UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): June 9, 2008

 

 

Infinity Pharmaceuticals, Inc.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   000-31141   33-0655706

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

780 Memorial Drive, Cambridge, MA   02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 453-1000

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01 Regulation FD Disclosure

From time to time, we intend to conduct meetings with third parties in which our current corporate slide presentation is presented. A copy of this slide presentation, dated June 9, 2008, is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information responsive to Item 7.01 of this Form 8-K and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) The following exhibits are included in this report:

 

Exhibit No.

  

Description

99.1    Slide presentation of Infinity Pharmaceuticals, Inc. dated June 9, 2008

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    INFINITY PHARMACEUTICALS, INC.
Date: June 9, 2008     By:  

/s/ Gerald E. Quirk

       

Gerald E. Quirk

Vice President and General Counsel

Infinity Overview
June 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, including the completion of the planned Phase 3 clinical trial of IPI-504 in refractory GIST; the presentation of
data for IPI-504 and IPI-926; estimates of 2008 financial performance; and the expectation that Infinity will have cash to
support its current operating plan into 2010.  
•
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 collaboration with MedImmune/AstraZeneca; 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 March 31, 2008, which was filed with the
Securities and Exchange Commission on May 9, 2008. 
•
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.

Infinity: Innovative small molecule cancer drug
discovery and development
Financial highlights
•
$105M in cash as of 3/31/2008
•
Significant pipeline
investment, and well-
controlled burn
NASDAQ: INFI
Founded: 2001
Headquarters: Cambridge, MA
Employees: ~140
R&D highlights
•
Lead program to enter Phase 3
registration trial in 3Q08
•
Broad internally-discovered
pipeline of novel candidates
•
Major alliance with AstraZeneca

INFI Investment Thesis
•
Sustainable pipeline of novel, small molecules
for key targets
–
Hsp90 inhibitors : IPI - 504 i.v . and IPI - 493 p.o .
–
Hedgehog
pathway inhibitor: IPI-926
•
International
Ph
3
trial
for
IPI-504
to
commence
in
3Q08
under
SPA
–
IPI-504
positioned
as
potential
first-in-class
anti-chaperone
agent
•
Broad, near - term potential
–
Multiple IPI-504 trials underway in major disease categories
•
Strong
balance
sheet ;
well-capitalized
–
Resources support current operating plan into 2010
•
Proven management team
–
First-
and best-in-class NDAs, value-creating business transactions

5
Solid tumors
Hsp90 oral: IPI-493
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride)
GIST/STS
NSCLC
HRPC
Taxotere
®
Combo
Additional Studies
Solid tumors
Hedgehog Pathway: IPI-926
Bcl-2/Bcl-xL
Discovery Programs
FPI mid-2008
In 2008
GIST Ph 3 FPI 3Q08
INFI: Building a sustainable oncology pipeline
FPI 2H 2008

6
Solid tumors
Hsp90 oral: IPI-493
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride)
GIST/STS
NSCLC
HRPC
Taxotere
®
Combo
Additional Studies
Solid tumors
Hedgehog Pathway: IPI-926
Bcl-2/Bcl-xL
Discovery Programs
FPI mid-2008
In 2008
GIST Ph 3 FPI 3Q08
Hsp90: Targeted Anti-Chaperone Therapy
FPI 2H 2008

Targeting the Hsp90 chaperone: a novel strategy
for cancer treatment
•
Lead product IPI-504 in late-stage clinical development
–
Water-soluable
i.v. formulation
–
Issued U.S. patent, worldwide patents pending
–
Currently being evaluated in multiple cancers
•
IPI-493 expected to enter the clinic in mid-2008
–
Novel oral formulation
–
Strong IP position; patent applications filed worldwide
–
Phase 1 study to commence mid-2008
7

8
Hsp90 Inhibition: How it works
Hsp90 is a
“chaperone”
protein
responsible for
supporting and stabilizing
numerous oncogenic proteins
IPI-504 binds
at ATP site
and inhibits
cell
stabilization
Unstable
oncogene
degraded;
tumor growth
inhibited

9
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)**

10
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 / IPI-493 (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: A new treatment
approach

11
Clinical development strategy
•
Rapid path to registration with IPI-504
–
Single-agent therapy, refractory settings
–
GIST & NSCLC
•
Broaden potential through 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 mid-2008

Phase 1 Trial of IPI-504
•
Patients with metastatic GIST refractory to Tyrosine Kinase Inhibitors (TKIs)
–
Gleevec®
and Sutent®
•
Inter-cohort dose escalation trial
–
Twice weekly dosing for 2 weeks every 21 days
–
Twice weekly dosing continuously
•
Endpoints: 
–
Safety and tolerability
–
Identify dose and schedule for full clinical development
–
Assessment of biological activity with anatomic and functional imaging (CT and 18FDG-PET
scans)
•
Amended in May 2007 to include other soft-tissue sarcomas
•
Expansion at MTD to confirm safety and tolerability
No currently-approved therapies in refractory GIST

Patients in Phase 1 GIST study experienced
multiple prior TKI therapies
Prior Therapy
Patients with refractory GIST
treated with IPI-504 (n=45)
Imatinib
45 (100%)
Imatinib > 400 mg
36 (80%)
Sunitinib
42 (93%)
Nilotinib
9 (20%)
3 or more treatments
17 (38%)
Prior surgery
33 (73%)
38% of patients had 3 or more prior therapies

Phase 1 results confirm activity and safety of IPI-
504 in refractory GIST
•
70%
overall
disease
control
after
2
cycles
in
patients
with
GIST
•
Estimated
Progression
Free
Survival
(PFS)
of
12
weeks
•
IPI-504
was
generally
well-tolerated
with
an
acceptable
safety
profile
GIST
Other STS
Number of patients ¹
36
11
Partial Response (PR) ²
1   ( 3%)
1   ( 9%)
Stable Disease (SD)
24   (67%)
4   (36%)
Progressive Disease (PD)
11   (30%)
6   (55%)
1.
90-400
mg/m ²
-
twice
weekly,
2
weeks
on
1
week
off
2.
Both
PRs
confirmed
Wagner et al., ASCO 2008

Baseline
Cycle 1, Day 21
After 10 days
off IPI-504
Cycle 1, Day 11
72 hours post
3
rd
dose
of
IPI-504
Cycle 3, Day 12
After IPI-504
dosing resumed
PET imaging demonstrates disease control in
refractory GIST
18
FDG-PET
of
Pt
201-007
following
progression
on
imatinib,
sunitinib,
and
nilotinib
(IPI-504
dose
-
150
mg/m ² )

Baseline
Cycle 3
1 year on imatinib at 400 & 800 mg; 1 year on sunitinib at 37.5 & 50mg
Patient remains on study as of cycle 5 (15 weeks)
Partial response by RECIST (70% reduction) in
metastatic GIST after pretreatment with TKIs

17
Stable
disease
for
>6
weeks
is
meaningful
in
the
refractory GIST setting
1
Results from the Phase 3 sunitinib
trial in GIST
TTP on Placebo:
6.4 weeks
TTP on sunitinib: 27.3 weeks
1
Goodman VL, Rock EP, Dagher
R, Ramchandani
RP, Abraham S, Gobburu
JVS, Booth BP,
Verbois
SL, Morse DL, Liang CY, Chidambaram N, Jiang JX, Tang S, Mahjoob
K, Justice R, Pazdur
R. Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal
stromal tumors and advanced renal cell carcinoma. Clin
Cancer Res (2007) 13:1367-1373.

IPI-504: Rapid Advancement into Phase 3
Phase 3 Registration trial to be initiated in 3Q 2008 under Special
Protocol Assessment, and with scientific advice from EMEA
•
Study designed in consultation with international group of KOLs
–
Randomized, double-blind, placebo-controlled study
•
Patients to be randomized 2:1 to either IPI-504 or placebo
•
Cross-over to treatment with IPI-504 if progression occurs
–
Approx. 200 patients; >50 sites worldwide
–
Patients with progressive GIST despite treatment with imatinib &
sunitinib
•
Endpoints
–
Primary: Progression-free survival (PFS)
–
Secondary: Disease control rate, time to progression, & overall survival
•
Expect trial to be completed in ~2 years from first patient enrolled
18

19
IPI-504 Phase 1/2 study in NSCLC: Potential
rapid path to market
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.

20
IPI-504 anti-chaperone therapy: Significant
potential beyond GIST & NSCLC
•
Phase 2 Hormone-resistant prostate cancer (HRPC)
–
2 groups: 1 docetaxel-naive, 1 post-docetaxel
treatment
–
Establish potential utility in combination and/or as oral therapy
•
Phase 1b combo with docetaxel
–
Patients with advanced solid tumors
–
Establish safety, MTD, and optimal schedule of administration
•
Additional trials planned to commence in 2008
–
Additional clinical studies of IPI-504
–
Phase 1 with IPI-493, oral Hsp90 inhibitor, in mid-2008

21
Infinity’s oral inhibitor of Hsp90: IPI - 493
•
Demonstrated
potent
and
selective
Hsp90
inhibition
preclinically
•
Excellent oral exposure : PK and half - life
•
Only
oral
geldanamycin
analogue
in
clinical
development
–
Previous class-based liabilities eliminated
•
IPI-493
on
track
to
enter
clinic
in
mid-2008
–
Rapid exploration of dose, schedule, and combinations
–
Leverage signal-finding efforts from Phase 2 studies with IPI-504

22
•
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

23
Solid tumors
Hsp90 oral: IPI-493
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride)
GIST/STS
NSCLC
HRPC
Taxotere
®
Combo
Additional Studies
Solid tumors
Hedgehog Pathway: IPI-926
Bcl-2/Bcl-xL
Discovery Programs
FPI mid-2008
In 2008
GIST Ph 3 FPI 3Q08
FPI 2H 2008
Hedgehog Pathway Inhibitor Program: IPI - 926

AACR Meeting Abstracts
on Hedgehog Pathway,
2004-2008
10
19
31
43
58
2004
2006
2006
2007
2008
Burgeoning interest in Hedgehog pathway

*Chen
et
al.,
2002
G&D
16:2743
Cyclopamine
The Hedgehog signaling pathway

Hh in
Cancer
Genetic mutation
medulloblastoma
basal cell carcinoma
Pathway activation
pancreatic, gastric,
prostate, glioma
Tumor progenitor cells
SCLC, glioblastoma,
breast, multiple myeloma
Hedgehog pathway implicated in variety of solid
tumors and heme. malignancies

Infinity’s Hedgehog inhibitor:  IPI-926
HO
O
NH
H
H
H
H
H
1
st
generation
2
nd
generation
Solubility
Chemical stability
Potency
(15nM in cell based assay)
Selectivity
Metabolic stability
IPI-926
Oral bioavailability
Long half-life
In vivo
activity
+
cyclopamine
O
H
H
O
NH
H
H
H
•
Issued
composition of matter patent
•
Infinity-discovered
&
100%
owned
royalty-free
worldwide

Daily oral administration of IPI-926 shows dose
dependent inhibition of tumor growth
-500.00
0.00
500.00
1000.00
1500.00
2000.00
2500.00
3000.00
3500.00
4000.00
4500.00
15
20
25
30
35
40
45
50
55
60
65
Days
VEH--30%
HPBCD in WFI
IPI-926 @
4mg/kg
IPI-926 @
10mg/kg
IPI-926 @
20mg/kg
Treatment phase
4/7 fully
regressed
B837Tx tumor
Ptch/Hic model of medulloblastoma
Pink et al., 2008 AACR

29
IPI-926 improves survival in orthotopic
medulloblastoma  model
0
1
2
3
4
5
6
7
8
9
10
11
10
14
18
22
26
30
34
38
42
46
50
Days post implant
Veh
IPI-926 @ 40mg/kg
Start of TX
End of TX
Mouse model, orthotopically
implanted B837Tx tumor
Pink et al., 2008 AACR

30
5 weeks total of IPI-926 follow-up treatment; 40 mg/kg, PO QD
IPI-926 delays tumor recurrence post-chemo
Traviglione
et al., 2008 AACR

31
Business Update

Infinity Goals 2008
•
Strong financial profile
•
Scientific excellence
•
Integrated Citizen-Ownership culture
•
Business and operational excellence
•
Retaspimycin
GIST
Phase
3
registration
trial
•
Retaspimycin
Phase
2
trials
for
additional
indications
•
IPI-493
Oral
Hsp90 :
Phase
1
clinical
study
•
IPI-926
Hedgehog :
Phase
1
clinical
study
•
Identify
strategic
opportunities
to
enhance
profile
Execute on
near-term
value-drivers
Maintain &
enhance
foundations
for success

Executing on our R&D and Business Strategy
Initiate IPI-493 Phase 1 clinical trial
Mid-2008
Initiate Phase 1 clinical study
2H 2008
File IND
2H 2008
Present preclinical data (AACR)
IPI-926: Hedgehog pathway inhibitor
Present preliminary IPI-504 Phase 2 data in HRPC
By end 2008
Present preliminary IPI-504 Phase 2 data in NSCLC
By end 2008
Initiate additional IPI-504 clinical studies
2H 2008
Initiate Phase 3 registration trial of IPI-504 in refractory GIST 
Q3 08
Secure SPA for IPI-504 Phase 3 GIST study
Present IPI-504 Phase 1 GIST data (ASCO)
IPI-504 & IPI-493: Hsp90 inhibitors

34
Strong balance sheet; well capitalized
•
$105M cash
and equivalents (3/31/08)
•
Burn rate well-controlled
–
50%
cost-sharing of Hsp90 program with MedImmune/AstraZeneca
•
Projected
2008
net
cash
burn:
$35M
-
$45M
•
Cash to support current plan into 2010
–
Sufficient capital to achieve key value creation milestones

Infinity Leadership
Michael Curtis, Ph.D., VP 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,
Sr
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

INFI Investment Thesis
•
Sustainable pipeline of novel, small molecules
for key targets
–
Hsp90 inhibitors : IPI - 504 i.v . and IPI - 493 p.o .
–
Hedgehog
pathway inhibitor: IPI-926
•
International
Ph
3
trial
for
IPI-504
to
commence
in
3Q08
under
SPA
–
IPI-504 positioned as potential first - in - class
anti-chaperone agent
•
Broad, near - term potential
–
Multiple IPI-504 trials underway in major disease categories
•
Strong
balance
sheet ;
well-capitalized
–
Resources support current operating plan into 2010
•
Proven management team
–
First-
and
best-in-class
NDAs,
value-creating
business
transactions