CAMBRIDGE, Mass., May 7, 2019 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its first
quarter 2019 financial results and provided an update on the
company, including its progress in expanding the breadth and depth
of the development of IPI-549 in over 500 patients. IPI-549 is a
first-in-class oral immuno-oncology product candidate that targets
immune-suppressive tumor-associated myeloid cells through selective
phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition. In the
first quarter of 2019, Infinity entered into a clinical
collaboration with Roche/Genentech moving into front-line triple
negative breast cancer (TNBC) and renal cell cancer (RCC) with
MARIO-3. In the first quarter of 2019, Infinity also closed the
Copiktra royalty monetization for $20.9M in net proceeds and earned a $2M milestone from PellePharm, providing
non-dilutive capital to fund the expanded development of IPI-549,
including MARIO-3.
"Shareholder value creation will be driven by the generation of
compelling clinical data with IPI-549, funded with
dilution-sensitive capital, and we are pleased to have made
important progress on both of these fronts in the first quarter of
this year. We continue to advance IPI-549 and remain focused on
achieving our key clinical milestones for 2019," said Adelene Perkins, Chief Executive Officer and
Chair of Infinity Pharmaceuticals. "We are studying IPI-549 in
earlier lines of therapy, new indications and novel, potentially
transformative immuno-oncology combinations in 2019."
Anticipated Milestones in 2019: Expanding Depth and Breadth
of IPI-549 Development
2Q2019
- Initiate MARIO-275, a Phase 2 study of IPI-549 in combination
with Opdivo®, in second-line immuno-oncology (I/O) naïve
urothelial cancer patients, in collaboration with BMS
2H2019
- Initiate MARIO-3, a Phase 2 study of novel triple combination
front-line therapy, in clinical collaboration with
Roche/Genentech:
-
- IPI-549 in combination with Tecentriq® and
Abraxane® in TNBC
- IPI-549 in combination with Tecentriq and Avastin®
in RCC
- Complete enrollment of MARIO-1 combination expansion cohorts
including:
-
- Augmented melanoma expansion cohort (n=40)
- TNBC expansion cohort (n=29)
- Advance into novel triple combination therapies beyond
checkpoint inhibitors: initiate triple therapy
(IPI-549+AB928+Abraxane) in previously treated advanced TNBC in
collaboration with Arcus Biosciences
First Quarter 2019 Financial Results
- At March 31, 2019, Infinity had
total cash, cash equivalents and available-for-sale securities of
$70.5 million, compared to
$58.6 million at December 31, 2018.
- Infinity recognized the $30
million gross proceeds from the Copiktra royalty
monetization as a liability, net of transaction costs, as of
March 31, 2019. We are amortizing the
liability to non-cash interest expense, and we will continue to
recognize the royalty revenue that Verastem pays to HealthCare
Royalty Partners III, L.P. (HCR) as non-cash royalty revenue. We
shared 25% of the proceeds, net of expenses, under the HCR
agreement with Takeda. In addition, we will pay to Takeda 25% of
royalties that, but for the HCR agreement, would have been payable
to us by Verastem during the term of the HCR agreement.
- Revenue during the first quarter of 2019 was $2.1 million, which primarily relates to the
achievement of a $2.0 million
milestone from PellePharm for the initiation of a Phase 3 study
investigating patidegib (a hedgehog pathway inhibitor) in patients
with Gorlin Syndrome. We did not have any revenue for the same
period in 2018.
- R&D expense for the first quarter of 2019 was $5.8 million, compared to $5.9 million for the same period in 2018.
- General and administrative expense was $3.4 million for the first quarter 2019, compared
to $3.6 million for the same period
in 2018.
- Royalty expense for the first quarter of 2019 was $6.8 million, which primarily relates to our
payment to Takeda in relation to the monetization of Copiktra
royalties.
- Net loss for the first quarter of 2019 was $13.7 million, or a basic and diluted loss per
common share of $0.24, compared to a
net loss of $9.5 million, or a basic
and diluted loss per common share of $0.18 for the same period in 2018.
2019 Updated Financial Guidance
- Net Loss: Infinity expects net loss for 2019 to range
from $40 million to $50 million including the Copiktra royalty
monetization.
- Cash and Investments: Infinity expects to end 2019 with
a year-end cash, cash equivalents and available-for-sale securities
balance ranging from $40 million to
$50 million including the Copiktra
royalty monetization.
- Cash Runway: Based on its current operational plans,
Infinity expects that its existing cash, cash equivalents and
available-for-sale securities will be adequate to satisfy the
company's capital needs into 2H 2020. Infinity's financial guidance
excludes additional funding or business development activities and
excludes the potential monetization of future milestones and/or
royalties payments from PellePharm, a private company, to whom
Infinity licensed patidegib in 2013.
Conference Call Information
Infinity will host a conference call today, May 7, 2019,
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
5779562. An archived version of the webcast will be available on
Infinity's website for 30 days.
About Infinity and IPI-549
Infinity is an innovative biopharmaceutical company dedicated to
advancing novel medicines for people with cancer. Infinity is
advancing IPI-549, a first-in-class, oral immuno-oncology
development candidate that selectively inhibits PI3K-gamma, in
multiple clinical studies. MARIO-1 is an ongoing Phase
1/1b study evaluating IPI-549 as a
monotherapy and in combination with Opdivo (nivolumab) in
approximately 220 patients with advanced solid tumors including
patients refractory to anti-PD-1 therapy. Infinity intends to
initiate MARIO-275, a global, randomized, combination study of
IPI-549 combined with Opdivo in I/O naïve urothelial cancer
patients in 2Q19, as well as to initiate MARIO-3, the first IPI-549
combination study in front-line advanced cancer patients in 2H19.
MARIO-3 will evaluate IPI-549 in combination with Tecentriq and
Abraxane in front-line TNBC and in combination with Tecentriq and
Avastin in front-line RCC. With the addition of MARIO-275 and
MARIO-3 to the ongoing MARIO-1 study, Infinity will be evaluating
IPI-549 in the anti-PD-1 refractory, I/O-naïve and front-line
settings in a total of ~500 patients. 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 other cancer therapies;
clinical trial plans and progress; 2019 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. 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; 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 May 7, 2019, 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)
|
|
|
March 31,
2019
|
|
December 31,
2018
|
Cash, cash
equivalents and available-for-sale securities
|
$
|
70,531
|
|
|
$
|
58,591
|
|
Other current
assets
|
3,641
|
|
|
1,227
|
|
Property and
equipment, net
|
51
|
|
|
28
|
|
Other long-term
assets
|
522
|
|
|
369
|
|
Total
assets
|
$
|
74,745
|
|
|
$
|
60,215
|
|
|
|
|
|
Current
liabilities
|
$
|
7,459
|
|
|
$
|
7,718
|
|
Liability related to
sale of future royalties, net
|
27,846
|
|
|
—
|
|
Other long-term
liabilities
|
35
|
|
|
38
|
|
Total stockholders'
equity
|
39,405
|
|
|
52,459
|
|
Total liabilities and
stockholders' equity
|
$
|
74,745
|
|
|
$
|
60,215
|
|
INFINITY
PHARMACEUTICALS, INC.
|
Condensed
Consolidated Statements of Operations
|
(in thousands,
except share and per share amounts)
|
(unaudited)
|
|
|
Three Months Ended
March 31,
|
|
2019
|
|
2018
|
Collaboration
revenue
|
$
|
2,000
|
|
|
$
|
—
|
|
Royalty revenue
|
142
|
|
|
—
|
|
Total
revenues
|
2,142
|
|
|
—
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
|
5,766
|
|
|
|
5,911
|
|
General and
administrative
|
3,398
|
|
|
3,606
|
|
Royalty expense
|
6,761
|
|
|
—
|
|
Total operating
expenses
|
15,925
|
|
|
9,517
|
|
Loss from
operations
|
(13,783)
|
|
|
(9,517)
|
|
Other income
(expense):
|
|
|
|
Investment and other
income
|
289
|
|
|
159
|
|
Interest expense
|
(304)
|
|
|
(93)
|
|
Total other income
(expense)
|
(15)
|
|
|
66
|
|
Loss before income
taxes
|
(13,798)
|
|
|
(9,451)
|
|
Income taxes
benefit
|
54
|
|
|
—
|
|
Net loss
|
$
|
(13,744)
|
|
|
$
|
(9,451)
|
|
Basic and diluted
loss per common share:
|
$
|
(0.24)
|
|
|
$
|
(0.18)
|
|
Basic and diluted
weighted average number of
common shares outstanding:
|
56,924,914
|
|
|
51,883,570
|
|
Contact
Stephanie
Ascher, Stern Investor Relations, Inc.
212-362-1200 or Stephanie@sternir.com
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SOURCE Infinity Pharmaceuticals, Inc.