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- Biotech company Cynata Therapeutics (CYP) has updated the market on its March quarterly activities
- During the quarter the company made further progress with its three Phase 2 clinical trial programs
- These trials will see Cynata’s Cymerus mesenchymal stem cell product be used to treat osteoarthritis, critical limb ischaemia, and graft-versus-host disease
- However, due to COVID-19 restrictions, the trials cannot begin until it is safe to do so
- Cynata also highlighted receiving a Canadian Patent and Notices of Allowances from Japan and Israel for its product
- During the quarter Cynata received approximately $2.5 million in research and development tax incentive refunds
- The company now has $6.9 million in cash as from March 31
- Cynata is down a slight 5.36 per cent and shares are currently trading for 66.3 cents each
Biotech company Cynata Therapeutics (CYP) has updated the market on its March quarterly activities.
During the quarter, Cynata made further progress with its three Phase 2 clinical trial programs for treating osteoarthritis, critical limb ischaemia, and graft-versus-host disease.
The company also received a Canadian Patent and Notices of Allowances from Japan and Israel for its Cymerus mesenchymal stem cell (MSC) product.
“Under the present circumstances, Cynata continues to make good progress. The current climate is inevitably causing an industry-wide slow-down of clinical trial enrolment, including our planned Phase 2 trials,” Chairman Dr Paul Wotton commented.
“We are advancing critical activities to the final stages before recruitment and are in continued discussions with hospitals and strategic partners, as well as our other collaborators, to ensure that we are positioned to commence the trials effectively after the crisis resolves,” he said.
Operations Update
Critical Limb Ischaemia
In mid-January of this year, Cynata received regulatory approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin the Phase 2 trial of patients with critical limb ischaemia (CLI).
This trial will see Cynata’s Cymerus mesenchymal stem cell (MSC) product, CYP-002, be used in patients with CLI.
MSCs are adult stem cells found in a wide range of human tissues including bone marrow, placenta, and fat tissue.
They are multi-potent, which means they can produce more than one cell type. For example, they can differentiate into cartilage cells, bone cells, and fat cells.
They have been shown to ease regeneration and effects on the immune system without relying on engraftment, which is when transplanted cells start to grown and make healthy cells.
CLI is an advanced stage of peripheral artery disease PAD, which is the narrowing of arteries in the limbs, particularly the legs.
CLI often results in the amputation of the affected limb and is a major risk factor in developing other issues such as a heart attack.
Cynata expects to begin trials at multiple centres in the U.K. and Australia, however, it expects that patient enrolment will be delayed due to COVID-19 restrictions such as border closures and social distancing measures.
Osteoarthritis
Cynata is also planning a Phase 2 trial to treat patients with osteoarthritis with its Cymerus MSCs.
The University of Sydney, who is sponsoring the trial, has advised Cynata that newly approved trials should not begin first visits until the COVID-19 pandemic resolves.
Although the start of the trial remains uncertain, Cynata is continuing with planning and protocol activities.
The trial will involve 448-patients and will be ones of the largest MSC trials to be conducted.
The aim is to assess the effect of Cymerus MSCs compared to a placebo on the knee structure over a two year period.
Graft-versus-host disease
Cynata’s final Phase 2 trial, which involves its Cymerus MSCs being used to treat graft-versus-host disease, is continuing with trial planning and start-up activities.
Graft-versus-host disease is when the body’s own immune system starts to attack donated tissue. This usually happens after a bone marrow transplant or another similar procedure.
Granted Patents
In the March quarter, the Intellectual Property Office of Canada granted Cynata a patent covering its MSC product. This expires on March 16, 2031.
Furthermore, Cynata also received Notice of Allowance’s from the Israel Patent Office and the Japan Patent Office, also for its Cymerus MSC product.
Both of these patents are expected to expire in March 2034.
Finances
During the quarter Cynata received approximately $2.5 million in research and development tax incentive refunds.
Of this, $1.89 million was received in January while the remaining $618,000 was received in March.
As a result of this, amongst other reasons, Cynata remains in a strong financial position with $6.9 million in cash as from March 31.
The company is now continuing to minimise corporate expenses and manage cash flow to remain in this strong position while activities are halted.
Cynata is down a slight 5.36 per cent and shares are trading for 66.3 cents each at 12:35 pm AEST.
