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Disclaimer This presentation includes forward-looking statements regarding Bionor Pharma ASA, including projections and expectations, which involve risk and uncertainty. Such statements are included without any guarantees to their future realization. Although Bionor Pharma ASA believes that the expectations regarding the Company reflected in such forward-looking statements are based on reasonable assumptions, no assurance can be given that such projections will be fulfilled. Any such forward-looking statement must be considered along with knowledge that actual events or results may vary materially from such predictions due to, among other things, political, economic, financial or legal changes in the markets in which Bionor Pharma ASA does business, and competitive developments or risks inherent to the Company’s business plans. Many of these factors are beyond Bionor Pharma ASA’s ability to control or predict. Given these uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. The Company does not intend, and does not assume any obligation, to update the forward-looking statements included in this presentation as of any date subsequent to the date hereof.
A brief introduction to Bionor PharmaNORDIC HEALTH CARE CONFERENCE, DNB MARKETS, 6 DECEMBER 2012
STEEN KRØYER, CEO
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This is Bionor Pharma
Norwegian led Proprietary platform Attractive portfolio
Experienced management World class advisors Substantial investment
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Bionor Pharma PipelineAn attractive product portfolio with long term patents
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Advisory Boards
Clinical Advisory Board
Richard Pollard, USAJürgen Rockstroh, GermanyBrian G. Gazzard, UKBarry S. Peters*, UKGuiseppe Pantaleo, SwitzerlandRobert R. Redfield, USADag Kvale, NorwayAngus «Gus» Dalgleish, UK
Providing independent clinical and scientific advice
Scientific Advisory Board
Leiv K. Sydnes, NorwayJohn E. Newbold, USAKristian Prydz, NorwayKnut Helkås Dahl**, Norway
Professors, except: *MBBS, DFFP, MD, FRCP ** MSc, PhD, ERT, DABT
Biographies available on bionorpharma.com
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The history of AIDS1968–2012
1968 1976 1981–1983 <1984 1986 1992
First US case of AIDS
Norwegian sailor, Arvid Noe dies of AIDS
First report on homosexual lifestyle association
Hiv virus identified by Francoise Barre-Sinousse, Pasteur Institute
US Department of Health: “We will have a preventive AIDS vaccine within two years!”
Over 1 mill. HIV infectedin the US
First AIDS medicine “cocktail” approved by FDA (Antiretroviral therapy, ART)
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The history of AIDS1968–2012
1997 2000 2007 2009–2011 2012
New, improved ART, with less side effects
15% of new infected tied to blood donation
First known HIV infected patient cured (“Berlin Patient”)
NIAID (National Institute for Allergy and Infectious Diseases) spends $680 million to combine 2 preventive vaccines, with marginal success
Eradication strategy highlighted• Approx.35 mill HIV infected globally (1400 in Norway)• Most common treatments today: ART – one pill every day / HAART (Highly Active ART) – combination of several ART, to reduce resistance.
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The conventional treatment
Conventional HIV medicine (ART) effectively reduces virus, and prevents it from multiplying in the bloodstream.
However:Does not destroy virus producing cells – puts the cells into resting state only
Risk of serious, irreversible side effects, especially by long term use
Resistance
Not lasting effects - must be taken daily
Limited access - only 1 in 4 who needs ART has access to it
Does not cure HIV
And why we need new HIV treatments
Platform Technology
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Our platform technologyWith roots back to diagnostic product development in 1985
The Challenge with viruses
Viruses escape from attacks by the immune system by continuously changing its surface structures (proteins)
How our vaccines work
The vaccine redirects the immune system to detect and target specific structures of the virus that remain unchanged and vulnerable
This results in removal of virus producing cells and reduction of virus level
CapabilitiesPrevents, treats, and potentially cures some of the world’s most deadly viruses
Bionor Pharma´s focus
Vaccines for unmet medical needs, such as HIV, universal influenza and Hepatitis C
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Further potential
The technology provides a platform with potential for developing new vaccine products for a large number of viruses diseases
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Vacc-4x
Peptides, chosen from unchanging parts of the virus
Synthesized and modified to increase killing of HIV infected cells
Produced by Bachem AG, Switzerland
Harvard researchers have recently documented that a HIV vaccine should target the unchanging structures of the virus (Dahirel et. Al., PNAS 2011)
Vacc-4x targets unchanging structures of the virus
Kills and removes virus producing cells – immune system educated
No adverse side effects
No development of resistance
A new generation of HIV treatment
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Immune activation is always required for AIDS to develop
Why do some people not get AIDS ?Why do chimpanzees not get AIDS ?
Answer: The only difference is that there is no evidence of immune activation (which is chronic and associated with inflammation, and has auto immune features).
How does HIV cause Immune activation ?Can we switch it off ?
Answer: This is the unique approach included by Bionor Pharma
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Angus "Gus" Dalgliesh,Member of Scientific Advisory Board
Chronic immune activation is like background noise on the radio which prevents the signal from being heard!
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Vacc-C5
Targets unchanging structures of the virus
Induces antibodies against HIV, which reduce hyperactivation of the immune system
Prevent spread of the virus
Improves the immune response
Vaccine induced antibodies in animals
First human trial approved, and started Q4 2012
Vacc-HIV: Combination of Vacc-C5 (inducing antibodies) and Vacc-4x (inducing killer T-cells), can thereby stimulate both parts of the immune system
Improves the immune response
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What does this mean?
Antibodies to the C5 region of HIV prevent immune activation, and thereby prevent disease progression
If we induce these antibodies (which is the aim of Vacc-C5), they could neutralize the disease
Stopping activation will stop virus production
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Other indications
Vacc-HCV
Hepatitis C
Vacc-HCV developed to treat and cure
Market size: ~ 170 million patients
Patent application filed June 2012
Potential partner to be identified
Other indications in the product pipeline
Vacc-FLU
Universal influenza vaccine: all pandemic influenza viruses
Market size: ~ 500 million patients
Preclinical development (including toxicology), planned finalized during 2013
Patent application filed June 2012
Potential partner to be identified
Cancer indications
Human papillomavirus (HPV, throat / cervical cancer)
Cytomegalovirus (CMV, e.g. brain tumor)
Patent applications filed June 2012
Clinical studiesPERFORMED AND ONGOING
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Vacc-4x: Completed clinical studies
1 - Open Study Phase I/II, NO: 11 patients, 100% immune response. Safe vaccine without side effects (1999-2000)
2 a - Open Study Phase II, NO: 40 patients (CD4 count at inclusion >300 cells/μl), ART-free period on average 31 months (2003-2004). Sustained CD4 counts, and transient reduction in viral load
2 b - Open Study Phase II Reboost , NO (7 years after 2a): 26 patients from 2a , with 2/3 of patients showing active memory response. Immune response enhanced after reboost with Vacc-4x (2010)
3 - Placebo-Controlled Study Phase II, USA and Europe (18 centers): 135 patients (CD4 count at inclusion >400 cells/μl). Statistically significant reduction of HIV viral load in active group compared to placebo. Supportive immunological data (2008-2010 )
4 - Open Study Phase I/II, Nasal Vaccination, NO: 24 patients, droplets of Vacc-4x in the nose, resulting in positive immune response. Potentially easier treatment and access for HIV patients globally (2011-2012)
Until mid 2012
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HIV viral load
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Reduction of HIV viral load following vaccination with Vacc-4x
Three new studies at sixteen sites
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Vacc-4x + Revlimid
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Reboost with Vacc-4x
Vacc-C5 phase I/II
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Vacc-4x reboost
Approval Q4 2012 USA + 4 European countries,11 clinics, ca. 40 patients
First patient enrolling Dec. 2012
Design Two immunizations of Vacc-4x while on ART, then up to 16 weeks of treatment interruption. Total study period 37 weeks.
Funded Globvac (Norwegian Research Council) and Bionor Pharma ASA
Reboost with Vacc-4x in patients from the phase II study
Patient group Participants from the previous phase II study with Vacc-4x
The primary endpoints Changes in viral load compared to the previous study and immune responses to the vaccine
Aim of the study To determine whether a lower viral load level (“set point”) can be achieved by re-boosting previously vaccinated HIV infected patients
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Vacc-4x + Revlimid®
Approved Germany, August 2012, 4 clinics, approx. 36 patients (~12+24)
First dose group initiated treatment October 2012
Design First dosing-study with ~12 patients, determining “maximum tolerated” dose of Revlimid®. Then 24 patients for 26 weeks.
Funded Jointly with Celgene, owner of the blockbuster cancer drug and immune modulator Revlimid®
Vacc-4x in combination with Celgene`s immune modulator Revlimid®
Patient group Well controlled viral load on conventional HIV medicine (ART), but failing to regain normal immune function (15-20% of all HIV patients)
Primary endpoints Changes in the amount of CD4 T-cells and immune responses to the vaccine
Aim of the study Determining whether the combination of Vacc-4x and Revlimid can result in improved response to Vacc-4x in HIV infected patients with poor immune recovery (low CD4 T-cells despite well controlled viral load on ART)
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Vacc-C5
Approved Oslo University Hospital, May 2012, 36 patients
First patient treated November 2012
Design “First time in man” open study, three different dose levels of Vacc-C5, each with two different adjuvants (supporting agents). Twenty six weeks study period for each patient.
Funded Bionor Pharma ASA
Clinical phase I/II study
Patient group Well controlled on conventional HIV medicine
Primary endpoint Evaluation of the vaccine’s safety
Secondary endpoint Antibody responses to the vaccine.
Aim of the study To determine whether antibodies to two specific , conserved areas of the HIV virus (C5 and gp41) are induced in HIV patients
Business Development
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Two Critical Steps
1STEP
Documentationprocess
Partneringprocess
2STEP
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Information Gathering & Preparation
TPP’s (For Key Assets)
Market & Commercial Research (Navigant, BCG, McKinsey, KOL’s + Community Dr, etc. Market entry/ramp up, pricing, commercialization options)
IP Position (Patents, Processes, Regulatory exclusivity)
Clinical/Regulatory FDA Clarity (Cost, Timelines, Inflection Points)
News Flow (Clinical Data, Patent Announcements, Other Application)
Financial Analysis (Value, rNPV’s, MC Simulations, DCF’s, POS’s, Key Assumptions)
MAT
ERIA
LS
DEL
IVER
AB
LES
Non-Confidential Teaser
Full Briefing Book
Complete Data Room
1STEP
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Partnering Process
Identification of likely partners (Vaccine Specific BD, Venture Sponsors w/in Big Pharma, others)
Diligence (Access to Briefing Book, Data room, Management Q&A)
Partnering Solutions (Research Agreements, License, M&A, which assets)
Indications of Interest & High Level Deal Terms
Key Meetings (Bio USA, JP Morgan, Regional Conferences, Others)
AC
TIVI
TIES
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TCO
ME
2-3 Potential partners
Auction process
Execute Deal
2STEP
Upcoming events
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Financial summary
OSE: BIONOR
Market Cap NOK 660 mill. / US$ 115 million Number of Shares: 198 million
Private Placement was successfully closed 14 June 2012, with gross proceeds of NOK 57.6 million. This placement together with previous cash secures the funding of planned scientific and business related activities until mid 2014
Cash as of Q3 2012: NOK 126.7 mill. / US$ 22.2 millionAnnual burn-rate: NOK 60-70 mill. / US$ 10-12 million
Secured funding until mid 2014
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Summary
Proven effect of technology platform and products
Comprehensive clinical and preclinical program ongoing
Partnering process next 12-18 months
Exciting news flow during 2013
Ongoing Clinical Studies and Business Development Process
Visit bionorpharma.com
for the latest information
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Thank you for your attention.