To access the live conference call, please dial (877) 868-1829 from the U.S. or (253) 237-1135 from other locations, shortly before 9:00 a.m. EST. The conference ID number is 98576283. 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 12:00 p.m. EST, Tuesday, February 26, 2013. To access the replay, please dial (855) 859-2056 from the United States or (404) 537-3406 from other locations and reference conference ID number 98576283.
About Curis, Inc.
Curis is an oncology-focused company seeking to develop and commercialize next generation targeted drug candidates for cancer treatment. Erivedge® is the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma and is being commercialized and developed by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech. Curis is also developing its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins; CUDC-907, a dual PI3K and HDAC inhibitor; and CUDC-101, an EGFR/HER2 and HDAC inhibitor. For more information, visit Curis' website at www.curis.com .
The Curis, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11347Cautionary Note Regarding Forward-Looking Statements: 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 expected benefits of the Company's recent financial, clinical and operational developments; the Company's potential positioning among oncology drug development companies; expectations regarding Erivedge sales; the Company's financial positioning for 2013 and beyond; the Company's expectations regarding potential milestone achievement in 2013 under both its internal and partnered drug development and commercialization programs; and the Company's 2013 financial guidance. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will", "may," "could" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, if Genentech's sales of Erivedge are lower than anticipated, the time period for repayment of the royalty-secured loan will be extended. There are also certain events of default in which the loan repayment could be accelerated, including actions by Curis' that could lead to Genentech's termination of the collaboration agreement between Curis and Genentech. Genentech and Roche may not ultimately demonstrate to the satisfaction of regulatory authorities outside the U.S., the safety and efficacy profile of Erivedge in the treatment of advanced BCC, in which case Erivedge may not be approved for sales and marketing for the treatment of such indication in the respective territory. Genentech and Roche may experience delays or failures in the manufacture of Erivedge. Erivedge's benefit/risk profile may not be widely accepted by the medical community or third-party payors for the treatment of advanced BCC. Regulatory and administrative governmental authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge. Competing drugs may be developed that are superior to Erivedge. Curis may not achieve meaningful amounts of royalty revenue from sales of Erivedge and may not receive contingent payments from existing or new collaborators. Curis and its collaborators may experience adverse results, delays and/or failures in their drug development programs. Curis' drug candidates may cause unexpected toxicities and/or fail to demonstrate sufficient safety and efficacy in clinical trials and may never achieve the requisite regulatory approval needed for commercialization. Curis will require substantial additional capital to fund the research and development of its drug development programs. The proceeds of Curis' royalty-secured loan may not be sufficient to fund its near-term capital requirements for advancing programs. Curis may not obtain or maintain necessary patent protection for its programs and could become involved in expensive and time consuming patent litigation and interference proceedings. Curis faces substantial competition from other companies developing cancer therapeutics. Unstable market and economic conditions may adversely affect Curis' financial conditions and its ability to access capital to fund the growth of its business. Curis also faces other important risks relating to its business, operations, financial condition and future prospects that are discussed in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and other filings that it periodically makes with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis' 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 or otherwise.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended||Year ended|
|December 31,||December 31,|
|Revenues||$ 1,686,406||$ 14,089,053||$ 16,971,991||$ 14,762,580|
|Cost of revenues||27,993||—||176,482||—|
|Research and development||2,707,400||4,447,859||15,492,302||13,692,659|
|In-Process research and development||9,500,000||—||9,500,000||—|
|General and administrative||2,883,498||2,076,087||10,423,014||8,272,424|
|Total operating expenses||15,118,891||6,523,946||35,591,798||21,965,083|
|Net loss from operations||(13,432,485)||7,565,107||(18,619,807)||(7,202,503)|
|Other income (expense), net||1,061,297||(1,503,232)||2,202,900||(2,656,392)|
|Net income (loss) income||$ (12,371,188)||$ 6,061,875||$ (16,416,907)||$ (9,858,895)|
|Basic net (loss)/income per common share||$ (0.15)||$ 0.08||$ (0.21)||$ (0.13)|
|Diluted net (loss)/income per common share||(0.15)||0.07||(0.21)||(0.13)|
|Basic weighted average common shares outstanding||79,971,888||76,649,034||79,059,153||76,351,856|
|Diluted weighted average common shares outstanding||79,971,888||81,354,223||79,059,153||76,351,856|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31, 2012||December 31, 2011|
|Cash, cash equivalents and investments||$ 58,701,423||$ 37,717,575|
|Investments – restricted||194,282||235,914|
|Property and equipment, net||434,168||455,730|
|Total assets||$ 69,980,408||$ 48,180,065|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable, accrued expenses and other liabilities||$ 4,224,731||$ 3,942,940|
|Total stockholders' equity||34,267,498||39,875,957|
|Total liabilities and stockholders' equity||$ 69,980,408||$ 48,180,065|
CONTACT: Michael P. Gray Chief Financial Officer Curis, Inc. 617-503-6632 email@example.com