Managing Director's Presentation to AGM
Released
Released
Announcement PDF
ASX RELEASE
27 August 2025
CEO & Managing Director’s Presentation to Annual General Meeting
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) is pleased
to release the CEO & Managing Director’s presentation to the Company’s Annual General Meeting (YE
31 March 2025) to be held today.
This ASX announcement is authorised for release by the Company Secretary.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein overexpressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid
tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data
in a range of preclinical cancer studies.
About the ACCENT Trial
The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics,
Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic
Cancer Patients’.
The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b),
completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing
the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with
gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.
The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine
and Abraxane. The primary endpoints are Objective Response Rate (ORR) and safety and tolerability,
with secondary endpoints including Progression Free Survival (PFS), Overall Survival (OS) and
Duration on Trial (DOT).
The trial is being conducted at seven sites in Australia and five sites in South Korea.
More information about the ACCENT trial can be found via the ACCENT trial site, the Amplia
Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.
The Company will provide further updates on the trial as data is accrued.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
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
and ovarian 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.
Level 5, 90 William Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
Annual General Meeting
27 August 2025
Chris Burns PhD GAICD FAHMS
ampliatx.com | @ampliatx
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DISCLAIMER
This presentation (Presentation) contains summary information about Amplia Therapeutics
market, regulatory and other relevant environments that will exist and affect Amplia’s business and
Limited ACN 165 160 841 and its subsidiaries (the Company or Amplia) which is current as at 30
operations in the future. The Company does not give any assurance that the assumptions will prove
June 2025. By attending an investor presentation or briefing, or accepting, accessing or reviewing
to be correct. There may be other factors that could cause actual results or events not to be as
this Presentation, you acknowledge and agree to the terms set out below.
anticipated, and many events are beyond the reasonable control of the Company. Readers are
Summary Information: This Presentation has been prepared for information purposes only and is
cautioned not to place undue reliance on forward-looking statements. Forward-looking statements
a summary only. It should be read in conjunction with Amplia’s most recent financial report and
in this Presentation are only made as at the date of this Presentation and the Company does not
other periodic and continuous disclosure information lodged with the Australian Securities
undertake any obligation to publicly update or revise any of the forward-looking statements or to
Exchange (ASX), which is available at www.asx.com.au. Subject only to any legal obligation to do so,
advise of any change in assumptions on which any such statement is based.
the Company does not have any obligation to correct or update the content of this Presentation.
Industry data and third party information: Industry data and third party information used in this
Not financial product advice: This Presentation does not, and does not purport to, contain all
Presentation may have been obtained from research, surveys, reports or studies conducted by third
information necessary to make an investment decision, is not intended as investment or financial
parties, including industry or general publications. Neither Amplia not its representatives have
advice (nor tax, accounting or legal advice) and must not be relied upon as such. This Presentation
independently verified any such market or industry data.
does not take into account the investment objectives, financial situation or needs of any particular
Financial Information: This Presentation contains historical financial information based on the
investor. Investors are encouraged to seek independent professional advice when deciding if an
Company’s results for the 12 month period ending 30 June 2025 and management accounts to 30
investment in the Company is appropriate. The Company is not licensed to provide financial
June 2025. All financial information disclosed in this Presentation is presented in Australian dollars
product advice in respect of its own securities. This Presentation is not a prospectus, product
unless otherwise noted. Any discrepancies between totals and sums of components in tables and
disclosure statement or other offering document under Australian law (or any other law). It is not,
figures contained in this Presentation are due to rounding.
and does not constitute, an invitation or offer of securities for subscription, purchase or sale in any
Disclaimer: To the maximum extent permitted by law, Amplia and its officers, directors, employees,
jurisdiction.
agents and advisers: (1) disclaim all responsibility and liability (including, without limitation, any
Investment risk and past performance: An investment in Amplia shares is subject to known and
liability arising from fault, negligence or negligent misstatement) for any loss arising from this
unknown risks, some of which are beyond the control of the Company and its directors. The
Presentation or reliance on anything contained in or omitted from it or otherwise arising in
Company does not guarantee any particular rate of return or the performance of Amplia. Past
connection with this Presentation; (2) disclaim any obligation or undertaking to release any update
performance is not, and should not be relied on as being, indicative of future performance.
or revision to the information in this Presentation to reflect any change in expectations or
Future performance and forward-looking statements: This Presentation includes forward
assumptions; and (3) do not make any representation or warranty, express or implied, as to the
looking statements, which can generally be identified by the use of words such as “may”, “will”,
accuracy, reliability, completeness of the information in this Presentation or that this Presentation
“expect”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “forecast” and “guidance”, or other
contains all material information about Amplia or that a prospective investor or purchaser may
similar words. They may include, without limitation, statements regarding plans, strategies and
require in evaluating a possible investment in Amplia or acquisition of shares, or the likelihood of
objectives and anticipated business developments. Forward-looking statements inherently involve
fulfilment of any forward-looking statement.
known and unknown risks, uncertainties and other factors that may cause Amplia’s actual results,
performance and achievements to differ materially from statements in this Presentation. Forwardlooking statements are based on the Company’s good faith assumptions as to the financial,
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EXECUTIVE SUMMARY
Developing a pipeline of small molecule inhibitors of FAK
Lead drug narmafotinib is best-in-class FAK inhibitor in development
Promising efficacy, durability and tolerability in Phase 2a ACCENT clinical
trial in pancreatic cancer
US trial of narmafotinib in pancreatic cancer to start imminently
FAST-track and Orphan Drug Designation granted from US FDA
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COMPANY SUMMARY
ASX: ATX
ATX Price and Volume - 12 months
Share price
(26 Aug 2025)
Share price range
(52 week low/high)
Shares on issue
Market capitalization
(26 Aug 2025)
$0.188
$0.049 - 0.42
486.48M
$91.2M (approx.)
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METASTATIC PANCREATIC CANCER
Limited treatment options; poor patient outcomes
5Y Survival
Limited Treatment Options
Treatment
3%
Gemcitabine +
Abraxane ®
Median Overall
Survival
5.5 months
8.5 months
6.4 months
11.1 months
Tolerability
(MPACT study)
FOLFIRINOX
(Prodige study)
Highly aggressive with multiple genetic
drivers
Median Progression
Free Survival
Most patients receive
gemcitabine + Abraxane
or FOLFIRINOX
or variations of these †
>50% pancreatic cancer patients
diagnosed with advanced (metastatic,
stage 4) disease at the time of diagnosis
Other regimens
20%
5-FU treatments
2.2%
Gem + Abraxane
46.4%
FOLFIRINOX
18.9%
Gemcitabine
12.4%
MPACT Trial - N Engl J Med. 2013, 369, 1691-703; PRODIGE trial - N Engl J Med. 2011, 364, 1817-1825; † - The Oncologist 2022, 27, 469–475
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THE AMPLIA ADVANTAGE
Three critical features
Efficacy
Narmafotinib
Tolerability
Durability
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Median Progression Free Survival (mPFS) data
All ACCENT patients @ 400 mg (n = 64)
Currently determined at 7.6 months - substantially
better than chemotherapy alone (5.5 months)
Interim data with 17 patients still on trial
Improvement over FOLFIRINOX chemotherapy (6.4
months)
mPFS
ACCENT Trial
MPACT Trial
PRODIGE Trial
(Narmafotinib/Gemcitabine/Abraxane)
(Gemcitabine/Abraxane)
(FOLFIRINOX)
7.6 months
5.5 months
6.4 months
PFS data calculation included patients from Phase 1b dosed with narmafotinib (400 mg) and all patients in Phase 2a. Interim data based on data cut-off 20 Jul 2025.
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
ACCENT Trial
(Narmafotinib/Gemcitabine/
Abraxane)
MPACT Trial
(Gemcitabine/
Abraxane)
CR
2%
0.2%
PR
29%
23%
SD
42%
27%
PD
16%
20%
NE *
11%
30%
ORR
31%
23%
DCR
73%
50%
DOT
202 days
117 days
Excellent response rate observed
1 confirmed Complete Response
16 confirmed Partial Responses
Incl. 1 patient determined to be a pathological Complete
Response
Objective response rate (ORR) of 31%
Disease control rate (DCR) of 73%
Excellent durability observed
Duration on Trial far exceeds historical MPACT data
7 patients on study > 1 year
At data cut-off (20 Jul 2025):
17 patients remain on study
Data for 6 patients at 6 months yet to be collected
Interim data based on data cut-off Jul 20, 2025. Responses are investigator read. * NE - Non-evaluable
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ACCENT TRIAL TOPLINE DATA
Promising evidence of efficacy, durability and tolerability
Excellent tolerability observed to date
Narmafotinib treatment results in negligible extra patient burden
Adverse Events (Grade 3 or above)
Adverse Event (AE) Grade ≥ 3
Narmafotinib +Gem/Abr
(ACCENT; N=55)
Gem/Abr
(MPACT; N=421)
Gem/Abr
(NAPOLI 3; N=379)
FOLFIRINOX
(PRODIGE; N=171)
NALIRIFOX
(NAPOLI 3; N=370)
Neutropenia
38.2%
38%
39%
46%
24%
Anemia
9.1%
13%
18%
8%
11%
Diarrhea
5.5%
6%
5%
13%
20%
Peripheral neuropathy
3.6%
17%
6%
9%
3%
Vomiting
3.6%
NR
2%
15%
7%
Febrile Neutropenia
5.5%
3%
NR
5%
NR
Thrombocytopenia
NR
13%
NR
9%
NR
Fatigue
NR
17%
5%
24%
6%
Hypokalemia
NR
NR
4%
NR
15%
Nausea
3.6%
NR
3%
NR
12%
ACCENT and MPACT trials have very similar inclusion criteria and trial designs however no head-to-head clinical trial has been conducted. Differences exist between ACCENT and other trials in design, inclusion
criteria and patient demographics. NR - Not Reached. NAPOLI 3 Trial - The Lancet 2023, 402(10409),1272-1281
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AMPLICITY TRIAL
Phase 1b/2a study in Pancreatic Cancer in the US and Australia
Objective
To determine safety and efficacy of narmafotinib when added to FOLFIRINOX in newly diagnosed
metastatic patients
Entry from clinicaltrials.gov/study/NCT07026279
To identify recommended phase 2 dose (RP2D)
Primary Endpoints
Safety, Tolerability
RP2D
Additional Endpoints
Objective Response Rate (RECIST v1.1)
Duration of Response
Progression free survival (PFS)
Overall Survival (OS)
Trial Sites
2 Australian sites open and recruiting
4 US sites in final stages of site initiation
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FUTURE OPPORTUNITIES
FAK inhibition will enhance multiple therapeutic strategies
Narmafotinib
(FAK inhibition)
CHEMOTHERAPY
IMMUNOTHERAPIES
Clinical and preclinical data incl.
ACCENT study
Preclinical data
RADIOTHERAPY
KRAS INHIBITORS
Published data
Preclinical data, incl.
collaboration
ANTIBODY DRUG
CONJUGATES
Published data
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UPCOMING MILESTONES
Q3 2025
ACCENT top-line data
Q4 2025
Q1 2026
Q2 2026
ACCENT further patient
ACCENT mature data
ACCENT trial completion
updates
(including OS)
possible
ACCENT request FDA type
C meeting - Phase 2b/3
AMPLICITY first trial data
AMPLICITY complete
AMPLICITY further
dose escalation
patient updates
FDA meeting and minutes
ACCENT trial pathway
dosed (part A)
ACCENT further patient
begins
IIT data updates (kRAS and Ovarian)
Initiate kRAS combination
Initiate IIT in ovarian
IIT
cancer
IIT funding outcome(s)
updates
ACCENT full data release
AMPLICITY 2-dose comparison trial
pivotal trial design
AMPLICITY first patient
2H 2026
ACCENT Phase 2b/3 trial planning
finalised
EU regulatory response
Drug product scale-up
Possible EU regulatory
filings
ACCENT Phase 2b/3 trial
protocol finalised
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THANK YOU
Chris Burns PhD GAICD FAHMS
CEO and MD
chris@ampliatx.com
Amplia Therapeutics Limited
ASX: ATX
info@ampliatx.com
ampliatx.com
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