Infinity Provides Company Update and Reports Full-Year 2012 Financial Results

  Infinity Provides Company Update and Reports Full-Year 2012 Financial
  Results

  – Cohort Expansions of Phase 1 Trial of IPI-145 in Patients with Advanced
                   Hematologic Malignancies Now Enrolling –

          – Key Data Expected from PI3K and Hsp90 Programs in 2013 –

Business Wire

CAMBRIDGE, Mass. -- March 5, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its full-year 2012
financial results and ongoing progress with IPI-145, its potent, oral
inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and
retaspimycin HCl, its potent and selective inhibitor of heat shock protein 90
(Hsp90), and anticipates reporting clinical data from both these programs this
year. Infinity also announced today that it initiated five new expansion
cohorts in its trial of IPI-145 in patients with advanced hematologic
malignancies.

“We made important progress on our product development goals last year,
reporting encouraging preliminary data from our Phase 1 trial of IPI-145 in
patients with advanced hematologic malignancies, initiating a Phase 2a trial
of IPI-145 in patients with asthma, and completing enrollment in our Phase 2,
double-blind, randomized, placebo-controlled trial of retaspimycin HCl in
non-small cell lung cancer,” stated Adelene Q. Perkins, Infinity’s president
and chief executive officer. “We entered 2013 in a strong financial position
with approximately $327 million in cash and investments and anticipate this
will be a year of fundamental progress for Infinity, as data generated from
our ongoing trials will inform our potential registration paths as we continue
building a sustainable, fully-integrated biopharmaceutical company.”

In December 2012, Infinity reported encouraging preliminary data at the Annual
Meeting of the American Society for Hematology (ASH) showing clinical activity
at each of the doses of IPI-145 evaluated from 8 mg through 75 mg twice daily
(BID), indicating a potential broad therapeutic window. Infinity has now
defined 75 mg BID as the maximum tolerated dose and has leveraged the adaptive
approach of its Phase 1 trial to continue to explore the safety,
pharmacokinetics and activity of IPI-145 at 75 mg BID in five additional
expansion cohorts of patients with the following hematologic malignancies:

1. Chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma and mantle cell
lymphoma
2. T-cell lymphomas
3. Aggressive B-cell lymphomas
4. Myeloid neoplasms
5. T-cell or B-cell acute lymphoblastic leukemia/lymphoma

“We are pleased to have completed the dose-escalation phase of our Phase 1
trial of IPI-145, enabling us to initiate additional expansion cohorts and
advance the program toward registration studies,” said Julian Adams, Ph.D.,
president of research and development at Infinity. “Furthermore, these high
dose expansion cohorts allow us to increase our patient experience in a broad
range of hematologic malignancies and to further optimize the dose of IPI-145.
In patients with chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma
and mantle cell lymphoma, the evaluation of a 75 mg BID expansion cohort
relative to the 25 mg BID expansion cohort initiated in July 2012 will allow
us to determine whether there is an enhanced benefit to treating these
patients at a higher dose.”

Expected 2013 Development Milestones
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

  *2013: Initiate at least two additional trials in patients with hematologic
    malignancies
  *2013: Report additional data from ongoing Phase 1 trial in patients with
    advanced hematologic malignancies
  *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

Full-Year 2012 Financial Results

  *At December 31, 2012, Infinity had total cash, cash equivalents and
    available-for-sale securities of $326.6  million, compared to $115.9
    million at December 31, 2011, and $189.4 million at September 30, 2012.
  *Total revenue for full-year 2012 was $47.1  million, compared to $92.8
    million for 2011. In 2012, revenue consisted of $45.0 million related to
    reimbursed research and development (R&D) services and $2.1 million
    related to the amortization of deferred revenue related to the grant of
    rights and licenses under Infinity’s previous strategic alliance with
    Purdue Pharmaceutical Products L.P. and Mundipharma International
    Corporation Limited and compared to $88.5 million and $4.3 million,
    respectively, for 2011.
  *A non-recurring gain related to the previous strategic alliance with
    Purdue and Mundipharma was $46.6 million for full-year 2012. Infinity does
    not have any future research and development (R&D) obligations to Purdue
    and Mundipharma.
  *R&D expense for full-year 2012 was $118.6 million, compared to $108.6
    million for 2011. The increase in R&D expense in 2012 compared to 2011 was
    primarily due to the December 2012 amended and restated agreement with
    Millennium: The Takeda Oncology Company, including recording the full
    release payment of $15M payable in installments as well as development
    milestones for IPI-145 and IPI-443, partially offset by the
    discontinuation of development of the company’s Hedgehog pathway program.

  *General and administrative (G&A) expense was $27.9  million for full-year
    2012, compared to $22.7 million for the same period in 2011. The increase
    in G&A expense in 2012 compared to 2011 was primarily due to higher
    stock-based compensation expense, early commercial development activities
    and corporate development activities.
  *Net loss for full-year 2012 was $54.0 million, or a basic and diluted loss
    per common share of $1.70, compared to $40.0 million, or a basic and
    diluted loss per common share of $1.50, for 2011.

Conference Call Information
Infinity will host a conference call on Tuesday, March 5, 2013, at 4:30 p.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. An archived version of the
webcast will be available on Infinity’s website for 30 days.

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. 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 of data and updates from clinical trials of its PI3K and Hsp90
programs; its ability to execute on its strategic plans; the therapeutic
potential of its PI3K inhibitors and retaspimycin HCl; its 2013 research and
development goals, including without limitation clinical and nonclinical
development plans, for its PI3K program and its Hsp90 program; and dose
optimization strategies. 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
annual report on Form 10-K filed with theSecurities and Exchange Commission
(SEC) onMarch 5, 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

(in thousands, except share and per share amounts)

(unaudited)
                                                               
                                                   December 31,  December 31,
                                                   2012           2011
                                                                  
Cash, cash equivalents and available-for-sale      $   326,635    $   115,937
securities, including long term
Other current assets                                   3,731          2,703
Property and equipment, net                            4,079          4,582
Other long-term assets                                1,215        1,268
                                                                  
Total assets                                       $   335,660   $   124,490
                                                                  
Current liabilities                                $   18,663     $   28,986
Due to Millennium, less current portion                6,252          —
Long-term debt due to Purdue entities, net of          —              37,553
debt discount
Deferred revenue from Purdue entities, less            —              42,147
current portion
Other long-term liabilities                            540            371
Total stockholders’ equity                            310,205      15,433
                                                                  
Total liabilities and stockholders’ equity         $   335,660   $   124,490
                                                                  

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)
                                                
                 Three Months Ended               Twelve Months Ended
                 December 31,                      December 31,
                 2012            2011            2012            2011
Collaborative
research and                                                   
development                                                      
revenue          $ —              $ 22,324         $ 47,114         $ 92,773
from Purdue
entities
                                                                    
Operating
expenses:
Research and       40,016           29,893           118,595          108,582
development
General and       7,110         6,043         27,882        22,719     
administrative
Total
operating          47,126           35,936           146,477          131,301
expenses
Gain on
termination of
Purdue            —             —             46,555        —          
entities
alliance
Loss from          (47,126    )     (13,612    )     (52,808    )     (38,528    )
operations
                                                                    
Other income
(expense):
Interest           —                (542       )     (1,908     )     (1,841     )
expense
Income from
Massachusetts      —                —                193              —
tax incentive
award
Interest and
investment        142           93            559           327        
income
Total other       142           (449       )   (1,156     )   (1,514     )
expense
Net loss         $ (46,984    )  $ (14,061    )  $ (53,964    )  $ (40,042    )
                                                                    
Basic and
diluted loss     $ (1.15      )  $ (0.53      )  $ (1.70      )  $ (1.50      )
per common
share
Basic and
diluted
weighted
average number    40,855,124    26,708,351    31,711,264    26,620,278 
of common
shares
outstanding

Contact:

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