Expected Timing of Clinical Trial Results
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Released
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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 27 May 2026
Expected Timing of Clinical Trial Results
Melbourne, Australia; 27 May 2026: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the
“Company”), a clinical-stage biotechnology company specialising in cell therapeutics, provides an
update on the expectedtimingof results fromtwo majorefficacytrialswithitsCymerus™iPSC1
-derived
MSC2
products.
Phase 3 Osteoarthritis Trial (CYP-004)
The Australian Phase 3 SCUlpTOR3
trial of CYP-004 in patients with osteoarthritis of the knee is being
conductedby theUniversityof Sydney(USYD)andfunded through an NHMRC4
projectgrant.CYP-004is
Cynata’s Cymerus™ iPSC-derived MSC product candidate for intra-articular injection (injection into a
joint),designed to calmjointinflammation,relievepainandprotectcartilage.Thetrialenrolledatotalof
321 patients, who were randomised to receive either CYP-004 or placebo, with co-primary endpoints
assessing change in pain and cartilage thickness.
USYDhas informedtheCompany thatthe study database has beensuccessfullylocked, the process of
data analysis is now progressing well, and results are expected during June 2026.
Phase 2 acute Graft versus Host Disease Trial (CYP-001)
The multi-national Phase 2 trial of CYP-001 in adults with acute graft versus host disease (aGvHD) is
being conducted by Cynata. CYP-001 is Cynata’sCymerus™ iPSC-derivedMSCproductfor intravenous
use, designed tomodulatetheimmunesystemandimproveboth responserates andsurvivaloutcomes
in aGvHD. A total of 65 participants were enrolled across clinical centres in Australia, the USA and
Europe, randomised to receive either steroids plus CYP-001 or steroids plus placebo. The primary
endpoint is Overall Response Rate at Day 28.
Database lock for this trial is expected to occur in early June 2026, with results anticipated in late June
or early July.
Dr Kilian Kelly, Cynata’s Chief Executive Officer and Managing Director, said:
"A great deal of progress has been made with the process of data monitoring, cleaning, quality control
andanalysisforthesetwohugelyimportant trials.Eachofthesereadoutsinitsownright hasthepotential
to betransformativefortheCompany, and toset us on course toimprovethelivesof manypatientswith
these serious diseases. We look forward to sharing the results with our investors as soon as possible."
-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 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
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.
1
iPSC = induced pluripotent stemcell.
2
MSC= mesenchymal stem (or stromal) cell.
3
SCUlpTOR = StemCells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis
4
NHMRC-= National Health and Medical Research Council
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