Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its full-year
2012 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), and anticipates reporting clinical data from both
these programs this year. Infinity also announced today that it
initiated five new expansion cohorts in its trial of IPI-145 in patients
with advanced hematologic malignancies.
“We made important progress on our product development goals last year,
reporting encouraging preliminary data from our Phase 1 trial of IPI-145
in patients with advanced hematologic malignancies, initiating a Phase
2a trial of IPI-145 in patients with asthma, and completing enrollment
in our Phase 2, double-blind, randomized, placebo-controlled trial of
retaspimycin HCl in non-small cell lung cancer,” stated Adelene Q.
Perkins, Infinity’s president and chief executive officer. “We entered
2013 in a strong financial position with approximately $327 million in
cash and investments and anticipate this will be a year of fundamental
progress for Infinity, as data generated from our ongoing trials will
inform our potential registration paths as we continue building a
sustainable, fully-integrated biopharmaceutical company.”
In December 2012, Infinity reported encouraging preliminary data at the
Annual Meeting of the American Society for Hematology (ASH) showing
clinical activity at each of the doses of IPI-145 evaluated from 8 mg
through 75 mg twice daily (BID), indicating a potential broad
therapeutic window. Infinity has now defined 75 mg BID as the maximum
tolerated dose and has leveraged the adaptive approach of its Phase 1
trial to continue to explore the safety, pharmacokinetics and activity
of IPI-145 at 75 mg BID in five additional expansion cohorts of patients
with the following hematologic malignancies:
1. Chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma and
mantle cell lymphoma
2. T-cell lymphomas
3. Aggressive B-cell
lymphomas
4. Myeloid neoplasms
5. T-cell or B-cell acute
lymphoblastic leukemia/lymphoma
“We are pleased to have completed the dose-escalation phase of our Phase
1 trial of IPI-145, enabling us to initiate additional expansion cohorts
and advance the program toward registration studies,” said Julian Adams,
Ph.D., president of research and development at Infinity. “Furthermore,
these high dose expansion cohorts allow us to increase our patient
experience in a broad range of hematologic malignancies and to further
optimize the dose of IPI-145. In patients with chronic lymphocytic
leukemia, indolent non-Hodgkin lymphoma and mantle cell lymphoma, the
evaluation of a 75 mg BID expansion cohort relative to the 25 mg BID
expansion cohort initiated in July 2012 will allow us to determine
whether there is an enhanced benefit to treating these patients at a
higher dose.”
Expected 2013 Development Milestones
Infinity is developing
a portfolio of PI3K inhibitors which includes IPI-145 and IPI-443,
potent, oral inhibitors of PI3K-delta and PI3K-gamma, as well as
retaspimycin hydrochloride (HCl), a potent and selective Hsp90
inhibitor. Infinity anticipates achieving the following development
milestones in 2013:
IPI-145
-
2013: Initiate at least two additional trials in patients with
hematologic malignancies
-
2013: Report additional data from ongoing Phase 1 trial in patients
with advanced hematologic malignancies
-
1H2013: Initiate a Phase 2 trial in patients with rheumatoid arthritis
-
2H2013: Provide update on Phase 2a trial in patients with mild,
allergic asthma
PI3K Pipeline Expansion
-
2H2013: Complete nonclinical studies of IPI-443 to enable Phase 1
development
Retaspimycin HCl in NSCLC
-
1H2013: Report topline overall survival data from Phase 2 trial in
combination with docetaxel
-
1H2013: Provide update on Phase 1b/2 trial in combination with
everolimus
Full-Year 2012 Financial Results
-
At December 31, 2012, Infinity had total cash, cash equivalents and
available-for-sale securities of $326.6 million, compared to
$115.9 million at December 31, 2011, and $189.4 million at September
30, 2012.
-
Total revenue for full-year 2012 was $47.1 million, compared to
$92.8 million for 2011. In 2012, revenue consisted of $45.0 million
related to reimbursed research and development (R&D) services and $2.1
million related to the amortization of deferred revenue related to the
grant of rights and licenses under Infinity’s previous strategic
alliance with Purdue Pharmaceutical Products L.P. and Mundipharma
International Corporation Limited and compared to $88.5 million and
$4.3 million, respectively, for 2011.
-
A non-recurring gain related to the previous strategic alliance with
Purdue and Mundipharma was $46.6 million for full-year 2012. Infinity
does not have any future research and development (R&D) obligations to
Purdue and Mundipharma.
-
R&D expense for full-year 2012 was $118.6 million, compared to $108.6
million for 2011. The increase in R&D expense in 2012 compared to 2011
was primarily due to the December 2012 amended and restated agreement
with Millennium: The Takeda Oncology Company, including recording the
full release payment of $15M payable in installments as well as
development milestones for IPI-145 and IPI-443, partially offset by
the discontinuation of development of the company’s Hedgehog pathway
program.
-
General and administrative (G&A) expense was $27.9 million
for full-year 2012, compared to $22.7 million for the same period in
2011. The increase in G&A expense in 2012 compared to 2011 was
primarily due to higher stock-based compensation expense, early
commercial development activities and corporate development activities.
-
Net loss for full-year 2012 was $54.0 million, or a basic and diluted
loss per common share of $1.70, compared to $40.0 million, or a basic
and diluted loss per common share of $1.50, for 2011.
Conference Call Information
Infinity will host a conference
call on Tuesday, March 5, 2013, at 4:30 p.m. ET 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 drug discovery and development company seeking to discover,
develop and deliver to patients best-in-class medicines for diseases
with significant unmet need. 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 of data and
updates from clinical trials of its PI3K and Hsp90 programs; its ability
to execute on its strategic plans; the therapeutic potential of its PI3K
inhibitors and retaspimycin HCl; its 2013 research and development
goals, including without limitation clinical and nonclinical development
plans, for its PI3K program and its Hsp90 program; and dose optimization
strategies. 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
annual report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on March 5, 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
(in thousands, except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities, including
long term
|
|
$
|
326,635
|
|
$
|
115,937
|
Other current assets
|
|
|
3,731
|
|
|
2,703
|
Property and equipment, net
|
|
|
4,079
|
|
|
4,582
|
Other long-term assets
|
|
|
1,215
|
|
|
1,268
|
|
|
|
|
|
Total assets
|
|
$
|
335,660
|
|
$
|
124,490
|
|
|
|
|
|
Current liabilities
|
|
$
|
18,663
|
|
$
|
28,986
|
Due to Millennium, less current portion
|
|
|
6,252
|
|
|
—
|
Long-term debt due to Purdue entities, net of debt discount
|
|
|
—
|
|
|
37,553
|
Deferred revenue from Purdue entities, less current portion
|
|
|
—
|
|
|
42,147
|
Other long-term liabilities
|
|
|
540
|
|
|
371
|
Total stockholders’ equity
|
|
|
310,205
|
|
|
15,433
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
335,660
|
|
$
|
124,490
|
|
|
|
|
|
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,
|
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Collaborative research and development revenue from Purdue
entities
|
|
$
|
—
|
|
|
$
|
22,324
|
|
|
$
|
47,114
|
|
|
$
|
92,773
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
40,016
|
|
|
|
29,893
|
|
|
|
118,595
|
|
|
|
108,582
|
|
General and administrative
|
|
|
7,110
|
|
|
|
6,043
|
|
|
|
27,882
|
|
|
|
22,719
|
|
Total operating expenses
|
|
|
47,126
|
|
|
|
35,936
|
|
|
|
146,477
|
|
|
|
131,301
|
|
Gain on termination of Purdue entities alliance
|
|
|
—
|
|
|
|
—
|
|
|
|
46,555
|
|
|
|
—
|
|
Loss from operations
|
|
|
(47,126
|
)
|
|
|
(13,612
|
)
|
|
|
(52,808
|
)
|
|
|
(38,528
|
)
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
—
|
|
|
|
(542
|
)
|
|
|
(1,908
|
)
|
|
|
(1,841
|
)
|
Income from Massachusetts tax incentive award
|
|
|
—
|
|
|
|
—
|
|
|
|
193
|
|
|
|
—
|
|
Interest and investment income
|
|
|
142
|
|
|
|
93
|
|
|
|
559
|
|
|
|
327
|
|
Total other expense
|
|
|
142
|
|
|
|
(449
|
)
|
|
|
(1,156
|
)
|
|
|
(1,514
|
)
|
Net loss
|
|
$
|
(46,984
|
)
|
|
$
|
(14,061
|
)
|
|
$
|
(53,964
|
)
|
|
$
|
(40,042
|
)
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
$
|
(1.15
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(1.70
|
)
|
|
$
|
(1.50
|
)
|
Basic and diluted weighted average number of common shares
outstanding
|
|
|
40,855,124
|
|
|
|
26,708,351
|
|
|
|
31,711,264
|
|
|
|
26,620,278
|
|