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Curis Reports First Quarter
2008 Financial Results
CAMBRIDGE, MA, April 30, 2008 Curis, Inc. (NASDAQ:CRIS), a drug development company focused on seeking to
develop the next generation of targeted medicines for cancer treatment, today reported its financial results for the first quarter ended March 31, 2008.
We are pleased with the compelling data steadily emanating from our programs, including the recent GDC-0449 Phase I data presented at AACR by Daniel Von Hoff, M.D., a phase I investigator, said Dan Passeri, Curis President
and Chief Executive Officer. In addition, we are hard at work advancing our pipeline of preclinical oncology drug candidates. We have continued to progress CUDC-101 towards clinical testing and expect to file an IND in the near future and
initiate a Phase I clinical trial in the middle of 2008.
For the first quarter of 2008, Curis reported a net loss of $3.4 million or ($0.05) per
share, as compared to a net loss of $3.5 million or ($0.07) per share for the same period in the prior year.
Revenues for the first quarter of 2008 were
$2.1 million as compared to $2.4 million for the first quarter of 2007, a decrease of $300,000, or 13%. The decrease in revenues was the result of a decrease in research and development contract revenues under collaborative arrangements, which
concluded at various times beginning in March 2007, offset by an increase in license fee revenues as follows:
Operating expenses for the first quarter of 2008 were $5.9 million as compared to $6.2 million for the first quarter of 2007, a decrease of $300,000, or 5%. The primary changes in research and development and general and administrative
expenses are as follows:
As of March 31, 2008, Curis cash, cash equivalents and marketable securities totaled $35.2 million, and there were 63,314,836 shares of Curis common stock outstanding. The Company expects that its
existing cash, cash equivalents and marketable securities, provides adequate capital to reach into the fourth quarter of 2009.
In addition to its existing
cash, cash equivalents and marketable securities, Curis would receive a $3.0 million dollar contingent payment from Genentech within 30 days of Genentech s initiation of a Phase II first-line metastatic colorectal cancer trial, should Genentech
initiate such Phase II trial. In addition, Curis would receive another $3.0 million cash payment should Genentech initiate a Phase II trial in an undisclosed advanced epithelial solid tumor. Genentech has publicly stated that it plans to initiate
the Phase II metastatic colorectal cancer trial in the first half of 2008 and that it expects to initiate the epithelial solid tumor trial in the second half of 2008.
We expect to continue to focus our resources on the advancement of our proprietary compound CUDC-101 into clinical testing, said Mike Gray, Curis Chief Financial Officer. In addition, we
continue to pursue collaboration opportunities with respect to one or more of our targeted cancer programs, including our multi-targeted cancer programs as well as our Hsp90 inhibitor class of compounds, and hope to announce a collaboration before
the end of the year.
First Quarter and Recent Highlights
Reported progress on clinical development of Hedgehog antagonist GDC-0449 with collaborator Genentech.
In March 2008, Genentech indicated that it plans to initiate three Phase II clinical trials of GDC-0449 in 2008, which
include a trial in first-line metastatic colorectal cancer in the first half of 2008 and trials in advanced basal cell carcinoma and in an undisclosed advanced solid tumor of epithelial origin during the second half of 2008. In connection with the
treatment of the first patient in each of the Phase II colorectal cancer and epithelial cancer trials, Genentech is obligated to make separate $3.0 million cash payments to Curis. As announced previously, Curis has already received a $3.0 million
cash payment upon initiation of an expansion cohort of the Phase I clinical trial in advanced basal cell carcinoma in October 2007.
presented from Phase I study of GDC-0449 at AACR.
In April 2008, at the American Association for Cancer Research Annual Meeting, Daniel D. Von Hoff,
M.D., an investigator of the GDC-0449 Phase I study, presented clinical trial data from nine patients treated with GDC-0449 with locally advanced, multifocal and metastatic basal cell carcinoma. In five patients with metastatic basal cell carcinoma
to the lungs, two patients had confirmed RECIST partial responses, two had ongoing stable disease and one had progressive disease. In four patients with clinically evaluable, locally advanced or multi-focal basal cell carcinoma, two patients
exhibited complete response in subcutaneous masses by physical exam and two patients had improvement in skin lesions. Gli-1, a biomarker for Hedgehog signaling activity, was reduced in all evaluated patients. No significant toxicities were observed
with GDC-0449 and no dose limiting toxicities were reached in the Phase I studies. Some patients experienced a loss of sense of taste, and there has been a small amount of hair and weight loss. Genentech has indicated that additional Phase I data,
including full toxicity data, are expected to be presented at the upcoming American Society of Clinical Oncology Annual Meeting being held in Chicago, Illinois on May 30-June 3, 2008.
Announced conclusion of Wyeth collaboration.
Wyeth notified Curis that it decided not to pursue its development efforts on the Hedgehog agonist program and would terminate the January 2004 collaboration agreement. Pursuant to the agreement, the collaboration will conclude on May 6, 2008.
Curis is dedicated to advancing this program and is seeking a new partner to help explore the future prospects of the Hedgehog agonist as a potential therapeutic for various diseases, including in neurological, cardiovascular and bone disorders, as
well as wound healing and hair growth.
Conference Call Information
Curis will hold a conference call today, April 30, 2008, at 9:00 A.M. EDT, to discuss the progress of GDC-0449, CUDC-101 and the Company s other targeted cancer programs, Curis financial results and
additional corporate activities.
To access the live conference call, please call (800) 901-5213 from the United States or Canada or
(617) 786-2962 from other locations, shortly before 9:00 A.M. EDT. The conference ID number is 35236902. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section. A replay will be available
approximately two hours after the completion of the call through 5:00 P.M. EDT, Wednesday, May 14, 2008. 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 number 74907300.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended | ||||||||
| March 31, 2008 | March 31, 2007 | |||||||
| Revenues | 2,067,583 | 2,362,786 | ||||||
| Operating expenses: | ||||||||
| Research and development | 3,475,812 | 3,295,615 | ||||||
| General and administrative | 2,415,494 | 2,951,585 | ||||||
| Total operating expenses | 5,891,306 | 6,247,200 | ||||||
| Net loss from operations | (3,823,723 | ) | (3,884,414 | ) | ||||
| Other income, net | 393,056 | 343,641 | ||||||
| Net loss | $ | (3,430,667 | ) | $ | (3,540,773 | ) | ||
| Basic and diluted net loss per common share | $ | (0.05 | ) | $ | (0.07 | ) | ||
| Basic and diluted weighted average common shares outstanding | 63,245,538 | 49,354,125 |
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2008 | December 31, 2007 | |||||
| ASSETS | ||||||
| Cash, cash equivalents and marketable securities | $ | 35,231,647 | $ | 41,459,176 | ||
| Long-term investments restricted | 210,007 | 210,007 | ||||
| Accounts receivable | 221,132 | 230,467 | ||||
| Property and equipment, net | 2,355,664 | 2,577,602 | ||||
| Goodwill | 8,982,000 | 8,982,000 | ||||
| Other assets | 423,480 | 357,433 | ||||
| Total assets | $ | 47,423,930 | $ | 53,816,685 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Accounts payable, accrued expenses and other liabilities | $ | 3,072,540 | $ | 4,715,772 | ||
| Debt obligations | 93,483 | 403,832 | ||||
| Deferred revenue | 1,852,518 | |||||
| Total liabilities | 3,166,023 | 6,972,122 | ||||
| Total stockholders equity | 44,257,907 | 46,844,563 | ||||
| Total liabilities and stockholders equity | $ | 47,423,930 | $ | 53,816,685 |
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines, primarily for cancer. In expanding its drug development efforts in the field of cancer
through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis website
Cautionary Statement: This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including without limitation: statements regarding the development plans and timelines for GDC-0449, CUDC-101 and the Company s other targeted cancer programs; the Company s receipt of one
or more contingent cash payments from Genentech in connection with Genentech s advancement of GDC-0449; the potential clinical and therapeutic benefits of GDC-0449 and the Company s other programs under development; the Company s
plans to enter into one or more collaborations in 2008; and the Company s estimate regarding the period in which its existing cash will fund its operations. 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 the 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 the views only as of today and should not be
relied upon as representing the views as of any subsequent date. Curis disclaims 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