Full Press Release Details
Reports Fourth Quarter and Year-End 2009 Financial Results
Conference call to be held today at 9:00 am EST --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 25, 2010--Curis, Inc.
(NASDAQ:CRIS), a drug development company seeking to develop proprietary
targeted medicines for cancer treatment, today reported its financial
results for the fourth quarter and fiscal year ended December 31, 2009.
"2009 was an important year for Curis, as we and our collaborators
Genentech and Debiopharm continued to advance the research and
development of our product candidate pipeline. Our strategy is to
develop drug candidates ourselves and with collaborators and believe
that this balanced approach has enabled us to develop a broad portfolio
of targeted small molecule cancer compounds that have the potential to
address substantial unmet needs in cancer," said Dan Passeri, Curis
President and Chief Executive Officer. "We expect that our efforts will
result in several important events for the company in 2010. Notably, our
collaborator Genentech expects to continue its ongoing clinical trials
of GDC-0449, including expecting Phase II data results for GDC-0449 in
metastatic colorectal cancer in the second half of 2010. Genentech and
Roche are also conducting an ongoing Phase II clinical trial in advanced
ovarian cancer as well as a pivotal Phase II study in advanced basal
cell carcinoma, or BCC. Pending a successful outcome of the ongoing
pivotal BCC study, Roche projects that regulatory submissions for
GDC-0449 in advanced basal cell carcinoma could occur in 2011. We also
expect to announce data from our Phase I clinical trial of CUDC-101, our
most advanced internal drug candidate, as well as the initiation by
Debiopharm of a Phase I clinical trial of Debio 0932, an Hsp90 inhibitor
that we licensed to Debiopharm in August 2009. We also plan to select a
new development candidate from our research programs in 2010 to advance
towards an IND filing in 2011. We look forward to providing you with
further updates throughout the year."
For the fourth quarter of 2009, Curis reported a net loss of $2.7
million or ($0.04) per share, as compared to a net loss of $2.2 million
or ($0.03) per share for the same period in 2008.
Revenues for the fourth quarter of 2009 were $1.7 million as compared to
$3.1 million for the same period in 2008. The decrease in revenues from
the prior year period was due to the recognition of $3 million in
license fee revenue during the fourth quarter of 2008 related to a
payment from our collaborator Genentech for its initiation of a Phase II
advanced ovarian cancer trial in December 2008. During the fourth
quarter of 2009, Curis recognized license fee revenues of $1.0 million
and research and development revenue of $532,000 related to the
company's August 2009 license agreement with Debiopharm.
Operating expenses for the fourth quarter of 2009 were $4.5 million as
compared to $5.4 million for the same period in 2008.
Research and development spending was $2.4 million for the fourth
quarter of 2009 as compared to $3.5 million for the same period in
2008. The decrease is primarily attributable to lower spending on
Curis' CUDC-305 (Debio 0932) program as a result of licensing this
program to Debiopharm in August 2009, for which all subsequent
development costs have been assumed by Debiopharm. Offsetting this
decrease, Curis increased spending on other preclinical targeted
General and administrative spending was $2.0 million for the fourth
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 consulting and legal service costs associated with
various corporate matters, including an arbitration proceeding that
Curis filed against a former collaborator in 2009 that was settled in
For the year ended December 31, 2009, Curis reported a net loss of $9.8
million or ($0.15) per share, as compared to a net loss of $12.1 million
or ($0.19) per share for the same period in the prior year.
Revenues for the year ended December 31, 2009 were $8.6 million as
compared to $8.4 million for the same period in 2008.
Operating expenses were $18.6 million for the year ended December 31,
2009 as compared to $21.5 million for the same period in 2008.
Research and development expenses were $9.9 million for the year ended
December 31, 2009, as compared to $13.2 million for the same period in
2008. This decrease was primarily the result of
decreases in Curis' 2009 spending associated with CUDC-101 and
CUDC-305 (Debio 0932) as compared to 2008.
General and administrative expenses were $8.7 million for the year
ended December 31, 2009, as compared to $8.3 million for the same
period in 2008. This increase was primarily due to increased spending
for legal services, including an arbitration proceeding that Curis
filed against a former collaborator in 2009 that was settled in
February 2010, as well as increased costs for business development
consulting efforts used to facilitate the company's licensing
agreement with Debiopharm.
As of December 31, 2009, Curis' cash, cash equivalents and marketable
securities totaled $25.0 million, and there were 67.3 million shares of
common stock outstanding.
-- Earned $8 million from Debiopharm under Hsp90 License Agreement
In February 2010, Debiopharm notified Curis that French regulatory
authorities had accepted its clinical trial application for Debio 0932,
an Hsp90 inhibitor. As a result, Curis earned an $8 million payment from
Debiopharm under the parties' August 2009 license agreement, which Curis
expects will be received during the first quarter of 2010. Debiopharm
plans to open a Phase I clinical trial evaluating the safety of Debio
0932 during the second quarter of 2010. The study will be an open label,
multi-center dose escalation trial evaluating the safety and maximum
tolerated dose of multiple doses of Debio 0932 in patients suffering
from advanced solid tumors or lymphoma.
-- Raised $16.25 million in registered direct offering
In January 2010, Curis completed a registered direct offering of
6,449,288 units at a price of $2.52 per unit, for gross proceeds of
$16.25 million before deducting placement agents' fees and offering
expenses. Each unit consists of one share of the company's common stock
and a warrant to buy 0.25 of a share of the company's common stock. The
warrants will be exercisable for a period of five years beginning on the
date of issuance, at an exercise price of $3.55 per share. Curis
received net proceeds from the sale of the units, after deducting