Cynata Therapeutics Ltd (ASX:CYP) (FRA:51S) (OTCMKTS:CYYNF) has met the clinical endpoints of a Phase 1 trial of its Cymerus mesenchymal stem cell (MSC) product candidate in people with steroid-resistant acute graft-versus-host disease (GvHD).
The company, which will present at the inaugural ASX Small and Mid-Cap Conference at Sydney’s Darling Harbour next Thursday, reported it had achieved a world first with the trial completion.
Cynata managing director and CEO Dr Ross Macdonald said: “The completion of this trial marks a major achievement not only for Cynata but also as a world-first for induced pluripotent stem cells-derived therapeutic products.
“Cynata is the only company with the ability to produce allogeneic MSC therapies at commercial scale without the limitation of multiple donors.”
Study results
Graft-versus-host disease can occur after a patient receives a tissue implant from another person and the donated material — such as donated bone marrow and cells — treat the recipient’s body as foreign and attack the patient’s body.
The company reported day-100 analysis of the patients in group of patients known as Cohort B that received a high dose of the CYP-001 product candidate.
Cynata said the trial’s positive safe and efficacy data was consistent with the day-100 results from the lower-dose Cohort B group and Cohort B 72 days earlier at the day-28 mark.
The analysis is the competition point for the primary evaluation period of the Phase 1 study’s enrolled patients.
Macdonald said: “The positive data supports the potential of Cymerus to generate off-the-shelf stem cell therapies for multiple diseases providing significant opportunities for monetisation and commercial partnerships.”
READ: Cynata Therapeutics treats final patient in stem cell clinical trial
Cynata product development vice-president Dr Killian Kelly will deliver a presentation on behalf of the company at the ASX Small and Mid-Cap Conference in Sydney on Thursday.
Kelly previously reported: “A positive trial outcome would bring us one step closer to providing the first-ever allogenic induced pluripotent stem cell-derived mesenchymal stem cell therapy to patients in need.”
Financial results
Cynata’s preliminary final report issued on Wednesday last week unveiled a 0.28 increase in its net loss to $4.6 million for the 2017-18 financial year, when compared to the 2016-17 result.
The company increased its net cash outflows by $13,726, or 0.34%, to $4.1 million when compared to the previous period.
Cynata increased its net assets by $1.5 million or 10.98% in the financial year to $15.4 million.
It ended June 30 with $12.2 million in cash, a 17.94% increase on the cash it held at the end of the 2017 financial year.
Upcoming meeting
Cynata will hold its annual general meeting on Wednesday, September 12 in Melbourne’s Carlton South at 10am EST.
Shareholders will be asked to vote on a number of motions at the meeting, including to ratify a share issue to be made as part of a placement.
Cynata product development vice-president Dr Killian Kelly will present at the inaugural ASX Small and Mid-Cap Conference in Sydney on Thursday, September 6. To attend the conference, register here.