Full Press Release Details
Reports Second Quarter 2010 Financial Results
Conference call to be held today at 9:00 am EDT --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 3, 2010--Curis, Inc.
(NASDAQ:CRIS), a drug development company seeking to develop next
generation targeted small molecule drug candidates for cancer treatment,
today reported its financial results for the second quarter ended June
"Although we were disappointed to announce during the second quarter of
2010 that the topline results from Genentech and Roche's Phase II
clinical trial with the hedgehog pathway inhibitor GDC-0449 in
metastatic colorectal cancer indicated that the trial did not meet its
primary endpoint, we are encouraged that Genentech is testing GDC-0449
in two additional tumor types, which should provide more information on
its potential in cancers where we believe the Hedgehog pathway acts via
different mechanisms of action," said Dan Passeri, Curis' President and
Chief Executive Officer. "We expect that results will be available from
the Phase II advanced ovarian cancer trial in the very near term and
that we will communicate the topline results within August. In addition,
Roche has indicated that it expects results from the pivotal
Phase II clinical trial in advanced basal cell carcinoma during the
first half of 2011 and that it plans to initiate a Phase II clinical
trial in operable basal cell carcinoma patients during the second half
Mr. Passeri continued, "We also have continued to make progress with our
other drug candidates, including CUDC-101, for which we recently
completed our Phase I dose escalation study, initiated a Phase Ib
expansion trial in patients with advanced, refractory head and neck,
gastric, breast and liver cancers, and plan to begin a Phase I/II
clinical trial in head and neck cancer. Also during the second quarter,
our licensee Debiopharm initiated a Phase I clinical trial of Hsp90
inhibitor Debio 0932, and we earned $3 million in July upon Debiopharm's
treatment of the fifth patient in this study. Lastly, we continue to
progress our preclinical research efforts and anticipate that we will
select a new development candidate during the second half of 2010."
For the second quarter of 2010, Curis reported a net loss of $2.1
million, or ($0.03) per share on both a basic and fully diluted share
outstanding basis, as compared to a net loss of $4.2 million or ($0.07)
per share on both a basic and fully diluted share outstanding basis for
the same period in 2009.
Revenues for the second quarter of 2010 were $99,000 as compared to
$63,000 for the same period in 2009.
Operating expenses for the second quarter of 2010 were $4.0 million as
compared to $4.3 million for the same period in 2009.
Research and development spending was $2.2 million for the second
quarter of 2010 as compared to $2.3 million for the same period in
2009. The decrease is primarily attributable to lower spending on
Debio 0932 as a result of licensing this program to Debiopharm in
August 2009. All subsequent development costs have been assumed by
Debiopharm. Offsetting this decrease, Curis increased spending on
other targeted cancer programs.
General and administrative spending was $1.8 million for the second
quarter of 2010 as compared to $2.0 million for the same period in
2009. The decrease in general and administrative expenses was
primarily due to non-recurring legal costs incurred during the second
quarter of 2009 related to an arbitration proceeding that was settled
during the first quarter of 2010.
Other income of $1.8 million for the second quarter of 2010 represents
the change in the fair value of a warrant liability established in
connection with Curis' January 2010 registered direct offering as a
result of a decrease in Curis' stock price from March 31, 2010 to June
For the six-month period ending June 30, 2010, Curis reported net income
of $2.7 million, or $0.04 per basic share outstanding and $0.03 per
fully diluted share outstanding, as compared to a net loss of $3.1
million or ($0.05) per share on both a basic and fully diluted share
outstanding basis for the same period in 2009.
Revenues for the six months ended June 30, 2010, were $12.7 million as
compared to $6.1 million for the same period in 2009.
Operating expenses were $10.9 million for the six months ended June 30,
2010, as compared to $9.3 million for the same period in 2009. Research
and development expenses were $4.7 million for the six months ended June
30, 2010, as compared to $5.2 million for the same period in 2009.
General and administrative expenses were $6.2 million for the six months
ended June 30, 2010, as compared to $4.1 million for the same period in
Other income of $0.9 million for the six-month period ended June 30,
2010 as compared to $0.2 million for the same period in 2009.
As of June 30, 2010, Curis' cash, cash equivalents and marketable
securities totaled $44.9 million, and there were 75.6 million shares of
common stock outstanding.
Updated Financial Guidance
As a result of lower than anticipated expenses associated with CUDC-101
and other development candidates, Curis expects that research and
development expenses will be between $10 and $13 million. The Company
had previously estimated that these expenses would be between $13 and
$17 million. As a result of lower than anticipated research and
development expenses and a $3 million payment earned under the Company's
license agreement with Debiopharm, Curis expects that its 2010 year end
cash, cash equivalents and marketable securities will be between $38 to
$40 million. The Company had previously estimated that its year end
cash, cash equivalents and marketable securities would be between $30
CUDC-101 (HDAC/EGFR/Her2 Inhibitor)
-- Initiated expansion of Phase Ib expansion clinical trial
In August 2010, Curis initiated a Phase I open-label expansion trial of
CUDC-101 in patients with advanced, refractory head and neck, gastric,
breast and liver cancers. The primary objectives of the Phase Ib
expansion trial are to obtain additional information on the safety and
tolerability of CUDC-101 in this patient population. Secondary
objectives are to assess the pharmacokinetics, to evaluate
pharmacodynamic biomarkers and to assess the efficacy and ability of
CUDC-101 to effectively inhibit HDAC, EGFR and Her2 in this patient
population. The study is expected to be conducted at five to eight
clinical sites within the United States and enroll approximately 40
-- Completed Phase I dose escalation clinical trial