Capital Raising Presentation
Released
Released
Announcement PDF
Capital Raising Presentation
July 2025
ampliatx.com | @ampliatx
IMPORTANT INFORMATION
This presentation (Presentation) has been prepared by Amplia Therapeutics Limited ACN 165 160 841 (the Company or Amplia) and is dated
Forward-looking statements, opinions and estimates provided in this Presentation are based on assumptions and contingencies which are subject to
23 July 2025. This Presentation has been prepared in relation to a proposed capital raising comprising a placement of new ordinary fully paid
change without notice, as are statements about market and industry trends, which are based on interpretations of current market conditions. Forward-
shares in Amplia (New Shares) to sophisticated and professional investors (Placement or Offer).
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subscription, purchase or sale in any jurisdiction.
accuracy, reliability, completeness of the information in this Presentation or that this Presentation contains all material information about Amplia or that a
Investment risk and past performance: An investment in Amplia shares is subject to known and unknown risks, some of which are beyond the
prospective investor or purchaser may require in evaluating a possible investment in Amplia or acquisition of shares, or the likelihood of fulfilment of any
control of the Company and its directors. The Company does not guarantee any particular rate of return or the performance of Amplia. Past
forward-looking statement. Bell Potter and its advisers, affiliates, related bodies corporate, directors, officers, employees and agents (BP Parties) make no
performance is not, and should not be relied on as being, indicative of future performance. Investors should have regard to the ‘Risks’ section of
recommendations as to whether you should participate in the Offer nor do they make any representations or warranties to you concerning the Offer, and
this Presentation.
you represent, warrant and agree that you have not relied on any statements made by the BP Parties in relation to the Offer and you expressly disclaim
Future performance and forward-looking statements: This Presentation contains certain references to forecasts, estimates, assumptions and
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other forward-looking statements and statements regarding the intent, belief or current expectations of Amplia. The words “likely”, “expect”,
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statements.
2
EXECUTIVE SUMMARY
Developing a pipeline of small molecule inhibitors of FAK – a validated cancer target
Lead compound Narmafotinib is the best-in-class Focal Adhesion Kinase (FAK) inhibitor in development
Promising clinical safety and tolerability positions Narmafotinib as the preferred agent to enhance activity of drugs for treatment of pancreatic cancer and other solid tumours
Ongoing Phase 1b/2a ACCENT trial is evaluating Narmafotinib in combination with the chemotherapies gemcitabine and Abraxane® in patients with advanced pancreatic cancer
Compelling pre-clinical data in ovarian cancer, idiopathic pulmonary fibrosis (IPF) and other solid tumours
Orphan Drug and Fast Track Designations granted by US FDA – eligible for accelerated approval and Priority Review Voucher
•
•
•
•
•
Ongoing Phase 2a ACCENT trial in pancreatic cancer has achieved superiority over chemotherapy alone
•
•
•
•
•
Positive interim data released in May 2025 showed that Narmafotonib is well tolerated and promising efficacy materially exceeding the current standard of care
Pathological complete response and complete response announced in June 2025 - extremely rare in advanced pancreatic cancer where the disease has metastasised
Key milestone already achieved with 17 confirmed partial responses recorded, demonstrating that the combination of Narmafotinib and chemotherapy is superior to chemotherapy alone
Trial is fully recruited with top-line data (PFS) expected in late July/early August 2025
Further mature data is expected in 1H 2026
Partnership Ready
•
•
Amplia’s partnering interest from global pharmaceutical companies has materially increased following recent interim data and patient updates in the ACCENT clinical trial
Management are in ongoing discussions with potential partners around regional licensing agreements
Other opportunities
•
•
•
Amplicity Phase 2 trial currently recruiting under approved FDA IND - Narmafotinib in combination with FOLFIRINOX (standard-of-care therapy for advanced pancreatic cancer in US)
Examining opportunities to combine Narmafotinib with kRAS inhibitors via a US investigator-initiated trial (IIT)
Ovarian cancer combination trial with standard-of-care intended to commence in 1H26 - promising preclinical data and enthusiastic support from key opinion leaders in US
Strong period of expected upcoming news flow
•
•
•
•
•
•
•
•
ACCENT top-line data (July/August 2025)
Amplicity first patient dosed (Q3 2025)
ACCENT request FDA type C meeting to discuss Phase 2b/3 pivotal trial design (Q3 2025)
ACCENT mature data (1H2026)
kRAS and Ovarian clinical trials commence (1H 2026)
ACCENT ongoing patient updates, approximately 20 patients remain on trial
ACCENT commence potential pivotal Phase 2b/3 trial (2H 2026)
Potential updates on licensing/partnering discussions
Capital raising of approximately $27.5 million
•
•
•
Undertaking a capital raising of $27.5 million via a two-tranche placement of $25.0m and a $2.5m share purchase plan
The Amplia directors will subscribe for $235,000 worth of shares (in total) under the placement, subject to shareholder approval
Following the capital raising, the company will be funded into 2027
36
EXPERIENCED BOARD + MANAGEMENT
Combined >120 years of drug development experience bringing 4 FDA approved drugs to market
SENIOR
MANAGEMENT
BOARD
Rhiannon Jones
PhD GAICD
COO
Warwick Tong
Robert Peach
Jane Bell AM
Chris Burns*
MB ChB MPP GAICD
Chair
PhD
Director
LLB, LLM (Lond), FAICD
Director
PhD GAICD FAHMS
CEO and MD
Jason Lickliter
MBBS FRACP
CMO
Tim Luscombe
BCom CA GIA(Cert)
CFO
* Co-recipient of 2024 PM’s
Prize for Innovation
4
Background on
pancreatic cancer
and Focal Adhesion
Kinase (FAK)
PANCREATIC CANCER
Increasing prevalence with limited innovation or new therapies approved beyond
traditional chemotherapy in recent decades
Increasing
Prevalence
Estimated 67,440 diagnoses
and 51,980 deaths in
US this year*
4,641 estimated diagnoses
in AU in 2024**
5 year
survival
Market
size
Difficult-to-treat:
typically detected late in
disease progression**
Global treatment market
estimated at ~US$2.65
†
billon in 2024
(advanced disease)
Projected to grow to
†
~US$9.57 billion by 2034
* American Cancer Society: https://cancerstatisticscenter.cancer.org/
† Towards Healthcare:
** Cancer Australia: https://www.canceraustralia.gov.au/cancertypes/pancreatic-cancer/statistics
https://www.towardshealthcare.com/insights/pancreaticcancer-market
6
CURRENT STANDARD OF CARE
Current standard-of-care for advanced pancreatic cancer remains chemotherapy. Amplia aims to
demonstrate that addition of Narmafotinib will enhance durability of response
Chemotherapy
Gemcitabine and nab-paclitaxel
(Abraxane®)
FOLFIRINOX
mPFS‡
5.5 months
7.2 months
mOS‡
8-9 months
11.1 months
Comments
• Regarded as better tolerated (lower adverse events),
but durability less than FOLFIRINOX
• Abraxane® coming off patent soon – owned by Bristol
Myers Squibb
• Regarded as more toxic and less well tolerated (more
AE’s*) , but more durable than gem/nab-P
• Off patent. New variant NALIRIFOX (Ipsen/Servier) has
had poor uptake since approval
‡ mPFS = Median Progression free survival; mOS = Median Overall Survival
* AE’s = Adverse Events
7
FOCAL ADHESION KINASE (FAK)
FAK is a key driver of cancer progression and fibrosis, offering broad clinical potential
across multiple therapeutic areas
FAK is a critical protein in cancer growth and spread, and in formation of fibrotic (scar) tissue
Potential applications extend beyond pancreatic cancer
Capital raising to rapidly advance applications into other indications
Broad clinical potential
Amplia’s drugs
potently and
selectively block the
activity of the FAK
protein
Cancer
Fibrosis
Scarring
8
FAK INHIBITION IN CANCER
FAK overactivation is driving poor patient outcomes — Narmafotinib delivers an
effective targeted response
FAK over-expressed and over-active in
many cancers
Higher FAK levels correlate with worse
patient outcomes
Multi-action of Narmafotinib
Anti-proliferative
Reduces cells’ ability
to proliferate
and migrate
Narmafotinib potently inhibits FAK and
thereby reduces cancer growth
Synergy with
chemotherapies
Enhances activity of
drugs and other
therapies
Tumour (blue - cancer cells;
green- fibroblasts; purple, grey
and yellow - suppressive
immune cells)
• within cancer cell
• in tumour microenvironment
Narmafotinib blocks critical
pathways supporting tumour growth
Anti-fibrotic
Reduces scar-tissue in
TME, improving
permeability to drugs
Immunomodulatory
Improves immune cell
reactivity to tumour
cells
9
LIMITED COMPETING FAK INHIBITORS
Amplia is one of only 3 companies with bona fide FAK inhibitors in development
VSTM.NASDAQ, Mkt Cap ~US$260m
• Co-development with a second drug (avutometinib)
• Targeting low-grade serous ovarian cancer (LGSOC) (~10% patients)
Verastem
• Accelerated FDA approval obtained in May 2025 following Phase 2 clinical trial
• Confirmatory Phase 3 underway
• Early data in high-grade serous ovarian cancer (HGSOC) study
• High percentage patients on trial presenting with proteinuria possibly indicating off-target drug
effect to kidneys
Inxmed (private)
• Phase 2 combination studies underway in Non-Small Cell Lung Cancer (NSCLC), Platinum-
Resistant Ovarian Cancer (PROC), Colorectal Cancer (CRC) and Small Cell Lung Cancer (SCLC)
Narmafotinib has an excellent selectivity profile,
improved PK and excellent tolerability in patients
10
ACCENT Trial
in Advanced
Pancreatic
Cancer
PHASE 1B/2A TRIAL DESIGN
Fully recruited with top-line data expected in late July/early August 2025
An open-label trial of Narmafotinib in combination with gemcitabine +
nab-paclitaxel in first-line patients with advanced pancreatic cancer
Trial Read-outs: Safety and Tolerabilty; Preliminary efficacy
COMPLETED
* Chosen dose for Phase 2a study
FULLY RECRUITED
12
PHASE 1B – OCTOBER 2023
Excellent safety profile established, allowing highest dose to be selected for Phase 2A and
positive efficacy signals
Duration on trial
Release October 2023 - Narmafotinib safe and well
tolerated
• All 14 patients elected to stay on drug post cycle 1
• One DLT*: uncontrolled nausea
• Fatigue (Grade 3 or below) in more than 1 patient likely drug related
Three dose levels examined
• Taken as capsule for 4 days prior to chemotherapy
• Chemotherapy given i.v. (3 doses every month)
• Narmafotinib 400 mg dose (oral, once-a-day) identified as
appropriate for Phase 2a study
* Dose-limiting toxicity
13
PHASE 2A INTERIM DATA – MARCH 2025
Released in March 2025. Showed longer duration and median survival than
chemotherapy alone and no serious adverse events
Duration on Trial*
High-level data (first 26 patients)*
• Duration on trial average ~7 months (208 days)
⚬ Historical median duration of treatment for
gemcitabine + nab-paclitaxel: 3.9 - 4.1 months
• 10/26 patients on trial longer than historical
mOS of 8.5-9.2 months for gem/Nab-P
⚬ Historical reference data based on MPACT and
NAPOLI-3 phase 3 trials with Gem/Nab-P in mPDAC
patients
*Based on data available March 7, 2025; responses are investigator read; analysis may change as data matures. PR = Partial response, SD = Stable Disease, PD = Progressive Disease.
14
PHASE 2A INTERIM DATA – MARCH 2025
38% response rate compares favourably to other historical trials at 23%
Collated data of ‘best response’ at
Best Response (evaluable patients)*
any scan indicates promising
activity
• 26 evaluable patients
• 15 patients recorded decrease in tumor
size >30%
• 11 as confirmed PRs (38% response
rate)
⚬ Compares favorably to historical data of
23%
Color indicates best response by RECIST (target & non-target lesions): Grey =
progressed; Yellow = stable disease; Green (hash) = PR (≥30% decrease from
baseline); Green (solid) = confirmed PR
*Based on data available in trial database on Mar 7, 2025; responses are investigator read; analysis may change as data matures.
15
PHASE 2A INTERIM DATA – MARCH 2025
Combination with gem + Abraxane leads to faster and more sustained response. If approved as a combination
therapy by FDA, it has the potential for Narmafotinib combination to become far more appealing
Comparison with historical gemcitabine+
Abraxane data suggests combination with
Narmafotinib leads to:
Response over time (all lesions)*
• Faster response
• Longer/sustained response
Historical gemcitabine+Abraxane data §
§ Pancreas 2017: 46; 203
*Based on data available in trial database on Mar 7, 2025; responses are investigator read; analysis may change as data matures
16
PHASE 2A UPDATE – JUNE/JULY 2025
17 Partial Responses, including 2 Complete Responses, from 55 patients* with 20 patients remaining on
trial and awaiting results
Response rate sufficient to demonstrate superiority of Narmafotinib combination over gem/Nab-P alone
• 17/55 patients (31%) better than 23% ORR in MPACT* study
• 20 patients still on study: anticipate additional PR
2 Complete Responses recorded
• 1 pathological CR - surgery followed by pathology of removed tissue
• 1 confirmed CR - by CT scan, over 2 months
• Both patients were existing PR patients; on trial >12 months
⚬ Confirmed CR patient remains on trial
Extremely rare in metastatic advanced cancer
• 1 CR from 431 patients in benchmark MPACT study†
• Pathological CRs occur in ~5% of locally advanced disease
⚬ Associated with improved overall survival
17 confirmed PRs recorded (as of July 2025)
• >30% reduction in tumor size sustained >2 months
• No new lesions
PFS to be reported end July
• Sufficient patients on study for >6 months
* The Phase 2a trial successfully recruited 55 patients in total, consisting of the primary 50-patient group
and 5 additional participants to compensate for non-evaluable cases
† New England Journal of Medicine 2013; 369: 1691 – 703
www.accenttrial.com
17
PATIENT CASE STUDY
Rare pathological Complete Response in ACCENT study
Patient diagnosed with stage 4 pancreatic cancer and
joined ACCENT study
Most patients who are diagnosed at this stage will not
survive 12 months
After 12 months, patient’s pancreatic tumour and liver
metastases reduced in size
• Surgically resectable (able to be removed by
surgery)
• No live cancer cells detected upon analysis
Patient has recovered from surgery
“I don’t know really what to say except that I’m just
so happy… I was given the opportunity to have a go
of it, and it’s actually worked”
* Source: The Australian July 5 2025
18
TOP-LINE DATA PREVIEW
Data comparison with previous gem/nab-P data from prior MPACT and NAPOLI-3 trials
Full data expected to be available end of
July / early August 2025
Aiming to see:
• Progression free survival (PFS) and Days
on trial (DOT) superior to existing
chemotherapy
• Continued positive safety and tolerability
• Similar or improved ORR and DCR
MPACT (n=431)
NAPOLI (n=383)
Overall survival (mo)
8.5
9.2
Progression free survival (mo)
5.5
5.6
DOT (days)
117
123
CR
0.20%
0.30%
PR
23%
36%
SD
27%
26%
PD
20%
14.5%
Not evaluable
30%
23%
23%
36%
48%
62%
Confirmed Objective (Overall)
response rate (ORR) (% CR, PR)
Confirmed Disease control rate
(DCR) (% CR, PR, or SD)
19
Potential regulatory pathway
Potential for Narmafotinib to receive accelerated approval following a pivotal Phase 2b/3 clinical trial
• Amplia’s Narmafotinib has potential for an accelerated path to market in in advanced pancreatic cancer following a
Phase 2b/3 pivotal trial – as per Verastem, Inc
• Verastem’s FAK inhibitor received FDA approval from its 184 patient Phase 2 RAMP 201 trial in recurrent Low-Grade
Serous Ovarian Cancer (LGSOC)
• Amplia intends to commence a Phase 2b/3 clinical trial in 2H 2026
Breakthrough and fast track
designation already received
(20/9/24)
2024
Request FDA meeting following
release of ACCENT Phase 2a topline data. Likely to take place late
2025 / early 2026
Feedback from FDA to
be received on request
for pivotal Phase 2b/3
trial design
2025
Potential to
commence pivotal
trial in 2H26
2026
ACCENT Phase 1b/2a
FDA
ACCENT
Type C
top-line
meeting*
data
* Type C, Type D or end-of-phase meeting
Pivotal
Phase 2b/3
20
ADDITIONAL
OPPORTUNITIES
AMPLICITY TRIAL
Combining Narmafotinib with most common chemotherapy for advanced pancreatic cancer in US
Phase 2 clinical study of Narmafotinib in
combination with FOLFIRINOX
• Strong pre-clinical evidence
• FDA has cleared IND
• Use modified FOLFIRINOX (better tolerability)
• Protocol revision cleared by FDA (Type D meeting)
• Project Optimus* compliant dose-escalation and 2 dose expansion
• Part A: is expected to include 20-27 patients and is already
fully funded
• Part B will include 40 patients (two cohorts of 20 patients)
• Part A commencing in Q3 2025
Protocol design
Part A:
- BOIN design;
estimate 20-27 patients
- Safety, PK, PD
600 mg
400 mg
200 mg
Part B:
- 20 patients per cohort
- Safety and efficacy
MTD§ from A
Dose below MTD
* www.fda.gov/about-fda/oncology-center-excellence/project-optimus
§ Maximum tolerated dose
22
kRAS Inhibitor Combinations
Narmafotinib to be explored with selected kRAS inhibitor in pancreatic cancer trial
kRAS inhibitors represent exciting new drug
class for pancreatic, lung and colorectal
cancer
•
Highly competitive - multiple drugs in clinical
development by Pharma/Biotech worldwide
•
Development of resistance and product differentiation
are major concerns
•
FAK inhibition enhances response to kRAS inhibitors in
animal models (internal and published data)
•
Verastem’s ‘AVMAPKI FAKZYNJA CO-PACK’ is validation
that FAK inhibition enhances Ras pathway inhibition in
kRAS mutant cancer
•
IIT* concepts in discussion with pancreatic specialists
•
Clinical trial expected to commence in 1H 2026
* Investigator Initiated Trial
FAK inhibition enhances
efficacy of kRAS inhibitor
Mouse model of pancreatic cancer
Narmafotinib and Adagrasib (kRASi) alone and in
combination
23
OVARIAN CANCER
IIT’s for clinical study of Narmafotinib plus standard-of-care therapy in ovarian cancer
submitted for funding and in discussion
Opportunities in:
• First-line therapy as a chemo-sensitiser in platinum-resistant cancer (neoadjuvant)
• In recurrence and acquired resistance
• In sub-type, ovarian clear cell carcinoma (~25% in Japan)
Investigator initiated trial (IIT) expected to commence in 1H 2026
1
All new patients
receiving
chemotherapy
Neoadjuvant
Last
platinum
treatment
Patients with
recurrence or nonresponsive to
chemotherapy
2
Refractory
Sensitive
24
Outlook &
catalysts
PARTNERING OPPORTUNITIES
Significant new partnering interest following highly prospective ACCENT clinical trial data
• Amplia’s partnering interest from global pharmaceutical companies has materially
increased following recent interim data and patient updates in the ACCENT clinical trial
• Heightened focus in Narmafotinib as the best-in-class Focal Adhesion Kinase (FAK) inhibitor
in development
• Strengthened balance sheet following the capital raising will ensure the company
retains flexibility to progress its clinical program and is in a position of strength when
negotiating with potential license partners
• Amplia’s management are in ongoing discussions with potential partners around
regional licensing agreements, including:
• Pharmaceutical companies with focus on orphan indications / GI cancer focus
• Strategic partners with focus on drug development in precision medicine
• Pharmaceutical companies with chemotherapy treatments coming off patent or seeking
differentiation
• Preference is to work with license partners who have specialist knowledge and
capability in Amplia’s key modalities
26
UPCOMING CATALYSTS
Significant pipeline of expected news flow with key catalysts imminent
•
Q3 2025
✓ ACCENT top-line data including progression free survival (Late July/early August 2025)
✓ ACCENT request FDA type C meeting to discuss Phase 2b/3 pivotal trial design
✓ Amplicity first patient dosed (part A dose escalation begins)
✓ ACCENT further patient updates
•
Q4 2025
✓ ACCENT further patient updates
✓ Amplicity first safety and efficacy data
✓ FDA meeting and minutes on ACCENT trial pathway
Q2
Q3
✓ Possible EU regulatory filings (Prime, Orphan)
•
Q4
1H 2026
✓ ACCENT further mature data
✓ Amplicity part A dose escalation completed and further data
✓ kRAS clinical trial commences
✓ Ovarian cancer investigator initiated trial (IIT) commences
•
2H 2026
✓ Amplicity Part B commences and patient response updates
✓ ACCENT Phase 2b/3 trial commences
•
Potential updates on partnering / licensing agreements
27
Capital raising
overview
28
CAPITAL RAISING OVERVIEW
Amplia is undertaking a capital raising of $27.5m via a placement and share purchase plan
Offer Structure
• Amplia is undertaking a capital raising (the “Offer”) of approximately $27.5 million comprising:
- an institutional placement (“Tranche 1 Placement”) to raise approximately $22.3 million utilising Amplia’s existing placement capacity under Listing Rules 7.1 and 7.1A;
- an institutional placement (“Tranche 2 Placement”) to raise approximately $2.5 million subject to shareholder approval;
- a placement to Amplia’s Directors to raise a total of $0.2 million, subject to shareholder approval (“Director Placement”, together the “Placement”); and
- a Share Purchase Plan (“SPP”) to be made available to certain eligible shareholders to raise approximately $2.5 million, subject to shareholder approval.
• Up to approximately 119.6 million new fully paid ordinary shares in Amplia (“New Shares”) to be issued under the Offer, representing approximately 30.8% of Amplia’s current shares on issue.
Placement Price
• New Shares issued under the Placement will be issued at a price of A$0.23 per New Share (“Placement Price”).
• The Placement price represents a:
- 19.3% discount to the last close price on Friday, 18 July 2025 of $0.285
- 22.8% discount to 5 trading day VWAP on Friday, 18 July 2025 of $0.298; and
- 0.6% premium to 30 trading day VWAP on Friday, 18 July 2025 of $0.229;
Share Purchase Plan
• A Share Purchase Plan (SPP) will also be offered to eligible shareholders, with Applications up to a maximum of $100,000.
• Amplia is targeting to raise approximately $2.5 million under the SPP.
• New Shares will be issued under the SPP at the lower of:
• The Placement price of $0.23 per New Share; or
• 5.0% discount to the VWAP of the Company’s shares traded on the ASX during the 5 trading days up to the closing date of the SPP, rounded to the nearest half cent.
• A transaction-specific prospectus (SPP Booklet) containing further details about the SPP, including the scale-back policy, will be made available to eligible shareholders.
• Record date for determining eligibility for the SPP is 7:00pm (AEST) on Tuesday, 22 July 2025.
• The Company has received binding commitments (“SPP Shortfall Commitment”) from institutional investors to subscribe for up to $2.5 million of new, fully paid ordinary shares if the SPP is not
fully subscribed by eligible shareholders, subject to shareholder approval.
• The Company reserves the right to accept over subscriptions under the SPP, subject to ASX Listing Rules and Corporations Act 2001 (Cth).
Director Placement
• Amplia’s directors have committed to subscribe for $235,000 worth of New Shares pursuant to the Director Placement, as follows (subject to shareholder approval):
- Dr Robert Peach $150,000 worth of New Shares;
- Dr Chris Burns - $20,000 worth of New Shares;
- Dr Warwick Tong - $35,000 worth of New Shares; and
- Jane Bell -$30,000 worth of New Shares
Prospectus
• The SPP will be undertaken pursuant to a transaction-specific prospectus.
Record Date
• The Record Date for the SPP is 7pm (AEST), Tuesday 22 July 2025.
Ranking
• All New Shares issued under the Offer will rank equally with existing Amplia shares from the date of issue.
Sole Lead Manager
• Bell Potter Securities Limited (“Bell Potter”) is acting as Sole Lead Manager and Bookrunner to the Offer.
29
SOURCES AND USE OF FUNDS
Following the capital
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