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 26, 2006

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

Discovery Partners International, Inc., 9640 Towne Center Drive, San Diego, CA 92121

(Former name or former address, if changed since last report)

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.

We intend to conduct meetings with third parties from time to time that include our current corporate slide presentation. A copy of this slide presentation, dated September 26, 2006, is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Form 8-K and the Exhibit attached 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) Exhibits

99.1 Slide Presentation of Infinity Pharmaceuticals, Inc. dated September 26, 2006

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 26, 2006	By:	/s/ Steven Holtzman
		Steven Holtzman Chief Executive Officer

EXHIBIT INDEX

Exhibit Number	Description
99.1	Slide Presentation of Infinity Pharmaceuticals, Inc. dated September 26, 2006

EX-99.1

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)

+

*