CYP-004 Osteoarthritis Trial Results
Released
Released
Announcement PDF
Cynata Therapeutics Limited
ABN – 98 104 037 372
Level 3, 100 Cubitt Street
Cremorne
VIC 3121
Australia
T: +613 7067 6940
E: info@cynata.com
www.cynata.com
ASX ANNOUNCEMENT 19 June 2026
CYP-004 Osteoarthritis Trial Results
Melbourne, Australia; 19 June 2026: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”),
a clinical-stage biotechnology company specialising in cell therapeutics, has received top-line results from the
University of Sydney’s Phase 3 SCUlpTOR1
trial of CYP-004 in patients with osteoarthritis of the knee.
Key findings:
• There were no safety concerns identified, with a similar adverse event profile between groups.
• There were no statistically significant differences between the active and control groups in either of the
co-primary endpoints:
o The proportion of participants reaching the patient-acceptable symptom state (PASS) threshold for
knee pain at 24 months was 51.7% in the active group compared to 48.1% in the control group
(p=0.5907).
o There was a mean loss of central medial femorotibial (cMFT) cartilage thickness of 0.27mm in the
active group compared to 0.21mm in the control group (p=0.1453).
• There was a substantial and durable reduction in knee pain intensity at all timepoints from 3-24 months
compared to baseline (secondary endpoint), with an average reduction in pain score of 26.8/100 in the
active group and 25.3/100 in the control group after 24 months. However, there were no significant
differences between groups at any timepoint.
Analysis of additional outcome measures is ongoing and will be reported in due course.
CYP-004 is Cynata’s Cymerus™ off-the-shelf iPSC2-derived MSC3 product candidate for intra-articular
injection.4 The SCUlpTOR trial was a randomised and placebo-controlled Phase 3 trial, conducted by the
University of Sydney, with funding provided under an Australian Government NHMRC5
project grant. Patients
were randomised to receive intra-articular injections of either saline (placebo control group) or CYP-004 (active
group). The trial was led by Professor David Hunter, the Florance and Cope Chair of Rheumatology and Professor
of Medicine at the University of Sydney and Royal North Shore Hospital.
Dr Kilian Kelly, Cynata’s CEO and Managing Director, said:
“The results of this trial are disappointing. The pain reduction in the control group was much better than
expected: the study design assumed that 35% of control patients would reach the PASS threshold, but it has
turned out that almost 50%have doneso.The pain reduction in the active group was inline with our expectations,
but unfortunately there is no evidence of a reduction in cartilage loss. We would like to thank Professor Hunter
and the rest of the study team for conducting the trial, as well as the patients who participated.”
In light of these outcomes, following the recently announced results of the Phase 2 clinical trial of CYP-001 in
patients with acute graft versus host disease (see announcement dated 17 June 2026), the Company is now
actively reviewing options for further development of the Cymerus™ technology, and will provide an update as
soon as possible.
Investor Webinar
An investor webinar will be held on Monday 22 June 2026, at 8:30am AEST, hosted by CEO and Managing
Director, Dr Kilian Kelly, and Chair, Dr Geoff Brooke. Please visit the following link to register:
https://cynata.com/webinars/rvJo2r-cynata-investor-webinar
-ENDS-
Authorised for release by Dr Kilian Kelly, CEO & Managing Director
Cynata Therapeutics Limited
ABN – 98 104 037 372
Level 3, 100 Cubitt Street
Cremorne
VIC 3121
Australia
T: +613 7067 6940
E: info@cynata.com
www.cynata.com
CONTACTS: Dr Kilian Kelly, CEO & MD, Cynata Therapeutics, +61 (03) 7067 6940, kilian.kelly@cynata.com
Lauren Nowak, Media Contact, +61 (0)400 434 299, investors@cynata.com
About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the
development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the
challenges and limitations of conventional MSC production by using induced pluripotent stem cells (iPSCs) to achieve economic
manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the necessity to obtain
tissue from multiple donors on an ongoing basis, and without the complexity and product inconsistency resulting from conventional
methods.
Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider,
Automic Group.
1
SCUlpTOR = Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis. Further details on
the trial can be found here: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000870954.
2
iPSC = induced pluripotent stem cell
3
MSC = mesenchymal stem (or stromal) cell
4
Intra-articular injection = injection into a joint
5
NHMRC = National Health and Medical Research Council
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