Full Press Release Details
For More Information:
Curis Reports Second
Quarter 2007 Financial Results
CAMBRIDGE, MA, July 31, 2007 Curis, Inc. (NASDAQ:CRIS), a drug development company focused on
seeking to develop novel targeted medicines primarily for cancer treatment, today reported its financial results for the second quarter ended June 30, 2007.
For the second quarter of 2007, Curis reported a net loss of $3,998,000 or ($0.08) per share, as compared to a net loss of $3,924,000 or ($0.08) per share for the same period in the prior year.
Net revenues for the second quarter of 2007 were $1,229,000 as compared to $2,559,000 for the second quarter of 2006, a decrease of $1,330,000, or 52%. The decrease in
net revenues was primarily the result of a decrease in research funding revenues offset by an increase in license fee revenues and a decrease in contra-revenues as follows:
Operating expenses for the second quarter of 2007 were $5,406,000 as compared to $6,811,000 for the second quarter of 2006, a decrease of $1,405,000, or 21%. The primary changes in research and development and general
and administrative expenses are as follows:
Other income (net) for the second quarter of 2007 was $180,000 as compared to other income of $328,000 for the same period in 2006, a decrease of $148,000, or 45%, which
was principally attributed to the write-down of an asset.
For the six month period ending June 30, 2007, Curis reported a net loss of $7,538,000 or
($0.15) per share, as compared to a net loss of $7,973,000 or ($0.16) per share for the same period in the prior year.
Net revenues for the six months
ended June 30, 2007 were $3,592,000 as compared to $4,597,000 for the same period in 2006, a decrease of $1,005,000, or 22%. The decrease in net revenues was primarily the result of a decrease in research funding revenues, offset by an increase
in license fee revenues and a decrease in contra-revenues.
Operating expenses were $11,653,000 and $13,200,000 for the six-month periods ended
June 30, 2007 and 2006, respectively, a decrease of $1,547,000, or 12%. Research and development expenses were $6,342,000 for the six months ended June 30, 2007 as compared to $7,325,000 for the same period in the prior year, a decrease of
$983,000, or 13%. General and administrative expenses were $5,311,000 for the six months ended June 30, 2007 as compared to $5,848,000 for the same period in the prior year, a decrease of $537,000, or 9%.
As of June 30, 2007, our cash, cash equivalents, marketable securities and investments totaled $30,228,000 and there
were 49,533,950 shares of common stock outstanding.
CUDC-101 Development Progress
In the first quarter of 2007, we announced the selection of our first development candidate, CUDC-101, from our Targeted Cancer Drug Development
Platform. CUDC-101 is a multi-target small molecule that is designed to inhibit three clinically validated cancer targets: the Epidermal Growth Factor Receptor (EGFR), Her2 and an undisclosed non-kinase target referred to as Target A. To date, we
have not publicly disclosed the identity of Target A for proprietary reasons, but we expect to disclose Target A sometime during the second half of 2007.
Curis researchers have shown that CUDC-101 demonstrates improved potency in a number of in vitro assays when compared to the individual validated drugs that inhibit EGFR and Target A and similar potency to existing
drugs that inhibit Her2. In addition, CUDC-101 has demonstrated improved potency in a number of in vitro assays when compared to these drugs in combination. Curis researchers have also demonstrated in vivo efficacy against a broad range of tumor
types in preclinical models.
We have been actively working toward our goal of filing an IND for CUDC-101 by the end of the first quarter
of 2008. Formulation studies and other IND-preparatory studies are currently under way. Preliminary preclinical toxicology testing has shown CUDC-101 to be well tolerated and we expect that formal toxicology testing will be initiated early in the
fourth quarter of 2007.
Second Quarter Updates
In May 2007, Procter & Gamble notified us of its decision to terminate the September 2005 collaboration agreement for topically applied Hedgehog agonist compounds for hair growth regulation, effective
November 9, 2007. We currently do not expect to further develop our current Hedgehog agonist compounds for hair growth regulation.
Also in May 2007, Ortho Biotech Products notified us of its decision to cease its development efforts on the BMP-7 program and terminate the November 2002 license agreement. Pursuant to the license agreement, the agreement will terminate on
August 16, 2007. On the termination date, the licenses granted by us to Ortho Biotech Products shall terminate and we will be free to re-license the technology. We currently intend to seek to license this technology to a third party
While we are disappointed that two of our collaborations concluded during the second quarter of 2007, we continue to make progress on
our core small molecule cancer assets. We are pleased with the progress of our Hedgehog antagonist collaboration, the lead molecule of which is currently in Phase I clinical testing. We have also made significant progress on our targeted cancer
programs that we are developing under our Targeted Cancer Drug Development Platform, said Daniel Passeri, Curis President and Chief Executive Officer. We have been striving toward achieving our goal of filing an IND for CUDC-101
the first development candidate from this platform by the end of the first quarter in 2008. In addition, we continue to progress collaboration discussions around CUDC-101. While we are progressing on CUDC-
101, we are also continuing our efforts to expand our targeted cancer drug candidate pipeline and we expect that we will select a second development
candidate from our Targeted Cancer Drug Development Platform by the end of 2007. Assuming that we meet this selection date and that subsequent IND-enabling preclinical studies are successful, we anticipate that we would file an IND for this second
development candidate by the end of 2008. We also currently plan to select at least one additional development compound from this platform in 2008. In addition to our efforts to advance proprietary cancer programs, we continue to remain optimistic
about our Phase I Hedgehog antagonist program under collaboration with Genentech and our Hedgehog agonist collaboration with Wyeth for stroke and cardiovascular disease indications.
We will hold a conference call today, July 31, 2007, at 10:00 A.M. EDT, to discuss our financial results, additional corporate activities and the progress of
CUDC-101, the other multi-target inhibitors that we are developing under our Targeted Cancer Drug Development Platform, and our product development programs under collaboration. Daniel Passeri, Curis President and Chief Executive Officer, will
To access the live conference call, please call (888) 680-0890 from the United States or Canada or (617) 213-4857 from other
locations, shortly before 10:00 A.M. EDT. The conference ID number is 63684401. The conference call can also be accessed on the Curis website at www.curis.com in the Investor Relations section. Replay will be available approximately two hours after
the completion of the call and through 5:00 P.M. EDT, Tuesday, August 14, 2007. To access the replay, please call (888) 286-8010 from the United States or Canada or (617) 801-6888 from other locations and reference the conference ID
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||
| Revenues: | ||||||||||||||||
| Gross revenues | $ | 1,228,724 | $ | 3,105,076 | $ | 3,591,510 | $ | 5,969,605 | ||||||||
| Contra-revenues from co-development with Genentech | (546,191 | ) | (1,372,291 | ) | ||||||||||||
| Net revenues | 1,228,724 | 2,558,885 | 3,591,510 | 4,597,314 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,046,824 | 3,840,313 | 6,342,439 | 7,324,958 | ||||||||||||
| General and administrative | 2,359,186 | 2,962,165 | 5,310,771 | 5,847,903 | ||||||||||||
| Amortization of intangible assets | 8,282 | 27,050 | ||||||||||||||
| Total operating expenses | 5,406,010 | 6,810,760 | 11,653,210 | 13,199,911 | ||||||||||||
| Net loss from operations | (4,177,286 | ) | (4,251,875 | ) | (8,061,700 | ) | (8,602,597 | ) | ||||||||
| Other income, net | 179,742 | 327,680 | 523,383 | 629,408 | ||||||||||||
| Net loss | $ | (3,997,544 | ) | $ | (3,924,195 | ) | $ | (7,538,317 | ) | $ | (7,973,189 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.08 | ) | $ | (0.08 | ) | $ | (0.15 | ) | $ | (0.16 | ) | ||||
| Basic and diluted weighted average common shares outstanding | 49,408,100 | 49,032,837 | 49,381,508 | 48,944,392 |
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2007 | December 31, 2006 | |||||
| ASSETS | ||||||
| Cash, cash equivalents and marketable securities | $ | 30,228,203 | $ | 36,656,007 | ||
| Long-term investments restricted | 201,844 | 201,844 | ||||
| Accounts and notes receivable | 283,419 | 1,315,412 | ||||
| Property and equipment, net | 3,209,547 | 4,393,604 | ||||
| Intangible assets, net | 8,982,000 | 8,982,000 | ||||
| Other assets | 253,117 | 719,386 | ||||
| Total assets | $ | 43,158,130 | $ | 52,268,253 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Accounts payable, accrued expenses and other liabilities | $ | 2,786,119 | $ | 3,504,659 | ||
| Debt obligations | 1,155,672 | 1,979,622 | ||||
| Deferred revenue | 8,897,934 | 10,886,833 | ||||
| Total liabilities | 12,839,725 | 16,371,114 | ||||
| Total stockholders equity | 30,318,405 | 35,897,139 | ||||
| Total liabilities and stockholders equity | $ | 43,158,130 | $ | 52,268,253 |
We are a drug development company that is committed to leveraging our innovative signaling pathway drug technologies to seek to create new medicines, primarily for cancer. In expanding our drug development efforts in the field of cancer
through our Targeted Cancer Drug Development Platform, we are building upon our previous experiences in targeting signaling pathways in the areas of cancer, neurological disease and cardiovascular disease. For more information, visit our website at
Cautionary Statement: This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including: our plans to file an IND application for CUDC-101 with the FDA in the first quarter of 2008, our plans to disclose the identity of Target A during the second half of 2007, our expectation
that we will begin formal toxicology testing for CUDC-101 during the fourth quarter of 2007, our expectation that we will advance at least one additional development candidate from our Targeted Cancer Drug Development Platform into development
candidate status in late 2007 and file an IND with the FDA for this second development candidate in the second half of 2008, our belief that we will select a third development candidate from the Targeted Cancer Drug Development Platform in 2008, and
our intention to seek to license our BMP-7 program during 2007. Forward-looking statements used in this press release may contain the words believes , expects , anticipates , plans , seeks ,
estimates , will , may or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause our actual
results to be materially different from those indicated by such forward-looking statements including, among other things:
In addition, any forward-looking statements represent our views only as of today and should not
be relied upon as representing our views as of any subsequent date. We disclaim any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or