– DYNAMOTM and DUOTM
Studies On-Track to Complete Enrollment in 2H15 –
– Infinity Receives FDA Fast Track Designation for Duvelisib for
Chronic Lymphocytic Leukemia –
– Further Expansion of Duvelisib Development Program Expected in 2015
–
Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its second
quarter 2015 financial results and ongoing progress with duvelisib
an oral, dual inhibitor of phosphoinositide-3-kinase
(PI3K)-delta and PI3K-gamma. Infinity also announced today that the
U.S. Food and Drug Administration (FDA) granted Fast Track designation
for the investigation of duvelisib for the treatment of patients with
chronic lymphocytic leukemia (CLL) who have received at least one prior
therapy. The FDA established the Fast Track designation process to
facilitate the development and expedite the review of investigational
medicines intended to treat serious or life-threatening conditions and
that demonstrate the potential to address unmet medical needs. Infinity
is conducting registration-focused trials evaluating the safety and
efficacy of duvelisib, including DYNAMOTM, a Phase 2 study in
patients with refractory indolent non-Hodgkin lymphoma (iNHL), and DUOTM,
a Phase 3 study in patients with CLL.
“The quarter was marked by continued clinical development progress for
duvelisib, particularly with DYNAMO and DUO. The first completion of
enrollment in either DYNAMO or DUO, both of which we expect to occur in
the second half of this year, will trigger a $130 million milestone
payment from AbbVie, our global development and commercialization
partner for duvelisib in oncology,” stated Adelene Perkins, Infinity’s
chair, president and chief executive officer. “We are also pleased to
have recently received Fast Track designation for the investigation of
duvelisib for the treatment of chronic lymphocytic leukemia, which
supports our belief in the potential of duvelisib to help fill an
important medical need. We look forward to leveraging the opportunities
that Fast Track designation allows in order to maximize the possibility
of an accelerated path to approval.”
Duvelisib is the only investigational PI3K-delta,gamma inhibitor in
Phase 3 clinical development and has the potential to be a
first-in-class treatment for certain types of hematologic malignancies,
or blood cancers. In addition to the DYNAMO and DUO studies, Infinity is
continuing to enroll patients in CONTEMPO, a Phase 1b/2 study in
treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a
Phase 1b study in CLL patients whose disease is refractory to or has
relapsed while receiving a BTK inhibitor. Infinity also expects that the
first clinical study of duvelisib in combination with venetoclax,
AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2)
selective inhibitor, will begin this year.
At the 2015 Annual Meeting of the American Society of Clinical Oncology
(ASCO), preclinical data were presented showing in vitro synergy between
duvelisib and venetoclax, and the combination of duvelisib plus
venetoclax showed greater inhibition of lymphoma tumor growth compared
to each of these agents alone. These preclinical data provide support
for the first clinical study combining duvelisib and venetoclax in
patients with hematologic malignancies.
Second Quarter 2015 Financial Results
-
At June 30, 2015, Infinity had total cash, cash equivalents and
available-for-sale securities of $199.5 million, compared to $233.6
million at March 31, 2015.
-
Revenue during the second quarter of 2015 was $4.9 million for
research and development (R&D) services associated with the strategic
collaboration with AbbVie for duvelisib in oncology. Infinity did not
record any revenue in the second quarter of 2014.
-
R&D expense for the second quarter of 2015 was $34.1 million, compared
to $28.2 million for the second quarter of 2014. The increase in R&D
expense was primarily due to higher contingent cash compensation and
expenses related to early discovery programs.
-
General and administrative (G&A) expense was $9.4 million for the
second quarter of 2015, compared to $7.1 million for the same period
in 2014. The increase in G&A expense was primarily related to higher
contingent cash compensation.
-
Net loss for the second quarter of 2015 was $38.4 million, or a basic
and diluted loss per common share of $0.78, compared to $38.0 million,
or a basic and diluted loss per common share of $0.78, for the same
period in 2014.
Conference Call Information
Infinity will host a conference call today 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 72290673. An archived version of the
webcast will be available on Infinity’s website for 30 days.
Infinity R&D Day, October 6, 2015
Infinity will host an R&D Day in New York City on Tuesday, October 6,
2015, from 7:30 a.m. to 12:00 p.m. ET. The event will be webcast
beginning at 8:00 a.m. ET and can be accessed in the Investors/Media
section of Infinity’s website, www.infi.com.
A replay of the event will also be available.
About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase
(PI3K)-delta and PI3K-gamma, two proteins with predominantly
non-overlapping roles known to support the growth and survival of
malignant B-cells.[i] Preclinical data suggest that
PI3K-delta signaling can lead to the proliferation of malignant B-cells,
and both PI3K-gamma and PI3K-delta play a role in the formation and
maintenance of the supportive tumor microenvironment.[ii]
Duvelisib is the only investigational PI3K-delta,gamma inhibitor in
Phase 3 clinical development and has the potential to be a
first-in-class treatment for certain types of hematologic malignancies,
or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly
developing duvelisib in oncology.
Duvelisib is being evaluated in registration-focused studies, including
DYNAMOTM, a Phase 2 study in patients with refractory
indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients
with previously treated follicular lymphoma, and DUOTM, a
Phase 3 study in patients with relapsed/refractory chronic lymphocytic
leukemia. Duvelisib is an investigational compound and its safety and
efficacy have not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
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: completing patient enrollment in DYNAMO and DUO in
the second half of 2015; the potential benefits of Fast Track
designation; seeking regulatory approval for duvelisib; the therapeutic
potential of PI3K inhibition and duvelisib, including in combination
with venetoclax; plans to initiate additional studies of duvelisib in
2015; and its ability to execute on its strategic plans. 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 quarterly report on Form
10-Q filed with the Securities and Exchange Commission (SEC) on August
6, 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
|
(unaudited)
|
(in thousands)
|
|
|
|
|
|
June 30,
2015
|
|
|
December 31,
2014
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
|
|
$
|
199,475
|
|
|
$
|
333,245
|
Loan commitment asset, net
|
|
|
|
|
—
|
|
|
|
647
|
Other current assets
|
|
|
|
|
8,992
|
|
|
|
11,195
|
Property and equipment, net
|
|
|
|
|
27,392
|
|
|
|
18,970
|
Other long-term assets
|
|
|
|
|
5,019
|
|
|
|
5,087
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
$
|
240,878
|
|
|
$
|
369,144
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
$
|
58,231
|
|
|
$
|
54,877
|
Deferred revenue, less current portion
|
|
|
|
|
70,171
|
|
|
|
85,510
|
Financing obligation
|
|
|
|
|
19,802
|
|
|
|
—
|
Construction liability
|
|
|
|
|
—
|
|
|
|
15,456
|
Other long-term liabilities
|
|
|
|
|
5,413
|
|
|
|
3,829
|
Total stockholders’ equity
|
|
|
|
|
87,261
|
|
|
|
209,472
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
|
|
$
|
240,878
|
|
|
$
|
369,144
|
|
|
|
|
|
|
|
|
INFINITY PHARMACEUTICALS, INC.
|
Condensed Consolidated Statements of Operations
|
(unaudited)
|
(in thousands, except share and per share amounts)
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
Collaboration revenue
|
|
|
|
$
|
4,880
|
|
|
|
$
|
—
|
|
|
|
|
$
|
9,244
|
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
34,062
|
|
|
|
|
28,165
|
|
|
|
|
|
122,490
|
|
|
|
|
62,656
|
|
General and administrative
|
|
|
|
|
9,410
|
|
|
|
|
7,057
|
|
|
|
|
|
17,960
|
|
|
|
|
13,861
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
43,472
|
|
|
|
|
35,222
|
|
|
|
|
|
140,450
|
|
|
|
|
76,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(38,592
|
)
|
|
|
|
(35,222
|
)
|
|
|
|
|
(131,206
|
)
|
|
|
|
(76,517
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
|
|
(99
|
)
|
|
|
|
(2,938
|
)
|
|
|
|
|
(747
|
)
|
|
|
|
(4,077
|
)
|
Investment and other income
|
|
|
|
|
263
|
|
|
|
|
136
|
|
|
|
|
|
223
|
|
|
|
|
304
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
|
|
164
|
|
|
|
|
(2,802
|
)
|
|
|
|
|
(524
|
)
|
|
|
|
(3,773
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(38,428
|
)
|
|
|
$
|
(38,024
|
)
|
|
|
|
$
|
(131,730
|
)
|
|
|
$
|
(80,290
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
|
|
$
|
(0.78
|
)
|
|
|
$
|
(0.78
|
)
|
|
|
|
$
|
(2.69
|
)
|
|
|
$
|
(1.66
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of common shares
outstanding
|
|
|
|
|
49,076,031
|
|
|
|
|
48,543,853
|
|
|
|
|
|
49,008,085
|
|
|
|
|
48,446,849
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[i] Winkler D.G., Faia K.L., DiNitto J.P. et al. (2013)
PI3K-d and PI3K-g inhibition by IPI_145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models. Chem
Biol 20: 1-11.
[ii] Peluso M., Faia K.L., Winkler D.G. et al. Duvelisib
(IPI-145) Inhibits Malignant B-cell Proliferation and Disrupts Signaling
from the Tumor Microenvironment through Mechanisms That Are Dependent on
PI3K-d and PI3K-g. Blood (ASH Annual Meeting Abstracts) 2014:
Abstract 328.
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