30 October 2015
Company Announcements Office
20 Bridge St
SYDNEY NSW 2000
Invion Limited (ASX:IVX) is pleased to lodge its Appendix 4C for the quarter ending 30 September 2015.
The Company held cash reserves of $0.5 million at the end of September, consistent with forecasts. Subsequent to the end of the quarter, on 9 October, the Company advised that its R&D tax incentive cash rebate of approximately $2.4 million had been received, increasing cash reserves, and that the Company had fully repaid its funding facility with Metamor Capital Partners in the amount of $1.04M.
In the September quarter, cash outflows relating to operating expenses were $2.7 million, with R&D expenditure comprising $1.8 million of this amount. Operating and R&D cash outlfows have been significantly reduced from previous quarters which were intensive in R&D spend related to the completion of two phase II clinical trials, and feasibility works for Invion’s inhaled respiratory drugs.
During the quarter, the Company announced that it had entered into a joint development and licensing agreement with Hovione Scientia Limited, for the development of a dry powder formulation of INV104 (zafirlukast) to be delivered by Hovione’s inhaler as a potential therapy for asthma.
The Company also announced data from the completion of its phase II clinical trial of INV103 (ala-Cpn10) in patients with systemic lupus (SLE). The review of safety and biomarker data in 28 subjects showed that the study had met its objectives and supported the continued development of INV103 in longer and larger trials in patients with autoimmune diseases. This program is currently under discussion with a number of groups with a view to partnering the asset.
Also during the quarter, the Company announced data from its completed phase II clinical trial of INV102 (nadolol) in smoking cessation. The data from the 155 patient study demonstrated that INV102 treated smokers were more likely to stop smoking completely or dramatically reduce the number of cigarettes smoked, and that INV102 is a safe and effective treatment for patients with chronic bronchitis who are enrolled in smoking cessation programs. The Company is preparing a submission for an End of Phase II meeting with the US Food and Drug Administration (FDA), to facilitate the commencement of the phase III program.
Following the successful completion of major milestones across four drug development programs during 2015 to date, the Board has accelerated a strategic review of the business and its opportunities, and has appointed Ferghana Partners Group (New York, London, Boston) to progress various potential opportunities under review. Ferghana’s expertise is in acquisitions, divestitures, corporate partnering and financial transactions in the global healthcare sector.
An Appendix 4C accompanies this announcement.
For and on behalf of the Board of Invion Limited
Company Secretary and Head of Operations
About Invion Limited
Invion is a life sciences company focussed on the development of treatments for major opportunities in respiratory and autoimmune disease. The Group has three drug assets in development across four development programs. INV102 (nadolol) is a beta adrenergic biased ligand targeted to reverse mucous metaplasia in the airway epithelium treat chronic inflammatory airway diseases. A large phase II study in smoking cessation reported successful data in Q4 2015 and feasibility for an inhaled version of the drug is well-progressed with 3M Drug Delivery Systems. A phase II asthma study funded by the US NIH is ongoing. 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 approved oral therapy, Invion is developing an inhaled version of the drug. 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 is an ASX listed company (ASX:IVX), with its clinical headquarters in Delaware, USA.
About Ferghana Partners Group
The Ferghana Partners Group (FPG) is an international provider of high level, independent corporate finance advice to firms in the Biotechnology, Pharmaceuticals, Diagnostics and Specialty Chemicals industries which together comprise the Life Sciences field. FPG provides advice on corporate partnering/development and ownership/business portfolio topics, such as Mergers, Acquisitions, Joint Ventures and Divestitures to its clients, as well as creating and executing Financial Transactions. The clients comprise established Specialty Chemical, Pharmaceutical and Diagnostics companies as well as emergent Pharma and Biotechnology companies with a therapeutic or diagnostic focus. Ferghana Partners LLP, is based in London, for UK and European business. It also covers Australia. Ferghana Partners Inc., is based in New York, for North American business (USA and Canada). It also has responsibility for Japan coverage.