Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

Infinity Provides Key 2013 Goals and Financial Guidance



  Infinity Provides Key 2013 Goals and Financial Guidance

 – Additional Data from Phase 1 Trial of IPI-145 in Hematologic Malignancies
                            Anticipated in 2013 –

            – Expands PI3K Franchise with New Product Candidate –

           – Strong Financial Position with Cash Runway into 2015 –

– Company to Present at JPMorgan Annual Healthcare Conference at 10 a.m. PT –

JPMorgan Healthcare Conference 2013

Business Wire

CAMBRIDGE, Mass. -- January 7, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its anticipated
pipeline goals and provided financial guidance for 2013. In the first half of
2013, Infinity expects to report data from both of its wholly owned clinical
programs, phosphoinositide-3-kinase (PI3K) and heat shock protein 90 (Hsp90),
that will inform potential paths to registration. Each program targets areas
of unmet patient need such as advanced hematologic malignancies, inflammatory
diseases and non-small cell lung cancer (NSCLC).

“Our pipeline, experienced leadership team and financial position provide the
foundation from which we are poised to execute our product development and
business strategy as we continue to build a fully integrated biopharmaceutical
company,” stated Adelene Q. Perkins, Infinity’s president and chief executive
officer. “We have worldwide commercial rights to our entire portfolio of
product development candidates and are entering the year with a strong balance
sheet that allows us to independently advance our programs while we consider
potential partnerships to complement our capabilities.”

Pipeline Expanded with IPI-443, a Potent PI3K-Delta,Gamma Inhibitor

Infinity today also announced its second potent, oral PI3K-delta,gamma
inhibitor, IPI-443. Nonclinical studies of IPI-443 are now under way, which
are designed to enable the initiation of Phase 1 clinical development.

“PI3K inhibition has therapeutic potential across both hematologic
malignancies and inflammatory diseases,” stated Julian Adams, Ph.D., president
of R&D at Infinity. “We believe that we have the potential to develop
best-in-class PI3K inhibitors and are pleased that IPI-443, our second product
candidate targeting PI3K-delta,gamma, has the potential to further maximize
our development opportunities across multiple disease pathways and
indications.”

2013 Program Goals

Infinity is developing a portfolio of PI3K inhibitors which includes IPI-145
and IPI-443, potent, oral inhibitors of PI3K-delta and PI3K-gamma, as well as
retaspimycin hydrochloride (HCl), a potent and selective Hsp90 inhibitor.
Infinity anticipates achieving the following development milestones in 2013:

IPI-145 in Hematologic Malignancies

  * 1H2013: Initiate up to five cohort expansions in the ongoing Phase 1 trial
    in patients with advanced hematologic malignancies
  * 1H2013: Define the recommended Phase 2 dose
  * 2013: Initiate at least two additional trials

IPI-145 in Inflammation

  * 1H2013: Initiate a Phase 2 trial in patients with rheumatoid arthritis
  * 2H2013: Provide update on Phase 2a trial in patients with mild, allergic
    asthma

PI3K Pipeline Expansion

  * 2H2013: Complete nonclinical studies of IPI-443 to enable Phase 1
    development

Retaspimycin HCl in NSCLC

  * 1H2013: Report topline overall survival data from Phase 2 trial in
    combination with docetaxel
  * 1H2013: Provide update on Phase 1b/2 trial in combination with everolimus

2013 Financial Guidance

Infinity entered 2013 with approximately $327 million in cash and investments
(unaudited). The company is providing the following guidance with respect to
its 2013 financial outlook:

  * Operating Expenses: Infinity expects operating expenses for 2013 to range
    from $115 million to $125 million.
  * Net Loss: Infinity expects net loss for 2013 to range from $115 million to
    $125 million.
  * Cash and Investments: Infinity expects to end 2013 with a year-end cash
    and investments balance ranging from $210 million to $220 million. Based
    on its current operating plan and exclusive of any business development
    activities, Infinity’s financial foundation provides a cash runway into
    2015.

Infinity to Present at J.P. Morgan 31^st Annual Healthcare Conference

Infinity will present at the J.P. Morgan 31^st Annual Healthcare Conference in
San Francisco on Monday, January 7, 2013 at 10:00 a.m. PT (1:00 p.m. ET). A
live webcast of Infinity’s presentation will be accessible on the
“investors/media” section of the company’s website, www.infi.com. The
presentation will be archived for 30 days following the event.

About Infinity’s PI3K Program

IPI-145 and IPI-443 are potent, oral inhibitors of Class I
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity believes
IPI-145 is the most advanced PI3K-delta,gamma inhibitor in clinical
development. The PI3Ks are a family of enzymes involved in multiple cellular
functions, including cell proliferation and survival, cell differentiation,
cell migration and immunity.^i The PI3K-delta and PI3K-gamma isoforms are
preferentially expressed in leukocytes, where they have distinct and
non-overlapping roles in immune cell development and function. Targeting
PI3K-delta and PI3K-gamma may provide multiple opportunities to develop
differentiated therapies for the treatment of inflammatory diseases as well as
hematologic malignancies.

IPI-145 is currently progressing in a Phase 1 trial in patients with advanced
hematologic malignancies. Preliminary data from this trial showed that IPI-145
was well tolerated to date and clinically active in patients with both B-cell
and T-cell malignancies, including chronic lymphocytic leukemia, indolent
non-Hodgkin’s lymphoma, mantle cell lymphoma, Hodgkin’s lymphoma and T-cell
lymphoma.^ii Infinity is also conducting a Phase 2a trial in patients with
mild, allergic asthma and is planning to begin a Phase 2 trial of IPI-145 in
patients with rheumatoid arthritis in the first half of 2013.

About Infinity’s Hsp90 Program

Retaspimycin HCl is an intravenously administered, potent and selective heat
shock protein 90 (Hsp90) inhibitor. The Hsp90 chaperone plays a key role in
regulating the stability of its client proteins.^iii Cancer cells express
elevated levels of Hsp90 relative to normal cells and depend on Hsp90 to
support certain oncoproteins and to buffer cellular stresses induced by
malignant transformation.^iii,iv Thus, Hsp90 is a fundamental hub in protein
interaction networks, maintaining the functional state of many proteins
critical for cancer growth, proliferation and survival.^iii,v Inhibition of
Hsp90 has the potential to shut down multiple oncogenic signaling pathways
simultaneously.^iv

Infinity has completed patient enrollment in a double-blind, randomized,
placebo-controlled Phase 2 trial designed to evaluate the anti-tumor activity,
tolerability and safety of retaspimycin HCl in combination with docetaxel
compared to docetaxel alone in patients with second- or third-line non-small
cell lung cancer (NSCLC) who are naïve to docetaxel treatment and have a
smoking history. This study is supported by data from a Phase 1b trial in
which retaspimycin HCl in combination with docetaxel was well tolerated and
clinically active in heavily pretreated patients with NSCLC.^vi A Phase 1b/2
trial of retaspimycin HCl in combination with everolimus in NSCLC patients
with a KRAS mutation is also ongoing.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative drug discovery and development company seeking to
discover, develop and deliver to patients best-in-class medicines for diseases
with significant unmet need. Infinity combines proven scientific expertise
with a passion for developing novel small molecule drugs that target emerging
disease pathways. Infinity’s programs focused on the inhibition of
phosphoinositide-3-kinase and heat shock protein 90 are evidence of its
innovative approach to drug discovery and development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include those regarding the Company’s expectations about: the
timing of data from clinical trials of its PI3K and Hsp90 programs; its
ability to execute on its strategic plans; its current cash position; the
therapeutic potential of its PI3K inhibitors and retaspimycin HCl; its 2013
research and development goals, including without limitation clinical
development plans, for its PI3K program and its Hsp90 program; and its
financial guidance for 2013 with respect to operating expenses, net loss and
cash and investments. Such statements are subject to numerous important
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 will report data in the time frames it has
estimated, that any product candidate Infinity is developing will successfully
complete necessary preclinical and clinical development phases or that
development of any of Infinity’s product candidates will continue. Further,
there can be no guarantee that any positive developments in Infinity’s product
portfolio will result in stock price appreciation. Management’s expectations
and, therefore, any forward-looking statements in this press release could
also be affected by risks and uncertainties relating to a number of other
factors, including the following: Infinity’s 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. FDA and other regulatory authorities,
investigational review boards at clinical trial sites and publication review
bodies; Infinity’s ability to obtain and maintain requisite regulatory
approvals and to enroll patients in its clinical trials; unplanned cash
requirements and expenditures; development of agents by Infinity’s competitors
for diseases in which Infinity is currently developing its product candidates;
and Infinity’s ability to obtain, maintain and enforce patent and other
intellectual property protection for any product candidates 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
current report on Form 8-K filed with the Securities and Exchange Commission
(SEC) on December 12, 2012, and other filings filed by Infinity with the SEC.
Any forward-looking statements contained in this press release 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.

^i Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the
traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK (Eds.) The biology of
cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.

^ii Flinn, I.W., Horwitz, S.M., Patel, M., Younes, A., Porter, J., Sweeney,
J., Allen, K., Kelly, P., Kahl, B. Clinical Safety and Activity in a Phase 1
Trial of IPI-145, a Potent Inhibitor of Phosphoinositide-3-Kinase-(δ,γ) in
Patients with Advanced Hematologic Malignancies. Poster presented at the 54th
Annual Meeting of the American Society for Hematology (ASH), Atlanta, GA,
2012.

^iii Whitesell L and Lindquist SL. Hsp90 and the chaperoning of cancer. Nat
Rev Cancer 2005, 5(10):761-772.

^iv Workman P, Burrows F, Neckers L, Rosen N. Drugging the cancer chaperone
Hsp90: Combinatorial therapeutic exploitation of oncogene addiction and tumor
stress. Ann NY Acad Sci 2007, 1113:202-216.

^v Taipale M, Jarosz DF, Lindquist S. Hsp90 at hub of protein homeostasis:
Emerging mechanistic insights. Nat Rev Mol Cell Bio 2010, 11:515-528.

^vi Riely GJ, Gettinger SN, Stoller RG, Gabrail NY, Weiss GJ, Tunkey C, et al.
Safety and activity of IPI-504 (restaspimycin HCl) and docetaxel in pretreated
patients with metastatic non-small cell lung cancer (NSCLC). Poster presented
at the 47th Annual Meeting of the American Society of Clinical Oncology,
Chicago, IL, 2011.

Contact:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement