AI assistant
INVION LIMITED — AGM Information 2012
Nov 7, 2012
65148_rns_2012-11-07_68a92763-e76e-4c5b-a613-7241c02317d5.pdf
AGM Information
Open in viewerOpens in your device viewer
ASX ANNOUNCEMENT
==> picture [161 x 76] intentionally omitted <==
8 November 2012
AGM 2012: CHAIRMAN’S ADDRESS & CEO PRESENTATION
Clinical stage drug development company, Invion Limited (ASX:IVX) is pleased to provide the Chairman’s Address and CEO presentation for the 2012 Annual General Meeting of Shareholders being held this morning at 10.30am (AEST) at the offices of McCullough Robertson Lawyers, Level 11, 66 Eagle Street Brisbane.
Address by Dr Ralph Craven, Chairman, Invion Limited
Good morning Shareholders
I am very pleased to have the opportunity to speak with you today about your company, Invion, and about the Board’s view of what success will look like for Invion Limited. This morning I will briefly recount the significant events of the last 12 months before handing over to our CEO Dr Bill Garner who will talk to us about the many activities already in the pipeline for the year ahead.
A great deal has changed in the last 12 months, and I am very pleased to be standing here as the Chair of the Board of this revitalized company at the commencement of what is going to be an exciting phase. I will take this opportunity to thank my colleagues on the Board, for their skill, drive and commitment in working to turn your company around. The focus of both Board and management is now on creating value, cost-effectively, from our assets.
For the year ended 30 June the company incurred an operating loss of $5.5 million and held net assets of $6 million. This is a greatly improved position to the previous year which recorded an operating loss of $13.6 million and net liabilities of $2 million. The improved position of the company is in large part a reflection of the strong focus of the Board on operational efficiency and sound financial management.
==> picture [43 x 23] intentionally omitted <==
During the second half of the year, the Board reviewed the company’s direction in detail. The outcomes included the identification and investigation of potential acquisition targets in order to expand and deepen the company’s drug pipeline. Three months ago, Shareholders were asked to consider and vote on the acquisition of a US-based company. The acquisition was approved, and on the 30[th] of August the company merged with Inverseon to bring into the stable new technology, clinical and regulatory expertise, and access to a $4.4 million grant from the US National Institutes of Health.
Invion Limited ABN 76 094 730 417
Unit 2, 120 Bluestone Circuit, Seventeen Mile Rocks, QLD 4073 P +61 7 3295 0500 F +61 7 3295 0599 www.invion.com.au
ASX ANNOUNCEMENT
==> picture [161 x 76] intentionally omitted <==
Invion’s focus is the development and commercialisation of new therapies for inflammatory diseases, and we now have two therapeutic candidates that target chronic inflammation. One of those – INV102 - is well-progressed into phase II territory. The other – Cpn10 – is benefitting from a revitalized development strategy at the hands of our new and highly experienced Chief Medical Officer, Dr Mitchell Glass.
Your company operates in the biotechnology and drug development commercialization sector. In common with other companies in this space, operations are subject to significant risks and uncertainty. Your Board recognises the expectations placed upon it, not only by shareholders but by a corporate world that is changing rapidly. We acknowledge the need to be innovative and focused on creating value, and aim to do so while also meeting high standards of good corporate governance.
Your Board is committed to the continuous improvement of its governance framework, and we have taken action this year to substantially enhance the company’s governance practices.
Invion is now a lean, primarily outsourced business that will utilise good networks both in Australia and the US to add value to its operations. The Board has restructured the remuneration packages of employees with the overall objectives of capital management and maximum stakeholder benefit from the focused hiring and retention of a high quality team. The provision of Options as part of the remuneration packages of employees links remuneration to the performance of the company and incentivises staff towards the future growth and success of the business.
Before closing, it is appropriate that in this address I acknowledge the legal proceedings commenced in February of this year against four former officers of the company. The proceedings are now at a point where defences and their replies have been filed. The company has also filed its replies to the counterclaim which has been made against the company. The Board is committed to bringing the case to resolution as swiftly as possible, and it is expected that a request for trial date will be lodged with the Supreme Court this calendar year. We expect the matter to go to trial in the first quarter of 2013.
In summary, Invion is a new, clinical-stage pharmaceutical drug development company with three phase II programs targeting inflammatory diseases. New management, new assets and a wealth of new experience on board means we are well positioned to deliver on the plans we have developed for the Invion portfolio. If you have not already done so I encourage you to visit our website and to do so regularly to keep up with what is happening in your company.
I would now like to introduce Managing Director and Chief Executive Officer, Dr Bill Garner.
==> picture [43 x 23] intentionally omitted <==
Invion Limited ABN 76 094 730 417
Unit 2, 120 Bluestone Circuit, Seventeen Mile Rocks, QLD 4073 P +61 7 3295 0500 F +61 7 3295 0599 www.invion.com.au
==> picture [279 x 131] intentionally omitted <==
==> picture [72 x 73] intentionally omitted <==
ASX:IVX
Clinical-stage drug development company targeting chronic inflammation
CEO’s address to the Invion Limited 2012 Annual General Meeting of Shareholders Dr William Garner 8 November 2012
==> picture [154 x 103] intentionally omitted <==
==> picture [154 x 103] intentionally omitted <==
Disclaimer
This presentation has been prepared by Invion Limited (Invion or the Company) solely for its use at presentations to be made by the Company.
The information contained in this presentation is an overview and does not contain all information necessary to make investment decisions. Although reasonable care has been taken to ensure that facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation, expressed or implied, is made as to the fairness, accuracy, completeness or correctness of the information and opinions contained in this presentation and no reliance should be placed on such information or opinions.
This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in the Company nor does it constitute financial advice nor take into consideration your investment objectives.
This presentation contains or may contain forward-looking statements that are based on management’s belief, assumptions and expectations and on information currently available to management. All statements that are not historical, including those statements that address future operating performance and events of developments that we expect or anticipate will occur in the future, are forward looking statements. Although management believes these forward looking statements are fair and reasonable you should not place undue reliance on these statements.
==> picture [121 x 57] intentionally omitted <==
2
Experienced leadership team
William J. Garner MD, CEO
-
EGB Advisors, Roche, Co-Founder DelMar Pharmaceuticals
-
Successful corporate founder and executive
Mitchell Glass MD, EVP R&D and CMO
-
24 year veteran of Pharma (AZ, GSK) and Biotech (AGIX)
-
Managed more than 40 drug developments including “first in class”
-
5 approved drugs (Accolate® /asthma, Coreg®/ heart failure, AVANDIA)
Ralph Craven, B Eng PhD, Chairman of the Board
-
Broad experience as company director, respected member of international energy industry
-
Ergon Energy, Arrow Energy, Tully Sugar
James Campbell, PhD MBA, Executive Director
-
Senior biotechnology executive with 20+ years experience in research, research management, advisory
-
COO and CFO, ChemGenex Pharmaceuticals; Principal, Gemini Biotechnology
Brett Heading, BCom LLB (Hons), Non-executive Director
-
Experienced corporate lawyer/ company director across property, agribusiness and life sciences sectors
-
Chairman of Partners, McCullough Robertson Lawyers
Warren Brown, B Eng, Non-executive Director
-
Experienced in corporate strategy and project management
-
Background in consulting engineering and contract negotiation
==> picture [121 x 57] intentionally omitted <==
3
Current pipeline
Preclinical
Phase I
Phase II
Oral INV102
Pre-requisites completed
Smoking cessation
In patients with chronic bronchitis[1.] (Target: NDA 2015)
Asthma[2. ] NIH funded (non dilutive funding)
Cpn10
Lupus (SLE)[3. ]
RA deferred, not discontinued
Inhaled INV102 Game changing
Chronic bronchitis[3.]
Cystic fibrosis[3.]
==> picture [245 x 65] intentionally omitted <==
NCE development
Beta-2 adrenergic inverse agonist
Academic alliance
-
INV102 added to Standard of Care; protected by dose titration scheme.
-
Data support product development of Inhaled INV102
-
Early partnering opportunity based on strategic interest
==> picture [121 x 57] intentionally omitted <==
4
==> picture [279 x 131] intentionally omitted <==
INV102 (nadolol) Existing drug repurposed for a new target
INV102 (nadolol): Overview
Nadolol repurposed for inflammatory diseases of the airways
Previous phase II trials demonstrated safety and dose-related activity in airways
-
Clinical safety database of over 10M patients to date
-
Two phase II trials to commence in 2012:
-
Lead indication: increase successful smoking cessation in patients with
chronic cough (chronic bronchitis).
==> picture [121 x 57] intentionally omitted <==
6
INV102 – Context and positioning
| β receptor class | β 1 receptor | β 2 receptor |
|---|---|---|
| Localization | Heart and circulatory | Airways |
| Clinical manifestation | Chronic Heart Failure (CHF) | Chronic bronchitis, asthma, |
| cystic fibrosis | ||
| Intracellular | Arrhythmia | Mucus metaplasia |
| inflammation | ||
| Therapeutic | Carvedilol, Metoprolol | Nadolol (INV102) |
| Economics | US$40M prior to approval (1996) | Significant opportunity. |
| US$1.2B first year post approval | $600M per annum in smoking | |
| (1997) | cessation in COPD |
==> picture [121 x 57] intentionally omitted <==
7
Airway healing: effect of oral INV102
==> picture [199 x 200] intentionally omitted <==
==> picture [202 x 200] intentionally omitted <==
==> picture [203 x 200] intentionally omitted <==
Control lung tissue
Lung tissue of ‘asthmatic’ mice - epithelial cells have been converted to mucus-producing goblet cells. No effect of alprenolol
Lung tissue of asthmatic mice treated with INV102 for 28 days: restored epithelium
1. Note: No effect on alprenolol
2. Note: Proof of concept has been achieved in pre-clinical studies with inhaled INV102 3. Note: Formoteral LABA, increases inflammation & mucus
==> picture [121 x 57] intentionally omitted <==
Chronic Exposure to Beta-Blockers Attenuates Inflammation and Mucin Content in a Murine Asthma Model. Nguyen et al. Am J Respir Cell Mol Biol. 2008 Mar;38(3):256-62. See also. β-Adrenoceptor signaling is required for the development of an asthma phenotype in a murine model. Nguyen et al. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2435-40.
8
Oral INV102 development strategy
-
Asthma trial: NIH to fund 6 month phase IIb study
-
Initiate by year end 2012 (run into 2015)
INV102 can treat underlying cause of chronic cough and mucus secretion which are a major barrier to smoking cessation and cause of peri-operative complications in patients with COPD (chronic obstructive pulmonary disease)
Phase II trial in smoking cessation to initiate by year end 2012
Total treatment period less than 5 months including titration
- Titration doses provide market exclusivity (e.g. carvedilol/ Coreg)
==> picture [121 x 57] intentionally omitted <==
9
1.
Respiratory Inflammation market $64B+
-
Smoking-Cessation Drug Market worth $2.4B in 2012[2. ]
-
Large COPD /Asthma drug market, valued at ~$34B[1.]
-
Advair Diskus[®] , approved for asthma and COPD, ($8.1B peak annual sales)[3.]
-
Singulair[®] , approved for asthma ($5.5B peak annual sales)[4.]
-
Symbicort[®] , approved for asthma and COPD ($3.1B worldwide sales)[1.]
-
FDA sanctions on Long-Acting Beta Agonists (LABAs)
-
Drugs associated with excess mortality
-
Black box warning on all LABAs and LABA/Steroid combinations, including Advair Diskus[®] and Symbicort[®] : increased risk of death
No drug targets mucus metaplasia
1. Respiratory and Inflammation, AstraZeneca Annual Report, 2011
2. Smoking Cessation Drugs: World Market Prospects 2012-2022 , Visiongain Reports 2012 3. Healthcare Finance , Bloomberg Brief, 13 August 2012
4. Full-Year and Fourth-Quarter 2011 Financial Results , Merck & Co
==> picture [121 x 57] intentionally omitted <==
10
==> picture [279 x 131] intentionally omitted <==
Cpn10
Targeting autoimmune disease
Cpn10 overview
-
Potential new anti-inflammatory biologic therapeutic
-
Modified version of a naturally occurring human protein, chaperonin10
-
Strong patent position covering composition of matter and trade secrets
-
Novel mechanism: effect on inflammation in the blood vessels is different to current leading therapies
-
Initial indication: lupus erythematosus (“lupus”): a true vasculitis
-
Under-served market - 1 drug approved by FDA in 50 years
-
IND filing positioned for end 2012
==> picture [121 x 57] intentionally omitted <==
12
Cpn10: lupus development plan
-
Strong pre-clinical data: improved kidney function, resolved cutaneous lupus, reduced renal and circulating levels of TNF-α and IL-6
-
Signs of biological activity in clinical trials to date
-
strong safety profile in >250 patients (9 trials)
-
trends for clinical benefit
-
Re-qualify existing material for IND for lupus intravenous dosing
-
Adequate cGMP material and toxicology coverage to support clinical trial
-
Pre-IND meeting 14 December 2012; IND to follow
-
Rapid, cost-effective means of determining clinical potential
-
phase II trial expected to initiate in 1H, 2013
==> picture [121 x 57] intentionally omitted <==
13
==> picture [279 x 131] intentionally omitted <==
CORPORATE SUMMARY
Financial overview
| Sector | Biotechnology |
|---|---|
| Principal activities | Clinical-stage pharmaceutical |
| drug development | |
| Intellectual Property assets | 2 drug candidates |
| Pipeline status | 3 phase II clinical programs |
| ASX code | IVX |
| Last trade (7 November 2012) | $0.052 (5.2cents) |
| Shares on issue | 384,531,941 |
| Market cap (7 November 2012) | $20 million |
| Cash at hand (30 September 2012) | $4.75 million |
==> picture [121 x 57] intentionally omitted <==
15
Business model mitigates risk
-
New clinical-stage company with developed assets targeting inflammation
-
2 phase II assets (INV102 and Cpn10) 3 clinical-stage programs (smoking cessation, asthma, lupus) Management team who have taken 5 NDAs through the FDA Mitigated risk:
-
assets with positive clinical data and strong safety databases
-
experienced and well-connected management
==> picture [121 x 57] intentionally omitted <==
16
==> picture [279 x 131] intentionally omitted <==
Managing Director & CEO Dr William Garner [email protected]
Corporate and Financial Melanie Farris, Company Secretary [email protected]
Investor & Media Relations Buchan Consulting [email protected] [email protected]
Invion Limited 2/120 Bluestone Circuit Seventeen Mile Rocks QLD 4073 Australia P: +61 7 3295 0500 F: +61 7 3295 0599