Amplia Therapeutics : Quarterly Activities and Cashflow Reports - Dec 2021 Qtr

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ASX RELEASE

24 January 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 31 December 2021.

Key Highlights from the Quarter

• Supplementary data from Phase 1 clinical trial confirmed that orally administered AMP945 is able to inhibit its intended target, FAK, in the tissues of human subjects;
• Completed GMP manufacture of a 2 kg batch of AMP945 for use in upcoming Phase 2 clinical trials and preclinical studies;
• Dr José Iglesias, a pharmaceutical industry leader with extensive experience in developing treatments for pancreatic cancer, appointed as Clinical Advisor; and
• Balance sheet strengthened to support Phase 2 clinical trials planned for 2022 through a $12.4M capital raise and access to an additional $3.2M arising from the R&D tax incentive program.

Amplia's CEO and Managing Director, Dr John Lambert, commented that "While 2021 was a challenging year for everyone, I am extremely proud of what our team at Amplia has been able to achieve. In the last quarter of 2021, we put in place all the elements to make 2022 a watershed year for the Company. We have a robust package of data supporting our strategy as we initiate the first Phase 2 trials for AMP945 and we have successfully completed a 2 kilogram GMP manufacturing run of AMP945 which provides sufficient drug material to complete two 3-month animal toxicology studies as well as take us deep into two Phase 2 clinical trials. And finally, through the much-appreciated support of our shareholders we have raised the capital to support these important activities."

Operations update

In November, Amplia provided additional data from its Phase 1 clinical trial demonstrating that oral dosing of AMP945 in healthy volunteers resulted in a reduction of the activity of FAK, the drug's intended target. The inhibition of FAK, which was measured in skin biopsies taken from participating subjects, indicates that after oral administration of AMP945, the drug is absorbed and distributed to tissues where it achieves the desired biological effect in human subjects.

A key focus for Amplia during the December quarter was preparation for the Phase 2 clinical trials of AMP945 in patients with pancreatic cancer and fibrotic lung disease. Significant progress has been made in the design and development of Amplia's trial of AMP945 in patients with fibrotic lung disease that is currently scheduled to start in 2H CY2022.

Critical to these preparations was the manufacture of AMP945 drug substance. Work conducted at Amplia's Contract Manufacturing Organisation (CMO) during the December quarter culminated in early January with the successful production of a 2 kilogram GMP (Good Manufacturing Practice) batch

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of AMP945. As part of this scale-up production, improvements were made to the manufacturing process that are expected to further support the future clinical and commercial development of AMP945. In addition to the planned Phase 2 clinical trials, this drug material will enable Amplia to supply two longer duration (3-month) animal toxicology studies required to support clinical trials in patients with fibrotic lung disease.

Furthermore, during the December quarter the Company made significant progress on the development of new manufacturing processes for AMP945 drug product capsules. This manufacturing development work is intended to underpin GMP manufacture of the commercial product through the introduction automated capsule filling, bottling and confirmation of product shelf-life. The Company expects to report on the outcome of these studies in the near future.

In October, Amplia announced it had appointed Dr José Iglesias as a Clinical Advisor. Dr Iglesias is an experienced pharmaceutical executive who has held senior roles at Eli Lilly, AMGEN, Abraxis and Celgene during the course of his 30-year career. Dr Iglesias was responsible for the Phase 3 clinical development of Abraxane® which has been incorporated into the worldwide standard-of-care for the treatment of patients with advanced pancreatic cancer. In October, Amplia also appointed Mr Hamish George of Melbourne-based Bio101 to provide Chief Financial Officer services to the Company.

In November, Amplia announced that it had successfully negotiated an amendment to its Licence Agreement with Cancer Research UK (CRUK) for its second FAK inhibitor AMP886. Under the renegotiated agreement, Amplia has until 31 December 2023 to file an Investigational New Drug (IND) application or initiate a Phase 1 clinical trial of AMP886. Amplia is actively exploring a number of cancer and fibrotic disease areas where AMP886 may have clinical utility based on its particular activity profile.

During the quarter, Amplia significantly strengthened its balance sheet to support the additional development activities and the initiation of two Phase 2 clinical trials. In November 2021, the Company announced a Placement and a fully underwritten 1-for-4 Entitlement Offer to raise a total of $12.4 million. The capital raise was successfully completed in December 2021.

Financial update

Amplia finished the December 2021 quarter with cash of $16.2 million (September 2021: $3.2 million).

The increase in cash was driven by:

• The Company successfully raising $12.4 million (fees excluded) through a Placement and Underwritten Entitlement Offer (as announced to the ASX on 8 November 2021);
• Receipt of the FY21 R&D Tax Incentive refund of $1.1 million (as announced to the ASX on 14 October 2021); and
• Receipt of Tranche 1 of the FY22 R&D Funding Loan of $1.3 million administered by Treasury Corporation of Victoria and Invest Victoria (as announced to the ASX on 2 December 2021).

During the quarter, the Company had net cash inflows of $0.18 million in relation to operating activities (September 2021: outflows $2.1 million). The net inflow was driven by the receipt of $1.1 million FY21 R&D Tax Incentive. Other operating cashflows included outflows of:

• $0.48 million for staff and administration/corporate costs; and
• $0.46 million for research and development, which was primarily focused on completing the Phase 1 clinical trial for AMP945 and preparing for the first stage of the Phase 2 clinical trial for AMP945.

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Having now raised sufficient funds to undertake the first stage of the Phase 2 clinical trial for AMP945, research and development expenditure is forecast to increase in the coming quarters.

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 $65,000 and solely relate to payments to the CEO/Managing Director in line with Dr Lambert's employment contract.

Outlook and future activities

Amplia's primary focus for 2022 will be on initiating Phase 2 clinical trials in pancreatic cancer and, in the second half of the year, lung fibrosis. The Company is required to apply for Human Research Ethics Committee (HREC) clearance to conduct these Phase 2 clinical trials. While all the preparations by the Company for the clinical trial of AMP945 in pancreatic cancer remain on track, the current Omicron outbreak is having a significant impact on the resources and focus of the healthcare system. In view of this, Amplia believes that it is likely that the initiation of recruitment for this trial may be delayed until early in the June quarter.

The Company is continuing to refine the design of the Phase 2 clinical trial of AMP945 in lung fibrosis and, during the March quarter, the Company will initiate two longer term (3-month) animal toxicology studies to support the extended dosing of AMP945 that will be used in this clinical trial. The Company is also undertaking further non-clinical studies evaluating clinical opportunities for AMP886, Amplia's second FAK inhibitor.

At this stage, other than the initiation of recruitment in its Phase 2 clinical trial of AMP945 for pancreatic cancer, the Company is not aware of any impact that the current Omicron outbreak may have on the timing of its other operational objectives.

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 [e-mail]

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 pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF).

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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 2021

Consolidated statement of cash flows	Current quarter	Year to date
			$A'000	(9 months)
				$A'000
1.	Cash flows from operating activities
1.1	Receipts from customers	-	-
1.2	Payments for
	(a)	research and development	(462)	(1,939)
	(b) product manufacturing and operating	-	-
		costs
	(c)	advertising and marketing	-	-
	(d)	leased assets	-	-
	(e)	staff costs	(142)	(570)
	(f) administration and corporate costs	(340)	(749)
1.3	Dividends received (see note 3)	-	-
1.4	Interest received	-	-
1.5	Interest and other costs of finance paid	-	-
1.6	Income taxes paid	-	-
1.7	Government grants and tax incentives	1,140	1,140
1.8	Other (provide details if material)	(13)	56
1.9	Net cash from / (used in) operating	183	(2,062)
	activities
2.	Cash flows from investing activities
2.1	Payments to acquire or for:
	(a)	entities	-	-
	(b)	businesses	-	-
	(c) property, plant and equipment	-	(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.

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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	(9 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)	-	-
2.6	Net cash from / (used in) investing	-	(7)
	activities
3.	Cash flows from financing activities
3.1	Proceeds from issues of equity securities	12,387	16,201
	(excluding convertible debt securities)
3.2	Proceeds from issue of convertible debt	-	-
	securities
3.3	Proceeds from exercise of options	30	69
3.4	Transaction costs related to issues of	(866)	(1,144)
	equity securities or convertible debt
	securities
3.5	Proceeds from borrowings	1,260	1,260
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	12,811	16,386
	activities

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

4.1	Cash and cash equivalents at beginning of	3,171	1,848
	period
4.2	Net cash from / (used in) operating	183	(2,062)
	activities (item 1.9 above)
4.3	Net cash from / (used in) investing activities	-	(7)
	(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.