As of March 31, 2013, the Company had recorded liabilities related to the loan of $30,395,000, which consisted of $30,137,000 in long- and short-term debt, net and accrued interest of $258,000. During the quarter ended June 30, 2013, the Company recorded interest and amortization of certain debt issuance costs totaling $945,000 and made a payment on May 31, 2013 to BioPharma II of $631,000, resulting in debt-related liabilities of $30,709,000 as of June 30, 2013, which consisted of $30,397,000 in long- and short-term debt, net and accrued interest of $312,000.
2013 Financial Guidance
The Company currently anticipates that it will end 2013 with cash, cash equivalents and investments of $49 million to $54 million, which includes the $6 million milestone payment that Curis earned in July 2013 related to the conditional approval of Erivedge in the European Union. This projected estimate excludes potential future milestone and royalty payments from existing or new collaborators, including royalty revenues related to net sales of Erivedge. The Company expects that all or substantially all royalty revenues earned by Curis Royalty in 2013 will be used to service the loan from BioPharma II.
Curis expects that 2013 research and development expenses will be in the range of $11 million to $15 million. This expense expectation includes approximately $800,000 to $900,000 in stock-based compensation expense in research and development for options that were outstanding at June 30, 2013.Recent Operational Highlights CUDC-427:
- Curis initiated the first of three planned clinical studies of CUDC-427. A Phase 1 dose-escalation study using a continuous, twice-daily oral dosing regimen in patients with advanced and refractory solid tumors or lymphomas was initiated in July 2013 and will include an expansion cohort, which is expected to primarily include patients with ovarian and fallopian tube cancers. This trial builds on the single agent clinical results reported by Genentech in the initial Phase 1 trial of intermittently dosed CUDC-427 (previously GDC-0917), where a complete response was observed in a patient with ovarian cancer.
- Phase 1 data for CUDC-427 in patients with refractory cancers was presented during an oral session at the American Society of Clinical Oncology's (ASCO) Annual Meeting on June 2, 2013.
- Curis announced the issuance of U.S. Patent No. 8,461,157, which along with another related patent issued in February 2013 (U.S. Patent No. 8,367,663) is expected to significantly enhance the intellectual property portfolio for the Company's proprietary compounds that target PI3K and HDAC enzymes within a single molecule including CUDC-907, for the treatment of certain human diseases.
- The European Commission granted conditional approval to Erivedge for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. This regulatory decision is applicable to all 28 member states of the European Union. Erivedge is being commercialized and developed by Genentech/Roche under a collaboration agreement between Curis and Genentech. Curis earned a $6 million milestone payment from Genentech/Roche upon the conditional approval of Erivedge.
- Erivedge was approved for marketing registration by Australia's Therapeutic Goods Administration (TGA) for the treatment of adult patients with metastatic BCC, or with locally advanced BCC where surgery and/or radiation therapy are not appropriate. Curis earned a $4 million milestone payment from Genentech/Roche for this approval.
- Curis appointed Mani Mohindru, Ph.D. as Vice President of Corporate Strategy and Investor Relations.
- Wedbush Securities Life Sciences Management Access Conference on August 13-14, 2013 in New York City
- Robert W. Baird & Co. 2013 Health Care Conference, September 10-11, 2013 in New York City
- Stifel Nicolaus Weisel Healthcare Conference 2013 on September 11-12, 2013 in Boston
- BioCentury Annual NewsMakers in the Biotech Industry Conference on September 27, 2013 in New York City
- Curis Research and Development Day on October 3, 2013 in New York City
- Brean Capital 2013 Life Sciences Summit on October 7, 2013 in New York City