September 2025 Quarterly Activity Report and Appendix 4C
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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 31 October 2025
September 2025 Quarterly Activity Report
Key highlights:
• Important period ahead for Cynata, with results of two randomised, controlled efficacy clinical
trials expected this financial year.
• Patient enrolment in the Phase 2 trial in acute Graft versus Host Disease is nearing completion,
with primary results anticipated during Q2 CY 2026.
• The final patient visit in the 321-patient Phase 3 trial in Osteoarthritis is expected in November
2025, with results anticipated during Q2 CY 2026.
• DSMB review of Cohort 1 of the Phase 1/2 kidney transplant trial expected in Q4 CY 2025.
• Ended the quarter with $3.2 million in cash, with R&D tax incentive rebate of ~$1.7m expected
imminently, providing funding runway through mid-CY 2026, covering all key clinical readouts.
• Quarterly cash outflows for the remainder of this financial year are expected to decrease, with
the Company now only funding one clinical trial.
• Webinar to be held on 6 November 2025 at 11:30am AEDT.
Melbourne, Australia; 31 October 2025: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the
“Company”), a clinical-stage biotechnology company specialising in cell therapeutics, provides its
Quarterly Activity Report for the three-month period ended 30 September 2025.
Phase 2 Acute Graft Versus Host Disease Trial: Results Expected Q2 CY 2026
Acute graft versus host disease (aGvHD) is a serious and often life-threatening complication of bone marrow
transplantation and similar procedures, where the donor’s immune cells (the graft) attack the recipient’s
tissues(the host). aGvHD affectsup to 50% of patientswho receive transplants from other donors. Standard
first-line treatment with steroids fails in around half of all aGvHD cases, which are known as “steroid-
resistant” or SR-aGvHD cases. Historical two-year survival rates in patients with SR-aGvHD are less than
20%.1
Cynata’s Cymerus™ MSC2
product, CYP-001, is designed to modulate the immune system and improve both
response rates and survival outcomes in aGvHD. In a successful Phase 1 trial in patients with SR-aGvHD,
87% of patients showed an Overall Response, 53% showed a Complete Response, and 60% survived for at
least two years. Importantly, there were no serious adverse events or safety concerns related to CYP-001
treatment. This ground-breaking trial led to two publications in the prestigious journal Nature Medicine.3,4
Cynata is now conducting a global Phase 2 trial in patients with high-risk aGvHD. Patients are randomised
to receive either standard steroid therapy plus CYP-001, or steroids plus placebo. The primary endpoint is
Overall Response Rate at Day 28.
A total of 59 patients have been enrolled in the trial so far. The trial was statistically powered based on the
assumption of 56 patients receiving study treatment (either placebo or CYP-001). The original enrolment
target was set at 60, to allow for up to four patients withdrawing from the trial between randomisation and
receipt of study treatment, which is not uncommon in this disease setting. However, there are now eight
randomised patientsin thistrial who withdrewbeforereceiving study treatment.In order to reach the original
target of treated patients, the Company has made the decision to enrol an additional four patients. In
summary, the current status is that 59 patients have been enrolled out of the revised target of 64.
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
The Company anticipates completing enrolment prior to the end of the 2025 calendar year and releasing the
primary results during Q2 CY 2026.
Phase 3 Osteoarthritis Trial: Results Expected Q2 CY 2026
Osteoarthritis is a degenerative joint condition affecting over 500 million people globally. Current treatment
options are limited to symptom management or invasive surgery, with no disease-modifying therapies
currently available.
A Phase 3 trial of Cynata’s Cymerus™ MSC product, CYP-004, known as the SCUlpTOR5
trial, is being
conducted by the University of Sydney and funded through an NHMRC6
project grant. The trial completed
enrolment of 321 patients in November 2023, and the final patient visit (following a two-year follow-up
period) is expected in November 2025. Based on advice from the University of Sydney, the Company
anticipates receiving and releasing the final results in Q2 CY 2026.
Following an advisory meeting with the Australian Therapeutic Goods Administration (TGA), Cynata is
optimistic that positive results could support marketing approval of CYP-004 in Australia.
Phase 1/2 Kidney Transplantation Trial: DSMB Review of First Cohort Expected Q4 CY 2025
Patients undergoing kidney transplantation typically require lifelong immunosuppressive therapy to prevent
organ rejection, typically with drugs known as calcineurin inhibitors. These drugs are effective, but they
come with serious long-term toxicity and health risks.
This investigator-led 16 patient trial, conducted at Leiden University Medical Centre (LUMC) in the
Netherlands, is assessing whether CYP-001 can reduce reliance on calcineurin inhibitors, potentially
offering patients safer long-term immune modulation.
The enrolment and treatment of the three patients in Cohort 1 is now complete. The outcome of a review of
this cohort by the study’s independent Data and Safety Monitoring Board (DSMB) is anticipated during Q4
CY 2025.
Corporate and Strategic Updates
Intellectual Property Portfolio
Cynata continues to have a strong relationship with Wisconsin Alumni Research Foundation (WARF), the
entity from which certain patents underpinning the Cymerus technology were licensed. Under the license
agreement, the Company has obligations to use commercially reasonable efforts to achieve certain
development milestones. Duringthe quarter,Cynataand WARF amended the agreement to adjust thetarget
milestone dates to reflect current expected development timelines.
Outlook
Cynata is entering one of the most defining phases in its development, with two late-stage clinical programs
approaching major data readouts that will define the Company’s next chapter. The Phase 3 osteoarthritis
and Phase 2 aGvHD trials are both on track to report results over the next 6-9 months — key milestones
designed to demonstrate the consistency, scalability, and clinical potential of our Cymerus™ platform.
Beyond these trials, Cynata’s broader outlook remains positive. The Company maintains a clear line of sight
to its next strategic horizon — progressing from clinical validation toward commercial opportunity. As the
global cell therapy sector matures, scalable and donor-independent manufacturing is emerging as a
defining advantage. Cynata’s Cymerus™ technology directly addresses that need, positioning the Company
as one of the few developers capable of supplying consistent, high-quality MSCs at true commercial scale.
Regulatory tailwinds are also accelerating. Agencies in major markets are introducing more flexible
frameworksfor advanced therapies,enablingfaster and moreefficient approval pathways.At thesametime,
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
investment and industry activity in regenerative medicine continue to grow, creating a favourable
environment for companies with validated technologies and late-stage clinical assets.
Cynata’s operational and financial foundations remain sound, with a defined funding runway through mid-
2026 covering all key data readouts. The Company continues to maintain strategic discipline — focusing
resources on value-driving milestones, advancing regulatory engagement, and preparing for potential
partnerships or licensing opportunities.
With major data catalysts ahead, an increasingly supportive policy environment, and a platform built for
scale, Cynata is well positioned to translate its scientific achievements into sustainable commercial
outcomes and long-term shareholder value.
Finance
TheCompany closed thequarter with$3.166mincash.Thisfiguredoesnot includethe anticipated Research
and Development Tax Incentive (R&DTI) rebate for the 2025 financial year, which the Company expects to
receive imminently, and which is now expected to be ~$1.7m.
Net operating cash outflows for the quarter totalled $1.883m, which is ~45% less than in the previous
quarter. The Company anticipates further decreases in quarterly cash outflows during the remainder of this
financial year, given that the Phase 2 aGvHD trial is now the only ongoing clinical trial that the Company is
funding, and most of the expenditure related to that trial has already been incurred. The other ongoing trials
(in kidney transplantation and osteoarthritis) are being conducted by partners and funded externally.
In accordance with ASX rules, the “Estimated quarters of funding available” reported in item 8.5 of the
Appendix 4C is calculated by dividing the Company’s cash balance at the end of the quarter by the net
operating cash outflows in the previous quarter, and the result of this calculation is 1.7 quarters of funding
available. However, taking into account the anticipated R&DTI rebate and decreasing quarterly cash
outflows for the remainder of this financial year, the Company continues to anticipate that its cash runway
will extend into mid-calendar year 2026.
Additionally,asannounced on 22 August 2025, theCompany hasentered intoanAt-the-Market Subscription
Agreement (“ATM”) with Acuity Capital. The ATM provides Cynata with up to $7,500,000 of standby equity
capital over the coming five years, to 31 July 2030. Importantly, Cynata has full discretion as to whether or
not to utilise the ATM, the maximum number of shares to be issued, the minimum issue price of shares and
the timing of each subscription (if any). There are no requirements on Cynata to utilise the ATM and Cynata
may terminate the ATM at any time, without cost or penalty. Neither Acuity Capital nor the ATM place any
restrictions at any time on Cynata raising capital through other methods.
In item 6 of the Appendix 4C cash flow report for the quarter, payments to related parties of approximately
$240kconsisted of salary and bonuspaid totheManagingDirector and fees paid toNon-ExecutiveDirectors.
Investor Communications
Webinar
An investor webinar will be held on Thursday 6th
November 2025 at 11:30am AEDT, hosted by CEO and
Managing Director, Dr Kilian Kelly.
Attendees are required to register in advance for the webinar – using the following link:
https://us02web.zoom.us/webinar/register/WN_QlGafabxSbmstpTJtioYGQ
Upon registration, attendees will receive details to access the webinar.
InvestorHub
Earlier this year, the Company launched a new InvestorHub portal and website, for dedicated investor
engagement.
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
This enables shareholders, stakeholders, prospective investors and partners to learn more about the
Company's activities and key projects. The Company regularly uploads new content to the hub, including
videos, key project news and updates.
Shareholders and interested partiescanjoinInvestorHub viathe“signup” buttonon theCompany’s website
(www.cynata.com).
-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
the challenges andlimitations ofconventional MSC productionby using inducedpluripotent 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 inconsistency resulting from
conventional 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 CYP-001 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.
1
Westin JR et al. Adv Hematol. 2011;2011:601953
2
MSC = mesenchymal stromal (or stem) cell
3
Bloor AJC, et al. Nat Med. 2020;26:1720–1725
4
Kelly K, et al. Nat Med. 2024;30:1556–1558
5
SCUlpTOR = Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis
6
National Health and Medical Research Council
Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
CYNATA THERAPEUTICS LIMITED
ABN Quarter ended (“current quarter”)
98 104 037 372 30 SEPTEMBER 2025
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(3 months)
$A’000
1. Cash flows from operating activities
- -
1.1 Receipts from customers
1.2 Payments for
(999) (999)
(a) research and development
(b) product manufacturing and operating
costs
- -
(c) advertising and marketing (57) (57)
(d) leased assets (including premises) - -
(e) staff costs (675) (675)
(f) administration and corporate costs (199) (199)
1.3 Dividends received (see note 3) - -
1.4 Interest received 47 47
1.5 Interest and other costs of finance paid - -
1.6 Income taxes paid - -
1.7 Government grants and tax incentives - -
1.8 Other - -
1.9 Net cash from / (used in) operating
activities
(1,883) (1,883)
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(3 months)
$A’000
2.2 Proceeds from disposal of:
- -
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
- -
3. Cash flows from financing activities
- -
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities
- -
3.3 Proceeds from exercise of options - -
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
- -
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and
borrowings
- -
3.8 Dividends paid - -
3.9 Other (provide details if material) - -
3.10 Net cash from / (used in) financing
activities
- -
4. Net increase / (decrease) in cash and
cash equivalents for the period
5,049 5,049
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above)
(1,883) (1,883)
4.3 Net cash from / (used in) investing activities
(item 2.6 above)
- -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(3 months)
$A’000
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
- -
4.5 Effect of movement in exchange rates on
cash held
- -
4.6 Cash and cash equivalents at end of
period
3,166 3,166
5. Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current quarter
$A’000
Previous quarter
$A’000
5.1 Bank balances 666 1,049
5.2 Call deposits 2,500 4,000
5.3 Bank overdrafts -
5.4 Other -
5.5 Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
3,166 5,049
6. Payments to related parties of the entity and their
associates
Current quarter
$A'000
6.1 Aggregate amount of payments to related parties and their
associates included in item 1
240
6.2 Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 4
+ See chapter 19 of the ASX Listing Rules for defined terms.
7. Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A’000
Amount drawn at
quarter end
$A’000
7.1 Loan facilities - -
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities - -
7.5 Unused financing facilities available at quarter end -
7.6 Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing facilities
have been entered into or are proposed to be entered into after quarter end, include a note
providing details of those facilities as well.
N/A
8. Estimated cash available for future operating activities $A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (1,883)
8.2 Cash and cash equivalents at quarter end (item 4.6) 3,166
8.3 Unused finance facilities available at quarter end (item 7.5) -
8.4 Total available funding (item 8.2 + item 8.3) 3,166
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
1.7
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1 Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Yes. The Company’s cash balance does not include the anticipated Research and
Development Tax Incentive (R&DTI) rebate for the 2025 financial year, which the Company
expects to receive imminently, and which is now expected to be ~$1.7m.
Net operating cash outflows for the quarter were 45% less than in the previous quarter. The
Company anticipates further decreases in quarterly cash outflows during the remainder of
this financial year, given that the Phase 2 aGvHD trial is now the only ongoing clinical trial
that the Company is funding, and most of the expenditure related to that trial has already
been incurred.
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
The Company has in a place an At-The-Market (ATM) facility with Acuity Capital that it can
utilise when required. The ATM provides Cynata with up to $7,500,000 of standby equity
capital over the coming five years to 31 July 2030. Additionally, the Company anticipates
receiving a Research & Development Tax Incentive (R&DTI) rebate of ~$1.7m imminently.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 5
+ See chapter 19 of the ASX Listing Rules for defined terms.
8.6.3 Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Yes. Based on the anticipated R&DTI rebate, decreasing quarterly cash outflows, and the
available ATM facility and the Company expects to be able to continue its operations and
meet its business objectives.
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Compliance statement
1 This statement has been prepared in accordance with accounting standards and policies which
comply with Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters disclosed.
Date: 31 October 2025
Authorised by: By the Board
(Name of body or officer authorising release – see note 4)
Notes
1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the
entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An
entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is
encouraged to do so.
2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been
prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”.
If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the
[name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a
disclosure committee, you can insert here: “By the Disclosure Committee”.
5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial
records of the entity have been properly maintained, that this report complies with the appropriate accounting standards
and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a
sound system of risk management and internal control which is operating effectively.
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