Full Press Release Details
Reports Fourth Quarter and Year-End 2010 Financial Results
Conference call to be held today at 9:00 am EST --
LEXINGTON, Mass.--(BUSINESS WIRE)--February 10, 2011--Curis, Inc.
(NASDAQ:CRIS), a drug development company developing next generation
targeted small molecule drug candidates for cancer treatment, today
reported its financial results for the fourth quarter and fiscal year
ended December 31, 2010.
"We have continued to advance and expand our proprietary pipeline in
2010 and early 2011, completing a Phase I dose escalation study and
initiating a Phase Ib expansion trial of CUDC-101, as well as selecting
new development candidate CUDC-907," said Daniel Passeri, Curis
President and Chief Executive Officer. "Looking forward, we expect that
our collaborator Genentech, a member of the Roche Group, will announce
topline results from its pivotal Phase II clinical study of GDC-0449
(RG3616), a first-in-class Hedgehog pathway inhibitor, in advanced basal
cell carcinoma during the first quarter of 2011. Pending a successful
outcome, Roche has indicated that it anticipates making regulatory
submissions for GDC-0449 in 2011, which would be an historic milestone
"In 2011, we also anticipate further progress on our proprietary
internal programs. For example, we hope to announce data from our
ongoing Phase Ib clinical trial of CUDC-101 and initiate a Phase I dose
escalation study of CUDC-101 in combination with cisplatin and radiation
in head and neck cancer patients. Moreover, assuming the successful
completion of IND-enabling preclinical studies, we expect to file IND
applications for an oral formulation of CUDC-101 and also for CUDC-907,
our novel HDAC and PI3K inhibitor." Mr. Passeri continued. "In addition,
our partner Debiopharm continues to advance its Phase I dose escalation
trial of Hsp90 inhibitor Debio 0932."
For the fourth quarter of 2010, Curis reported a net loss of $5.6
million, or ($0.07) per share, as compared to a net loss of $2.7 million
or ($0.04) per share for the same period in 2009.
Revenues for the fourth quarter of 2010 were $100,000 as compared to
$1.7 million for the same period in 2009. The decrease is primarily due
to the fact that in the fourth quarter of 2009 Curis recognized $1.5
million in revenue related to the Company's August 2009 license
agreement with Debiopharm.
Operating expenses for the fourth quarter of 2010 were $5.7 million as
compared to $4.5 million for the same period in 2009.
Research and development spending was $3.7 million for the fourth
quarter of 2010 as compared to $2.4 million for the same period in
2009. The increase is primarily attributable to increased spending
associated with the Company's ongoing Phase Ib expansion trial of
General and administrative spending was $2.1 million for the fourth
quarter of 2010 as compared to $2.0 million for the same period in
2009. This increase is primarily due to an increase in
occupancy-related costs associated with the Company's facility move to
Lexington, Massachusetts in December 2010.
Other income for the fourth quarter of 2010 consisted primarily of
federal tax grants totaling $500,000 that Curis was awarded pursuant to
the qualifying therapeutic discovery project tax credit program
implemented by the IRS under the Patient Protection and Affordable Care
Act of 2010. Offsetting other income was an increase in the fair value
of the warrant liability associated with the Company's issuance of
warrants pursuant to its registered direct offering in January 2010,
resulting in a charge of $500,000 for the fourth quarter of 2010.
For the year ended December 31, 2010, Curis reported a net loss of $4.4
million or ($0.06) per share, as compared to a net loss of $9.8 million
or ($0.15) per share for the same period in 2009.
Revenues for the year ended December 31, 2010 were $16.0 million as
compared to $8.6 million for the same period in 2009. The increase is
primarily due to $11 million in license fee revenue that the Company
earned in 2010 from Debiopharm in connection with the acceptance by
regulatory authorities of Debiopharm's clinical trial application and
the treatment of the fifth patient in its ongoing Phase I clinical trial
of Debio 0932. Revenues for the year ended December 31, 2010 also
included $4 million in proceeds pursuant to a settlement agreement the
Company entered into with a third party in February 2010. Revenues for
the year ended December 31, 2009 were primarily comprised of a $6
million contingent payment the Company received from Genentech for
Genentech's initiation of a pivotal Phase II clinical trial in advanced
basal cell carcinoma (BCC) and $2.2 million related to the Company's
license agreement with Debiopharm.
Operating expenses were $21.6 million for the year ended December 31,
2010, as compared to $18.6 million for the same period in 2009.
Research and development expenses were $11.4 million for the year
ended December 31, 2010, as compared to $9.9 million for the same
period in 2009. This increase was primarily the result of increased
spending on outside services and clinical costs related to the
Company's CUDC-101 program.
General and administrative expenses were $10.3 million for the year
ended December 31, 2010, as compared to $8.7 million for the same
period in 2009. This increase was primarily due to approximately
$800,000 in increased spending for legal services related to
arbitration proceedings in 2010 as compared to 2009 and increased
personnel costs of $500,000 relating to short-term incentive
compensation payments made to the Company's executive officers as well
as the elimination of executive officer pay reductions that were
implemented in 2008.
Other income of $1.2 million for the year ended December 31, 2010 was
primarily comprised of a $600,000 gain related to the change in the fair
value of the Company's warrant liability and the receipt of $500,000 in
federal tax grant proceeds. Other income was $200,000 for the year ended
As of December 31, 2010, Curis' cash, cash equivalents and marketable
securities totaled $40.4 million and there were 75.8 million shares of
common stock outstanding.
CUDC-907 selected as development candidate
In January 2011, Curis selected CUDC-907, an orally available, synthetic
small molecule inhibitor of phosphatidylinositol-3-kinase (PI3K) and
histone deacetylase (HDAC) as a development candidate from its
network-targeted cancer programs. Activation of the PI3K signaling