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8-K - FORM 8-K - INFINITY PHARMACEUTICALS, INC. | d8k.htm |
Innovation.
Evolution.
Impact.
Exhibit 99.1 |
Innovation. Evolution. Impact.
2
Safe Harbor Statement
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 the therapeutic
potential of Infinitys Hedgehog pathway, FAAH, PI3K and Hsp90 chaperone
inhibitors; future development activity for IPI-504, IPI-493, IPI-926, IPI-940 and IPI-145; the presentation of
clinical data for IPI-504, IPI-493 and IPI-926; estimates of 2010
financial performance; the continuation of the Purdue/Mundipharma
alliance;
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 Infinitys strategic alliance
with Purdue/Mundipharma
will continue for its expected term or that these entities will
fund Infinitys programs as agreed, or that any
product candidate Infinity is developing will successfully complete necessary
preclinical and clinical development phases. Further, there can be no
guarantee that any positive developments in Infinitys product portfolio will result in stock price appreciation.
Infinitys
expectations
could
also
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, including
in connection with business development activities; market acceptance of any products Infinity or its
partners may successfully develop; Infinitys license and development agreement
with Intellikine 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 on August 4, 2010.
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.
2
2 |
Innovation. Evolution. Impact.
Infinity:
Innovation. Evolution. Impact.
3
Integrated Team
Proven drug developers
and company builders
Financial Strength
Cash runway into 2013
Ownership of Valuable Product Rights
Establishing commercial infrastructure in US
Diverse Pipeline of Broadly
Applicable Targeted Therapies
Spanning Oncology and
Autoimmune/Inflammatory Diseases
Four candidates in the clinic
Fifth new IND planned for 2011 |
Innovation. Evolution. Impact.
Financial Strength to Create Value
4
~$288M to aggressively invest in pipeline and access external opportunities
~$288M
~$120M
~$120M in Cash & Investments
at 6/30/10
~$238M
$150M in Committed
R&D Funding for 2010 & 2011
($32.5M received 1H10)
$50M Line of Credit
(10
year balloon note at prime) |
Innovation. Evolution. Impact.
Financial Strength:
Aggressive Investment, Cash Runway into 2013
~$288 million to invest in pipeline and access external
opportunities
Projected 2010 cash burn of $3545M
Anticipated year-end cash and investments balance of $8595M
Based on current operating plan; excludes $50M line of credit from
Purdue
5 |
Innovation. Evolution. Impact.
Strategic Partnerships Enabling INFI To Become
a Fully Integrated Biopharmaceutical Company
100% R&D funding for partnered programs, including Hedgehog, PI3K, FAAH
and early discovery programs
INFI leads all discovery and development efforts through registration for programs
other than FAAH
Retention of valuable commercial rights and downstream financial
participation
INFI has U.S. commercialization rights to all programs other than FAAH
Significant royalties on ex-U.S. sales and U.S. sales of FAAH inhibitors
Access to worldwide leadership in pain management and ex-US commercial
markets |
Innovation. Evolution. Impact.
Developing a Pipeline of Broadly Applicable,
Targeted Therapies
7
IPI-926
Hedgehog
Pain
Oncology
Autoimmune and
Inflammatory
Disease
IPI-145
PI3K
/
IPI-940
FAAH
IPI-504; IPI-493
Hsp90 |
Broadly Applicable, Targeted Therapies
in Oncology |
Innovation. Evolution. Impact.
9
IPI-926:
Significant Anti-Cancer Opportunity by Inhibiting
Malignant Activation of the Hedgehog Pathway
Signal to tumor progenitor cell
Signal to tumor microenvironment
Signal to tumor cell |
Innovation. Evolution. Impact.
IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
10
1
Olive et al., 21 May 2009 Science
2
Travaglione et al., 2010 AACR
IPI-926 + gemcitabine
doubles median
survival in pancreatic cancer model¹
IPI-926 + Abraxane
®
significantly decreased tumor
growth (77%) and increased tumor perfusion in
pancreatic cancer model²
Days Post Implant
Final IPI-926 dose
On treatment
Re-growth
Final nab-paclitaxel
dose
Signal to tumor progenitor cell
Signal to tumor microenvironment
Signal to tumor cell |
Innovation. Evolution. Impact.
IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
11
IPI-926 in SCLC model¹
1
Travaglione et al., 2008 AACR
3
Mandley
et al., 2010 AACR
Days Post Implant
Mice randomized
+/-
IPI-926
Last day of E/P treatment
E/P -
IPI-926
E/P -Vehicle
Vehicle
IPI-926
82%
2
Proctor et al., 2010 AACR
IPI-926 in castration resistant
prostate cancer model²
IPI-926 in NSCLC model³
70%
36%
70%
Begin dosing IPI-926 +
docetaxel
Final docetaxel
dose
Signal to tumor progenitor cell
Signal to tumor microenvironment
Signal to tumor cell |
Innovation. Evolution. Impact.
IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
12
IPI-926 results in 100%
survival in medulloblastoma
model³
3
Olson et al., 2009 AACR
Days
IPI-926
Vehicle
Signal to tumor progenitor cell
Signal to tumor microenvironment
Signal to tumor cell |
Innovation. Evolution. Impact.
Advanced basal cell
carcinoma, medulloblastoma
IPI-926: Targeting a Broad Range of Difficult to
Treat Cancers
13
IPI-926 in Phase 1b/2 study (combination with gemcitabine)
in pancreatic cancer and Ph 1 study in advanced solid tumors
Preliminary Phase 1 data anticipated in 2010
Pancreatic cancer
Small cell lung, non-small cell
lung, ovarian and prostate
cancers; heme
malignancies
Improve Access of Chemo to Tumor
Delay Tumor Re-Growth
Induce Apoptosis |
Innovation. Evolution. Impact.
14
Hsp90 chaperone stabilizes
oncoproteins
Hsp90 inhibitors combinable with
best available therapies
Inhibiting Hsp90 degrades
oncoproteins, stopping tumor growth
IPI-504 and IPI-493:
Broadly Attacking Oncoproteins
through
Hsp90 Chaperone Inhibition |
Innovation. Evolution. Impact.
IPI-504 i.v.: Current Status
Well-tolerated in multiple studies at
biologically active doses
Phase 2 mBC
with Herceptin
®
Phase 2 study NSCLC
Phase 1b solid tumor with Taxotere
®
Two NSCLC studies ongoing
Validation in NSCLC patients with
ALK rearrangements (IST)
Phase 1b study with Taxotere
®
No new trials planned at this time
Any future studies will be based on
data and market insights
15
1
Sequist et al., 2010 ASCO |
Innovation. Evolution. Impact.
IPI-493 Oral: Distinct Pharmaceutical Properties
Phase 1 program underway
Two ongoing Phase 1 studies
one in hematologic malignancies
and one in solid tumors
Studies designed to assess efficacy and dosing regimen
Demonstration of client protein degradation by IPI-493 a key
milestone for further investment
Phase 1 data and articulation of future plans anticipated in 2011
16 |
Broadly Applicable, Targeted Therapies
in Pain and Inflammation |
Innovation. Evolution. Impact.
18
IPI-940:
Combating the Magnitude of Neuropathic Pain by
Inhibiting Fatty Acid Amide Hydrolase
(FAAH) |
Innovation. Evolution. Impact.
IPI-940: Novel Agent Enabling the Bodys Natural
Analgesia
Novel, oral agent designed to potentiate the magnitude and
duration of bodys natural analgesia
Ongoing evaluation in Phase 1 study in normal, healthy
volunteers
Consists of single-
and multiple-ascending dose studies
Phase 1 completion anticipated in 2010
19 |
Innovation. Evolution. Impact.
IPI-940: Targeting Broad Areas of Unmet Need
Neuropathic pain
Postherpetic
neuralgia
HIV pain
Peripheral diabetic neuropathy
Chemotherapy-induced neuropathy
Trigeminal neuralgia
Fibromyalgia
Osteoarthritis pain
Anxiety and depression
Inflammatory conditions
20 |
Innovation. Evolution. Impact.
21
IPI-145; PI3K
Inhibitors:
Leveraging Oncology Expertise to Address
Significant Untapped Opportunity in Autoimmune/
Inflammatory Disease and Oncology
Tyrosine kinase
receptors
G-coupled protein
receptors
PIP2
PI3K-
PI3K-
,
,
PH domain
Kinase
domain |
Innovation. Evolution. Impact.
PI3K
: Distinct and Overlapping Roles in
Immunity, with Significant Therapeutic Potential
PI3K plays key regulatory role in cell proliferation and survival, cell
differentiation, cell trafficking and immunity
Delta and gamma isoforms
are restricted to immune system cells
Strongly implicated in broad range of immune-mediated inflammatory and
allergic disorders and hematologic cancers
22
Adaptive
Innate
Expression
Diseases
Function
T-
and B-cells
Activation
Proliferation
Migration
Mast Cells
Neutrophils
Activation
Leukocyte Chemotaxis
Microglial
Activation
Endothelial Activation
GvD
Cancer
Asthma
Lung Inflammation
RA, MS
Heme
Cells
ALE
Atherosclerosis
Sepsis |
Innovation. Evolution. Impact.
IPI-145: Only PI3K
Dual-Selective Inhibitor for
Autoimmune-Inflammatory Disease
IPI-145 is a novel, orally available, small molecule dual-specific
inhibitor of PI3K
and PI3K
Demonstrated activity in preclinical models of rheumatoid arthritis,
allergy, and inflammation
Phase 1 development in autoimmune-inflammatory conditions
expected to begin in 2011
Research collaboration with Intellikine
to identify additional
differentiated PI3K
and/or PI3K
inhibitors for development in
oncology
23 |
Innovation. Evolution. Impact.
Key 2010 Development Objectives
IPI-926 (Hedgehog Pathway Inhibitor)
Phase 1 data presentation
Phase 2 initiation in pancreatic cancer
IPI-504 (Hsp90 Chaperone Inhibitor)
Phase 2 data presentation in NSCLC
Phase 2 data read-out in HER2+ breast cancer
IPI-493 (Hsp90 Chaperone Inhibitor)
Phase 1 initiation in hematological malignancies
IPI-940 (FAAH Inhibitor)
Phase 1 completion
IPI-145 (PI3K
Inhibitor)
Advance IND-enabling studies
24 |
Innovation. Evolution. Impact.
Our Vision for Creating Value for Patients and
Shareholders
World-class organization and pipeline
Global discovery and development
U.S. commercialization
Strategic
partnering
of
products,
on
attractive
financial
terms,
for
market
access
Ex-U.S.
Products best served by a GP sales force
Operational capabilities and financial strength to access additional
external opportunities
25 |
Innovation. Evolution. Impact.
Infinity:
Innovation. Evolution. Impact.
26
Integrated Team
Proven drug developers
and company builders
Financial Strength
Cash runway into 2013
Ownership of Valuable Product Rights
Establishing commercial infrastructure in US
Diverse Pipeline of Broadly
Applicable Targeted Therapies
Spanning Oncology and
Autoimmune/Inflammatory Diseases
Four candidates in the clinic
Fifth new IND planned for 2011 |
Innovation.
Evolution.
Impact. |