LEXINGTON, Mass., Aug. 2, 2018 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
and commercialization of innovative therapeutics for the treatment
of cancer, today reported its financial results for the second
quarter ended June 30, 2018.
"Our second quarter has been marked by continued progress in
advancing our three clinical drug candidates further in their
respective development," said Ali
Fattaey, Ph.D., Chief Executive Officer of Curis. "We
continue to assess and hold productive discussions with the FDA to
identify a path to register fimepinostat, which could provide
much-needed benefit for patients with R/R DLBCL, and in particular
those whose disease have MYC alterations. CA-170, our orally
available small-molecule checkpoint inhibitor, continues to
progress in Phase 1 and Phase 2 clinical studies with a planned
update in the second half of 2018. Patient enrollment continues for
our recently initiated Phase 1 study of precision oncology
candidate CA-4948, currently the only IRAK4 kinase inhibitor in
clinical development for cancer. In addition, we recently welcomed
Dr. Robert Martell into his new role
as Head of Research and Development. Dr. Martell is a practicing
oncologist whose extensive experience in drug development will help
strengthen Curis's oncology portfolio. We believe Curis remains on
track to advancing multiple attractive candidates with potential to
substantially impact current oncology care."
Second Quarter 2018 Financial Results
Curis reported a net loss of $8.7
million, or $0.26 per share on
both a basic and diluted basis for the second quarter of 2018, as
compared to a net loss of $14.1
million, or $0.49 per share on
both a basic and diluted basis for the same period in
2017. Curis reported a net loss of $19.4 million, or $0.59 per share, on both a basic and diluted
basis for the six months ended June 30, 2018, as compared to a
net loss of $29.8 million, or
$1.04 per share on both a basic and
diluted basis for the same period in 2017.
Revenues for the second quarter of 2018 were $2.4 million, as compared to $2.1 million for the same period in 2017.
Revenues for the six months ended June 30, 2018 were
$4.8 million, as compared to
$4.2 million for the same period in
2017. Revenues for both periods comprise primarily royalty revenues
recorded on Genentech and Roche's net sales of
Erivedge®.
Operating expenses were $10.2
million for the second quarter of 2018, as compared to
$15.2 million for the same period in
2017. Operating expenses for the six months ended June 30,
2018 were $22.6 million, as compared
to $32.4 million for the same period
in 2017, and comprised the following:
Costs of Royalty Revenues. Costs of royalty
revenues, resulting from payments to third-party university patent
licensors associated with Genentech and Roche's Erivedge net sales,
were $0.1 million for both the second
quarter of 2018 and 2017. Cost of royalty revenues for the
six months ended June 30, 2018 were $0.3 million, as compared to $0.2 million for the same period in 2017.
Research and Development Expenses. Research and
development expenses were $6.5
million for the second quarter of 2018, as compared to
$11.3 million for the same period in
2017. The decrease was primarily driven by decreased costs related
to clinical activities for fimepinostat and CA-170, partially
offset by increased costs related to CA-4948. Research and
development expenses were $14.7
million for the six months ended June 30, 2018 as
compared to $24.8 million for the
same period in 2017.
General and Administrative Expenses. General and
administrative expenses were $3.6
million for the second quarter of 2018 as compared to
$3.8 million for the same period in
2017. The decrease in general and administrative expenses was
primarily driven by lower personnel and stock-based compensation
expense partially offset by higher legal services for the period.
General and administrative expenses were $7.6 million for the six months ended
June 30, 2018, as compared to $7.4
million for the same period in 2017.
Other Expenses. Net other expense for the second quarter
2018 totaled $0.8 million as compared
to $1.0 million for the same period
in 2017. Net other expense primarily consisted of interest expense
related to Curis Royalty's (a wholly
owned subsidiary of Curis) debt obligations. Other expense, net was
$1.6 million and $1.7 million for the six months ended
June 30, 2018 and 2017, respectively.
As of June 30, 2018, Curis's cash, cash equivalents,
marketable securities and investments totaled $40.4 million and there were approximately 33.2
million shares of common stock outstanding.
Recent Operational Highlights
Precision oncology, fimepinostat (formerly CUDC-907):
- Fimepinostat received Fast Track designation from the FDA for
development in adult patients with relapsed or refractory DLBCL
after two or more lines of systemic therapy.
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene
collaboration):
- Patient enrollment remained on track for the Phase 1 dose
escalation trial evaluating CA-170 in patients with advanced solid
tumors or lymphomas.
- Curis collaborator Aurigene continued to enroll patients in a
Phase 2 clinical study of CA-170 at select trial sites in
India.
- Investigators have recently identified that mesothelioma tumor
samples express high levels of VISTA immune checkpoint
protein. We are extending our current Phase 1 trial to enroll
a cohort of patients with mesothelioma.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene
collaboration):
- Curis continued to enroll patients with relapsed or refractory
non-Hodgkin lymphoma in a Phase 1 clinical trial evaluating
CA-4948, a novel oral, small molecule IRAK4 kinase Inhibitor that
has shown potent in vivo anti-tumor activity in preclinical
animal models.
- We have recently generated non-clinical data that demonstrate
CA-4948 is active in in vivo models of AML. We are extending
our current Phase 1 clinical trial to enroll a cohort of patients
with AML.
Recent Corporate Highlights
- Robert Martell, M.D., Ph.D., a
practicing oncologist and experienced drug developer, was appointed
Head of Research and Development and will directly manage the
day-to-day operations of clinical development and research.
- Curis announced a 1-for-5 reverse stock split reducing the
number of Curis's outstanding common stock from approximately 165.6
million to approximately 33.1 million on March 29, 2018, the date of the reverse
split.
Upcoming Activities
- Curis anticipates providing an outline of the clinical
development path for fimepinostat in 2H 2018.
- Curis and collaborator Aurigene expect to provide additional
updates in 2H 2018 on the clinical progress of CA-170, which is
currently being evaluated in one Phase 1 and one Phase 2
study.
- Curis expects to provide an update in 2H 2018 on the progress
of CA-4948, which is currently being evaluated in a Phase 1 trial
in patients with advanced lymphomas.
Conference Call Information
Curis management will host a conference call today, August 2, 2018, at 8:30
a.m. EDT, to discuss these financial results, as well as
provide a corporate update.
To access the live conference call, please dial 1-888-346-6389
(United States) or 1-412-317-5252
(International), shortly before 8:30 a.m.
EDT. The conference call can also be accessed on the Curis
website at www.curis.com in the Investors section. A replay of the
call will be available on the Curis website shortly after the
commencement of the meeting.
About Curis, Inc.
Curis is a biotechnology company focused on the development and
commercialization of innovative therapeutics for the treatment of
cancer, including fimepinostat, which is being investigated in
clinical studies in patients with DLBCL 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
antagonists of immune checkpoints including, the PDL1/VISTA
antagonist CA-170, and the PDL1/TIM3 antagonist CA-327, as well as
the IRAK4 kinase inhibitor, CA-4948. CA-170 is currently undergoing
testing in a Phase 1 trial in patients with advanced solid tumors
and lymphomas, and in a Phase 2 trial in India conducted by Aurigene. CA-4948 is
currently undergoing testing in a Phase 1 trial in patients with
non-Hodgkin 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 U.S. 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 fimepinostat, CA-170, and CA-4948, 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 fimepinostat.
Forward-looking statements may contain the words "believes,"
"expects," "anticipates," "plans," "intends," "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
|
|
Six months
ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
2,394
|
|
|
$
|
2,102
|
|
|
$
|
4,868
|
|
|
$
|
4,294
|
|
Research and
development, net
|
|
(36)
|
|
|
(41)
|
|
|
(42)
|
|
|
(102)
|
|
Total
revenues:
|
|
2,358
|
|
|
2,061
|
|
|
4,826
|
|
|
4,192
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Costs of royalty
revenues
|
|
134
|
|
|
96
|
|
|
263
|
|
|
207
|
|
Research and
development
|
|
6,451
|
|
|
11,255
|
|
|
14,717
|
|
|
24,795
|
|
General and
administrative
|
|
3,633
|
|
|
3,819
|
|
|
7,614
|
|
|
7,351
|
|
Total operating
expenses
|
|
10,218
|
|
|
15,170
|
|
|
22,594
|
|
|
32,353
|
|
|
|
|
|
|
|
|
|
|
Net loss from
operations
|
|
(7,860)
|
|
|
(13,109)
|
|
|
(17,768)
|
|
|
(28,161)
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(104)
|
|
Interest
income
|
|
189
|
|
|
138
|
|
|
375
|
|
|
208
|
|
Interest
expense
|
|
(993)
|
|
|
(1,119)
|
|
|
(2,018)
|
|
|
(1,775)
|
|
Other expense,
net
|
|
(804)
|
|
|
(981)
|
|
|
(1,643)
|
|
|
(1,671)
|
|
Net loss
|
|
(8,664)
|
|
|
(14,090)
|
|
|
(19,411)
|
|
|
(29,832)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.26)
|
|
|
$
|
(0.49)
|
|
|
$
|
(0.59)
|
|
|
$
|
(1.04)
|
|
Basic and diluted
weighted average common shares outstanding
|
|
33,135,391
|
|
|
28,757,341
|
|
|
33,094,772
|
|
|
28,580,828.8
|
|
CURIS,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
|
(In
thousands)
|
|
|
|
June
30, 2018
|
|
December 31,
2017
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
40,420
|
|
|
$
|
60,232
|
|
Investments –
restricted
|
|
153
|
|
|
153
|
|
Accounts
receivable
|
|
2,505
|
|
|
3,073
|
|
Property and
equipment, net
|
|
352
|
|
|
366
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expense and
other assets
|
|
779
|
|
|
992
|
|
Total
assets
|
|
$
|
53,191
|
|
|
$
|
73,798
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
7,584
|
|
|
$
|
8,250
|
|
Debt obligations,
net
|
|
38,497
|
|
|
41,555
|
|
Total
liabilities
|
|
46,081
|
|
|
49,805
|
|
Total stockholders'
equity
|
|
7,110
|
|
|
23,993
|
|
Total liabilities and
stockholders' equity
|
|
$
|
53,191
|
|
|
$
|
73,798
|
|
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SOURCE Curis, Inc.