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Page 1: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84
Page 2: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

9th Annual Conference

Biotech Showcase

January 10, 2017

CEO Erik Kinnman,

MD, PhD, MBA

Page 3: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Important information - Disclaimer

This presentation (the “Presentation”) has been prepared by NeuroVive Pharmaceutical AB (publ), 556595-6538 (“NeuroVive” or the “Company”).

The Presentation is governed by Swedish law. The courts of Sweden have exclusive jurisdiction to settle any dispute arising out of or in connection with this Presentation.

This Presentation does not constitute an offer of financial instruments to the public or an admission of such financial instruments to trading on a regulated market requiring an approved prospectus under the Swedish Financial Instruments Trading Act (1991:980) and, accordingly, this Presentation does not constitute a prospectus for these purposes and have not been, and will not be, approved or registered by the Swedish Financial Supervisory Authority (Sw: Finansinspektionen) under the Swedish Financial Instruments Trading Act.

Forward-looking statements

The Presentation contains certain forward-looking statements that reflect NeuroVive’s current views or expectations with respect to future events and financial and operational development. The words “intend”, “estimate”, “expect”, “may”, “plan”, “anticipate” or similar expressions regarding indications or predictions of future developments or trends and which are not based on historical facts constitute forward-looking information. Although NeuroVive believes that these statements are based on reasonable assumptions and expectations, NeuroVive cannot give any assurances that such statements will materialize. Forward-looking statements are in its nature involved with both known and unknown risks and uncertainties, since they are depending on future events and circumstances. Forward-looking statements do not constitute any representations and warranties of future development and the outcome could differ materially from the information set out in the forward-looking statements.

The forward-looking statements included in this Presentation apply only to the date of this Presentation. NeuroVive undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events orsimilar circumstances other than as required by applicable law.

Page 4: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NeuroVive in brief

• Swedish specialist pharma company

• Focused on mitochondrial medicine

• One project in patient studies

• Strong and agile network pharma organization

• Listed on Nasdaq Stockholm (NVP.ST)

• Market cap 19 MUSD

• Average trading volume 320,000 (Jan 2017)

• OTCQX (NEVPF:US) June 2, 2016

Page 5: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Mitochondria

Food

Oxygen Energy

• Essential for body energy and functioningof vital organs

• Resists, repairs damage and controls cell death

• A non-functioning or damaged mitochondrionleads to cell death and organ damage

NeuroVive develops compounds that protect and enhance mitochondrial function

Page 6: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NeuroVive Project Pipeline

Page 7: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Traumatic brain injury (TBI)

• Traumatic brain injury occurs after external trauma

• Deteriorates for several days

• Leads to significant neurological disabilities and high burden of disease

• >3 million patients annually in US and EU

• 15 % medium to severe damage

• 60 BUSD in direct medical and indirect costs in the US 20001

1 www.cdc.gov/traumaticbraininjury/pdf/BlueBook_factsheet-a.pdf

Page 8: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

TBI NeuroSTAT® Clinical phase II study

• Orphan drug designation EU and US

• Open phase II safety pharmacokinetic study

• 2 doses, 5 day treatment

• 16/20 patients have been recruited

• Complementary experimental efficacy study at University of Pennsylvania ongoing

• Readout expected H1 2017

• NeuroSTAT possible market approval year

• 2024E*: US & EU5

• 2026E*: JP & CH

• Peak sales 2 BUSD (2030E*)

* Monocl Strategy Services 2015

Page 9: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Mitochondrial disorders

• Rare and heritable mutations- 12.5 per 100,000

• Deteriorates continuously with periods of energy crisis

• Several organs and tissues risk being affected

Page 10: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Eyes

Drooping eyelids (ptosis),

inability to move the eyes

sideways (external

ophthalmoplegia), blindness

(retinitis pigmentosa)

Muscles

Muscle weakness, exercise

intolerance, seizures

Digestive system

Regurgitation, vomiting,

chronic diarrhea, intestinal

obstruction

Pancreas

Diabetes

Liver

Liver failure is rare except in

infants experienceing loss of

mitochondrial DNA

Kidney

Fanconi syndrome (the

loss of key metabolites in

the urine)

Heart

Cardiomyopathy (heart failure,

conduction block)

Nervous system

Seizures, tremors, mental

retardation, deafness, dementia,

stroke before the age of 40,

balance disorders, effects on the

peripheral nervous system

Mitochondrial disorders - Systemic effects

Page 11: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NVP015 for mitochondrial disorders

• Energy regulating substance

• Candidate drug selection H2 2017

• Overcomes complex I deficiencies

• Limits the complications of an energy crisis

• Pharmaceutical strategy published in Nature Communications August 20161

• NVP015 possible market approval

• 2024E2: US & EU5

• 2026E2: JP & CH

• Peak sales 375 MUSD (2031E2)

1 Ehinger et al. Nature Communications, 7:12317, August, 20162 Monocl Strategy Services 2015

Mitochondria

Cell

Blood

Page 12: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NV556 organ protection

Energy

NV566PT-pore block

• NV556 in preclinical development

• Possible clinical indications:

• Liver disease

• Myopathies

• Acute kidney injury

Page 13: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NASH – non-alcoholic steatohepatitis

Fatty liver

Fibrosis

Cirrhosis

• Part of nonalcoholic fatty liver disease (NAFLD)

• 30% of the US population

• Strong association NASH and diabetes/obesity

• 3-5 % of the US population (15M people)

• Buildup of fat and inflammation in the liver

• May lead to liver cirrhosis and hepatocellular carcinoma

• No registered drugs on the market1

• 15 BUSD global market estimated by 20252

1 Vernon G. et al. Aliment Pharmacol Ther. 2011;34(3):274-852 Cassidy S. & Syed B.A. Nature Reviews Drug Discovery 15, 745–746 (2016)

Page 14: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Two out-licensing projects

NV556

• Orally available

• Extensive preclinical development documentation

• Good safety profile

• Prevents fibrosis development in a well-validated experimental model of NASH

• Confirmatory long term studies ongoing

NVP022

• New compound class directed towards mitochondrial metabolic signaling pathways

• Compounds under evaluation

• Complementary to NV556 NASH treatment

Page 15: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NASH – Disease development

Metabolicpathways

Inflammation

Fibrosis

Cirrhosis

Disease severity

Time

NV556

NVP022NASH

NAFLD

Page 16: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Mitochondrial myopathy

• Symptoms include muscle weakness, exercise intolerance and fatigue

• Caused by malfunctioning mitochondria

• Kearns-Sayre syndrome, myoclonus epilepsy with ragged-red fibers, and MELAS

• Myopathy most common symptom in mitochondrial disease 12.5/100,000

• No approved drugs

• NV556 will be studied in experimental models of mitochondrial myopathy in collaboration with Prof. Håkan Westerblad at the Karolinska Institutet

Mitochondrial myopathy

Page 17: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NeuroVive business model

Discovery Pre-clinicalPhase I

(first in human)

Phase IIa

(proof of principle)

Phase IIb and

Phase III (confirmatory)

Marketing & Sales

Common specialist/open

care productsOut-license

Idea Product

NeuroVive development of orphan/niche products

In-license Orphan/niche products

Page 18: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Long term company goals

• Profitable growth in 5-10 years

• Bring orphan/niche projects to the market and build commercial organization

• Out-license large indication specialist and open care projects

• Build on scientific mitochondrial medicine excellence

• Develop drugs in a strong and agile network pharma organization

Page 19: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Agile and lean clinical development

• Investigator initiated trials

• Enable access to ”soft money”

• Smart clinical trial design

• E.g. adaptive designs, biomarkers, enriched trials

• Orphan drug designation, breakthrough therapy

• Faster to the market and limited documentation need

• Orphan drug status

• Higher price: average 110,000 USD up to 400,000 USD/patient/year in the US

• Market exclusivity 7 years in US (10 years in EU)

Page 20: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NeuroVive AsiaTaipei, TWN

Research

Philippe GalleyCA, U.S.

PENN UniversityPennsylvania, U.S.

Isomerase Cambridge, UK

Lund UniversityLund, SE

A1M PharmaLund, SE

Suzhou HuasaiZhangjiagang, CN

Shanghai Chempartner, Shanghai, CN NeuroVive Asia

Taiipei, TWN

Cambridge Major Laboratories Europe, Holland

Innovative networking model

Page 21: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

SDSStockholm, SE

Fresenius KabiGraz-Puntigam, AT

Sanofi KoreaSeoul, KR

Sihuan PharmaceuticalBeijing, CN

Skåne University Hospital Lund, SE

RigshospitaletKöpenhamn, DK

NeuroVive AsiaTaipei, TWN

Development

Maas Biolab, LLCAlbuquerque, NM

Innovative networking model

Page 22: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Financial position

30 September 2016 MUSD

Intangible assets 7.4

Liquid assets 11.2

Short-term debts 1.1

Burn rate until 201609* 8

Burn rate 201512* 10

* Cash flow from operating and investment activities

Page 23: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NeuroVive summary

• Strong portfolio with one ongoing clinical study and several research projects

• World leading in mitochondrial medicine

• Business model that enables near term revenue and value creation mid- to long term

Page 24: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Erik Kinnman,

CEO

Expertise: Research

and development,

strategy, IR, business

development.

MD, PhD, MBA

Catharina

Johansson, CFO

Expertise: Growth

companies within

medical technology,

multinational operations

and partnership

activities

Eskil Elmér,

CSO, Founder

Expertise: Preclinical

and clinical research.

MD, PhD

Magnus Hansson,

CMO

Expertise: Preclinical

and clinical research

and development. MD,

PhD

Cecilia Hofvander,

IR & Comm Director

Expertise: More than 15

years experience from

investor relations within

small/mid cap biotech

NeuroVive's Management Team

Page 25: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

NeuroVive's Board of Directors

Greg Batcheller, Executive ChairmanExecutive Chairman since 2008 and board member since

2000. Batcheller is a commercial lawyer, business developer

and project manager. He has many years’ experience in

working with pharmaceuticals, biotechnology and medical

equipment.

Arne FerstadBoard member since 2010. Ferstad is co-owner of Ankor

Consultants, based in London. He has held the position of

chairman for Baxter Healthcare in the Nordic and Benelux

countries, as well as being European president of Baxter

healthcare’s Renal Division. Prior to that, Arne held several

executive leadership positions in Asia, the U.S. and Europe

for Baxter.

Boel FlodgrenBoard member since 2013. Boel is a professor in commercial

law and former principal at Lund University. She has an

extensive experience in research and teaching within the

field of business law at Swedish as well as foreign universities

such as Stanford and Harvard, U.S.

Anna Malm BernstenBoard member since 2013. Bernsten has an extensive

international experience in strategic marketing, product

launching and business development within pharmaceutical

and biotech companies such as Medivir, GE Healthcare and

Pharmacia&Upjohn.

Marcus KeepBoard member since 2000. Neuro surgeon at PinnacleHealth

Neurological Surgery in Harrisburg, Pennsylvania, U.S. Keep is

also CEO and Executive Chairman of Maas Biolab, LLC, one of

the largest shareholders in NeuroVive. He was formerly

assistant professor of neurosurgery at the University of

Hawaii and the University of New Mexico. Keep was a visiting

researcher at Lund University between 1994 - 1996.

David Laskow-PooleyBoard member since 2016. Laskow-Pooley is a member of the

board of TapImmune Inc, USA, OBN Ltd, England and

Pharmafor Ltd, England. Laskow-Pooley earned his degree in

BSc Pharmacy (1st), Pharmaceutical/ Chemical engineering

specialty and QP. from Sunderland School of Pharmacy,

England.

Helena LevanderBoard member since 2012. Levander is the founder of nordic

Investor Services. She has extensive experience in financial

markets and asset management through working with SEB,

Nordea and Odin Funds.

Page 26: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

Major shareholders 30 September 2016

Owner Voting rights and capital

(%)

Avanza Pension Försäkrings AB 12.42

EuroClear Bank S.A/N.V(Registers holdings for Maas Biolab, LLC and Marcus

Keep and others Based in the U.S.

8.98

Baulos Capital 8.84

Nordnet Pensionförsäkring AB 2.96

Danske Bank International S.A. 2.23

Handelsbanken Liv 2.09

Redmayne Nominees Ltd UK Clients 1.43

Eskil Elmér 0.87

Greg Batcheller 0.82

Skandia försäkring 0.76

Remaining ̴7,200 owners 58.6

In total 100

Page 27: 9th Annual Conference Biotech Showcase - Neurovive · 9th Annual Conference Biotech Showcase January 10, 2017 ... CMO Expertise: Preclinical ... Baulos Capital 8.84

www.neurovive.com