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OptiNose The Key to Successful Nasal Drug Delivery Introduction Summary July 2008

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Page 1: OptiNose The Key to Successful Nasal Drug Delivery...drug delivery targeting sites beyond the nasal valve Traditional nasal delivery methods - spray pumps, pMDIs, powder inhalers and

OptiNose

The Key to Successful Nasal Drug Delivery

Introduction Summary July 2008

Page 2: OptiNose The Key to Successful Nasal Drug Delivery...drug delivery targeting sites beyond the nasal valve Traditional nasal delivery methods - spray pumps, pMDIs, powder inhalers and

ConfidentialNot to be distributed without the written consent of the Company 2

Company Update

• OptiNose AS is a privately owned company founded in October 2000

• Portfolio of patents and patent applications broadly securing its technology• Core patent granted in US and Europe • Follow on patents claiming aspects of technology and

product focussed applications

• Shareholders: Founders, Inspire AS, Andromeda-fund BV, WFD Ventures LLC

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ConfidentialNot to be distributed without the written consent of the Company 33

Management Team

CEO – Helena Kyttari Djupesland MBA• VP Operations GE, Kvaerner, Storebrand

CSO Per Djupesland MD, Ph.D.• Otorhinolaryngology specialist, sinus surgeon

Finance Director Henrik Andersen• Finance Director Merck Inc, Arthur Andersen

Head of Commercial Development Martin Waymark• Cardinal Health, Boots, GSK

Head of Device Development Colin Sheldrake Ph.D.• Chiron, PowderJect, Rolls Royce

Head of QA/ Reg Affairs Tony Flint Ph.D.• Thermocore, SGS Notified Body, Quintiles

Head of Clinical Operations Graeme Hewson Ph.D.(interim)• Corgentech, Roche, Parke Davis

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ConfidentialNot to be distributed without the written consent of the Company 44

Business Model Focused on Creating Value for Shareholders and Partners

Mission statementTo combine unique and superior nasal drug delivery technology with pharmaceutically active substances to achieve significant therapeutic benefits, improved safety profiles and increased reproducibility

Business ModelOptiNose’s commercial strategy is dual pronged:

•Develop a portfolio of products for out-licensing combining selected off-patent drugs with OptiNose’s patented delivery technology

•Partner with major pharma, specialist pharma and biotech companies to combine OptiNose’s patented delivery technology with proprietary compounds

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ConfidentialNot to be distributed without the written consent of the Company 55

Nasal Delivery Offers Significant Advantages for Treating Many Diseases

Topical

Therapeutic fields of interest Classes of substances & drugsTopical steroidsAntihistaminesImmuno-modulatorsDecongestantsVaccines

Allergic rhinitisNon-allergic rhinitisRhinosinusitisNasal polyposisAcute sinusitisCommon coldVaccination

Therapeutic fields of interest Classes of substances & drugsPolar drugs with poor GI-absorptionProteins & peptides degraded in GI-tractHydrophilic & high molecular weight peptidesSmall molecules with intended fast action

Analgesics (fast action)Migraine & headache (fast action)Insomnia & sedation (fast action)ObesityDiabetes I & IIOther endocrine diseases

Systemic

Nose-to-brain

Therapeutic fields of interest Classes of substances & drugsNeuroactive polar drugs with poor GI-absorption

Neuroactive proteins & peptides Neuroactive small molecules with fast action

Analgesics (fast action)Migraine & headache (fast action)Insomnia & sedation (fast action)Alzheimers & Parkinson'sNeurodegenerative diseasesObesityOther endocrine diseases

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ConfidentialNot to be distributed without the written consent of the Company 66

Drug Delivery Targets for Treating Disease are Beyond the Nasal Valve

Systemic deliveryTrue nasal mucosa lies beyond nasal valve. Anterior third of nose lined by skin-like epithelium.

Topical & Vaccine deliveryEntrances to sinuses and other structures affected by diseases of the nose lie in the posterior two thirds of the nasal cavity.

Nose-to-Brain deliveryNerves penetrate in the upper olfactory region of the nasal cavity.

NasalvalveNasalvalveNasalvalve

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ConfidentialNot to be distributed without the written consent of the Company 77

Traditional Nasal Delivery Devices Do Not Deliver Drug to Targets of Interest

Conclusion:Existing delivery methods are not optimal for nasal drug delivery targeting sites beyond the nasal valve

Traditional nasal delivery methods -spray pumps, pMDIs, powder inhalers and drops - deliver most of the dose (50-100%) anterior to the nasal valve.

The fraction bypassing the nasal valve passes mainly along the floor of the nose and is swallowed.

The assessment of topical nasal drug distribution. Aggrawal R et al. ClinOtolaryngol. 2004, 29, 201-205.

Literature Review:

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ConfidentialNot to be distributed without the written consent of the Company 88

OptiNose’s Delivery Technology Reaches Targets Beyond Nasal Valve - How it Works

Breath ActuatedBi-Directional Delivery

While exhaling into the device, the soft palate automatically closes off the nasal cavity completely …

… the breath enters one nostril through a sealing nozzle

… and triggers the release of particles into the airflow - carrying particles beyond the nasal valve to target sites

… the air flow passes through the communication posterior to the nasal septum

… and exits through the other nasal passage in the opposite direction

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ConfidentialNot to be distributed without the written consent of the Company 9

Device detailsnot disclosedDevice detailsnot disclosedDevice detailsnot disclosed

Spray nozzleSpray nozzle

OptiNose Delivers Liquids to Targets of Interest Beyond Nasal Valve - Spray Pumps Do Not

OptiNose standard deviceExcellent deposition in middle meatus

OptiNose N2B deviceExcellent deposition in olfactory region

Traditional spray pumpVirtually no delivery to target sites; drug is swallowed

Device detailsnot disclosedDevice detailsnot disclosed

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ConfidentialNot to be distributed without the written consent of the Company 1010

OptiNose Achieves >90% Deposition Beyond the Nasal Valve with Excellent Reproducibility

Initial deposition (0-2minut

OptiNose powder device

• >90% of dose is deposited beyond the nasal valve

• >70% of dose deposited in the upper posterior 2/3 of the nasal cavity

• High reproducibility of deposition beyond the nasal valve

• No lung deposition

• Fulfils the ideal requirements for nasal delivery

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ConfidentialNot to be distributed without the written consent of the Company 1111

OptiNose Prevents Drug Deposition in Lungs

Nasal inhalation OptiNose

27% of dosein lungs

No radioactivityabove backgr.

Inhalation of 2-5 micron particles from

PARI Nebulizer

Djupesland PG et al. JAM 2004; 17(3); 249-59.

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ConfidentialNot to be distributed without the written consent of the Company 12

Pipeline Status

Preclinical Phase I Phase II Phase IIIRespiratory

Nasal polyposis OptiNose Liquid

Chronic rhinosinusitis OptiNose Liquid

Neurology

Migraine OptiNose Powder

Sedation Collaboration Liquid

Sedation Collaboration Powder

Breakthrough Pain OptiNose Liquid

Vaccine

Influenza Collaboration Liquid

Diphtheria Collaboration Liquid

Undisclosed Collaboration Powder

Other

Peptide OptiNose Powder

Undisclosed Collaboration Liquid

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Migraine: First disease target for PowderDelivery Therapy

28 million people in US suffer withmigraine

• Overall prevalence 18.2% among females and 6.5% among males

• Frost and Sullivan report: US migraine market $2.39 billion; 13.9% growth

• Sumatriptan succinate is gold standard

Triptans administered with existingnasal sprays have pharmacokinetics andonset of action comparable to oraltablets

OptiNose can deliver to posterior twothirds of nose providing opportunity for:

• faster onset of action• greater effect at lower dose• reduced side effects

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ConfidentialNot to be distributed without the written consent of the Company 14

Epidemiology data shows very large unmet market need

• Chronic rhinosinusitis (CRS) is the most common chronic disease in the US today

• More than 32 million US residents report CRS

• Up to 18 million US residents are diagnosed by health professionals*

• Estimated 2-4 million US residents develop nasal polyps

• More than 500,000 sinus surgeries are performed annually in the US

• Intranasal steroids already a $3 billion market

• No pharmaceutical product is approved for the treatment of CRS

*EPOS 2007

OptiNose selected Chronic Rhinosinusitis & Nasal Polyposis as disease targets for topical therapy

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OptiNose AS Oslo Innovation CenterGaustadalléen 21 N-0349 Oslo, Norway

[email protected]: +47 22 95 80 17 Fax: +47 22 95 80 98 Mobile: +47 90 88 56 43Web: www.optinose.no