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): September 8, 2009

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 September 8, 2009, 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 exhibit is included in this report:

Exhibit No.	Description
99.1	Slide presentation of Infinity Pharmaceuticals, Inc. dated September 8, 2009

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: September 8, 2009	By:	/s/    Gerald E. Quirk
		Gerald E. Quirk
		Vice President and General Counsel

EX-99.1

NASDAQ: INFI

September 2009

Infinity

Innovative. Independent. Inspired.

Exhibit 99.1

Innovative. Independent. Inspired.

2

Safe Harbor Statement

2

2

•

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 August

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. 

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 support operating plan into 2013

Phase 2: Hsp90 chaperone inhibition

Phase 1: Hedgehog pathway inhibition

Near IND: Neuropathic pain (FAAH)

World-class discovery organization

Innovative. Independent. Inspired.

Financial strength today to aggressively invest

in pipeline

–

without dilution

•

$150 million in cash & equivalents as of June 30, 2009

•

Purdue

/

Mundipharma

collaboration

–

Access to $50 million line of credit (interest at prime; payment due 2019)

–

Up to $175 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 7/1/2009, assuming Purdue funding through 2011. Funding from Purdue includes ~$25M in 2H2009,

up to $65M in 2010 (committed), and up to $85M in 2011

Innovative. Independent. Inspired.

5

5

Infinity: Developing Breakthrough Therapeutics

5

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

Hsp90 Chaperone Inhibitors

Hsp90 IV: IPI-504 (retaspimycin

hydrochloride)

NSCLC

HER2+ mBC

Solid Tumors

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 July 2009

Herceptin®

Combination

Taxotere®

Combination

Innovative. Independent. Inspired.

6

Hsp90 Chaperone Inhibition Program:

New angle of attacking oncoproteins

Innovative. Independent. Inspired.

7

7

Hsp90 chaperone function

7

•

Hsp90 chaperone

stabilizes the

oncoprotein, enabling

growth signaling and

tumor cell proliferation.

Innovative. Independent. Inspired.

8

8

Hsp90 chaperone inhibition:

A new

angle

for targeting oncoproteins

8

•

Currently, targeted

therapies inhibit

oncoproteins in

distinctly different ways

that do not affect the

critical function of

Hsp90.

•

Through the inhibition of

Hsp90, oncoproteins

can now be targeted

from an entirely new

angle

mAB

TKI

Innovative. Independent. Inspired.

9

9

Hsp90 chaperone inhibition:

Arresting tumor cell growth

9

•

When the chaperone

function of Hsp90 is

inhibited, oncoproteins

become unstable,

unfolded, and unable to

signal.

•

Unfolded oncoproteins

will then be degraded

rapidly by the

proteasome, arresting

tumor cell growth.

Innovative. Independent. Inspired.

10

10

Infinity’s Hsp90 chaperone inhibition program

10

Broad medical & commercial potential

Lung cancer

Breast cancer

Additional tumors

–IPI-504

IV

(retaspimycin

hydrochloride)

–IPI-493

oral

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

•

Clinical data expected

2010

•

Future plans: Fall 2009

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

•

Clinical data expected

2010

•

Future plans: Fall 2009

Breast cancer

HER2+

45,000 US

incidence

•

IPI-504 Ph 2 in HER2+ mBC, combination

with Herceptin®

underway

Demonstrated potency and tumor growth

inhibition in preclinical models

•

Clinical data expected

2010

Innovative. Independent. Inspired.

13

13

Infinity’s Hsp90 chaperone inhibition program

Broad medical & commercial potential

13

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

•

Clinical data expected

2010

•

Future plans: Fall 2009

Breast cancer

HER2+

45,000 US

incidence

•

IPI-504 Ph 2 in HER2+ mBC, combination

with Herceptin®

underway

Demonstrated potency and tumor growth

inhibition in preclinical models

•

Clinical data expected

2010

Additional

tumors

•

IPI 493 oral Ph 1 study underway

•

Additional opportunities with IPI-504

•

Additional IPI-504

study anticipated by

early 2010

Innovative. Independent. Inspired.

14

Hedgehog Program

Innovative. Independent. Inspired.

15

The Hedgehog pathway:

A promising new focus for targeted drug therapy

15

15

•

The Hedgehog 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.

16

The role of Smoothened in malignant activation

of the Hedgehog pathway

16

16

•

In certain cancers, such

as small cell lung

cancer, 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

Innovative. Independent. Inspired.

17

Malignant activation of the Hedgehog pathway

can also affect the tumor microenvironment

Travaglione et al., 2008 EORTC

•

In certain cancers, such

as pancreatic  cancer,

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

Innovative. Independent. Inspired.

18

Infinity’s IPI-926

inhibits the Hedgehog pathway

18

18

•

IPI-926 inhibits Smo,

preventing the signaling

cascade that otherwise

leads to tumor cell

growth and survival

IPI-926

IPI-926 in ongoing

Ph 1 clinical trial

Innovative. Independent. Inspired.

19

19

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.

20

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

•

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 moving well through Phase 1 study

21

Innovative. Independent. Inspired.

22

Early Pipeline: Neuropathic Pain

Innovative. Independent. Inspired.

Fatty acid amide hydrolase (FAAH):

23

23

Next Generation Innovation: IPI-940 for

neuropathic pain

23

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.

24

24

Infinity: Developing Breakthrough Therapeutics

24

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

Hsp90 Chaperone Inhibitors

Hsp90

IV:

IPI-504

(retaspimycin

hydrochloride)

NSCLC

HER2+ mBC

Solid Tumors

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 July 2009

Herceptin®

Combination

Taxotere®

Combination

Innovative. Independent. Inspired.

25

25

•

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)

25

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.

26

26

Business and Commercial Objectives

26

•

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

–

Cash into 2013

–

Opportunities for additional capital including

Purdue warrants, Hsp90 partnering

Innovative. Independent. Inspired.

27

Financial Strength:

Aggressive Investment, Cash into 2013

2009

Key objectives

•

Advance Hsp90 trials

•

Advance Hedgehog trial

•

IND in neuropathic pain (FAAH)

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)**

27

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.

Infinity: Uniquely positioned for success

Full ownership of industry-leading Hsp90 chaperone inhibitors

US Commercialization rights to all oncology programs

Worldwide royalties to 20% on neuropathic pain program

28

Financial strength

Value-creating

asset ownership

Innovative

pipeline

Cash and funding to support operating plan into 2013

Phase 2: Hsp90 chaperone inhibition

Phase 1: Hedgehog pathway inhibitor

Near IND: Neuropathic pain (FAAH)

World-class discovery organization

Innovative. Independent. Inspired.

29

29

Infinity

Innovative. Independent. Inspired.

29