Final Patient Visit Complete in Phase 3 Osteoarthritis Trial
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 24 November 2025
Final Patient Visit Complete in Phase 3 Osteoarthritis Trial
Melbourne, Australia; 24November 2025:CynataTherapeuticsLimited(ASX:“CYP”,“Cynata”,orthe
“Company”),a clinical-stagebiotechnologycompanyspecialisingincelltherapeutics,announces the
completionof the finalparticipantstudyvisitinthe Phase3 SCUlpTOR1
trialof CYP-004inpatients with
osteoarthritis of the knee.
This formallycompletesthe2-yearfollow-upof participantsinthistrial.Cynata’spartner,theUniversity
of Sydney,willnowwork tocompletedatamonitoringand qualitycontrolactivities,followedbyanalysis
of the data. Results of the trial are expected to be released in Q2 CY 2026.
Dr JolantaAirey, Cynata’s ChiefMedical Officer, said:“Completionof the follow-up of participantsis
a majormilestone,whichnowsets inmotionthe finalsteps before the resultsof thetrialarereleased in
the coming months. The trial is designed to determine if CYP-004 has a disease-modifying effect, in
addition to relieving the symptoms of osteoarthritis. We are very much looking forward to the results.”
Market opportunity and unmet need
Osteoarthritisisoneof the world’slargestchronicdiseasemarkets,affectingaround600millionpeople
globally and is associated with an economic burden of >US$468 billion annually in the United States
alone.2
There isno curativetherapytoday - care typicallyprogressesfromlifestylechangemeasures to
anti-inflammatories and corticosteroid injections, with many patients ultimatelyfacing invasive, costly
joint-replacement surgery that is not suitable for all.
CYP-004 is Cynata’s Cymerus™ off-the-shelf iPSC3
-derived MSC4
product candidate for intra-articular
injection.Itis a targeted, intra-articularinjection5
designedtocalm jointinflammation,relievepainand
protect cartilage.
About the Phase 3 SCUlpTOR trial
The SCUlpTOR trial is a randomised and placebo-controlled Phase 3 trial of CYP-004 in patients with
osteoarthritisof theknee.The trialisbeingconducted bythe Universityof Sydney,withfundingprovided
under anAustralianGovernmentNationalHealthandMedicalResearchCouncil(NHMRC)projectgrant.
The trial is being 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.
-ENDS-
Authorised for release by Dr Kilian Kelly, CEO & Managing Director
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 thechallenges and limitations of conventional MSCproduction byusing induced pluripotent stemcells (iPSCs) to
achieve economic manufacture of cell therapy products,including mesenchymal stromal cells (MSCs),at commercial scale
without the necessity to obtain tissue from multiple donors on an ongoing basis, and without the complexity and product
inconsistencyresulting fromconventional methods.
Cynata has demonstrated positive safety and efficacy data for its Cymerus™ product candidates CYP-001 and CYP-006TK in
Phase 1 clinical trials in steroid-resistant acute graft versus host disease (GvHD) and diabetic foot ulcers (DFU), respectively.
Further clinical trials are now ongoing:a Phase 2 trial of CYP-001 in GvHD under a cleared US FDA IND; a Phase 1/2 trial of
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
CYP-001 in patients undergoing kidneytransplantation;and aPhase3 trial of CYP-004 in osteoarthritis.In addition,Cynatahas
demonstrated utility of its Cymerus™ technology in preclinical models of numerous other diseases, including critical limb
ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and
cytokinerelease syndrome.
Cynata Therapeutics encourages all current investors to go paperless by registering their details withthe designatedregistryservice
provider, Automic Group
1
SCUlpTOR = StemCells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis
2
Total EconomicImpact on theUS Economy|BMUS: TheBurden of Musculoskeletal Diseases in theUnited States, Table 8.13
3
iPSC = induced pluripotent stemcell
4
MSC= mesenchymal stromal (or stema) cell
5
Intra-articular injection =injection into ajoint
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