Infinity Reports First Quarter 2013 Financial Results and Provides Company Update

  Infinity Reports First Quarter 2013 Financial Results and Provides Company
  Update

     – Phase 1 Clinical Data for IPI-145 to be Presented at ASCO and the
               International Conference on Malignant Lymphoma –

– IPI-145 Granted Orphan Drug Designation by FDA and EMA for the Treatment of
        Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma –

 – The ASPIRA Trial, a Phase 2 Study Evaluating IPI-145 for the Treatment of
                 Rheumatoid Arthritis, Open for Enrollment –

Business Wire

CAMBRIDGE, Mass. -- May 07, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its first quarter 2013
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). Infinity announced today that abstracts describing Phase 1 data of
IPI-145 in people with advanced hematologic malignancies have been accepted
for presentation at both the American Society of Clinical Oncology (ASCO) 2013
Annual Meeting and the 12^th International Conference on Malignant Lymphoma
(ICML). Infinity also announced that IPI-145 has been granted orphan drug
designation by the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) for the treatment of chronic lymphocytic leukemia (CLL)
and small lymphocytic lymphoma (SLL) and that the ASPIRA (Adult Study of PI3K
Inhibition in RA) trial, a Phase 2 study of IPI-145 in people with rheumatoid
arthritis (RA), is open for enrollment.

“Infinity is continuing to rapidly advance the development of its lead product
candidate, IPI-145, toward the goal of addressing significant medical needs,”
commented Adelene Q. Perkins, Infinity’s president and chief executive
officer. “We look forward to providing updated data on our ongoing Phase 1
study of IPI-145 in people with advanced hematologic malignancies at two
medical meetings in June. Beyond this Phase 1 study, we are planning to
initiate at least two additional company-sponsored studies of IPI-145 in
hematologic malignancies this year.”

“Infinity is also evaluating IPI-145 in inflammatory indications and has made
important progress advancing studies of IPI-145 in rheumatoid arthritis and
asthma. The ASPIRA trial, a Phase 2 study of IPI-145 in people with
moderate-to-severe rheumatoid arthritis, is now open for enrollment, and we
expect to provide an update on the Phase 2 study of IPI-145 in people with
mild, allergic asthma in the second half of 2013,” Ms. Perkins continued.

Recent pipeline highlights include the following:

  *Phase 1 data of IPI-145 to be presented at ASCO: Two abstracts describing
    new data from the Phase 1 study of IPI-145 in people with advanced
    hematologic malignancies were accepted for presentation at the ASCO 2013
    Annual Meeting to be held May 31 - June 4, 2013, in Chicago, Ill. The
    presentations will include a poster presentation describing data from
    people with relapsed or refractory CLL or SLL and an oral presentation
    describing data from people with relapsed or refractory lymphoma.

    In March 2013, Infinity announced that the maximum tolerated dose of 75 mg
    twice daily (BID) had been reached and that five additional expansion
    cohorts had been initiated in the following hematologic malignancies:
    1. CLL, indolent non-Hodgkin lymphoma (NHL) and mantle cell lymphoma (MCL)
    2. T-cell lymphomas
    3. Aggressive B-cell lymphomas
    4. Myeloid neoplasms
    5. T-cell or B-cell acute lymphoblastic leukemia/lymphoma

    In connection with the upcoming ASCO meeting, Infinity will host an
    investor reception on Monday, June 3, 2013, from 8:00 p.m. to 9:30 p.m.
    CDT (9:00 pm to 10:30 pm EDT) to discuss IPI-145 and to review the data
    presented at the meeting. The reception will be webcast beginning at 8:30
    p.m. CDT (9:30 p.m. EDT) and will be accessible in the “investors/media”
    section of Infinity’s website, www.infi.com. A replay of the event will
    also be available.

  *Phase 1 data of IPI-145 to be presented at ICML: Three abstracts
    describing data from the Phase 1 study of IPI-145 in people with advanced
    hematologic malignancies were accepted for presentation at the 12^th ICML
    to be held June 19 - 22, 2013, in Lugano, Switzerland. The presentations
    will include an oral presentation describing data from people with
    relapsed or refractory B-cell lymphoma, an oral presentation describing
    data from people with relapsed or refractory CLL or SLL and a poster
    presentation describing data from people with relapsed or refractory
    T-cell lymphoma.
  *IPI-145 granted orphan drug designation by FDA and EMA: Infinity today
    announced that the FDA and EMA have granted orphan drug designation for
    IPI-145 for the treatment of CLL and SLL. 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 the EU, an orphan drug designation by the EMA provides similar
    incentives, including clinical protocol assistance, direct access to
    centralized marketing authorization and reductions in certain fees.
  *First investigator-sponsored study of IPI-145 open for enrollment:
    Infinity today announced that an investigator-sponsored Phase 1b,
    open-label, dose-escalation study of IPI-145 in approximately 70 people
    with B-cell NHL, CLL and T-cell lymphoma is open for enrollment. The study
    is designed to evaluate the safety, pharmacokinetics and clinical activity
    of IPI-145 in combination with rituxan (a monoclonal antibody therapy),
    bendamustine (a chemotherapy) or both rituxan and bendamustine. Following
    the determination of the maximum tolerated dose of each combination in the
    dose-escalation phase, an expansion phase will commence.
  *Phase 2 study of IPI-145 in RA open for enrollment: Infinity today
    announced that the ASPIRA trial is now open for enrollment. This Phase 2,
    double-blind, randomized, placebo-controlled study is designed to evaluate
    the efficacy, safety and pharmacokinetics of three dose levels of IPI-145
    given twice daily (BID) for 12 weeks in combination with methotrexate
    compared to treatment with placebo plus methotrexate. The study is
    expected to enroll approximately 316 adults with moderate-to-severe RA.
    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.
  *Topline data from clinical studies of retaspimycin HCl in NSCLC now
    expected in 2H13: Infinity today provided an update on the expected timing
    for the availability of topline data from its Phase 2, randomized,
    double-blind, placebo-controlled study of retaspimycin HCl in combination
    with docetaxel (a chemotherapy) in people with non-small cell lung cancer
    (NSCLC). Due to the anticipated timing of planned correlative studies and
    biomarker analyses, the company now expects to report topline data from
    this study in the second half of 2013. Since the study is blinded, it is
    unknown how the event rates in the study may differ between those
    receiving retaspimycin HCl plus docetaxel versus those receiving placebo
    plus docetaxel.

    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 people with second- or third-line NSCLC who are
    naïve to docetaxel treatment and have a smoking history. The primary
    efficacy endpoint of this study is overall survival. 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.^1

    Infinity is also conducting a Phase 1b/2 study of retaspimycin HCl in
    combination with everolimus in people 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.

First Quarter 2013 Financial Results

  *At March 31, 2013, Infinity had total cash, cash equivalents and
    available-for-sale securities of $303.1  million, compared to $326.6
    million at December 31, 2012.
  *Infinity did not record any revenue during the first quarter of 2013.
    Total revenue was $25.2 million for the same period in 2012, which was
    composed of $24.2 million for reimbursed 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.
  *Research and development (R&D) expense for the first quarter of 2013 was
    $20.2 million, compared to $28.6 million for the same period in 2012. The
    decrease in R&D expense for the first 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 $7.4  million for the first
    quarter of 2013, compared to $6.8 million for the same period in 2012. The
    increase in G&A expense in the first quarter of 2013 compared to the same
    period in 2012 was primarily due to higher stock-based compensation
    expense.
  *Infinity did not record any interest expense during the first quarter of
    2013. Interest expense was $0.7 million during the same period of 2012
    before Infinity extinguished the debt with Purdue Pharma L.P. in September
    2012.
  *Net loss for the first quarter of 2013 was $27.3 million, or a basic and
    diluted loss per common share of $0.57, compared to $10.7 million, or a
    basic and diluted loss per common share of $0.40, for the same period in
    2012.

Conference Call Information
Infinity will host a conference call on Tuesday, May 7, 2013, at 4:30 p.m. EDT
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 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; incentives of orphan drug designation, its ability to execute on its
strategic plans; and the therapeutic potential of its PI3K inhibitors and
retaspimycin HCl. 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
quarterly report on Form 10-Q filed with theSecurities and Exchange
Commission (SEC) onMay 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)
                                                          
                                            March 31, 2013  December 31, 2012
                                                             
Cash, cash equivalents and
available-for-sale securities, including    $    303,148     $     326,635
long term
Other current assets                             5,267             3,731
Property and equipment, net                      3,925             4,079
Other long-term assets                          1,153           1,215
                                                             
Total assets                                $    313,493    $     335,660
                                                             
Current liabilities                         $    17,287      $     18,663
Due to Millennium, less current portion          6,302             6,252
Other long-term liabilities                      539               540
Total stockholders’ equity                      289,365         310,205
                                                             
Total liabilities and stockholders’         $    313,493    $     335,660
equity
                                                             

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share amounts)
                                             
                                               Three Months Ended
                                               March 31,
                                               2013            2012
Collaborative research and development         $ -             $ 25,202
revenue from Purdue entities
                                                                             
Operating expenses:
Research and development                         20,231           28,551
General and administrative                      7,430         6,812      
Total operating expenses                        27,661        35,363     
                                                                
Loss from operations                             (27,661    )     (10,161    )
                                                                
Other income (expense):
Interest expense                                 -                (681       )
Investment and other income                     335           120        
Total other income (expense)                    335           (561       )
                                                                
Net loss                                       $ (27,326    )  $ (10,722    )
                                                                
Basic and diluted loss per common share        $ (0.57      )  $ (0.40      )
                                                                
                                                                
Basic and diluted weighted average number of    47,620,147    26,776,856 
common shares outstanding
                                                                

^1 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 47th 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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