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Allon Therapeutics Inc.

TSX: NPC

ORPHAN DRUG STRATEGY WITH FAST FACTS


SHARES ISSUED AND OUTSTANDING: 78.0 M
A $750 MILLION TARGET MARKET STOCK SYMBOL: NPC
STOCK EXCHANGE LISTING: TORONTO STOCK EXCHANGE (TSX)
LESS COSTLY, QUICKER TO APPROVAL,
7 YEARS OF MARKET EXCLUSIVITY
2010: Q4

Drugs that impact


Clinical development neurodegenerative diseases
INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Allon Therapeutics Inc. (TSX: NPC) is a clinical-
stage biotechnology company focused on
Davunetide PSP developing the first drugs that impact the
Alzheimer’s progression of neurodegenerative diseases.
Schizophrenia Therapies available today treat only symp-
2nd generation Dementias toms and have no effect on the course of
the disease.
AL 309 Neuropathy
Major market strategy –
AL 408 Neuroprotection
demonstrated human efficacy
AL 508 Neuroprotection Allon has two opportunities in major markets
of unmet need: Alzheimer’s disease and
Completed Next Steps
cognitive impairment associated with
schizophrenia. For both of these indica-
Phase 2a data from aMCI study provides
tions, the Company has demonstrated
human proof of concept for frontotemporal
human efficacy in Phase 2 clinical trials and
dementias and Alzheimer’s disease.
intends to advance to commercialization in
these markets in partnership with a major
Davunetide repairs impaired tau Davunetide reduces impaired tau pharmaceutical company.
(Frontotemporal dementias) (Alzheimer’s)
Complementary
Reduction Reduction Reduction
100% orphan strategy
tau phosphorlation

20% In 2010, Allon embarked on a complemen-


tary strategic path: pursuing approval in
a smaller “orphan drug” disease called
70% 70% Progressive Supranuclear Palsy (PSP). This
market is estimated at $600 million, but
0% with a more direct and less costly pathway,
Normal Disease Treated Amyloid Beta Tau and the opportunity to retain more of the
Studies have shown that davunetide can Studies in mice bred to have Alzheimer’s value for Allon and its shareholders.
repair tau protein in the brains of mice that disease, show that Allon’s davunetide is PSP is made more attractive by “orphan
are bred to have a tau impairment, known the first clinical compound in the world drug” regulations that streamline the ap-
as tau hyperphosphorylation, common to have an affect on both pathologies of proval process and exclude competition for
to half of frontotemporal dementias the disease: amyloid beta plaques and several years. Many of the world’s leading
(FTDs). Other studies have shown that neurofibrillary tangles. Research has biotech and pharma companies have suc-
these pathological improvements result established that impairment of the brain ceeded with this strategy.
in dramatically improved cognitive protein tau is involved in tangles.
performance in these mice. Continued next page
Allon Therapeutics Inc. TSX: NPC www.allontherapeutics.com

Clinical program: Davunetide improves recognition,


faster route to value short term and working memory Davunetide improves short term memory
There is a strong scientific rationale 100 16 (b) (c)
(b) (a)
for Allon’s strategy: The pathology of 80

% improvement
% improvement
12
PSP involves impairment of the brain (a)
60
protein tau – and Allon’s animal 8
40
research plus Phase 2 clinical trial in
20 4
pre-Alzheimer’s patients demonstrate
that davunetide is the most advanced 0 0
tau therapy in the world. 0 4 8 12 16 0 4 8 12 16
weeks weeks
Allon expects to begin an advanced
efficacy trial in PSP patients at mid- Davunetide (a) p = 0.039
62.4% Davunetide (a) p = 0.059 (c) p = 0.052
year 2010 -- and believes that suf- Placebo (b) p = 0.038 Improvement Placebo (b) p = 0.032
ficiently positive results would enable
davunetide to qualify for approval in The Phase 2a clinical trial showed that Davunetide provided improvement in
PSP from the U.S. Food and Drug Ad- davunetide improves memory function in memory function in a second test that is
ministration (FDA) based on this trial. aMCI subjects. The delayed match-to-sample important in both aMCI and AD. This shows
test (12 sec delay) focuses on important areas of the activity of davunetide on memory which
2010 progress in Allon’s PSP working, recognition and short-term memory requires effective processing of language,
program includes: which are important in aMCI and AD. speech and sub-vocal parts of the brain.
≠ Orphan drug designation for davu-
netide in the United States (FDA) and ≠ Initiation of a pilot study at Uni- Because orphan drug designation
the European Union, the world’s two versity of California, San Francisco to does not restrict a drug from larger
largest pharmaceutical markets; validate the trial design for the mid- diseases, it will have no impact on the
year efficacy clinical trial. Company’s strategy to seek approval
≠ Fast track status in the U.S. (FDA);
in much larger larger markets, such
Allon believes this next trial will
≠ A Phase 1 clinical trial that ex- as Alzheimer’s and schizophrenia, in
not just provide data for a potential
panded the demonstrated safety collaboration with a major pharma
approval in PSP, but will also define
range and pharmacokinetic profile of partner.
the opportunity in other tau-related
davunetide at dosage levels higher
diseases, such as Alzheimer’s, schizo-
than previously investigated in the
phrenia and several types of fronto-
Company’s clinical trials; and
temporal dementia.

Allon Therapeutics Inc.


506 – 1168 Hamilton St, Vancouver, BC, Canada V6B 2S2
Telephone: 604-736-0634 Fax: 604-736-1616
www.allontherapeutics.com

For more information Analyst Coverage Allon Therapeutics Inc. is a efficacy programs pursuing
clinical-stage biotechnology large underserved markets:
Aaron Keay 604-323-6911 Neil Marouka 416-869-3073
company focused on developing Alzheimer’s disease, frontotem-
Director, Investor Relations Canaccord Adams
akeay@allontherapeutics.com neil.marouka@canaccordadams.com the first drugs that impact the poral dementia, and schizo-
progression of neurodegen- phrenia-related cognitive im-
Gordon C. McCauley 604-734-5060 Cosme Ordenez 514-288-9279
erative diseases. Allon’s drug pairment. The Company is listed
President & CEO GMP Securities
gmccauley@allontherapeutics.com cosmeo@gmpsecurities.com davunetide has demonstrated on the Toronto Stock Exchange
human efficacy in amnestic under the trading symbol “NPC”
Matthew J. Carlyle, CFA 604-734-5065 Catherine Bouchard 514-350-2930
mild cognitive impairment, (Neuro Protection CompanyTM)
Chief Financial Officer Laurentian Bank Securities
mcarlyle@allontherapeutics.com bouchardca@lb-securities.com a precursor to Alzheimer’s and based in Vancouver. For
disease, and schizophrenia- additional information please
related cognitive impairment. visit the Company’s website:
Allon has Phase 2 human www.allontherapeutics.com.