LEXINGTON, Mass., March 8,
2018 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a
biotechnology company focused on the development and
commercialization of innovative and effective therapeutics for the
treatment of cancer, today reported its financial results for the
fourth quarter and year ended December 31, 2017.
"2017 exemplified Curis's business strategy, marking the
Company's first time with three anti-cancer drug candidates in
clinical development" said Ali
Fattaey, Ph.D., Chief Executive Officer of Curis. "We are
excited about CUDC-907 treatment providing durable responses in
nearly 1 in 4 DLBCL patients whose cancers have MYC alterations. We
are working closely with regulatory authorities to define a pivotal
path to register CUDC-907 in this patient population, which has no
viable treatment options."
"Our progress with testing CA-170, the first and only oral small
molecule checkpoint inhibitor, has now extended beyond the Phase 1
trial, with our partner Aurigene having initiated a Phase 2 trial
in India. This will greatly accelerate access to select
populations of patients that have not experienced prior
immunotherapy."
"As noted, with initiation of patient enrollment in CA-4948's
Phase 1 lymphoma study, for the first time, Curis has 3 different
cancer drugs in clinical testing at the same time. We are
excited about the prospects for these drugs and their value to
Curis's success in 2018."
Full Year and Fourth Quarter 2017 Financial Results
For the year ended December 31, 2017, Curis reported a net
loss of $53.3 million, or
$(0.36) per share on both a basic and
diluted basis, as compared to a net loss of $60.4 million, or $(0.45) per share on both a basic and diluted
basis in 2016. For the fourth quarter of 2017, Curis reported
a net loss of $8.0 million or
$(0.05) per share on both basic and
diluted basis, as compared to a net loss of $11.3 million, or $(0.08) per share on both basic and diluted basis
for the same period in 2016. The net loss for the year ended
December 31, 2016, includes a non-cash in-process research and
development charge of $18.0 million
related to the amendment of Curis's license agreement with
Aurigene.
Revenues for the year ended December 31, 2017 were
$9.9 million, as compared to
$7.5 million for the same period in
2016. Revenues for both periods comprise primarily royalty revenues
recorded on Genentech and Roche's net sales of
Erivedge®. Revenues for the fourth quarters of 2017 and
2016 were $3.3 million and
$2.4 million, respectively.
Operating expenses were $59.7
million for the year ended December 31, 2017, as
compared to $65.6 million for the
same period in 2016. Operating expenses for the fourth quarter of
2017 were $10.4 million, as compared
to $13.1 million for the same period
in 2016, and comprised the following:
Costs of Royalty Revenues. Costs of royalty
revenues, primarily amounts due to third-party university patent
licensors in connection with Genentech and Roche's Erivedge net
sales, were $0.5 million for the year
ended December 31, 2017, as compared to $0.4 million for the same period in 2016. Cost of
royalty revenues were $0.2 million
for the fourth quarter of 2017, as compared to $0.1 million for the same period in 2016.
In-Process Research and Development Expense. The
Company recorded a one-time in-process research and development
expense of $18.0 million for the year
ended December 31, 2016, related to the issuance of common
stock to Aurigene. These shares were issued as consideration for
the rights granted under the terms of the September 2016 amendment to the collaboration
agreement.
Research and Development Expenses. Research and
development expenses were $45.1
million for the year ended December 31, 2017, as
compared to $31.6 million for the
same period in 2016. The increase was primarily due to two payments
to Aurigene for $3.8 million each,
for an exclusivity option which were paid in January 2017 and September
2017 as well as increased costs related to ongoing clinical
activities for CA-170. Employee-related expenses increased over the
prior year period primarily due to higher stock based compensation
and personnel costs. Research and development expenses were
$6.9 million for the fourth quarter
of 2017, as compared to $9.2 million
for the same period in 2016.
General and Administrative Expenses. General and
administrative expenses were $14.1
million for the year ended December 31, 2017, as
compared to $15.6 million for the
same period in 2016. The decrease in general and administrative
expenses was driven primarily by lower legal, professional and
consulting services and other administrative expenses, offset
slightly by higher stock-based compensation for the period. General
and administrative expenses were $3.3
million for the fourth quarter of 2017, as compared to
$3.8 million for the same period in
2016.
Other expense, net was $3.6
million for the year ended December 31, 2017, as
compared to $2.4 million for the same
period in 2016. Other expense, net primarily consisted of interest
expense related to the debt obligations of Curis Royalty (a wholly owned subsidiary of
Curis). The increase in interest expense in the current year was
related to a higher principal balance of Curis Royalty's outstanding debt with HealthCare
Royalty, which was refinanced in the first quarter of 2017. Other
expense, net was $0.9 million for the
fourth quarter of 2017, as compared to $0.6
million for the same period in 2016.
As of December 31, 2017, Curis's cash, cash equivalents,
marketable securities and investments totaled $60.2 million and there were approximately 164.2
million shares of common stock outstanding.
Recent Operational Highlights
Precision oncology, CUDC-907:
- In December 2017, investigators
presented results from the combined analysis of the Phase 1 and
Phase 2 trial results of CUDC-907 in patients with
relapsed/refractory DLBLC, including those with MYC-altered
disease, at the American Society of Hematology's annual meeting in
Atlanta, Georgia.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene
collaboration):
- In December 2017, Curis
scientists presented non-clinical results demonstrating significant
anti-tumor activity when CA-4948 was combined with the BCL2
antagonist drug venetoclax, at the American Society of Hematology's
annual meeting in Atlanta,
Georgia.
- In January 2018, Curis announced
initiation of patient dosing in a Phase 1 trial of CA-4948 for
treatment of patients with lymphoma. CA-4948 was discovered at
Aurigene and is the second licensed program from the Curis-Aurigene
collaboration to enter the clinic.
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene
collaboration):
- In November 2017, investigators
presented preliminary results from the dose escalation stage of the
Phase 1 trial of CA-170 in patients with advanced solid tumors or
lymphomas, at the annual meeting of the Society for Immunotherapy
of Cancer, in National Harbor, Maryland.
- Curis collaborator, Aurigene, initiated patient enrollment of
cancer patients in a Phase 2 clinical study of CA-170 at trial
sites in India.
Immuno-oncology, CA-327 (PDL1 and TIM3 antagonist; Aurigene
collaboration):
- In November 2017, Curis
scientists presented non-clinical results demonstrating CA-327's
ability to modulate tumor immune profile in mouse models, as well
as its anti-cancer activity as a single agent or in combination
with CA-170, at the annual meeting of the Society for Immunotherapy
of Cancer, in National Harbor, Maryland.
Upcoming Activities
Curis expects that it will make presentations at the following
conferences through April 2018:
- Cowen & Company 38th Annual Health Care Conference
(March 12-14) in Boston
Conference Call Information
Curis management will host a conference call today,
March 8, 2018, at 8:30 a.m. EST,
to discuss these financial results, as well as provide a corporate
update.
To access the live conference call, please dial (877) 870-4263
from the United States or (412)
317-0790 from other locations, shortly before 8:30 a.m. EST. The conference call can also be
accessed on the Curis website at www.curis.com in the Investors
section.
About Curis, Inc.
Curis is a biotechnology company focused on the development and
commercialization of innovative and effective drug candidates for
the treatment of human cancers, including CUDC-907, which is being
investigated in clinical studies in patients with lymphomas and
solid tumors. Curis is also engaged in a collaboration with
Aurigene in the areas of immuno-oncology and precision oncology. As
part of this collaboration, Curis has exclusive licenses to oral
small molecule dual antagonists of PD1 and VISTA, including
PDL1/VISTA antagonist CA-170, and oral small molecule dual
antagonists of PD1 and TIM3, including PDL1/TIM3 antagonist CA-327,
as well as to molecules designed to inhibit the IRAK4 kinase,
including CA-4948. CA-170 is currently undergoing testing in a
Phase 1 trial in patients with advanced solid tumors and
lymphomas. CA-4948 is currently undergoing testing in a Phase
1 trial in patients with lymphoma. Curis is also party to a
collaboration with Genentech, a member of the Roche Group, under
which Genentech and Roche are commercializing Erivedge® for the
treatment of advanced basal cell carcinoma. For more information,
visit Curis's website at www.curis.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, including without limitation statements regarding any
expectations of revenue, expenses, earnings or losses from
operations, or other financial results, statements with respect to
the plans, strategies and objectives of management for future
operations, the potential for the Company's proprietary drug
candidates, including CUDC-907, the potential advantages and
benefits of small molecule checkpoint antagonists, the Company's
plans and expectations for the collaboration with Aurigene,
including its plans to discover and develop multiple
first-in-class oral, small molecule checkpoint antagonists for the
treatment of patients with cancer, and the Company's plans to
advance its development programs, including the timing of IND
filings and the Company's plans for CUDC-907. Forward-looking
statements may contain the words "believes," "expects,"
"anticipates," "plans," "seeks," "estimates," "assumes," "will,"
"may," "could" or similar expressions. These forward-looking
statements are not guarantees of future performance and involve
risks, uncertainties, assumptions and other important factors that
may cause actual results to be materially different from those
indicated by such forward-looking statements. For example, Curis
may experience adverse results, delays and/or failures in its drug
development programs and may not be able to successfully advance
the development of its drug candidates in the time frames it
projects, if at all. Curis's drug candidates may cause unexpected
toxicities, fail to demonstrate sufficient safety and efficacy in
clinical studies and/or may never achieve the requisite regulatory
approvals needed for commercialization. Favorable results seen in
preclinical studies and early clinical trials of Curis's drug
candidates may not be replicated in later trials. There can be no
guarantee that the collaboration agreement with Aurigene will
continue for its full term, that Curis or Aurigene will each
maintain the financial and other resources necessary to continue
financing its portion of the research, development and
commercialization costs, or that the parties will successfully
discover, develop or commercialize drug candidates under the
collaboration. Regulatory authorities may determine to delay or
restrict Genentech's and/or Roche's ability to continue to develop
or commercialize Erivedge in BCC. Erivedge may not demonstrate
sufficient or any activity to merit its further development in
disease indications other than BCC. Competing drugs may be
developed that are superior to Erivedge. Curis faces risks relating
to its wholly-owned subsidiary's royalty-collateralized loan
transaction, including the risk that it may not receive sufficient
levels of royalty revenue from sales of Erivedge to satisfy the
debt obligation or may otherwise lose its rights to royalties and
royalty-related payments as a result of a foreclosure of the loan.
Curis will require substantial additional capital to fund its
business and such capital may not be available on reasonable terms,
or at all. Curis faces substantial competition. Curis also faces
risks relating to potential adverse decisions made by the FDA and
other regulatory authorities, investigational review boards, and
publication review bodies. Curis may not obtain or maintain
necessary patent protection and could become involved in expensive
and time consuming patent litigation and interference proceedings.
Unstable market and economic conditions and unplanned expenses may
adversely affect Curis's financial conditions and its ability to
access the substantial additional capital needed to fund the growth
of its business. Important factors that may cause or contribute to
such differences include the factors set forth under the caption
"Risk Factors" in our most recent Form 10-K and Form 10-Q and the
factors that are discussed in other filings that we periodically
make with the Securities and Exchange Commission ("SEC"). In
addition, any forward-looking statements represent the views of
Curis only as of today and should not be relied upon as
representing Curis's views as of any subsequent date. Curis
disclaims any intention or obligation to update any of the
forward-looking statements after the date of this press release
whether as a result of new information, future events or otherwise,
except as may be required by law.
CURIS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
(UNAUDITED) (In thousands, except share
and per share data)
|
|
|
|
Three months
ended
|
|
Year
ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
3,144
|
|
|
$
|
2,407
|
|
|
$
|
9,849
|
|
|
$
|
7,810
|
|
Research and
development, net
|
|
118
|
|
|
(45)
|
|
|
49
|
|
|
(283)
|
|
Total
revenues:
|
|
3,262
|
|
|
2,362
|
|
|
9,898
|
|
|
7,527
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Costs of royalty
revenues
|
|
165
|
|
|
121
|
|
|
496
|
|
|
399
|
|
Research and
development
|
|
6,919
|
|
|
9,159
|
|
|
45,096
|
|
|
31,590
|
|
In-process research
and development
|
|
—
|
|
|
—
|
|
|
—
|
|
|
17,989
|
|
General and
administrative
|
|
3,305
|
|
|
3,845
|
|
|
14,066
|
|
|
15,588
|
|
Total operating
expenses
|
|
10,389
|
|
|
13,125
|
|
|
59,658
|
|
|
65,566
|
|
|
|
|
|
|
|
|
|
|
Net loss from
operations
|
|
(7,127)
|
|
|
(10,763)
|
|
|
(49,760)
|
|
|
(58,039)
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income
|
|
—
|
|
|
—
|
|
|
(104)
|
|
|
(1)
|
|
Interest
income
|
|
181
|
|
|
80
|
|
|
513
|
|
|
406
|
|
Interest
expense
|
|
(1,082)
|
|
|
(652)
|
|
|
(3,966)
|
|
|
(2,777)
|
|
Other expense,
net
|
|
(901)
|
|
|
(572)
|
|
|
(3,557)
|
|
|
(2,372)
|
|
Net loss
|
|
(8,028)
|
|
|
(11,335)
|
|
|
(53,317)
|
|
|
(60,411)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.05)
|
|
|
$
|
(0.08)
|
|
|
$
|
(0.36)
|
|
|
$
|
(0.45)
|
|
Basic and diluted
weighted average common shares outstanding
|
|
164,008,252
|
|
|
140,715,621
|
|
|
149,133,466
|
|
|
132,785,687
|
|
CURIS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED) (In
thousands)
|
|
|
|
December 31,
2017
|
|
December 31,
2016
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
60,232
|
|
|
$
|
44,485
|
|
Investments –
restricted
|
|
153
|
|
|
153
|
|
Accounts
receivable
|
|
3,073
|
|
|
2,459
|
|
Property and
equipment, net
|
|
366
|
|
|
413
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Other
assets
|
|
992
|
|
|
1,260
|
|
Total
assets
|
|
$
|
73,798
|
|
|
$
|
57,752
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
8,250
|
|
|
$
|
8,626
|
|
Debt obligations,
net
|
|
41,555
|
|
|
19,860
|
|
Total
liabilities
|
|
49,805
|
|
|
28,486
|
|
Total stockholders'
equity
|
|
23,993
|
|
|
29,266
|
|
Total liabilities and
stockholders' equity
|
|
$
|
73,798
|
|
|
$
|
57,752
|
|
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SOURCE Curis, Inc.