CAMBRIDGE, Mass., March 14, 2017 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its full-year
2016 financial results and provided an update on the company,
including its progress with IPI-549, a potentially first-in-class
immuno-oncology product candidate that selectively inhibits
PI3K-gamma. Infinity is evaluating IPI-549 as a monotherapy and in
combination with Opdivo® (nivolumab), a PD-1 immune
checkpoint inhibitor, in a Phase 1 study in patients with advanced
solid tumors, and updated data from the study will be presented in
April at the American Association for Cancer Research (AACR) Annual
Meeting 2017 in Washington, D.C.
IPI-549 is believed to be the only selective PI3K-gamma inhibitor
in clinical development.
Infinity anticipates completing the monotherapy dose-escalation
phase of the study in the first half of 2017 and initiating a
monotherapy expansion cohort in the second half of the year. The
company also expects to complete the dose-escalation phase
evaluating IPI-549 in combination with Opdivo in the second half of
2017, and subsequently initiate multiple combination expansion
cohorts. The combination expansion cohorts will include 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 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]
"We are very pleased with the progress we have made in our Phase
1 clinical study of IPI-549. Both the monotherapy and combination
dose-escalation phases of the study have been rapidly enrolling,
and we are on track to initiate multiple expansion cohorts in the
second half of the year," stated Adelene
Perkins, Infinity's chair and chief executive officer.
"While new immunotherapies, such as checkpoint inhibitors, are
showing great promise in the treatment of various cancers,
additional treatment options are needed for patients who relapse or
do not respond to currently available therapies. Our preclinical
data recently published in Nature demonstrate that IPI-549
reprograms macrophages from a pro-tumor to an anti-tumor phenotype
and is able to help overcome resistance to checkpoint inhibition,
providing a compelling rationale for our ongoing clinical
study."
Recent developments include the following:
IPI-549
- Updated Phase 1 data to be presented at AACR: In March,
Infinity announced that updated data from the ongoing Phase 1 study
of IPI-549 will be presented at the AACR Annual Meeting 2017 in
Washington, D.C. during two
sessions. Jeffery Kutok, M.D.,
Ph.D., Infinity's chief scientific officer, will review the IPI-549
program during an educational session. The presentation,
"Reprogramming Tumor-Associated Macrophages by Targeting PI3K-gamma
Through a Small Molecule Approach," will take place during an
educational session on Saturday, April 1,
2017, from 3:15 – 3:45 p.m.
ET.
Additionally, a poster presentation, "IPI-549-01 - A Phase 1/1b,
First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as
Monotherapy and in Combination with Nivolumab in Patients with
Advanced Solid Tumors" (Abstract CT089), will take place during a
clinical trial poster session on Tuesday,
April 4, 2017, from 8:00 a.m.
– 12:00 p.m. ET. Jedd Wolchok, M.D., Ph.D., Chief of the Melanoma
and Immunotherapeutics Service at Memorial Sloan Kettering Cancer
Center (MSK), as well as Associate Director of the Ludwig Center
for Cancer Immunotherapy and Director of the Parker Institute for
Cancer Immunotherapy, both at MSK, is the lead author for the
poster. He also serves as the lead investigator for the Phase 1
clinical study of IPI-549.
- IPI-549 featured at TAT 2017: In March, data from 12
patients enrolled in the monotherapy dose-escalation portion of the
Phase 1 study of IPI-549 were presented at the 15th
International Congress on Targeted Anticancer Therapies (TAT 2017).
The presentation, "A Phase 1/1b, First-in-Human Study of IPI-549, a
PI3K-Gamma Inhibitor and Myeloid Targeting Agent, as Monotherapy
and in Combination with Nivolumab in Patients with Advanced Solid
Tumors," was given by Anthony
Tolcher, M.D., FRCP(C), clinical director at South Texas
Accelerated Research Therapeutics and an investigator for the Phase
1 study. Due to AACR embargo policies, the data presented at TAT
will be made available during the AACR Annual Meeting 2017. IPI-549
was also discussed during the TAT 2017 Honorary Award Invited
Lecture, "Immunologic Checkpoint Blockade: Exploring Combinations
and Mechanisms," which was given by Dr. Wolchok.
- Preclinical and Phase 1 clinical data on IPI-549 presented
at PI3K Keystone Symposia Conference: In January, during a
plenary session at the Keystone Symposia Conference, "PI3K Pathways
in Immunology, Growth Disorders and Cancer," Infinity presented
preclinical data for IPI-549 which demonstrated that IPI-549 is
able to help overcome resistance to checkpoint inhibition by
reprograming macrophages from a pro-tumor to an anti-tumor
phenotype. Initial Phase 1 monotherapy data from nine patients with
advanced solid tumors were also summarized and showed that the
safety, pharmacokinetics and pharmacodynamics of IPI-549
monotherapy treatment appeared favorable.
Corporate
- Jeffery Kutok, M.D., Ph.D.,
promoted to chief scientific officer: In February, Infinity
announced the promotion of Dr. Kutok to the role of chief
scientific officer. In this role, he will be responsible for
overseeing biology and translational science efforts, including
preclinical collaborations, to support the ongoing development of
IPI-549. Dr. Kutok joined Infinity in 2010 and was promoted to vice
president, biology and translational science in 2013.
- Additional organizational changes: In January, Infinity
announced the promotion of Lawrence
Bloch, M.D., J.D., to president. In his new role, Dr. Bloch
retained responsibility for the finance, business development,
corporate communications and investor relations functions at
Infinity and assumed responsibility for pharmaceutical development
as well as facilities operations. Also in January, the company
promoted Claudio Dansky Ullmann,
M.D., to senior vice president, clinical development; Joseph Pearlberg, M.D., Ph.D., to vice
president, clinical development; and Melissa Hackel to vice president, finance.
Additionally, Infinity announced the retirement of Julian Adams, Ph.D., who had led the company's
research and development (R&D) teams since joining Infinity in
2003.
2017 Program Goals for IPI-549
In January 2017, Infinity outlined
its anticipated program milestones for the year:
- Present preclinical and clinical data from Phase 1 study at the
PI3K Keystone Symposia Conference in January
2017
- Report Phase 1 data from the monotherapy dose-escalation phase
as well as the IPI-549 in combination with Opdivo dose-escalation
phase in 2017
- Complete the dose-escalation phase evaluating IPI-549
monotherapy in the first half of 2017
- Begin enrolling patients with advanced solid tumors in the
monotherapy expansion cohort during the second half of 2017
- Complete the dose-escalation phase evaluating IPI-549 in
combination with Opdivo in the second half of 2017
- Begin enrolling patients with NSCLC, melanoma and SCCHN in
expansion cohorts evaluating IPI-549 in combination with Opdivo in
the second half of 2017
Full-Year 2016 Financial Results
- At December 31, 2016, Infinity
had total cash, cash equivalents and available-for-sale securities
of $92.1 million, compared to
$245.2 million at December 31, 2015.
- Revenue during 2016 was $18.7
million related to Infinity's previous collaboration
agreement with AbbVie Inc. Revenue during 2015 was $109.1 million, all of which related to the
AbbVie collaboration.
- R&D expense for the full-year 2016 was $119.6 million, compared to $199.1 million for 2015. The decrease in R&D
expense in 2016 compared to 2015 was primarily related to a 2015
option exercise payment to Takeda Pharmaceutical Company
Limited and a reduction in clinical development expenses for
duvelisib in 2016.
- General and administrative expense was $42.2 million for the full-year 2016
compared to $37.1 million for 2015.
The increase in general and administrative expense in 2016 compared
to 2015 was primarily due to restructuring activities.
- In 2016, Infinity recorded a non-recurring gain on AbbVie's
opt-out of the duvelisib collaboration of $112.2 million. This non-recurring gain
represents the remaining deferred revenue of $112.2 million as of June
24, 2016, from the previous collaboration with AbbVie for
duvelisib. The AbbVie opt-out is irrevocable, and Infinity has no
obligation to continue to provide AbbVie any services. Infinity did
not record any gains during 2015.
- Net loss for the full-year 2016 was $30.1 million, or a basic and diluted loss per
common share of $0.61, compared to a
net loss of $128.4 million, or a
basic and diluted loss per common share of $2.62 for the full-year 2015.
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 year-end 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, cash equivalents and available-for-sale
securities at December 31, 2016, 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, March 14, 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) and 1-631-291-4526 (international)
five minutes prior to start time. The conference ID number is
64141040. An archived version of the webcast will be available on
Infinity's website for 30 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.[5] The study includes monotherapy and combination
dose-escalation phases, in addition to a monotherapy expansion
cohort and combination expansion cohorts. The expansion cohorts
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; clinical trial plans regarding IPI-549; plans to
report clinical data of IPI-549; 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 phases or that
Infinity will receive any of the benefits of its agreement
with Verastem, Inc. including the receipt of milestone
and royalty payments. Further, there can be no guarantee that any
positive developments in Infinity's product portfolio or the
potential sale of duvelisib 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 annual report on Form
10-K filed with the Securities and Exchange Commission (SEC)
on March 14, 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.
INFINITY
PHARMACEUTICALS, INC.
Condensed
Consolidated Balance Sheets
(in
thousands)
(unaudited)
|
|
|
December
31,
2016
|
December
31,
2015
|
|
|
|
Cash, cash
equivalents and available-for-sale securities
|
$92,064
|
$245,231
|
Other current
assets
|
9,596
|
9,466
|
Property and
equipment, net
|
23,424
|
28,240
|
Other long-term
assets
|
571
|
5,884
|
|
|
|
Total
assets
|
$125,655
|
$288,821
|
|
|
|
Current
liabilities
|
$ 23,863
|
$ 70,056
|
Deferred revenue,
less current portion
|
—
|
95,531
|
Financing obligation,
less current portion
|
19,149
|
19,591
|
Other long-term
liabilities
|
189
|
5,086
|
Total stockholders'
equity
|
82,454
|
98,557
|
|
|
|
Total liabilities and
stockholders' equity
|
$125,655
|
$288,821
|
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,
|
|
2016
|
2015
|
2016
|
2015
|
|
|
|
|
|
Collaboration
revenue
|
$
—
|
$
9,080
|
$
18,723
|
$
109,066
|
Operating
expenses:
Research and development
|
14,662
|
38,890
|
119,611
|
199,109
|
General and administrative
|
8,571
|
9,351
|
42,219
|
37,065
|
Total operating
expenses
|
23,233
|
48,241
|
161,830
|
236,174
|
Gain on AbbVie
Opt-Out
|
—
|
—
|
112,216
|
—
|
Loss from
operations
|
(23,233)
|
(39,161)
|
(30,891)
|
(127,108)
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
(304)
|
(311)
|
(1,225)
|
(1,368)
|
Investment and other income
|
607
|
137
|
2,015
|
435
|
Total other income
(expense)
|
303
|
(174)
|
790
|
(933)
|
Loss before income
taxes
|
(22,930)
|
(39,335)
|
(30,101)
|
(128,041)
|
Income
taxes
|
—
|
145
|
—
|
(335)
|
Net loss
|
$
(22,930)
|
$
(39,190)
|
$
(30,101)
|
$
(128,376)
|
|
|
|
|
|
Basic and diluted
loss per common
|
|
|
|
|
share
|
$
(0.46)
|
$
(0.80)
|
$
(0.61)
|
$
(2.62)
|
Basic and diluted
weighted average number of common shares outstanding
|
50,099,153
|
49,227,905
|
49,608,234
|
49,083,479
|
Contact:
Jaren Irene
Madden, Senior Director,
Investor Relations and Corporate Communications
617-453-1336 or 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 March 2, 2017.
[2] Conquer Cancer Foundation, Head and Neck Cancer
Statistics,
http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics,
Last Accessed March 2, 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] www.clinicaltrials.gov, NCT02637531.
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SOURCE Infinity Pharmaceuticals, Inc.