Company Presentation June 2019 1 | FORWARD LOOKING STATMENTS This - - PowerPoint PPT Presentation

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Company Presentation June 2019

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This presentation contains forward-looking statements that provide Saniona’s expectations or forecasts of future events such as new product developments, regulatory approvals and financial performance. Such forward looking statements are subject to risks, uncertainties and may be impacted by inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of Saniona’s forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, breaches or terminations of contracts, government-mandated or market driven price decreases, introduction of competing products, exposure to product liability claims and other lawsuits, changes in reimbursement rules, changes of laws regulations or interpretation thereof, and unexpected cost

• increases. Saniona undertakes no obligation to update forward looking

statements.

FORWARD LOOKING STATMENTS

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Saniona – Investment highlights

Saniona is a leading late stage biotech company addressing diseases of the central nervous system (CNS) and eating

• disorders. The company has five projects in clinical development and several partnership agreements

A world leading R&D team focusing on ion channels and a management team with excellent track record in drug development and from making license deals and partnership agreements with both Big Pharma and VCs A drug that works in obesity and two orphan drug indications with billion dollar potential Tesofensine has demonstrated positive Phase 3-data in obesity, the partner Medix is now planning to launch in Mexico, Saniona will receive milestones and royalties – a $250M market in Mexico alone Tesomet with promising Phase 2a-data in Prader Willi Syndrome (PWS), a rare genetic disorder resulting in a chronic feeling of extreme hunger (hyperphagia) – a $3bn market potential Tesomet in Phase 2a for hypothalamic obesity (HO), an acquired eating disorder caused by damage to the appetite centre usually following surgical removal a brain tumour – a >$1bn market opportunity Exciting near term news flow with the potential to generate shareholder value Phase 2a data from the open label extension in PWS Phase 2a data in HO Market approval of Tesofensine in Mexico Inititation of Phase 1 with SAN711 for chronic pain and itching Boehringer Ingelheim initiates Phase 1 for Schizophrenia Saniona’s world class technology platform will continue to generate assets and early stage partnership opportunities

Treating diseases of the central nervous system and eating disorders

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Proprietary Pipeline

Near term news flow and value generation

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Product Indication Preclinical Phase 1 Phase 2 Milestone

Tesomet tesofensine + metoprolol

(monoamine reuptake inhibitor + beta blocker)

Prader Willi Syndrome Ph2a data Q1 19 Ph2b/3 start 2019/20 Hypothalamic

• besity

Ph2a start Q1 19 SAN711

(GABA α3 PAM)

Neuropathic pain Itching Ph1 ready IK Program Inflammation, IBD Candidate selection H1 19

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Partnered pipeline

Near term news flow and non-dilutive cash

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Product Indication Preclinical Phase 1 Phase 2 Phase 3

Tesofensine Obesity CAD-1883 Essential tremor Ataxia Not disclosed Schizophrenia NS2359 Cocaine Addiction

Upfront: 5M € Milestones: 85M € Royalties Spinout Minority stake Royalties NS2359 off patent; financed by US grants

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Medix partnership

Regional deal structure

Medix holds the rights to tesofensine & Tesomet in Mexico & Argentina Medix finances clinical studies and commercialization Saniona receives double digit royalties Saniona retains rights to rest of the world including exclusive rights to Medix’ clinical data

Medix could be on the market in Mexico in 2020 and in Argentina one year later

Medix to launch product in Mexico and Argentina following successful completion of Phase 3 study in 20 Tesofensine well tolerated and archived 10% average weight loss in 6 month - better than any of the existing drugs

• n the market

With ~50% market share, Medix is market leader in the $250M Rx Obesity Market in Mexico 2018 2019 2020 2021 2022 Mexico Argentina

Phase 3 Cofepris review Commercialization Argentina NDA Commercialization

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Tesomet: tesofensine + metoprolol

Tesofensine, in preclinical models and clinical trials, has shown efficacy and safety

• Reduction in food intake
• Weight loss efficacy
• Effects on glycemic parameters relevant for type 2 diabetes
• Excellent safety and tolerability

Tesomet = tesofensine + beta blocker (metroprolol)

• Neutralizes slight heart rate increase observed with tesofensine
• Allows for strong intellectual property protection through 2036

TESOFENSINE METOPROLOL

Effective weight loss drug Beta blocker to control slight increase in heart rate COMPOSITION

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Tesomet: Go-2-Market opportunity in orphan indications

Prader Willi Syndrome

Positive Phase 2a in PWS adults Phase 2a in adolescent patients ongoing Life-threatening hyperphagia and obesity Prevalence: 1/40.000 Estimated market size: ~3B USD

Hypothalamic Obesity

Phase 2 study preparations Life-threatening hyperphagia and obesity Prevalence: 1/(50.000-100,000) Estimated market size: >1B USD

Potential for market entry within 4 years – Total investment of $30-40M - >$4B opportunity 2018 2019 2020 2021 2022 Prader Willi Syndrome Hypothalamic

• besity

Open label Phase 2a Phase 2b Phase 3 FDA filing Phase 2a Phase 3 FDA filing

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Tesomet - lead indication: Prader-Willi syndrome

Genetic disease caused by mutations/deletion of genes on chromosome 15 Chronic feeling of extreme hunger (hyperphagia) no matter how much the patient eats Other symptoms and characteristics Mental retardation and behavioural problems Low metabolic rate (50% of normal) Sensitive to some medicines (½ dose prescribed) Medical need Acute life-threating hyperphagia (choking, bowel rupture) Life-threatening obesity Economic and social costs Quality of life for patients and families Family stress and loss of income Care and medical costs (USD 100-300K per year) Short life expectation (average in 30s) No effective treatment available today

}

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PWS opportunity has blockbuster potential

Accessible market value equals 3 Billion USD (Analyst estimates)

Premium pricing potential

Orphan drug status will ensure premium pricing Majority of drugs with less that 10,000 patients in the US tend to be priced above 200K USD per year

Large commercial opportunity

No drugs approved for treating hyperphagia

Low investment

Clear endpoint with short studies (Phase 3: 100 patients / 6 months) Straightforward commercialization (most patients are managed by specialists in central centers)

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Summary of Phase 2a studies in patients with PWS

3-months double blind Phase 2a study in adults with PWS provides proof-of-concept for Tesomet Tesomet provides strong reduction in hyperphagia and weight at optimal dose for obese patient of 0.5 mg/day 0.5 mg/day is too high in some PWS patients because of a different body composition and slow metabolism 3-months double blind study followed by two 3-months open label dose-finding studies in adolescents with PWS Tesomet at 0.125 mg/day is well tolerated but does not provide the intended blood concentration and efficacy Tesomet at 0.25 mg/day initiated in March – to be completed in July Tesomet appears to be well tolerated at 0.25 mg/day and first data point suggests that patients have stabilized in weight with a small weight loss recorded in some patients Conclusion Tesomet is a promising highly effective treatment option for control of hyperphagia and weight in PWS The results provide sufficient information to start a Phase 2b / Phase 3 program Many patients may have full benefit of 0.25 mg per day whereas the optimal dose may be between 0.25 mg and 0.5 mg per day for some patients Potential adaptive design in clinical studies with a starting dose of 0.25 mg per day

Proof-of-concept for Tesomet, which should be given at lower doses as is the case for many other drugs

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Pivotal PWS clinical program

Potential high level overlapping Phase 2b/Phase 3clinical program design

Screening Randomisation Fixed dose Flexible dose Placebo 1 2 3 4 5 6 7 8 10 11 12 9 Double-blind Part Open Label Last dose from DB Part Fixed dose – t.b.c. Fixed dose

Phase 2 (pivotal trial #1)

Screening Randomisation Fixed OR flexible dose Placebo 1 2 3 4 5 6 7 8 10 11 12 9 Double-blind Part Open Label Fixed or fdose – t.b.c. Fixed dose

Phase 3 (pivotal trial #2)

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Tesomet: Phase 2a Study in PWS adults

Study set up Exploratory randomized, double-blind, placebo- controlled 12 weeks study in 9 patients

• Tesomet 6
• Placebo 3

Positive effect on key efficacy endpoints

• Reduced craving for

food

• Weight loss

PK and Safety

• No SAE
• AE mainly CNS related
• Half-life longer than

expected in PWS patients

Results from Phase 2a study in February 2018 (0.5 mg per day)

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Tesomet: Phase 2a Study in PWS adults

Results

PWS hyperphagia score

(data show mean and SD)

Week 8 Week 13 Tesomet 5.00 % (n=5) 6.75 % (n=2) Placebo 0.46 % (n=2) 0.75 % (n=2)

20 40 60 80 100 5 10 15 20

days of treatment Hyperphagia score

placebo treatment

PWS weight loss

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Tesomet: Phase 2a Study in PWS adolescents

Study set up Exploratory randomized, double-blind, placebo- controlled 12 weeks study in 9 adolescents

• Tesomet 5
• Placebo 4

Reduction in hyperphagia in both treatment and placebo group

• No significant difference

in hyperphagia and weight PK and Safety

• Well tolerated
• -Long half-life in PWS

patients confirmed

• Plasma level did not

reach target

Second part of Phase 2a study conducted at quarter of dose (0.125 mg per day) Study continued to open label extension at higher dose (0.25 mg per day)

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Tesomet – Hypothalamic Obesity (HO)

Acquired eating disorder caused by damage to the appetite centre 90% of patients acquire HO following surgical removal of a benign brain tumour, craniopharyngioma Post surgical obesity and hyperphagia Memory impairment, attention, impulse control, motivation Depression and suicide Medical need Life-threatening obesity Quality of life (socialization, depression, suicide) Economic and social costs Quality of life for patients Care and medical costs No effective and approved treatment

• f HO available today

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HO opportunity has blockbuster potential

Accessible market value equals more than 1 Billion USD (analyst estimates)

Prevalence of craniopharyngioma 1:50,000 of which ~50% develop HO

Premium pricing potential

Orphan drug status on craniopharyngioma will ensure premium pricing Majority of drugs with less that 10,000 patients in the US tend to be priced above 200K USD per year

Large commercial opportunity

No drugs approved for post surgical HO

Low investment

Clear endpoint with short studies (Phase 3: 100 patients / 6-12 months) Straightforward commercialization

HO prevalence

5,500 120-150 KUSD 3,400 120-150 KUSD 1,300

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Tesomet: Phase 2a study in hypothalamic obesity

One centre at Rigshospitalet, Copenhagen Phase 2 Study Design Randomized, double-blind, placebo controlled trial Up to 25 patients:

• placebo
• Tesomet: (0.50mg tesofensine + 50

mg metoprolol)

• 24 weeks treatment period
• 24 weeks open label study where all

patients are offered Tesomet Clinical endpoints: Primary endpoint: Safety Secondary endpoints include:

• Change in bodyweight compared to

baseline at 24 weeks

• Appetite score
• Metabolic including glycemic

endpoints

• Quality of life

Sibutramine (now withdrawn) has showed significant decrease in BMI and body weight in in HO supporting potential benefit of Tesomet in this indication

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Ion channel platform is rapidly fuelling early stage pipeline

Leverage research platform through partnerships and develop at least one candidate to Phase 2 internally

Product/Target Indication Preclinical Research Preclinical Development Phase 1 Phase 2 CAD-1883 Essential tremor Ataxia SAN711 Neuropathic pain Itching Not disclosed Schizophrenia IK Program Inflammation, IBD Kv7 program Pain, epilepsy, UI Nicotine α6 Program Parkinson’s Disease Upfront: 5M € Milestones: 85M € Royalties Spinout Minority stake Royalties

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SAN711 for neuropathic pain and Itching with orphan potential

Class GABA Modulator (selective α3, first in class, small molecule) Status Phase 1 ready Indication Neuropathic pain: +10 million patients Itching: e.g. chronic kidney disease associated pruritus 4.5 million patients in the US Orphan itch indications: prurigo nodularis; brachioradial pruritus Market Neuropathic pain: USD 6 billion

• Standard pain killers not working
• Narcotic analgesics only used in cancer due to tolerance

development and abuse liability

• Antiepileptic and antidepressants have some effect
• Experimental drugs

Medical Need Efficacy and reduction of adverse effects

• 50 % achieves no pain relief and the rest obtains partial response
• nly
• Only 25 % obtains a pain reduction of 50 % or more (score)

MoA Restores the endogenous pain control system in the spinal cord Patent Until 2038

Phase 1 ready in Q1 2019

Neuropathic pain Itching Prurigo Nodularis

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SAN711 effective in neuropathic pain model

SAN711 reduces neuropathic pain in rats with an effect similar to morphine The effect of SAN711 is maintained after prolonged treatment for 7 days while the pain relieving effect of morphine is completely lost due to development of tolerance SAN711 does not lead to sedative effects in rats exploring a novel environment

Efficacy maintained after prolonged treatment

SAN711 alleviate nerve-injury induced neuropathic pain in rats

Veh 3 mg/kg 10 mg/kg 30 mg/kg

Total dist. (30 min.)

20 40 60 80 100

SAN711 does not lead to sedation in rats

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Financial statements - million SEK

2018, 2017 and accumulated since the company became operations in 2012

Income statement MSEK 2018 2017 2012 - 2018 Net sales 54.9 20.7 207.1 Operating expenses

• 109.1
• 77.9
• 354.6

Operating profit/loss

• 54.2
• 57.2
• 147.5

Financial items 5.9 0.9 6.9 Tax on net profit 7.2 7.1 20.7 Profit/loss

• 41.1
• 49.2
• 119.8

Other comprehensive income 0.6

• 1.0
• 1.2

Total comprehensive income

• 40.4
• 50.2
• 121.0

Balance sheet MSEK Dec/18 Dec/17 Non-current assets 12.4 7.8 Current receivables 16.0 18.3 Cash and cash equivalent 54.7 22.3 Total assets 83.1 48.4 Equity 39.5 37.6 Total liabilities 43.6 10.7 Total equity and liabilities 83.1 48.4 Cash flows MSEK 2018 2017 2012 - 2018 Operating activities

• 22.9
• 57.3
• 105.8

Investing activities 0.9

• 6.0
• 10.1

Financing activities 46.7 33.2 164.3 Cash flow 24.7

• 30.1

48.4

Revenues 55 MSEK up from 21 MSEK due to significant milestone from Boehringer Ingelheim Operating expenses 109 MSEK up from 78 MSEK due to investments in clinical studies Cash end of year: 55 MSEK Raised more funding through non dilutive income than from financing Accumulated (2012-2018) Income: 207 MSEK finance activities: 164 MSEK

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Near term value inflection points

Go-2-Market opportunity with Tesomet in orphan indications Data from open label extension studies of Phase 2a in adolescents with PWS Initiate Phase 2b/3 PWS study Data from Phase 2a in hypothalamic obesity Additional value drivers from Medix tesofensine collaboration Tesofensine NDA filing in Mexico Approval and launch in Mexico Tesofensine NDA filing in Argentina Unique platform fuels early stage pipeline and generate cash for the company SAN711: Initiation of Phase 1 for chronic pain and itching IK program: Candidate selection CAD-1883: Initiation of Phase 2 for ataxia Boehringer Ingelheim program: Initiation of Phase 1 for Schizophrenia Potential new collaborations

1 3 2

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Saniona – Investment highlights

Saniona is a leading late stage biotech company addressing diseases of the central nervous system (CNS) and eating disorders. The company has five projects in clinical development and several partnership agreements A world leading R&D team focusing on ion channels and a management team with excellent track record in drug development and from making license deals and partnership agreements with both Big Pharma and VCs A drug that works in obesity and two orphan drug indications with billion dollar potential Tesofensine has demonstrated positive Phase 3-data in obesity, the partner Medix is now planning to launch in Mexico, Saniona will receive milestones and royalties – a $250M market in Mexico alone Tesomet with promising Phase 2a-data in Prader Willi Syndrome (PWS), a rare genetic disorder resulting in a chronic feeling of extreme hunger (hyperphagia) – a $3bn market potential Tesomet in Phase 2a for hypothalamic obesity (HO), an acquired eating disorder caused by damage to the appetite centre usually following surgical removal a brain tumour – a >$1bn market opportunity Exciting near term news flow with the potential to generate shareholder value

Saniona’s world class technology platform will continue to generate assets and early stage partnership

• pportunities

Treating diseases of the central nervous system and eating disorders

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Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: +45 70705225 Web: saniona.com