Ann: Quarterly Activities and Cashflow Reports and Presentation, page-2

Looks good to me at least.....
"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 2021.
Key Highlights from the Quarter
• Completed dosing in the Phase 1 clinical trial of AMP945 in healthy volunteers;
• Finalised and executed Collaboration Agreement with the Garvan Institute of Medical
Research;
• Preclinical data shows AMP945 confers 27% survival benefit in challenging animal model of
pancreatic cancer;
• Raised A$3.8M to prepare for initiation of Phase 2 clinical program for AMP945. Amplia’s CEO and Managing Director, Dr John Lambert, commented that “The progress Amplia has
made during this quarter has put the Company in a strong position for its next stage of clinical
development. The results from our successful Phase 1 clinical trial announced last week have
confirmed that AMP945 has a profile which makes it very suitable for advancing into Phase 2 clinical
trials in both patients with pancreatic cancer and idiopathic lung fibrosis (IPF). Our Collaboration
Agreement with the Garvan announced last quarter was finalised and the collaboration has already
provided valuable data validating our strategy to add AMP945 into existing standard-of-care therapies
to enhance the currently poor response experienced by patients with pancreatic cancer. Amplia is very
appreciative of the support it received from new and existing shareholders, with $3.8M of new capital
raised during the quarter that will enable the Company to prepare for the launch of its Phase 2 clinical
program later this year”.
Operations update
During the quarter, Amplia completed dosing in its Phase 1 clinical trial of AMP945 in healthy volunteer
and has recently received the final data. The trial achieved its Primary Endpoints by demonstrating
that AMP945 is safe and well-tolerated at the doses tested when it is administered as a single oral dose
or as repeated, daily oral doses over seven days. Furthermore, oral administration was able to achieve
the levels of AMP945 in the bloodstream that are required to inhibit the drugs intended target, FAK,
and the pharmacokinetic data supports once daily, oral dosing of AMP945. These data are extremely
pleasing and fully support advancing AMP945 into Phase 2 clinical trials for both pancreatic cancer and
IPF. The plans for a Phase 2 clinical trial of AMP945 in patients with pancreatic cancer are well advanced
and the Company expects to finalise the design of this trial during the current Quarter. Amplia has
engaged a range of clinicians, regulatory and biostatistics consultants and other experts to assist with
this process and is incorporating their advice into the design of this trial. In parallel, Amplia has
commenced the scale-up manufacture of AMP945 and longer-term animal toxicology studies required


to support a Phase 2 clinical trial of AMP945 in patients with IPF which is currently scheduled to start
in mid-2022. In June, Amplia finalised the commercial terms and executed its Research Collaboration Agreement
with the Garvan Institute of Medical Research (the “Garvan” in Sydney. This collaboration provides
the Company with access to the Garvan’s research strength in FAK biology and its extensive clinical
research network. Amplia has been working with Professor Paul Timpson, a world-renowned expert in
FAK biology, from the Garvan for over two years and appointed him to the Company’s Scientific
Advisory Board in February 2020. During the quarter, Amplia reported preclinical data generated by Professor Timpson’s laboratory as
part of the Company’s collaboration with the Garvan. In June, the company reported that these
changes were associated with a statistically significant, 27% improvement in survival in a highly
aggressive animal model of pancreatic cancer (the KPC mouse model). These results provide further
support and validation of the scientific rationale for incorporating FAK inhibitors into treatment
regimens for pancreatic cancer and indicate that they have the potential to have a positive impact on
the clinical outcomes for these patients.
Financial update
Amplia finished the June 2021 quarter with cash of $4,081,000. During the quarter, the Company used
$1,344,000 in operating activities, with $993,000 being used for research and development that was
primarily focused on close-out of the Phase 1 clinical trial of AMP945. Having completed recruitment in the Phase 1 clinical trial, research and development expenditure is
forecast to decrease in the coming quarter.
Payments to Related Entities
In Section 6.1 of the Appendix 4C lodged for this quarter, the Company discloses payments to related
parties of $131,000. These payments reflect salary, superannuation and a short-term incentive paid to
the CEO/Managing Director in line with Dr Lambert’s employment contract.
Outlook and future activities
Amplia’s primary focus will be on preparing for Phase 2 clinical trials of AMP945. This will involve
working with the Company’s clinical advisors to further refine clinical study designs, fully scoping the
studies and preparing for regulatory and ethics committee submissions required to allow initiation of
Phase 2 studies. In addition, the Company will continue its parallel program of non-clinical studies for
AMP945 and AMP886 in order to expand the Company’s data set supporting the potential utility of
AMP945 and AMP886 in other therapeutic areas of commercial potential. This ASX announcement was approved and authorised for release by the Board of Amplia
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