EX-99.1 2 dex991.htm SLIDE PRESENTATION Slide Presentation
Introduction to
Infinity Pharmaceuticals
(NASDAQ: INFI)
September 26, 2006
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 these forward-
looking statements. 
•
These forward-looking statements include, but may not be limited to: statements regarding the expected
benefits of our merger with Discovery Partners; our ability to advance our pipeline of anti-cancer agents and
create substantial value for patients and stockholders; the efficacy, safety, and intended utilization of our
product candidates; the results of discovery efforts and clinical trials; plans regarding regulatory filings, future
research and clinical trials; current and future collaborative activities; the strength of our patent position; and
our expectation that we will have cash to support our current operating plan through at least December 31, 2009. 
•
These forward-looking statements are subject to numerous factors, risks and uncertainties that may cause
actual events or results to differ materially from our current expectations.  For example, we cannot guarantee
that any product candidate we are developing will successfully complete necessary preclinical and clinical
development phases, be approved for sale in any market or that, if approved, revenues from sales of such
product will reach any specific level.  In particular, our 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; our dependence on our collaborations with MedImmune
and Novartis; our ability to obtain any additional funding necessary to conduct our research, development and
commercialization activities; unplanned cash requirements and expenditures; and our ability to obtain, maintain
and enforce patent and other intellectual property protection for our product candidates.  These and other risks
that may impact our expectations are described in greater detail
in the document entitled  "Risk Factors" that we
filed with the SEC on September 18, 2006 as Exhibit 99.2 to our current report on Form 8-K. 
•
In addition, any forward-looking statements contained in this presentation speak only as of September 26, 2006,
and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new
information, future events or otherwise.
*

3
Mission
To develop targeted therapies for the treatment
of cancer and related conditions discovered
through the use of our innovative small
molecule drug technologies
*

4
Strategy
•
Targets
–
“Well-credentialed, but not well-trodden”
•
Drugs
–
Internally discovered, novel small molecules
•
Products
–
Opportunity for first-in class or fast follower best-in-class
*

5
•
Lead clinical product in two disease-focused Phase I cancer studies
–
IPI-504, a novel Hsp90 inhibitor
–
Phase II expected in 2007
•
Pipeline of internally-discovered cancer drug candidates
–
Hedgehog pathway inhibitors (systemically administered)
–
Bcl
family inhibitors
–
Additional discovery programs
•
5 Pharma/Biotech corporate alliances
–
MedImmune, Novartis
(2), Amgen, and J & J
•
Significant cash position after reverse merger and MEDI alliance
–
~$125M in cash as of 9/25/06, with another $35M to come MedImmune
–
Projected cash runway through end of 2009
–
Achieve key value-driving events before additional financing required
•
Proven biotech leadership team
Snapshot of Infinity Pharmaceuticals (NASDAQ: INFI)
*

6
Lead clinical program
IPI-504 –
a novel Hsp90 inhibitor
*
*
*
*
*
*
*    *                       *

7
•
Novel chemical entity
•
Two disease-focused Phase I trials
–
GIST, Multiple Myeloma
•
Preclinical evidence of broad therapeutic potential
–
Large therapeutic window consistent with
targeted therapies
–
Activity in resistant settings
•
Patient-friendly formulations
–
Water-soluble IV
–
Oral under development
•
Strong intellectual property position
•
Ready for Phase II in 2007
Infinity’s lead clinical product: IPI-504 (Hsp90 inhibitor)
IPI-504
OH
N
H
N
OH
O
OH
Me
O
O
O
O
NH
2
H
H
+
Cl
-
*
*

8
Heat Shock Protein 90 (Hsp90) is an emerging cancer
target
Hsp90 in cancer cells differs from
Hsp90 in normal cells
Function of Hsp90 in cancer cells
•
Stabilization and enablement of
oncogenic proteins responsible
for cancer cell proliferation and
survival
•
Opportunity for preferential
targeting of drug candidates to
cancer cells
*

9
Dependence
on Hsp90
Apoptosis
Tyrosine kinase
inhibitor
(e.g
Gleevec, Tarceva)
Oncogene
Cancer cell
survival &
proliferation
Resistance
mutations
Targeting specific oncogenic Hsp90 client proteins
Hsp90
inhibitor
(single agent or
combination)
Hsp90
inhibitor
(single agent)
*

10
Velcade
Gleevec / dasatinib
Investigational
Gleevec / Sutent
Herceptin
Tarceva
/ Erbitux
Sorafenib
/ Sutent
Sorafenib
Investigational
Targeted therapy
The emerging world of targeted cancer therapies
Indication
Myeloma
CML
AML
GIST
Breast (HER2+)
NSCLC
Renal cell
Melanoma
Prostate (PTEN -/-)
NF-
B
Bcr-Abl
Flt3
c-Kit
HER2
EGFR
VEGFR / HIF-1a
b-Raf
p-Akt
Molecular Target
*

11
The emerging world of targeted cancer therapies
NF-
B
Bcr-Abl
Flt3
c-Kit
HER2
EGFR
VEGFR / HIF-1a
b-Raf
p-Akt
Molecular Target
•
All are clients of Hsp90
•
Inhibiting Hsp90 affects the
stability of these targets
•
Attractive alternative to
chasing tumor-specific
resistance mutations
*

12
IPI-504 advantages
17-AAG
(multiple
formulations)
Highly soluble, allowing for patient-
friendly formulations:
•
Water-soluble IV
•
Oral under development
Novel chemical entity
x
Chemical entity is off-patent
x
Highly insoluble, requiring sub-
optimal DMSO-
and Cremophor-
based formulations
Equivalent potency and selectivity
Potent & selective inhibitor of Hsp90
Well-tolerated to date in Phase I
trials (dose-escalating at 400 mg/m
2
)
IPI-504
O
N
H
H
N
O
Me
O
OH
Me
Me
O
Me
O
O
O
NH
Me
Me
IPI-504
OH
N
H
N
OH
O
OH
Me
O
O
O
O
NH
2
H
H
+
Cl
-
*

13
GIST: Gleevec-resistant cells more sensitive to IPI-504
GIST 882*
Gleevec-Sensitive
(primary: exon
13, K642E)
10
100
1000
10
20
30
40
50
10000
60
70
Compounds concentrations (nM)
10
100
1000
10
20
30
40
50
10000
10000
60
70
Compounds concentrations (nM)
IPI-504 : EC50 = 121 +/-
21 nM
IM :        EC50 = 147 +/-
42 nM
Gleevec-
Resistant
(primary: exon
11, V560D +
Gleevec
resistance:
exon
17,
D820A)
10
100
1000
5
15
25
35
45
55
65
75
85
Compounds concentrations (nM)
IPI-504
Imatinib
GIST 48*
IPI-504 : EC50 = 54 +/-
7 nM
IM : 25% inhibition @ 10uM
Collaboration:
Fletcher, Demetri, DFCI
*

14
Placebo
Gleevec
IPI-504
Collaboration:
Shauguang
Li, Jackson Labs
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
15
17
19
21
23
25
27
29
31
33
Days
Oral IPI-504: survival benefit in Gleevec-resistant T315I
CML transplantation model
*

15
Placebo
Gleevec
IPI-504
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
15
17
19
21
23
25
27
29
31
33
Days
Oral IPI-504: survival benefit in Gleevec-resistant T315I
CML transplantation model
Collaboration:
Shauguang
Li, Jackson Labs
*

16
Placebo
Gleevec
IPI-504
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
15
17
19
21
23
25
27
29
31
33
Days
Oral IPI-504: survival benefit in Gleevec-resistant T315I
CML transplantation model
Collaboration:
Shauguang
Li, Jackson Labs
*

17
•
Development and registration of IPI-504 in hematologic
malignancies and solid tumors
–
Preclinical support  for broad role of Hsp90
•
Early human proof-of-concept with most rapid path to registration
–
Strong scientific rationale
–
Trials targeted to homogenous patient population (disease-focused)
–
Surrogate markers
–
Rapid patient accrual
–
Single-agent activity in refractory setting (potential for expedited
approval)
•
In parallel, initiate broader development for larger indications
(additional diseases, combination therapy, front-line therapy)
IPI-504 Clinical Development Strategy
*

18
Principal Investigator:
•
Dr. George Demetri, DFCI
Objectives:
•
Safety, PK, dose-ranging
•
Establish Phase II dose
Surrogate marker of response:
•
PET scans
Solid Tumor
Gastrointestinal Stromal Tumors
(Gleevec-resistant)
Schedule / status:
•
Days 1, 4, 8, 11 of 21 day
•
Continuing dose escalation
Current ongoing phase I clinical trials
Principal Investigator:
•
Dr. Paul Richardson, DFCI
•
Dr. Sundar Jagannath, SVCCC
•
Dr. David Siegel, HUMED
Objectives:
•
Safety, PK, dose-ranging
•
Establish Phase II dose
Surrogate marker of response:
•
M protein levels
Hematologic
Multiple Myeloma
(relapsed, refractory)
Schedule / status:
•
Days 1, 4, 8, 11 of 21 day
•
Continuing dose escalation
*

19
Phase I dose escalation for IPI-504 (GIST)
•
1 cycle = 21 days
•
4 doses (days 1, 4, 8, 11 followed by 10 days off)
Phase I schedule
25%
500
6
33%
400
5
33%
300
4
50%
225
3
66%
150
2
100%
90
1
Escalation over
previous dose
Dose (mg/m2)
Group
*

20
On-going trial
Phase I/II –
Solid
2005
2006
2007
2008
Phase I
•
Multiple myeloma
•
GIST
•
Solid tumor TBD
Phase II
•
Solid tumor TBD
•
Hem. Tumor TBD
•
Others
Phase II –
Solid
TBD based on data/results
IPI-504: Clinical Plan
Phase II –
Hem.
*

21
IPI-504
*

22
Lead preclinical program
Hedgehog pathway inhibitors
*
*
*
*
*
*
*                       *        *

23
•
Systemic inhibitors of the Hedgehog signaling pathway
–
Proprietary NCE’s
–
Systemic (sub-cu and oral) products
•
Broad anti-cancer potential
–
Strong preclinical data supporting pancreatic, metastatic
prostate, SCLC, others
–
Single agent activity in preclinical studies
–
Potential for synergy with standards of care
–
Possible role in cancer progenitor cells
•
Multiple drug candidates
–
Lead molecule, IPI-609: IND-ready
–
Additional attractive analogs under evaluation
–
Select preferred clinical candidate over next 6-12 months
Infinity’s Hedgehog inhibitor program
*

24
Cancers have hijacked components of the Hedgehog
pathway
1
Hahn
et
al.,
1996,
Cell
85:
841
2
Bale
&
Yu,
2001,
Human
Molec.
Genetic.
10:
757
(review)
3
Berman
et
al.,
2002
Science
297:
1559
4
Berman
et
al.,
2003
Nature
425:
846
5
Kayed
et
al.,
2004
Int.
J.
Cancer
110:
668
6
Thayer
et
al.,
2003
Nature
425:
851
7
Karhadkar
et
al.,
2004
Nature,
431:
707
8
Fan
et
al.,
2004
Endocrinology
145:
3961
9
Watkins
et
al.,
2003,
Nature
422:
313
10
Sicklick
2005
ASCO;
Mohini,
2005
AACR
11
Kubo
et
al.,
2004
Cancer
Res.
64
:6071
State
Normal
Basal cell carcinoma
1,2
Medulloblastoma
3
Pancreatic cancer
4,5,6
Prostate cancer
7,8
Small cell lung cancer
9
Hepatocellular
cancer
10
Breast Cancer
11
Pathway activation
OFF
ON
ON
ON
ON
ON
ON
ON
*
*

25
0
200
400
600
800
1000
1200
1400
1600
31
36
41
46
51
56
61
Days
Vehicle
IPI-609 10 mpk/day
IPI-609 shows activity in PC-3 prostate xenograft
*

26
IPI-609 slows tumor growth rates
0
200
400
600
800
1000
1200
30
35
40
45
50
55
60
Day
Linear Fit
Bivariate Fit of P 10 By Day
200
400
600
800
1000
1200
30
35
40
45
50
55
60
Day
Linear Fit
Bivariate Fit of VP 6 By Day
Median vehicle-treated
animals
Median IPI-609 treated
animals
PC-3 prostate xenograft:
*

27
Clinical development strategy of hedgehog pathway
inhibitors
•
Strong scientific rationale supports targeting of cancers dependent
on the Hedgehog pathway
–
Pancreatic
–
Small cell lung
–
Metastatic prostate
–
Metastatic breast
–
Ovarian
–
Others (medulloblastoma, glioma, basal cell carcinoma, etc.)
•
Identify a rapid path to registration
–
Potential for sole agent activity or
–
Combination with standard of care
*

28
Corporate Alliances
Strong validation, significant value retention
*
*
*
*
*
*
*         *    *

29
•
Diversity Oriented Synthesis (DOS) platform
–
Creates novel, “natural-product like”
drug candidates
–
Potential to access previously “undruggable”
targets
•
2004 –
2006:  > $60M upfront/committed cash
•
Additional milestone and royalty potential
•
No license of proprietary Infinity product rights
•
Amgen extension in 2006
Small Molecule Technology Access Alliances
*

30
•
Potential additional
milestones
Early product pipeline: Bcl
family alliance with Novartis
•
Joint discovery of novel Bcl
family (Bcl-2, Bcl-xL) targeted
cancer drugs
•
Infinity participation in clinical
development (at NVS expense)
COLLABORATION
•
Infinity participation in US sales
effort (at NVS expense)
$30M
•
Upfront &
committed funds
FINANCIALS
•
Royalties on WW sales
>$370M
*

31
Cancer Drug Development and
Worldwide Commercialization Agreement
August 28, 2006
*
*
*

32
•
Potential additional
milestones       
Lead products: Hsp90 and Hedgehog alliance with MEDI
•
Infinity leads early translational
development through proof of
concept in humans
•
MedImmune
leads later clinical
development, registration, and sales
and marketing, with Infinity
participation
COLLABORATION
•
Infinity has right to provide up to
35% of US promotional activity (cost
shared by alliance)
$70M
•
Upfront license fee
FINANCIALS
•
50/50 worldwide R&D cost
share
•
50/50 worldwide profit share
(regardless of who sells)
$430M
*

33
Discovery
Preclinical
Start Clinical
Trials
Hsp90
(IPI-504)
Bcl-2/Bcl-xL
2005
2007/2008
50% WW profit
share with MEDI
50% WW profit
share with MEDI
Royalty from
Novartis
Non-exclusive
–
Amgen
–
Novartis
–
J&J
Small molecule drug technologies
Alliance and financing strategy: value retention
Hedgehog 
Pathway
inhibitors
2007/2008
*

34
Financing
Creative access to capital
*
*
*
*
*
*

35
•
Reverse merger employed to ensure certainty of valuation and
amount of cash raised, with low market-based risk
•
Infinity received $78M in cash from DPI
•
Ownership of combined entity:
–
Issued and outstanding basis:
34% DPI
66% Infinity
19.4M shares
–
Fully-diluted basis:
31% DPI
69% Infinity
20.9M shares
Infinity (NASDAQ: INFI) public via reverse merger (9/12/06)
*

36
Team
Proven track record
*
*
*
*
*
*
*                        *      *

37
Leadership
Mr. Steven Holtzman, CEO
Millennium, DNX
Dr. Julian Adams, President & CSO
Millennium, ProScript
Boehringer
Ingelheim, Merck
Ms. Adelene Perkins, CBO
Transform, Genetics Institute,
Bain, GE
Dr. David Grayzel, VP Clinical
Development & Medical Affairs
Dyax,  Mass General Hospital
Steven Kafka, Ph.D., VP Strategic Product
Planning & Finance
Millennium, Strategic Decisions Group
Dr. Vito Palombella, VP Discovery Research
Syntonix, Millennium, ProScript
Gerald Quirk, Esq., VP & General Counsel
Genzyme, Palmer & Dodge
Dr. Jeffrey Tong, VP Corporate & Product
Development
McKinsey & Co, Harvard Center for Genomics
Research
Dr. Jim Wright, VP Pharmaceutical Development
Millennium, Alkermes, Boehringer
Ingelheim,
Syntex, U. of Wisconsin
*

38
Infinity Pharmaceuticals
Summary
*
*
*
*
*
*
*                    *            *

39
•
Product Pipeline
–
IPI-504
•
Complete Phase I trials
•
Publish First Clinical Data
•
Successful execution of technology access
alliances
•
At least one new corporate alliance
•
Financing event
–
Year-end
cash
runway:
12-24
months
2006 Goals and Achievements
AMGN
extension
Expected
at EORTC
11/7/06
NVS (Bcl)
MEDI (Hsp90, HH)
+
Reverse merger
with DPI
(~$125M cash
as of 9/25/06)
+
*