Full Press Release Details
Reports First Quarter 2011 Financial Results
Conference call to be held today at 9:00 a.m. EDT --
LEXINGTON, Mass.--(BUSINESS WIRE)--April 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 first quarter ended March
"We anticipate 2011 will be a transitional and productive period for
Curis. To date, we have achieved important advances in both our internal
and partnered programs. Notably, in March our collaborator Genentech
informed us that it had obtained positive results from the pivotal Phase
II clinical trial of Hedgehog pathway inhibitor vismodegib (formerly
designated GDC-0449) in advanced basal cell carcinoma patients. It is
important to note that these patients currently have no therapeutic
alternatives and the positive results potentially represent an important
development for these patients. We are looking forward to the
presentation of the full data from this trial at the 7th
Annual Congress of the European Association of Dermato-Oncology, in
Nantes, France, June 20-23, 2011 and to an anticipated U.S. new drug
application submission by Roche later this year, which, if approved
would be transformative for Curis, as we believe the future milestone
and royalty revenue associated with such approval could provide a
material source of capital for Curis," said Daniel Passeri, Curis
President and Chief Executive Officer.
Mr. Passeri continued, "Regarding our internal pipeline, we have
continued enrolling patients in our ongoing CUDC-101 Phase I expansion
study and are pleased with our results to-date, including observations
of signs of clinical activity in advanced liver cancer patients. We
expect to initiate a Phase I dose escalation study of CUDC-101 in
combination with cisplatin and radiation in head and neck cancer
patients during the first half of 2011 and are also exploring potential
development strategies for CUDC-101 in advanced liver cancer. We also
anticipate that we will begin Phase I testing of an oral formulation of
CUDC-101 later this year. Furthermore, we continue to expand our
proprietary pipeline of network-targeted inhibitors and have recently
selected CUDC-907, a PI3K and HDAC inhibitor, as a development candidate
and have been advancing this molecule towards an anticipated IND filing
by the end of this year."
For the first quarter of 2011, Curis reported a net loss of $6.8
million, or ($0.09) per share on both a basic and fully diluted share
outstanding basis, as compared to net income of $4.8 million or $0.07
per basic share outstanding and $0.06 per fully diluted share
outstanding for the same period in 2010.
Revenues for the first quarter of 2011 were $100,000, as compared to
$12.6 million for the same period in 2010. No license fee revenue was
recorded under Curis' ongoing collaborations with Genentech and
Debiopharm for the three months ended March 31, 2011. During the quarter
ended March 31, 2010, Curis recorded license fee revenue of $8.3 million
under its 2009 license agreement with Debiopharm and also received
proceeds of $4.0 million pursuant to a settlement agreement that the
Company entered into with a former collaborator in February 2010.
Operating expenses for the first quarter of 2011 were $5.5 million, as
compared to $6.9 million for the same period in 2010, a decrease of $1.4
Research and development spending was $3.1 million for the first
quarter of 2011 as compared to $2.5 million for the same period in
2010, an increase of $0.6 million, or 24%. The increase in research
and development expenses is primarily the result of an increase of
$700,000 associated with the ongoing Phase I expansion trial of
General and administrative spending was $2.4 million for the first
quarter of 2011 as compared to $4.4 million for the same period in
2010, a decrease of $2.0 million, or 45%. This decrease was primarily
due to decreased spending for legal services. During the three months
ended March 31, 2010, Curis incurred approximately $1.5 million in
expenses related to an arbitration proceeding against a former
collaborator. The arbitration was settled in February 2010 and no
legal expenses were incurred by Curis beyond the first quarter of
2010. In addition, personnel costs decreased $300,000 for the first
quarter of 2011 as compared to the prior year period primarily due to
the payment of discretionary bonuses to Curis' executive officers upon
receipt of a milestone payment from Debiopharm in March 2010.
Other expense, net, was $1.5 million for the first quarter of 2011
compared to $900,000 for the same period in 2010, an increase of
$600,000, or 67%. Other expense, net, primarily represents the change in
the fair value of a warrant liability established in connection with
Curis' January 2010 registered direct offering.
As of March 31, 2011, Curis' cash, cash equivalents and marketable
securities totaled $36.5 million, and there were 76.3 million shares of
common stock outstanding.
-- Announced positive outcome from collaborator Genentech's Phase II
clinical trial of vismodegib (GDC-0449, RG3616) in advanced basal cell
In March 2011, Genentech informed Curis that the pivotal Phase II
clinical trial of vismodegib in advanced basal cell carcinoma, or BCC,
had met its primary endpoint of achieving a target overall response rate
showing that vismodegib shrank advanced BCC tumors in a pre-defined
percentage of people in the study. A preliminary safety assessment
showed the most common adverse events were consistent with previous
experience with vismodegib and included muscle spasms, hair loss,
altered taste sensation, weight loss, fatigue, nausea, decreased
appetite and diarrhea. Serious adverse events were observed, including
fatal events. The deaths are being further evaluated, but do not appear
to be related to vismodegib. Importantly, Genentech has indicated that
it anticipates submitting a new drug application (NDA) to the U.S. Food
and Drug Administration (FDA) in 2011 to seek approval to commercialize
vismodegib. Roche has indicated that the timing of a European regulatory
submission is subject to planned discussions with the European Medicines
-- Announced promising interim results from investigator-initiated
Phase II study of vismodegib; data shows effect in prevention and
treatment of BCC in Basal Cell Nevus Syndrome patients
Interim Phase II clinical data on vismodegib was presented at the 2011
Annual Meeting of the American Association for Cancer Research (AACR) in
patients with Basal Cell Nevus Syndrome, or BCNS, which is also commonly