CAMBRIDGE, Mass., Aug. 3, 2017 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its second
quarter 2017 financial results and provided an update on the
company, including its progress with IPI-549, an oral
immuno-oncology product candidate that selectively inhibits
phosphoinositide-3-kinase gamma (PI3K-gamma). Infinity is
evaluating IPI-549 as a monotherapy and in combination with
Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor,
in a four-part Phase 1 study in patients with advanced solid
tumors. Infinity announced today that it has completed an
evaluation of escalating monotherapy doses of IPI-549 ranging from
10 mg once daily (QD) to 60 mg QD and has selected the 60 mg dose
for evaluation in the monotherapy expansion component of the study.
The selection of the 60 mg QD dose was based on pharmacokinetic and
pharmacokinetic analyses, which showed that IPI-549 maintained full
suppression of PI3K-gamma at this dose level. Data also showed that
the IPI-549 dosed at 60 mg QD was well tolerated, and no
dose-limiting toxicities were observed. The monotherapy expansion
component of the study is now open for enrollment and will evaluate
the safety and activity of IPI-549 dosed at 60 QD in approximately
25 patients.
Dose escalation evaluating IPI-549 in combination with Opdivo is
ongoing, and Infinity expects to initiate the combination expansion
component of the study in the second half of 2017. IPI-549 is
believed to be the only selective PI3K-gamma inhibitor in clinical
development.
"We have initiated the monotherapy expansion component of our
Phase 1 study and are eager to also move forward with the
combination expansion, allowing us to generate additional clinical
and translational data from monotherapy treatment as well as from
the combination of IPI-549 and Opdivo in specific types of solid
tumors," stated Adelene Perkins,
Infinity's chair and chief executive officer. "We also recently
undertook an important strategic initiative and amended our license
agreement with Takeda Oncology for IPI-549. We issued Takeda an
unsecured $6.0 million convertible
note in exchange for eliminating future royalty obligations on
IPI-549. This amendment reflects our strong belief in the potential
of IPI-549 to be a first-in-class, oral immuno-oncology therapy and
reduces the total royalty burden on any future net sales of IPI-549
to four percent due to Mundipharma and Purdue from a previous agreement."
The ongoing Phase 1 study is designed to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics and activity of
IPI-549 as a monotherapy and in combination with the approved dose
of Opdivo in approximately 175 patients with advanced solid tumors.
The study includes four parts: monotherapy dose escalation,
combination therapy dose escalation, monotherapy expansion and
combination therapy expansion. The combination expansion component
of the study will include multiple cohorts designed to evaluate
IPI-549 in patients with specific types of cancer, including
patients with non-small cell lung cancer (NSCLC), melanoma and
squamous cell carcinoma of the head and neck (SCCHN) whose tumors
show initial resistance or subsequently develop resistance to
immune checkpoint blockade therapy. There is a great need for
additional treatment options for the growing number of patients
living with these cancers, which account for more than 17 percent
of all new cancer cases in the U.S.1,2
Recent Developments
- Agreement with Takeda Oncology amended: In July,
Infinity amended its license agreement with Takeda Oncology for
IPI-549. Under the amended agreement, Infinity will no longer have
an obligation to pay Takeda future royalties on worldwide net sales
of selective inhibitors of PI3K-gamma, including IPI-549. In
exchange for eliminating the royalty obligation, Infinity issued to
Takeda an unsecured $6.0 million
convertible note that matures on July 26,
2018, and accrues interest at an annual rate of eight
percent. The company is obligated to pay the principal amount
together with any accrued interest on or before the maturity date
in cash or in shares of Infinity common stock, at the election of
Takeda. The share payment price would equal the average closing
price of Infinity's common stock for the 20 days prior to the
payment date.
Infinity remains obligated to pay development, regulatory and
commercial milestones to Takeda for IPI-549. The remaining
milestones comprise up to a total of $5
million in development milestones, up to $50 million in success-based regulatory
milestones, and up to $115 million in
commercial milestones, which are due once certain sales thresholds
have been met.
Under a previous agreement, Infinity is obligated to pay
Mundipharma International Corporation Limited and Purdue
Pharmaceutical Products L.P. a four percent royalty in the
aggregate on worldwide net sales of IPI-549, which steps down to
one percent in the U.S. after a certain sales threshold is
met.
- Recommended IPI-549 monotherapy dose determined and
monotherapy expansion initiating: Infinity reported today that
it has completed patient enrollment in the monotherapy
dose-escalation component of the Phase 1 study and has selected
IPI-549 dosed at 60 mg QD as the recommended dose for evaluation in
the monotherapy expansion. Infinity selected the 60 mg QD dose
based on pharmacokinetic and pharmacodynamic analyses, which showed
that IPI-549 maintained full suppression of PI3K-gamma at this dose
level. Data also showed that IPI-549 dosed at 60 mg QD was well
tolerated, and no dose-limiting toxicities were observed. The
monotherapy expansion is now open for patient enrollment.
- IPI-549 combination dose escalation ongoing: Infinity
also announced today that it is continuing to evaluate data from
the dose-escalation component of the Phase 1 study assessing
IPI-549 30 mg QD in combination with the approved dose of Opdivo.
The company expects to complete combination dose escalation and
initiate the combination expansion component of the study in the
second half of 2017.
- Presentation of preclinical rationale for IPI-549 at
Precision: Lung Cancer World R&D Summit: In July,
Jeffery Kutok, M.D., Ph.D.,
Infinity's chief scientific officer, gave an oral presentation
entitled "Reprogramming Tumor-Associated Macrophages by Targeting
PI3K-Gamma with IPI-549" at the 2017 Precision: Lung Cancer World
R&D Summit held in Boston, MA.
In his presentation, Dr. Kutok discussed the preclinical rationale
for targeting PI3K-gamma previously reported in two publications in
Nature.3,4. Preclinical research in solid tumor
models has demonstrated that PI3K-gamma blockade in
tumor-associated macrophages by IPI-549 results in a
transcriptional reprogramming of the M2, or pro-tumor macrophage
phenotype, to the M1, or anti-tumor phenotype. In this setting,
IPI-549 was active as a monotherapy and showed even greater
activity in combination with checkpoint inhibitor therapies.
Importantly, in specific models resistant to checkpoint inhibitor
therapy, IPI-549 in combination with checkpoint inhibitors was able
to overcome this resistance. Taken together, these preclinical data
demonstrate that PI3K-gamma plays a key role in the
immuno-suppressive tumor microenvironment and provide a strong
rationale for the ongoing Phase 1 study.
Dr. Kutok also summarized the Phase 1 clinical data previously
reported at the American Association for Cancer Research (AACR)
Annual Meeting 2017. These data demonstrated that IPI-549 was well
tolerated both as a monotherapy and in combination with
Opdivo.5 Additionally, data from the
monotherapy component of the study showed IPI-549 has a favorable
pharmacokinetic and pharmacodynamic profile that supports once
daily dosing.5
- Exited lease for Infinity's office facility at 784 Memorial
Drive: In June, Infinity exited its lease agreement for its
office facility, allowing the lease to end effective August 31, 2017. Infinity made a termination
payment of $4.5 million in
June 2017 and will make a final
payment of $0.5 million in
August 2017. The original lease
agreement was to expire in March
2025. Future payment obligations on the lease, excluding
operating costs and taxes, as of June 30,
2017, decreased from $16.9
million to $0.2 million.
Infinity will be moving into office space with a significantly
smaller lease obligation.
Second Quarter 2017 Financial Results
- At June 30, 2017, Infinity had
total cash and cash equivalents of $66.2
million, compared to $75.4
million at March 31, 2017.
Cash used for operating activities during the second quarter of
2017 included payments of $0.8
million related to the company's 2016 restructuring
activities and $4.5 million related
to exiting the company's lease for 784 Memorial Drive.
- Infinity did not record any revenue during the second quarter
of 2017. Revenue for the second quarter of 2016 was $9.5 million, all of which related to Infinity's
previous collaboration agreement with AbbVie Inc.
- Research and development (R&D) expense for the second
quarter of 2017 was $3.9 million,
compared to $52.9 million for the
same period in 2016. The decrease in R&D expense was primarily
due to the decrease in clinical development expenses following
Infinity's out-license of duvelisib in addition to the company's
2016 restructuring activities.
- General and administrative (G&A) expense was $6.2 million for the second quarter of 2017
compared to $15.7 million for the
same period in 2016. The decrease in G&A expense was primarily
due to the company's 2016 restructuring activities.
- Other expense of $6.9 million for
the second quarter of 2017 related to expense recognized to exit
the company's facility lease agreement.
- Net loss for the second quarter of 2017 was $17.0 million, or a basic and diluted loss per
common share of $0.34, compared to
net income of $53.0 million, or a
basic and diluted earnings per common share of $1.05, for the second quarter of 2016. During the
second quarter of 2016, Infinity recorded a non-recurring gain on
AbbVie opt-out of the duvelisib collaboration of $112.2 million.
Cash and Investments Outlook
Infinity's 2017 financial
outlook remains as follows:
- Net loss: Infinity expects net loss for 2017 to range
from $40 million to $50 million.
- Cash and Investments: Infinity expects to end 2017 with
a cash, cash equivalents and available-for-sale securities balance
ranging from $40 million to $50
million.
Based on its current operational plans, Infinity expects that
its existing cash and cash equivalents at June 30, 2017, will be adequate to satisfy the
company's capital needs into the first quarter of 2019. The
company's financial outlook excludes additional funding or business
development activities.
Conference Call Information
Infinity will host a
conference call today, August 3,
2017, 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 40376609. An archived version of the
webcast will be available on Infinity's website for 60 days.
About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology
development candidate that selectively inhibits PI3K-gamma. In
preclinical studies, IPI-549 reprograms macrophages from a
pro-tumor to an anti-tumor phenotype and is able to overcome
resistance to checkpoint
inhibition.3,4 As such, IPI-549
may have the potential to treat a broad range of solid tumors and
represents a potentially complementary approach to restoring
anti-tumor immunity in combination with other immunotherapies such
as checkpoint inhibitors.
A Phase 1 study of IPI-549 in patients with advanced solid
tumors is ongoing to explore the activity, safety, tolerability,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo® (nivolumab), a PD-1
immune checkpoint inhibitor, in patients with advanced solid
tumors.6 The four-part study includes monotherapy and
combination dose-escalation components, in addition to monotherapy
expansion and combination expansion components. The expansion
component of the study evaluating IPI-549 plus Opdivo will include
patients with non-small cell lung cancer (NSCLC), melanoma and
squamous cell carcinoma of the head and neck (SCCHN). Patients
enrolled in these combination expansion cohorts represent a
difficult-to-treat population, as they must have demonstrated
initial resistance or subsequently develop resistance to a PD-1 or
PD-L1 therapy immediately prior to enrolling in the study. Overall,
the study is expected to enroll approximately 175 patients.
IPI-549 is an investigational compound and its safety and
efficacy has not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
About Infinity
Infinity is an innovative
biopharmaceutical company dedicated to advancing novel medicines
for people with cancer. Infinity is advancing IPI-549, an oral
immuno-oncology development candidate that selectively inhibits
PI3K-gamma. A Phase 1 study in patients with advanced solid tumors
is ongoing. For more information on Infinity, please refer to
Infinity's website at www.infi.com.
Cautionary Note Regarding 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 therapeutic potential of PI3K-gamma selective
inhibition and IPI-549, alone and in combination with checkpoint
inhibitors, including Opdivo® (nivolumab); the company's
expectations about the potential value of the buyout of future
royalty obligations related to IPI-549; clinical trial plans
regarding IPI-549; plans to report clinical data of IPI-549; plans
regarding the company's office space; 2017 financial guidance; and
the company's 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 IPI-549 will successfully complete
necessary preclinical and clinical development or that any positive
developments in Infinity's product portfolio or other strategic
options Infinity may pursue 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 Verastem to fully
perform under the license agreement; the content and timing of
decisions made by the U.S. FDA and other regulatory
authorities; 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 IPI-549; and Infinity's
ability to obtain, maintain and enforce patent and other
intellectual property protection for IPI-549. 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 3,
2017, 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.
OPDIVO® is a registered trademark of Bristol-Myers
Squibb.
INFINITY
PHARMACEUTICALS, INC.
|
|
Condensed
Consolidated Balance Sheets
(unaudited)
(in
thousands)
|
|
|
|
June 30,
2017
|
|
December 31,
2016
|
Cash, cash
equivalents and available-for-sale securities
|
$
|
66,197
|
|
|
$
|
92,064
|
|
Other current
assets
|
2,580
|
|
|
9,596
|
|
Property and
equipment, net
|
22,040
|
|
|
23,424
|
|
Other long-term
assets
|
28
|
|
|
571
|
|
Total
assets
|
$
|
90,845
|
|
|
$
|
125,655
|
|
|
|
|
|
Current
liabilities
|
$
|
10,936
|
|
|
$
|
23,863
|
|
Financing obligation,
less current portion
|
20,799
|
|
|
19,149
|
|
Other long-term
liabilities
|
208
|
|
|
189
|
|
Total stockholders'
equity
|
58,902
|
|
|
82,454
|
|
Total liabilities and
stockholders' equity
|
$
|
90,845
|
|
|
$
|
125,655
|
|
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,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Collaboration
revenue
|
$
|
—
|
|
|
$
|
9,467
|
|
|
$
|
—
|
|
|
$
|
18,723
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
3,901
|
|
|
52,947
|
|
|
7,940
|
|
|
92,135
|
|
General and
administrative
|
6,205
|
|
|
15,692
|
|
|
12,642
|
|
|
26,528
|
|
Total operating
expenses
|
10,106
|
|
|
68,639
|
|
|
20,582
|
|
|
118,663
|
|
Gain on AbbVie
Opt-Out
|
—
|
|
|
112,216
|
|
|
—
|
|
|
112,216
|
|
Income (loss) from
operations
|
(10,106)
|
|
|
53,044
|
|
|
(20,582)
|
|
|
12,276
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense
|
(300)
|
|
|
(307)
|
|
|
(602)
|
|
|
(616)
|
|
Other expense
|
(6,882)
|
|
|
—
|
|
|
(6,882)
|
|
|
—
|
|
Investment and other
income
|
334
|
|
|
254
|
|
|
637
|
|
|
667
|
|
Total other income
(expense)
|
(6,848)
|
|
|
(53)
|
|
|
(6,847)
|
|
|
51
|
|
Net income
(loss)
|
$
|
(16,954)
|
|
|
$
|
52,991
|
|
|
$
|
(27,429)
|
|
|
$
|
12,327
|
|
Earnings (loss) per
common share:
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.34)
|
|
|
$
|
1.05
|
|
|
$
|
(0.54)
|
|
|
$
|
0.24
|
|
Diluted
|
$
|
(0.34)
|
|
|
$
|
1.05
|
|
|
$
|
(0.54)
|
|
|
$
|
0.24
|
|
Weighted average
number of
common shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
50,455,832
|
|
|
49,437,062
|
|
|
50,439,682
|
|
|
49,388,475
|
|
Diluted
|
50,455,832
|
|
|
49,439,537
|
|
|
50,439,682
|
|
|
49,399,926
|
|
Contact:
Jaren Irene
Madden, Senior Director,
Investor Relations and Corporate Communications
Jaren.Madden@infi.com
__________________________________
1 American Cancer Society, Cancer Facts and
Statistics 2016,
http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index
and
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics,
Last Accessed April 27, 2017.
2 Conquer Cancer Foundation, Head and Neck Cancer
Statistics,
http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics,
Last Accessed April 27, 2017.
3 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et
al. PI3Kγ is a molecular switch that controls immune suppression.
Nature, 2016 Nov;539:437–442.
4 De Henau, O., Rausch, M., Winkler, D., Campesato, L.,
et al. Overcoming resistance to checkpoint blockade therapy by
targeting PI3Kγ in myeloid cells. Nature, 2016
Nov;539:443-447.
5 Tolcher, A., Hong, D., Sullivan, R., Chmielowski, B.,
et al. AACR Annual Meeting 2017.
6 www.clinicaltrials.gov, NCT02637531.
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SOURCE Infinity Pharmaceuticals, Inc.