Appendix 4C - quarterly
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ASX ANNOUNCEMENT: APPENDIX 4C
29 April 2016
The Manager
Company Announcements Office
ASX Limited
20 Bridge St
SYDNEY NSW 2000
Dear Sir
APPENDIX 4C
Invion Limited (ASX:IVX) is pleased to lodge its Appendix 4C for the quarter ending 31 March 2016.
The Company held cash reserves of $0.852 million at the end of March, with cash outflows during the
quarter at $1.2 million. Operating and R&D cash outflows continue to be significantly reduced from
earlier quarters following the completion of major program activity.
Following the recent meeting with the US Food & Drug Administration (FDA) regarding the smoking
cessation program for INV102 (nadolol), and reflecting the reduced R&D and operational activity while
business development activities continue, the company has reduced headcount to further significantly
reduce burn rate in the coming quarters.
Business Update
In late 2015, Invion completed all projected R&D activities on its three drug assets across four
development programs, and subsequently appointed Ferghana Partners Group to progress various
potential commercial opportunities.
The major R&D milestones included:
― Data from phase 2 clinical trial of INV013 (ala-Cpn10) in lupus patients;
― Selection of formulation and device and commencement of manufacture of
toxicology and clinical supplies for INV104 (zafirlukast);
― Positive safety and efficacy data from phase 2 oral INV102 (nadolol) study in patients
undergoing smoking cessation and completion of enrolment of NIH-funded phase 2
study of INV102 (nadolol) in asthma patients; and
― Pre-IND status as a potential therapy for asthma, COPD & cystic fibrosis, and
manufacture of toxicology and clinical supplies and commencement of toxicology
studies for inhaled INV102 (nadolol)
An Appendix 4C accompanies this announcement.
For and on behalf of the Board of Invion Limited
MELANIE FARRIS
Company Secretary and Head of Operations
Invion Limited ABN 76 094 730 417
GPO Box 1557, Brisbane, QLD 4073 P +61 7 3295 0500 F +61 7 3295 0599 www.inviongroup.com
ASX ANNOUNCEMENT: APPENDIX 4C
About Invion Limited
Invion is a life sciences company focussed on the development of treatments for major opportunities in
respiratory and autoimmune disease. Invion has three drug assets in development across four
development programs. Invion is an ASX listed company (ASX:IVX), with operations in Brisbane, Australia
and Delaware, USA.
INV102 (nadolol) is a beta adrenergic biased ligand targeted to reverse mucous metaplasia in
the airway epithelium treat chronic inflammatory airway diseases. In Q4 2015, Invion reported
that data from a 155 patient phase 2 study of oral INV102 in smoking cessation demonstrated
good safety and that treated patients were more likely to stop smoking completely or
dramatically reduce the number of cigarettes smoked. An End of Phase 2 Meeting with the
FDA was held in 1Q 2016. Feasibility for an inhaled version of the drug to potentially treat COPD
and cystic fibrosis is well-progressed with 3M Drug Delivery Systems, and toxicological studies
have commenced. In addition, a phase 2 study of oral INV102 in mild asthma patients funded
by the US NIH is fully recruited and will complete dosing in 1H 2016.
INV104 (zafirlukast) is a leukotriene receptor antagonist (LTRA) that reduces inflammation,
constriction of the airways, and the build-up of mucus in the lungs. An FDA-approved oral
therapy, Invion is, through a joint development and licensing agreement with Hovione Scientia
Limited, developing a proprietary dry powder formulation of the drug for the development of
INV104 (zafirlukast) as a potential inhaled therapy for asthma.
INV103 (ala-Cpn10) is a modified, naturally occurring human protein which has been proposed
as a founding member of the Resolution Associated Molecular Pattern (RAMPs) family
hypothesised to maintain and restore immune homeostasis. Invion reported final data from its
phase 2 clinical trial in lupus patients in Q3 2015. 30mg and 100mg iv twice weekly showed
reduced response to stimulation by LPS after 1 month of dosing. These data, which reflect
relevant activity at the target cell type in patients with a target (autoimmune) disease, has
formed the foundation of partnering discussions for this program.
Invion Limited ABN 76 094 730 417
GPO Box 1557, Brisbane, QLD 4073 P +61 7 3295 0500 F +61 7 3295 0599 www.inviongroup.com
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Appendix 4C
Quarterly report
for entities admitted
on the basis of commitments
Introduced 31/3/2000. Amended 30/9/2001
Name of entity
INVION LIMITED
ABN
Quarter ended (“current quarter”)
76 094 730 417
31-March-2016
Consolidated statement of cash flows
Current quarter
Year to date
Cash flows related to operating activities
(6 months)
$A’000
1.1
Receipts from customers
Payments for
1.2
1.3
1.4
1.5
1.6
1.7
$A’000
-
140
(a) staff costs
(b) patent costs
(496)
(27)
(1,330)
(153)
(c) research and development
(102)
(2,974)
(d) leased assets
(e) other working capital
(3)
(645)
-
(7)
(1,443)
(62)
-
-
2,406
-
-
(1,273)
(3,423)
Dividends received
Interest and other items of a similar nature received
Interest and other costs of finance paid
Income taxes paid
(a) Research & Development tax
Other
refund
(b) Other
Net operating cash flows
Appendix 4 C Page 1
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Current quarter
Year to date
(6 months)
$A’000
1.8
Net operating cash flows (carried forward)
$A’000
(1,273)
(3,423)
(a) businesses
(b) equity investments
(c) intellectual property
(d) physical current assets
(e) other non-current assets
-
-
(a) businesses
(b) equity investments
Proceeds from disposal of:
(c) intellectual property
(d) physical current assets
(e) other non-current assets
Loans to other entities
Loans repaid by other entities
Other
-
-
-
-
Cash flows related to investing activities
1.9
1.10
1.11
1.12
1.13
Payment for acquisition of:
Net investing cash flows
1.14
Total operating and investing cash flows
(1,273)
(3,423)
1.15
Cash flows related to financing activities
Proceeds from issues of shares
10
3,110
1.16
Proceeds from shares not yet issued
1.17
Proceeds from borrowings
-
-
1.18
Repayment of borrowings
-
(974)
1.19
Dividends paid
-
-
1.2
Other Creditors (costs of fund raising)
-
(213)
10
1,923
Net increase (decrease) in cash held
(1,263)
(1,500)
1.21
Cash at beginning of quarter/year to date
2,107
2,285
1.22
Exchange rate adjustments to item 1.20
8
67
1.23
Cash at end of quarter/year to date
852
852
-
Net financing cash flows
Appendix 4 C Page 2
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Payments to directors of the entity and associates of the directors
Payments to related entities of the entity and associates of the related entities
Current quarter
$A'000
196
1.24 Aggregate amount of payments to the parties included in item 1.2 (a)
-
1.25 Aggregate amount of loans to the parties included in item 1.11
1.26 Explanation necessary for an understanding of the transactions
Payments to directors includes directors fees and executive directors salaries.
Non-cash financing and investing activities
2.1
Details of financing and investing transactions which have had a material effect on consolidated assets and
liabilities but did not involve cashflows
N/A
2.2
Details of outlays made by other entities to establish or increase their share in businesses in which the reporting
entity has an interest
N/A
Financing facilities available
Add notes as necessary for an understanding of the position. (See AASB 1026 paragraph 12.2).
Amount available
$A’000
Amount used
$A’000
3.1
Loan facilities
-
-
3.2
Credit standby arrangements
-
-
3.3
Convertible loan facility
-
-
Appendix 4 C Page 3
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Reconciliation of cash
Reconciliation of cash at the end of the quarter (as shown in the
consolidated statement of cash flows) to the related items in the
accounts is as follows.
4.1
Cash on hand and at bank
4.2
Current quarter
Previous quarter
$A’000
$A’000
852
2,107
Deposits at call
-
-
4.3
Bank overdraft
-
-
4.4
Other (provide details)
-
-
852
2,107
Total: cash at end of quarter (item 1.23)
Acquisitions and disposals of business entities
5.1
Name of entity
5.2
Place of incorporation or registration
5.3
Consideration for acquisition or disposal
5.4
Total net assets
5.5
Nature of business
Acquisitions
Disposals
N/A
N/A
Compliance statement
This statement has been prepared under accounting policies which comply with accounting standards as defined
1 in the Corporations Act (except to the extent that information is not required because of note 2) or other
standards acceptable to ASX.
2 This statement does give a true and fair view of the matters disclosed.
Sign here: Original signed
Date:
Company Secretary
Print name: Melanie Farris
Appendix 4 C Page 4
29-April-2016
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