EX-99.1 2 dex991.htm SLIDE PRESENTATION OF INFINITY PHARMACEUTICALS, INC. DATED NOVEMBER 16, 2009 Slide presentation of Infinity Pharmaceuticals, Inc. dated November 16, 2009
NASDAQ: INFI
November 2009
Infinity
Innovative. Independent. Inspired.
Exhibit 99.1

Innovative. Independent. Inspired.
2
Safe Harbor Statement
•
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 statements regarding future clinical trial activity for IPI-504 and IPI-493; the presentation of
clinical data for IPI-504 and IPI-493; the filing of an IND for IPI-940; estimates of 2009 financial performance; the continuation of the
Purdue/Mundipharma
alliance
and
the
exercise
of
warrants
held
by
Purdue,
and
the
expectation
that
Infinity
will
have
capital
to
support its current operating plan into 2013.
•
Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to
differ materially from the company's current expectations. For example, there can be no guarantee that Infinity’s strategic alliance
with
Purdue/Mundipharma
will
continue
for
its
expected
term
or
that
these
entities
will
fund
Infinity’s
programs
as
agreed,
or
that
any
product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases. In addition,
Infinity’s 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; unplanned cash requirements and
expenditures; market acceptance of any products Infinity or its partners may successfully develop; and Infinity's ability to obtain,
maintain and enforce patent and other intellectual property protection for any product candidate it is developing.
•
These
and
other
risks
which
may
impact
management's
expectations
are
described
in
greater
detail
under
the
caption
"Risk
Factors"
included in Infinity's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission in November 2009.
•
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.
•
Our Internet
website
is
http://www.infi.com.
We
regularly
use
our
website
to
post
information
regarding
our
business,
product
development programs and governance.  We encourage investors to use www.infi.com, particularly the information in the section
entitled
“Investors/Media,”
as
a
source
of
information
about
Infinity.
References
to
www.infi.com
in
this
presentation
are
not
intended
to,
nor
shall
they
be
deemed
to,
incorporate
information
on
www.infi.com
into
this
presentation
by
reference.
2
2

Innovative. Independent. Inspired.
Infinity: Uniquely positioned for success
Full ownership of industry-leading Hsp90 chaperone inhibitors
U.S. commercialization rights to all oncology programs
Worldwide royalties up to 20% on neuropathic pain program
3
Financial strength
Value-creating
asset ownership
Innovative
pipeline
Cash and funding to aggressively invest in programs to key
clinical inflection points
Phase 2: Hsp90 chaperone inhibition
Phase 1: Hedgehog pathway inhibition
Near IND: Fatty acid amide hydrolase
(FAAH) inhibition
World-class discovery organization

Innovative. Independent. Inspired.
Financial strength today to aggressively invest
in pipeline
•
$140 million in cash & equivalents as of September 30, 2009
•
Purdue
/
Mundipharma
collaboration
–
Access to $50 million line of credit (interest at prime; payment due 2019)
–
Up to $162.5 million in R&D funding through 2011*; options to extend
through 2013
•
~ 26 million shares outstanding
–
Up to $200 million in proceeds from Purdue exercisable warrants
(6 million shares at exercise price of $15 to $40 per share)
4
*As of 9/30/2009, assuming Purdue funding through 2011. Funding from Purdue includes 12.5M in 4Q9
(committed), up to $65M in 2010 (committed), and up to $85M in 2011

Innovative. Independent. Inspired.
5
Financial Strength:
Runway to Clinical Inflection Points
2009
Key objectives
•
Advance Hsp90 trials
•
Advance Hedgehog trial
•
IND for FAAH inhibitor program
Total investment
$80 –
90M
$157M
2009 starting
cash*
2009 ending cash
$127 –
137M
*$127M on 12/31/08, plus $30M Purdue equity investment 1/7/09
** After $12.5M residual funding from AstraZeneca
Net cash burn
(Purdue funds non-Hsp90)
($20 -
30M)**
5
2010-2012
•
Advance late-stage Hsp90 program
•
Initiate addt’l
Hh
and FAAH  studies
•
Strategically enhance pipeline
$375 –
425M
($140 –
170M)
Additional sources of cash
$50M Purdue line of credit
•
Up to $200M Purdue warrants
•
Partner Hsp90 ex-U.S.

Innovative. Independent. Inspired.
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6
Infinity: Developing Breakthrough Therapeutics
6
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Hsp90 Chaperone Inhibitors
Hsp90 IV: IPI-504 (retaspimycin
hydrochloride)
NSCLC
HER2+ mBC
Solid Tumors
Liposarcoma
Hsp90 oral: IPI-493
Solid Tumors
Hedgehog Pathway: IPI-926
Solid Tumors
FAAH: IPI-940
Bcl-2/Bcl-xL*
Discovery Programs
*Transitioned to Novartis
Pipeline at November 2009
Herceptin®
Combination
Taxotere®
Combination
Expected to Begin Early 2010

Innovative. Independent. Inspired.
7
Hsp90 Chaperone Inhibition Program:
New angle of attacking oncoproteins

Innovative. Independent. Inspired.
8
8
Hsp90 chaperone inhibition:
A new
angle
for targeting oncoproteins
8
•
Hsp90 chaperone
stabilizes
oncoprotein,
enabling growth
signaling and tumor
cell proliferation
•
Inhibit Hsp90 and
oncoproteins
become
unstable, unfolded, and
unable to signal
•
Unfolded oncoproteins
will then be degraded
rapidly, arresting tumor
cell growth
•
Currently, targeted
therapies inhibit
oncoproteins
in
distinctly different ways
that do not affect the
critical function of
Hsp90

Innovative. Independent. Inspired.
Hsp90 Chaperone Inhibition: Broad medical &
commercial potential
9
Lung cancer
Breast cancer
Additional tumors
Address substantial
oncology market with a
new treatment approach
Combine Hsp90 chaperone
therapy with existing
standards of care to delay
recurrence
Serve as late-line therapy
where tumors have
become refractory to other
drugs
IPI-504 IV
(retaspimycin
hydrochloride)
IPI-493 oral

Innovative. Independent. Inspired.
10
10
Infinity’s Hsp90 chaperone inhibition program
Broad medical & commercial potential
10
Lung
cancer
Non-small cell
180,000 US
incidence
•
IPI-504 Ph 2 in NSCLC (ASCO 2009)
14% ORR in wtEGFR
patients
•
IPI-504
Ph
1b
combo
with
Taxotere
®
(ASCO 2009)
Generally well-tolerated; combinable
•
Molecular
characterization ongoing
•
Ph 2 data and further
clinical development
expected 2010
INDICATION
TRIALS & DATA
CATALYTS

Innovative. Independent. Inspired.
11
11
Infinity’s Hsp90 chaperone inhibition program
Broad medical & commercial potential
11
Lung cancer
Non-small cell
180,000 US
incidence
•
IPI-504 Ph 2 in NSCLC (ASCO 2009)
14% ORR in wtEGFR
patients
•
IPI-504 Ph 1b combo with Taxotere
®
(ASCO 2009)
Generally well-tolerated; combinable
•
Molecular
characterization ongoing
•
Ph 2 data and further
clinical development
expected 2010
Breast cancer
HER2+
45,000 US
incidence
•
IPI-504 Ph 2 in HER2+ mBC
combination
with Herceptin
®
Demonstrated potency and tumor growth
inhibition in preclinical models
•
Clinical data expected
2010
INDICATION
TRIALS & DATA
CATALYTS

Innovative. Independent. Inspired.
12
12
Infinity’s Hsp90 chaperone inhibition program
Broad medical & commercial potential
12
Lung cancer
Non-small cell
180,000 US
incidence
•
IPI-504 Ph 2 in NSCLC (ASCO 2009)
14% ORR in wtEGFR
patients
•
IPI-504 Ph 1b combo with Taxotere
®
(ASCO 2009)
Generally well-tolerated; combinable
•
Molecular
characterization ongoing
•
Ph 2 data and further
clinical development
expected 2010
Breast cancer
HER2+
45,000 US
incidence
•
IPI-504 Ph 2 in HER2+ mBC
combination
with Herceptin
®
Demonstrated potency and tumor growth
inhibition in preclinical models
•
Clinical data expected
2010
Additional
tumors
•
IPI-493 oral Ph 1 study in solid tumors
•
IPI-504 Ph 2 in dedifferentiated
liposarcoma
expected to begin early 2010
•
Ph 1 data and further
IPI-493 clinical
development expected
2010
INDICATION
TRIALS & DATA
CATALYTS

Innovative. Independent. Inspired.
13
Hedgehog Program

Innovative. Independent. Inspired.
14
The Hedgehog
pathway:
A promising new focus for targeted drug therapy
14
14
•
The Hedgehog (Hh) pathway is
not active in most adult cells
•
Smoothened (Smo)  --
which
can promote growth of certain
cancers –
is held in an inactive
state by Patched (Ptc)
•
Gli
transcription factors do not
enter the nucleus to promote
transcription
Malignant activation of the Hedgehog pathway may be implicated in many
insidious cancers including pancreatic, ovarian, small cell lung, breast, brain, and
basal cell (skin) cancers

Innovative. Independent. Inspired.
15
The role of Smoothened in malignant activation
of the Hedgehog pathway
15
15
•
Tumor
cells
produce
Hh
ligand
that binds to Ptc, allowing Smo
to initiate a signaling
cascade through Gli
•
Gli
dependent transcription of
genes can now promote tumor
survival and growth
•
Tumor
derived
Hh
ligands
act
through
Smo
on
stromal
cells
in
the tumor microenvironment
•
Stromal
cells in the
microenvironment provide
support for growth and survival
of tumor cells
•
Hh
signaling activated by
genetic mutation
•
Loss-of-function mutations in
Ptc
allow Smo
to initiate a
signaling cascade in the
absence of Hh
ligand, leading
to tumor survival and growth
Ligand-Dependent Signaling
Ligand-Independent
Signaling

Innovative. Independent. Inspired.
16
Infinity’s IPI-926
inhibits Smoothened
16
16
•
IPI-926 inhibits Smo,
preventing the signaling
cascade that otherwise
leads to tumor cell
growth and survival
IPI-926 in ongoing
Ph 1 clinical trial
IPI-926

Innovative. Independent. Inspired.
17
17
Significant anti-tumor activity with IPI-926
in
small cell lung cancer model
Days Post Implant
5 weeks total of IPI-926 follow-up
treatment; 40 mg/kg, PO QD
Travaglione
et al., 2008 AACR

Innovative. Independent. Inspired.
18
IPI-926
+ Gemcitabine
provides a survival
benefit
in
pancreatic
cancer
model
IPI-926 depletes tumor stroma
through down-regulation of Hh
signaling, resulting in increased
drug delivery to the tumor
Olive et al., 2009 Science
0
15
30
45
60
75
90
0
20
40
60
80
100
Days of Treatment
Vehicle
Gem
IPI-926
IPI-926/Gem
Model resembling human
pancreatic cancer responds
poorly to gemcitabine
due to
lack of tumor perfusion

Innovative. Independent. Inspired.
Compelling potential path forward for Phase 2
development in 2010
•
Recent Science
article highlights promising role of IPI-926 in
chemo-resistant pancreatic cancer model
•
Evidence for Hh
inhibition as maintenance therapy in
chemo-responsive tumor models, including SCLC and ovarian
•
IPI-926 advancing through Phase 1 study
19

Innovative. Independent. Inspired.
20
Early Pipeline:
Fatty Acid Amide Hydrolase
(FAAH)

Innovative. Independent. Inspired.
Fatty acid amide hydrolase
(FAAH):
21
21
Next Generation Innovation: IPI-940 for
neuropathic pain
21
Advance IPI-940 to IND
by year-end 2009
FAAH inhibition increases the duration of anandamide’s
analgesic effect, prolonging pain relief at the site of release
CB1
Anandamide

Innovative. Independent. Inspired.
22
22
Infinity: Developing
Breakthrough Therapeutics
22
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Hsp90 Chaperone Inhibitors
NSCLC
HER2+ mBC
Solid Tumors
Liposarcoma
Hsp90 oral: IPI-493
Solid Tumors
Hedgehog
Pathway: IPI-926
Solid Tumors
FAAH: IPI-940
Bcl-2/Bcl-xL*
Discovery Programs
*Transitioned to Novartis
Pipeline at November 2009
Herceptin®
Combination
Taxotere®
Combination
Expected to Begin Early 2010
Hsp90 IV: IPI-504 (retaspimycin hydrochloride)

Innovative. Independent. Inspired.
23
23
•
Report IPI-504 NSCLC Ph 2 data, mid-2009
•
Report IPI-504 Ph 1b Taxotere®
combo data, mid-2009
•
Advance oral IPI-493 Ph 1
•
Initiate additional trials (including HER2+ mBC)
23
2009 R&D Milestones
Hsp90: IPI-504 and IPI-493 oral
•
Advance
IPI-940
to
IND
FAAH: IPI-940
•
Report IPI-926 preclinical data, multiple tumor models, mid-2009
Hedgehog: IPI-926

Innovative. Independent. Inspired.
24
24
Business and Commercial Objectives
24
•
Build market presence
–
Infinity to commercialize all oncology products in U.S.
–
Potential to partner Hsp90 for ex-U.S. marketing
–
Purdue/Mundipharma
ex-U.S. marketing
•
Identify strategic opportunities to enhance profile
•
Maintain strong financial profile
–
Opportunities for additional capital including
Purdue warrants, Hsp90 partnering

Innovative. Independent. Inspired.
Infinity: Uniquely positioned for success
Full ownership of industry-leading Hsp90 chaperone inhibitors
U.S. commercialization rights to all oncology programs
Worldwide royalties up to 20% on neuropathic pain program
25
Financial strength
Value-creating
asset ownership
Innovative
pipeline
Cash and funding to aggressively invest in programs to key
clinical inflection points
Phase 2: Hsp90 chaperone inhibition
Phase 1: Hedgehog pathway inhibition
Near IND: Fatty acid amide hydrolase
(FAAH) inhibition
World-class discovery organization

Innovative. Independent. Inspired.
26
26
Infinity
Innovative. Independent. Inspired.
26