Appendix 4C - quarterly
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W H ER E
B I O T E C H N O L OG Y
&
NANOTECHNOLOGY
M EET
®
B I O S Y S T E M S
Imagion Biosystems
September 2018 Quarterly Update
Highlights:
•
•
•
Imagion Biosystems hits nanoparticle formulation milestone
Appointment of Dr John Hazle as Non-Executive Director
Pro-Rata Non-Renounceable Rights Issue to fund first-in-human study for metastatic breast
cancer
MELBOURNE — 30 October 2018 — Imagion Biosystems Limited (ASX: IBX), a company
dedicated to improving healthcare through the earlier detection of cancer, is pleased to provide
an update on its activities for the quarter ended 30 September 2018 and an update on business
progress.
Operational highlights
During September Imagion Biosystems achieved a key milestone in its drive to first-in-human
testing, successfully optimising the nanoparticle formulation for its first intended clinical product.
Imagion Biosystems will now move its product toward clinical development, first with a test for the
detection of HER2 breast cancer cells in the lymph nodes.
Imagion Biosystems manufacturing partner will produce the first batch of the HER2 nanoparticle
test reagent, to be used in a toxicology study required ahead of the intended first-in-human study
expected in early 2019.
During the remainder of 2018 and prior to the initiation of Imagion Biosystem’s first-in-human
study, the Company expects to:
• Undertake testing of nanoparticles for safety and toxicity
• Initiate production of a second batch of material for the initial human research study
• Seek regulatory and institutional approval for the first-in-human study
Corporate
During September Imagion Biosystems announced a pro-rata non-renounceable rights issue to
shareholders, on the basis of 1 new share for every 2 Imagion shares held as at 7.00pm (Melbourne
time) Friday 28 September 2018.
Pursuant to the Offer, the Company will issue up to 107,147,608 fully paid ordinary shares in the
Company (New Shares) at an issue price of $0.04 each, to raise up to$4.3 million (before costs).
The entitlement to subscribe for New Shares under the Offer will be non-renounceable.
Imagion Biosystems is raising funds to support the first-in-human study, expected to be conducted
at the MD Anderson Cancer Center in Texas, USA in early 2019. The study will commence following
small scale production transfer and safety testing of the breast cancer test reagent.
The funds raised will ensure Imagion Biosystems has adequate resources to undertake and
complete this early feasibility study which marks an important milestone in the product
development and regulatory path.
W H ER E
B I O T E C H N O L OG Y
&
NANOTECHNOLOGY
M EET
®
B I O S Y S T E M S
During July, Imagion Biosystems appointed Dr John Hazle as Non-Executive Director of the
Company. Dr Hazle is the Professor and Chair of the Department of Imaging Physics at The
University of Texas MD Anderson Cancer Center. John will chair Imagion Biosystems Scientific
Advisory Board.
About Imagion Biosystems
Imagion Biosystems is at the crossroads of biotechnology and nanotechnology. Its novel
bioimaging and nanomagnetic detection systems have been developed specifically to detect
cancer and other diseases earlier and with higher specificity than is currently possible. With
TM
MagSense technology, the company has the potential to optimize patient care and reduce
mortality rates across various cancer indications. Imagion Biosystems listed on the Australian
Securities Exchange (ASX) in June 2017.
For further information please visit www.imagionbiosystems.com
Australian Media & Investor Relations:
Matt Wright, NWR Communications
matt@nwrcommunications.com.au
+61-451-896-420
U.S. Media Contact:
Matthew Wygant
matthew@biotechwriting.com
+1-408-905-7630
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
+Rule 4.7B
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16
Name of entity
Imagion Biosystems Limited
ABN:
Quarter ended (“current quarter”)
42 616 305 027
30 September 2018
Current quarter
$A’000
Year to date (9
months)
$A’000
54
80
(616)
(1,694)
-
-
(13)
(76)
-
(5)
(e) staff costs
(812)
(2,552)
(f)
(203)
(733)
Consolidated statement of cash flows
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
(a) research and development
(b) product manufacturing and operating
costs
(c) advertising and marketing
(d) leased assets
administration and corporate costs
1.3
Dividends received (see note 3)
-
-
1.4
Interest received
6
61
1.5
Interest and other costs of finance paid
1
(1)
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
-
1.8
Other (GST Refund)
20
40
1.9
Net cash from / (used in) operating
activities
(1,563)
(4,880)
2.
Cash flows from investing activities
2.1
Payments to acquire:
(a) property, plant and equipment
-
(33)
(b) businesses (see item 10)
-
-
(c) investments
-
-
+ See chapter 19 for defined terms
1 September 2016
Page 1
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
Current quarter
$A’000
Year to date (9
months)
$A’000
(d) intellectual property
-
-
(e) other non-current assets
-
-
(a) property, plant and equipment
-
-
(b) businesses (see item 10)
-
-
(c) investments
-
-
(d) intellectual property
-
-
(e) other non-current assets
-
-
2.3
Cash flows from loans to other entities
-
-
2.4
Dividends received (see note 3)
-
-
2.5
Other (provide details if material)
-
-
2.6
Net cash from / (used in) investing
activities
-
(33)
3.
Cash flows from financing activities
3.1
Proceeds from issues of shares
-
-
3.2
Proceeds from issue of convertible notes
-
-
3.3
Proceeds from exercise of share options
-
-
3.4
Transaction costs related to issues of
shares, convertible notes or options
-
-
3.5
Proceeds from borrowings
-
-
3.6
Repayment of borrowings
(45)
(94)
3.7
Transaction costs related to loans and
borrowings
-
-
3.8
Dividends paid
-
-
3.9
Other (provide details if material)
-
-
3.10
Net cash from / (used in) financing
activities
(45)
(94)
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
quarter/year to date
3,606
6,901
(1,563)
(4,880)
Consolidated statement of cash flows
2.2
Proceeds from disposal of:
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
-
(33)
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
(45)
(94)
+ See chapter 19 for defined terms
1 September 2016
Page 2
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Current quarter
$A’000
Year to date (9
months)
$A’000
4.5
Effect of movement in exchange rates on
cash held
(12)
92
4.6
Cash and cash equivalents at end of
quarter
1,986
1,986
5.
Reconciliation of cash and cash
equivalents
Current quarter
$A’000
Previous quarter
$A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1
Bank balances
1,986
3,606
5.2
Call deposits
-
-
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
1,986
3,606
6.
Payments to directors of the entity and their associates
Current quarter
$A'000
6.1
Aggregate amount of payments to these parties included in item 1.2
99
6.2
Aggregate amount of cash flow from loans to these parties included
in item 2.3
-
6.3
Include below any explanation necessary to understand the transactions included in
items 6.1 and 6.2
7.
Payments to related entities of the entity and their
associates
7.1
Aggregate amount of payments to these parties included in item 1.2
-
7.2
Aggregate amount of cash flow from loans to these parties included
in item 2.3
-
7.3
Include below any explanation necessary to understand the transactions included in
items 7.1 and 7.2
+ See chapter 19 for defined terms
1 September 2016
Current quarter
$A'000
Page 3
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
8.
Financing facilities available
Add notes as necessary for an
understanding of the position
Total facility amount
at quarter end
$A’000
Amount drawn at
quarter end
$A’000
8.1
Loan facilities
-
-
8.2
Credit standby arrangements
-
-
8.3
Other (please specify)
-
-
8.4
Include below a description of each facility above, including the lender, interest rate and
whether it is secured or unsecured. If any additional facilities have been entered into or are
proposed to be entered into after quarter end, include details of those facilities as well.
9.
Estimated cash outflows for next quarter
9.1
Research and development
568
9.2
Product manufacturing and operating costs
330
9.3
Advertising and marketing
18
9.4
Leased assets
9
9.5
Staff costs
671
9.6
Administration and corporate costs
330
9.7
Other (provide details if material)
-
9.8
Total estimated cash outflows
1,926
10.
Acquisitions and disposals of
business entities
(items 2.1(b) and 2.2(b) above)
10.1
Name of entity
10.2
Place of incorporation or
registration
10.3
Consideration for acquisition or
disposal
10.4
Total net assets
10.5
Nature of business
+ See chapter 19 for defined terms
1 September 2016
Acquisitions
$A’000
Disposals
Page 4
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
Compliance statement
1
This statement has been prepared in accordance with accounting standards and policies which
comply with Listing Rule 19.11A.
2
This statement gives a true and fair view of the matters disclosed.
Sign here:
............................................................
Director
Print name:
Robert Proulx
Date: 30 October 2018
Notes
1.
The quarterly report provides a basis for informing the market how the entity’s activities have been
financed for the past quarter and the effect on its cash position. An entity that wishes to disclose
additional information is encouraged to do so, in a note or notes included in or attached to this
report.
2.
If this quarterly report has been prepared in accordance with Australian Accounting Standards,
the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If
this quarterly report has been prepared in accordance with other accounting standards agreed by
ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this
report.
3.
Dividends received may be classified either as cash flows from operating activities or cash flows
from investing activities, depending on the accounting policy of the entity.
+ See chapter 19 for defined terms
1 September 2016
Page 5
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