Full Press Release Details
Reports Third Quarter 2011 Financial Results
Conference call to be held today at 9:00 a.m. EDT --
LEXINGTON, Mass.--(BUSINESS WIRE)--October 27, 2011--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
"The third quarter marked an important period for Curis, due to our
collaborator Genentech's NDA submission to the FDA seeking sales and
marketing approval for vismodegib (GDC-0449, RG3616) in the U.S. to
treat people with advanced basal cell carcinoma (BCC)," said Dan
Passeri, Curis President and Chief Executive Officer. "We believe that
this first-in-class molecule has the potential to provide an important
new treatment option for patients with advanced BCC. Importantly, Curis
is eligible to receive an $8 million milestone payment from Genentech
upon FDA acceptance of this submission and, if the drug subsequently
receives FDA approval, we will receive an additional milestone payment
as well as royalties on any future sales. We also continue to anticipate
that Roche will file an MAA submission with the EMA for regulatory
approval of vismodegib in the European Union, the timing of which is
subject to ongoing discussions between Roche and European health
Mr. Passeri continued, "In addition, we continued to advance our
pipeline, beginning with our Phase I dose escalation, combination trial
of our first-in-class EGFR, Her2 and HDAC inhibitor CUDC-101 in head and
neck cancer patients. We also completed enrollment in our Phase I
expansion study of CUDC-101 in several cancer types and are very pleased
with the results observed to-date, which include observations of
long-term stable disease across several cancer types, data that
demonstrate that we are hitting our intended molecular targets and a
favorable safety profile, consistent with that observed in our Phase I
dose escalation study. Looking ahead, we expect to initiate a Phase I
clinical trial for an oral formulation of CUDC-101 and also a Phase I
trial for new development candidate CUDC-907, a PI3K and HDAC inhibitor,
in the first half of 2012, and Debiopharm, our licensee for our Hsp90
inhibitor Debio 0932, has indicated that it plans to initiate Phase Ib
studies of Debio 0932 in the near term."
For the third quarter of 2011, Curis reported a net loss of $4.2
million, or ($0.05) per share, as compared to a net loss of $1.5 million
or ($0.02) per share for the same period in 2010.
Revenues for the third quarter of 2011 were $100,000, as compared to
$3.2 million for the same period in 2010. This decrease is primarily the
result of $3.0 million in license fee revenue that was recorded during
the third quarter of 2010 as a result of a milestone payment that Curis
received from Debiopharm in such quarter.
Operating expenses were $5.0 million for the third quarter of each of
Research and development spending was $3.0 million for the third
quarter of each of 2011 and 2010. While spending was unchanged from
the prior year period, spending related to CUDC-907, which was named a
development candidate in January 2011, increased as a result of the
commitment of increased resources to advance CUDC-907 through IND
enabling studies and toward an IND filing. Spending related to the
Phase I expansion trial for CUDC-101 decreased as this study neared
its conclusion. This decrease was offset by increased spending related
to the initiation of a Phase I trial of CUDC-101 in combination with
cisplatin and radiation in HPV- locally advanced head and neck cancer
patients as well as the Company's preclinical development work on an
oral formulation of CUDC-101. An increase in the overall investment in
CUDC-101 and CUDC-907, particularly in terms of Curis employee costs
allocated to these programs, resulted in a decrease in spending on
Curis' research-stage programs.
General and administrative spending was $1.9 million for the third
quarter of 2011 as compared to $2.0 million for the same period in
2010, a decrease of $100,000, or 5%. This decrease was primarily due
to decreased consulting and professional fees.
Other income was $600,000 for the third quarter of 2011 compared to
$250,000 for the same period in 2010, an increase of $350,000, or 140%.
Other income primarily represents the decrease in the fair value of the
warrant liability incurred in connection with Curis' January 2010
registered direct offering.
For the nine-month period ending September 30, 2011, Curis reported a
net loss of $15.9 million, or ($0.21) per share on both a basic and
fully diluted shares outstanding basis, as compared to net income of
$1.2 million or $0.02 per share on both a basic and fully diluted shares
outstanding basis for the same period in 2010.
Revenues for the nine months ended September 30, 2011, were $700,000 as
compared to $15.9 million for the same period in 2010. This decrease is
primarily the result of $11.3 million in license fee revenue that was
recorded during the nine months ended September 30, 2010 as a result of
milestone payments that Curis received from Debiopharm during such
period. During the prior year period, Curis also received proceeds of
$4.0 million pursuant to a settlement agreement that the Company entered
into with a former collaborator in February 2010. No license fee revenue
was recorded under Curis' ongoing collaborations with Genentech and
Debiopharm for the nine months ended September 30, 2011.
Operating expenses were $15.4 million for the nine months ended
September 30, 2011, as compared to $15.9 million for the same period in
2010. Research and development expenses were $9.2 million for the nine
months ended September 30, 2011, as compared to $7.7 million for the
same period in 2010. General and administrative expenses were $6.2
million for the nine months ended September 30, 2011, as compared to
$8.2 million for the same period in 2010.
Other expense was $1.2 million for the nine-month period ended September
30, 2011, as compared to other income of $1.2 million for the same
As of September 30, 2011, Curis' cash, cash equivalents and marketable
securities totaled $28.4 million, and there were 76.6 million shares of
common stock outstanding.
-- Genentech Submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA)
In September 2011, Curis' collaborator Genentech, a member of the Roche
group, submitted a New Drug Application (NDA) to the FDA seeking sales
and marketing approval for vismodegib to treat people with advanced