Quarterly Activities/Appendix 4C Cash Flow Report
Released
Released
Announcement PDF
ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com
29 OCTOBER 2025
ASX RELEASE
QUARTERLY ACTIVITIES AND CASH FLOW REPORTS – SEPTEMBER 2025
Key Highlights from the Quarter
• Further promising developments from the ongoing ACCENT trial of narmafotinib in
metastatic pancreatic cancer were presented, including additional confirmed responses
and an interim median Progression Free Survival figure of 7.6 months. This latter result is a 2
month improvement on historical data for chemotherapy alone
• Ethics approval was obtained in Australia for the new trial of narmafotinib, investigating a
combination with the chemotherapy FOLFIRINOX, and the first patients in this trial have been
dosed
• A key patent protecting narmafotinib has been allowed by the US Patent and Trademarks
Office
• Completion of a capital raise of A$27.5 million (before costs) funding the company into 2027
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), a company
developing new approaches for the treatment for cancer and fibrosis, is pleased to announce further
progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its
Appendix 4C Cash Flow Report (attached) for the quarter ending 30 September 2025.
Operations Update
The Company continues to make significant strides in the clinical development of its best-in-class FAK
inhibitor, narmafotinib, for the treatment of metastatic pancreatic cancer. The Company has reported
encouraging results from ongoing trials, regulatory milestones, and patent advancements, reinforcing its
commitment to improving outcomes for patients with this challenging disease.
Clinical Trial Updates
In July the Company announced that the ACCENT clinical trial, which investigates narmafotinib in
combination with standard chemotherapies gemcitabine and Abraxane®, recorded additional confirmed
partial responses (PRs) bringing the total at that time to 17. A confirmed partial response (PR) is defined
as tumour shrinkage exceeding 30%, sustained for at least two months and without the appearance of
new cancerous lesions. The objective response rate (ORR) in the trial increased from 29% (16 out of 55
patients) to 31% (17 out of 55 patients), surpassing the 23% response rate reported for chemotherapy
alone1
. These data include a patient where a complete response (CR) was recorded and an additional
patient who, after surgical intervention, was reported as a pathological CR, both of which are very rare
occurrences in the treatment of metastatic pancreatic cancer. More recently, the Company updated the
ORR to 33% (18 out of 55 patients) after an additional patient recorded a confirmed PR2
.
Interim data in the ACCENT trial up to 20 July 2025 was disclosed on 6 August2025 and indicated a median
progression-free survival (PFS) of 7.6 months, notably higher than the 5.5 months observed with
chemotherapy alone and exceeding results from other similar trials. For this metastatic patient
population where the cancer is highly aggressive, a two-month improvement in PFS is considered a
notable improvement, and indeed the last drug approved in pancreatic cancer (NALIRIFOX) was based on
a two-month improvement in overall survival over standard-of-care treatment.
Importantly, narmafotinib continues to show good tolerability in patients. The adverse event profile for the
narmafotinib combination closely mirrors that of the chemotherapy regimen alone, with negligible
additional patient burden for most participants. Durability of response is also promising, with seven
patients remaining on trial for more than 12 months. The mean duration on trial for patients determined
at 20 July 2025 was 202 days, compared to 117 days in the MPACT study. This has improved to 219 days
from an analysis at the end of the quarter2
.
Expansion into FOLFIRINOX Combination
Last year the Company reported that its planned trial in the US, under an Investigational New Drug (IND)
application, had been cleared by the US Food and Drug Administration (FDA)3
. In July this year, Amplia
received ethics approval in Australia for the new Phase 1b/2a clinical trial combining narmafotinib with
FOLFIRINOX chemotherapy, following on from US ethics approval received the month prior. FOLFIRINOX,
a more aggressive chemotherapy treatment, is commonly used in the treatment of advanced pancreatic
cancer in the US and Western Europe. This open-label trial aims to identify the optimal daily dose of
narmafotinib, given orally, when paired with FOLFIRINOX, which is administered intravenously every two
weeks. The trial is designed following the Project Optimus guidance from the FDA4
, and will proceed in
two stages:dose exploration with up to 27 patients and a two dose comparison across 40 patients. Patient
recruitment has commenced at sites in Melbourne and Sydney, with several US sites to begin recruitment
later this year. The first participants, of a cohort of up to nine patients, have already started dosing,
marking an important milestone for the program.
Regulatory and Commercial Progress
On the regulatory front, the United States Adopted Names (USAN) Council has approved "narmafotinib"
as the generic drug name for Amplia’s FAK inhibitor, following earlier approval by the World Health
Organization (WHO) for global use. This formal recognition is crucial for the drug’s commercial
development, particularly in the US market.
Amplia has also announcedthe allowance of a keypatent by theUS Patent and Trademark Office,covering
the specific salt and crystal form of narmafotinib used in clinical trials. The patent, which secures
protection until at least 2040 in multiple jurisdictions including Australia, Japan, Europe, India, Korea,
Singapore, and New Zealand, ensures the company’s intellectual property remains safeguarded and
commercially valuable.
Future Outlook
As trials mature and further data become available, Amplia remains optimistic about improving outcomes
for pancreatic cancer patients through innovative combination therapies. Business development and
partnering discussions have advanced in recent months with a number of potential partners and
collaborators showing interest in the developing dataset.
1
New England Journal of Medicine 2013; 369: 1691 – 703
2
ASX Announcement 9 October 2025
3
ASX Announcement 18 January 2024
4
https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus (accessed October 2025)
Capital Raise
On 23 July 2025 the Company announced a capital raise of $27.5 million (before costs) to support the
ongoing clinical activities and additional planned activities, funding the Company into 2027. The capital
raise comprised a successful institutional placement raising A$25.0 million (before costs) and a Share
Purchase Plan seeking to raise an additional $2.5 million. The Placement was strongly supported by
existing and new institutional and sophisticated investors in Australia and offshore.
Financial update
Amplia finished the September 2025 quarter with acash position of $29.2 million (June 2025:$7.0 million).
The Company also received its Research and Development Tax Incentive refund for the year ended 31
March 2025 of $3.8m in October 2025, giving Amplia a $33.0 million proforma cash balance on 30
September 2025.
During the quarter, the Company had net operating cash outflows of $3.8 million in relation to operating
activities (June 2025: $3.8 million). Operating cashflows included:
• Outflows of $1.1 million for staff and administration/corporate costs; and
• Outflows of $2.6 million for research and development costs, which primarily related to trial costs,
Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in
relation to the ACCENT Phase 2 clinical trial for narmafotinib with gemcitabine and Abraxane® and
initiation costs with its FOLFIRINOX clinical trial for narmafotinib combined with FOLFIRINOX.
Payments to Related Entities
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in
item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments
made for the quarter equals $172,500 and relate to payments to the CEO/Managing Director in line with
employment contracts and payments to the Non-Executive Directors.
- End -
For Further Information
Dr. Christopher Burns
CEO and Managing Director
chris@ampliatx.com
www.ampliatx.com
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
About Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal
Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field
of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian
cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary
fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and
LinkedIn.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed
in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug,
which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical
cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in
combination with the chemotherapies gemcitabine and Abraxane®
in first-line patients with advanced
pancreatic cancer. The trial has already achieved its desired outcome in achieving a response rate of 33%,
superior to chemotherapy alone and an interim mPFS of 7.6 months has been reported. A second trial –
AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US,
investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic
cancer patients.
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
AMPLIA THERAPEUTICS LIMITED
ABN Quarter ended (“current quarter”)
16 165 160 841 30 September 2025
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(6 months)
$A’000
1. Cash flows from operating activities
- -
1.1 Receipts from customers
1.2 Payments for
(2,600) (5,588)
(a) research and development
(b) product manufacturing and operating
costs
- -
(c) advertising and marketing - -
(d) leased assets - -
(e) staff costs (373) (912)
(f) administration and corporate costs (760) (1,116)
1.3 Dividends received (see note 3) - -
1.4 Interest received 68 156
1.5 Interest and other costs of finance paid - -
1.6 Income taxes paid - -
1.7 Government grants and tax incentives - -
1.8 Other (payment of GST) (169) (183)
1.9 Net cash from / (used in) operating
activities
(3,834) (7,643)
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment (21) (26)
(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
(6 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 (bank guarantee and security
deposit)
- (64)
2.6 Net cash from / (used in) investing
activities
(21) (90)
3. Cash flows from financing activities
27,647 27,647
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 238 238
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
(1,809) (1,809)
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 (repayment of lease liability) (18) (32)
3.10 Net cash from / (used in) financing
activities
26,058 26,044
4. Net increase / (decrease) in cash and
cash equivalents for the period
6,963 10,863
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above)
(3,834) (7,643)
4.3 Net cash from / (used in) investing activities
(item 2.6 above)
(21) (90)
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
(6 months)
$A’000
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
26,058 26,044
4.5 Effect of movement in exchange rates on
cash held
(10) (18)
4.6 Cash and cash equivalents at end of
period
29,156 29,156
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 2,428 1,338
5.2 Call deposits 26,728 5,625
5.3 Bank overdrafts - -
5.4 Other (provide details)
5.5 Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
29,156 6,963
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
173
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.
The amount at 6.1 includes Director fees and salary (including superannuation) for the CEO and Managing
Director and Non-Executive Directors.
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) (3,834)
8.2 Cash and cash equivalents at quarter end (item 4.6) 29,156
8.3 Unused finance facilities available at quarter end (item 7.5) -
8.4 Total available funding (item 8.2 + item 8.3) 29,156
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
7.6
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?
Answer: N/A
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?
Answer: N/A
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?
Answer: N/A
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.
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.
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.
29 October 2025
Date: ...................................................................................
The Board of Directors
Authorised by: ...................................................................................
(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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