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A brief introduction to Bionor Pharma

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A brief introduction to Bionor Pharma

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  1. 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.

  2. A brief introduction to Bionor Pharma Nordic Health Care Conference, DNB Markets, 6 December 2012 Steen Krøyer, CEO

  3. This is Bionor Pharma Norwegian led Proprietary platform Attractive portfolio Experienced management World class advisors Substantial investment

  4. Bionor Pharma Pipeline • An attractive product portfolio with long term patents

  5. Advisory Boards • Providing independent clinical and scientific advice Biographies available on bionorpharma.com • Clinical Advisory Board • Richard Pollard, USAJürgen Rockstroh, GermanyBrian G. Gazzard, UKBarry S. Peters*, UKGuiseppe Pantaleo, SwitzerlandRobert R. Redfield, USADag Kvale, NorwayAngus «Gus» Dalgleish, UK 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

  6. The history of AIDS First AIDS medicine “cocktail” approved by FDA (Antiretroviral therapy, ART) • 1968–2012 US Department of Health: “We will have a preventive AIDS vaccine within two years!” Norwegian sailor, Arvid Noe dies of AIDS < 1981–1983 1968 1976 1984 1992 1986 First US case of AIDS First report on homosexual lifestyle association Over 1 mill. HIV infectedin the US Hiv virus identified by Francoise Barre-Sinousse, Pasteur Institute

  7. The history of AIDS NIAID (National Institute for Allergy and Infectious Diseases) spends $680 million to combine 2 preventive vaccines, with marginal success 15% of new infected tied to blood donation • 1968–2012 2009–2011 1997 2007 2012 2000 New, improved ART, with less side effects First known HIV infected patient cured (“Berlin Patient”) 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.

  8. The conventional treatment • And why we need new HIV treatments • 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

  9. Platform Technology

  10. Our platform technology 4 • With roots back to diagnostic product development in 1985 5 5 3 1 The Challenge with viruses Capabilities Prevents, treats, and potentially cures some of the world’s most deadly viruses Viruses escape from attacks by the immune system by continuously changing its surface structures (proteins) Bionor Pharma´s focus Vaccines for unmet medical needs, such as HIV, universal influenza and Hepatitis C 2 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 Further potential The technology provides a platform with potential for developing new vaccine products for a large number of viruses diseases

  11. Vacc-4x • A new generation of HIV treatment • 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

  12. 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

  13. 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!

  14. Vacc-C5 • Improves the immune response • 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

  15. 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

  16. Other indications • Other indications in the product pipeline • 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 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

  17. Clinical studies Performed and ongoing

  18. Vacc-4x: Completedclinical studies Until mid 2012 • 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)

  19. HIV viral load

  20. Reductionof HIV viralloadfollowingvaccination with Vacc-4x

  21. Three new studies at sixteen sites 1 1 4 4 2 1 3 Vacc-4x + Revlimid Reboost with Vacc-4x Vacc-C5 phase I/II

  22. Vacc-4x reboost • Reboost with Vacc-4x in patients from the phase II study • Approval Q4 2012USA + 4 European countries,11 clinics, ca. 40 patients • First patient enrollingDec. 2012 • Design Two immunizationsof Vacc-4x whileon ART, then up to 16 weeksoftreatmentinterruption. Total studyperiod 37 weeks. • FundedGlobvac (Norwegian Research Council) and Bionor Pharma ASA Patient groupParticipants fromthepreviousphase II studywith Vacc-4x The primary endpoints Changes in viral load compared to the previous study and immune responses to the vaccine Aim of the studyTo determine whether a lower viral load level (“set point”) can be achieved by re-boosting previously vaccinated HIV infected patients

  23. Vacc-4x + Revlimid® • Vacc-4x in combination with Celgene`s immune modulator 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® Patient groupWell controlled viral load on conventional HIV medicine (ART), but failing to regain normal immune function (15-20% of all HIV patients) Primary endpointsChanges in the amount of CD4 T-cells and immune responses to the vaccine Aim of the studyDetermining 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)

  24. Vacc-C5 • Clinical phase I/II study • ApprovedOslo University Hospital, May 2012, 36 patients • First patient treated November 2012 • Design“First time in man” open study, threedifferent dose levelsof Vacc-C5, eachwithtwodifferentadjuvants (supporting agents). Twentysixweeksstudyperiod for eachpatient. • FundedBionor Pharma ASA Patient groupWellcontrolledonconventional HIV medicine Primary endpointEvaluation of the vaccine’s safety Secondary endpointAntibody responses to the vaccine. Aim of the studyTo determine whether antibodies to two specific , conserved areas of the HIV virus (C5 and gp41) are induced in HIV patients

  25. Business Development

  26. Two Critical Steps STEP STEP 1 2 Documentationprocess Partneringprocess

  27. Information Gathering & Preparation STEP 1 Non-Confidential Teaser Full Briefing Book Complete Data Room 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) MATERIALS DELIVERABLES

  28. Partnering Process STEP 2 2-3 Potential partners Auction process Execute Deal 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) ACTIVITIES OUTCOME

  29. Upcoming events

  30. Financial summary • Secured funding until mid 2014 • 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

  31. Summary • Ongoing Clinical Studies and Business Development Process • Proven effect of technology platform and products • Comprehensive clinical and preclinical program ongoing • Partnering process next 12-18 months • Exciting news flow during 2013 Visit bionorpharma.com for the latest information

  32. Thank you for your attention.

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