Full Press Release Details
Reports Second Quarter 2011 Financial Results
Conference call to be held today at 9:00 a.m. EDT --
LEXINGTON, Mass.--(BUSINESS WIRE)--July 28, 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 second quarter ended June
"The second quarter was highlighted by our collaborator Genentech's
presentation of results from its pivotal study of vismodegib (GDC-0449,
RG3616) in advanced basal cell carcinoma patients," said Dan Passeri,
Curis President and Chief Executive Officer. "We are highly encouraged
by the quality and substance of the positive data generated in this
clinical study, including the overall response rates observed, and we
look forward to Genentech and Roche's planned regulatory submissions for
vismodegib in this patient population."
Mr. Passeri continued, "With regard to our proprietary programs, in the
second quarter we initiated our planned Phase I dose escalation trial of
CUDC-101, our first-in-class EGFR, Her2 and HDAC inhibitor, in
combination with cisplatin and radiation in advanced head and neck
cancer patients, and we expect that we will treat the first patient in
this study in the very near term. We continue to demonstrate clinical
activity in the indications being surveyed in our ongoing Phase I
expansion study with long-term stable disease observed in several cancer
types. We also have advanced preclinical efforts on an oral formulation
of CUDC-101 and expect that we will initiate a Phase I study of the oral
formulation in late 2011 or early 2012. Additionally, we are advancing
CUDC-907, a first-in-class PI3K and HDAC inhibitor, towards clinical
testing and anticipate that we will file an IND for this candidate in
For the second quarter of 2011, Curis reported a net loss of $4.9
million, or ($0.06) per share on both a basic and fully diluted shares
outstanding basis, as compared to a net loss of $2.1 million or ($0.03)
per share on both a basic and fully diluted shares outstanding basis for
the same period in 2010.
Revenues for the second quarter of 2011 were $400,000, as compared to
$100,000 for the same period in 2010. This increase is the result of a
$300,000 license fee payment received by Curis during the second quarter
Operating expenses for the second quarter of 2011 were $5.0 million, as
compared to $4.0 million for the same period in 2010, an increase of
$1.0 million, or 25%.
Research and development spending was $3.1 million for the second
quarter of 2011 as compared to $2.2 million for the same period in
2010, an increase of $900,000, or 41%. The increase in research and
development expenses is primarily attributable to an additional
$800,000 in costs associated with the continued development of
CUDC-101, including the ongoing Phase I expansion trial, costs related
to the initiation of a Phase I trial in advanced head and neck cancers
and manufacturing costs related to an oral formulation of CUDC-101
General and administrative spending was $1.9 million for the second
quarter of 2011 as compared to $1.8 million for the same period in
2010, an increase of $100,000, or 6%. This increase was primarily due
to increased legal costs, specifically patent costs and fees related
to foreign patent filings.
Other expense was $300,000 for the second quarter of 2011 compared to
other income of $1.8 million for the same period in 2010, a decrease of
$2.1 million, or 117%. Other expense primarily represents the increase
in the fair value of a warrant liability incurred in connection with
Curis' January 2010 registered direct offering.
For the six-month period ending June 30, 2011, Curis reported a net loss
of $11.7 million, or ($0.15) per both a basic and fully diluted shares
outstanding basis, as compared to net income of $2.7 million or $0.04
per basic shares outstanding and $0.03 per fully diluted shares
outstanding for the same period in 2010.
Revenues for the six months ended June 30, 2011, were $500,000 as
compared to $12.7 million for the same period in 2010.
Operating expenses were $10.5 million for the six months ended June 30,
2011, as compared to $10.9 million for the same period in 2010. Research
and development expenses were $6.2 million for the six months ended June
30, 2011, as compared to $4.7 million for the same period in 2010.
General and administrative expenses were $4.3 million for the six months
ended June 30, 2011, as compared to $6.2 million for the same period in
Other expense was $1.8 million for the six-month period ended June 30,
2011, as compared to other income of $900,000 for the same period in
As of June 30, 2011, Curis' cash, cash equivalents and marketable
securities totaled $32.7 million, and there were 76.5 million shares of
common stock outstanding.
-- Genentech presented positive data of vismodegib pivotal clinical
trial in advanced basal cell carcinoma (BCC)
In June, Curis' collaborator Genentech, a member of the Roche group,
presented detailed results from its pivotal Phase II clinical trial of
vismodegib (GDC-0449, RG3616) in advanced basal cell carcinoma patients
at the Seventh European Association of Dermato-Oncology (EADO) Congress
The pivotal study (ERIVANCE BCC) is an international, single-arm,
multicenter, two-cohort, open-label Phase II study that enrolled 104
patients with advanced BCC, including locally advanced BCC (71) and
metastatic BCC (33). The overall response rate in the pivotal Phase II
trial as assessed by an independent review facility showed that
vismodegib substantially shrank tumors or healed visible lesions, with
observed response rates of 43% of patients in the locally advanced BCC
cohort and 30% of patients in the metastatic BCC cohort. In the pivotal
Phase II trial, study investigators assessed the overall response rate
to be 55%, with 60% in the locally advanced BCC cohort, and 46% in the
metastatic BCC cohort. The clinical benefit rate (defined as patients
who experienced response as well as those who experienced prolonged
stable disease for more than 24 weeks) showed vismodegib shrank tumors
or healed visible lesions, or prevented them from growing any further in
75% of patients with locally advanced BCC and 76% of patients with
metastatic BCC, as assessed by independent review.
The median duration of progression-free survival (PFS) by independent
review for both metastatic and locally advanced BCC patients was 9.5
months. The median duration of response by independent review was 7.6
months for both metastatic and locally advanced BCC patients. The median