8-K

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): January 7, 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 January 7, 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 8.01. Other Events.

On January 7, 2008, we issued a press release announcing our corporate goals for 2008. The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

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 January 7, 2008
99.2	Press release of Infinity Pharmaceuticals, Inc. dated January 7, 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: January 7, 2008	By:	/s/ Adelene Q. Perkins
		Adelene Q. Perkins
		Executive Vice President & Chief Business Officer

EX-99.1

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

EX-99.2

Exhibit 99.2

FOR IMMEDIATE RELEASE

INFINITY REVIEWS 2007 ACHIEVEMENTS AND ANNOUNCES 2008 GOALS

– Expects to advance IPI-504, Infinity’s lead Hsp90 molecule, into registration trial and to broaden its

commercial potential with expanded clinical development –

CAMBRIDGE, Mass. – January 7, 2008 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), an innovative cancer drug discovery and development company, today announced its 2008 product development and business goals, and provided financial guidance. Infinity’s 2008 objectives build upon its scientific and business successes in 2007.

Key highlights from 2007:

• Reported additional evidence of biological activity of IPI-504, the company’s lead heat shock protein 90 (Hsp90) inhibitor, in patients with gastrointestinal stromal tumors (GIST),

• Completed enrollment of 19/20 patients in the expansion portion of the Phase 1 GIST trial and initiated plans for a potential registration trial;

• Showed evidence of biological activity of IPI-504 in patients with non-small cell lung cancer (NSCLC), and initiated the Phase 2 portion of the study;

• Initiated additional clinical trials of IPI-504, including a Phase 2 single-agent study in patients with hormone-resistant prostate cancer (HRPC) and a Phase 1b study in combination with Taxotere^® (docetaxel) in patients with advanced solid tumors;

• Regained all worldwide, royalty-free rights to Infinity’s Hedgehog pathway inhibitor program, and selected a Hedgehog inhibitor development candidate, IPI-926;

• Ended 2007 with approximately $114 million in cash and equivalents (unaudited), providing cash to support the company’s current operating plan through at least the end of 2009.

“In 2007 we accomplished our major scientific and business objectives,” said Steven H. Holtzman, Chair and Chief Executive Officer of Infinity. “Our lead molecule, IPI-504, has shown biological activity and has been well-tolerated in multiple clinical trials, and we believe we have established a strategy for bringing IPI-504 rapidly to market for the potential treatment of a number of cancers. We continue to maintain our strong financial position, and expect to achieve several near-term, value-creating milestones in 2008.”

2008 Infinity Goals and Financial Guidance

• Launch a Phase 3 registration trial of IPI-504 in GIST: Pending ongoing consultation with advisors and regulatory authorities, and analysis of data from the ongoing fully-expanded Phase 1 clinical trial, Infinity, in collaboration with its partner MedImmune (a unit of AstraZeneca), expects to launch a registration trial of IPI-504 in refractory GIST in the third quarter of 2008.

• Initiate Phase 2 clinical trials of IPI-504 in additional indications: Infinity expects to continue broadening the commercial potential of IPI-504 by initiating Phase 2 trials in additional solid tumor indications;

• Commence a Phase 1 clinical study with an oral Hsp90 inhibitor: Infinity has been conducting comparative preclinical studies of its oral Hsp90 candidates, and, pending final analysis of preclinical data, expects to advance IPI-493 into the clinic in the first half of 2008;

• Begin clinical development of Hedgehog pathway inhibitor: IPI-926, Infinity’s orally-available Hedgehog pathway inhibitor molecule, has shown highly potent and selective inhibition of the pathway and anti-tumor activity in preclinical models. Infinity expects to file an investigational new drug (IND) application for IPI-926 by the third quarter of 2008 and to commence human clinical studies shortly thereafter;

• Maintain a strong financial profile: Based on its current operating plan, and absent additional financing or business development activities, Infinity expects a net cash burn of $35-45 million in 2008. This will provide cash to support Infinity’s current operating plan through at least the end of 2009, enabling the company to evaluate strategic opportunities to enhance its product pipeline and to reach key value-creating milestones.

Infinity today also announced its anticipated key milestones for 2008:

• Present updated data on Phase 1 trial of IPI-504 in patients with GIST (ASCO 2008)

• Present preclinical data on its lead Hedgehog inhibitor, IPI-926 (AACR 2008)

• Initiate additional Phase 2 studies of IPI-504 (1H 2008)

• Initiate Phase 1 trial of an oral Hsp90 inhibitor (1H 2008)

• Initiate registration trial of IPI-504 in patients with GIST (3Q 2008)

• Present preliminary data from IPI-504 Phase 2 trial in patients with NSCLC (2H 2008)

• Present preliminary data from IPI-504 Phase 2 trial in patients with HRPC (2H 2008)

• Initiate Phase 1 trial of its oral hedgehog pathway inhibitor, IPI-926 (2H 2008)

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. For more information on Infinity, please refer to the company’s website at http://www.infi.com.

Forward-Looking Statements

This press release 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, IPI-493 and IPI-926; the presentation of preclinical and clinical 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 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 the company’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, management’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; 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 management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q for the quarter ended September 30, 2007, as filed with the Securities and Exchange Commission on November 7, 2007. Further, any forward-looking statements contained in this press release 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. INFI-G

Contact

Infinity Pharmaceuticals, Inc.

Monique Allaire, 617-453-1105

Monique.Allaire@infi.com

http:www.infi.com

# # #