EX-99.1 2 dex991.htm SLIDE PRESENTATION OF INFINITY PHARMACEUTICALS, INC. Slide presentation of Infinity Pharmaceuticals, Inc.
NASDAQ: INFI
JP Morgan Healthcare Conference
Steven H. Holtzman, CEO
January 7 -
10, 2008
Exhibit 99.1


2
Forward-Looking Statements
This
presentation
contains
forward-looking
statements
within
the
meaning
of
The
Private
Securities
Litigation
Reform
Act
of
1995.
These
statements
involve
risks
and
uncertainties
that
could
cause
actual
results
to
be
materially
different
from
historical
results
or
from
any
future
results
expressed
or
implied
by
such
forward-looking
statements. 
Such
forward-looking
statements
include
those
regarding
future
clinical
trial
activity
for
IPI-504,
IPI-493
and
IPI-926; the presentation of
preclinical
and
clinical
data
for
IPI-504
and
IPI-926;
estimates
of
2007
and
2008
financial
performance;
and
the
expectation
that
Infinity
will have cash
to
support
its
current
operating
plan
through
at
least
the end
of
2009.  
Such
statements
are
subject
to
numerous
factors,
risks
and
uncertainties
that
may
cause
actual
events
or
results
to
differ
materially
from
Infinity's
current
expectations.
For
example,
there
can
be
no
guarantee
that
any
product
candidate
Infinity
is
developing
will
successfully
complete
necessary
preclinical
and
clinical
development
phases.
In
particular,
expectations
could
be
affected
by
risks
and
uncertainties
relating
to:
results
of
clinical
trials
and
preclinical
studies,
including
subsequent
analysis
of
existing
data
and
new
data
received
from
ongoing
and
future
studies;
the
content
and
timing
of
decisions
made
by
the
U.S.
Food
and
Drug
Administration
and
other
regulatory
authorities,
investigational
review
boards
at
clinical
trial
sites,
and
publication
review
bodies;
Infinity's
ability
to
enroll
patients
in
its
clinical
trials;
Infinity's
dependence
on
its
collaborations
with
MedImmune
and
Novartis;
Infinity's
ability
to
obtain
additional
funding
required
to
conduct
its
research,
development
and
commercialization
activities;
unplanned
cash
requirements
and
expenditures;
and
Infinity's
ability
to
obtain,
maintain
and
enforce
patent
and
other
intellectual
property
protection
for
any
product
candidates
it
is
developing.
These
and
other
risks
which
may
impact
Infinity’s
expectations
are
described
in
greater
detail
under
the
caption
"Risk
Factors“
included
Infinity's
quarterly
report
on
Form
10-Q
for
the
quarter
ended
September
30,
2007,
which
was
filed
with
the
Securities
and
Exchange
Commission
on
November
7,
2007. 
Further,
any
forward-looking
statements
contained
in
this
presentation
speak
only
as
of
the
date
hereof,
and
Infinity
expressly
disclaims
any
obligation
to
update
any
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
All
trademarks
used
in
this
presentation
are
the
property
of
their
respective
owners.


3
INFI: A compelling investment, TODAY
Lead product (Hsp90) biologically active and well-tolerated
Registration trial expected to commence 3Q 2008
Broad, near-term market potential
8+ Hsp90 trials underway in 2008
Sustainable growth potential
Pipeline of novel small molecules, including Hedgehog inhibitor
Proven team
First-
and best-in-class NDAs, value-creating business transactions
Compelling valuation
Steady news flow through 2008


4
0.0
1.0
2.0
3.0
Rituxan
Herceptin
Avastin
Eloxatin
Taxotere
Gleevec
Gemzar
0
50,000
100,000
150,000
200,000
250,000
Prostate
Lung
Breast
Colorectal
Bladder
NHL
Melanoma
Leukemia
Hsp90 Inhibition: A Major New Target
** Sales in top 7 markets. Source: “Commercial insight: Top 20
cancer therapy brands 2006.”
Datamonitor, July 2007
* Source: American Cancer Society: Cancer Facts and Figures 2007.
Atlanta, Ga: American Cancer Society, 2007
Top cancers in U.S by incidence*
Clinical development underway
in the three most common
cancers
Potential for application in
combination with major
products
2006 sales cytotoxic/targeted therapies ($B)**


5
Evidence
of
IPI-504
activity
in
GIST
Courtesy of Van den Abbeele
& Demetri:
Dana-Farber Cancer Institute
Harvard Medical School
Baseline
Baseline
Cycle 1, Day 22
Cycle 1, Day 22
10 days off treatment
Cycle 1, Day 12
24
hrs
post
4
th
dose
Cycle 1, Day 12
IPI-504
PET
response
at 400
mg/m
2


6
Evidence of IPI-504 activity in NSCLC
Baseline
Cycle
1,
Day
8
Courtesy of:
IPI-504 PET
response at
150 mg/m
2


7
Hsp90 Inhibition: How it works
Hsp90 is a chaperone
protein
responsible for proper folding and
function of some oncogenic
proteins
IPI-504 binds
at ATP site
and inhibits
proper folding
Unstable
oncogene
degraded;
tumor growth
inhibited


8
Broad applicability of client protein rationale
Cancer(s)
GIST
NSCLC
Prostate (PTEN -/-)
Breast (HER2+)
Melanoma
CML
AML
c-Kit
EGFR / C-met
AR / p-Akt
HER2 / ER
b-Raf
(V800E)
Bcr-Abl
Flt3
Hsp90 client proteins


9
Oncogenic protein
drives cancer cell
survival & growth
Cancer
cell death
Tyrosine kinase
inhibitor
(e.g., Gleevec, Tarceva)
Normal
protein
Resistance mutations
evade TKI therapy
IPI-504 / Oral
IPI-504
Dependent
on Hsp90
for function
Still depends
on Hsp90 for
function
Rapid registration
in
refractory setting
Expand potential
in
front-line / combo
Hsp90 development paradigm: an alternative to
direct inhibition of oncogenic
proteins


10
Infinity’s Hsp90 Inhibitors
IPI-504
Small molecule
Semi-synthetic analog of
geldanamycin
Delivered as water-based
i.v. infusion; oral form
also available
Issued U.S. patent
IPI-493
Small molecule
Semi-synthetic analog of
geldanamycin
Oral formulation
Strong IP position;
patent applications filed
worldwide


11
Hsp90 Clinical Development Strategy
Rapid path to registration with IPI-504 i.v.
Single-agent therapy, refractory settings
GIST & NSCLC
Trials for additional indications
Signal-finding trials in additional tumors (HRPC, others)
Combination therapy with standards of care (Taxotere®, others)
Rapid development of oral
Earlier lines of therapy, combinations, chronic therapy
Phase 1 expected to commence 1H 08


12
IPI-504:
Potential
first-in-class
Hsp90
Encouraging clinical data
Phase 1 dose-escalation trial
Refractory patient population
(Gleevec®
and Sutent®)
Preliminary data at ASCO 2007*
76% Stable Disease (RECIST)
33% received at least 5 cycles
Stable Disease is meaningful
Plan to launch Registration Trial
Expansion portion
19/20 patients @ MTD
Active consultation with
regulators and advisors
Received U.S. and EU orphan
designations
*George D. Demetri, et al,
(Poster Number 8, Abstract No: 10023) and A.D. Van den Abbeele, et al, (Poster
Number 1, Abstract No: 3530)
No approved therapies in 3
rd
line GIST


13
IPI-504: Pursuing Rapid Path to Market in NSCLC
Encouraging clinical data
Completed Ph 1 portion
Stage IIIb/IV NSCLC patients with
>12 weeks previous TKI therapy
Phase 1 data at EORTC 2007*
12 patients, dose-escalation
7 of 9 (78%) Stable Disease
1 pt with mtEGFR
experienced
extended SD >6 months (28 weeks)
Correlative PET activity observed
Clear path forward
Initiated Phase 2 portion
Evaluate mtEGFR
and wild-type
Potential to expand
Combination therapy strategy
Phase 1 single agent drives
exploration of mechanistic
combinations
Important potential setting for oral
No approved therapies in TKI-resistant NSCLC
* Sequist, L., Janne, P., Sweeney, J., Walker, J., Grayzel, D., Lynch, T. (2007) Phase 1/ 2 Trial of the Novel Hsp90 Inhibitor, IPI-
504, in Patients with Relapsed and/or Refractory Stage IIIb
or Stage IV Non-Small Cell Lung Cancer (NSCLC) Stratified by
EGFR Mutation Status.
ACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, B79, 2007.


14
IPI-504: Significant commercial potential
In addition to ongoing trials in GIST and NSCLC:
Phase
2
Hormone-resistant
prostate
cancer
(HRPC)
2 groups: 1 pre-
and 1 post-Taxotere®
treatment
Establish potential utility in combination and/or as oral therapy
Combo
with
Taxotere®
in
patients
with
advanced
solid
tumors
Establish safety, MTD, and optimal schedule of administration
Additional
trials
planned
to
commence
in
2008
Phase 2 single agent trials
Additional combination study
Expect
to
enter
clinic
with
oral
in
2008


15
Infinity’s oral Hsp90 program
Demonstrated
potent
and
selective
Hsp90
inhibition
preclinically
Excellent oral exposure: PK and half-life
Move forward with strongest possible product profile
Differentiate from wholly-synthetic competitors
On
track
to
enter
clinic
in
2008
Rapid exploration of dose, schedule, and combinations
Leverage signal-finding efforts from Phase 2 studies with i.v
IPI-504
Likely to advance IPI-493 pending final preclinical data


16
Hsp90 program milestones for 2008
2H 2008
Initiate registration
trial of IPI-504 in GIST
Present preliminary Phase 2 NSCLC data
Present preliminary Phase 2 HRPC data
1H 2008
Present
updated
Phase
1
GIST
data
(ASCO)
Initiate
additional
Phase
2
trials
with
IPI-504
Initiate oral
Phase 1 trial


17
Worldwide collaboration: R&D and commercial
Compelling economics: Control INFI cash burn,
significant downstream participation
$70M upfront; $215M potential milestones
R&D cost share and 50/50 WW profit split
Co-promotion
rights
in
US
Provides
global
oncology
infrastructure
and
reach
MedImmune/AstraZeneca
alliance
on
Hsp90


18
Infinity: Building a sustainable oncology pipeline


19
Role of Hedgehog pathway in cancer
Embryonic pathway
Aberrantly active in a variety of cancers
Genetically-defined
Examples:
Childhood
medulloblastoma
Basal cell carcinoma
Rhabdomyosarcoma
Pathway up-regulation
Examples:
Pancreatic
Small cell lung
Breast
Ovarian


20
Burgeoning interest in Hedgehog pathway
2004
2005
2006
2007
10
19
31
43
AACR Meeting Abstracts
on Hedgehog Pathway,
2004-2007


21
Infinity’s Hedgehog program: IPI-926
Superior semi-synthetic analog of cyclopamine
Promising preclinical data
Highly
potent,
selective
inhibition
of
Hedgehog
pathway
Oral bioavailability, extended half-life
Anti-tumor activity in vivo
IND and Phase 1 clinical study anticipated in 2008
Issued
composition of matter patent
Infinity-discovered & 100% owned royalty-free worldwide


22
Hedgehog program milestones
2009
Preliminary Phase 1 data
Initiate Phase 2
trials
Expand
clinical development
2008
Preclinical data
at AACR
File IND
Initiate Phase 1 clinical trial


23
Business Update


24
Strong balance sheet and cash runway
$114M
cash and equivalents (12/31/07, unaudited)
Burn rate well-controlled
via alliances
50%
cost-sharing of Hsp90 program with MedImmune
100%
of Bcl-2 program funded by Novartis
Projected 2008 net cash burn: $35-45M
Cash to support current plan through at least end of 2009
Sufficient capital to achieve key value creation milestones


25
Infinity
Leadership
Michael
Curtis,
Ph.D.,
Sr
Dir
Pharm.
Devel.
TKT, Syntonix, Genzyme, Bristol-Myers Squibb
David
Grayzel,
M.D.,
VP
Clin
Dev.
&
Med.
Affairs
Dyax,  Mass General Hospital
John
Keilty,
Sr
Dir
Informatics
Millennium,
UMass
Medical
School
Vito Palombella, Ph.D., VP Drug Discovery
Syntonix, Millennium, ProScript
Steven Kafka, Ph.D., VP Finance
Millennium, Strategic Decisions Group
Jeanette Kohlbrenner, Dir Human Resources
Genetics Institute, Syntonix
Gerald Quirk, Esq., VP & General Counsel
Genzyme, Palmer & Dodge
Jeffrey Tong, Ph.D., VP Corp. & Product Dev.
McKinsey & Co, Harvard Ctr. for Genomics
Research
Steven Holtzman
Chair, President & CEO
Millennium, DNX
Julian Adams, Ph.D.
CSO & President of R&D
Millennium, ProScript,
Boehringer
Ingelheim,
Merck
Adelene Perkins
Chief Business Officer
& EVP
Transform, Genetics Institute,
Bain, GE


26
2007 Report Card
Initiate Phase 1/2 trial of IPI-504 in NSCLC
Feb 07
Complete Phase 1 trial of IPI-504 in GIST
Registration trial
plans underway
Progress IPI-504 to one or more Phase 2 trials
HRPC, Nov 07
NSCLC, Dec 07
Initiate IPI-504 combination study
Taxotere, Dec 07
Enter clinic with oral formulation of IPI-504
Select Hedgehog clinical candidate
Continue progress with Novartis on Bcl-2
Ongoing
Advance early discovery programs
Ongoing
Discovered
IPI-493
Q2 07
Maintain a strong balance sheet
Sustain excellence in strategic alliances
MedImmune, Novartis
Employ position of strength strategically to
create shareholder value
Regained Hedgehog
rights
$114M cash year-end


27
Infinity
Goals
2008
Strong financial profile
Scientific excellence
Integrated Citizen-Ownership culture
Business and operational excellence
IPI-504
GIST
Phase
3
registration
trial
IPI-504
Phase
2
trials
for
additional
indications
Oral
Hsp90:
Phase
1
clinical
study
IPI-926
Hedgehog:
Phase
1
clinical
study
Identify
strategic
opportunities
to
enhance
profil
e
Execute on
near-term
value-drivers
Maintain &
enhance
foundations
for success


28
INFI: A compelling investment, TODAY
Lead product (Hsp90) biologically active and well-tolerated
Registration
trial
expected
to
commence
3Q
2008
Broad, near-term market potential
8+ Hsp90 trials underway in 2008
Sustainable growth potential
Pipeline of novel small molecules, including Hedgehog inhibitor
Proven team
First-
and best-in-class NDAs, value-creating business transactions
Compelling valuation
Steady news flow through 2008


NASDAQ: INFI
JP Morgan Healthcare Conference
January 7 -
10, 2008