June 2025 Quarterly Activity Report and Appendix 4C
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
30 July 2025
June 2025 Quarterly Activity Report
Key highlights:
•
Cynata enters a phase of significant momentum, with three clinical trials progressing
across high-value therapeutic areas with substantial unmet needs.
•
The Phase 2 trial in acute Graft versus Host Disease (aGvHD) is >75% enrolled, with patient
recruitment progressing and primary results anticipated during H1 2026.
•
The fully enrolled, 321-patient Phase 3 trial in Osteoarthritis is nearing completion in the
coming months, with top-line results anticipated between February and April 2026.
•
Cohort 1 of the kidney transplant trial has completed treatment, with DSMB review results
expected in Q4 2025.
•
Cynata remains well-capitalised with $5 million in cash, with expected R&D tax incentive
rebate ~$1.25m in coming months, providing funding runway through mid-2026, covering all
key clinical readouts.
•
Positive pre-clinical results in ischaemic heart disease models demonstrated improved
cardiac function, supporting potential expansion into large cardiovascular markets.
•
Upcoming clinical milestones have the potential to represent inflection points for valuation,
partnering, and product approval pathways.
Melbourne, Australia; 30 July 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 June 2025.
Acute Graft versus Host Disease (aGvHD) – Phase 2 Trial >75% enrolled; Results Expected H1 2026
aGvHD is a serious and often life-threatening complication of bone marrow transplantation, where the
donor’s immune cells (the graft) attack the recipient’s tissues (the host). It affects up to 50% of transplant
patients, particularly those with high-risk disease. Standard treatment involves corticosteroids, but
these fail in around half of all cases, and the two-year survival rate in steroid-treated patients is less than
20%.
Cynata’s Cymerus™ MSC 1 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, 87% of patients
improved by at least one grade, 53% showed no signs of aGvHD, and 60% were alive at two years.
Importantly, there were no serious adverse events related to treatment, and the results were published
in the prestigious journal Nature Medicine.
Cynata is now conducting a global Phase 2 trial, enrolling 60 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 at Day 28.
Patient enrolment is now over 75% complete. A fluctuation in enrolment rate, commonly observed in
rare disease studies has been experienced, but enrolment continues to progress and recruitment
initiatives are being reinforced. The Company anticipates completing enrolment within the coming
months and releasing the primary results during H1 2026.
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
Osteoarthritis – Phase 3 Trial Completed Recruitment; Results Expected Feb-Apr 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 therapies available
that address cartilage loss and inflammation at the source.
Cynata’s Phase 3 trial, known as SCUlpTOR, is being conducted by the University of Sydney and funded
through an NHMRC project grant. The trial completed enrolment of 321 patients in November 2023, with
all patients now having received their study treatments. Follow-up is ongoing, with final 24-month results
anticipated between February and April 2026.
Following a recent advisory meeting with the Australian Therapeutic Goods Administration (TGA), Cynata
is optimistic that positive results could support marketing approval of CYP-004 in Australia.
Kidney Transplantation – First Cohort Complete; DSMB Review Expected Q4 CY 2025
Patients undergoing kidney transplantation typically require lifelong immunosuppressive therapy to
prevent organ rejection. 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. Once the third and final
patient treated in this cohort is followed up for six weeks, the study’s independent Data and Safety
Monitoring Board (DSMB) will review the data from this Cohort. The results of this review are anticipated
by Q4 2025.
Additional Applications: Expanding Therapeutic and Commercial Potential
Beyond the three readouts above, Cynata is also progressing promising clinical and preclinical programs
that demonstrate the flexibility and broad utility of its Cymerus™ MSC platform.
Diabetic Foot Ulcers (CYP-006TK) – Phase 1 Trial Completed with Strong Efficacy
Cynata recently completed a successful Phase 1 trial in patients with diabetic foot ulcers (DFU) –
chronic, non-healing wounds that can lead to infection, hospitalisation, and amputation.
As announced on 5 December 2024, CYP-006TK, delivered via a novel silicone dressing, showed a mean
wound reduction of 83.6% after 24 weeks, compared to 47.8% with standard care. The difference was
even greater in patients with larger wounds. The therapy was well tolerated, with no serious adverse
events reported.
Given the high unmet need in DFU and the strength of these results, Cynata is actively engaging potential
commercial partners and planning further clinical development.
Preclinical Heart Disease Program – Positive Data in Ischaemic Heart Disease
On 7 April 2025, Cynata reported positive preclinical results from studies investigating Cymerus™ MSCs
in ischaemic heart disease—the leading cause of death globally.
In collaboration with academic partners, Cynata tested a new encapsulation device that delivers MSCderived factors over time. In rat models of heart attack, treated animals showed significantly improved
cardiac function, reduced scar tissue, and lower levels of heart muscle thickening. These findings were
supported by in vitro data using 3D human heart tissue (“cardiac spheroids”), which demonstrated
enhanced tissue survival and function.
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
Corporate and Strategic Updates
SMART CRC
On 24 April 2025, the Australian Federal Government announced the funding of the Solutions for
Manufacturing Advanced Regenerative Therapies Cooperative Research Centre (the “SMART CRC”).
Cynata was a participant in the funding bid and intends to act as a Core Partner in the SMART CRC,
subject to agreement on project plans and execution of formal agreements.
The SMART CRC will be a national coordinated effort that harnesses Australia’s strengths across the
entire value chain with a total budget of $238M and over 60 partners spanning industry, government,
healthcare, universities, and research institutes.
New InvestorHub and Website
As announced on 22 May 2025, the Company launched a new InvestorHub portal and website, for
dedicated investor engagement.
This enables shareholders, stakeholders, prospective investors and partners to learn more about the
Company's activities and key projects. The Company will regularly upload new content to the hub,
including videos, key project news and updates.
The refreshed website and associated InvestorHub can be accessed via the same web address as
previously: www.cynata.com. Shareholders and interested parties can join InvestorHub via the “sign up”
button on the website.
Outlook: Momentum Building into a Catalyst-Rich Period
Cynata is approaching a pivotal period, with three clinical trials progressing towards readouts over the
next 9–12 months. These include Phase 2 results in aGvHD, Phase 3 results in osteoarthritis, and a
preliminary Phase 1/2 safety readout in kidney transplantation – all targeting large markets with limited
treatment options and high unmet need.
Cynata’s strategy is to develop multiple candidate products in clinical indications of high unmet need.
This includes common diseases affecting millions of patients worldwide. With no internal salesforce or
in-house manufacturing, we aim to pursue a partnership-led model, leveraging the strengths of global
collaborators to drive execution and market access.
Importantly, we are able to capitalise on years of proof-of-concept research and billions already spent
by MSC peers to educate markets and validate clinical use-cases. We plan to introduce more potent,
scalable, and consistent iPSC 2-derived MSC products into markets where demand is proven and
competition remains low.
We are also operating in a market environment with accelerating tailwinds, including a global increase
in MSC clinical trials now reaching maturity, increasing regulatory support through Fast Track and
Orphan Drug pathways, and a rising burden of chronic disease and ageing populations that is driving
growing demand for regenerative medicine solutions.
Finance
The Company closed the quarter with $5.049m in cash. Net operating cash outflows for the quarter
totalled $3.454m.
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 1.5 quarters of
funding available. However, as the net operating cash outflows in the previous quarter were not
representative of forecasted expenditure in the year ahead, this is not consistent with the Company’s
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
expectations. The Company anticipates its cash runway to extend into mid calendar year 2026. The
Company notes that payments of approximately $1.9m were made during the quarter to the contract
research organisation managing the Phase 2 GvHD clinical trial. As the payment schedule under this
contract is milestone-based, payments per month/quarter vary significantly, and the payments made in
the recently completed quarter are expected to far exceed those due in any quarter over the coming year.
Notably, the Company is now only funding one ongoing clinical trial (its Phase 2 aGvHD trial). The other
ongoing trials (in kidney transplantation and osteoarthritis) are being conducted by partners and funded
externally. Furthermore, the Company anticipates receiving a Research and Development Tax Incentive
rebate of ~$1.25m in the coming months.
In item 6 of the Appendix 4C cash flow report for the quarter, payments to related parties of
approximately $184k consisted of salary paid to the Managing Director and fees paid to Non-Executive
Directors.
Investor Webinar
An investor webinar will be held on Tuesday 5th August 2025 at 11:00am 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_CeYzDl8ISkWOSzWOvkbCjQ
Upon registration, attendees will receive details to access the webinar.
-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, 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 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 MSC = mesenchymal stromal (or stem) cell
2 iPSC = induced pluripotent stem cell
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
Rule 4.7B
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 JUNE 2025
Consolidated statement of cash flows
Current quarter
$A’000
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
Year to date
(12 months)
$A’000
-
-
(2,717)
(7,413)
-
-
(118)
(289)
-
-
(e) staff costs
(468)
(2,299)
(f)
(244)
(874)
-
-
93
254
(a) research and development
(b) product manufacturing and operating
costs
(c) advertising and marketing
(d) leased assets (including premises)
administration and corporate costs
1.3
Dividends received (see note 3)
1.4
Interest received
1.5
Interest and other costs of finance paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives (2024
R&D Tax Incentive)
-
1,885
1.8
Other
-
-
1.9
Net cash from / (used in) operating
activities
(3,454)
(8,736)
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
-
-
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
(f)
2.2
other non-current assets
Current quarter
$A’000
Year to date
(12 months)
$A’000
-
-
(a) entities
-
-
(b) businesses
-
-
(c) property, plant and equipment
-
-
(d) investments
-
-
(e) intellectual property
-
-
(f)
-
-
Proceeds from disposal of:
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)
-
8,116
3.2
Proceeds from issue of convertible debt
securities
-
-
3.3
Proceeds from exercise of options
-
21
3.4
Transaction costs related to issues of
equity securities or convertible debt
securities
-
(562)
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
-
7,575
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
8,503
6,205
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(3,454)
(8,736)
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
-
-
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 2
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Current quarter
$A’000
Year to date
(12 months)
$A’000
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
-
7,575
4.5
Effect of movement in exchange rates on
cash held
-
5
4.6
Cash and cash equivalents at end of
period
5,049
5,049
5.
Reconciliation of cash and cash
equivalents
Current quarter
$A’000
Previous quarter
$A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1
Bank balances
1,049
2,003
5.2
Call deposits
4,000
6,500
5.3
Bank overdrafts
-
5.4
Other
-
5.5
Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
6.
Payments to related parties of the entity and their
associates
6.1
Aggregate amount of payments to related parties and their
associates included in item 1
184
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
-
5,049
8,503
Current quarter
$A'000
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.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 3
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
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)
(3,454)
8.2
Cash and cash equivalents at quarter end (item 4.6)
5,049
8.3
Unused finance facilities available at quarter end (item 7.5)
8.4
Total available funding (item 8.2 + item 8.3)
8.5
Estimated quarters of funding available (item 8.4 divided by
item 8.1)
5,049
1.5
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?
No. The Company notes that payments of approximately $1.9m were made during the
quarter to the contract research organisation managing the Company’s Phase 2 GvHD
clinical trial. As the payment schedule under this contract is milestone-based, payments per
month/quarter vary significantly, and the payments made in the recently completed quarter
are expected to far exceed those due in any quarter over the coming year. The Company
anticipates its cash runway to extend into mid calendar year 2026.
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 anticipates receiving a Research and Development Tax Incentive rebate of
~$1.25m in the coming months.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 4
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
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. As noted above, the Company anticipates its cash runway to extend into mid calendar
year 2026. Importantly, the Company anticipates reporting results from two major clinical
trials during that period.
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:
30 July 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.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 5
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