Investor Webinar
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
5 May 2025
Investor Webinar
Melbourne, Australia; 5 May 2025: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the
“Company”), a clinical-stage biotechnology company specialising in cell therapeutics, reminds
shareholders that CEO and Managing Director, Dr Kilian Kelly, will host an investor webinar today,
Monday 5 May 2025 at 10:30am AEST.
Attendees are required to register in advance for the webinar – using the following link:
https://us02web.zoom.us/webinar/register/WN_AvnG-LrtTYOzU3TvHGdn3A
Upon registration, attendees will receive a link to access the webinar.
A copy of the presentation to be delivered during the webinar is attached to this announcement.
-ENDSAuthorised 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, lauren@littlebigdeal.au
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 of other production methods 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 limitation of
multiple donors.
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 CYP001 in patients undergoing kidney transplantation; and a Phase 3 trial of CYP-004 in osteoarthritis. In addition, Cynata has
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
cytokine release syndrome.
Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service
provider, Automic Group.
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
A Clinical Stage
Company Pioneering
the Next Generation
of Cellular Therapies
Investor Webinar
5 May 2025
Important information
Summary information
Forward-looking statements
This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries (CYP, or
Cynata) which is current as at 2 May 2025. This Presentation should be read in conjunction with CYP’s other periodic
and continuous disclosure information lodged with the Australian Securities Exchange (ASX), which are available at
www.asx.com.au.
This Presentation contains certain ‘forward looking statements’, which can generally be identified by the use of forward
looking words such as ‘expect’, ‘anticipate’, ‘likely’, ‘intend’, ‘should’, ‘could’, ‘may’, ‘predict’, ‘plan’, ‘propose’, ‘will’,
‘believe’, ‘forecast’, ‘estimate’, ‘target’, ‘outlook’, ‘guidance’, ‘potential’ and other similar expressions. The forward looking
statements contained in this Presentation are not guarantees or predictions of future performance and involve known
and unknown risks and uncertainties and other factors, many of which are beyond the control of CYP, its directors and
management, and may involve significant elements of subjective judgment and assumptions as to future events which
may or may not be correct. There can be no assurance that actual outcomes will not differ materially from these forward
looking statements. A number of important factors could cause actual results or performance to differ materially from the
forward looking statements. No representation or warranty, express or implied, is made as to the accuracy, likelihood of
achievement or reasonableness of any forecasts, prospects, returns or statements in relation to future matters contained
in this Presentation. The forward looking statements are based on information available to CYP as at the date of this
Presentation. Except as required by law or regulation (including the ASX Listing Rules), CYP and its directors, officers,
employees, advisers, agents and intermediaries undertake no obligation to provide any additional or updated information
whether as a result of new information, future events or results or otherwise. You are strongly cautioned not to place
undue reliance on forward-looking statements.
Not an offer
This Presentation is not a prospectus, product disclosure statement or other offering document under Australian law (and
will not be lodged with the ASIC) or any other law. This Presentation is for information purposes only and is not an
invitation or offer of securities for subscription, purchase or sale in any jurisdiction. The release, publication or distribution
of this Presentation (including an electronic copy) outside Australia may be restricted by law. If you come into possession
of this Presentation, you should observe such restrictions. Any non-compliance with these restrictions may contravene
applicable securities laws.
Not investment advice
This Presentation does not constitute investment or financial product advice (nor tax, accounting or legal advice) or any
recommendation by CYP or its advisers to acquire CYP securities. This Presentation has been prepared without taking
account of any person’s individual investment objectives, financial situation or particular needs. Before making an
investment decision, prospective investors should consider the appropriateness of the information having regard to their
own investment objectives, financial situation and needs and seek legal, accounting and taxation advice appropriate to
their jurisdiction. CYP is not licensed to provide financial product advice in respect of CYP securities.
Investment risk and past performance
An investment in CYP securities is subject to known and unknown risks, some of which are beyond the control of CYP
and its directors. CYP does not guarantee any particular rate of return or performance of CYP. Past performance cannot
be relied upon as an indicator of (and provides no guidance as to) future CYP performance including future share price
performance.
Financial data
All financial information in this Presentation is in Australian currency (A$) unless otherwise stated. This Presentation
contains historical financial information based on financial information that has been disclosed to the ASX. Any
discrepancies between totals and sums of components in tables and figures in this Presentation are due to rounding.
Industry and Market data
Certain market and industry data used in connection with this Presentation may have been obtained from research,
surveys or studies conducted by third parties, including industry or general publications. Neither CYP nor its
representatives have independently verified any such market or industry data provided by third parties or industry or
general publications.
Disclaimer
To the maximum extent permitted by law, CYP and its advisers, affiliates, related bodies corporate, directors, officers,
partners, employees and agents (Related Persons) exclude and disclaim all liability, including without limitation for
negligence, for any expenses, losses, damages or costs arising from this Presentation or reliance on anything contained
in or omitted from it. To the maximum extent permitted by law, CYP and its Related Persons make no representation or
warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this Presentation
and disclaim any obligation or undertaking to release any update or revision to the information in this Presentation to
reflect any change in expectations or assumptions. Statements made in this Presentation are made only as at the date
of this Presentation. The information in this Presentation remains subject to change without notice.
2
Corporate overview
Cynata Therapeutics Limited (ASX:CYP)
Largest shareholders
•
Clinical stage biotechnology company, headquartered in
Melbourne, Australia
•
Commercialising the novel Cymerus
•
Scalable and consistent production of potent cell-based
therapies for a range of serious medical disorders
iPSC1-based platform
3.6%
Share price performance
Share price (2 May 2025)
A$0.195
Shares on issue
~225m
Market capitalisation
~A$44m
Cash2
~ A$8.5m
2 As at 31 March 2025
10.0%
Top 20 shareholders hold ~47% of shares on issue
Financial information
1 iPSC = induced Pluripotent Stem Cell
10.3%
3
Clinical pipeline
INDICATION
PHASE 1
PHASE 2
PHASE 3
Osteoarthritis (OA)
(managed by USYD, funded by NHMRC)
Acute Graft vs Host Disease
(aGvHD)
FDA Orphan Designation
Diabetic Foot Ulcers (DFU)
Kidney Transplantation
(managed and funded by LUMC)
Note: Cynata retains commercial rights for both of the partner funded & managed programs
4
March 2025
Quarter –
Key Highlights
Phase 2 clinical trial in aGvHD
• Trial ongoing at >35 clinical centres in Australia,
USA, EU and Turkey
• Patient enrolment has progressed very well in
recent months; now >60% complete
• Completion of enrolment anticipated ~Jul 2025
• Primary results (after 100 days’ follow-up) still
anticipated late 2025
Phase 3 clinical trial in osteoarthritis
•
•
•
•
Patient enrolment completed in Nov 2023
Patient treatment completed in Nov 2024
Last patient visit expected in Nov 2025
Results expected H1 2026
Phase 1 clinical trial in kidney
transplantation
• First patient received CYP-001 in Dec 2024
• Patient enrolment continues; Cohort 1 completion
expected during the currently ongoing quarter
Further scientific validation
•
Paper underlining strengths of Cymerus platform published
in npj Regenerative Medicine, a leading peer-reviewed journal
published by Nature Portfolio
•
Key findings:
•
Effects of MSCs largely driven by secretomes (proteins
and other molecules released by cells)
•
Cymerus MSC secretomes contained many more unique
proteins and showed greater immunomodulatory effects
than secretomes of donor-tissue derived MSCs
•
Secretomes of iPSC-derived and umbilical cord-derived
MSCs resulted in significantly faster wound closure than
bone marrow or adipose tissue-derived MSCs
Reminder – DFU Phase 1 trial results
Diabetes fastest
growing disease
worldwide1
Est. 38 million
Americans have
diabetes2
Up to 34% of those
with diabetes will
develop a foot ulcer3
150,000+ lower
extremity amputations
per year in the US
following chronic
DFU4
12w
1.
2.
3.
24w
Hossain et al. Health Sci Rep. 7(3):e2004 (2024).
American Diabetes Association: https://diabetes.org/about-diabetes/statistics/about-diabetes
McDermott et al. Diabetes Care. 46:209–221 (2023).
Estimated annual
costs to US public and
private payers: US$9–
13 billion5
Larger wounds measuring >200 mm²
These results are highly
encouraging when
compared with the
results achieved using
current standard of care
(SOC)
Reduction in
wound size
(i.e. improvement)
Mean change in wound surface area (all wounds)
More than 15% of foot
ulcers result in
amputation of the foot
or limb3
12w
24w
4. American Diabetes Association: https://diabetes.org/advocacy/amputation-prevention-alliance
5. Raghav et al. Ther Adv Endocrinol Metab. 9(1) 29-31 (2018).
For further information on the Phase 1 clinical trial: https://clinicaltrials.gov/study/NCT05165628
10
Outlook and
commercial
potential
Industry connections
• We are continuing to progress partnering discussions with various partners, regarding various assets
• Upcoming catalysts will accelerate and broaden partnering discussions
• We continue to attend leading conferences in our sector, to tell our story and open new discussion
JP Morgan BioWeek/Biotech Showcase
Company presentation,
partnering meetings
Advanced Therapies Congress
Company presentation,
partnering meetings
International Society of Cell and Gene Therapy
Invited speaker,
partnering meetings
International Society of Stem Cell Research
Invited speaker
BIO International
Partnering meetings
San Francisco, January 2025
London, March 2025
New Orleans, May 2025
Hong Kong, June 2025
Boston, June 2025
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Upcoming catalysts*
DFU results announced Dec 2024; results from three further trials expected by 1H 2026
PHASE 1
DFU
Results
announced
– Dec 2024
PHASE 2
aGvHD
Enrolment
complete
Results
Phase 3
osteoarthritis
Results
Phase 1/2
kidney
transplantation
Results
(Cohort 1)
Q1 2025
Q2 2025
Q3 2025
* Timing of events is approximate, based on the Company’s information as at the date of this presentation, and subject to change
Q4 2025
Q1 2026
Q2 2026
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Cynata Therapeutics Ltd
Level 3, 100 Cubitt Street
Cremorne, Victoria 3121, Australia
info@cynata.com
www.cynata.com
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