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ASX-listed stem cell company, Cynata Therapeutics (ASX:CYP), has been on a tear recently. At the time of writing its share price is up 54 percent since summer officially began on 1 December.

On 11 February it reached an all-time high of $1.58 and is nearly double the share price of 12 months ago.

One of the key catalysts driving the interest in Cynata could be the impending 90-day deadline of its strategic investor and licencing partner, FujiFilm, to exercise its licence option over the CYP-001 product.

The CYP-001 product completed its phase 1 clinical trial in the treatment of graft-versus-host-disease (GvHD) in August last year with outstanding results.

It met all safety and efficacy end-points and reported an overall response rate at day-100 of 93 percent and a complete response rate of 53 percent.

Upon exercising the licence, Cynata will receive USD3m in an upfront licencing fee from FujiFilm and will be entitled to a further AU$60m in milestone payments plus royalties. Furthermore, ‘double digit’ royalties are to be paid on top of all this.

FujiFilm have 90-days to exercise their licence option from when the full trial report was delivered, which was completed on 18 Dec.

It is also set to commence three phase 2 clinical trials this year – and there aren’t many small cap listed biotech companies that can say that.

Two of its trials are also being substantially funded by external collaborations and strategic partners.

Later this year, it will begin a phase 2 trial in osteoarthritis with the University of Sydney that will recruit 448 patients throughout Sydney and Tasmania.

Cynata will make no cash contribution to the trial. It will be funded by a grant of $1.98 million from the Australian National Health and Medical Research Council (NHMRC). It will also be one of the largest stem cell trials globally.

It is also assessing a trial to treat critical limb ischemia (CLI) – an advanced stage of peripheral artery disease that results in severely impaired blood flow, causing pain, tissue damage, ulceration and gangrene. CLI often results in amputation of the affected limb.

Cymerus™ MSCs have been successfully tested in a mouse model demonstrating the return of blood flow to the lower limb.

Cynata continues to evaluate other high-potential target areas and commercial opportunities for its mesenchymal stem cell (MSC) products and its proprietary Cymerus platform.

2019 is set to be transformational year for Cynata as it continues to demonstrate the broad applicability of its MSC-based therapeutic products and moves closer to the goal of commercialising its products.

Star Investing has a commercial partnership with Cynata Therapeutics. This content does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.