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Annual Report 2019
About OncoSil™
OncoSil Medical is an Australian-based and ASX listed medical
device company focused on localised treatments for patients with pancreatic
and liver cancer. The Group’s lead product, OncoSil™, is a first in class medical
device comprising Microparticles containing Phosphorus-32 (P-32), a pure
beta-emitter radioisotope, implanted directly into a patient’s pancreatic tumour
via an endoscopic ultrasound. This treatment, known as brachytherapy,
is intended to deliver more concentrated and localised radiation.
Contents
1 Chairman’s Letter
2 CEO’s Report
4 An incredibly important focus
5
OncoSil™ device and
technology platform
Presentations from Leading
International Meetings
6
8 Key Milestones
8 Compassionate Access Program
10 Directors’ report
23 Auditor’s independence declaration
24 Statement of profit or loss
and other comprehensive income
25 Statement of financial position
26 Statement of changes in equity
27 Statement of cash flows
28 Notes to the financial statements
50 Directors’ declaration
51 Independent auditor’s report
56 Shareholder information
58 Corporate directory
Chairman’s Letter
Dear Shareholder,
On behalf of the OncoSil Medical
Board, I am pleased to present
our 2018-2019 Annual Report.
In July 2018, the final patient was
recruited in the PanCO trial, which
is the main clinical trial OncoSil™
has been running (in Australia,
UK and Belgium) to collect safety
and effectiveness data on the
OncoSil device for treating non
resectable pancreatic cancer.
Thus, the focus of the company
for Fiscal 2019 has been collecting
and analysing these PanCO
clinical data, with the aim of
obtaining European regulatory
approval (CE Mark).
Despite the initial unfavourable
assessment from the British
Standards Institute (BSI) and
its Clinical Oversight Committee
(COC) regarding the CE Marking
application submitted last year
for the OncoSil™ device, we have
since submitted updated clinical
data and analysis from the positive
results seen in the PanCO study.
In December 2018 we strengthened
the Board with the addition of
Michael Bassett. Mr Bassett has
an extensive background in capital
markets and small-cap ASX stocks
with a particular emphasis on life
science companies.
On behalf of the Board, I would
like to thank our Chief Executive
Officer Daniel Kenny, and the
entire OncoSil Medical team
for their contributions throughout
the year. I would also like to thank
the Board for their tireless efforts
in 2019.
We look forward to building
on our recent momentum for
the OncoSil™ device as we
continue to make a difference
through our important mission
of transforming the prognosis
of pancreatic cancer.
Sincerely,
Dr Chris Roberts, AO
Chairman, OncoSil Medical
Our comprehensive response
to BSI was developed and
prepared with the support of
leading, pre-eminent medical
experts, addressing issues and
concerns from BSI and the COC.
Obtaining CE Marking remains
the Company’s focus in the short
term and we look forward to
updating investors on
developments on this front.
Clinical data from the PanCO
study were presented at the
American Society of Clinical
Oncology (ASCO) Annual Meeting
2019 in Chicago. The study data
showed promising overall survival
estimates for these patients with
non resectable locally advanced
pancreatic cancer (LAPC), with
mean overall survival of 16 months.
This is a significant result given the
accepted population median
overall survival estimates of
patients is only 9 – 11 months.
Of the 42 patients implanted
with OncoSil™ in the PanCO trial,
10 patients have undergone
surgical resection of the tumour
with curative intent. This is
remarkable given the patients
were not candidates for surgery
prior to implantation, and is
indicative of the effect radiation
has had on shrinking tumours.
1
OncoSil Medical
Annual Report 2019
CEO’s Report
In 2019, OncoSil’s primary
focus was to continue its efforts
to commercialise our lead
device, OncoSil™.
The Company achieved a number
of key clinical and operational
milestones as it continues to bring
the OncoSil™ device to market.
In October 2018, the Company
submitted its Clinical Evaluation
Report to the British Standards
Institute (BSI) in support of CE
Marking based on the results from
the PanCO study. In March 2019,
BSI and its Clinical Oversight
Committee (COC) notified
OncoSil of its initial unfavourable
assessment of the Company’s
CE Marking application.
On 30 July, the Company submitted
a detailed and comprehensive
response to questions raised
by BSI and its Clinical Oversight
Committee. This response was
developed and prepared with the
support of leading, pre-eminent
experts in medical oncology,
radiation oncology and Hepato-
Pancreato-Biliary surgery.
We believe our submission is
robust and addresses all issues
and concerns from the notified
body and look forward to updating
shareholders on progress to the
final CE Marking determination.
Clinical advancements
In July 2018, OncoSil successfully
completed patient recruitment
for its PanCO study across all
participating sites in Australia, the
UK and Belgium – with 50 patients
enrolled in total. 42 of these patients
were subsequently implanted with
the OncoSil™ device.
With a median follow-up of
16.1 months (as of May 2019), the
PanCO study results now provide
a long-term assessment of the
safety and tolerability of the
OncoSil™ device, as well as
clearly demonstrating clinically
relevant benefits for patients with
unresectable locally advanced
pancreatic cancer including:
“ We believe our submission is robust and
addresses all issues and concerns from the
notified body and look forward to updating
shareholders on progress to the final CE
Marking determination.”
•
•
•
Local Disease Control
Rate (LDCR) at 16 weeks
of 90.5% (N=42, p<0.0001),
a positive and important
independent prognostic
indicator for Overall
Survival
Prolonged median
Overall Survival of
16.0 months in the per
protocol population
(implanted)
Encouraging rate
of surgical resection
with curative intent –
in nearly one in four
PanCO patients (23.8%)
that received OncoSil™.
The rate of R0 margin
status was 80%. Surgical
resection of pancreatic
cancer, particularly
in patients previously
determined to be
unresectable, profoundly
improves patients
prognosis from a five-
year survival rate of 5%
to greater than 20%.
2
With our recent response to the
BSI and COC, coupled with the
positive Overall Survival data and
other encouraging clinical results
from the PanCO study, we remain
positive of the significant milestones
ahead for OncoSil.
We look forward to building
on our accomplishments to date
throughout 2020, as we work
towards commercialising our
device and improving patient
outcomes in the area of
pancreatic cancer.
Sincerely,
Daniel Kenny
Chief Executive Officer,
OncoSil Medical
The Overall Survival result
is comparable to, and in many
cases surpasses that of the best
available published literature
in patients with locally advanced
pancreatic cancer (LAPC). Using
these data, we have submitted
our formal response to the initial
unfavourable assessment by the
British Standards Institute (BSI)
and its Clinical Oversight
Committee (COC) for CE Marking
for the OncoSil™ device.
Additionally, in 2019, US FDA
confirmed the PanCO (ex-US)
clinical study safety data met
Investigational Device Exemption
(IDE) requirements and that
OncoSil could proceed to run its
full US pivotal study without further
US patient data. The Company’s
US OncoPaC-1 clinical study
has since completed patient
recruitment, with 9 patients
enrolled and implanted with
the OncoSil™ device.
As part of our commercialisation
strategy, during the year, we also
appointed IQVIA as the EU market
access and reimbursement
advisor. We continue to work
with the group in the lead up
to the COC’s review and final
CE Marking determination.
Financial position
The net cash outflow from
operations for the year was
$7.5 million, resulting in a cash
balance of $7.7 million as at
30 June.
As a precaution, since the third
quarter of the financial year,
OncoSil has been operating
under a revised business plan
as it awaits CE Marking decision.
We have targeted a reduction
in annualised cash cost base
through reductions in operating
expenditure, R&D expenditure
and have also paused new
clinical trial and study activities
until greater certainty around
CE Marking is achieved.
OncoSil intends to continue
with such measures in the future
with the aim of maximizing long-
term shareholder value with
respect to the road ahead.
Finally, we understand that the
road to commercialisation is not
always a straightforward path,
and so we would like to thank our
shareholders for their continued
support and investment in OncoSil
Medical during the year.
3
OncoSil Medical
Annual Report 2019
An incredibly important focus
About Pancreatic Cancer
Pancreatic cancer occurs when
abnormal cells in the pancreas
grows out of control, with symptoms
varying according to the tumour
type and location. Unfortunately,
symptoms are often difficult to
detect in the early stages of the
disease, meaning tumours can
grow over time without detection.
There are an average of 79,000
new cases of pancreatic cancer
in the EU each year, 42,000 in
the US, and 3,350 in Australia.
Treatment options remain
limited for patients with the
disease, making OncoSil’s goal
of delivering targeted and effective
therapy incredibly important.
What’s the need?
There is significant unmet
patient need in the treatment
of pancreatic cancer. Consider
the following pancreatic
cancer facts:
•
•
The fourth highest cause
of cancer death1
Projected to be the second
leading cause of cancer
related deaths by 2030
in Western countries2
%
SURVIVAL
RATE
•
•
•
•
277,000 new cases
diagnosed annually
worldwide3
5-year overall survival
rate for pancreatic cancer
has only increased by 1%
(from 5% to 6%) in the past
three decades4
Highest mortality rate
of all major cancers5
1 in 64 – The average lifetime
risk of a person diagnosed
with pancreatic cancer6
Age-Standerdised Ten-Year Net Survival, Selected Cancers, Adults (Aged 15-99) England and Wales, 2010-2011
Age-Standerdised Ten-Year Net Survival, Selected Cancers, Adults (Aged 15-99) England and Wales, 2010-2011
All cancers
All cancers
Incidence
Testis
Testis
Malignant Melanoma
Malignant Melanoma
Prostate
Prostate
Hodgkin lymphoma
Hodgkin lymphoma
Breast
Breast
Uterus
Uterus
NHL
NHL
Cervix
Cervix
Larynx
Larynx
Bowel
Bowel
Bladder
Bladder
Kidney
Kidney
Leukaemia
Leukaemia
Ovary
Ovary
Myeloma
Myeloma
Stomach
Stomach
Brain
Brain
Oesophagus
Oesophagus
Lung
Lung
Pancreas
Pancreas
0%
0%
survival
survival
100%
100%
50%
50%
98%
98%
89%
89%
84%
84%
80%
80%
78%
78%
77%
77%
63%
63%
63%
63%
62%
62%
57%
57%
50%
50%
50%
50%
46%
46%
35%
35%
33%
33%
15%
15%
13%
13%
12%
12%
5%
5%
1%
1%
1 Spadi, R. et al. (2016) Current therapeutic strategies for advanced pancreatic cancer: A review for clinicians. World Journal of Clinical Oncology Vol 7 Issue 1 pp 27-43.
2 Ibid.
3 Chiorean, E. G and Coveler, A.L. (2015) Pancreatic cancer: optimizing treatment options, new, and emerging targeted therapies. Drug Design, Development and
Therapy Vol 9 pp 3529-3545.
4 Ibid.
5 Hirshberg Foundation for Pancreatic Cancer Research, Pancreatic Cancer Facts http://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/
6 American Cancer Society, Lifetime risk of pancreatic cancer, https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
4
OncoSil™ device and
technology platform
OncoSil™ is a single-use
brachytherapy device that
implants a pre-determined
dose of beta radiation directly
into cancerous tissue. The beta
particles emitted by OncoSil™
travel a short distance in the
tissue causing damage to cancer
cell DNA, which renders them
incapable of further cell division
and proliferation.
The device is used for the
treatment of pancreatic cancer
and intended for patients who
are unable to undergo surgery to
remove their tumours due to either
tumour size, or the location in the
pancreas. Approximately 20 per
cent of patients at diagnosis are
able to have an operation to remove
their pancreatic tumour, which is
currently the most effective way
to treat pancreatic cancer.
OncoSil™ is made with
Microparticles that are a
combination of silicon and
radioactive phosphorus, which
are injected as a suspension
directly into a pancreatic tumour.
Implantation of the device is
straightforward and involves the
use of an endoscope. Using real
time imaging, a needle is guided
through the endoscope to the
tumour and OncoSil™ is injected
directly into the cancer while the
patient is sedated. The procedure
typically takes less than 30 minutes
and most patients are able to leave
the hospital the same day.
OncoSil™ is used in combination
with modern chemotherapy and
aims to provide local tumour
control and may have an impact
on reducing cancer symptoms.
It may also be able to convert
certain patients by shrinking
tumours into an operative
state to provide a potentially
curative option.
Recent data from the global
PanCO trial has been positive,
with median Overall Survival
presented for the first time at the
United States premier oncology
meeting, the American Society of
Clinical Oncology (ASCO) in 2019.
Median overall survival was 16
months after using the OncoSil™
device in combination with modern
chemotherapy. This is comparable
to, and in many cases, surpasses
that of the best available published
literature in the patient population.
5
OncoSil Medical
Annual Report 2019
Presentations from Leading
International Meetings
Throughout the year, OncoSil
trial investigators have shared
data from the PanCO trial with
the global medical community
across Australia, Europe and
the US at major oncology and
nuclear medicine conferences.
A number of trial sites, including
the Hammersmith Hospital in
the UK and the Royal Adelaide
Hospital, also shared their
experience of the PanCO trial
throughout 2019.
These conferences include:
•
Australia & New Zealand
Gastric & Oesophageal
Surgery Association
(ANZGOSA) and Australia
and New Zealand Hepatic,
Pancreatic and Biliary
Association (ANZHPBA)
Combined Meeting 2018 in
Wellington, New Zealand
•
31st European Association
of Nuclear Medicine 2018
in Düsseldorf, Germany
•
•
•
United European
Gastroenterology Week
2018 in Vienna, Austria
9th Annual Scientific
Meeting of the Australian
and New Zealand Society of
Nuclear Medicine (ANZSNM)
2019 in Adelaide, South
Australia
American Society of Clinical
Oncology (ASCO) Annual
Meeting 2019 in Chicago,
United States
Imaging and Radiation Safety Considerations for 32P Radionuclide
Therapy of Inoperable Pancreatic Primary Cancer
Enid M Eslick1,2, Michelle Bradney2, Dale L Bailey1,3
1Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, AUS
2OncoSil Medical Ltd, Sydney, AUS
3PharmaScint, Sydney, AUS
Royal North Shore Hospital
Introduction
Results
OncoSil Medical Ltd (Sydney, Australia) have a novel therapeutic approach to
treating inoperable primary pancreatic cancers by injecting the tumour directly
with particles of silicon impregnated with phosphorus-32 (32P), “OncoSil”.
The OncoSil particles in solution are administered via an endoscopic
procedure with ultrasound guidance. Typical amounts required for treatment
are of the order of tens of MBqs with 40 MBq being thought to be a typical
dose (1).
Figure 1: OncoSil treatment delivered by endoscopic ultrasound guidance.
Endoscopist and Nuclear Medicine Physician are in close proximity to OncoSil treatment.
OncoSil treatment syringe is
encased by syringe shield
The considerable high energy bremsstrahlung photons produced presents a
dichotomy in terms of radiation protection and imaging. The question of the
exposure levels of treating physicians in close proximity to the OncoSil
radiation source has been raised.
After an implantation procedure, it is highly desirable
to be able to measure the distribution of implanted
radioactive microspheres (1). Imaging can be used to
confirm appropriate implantation of the therapy as well
as being potentially quantifiable to be used in
dosimetric analysis of surrounding tissues assuming no
redistribution of the microspheres (2). However, the
lack of radiation emitted from the nucleus in the form
of gamma rays or positrons makes imaging of 32P
challenging.
Figure 2: Schematic of
distribution of OncoSil in
pancreatic tumour
Aims: The purpose of this work was to determine (a) the potential radiation
exposure to staff during the OncoSil treatments (b) the image quality of 32P
bremsstrahlung imaging.
Methods
survey meter was used for
A water-filled IEC body phantom (Data Spectrum Corp, Hillsborough, NC)
containing an internal spherical component of 35 mls located off the central
axis was used to simulate the body situation. A representative upper therapeutic
limit of approximately 60 MBq of OncoSil solution filled the spherical
compartment. A Radeye B20-ER (Thermo Fisher Scientific Messtechnik
GmbH)
assessments.
Measurements were done at several
the phantom where
caregivers would typically be positioned during a treatment. The attenuation
effect of a lead apron was assessed. A Siemens Intevo.6 SPECT/CT gamma
camera system (Siemens Healthineers, Hoffman Estates, USA) was used to
image the phantom with medium energy collimators. Energy spectra were
acquired after
Images were
reconstructed using ordered subset ML-EM (OSEM) reconstruction algorithm
(7).
removing the collimator
radiation exposure
from the detector.
locations about
Figure 3: OncoSil solution added to the largest
sphere in the phantom.
Figure 4: OncoSil solution added to the largest
sphere in the phantom.
www.postersession.com
The exposure rate from an upper therapeutic limit of 60 MBq in-vivo is approx.
10 µSv.hr-1 and that from a typical treatment of 40 MBq in-vivo is 6.4 µSv.hr-1. A
caregiver would need to stand at the side of a patient closest to the implanted
OncoSil microspheres in the pancreas, in close proximity, for 100 hours to
approach 1 mSv.
(a)
(b)
(c)
Measurement
Location
Bkg
Without lead
apron
0.3
A
B
C
D
E
F
G
13.5
1.4
1.3
0.6
0.4
0.3
1.3
With lead apron*
0.3
3.2
0.3
-
-
-
-
0.3
*Measurements not taken as at the level of Background
Figure 5: (a) Cross section of IEC body phantom showing the
approximate location of
the sphere containing the OncoSil
solution (radiation symbol). Distances are in mm; (b) SPECT/CT
fused image of body phantom with 32P in the largest sphere; (c)
Exposure measurement (µSv.hr-1) simulating a patient treatment
scenario for 85MBq of 32P in the radiation source.
The PHA spectrum acquired on the gamma camera showed that the majority of
photons were below 150 keV, however there was an appreciable tail extending
beyond 200 keV. The imaging window was thus set to 50-100 keV. Successful
imaging has been obtained in the currently active clinical trial.
(a)
(b)
Figure 6: (a) Photon spectrum from gamma camera (uncollimated) for 32P in the filled IEC body phantom.
The window is set from ~50 – 100 keV (75% keV centerline with a 60% window); (b) a SPECT/CT fused
image from a patient treated with OncoSil on the currently active trial.
Conclusions
The exposure of staff in close proximity to the OncoSil radiation source during
treatment is very small based on these phantom measurements, however, while the
exposure rates that we have measured are indicative, actual values may be higher or
lower depending on the operator and dose used. Electronic personal dosimeters
which provide an instantaneous read-out would be a suitable option. Similarly,
exposure of nuclear medicine staff involved in the dose preparation (which has not
been measured here) should also be considered. Acceptable image quality of [32P]-
OncoSil has been demonstrated on an unmodified, conventional gamma camera
using medium energy collimation. The use of a more sophisticated reconstruction
algorithm could improve both image quality and qualitative accuracy further,
although,
the ultimate quantification potentially achievable when imaging
bremsstrahlung radiation remains questionable.
Bibliography
1. Private correspondence – OncoSil Medical Ltd
2. Lhommel R, van Elmbt L, Goffette P, et al. Feasibility of 90Y TOF PET-based dosimetry in liver metastasis therapy using
SIR-Spheres. Eur J Nucl Med Mol Imaging. 2010;37:1654-1662.
3. Willowson K, Forwood NJ, Jakoby B, Smith AR, Bailey DL. Quantitative 90Y image reconstruction in PET. Med Phys.
2012;39:7153-7159.
4. Willowson KP, Tapner M, Quest_Investigator_Team, Bailey DL. A multicentre comparison of quantitative 90Y PET/CT for
dosimetric purposes after radioembolization with resin microspheres: The QUEST Phantom Study. Eur J Nucl Med Mol
Imaging. 2015;42:1202-1222.
5. Willowson KP, Bernard EJ, Maher R, Clarke SJ, Bailey DL. Changing Therapeutic Paradigms: Predicting mCRC Lesion
Response to Selective Internal Radionuclide Therapy (SIRT) based on Critical Absorbed Dose Thresholds: A Case Study.
Asia Oceania J Nucl Med Biol. 2017;5:66-69.
6. Hudson HM, Larkin RS. Accelerated image reconstruction using ordered subsets of projection data. IEEE Trans Med Imag.
1994;MI-13:601-609.
Clinical Posters
ASCO poster V2_Layout 1 28/05/2019 08:56 Page 1
PanCO: An Open-Label, Single-Arm Pilot Study of Phosphorus-32 (P-32; Oncosil™)
Microparticles in Patients with Unresectable Locally Advanced Pancreatic Adenocarcinoma (LAPC)
in Combination with FOLFIRINOX or Gemcitabine + Nab-Paclitaxel (GNP) Chemotherapies
1P Ross, 2D Croagh, 3M Aghmesheh, 4A Nagrial, 5N Nguyen, 6M Nikfarjam, 7H Wasan, 8T Ajithkumar, 9C Iwuji, 10A Hendlisz, 11T Maher, 11A Kraszewski, 2M Harris
1Guy’s and St Thomas’ NHS Foundation Trust, London, UK, 2Monash Health, Melbourne, Victoria, Australia, 3Southern Medical Day Care Centre, Wollongong, NSW, Australia, 4Westmead Hospital, Sydney, NSW, Australia, 5Royal Adelaide Hospital, South Australia, Australia, 6Austin Health, Melbourne,
Victoria, Australia, 7Imperial College Healthcare NHS Trust, UK, 8Cambridge University Hospitals NHS Foundation Trust, UK, 9University Hospitals of Leicester NHS Trust, UK, 10Institut Jules Bordet Université Libre de Bruxelles, Brussels, Belgium, 11Oncosil Medical Ltd, Sydney, NSW, Australia
Abstract 4125
Statistical Assumptions for Efficacy Week 16
LDCR assessment
• Null hypothesis H0: p = 0.55
• Alternative hypothesis H1: p = 0.75
• Level of significance = 0.05 with a 2-sided test to achieve a power of 80%
Most commonly reported AEs
All Grade AEs in ≥ 20 % of Study Participants - (ITT population)
Total AEs
(n=50: GNP=40; FFX=10)
Adverse Events (AEs), n (%)
All-Grade
Grade ≥ 3
Introduction
• Locally advanced pancreatic cancer (LAPC) accounts for 30% to 40% of all
pancreatic cancer presentations.1
• Poor prognosis with a median survival of less than 12 months.2
• Current standard treatment is chemotherapy or chemo-radiotherapy.
• Chemo-radiotherapy has not demonstrated unequivocal overall survival
advantage.
• OncosilTM is a brachytherapy device consisting of phosphorus-32 (P-32)
micro-particles.
• P-32 has been investigated in combination with gemcitabine monotherapy in
23 patients with LAPC and metastatic disease in two studies.
• Demonstrated that P-32 has an acceptable tolerability and safety profile.
• Efficacy data showed potential with a target tumour response rate of 23%
and a target disease control rate of 82%.
• The presented data are results from an ongoing international, multi-
institutional, single-arm pilot study which is being conducted at 12 sites in
Australia, the UK and Belgium.
Objective
The study objective is to further investigate the safety, efficacy, feasibility and
performance of the OncoSil™ device when implanted intratumourally using
EUS in a patient population undergoing standard chemotherapy for
unresectable LAPC.
Study Design
Study design
Screening
(1-14 days)
Enrol to:
OncosilTM +
FOLFIRINOX
or
gemcitabine
+
nab-paclitaxel
Chemo to
begin within
14 days
post
enrollment
OncosilTM Implantation
FOLFIRINOX or gemcitabine
+
nab-paclitaxel
Continuation of chemotherpay
PD
Overall
survival
Wk 1
Wk 2
Wk 3
Wk 4
Wk 5 onwards
Methods
• P-32 was implanted directly into the pancreatic tumour via EUS guidance,
using a fine needle aspiration (FNA) needle.
• The dose of P-32 was calculated from the tumour volume to administer a
predicted absorbed dose of 100 Gy.
• Diffusion pattern of the P-32 following implantation was assessed by EUS and
Bremsstrahlung SPECT/CT within 4 hours and at 7 days post-implantation.
• Safety data was collected weekly with toxicity graded using the Common
Terminology Criteria for Adverse Events (CTCAE v4.0).
• Response assessment was by CT scans every 8 weeks and reported weekly
with toxicity graded using RECIST 1.1.
• FDG-PET scans were performed at Baseline and at Week 12.
Key eligibility criteria
• Histologically or cytologically proven adenocarcinoma of the pancreas
• Unresectable locally advanced pancreatic carcinoma
• Target tumour diameter 2-6cm
• ECOG Performance Status 0 to 1
• No distant metastases
• No prior radiotherapy or chemotherapy for pancreatic cancer
Primary endpoint:
• Safety and Tolerability
Secondary endpoints: Efficacy
• Local Disease Control Rate (LDCR) at 16 weeks
• Local Progression Free Survival (LPFS), within the pancreas
• Progression Free Survival (PFS), all sites
• Overall Survival (OS)
ASCO Annual Meeting, Chicago, USA, May 31–June 4, 2019
Results
• 50 patients enrolled - Intent-to-Treat (ITT) population.
• 42 patients implanted with the OncoSilTM device - Per Protocol (PP) population.
• 8 participants were enrolled but withdrawn pre-implant;
– adverse health condition prior to or at the time of scheduled implant (4)
– finding of adverse anatomical conditions making it impractical or inadvisable
to implant via EUS (2)
– finding of metastatic disease following enrolment (2).
Participant Demographics & Baseline Characteristics
(ITT population)
Demographic/Characteristic
Age, years
Median (Range)
Sex
Male, n (%)
Female, n (%)
Race, n (%)
White/Caucasian
Black/African American
Asian
Other
ECOG PS, n (%)
0
1
Cancer Antigen 19-9 (CA 19-9), (U/mL)
Median (Range)
Tumour location within the pancreas, n (%)
Head
Body
Longest diameter of target lesion, cm
Median (Range)
Tumour volume, cc
Median (Range)
Study Days to Implantation
Median (Range)
Chemotherapy, n (%)
Gemcitabine + nab-paclitaxel
FOLFIRINOX
N=50
65 (42-84)
28 (56%)
22 (44%)
40 (80%)
2 (4%)
7 (14%)
1 (2%)
26 (58%)
24 (42%)
N=49/50
163 (1-6576)
41 (82%)
9 (18%)
4.5 (2.6-7.1)
24.35 (7.9-68.7)
N=42
31 (21-77)
40 (80%)
10 (20%)
Safety and Tolerability
• One hundred Serious Adverse Events (SAEs) were reported.
• Two AEs were reported as Serious Adverse Device Events (SADE):
– abdominal pain
– venous intravasation.
Most commonly reported AEs considered as possibly or probably
related to the study device and/or to the implant procedure –
(Per Protocol/Implanted Population, N=42)
Gemcitabine + nab-Paclitaxel (GNP)
or FOLFIRINOX (FFX) (N=42)
Total AEs
Adverse Events (AEs), n (%)
Patients with ≥ 1 Adverse Event
Abdominal pain
Nausea
Fatigue
Weight decreased
All-Grade
19 (45.2%)
3 (7.1%)
5 (11.9%)
7 (16.7%)
3 (7.1%)
Grade ≥ 3
2 (4.8%)
1 (2.4%)
0
1 (2.4%)
0
38 (90.5%)
Overall Survival (Per Protocol population)
CA 19-9 tumour marker
% change in CA 19-9 Tumour Marker from Baseline to Week 16
(Per Protocol population)
OncoSilTM Implantation and Intra-tumoural Localisation
• Device considered straightforward to implant by endoscopists.
• No significant or serious procedural complications.
• EUS views shown below demonstrate the utility of EUS in accessing tumours.
59
50
41
33
4
0
0
134
90
)
%
(
e
n
i
l
e
s
a
b
m
o
r
f
e
g
n
a
h
C
140
120
100
80
60
40
20
0
–20
–40
–60
–80
–100
EUS imaging
Before FNA needle insertion
Before FNA needle insertion with Doppler
FNA needle inserted in tumour
-33
-42
-48
-59
-63 -65 -67 -68 -70 -73
-78 -78
-83 -85 -86 -88 -88 -89 -91
-95 -96 -96 -96 -97 -98 -98 -99 -99 -100
Duodenum
Pancreatic mass
Mesenteric vessels
FNA needle
Stent
• 11/38 patients (29%) demonstrated a decrease in CA 19-9 of > 90%.
PET scan assessments
• 39 of 42 patients had evaluable PET scan assessments at Baseline and at
Week 12.
• Metabolic resolution (100% reduction in TLG and SUV Max) and absence of
defined viable neoplastic disease was reported for 5 participants at Week 12.
– 4 have undergone surgical resection with curative intent.
Overall Survival
• 21 patient deaths at time of analysis.
• Median OS = 16 months.
• 12 month survival rate = 64%.
• Device localisation by Bremsstrahlung SPECT/CT was acceptable.
Bremsstrahlung SPECT/CT
Transaxial
MIP
Day 1 4-hour
Day 7
Images show excellent
intra-tumoural retention
of activity within the
pancreatic head at 2 hours
post-implantation and at
7 days post-implantation.
)
%
(
S
O
f
o
n
o
i
t
r
o
p
o
r
P
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
0
Median (Month): 16.0, 95% CI: 11.1–
1-year OS: 64.0%, 95% CI: 47.5%, 76.5%
95% CI
Censored
0
2
4
6
8
Number in the Risk Set:
10
Month
12
14
16
18
20
42
42
42
41
41
40
39
39
36
33
32
29
21
18
14
11
8
6
6
6
Chemotherapy utilisation (Per Protocol population)
Total Number of Cycles
Median (Range)
Duration of Exposure (Days)*
Median (Range)
GNP
(N=34)
FFX
(N=8)
5 (1-14)
6 (3-13)
147 (7-420)
89.5 (37-316)
*Duration of exposure (days): Date of first treatment to date of treatment discontinuation
Surgical Resection with curative intent
• Ten implanted patients underwent surgical resection by Whipple procedure.
– 20% resection rate in the ITT population.
– 23.8% resection rate in the PP population.
• 9 patients received concomitant GNP and 1 patient received FFX.
• Resections took place from 70 to 267 days post-implantation.
• Histopathological assessment confirmed R0 surgical margin status in
8 patients and R1 status in 2 patients.
Conclusions
The PanCO study demonstrates:
• Evidence of acceptable local tumour control (RECIST; tumour volume,
PET) with OncoSil™ and chemotherapy, with potential for downstaging
to resectability;
• Promising preliminary survival estimate – median OS = 16 months;
• A satisfactory safety profile when OncoSil™ is combined with
contemporary chemotherapy;
• Confirmation of the feasibility of EUS-directed implantation.
The PanCO study results justify future studies to further develop
the use of the OncoSil™ device in PDAC.
References
1. Ariake K, et al. Surg Case Rep 2017;3:15.
2. Ducreux M, et al. Annals of Oncology 26 (Supplement 5):v56-v68, 2015.
Acknowledgements
The study is supported by Oncosil Medical Ltd.
Nab-paclitaxel was supported by Specialised Therapeutics Australia Pty Ltd.
Disclosures
P Ross, D Croagh, M Aghmesheh, A Nagrial, N Nguyen, M Nikfarjam, H Wasan,
T Ajithkumar, C Iwuji, A Hendlisz & M Harris are participating investigators in the study.
T Maher & A Kraszewski are employees of Oncosil Medical Ltd.
ClinicalTrials.gov Identifier: NCT03003078
Contact: Paul.Ross@gstt.nhs.uk
Participants with ≥ 1 adverse event
Anaemia
Neutropenia
Thrombocytopenia
Abdominal Pain
Constipation
Diarrhoea
Nausea
Vomiting
Fatigue
Peripheral Oedema
Pyrexia
Weight Decreased
Decreased Appetite
Hypokalaemia
Peripheral Neuropathy
Alopecia
Rash
Efficacy
Radiological response
50 (100)
15 (30)
23 (46)
13 (26)
27 (54)
24 (48)
30 (60)
30 (60)
17 (34)
39 (78)
10 (20)
17 (34)
14 (28)
19 (38)
10 (20)
18 (36)
21 (42)
13 (26)
Local Disease Control Rate at 16 Weeks & 24 Weeks
Response Rate
41 (82)
7 (14)
18 (36)
3 (6)
7 (14)
1 (2)
1 (2)
5 (10)
4 (8)
7 (14)
1 (2)
4 (8)
1 (2)
1 (2)
4 (8)
1 (2)
0
0
PP
(N=42)
Number of subjects with local
disease control at Week 16 (%)
Proportion of subjects with local
disease control at Week 16 (95% CI)
ITT
(N=50)
41 (82%)
0.82 (0.69,0.91)
0.90 (0.77,0.97)
p-value
0.0001
<0.0001
Number of subjects with local
disease control at Week 24 (%)
Proportion of subjects with local
disease control at Week 24 (95% CI)
31 (62%)
30 (71.4%)
0.62 (0.47,0.75)
0.71 (0.55,0.84)
Response Rate
28%
31%
Tumour Volume
• Tumour volume assessment was a pre-specified exploratory analysis.
Maximum Percentage Change in Tumour Volume from Baseline
(Per Protocol population)
)
%
(
e
n
i
l
e
s
a
b
m
o
r
f
e
g
n
a
h
C
100
90
80
70
60
50
40
30
20
10
0
–10
–20
–30
–40
–50
–60
–70
–80
–90
–100
11*
7*
5*
-6^
-9*
-17†
-18^
-20‡
* Week 8
^ Week 16
† Week 24
‡ Week 32
-31*
-31^
-33^ -34*
-35^
-37†-38*-38^
-40^-41^
-45‡-45^ -46†
-52‡ -52‡-52^
-56*-57*-58^ -58*-58^
-61^
-65*
-67^
-72^
-72†-73† -74†
-76‡
-79†-80^-81^
-84‡
-90^
Abstract OP124
PanCO: An Open-Label, Single-Arm Pilot Study of Oncosil™ in Patients
with Unresectable Locally Advanced Pancreatic Adenocarcinoma in
Combination with FOLFIRINOX or Gemcitabine+Nab-Paclitaxel
Chemotherapies
ClinicalTrials.gov Identifier: NCT03003078
D Croagh1, D Williams2, V Kwan3, N Nguyen4, N Phillips5, E Godfrey6, T Maher8, A Kraszewski8, P Ross7
1Monash Health, Melbourne, Victoria, Australia, 2St Vincent’s Hospital, Sydney, NSW, Australia, 3Westmead Hospital,
Sydney, NSW, Australia, 4Royal Adelaide Hospital, South Australia, Australia, 5Imperial College Healthcare NHS Trust,
UK, 6Cambridge University Hospitals NHS Foundation Trust, UK, 7Guy’s and St Thomas’ NHS Foundation Trust,
London, UK, 8Oncosil Medical Ltd, Sydney, NSW, Australia
Sponsor: OncoSil Medical Ltd.
Presentation by
Dr Daniel Croagh
Monash Health, Melbourne, Australia
© UEG. 2018
6
World Federation
of Nuclear
Medicine and
Biology 2018
Digestive Disease
Week 2018
Conference
Poster/Presentation Title
Presentation
Type
Date of
Presentation
Comments
World Federation
of Nuclear
Medicine and
Biology 2018
Biodistribution of implanted Phosphorus-32
into unresectable locally advanced pancreatic
adenocarcinoma, given in combination with
gemcitabine+nab-paclitaxel chemotherapy
– A single centre experience
Poster
23 April 2018
Imaging and Radiation Safety Considerations
for 32P Radionuclide Therapy of Inoperable
Pancreatic Primary Cancer
Poster
23 April 2018
Single centre
experience from
Monash Health
AU (PanCO)
Royal North
Shore Hospital
data
PanCO: An Open Label, Single Arm Pilot Study
of Oncosil™, Administered to Study Participants
with Unresectable Locally Advanced Pancreatic
Adenocarcinoma, Given in Combination with Folfirinox
or Gemcitabine+Nab-Paclitaxel Chemotherapies
Poster
4 June 2018
PanCO data
ESMO World
Congress on
Gastrointestinal
Cancer 2018
PanCO: An Open-Label, Single-Arm Pilot Study
of Oncosil™ in Patients with Unresectable Locally
Advanced Pancreatic Adenocarcinoma in Combination
with FOLFIRINOX or Gemcitabine+Nab-Paclitaxel
Chemotherapies
Poster
21 June 2018
PanCO data
ANZGOSA
ANZHPBA 2018
Neoadjuvant chemo-ERT for pancreatic adenocarcinoma:
Study proposal for neoadjuvant chemobrachytherapy in
resectable pdac
Oral
presentation
8 October 2018
European
Association of
Nuclear Medicine
2018
Practical and Technical UK Experience of using
32P– OncoSil™ in treating patients with unresectable
locally advanced pancreatic adenocarcinoma, in
combination with FOLFIRINOX or gemcitabine
+nab-paclitaxel chemotherapies
United European
Gastroenterology
Week 2018
PanCO: An Open-Label, Single-Arm Pilot Study
of Oncosil™ in Patients with Unresectable Locally
Advanced Pancreatic Adenocarcinoma in Combination
with FOLFIRINOX or Gemcitabine+Nab-Paclitaxel
Chemotherapies
ANZSNM 2019
Combined chemotherapy with endoscopic Ultrasound
(EUS) guided 32P OncoSil™ implantation for locally
advanced pancreatic cancer: preliminary results from
the Royal Adelaide Hospital (RAH)
ASCO 2019
ASTRO 2019
National Cancer
Research Institute
UK 2019
PanCO: An Open-Label, Single-Arm Pilot Study of
Phosphorus-32 (P-32; Oncosil™) Microparticles in Patients
with Unresectable Locally Advanced Pancreatic
Adenocarcinoma (LAPC) in Combination with
FOLFIRINOX or Gemcitabine + Nab-Paclitaxel (GNP)
Chemotherapies
OncoPaC-1: An Open-label, Single-Arm Pilot Study
of Phosphorus-32 Microparticles Brachytherapy in
Combination with Gemcitabine +/- Nab-Paclitaxel in
Unresectable Locally Advanced Pancreatic Cancer
PanCO: An Open-Label, Single-Arm Pilot Study
of Phosphorus-32 (P-32; Oncosil™) Microparticles
in Patients with Unresectable Locally Advanced
Pancreatic Adenocarcinoma (LAPC) in Combination
with FOLFIRINOX or Gemcitabine + Nab-Paclitaxel
(GNP) Chemotherapies
e-Poster
13-17 October
2017
Invited
presentation by
Dr Dan Croagh
Single centre
experience from
Hammersmith
Hospital UK
(PanCO)
Oral
presentation
22 October 2018
PanCO data
Oral
presentation
28 April 2019
Single centre
experience from
Royal Adelaide
Hospital, AU
(PanCO)
Poster
3 June 2019
PanCO data
Accepted
as a Poster
presentation
17 September
2019
OncoPaC-1 data
Accepted
as Poster
& e-Poster
3-5 November
2019
PanCO data
(ASCO encore
publication)
7
OncoSil Medical
Annual Report 2019
Key Milestones
July 2018
September 2018
December 2018
PanCO study closes
global recruitment with
50 patients enrolled
across Australia, UK
and Belgium.
Highly encouraging
clinical results from
Interim Analysis for
OncoSil’s PanCO study,
with strong clinical
performance recorded
across multiple metrics.
Successfully completed
patient recruitment for
the US OncoPaC-1
clinical study, with nine
patients enrolled.
December 2018
June 2019
July 2019
All patients enrolled in
the OncoPaC-1 clinical
study successfully
implanted with the
OncoSil™ device.
Positive Overall Survival
data for PanCO study
announced at the
American Society of
Clinical Oncology
(ASCO) Annual Meeting
2019 in Chicago.
OncoSil submits formal
response to British
Standards Institute
and Clinical Oversight
Committee regarding
CE Marking certification
of the OncoSil™ device.
Compassionate Access Program
Royal Adelaide Hospital gives
patients compassionate access
to OncoSil™
Pancreatic cancer is one of the
most common cancers worldwide
and is the fifth most common
cause of cancer death.
Its symptoms include severe pain,
nausea and jaundice, but they
are often unnoticed until the
cancer has metastasised.
Current standards of care,
such as chemotherapy, often
have limited effectiveness
and can be toxic to patients.
While the OncoSil™ device can
treat patients with early-stage
pancreatic cancer, OncoSil
believes it has a humanitarian duty
to offer the treatment to patients
who have more advanced cases
of this deadly disease.
Associate Professor Dylan
Bartholomeusz, Head of Nuclear
Medicine at the hospital, says the
compassionate access program is
important for pancreatic patients,
given the limited effectiveness
of existing treatments.
The Royal Adelaide Hospital,
a leading pancreatic cancer
centre and one of the trial sites
for OncoSilTM PanCO trial, provides
compassionate access through
the TGA Special Access Scheme
(SAS) to the Oncosil™ device for
patients with locally advanced
pancreatic cancer.
“ In a clinical sense, pancreatic
cancer has a very poor outcome.
Usually, patients are diagnosed
quite late, so the survival rate is
low. When it comes to patients
with late stages of the disease,
no treatment has had a real
impact so far,” he says.
8
“ Patients in the compassionate
use program were all referred
to use OncoSil™ by their
Oncologists, and come from all
over Adelaide. Pancreatic cancer
has always had a very poor
prognosis, so we’re pleased to
be able to provide better patient
outcomes for this deadly disease.”
However, Professor
Bartholomeusz says results
from the compassionate access
program, where patients are
implanted with the OncoSil™
device in conjunction with
systemic chemotherapy, have
been encouraging.
“ We’ve treated five patients in
the last six months under the
TGA Special Access Scheme
and the results have been
promising. All the patients had
advanced pancreatic cancer.
Patients treated have a reduction
in their cancer symptoms.”
No disruption for patients
Professor Nam Nguyen, a
Gastroenterologist specialising
in pancreatic cancer at the
hospital, says another benefit
of the OncoSil™ treatment is
that it does not interrupt patients’
chemotherapy.
“ This treatment is essentially an
injection, and this is important
for patients because it doesn’t
require them to take special
precautions, nor does it impact
their chemotherapy,” Professor
Nguyen says.
“ Like the patients in the PanCO
trial, all the patients who have
used OncoSil™ under
compassionate use left the
clinic the same day. With other
treatments, patients often have
to be off chemotherapy for a week
or so, but with this technique,
there is no disruption.”
Professor Nguyen says the Royal
Adelaide Hospital is a centre of
excellence for pancreatic cancer
treatment, and access to OncoSil™,
an Australian therapy, enables it
to continue developing expertise
in this area.
Pancreatic cancer is difficult
to detect because there are
few symptoms. Treatments
often have poor outcomes, but
targeted treatments, such as
OncoSil which ‘get in there’
and treat the primary cancer,
are showing promise.
- Associate Professor
Dylan Bartholomeusz
9
OncoSil Medical
Annual Report 2019
Directors’ report
OncoSil Medical Ltd
Directors' report
30 June 2019
The directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as
the 'Group') consisting of OncoSil Medical Ltd (referred to hereafter as the 'Company' or 'parent entity') and the entities it
controlled at the end of, or during, the year ended 30 June 2019.
Directors
The following persons were directors of OncoSil Medical Ltd during the whole of the financial year and up to the date of this
report, unless otherwise stated:
Dr Chris Roberts AO - Non-Executive Chairman
Mr Daniel Kenny - Chief Executive Officer and Managing Director
Dr Roger Aston - Non-Executive Director
Dr Martin Cross - Non-Executive Director
Mr Michael Bassett - Non-Executive Director (appointed on 10 December 2018)
Information on directors
Name:
Title:
Qualifications:
Experience and expertise:
Dr Chris Roberts AO
Non-Executive Chairman
BE(Hons), MBA, PhD, Hon DSc(Macq), Hon DSc(UNSW), FTSE, FAICD, Hon
FIEAust
Dr Roberts AO is a highly experienced director and senior executive with over 41
years’ experience in the medical innovation space. He was CEO/President of
Cochlear Limited (ASX: COH) from February 2004 to August 2015. He was also
Chairman of Sirtex Medical Ltd (ASX: SRX), from March 2000 to December 2002,
and was Executive Vice-President of global sleep disorder treatment company
ResMed Inc (NYSE: RMD, ASX: RMD) from 1992 to 2004. He is a PLuS Alliance
Professor appointed across 3 universities: UNSW, King’s College London and
Arizona State University. Dr Roberts AO also sits on the boards of a number of other
entities and groups including; Clarity Pharmaceuticals Limited, Innovation Science
Australia, Atmo Biosciences Pty Ltd and O’Connell Street Associates.
None
Other current directorships:
Former directorships (last 3 years): ResMed Inc. (NYSE:RMD, ASX:RMD)
Special responsibilities:
Interests in shares:
Member of the Nomination and Remuneration Committee and member of Audit and
Risk Committee
11,125,000 ordinary shares (10,000,000 shares under Employee Share Plan 'ESP')
Experience and expertise:
Name:
Title:
Qualifications:
Mr Daniel Kenny
Chief Executive Officer and Managing Director
B.Sc Physics (UNSW), MAICD, completed executive business studies at both
INSEAD and London Business School, and is a graduate of the Australian Institute of
Physics.
Mr Kenny has over 32 years' experience in the Global Pharmaceutical and Medical
Device Industry. He commenced his career undertaking clinical research in the fields
of ophthalmology and HIV/AIDS prior to joining the pharmaceutical industry. Mr
Kenny's industry career experience extends to FDA and EU product and device
registration, clinical development, marketing and sales, in-licensing and business
development. Prior to working with OncoSil Medical Ltd, he held senior executive
appointments with ABIVAX, Baxter International and Roche.
Other current directorships:
None
Former directorships (last 3 years): None
Special responsibilities:
Member of the Nomination and Remuneration Committee and member of Audit and
Risk Committee
23,341,667 ordinary shares (20,300,000 shares under ESP)
Interests in shares:
10
2
OncoSil Medical Ltd
Directors' report
30 June 2019
Name:
Title:
Qualifications:
Experience and expertise:
Other current directorships:
Dr Roger Aston
Non-Executive Director
B.Sc (Hons) and Ph.D. (Manchester)
Dr Aston is a scientist and seasoned biotechnology entrepreneur. He has been
closely involved in start-up companies and major pharmaceutical companies. Aspects
of his experience include US Food and Drug ('FDA') and European Union ('EU')
product registration, clinical trials, global licensing agreements, fundraising through
private placements, and a network of contacts within the pharmaceutical, banking and
stock broking sectors. Dr Aston has also held Directorships/Chairmanships with
Clinuvel Ltd, HalcyGen Ltd, Regeneus Ltd and Ascent Pharma Ltd, was a member of
the AusIndustry Biological Committee advising
Industry Research and
Development Brand. More recently, Dr Aston was Executive Chairman of Mayne
Pharma Group from 2009 to 2011 and later, CEO of Mayne Pharma Group.
Chairman of: Immuron Limited (ASX: IMC), ResApp Health Limited (ASX: RAP),
PharmAust Ltd (ASX: PAA) and its subsidiary Pitney Pharmaceuticals Pty Ltd
the
Former directorships (last 3 years): Regeneus Limited (ASX: RGS)
Special responsibilities:
Member of the Nomination and Remuneration Committee and Chairman of the Audit
and Risk Committee
12,516,547 ordinary shares (500,000 shares under ESP)
Interests in shares:
Name:
Title:
Qualifications:
Experience and expertise:
Dr Martin Cross
Non-Executive Director
B.SC (Hons) and Ph.D. (Aberdeen) FAICD
Dr Cross is a highly regarded pharmaceutical executive with over 35 years’
experience including corporate and industry leadership roles directly influencing
healthcare policy and government legislation in Australia and global business
management, marketing and sales roles. From 2013 to 2015, Dr Cross was Chairman
of Medicines Australia, the country’s peak body representing the research based
pharmaceutical industry in Australia. Prior to leading Medicines Australia, from 2010
to 2013 Dr Cross was Chairman of both the Generics Medicine Industry Association
and Pharmaceutical Industry Council. During this time, Dr Cross was also Managing
Director of Alphapharm in Australia and New Zealand, with responsibility for 750
employees and sales of over US $500m per annum. From 2003 to 2008, Dr Cross
was Country Head and Managing Director of Novartis Australia and New Zealand,
and Head of Global Marketing and Sales Capabilities from 2001 to 2003, based in
Switzerland.
Non-Executive Director Cellmid Limited (ASX:CDY)
Chairman of the Nomination and Remuneration Committee and member of the Audit
and Risk Committee
1,880,000 ordinary shares
Mr Michael Bassett
Non-Executive Director
B.Econ, member of the Australian Institute of Company Directors.
Mr Bassett has over 25 years' experience in capital markets and has held senior
management roles at Australia's leading fund management and investment banking
firms. His career focus involved analysing, advising and investing in small-cap ASX-
listed companies with strong prospects for shareholder value creation. Mr Bassett
previously worked as a Portfolio Manager for the successful Regal Australian Small
Companies Fund with a significant focus on Life Science companies. Prior to this he
held senior management positions within Credit Suisse's Institutional Equities
business, Deutsche Asset Management and Merrill Lynch.
Managing Director of a market consultancy business that works with boards and
senior management to optimise their capital market strategies.
Other current directorships:
Former directorships (last 3 years): None
Special responsibilities:
Interests in shares:
Name:
Title:
Qualifications:
Experience and expertise:
Other current directorships:
Former directorships (last 3 years): None
None
Special responsibilities:
1,023,000 ordinary shares
Interests in shares:
3
11
OncoSil Medical
Annual Report 2019
Directors’ report cont.
OncoSil Medical Ltd
Directors' report
30 June 2019
'Other current directorships' quoted above are current directorships for listed entities only and excludes directorships of all
other types of entities, unless otherwise stated.
'Former directorships (last 3 years)' quoted above are directorships held in the last 3 years for listed entities only and
excludes directorships of all other types of entities, unless otherwise stated.
Company secretary
Tom Milicevic is the Company Secretary.
Mr Milicevic (B.Comm (Western Sydney), FCPA, MBA, MGSM), is an experienced commercial, financial and management
accountant with more than 22 years’ experience in a career which includes a number of major Australian and international
public companies. Prior to joining OncoSil Medical Ltd, he was chief executive officer ('CEO') and chief financial officer
('CFO') of orthopaedic medical device company, Allegra Orthopaedics Limited (ASX: AMT) and successfully led that
company through its Initial Public Offering ('IPO') and ASX listing. Mr Milicevic was also CFO for Babcock & Brown
Residential Land Partners, an ASX listed fund, where he was the financial lead on the stapled security’s $175,000,000
IPO. His previous roles also includes CFO and Company Secretary with an ASX listed oncology biotech, and senior
finance and accounting roles with ASX 100 Australian companies.
Principal activities
The principal activities of the Group during the financial year focused on the development of its lead product candidate, the
OncoSil™ localised radiation therapy for the treatment of pancreatic cancer.
Dividends
There were no dividends paid, recommended or declared during the current or previous financial year.
Review of operations
The loss for the Group after providing for income tax amounted to $8,566,731 (30 June 2018: $8,539,542).
OncoSil Medical Limited is an Australian-based and ASX listed medical device company focused on localised treatments
for patients with pancreatic and liver cancer. The Group’s lead product, OncoSil™, is a first in class medical device
comprising microparticles containing Phosphorous-32 (P-32), a pure beta-emitter radioisotope, implanted directly into a
patient’s pancreatic tumours via an endoscopic ultrasound. This treatment, known as brachytherapy, is intended to deliver
more concentrated and localised radiation.
Over the past twelve months, the Group’s focus has been to advance and complete its global pancreatic clinical study,
PanCO, and are using this data to support its CE Mark application for the OncoSil™ device in the European Union. The
Group notes the initial unfavourable assessment from the Notified Body (The British Standards Institution "BSI") for the
application and has since submitted a formal response using the positive Overall Survival dataset from the PanCo study.
The Group has made progress on its mission in FY19, including:
●
●
Successful completion of patient recruitment for the PanCO study across Australia, UK and Belgium;
Successful completion of patient recruitment for the US OncoPaC-1 clinical study, with all patients enrolled in the
study successfully implanted with the OncoSil™ device;
Appointed IQVIA as European Union Market Access and Remuneration Advisor;
Reported positive Interim Analysis of PanCo study with strong clinical performance recorded across multiple metrics;
Reported positive Overall Survival data for the PanCO study, and presented this at the American Society of Clinical
Oncology (ASCO) Annual Meeting 2019; and
Submission of OncoSil's formal response to the BSI and Clinical Oversight Committee regarding CE Marking
certification of the OncoSil™ device.
●
●
●
●
12
4
OncoSil Medical Ltd
Directors' report
30 June 2019
Clinical – Completed patient recruitment for global PanCO study and positive study data
●
●
In September 2018, the Group reported the successful completion of patient enrolment for the PanCO study across all
participating sites in Australia, the UK and Belgium – with 50 patients enrolled in total. The Group also reported highly
encouraging results from the Interim Analysis which showed that:
- Disease Control Rate (DCR) of 100% at Week 8 in the per protocol population;
- Local Disease Control Rate (LDCR) of 88% at Week 16 in the implanted population;
- Strong evidence of target tumour regression, with statistically significant, and in some cases, substantial volumetric
reduction; and
- Well tolerated and reassuring safety profile confirmed by independent Safety Review Committee.
Positive Overall Survival data from the PanCo study was presented at the (ASCO) Annual Meeting in June 2019
which showed:
- Medical overall survival of 16 months – given the accepted population median Overall Survival estimates of patients
with locally advanced pancreatic cancer (LAPC) is only 9-11 months, this result is comparable to, and in many cases
surpasses, that of the best available published literature in the LAPC population;
- Encouraging rate of surgical resection with curative intent of 23.8% with a R0 margin status of 80%;
- LDCR at 16 weeks was 90.5%, a positive and important independent prognostic factor for the Overall Survival of
patients;
- A satisfactory safety profile when OncoSil™ is combined with contemporary chemotherapy; and
- Confirmation of the feasibility of EUS directed implantation.
●
US FDA confirmed that the PanCo study (ex-US) safety data met IDE requirements and that OncoSil could proceed
with to a full US pivotal study without further US patient data.
●
The Group’s OncoPaC-1 clinical study successfully completed recruitment, with nine patients successfully implanted.
Regulatory – OncoSil provides detailed response to BSI and COC
●
●
●
While outside the financial year, on 30 July 2019, OncoSil submitted a comprehensive response to questions from the
British Standards Institute (BSI) and its Clinical Oversight Committee (COC) regarding the certification of the
OncoSil™ device based on the positive results of the PanCO study;
The response was prepared and developed with the support of leading medical experts and enables a treatment
comparison that demonstrates the OncoSil™ device provides statistically significant and clinically meaningful benefits
over and above chemotherapy alone for patients with unresectable LAPC; and
OncoSil will keep shareholders informed of developments with respect to the review and the progress of the CE
Marking determination.
Corporate – Revised business plan
●
While OncoSil awaits the outcome of the CE Marking decision, the Group will operate under a revised business plan
to target a reduction in annualised cost base through reduced operating expenditure and R&D expenditure. The
Group has also put a pause on any new clinical trial and study activities until certainty around the CE Marking is
achieved.
Significant changes in the state of affairs
There were no significant changes in the state of affairs of the Group during the financial year.
Matters subsequent to the end of the financial year
No matter or circumstance has arisen since 30 June 2019 that has significantly affected, or may significantly affect the
Group's operations, the results of those operations, or the Group's state of affairs in future financial years.
5
13
OncoSil Medical
Annual Report 2019
Directors’ report cont.
OncoSil Medical Ltd
Directors' report
30 June 2019
Likely developments and expected results of operations
The Company continues to progress towards achieving a CE Mark for our OncoSil™ device which will enable future
commercial sales in the European Union, Australia/New Zealand and certain parts of Asia. When a CE Marking
determination is made, the Company would be committed to a post marketing surveillance program, the nature and costs
associated are yet to be determined. In addition, the Global Pivotal OncPac-1 Clinical Study continues, aimed at supporting
a Pre Marketing application in the United States in future years. There can be no guarantees that in the future we will
achieve these regulatory approvals, or on the basis sought by the Company, and there are no guarantees of the rate of
enrolment of the OncPac-1 Clinical Study or the outcome of clinical results. Manufacturing capabilities, supply chain and
sales and marketing infrastructure will continue to be progressed to support both planned commercial and clinical activities.
Environmental regulation
The Group is not subject to any significant environmental regulation under Australian Commonwealth or State law.
Meetings of directors
The number of meetings of the Company's Board of Directors ('the Board') and of each Board committee held during the
year ended 30 June 2019, and the number of meetings attended by each director were:
Full Board
Nomination and
Remuneration Committee
Audit and Risk Committee
Attended
Held
Attended
Held
Attended
Held
Dr Chris Roberts AO
Mr Daniel Kenny
Dr Roger Aston
Dr Martin Cross
Mr Michael Bassett
9
9
9
9
4
9
9
9
9
4
1
1
1
1
-
1
1
1
1
-
2
2
2
2
-
2
2
2
2
-
Held: represents the number of meetings held during the time the director held office or was a member of the relevant
committee.
Remuneration report (audited)
The remuneration report, which has been audited, details the key management personnel ('KMP') remuneration
arrangements for the Group, in accordance with the requirements of the Corporations Act 2001 and its Regulations.
KMP are those persons having authority and responsibility for planning, directing and controlling the activities of the entity,
directly or indirectly, including all directors.
The remuneration report is set out under the following main headings:
●
●
●
●
●
●
Principles used to determine the nature and amount of remuneration
Details of remuneration
Service agreements
Share-based compensation
Additional information
Additional disclosures relating to KMP
Principles used to determine the nature and amount of remuneration
The objective of the Group's executive reward framework is to ensure the remuneration package properly reflects each
person's duties and responsibilities and that remuneration is competitive in attracting, retaining and motivating people of
the highest quality. The framework aligns executive reward with the achievement of strategic objectives and the creation of
value for shareholders, and it is considered to conform to the market best practice for the delivery of reward. The Board of
Directors ('the Board') ensures that executive reward satisfies the following key criteria for good reward governance
practices:
●
●
●
●
competitiveness and reasonableness;
acceptability to shareholders;
performance linkage / alignment of executive compensation; and
transparency.
The Nomination and Remuneration Committee ('NRC') is responsible for determining and reviewing remuneration
arrangements for its directors and executives. The performance of the Group depends on the quality of its directors and
executives. The remuneration philosophy is to attract, motivate and retain high performance and high quality personnel.
14
6
OncoSil Medical Ltd
Directors' report
30 June 2019
The NRC has structured an executive remuneration framework that is market competitive and complementary to the
reward strategy of the Group.
The Board have considered that the reward framework is designed to align to shareholders' interests by:
●
●
having economic profit as a core component of plan design;
focusing on sustained growth in shareholder wealth, consisting of dividends and growth in share price, and delivering
constant or increasing return on assets as well as focusing the executive on key non-financial drivers of value; and
attracting and retaining high calibre executives.
●
Additionally, the reward framework should seek to enhance executives' interests by:
●
rewarding executives for Group and individual performance against targets set by reference to appropriate
benchmarks;
aligning the interests of executives with those of shareholders;
linking reward with the strategic goals and performance of the Group; and
ensuring total remuneration is competitive by market standards.
●
●
●
In accordance with best practice corporate governance, the structure of non-executive director and executive director
remuneration is separate.
Non-executive directors remuneration
Fees and payments to non-executive directors reflect the demands and responsibilities of their role. Non-executive
directors' fees and payments are reviewed annually by the NRC. The NRC may, from time to time, receive advice from
independent remuneration consultants to ensure non-executive directors' fees and payments are appropriate and in line
with the market. The chairman's fees are determined independently to the fees of other non-executive directors based on
comparative roles in the external market. The chairman is not present at any discussions relating to the determination of
his own remuneration.
Non-executive directors are also entitled to government statutory superannuation guarantee contribution. They may also
be granted shares, aligning their interests with those of the shareholders.
ASX listing rules require the aggregate non-executive directors' remuneration be determined periodically by a general
meeting. The most recent determination was at the Annual General Meeting held on 26 November 2015, where the
shareholders approved a maximum annual aggregate director's fees payable to non-executive directors of $500,000.
Executive remuneration
The Group aims to reward executives based on their position and responsibility, with a level and mix of remuneration which
has both fixed and variable components.
The executive remuneration and reward framework has four components:
●
●
●
●
base pay and non-monetary benefits
short-term performance incentives
share-based payments
other remuneration such as superannuation and long service leave
The combination of these comprises the executive's total remuneration.
Structure
Executive directors are contracted to the Group either on a consultancy basis with remuneration and terms stipulated in
individual consultancy arrangements or pursuant to an employment contract with remuneration and terms stipulated in
individual employment agreements.
Fixed remuneration, consisting of base salary, superannuation and non-monetary benefits, are reviewed annually by the
NRC based on individual and business unit performance, the overall performance of the Group and comparable market
remuneration.
Executives are given the opportunity to receive their base emolument in a variety of forms including cash and fringe
benefits such as motor vehicles and expense payment plans. It is intended that the manner of payment chosen will be
optimal for the recipient without creating undue cost for the Group.
7
15
OncoSil Medical
Annual Report 2019
Directors’ report cont.
OncoSil Medical Ltd
Directors' report
30 June 2019
The short-term incentives ('STI') program is designed to align the targets of the business units with the performance hurdle
of executives. STI payments are granted to executives based on specific annual targets and key performance indicators
('KPI's') being achieved. In particular, all executive directors and other KMP may be entitled to annual bonuses payable
upon the achievement of annual corporate or profitability measures. The Group seeks to emphasise payment for results
through providing various cash bonus reward schemes, specifically the incorporation of incentive payments based on
achievement of approved targets.
The long-term incentives (‘LTI’) include long service leave and share-based payments. Limited recourse loans are awarded
to executives in order for the executive to subscribe for ordinary shares in the Company under the OncoSil Employee
Share Plan. These share will vest upon satisfaction of long-term KPI's as agreed with the executive, measured over terms
varying from three to five years. These KPI's include, but are not limited to, an increase in shareholders’ value, revenue
targets or meeting regulatory and clinical measures. The NRC reviewed the long-term equity-linked performance incentives
specifically for executives during the year ended 30 June 2019.
Group performance and link to remuneration
Remuneration for certain individuals is directly linked to the performance of the Group. A portion of cash bonus and
incentive payments are dependent on defined earnings per share targets being met. The remaining portion of the cash
bonus and incentive payments are at the discretion of the NRC. Refer to the section 'Additional information' below for
details of the earnings and total shareholders return for the last five years.
Use of remuneration consultants
During the financial year ended 30 June 2018, the Group, through the Nomination and Remuneration Committee, engaged
Godfrey Remuneration Group Pty Ltd, remuneration consultants, to review its existing remuneration policies and provide
recommendations on how to improve both the STI and LTI programs. This has resulted in the production of a remuneration
benchmarking report for the use of the Nomination and Remuneration Committee, and the adjustment of salaries for the
executives and non-executive directors by CPI or 2% effective 1 July 2018. In addition, the Group will initiate an annual
long term incentive equity grant under the existing Employee Loan Share Scheme as part of the executives LTI component
of remuneration. Godfrey Remuneration Group Pty Ltd was paid $26,000 for these services. No consultants were used
during the financial year ended 30 June 2019 as the position of the Board remained consistent with the previous year.
An agreed set of protocols were put in place to ensure that the remuneration recommendations would be free from undue
influence from key management personnel. These protocols include requiring that the consultant not directly communicate
with affected key management personnel and that the consultant not provide any information relating to the outcome of the
engagement directly with the affected key management personnel. The Board is also required to make inquiries of the
consultant's processes at the conclusion of the engagement to ensure that they are satisfied that any recommendations
made have been free from undue influence. The Board is satisfied that these protocols were followed and as such there
was no undue influence.
Voting and comments made at the Company's 2018 Annual General Meeting ('AGM')
At the 2018 AGM, less than 1% voted against the adoption of the remuneration report for the year ended 30 June 2018.
The Company did not receive any specific feedback at the AGM regarding its remuneration practices.
Details of remuneration
Amounts of remuneration
The KMP of the Group consisted of the directors of OncoSil Medical Ltd and the following persons:
●
Mr Tom Milicevic - Chief Financial Officer and Company Secretary
16
8
OncoSil Medical Ltd
Directors' report
30 June 2019
Details of the remuneration of KMP of the Group are set out in the following tables.
Short-term benefits
Post-
employment
benefits
Cash salary
and fees
$
Cash
bonus
$
Non-
Super-
monetary annuation
$
$
Long-term
benefits
Long
service
leave
$
Share-based payments
Equity-
settled
options
$
Equity-
settled
shares
$
Total
$
2019
Non-Executive
Directors:
Dr Chris Roberts
AO (chairman) *
Dr Roger Aston
Dr Martin Cross
Mr Michael
Bassett **
80,000
73,059
73,059
44,822
Executive
Directors:
Mr Daniel Kenny
473,939
Other Key
Management
Personnel:
Mr Tom
Milicevic
279,771
1,024,650
-
-
-
-
-
-
-
-
-
-
-
-
6,941
6,941
-
-
25,365
-
-
24,983
64,230
-
-
-
-
-
-
-
-
-
-
-
208,000
6,977
-
288,000
86,977
80,000
-
44,822
-
383,487
882,791
-
-
417,209
112,455
710,919 1,799,799
*
**
The remuneration payments to Dr Chris Roberts were made to his director-related entity, Robertsplan Pty Ltd.
Represents remuneration for the period from date of appointment 10 December 2018 to 30 June 2019. The
remuneration payments to Michael Bassett were made to his director-related entity, Market Connect Australia Pty Ltd.
During the year 3,300,000 shares were granted to Daniel Kenny and 650,000 shares to Tom Milicevic under the Group's
Employee Share Plan. The value in the above remuneration table represents the amortised value of these shares.
For the financial year ended 30 June 2019, management tabled an initiative to forfeit short term incentives. Although,
individual performance measures warranted participation in the annual short term incentive program, management
unanimously agreed to forfeit any short term incentive payment attributable to the current financial year. The Board was
fully supportive of managements initiative.
9
17
OncoSil Medical
Annual Report 2019
Directors’ report cont.
OncoSil Medical Ltd
Directors' report
30 June 2019
Short-term benefits
Post-
employment
benefits
Cash salary
and fees
$
Cash
bonus
$
Non-
Super-
monetary annuation
$
$
Long-term
benefits
Long
service
leave
$
Share-based payments
Equity-
settled
options
$
Equity-
settled
shares
$
Total
$
2018
Non-Executive
Directors:
Dr Chris Roberts
AO (chairman) *
Dr Roger Aston
Dr Martin Cross
Executive
Directors:
Mr Daniel Kenny
Other Key
Management
Personnel:
Mr Tom
Milicevic
80,000
73,059
73,059
-
-
-
-
-
-
-
6,941
6,941
460,030
193,800
-
30,673
266,696
952,844
66,800
260,600
-
-
24,549
69,104
-
-
-
-
-
-
-
-
-
208,000
16,996
-
288,000
96,996
80,000
-
384,545 1,069,048
-
-
101,250
459,295
710,791 1,993,339
*
The remuneration payments to Dr Chris Roberts were made to his director-related entity, Robertsplan Pty Ltd.
The proportion of remuneration linked to performance and the fixed proportion are as follows:
Name
Non-Executive Directors:
Dr Chris Roberts AO
Dr Roger Aston
Dr Martin Cross
Mr Michael Bassett
Executive Directors:
Mr Daniel Kenny
Other Key Management
Personnel:
Mr Tom Milicevic
Fixed remuneration
2018
2019
At risk - STI
At risk - LTI
2019
2018
2019
2018
28%
92%
100%
100%
28%
82%
100%
-
56%
46%
72%
63%
-
-
-
-
-
-
-
-
-
-
72%
8%
-
-
72%
18%
-
-
18%
44%
36%
15%
28%
22%
The proportion of the cash bonus paid/payable or forfeited is as follows:
Name
Executive Directors:
Mr Daniel Kenny
Other Key Management Personnel:
Mr Tom Milicevic
Cash bonus paid/payable
2019
2018
Cash bonus forfeited
2018
2019
-
-
90%
100%
10%
100%
100%
-
18
10
OncoSil Medical Ltd
Directors' report
30 June 2019
Service agreements
Remuneration and other terms of employment for key management personnel are formalised in service agreements.
Details of these agreements are as follows:
Name:
Title:
Agreement commenced:
Term of agreement:
Details:
Name:
Title:
Agreement commenced:
Term of agreement:
Details:
Daniel Kenny
Chief Executive Officer and Managing Director
5 January 2015
No fixed term
Base salary for the year ending 30 June 2019 of $448,000 plus superannuation, to be
reviewed annually by the NRC, six months termination notice by either party, cash
bonus up to 50% of salary subject to achievement of KPI's as set by the Board. There
is a restraint period of six months ending on the date of termination of employment.
He is eligible to participate in the long term incentive plan as approved by
shareholders.
Tom Milicevic
Chief Financial Officer and Company Secretary
22 October 2015
No fixed term
Base salary for the year ending 30 June 2019 of $278,000 plus superannuation, to be
reviewed annually by the NRC, three months termination notice by either party, cash
bonus up to 25% of salary subject to achievement of KPI's as set by the Board. There
is a restraint period of six months ending on the date of termination of employment.
He is eligible to participate in the long term incentive plan as approved by
shareholders.
Key management personnel have no entitlement to termination payments in the event of removal for misconduct.
Share-based compensation
Issue of shares
There were no shares issued to directors and other key management personnel as part of compensation during the year
ended 30 June 2019 other than those issued under the Employee Share Plan below.
Employee Share Plan ('ESP')
Certain employees have been issued limited recourse loans to acquire shares in the Company. In accordance with the
Accounting Standards, these shares are accounted for in a similar manner as options.
Terms and conditions of share based payment arrangements affecting the remuneration of key management personnel in
the current financial year:
Number of
shares
granted
Grant date
Expiry date
Exercise price at grant date
Fair value
per share
Name
Dr Chris Roberts
AO
Mr Daniel Kenny
10,000,000
10/05/2016
10/05/2021
14,000,000
10/05/2016
3,000,000 28/11/2014
3,300,000 31/10/2018
10/05/2021
31/12/2019
31/10/2021
Dr Roger Aston
500,000
28/11/2014
31/12/2019
Mr Tom Milicevic
5,000,000
13/01/2016
650,000 31/10/2018
13/01/2019
31/10/2021
$0.22
$0.104
$0.22
$0.13
$0.18
$0.104
$0.047
$0.078
$0.18
$0.056
$0.13
$0.18
$0.081
$0.078
The shares cannot be traded by the holder until their related loan has been settled and the shares released.
11
19
OncoSil Medical
Annual Report 2019
Directors’ report cont.
OncoSil Medical Ltd
Directors' report
30 June 2019
Other than the above, there were no options over ordinary shares granted to or vested in directors and other KMP as part
of compensation during the year ended 30 June 2019.
Additional information
The earnings of the Group for the five years to 30 June 2019 are summarised below:
2015
$
2016
$
2017
$
2018
$
2019
$
Revenue/income
Loss after income tax
3,028,014
(2,879,031)
4,141,691
(4,768,598)
3,755,765
(7,016,079)
4,549,584
(8,539,542)
3,845,045
(8,566,731)
The factors that are considered to affect total shareholders return ('TSR') are summarised below:
Share price at financial year end ($)
Basic earnings per share (cents per share)
0.10
(0.81)
0.14
(1.23)
0.10
(1.49)
0.23
(1.66)
0.05
(1.36)
2015
2016
2017
2018
2019
Additional disclosures relating to KMP
Shareholding
The number of shares in the Company held during the financial year by each director and other members of KMP of the
Group including their personally related parties (including those held under an Employee Share Plan), is set out below:
Balance at Received
the start of
the year
as part of
remuneration Additions
Disposals/
other
Balance at
the end of
the year
Ordinary shares
Dr Chris Roberts AO
Mr Daniel Kenny
Dr Roger Aston
Dr Martin Cross
Mr Michael Bassett
Mr Tom Milicevic
11,125,000
20,041,667
12,516,547
1,291,667
-
5,096,667
50,071,548
-
-
-
-
-
-
-
-
3,300,000
-
588,333
1,023,000
650,000
5,561,333
- 11,125,000
- 23,341,667
- 12,516,547
1,880,000
-
1,023,000
-
-
5,746,667
- 55,632,881
Loan shares holding
The number of loan shares over ordinary shares in the Company held during the financial year by each director and other
members of KMP of the Group, is set out below:
Loan shares over ordinary shares
Dr Chris Roberts AO
Mr Daniel Kenny
Dr Roger Aston
Mr Tom Milicevic
Unreleased vested loan shares
Mr Daniel Kenny
Dr Roger Aston
Mr Tom Milicevic
Balance at
the start of
the year
Granted
Exercised
Vested
Balance at
the end of
the year
10,000,000
17,000,000
500,000
5,000,000
32,500,000
-
3,300,000
-
650,000
3,950,000
-
-
-
-
-
- 10,000,000
- 20,300,000
500,000
-
3,650,000
(2,000,000)
(2,000,000) 34,450,000
Unreleased
subject to
loan
repayment
3,000,000
500,000
2,000,000
5,500,000
20
12
OncoSil Medical Ltd
Directors' report
30 June 2019
Other transactions with KMP and their related parties
Payment of Director's fees to Dr Chris Roberts AO, were made to his director-related entity, Robertsplan Pty Ltd during the
financial year of $80,000 (2018: $80,000).
Payment of Director's fees to Mr Michael Bassett, were made to his director-related entity, Market Connect Australia Pty
Ltd during the financial year of $44,823 (2018: Nil).
This concludes the remuneration report, which has been audited.
Shares under option
There were no unissued ordinary shares of OncoSil Medical Ltd under option outstanding at the date of this report.
Shares issued on the exercise of options
There were no ordinary shares of OncoSil Medical Ltd issued on the exercise of options during the year ended 30 June
2019 and up to the date of this report.
Indemnity and insurance of officers
The Company has indemnified the directors and executives for costs incurred, in their capacity as a director or executive,
for which they may be held personally liable, except where there is a lack of good faith.
During the financial year, the Company paid a premium in respect of a contract to insure the directors and executives of
the Company against a liability to the extent permitted by the Corporations Act 2001. The contract of insurance prohibits
disclosure of the nature of the liability and the amount of the premium.
Indemnity and insurance of auditor
The Company has not, during or since the end of the financial year, indemnified or agreed to indemnify the auditor of the
Company or any related entity against a liability incurred by the auditor.
During the financial year, the Company has not paid a premium in respect of a contract to insure the auditor of the
Company or any related entity.
Proceedings on behalf of the Company
No person has applied to the Court under section 237 of the Corporations Act 2001 for leave to bring proceedings on
behalf of the Company, or to intervene in any proceedings to which the Company is a party for the purpose of taking
responsibility on behalf of the Company for all or part of those proceedings.
Non-audit services
There were no non-audit services provided during the financial year by the auditor.
Officers of the Company who are former partners of Crowe Sydney
There are no officers of the Company who are former partners of Crowe Sydney.
Auditor's independence declaration
A copy of the auditor's independence declaration as required under section 307C of the Corporations Act 2001 is set out
immediately after this directors' report.
Auditor
Crowe Sydney continues in office in accordance with section 327 of the Corporations Act 2001.
13
21
OncoSil Medical
Annual Report 2019
Directors’ report cont.
OncoSil Medical Ltd
Directors' report
30 June 2019
This report is made in accordance with a resolution of directors, pursuant to section 298(2)(a) of the Corporations Act
2001.
On behalf of the directors
___________________________
Dr Chris Roberts AO
Non-Executive Chairman
23 August 2019
Sydney
22
14
Auditor’s independence declaration
Crowe Horwath Sydney
ABN 97 895 683 573
Member of Crowe Global
Audit and Assurance Services
Level 15 1 O'Connell Street
Sydney NSW 2000
Australia
Tel +61 2 9262 2155
Fax +61 2 9262 2190
www.crowe.com.au
23 August 2019
The Board of Directors
OncoSil Medical Ltd
Suite 402 Level 4
50 Berry Street,
North Sydney NSW 2060
Dear Board Members
OncoSil Medical Ltd
In accordance with section 307C of the Corporations Act 2001, I am pleased to provide the following
declaration of independence to the Directors of OncoSil Medical Ltd.
As lead audit partner for the audit of the financial report of OncoSil Medical Ltd for the financial year
ended 30 June 2019, I declare that to the best of my knowledge and belief, that there have been no
contraventions of:
the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and
(i)
(ii) any applicable code of professional conduct in relation to the audit.
Yours sincerely
Crowe Sydney
John Haydon
Senior Partner
The title ‘Partner’ conveys that the person is a senior member within their respective division, and is among the group of persons who hold an
equity interest (shareholder) in its parent entity, Findex Group Limited. The only professional service offering which is conducted by a partnership
is the Crowe Australasia external audit division. All other professional services offered by Findex Group Limited are conducted by a privately
owned organisation and/or its subsidiaries.
Findex (Aust) Pty Ltd, trading as Crowe Australasia is a member of Crowe Global, a Swiss verein. Each member firm of Crowe Global is a
separate and independent legal entity. Findex (Aust) Pty Ltd and its affiliates are not responsible or liable for any acts or omissions of Crowe
Global or any other member of Crowe Global. Crowe Global does not render any professional services and does not have an ownership or
partnership interest in Findex (Aust) Pty Ltd. Services are provided by Crowe Sydney, an affiliate of Findex (Aust) Pty Ltd. Liability limited by a
scheme approved under Professional Standards Legislation. Liability limited other than for acts or omissions of financial services licensees.
© 2019 Findex (Aust) Pty Ltd
15
23
OncoSil Medical
Annual Report 2019
Statement of profit or loss
and other comprehensive income
OncoSil Medical Ltd
Statement of profit or loss and other comprehensive income
For the year ended 30 June 2019
OncoSil Medical Ltd
Statement of profit or loss and other comprehensive income
For the year ended 30 June 2019
Revenue
Other income
Interest revenue calculated using the effective interest method
Revenue
Expenses
Other income
Employee benefits expense
Interest revenue calculated using the effective interest method
Research and development expenses
Occupancy expenses
Expenses
Consulting, finance and legal expenses
Employee benefits expense
Share-based payments
Research and development expenses
Other administrative expenses
Occupancy expenses
Consulting, finance and legal expenses
Loss before income tax expense
Share-based payments
Other administrative expenses
Income tax expense
Loss before income tax expense
Loss after income tax expense for the year attributable to the owners of
OncoSil Medical Ltd
Income tax expense
Note
Note
5
Consolidated
2019
$
2018
$
Consolidated
2019
3,640,933
$
204,112
2018
4,404,820
$
144,764
5
6
6
3,640,933
(4,002,787)
204,112
(5,576,351)
(174,292)
(1,212,226)
(4,002,787)
(1,133,097)
(5,576,351)
(313,023)
(174,292)
(1,212,226)
(8,566,731)
(1,133,097)
(313,023)
4,404,820
(4,848,148)
144,764
(5,825,985)
(193,189)
(1,022,457)
(983,442)
(215,905)
(4,848,148)
(5,825,985)
(193,189)
(1,022,457)
(8,539,542)
(983,442)
(215,905)
7
-
-
(8,566,731)
(8,539,542)
7
(8,566,731)
-
(8,539,542)
-
Other comprehensive income
Loss after income tax expense for the year attributable to the owners of
OncoSil Medical Ltd
Items that may be reclassified subsequently to profit or loss
Foreign currency translation
Other comprehensive income
Other comprehensive income for the year, net of tax
Items that may be reclassified subsequently to profit or loss
Foreign currency translation
Total comprehensive income for the year attributable to the owners of OncoSil
Medical Ltd
Other comprehensive income for the year, net of tax
(8,566,731)
(8,539,542)
(45,934)
(36,640)
(45,934)
(36,640)
(45,934)
(36,640)
(8,612,665)
(45,934)
(8,576,182)
(36,640)
Total comprehensive income for the year attributable to the owners of OncoSil
Medical Ltd
Cents
(8,612,665)
Cents
(8,576,182)
Basic earnings per share
Diluted earnings per share
Basic earnings per share
Diluted earnings per share
24
24
(1.36)
(1.36)
(1.66)
(1.66)
Cents
Cents
24
24
(1.36)
(1.36)
(1.66)
(1.66)
The above statement of profit or loss and other comprehensive income should be read in conjunction with the
accompanying notes
16
24
The above statement of profit or loss and other comprehensive income should be read in conjunction with the
accompanying notes
16
Statement of financial position
OncoSil Medical Ltd
Statement of financial position
As at 30 June 2019
OncoSil Medical Ltd
Statement of financial position
As at 30 June 2019
Assets
Current assets
Cash and cash equivalents
Trade and other receivables
Other assets
Total current assets
Assets
Current assets
Cash and cash equivalents
Trade and other receivables
Other assets
Total current assets
Non-current assets
Plant and equipment
Total non-current assets
Total assets
Non-current assets
Plant and equipment
Total non-current assets
Liabilities
Total assets
Note
Consolidated
2019
$
2018
$
Consolidated
Note
8
9
10
2018
2019
$
$
7,689,234 15,205,216
4,482,827
3,819,044
108,030
97,603
11,605,881 19,796,073
8
9
10
7,689,234 15,205,216
4,482,827
3,819,044
108,030
97,603
62,466
11,605,881 19,796,073
62,466
86,255
86,255
11,668,347 19,882,328
62,466
62,466
86,255
86,255
11,668,347 19,882,328
Liabilities
Current liabilities
Trade and other payables
Employee benefits
Total current liabilities
Current liabilities
Trade and other payables
Employee benefits
Total current liabilities
Total liabilities
11
11
767,608
225,603
993,211
1,598,899
128,725
1,727,624
767,608
225,603
993,211
1,598,899
128,725
1,727,624
993,211
1,727,624
Net assets
Total liabilities
Net assets
Equity
Equity
Issued capital
Issued capital
Reserves
Reserves
Accumulated losses
Accumulated losses
Total equity
Total equity
993,211
1,727,624
10,675,136 18,154,704
10,675,136 18,154,704
12
12
13
13
52,257,231 52,257,231
4,933,232
(39,035,759)
52,257,231 52,257,231
6,020,395
4,933,232
6,020,395
(47,602,490)
(39,035,759)
(47,602,490)
10,675,136 18,154,704
10,675,136 18,154,704
The above statement of financial position should be read in conjunction with the accompanying notes
17
The above statement of financial position should be read in conjunction with the accompanying notes
17
25
OncoSil Medical
Annual Report 2019
Statement of changes in equity
OncoSil Medical Ltd
Statement of changes in equity
For the year ended 30 June 2019
OncoSil Medical Ltd
Statement of changes in equity
Consolidated
For the year ended 30 June 2019
Balance at 1 July 2017
Loss after income tax expense for the year
Consolidated
Other comprehensive income for the year, net of tax
Balance at 1 July 2017
Total comprehensive income for the year
Loss after income tax expense for the year
Transactions with owners in their capacity as owners:
Other comprehensive income for the year, net of tax
Contributions of equity, net of transaction costs (note 12)
Share-based payments (note 13)
Total comprehensive income for the year
Balance at 30 June 2018
Transactions with owners in their capacity as owners:
Contributions of equity, net of transaction costs (note 12)
Share-based payments (note 13)
Balance at 30 June 2018
Consolidated
Balance at 1 July 2018
Loss after income tax expense for the year
Consolidated
Other comprehensive income for the year, net of tax
Balance at 1 July 2018
Total comprehensive income for the year
Loss after income tax expense for the year
Transactions with owners in their capacity as owners:
Other comprehensive income for the year, net of tax
Share-based payments (note 13)
Total comprehensive income for the year
Balance at 30 June 2019
Transactions with owners in their capacity as owners:
Share-based payments (note 13)
Issued
capital
$
Reserves
$
Accumulated
losses
$
Total equity
$
36,644,596
Issued
capital
$
-
-
36,644,596
-
-
-
15,612,635
-
-
52,257,231
15,612,635
-
Issued
capital
52,257,231
$
3,986,430
Reserves
-
$
(36,640)
3,986,430
(36,640)
-
(36,640)
-
983,442
(36,640)
4,933,232
-
983,442
Accumulated
losses
(8,539,542)
$
-
(30,496,217) 10,134,809
Total equity
(8,539,542)
$
(36,640)
(30,496,217) 10,134,809
(8,576,182)
(8,539,542)
(8,539,542)
(8,539,542)
(36,640)
-
- 15,612,635
983,442
-
(8,576,182)
(8,539,542)
(39,035,759) 18,154,704
- 15,612,635
983,442
-
Accumulated
Total equity
losses
(39,035,759) 18,154,704
$
$
Reserves
4,933,232
$
52,257,231
Issued
capital
$
-
-
52,257,231
-
-
-
-
-
52,257,231
4,933,232
Reserves
Accumulated
losses
(8,566,731)
$
-
(39,035,759) 18,154,704
Total equity
(8,566,731)
$
(45,934)
(39,035,759) 18,154,704
(8,612,665)
(8,566,731)
(45,934)
1,133,097
(8,612,665)
(47,602,490) 10,675,136
(8,566,731)
(8,566,731)
-
-
(8,566,731)
-
$
(45,934)
4,933,232
(45,934)
-
(45,934)
1,133,097
(45,934)
6,020,395
-
1,133,097
-
1,133,097
Balance at 30 June 2019
52,257,231
6,020,395
(47,602,490) 10,675,136
The above statement of changes in equity should be read in conjunction with the accompanying notes
18
26
The above statement of changes in equity should be read in conjunction with the accompanying notes
18
Statement of cash flows
OncoSil Medical Ltd
Statement of cash flows
For the year ended 30 June 2019
OncoSil Medical Ltd
Statement of cash flows
For the year ended 30 June 2019
Cash flows from operating activities
Payments to suppliers and employees
Interest received
Research and development tax incentive
Cash flows from operating activities
Net cash used in operating activities
Payments to suppliers and employees
Interest received
Research and development tax incentive
Cash flows from investing activities
Payments for property, plant and equipment
Net cash used in operating activities
Net cash used in investing activities
Cash flows from investing activities
Payments for property, plant and equipment
Cash flows from financing activities
Proceeds from issue of shares
Share issue transaction costs
Net cash used in investing activities
Net cash from financing activities
Cash flows from financing activities
Proceeds from issue of shares
Net increase/(decrease) in cash and cash equivalents
Share issue transaction costs
Cash and cash equivalents at the beginning of the financial year
Net cash from financing activities
Cash and cash equivalents at the end of the financial year
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the financial year
Note
Note
Consolidated
2019
$
2018
$
Consolidated
(11,991,410)
2019
204,112
$
4,286,144
(11,988,290)
2018
144,764
$
3,446,185
23
23
12
12
12
12
8
(7,501,154)
(11,991,410)
204,112
4,286,144
(14,828)
(7,501,154)
(14,828)
(8,397,341)
(11,988,290)
144,764
3,446,185
(10,696)
(8,397,341)
(10,696)
(14,828)
(10,696)
- 16,709,014
(1,096,379)
-
(10,696)
(14,828)
- 15,612,635
- 16,709,014
(7,515,982)
7,204,598
-
(1,096,379)
8,000,618
15,205,216
- 15,612,635
7,689,234 15,205,216
(7,515,982)
7,204,598
8,000,618
15,205,216
Cash and cash equivalents at the end of the financial year
8
7,689,234 15,205,216
The above statement of cash flows should be read in conjunction with the accompanying notes
19
The above statement of cash flows should be read in conjunction with the accompanying notes
19
27
OncoSil Medical
Annual Report 2019
Notes to the financial statements
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 1. General information
The financial statements cover OncoSil Medical Ltd as a Group consisting of OncoSil Medical Ltd (the 'Company' or 'parent
entity') and the entities it controlled at the end of, or during, the year (the 'Group'). The financial statements are presented
in Australian dollars, which is OncoSil Medical Ltd's functional and presentation currency.
OncoSil Medical Ltd is a listed public company limited by shares, incorporated and domiciled in Australia. Its registered
office and principal place of business is:
Suite 402, Level 4
50 Berry Street
North Sydney NSW 2060
A description of the nature of the Group's operations and its principal activities are included in the directors' report, which is
not part of the financial statements.
The financial statements were authorised for issue, in accordance with a resolution of directors, on 23 August 2019. The
directors have the power to amend and reissue the financial statements.
Note 2. Significant accounting policies
The principal accounting policies adopted in the preparation of the financial statements are set out either in the respective
notes or below. These policies have been consistently applied to all the years presented, unless otherwise stated.
New or amended Accounting Standards and Interpretations adopted
The Group has adopted all of the new or amended Accounting Standards and Interpretations issued by the Australian
Accounting Standards Board ('AASB') that are mandatory for the current reporting period, being AASB 9 'Financial
Instruments' and 'AASB 15 Revenue from Contracts with Customers'.
AASB 9 Financial Instruments
The Group has adopted AASB 9 from 1 July 2018. The standard introduced new classification and measurement models
for financial assets. A financial asset shall be measured at amortised cost if it is held within a business model whose
objective is to hold assets in order to collect contractual cash flows which arise on specified dates and that are solely
principal and interest. A debt investment shall be measured at fair value through other comprehensive income if it is held
within a business model whose objective is to both hold assets in order to collect contractual cash flows which arise on
specified dates that are solely principal and interest as well as selling the asset on the basis of its fair value. All other
financial assets are classified and measured at fair value through profit or loss unless the entity makes an irrevocable
election on initial recognition to present gains and losses on equity instruments (that are not held-for-trading or contingent
consideration recognised in a business combination) in other comprehensive income ('OCI'). Despite these requirements, a
financial asset may be irrevocably designated as measured at fair value through profit or loss to reduce the effect of, or
eliminate, an accounting mismatch. For financial liabilities designated at fair value through profit or loss, the standard
requires the portion of the change in fair value that relates to the entity's own credit risk to be presented in OCI (unless it
would create an accounting mismatch). New simpler hedge accounting requirements are intended to more closely align the
accounting treatment with the risk management activities of the entity. New impairment requirements use an 'expected
credit loss' ('ECL') model to recognise an allowance. Impairment is measured using a 12-month ECL method unless the
credit risk on a financial instrument has increased significantly since initial recognition in which case the lifetime ECL
method is adopted. For receivables, a simplified approach to measuring expected credit losses using a lifetime expected
loss allowance is available. There was no impact on the financial statements as the main financial assets recognised
represent cash and cash equivalents and trade receivables that do not carry a significant financing component and involve
a single cash flow representing the repayment of principal, which in the case of trade receivables is the transaction price.
Both asset classes will continue to be measured at face value. Other financial asset classes are not material to the Group.
Financial liabilities of the Group are not impacted as the Group does not carry them at fair value.
28
20
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 2. Significant accounting policies (continued)
AASB 15 Revenue from Contracts with Customers
The Group has adopted AASB 15 from 1 July 2018. The standard provides a single comprehensive model for revenue
recognition. The core principle of the standard is that an entity shall recognise revenue to depict the transfer of promised
goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in
exchange for those goods or services. The standard introduced a new contract-based revenue recognition model with a
measurement approach that is based on an allocation of the transaction price. This is described further in the accounting
policies below. Credit risk is presented separately as an expense rather than adjusted against revenue. Contracts with
customers are presented in an entity's statement of financial position as a contract liability, a contract asset, or a
receivable, depending on the relationship between the entity's performance and the customer's payment. Customer
acquisition costs and costs to fulfil a contract can, subject to certain criteria, be capitalised as an asset and amortised over
the contract period. Due to the nature of the income the Group received, being mainly the research and development tax
incentive and interest received from cash deposits, there is no impact under this standard in the financial statements.
Impact of adoption
AASB 9 and AASB 15 were adopted using the modified retrospective approach and as such comparatives have not been
restated. The impact of adoption on opening retained profits as at 1 July 2018 was $nil.
There has been no impact on the financial statements on the adoption of AASB 9 and AASB 15.
Basis of preparation
These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and
Interpretations issued by the Australian Accounting Standards Board ('AASB') and the Corporations Act 2001, as
appropriate for for-profit oriented entities. These financial statements also comply with International Financial Reporting
Standards as issued by the International Accounting Standards Board ('IASB').
Historical cost convention
The financial statements have been prepared under the historical cost convention.
Critical accounting estimates
The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires
management to exercise its judgement in the process of applying the Group's accounting policies. The areas involving a
higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial
statements, are disclosed in note 3.
Parent entity information
In accordance with the Corporations Act 2001, these financial statements present the results of the Group only.
Supplementary information about the parent entity is disclosed in note 21.
Principles of consolidation
The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of OncoSil Medical Ltd as at
30 June 2019 and the results of all subsidiaries for the year then ended. OncoSil Medical Ltd and its subsidiaries together
are referred to in these financial statements as the 'Group'.
Subsidiaries are all those entities over which the Group has control. The Group controls an entity when the Group is
exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns
through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is
transferred to the Group. They are de-consolidated from the date that control ceases.
Intercompany transactions, balances and unrealised gains on transactions between entities in the Group are eliminated.
Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred.
Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted
by the Group.
The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in ownership interest,
without the loss of control, is accounted for as an equity transaction, where the difference between the consideration
transferred and the book value of the share of the non-controlling interest acquired is recognised directly in equity
attributable to the parent.
21
29
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 2. Significant accounting policies (continued)
Where the Group loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and non-
controlling interest in the subsidiary together with any cumulative translation differences recognised in equity. The Group
recognises the fair value of the consideration received and the fair value of any investment retained together with any gain
or loss in profit or loss.
Foreign currency translation
The financial statements are presented in Australian dollars, which is OncoSil Medical Ltd's functional and presentation
currency.
Foreign currency transactions
Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the
transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the
translation at financial year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are
recognised in profit or loss.
Foreign operations
The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the
reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average
exchange rates, which approximate the rates at the dates of the transactions, for the period. All resulting foreign exchange
differences are recognised in other comprehensive income through the foreign currency reserve in equity.
The foreign currency reserve is recognised in profit or loss when the foreign operation or net investment is disposed of.
Current and non-current classification
Assets and liabilities are presented in the statement of financial position based on current and non-current classification.
An asset is classified as current when: it is either expected to be realised or intended to be sold or consumed in the
Group's normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within 12 months
after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle
a liability for at least 12 months after the reporting period. All other assets are classified as non-current.
A liability is classified as current when: it is either expected to be settled in the Group's normal operating cycle; it is held
primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no
unconditional right to defer the settlement of the liability for at least 12 months after the reporting period. All other liabilities
are classified as non-current.
Deferred tax assets and liabilities are always classified as non-current.
Plant and equipment
Plant and equipment is stated at historical cost less accumulated depreciation and impairment. Historical cost includes
expenditure that is directly attributable to the acquisition of the items.
Depreciation is calculated on a straight-line basis to write off the net cost of each item of property, plant and equipment
over their expected useful lives as follows:
Office equipment 3-15 years
The residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each reporting
date.
An item of property, plant and equipment is derecognised upon disposal or when there is no future economic benefit to the
Group. Gains and losses between the carrying amount and the disposal proceeds are taken to profit or loss.
Leases
The determination of whether an arrangement is or contains a lease is based on the substance of the arrangement and
requires an assessment of whether the fulfilment of the arrangement is dependent on the use of a specific asset or assets
and the arrangement conveys a right to use the asset.
30
22
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 2. Significant accounting policies (continued)
A distinction is made between finance leases, which effectively transfer from the lessor to the lessee substantially all the
risks and benefits incidental to the ownership of leased assets, and operating leases, under which the lessor effectively
retains substantially all such risks and benefits.
Operating lease payments, net of any incentives received from the lessor, are charged to profit or loss on a straight-line
basis over the term of the lease.
Research and development costs
Research costs are expensed in the period in which they are incurred. Development costs are capitalised when it is
probable that the project will be a success considering its commercial and technical feasibility; the Group is able to use or
sell the asset; the Group has sufficient resources and intent to complete the development and its costs can be measured
reliably.
Employee benefits
Short-term employee benefits
Liabilities for wages and salaries and other employee benefits expected to be settled wholly within 12 months of the
reporting date are measured at the amounts expected to be paid when the liabilities are settled.
Long-term employee benefits
Employee benefits not expected to be settled within 12 months of the reporting date are measured as the present value of
expected future payments to be made in respect of services provided by employees up to the reporting date using the
projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee
departures and periods of service. Expected future payments are discounted using market yields at the reporting date on
high quality corporate bonds with terms to maturity and currency that match, as closely as possible, the estimated future
cash outflows.
Defined contribution superannuation expense
Contributions to defined contribution superannuation plans are expensed in the period in which they are incurred.
Goods and Services Tax ('GST') and other similar taxes
Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not
recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part
of the expense.
Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST
recoverable from, or payable to, the tax authority is included in other receivables or other payables in the statement of
financial position.
Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing
activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows.
Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.
Comparatives
Certain comparatives in the statement of profit or loss and other comprehensive income, where necessary, have been
reclassified for consistency with the current period presentation.
New Accounting Standards and Interpretations not yet mandatory or early adopted
Australian Accounting Standards and Interpretations that have recently been issued or amended but are not yet
mandatory, have not been early adopted by the Group for the annual reporting period ended 30 June 2019. The Group's
assessment of the impact of these new or amended Accounting Standards and Interpretations, most relevant to the Group,
are set out below.
23
31
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 2. Significant accounting policies (continued)
AASB 16 Leases
This standard is applicable to annual reporting periods beginning on or after 1 January 2019. The standard replaces AASB
117 'Leases' and for lessees will eliminate the classifications of operating leases and finance leases. Subject to exceptions,
a 'right-of-use' asset will be capitalised in the statement of financial position, measured at the present value of the
unavoidable future lease payments to be made over the lease term. The exceptions relate to short-term leases of 12
months or less and leases of low-value assets (such as personal computers and small office furniture) where an
accounting policy choice exists whereby either a 'right-of-use' asset is recognised or lease payments are expensed to profit
or loss as incurred. A liability corresponding to the capitalised lease will also be recognised, adjusted for lease
prepayments, lease incentives received, initial direct costs incurred and an estimate of any future restoration, removal or
dismantling costs. Straight-line operating lease expense recognition will be replaced with a depreciation charge for the
leased asset (included in operating costs) and an interest expense on the recognised lease liability (included in finance
costs). In the earlier periods of the lease, the expenses associated with the lease under AASB 16 will be higher when
compared to lease expenses under AASB 117. However, EBITDA (Earnings Before Interest, Tax, Depreciation and
Amortisation) results will be improved as the operating expense is replaced by interest expense and depreciation in profit
or loss under AASB 16. For classification within the statement of cash flows, the lease payments will be separated into
both a principal (financing activities) and interest (either operating or financing activities) component. For lessor accounting,
the standard does not substantially change how a lessor accounts for leases. The Group will adopt this standard from 1
July 2019.
If AASB 16 was implemented by the Group as at 30 June 2019, the impact would be an increase in assets and
corresponding increase in liabilities of $212,891. This represents the net present value of all estimated office lease
payments. Under the same lease assumptions, the Group expects a lease expense of $127,734 in the year ending 30
June 2020 (comparatively, an expense of $131,319 would be expected under the current accounting methodologies being
applied).
New Conceptual Framework for Financial Reporting
A revised Conceptual Framework for Financial Reporting has been issued by the AASB and is applicable for annual
reporting periods beginning on or after 1 January 2020. This release impacts for-profit private sector entities that have
public accountability that are required by legislation to comply with Australian Accounting Standards and other for-profit
entities that voluntarily elect to apply the Conceptual Framework. Phase 2 of the framework is yet to be released which will
impact for-profit private sector entities. The application of new definition and recognition criteria as well as new guidance on
measurement will result in amendments to several accounting standards. The issue of AASB 2019-1 Amendments to
Australian Accounting Standards – References to the Conceptual Framework, also applicable from 1 January 2020,
includes such amendments. Where the Group has relied on the conceptual framework in determining its accounting
policies for transactions, events or conditions that are not otherwise dealt with under Australian Accounting Standards, the
Group may need to revisit such policies.
Note 3. Critical accounting judgements, estimates and assumptions
The preparation of the financial statements requires management to make judgements, estimates and assumptions that
affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in
relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates
and assumptions on historical experience and on other various factors, including expectations of future events,
management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will
seldom equal the related actual results. The judgements, estimates and assumptions that have a significant risk of causing
a material adjustment to the carrying amounts of assets and liabilities (refer to the respective notes) within the next
financial year are discussed below.
Share-based payment transactions
The Group measures the cost of equity-settled transactions with employees by reference to the fair value of the equity
instruments at the date at which they are granted. The fair value is determined by using the Black-Scholes model taking
into account the terms and conditions upon which the instruments were granted. The accounting estimates and
assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and
liabilities within the next annual reporting period but may impact profit or loss and equity.
32
24
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 3. Critical accounting judgements, estimates and assumptions (continued)
Research and development tax incentive
The Group measures the research and development tax incentive ('RDTI') based on the preparation of the income tax
return for the year therefore assumptions and judgement are involved to determine whether some costs are appropriated to
RDTI.
Recovery of deferred tax assets
Deferred tax assets are recognised for deductible temporary differences only if the Group considers it is probable that
future taxable amounts will be available to utilise those temporary differences and losses.
Note 4. Operating segments
Identification of reportable operating segments
The Group operates in one segment being the device development for new medical treatments. This is based on the
internal reports that are reviewed and used by the Board of Directors (who are identified as the Chief Operating Decision
Makers ('CODM')) in assessing performance and in determining the allocation of resources. There is no aggregation of
operating segments.
The information reported to the CODM is on at least a monthly basis. The financial information presented in these financial
statements are the same as that presented to the CODM.
Note 5. Other income
Research and development tax incentive
Net gain on disposal of asset
Net gain/(loss) on foreign exchange
Other income
Other income
Consolidated
2019
$
2018
$
3,626,082
-
14,851
-
4,440,918
713
(43,632)
6,821
3,640,933
4,404,820
Accounting policy for revenue recognition
Revenue is recognised when it is probable that the economic benefit will flow to the Group and the revenue can be reliably
measured. Revenue is measured at the fair value of the consideration received or receivable.
Research and development tax incentive
The research and development tax incentive ('RDTI') represents a refundable tax offset that is available on eligible
research and development expenditure incurred by the Group. The RDTI is considered to be a form of government
assistance and the accounting policy adopted is analogous to accounting for government grants.
RDTI are recognised at their fair value where there is a reasonable assurance that the incentive will be received and the
Group will comply with all attached conditions.
RDTI relating to expenses are recognised as incurred at the point of time in profit or loss.
Dividends
Dividend revenue is recognised when it is received or when the right to receive payment is established.
Other income
Other income is recognised when it is received or when the right to receive payment is established.
Interest
Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the
amortised cost of a financial asset and allocating the interest income over the relevant period using the effective interest
rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset
to the net carrying amount of the financial asset.
25
33
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 6. Expenses
Loss before income tax includes the following specific expenses:
Depreciation
Office equipment
Employee benefits (excluding share-based payments)
Employee benefits
Defined contribution superannuation expense
Total employee benefits expense
Rental expense relating to operating leases
Minimum lease payments
Note 7. Income tax
Numerical reconciliation of income tax expense and tax at the statutory rate
Loss before income tax expense
Tax at the statutory tax rate of 27.5%
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Research and development - write back
Share-based payments
Others
Future income tax benefit not brought to account
Income tax expense
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised
Potential tax benefit @ 27.5%
Consolidated
2019
$
2018
$
38,617
39,913
3,804,313
198,474
4,559,883
288,265
4,002,787
4,848,148
163,052
191,682
Consolidated
2019
$
2018
$
(8,566,731)
(8,539,542)
(2,355,851)
(2,348,374)
1,391,559
311,602
(97,242)
749,932
1,778,902
270,446
70,722
228,304
-
-
Consolidated
2019
$
2018
$
9,651,356
7,186,433
2,654,123
1,976,269
The above potential tax benefit for tax losses has not been recognised in the statement of financial position. These tax
losses can only be utilised in the future if the continuity of ownership test is passed, or failing that, the same business test
is passed.
Accounting policy for income tax
The income tax expense or benefit for the period is the tax payable on that period's taxable income based on the
applicable income tax rate for each jurisdiction, adjusted by the changes in deferred tax assets and liabilities attributable to
temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable.
34
26
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 7. Income tax (continued)
Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to be applied when
the assets are recovered or liabilities are settled, based on those tax rates that are enacted or substantively enacted,
except for:
●
When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a
transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting
nor taxable profits; or
When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and
the timing of the reversal can be controlled and it is probable that the temporary difference will not reverse in the
foreseeable future.
●
Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it is probable that
future taxable amounts will be available to utilise those temporary differences and losses.
The carrying amount of recognised and unrecognised deferred tax assets are reviewed at each reporting date. Deferred
tax assets recognised are reduced to the extent that it is no longer probable that future taxable profits will be available for
the carrying amount to be recovered. Previously unrecognised deferred tax assets are recognised to the extent that it is
probable that there are future taxable profits available to recover the asset.
Deferred tax assets and liabilities are offset only where there is a legally enforceable right to offset current tax assets
against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable
authority on either the same taxable entity or different taxable entities which intend to settle simultaneously.
Note 8. Current assets - cash and cash equivalents
Cash at bank
Cash on deposit
Consolidated
2019
$
2018
$
7,574,359 15,092,466
112,750
114,875
7,689,234 15,205,216
Accounting policy for cash and cash equivalents
Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly
liquid investments with original maturities between three and six months that are readily convertible to known amounts of
cash and which are subject to an insignificant risk of changes in value.
Note 9. Current assets - trade and other receivables
Other receivables
Research and development tax incentive receivable
Consolidated
2019
$
2018
$
38,188
3,780,856
41,909
4,440,918
3,819,044
4,482,827
Accounting policy for trade and other receivables
Other receivables are recognised at amortised cost, less any allowance for expected credit losses.
27
35
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 10. Current assets - other assets
Prepayments
Other deposits
Other current assets
Note 11. Current liabilities - trade and other payables
Trade payables
Payroll liabilities
Other payables
Consolidated
2019
$
2018
$
28,389
69,214
-
23,063
69,214
15,753
97,603
108,030
Consolidated
2019
$
2018
$
363,987
98,784
304,837
857,113
702,982
38,804
767,608
1,598,899
Refer to note 15 for further information on financial instruments.
Accounting policy for trade and other payables
These amounts represent liabilities for goods and services provided to the Group prior to the end of the financial year and
which are unpaid. Due to their short-term nature they are measured at amortised cost and are not discounted. The
amounts are unsecured, non-interest bearing and are usually paid within 60 days of recognition.
Note 12. Equity - issued capital
Consolidated
2019
Shares
2018
Shares
2019
$
2018
$
Ordinary shares - fully paid
630,708,788 624,158,788 52,257,231 52,257,231
Movements in ordinary share capital
Details
Date
Shares
Issue price
$
Balance
Shares buy-back
Employee loan shares issued
Placement issue of shares
Placement issue of shares
Placement issue of shares
Transaction costs
Balance
Employee loan shares issued
1 July 2017
30 January 2018
2 March 2018
28 March 2018
20 April 2018
17 May 2018
487,455,468
(7,000,000)
4,461,538
72,624,415
33,333,433
33,283,934
-
36,644,596
-
-
8,714,930
4,000,012
3,994,072
(1,096,379)
$0.00
$0.22
$0.12
$0.12
$0.12
$0.00
30 June 2018
31 October 2018
624,158,788
6,550,000
52,257,231
-
$0.18
Balance
30 June 2019
630,708,788
52,257,231
36
28
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 12. Equity - issued capital (continued)
Ordinary shares
Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the Company in
proportion to the number of and amounts paid on the shares held. The fully paid ordinary shares have no par value and the
Company does not have a limited amount of authorised capital.
On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each
share shall have one vote.
Share buy-back
There is no current on-market share buy-back.
Capital risk management
The Group's policy is to maintain a strong capital base so as to maintain investor, creditor and market confidence and to
sustain future development of the business. Given the state of the Group's development there are no formal targets set for
return of capital.
Capital is regarded as total equity, as recognised in the statement of financial position, plus net debt. Net debt is calculated
as total borrowings less cash and cash equivalents.
The Group is not subject to any financing arrangements covenants or externally imposed capital requirements.
The capital risk management policy remains unchanged from the 30 June 2018 Annual Report.
Accounting policy for issued capital
Ordinary shares are classified as equity.
Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax,
from the proceeds.
Note 13. Equity - reserves
Foreign currency reserve
Share-based payments reserve
Consolidated
2019
$
2018
$
(161,262)
6,181,657
(115,328)
5,048,560
6,020,395
4,933,232
Foreign currency reserve
The reserve is used to recognise exchange differences arising from the translation of the financial statements of foreign
operations to Australian dollars. It is also used to recognise gains and losses on hedges of the net investments in foreign
operations.
Share-based payments reserve
The reserve is used to recognise the value of equity benefits provided to: employees and directors as part of their
remuneration under an Employee Share Plan; directors on terms determined by the Board and approved by shareholders;
and other parties as part of their compensation for services.
29
37
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 13. Equity - reserves (continued)
Movements in reserves
Movements in each class of reserve during the current and previous financial year are set out below:
Consolidated
Balance at 1 July 2017
Foreign currency translation
Share-based payments
Balance at 30 June 2018
Foreign currency translation
Share-based payments
Balance at 30 June 2019
Note 14. Equity - dividends
Foreign
currency
$
Share-based
payments
$
Total
$
(78,688)
(36,640)
-
4,065,118
-
983,442
3,986,430
(36,640)
983,442
(115,328)
(45,934)
-
5,048,560
-
1,133,097
4,933,232
(45,934)
1,133,097
(161,262)
6,181,657
6,020,395
There were no dividends paid, recommended or declared during the current or previous financial year.
Note 15. Financial instruments
Financial risk management objectives
The Group's activities expose it to a variety of financial risks: market risk, credit risk and liquidity risk. The Group's overall
risk management program focuses on the unpredictability of financial markets and seeks to minimise potential adverse
effects on the financial performance of the Group. The Group uses different methods to measure different types of risk to
which it is exposed. These methods include sensitivity analysis in the case of interest rate and ageing analysis for credit
risk.
Risk management is carried out by senior finance executives ('finance') under policies approved by the Board of Directors
('the Board'). These policies include identification and analysis of the risk exposure of the Group and appropriate
procedures, controls and risk limits. Finance identifies, evaluates financial risks within the Group's operating units. Finance
reports to the Board on a monthly basis.
Market risk
Foreign currency risk
The Group is not exposed to significant foreign currency risk.
Price risk
The Group was exposed to securities price risk on investments held for trading over the medium to long term in the
comparative period. Such risk was managed through diversification of investments across industries and geographical
locations.
Interest rate risk
The Group's main interest rate risk arises from cash at bank and short term deposits. The policy is to maintain a mix of
fixed and floating rate deposits.
The carrying value of the Group's cash and cash equivalents at the reporting date, subject to interest rate risk are detailed
in note 8. The effect a 100 (2018: 100) basis point interest rate change is detailed below. The method used to arrive at the
possible change in basis points was based on the analysis of the average change of the Reserve Bank of Australia ('RBA')
monthly issued cash rate over the past five years.
38
30
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 15. Financial instruments (continued)
Consolidated - 2019
Basis points
change
profit before
tax
Effect on
equity
Basis points
change
profit before
tax
Effect on
equity
Basis points increase
Effect on
Basis points decrease
Effect on
Cash and cash equivalents
100
76,892
55,747
(100)
76,892
55,747
Consolidated - 2018
Basis points
change
profit before
tax
Effect on
equity
Basis points
change
profit before
tax
Effect on
equity
Basis points increase
Effect on
Basis points decrease
Effect on
Cash and cash equivalents
100
152,052
110,238
(50)
76,026
55,119
Credit risk
Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the
Group. The Group has a strict code of credit, including obtaining agency credit information, confirming references and
setting appropriate credit limits. The Group obtains guarantees where appropriate to mitigate credit risk. The maximum
exposure to credit risk at the reporting date to recognised financial assets is the carrying amount, net of any provisions for
impairment of those assets, as disclosed in the statement of financial position and notes to the financial statements. The
Group does not hold any collateral.
The credit risk on liquid funds is limited because the counter party is a bank with high credit rating.
Liquidity risk
Vigilant liquidity risk management requires the Group to maintain sufficient liquid assets (mainly cash and cash
equivalents) to be able to pay debts as and when they become due and payable.
The Group manages liquidity risk by maintaining adequate cash reserves by continuously monitoring actual and forecast
cash flows and matching the maturity profiles of financial assets and liabilities.
The Group's objective is to maintain a balance between continuity of funding and flexibility through the use of finance
leases and equity funding.
Remaining contractual maturities
The following tables detail the Group's remaining contractual maturity for its financial instrument liabilities. The tables have
been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the
financial liabilities are required to be paid. The tables include both interest and principal cash flows disclosed as remaining
contractual maturities and therefore these totals may differ from their carrying amount in the statement of financial position.
Consolidated - 2019
Non-derivatives
Non-interest bearing
Trade payables
Payroll liabilities
Other payables
Total non-derivatives
1 year or less
$
Between 1
and 2 years
$
Between 2
and 5 years
$
Over 5 years
$
Remaining
contractual
maturities
$
363,987
98,784
304,837
767,608
-
-
-
-
-
-
-
-
-
-
-
-
363,987
98,784
304,837
767,608
31
39
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 15. Financial instruments (continued)
Consolidated - 2018
Non-derivatives
Non-interest bearing
Trade payables
Payroll liabilities
Other payables
Total non-derivatives
1 year or less
$
Between 1
and 2 years
$
Between 2
and 5 years
$
Over 5 years
$
Remaining
contractual
maturities
$
857,113
702,982
38,804
1,598,899
-
-
-
-
-
-
-
-
-
-
-
-
857,113
702,982
38,804
1,598,899
The cash flows in the maturity analysis above are not expected to occur significantly earlier than contractually disclosed
above.
Fair value of financial instruments
Unless otherwise stated, the carrying amounts of financial instruments reflect their fair value.
Note 16. Key management personnel disclosures
Compensation
The aggregate compensation made to directors and other members of key management personnel of the Group is set out
below:
Short-term employee benefits
Post-employment benefits
Share-based payments
Note 17. Remuneration of auditors
Consolidated
2019
$
2018
$
1,024,650
64,230
710,919
1,213,444
69,104
710,791
1,799,799
1,993,339
During the financial year the following fees were paid or payable for services provided by Crowe Sydney, the auditor of the
Company:
Audit services - Crowe Sydney
Audit or review of the financial statements
Note 18. Contingent liabilities
There has been no change in the status of contingent liabilities since 30 June 2018.
Consolidated
2019
$
2018
$
53,700
49,750
40
32
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 18. Contingent liabilities (continued)
On 16 April 2013, OncoSil Medical Ltd settled the acquisition of OncoSil Medical (UK) Limited (formerly Enigma
Therapeutics Limited "OncoSil UK"). OncoSil UK holds a licence to commercialise OncoSil™ (formerly BrachySil™), a
targeted brachytherapy product for the treatment of cancer ('the Product') under a licence agreement from pSiMedica.
pSiMedica has granted to OncoSil UK an exclusive world-wide royalty-bearing license for the term of the pSiMedica
Transaction (with limited rights to sub-license) under the Licensed Patents solely to make, use, sell, offer to sell and import
the Product in the field of therapy in human neoplastic disease (cancer). Key terms of the license agreement have been
summarised below:
●
●
OncoSil UK is required to make a payment of up to US$100,000 to pSiMedica annually to support existing patents;
and
OncoSil UK is required to make the following payments for patents and subject to the Product completing positive
clinical trials and becoming registered for sale.
(i) During the term of the licence, 8% of future net sales (future sales which cannot be guaranteed) of the Product or any
other product protected by the rights arising from the Assigned Patents (if sold by OncoSil UK or its affiliates) and services
performed using the Product or such other products, on a product-by-product and country-by-country basis. Only half of
this payment must be made whenever approved generic competitor products derived from the Product maintain at least a
20% world-wide market share of sales, on a country-by-country and product-by-product basis.
(ii) 20% of any form of consideration, payments, royalties, third party net sales income and other payments received from
third party licensing deals and various other agreements with third parties in relation to the Product or any other product
protected by the rights arising from the Assigned Patents, for the term of the pSiMedica licence, on a product-by-product
and country-by-country basis.
(iii) Potential milestone payments based only upon the Product being a commercial success, which cannot be guaranteed
now or in the future (ranging from US$1,000,000 to US$5,000,000) upon:
- OncoSil UK, its affiliates and any of OncoSil UK's third party transferees together potentially achieving US$5,000,000
aggregate net sales of the Product and any other product protected by the rights arising from the Assigned Patents, for (i)
an indication and (ii) a second indication;
- aggregate net sales of the Product and any other product protected by the rights arising from the Assigned Patents, paid
to OncoSil UK, its affiliates and third party transferees in a calendar year of US$20,000,000 or more; and
- aggregate net sales of the Product and any other product protected by the rights arising from the Assigned Patents, paid
to OncoSil UK, its affiliates and third party transferees in a calendar year of US$100,000,000 or more.
Termination of licence agreement
Unless terminated early for reasons such as a material breach, or by pSiMedica due to a patent challenge being brought
against pSiMedica in certain circumstances (including by OncoSil UK), the term of the licence for the Licensed Patents and
OncoSil UK's rights to exploit the product and any other products arising from the Assigned Patents, remain in effect on a
country-by-country and product-by-product basis, until the later to occur of:
●
●
the date on which the product or any other product protected by the rights arising from the Assigned Patents in such
country is no longer covered or protected by a potential claim of the Licensed Patents or the Assigned Patents in such
country; and
ten years from the date of first commercial sale of a product or any other product protected by the rights arising from
the Assigned Patents in such country.
In addition, if OncoSil UK reasonably forms the view that it is not capable of commercialising OncoSil™, OncoSil UK shall
have the right to terminate the license agreement by giving 60 days prior written notice to pSiMedica.
The directors are not aware of any other commitments or contingencies as at 30 June 2019.
33
41
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 19. Commitments
Lease commitments - operating
Committed at the reporting date but not recognised as liabilities, payable:
Within one year
One to five years
Consolidated
2019
$
2018
$
131,319
87,546
131,319
218,865
218,865
350,184
Operating lease commitments include contracted amounts for commercial premises under non-cancellable operating
leases expiring on 28 February 2021, with, in some cases, options to extend. The lease payments are increased on an
annual basis to reflect market rentals.
Note 20. Related party transactions
Parent entity
OncoSil Medical Ltd is the parent entity.
Subsidiaries
Interests in subsidiaries are set out in note 22.
Key management personnel
Disclosures relating to key management personnel are set out in note 16 and the remuneration report included in the
directors' report.
Transactions with related parties
Payment of Director's fees to Dr Chris Roberts AO, were made to his director-related entity, Robertsplan Pty Ltd during the
financial year of $80,000 (2018: $80,000).
Payment of Director's fees to Mr Michael Bassett, were made to his director-related entity, Market Connect Australia Pty
Ltd during the financial year of $44,822 (2018: Nil).
Receivable from and payable to related parties
There were no trade receivables from or trade payables to related parties at the current and previous reporting date.
Loans to/from related parties
There were no loans to or from related parties at the current and previous reporting date.
Terms and conditions
All transactions were made on normal commercial terms and conditions and at market rates.
Note 21. Parent entity information
Set out below is the supplementary information about the parent entity.
Statement of profit or loss and other comprehensive income
Loss after income tax
Total comprehensive income
42
34
Parent
2019
$
2018
$
(7,909,445)
(7,898,955)
(7,909,445)
(7,898,955)
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 21. Parent entity information (continued)
Statement of financial position
Total current assets
Total assets
Total current liabilities
Total liabilities
Equity
Issued capital
Share-based payments reserve
Accumulated losses
Total equity
Parent
2019
$
2018
$
13,552,451 21,030,265
13,614,917 21,116,520
972,307
1,697,562
972,307
1,697,562
52,257,231 52,257,231
5,048,559
(37,886,832)
6,181,656
(45,796,277)
12,642,610 19,418,958
Guarantees entered into by the parent entity in relation to the debts of its subsidiaries
The parent entity had no guarantees in relation to the debts of its subsidiaries as at 30 June 2019 and 30 June 2018.
Contingent liabilities
The parent entity had no contingent liabilities as at 30 June 2019 and 30 June 2018.
Capital commitments - Property, plant and equipment
The parent entity had no capital commitments for property, plant and equipment as at 30 June 2019 and 30 June 2018.
Significant accounting policies
The accounting policies of the parent entity are consistent with those of the Group, as disclosed in note 2, except for the
following:
●
●
Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity.
Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may be an
indicator of an impairment of the investment.
Note 22. Interests in subsidiaries
The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in
accordance with the accounting policy described in note 2:
Name
OncoSil Medical UK Limited
OncoSil Medical Germany GmbH
OncoSil Medical US Inc.
OncoSil Medical NZ Limited
Principal place of business /
Country of incorporation
United Kingdom
Germany
United States
New Zealand
Ownership interest
2018
2019
%
%
100%
100%
100%
100%
100%
100%
100%
100%
35
43
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 23. Reconciliation of loss after income tax to net cash used in operating activities
Loss after income tax expense for the year
Adjustments for:
Depreciation and amortisation
Share-based payments
Foreign exchange differences
Gain on disposal of assets
Change in operating assets and liabilities:
Decrease/(increase) in other operating assets
Increase/(decrease) in trade and other payables
Increase/(decrease) in employee benefits
Net cash used in operating activities
Note 24. Earnings per share
Consolidated
2019
$
2018
$
(8,566,731)
(8,539,542)
38,617
1,133,097
(45,934)
-
39,913
983,442
(36,640)
(713)
659,359
(816,440)
96,878
(902,071)
75,337
(17,067)
(7,501,154)
(8,397,341)
Consolidated
2019
$
2018
$
Loss after income tax attributable to the owners of OncoSil Medical Ltd
(8,566,731)
(8,539,542)
Weighted average number of ordinary shares used in calculating basic earnings per share
628,519,473 515,600,535
Weighted average number of ordinary shares used in calculating diluted earnings per share 628,519,473 515,600,535
Number
Number
Basic earnings per share
Diluted earnings per share
Cents
Cents
(1.36)
(1.36)
(1.66)
(1.66)
69,550,001 ESP have not been included in the diluted earnings per share calculation as they are anti-dilutive.
Accounting policy for earnings per share
Basic earnings per share
Basic earnings per share is calculated by dividing the profit attributable to the owners of OncoSil Medical Ltd, excluding
any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding
during the financial year, adjusted for bonus elements in ordinary shares issued during the financial year.
Diluted earnings per share
Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account
the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the
weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential
ordinary shares.
44
36
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 25. Share-based payments
The Group's Employee Share Plan (‘ESP’) is designed as an incentive for senior managers and above. Under the plan,
participants are granted shares which only vest if certain performance standards are met. The issue price is fully financed
by a limited recourse loan provided by the Group. Dividends are for the benefit of the employee. Employees are not
permitted to deal in the shares until the limited recourse loan has been repaid. Shares issued under the ESP are
accounted for in a similar manner as options. There are no cash settlement alternatives.
The following shares were on issue under the ESP at reporting date and held as security against limited recourse loan
arrangements:
2019
Grant date
Expiry date
price
Exercise
Balance at
the start of
the year
Granted
30/10/2013
28/11/2014
28/11/2014
08/10/2015
13/01/2016
13/01/2016
13/01/2016
10/05/2016
12/08/2016
11/12/2017
02/03/2018
02/03/2018
31/10/2018
31/10/2018
31/12/2019
31/12/2019
31/12/2019
08/10/2018
13/01/2019
13/01/2019
13/01/2020
10/05/2021
30/06/2021
11/12/2020
02/03/2021
02/03/2021
31/10/2021
31/10/2021
5,000,000
$0.15
500,000
$0.18
3,000,000
$0.13
1,538,462
$0.13
769,231
$0.13
5,730,769
$0.13
8,500,000
$0.13
$0.22 24,000,000
4,000,000
$0.22
769,231
$0.22
4,230,769
$0.22
1,000,000
$0.22
-
$0.18
-
$0.18
59,038,462
-
-
-
-
-
-
-
-
-
-
-
-
3,275,000
3,275,000
6,550,000
Expired/
forfeited/
other
Balance at
the end of
the year
5,000,000
-
500,000
-
3,000,000
-
-
-
-
-
-
-
8,500,000
-
- 24,000,000
4,000,000
-
769,231
-
4,230,769
-
1,000,000
-
3,275,000
-
-
3,275,000
- 57,550,000
Vested*
-
-
-
(1,538,462)
(769,231)
(5,730,769)
-
-
-
-
-
-
-
-
(8,038,462)
Weighted average exercise price
$0.18
$0.18
$0.13
$0.00
$0.19
*
During the year 1,538,462 shares with expiry date 8 October 2018 vested.
During the year, of the 15,000,000 shares with expiry date 13 January 2019, 6,500,000 shares vested. The expiry
date of the remaining 8,500,000 shares was extended until 13 January 2020.
The vesting conditions for the loan shares issued during the year on 31 October 2018 are as follow;
●
The first tranche of 3,275,000 shares will vest automatically if and when OncoSil Total Shareholder Return (TSR) has
a compound annual growth rate (CAGR) of 15%, provided that the Participant has been continuously employed with
the Company at the time the CAGR achieves 15% - 3 year loan. 1,650,000 of these shares were issued to Daniel
Kenny (CEO and Managing Director) and 325,000 shares were issued to Tom Milicevic (CFO). The second tranche of
3,275,000 shares will vest automatically if and when TSR has a CAGR of 25%, provided that the Participant has been
continuously employed with the Company at the time the CAGR achieves 25% - 3 year loan. 1,650,000 of these
shares were issued to Daniel Kenny (CEO and Managing Director) and 325,000 shares were issued to Tom Milicevic
(CFO)
The following unvested shares were on issue under the ESP as at 30 June 2018 and were being held as security against
limited recourse loan arrangements:
37
45
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 25. Share-based payments (continued)
2018
Grant date
Expiry date
price
Exercise
Balance at
the start of
the year
Granted
30/10/2013
28/11/2014
28/11/2014
08/10/2015
13/01/2016
13/01/2016
13/01/2016
10/05/2016
12/08/2016
11/12/2017
02/03/2018
02/03/2018
31/12/2019
31/12/2019
31/12/2019
08/10/2018
13/01/2019
13/01/2019
13/01/2020
10/05/2021
30/06/2021
11/12/2020
02/03/2021
11/08/2021
5,000,000
$0.15
500,000
$0.18
6,000,000
$0.13
2,307,693
$0.13
769,231
$0.13
5,730,769
$0.13
$0.13
8,500,000
$0.22 24,000,000
4,000,000
$0.22
769,231
$0.22
-
$0.22
-
$0.22
57,576,924
-
-
-
-
-
-
-
-
-
-
4,230,769
1,000,000
5,230,769
Expired/
forfeited/
other
Balance at
the end of
the year
5,000,000
-
500,000
-
3,000,000
-
1,538,462
(769,231)
769,231
-
5,730,769
-
-
8,500,000
- 24,000,000
4,000,000
-
769,231
-
4,230,769
-
1,000,000
-
(769,231) 59,038,462
Vested
-
-
(3,000,000)
-
-
-
-
-
-
-
-
-
(3,000,000)
Weighted average exercise price
$0.18
$0.22
$0.00
$0.13
$0.18
The details of loan shares issued as at 30 June 2018 are as follows:
In relation to 4,230,769 shares granted on 2 March 2018, these are subject to various operational milestones and
continuous employment with the company until the applicant reaches the 4th anniversary of employment – 5 year loan.
In relation to 1,000,000 shares granted on 2 March 2018, terms include continuous employment with the company until the
applicant reaches the 4th anniversary of employment – 5 year loan.
There are 4 separate loan tranches each representing 25% of the total number of shares as disclosed;
ꞏ Tranche 1 shares will vest automatically upon OncoSil™ total revenue reaching a cumulative total of at least $10m
. Tranche 2 shares will vest automatically upon OncoSil™ total revenue reaching a cumulative total of at least $15m
ꞏ Tranche 3 shares will vest automatically upon OncoSil™ total revenue reaching a cumulative total of at least $30m
ꞏ Tranche 4 shares will vest automatically upon OncoSil™ total revenue reaching a cumulative total of at least $50m
In relation to 4,000,000 shares granted on 12 August 2016, employees were issued such shares as per the existing
employee loan share plan approved by shareholders on 29 April 2014.*
In relation to 24,000,000 shares granted on 10 May 2016, these related to shares issued to Daniel Kenny (CEO and
Managing Director) and Dr Chris Roberts (Director) who were issued 14,000,000 and 10,000,000 shares respectively as
per the existing employee loan share plan approved by shareholders 29 April 2014.*
* The vesting conditions are the same as the 4 tranches above. The 1,000,000; 4,000,000 and 24,000,000 shares have the
same vesting conditions.
In relation to 14,230,769 shares granted on 13 January 2016 4,230,679 shares were issued to Tom Milicevic and
10,000,000 shares were issued to two senior executives of the Company under an existing employee loan share plan
approved by shareholders on 29 April 2014. The vesting conditions attached to the 5,000,000 shares issued to Tom
Milicevic are as follows:
46
38
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 25. Share-based payments (continued)
●
●
Tranche 1 - 1,500,000 shares which will vest automatically (within 4 year period from date of issue) when the total
shareholder returns (TSR) in respect of holding ordinary shares in OncoSil Medical Ltd equals 175% - where the TSR
is calculated using the average closing share price over the period of 30 consecutive trading days concluding on the
issue date for the relevant shares as compared to the average closing share price over the period of 30 consecutive
trading days concluding on the relevant calculation date. Notwithstanding the achievement of this TSR, the Tranche 1
shares will not vest until the expiry of 1 year from the date of issue of the Tranche 1 shares.
Tranche 2 – 1,500,000 shares which will vest automatically (within 4 year period from date of issue) (but subject to
below) when the TSR in respect of holding ordinary shares in the Company equals 250% - where the TSR is
calculated using the average closing share price over the period of 30 consecutive trading days concluding on the
issue date for the relevant shares as compared to the average closing share price over the period of 30 consecutive
trading days concluding on the relevant calculation date. Notwithstanding the achievement of this TSR, the Tranche 2
shares will not vest until the expiry of 1 year from the date of issue of the Tranche 2 shares.
●
Tranche 3 – 2,000,000 shares which will vest automatically when Mr Tom Milicevic reaches his 3rd anniversary of
continuous employment with the Company.
In relation to 769,231 shares granted on 13 January 2016, these were issued to Tom Milicevic. These are subject to
various operational milestones and continuous employment with the company until the applicant reaches the 3rd
anniversary of employment – 3 year loan.
In relation to 2,307,683 shares granted on 8 October 2015, these were issued to 3 employees (769,231 each) as per the
existing employee loan share plan approved by shareholders on 29 April 2014. These are subject to various operational
milestones and continuous employment with the company until the applicant reaches the 3rd anniversary of employment –
3 year loan.
The 3,000,000 shares and 500,000 shares granted on 28 November 2014 will vest when the company receives FDA
approval.
Set out below are the vested and unreleased loan shares subject to loan repayment at the end of the financial year:
Grant date
Expiry date
19/05/2014
28/11/2014
28/11/2014
07/10/2015
07/10/2015
13/01/2016
13/01/2016
13/01/2016
19/05/2017
31/12/2018
31/12/2018
07/10/2018
07/10/2018
13/01/2019
13/01/2019
13/01/2019
2019
2018
Number
Number
461,539
500,000
3,000,000
769,231
769,231
2,000,000
2,000,000
2,500,000
461,539
500,000
3,000,000
-
-
-
-
-
12,000,001
3,961,539
39
47
OncoSil Medical
Annual Report 2019
Notes to the financial statements cont.
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 25. Share-based payments (continued)
Share based payments were priced using Black-Scholes option pricing model inputs to determine the fair value at the grant
date as follows:
Grant date
Expiry date
Share price Exercise
at grant date
price
Expected
volatility
Dividend
Risk-free
Fair value
yield
interest rate at grant date
31/10/2018
31/10/2018
02/03/2018
02/03/2018
12/08/2016
10/05/2016
13/01/2016
28/11/2014
28/11/2014
30/10/2013
31/10/2021
31/10/2021
11/08/2021
02/03/2021
30/06/2021
10/05/2021
13/01/2019
31/12/2019
31/12/2019
31/12/2019
$0.19
$0.19
$0.13
$0.13
$0.14
$0.15
$0.12
$0.08
$0.08
$0.13
$0.18
$0.18
$0.22
$0.22
$0.22
$0.22
$0.13
$0.13
$0.18
$0.15
62.70%
62.70%
99.00%
99.00%
99.00%
99.00%
99.00%
109.80%
109.80%
82.00%
-
-
-
-
-
-
-
-
-
-
2.10%
2.10%
2.50%
2.50%
2.50%
2.50%
1.95%
2.50%
2.50%
2.50%
$0.078
$0.078
$0.073
$0.073
$0.096
$0.104
$0.081
$0.059
$0.056
$0.089
Terms of limited recourse loan arrangement
The loans issued are limited recourse such that on the repayment date the repayment obligation under the loan will be
limited to the lesser of:
(a) the outstanding balance of the loan; and
(b) the market value of the loan shares on that date.
In addition, where the participant has elected for the loan shares to be provided to the Company in full satisfaction of the
loan, the Company must accept the loan shares as full settlement of the repayment obligation under the loan.
The total value of loans outstanding under the Employee Share Plan at reporting date was $10,994,000 (2018:
$10,860,000).
The weighted average remaining contractual life of loan shares outstanding at the end of the financial year was 18 months
(2018: 27 months).
Accounting policy for share-based payments
Equity-settled share-based compensation benefits are provided to employees.
Equity-settled transactions are awards of shares, or options over shares, that are provided to employees in exchange for
the rendering of services.
The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently determined
using the Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact
of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield
and the risk free interest rate for the term of the option, together with non-vesting conditions that do not determine whether
the Group receives the services that entitle the employees to receive payment. No account is taken of any other vesting
conditions.
The cost of equity-settled transactions are recognised as an expense with a corresponding increase in equity over the
vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the
best estimate of the number of awards that are likely to vest and the expired portion of the vesting period. The amount
recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already
recognised in previous periods.
Market conditions are taken into consideration in determining fair value. Therefore any awards subject to market conditions
are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are
satisfied.
If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made.
An additional expense is recognised, over the remaining vesting period, for any modification that increases the total fair
value of the share-based compensation benefit as at the date of modification.
48
40
OncoSil Medical Ltd
Notes to the financial statements
30 June 2019
Note 25. Share-based payments (continued)
If the non-vesting condition is within the control of the Group or employee, the failure to satisfy the condition is treated as a
cancellation. If the condition is not within the control of the Group or employee and is not satisfied during the vesting
period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited.
If equity-settled awards are cancelled, they are treated as if they had vested on the date of cancellation, and any remaining
expense is recognised immediately. If a new replacement award is substituted for the cancelled award, the cancelled and
new award is treated as if they were a modification.
Note 26. Events after the reporting period
No matter or circumstance has arisen since 30 June 2019 that has significantly affected, or may significantly affect the
Group's operations, the results of those operations, or the Group's state of affairs in future financial years.
41
49
OncoSil Medical
Annual Report 2019
Directors’ declaration
OncoSil Medical Ltd
Directors' declaration
30 June 2019
In the directors' opinion:
●
●
●
●
the attached financial statements and notes comply with the Corporations Act 2001, the Accounting Standards, the
Corporations Regulations 2001 and other mandatory professional reporting requirements;
the attached financial statements and notes comply with International Financial Reporting Standards as issued by the
International Accounting Standards Board as described in note 2 to the financial statements;
the attached financial statements and notes give a true and fair view of the Group's financial position as at 30 June
2019 and of its performance for the financial year ended on that date; and
there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due
and payable.
The directors have been given the declarations required by section 295A of the Corporations Act 2001.
Signed in accordance with a resolution of directors made pursuant to section 295(5)(a) of the Corporations Act 2001.
On behalf of the directors
___________________________
Dr Chris Roberts AO
Non-Executive Chairman
23 August 2019
Sydney
50
42
Independent auditor’s report
Crowe Sydney
ABN 97 895 683 573
Member of Crowe Global
Audit and Assurance Services
Level 15, 1 O’Connell Street
Sydney NSW 2000
Australia
Tel +61 2 9262 2155
Fax +61 2 9262 2190
www.crowe.com.au
Independent Auditor’s Report to the Members of
OncoSil Medical Ltd
Report on the Audit of the Financial Report
Opinion
We have audited the financial report of OncoSil Medical Ltd (the Company) and its subsidiaries (the
Group), which comprises the statement of financial position as at 30 June 2019, the statement of profit
or loss and other comprehensive income, the statement of changes in equity and the statement of
cash flows for the year then ended, and notes to the financial statements, including a summary of
significant accounting policies, and the directors’ declaration.
In our opinion, the accompanying financial report of the Group is in accordance with the Corporations
Act 2001, including:
(a) giving a true and fair view of the Group’s financial position as at 30 June 2019 and of its financial
performance for the year then ended; and
(b) complying with Australian Accounting Standards and the Corporations Regulations 2001.
Basis for Opinion
We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under
those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial
Report section of our report. We are independent of the Group in accordance with the auditor
independence requirements of the Corporations Act 2001 and the ethical requirements of the
Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional
Accountants (the Code) that are relevant to our audit of the financial report in Australia. We have also
fulfilled our other ethical responsibilities in accordance with the Code.
The title ‘Partner’ conveys that the person is a senior member within their respective division, and is among the group of persons who hold an
equity interest (shareholder) in its parent entity, Findex Group Limited. The only professional service offering which is conducted by a partnership
is the Crowe Australasia external audit division. All other professional services offered by Findex Group Limited are conducted by a privately
owned organisation and/or its subsidiaries.
Findex (Aust) Pty Ltd, trading as Crowe Australasia is a member of Crowe Global, a Swiss verein. Each member firm of Crowe Global is a
separate and independent legal entity. Findex (Aust) Pty Ltd and its affiliates are not responsible or liable for any acts or omissions of Crowe
Global or any other member of Crowe Global. Crowe Global does not render any professional services and does not have an ownership or
partnership interest in Findex (Aust) Pty Ltd. Services are provided by Crowe Sydney, an affiliate of Findex (Aust) Pty Ltd. Liability limited by a
scheme approved under Professional Standards Legislation. Liability limited other than for acts or omissions of financial services licensees.
© 2019 Findex (Aust) Pty Ltd.
43
51
OncoSil Medical
Annual Report 2019
Independent auditor’s report cont.
Independent Auditor’s Report
OncoSil Medical Ltd
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis
for our opinion.
Key Audit Matters
Key audit matters are those matters that, in our professional judgement, were of most significance in
our audit of the financial report of the current period. These matters were addressed in the context of
our audit of the financial report as a whole, and in forming our opinion thereon, and we do not provide
a separate opinion on these matters.
Key Audit Matter
How we addressed the Key Audit Matter
Research and Development Tax Incentive
Refer to Note 3 and Note 5
Under the Research and Development (R&D)
Tax Incentive scheme, the Group is entitled to
receive a 43.5% refundable tax offset of eligible
expenditure if its turnover is less than $20 million
per annum provided it is not controlled by the
income tax exempt entities.
The R&D plan is filed with AusIndustry in the
following financial year, and based on this filing,
the Group receives the incentive in cash. The
Group prepared an estimate of its total R&D
expenditure to determine the potential claim
under the R&D tax incentive legislation.
As at 30 June 2019, the Group had an
estimated claim of $3.8 million relating to the
year ended 30 June 2019.
The R&D tax incentive is a key audit matter due
to the size of the balance and because
interpretation of the R&D tax legislation is
required by the Group to assess the eligibility of
the R&D expenditure under the scheme.
We performed the following key procedures:
• Agreed the estimate made in previous year
to the amount of cash received after
lodgement of the R&D tax claim.
• Compared the nature of R&D expenditure
included in the current year estimate to the
prior year estimate.
• Tested a sample of R&D expenses for
eligibility under the R&D Tax Incentive
scheme.
• Compared the amount of eligible
expenditures used to calculate the estimate
to the expenditure recorded in the general
ledger.
•
Inspected copies of relevant documents
lodged with AusIndustry and the ATO
related to historic claims.
• Reviewed the related financial statement
disclosures.
52
44
Independent Auditor’s Report
OncoSil Medical Ltd
Other Information
The directors are responsible for the other information. The other information comprises the
information included in the Group’s annual report for the year ended 30 June 2019, but does not
include the financial report and our auditor’s report thereon.
Our opinion on the financial report does not cover the other information and accordingly we do not
express any form of assurance conclusion thereon.
In connection with our audit of the financial report, our responsibility is to read the other information
and, in doing so, consider whether the other information is materially inconsistent with the financial
report or our knowledge obtained in the audit or otherwise appears to be materially misstated.
If, based on the work we have performed, we conclude that there is a material misstatement of this
other information, we are required to report that fact. We have nothing to report in this regard.
Responsibilities of the Directors for the Financial Report
The directors of the Company are responsible for the preparation of the financial report that gives a
true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001
and for such internal controls as the directors determine is necessary to enable the preparation of the
financial report that gives a true and fair view and is free from material misstatement, whether due to
fraud or error.
In preparing the financial report, the directors are responsible for assessing the ability of the Group to
continue as a going concern, disclosing, as applicable, matters related to going concern and using the
going concern basis of accounting unless the directors either intend to liquidate the Group or to cease
operations, or have no realistic alternative but to do so.
Auditor’s Responsibilities for the Audit of the Financial Report
Our objectives are to obtain reasonable assurance about whether the financial report as a whole is
free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that
includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that
an audit conducted in accordance with the Australian Auditing Standards will always detect a material
misstatement when it exists. Misstatements can arise from fraud or error and are considered material
if, individually or in the aggregate, they could reasonably be expected to influence the economic
decisions of users taken on the basis of this financial report.
As part of an audit in accordance with the Australian Auditing Standards, we exercise professional
judgement and maintain professional scepticism throughout the audit. We also:
•
Identify and assess the risks of material misstatement of the financial report, whether due to fraud
or error, design and perform audit procedures responsive to those risks, and obtain audit evidence
that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a
material misstatement resulting from fraud is higher than for one resulting from error, as fraud may
involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal
controls.
45
53
OncoSil Medical
Annual Report 2019
Independent auditor’s report cont.
Independent Auditor’s Report
OncoSil Medical Ltd
• Obtain an understanding of internal controls relevant to the audit in order to design audit
procedures that are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Group’s internal controls.
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting
estimates and related disclosures made by the directors.
•
• Conclude on the appropriateness of the directors’ use of the going concern basis of accounting
and, based on the audit evidence obtained, whether a material uncertainty exists related to events
or conditions that may cast significant doubt on the Group’s ability to continue as a going concern.
If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s
report to the related disclosures in the financial report or, if such disclosures are inadequate, to
modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of
our auditor’s report. However, future events or conditions may cause the Group to cease to
continue as a going concern.
Evaluate the overall presentation, structure and content of the financial report, including the
disclosures, and whether the financial report represents the underlying transactions and events in
a manner that achieves fair presentation.
•
• Obtain sufficient appropriate audit evidence regarding the financial information of the entities or
business activities within the Group to express an opinion on the group financial report. The
auditor is responsible for the direction, supervision and performance of the group audit. The
auditor remains solely responsible for the audit opinion.
We communicate with the directors regarding, among other matters, the planned scope and timing of
the audit and significant audit findings, including any significant deficiencies in internal controls that we
identify during the audit.
We also provide the directors with a statement that we have complied with relevant ethical
requirements regarding independence, and to communicate with them all relationships and other
matters that may reasonably be thought to bear on our independence, and where applicable, related
safeguards.
From the matters communicated with the directors, we determine those matters that were of
most significance in the audit of the financial report of the current period and are therefore the key
audit matters. We describe these matters in the auditor’s report unless law or regulation
precludes public disclosure about the matter or when, in extremely rare circumstances, we
determine that a matter should not be communicated in the auditor’s report because the adverse
consequences of doing so would reasonably be expected to outweigh the public interest benefits of
such communication.
Report on the Remuneration Report
Opinion on the Remuneration Report
We have audited the remuneration report included in pages 14 to 21 of the directors’ report for the year
ended 30 June 2019.
In our opinion, the remuneration report of OncoSil Medical Ltd, for the year ended 30 June 2019,
complies with section 300A of the Corporations Act 2001.
54
46
Independent Auditor’s Report
OncoSil Medical Ltd
Responsibilities
The directors of the Company are responsible for the preparation and presentation of the
remuneration report in accordance with section 300A of the Corporations Act 2001. Our responsibility
is to express an opinion on the remuneration report, based on our audit conducted in accordance with
Australian Auditing Standards.
Crowe Sydney
John Haydon
Senior Partner
23 August 2019
Sydney
47
55
OncoSil Medical
OncoSil Medical
Annual Report 2019
Annual Report 2019
Shareholder information
OncoSil Medical Ltd
The shareholder information set out below was applicable as at 10 September 2018.
Distribution of equitable securities
Analysis of number of equitable security holders by size of holding:
Holdings Ranges
1-1,000
1,001-5,000
5,001-10,000
10,001-100,000
100,001-9,999,999,999
Totals
Holding less than a marketable parcel
Equity security holders
Twenty largest quoted equity security holders
# of holders of
options over
ordinary
shares
ordinary
shares
109
297
448
1,795
796
3,445
450
0
0
0
0
0
0
0
The names of the twenty largest security holders of quoted equity securities are listed below:
Holder Name
CITICORP NOMINEES PTY LIMITED
WEBINVEST PTY LTD
MR DANIEL KENNY
MERRILL LYNCH (AUSTRALIA) NOMINEES PTY LIMITED
BANNABY INVESTMENTS PTY LIMITED
MR ROGER ASTON
ROJO NERO CAPITAL PTY LTD
TISIA NOMINEES PTY LTD
CS FOURTH NOMINEES PTY LIMITED
UBS NOMINEES PTY LTD
MR CHRISTOPHER GRAHAM ROBERTS
CS THIRD NOMINEES PTY LIMITED
WESTCAP PTY LTD
MR ADRIAN DARBY
MS NICOLE WILSON
MR TOM MILICEVIC
MR ASHISH SOMAN
MR DAVID CHARLES JAMES
MR MICHAEL WARRENER
BRISPOT NOMINEES PTY LTD
Total of Securities
56
Ordinary shares
% of total
shares issued
7.61%
3.84%
3.21%
3.11%
3.02%
2.94%
2.58%
2.01%
1.92%
1.83%
1.62%
1.40%
1.16%
0.95%
0.84%
0.82%
0.80%
0.80%
0.80%
0.80%
37.18%
# held
28,354,197
24,680,000
23,341,667
18,878,071
18,842,690
12,516,547
11,718,422
11,584,768
11,279,073
10,485,612
10,125,000
7,510,000
5,957,687
5,857,480
5,650,000
5,650,000
5,650,000
5,650,000
5,650,000
5,106,918
234,488,132
630,708,788
Unquoted equity securities
Options over ordinary shares issued
Not applicable
Substantial holders
Substantial holders in the Company are set out below:
REGAL FUNDS MANAGEMENT PTY LIMITED
Voting rights
The voting rights attached to ordinary shares are set out below:
# of shares
# of holders
0
0
# of shares
# of holders
38,416,218
6.09%
Ordinary shares
On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each
share shall have one vote.
There are no other classes of equity securities.
57
OncoSil Medical
Annual Report 2019
Corporate directory
OncoSil Medical Limited ABN 89 113 824 141
www.oncosil.com.au
Directors
Dr Chris Roberts Non-Executive Chairman
Mr Daniel Kenny CEO and Managing Director
Dr Roger Aston Non-Executive Director
Dr Martin Cross Non-Executive Director
Mr Michael Bassett Non Executive Director
Company Secretary
Tom Milicevic CFO and Company Secretary
Registered Office
Suite 402, Level 4, 50 Berry St
North Sydney NSW 2060
T: +61 2 9223 3344
Bankers
Westpac Banking Corporation
341 George St
Sydney NSW 2000
Auditors
Crowe Sydney
Level 15, 1 O’Connell St
Sydney NSW 2000
T: +61 2 9262 2155
Legal Counsel
K&L Gates
Level 25, South Tower, 525 Collins St
Melbourne VIC 3000
T: +61 3 9205 2000
Davies Collison Cave
Level 14, 255 Elizabeth St
Sydney NSW 2000
T: +61 2 9293 1000
Stock Exchange
OncoSil Medical Limited shares are listed
on the Australian Securities Exchange
ASX code: OSL
Share Registry
Boardroom Pty Ltd
Level 12, 225 George St
Sydney NSW 2000
T: 1300 737 760
58
www.colliercreative.com.au #ONC0005
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OncoSil Medical Limited
www.oncosil.com.au
T: +61 2 9223 3344
F: +61 2 9252 3988