Full Press Release Details
Reports Third Quarter 2010 Financial Results
Conference call to be held today at 9:00 am EDT --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 28, 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 third quarter ended
"We had a productive and encouraging third quarter, highlighted by our
initiation of the Phase Ib expansion trial of CUDC-101, our
first-in-class HDAC, EGFR and Her2 inhibitor in patients with specific
types of cancer, including head and neck, breast, gastric, liver and
non-small cell lung cancers," said Dan Passeri, Curis President and
Chief Executive Officer. "To date, we have engaged five clinical centers
and treated 14 patients in this 50 patient-study, and we are hopeful
that we can continue to enroll this trial at a solid pace through
enrollment completion and that the results will provide meaningful data
to guide the continued development of CUDC-101. In addition to this
Phase Ib study, we expect to initiate a Phase I study of CUDC-101 in
combination with cisplatin and radiation in head and neck cancer
patients later this year or early in 2011 and, assuming that an
acceptable safety profile is achieved in this study, advance to a Phase
"Our other compounds also continue to advance. We are pleased with
Genentech's recent initiation of a Phase II clinical trial in operable
basal cell carcinoma (BCC), demonstrating Genentech's ongoing commitment
to exploring the treatment of various forms of BCC with GDC-0449.
Additionally, our partner Debiopharm has advanced Hsp90 inhibitor Debio
0932 in its ongoing Phase I clinical trial; we received $3 million upon
Debiopharm's treatment of the fifth patient in this study during this
For the third quarter of 2010, Curis reported a net loss of $1.5
million, or ($0.02) per share on both a basic and fully diluted share
outstanding basis, as compared to a net loss of $4.1 million or ($0.06)
per share on both a basic and fully diluted share outstanding basis for
the same period in 2009.
Revenues for the third quarter of 2010 were $3.2 million as compared to
$800,000 for the same period in 2009. Curis received a $3.0 million
contingent payment from Debiopharm during the third quarter of 2010 upon
Debiopharm's treatment of the fifth patient in its ongoing Phase I
clinical trial of Debio 0932.
Operating expenses for the third quarter of 2010 were $5.0 million as
compared to $4.9 million for the same period in 2009.
Research and development spending was $3.0 million for the third
quarter of 2010 as compared to $2.3 million for the same period in
2009. The increase is primarily attributable to increased spending on
CUDC-101 as the Company continues to enroll patients in the Phase Ib
expansion trial. This increase is primarily related to outside costs
consisting of clinical research organizations, patient costs, and
formulation and manufacturing costs of clinical material. In addition,
spending on other targeted cancer programs increased from the prior
year period primarily due to increased employee-related costs,
including salaries, lab supplies and facility costs, as employees from
the Debio 0932 program were reallocated to continue the Company's
ongoing efforts to select additional pre-clinical candidates for
future clinical development.
General and administrative spending was $2.0 million for the third
quarter of 2010 as compared to $2.6 million for the same period in
2009. The decrease is primarily due to non-recurring consulting fees
and legal costs. Legal costs incurred during the third quarter of 2009
related to an arbitration proceeding that was settled during the first
Other income of $250,000 for the third quarter of 2010 primarily
represents the change in the fair value of a warrant liability
established in connection with Curis' January 2010 registered direct
As of September 30, 2010, Curis' cash, cash equivalents and marketable
securities totaled $43.7 million, and there were 75.6 million shares of
common stock outstanding.
CUDC-101 (HDAC/EGFR/Her2 Inhibitor)
-- Initiated Phase Ib expansion clinical trial
In August 2010, Curis initiated a Phase I open-label expansion trial at
five clinical sites within the U.S. of CUDC-101 in approximately 40
patients with advanced, refractory head and neck, gastric, breast and
liver cancers. In October, the protocol was amended to include up to 10
additional patients with non-small cell lung cancer, so that a total of
50 patients will be studied in this trial. 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 histone deacetylase, or HDAC, epidermal
growth factor receptor, or EGFR, and human epidermal growth factor
receptor 2, or Her2, in this patient population.
GDC-0449 (Hedgehog Pathway Inhibitor in Collaboration with
-- Announced initiation of Genentech's Phase II clinical trial in
operable basal cell carcinoma
In October 2010, Curis announced that its collaborator Genentech, a
member of the Roche Group, initiated a Phase II clinical trial of
GDC-0449, an orally-administered small molecule Hedgehog Pathway
Inhibitor, as a single-agent therapy for patients with operable nodular
BCC. This Phase II clinical trial is in addition to the pivotal Phase II
clinical trial currently being conducted by Genentech in patients with
inoperable locally advanced or metastatic BCC.
-- Announced Roche and Genentech's Phase II clinical trial results in
advanced ovarian cancer
In October 2010, Curis also announced that Genentech completed further
analyses of results from its recently-completed Phase II clinical trial
of GDC-0449 in advanced ovarian cancer. The median time to disease
progression in the Phase II study was 7.5 months for patients who
received GDC-0449 compared to 5.8 months for patients who received
placebo (HR=0.791, p=0.3944). Genentech has concluded that these results
did not demonstrate sufficient clinically meaningful improvement in
progression-free survival to warrant additional clinical testing of
GDC-0449 in ovarian cancer at this time. No obvious new safety signals
were observed, and ongoing trials in other tumor types have not been