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Infinity Reports Second Quarter 2013 Financial Results and Provides Company Update



  Infinity Reports Second Quarter 2013 Financial Results and Provides Company
  Update

    – Phase 3 Monotherapy Trial of IPI-145 in Relapsed/Refractory Chronic
   Lymphocytic Leukemia and Small Lymphocytic Lymphoma Expected to Begin in
                           Fourth Quarter of 2013 –

  – Phase 2 Monotherapy Trial of IPI-145 in Refractory Indolent Non-Hodgkin
                        Lymphoma Currently Enrolling –

    – IPI-145 Granted Orphan Drug Designation by FDA for the Treatment of
                            Follicular Lymphoma –

             – Company Provides Updated 2013 Financial Guidance –

Business Wire

CAMBRIDGE, Mass. -- August 8, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported its second
quarter 2013 financial results and provided an update on its clinical
pipeline. Infinity today announced that, in the fourth quarter of 2013, it
expects to initiate a Phase 3 trial of IPI-145, its potent, oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with
chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This
randomized study is designed to evaluate the safety and efficacy of IPI-145
dosed at 25 mg twice daily (BID) compared to ofatumumab in approximately 300
relapsed or refractory patients. In June 2013, Infinity initiated a Phase 2,
open-label, single-arm study designed to evaluate the safety and efficacy of
IPI-145 dosed at 25 mg BID in approximately 120 patients with refractory
indolent non-Hodgkin lymphoma (iNHL). These monotherapy trials are supported
by encouraging data presented at medical meetings earlier this year that
showed IPI-145 was clinically active and well tolerated in a broad range of
hematologic malignancies, including CLL/SLL and iNHL.

“With the ongoing Phase 2 trial in patients with iNHL and our planned Phase 3
study in patients with CLL or SLL, Infinity expects to have two important
clinical trials of IPI-145 in patients with blood cancer under way by the end
of the year. These two clinical trials are key components of Infinity’s
strategy for rapidly progressing IPI-145 toward registration with the goal of
establishing IPI-145 as the best-in-class PI3K inhibitor for the treatment of
patients with blood cancer,” commented Adelene Q. Perkins, Infinity’s chair
and chief executive officer. “In addition to the anticipated initiation of our
Phase 3 trial of IPI-145, in the second half of the year we expect to report
topline data from our Phase 2 study of our Hsp90 inhibitor, retaspimycin HCl,
in patients with non-small cell lung cancer and topline data from our Phase 2a
study of IPI-145 in patients with mild, allergic asthma.”

Pipeline highlights include the following:

  * Phase 3 monotherapy study of IPI-145 in CLL/SLL expected to begin in 4Q13:
    Infinity today announced that it anticipates initiating a Phase 3 study of
    IPI-145 in patients with CLL/SLL in the fourth quarter of 2013. This
    randomized study is designed to evaluate the safety and efficacy of
    IPI-145 dosed at 25 mg BID compared to ofatumumab in approximately 300
    patients with relapsed or refractory CLL and SLL. The primary endpoint of
    the study is progression-free survival.

    This Phase 3 trial is supported by data from the ongoing Phase 1 study
    that showed IPI-145 was well tolerated with a 55 percent response rate in
    patients with CLL, with 12 partial responses among 22 patients evaluable
    for response. Partial responses were defined by the International Workshop
    on Chronic Lymphocytic Leukemia (IWCLL) criteria.^1 Additionally, stable
    disease was reported in nine patients, seven of whom had nodal responses.
    Responses occurred early, with a median time to response of 1.9 months
    (range: 1.8 – 5.6 months). These Phase 1 data were reported in June at the
    American Society of Clinical Oncology (ASCO) Annual Meeting and the 12^th
    International Conference on Malignant Lymphoma (ICML).^2,3
  * Phase 2 monotherapy study of IPI-145 in patients with iNHL initiated: In
    June, Infinity announced the initiation of a Phase 2, open-label,
    single-arm study designed to evaluate the safety and efficacy of IPI-145
    dosed at 25 mg BID in approximately 120 patients with iNHL whose disease
    is refractory to radioimmunotherapy or to both rituximab and chemotherapy.
    Patients enrolled in the study must have progressed within six months of
    receiving their last therapy. The primary endpoint of the study is
    response rate according to the International Working Group (IWG)
    criteria.^4

    In June, Infinity reported Phase 1 data at ASCO and ICML showing that
    IPI-145 was well tolerated with a 68 percent response rate in patients
    with iNHL. Among 19 patients evaluable for response, three patients had
    complete responses and 10 patients had partial responses.^5,6 Responses
    occurred early, with a median time to response of 1.8 months (range: 1.7 –
    4.1 months).
  * IPI-145 granted orphan drug designation by FDA for follicular lymphoma:
    Infinity today announced that the United States Food and Drug
    Administration (FDA) has granted orphan drug designation for IPI-145 for
    the treatment of follicular lymphoma, the most common subtype of iNHL. In
    the U.S., an orphan drug designation by the FDA provides incentives for
    sponsors to develop products for rare diseases, including clinical trial
    design assistance, tax credits and a waiver of Prescription Drug User Fee
    Act (PDUFA) fees. In May 2013, Infinity announced that the FDA and
    European Medicines Agency (EMA) had granted orphan drug designation for
    IPI-145 for the treatment of CLL/SLL.
  * Data from clinical studies of retaspimycin HCl in NSCLC anticipated in
    2H13: Infinity expects to report topline data from its Phase 2,
    randomized, double-blind, placebo-controlled study of retaspimycin HCl in
    combination with docetaxel (a chemotherapy) in patients with non-small
    cell lung cancer (NSCLC) in the second half of 2013. The study is designed
    to evaluate the anti-tumor activity, tolerability and safety of
    retaspimycin HCl in combination with docetaxel compared to placebo plus
    docetaxel in patients with second- or third-line NSCLC who are naïve to
    docetaxel treatment and have a smoking history. Efficacy endpoints of this
    study include overall survival in the total patient population, in
    patients with squamous cell histology and in patients with a novel,
    pre-specified biomarker identified by Infinity. This study is supported by
    data from a Phase 1b study in which retaspimycin HCl in combination with
    docetaxel was well tolerated and clinically active in heavily pretreated
    patients with NSCLC.^7

    Infinity is also conducting a Phase 1b/2 study of retaspimycin HCl in
    combination with everolimus in patients with NSCLC with a KRAS mutation.
    The dose-exploration phase of this study is still ongoing, and the company
    expects to provide an update on this study in the second half of 2013.
  * Data from Phase 2a study of IPI-145 in asthma anticipated in 2H13:
    Infinity expects to provide topline data from its Phase 2a study of
    IPI-145 in patients with mild, allergic asthma during the second half of
    2013. Endpoints of this multi-dose, two-way crossover study include
    safety, pharmacokinetics and FEV[1] (forced expiry volume in one second),
    a standard measure of lung function.

    Infinity is also enrolling patients with moderate to severe rheumatoid
    arthritis (RA) in ASPIRA (Adult Study of PI3K Inhibition in RA), a Phase
    2, double-blind, randomized, placebo-controlled study designed to evaluate
    the efficacy, safety and pharmacokinetics of three dose levels of IPI-145
    given twice daily for 12 weeks in combination with methotrexate compared
    to treatment with placebo plus methotrexate. The study is expected to
    enroll approximately 316 patients. The primary efficacy endpoint of the
    study is ACR20 response rate, which is defined as the proportion of people
    who achieve at least a 20 percent improvement in American College of
    Rheumatology (ACR) response criteria.

Second Quarter 2013 Financial Results

  * At June 30, 2013, Infinity had total cash, cash equivalents and
    available-for-sale securities of $277.2 million, compared to $303.1
    million at March 31, 2013.
  * Infinity did not record any revenue during the second quarter of 2013.
    Total revenue was $21.9 million for the same period in 2012, which was
    composed of $20.9 million for reimbursed research and development (R&D)
    services performed under a previous strategic alliance with Purdue
    Pharmaceutical Products L.P. and Mundipharma International Corporation
    Limited and $1.0 million from the amortization of deferred revenue
    associated with the grant of rights and licenses under this alliance.
  * R&D expense for the second quarter of 2013 was $26.1 million, compared to
    $28.5 million for the same period in 2012. The decrease in R&D expense for
    the second quarter of 2013 compared to the same period in 2012 was
    primarily related to the discontinuation of development of the company’s
    Hedgehog pathway program.
  * General and administrative (G&A) expense was $6.7  million for the second
    quarter of 2013, compared to $7.7 million for the same period in 2012. The
    decrease in G&A expense in the second quarter of 2013 compared to the same
    period in 2012 was primarily due to lower consulting expenses.
  * Infinity did not record any interest expense during the second quarter of
    2013. Interest expense was $0.7 million during the same period of 2012
    before Infinity extinguished its debt to Purdue Pharma L.P. in September
    2012.
  * Net loss for the second quarter of 2013 was $32.6 million, or a basic and
    diluted loss per common share of $0.68, compared to $14.7 million, or a
    basic and diluted loss per common share of $0.54, for the same period in
    2012.

2013 Financial Guidance

Infinity today provided updated financial guidance for 2013. These updates are
due to rapidly advancing IPI-145 in the clinic, including the anticipated
increased clinical costs associated with conducting the Phase 3, randomized
trial of IPI-145 compared to ofatumumab in patients with CLL/SLL that is
expected to commence in the fourth quarter of 2013, together with an
anticipated $10 million milestone payment triggered by the initiation of this
Phase 3 trial that is due under the company’s development and license
agreement with Millennium: The Takeda Oncology Company and Takeda
Pharmaceutical Company Limited.

Infinity’s current financial expectations for 2013 are as follows:

  * Operating Expenses: Infinity expects operating expenses for 2013 to range
    from $135 million to $145 million, compared to prior expectations of $115
    million to $125 million.
  * Net Loss: Infinity expects net loss for 2013 to range from $135 million to
    $145 million, compared to prior expectations of $115 million to $125
    million.
  * Cash and Investments: Infinity expects to end 2013 with a year-end cash
    and investments balance ranging from $190 million to $200 million,
    compared to prior expectations of $210 million to $220 million. Based on
    its current operating plan and exclusive of any business development
    activities, Infinity believes that it has sufficient cash and investments
    to support its operations into 2015.

Conference Call Information

Infinity will host a conference call on Thursday, August 8, 2013, at 8:30 a.m.
ET to discuss these financial results and provide an update on the company. A
live webcast of the conference call can be accessed in the “investors/media”
section of Infinity’s website at www.infi.com. To participate in the
conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526
(international) five minutes prior to start time. The conference call ID is
23079300. An archived version of the webcast will be available on Infinity’s
website for 30 days.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative biopharmaceutical company dedicated to discovering,
developing and delivering best-in-class medicines to people with
difficult-to-treat diseases. 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. For more information on
Infinity, please refer to the company’s website at www.infi.com.

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 and type of data and updates from, as well as progress in, clinical
trials of its PI3K and Hsp90 programs; plans to initiate additional clinical
trials; its ability to execute on its strategic plans; the therapeutic
potential of its PI3K inhibitors and retaspimycin HCl; the timing of milestone
payments; and 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 initiate clinical trials
or 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 quarterly report on Form 10-Q filed with the Securities
and Exchange Commission (SEC) on August 8, 2013, 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.

 
INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
 
                                             June 30, 2013   December 31, 2012
                                                            
Cash, cash equivalents and
available-for-sale securities, including     $277,237        $326,635
long term
Other current assets                         5,146           3,731
Property and equipment, net                  4,179           4,079
Other long-term assets                       1,161           1,215
                                                              
Total assets                                 $287,723        $335,660
                                                              
Current liabilities                          $ 20,846        $ 18,663
Due to Millennium, less current portion      6,353           6,252
Other long-term liabilities                  618             540
Total stockholders’ equity                   259,906         310,205
                                                              
Total liabilities and stockholders’ equity   $287,723        $335,660

 
INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
 
                 Three Months Ended June 30,       Six Months Ended June 30,
                   2013             2012             2013             2012        
Collaborative
research and
development      $ —              $ 21,911         $ —              $ 47,113
revenue from
Purdue
entities
Operating
expenses:
Research and       26,080           28,532           46,311           57,083
development
General and        6,675            7,666            14,105           14,477      
administrative
                                                                     
Total
operating          32,755           36,198           60,416           71,560      
expenses
                                                                     
Loss from          (32,755    )     (14,287    )     (60,416    )     (24,447    )
operations
Other income
(expense):
Interest           —                (694       )     —                (1,375     )
expense
Income from
Massachusetts      —                193              —                193
tax incentive
award
Investment and     164              127              499              247         
other income
                                                                     
Total other
income             164              (374       )     499              (935       )
(expense)
                                                                     
Net loss         $ (32,591    )   $ (14,661    )   $ (59,917    )   $ (25,382    )
                                                                     
Basic and
diluted loss     $ (0.68      )   $ (0.54      )   $ (1.25      )   $ (0.94      )
per common
share
                                                                     
Basic and
diluted
weighted
average number     47,915,726       27,061,435       47,785,620       26,919,146  
of common
shares
outstanding
                                                                                  

^1 Hallek M, et al. (2008) Guidelines for the diagnosis and treatment of
chronic lymphocytic leukemia: A report from the International Workshop on
Chronic Lymphocytic Leukemia updating the National Cancer Institute – Working
Group 1996 Guidelines. Blood 111: 5446-5456.
^2 Patel M, Kahl B, Horwitz S, Younes A, O’Brien S, Foss F, et al. Preliminary
Safety and Efficacy of IPI-145, a Potent Inhibitor of
Phosphoinositide-3-Kinase-δ,γ in Patients with Relapsed/Refractory CLL. Poster
presented at the 2013 Meeting of the American Society of Clinical Oncology,
Chicago, Ill, 2013.
^3 Flinn I, Patel M, Horwitz S, Younes A, Foss F, Oki Y, et al. Preliminary
Safety and Efficacy of IPI-145, a Potent Inhibitor of
Phosphoinositide-3-Kinase-δ,γ in Patients with Relapsed/Refractory CLL/SLL.
Presented at the 12^th International Conference on Malignant Lymphoma, Lugano,
Switzerland.
^4 Cheson BD, et al. (2007) Revised response criteria for malignant lymphoma.
J. Clin Oncol 25:579-586.
^5 Horwitz S, Flinn I, Patel M, Younes A, Foss F, Oki Y, et al. Preliminary
Safety and Efficacy of IPI-145, a Potent Inhibitor of
Phosphoinositide-3-Kinase-δ,γ, in Patients with Relapsed/Refractory Lymphoma.
Presented at the 2013 Meeting of the American Society of Clinical Oncology,
Chicago, Ill, 2013.
^6 Kahl B, Patel M, Younes A, Horwitz S, Foss F, Oki Y, et al. Preliminary
Safety and Efficacy of IPI-145, a Potent Inhibitor of
Phosphoinositide-3-Kinase-δ,γ in Patients with Relapsed/Refractory B-Cell
Lymphoma. Presented at the 12^th International Conference on Malignant
Lymphoma, Lugano, Switzerland.
^7 Riely GJ, Gettinger SN, Stoller RG, Gabrail NY, Weiss GJ, Tunkey C, et al.
Safety and activity of IPI-504 (retaspimycin HCl) and docetaxel in pretreated
patients with metastatic non-small cell lung cancer (NSCLC). Poster presented
at the 47^th Annual Meeting of the American Society of Clinical Oncology,
Chicago, Ill, 2011.

Contact:

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