Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its
full-year 2014 financial results and ongoing progress with duvelisib
(IPI-145), an oral, dual inhibitor of phosphoinositide-3-kinase
(PI3K)-delta and PI3K-gamma. Infinity anticipates that it will report
topline data from DYNAMOTM, a Phase 2 study of duvelisib in
patients with refractory indolent non-Hodgkin lymphoma (iNHL), in the
second half of 2015 following the completion of patient enrollment in
the first half of the year. Infinity also expects to complete enrollment
of DUOTM, a Phase 3 study of duvelisib in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL), in the second
half of 2015. Additionally, Infinity anticipates that three
company-sponsored clinical studies of duvelisib will be initiated in
2015, including the first clinical study of duvelisib in combination
with venetoclax (ABT-199).
“In 2014, Infinity continued to advance duvelisib in
registration-focused studies and entered a global collaboration with
AbbVie to expand and accelerate the development and commercialization of
duvelisib in oncology. We continue to be encouraged by the clinical
activity and early signs of durability that we have observed in our
Phase 1 study of duvelisib, which complements our growing scientific
understanding of the potential impact that dual inhibition of PI3K-delta
and PI3K-gamma may have on thwarting the growth and survival of certain
blood cancers,” stated Adelene Perkins, chair, president and chief
executive officer at Infinity. “Our progress in 2014 positions us to
achieve several important milestones this year as we work toward our
goal of building a fully integrated biotechnology company. Importantly,
in the second half of this year we expect to report topline data from
DYNAMO, which could help to establish duvelisib as the best oral therapy
for the treatment of iNHL. Two important components of our strategy to
achieve better patient outcomes include the inhibition of both the delta
and gamma isoform of PI3K with duvelisib and the combination of novel
therapies. We expect that the first clinical study of duvelisib in
combination with venetoclax will be initiated this year.”
Recent highlights include the following:
-
Initiated DYNAMO+R, a Phase 3 study in patients with previously
treated follicular lymphoma: In December 2014, Infinity announced
the initiation of DYNAMO+R, a Phase 3, randomized, double-blind,
placebo-controlled study comparing duvelisib plus Rituxan®
(rituximab) to placebo plus Rituxan in approximately 400 patients with
previously treated follicular lymphoma. The primary endpoint of the
study is progression-free survival.
-
Initiated two additional studies of duvelisib: As part of
Infinity’s development strategy to demonstrate the therapeutic
potential of duvelisib in multiple indications and lines of treatment,
the company today announced that it has initiated its Phase 1b/2
clinical study in patients with previously untreated follicular
lymphoma, which is designed to evaluate the safety and activity of
duvelisib in combination with Gazyva® (obinutuzumab) or
Rituxan. The company also announced today that it has initiated the
Phase 1b clinical study of duvelisib in combination with Gazyva in
patients with CLL whose disease has progressed following treatment
with a Bruton’s tyrosine kinase (BTK) inhibitor.
-
Announced encouraging new clinical data of duvelisib at American
Society of Hematology Annual Meeting (ASH): In December 2014,
Infinity reported updated data from a Phase 1 monotherapy study of
duvelisib, which showed activity among patients with relapsed/refractory
iNHL. Data demonstrated that duvelisib administered as a
monotherapy at 25 mg twice daily (BID) was clinically active, with a
72 percent overall response rate (13 of 18 evaluable patients) and a
33 percent complete response rate (6 of 18 evaluable patients). Among
patients with follicular lymphoma, the overall response rate was 69
percent (9 of 13 evaluable patients), including a 38 percent complete
response rate (5 of 13 evaluable patients). The median progression
free survival and median overall survival had not yet been reached,
with 69 percent progression-free survival and 89 percent overall
survival at 24 months. The majority of adverse events were Grade 1 or
2, reversible and/or clinically manageable.
During the
meeting, Infinity also reported
updated Phase 1 monotherapy data of duvelisib dosed at 25 mg BID in
patients with relapsed/refractory
CLL demonstrating that duvelisib treatment led to an overall
response rate of 57 percent, including one complete response, and
adverse events were mostly Grade 1 or 2, reversible and/or clinically
manageable. Additional data reported from the Phase 1 study of
duvelisib included new data showing preliminary activity and safety in patients
previously treated with ibrutinib and updated data showing
activity and safety in patients with relapsed/refractory
T-cell lymphoma.
-
Announced encouraging new preclinical results of duvelisib at ASH: In
December 2014, Infinity also announced preclinical
translational data providing new insights into the roles of
PI3K-delta and PI3K-gamma in malignant B-cell growth and survival.
Research presented supports the hypothesis that PI3K-delta is
important in the proliferation of malignant B-cells, and that both
PI3K-delta and PI3K-gamma play an important role in the formation and
maintenance of the supportive tumor microenvironment. These data,
taken together, suggest that PI3K-delta and PI3K-gamma may have
complementary effects on malignant B-cell growth and survival.
-
Reported topline results from a Phase 2 study of duvelisib in
rheumatoid arthritis: In January, Infinity announced that ASPIRA,
a Phase 2 study of duvelisib, an oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, with background
methotrexate in patients with moderate-to-severe rheumatoid arthritis
(RA) did not meet its primary endpoint, ACR20 response rate at 12
weeks. Infinity will not proceed with further clinical development in
RA with duvelisib or IPI-443, its second PI3K-delta,gamma inhibitor.
Infinity expects that any further development of IPI-443 in
inflammatory diseases would be conducted through out-licensing or
partnering efforts.
2015 Development Milestones
Infinity anticipates achieving the following development milestones in
2015:
Novel Duvelisib Combinations
-
Initiation by AbbVie of the first clinical study of duvelisib in
combination with venetoclax
Duvelisib in iNHL
-
Complete enrollment in DYNAMO during the first half of 2015
-
Report topline data from DYNAMO during the second half of
2015
-
Initiate two additional clinical studies
Duvelisib in CLL
-
Complete enrollment in DUO during the second half of 2015
Full-Year 2014 Financial Results
-
At December 31, 2014, Infinity had total cash, cash equivalents and
available-for-sale securities of $333.2 million, compared to
$214.5 million at December 31, 2013, and $379.5 million at September
30, 2014.
-
Revenue during 2014 was $165.0 million, which was composed of a
one-time license fee of $159.1 million associated with the strategic
collaboration with AbbVie and $5.9 million in research and development
(R&D) services. Infinity did not record any revenue in 2013.
-
R&D expense for full-year 2014 was $143.6 million, compared to $99.8
million for 2013. The increase in R&D expenses in 2014 compared to
2013 was primarily due to higher clinical development expenses for
duvelisib.
-
General and administrative expense was $29.3 million for the
full-year 2014 and $27.9 million for the full-year 2013.
-
Net loss for full-year 2014 was $17.4 million, or a basic and diluted
loss per common share of $0.36, compared to $126.8 million, or a basic
and diluted loss per common share of $2.64 for 2013.
Conference Call Information
Infinity will host a conference call on Tuesday, February 24, 2015, at
4:30 p.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 79964543. 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 plans to complete patient enrollment in DYNAMO
in the first half of 2015 and in DUO in the second half of 2015; its
plans to report topline data from DYNAMO in the second half of 2015; its
plans to initiate three additional studies of duvelisib in 2015; its
expectations regarding further development of duvelisib or IPI-443 in
RA; its ability to execute on its strategic plans; the potential
complementary effects of PI3K-delta and PI3K-gamma; and the therapeutic
potential of PI3K inhibition and duvelisib. 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 Infinity’s strategic collaboration with AbbVie will
continue or 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; a failure of Infinity and/or AbbVie to fully perform under the
strategic collaboration and/or an early termination of the collaboration
and license agreement; 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 or intends to develop
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 the Securities and Exchange Commission (SEC) on February
24, 2015, 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
|
(in thousands)
|
(unaudited)
|
|
|
|
December 31, 2014
|
|
|
December 31, 2013
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities, including
long term
|
|
$333,245
|
|
|
$214,468
|
Loan commitment asset from Deerfield, net
|
|
647
|
|
|
—
|
Other current assets
|
|
11,195
|
|
|
11,055
|
Property and equipment, net
|
|
18,970
|
|
|
4,010
|
Other long-term assets
|
|
5,087
|
|
|
1,177
|
|
|
|
|
|
|
Total assets
|
|
$369,144
|
|
|
$230,710
|
|
|
|
|
|
|
Current liabilities
|
|
$ 54,877
|
|
|
$ 22,206
|
Due to Takeda, less current portion
|
|
—
|
|
|
6,456
|
Deferred revenue, less current portion
|
|
85,510
|
|
|
—
|
Construction liability
|
|
15,456
|
|
|
—
|
Other long-term liabilities
|
|
3,829
|
|
|
773
|
Total stockholders’ equity
|
|
209,472
|
|
|
201,275
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
$369,144
|
|
|
$230,710
|
|
|
|
|
|
|
|
INFINITY PHARMACEUTICALS, INC.
|
Condensed Consolidated Statements of Operations
|
(in thousands, except share and per share amounts)
|
(unaudited)
|
|
|
|
Three Months Ended December 31,
|
|
|
Twelve Months Ended December 31,
|
|
|
|
2014
|
|
|
|
2013
|
|
|
|
|
2014
|
|
|
|
2013
|
|
Collaboration revenue
|
|
$
|
4,356
|
|
|
$
|
—
|
|
|
|
$
|
164,995
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
36,082
|
|
|
|
26,592
|
|
|
|
|
143,633
|
|
|
|
99,760
|
|
General and administrative
|
|
|
7,382
|
|
|
|
6,492
|
|
|
|
|
29,285
|
|
|
|
27,916
|
|
Total operating expenses
|
|
|
43,464
|
|
|
|
33,084
|
|
|
|
|
172,918
|
|
|
|
127,676
|
|
Loss from operations
|
|
|
(39,108
|
)
|
|
|
(33,084
|
)
|
|
|
|
(7,923
|
)
|
|
|
(127,676
|
)
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(1,035
|
)
|
|
|
—
|
|
|
|
|
(9,649
|
)
|
|
|
—
|
|
Interest and investment income
|
|
|
(17
|
)
|
|
|
159
|
|
|
|
|
339
|
|
|
|
896
|
|
Total other income (expense)
|
|
|
(1,052
|
)
|
|
|
159
|
|
|
|
|
(9,310
|
)
|
|
|
896
|
|
Loss before income taxes
|
|
|
(40,160
|
)
|
|
|
(32,925
|
)
|
|
|
|
(17,233
|
)
|
|
|
(126,780
|
)
|
Income taxes
|
|
|
(183
|
)
|
|
|
—
|
|
|
|
|
(183
|
)
|
|
|
—
|
|
Net loss
|
|
$
|
(40,343
|
)
|
|
$
|
(32,925
|
)
|
|
|
$
|
(17,416
|
)
|
|
$
|
(126,780
|
)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
$
|
(0.83
|
)
|
|
$
|
(0.68
|
)
|
|
|
$
|
(0.36
|
)
|
|
$
|
(2.64
|
)
|
Basic and diluted weighted average number of common shares
outstanding
|
|
|
48,788,917
|
|
|
|
48,114,922
|
|
|
|
|
48,561,653
|
|
|
|
47,936,001
|
|
Copyright Business Wire 2015