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Allon Therapeutics Inc'

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Significant and reproducible reduction in levels of beta-amyloid and phosphorylated tau ... program to impact both amyloid beta and neurofibrillary tangles ... – PowerPoint PPT presentation

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Title: Allon Therapeutics Inc'


1

Allon Therapeutics Inc.
Corporate Overview August 2009
2
Forward Looking Statements
Statements contained herein, other than those
which are strictly statements of historical fact
may include forward-looking information. Such
statements will typically contain words such as
"believes", "may", "plans", "will", "estimate",
"continue", "anticipates", "intends", "expects",
and similar expressions. While forward-looking
statements represent managements outlook based
on assumptions that management believes are
reasonable, forward-looking statements by their
nature are subject to known and unknown risks,
uncertainties and other factors that may cause
the actual results, events or developments to be
materially different from any future results,
events or developments expressed or implied by
them. Such factors include, among others, the
inherent uncertainty involved in scientific
research and drug development, Allon's early
stage of development, lack of product revenues,
its additional capital requirements, the risks
associated with successful completion of clinical
trials and the long lead-times and high costs
associated with obtaining regulatory approval to
market any product which Allon may eventually
develop. Other risk factors include the limited
protections afforded by intellectual property
rights, rapid technology and product obsolescence
in a highly competitive environment and Allons
dependence on collaborative partners and contract
research organizations. These factors can be
reviewed in Allons public filings at
www.SEDAR.com and should be considered carefully.
Readers are cautioned not to place undue reliance
on such forward-looking statements and Allon
disclaims any obligation to update or announce
changes in any such factors except in its
periodic filings.
3
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4
Fundamental Mechanism of Action
MicrotubulesEssential for neuronal structure and
function
5

ADNP Platform Davunetide Human Proof of Concept
6
Davunetide Impacts Both AD Hallmarks
TAU Phosphorylation
120
100
80
60
Phosphorylated Tau level
( of vehicle group)

40


20
plt0.001
0
AL-108
AL-108
AL-108
Veh.
Veh.
Veh.
AT8
AT180
CP13
202
205
231
202
(Ser
/Thr
)
(Thr
)
(Ser
)
  • Significant and reproducible reduction in levels
    of beta-amyloid and phosphorylated tau
  • Significant behavioral outcome in animals

7
Davunetide Phase II Alzheimers Program aMCI
  • Study reported Q108
  • 144 subjects amnestic MCI
  • Demographics aMCI patients
  • 17 clinical sites in the U.S.
  • Randomised, placebo controlled, double blind
  • Two doses (5 mg QD 15 mg BID) x 12 weeks
  • Placebo matched to both low and high dose
    davunetide
  • Cognitive assessments at weeks -4, 0, 4, 8, 12,
    16
  • All cognitive measurements relevant to AD
    clinical practice

8
Delayed Match-to-Sample (DMTS)
  • Measures working memory, recognition and short
    term memory

Swainson et al, Dementia Geriatric Cognitive
Disorders, 2001
9
DMTS 12 Second Delay
  • Statistically significant, dose dependant and
    durable impact seen at 12 second delay when
    memory is measured

10
Digit Span
  • Measures working memory which requires functional
    processing of language, speech and sub-vocal
    domains

2, 9, 4, 3
Morris et al, Arch Neurol. 2001, 58, 397-405
11
Digit Span Forward
  • Statistically significant, dose dependant, and
    durable impact on working memory

11
12
Clear Cognitive Enhancement
85
Davunetide
80
75
Normal
70
65
DMTS, 12 s delay (correct)
60
55
50
45
AD
40
Baseline
Week 4
Week 8
Week 12
Week 16
  • Cognitive enhancements provides for symptomatic
    regulatory pathway

Swainson et al, Dementia Geriatric Cognitive
Disorders, 2001
13
Summary
  • Statistically significant, dose dependent and
    durable impact observed when memory domains are
    challenged
  • Drug effect and/or trending observed when the
    challenge is both memory and executive function
  • No effect on anxiety
  • Consistent drug effect through most efficacy
    endpoints
  • Drug is safe well tolerated with modest drug
    related adverse events
  • Clear human proof-of-concept in relevant
    indication warrants proceeding to PIIb in AD
    other types of dementia

14
Phase II Schizophrenia Cognitive Impairment Design
  • 60 patients clinically stable
  • Randomized, double blind, placebo controlled
  • Two doses of 5 mg QD/15 mg BID for 12 weeks
  • Placebo matched to both low and high dose
    davunetide
  • 7 US sites
  • Endpoint MATRICS UPSA SCoRS (baseline 6
    12 weeks)
  • 3 imaging biomarkers to evaluate structural
    changes
  • TURNS / NIMH funded

15
Phase II Schizophrenia Top-Line Results
  • Statistically significant efficacy (p0.015) was
    achieved on the UCSD (University of California at
    San Diego) Performance-based Skills Assessment
    (UPSA)
  • UPSA scale assesses the functional capacity of
    skills for daily living
  • UPSA recognized by drug regulators as important
    co-primary endpoint in patients suffering from
    schizophrenia-related cognitive impairment
  • No significance on MATRICS (Measurement and
    Treatment Research to Improve Cognition in
    Schizophrenia) composite battery of tests
  • Safe and well tolerated

16
Next Steps
  • Strategic transaction with the Alzheimers
    program
  • Defining the way forward in AD
  • Initiate PII/III study in FTD
  • Work towards accelerated approval
  • Continue the drug development work
  • Optimized formulation, second generation
    products, shepherd the pipeline

17
Phase II FTD
  • Progressive early-onset dementia
  • Typical patient 45-65 years
  • 50 tau-related
  • Atrophy as high as 16 / year
  • Survival 3-5 years in aggressive forms
  • No available treatment

18
Balanced Clinical Development Strategy
19
Capital Snapshot
  • 14.5-mm cash (June 30 09)
  • 09 burn rate 700k/month
  • Cash into 2011
  • 78-mm shares (Basic)
  • Market cap 40-mm
  • No preferreds no debt

20
Analyst Coverage
21
Proven Management Team
  • Gordon C. McCauley President CEO
  • (Co-founder Neuro Discovery Fund, 20 years
    mgmt. experience)
  • Matthew J. Carlyle, CFA Chief Financial
    Officer(Co-founder Neuro Discovery Fund, 10
    years mgmt. experience)
  • J. Steven Whitaker, M.D., J.D. Chief Medical
    Officer
  • (ICOS, Lilly ICOS)
  • Bruce H. Morimoto, Ph.D. VP, Drug
    Development(Neuromed, Amur, Phoenix, MDS)
  • Alistair J. Stewart PhD - VP, Commercial
    Research(Xenova, QLT, enGene)
  • Illana Gozes, Ph.D. Chief Scientific
    Officer(Prof. Tel Aviv University)

22
Respected Advisors
Scientific Advisory Board
Board of Directors
  • Prof. Illana Gozes, Ph.D., Chair
  • Dr. Keith L. Black(UCLA)
  • Dr. Michael E. Charness(Harvard University)
  • Dr. Howard Fillit(Institute for the Study of
    Aging)
  • Mati Fridkin, Ph.D.(Weizmann Institute of
    Science)
  • Dr. Michael A. Moskowitz(Harvard University)
  • Anthony G. Phillips, Ph.D.(University of British
    Columbia)
  • Esther Shohami, Ph.D.(Hebrew University of
    Jerusalem)
  • Remi Quirion, Ph.D.(Douglas Hospital Research
    Centre)
  • Prof. Trevor Robbins(Cambridge University)
  • James J. Miller, Ph.D., Chair
  • (Former CEO QLT/INEX, NDI Capital)
  • Dr. Martin Barkin(Former CEO, Draxis Health)
  • Prof. Illana Gozes, Ph.D.(Founder Allon, Prof.
    TAU)
  • Frank A. Holler
  • (Former CEO, Xenon, ID, Co-founder
    Angiotech, CEO, BC Advantage Funds)
  • Gordon C. McCauley
  • (Founder NDI, CEO)
  • C. Michael OBrian
  • (President, Nairbo Investments)
  • Anthony G. Phillips, Ph.D.(CIHR Neuroscience,
    UBC)

23
Allon Summary
  • Phase II human proof of concept
  • Advancing to PII in FTD
  • Advancing in AD/CIAS to PIIb
  • First clinical program to impact both amyloid
    beta and neurofibrillary tangles
  • 12 families of 53 issued patents (including
    composition of matter) and 30 pending
  • Broaden the offering with undervalued assets
  • Management team with consistent track record of
    execution and achievement

24
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