Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the
development and commercialization of innovative and effective drug
candidates for the treatment of human cancers, reported today its
financial results for the second quarter ended June 30, 2017.
Curis also reported today data from the interim analysis of the
Phase 2 trial of CUDC-907 in patients with MYC-altered DLBCL.
Of the 36 evaluable patients with MYC-altered DLBCL in the
interim analysis, 7 patients experienced confirmed durable
objective responses (19.4% ORR), including 3 with complete
responses. In addition, and consistent with the original
hypothesis, all 7 responders in the Phase 2 study had MYC-altered
disease, while no objective responses were observed in 12 patients
with MYC-negative disease status.
“The ability of CUDC-907 treatment to result in durable complete
responses, and the continued correlation of this benefit
selectively in patients with MYC-altered disease, is encouraging
for the continued development of CUDC-907,” said Ali Fattaey,
President and CEO. “While we believe the results from this Phase 2
trial are insufficient to serve as the basis of a request for
accelerated approval of CUDC-907, we are evaluating alternative
designs for a separate registration-enabling trial to demonstrate
CUDC-907’s benefit for patients with MYC-altered DLBCL.”
"The reported response rate is impressive, especially in this
population of patients with relapsed/refractory MYC-altered
lymphomas who rarely respond to salvage therapies," said Dr. Daniel
J. Landsburg, Assistant Professor of Clinical Medicine at the
Abramson Cancer Center at the Hospital of the University of
Pennsylvania. "I believe this agent warrants continued
investigation."
Second Quarter 2017 Financial Results
Curis reported a net loss of $14.1 million, or $0.10 per share,
on both a basic and diluted basis for the second quarter of 2017,
as compared to a net loss of $11.3 million, or $0.09 per share, on
both a basic and diluted basis for the same period in
2016. Curis reported a net loss of $29.8 million, or $0.21 per
share, on both a basic and diluted basis for the six months ended
June 30, 2017, as compared to a net loss of $20.7 million, or
$0.16 per share on both a basic and diluted basis for the same
period in 2016.
Revenues for the second quarter of 2017 were $2.1 million, as
compared to $1.7 million for the same period in 2016. Revenues for
the six months ended June 30, 2017 were $4.2 million, as
compared to $3.4 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®.
Operating expenses were $15.2 million for the second quarter of
2017, as compared to $12.4 million for the same period in 2016.
Operating expenses for the six months ended June 30, 2017 were
$32.4 million, as compared to $22.9 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 $0.1
million for both the second quarter of 2017 and 2016. Cost of
royalty revenues for the six months ended June 30, 2017 and
2016 were $0.2 million for both periods.
Research and Development Expenses. Research and
development expenses were $11.3 million for the second quarter of
2017, as compared to $8.8 million for the same period in 2016. The
increase was primarily due to increased direct spending related to
clinical activities of CUDC-907 and CA-170 and increased
employee-related expenses primarily due to additional headcount to
support the multiple programs. Research and development expenses
were $24.8 million for the six months ended June 30, 2017 as
compared to $15.7 million for the same period in 2016.
General and Administrative Expenses. General and
administrative expenses were $3.8 million for the second quarter of
2017 as compared to $3.4 million for the same period in 2016. The
increase in general and administrative expenses was driven
primarily by higher personnel costs and stock-based compensation
expense due to increased headcount. General and administrative
expenses were $7.4 million for the six months ended June 30,
2017, as compared to $7.1 million for the same period in prior
2016.
Other expense, net was $1.0 million for the second quarter of
2017, as compared to $0.6 million for the same period in 2016.
Other expense, net primarily consisted of interest expense related
to Curis Royalty's (a wholly owned subsidiary of Curis) debt
obligations. Other expense, net was $1.7 million and $1.2 million
for the six months ended June 30, 2017 and 2016,
respectively.
As of June 30, 2017, Curis's cash, cash equivalents,
marketable securities and investments totaled $51.0 million and
there were approximately 143.9 million shares of common stock
outstanding. On a fully-diluted basis, which includes 18.6
million options, there were 162.5 million shares outstanding.
Recent Operational Highlights
Precision oncology (CUDC-907: HDAC / PI3K inhibitor
program):
The following summarizes the CUDC-907 Phase 1 trial results and
Phase 2 interim analysis:
http://www.globenewswire.com/NewsRoom/AttachmentNg/00057193-8320-464f-ad49-fb2f9a7263ce
Immuno-oncology (CA-170: PD-L1 / VISTA antagonist
program; Aurigene collaboration):
- In May 2017, Curis presented the CA-170 Phase 1
trials-in-progress poster at the 2017 American Society of Clinical
Oncology (ASCO) Annual Meeting.
Upcoming Activities
Curis expects that it will make presentations at the following
conferences through September 2017:
- CA-170 poster presentation at the European Society for Medical
Oncology (ESMO) Conference (Sept. 8-12, 2017) in Madrid.
Conference Call Information
Curis management will host a conference call today,
August 3, 2017, at 8:30 a.m. EDT to discuss these financial
results and provide a corporate update.
To access the live conference call please dial (877) 868-1829
from the United States or (253) 237-1135 from other locations
shortly before 8:30 a.m. EDT. The conference ID number is 61970970.
The conference call can also be accessed on the Curis website at
www.curis.com in the Investors section.
About Curis
Curis is a biotechnology company focused on the development and
commercialization of innovative and effective drug candidates for
the treatment of human cancers, including its lead development
candidate, CUDC-907 which is being investigated in clinical studies
in patients with lymphomas and solid tumors. Curis is also engaged
in a broad 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 the PD1 and VISTA pathways, including PDL1/VISTA
antagonist CA-170, and oral small molecule antagonists of the PD1
and TIM3 pathways, 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. 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, and
are further developing Erivedge in myelofibrosis. 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 |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Revenues: |
|
|
|
|
|
|
|
|
Royalties |
|
$ |
2,102 |
|
|
$ |
1,842 |
|
|
$ |
4,294 |
|
|
$ |
3,586 |
|
Research
and development, net |
|
(41 |
) |
|
(162 |
) |
|
(102 |
) |
|
(180 |
) |
Total
revenues: |
|
2,061 |
|
|
1,680 |
|
|
4,192 |
|
|
3,406 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Costs of
royalty revenues |
|
96 |
|
|
95 |
|
|
207 |
|
|
184 |
|
Research
and development |
|
11,255 |
|
|
8,822 |
|
|
24,795 |
|
|
15,650 |
|
General
and administrative |
|
3,819 |
|
|
3,443 |
|
|
7,351 |
|
|
7,059 |
|
Total
operating expenses |
|
15,170 |
|
|
12,360 |
|
|
32,353 |
|
|
22,893 |
|
|
|
|
|
|
|
|
|
|
Net loss from
operations |
|
(13,109 |
) |
|
(10,680 |
) |
|
(28,161 |
) |
|
(19,487 |
) |
|
|
|
|
|
|
|
|
|
Other (expense)
income |
|
- |
|
|
- |
|
|
(104 |
) |
|
- |
|
Interest income |
|
138 |
|
|
119 |
|
|
208 |
|
|
224 |
|
Interest expense |
|
(1,119 |
) |
|
(729 |
) |
|
(1,775 |
) |
|
(1,468 |
) |
Other expense, net |
|
(981 |
) |
|
(610 |
) |
|
(1,671 |
) |
|
(1,244 |
) |
Net
loss |
|
(14,090 |
) |
|
(11,290 |
) |
|
(29,832 |
) |
|
(20,731 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share |
|
$ |
(0.10 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.16 |
) |
Basic and diluted
weighted average common shares outstanding |
|
143,786,705 |
|
|
129,270,639 |
|
|
142,904,144 |
|
|
129,142,989 |
|
|
|
CURIS, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(UNAUDITED) |
(In thousands) |
|
|
|
June 30, 2017 |
|
December 31, 2016 |
ASSETS |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
51,042 |
|
|
$ |
44,485 |
|
Investments –
restricted |
|
153 |
|
|
153 |
|
Accounts
receivable |
|
2,231 |
|
|
2,459 |
|
Property and equipment,
net |
|
426 |
|
|
413 |
|
Goodwill |
|
8,982 |
|
|
8,982 |
|
Prepaid expenses and
other assets |
|
961 |
|
|
1,260 |
|
Total
assets |
|
$ |
63,795 |
|
|
$ |
57,752 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
Accounts payable,
accrued expenses and other liabilities |
|
$ |
10,682 |
|
|
$ |
8,626 |
|
Debt obligations,
net |
|
43,885 |
|
|
19,860 |
|
Total
liabilities |
|
54,567 |
|
|
28,486 |
|
Total stockholders'
equity |
|
9,228 |
|
|
29,266 |
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
63,795 |
|
|
$ |
57,752 |
|
|
For More Information:
James E. Dentzer
Chief Financial Officer & Chief Administrative Officer
Curis, Inc.
617-503-6500
jdentzer@curis.com
Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
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