Cynata Therapeutics Ltd
ASX:CYP
Cynata Therapeutics Ltd
Cynata Therapeutics Ltd. engages in the development and commercialization of therapeutic products. The firm is engaged in the development and commercialization of a mesenchymal stem cell (MSC) technology for human therapeutic use, which the Company has branded as Cymerus. The Cymerus technology facilitates the manufacture of MSCs from a single donor and a single donation, which enables the development of therapeutic stem cell products. The firm's Cymerus platform stem cell technology is based upon stem cells known as mesenchymoangioblasts (MCAs). Its technology utilizes induced pluripotent stem cells (iPSCs) originating from an adult donor as the starting material for generating MCAs and in turn for manufacturing the MSC therapeutic product. The Company’s lead product candidate, CYP-001, which has met all clinical endpoints and demonstrated safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase I trial.
Cynata Therapeutics Ltd. engages in the development and commercialization of therapeutic products. The firm is engaged in the development and commercialization of a mesenchymal stem cell (MSC) technology for human therapeutic use, which the Company has branded as Cymerus. The Cymerus technology facilitates the manufacture of MSCs from a single donor and a single donation, which enables the development of therapeutic stem cell products. The firm's Cymerus platform stem cell technology is based upon stem cells known as mesenchymoangioblasts (MCAs). Its technology utilizes induced pluripotent stem cells (iPSCs) originating from an adult donor as the starting material for generating MCAs and in turn for manufacturing the MSC therapeutic product. The Company’s lead product candidate, CYP-001, which has met all clinical endpoints and demonstrated safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase I trial.
Clinical Progress: Cynata made notable progress in its clinical pipeline, with multiple trials advancing towards critical milestones.
Upcoming Catalysts: Three major clinical readouts are expected within the next year: Phase II GvHD, Phase III osteoarthritis, and initial kidney transplant trial results.
Osteoarthritis Trial: Enrollment and treatment for the 321-patient Phase III osteoarthritis trial are complete, with final results anticipated between February and April next year.
GvHD Trial: The Phase II GvHD trial has surpassed 75% enrollment, with completion targeted in the next few months and primary results expected in the first half of next calendar year.
Cash Runway: The company expects its cash to last until mid-2026, covering all upcoming major data readouts.
Regulatory Path: Positive feedback from Australian regulators suggests the osteoarthritis trial could support a marketing approval if results are strong.
Manufacturing Edge: Cynata’s iPSC-based platform offers the potential for scalable, consistent, and potent MSC production, differentiating it from competitors.
Business Development: There is ongoing interest in partnering, especially regarding the diabetic foot ulcer program, though deal complexity is noted.
