Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced today its
full-year 2013 financial results, a $100M debt facility and ongoing
progress with IPI-145, the Company’s oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma.
“Throughout 2013, Infinity made significant progress with IPI-145,
demonstrating broad activity and tolerability across multiple
hematologic malignancies,” commented Adelene Q. Perkins, Infinity’s
chair and chief executive officer. “Based on the highest monotherapy
response rate yet reported with any targeted drug in iNHL, our goal is
to establish IPI-145 as the best available treatment in iNHL with broad
potential in a number of other hematological malignancies.”
Recent Infinity pipeline highlights include:
-
Reported encouraging Phase 1 clinical data, which build on the
clinical activity and tolerability profile of IPI-145, at the 55th
Annual Meeting of the American Society for Hematology (ASH):
-
Infinity reported Phase 1 data of IPI-145 monotherapy in patients
with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL),
demonstrating that IPI-145 was generally well tolerated and
clinically active, with an overall response rate (ORR) of 73
percent, including three complete responses, among 15 patients
receiving IPI-145 dosed at ≤ 25 mg twice daily (BID). Data also
showed that 53 percent of patients remained progression free for
over one year. These data support the clinical rationale for DYNAMOTM,
the ongoing Phase 2 study of IPI-145 in patients with
refractory iNHL.
-
Additionally, the Phase 1 study of IPI-145 for the treatment of
chronic lymphocytic leukemia (CLL) showed that IPI-145 was
generally well tolerated and highly active in patients with
relapsed/refractory CLL, including a nodal response rate of 89
percent and an ORR of 48 percent as defined by the International
Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria1,
with one complete response and 12 partial responses among 27
patients receiving IPI-145 at doses ≤ 25 mg BID. Onset of activity
was rapid, with the majority of responses occurring in less than
two months. These data support the clinical rationale for DUOTM,
Infinity’s Phase 3 monotherapy study in patients with
relapsed/refractory CLL, which is currently enrolling.
-
Early Phase 1 data in aggressive non-Hodgkin lymphoma (aNHL) and
preclinical data in diffuse large B-cell lymphoma (DLBCL) were
also reported. Phase 1 data in 14 patients with aNHL showed that
IPI-145 led to a reduction in adenopathy (decrease in the size of
lymph nodes) in three of eight patients with DLBCL and, notably,
two of three patients with Richter transformation. A partial
response in one of three patients with transformed follicular
lymphoma was also reported. IPI-145 was generally well tolerated.
-
Reported updated Phase 1 data of IPI-145 in T-cell malignancies at
the 6th Annual T-Cell Lymphoma Forum in
January: Infinity reported encouraging updated data from its
ongoing Phase 1 study of IPI-145
in patients with relapsed/refractory T-cell lymphoma. Preliminary data
showed that IPI-145 was generally well tolerated and clinically active
in patients with T-cell lymphoma, with an ORR of 38 percent, including
one complete response and nine partial responses among 26 patients
evaluable for response. Among the 11 patients with peripheral T-cell
lymphoma (PTCL) evaluable for activity, IPI-145 led to one complete
response and five partial responses, for an ORR of 55 percent. Among
the 15 patients with cutaneous T-cell lymphoma (CTCL) evaluable for
activity, treatment with IPI-145 led to four partial responses, for an
ORR of 27 percent. Stable disease was observed in seven patients with
CTCL.
-
Initiated DYNAMO, a Phase 2 study of IPI-145 for the treatment of
iNHL: Based on the clinical activity seen in Phase 1, Infinity
initiated DYNAMO, a Phase 2 study evaluating the safety and efficacy
of IPI-145 in approximately 120 patients with iNHL whose disease is
refractory to radioimmunotherapy or to both rituximab and
chemotherapy, and who 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 criteria.
-
Initiated DUO, a Phase 3 study of IPI-145 for the treatment of CLL:
Based on the encouraging Phase 1 data in CLL, Infinity initiated DUO,
a Phase 3 randomized trial that 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. The
primary endpoint of the study is progression-free survival.
2014 Development Milestones
Infinity anticipates achieving the following development milestones in
2014:
IPI-145 in Hematologic Malignancies
-
Initiate DYNAMO+R, a Phase 3 study in combination with rituximab in
patients with relapsed iNHL
-
Initiate a Phase 2 study in treatment-naïve patients with iNHL
-
Initiate at least one additional clinical trial
IPI-145 in Inflammation
-
Report topline data from ASPIRA, a Phase 2 study in patients with
moderate-to-severe rheumatoid arthritis
-
Report topline data from the Phase 2a study in patients with mild,
allergic asthma
PI3K Pipeline Expansion
-
Announce development strategy for IPI-443
Full-Year 2013 Financial Results and 2014 Debt Facility
Infinity announced today that the Company has entered into an agreement
with affiliates of Deerfield Management Company, L.P., a leading
healthcare investment organization and Infinity shareholder, to provide
Infinity with a $100 million debt facility. Infinity has the right to
draw down on the facility in $25 million increments at any time over the
next 12 months but is under no obligation to do so.
"This financing facility provides Infinity with important flexibility as
we execute on our strategic development plan, including advancing
IPI-145 in potential registration studies,” stated Larry Bloch,
executive vice president, chief financial officer and chief business
officer of Infinity.
-
At December 31, 2013, Infinity had total cash, cash equivalents and
available-for-sale securities of $214.5 million, compared to
$326.6 million at December 31, 2012, and $250.9 million at September
30, 2013.
-
Infinity did not record any revenue in 2013. In 2012, revenue
consisted of $47.1 million related to research and development (R&D)
revenue from Infinity’s previous strategic alliance with Purdue
Pharmaceutical Products L.P. and Mundipharma International Corporation
Limited.
-
R&D expense for full-year 2013 was $99.8 million, compared to $118.6
million for 2012. The decrease in R&D expense in 2013 compared to 2012
was primarily due to the conclusion of clinical development activities
associated with the company’s Hsp90 and Hedgehog pathway programs, as
well as decreased milestone payments to Millennium: The Takeda
Oncology Company for IPI-145 and IPI-443, partially offset by higher
clinical development expenses for IPI-145.
-
General and administrative expense was $27.9 million for both
the full-year 2013 and 2012.
-
Net loss for full-year 2013 was $126.8 million, or a basic and diluted
loss per common share of $2.64, compared to $54.0 million, or a basic
and diluted loss per common share of $1.70 for 2012.
Conference Call Information
Infinity will host a conference call on Tuesday, February 25, 2014, at
8:30 a.m. ET to discuss these financial results and company updates. 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 ID number is 49396389. 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: its program goals for 2014, including the timing and
type of data and updates from, as well as progress in, clinical trials
of its PI3K program, its plans to initiate additional clinical trials in
its PI3K program, and plans to announce a development strategy for
IPI-443; its ability to execute on its plans and strategies; 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. Food and Drug Administration 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; general
economic and market conditions; 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 the Securities and Exchange Commission (SEC) on
February 25, 2014, 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.
1 Halleck 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.
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INFINITY PHARMACEUTICALS, INC.
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Condensed Consolidated Balance Sheets
|
(in thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
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December 31,
2013
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December 31,
2012
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Cash, cash equivalents and available-for-sale securities, including
long term
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$
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214,468
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$
|
326,635
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Other current assets
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|
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|
|
|
11,055
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|
|
|
|
|
3,731
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Property and equipment, net
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|
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|
4,010
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|
|
|
|
|
4,079
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Other long-term assets
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|
|
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|
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1,177
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|
|
|
|
|
1,215
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Total assets
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$
|
230,710
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$
|
335,660
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Current liabilities
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|
$
|
22,206
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$
|
18,663
|
Due to Millennium, less current portion
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|
6,456
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|
|
6,252
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Other long-term liabilities
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|
|
773
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|
|
|
|
|
540
|
Total stockholders’ equity
|
|
|
|
|
|
201,275
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|
310,205
|
|
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|
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|
|
Total liabilities and stockholders’ equity
|
|
|
|
|
$
|
230,710
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|
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|
|
$
|
335,660
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|
|
|
|
|
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|
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|
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INFINITY PHARMACEUTICALS, INC.
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Condensed Consolidated Statements of Operations
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(in thousands, except share and per share amounts)
|
(unaudited)
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Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2013
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|
2012
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|
2013
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|
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|
|
2012
|
|
Collaborative research and development revenue from Purdue entities
|
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|
$
|
—
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|
$
|
—
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|
|
$
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—
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|
$
|
47,114
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Operating expenses:
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|
|
|
|
|
|
|
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|
|
|
|
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Research and development
|
|
|
|
|
26,592
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|
|
|
|
|
40,016
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|
|
|
|
|
99,760
|
|
|
|
|
|
118,595
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General and administrative
|
|
|
|
|
6,492
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|
|
|
|
|
7,110
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|
|
|
|
|
27,916
|
|
|
|
|
|
27,882
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|
Total operating expenses
|
|
|
|
|
33,084
|
|
|
|
|
|
47,126
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|
|
|
|
|
127,676
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|
|
|
|
|
146,477
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|
Gain on termination of Purdue entities alliance
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|
|
|
|
—
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|
|
|
|
|
—
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|
|
|
|
|
—
|
|
|
|
|
|
46,555
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Loss from operations
|
|
|
|
|
(33,084
|
)
|
|
|
|
|
(47,126
|
)
|
|
|
|
|
(127,676
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)
|
|
|
|
|
(52,808
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest expense
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
(1,908
|
)
|
Income from Massachusetts tax incentive award
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
193
|
|
Interest and investment income
|
|
|
|
|
159
|
|
|
|
|
|
142
|
|
|
|
|
|
896
|
|
|
|
|
|
559
|
|
Total other income (expense)
|
|
|
|
|
159
|
|
|
|
|
|
142
|
|
|
|
|
|
896
|
|
|
|
|
|
(1,156
|
)
|
Net loss
|
|
|
|
$
|
(32,925
|
)
|
|
|
|
$
|
(46,984
|
)
|
|
|
|
$
|
(126,780
|
)
|
|
|
|
$
|
(53,964
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
|
|
$
|
(0.68
|
)
|
|
|
|
$
|
(1.15
|
)
|
|
|
|
$
|
(2.64
|
)
|
|
|
|
$
|
(1.70
|
)
|
Basic and diluted weighted average number of common shares
outstanding
|
|
|
|
|
48,114,922
|
|
|
|
|
|
40,855,124
|
|
|
|
|
|
47,936,001
|
|
|
|
|
|
31,711,264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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