ATX Quarterly Activities and Cashflow Reports - June 23 Qtr
Released
Released
Announcement PDF
ASX RELEASE
31 July 2023
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 June 2023.
Key Highlights from the Quarter
•
•
•
•
Completion of Cohort 2 and currently dosing Cohort 3 in the Phase 1b stage of the ACCENT
trial
Reported exciting preclinical data showing AMP945 enhances the activity of an alternate
treatment for pancreatic cancer called FOLFIRINOX, in a model of the disease
Initiated a study with CSIRO to explore topical delivery of our FAK inhibitors for wound healing
Announced the name narmafotinib for AMP945
Operations Update
Clinical Development
The primary focus of the company continues to be the ACCENT clinical trial. This trial, in advanced
pancreatic cancer patients, tests the activity of our FAK inhibitor AMP945 in combination with
standard-of-care chemotherapy of gemcitabine and nab-paclitaxel (see ClinicalTrials.gov, identifier
NCT05355298). The trial is in two phases: the first is a dose-escalation phase to identify an optimal
dose of AMP945 that is safe and tolerable; and the second is a dose-expansion phase where activity of
the optimal dose is determined in a larger patient group. We are recruiting patients at seven sites in
Melbourne, Sydney and Brisbane and during the quarter completed dosing cohort 2, and are currently
dosing patients in cohort 3, of the dose-escalation stage of the trial.
We anticipate moving to the Phase 2a dose escalation stage of the trial in the coming months and
planning is well advanced to bring on additional sites in South Korea.
Non-clinical Development
Preclinical studies of AMP945 continue to explore additional opportunities for the drug. Over the
quarter we reported exciting preliminary data from our collaborators at the Garvan Institute in Sydney
that we disclosed at the recent American Society of Clinical Oncology meeting in Chicago. This
preclinical data demonstrates that AMP945 enhances the activity of an alternative treatment for
pancreatic cancer called FOLFIRINOX, in a mouse model of the disease. The potential beneficial effects
of AMP945 when combined with FOLFIRINOX is particularly exciting given that FOLFIRINOX is the
standard treatment for pancreatic cancer in many countries, including the US.
This quarter we also reported initiation of a collaboration with CSIRO to investigate topical delivery of
our FAK inhibitors to wounds and burns. This research builds on published work in the scientific
literature showing that FAK inhibition can speed up wound healing and reduce scarring.
Finally, we announced in June that the World Health Organization has granted the international
nonproprietary name (INN) narmafotinib for AMP945.
Level 17, 350 Queen St, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
Financial update
Amplia finished the June 2023 quarter with cash of $7.8 million (March 2023: $9.3 million).
During the quarter, the Company had net cash outflows of $1.4 million in relation to operating
activities (March 2023: $1.3 million). Operating cashflows included outflows and inflows of:
•
•
$0.8 million for staff and administration/corporate costs; and
$0.6 million for research and development costs, which primarily related to Contract Research
Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the first
stage of the Phase 1b/2a clinical trial for Narmafotinib (AMP945).
Research and development expenditure is forecast to increase in the coming quarters in line with the
progression of Phase 1b/2a of the ACCENT clinical trial for Narmafotinib.
Successful Research and Development Tax Incentive Advanced Overseas Finding (AOF) outcome
The Company received a positive outcome on the AOF that was pending at the time the Company
submitted its FY23 Annual Report (30 May 2023). The positive outcome results in the Company
expecting a further $1,260,024 for its Research and Development Tax Incentive refund for FY23,
taking the total expected refund to $2,408,458.
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’s in line with employment contracts and payments to the Non-Executive Directors.
Outlook and future activities
Over the coming quarter, the Company expects to report further progress in the ACCENT trial as we
finalise dose selection for the Phase 2 portion of the trial. Further progress on the regulatory
submission to South Korea will also be reported.
Preclinical studies with AMP945 in additional cancer and non-cancer indications are underway to
identify further clinical and commercial opportunities for the drug. Results from these studies will be
reported in due course.
This ASX announcement was approved and authorised for release by the Board of Amplia
Therapeutics.
- 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 immunology 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
30 June 2023
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
(3 months)
$A’000
-
-
(641)
(641)
(b) product manufacturing and operating
costs
-
-
(c) advertising and marketing
-
-
(d) leased assets
-
-
(e) staff costs
(478)
(478)
(f)
(293)
(293)
-
-
(a) research and development
administration and corporate costs
1.3
Dividends received (see note 3)
1.4
Interest received
29
29
1.5
Interest and other costs of finance paid
(22)
(22)
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
-
1.8
Other (provide details if material)
(8)
(8)
1.9
Net cash from / (used in) operating
activities
(1,413)
(1,413)
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
(3 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)
-
-
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
-
-
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)
(20)
(20)
3.10
Net cash from / (used in) financing
activities
(20)
(20)
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
9,257
9,257
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(1,413)
(1,413)
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
(3 months)
$A’000
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
(20)
(20)
4.5
Effect of movement in exchange rates on
cash held
5
5
4.6
Cash and cash equivalents at end of
period
7,829
7,829
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
962
1,273
5.2
Call deposits
6,867
7,984
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)
7,829
9,257
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
2,100
2,100
7.1
Loan facilities
7.2
Credit standby arrangements
-
-
7.3
Other (please specify)
-
-
7.4
Total financing facilities
2,100
2,100
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.
-
The Loan facility is a non-dilutive funding facility of up to $2.1million with Treasury
Corporation of Victoria (TCV) as part of the Victorian Government’s R&D Cash Flow
Loan Initiative. The Facility was received in two tranches: the first of $1.26 million
was received in December 2021; and the second of $0.84 million was received in
February 2022. The amount of the second tranche funding was capped so as not to
exceed a total Facility draw down of 80% of the Company’s forecast R&D Tax
Incentive (RDTI) rebate for FY2022. Interest on Facility advances is variable at the
“TCV 11am” loan interest rate (currently 4.265%). Repayment of the Facility is
timed to coincide with receipt of the Company’s FY2023 RDTI refund, expected by
31 October 2023, but may be repaid earlier. The Facility is secured by the FY2022
and FY2023 RDTI refunds. As at 30 June 2023, the total loan facility was $2.10
million, being fully drawn.
8.
Estimated cash available for future operating activities
$A’000
8.1
Net cash from / (used in) operating activities (item 1.9)
(1,413)
8.2
Cash and cash equivalents at quarter end (item 4.6)
7,829
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)
7,829
5.5
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?
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
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?
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.
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:
31 July 2023
Authorised 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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