To access the live conference call, please dial (877) 868-1829 from the U.S. or (253) 237-1135 from other locations, shortly before 8:30 a.m. ET. The conference ID number is 86137584. 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. ET, Friday, November 15, 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 86137584.
About Curis, Inc.
Curis is an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers. Erivedge is the first and only FDA-approved medicine for the treatment of advanced BCC 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 seeking to further the development of its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC inhibitor. For more information, visit Curis' website at www.curis.com .
Cautionary 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 Company's clinical development plans and timelines, any expressed or implied statements about the efficacy and safety of its drug candidates, including CUDC-427 and CUDC-907, any statements about its efforts to satisfactorily respond to the FDA's request for data and analysis in response to the partial clinical hold on CUDC-427 or about future development of CUDC-427 in view of the partial clinical hold, its expectations regarding growth in Erivedge sales and successful commercialization in additional markets, and the expected benefit of patent issuances, its plans to present data at ASH and its estimates with respect to its cash and cash equivalent balances at year end. Forward-looking statements 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, Curis may not be able to satisfactorily respond to the FDA's request for additional data and analysis regarding CUDC-427. The FDA may not lift the clinical hold and allow Curis to pursue further development of CUDC-427, and even if the FDA lifts the clinical hold, or if the FDA or other regulatory agencies continue to express safety concerns even after the hold is lifted, future preclinical or clinical studies involving CUDC-427 may be more burdensome or include additional preclinical or clinical endpoints that are difficult to meet. Genentech and Roche may not obtain additional regulatory approvals for Erivedge abroad. 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, in which case revenues from sales of Erivedge could be adversely affected. Regulatory 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 faces risks relating to its wholly-owned subsidiary's Erivedge royalty-collateralized loan transaction, including the risk that it may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy the debt obligation or may otherwise lose its rights to royalties and royalty related payments as a result of a foreclosure of the loan. Curis and its collaborators may experience adverse results, delays and/or failures in their drug development programs. Curis and its collaborators' drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical trials and/or may never achieve the requisite regulatory approval needed for commercialization. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time consuming patent litigation and interference proceedings. Curis faces substantial competition. 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 period ended June 30, 2013 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||Nine months ended|
|September 30,||September 30,|
|Royalties||$ 1,080,233||$ 446,402||$ 2,549,945||$ 969,774|
|Research and development||121,850||131,357||927,950||315,811|
|Costs of revenues||54,014||22,320||127,499||148,489|
|Research and development||4,170,751||3,042,498||9,965,847||12,784,902|
|General and administrative||2,846,950||2,473,853||8,317,741||7,539,516|
|Total operating expenses||7,071,715||5,538,671||18,411,087||20,472,907|
|Net income (loss) from operations||130,368||(4,960,912)||(4,933,192)||(5,187,322)|
|Change in fair value of warrant liability||(1,072,687)||1,541,779||(438,286)||1,054,379|
|Other income (expense), net||(1,998,206)||1,575,908||(3,190,788)||1,141,603|
|Net loss||$ (1,867,838)||$ (3,385,004)||$ (8,123,980)||$ (4,045,719)|
|Basic and diluted net loss per common share||$ (0.02)||$ (0.04)||$ (0.10)||$ (0.05)|
|Basic and diluted weighted average common shares outstanding||82,456,708||79,639,433||81,235,922||78,752,687|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash, cash equivalents and investments||$ 67,138,656||$ 58,701,423|
|Investments – restricted||180,364||194,282|
|Property and equipment, net||467,489||434,168|
|Total assets||$ 78,546,976||$ 69,768,349|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable, accrued expenses and other liabilities||4,465,518||4,173,747|
|Total stockholders' equity||41,573,338||34,267,498|
|Total liabilities and stockholders' equity||$ 78,546,976||$ 69,768,349|
CONTACT: For More Information: Mani Mohindru, Ph.D. Vice President, Corporate Strategy and Investor Relations Curis, Inc. 617-503-6605 firstname.lastname@example.org Michael P. Gray Chief Business and Chief Financial Officer Curis, Inc. 617-503-6632 email@example.com