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 the Securities and
Exchange Commission (SEC) on November 7, 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2013
|
|
|
|
|
December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities, including
long term
|
|
|
|
|
$250,857
|
|
|
|
|
$326,635
|
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 portion
|
|
|
|
|
6,405
|
|
|
|
|
6,252
|
Other long-term liabilities
|
|
|
|
|
611
|
|
|
|
|
540
|
Total stockholders’ equity
|
|
|
|
|
230,260
|
|
|
|
|
310,205
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
|
|
|
$260,812
|
|
|
|
|
$335,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months Ended September 30,
|
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|
|
Nine months ended September 30,
|
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|
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|
|
2013
|
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|
|
|
|
2012
|
|
|
|
|
|
2013
|
|
|
|
|
|
2012
|
|
Collaborative research and development revenue from Purdue entities
|
|
|
|
$
|
—
|
|
|
|
|
$
|
—
|
|
|
|
|
$
|
—
|
|
|
|
|
$
|
47,114
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
26,857
|
|
|
|
|
|
21,495
|
|
|
|
|
|
73,168
|
|
|
|
|
|
78,578
|
|
General and administrative
|
|
|
|
|
7,319
|
|
|
|
|
|
6,294
|
|
|
|
|
|
21,424
|
|
|
|
|
|
20,771
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total operating expenses
|
|
|
|
|
34,176
|
|
|
|
|
|
27,789
|
|
|
|
|
|
94,592
|
|
|
|
|
|
99,349
|
|
Gain on termination of Purdue entities alliance
|
|
|
|
|
—
|
|
|
|
|
|
46,555
|
|
|
|
|
|
—
|
|
|
|
|
|
46,555
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
|
|
(34,176
|
)
|
|
|
|
|
18,766
|
|
|
|
|
|
(94,592
|
)
|
|
|
|
|
(5,680
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
|
|
—
|
|
|
|
|
|
(533
|
)
|
|
|
|
|
—
|
|
|
|
|
|
(1,908
|
)
|
Income from Massachusetts tax incentive award
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
193
|
|
Investment and other income
|
|
|
|
|
238
|
|
|
|
|
|
170
|
|
|
|
|
|
737
|
|
|
|
|
|
416
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
|
|
238
|
|
|
|
|
|
(363
|
)
|
|
|
|
|
737
|
|
|
|
|
|
(1,299
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
|
$
|
(33,938
|
)
|
|
|
|
$
|
18,403
|
|
|
|
|
$
|
(93,855
|
)
|
|
|
|
$
|
(6,979
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
Copyright Business Wire 2013