Attached files
| file | filename |
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| 8-K - FORM 8-K - INFINITY PHARMACEUTICALS, INC. | d8k.htm |
| EX-99.1 - PRESS RELEASE - INFINITY PHARMACEUTICALS, INC. | dex991.htm |
 Innovation.
Evolution.
Impact.
Exhibit 99.2 |
 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 Infinity’s 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 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. Further, there can be no
guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation.
Infinity’s
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; 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 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
Immune/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.
5
5
Strategic Partnerships with Purdue Pharma and
Mundipharma
Purdue Pharma:
IPI-940 for Neuropathic
and Inflammatory Pain
Mundipharma:
Oncology and Immune/
Inflammatory Diseases
•
100% R&D funding of FAAH program
•
INFI development rights through Phase 1
•
Access to worldwide leadership in pain management
•
Up to 20% royalties on global sales
•
100% R&D funding for partnered programs (incl.
Hedgehog, PI3K and early discovery programs)
•
INFI leading worldwide discovery & development
•
Full U.S. commercial rights by INFI
•
Access to established ex-U.S. commercial capabilities
•
Up to 20% royalties on ex-U.S. sales
Enabling INFI to become a fully integrated biopharmaceutical company
|
 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 $35–45M
•
Anticipated year-end cash and investments balance of $85–95M
–
Based on current operating plan; excludes $50M line of credit from Purdue
•
Low share base (~26.3 million shares outstanding)
6 |
 Innovation. Evolution. Impact.
7
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
8
1
Olive et al., 21 May 2009 Science
Controls
IPI-926 + Gemcitabine
2
Travaglione et al., 2010 AACR
IPI-926 + gemcitabine
doubles median
survival
in
pancreatic
cancer
model
IPI-926
+
Abraxane
®
significantly
decreased
tumor
growth (77%) and increased tumor perfusion in
pancreatic
cancer
model
Days Post Implant
Final IPI-926 dose
On treatment
Re-growth
Final nab-paclitaxel
dose
0
10
20
30
40
50
60
70
80
90
0
20
40
60
80
100
Days
2
1 |
 Innovation. Evolution. Impact.
IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
9
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
model
IPI-926
in
NSCLC
model
70%
36%
70%
Begin dosing IPI-926 +
docetaxel
Final docetaxel
dose
2
3 |
 Innovation. Evolution. Impact.
IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
10
IPI-926 results in 100%
survival in medulloblastoma
model
3
Olson et al., 2009 AACR
Days
IPI-926
Vehicle
3 |
 Innovation. Evolution. Impact.
Advanced basal cell
carcinoma, medulloblastoma
IPI-926: Targeting a Broad Range of Difficult to
Treat Cancers
11
IPI-926 in Phase 1b/2 study (combination with gemcitabine)
in pancreas cancer and Ph 1 study in advanced solid tumors
Preliminary Phase 1 data anticipated in 2010
Pancreas cancer
Small cell lung, non-small cell
lung, ovarian and prostate
cancers; heme malignancies |
 Innovation. Evolution. Impact.
12
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.: Disciplined Portfolio Decisions
•
Interim data from first cohort of patients in Phase 2 study in HER2+ breast
cancer in combination with Herceptin®
–
IPI-504
generally
well-tolerated
at
300
mg/m²
dosed
once
weekly
in
combination
with
Herceptin
in heavily pre-treated population
–
Clinical activity seen at this dose and schedule, but insufficient to warrant
further development
in
this
indication
in
light
of
evolving
standards
of
care
–
Data to be presented at medical meeting in 2011
•
Phase 2 results in NSCLC presented at ASCO 2010
–
IPI-504 generally well-tolerated and active in NSCLC
–
NSCLC patients with ALK rearrangements may preferentially respond to Hsp90
chaperone inhibition
•
67%
response
rate
among
patients
with
ALK
rearrangements
–
two
patients
with
PRs
and
a
third
patient
with
24%
disease
reduction,
all
received
IPI-504
for
>6
months
–
Validation
in
patients
with
NSCLC
and
ALK
rearrangements
ongoing
in
an
IST
at
MGH by Dr. Lecia
Sequist
•
Phase 1b trial in combination with Taxotere®
focused on NSCLC patients
remains ongoing
•
No new IPI-504 trials planned; future studies, if any, will be based on data
from ongoing trials, relevant preclinical data, and other portfolio
choices 13 |
 Innovation. Evolution. Impact.
IPI-493 Oral: Establish Optimal Dose & Schedule
•
IPI-493
–
Distinct pharmaceutical properties
–
Oral availability may provide flexibility in dose and schedule
–
Potential to be used in early lines of therapy
•
Stage-gated clinical development program to assess safety and
establish acceptable dosing regimen for future studies
–
Two ongoing Phase 1 dose-escalation studies –
one in hematologic
malignancies and other in solid tumors
–
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
14 |
 Innovation. Evolution. Impact.
15
IPI-940:
Combating the Magnitude of Neuropathic Pain by
Inhibiting Fatty Acid Amide Hydrolase (FAAH)
FAA
H
IPI-940
(FAAH Inhibitor) |
 Innovation. Evolution. Impact.
IPI-940: Novel Agent Enabling the Body’s Natural
Analgesia
•
Novel, oral agent potentiating the magnitude and duration of
body’s natural analgesia
–
Designed to avoid common side effects
•
Ongoing evaluation in Phase 1 study in normal, healthy volunteers
–
Consists of single-
and multiple-ascending dose studies
•
Phase 1 completion anticipated in 2010
16 |
 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
17 |
 Innovation. Evolution. Impact.
18
IPI-145; PI3K
Inhibitors:
Leveraging Oncology Expertise to Address
Significant Untapped Opportunity in Autoimmune/
Inflammatory Disease and Oncology |
 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 of PI3K are restricted to immune
system cells
–
Strongly implicated in broad range of immune-mediated inflammatory and
allergic disorders and hematologic cancers
19 |
 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 immune-inflammatory conditions expected to begin
in 2011
•
Research
collaboration
with
Intellikine
to
identify
additional
differentiated
PI3K
and/or
PI3K
inhibitors
for
development
in
oncology
20 |
 Innovation. Evolution. Impact.
Key 2010 Development Objectives
•
IPI-926 (Hedgehog Pathway Inhibitor)
–
Phase 1 data presentation
–
Phase 2 initiation in pancreas 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
21 |
 Innovation. Evolution. Impact.
Delivering Patient Benefit and Creating
Shareholder Value
•
U.S. commercialization rights to entire oncology and immune/
inflammatory portfolio other than FAAH
–
Building commercial infrastructure to inform development decisions and
optimize long-term value of company and product portfolio
•
Unencumbered global development and commercialization rights
to Hsp90 chaperone inhibitor program
•
Significant financial participation ex-U.S.
–
Ex-U.S. royalty up to 20% by Mundipharma for partnered programs
–
Global royalty up to 20% by Purdue/Mundipharma for FAAH program
•
Operational capabilities and financial strength to access additional
external strategic opportunities
22 |
 Innovation. Evolution. Impact.
Infinity:
Innovation. Evolution. Impact.
23
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
Immune/Inflammatory Diseases
Four candidates in the clinic
Fifth new IND planned for 2011 |