SAniona company Presentation

SANIONA COMPANY PRESENTATION
JANUARY, 2015
January 2015
1
AGENDA
Understanding the values of Saniona
Our research and product portfolio
Financial position and new issue of shares
January 2015
2
RISK AND REWARDS
January 2015
3
BENCHMARK ACQUISITION
Convergence Pharmaceuticals
Ion channel products
Lead program in Phase 2 for neuropathic
pain
Biogen Idec acquired Convergence for a total
of up to $675 million on Jan 11
$200 million in upfront
$475 million in milestones
Saniona is currently raising SEK 24M at a premoney valuation of SEK 97M with the aim of
taking AN363 through Phase 1 clinical
development for neuropathic pain
This project is one of 16 programs of which
five are active today.
January 2015
4
WHAT HAVE WE ACHIEVED THE LAST YEAR
February 2014
Pfizer agreement
March
Biogen and Atlas Ventures invest up to USD 17 million into Saniona’s ataxia
program
April
Saniona raises SEK 17 million in IPO and are listed on AktieTorget in April
July
Saniona selects AN363 development candidate
and initiate preclinical development with the aim of initiating Phase 1 in Q4 2015
August
Janssen and Saniona extend research collaboration with 12 months
September
Ataxion and Saniona extend research collaboration with 12 months
October
Tesofensine acquired – unique phase 2 obesity/diabetes asset
November
Risk sharing agreement for development of AN363
November
Pain data on AN363 presented
December
Biogen/Atlas research milestone
January 2015
New rights issue of 24 mill SEK
January 2015
Pfizer research milestone
January 2015
5
2015 MILESTONE TRIGGERS (12-15 MONTHS)
Partnerships
Milestone in research collaboration with Pfizer
Selection of clinical candidate with a partner
Potential additional partnerships based on ongoing and future discussions
Internal pipeline
AN363
GMP manufacture and tox studies
IND/CTA regulatory filing and approval
Initiation of phase 1
Positioning of tesofensine for partnering and further clinical studies
Progression of at least one of the current clinical asset together with partners
Selection of 2nd preclinical candidate
January 2015
6
UNDERSTANDING THE VALUES OF SANIONA
Products
5 active programs and >10 other opportunities
• more than euro 250 mill invested in assets
Pipeline
Three big pharma partnerships
• Pfizer, Johnson&Johnson, Biogen/Atlas
• Full financing of drug discovery
• Major upside potential
Partnerships
World class ion channel team
Platform
January 2015
7
SANIONA STRATEGY
Saniona follows three main strategies

Research collaborations with partners
Saniona projects
Two ongoing collaborations:
– Pfizer and Janssen
Own development
Partners

Own early phase development
Janssen
Alliance
Pfizer
Alliance
AN346
AN363
CNS
Neurology
IBD
Chronic
pain
Outlicensing planned in clinical phase

Potassium
channel
modulator
Spin out

Financed by venture/Pharma partner:
Biogen/Atlas and Ataxion is an example
Ataxia
Biogen/Atlas
Ataxion
January 2015
8
CURRENT PARTNERSHIPS
Collaboration based on Saniona ion channel program for neurological indications
Pfizer has exclusive commercialisation rights
Up to 52M USD in milestone payments plus royalties on product sales
Financed by Pfizer
Collaboration based on Saniona ion channel program for treatment of diseases of
the central nervous system (CNS)
Janssen has an option to obtain exclusive commercialisation rights
Up to 75M € in milestone payments plus royalties on product sales
Financed by Janssen
Ataxion is a spin-out (USA) from Saniona
Biogen has an option to acquire company following Phase 1
Up to 14% of acquisition price plus royalties on product sales
Financed by Biogen Idec and Atlas Venture (US$ 17 million)
January 2015
9
OUR PIPELINE
Product or program
Indication
Preclinical
research
Active and currently supported program s
AN363
Neuropathic pain
AN346
Inflammation, IBD
Janssen program
CNS
Ataxion program
Ataxia
Pfizer program
Neurological disease
Other internal programs
CNS
Program s subject to partnering or spinouts
Tesofensine monotherapy
Obesity
Tesofensine combination therapy Obesity
AN788
Depression
AN761
Cognitive impairment
January 2015
10
Preclinical
Clinical
developm ent Phase 1
Clinical
Phase 2
AN363 FOR NEUROPATHIC PAIN
Class
GABA Modulator
Status
Preclinical development
Phase 1 to be initiated in Q4 2015
Indication
Neuropathic pain
Prevalence
+ 10 mill globally
Market
+ USD 6 billion
Medical need
Efficacy and less adverse effect
MoA
Selective GABAa2/3 PAM restores the endogenous
pain control system in spinal cord
Goal
Development of a
• first in class
• effective
• well tolerated
product for first line treatment of neuropathic pain
Patent
Until 2029
January 2015
11
AN363 MODE OF ACTION IN NEUROPATHIC PAIN
AN363
Cl-
α2/3
GABA
Na+
January 2015
12
AN363 EFFECTIVE IN NEUROPATHIC PAIN MODEL
Mechanical allodynia rat CCI model
Paw withdrawal threshold
g (n=7-21)
20
Other paw
Vehicle (5%DMSO+0.5%HPMC)
AN363- 1mg/kg/10ml PO
AN363- 3mg/kg/10ml PO
AN363- 10mg/kg/10ml PO
AN363- 30mg/kg/10ml PO
****
15
****
****
****
10
**
5
0
0
30
90
60
120
Post treatment (min)
** P<0.01, ****P<0.0001 vs vehicle, 2way ANOVA Bonferroni multiple comparisons
January 2015
13
morphine
AN346 FOR INFLAMMATORY BOWEL DISEASE
Class
Ion Channel Blocker
Status
Candidate selection
Indication
Inflammatory Bowel Disease: Cronhs and Colitis
Prevalence
~ 400/100.000 (~1.4 mill in USA)
Market
~ 4 billion €
Treatment
Maintenance: 5-ASA
Induction and remission: Steroids, biologics and surgery
Medical need
Efficacy and less adverse effect
30 – 40% of all Colitis patients and almost all Cronhs
patients require surgery at least once in their lifetime
MoA
Block of IK channel in immune cells
Goal
Development of a unique
• first in class
• effective
• well tolerated
product for first line treatment and maintenance of IBD
IP protection
2032
January 2015
14
AN346 MODE OF ACTION IN INFLAMMATORY BOWEL DISEASE
AN346
K+ +
K +
K +
K +
K
Ca++
Ca++ ++
Ca
Ca++Ca++
January 2015
15
AN346 NORMALISES COLON HISTOLOGY
Induced IBD (+ DNDS)
Control
Sulfazalasine (5-ASA)
January 2015
AN346
16
TESOFENSINE FOR OBESITY/DIABETES
Class
Triple monoamine reuptake inhibitor (MRI)
Status
Phase 2 completed (Monotherapy)
Indication
Obesity / type II diabetes
Prevalence
2.1 billion overweight WW in 2013 ~ 38% (Lancet)
Market
+ USD 750 million (2019 estimate: 2.6 billion)
Medical need
Efficacy and safety
MoA
Triple MRIs regulate appetite, metabolic drive and
craving for sweet and fat (“food addiction”)
Goal
Development of a
• Highly efficacious
• well tolerated
product for first line treatment of obesity and type II
diabetes
Patents
January 2015
Composition of matter until 2017; additional patents
and patent applications covering use, combinations,
production and formulation extending until 2034.
17
18.0-21.9%
22.0-25.9%
>26.0%
TESOFENSINE MECHANISM OF ACTION
Tesofensine blocks uptake of dopamine, serotonin and noradrenaline
Regulates
appetite
craving for sweet and fat (“food addiction”)
metabolic drive
January 2015
18
TESOFENSINE
A UNIQUE TREATMENT OPPORTUNITY IN OBESITY
Weight reduction
Unique weight loss
14-15% at 48 weeks (Placebo ~ 2%)
10.0%
Potentially competitive to surgery (1520%)
9.0%
Potential prevention and treatment of
Type 2 diabetes
7.0%
8.0%
6.6%
6.0%
6.0%
Full and clean tox package
5.0%
Well tolerated in obese and elderly (+1200
individuals)
4.0%
5.2%
3.1%
3.0%
Adverse Effects similar to placebo
2.0%
Increase in heart rate
1.0%
2.4%
0.0%
Novel patent application on combination
product
January 2015
9.2%
Xenical,
Belvig,
Contrave,
3x120mg, 4 2x10mg, 1 2x360/32mg,
years
year
56 weeks
19
Victoza,
3mg, 56
weeks
Qsymnia, Tesofensine,
7.5/46mg, 0,50mg, 24
56 weeks
weeks
FINANCIAL POSITION AND RIGHTS ISSUE
January 2015
20
FINANCIAL POSITION
2014-01-30 2014-01-01 2014-01-01 2013-01-01
2014-09-30 2014-01-29 2014-09-30 2013-12-31
8 mån
1 mån
9 mån
12 mån
Koncernen /
Koncernen Saniona ApS
Saniona ApS
Saniona ApS
Resultaträkning
Nettoomsättning
Rörelsens kostnader
Rörelseresultat
14 459
-18 488
-4 029
3 539
-1 526
2 013
17 998
-20 014
-2 016
13 323
-14 983
-1 660
Balansräkning
Likvida medel
Balansomslutning *
14 170
20 607
11 309
15 071
14 170
20 607
914
3 975
-12 404
8 490
-3 914
-2 143
2 886
10 395
13 281
-6 238
Kassaflödesanalys
Löpande
verksamheten
Periodens kassaflöde
* Ingen immateriella anläggningstillgångar registrerat
Booket värde af utrustning 1,2 MSEK (nyprisvärde cirka 30 MSEK)
January 2015
21
SÅ HÄR ANVÄNDER VI EMISSIONSLIKVIDEN
Emissionslikviden på 24,3 MSEK ska accelerera tillväxten i bolaget och användas till:
Preklinisk och FAS1-utveckling av AN363 till neuropatisk smärta
Positionering av tesofensine för partnerskap och ytterligare kliniska studier
Val av ytterligare preklinisk kandidat
Förädling av andra projekt för partnerskap
Bolaget har med emissionslikviden tillräcklig finansiering för att ta AN363 genom FAS1-utveckling
och hade i november 2014 en kassa på ca 10 MSEK
January 2015
22
NEW FINANCE ROUND
IPO in April 2014 at 5 SEK per share
Share price at present is around 9 SEK
Share price for new issue is SEK 7 per
share equal to a pre money valuation of
SEK 97M
Share
Index
SEK
January 2015
23
Market Cap
MSEK
MUSD
Offering
7,0
100
97
12
Current share price
9,0
129
125
15
Autumn
11,0
157
153
19
Redeye valuation
19,5
279
271
33
BENCHMARK ACQUISITION
Convergence Pharmaceuticals
Ion channel products
Lead program in Phase 2 for neuropathic
pain
Biogen Idec acquired Convergence for a total
of up to $675 million on Jan 11
$200 million in upfront
$475 million in milestones
Saniona is currently raising SEK 24M at a premoney valuation of SEK 97M with the aim of
taking AN363 through Phase 1 clinical
development for neuropathic pain
This project is one of 16 programs of which
five are active today.
January 2015
24
ERBJUDANDET I SAMMANDRAG (FÖRETRÄDESEMISSION)
Teckningstid:
22 januari – 5 februari 2015
Företrädesrätt:
För varje befintlig aktie erhålls en (1) teckningsrätt
Innehav av 4 teckningsrätter berättigar till teckning av 1
nya aktie
Handel med teckningsrätter:
22 januari – 3 februari 2015
Teckningskurs:
7,00 SEK per aktie
Emissionsvolym:
Högst 3 470 550 aktier, motsvarande 24 293 850 SEK
Antal aktier före nyemission:
13 882 200 aktier
Pre-money värdering:
97,2 MSEK
Teckningsförbindelser:
15,3 MSEK ~ 63% av emissionsvolymen
Marknadsplats:
AktieTorget
January 2015
25
BOARD AND MANAGEMENT
Leif Andersson, board member
Ex-partner Sund Kommunikation
Claus Braestrup, Chairman
Ex-CEO Lundbeck
Thomas Feldthus
CFO and board member
January 2015
Anker Lundemose, Board member
CEO Mission Therapeutics
Jørgen Drejer
CEO and board member
26
SUMMARY
Low burn and high ambitions
World class research team
Range of validated discovery and development stage programs
Proven track record for partnering with 3 major collaborations in
2 years
Significant milestones achieved since April 2014
Transforming into a clinical stage company
First compound planned for the clinic this year
Acquired a unique phase 2 asset
January 2015
27
Saniona AB
Baltorpvej 154
DK-2750 Ballerup
Denmark
Tel: +45 70705225
Web: saniona.com
January 2015
28