LEXINGTON, Mass., Nov. 1,
2018 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a
biotechnology company focused on the development of innovative
therapeutics for the treatment of cancer, today reported financial
results for the third quarter ended September 30, 2018.
"Following Curis's recent leadership change, we are increasing
our focus on the clinical execution of our three first-in-class
therapeutics that have the potential to be significant and
innovative cancer treatments. We expect all three drug candidates
to progress rapidly in the clinic and have data readouts in 2019,"
said James Dentzer, President &
Chief Executive Officer of Curis. "To achieve this goal, we are
re-allocating resources to prioritize clinical operations and have
implemented a reduction in headcount and expenditure on
pre-clinical science, pipeline expansion, and general and
administrative expenses. We expect these reductions will offset an
increase in headcount and costs associated with clinical operations
and result in net savings for the Company, reducing cash burn from
approximately $11 million to
$8 million per quarter. This renewed
focus on clinical execution will benefit patients in need of
life-changing medications and shareholders alike," Mr. Dentzer
concluded.
Third Quarter 2018 Financial Results
Curis reported a net loss of $7.2
million, or $0.22 per share on
a basic and diluted basis for the third quarter of 2018, as
compared to a net loss of $15.5
million, or $0.53 per share
respectively for the same period in 2017.
Revenues for the third quarter of 2018 were $2.8 million, as compared to $2.4 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 $9.3
million for the third quarter of 2018, as compared to
$16.9 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 $0.2 million as compared to
$0.1 million for the same period in
2017.
Research and Development Expenses. Research and
development expenses were $5.0
million, as compared to $13.4
million for the same period in 2017. The decrease was
primarily driven by decreased costs related to clinical activities
and manufacturing for fimepinostat, CA-170 and CA-4948 and a
payment to Aurigene of $3.8 million
for an exclusivity option in September
2017.
General and Administrative Expenses. General and
administrative expenses were $4.1
million as compared to $3.4
million for the same period in 2017. The increase in general
and administrative expenses was primarily driven by higher
personnel costs and professional and consulting services partially
offset by lower stock-based compensation for the period.
Other Expenses. Net other expenses 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.
As of September 30, 2018, Curis's cash, cash equivalents
and investments totaled $30.8 million
and there were approximately 33.1 million shares of common stock
outstanding.
Recent Operational Highlights
Precision oncology, fimepinostat (formerly CUDC-907):
- Having received Fast Track designation for fimepinostat, Curis
is working with the FDA and select clinical sites to initiate a
combination study of fimepinostat (a MYC inhibitor) with venetoclax
(a BCL-2 inhibitor) in DLBCL, including patients with DH/DE
Lymphoma.
- DLBCL with alterations in both the MYC gene and the BCL2 gene
is defined as Double-Hit Lymphoma. In preclinical studies, the
combination of fimepinostat with venetoclax has demonstrated highly
synergistic effect, resulting in significant tumor size
reduction.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene
collaboration):
- Curis continues to enroll patients with relapsed or refractory
non-Hodgkin lymphoma in a dose escalation study evaluating CA-4948,
a first-in-class oral, small molecule IRAK4 kinase inhibitor.
CA-4948 is designed to target cancers with MYD88 mutations in DLBCL
and Waldenström's macroglobulinemia.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene
collaboration):
- Patient treatment continues in the dose escalation study
evaluating CA-170 in patients with advanced solid tumors or
lymphomas.
- Curis is working with select clinical sites to initiate a study
of CA-170 in patients with mesothelioma, following evidence of
mesothelioma tumor samples expressing high levels of VISTA. Recent
publications have identified VISTA as a possible resistance
mechanism to treatment with anti-PD1 antibodies in several cancer
indications.
- Curis collaborator Aurigene continues to enroll immunotherapy
treatment-naïve patients in a clinical study of CA-170 at select
trial sites in India.
Recent Corporate Highlights
- In September, Curis announced change in leadership with the
appointment of James Dentzer to the
position of President and Chief Executive Officer.
- In October, Curis implemented a 27% reduction in headcount and
a re-allocation of pre-clinical resources to strengthen focus on
clinical development. The Company expects the net result of expense
reductions in pre-clinical R&D and G&A and targeted
increases in clinical operations to result in a total cash burn
reduction from approximately $11
million to $8 million per
quarter going forward.
Upcoming Activities
- Curis will provide an update on the dose escalation study of
CA-170 at the annual SITC conference in November.
2019 Data Catalysts
- Curis expects to commence enrollment in a combination study
evaluating a fimepinostat and venetoclax regimen in patients with
R/R DLBCL, including patients with DH/DE Lymphoma, in the first
half of 2019 and report initial data in the second half of
2019.
- Curis expects to report initial data from an ongoing dose
escalation study evaluating CA-4948 in patients with R/R DLBCL and
WM, including patients with MYD88-altered disease, by mid-year
2019.
- Curis expects to commence enrollment in a clinical study
evaluating CA-170 in patients with mesothelioma (high VISTA
expressors) in the first half of 2019 and report initial data in
the second half of 2019.
Conference Call Information
Curis management will host a conference call today, November 1, 2018, at 8:30
a.m. ET, 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.
ET. 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 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 VISTA/PDL1 antagonist CA-170, and the
TIM3/PDL1 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-4948, CA-170, 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," "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
|
|
Nine months
ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
2,781
|
|
|
$
|
2,412
|
|
|
$
|
7,649
|
|
|
$
|
6,706
|
|
Research and
development, net
|
|
66
|
|
|
32
|
|
|
24
|
|
|
(70)
|
|
Total
revenues:
|
|
2,847
|
|
|
2,444
|
|
|
7,673
|
|
|
6,636
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Costs of royalty
revenues
|
|
154
|
|
|
124
|
|
|
417
|
|
|
331
|
|
Research and
development
|
|
4,983
|
|
|
13,382
|
|
|
19,700
|
|
|
38,177
|
|
General and
administrative
|
|
4,127
|
|
|
3,409
|
|
|
11,741
|
|
|
10,760
|
|
Total operating
expenses
|
|
9,264
|
|
|
16,915
|
|
|
31,858
|
|
|
49,268
|
|
|
|
|
|
|
|
|
|
|
Net loss from
operations
|
|
(6,417)
|
|
|
(14,471)
|
|
|
(24,185)
|
|
|
(42,632)
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(104)
|
|
Interest
income
|
|
166
|
|
|
123
|
|
|
541
|
|
|
331
|
|
Interest
expense
|
|
(972)
|
|
|
(1,109)
|
|
|
(2,990)
|
|
|
(2,884)
|
|
Other expense,
net
|
|
(806)
|
|
|
(986)
|
|
|
(2,449)
|
|
|
(2,657)
|
|
Net loss
|
|
(7,223)
|
|
|
(15,457)
|
|
|
(26,634)
|
|
|
(45,289)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.22)
|
|
|
$
|
(0.53)
|
|
|
$
|
(0.80)
|
|
|
$
|
(1.57)
|
|
Basic and diluted
weighted average common shares outstanding
|
|
33,161,592
|
|
|
29,302,839
|
|
|
33,117,290
|
|
|
28,824,143
|
|
CURIS,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
|
(In
thousands)
|
|
|
|
September 30,
2018
|
|
December 31,
2017
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
30,833
|
|
|
$
|
60,232
|
|
Investments –
restricted
|
|
153
|
|
|
153
|
|
Accounts
receivable
|
|
2,855
|
|
|
3,073
|
|
Property and
equipment, net
|
|
312
|
|
|
366
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expense and
other assets
|
|
1,130
|
|
|
992
|
|
Total
assets
|
|
$
|
44,265
|
|
|
$
|
73,798
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
6,337
|
|
|
$
|
8,250
|
|
Debt obligations,
net
|
|
37,146
|
|
|
41,555
|
|
Total
liabilities
|
|
43,483
|
|
|
49,805
|
|
Total stockholders'
equity
|
|
782
|
|
|
23,993
|
|
Total liabilities and
stockholders' equity
|
|
$
|
44,265
|
|
|
$
|
73,798
|
|
View original
content:http://www.prnewswire.com/news-releases/curis-reports-third-quarter-2018-financial-results-300741716.html
SOURCE Curis, Inc.