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    ATX   AU0000023822

AMPLIA THERAPEUTICS LIMITED

(ATX)
Delayed Australian Stock Exchange  -  11:33 2022-09-27 pm EDT
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Amplia Therapeutics : Quarterly Activities and Cashflow Reports - June 2022 Qtr

07/27/2022 | 08:48pm EDT

For personal use only

ASX RELEASE

28 July 2022

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 2022.

Key Highlights from the Quarter

  • Positive pre-IND meeting feedback received from US FDA;
  • First site opened for recruitment in ACCENT Phase 2 clinical trial of AMP945 in pancreatic cancer;
  • Significant progress in manufacturing and toxicology studies of AMP945.

Operations Update

During the Quarter, Amplia received positive pre-IND (Type B) feedback from the US FDA on the Company's proposed development plans for its investigational focal adhesion kinase inhibitor, AMP945, in people with pancreatic cancer. The Company also sought FDA's specific feedback on the design of its ACCENT clinical trial of AMP945 in first-line patients with advanced pancreatic cancer.

The FDA agreed that the available and planned pre-clinical data appear to support both the trial and a future marketing application in the proposed indication. The FDA advised that the design of the ACCENT trial, including selection of the first-line patient population and the proposed dose-escalation followed by a Simon 2-stage design, is generally acceptable. FDA also confirmed Amplia's understanding that dose selection for the Simon 2 stage expansion phase of the trial should be based on a combined view of safety, efficacy, pharmacokinetics and pharmacodynamics across a wide range of doses.

Additionally, during the Quarter, ethics committee approval was received to conduct the trial and the first site for recruitment of patients to the ACCENT trial was opened at Monash Health in Victoria, Australia. Three additional sites are scheduled to be activated in late July/early August. Previously the Company had forecast that the first patient would be recruited to the trial in the second calendar quarter of 2022 but this target was not met, primarily due to a longer than expected timeline to finalise contracts and governance arrangements with the various clinical sites. These matters have now been resolved allowing the ACCENT trial to recruit patients as planned. In order to recover any delays caused by slower than expected clinical trial start-up, the Company is assessing additional sites, increased patient outreach options and is planning an acceleration of South Korean site activation.

The Company has continued to make progress towards the initiation of a Phase 2 clinical study in Idiopathic Pulmonary Fibrosis patients with completion of dosing in the enabling 3-month toxicology studies of AMP945. Draft reports from these studies are expected in August 2022 and the Company will inform the market of any material outcomes.

Manufacture of AMP945 drug substance for use in non-clinical and clinical studies was also conducted with higher than expected yields of AMP945 being obtained, reflecting improved manufacture process understanding.

Level 17, 350 Queen Street, Melbourne VIC 3000

Email info@ampliatx.com

www.ampliatx.com

For personal use only

A manufacture process for AMP945 higher potency drug product capsules was also developed. By delivering doses with fewer capsules, patient convenience and adherence to clinical trial protocols will be enhanced. Ongoing stability studies of AMP945 drug substance and drug product also show that AMP945 remains within specification for extended periods of time, supporting a likely long product shelf-life.

In June, new data from preclinical studies was disclosed showing that AMP945 had comparable activity to OFEV®, the current market leader in the treatment of idiopathic pulmonary fibrosis. The Company expects that this new information will encourage interest from both clinical investigators and patients.

After joining the Company in February 2021 as Director Operations, Dr Rhiannon Jones was promoted to Chief Operations Officer (COO) effective July 1, 2022. Dr Jones has been leading much of Amplia's manufacturing activities and her promotion to this broader role is a reflection of Amplia's growth into a more mature clinical-stage company.

Financial update

Amplia finished the June 2022 quarter with cash of $12.7 million (March 2022: $14.6 million).

During the quarter, the Company had net cash outflows of $1.8 million in relation to operating activities (March 2022: $2.3 million). Operating cashflows included outflows of:

  • $0.3 million for staff and administration/corporate costs; and
  • $1.2 million for research and development costs, which primarily related to toxicology studies, ACCENT trial clinical costs and manufacturing costs of AMP945 drug substance and product.

Research and development expenditure is forecast to increase in the coming quarters in line with the commencement of the Phase 2 clinical trial for AMP945, which is expected to commence recruitment in the coming weeks with the first patient expected to be dosed in July-August 2022.

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 $102,230 and relate to payments to the CEO/Managing Director in line with Dr Lambert's employment contract and payments to the Non-Executive Directors.

Outlook and future activities

In the coming quarter, the Company expects to report on recruitment progress in the ACCENT trial as well as updates on progression towards optimal dose selection. The Company also expects to receive draft study reports from 3-month toxicology studies and will report top-line outcomes from these studies.

Work on Amplia's second FAK inhibitor, AMP886, is ongoing and outcomes from preclinical and manufacturing development work will be provided when ongoing studies are completed.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

- End -

For Further Information

Dr. John Lambert

CEO and Managing Director

For personal use only

john@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 cancer and Amplia has a particular development focus in fibrotic tumours such as pancreatic and ovarian cancers. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF).

For personal use only

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 2022

Consolidated statement of cash flows

Current quarter

Year to date

$A'000

(3 months)

$A'000

1.

Cash flows from operating activities

1.1

Receipts from customers

-

-

1.2

Payments for

(a)

research and development

(1,246)

(1,246)

(b) product manufacturing and operating

-

-

costs

(c)

advertising and marketing

-

-

(d)

leased assets

-

-

(e)

staff costs

(317)

(317)

(f) administration and corporate costs

(284)

(284)

1.3

Dividends received (see note 3)

-

-

1.4

Interest received

1

1

1.5

Interest and other costs of finance paid

(2)

(2)

1.6

Income taxes paid

-

-

1.7

Government grants and tax incentives

41

41

1.8

Other (provide details if material)

(25)

(25)

1.9

Net cash from / (used in) operating

(1,832)

(1,832)

activities

2.

Cash flows from investing activities

2.1

Payments to acquire or for:

(a)

entities

-

-

(b)

businesses

-

-

(c) property, plant and equipment

(7)

(7)

(d)

investments

-

-

(e)

intellectual property

-

-

(f)

other non-current assets

-

-

ASX Listing Rules Appendix 4C (17/07/20)

Page 1

+ See chapter 19 of the ASX Listing Rules for defined terms.

For personal use only

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Consolidated statement of cash flows

Current quarter

Year to date

$A'000

(3 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 (provide details if material)

(53)

(53)

2.6

Net cash from / (used in) investing

(60)

(60)

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

22

22

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)

-

-

3.10

Net cash from / (used in) financing

22

22

activities

4. Net increase / (decrease) in cash and cash equivalents for the period

4.1

Cash and cash equivalents at beginning of

14,609

14,609

period

4.2

Net cash from / (used in) operating

(1,832)

(1,832)

activities (item 1.9 above)

4.3

Net cash from / (used in) investing activities

(60)

(60)

(item 2.6 above)

ASX Listing Rules Appendix 4C (17/07/20)

Page 2

+ See chapter 19 of the ASX Listing Rules for defined terms.

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Amplia Therapeutics Ltd. published this content on 28 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 July 2022 00:47:03 UTC.


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Sales 2022 1,98 M - -
Net income 2022 -3,64 M - -
Net cash 2022 12,5 M - -
P/E ratio 2022 -5,79x
Yield 2022 -
Capitalization 18,6 M 12,0 M -
EV / Sales 2021 17,1x
EV / Sales 2022 7,87x
Nbr of Employees -
Free-Float 78,0%
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Managers and Directors
John Nicholas Lambert Chief Executive Officer, Director & MD
Hamish George Chief Financial Officer
Warwick Tong Independent Non-Executive Chairman
Mark Devlin Chief Scientific Officer
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