Full Press Release Details
Reports Third Quarter 2009 Financial Results
Conference call to be held today at 9:00 am EDT --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 29, 2009--Curis, Inc.
(NASDAQ:CRIS), a drug development company seeking to develop proprietary
targeted medicines for cancer treatment, today reported its financial
results for the third quarter ended September 30, 2009.
"The third quarter of 2009 was significant for Curis, as we entered into
a license agreement with Debiopharm for our novel Hsp90 technologies and
announced the publication of highly encouraging Phase I clinical data on
GDC-0449, a Hedgehog pathway inhibitor under collaboration with
Genentech, in the New England Journal of Medicine," said Dan
Passeri, Curis President and Chief Executive Officer. "With such
accomplished collaborators as Genentech and Debiopharm progressing
assets under our respective collaborations, we are now squarely focused
on the continued development of CUDC-101, our first-in-class
HDAC/EGFR/Her2 inhibitor, which is representative of our proprietary
preclinical multi-targeted cancer programs."
For the third quarter of 2009, Curis reported a net loss of $4.1 million
or ($0.06) per share, as compared to a net loss of $4.6 million or
($0.07) per share for the same period in 2008.
Revenues for the third quarter of 2009 were $800,000 as compared to
$100,000 for the same period in 2008. The increase in revenues from the
prior year period was due to license fee revenues recognized under the
Company's August 2009 license agreement with Debiopharm.
Operating expenses were $4.9 million in each of the third quarters of
2009 and 2008, respectively.
Research and development spending was $2.3 million for the third
quarter of 2009 as compared to $3.0 million for the same period in
2008. The decrease is primarily attributable to lower spending on
Curis' CUDC-305 program as a result of licensing this program to
Debiopharm on August 5, 2009, which resulted in all subsequent
development costs being assumed by Debiopharm. Offsetting this
decrease, Curis increased spending on other preclinical targeted
cancer programs as the Company continued to seek to select additional
preclinical candidates for future development.
General and administrative spending was $2.6 million for the third
quarter of 2009 as compared to $1.9 million for the same period in
2008. The increase in general and administrative expenses was
primarily due to business development efforts to support the Curis'
Heat Shock Protein, or Hsp90, inhibitor technology licensing efforts
and legal services associated with various corporate matters. In
addition, personnel costs increased for the quarter ended September
30, 2009 as compared to the prior year.
For the nine-month period ending September 30, 2009, Curis reported a
net loss of $7.1 million or ($0.11) per share, as compared to a net loss
of $10.0 million or ($0.16) per share for the same period in the prior
Revenues for the nine months ended September 30, 2009, were $6.9 million
as compared to $5.3 million for the same period in 2008.
Operating expenses were $14.2 million for the nine months ended
September 30, 2009, as compared to $16.1 million for the same period in
2008. Research and development expenses were $7.5 million for the nine
months ended September 30, 2009, as compared to $9.7 million for the
same period in 2008. General and administrative expenses were $6.7
million for the nine months ended September 30, 2009, as compared to
$6.4 million for the same period in 2008.
As of September 30, 2009, Curis' cash, cash equivalents and marketable
securities totaled $27.2 million, and there were 66.5 million shares of
common stock outstanding.
Third Quarter Highlights
-- Exclusive License Agreement with Debiopharm Covering Hsp90
In August 2009, Curis entered into a worldwide, exclusive license
agreement with Debiopharm, for Curis' Hsp90 technology, including
CUDC-305, the company's lead Hsp90 inhibitor development candidate.
Under the agreement, Debiopharm has assumed all future development
responsibility and will incur all future costs related to the licensed
Hsp90 technology. Curis received a $2 million up-front license fee and
expects to receive additional near-term payments, including a payment
upon the acceptance of Debiopharm's application to begin Phase I
clinical trials and upon treatment of the fifth patient in the first
Phase I clinical trial. The up-front and near term payments under this
transaction are expected to provide Curis with capital to fund its
planned operations into the second half of 2011. Curis is eligible to
receive additional contingent payments assuming the successful
achievement of other specified clinical development and regulatory
approval objectives as well as royalties on sales, if any, of any
products that are successfully commercialized by Debiopharm or its
sublicensees. Curis currently expects that Debiopharm will file an
application with regulatory authorities to begin Phase I clinical
testing for this compound, which has been renamed Debio 0932, in the
fourth quarter of 2009.
-- Publication of GDC-0449 Phase I Clinical Data in New England
In September 2009, Curis announced the publication of two articles in The
New England Journal of Medicine (NEJM) that discuss clinical data
generated in Phase I clinical testing of GDC-0449, a Hedgehog pathway
inhibitor under collaboration with Genentech.
The first article reported data on 33 advanced basal cell carcinoma
patients that were treated in the Phase I clinical trial. Of these
patients, 18, or 55%, responded to GDC-0449, including 2 complete
responses and 16 partial responses. Of the remaining 15 patients, 11
patients had stable disease as a best response and 4 patients had
progressive disease. At the time of the data cut-off for the paper, the
median time on study and the median duration of response for these
patients was 9.8 and 8.8 months, respectively, with 19 patients still on
study. The article also summarized safety, pharmacokinetic and
pharmacodynamic data for this patient population.
The second paper discussed symptomatic improvement and rapid but
transient tumor regression observed in an adult medulloblastoma patient
treated with GDC-0449.
Updated 2009 Financial Guidance
Curis expects to end 2009 with cash, cash equivalents and marketable