Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - INFINITY PHARMACEUTICALS, INC. | d8k.htm |
| EX-99.2 - PRESS RELEASE - INFINITY PHARMACEUTICALS, INC. | dex992.htm |
 Innovation.
Evolution.
Impact.
Exhibit 99.1 |
 Innovation. Evolution. Impact.
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 the therapeutic potential
of Infinity’s Hedgehog pathway, FAAH, and Hsp90 chaperone inhibitors; future clinical trial
activity for IPI-504, IPI-493, IPI-926 and IPI-940; 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 annual report on Form 10-Q filed
with the U.S. Securities and Exchange Commission in May 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.
|
 3
Infinity:
Innovation. Evolution. Impact.
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
Four candidates in the clinic
Innovation. Evolution. Impact. |
 Financial Strength to Create Value
4
~$310M to aggressively invest in pipeline and access external opportunities
~$310M
~$126M
~$126M in Cash & Investments
at 3/31/10
~$260M
$150M in Committed
R&D Funding for 2010 & 2011
($16M received 1Q10)
$50M Line of Credit
(10
year balloon note at prime) Innovation. Evolution. Impact.
|
 Innovation.
Evolution. Impact. 5
5
Strategic Partnerships with Purdue Pharma
and
Mundipharma
Purdue Pharma:
Neuropathic &
Inflammatory Pain
Mundipharma:
Oncology
•
100% R&D funding of partnered programs
•
INFI developmental 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
•
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
•
~$310 million to invest in pipeline and access external
opportunities
•
Projected
2010
cash
burn
of
$25M
-
$35M
•
Anticipate year-end cash and investments balance of
$95M -
$105M
–
Based on current operating plan; excludes $50M line of credit from Purdue
•
Low share base (~26 million shares outstanding)
6 |
 Innovation.
Evolution. Impact. 7
IPI-926:
Significant Anti-Cancer Opportunity by Inhibiting
Malignant Activation of the Hedgehog Pathway
Signal to progenitor cell
Signal to tumor microenvironment
Signal to tumor cell |
 Innovation.
Evolution. Impact. Controls
IPI-926 + Gemcitabine
IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
8
1
Olive et al., 21 May 2009 Science
Days
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
increases
tumor
perfusion
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
1
2 |
 IPI-926: Inhibiting Multiple Modes of Malignant
Activation to Prolong Survival
9
IPI-926 in SCLC model
1
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
2
IPI-926 in NSCLC model
3
70%
36%
70%
Begin dosing IPI-926 +
docetaxel
Final docetaxel
dose
Innovation. Evolution. Impact. |
 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
3
Olson et al., 2009 AACR |
 Advanced BCC,
Medulloblastoma
IPI-926: Targeting a Broad Range of Difficult to
Treat Cancers
11
IPI-926 in Phase 1b/2 study in pancreas cancer
and Ph 1 study in advanced solid tumors
Preliminary Ph 1 data anticipated in 2010
Pancreas cancer
SCLC, ovarian cancer,
NSCLC, CRPC, and
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. |
 Innovation. Evolution. Impact.
IPI-504 i.v.: Establish Therapeutic Window
•
Ph
2
Results
in
NSCLC
(Presented
at
ASCO
2010;
enrollment
completed
2009)
–
IPI-504 generally well-tolerated and active in NSCLC
•
7% objective response rate in overall study population
–
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
•
Ph 2 development in HER2+ breast cancer in combination with
Herceptin
®
–
Preliminary data anticipated in 2010
•
Rigorous effort to evaluate therapeutic window and appropriate
patient populations
–
Determine potential path forward with i.v. agent
13 |
 Innovation. Evolution. Impact.
IPI-493 oral: Establish Optimal Dose & Schedule
•
IPI-493
–
Oral availability may provide flexibility in dose and schedule
–
Potential to be combined with other cancer drugs in early lines of therapy
•
Clinical development to assess safety and establish dosing
regiment for future studies
–
Ongoing Ph 1 study in solid tumors
–
Near-term initiation of Ph 1study in hematological malignancies
•
Ability to examine PK-PD relationship and client protein degradation by
IPI-493 •
Ph 1 data anticipated in 2011
14 |
 Innovation. Evolution. Impact.
15
IPI-940:
Combating the
Magnitude of
Neuropathic Pain
by Inhibiting
Fatty Acid Amide
Hydrolase
(FAAH)
FAAH
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 (e.g., drowsiness)
•
Ongoing evaluation in Ph 1 study in normal, healthy volunteers
–
Consists of single-
and multiple-ascending dose studies
•
Ph 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
•
Osteoarthritic
pain
•
Anxiety & Depression
•
Inflammatory Conditions
17 |
 Innovation. Evolution. Impact.
Key 2010 Development Objectives
•
IPI-926 (Hedgehog Pathway Inhibitor)
–
Phase 1 data in solid tumors
–
Phase 2 initiation in pancreatic cancer
•
IPI-504 (Hsp90 Chaperone Inhibitor)
–
Phase 2 data in NSCLC
–
Phase 2 data in HER2+ breast cancer
•
IPI-493 (Hsp90 Chaperone Inhibitor)
–
Phase 1 initiation in hematological malignancies
•
IPI-940 (FAAH Inhibitor)
–
Phase 1 completion
18 |
 Innovation. Evolution. Impact.
•
U.S. commercialization rights to entire oncology portfolio
–
Building commercial infrastructure
•
Significant financial participation ex-U.S.
–
Ex-U.S. royalty up to 20% by Mundipharma
for oncology programs
–
Global royalty up to 20% by Purdue for FAAH program
•
Operational capabilities and financial strength to access external
strategic opportunities
Delivering Patient Benefit and Creating
Shareholder Value
19 |
 Infinity:
Innovation. Evolution. Impact.
20
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
Four candidates in the clinic
Innovation. Evolution. Impact. |