Quarterly Activities/Appendix 4C Cash Flow Report
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Released
Announcement PDF
ASX RELEASE
30 January 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 December 2024.
Key Highlights from the Quarter
•
•
•
Recruitment of the second and final cohort of patients into the ACCENT Phase 2a trial in
pancreatic cancer is underway with 12 patients, of a required 24, recruited by mid-December
Three additional confirmed partial responses (PRs) were recorded for patients from the initial
26 patient cohort of the Phase 2a trial, bringing the total to 9 confirmed PRs
A research collaboration with Next&Bio, a Korean company specializing in drug screening using
patient-derived cancer cells, has been initiated
Operations Update
This quarter the Company has focused on additional recruitment into the Company’s Phase 2a ACCENT
trial in pancreatic cancer, and monitoring data from patients on the trial. This trial, known as the
ACCENT trial, explores the combination of the Company’s best-in-class FAK inhibitor narmafotinib with
the chemotherapy drugs gemcitabine and Abraxane®, in first-line patients with advanced pancreatic
cancer. In total, 50 patients are required for the ACCENT Phase 2a trial.
The Company reported completion of the first portion of the Phase 2a ACCENT trial in September 2024
after successfully recording six (6) confirmed partial responses (PRs) from 26 patients. A confirmed PR
is recorded when there is at least a 30% decrease in the overall size of tumour lesions sustained for
two or more months, with no new tumour lesions apparent. The observation of six confirmed partial
responses among patients treated with narmafotinib in conjunction with gemcitabine and Abraxane®
provided sufficient evidence to support the re-initiation of patient enrolment for the remaining 24
participants of the clinical trial. In December we announced that 12 new patients had already been
recruited into the trial.
In December, the Company reported that an additional 3 confirmed PRs from the initial 26 patient
cohort had been recorded, bringing the total to nine (9) confirmed partial responses (PRs). This
represents an objective response rate of ~35%, significantly better than the 23% reported for the
historical trial 1 being used as the benchmark for this study. Further, the Company also reported that
the median duration on trial for the 26 patients was 172 days, representing a 47% improvement over
the historical data of 117 days. The duration on trial is a measure of how effective the treatment is in
inhibiting disease progression.
In November we announced that The Company had entered into a preclinical research collaboration
with the Korean biotech Next&Bio. The goal of the collaboration is to test how effective Amplia’s FAK
inhibitors are in killing pancreatic cancer cells directly isolated from patients, when combined with a
new class of drugs called kRas inhibitors. These drugs have the potential to be used in the treatment
of pancreatic cancer, and other cancers such as lung and colorectal cancer, in coming years.
1
New Engl. J. Med. 2013, vol 369, 1691-1703.
Level 17, 350 Queen St, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
Financial update
Amplia finished the December 2024 quarter with a strong cash position of $13.7 million (September
2024: $4.6 million).
During the quarter, the Company had net operating cash outflows of $3.0 million in relation to
operating activities (September 2024: $1.3 million inflows). Operating cashflows included:
•
•
Outflows of $0.7 million for staff and administration/corporate costs; and
Outflows of $2.2 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 1b/2a clinical trial for narmafotinib (AMP945).
During the quarter, the company completed a capital raise of $13.0 million before costs to support
completion of the Phase 2a ACCENT trial in pancreatic cancer with the Company’s lead compound
narmafotinib and undertaking of a trial in the US in combination with FOLFIRINOX. The capital raise
was a combination of a placement raising $7.8 million and a 1 for 6.45 pro-rata accelerated nonrenounceable entitlement offer to eligible Amplia shareholders to raise up to approximately A$5.2
million. Shares were issued at $0.115 per shares with three (3) free attaching options for every 4 new
shares issued each with an expiry date of 31 October 2027 and an exercise price of $0.1725.
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 $112,500 and relate to payments to the CEO/Managing Director
in line with employment contracts and payments to the Non-Executive Directors.
Outlook and future activities
The Company will continue to focus on timely execution of the Phase 2a portion of the ACCENT trial,
with a particular focus on completion of enrolment of the remaining 24 patients required. The US trial
of narmafotinib, in combination with the chemotherapy regimen FOLFIRINOX, is also being actively
progressed in the coming quarters. Finalising regulatory and ethical submissions will be the focus of
the coming quarter. Additional clinical opportunities for narmafotinib, including preclinical studies
with novel combination therapies, are being actively explored and will be reported as data comes to
hand.
- 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 December 2024
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
(9 months)
$A’000
-
-
(2,186)
(5,250)
(b) product manufacturing and operating
costs
-
-
(c) advertising and marketing
-
-
(d) leased assets
-
-
(e) staff costs
(346)
(949)
(f)
(305)
(1,087)
-
-
27
112
(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)
(198)
(219)
1.9
Net cash from / (used in) operating
activities
(3,008)
(4,283)
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
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
(9 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
-
-
3.
Cash flows from financing activities
3.1
Proceeds from issues of equity securities
(excluding convertible debt securities)
13,013
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
(893)
(1,185)
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)
(63)
3.10
Net cash from / (used in) financing
activities
12,099
14,566
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
4,558
3,385
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(3,008)
(4,283)
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
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
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
Year to date
(9 months)
$A’000
12,099
14,566
67
48
13,716
13,716
Current quarter
$A’000
Previous quarter
$A’000
5.1
Bank balances
1,510
1,179
5.2
Call deposits
12,206
3,379
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)
13,716
4,558
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
113
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)
(3,008)
8.2
Cash and cash equivalents at quarter end (item 4.6)
13,716
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)
13,716
4.6
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.
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 January 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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