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Infinity Reports Third Quarter 2013 Financial Results and Provides Company Update

  Infinity Reports Third Quarter 2013 Financial Results and Provides Company
  Update

     – Clinical and Preclinical Data for IPI-145 to Be Presented at ASH –

Business Wire

CAMBRIDGE, Mass. -- November 7, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported its third quarter
2013 financial results and provided an update on its clinical pipeline.
Earlier today, Infinity announced that five abstracts describing clinical and
preclinical data for IPI-145, the company’s oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at
the American Society of Hematology (ASH) 2013 Annual Meeting, which is being
held December 7-10 in New Orleans, Louisiana. Based on encouraging Phase 1
data for IPI-145 in advanced hematologic malignancies (or blood cancers),
Infinity is conducting a Phase 2 study designed to evaluate the safety and
efficacy of IPI-145 in patients with indolent non-Hodgkin lymphoma (iNHL) and
is planning to initiate a Phase 3 study of IPI-145 in patients with chronic
lymphocytic leukemia (CLL) in the fourth quarter of 2013.

“We are focused on rapidly progressing IPI-145 in the clinic, with the goal of
establishing IPI-145 as the best-in-class PI3K inhibitor for the treatment of
blood cancers. We are continuing to enroll patients in our Phase 2 study of
IPI-145 in iNHL and are on track to start our Phase 3 study of IPI-145 in CLL
by the end of the year. These two monotherapy trials are key components of our
registration strategy,” commented Adelene Q. Perkins, Infinity’s chair and
chief executive officer. “In addition to these monotherapy trials, we expect
to announce additional studies in 2014 and beyond that are designed to
continue to differentiate IPI-145 from other agents in development for blood
cancers.”

Recent developments include the following:

  *New Data Supporting the Potential of IPI-145 in Blood Cancers to Be
    Presented at ASH: In a separate press release issued earlier today,
    Infinity announced that five abstracts have been accepted for presentation
    at the ASH 2013 Annual Meeting. Key results to be presented during the
    meeting include updated data from Infinity’s Phase 1 study evaluating the
    safety, clinical activity and pharmacokinetics of IPI-145 in patients with
    CLL. Updated topline Phase 1 data on the activity of IPI-145 in patients
    with iNHL and T-cell lymphoma will also be reported. Additionally, the
    company will present preclinical and/or translational data supporting the
    potential of IPI-145 across a range of hematologic malignancies, including
    iNHL, CLL, diffuse large B‐cell lymphoma (DLBCL) and T‐cell acute
    lymphoblastic leukemia (ALL).

    Infinity will host a reception on Sunday, December 8, 2013, from 11:00
    a.m. to 12:30 p.m. CT (12:00 p.m. to 1:30 p.m. ET) in New Orleans to
    review its PI3K program in hematologic malignancies and discuss the
    IPI-145 data being presented at the ASH 2013 Annual Meeting. The event
    will be webcast and can be accessed in the Investors/Media section of
    Infinity's website at www.infi.com. An archived version of the webcast
    will also be available.

    IPI-145 also has therapeutic potential in inflammatory diseases, and
    Infinity is conducting a Phase 2 trial of IPI-145 in patients with
    rheumatoid arthritis as well as an exploratory, signal-finding Phase 2a
    study of IPI-145 in mild, allergic asthma.

  *Leadership Team Expanded: In September, Infinity announced the appointment
    of David A. Roth, M.D., as senior vice president, clinical development and
    medical affairs. In this role, Dr. Roth is responsible for the clinical
    development organization and clinical operations as well as medical
    affairs. Dr. Roth brings to Infinity over 20 years of experience in
    hematology and oncology research and development. Dr. Roth joined Infinity
    from Pfizer Inc. where he most recently served as a vice president in
    Pfizer’s oncology business unit.
  *Topline Data from Phase 2 Study of Retaspimycin HCl Reported: In
    September, Infinity reported topline data from its Phase 2 study of
    retaspimycin HCl, an Hsp90 inhibitor, in patients with non-small cell lung
    cancer (NSCLC). In this double-blind, randomized, placebo-controlled
    study, retaspimycin HCl did not meet its pre-specified efficacy endpoints
    for demonstrating an improvement in overall survival in the total patient
    population or in patients with squamous cell carcinoma. The company will
    not initiate any new trials with retaspimycin HCl.

Third Quarter 2013 Financial Results

  *At September 30, 2013, Infinity had total cash, cash equivalents and
    available-for-sale securities of $250.9 million, compared to $277.2
    million at June 30, 2013.
  *Infinity did not record any revenue during the third quarter of 2013 or
    2012.
  *Research and development (R&D) expense for the third quarter of 2013 was
    $26.9 million, which compares to $21.5 million for the same period in
    2012. The increase in R&D expense for the third quarter of 2013 compared
    to the same period in 2012 was related to clinical development of IPI-145,
    partially offset by the discontinuation of development of the company’s
    Hedgehog pathway program.

  *General and administrative (G&A) expense was $7.3  million for the third
    quarter of 2013, which compares to $6.3 million for the same period in
    2012. The increase in G&A expense for the third quarter of 2013 compared
    to the same period in 2012 was primarily related to increased stock-based
    compensation expense as well as market development activities as the
    company advances IPI-145 into late-stage development.
  *Net loss for the third quarter of 2013 was $33.9 million, or a basic and
    diluted loss per common share of $0.71, which compares to net income of
    $18.4 million, or a basic earnings per common share of $0.57 and a diluted
    earnings per common share of $0.52, for the same period in 2012.

Conference Call Information

Infinity will host a conference call at 4:30 p.m. ET today to review its third
quarter 2013 financial results, share an update on its business and provide an
overview of the ASH abstracts referenced above. 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) and 1-631-291-4526 (international) five minutes
prior to start time. The conference ID number is 34959052. 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. 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 program; plans to initiate additional clinical trials in
its PI3K program; plans not to initiate new trials with retaspimycin HCl; its
ability to execute on its strategic plans; and the therapeutic potential of
IPI-145 and PI3K inhibition. 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 theSecurities
and Exchange Commission (SEC) onNovember 7, 2013, and other filings filed by
Infinity with theSEC. 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)
                                                         
                                            September 30,     December 31,
                                            2013                  2012
                                                                  
Cash, cash equivalents and
available-for-sale securities,              $250,857              $326,635
including long term
Other current assets                        4,701                 3,731
Property and equipment, net                 4,089                 4,079
Other long-term assets                      1,165             1,215
                                                                  
Total assets                                $260,812          $335,660
                                                                  
Current liabilities                         $ 23,536              $ 18,663
Due to Millennium, less current             6,405                 6,252
portion
Other long-term liabilities                 611                   540
Total stockholders’ equity                  230,260           310,205
                                                                  
Total liabilities and stockholders’         $260,812          $335,660
equity

                                                                       
INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share amounts)
                                                                                    
                     Three Months Ended September 30,          Nine months ended September 30,
                      2013               2012               2013               2012       
Collaborative
research and
development          $ —                  $ —                  $ —                  $ 47,114
revenue from
Purdue
entities
Operating
expenses:
Research and           26,857               21,495               73,168               78,578
development
General and           7,319              6,294              21,424             20,771     
administrative
                                                                                    
Total
operating              34,176               27,789               94,592               99,349
expenses
Gain on
termination of
Purdue                —                  46,555             —                  46,555     
entities
alliance
                                                                                    
Income (loss)
from                   (34,176    )         18,766               (94,592    )         (5,680     )
operations
Other income
(expense):
Interest               —                    (533       )         —                    (1,908     )
expense
Income from
Massachusetts          —                    —                    —                    193
tax incentive
award
Investment and        238                170                737                416        
other income
                                                                                    
Total other
income                238                (363       )        737                (1,299     )
(expense)
                                                                                    
Net income           $ (33,938    )       $ 18,403            $ (93,855    )       $ (6,979     )
(loss)
                                                                                    
Earnings
(loss) per
common share:
Basic                $ (0.71      )       $ 0.57              $ (1.96      )       $ (0.24      )
                                                                                    
Diluted              $ (0.71      )       $ 0.52              $ (1.96      )       $ (0.24      )
                                                                                    
Weighted
average number
of common
shares
outstanding:
Basic                 48,052,939         32,039,866         47,875,706         28,638,512 
                                                                                    
Diluted               48,052,939         35,173,223         47,875,706         28,638,512 

Contact:

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