CAMBRIDGE, Mass., Nov. 7, 2017 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its third
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 1/1b study in patients with advanced solid
tumors. In preclinical studies, IPI-549 reprograms macrophages from
a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to
overcome resistance to checkpoint inhibition as well as to enhance
the activity of checkpoint inhibitors.1,2 IPI-549 is
believed to be the only selective PI3K-gamma inhibitor in clinical
development.
On November 10, 2017, a
late-breaking abstract summarizing data from the recently completed
monotherapy dose-escalation component of the study will be
presented at the 2017 Society for Immunotherapy of Cancer (SITC)
Annual Meeting taking place in National Harbor, MD. The
presentation, which will be made during an oral session on new
agents, will include an analysis of the safety, activity,
pharmacokinetics and pharmacodynamics of IPI-549 in 19 patients who
received once daily (QD) doses of IPI-549 ranging from 10 mg to 60
mg. Initial translational data describing how inhibiting PI3K-gamma
may elicit an immune response and identifying potential biomarkers
of immune response will also be presented. In August, Infinity
announced that the company designated the 60 mg QD dose for
evaluation in the monotherapy expansion component of the study,
which is now under way.
"We are looking forward to sharing the full data from the
completed monotherapy dose escalation component of our study later
this week at the SITC Annual Meeting. In addition to reporting on
the safety and activity of IPI-549 monotherapy, for the first time
we will present initial translational data from patients treated
with IPI-549 as a monotherapy that can help us better understand
how IPI-549 may activate an immune response," stated Adelene Perkins, Infinity's chair and chief
executive officer. "Patient enrollment in the monotherapy expansion
component of the study is progressing very well, and we expect to
initiate the combination expansion portion of the study by the end
of this year, positioning us for data readouts from the monotherapy
expansion cohort as well as data from the combination dose
escalation and disease-specific expansion cohorts, all in the first
half of 2018."
The Phase 1/1b study of IPI-549 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 200 patients with advanced
solid tumors. The study includes four components: monotherapy dose
escalation, combination therapy dose escalation, monotherapy
expansion and combination expansion. The combination expansion 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 head and neck squamous cell
carcinoma (HNSCC) whose tumors show initial resistance or
subsequently develop resistance to immune checkpoint blockade
therapy. Additionally, the combination expansion component will
also evaluate a cohort of patients with triple negative breast
cancer (TNBC) who have not been previously exposed to anti-PD-1 or
anti-PD-L1 therapy.
Based on progress made during 2017, Infinity expects to achieve
the following IPI-549 data milestones in 2018:
- Report data from the monotherapy expansion component of the
study in the first half of 2018
- Report data from the combination dose-escalation component of
the study in the first half of 2018
- Report initial data from the combination expansion component of
the study in the first half of 2018, with more mature data from the
combination expansion in the second half of 2018
"We are also focused on maintaining strong fiscal discipline and
anticipate that we have cash runway into the first quarter of 2019,
allowing us to generate safety and activity data on all four
components of our Phase 1/1b study of IPI-549," commented
Lawrence Bloch, M.D., J.D.,
president of Infinity. "We also have the potential to receive a
future $22 million payment from
Verastem upon the first regulatory approval of duvelisib, which we
out-licensed in 2016, that could further strengthen our financial
profile."
Recent Corporate Developments
- $6.0 million payment received
from Verastem: In October, Infinity received a $6.0 million cash payment from Verastem, Inc. The
payment was made following the determination that the Phase 3 DUO
clinical study evaluating the efficacy and safety of duvelisib in
patients with relapsed or refractory chronic lymphocytic leukemia
or small lymphocytic lymphoma met certain pre-specified criteria at
completion. Infinity out-licensed duvelisib to Verastem in
November 2016.
Verastem recently provided guidance that it plans to submit a new
drug application for duvelisib in the first quarter of 2018.
Infinity is entitled to receive a $22
million payment from Verastem upon the first regulatory
approval for duvelisib inside or outside the U.S.
Recent Clinical Developments
- IPI-549 selected for an oral presentation at SITC Annual
Meeting: In October, Infinity announced that a late-breaking
abstract describing new data for IPI-549 was selected for
presentation during an oral session on new agents at the SITC
Annual Meeting. The abstract, "Monotherapy dose escalation clinical
and translational data from first-in-human study in advanced solid
tumors of IPI-549, an oral, selective, PI3K-gamma inhibitor
targeting tumor macrophages" (Abstract O43), will be presented on
Friday, November 10, 2017, from
2:15 p.m. – 2:30 p.m. ET. The lead author and presenter is
David Hong, M.D., Deputy Chair,
Department of Investigational Cancer Therapeutics, Division of
Cancer Medicine, The University of
Texas MD Anderson Cancer Center, Houston, TX. An identically titled
accompanying poster will also be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m.
ET and 6:30 p.m. –
8:00 p.m. ET.
Additionally, a clinical trials in progress poster, "Phase 1/1b,
first-in-human study of the PI3K-gamma inhibitor IPI-549 as
monotherapy and combined with nivolumab in patients with advanced
solid tumors" (Abstract P219), will be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m.
ET and 6:30 p.m. –
8:00 p.m. ET. The lead author on the
poster is Antoni Ribas, M.D., Ph.D.,
Parker Institute Center Director at the University of California, Los Angeles (UCLA).
Infinity will host a reception for investors and analysts on
Friday, November 10, 2017, from
6:00 a.m. to 8:00 a.m. ET to discuss
the clinical development of IPI-549, including a review of data
from the ongoing clinical study. The presentation portion of the
reception will be webcast live beginning at 6:30 a.m. ET. The webcast and accompanying slides
will be available in the "investors/media" section of the company's
website, www.infi.com. A replay of the event will also be
available.
- Expanded clinical collaboration with Bristol-Myers
Squibb: In September, Infinity announced that it expanded its
existing clinical collaboration with Bristol-Myers Squibb
evaluating IPI-549 in combination with Opdivo to include patients
with TNBC who have not been previously exposed to anti-PD-1 or
anti-PD-L1 therapy. The TNBC cohort will be part of the combination
expansion component of the Phase 1/1b study.
- Phase 1/1b study of IPI-549 advancing: The company is
continuing to advance the Phase 1/1b study of IPI-549 both as a
monotherapy and in combination with Opdivo in patients with solid
tumors. Infinity has completed an evaluation of escalating
monotherapy doses of IPI-549 ranging from 10 mg QD to 60 mg QD and
selected the 60 mg dose for evaluation in the monotherapy expansion
component of the study. Dose escalation evaluating IPI-549 40 mg QD
in combination with Opdivo is ongoing, and Infinity expects to
initiate the combination expansion component of the study by the
end of 2017.
Third Quarter 2017 Financial Results
- At September 30, 2017, Infinity
had total cash, cash equivalents and available-for-sale securities
of $55.6 million, compared to
$66.2 million at June 30, 2017. The September 30, 2017 cash and investments balance
excludes the $6.0 million payment
from Verastem, which Infinity received in October 2017.
- Revenue for the third quarter of 2017 was $6.0 million, all of which related to the amounts
due from Verastem for the DUO study meeting the pre-specified
criteria at completion. Infinity did not record any revenue during
the third quarter of 2016.
- Research and development (R&D) expense for the third
quarter of 2017 was $9.3 million,
compared to $12.8 million for the
same period in 2016. The decrease in R&D expense was related to
the company's 2016 restructuring activities, partially offset by
the $6.0 million convertible note
issued to Takeda in exchange for eliminating Infinity's royalty
obligation to Takeda for selective inhibitors of PI3K gamma,
including IPI-549.
- General and administrative (G&A) expense was $4.5 million for the third quarter of 2017
compared to $7.1 million for the same
period in 2016. The decrease in G&A expense was primarily due
to the company's 2016 restructuring activities.
- Net loss for the third quarter of 2017 was $7.1 million, or a basic and diluted loss per
common share of $0.14, compared to
net loss of $19.5 million, or a basic
and diluted loss per common share of $0.39, for the third quarter of 2016.
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 cash, cash equivalents and available-for-sale securities at
September 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, November 7,
2017, 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 97100725. 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, M2, to an anti-tumor, M1, phenotype and is able to
overcome resistance to checkpoint inhibition as well as to enhance
the activity of checkpoint inhibitors.1,2 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.
The ongoing Phase 1/1b study being conducted by Infinity is
designed to evaluate the safety, tolerability, activity,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo in approximately 200 patients with
advanced solid tumors.3 The four-part study includes
monotherapy and combination dose-escalation components, in addition
to monotherapy expansion and combination expansion components.
Patient enrollment is complete in monotherapy dose-escalation, and
monotherapy expansion is ongoing. Combination dose-escalation is
also ongoing, and combination expansion is expected to begin by the
end of 2017.
The combination expansion component includes 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 head and neck squamous cell carcinoma (HNSCC) whose
tumors show initial resistance or subsequently develop resistance
to immune checkpoint blockade therapy. This combination expansion
component will now also add a cohort of patients with triple
negative breast cancer (TNBC) who have not been previously exposed
to immune checkpoint blockade therapy. Although there has been
great progress in the treatment of cancer, there remains a need for
additional treatment options. NSCLC, melanoma, HNSCC and TNBC
account for more than 22 percent of all new cancer cases in the
U.S.4,5
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); clinical
trial plans regarding IPI-549; plans to report clinical data of
IPI-549; the potential receipt and benefits of the $22 million payment from Verastem; 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 November
7, 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)
|
|
|
September 30,
2017
|
|
December 31,
2016
|
Cash, cash
equivalents and available-for-sale
securities
|
$
|
55,575
|
|
|
$
|
92,064
|
Other current
assets
|
8,364
|
|
|
9,596
|
Property and
equipment, net
|
309
|
|
|
23,424
|
Other long-term
assets
|
23
|
|
|
571
|
Total
assets
|
$
|
64,271
|
|
|
$
|
125,655
|
|
|
|
|
Note
payable
|
$
|
6,000
|
|
|
$
|
—
|
Other current
liabilities
|
4,871
|
|
|
23,863
|
Financing obligation,
less current portion
|
—
|
|
|
19,149
|
Other long-term
liabilities
|
26
|
|
|
189
|
Total stockholders'
equity
|
53,374
|
|
|
82,454
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
64,271
|
|
|
$
|
125,655
|
INFINITY
PHARMACEUTICALS, INC.
|
Condensed
Consolidated Statements of Operations
|
(unaudited)
|
(in thousands,
except share and per share amounts)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Collaboration
revenue
|
$
|
6,000
|
|
|
$
|
—
|
|
|
$
|
6,000
|
|
|
$
|
18,723
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
9,338
|
|
|
12,814
|
|
|
17,278
|
|
|
104,949
|
General and
administrative
|
4,505
|
|
|
7,120
|
|
|
17,147
|
|
|
33,648
|
Total operating
expenses
|
13,843
|
|
|
19,934
|
|
|
34,425
|
|
|
138,597
|
Gain on AbbVie
Opt-Out
|
—
|
|
|
—
|
|
|
—
|
|
|
112,216
|
Loss from
operations
|
(7,843)
|
|
|
(19,934)
|
|
|
(28,425)
|
|
|
(7,658)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense
|
(287)
|
|
|
(305)
|
|
|
(890)
|
|
|
(921)
|
Other expense
|
—
|
|
|
—
|
|
|
(6,882)
|
|
|
—
|
Investment and other
income
|
1,026
|
|
|
741
|
|
|
1,663
|
|
|
1,408
|
Total other income
(expense)
|
739
|
|
|
436
|
|
|
(6,109)
|
|
|
487
|
Net loss
|
$
|
(7,104)
|
|
|
$
|
(19,498)
|
|
|
$
|
(34,534)
|
|
|
$
|
(7,171)
|
Basic and diluted
loss per common
share:
|
$
|
(0.14)
|
|
|
$
|
(0.39)
|
|
|
$
|
(0.68)
|
|
|
$
|
(0.15)
|
Basic and diluted
weighted average
number of common shares outstanding:
|
50,635,828
|
|
|
49,583,776
|
|
|
50,505,783
|
|
|
49,448,725
|
Contact:
Jaren Irene
Madden, Senior Director,
Investor Relations and Corporate Communications
Jaren.Madden@infi.com
1 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.
2 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.
3 www.clinicaltrials.gov, NCT02637531.
4 American Cancer Society, Cancer Facts and
Statistics 2017,
http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index
and
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics,
Last Accessed September 22, 2017.
5 Conquer Cancer Foundation, Head and Neck Cancer
Statistics,
http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics,
Last Accessed September 22, 2017.
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SOURCE Infinity Pharmaceuticals, Inc.