the new SPA.
- Cynata will look to confirm Phase 2 GvHD trial planning, and to meet with the FDA to conduct the Phase 2 GvHD trial in the US.
- Cynata aims to complete recruitment of the 24 patients in the MEND trial and the 440 patients in the Phase 3 osteoarthritis trial.
- The Company intends to commence the planned clinical trial in DFU in 4Q CY21, upon completion of trial start up activities and relevant approvals.
- In light of the Phase 2 GvHD trial and exposure to the diabetes sector through the DFU trial, Cynata will look to partner the Phase 2 trial in Critical Limb Ischemia (CLI), to provide flexibility to accelerate progress while continuing to advance the pipeline.
- The Company continues to engage in commercial discussions and explore corporate partnerships.
Cynata’s achievements in financial year 2021 are a testament to the outstanding team that has managed to prudently navigate through several unexpected circumstances. Meanwhile, the diverse clinical pipeline and potential commercial pathways have placed the Company in a strong position for growth and execution of its strategies to build shareholder value.
Cynata shares are trading at AU$0.615 as of 12:52 PM AEDT.