CAMBRIDGE, Mass., Nov. 9, 2016 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its third
quarter 2016 financial results and its transition of the company to
focus on IPI-549, a potentially first-in-class immuno-oncology
product candidate that selectively inhibits PI3K-gamma. IPI-549 is
the first and only PI3K-gamma inhibitor in clinical development. In
October, Infinity licensed duvelisib, an investigational, oral,
dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma, to Verastem, Inc.
"During the third quarter, we undertook a number of important
initiatives to focus Infinity on the advancement of IPI-549, a
promising novel approach to targeting the immune-suppressive tumor
microenvironment," stated Adelene
Perkins, president and chief executive officer. "Refocusing
Infinity required a significant organizational restructuring, an
amendment to our license agreement from Takeda for both duvelisib
and IPI-549, and the license of duvelisib to Verastem. We are
pleased that Verastem will now be advancing duvelisib for patients
and our corporate imperative going forward is to maximize the value
of IPI-549."
"We are encouraged by the initial IPI-549 clinical monotherapy
data recently presented, and we expect to begin evaluating IPI-549
in combination with Opdivo, a PD-1 immune checkpoint inhibitor,
this fall. We anticipate reporting updated Phase 1 data from the
Phase 1 study in the first half of 2017. Data in two recent
Nature publications provide a strong rationale for advancing
IPI-549 and show that IPI-549 in combination with immune checkpoint
inhibitors may overcome resistance to checkpoint blockade," Ms.
Perkins continued.
Recent developments include the following:
IPI-549
- Entered clinical collaboration with BMS to evaluate IPI-549
in combination with Opdivo: Earlier today, Infinity and
Bristol-Myers Squibb announced a clinical trial collaboration to
evaluate IPI-549 in combination with Bristol-Myers Squibb's Opdivo
(nivolumab) in patients with advanced solid tumors. The
dose-escalation portion exploring IPI-549 as a monotherapy in
Infinity's Phase 1 study is continuing, and the first
dose-escalation cohort studying IPI-549 in combination with Opdivo
is expected to begin this fall.
The ongoing Phase 1 clinical study
of IPI-549 is designed to explore the activity, safety,
tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a
monotherapy and in combination with Opdivo in approximately 175
patients with advanced solid tumors. Once the dose-escalation phase
evaluating IPI-549 plus Opdivo is completed, an expansion phase is
planned to evaluate the combination in patients with selected solid
tumors, including non-small cell lung cancer (NSCLC), melanoma and
squamous cell carcinoma of the head and neck (SCCHN).
- Initial clinical data presented at AACR cancer
immuno-therapy conference: In September, Infinity announced
initial clinical data for IPI-549. Preliminary Phase 1 results from
nine patients with advanced solid tumors showed that the safety,
pharmacokinetics and pharmacodynamics of IPI-549 monotherapy
treatment appeared favorable. These data were presented in a poster
session at the Second CRI-CIMT-EATI-AACR International Cancer
Immunotherapy Conference: Translating Science into
Survival.1
- Preclinical data on IPI-549 published in two Nature
articles: Earlier today, Infinity announced the publication of
new findings by research collaborators, including Drs. Jedd Wolchok and Taha Merghoub at Memorial Sloan
Kettering Cancer Center, and Infinity scientists in the
November 9 online issue of
Nature. The paper, entitled "Overcoming resistance to
checkpoint blockade by targeting PI3K-gamma in tumor-infiltrating
myeloid cells," 2 describes research showing that the
presence of suppressive myeloid cells play a critical role in tumor
resistance to checkpoint inhibitors and that IPI-549 is able to
help recover sensitivity to checkpoint inhibition in this setting
by remodeling the immune-suppressive tumor microenvironment
primarily through its effects on myeloid cells.
In September, Infinity announced
the first Nature publication on PI3K-gamma by research
collaborators, including Dr. Judith
Varner, at University of California San
Diego School of Medicine and Moores Cancer Center and
Infinity scientists in the September
19 online issue of Nature. The paper, entitled
"PI3K-gamma is a molecular switch that controls immune
suppression," 3 describes preclinical data showing that
macrophage PI3K-gamma signaling promotes immune suppression by
inhibiting activation of anti-tumor T cells. Additionally, blocking
PI3K-gamma activated the immune response and significantly
suppressed growth of implanted tumors in animal models. Inhibiting
PI3K-gamma also boosted sensitivity of some tumors to existing
anti-cancer drugs and showed synergy with existing
immuno-therapies.
These two articles will publish
back-to-back in the November 17,
2016, print edition of Nature. Taken together, these
findings reinforce the therapeutic potential of IPI-549 to alter
the immune-suppressive microenvironment, promoting an anti-tumor
immune response that may lead to tumor growth inhibition and
providing a strong rationale for the ongoing Phase 1 study.
Corporate
- Amended license of duvelisib from Takeda: In September,
Infinity amended its agreement with Takeda for the license of
duvelisib and IPI-549. Under the amended agreement with Takeda,
upon entry into the Verastem Agreement, Infinity's milestone
obligations for its first licensed compound (duvelisib) were
terminated and deemed satisfied. In exchange, Infinity and Takeda
will share equally in potential future royalties on net sales of
duvelisib that Infinity is eligible to receive from Verastem.
Additionally by satisfying milestone obligations on duvelisib under
the Takeda license, IPI-549 now qualifies for the lower milestone
obligations of the second licensed compound. As a result,
Infinity's potential regulatory milestone payments to Takeda
related to IPI-549 have been reduced by up to $120 million, from up to $170 million to up to $50
million. Development milestones of $5.0 million, as well as potential commercial
milestones, remain unchanged by the amendment.
- Duvelisib licensed to Verastem: In November, Infinity
and Verastem announced that the companies entered into a license
agreement for exclusive worldwide rights to develop and
commercialize duvelisib. Under the agreement, Infinity is eligible
to receive up to a total of $28
million across two milestone payments: $6.0 million upon positive data from the Phase 3
DUO® study in patients with relapsed/refractory chronic
lymphocytic leukemia, and $22 million
upon the first regulatory approval of duvelisib inside or outside
of the U.S. Verastem is also obligated to pay Infinity tiered
mid-to-high single-digit royalties on net sales of duvelisib and
will be responsible for the royalties on net sales of duvelisib
owed by Infinity to Mundipharma International Corporation Limited
and Purdue Pharmaceutical Products L.P.
- Reduced facility lease commitments: In November,
Infinity and Alexandria Real Estate Equities (ARE) entered into an
agreement to terminate Infinity's lease for its facilities at 780
Memorial Drive in Cambridge, MA,
effective as of October 31, 2016. In
connection with the termination, Infinity paid ARE a termination
payment of approximately $1.8
million. Infinity elected to terminate its lease to
consolidate its facilities as part of its strategic restructuring
efforts.
Third Quarter 2016 Financial Results
- At September, 2016, Infinity had total cash, cash equivalents
and available-for-sale securities of $112.3
million, compared to $146.4
million at June 30, 2016.
- Infinity did not record any revenue during the third quarter of
2016. Revenue for the third quarter of 2015 was $90.7 million for research and development
(R&D) services associated with the previous collaboration with
AbbVie for duvelisib in oncology.
- R&D expense for the third quarter of 2016 was $12.8 million compared to $37.7 million for the same period in 2015. The
decrease in R&D expense was primarily related to a decrease in
activities for duvelisib and a decrease in compensation as a result
of the restructuring announced earlier this year.
- General and administrative (G&A) expense was $7.1 million for the third quarter of 2016,
compared to $9.8 million for the same
period in 2015. The decrease in G&A expense was primarily
related a decrease in commercial-readiness activities for
duvelisib.
- Net loss for the third quarter of 2016 was $19.5 million, or a basic and diluted earnings
per common share of $0.39, compared
to a net income of $42.5 million, or
a basic earnings per common share of $0.85 and diluted earnings per common share of
$0.84, for the same period in
2015.
Cash and Investments Outlook
Following the license
agreement with Verastem and further restructuring activities,
Infinity today provided an update on its anticipated year-end 2016
cash and investments balance and expected cash runway.
- Infinity expects to end 2016 with a year-end cash and
investments balance ranging from $70 million
to $80 million, compared to prior expectations of
$45 million to $55 million.
- Infinity expects that its existing cash, cash equivalents and
available-for-sale securities at September
30, 2016, will be adequate to satisfy the company's capital
needs into the first quarter of 2018 based on its current
operational plans, compared to previous guidance of cash runway
into the third quarter of 2017.
The company's updated financial guidance is in the absence of
additional funding or business development activities and has
expenses related to duvelisib beyond November 1, 2016, capped at $4.5 million. Additionally, Infinity's updated
cash runway expectation excludes any potential milestone payments
from Verastem related to duvelisib.
Conference Call Information
Infinity will host a
conference call today, November 9,
2016, 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 1138542. An archived version of the
webcast will be available on Infinity's website for 30 days.
About IPI-549
IPI-549 is an investigational, orally
administered immuno-oncology development candidate that selectively
inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits
immune suppressive macrophages within the tumor microenvironment,
whereas other immunotherapies such as checkpoint modulators more
directly target immune effector cell function. 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.4
IPI-549 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
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; the receipt of
milestone and royalty payments under the agreement
with Verastem; the preservation of Infinity's cash; expected
benefits of the company's restructuring; anticipated year-end 2016
cash and investments balance and cash runway; 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 the agreement
with Verastem 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 quarterly report on
Form 10-Q filed with the Securities and Exchange Commission
(SEC) on November 9, 2016, 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)
|
|
September 30,
2016
|
December
31,
2015
|
|
|
|
Cash, cash
equivalents and available-for-sale securities,
including long term
|
$112,298
|
$245,231
|
Other current
assets
|
11,178
|
9,466
|
Property and
equipment, net
|
24,451
|
28,240
|
Other long-term
assets
|
3,975
|
5,884
|
|
|
|
Total
assets
|
$151,902
|
$288,821
|
|
|
|
Current
liabilities
|
$ 25,900
|
$ 70,056
|
Deferred revenue,
less current portion
|
—
|
95,531
|
Financing obligation,
less current portion
|
19,262
|
19,591
|
Other long-term
liabilities
|
4,619
|
5,086
|
Total stockholders'
equity
|
102,121
|
98,557
|
|
|
|
Total liabilities and
stockholders' equity
|
$151,902
|
$288,821
|
INFINITY
PHARMACEUTICALS, INC.
|
Condensed
Consolidated Statements of Operations
|
(unaudited)
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
Nine Months Ended June 30,
|
|
2016
|
2015
|
2016
|
2015
|
Collaboration
revenue
|
$
—
|
$
90,743
|
$
18,723
|
$
99,987
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
12,814
|
37,729
|
104,949
|
160,220
|
General and
administrative
|
7,120
|
9,754
|
33,648
|
27,713
|
|
|
|
|
|
Total operating
expenses
|
19,934
|
47,483
|
138,597
|
187,933
|
Gain on AbbVie
Opt-Out
|
—
|
—
|
112,216
|
—
|
Income (loss) from
operations
|
(19,934)
|
43,260
|
(7,658)
|
(87,946)
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
(305)
|
(311)
|
(921)
|
(1,058)
|
Investment and other
income
|
741
|
75
|
1,408
|
298
|
Total other income
(expense)
|
436
|
(236)
|
487
|
(760)
|
|
|
|
|
|
Income (loss) before
income taxes
|
(19,498)
|
43,024
|
(7,171)
|
(88,706)
|
Income
taxes
|
—
|
(480)
|
—
|
(480)
|
Net income
(loss)
|
$
(19,498)
|
$
42,544
|
$
(7,171)
|
$
(89,186)
|
|
|
|
|
|
Earnings (loss) per
common share:
|
|
|
|
|
Basic
|
$
(0.39)
|
$
0.85
|
$
(0.15)
|
$
(1.82)
|
|
|
|
|
|
Diluted
|
$
(0.39)
|
$
0.84
|
$
(0.15)
|
$
(1.82)
|
|
|
|
|
|
Weighted average
number of common shares outstanding:
|
|
|
|
|
Basic
|
49,583,776
|
49,188,443
|
49,448,725
|
49,051,836
|
|
|
|
|
|
Diluted
|
49,583,776
|
49,764,910
|
49,448,725
|
49,051,836
|
|
|
|
|
|
Contact:
Jaren Irene Madden, Senior
Director
Investor Relations and Corporate Communications
617-453-1336 or Jaren.Madden@infi.com
1 Tochler, A., Hong D., Sullivan R, et al.
IPI-549-01: A Phase 1/1b first-in-human study of IPI-549, a
PI3K-gamma inhibitor, as monotherapy and in combination with an
anti-PD1 antibody in subjects with advanced solid tumors. Presented
at Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy
Conference: Translating Science into Survival (Poster B070),
2016.
2 De Henau O., Rausch M., Winkler D., Campesato L.F.
et al. Overcoming resistance to checkpoint blockade by targeting
PI3K-gamma in tumor-infiltrating myeloid cells. Nature,
Advanced Online Publication, November
2016, http://www.nature.com/nature.
3 Kaneda, M.M., Messer, K.S., Ralainirina N. et al.
PI3K-gamma is a molecular switch that controls immune suppression.
Nature, 2016; DOI: 10.1038/nature19834.
4 www.clinicaltrials.gov, NCT02637531
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SOURCE Infinity Pharmaceuticals, Inc.