Quarterly Activities/Appendix 4C Cash Flow Report
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Released
Announcement PDF
ASX RELEASE
30 October 2024
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 30 September 2024.
Key Highlights from the Quarter
•
•
•
•
•
The first cohort of 26 patients in the Phase 2a trial of narmafotinib for pancreatic cancer has
been completed
Six confirmed partial responses have been observed in the first patient cohort, indicating
sufficient activity of the drug combination for trial expansion
Recruitment to enrol an additional 24 patients to reach a total of 50 has resumed: as of 24
October, 3 patients have been enrolled in this cohort
Narmafotinib has received Fast Track Designation from the US FDA
A key patent for narmafotinib has been granted in Europe and Japan, securing intellectual
property protection for the form of the drug currently in clinical development
Operations Update
This quarter the Company has focused on completion of the first stage of the ongoing Phase 2a trial of
narmafotinib in pancreatic cancer. This trial explores the safety, tolerability, and most importantly,
efficacy of the Company’s best-in-class FAK inhibitor narmafotinib, in combination with the
chemotherapy drugs gemcitabine and Abraxane®, in newly diagnosed patients with advanced
pancreatic cancer.
The Company reported completion of recruitment of the first cohort of 26 patients in early July, just
under six months after dosing the first patient. At the end of July we reported that three (3) confirmed
partial responses had been recorded in this patient cohort, meaning that a 30% or greater reduction
in the overall size of tumour lesions, with no new tumour lesions, had been observed in three patients
and was sustained for >2 months. Through August, two further confirmed partial responses were
observed, with a sixth confirmed partial response reported in September.
Observing six confirmed PRs from the 26 patients in the first cohort of the Phase 2a trial, indicates that
the combination of narmafotinib with the chemotherapies gemcitabine and Abraxane® is sufficiently
active to support continuation of the trial. Thus, an additional 24 patients will now be enrolled at our
trial sites in Australia and South Korea with enrolment expected to be completed by end of Q1 2025,
and three patients have already been enrolled as of 24 October. The trial size of 50 patients in total
was calculated based on previous studies using gemcitabine and Abraxane in advanced pancreatic
cancer and from which a statistically meaningful benefit can be determined.
In September we also announced that the United States Food and Drug Administration (FDA) granted
Fast Track Designation to narmafotinib for the treatment of advanced pancreatic cancer. Fast Track
Designation is available to drugs that may provide an advantage over current therapies in the
treatment of serious conditions and is designed to speed the development of these drugs to enable
patients to receive them sooner. With this designation, the Company will have increased opportunities
to interact with the FDA through meetings and written communication, and furthermore, narmafotinib
may be eligible for Accelerated Approval and Priority Review.
Level 17, 350 Queen St, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
In August we announced that two of the world’s premier patent agencies, the European Patent Office
and the Japan Patent Office, had independently notified the Company that a key patent for the
Company had been granted in their respective jurisdictions. The patent, entitled A salt and crystal form
of a FAK Inhibitor, describes the specific chemical form of narmafotinib with excellent stability and
manufacturability that also provides improved drug levels upon dosing. Importantly, it is this specific
form of the drug that is being developed clinically by the Company, including in the current Phase 2a
ACCENT trial in advanced pancreatic cancer.
Financial update
Amplia finished the September 2024 quarter with cash of $4.6 million (June 2024: $4.8 million).
During the quarter, the Company had net operating cash inflows of $1.3 million in relation to operating
activities (June 2024: $2.5 million outflows). Operating cashflows included:
•
•
•
Outflows of $0.7 million for staff and administration/corporate costs; and
Outflows of $1.3 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 1b/2a clinical trial for narmafotinib (AMP945).
Inflows of $3.2 million from government grants and tax incentives, which primarily related to
the Company’s FY24 R&D Tax Incentive refund.
During the quarter, on the receipt of the Company’s FY24 R&D Tax Incentive refund of $3.2 million,
the Company fully repaid the $1.47 million R&D funding loan to Non-Executive Director Robert
Peach.
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.
Outlook and future activities
The Company will continue to focus on timely execution of the Phase 2a portion of the ACCENT trial.
Additional clinical opportunities for narmafotinib, including preclinical studies with novel combination
therapies, are being explored.
- 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),
Threads (@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
30 September 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
(6 months)
$A’000
-
-
(1,303)
(3,064)
(b) product manufacturing and operating
costs
-
-
(c) advertising and marketing
-
-
(d) leased assets
-
-
(e) staff costs
(295)
(603)
(f)
(382)
(782)
-
-
(a) research and development
administration and corporate costs
1.3
Dividends received (see note 3)
1.4
Interest received
59
85
1.5
Interest and other costs of finance paid
(79)
(80)
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
3,190
3,190
1.8
Other (refund of GST)
61
(21)
1.9
Net cash from / (used in) operating
activities
1,251
(1,275)
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
(6 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)
-
4,268
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
-
(292)
3.5
Proceeds from borrowings
-
-
3.6
Repayment of borrowings
(1,467)
(1,467)
3.7
Transaction costs related to loans and
borrowings
-
-
3.8
Dividends paid
-
-
3.9
Other (repayment of lease liability)
(21)
(42)
3.10
Net cash from / (used in) financing
activities
(1,488)
2,467
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
4,813
3,385
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
1,251
(1,275)
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
Current quarter
$A’000
Year to date
(6 months)
$A’000
(1,488)
2,467
Effect of movement in exchange rates on
cash held
(18)
(19)
4.6
Cash and cash equivalents at end of
period
4,558
4,558
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
1,179
181
5.2
Call deposits
3,379
4,632
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)
4,558
4,813
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)
1,251
8.2
Cash and cash equivalents at quarter end (item 4.6)
4,558
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)
4,558
N/A
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 October 2024
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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