Quarterly Activities/Appendix 4C Cash Flow Report
Released
Released
Announcement PDF
ASX RELEASE
30 April 2025
QUARTERLY ACTIVITIES AND CASH FLOW REPORTS
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 31 March 2025.
Key Highlights from the Quarter
•
ACCENT Trial Progress: The Phase 2a ACCENT trial, investigating narmafotinib with standard
chemotherapy for advanced pancreatic cancer, completed recruitment two months ahead of
schedule.
•
Promising Initial Results: Interim data from the ACCENT trial shows 13 patients achieved
confirmed partial responses, suggesting the narmafotinib combination may be more effective
than chemotherapy alone.
•
FOLFIRINOX Trial Advancement: Significant progress has been made in initiating a second trial
in the US and Australia, combining narmafotinib with FOLFIRINOX.
•
FDA Feedback: The FDA provided positive feedback on modifications to the FOLFIRINOX trial
protocol.
Operations Update
This quarter the Company completed recruitment for the Phase 2a ACCENT trial in pancreatic cancer.
Full enrolment of the trial was completed two months ahead of schedule and in total 55 patients were
recruited. The ACCENT trial explores the combination of the Company’s best-in-class FAK inhibitor
narmafotinib (AMP945) with standard-of-care chemotherapy in newly diagnosed patients with
advanced pancreatic cancer.
At the end of March, the Company reported that a total of 13 patients had recorded confirmed partial
responses (PR’s), meaning that in these patients, tumour shrinkage >30% had been measured and that
this was sustained for two months with no new lesions apparent. This is notable as the trial has been
designed so that an outcome of 15 PR’s would indicate the narmafotinib combination performs better
than chemotherapy alone. At the end of March, 29 patients were still on study with tumour responses
continuing to be measured every two months. Of these, over 15 patients had still not been assessed
for responses at the 4 month timepoint.
Significant progress has been made towards initiation of the second trial of narmafotinib in pancreatic
cancer, this time combining the drug with the chemotherapy FOLFIRINOX. This trial will be run in the
USA, with additional sites in Australia, under the Investigational New Drug application that was cleared
by the US Food and Drug Administration (FDA) last year. FOLFIRINOX is the preferred first-line
treatment option for advanced pancreatic cancer in the USA and the Company has previously disclosed
data indicating that narmafotinib enhances the activity of FOLFIRINOX in preclinical models of
pancreatic cancer.
At the beginning of March, the Company received feedback from the FDA regarding specific changes
to the clinical trial protocol that it had previously suggested. In the written response, the FDA noted
Level 17, 350 Queen St, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study
protocol and begin formal trial initiation activities.
In March, the Company also announced that additional ACCENT trial data had been selected for
presentation at the American Association of Cancer Research annual meeting, a highly prestigious
cancer meeting that attracts scientists, clinicians and representatives from pharma and biotech from
across the globe. The poster, Narmafotinib (AMP945) in combination with gemcitabine and nabpaclitaxel in first-line patients with advanced pancreatic cancer (ACCENT trial) a Phase 1b 2a study:
Interim analysis Part B, was presented on Monday 28 April at 2pm (US CDT).
Outlook and future activities
The Company will continue to focus on execution of the Phase 2a portion of the ACCENT trial and will
report key trial data to the market as it becomes available. Activities supporting initiation of the US
trial of narmafotinib in combination with FOLFIRINOX, will continue to be progressed with the aim to
have the first patient dosed before the end of the quarter.
Financial update
Amplia finished the March 2025 quarter with a strong cash position of $10.9 million (December 2024:
$13.7 million).
During the quarter, the Company had net operating cash outflows of $2.7 million in relation to
operating activities (December 2024: $3.0 million). Operating cashflows included:
•
•
Outflows of $0.7 million for staff and administration/corporate costs; and
Outflows of $2.3 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 Phase 2a clinical trial for narmafotinib (AMP945).
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 $147,500 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
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
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 Twitter (@ampliatx)
and LinkedIn.
Rule 4.7B
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
31 March 2025
Consolidated statement of cash flows
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
Current quarter
$A’000
Year to date
(12 months)
$A’000
-
-
(2,304)
(7,554)
(b) product manufacturing and operating
costs
-
-
(c) advertising and marketing
-
-
(d) leased assets
-
-
(e) staff costs
(301)
(1,250)
(f)
(390)
(1,477)
-
-
125
237
(a) research and development
administration and corporate costs
1.3
Dividends received (see note 3)
1.4
Interest received
1.5
Interest and other costs of finance paid
-
(80)
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
3,190
1.8
Other (refund of GST)
142
(77)
1.9
Net cash from / (used in) operating
activities
(2,728)
(7,011)
2.
Cash flows from investing activities
2.1
Payments to acquire or for:
(a) entities
-
-
(b) businesses
-
-
(2)
(2)
(d) investments
-
-
(e) intellectual property
-
-
(f)
-
-
(c) property, plant and equipment
other non-current assets
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
2.2
Current quarter
$A’000
Year to date
(12 months)
$A’000
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
(2)
(2)
3.
Cash flows from financing activities
3.1
Proceeds from issues of equity securities
(excluding convertible debt securities)
-
17,281
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
(100)
(1,285)
3.5
Proceeds from borrowings
-
-
3.6
Repayment of borrowings
-
(1,467)
3.7
Transaction costs related to loans and
borrowings
-
-
3.8
Dividends paid
-
-
3.9
Other (repayment of lease liability)
(21)
(84)
3.10
Net cash from / (used in) financing
activities
(121)
14,445
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
13,716
3,385
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(2,728)
(7,011)
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
(2)
(2)
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)
(121)
14,445
4.5
Effect of movement in exchange rates on
cash held
(2)
46
4.6
Cash and cash equivalents at end of
period
10,863
10,863
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
627
1,510
5.2
Call deposits
10,236
12,206
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)
10,863
13,716
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
148
6.2
Aggregate amount of payments to related parties and their associates
included in item 2
-
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.
The amount at 6.1 includes Director fees and salary (including superannuation) for the CEO and Managing
Director and Non-Executive Directors.
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)
(2,728)
8.2
Cash and cash equivalents at quarter end (item 4.6)
10,863
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)
10,863
4.0
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.
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
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.
30 April 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.
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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