Full Press Release Details
Reports Fourth Quarter and Year-End 2008 Financial Results
Call to be Held Today at 9:00 a.m. EST
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 10, 2009--Curis, Inc.
(NASDAQ:CRIS), a drug development company seeking to develop next
generation proprietary targeted medicines for cancer treatment, today
reported its financial results for the fourth quarter and fiscal year
ended December 31, 2008.
"The fourth quarter and early 2009 have been important periods for
Curis, as our collaborator Genentech initiated a Phase II trial of
GDC-0449 in advanced ovarian cancer and announced plans to initiate a
pivotal Phase II clinical trial in advanced basal cell carcinoma in
early 2009. These trials provide Curis with a meaningful source of
non-dilutive capital. We received $3 million following the December 2008
initiation of the ovarian cancer trial and will receive an additional $6
million following the initiation of the advanced basal cell carcinoma
trial, which is expected to begin shortly," said Mike Gray, Curis' Chief
Operating and Chief Financial Officer. "We expect that our current
capital resources, combined with this expected $6 million payment, are
sufficient to fund our planned operations into at least mid-2010. In
addition, our strategy is to consummate at least one corporate
collaboration or licensing transaction for CUDC-101, CUDC-305 or another
of our proprietary cancer programs in 2009. If we are able to
successfully enter into an arrangement for at least one of these
programs, we expect that payments received in such an arrangement would
further extend our ability to finance our operations."
"We continue to execute on our strategic plan and believe that we remain
in a strong position to advance our business as our proprietary programs
also continue to make excellent progress," said Dan Passeri, Curis'
President and Chief Executive Officer. "We have opened for enrollment
the third cohort of our Phase I dose-escalation trial of CUDC-101, our
first-in-class HDAC, EGFR and Her2 inhibitor, and we expect that
additional positive data from this trial would continue to generate
interest from potential collaborators in this compound and in our other
multi-targeted cancer programs."
Mr. Passeri continued, "In addition, IND-enabling toxicology studies for
CUDC-305, our Hsp90 inhibitor, are near completion and preliminary data
suggests that CUDC-305 has a favorable safety profile. We believe that
this safety data is a key metric to potential partners for this target,
and once the final data is in hand, we plan to accelerate our
discussions with potential partners for this molecule."
For the fourth quarter of 2008, Curis reported a net loss of $2.2
million or ($0.03) per share, as compared to net income of $4.3 million
or $0.07 per share for the same period in the prior year.
Revenues for the fourth quarter of 2008 were $3.1 million as compared to
$11.5 million for the same period in the prior year, a decrease of 73%.
Revenues under research and development contracts were $100,000 for the
fourth quarter of 2008 as compared to $500,000 for the same period in
the prior year. This decrease was primarily the result of the conclusion
of Curis' collaboration with Procter & Gamble in November 2007 and the
termination of its Hedgehog agonist collaboration with Wyeth in February
2008. Curis recognized $3.0 million in license revenues during the
fourth quarter of 2008 related to receipt of a contractual payment from
Genentech for the initiation of a Phase II clinical trial of GDC-0449 in
advanced ovarian cancer under its June 2003 Hedgehog pathway inhibitor
collaboration, as compared to $11.0 million of license revenues for the
same period in the prior year. During the fourth quarter of 2007, Curis
recognized $10.5 million in license revenue under this same
collaboration with Genentech, primarily resulting from a change in the
estimated performance period under this collaboration.
Operating expenses for the fourth quarter of 2008 were $5.4 million as
compared to $7.7 million for the same period in the prior year, a
decrease of 30%. In October 2008, Curis implemented spending reductions
in various preclinical research and general and administrative areas.
Research and development spending was $3.5 million for the fourth
quarter of 2008 as compared to $5.2 million for the same period in the
prior year, a decrease of 33%. The decrease is attributable to
decreased spending of $400,000 under Curis' former collaboration with
Wyeth as well as decreased spending of $600,000 on the Company's
targeted cancer programs, primarily related to toxicology testing of
CUDC-101 that occurred during the fourth quarter of 2007 in support of
the IND application that was filed in May 2008. Also included in the
fourth quarter 2007 research and development expenses was a $750,000
license fee payment to a former collaborator as a result of Curis'
December 2007 BMP-7 transaction with Stryker Corporation.
General and administrative spending was $1.9 million for the fourth
quarter of 2008 as compared to $2.4 million for the same period in the
prior year, a decrease of 21%. The decrease in general and
administrative expenses was primarily due to decreases in stock-based
compensation, personnel costs and legal fees resulting from the
spending reductions implemented during October 2008.
For the year-ended December 31, 2008, Curis reported a net loss of $12.1
million or ($0.19) per share, as compared to a net loss of $7.0 million
or ($0.13) per share for the prior year.
Revenues for the year ended December 31, 2008 were $8.4 million as
compared to $16.4 million for the same period in the prior year, a
Operating expenses were $21.5 million for the year ended December 31,
2008, as compared to $24.8 million for the prior year, a decrease of
13%. Research and development expenses were $13.2 million for the year
ended December 31, 2008, as compared to $14.8 million for the prior
year, a decrease of 11%. General and administrative expenses were $8.3
million for the year ended December 31, 2008, as compared to $10.0
million for the prior year, a decrease of 17%.
As of December 31, 2008, Curis' cash, cash equivalents and marketable
securities totaled $28.9 million, and there were 63,653,698 shares of
common stock outstanding.
2009 Curis Objectives
Curis also announced its clinical and business objectives for 2009.
Genentech's advancement of GDC-0449, including the planned initiation
of a pivotal Phase II trial of GDC-0449 in advanced basal cell
carcinoma in February 2009. Initiation of this trial will result in a