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"We achieved several critical milestones during the first quarter of the year, outlining specific plans to advance our lead SMDC, vintafolide, toward regulatory filings in the EU and the U.S., and establishing a global collaboration with Merck, which will accelerate and expand development of vintafolide and will allow us to build a commercial organization," said
Recent Highlights
Endocyte received$120 million upfront payment inMay 2012 and is eligible for additional development, regulatory and commercial milestone payments of up to$880 million ; Hart-Scott-Rodino clearance has been obtainedEndocyte retained co-promotion rights for vintafolide with Merck in the U.S., while Merck has exclusive promotion rights in the rest of world- Following potential regulatory approval,
Endocyte will receive equal profit share in the U.S. and double digit percentage royalties on sales in the rest of the worldEndocyte retained global rights to develop and commercialize the companion diagnostic imaging agent, etarfolatideEndocyte will continue to be responsible for the execution of the Phase 3 PROCEED and Phase 2b TARGET trials- While
Endocyte has responsibility for funding the majority of the Phase 3 PROCEED trial, Merck is responsible for funding a portion of that trial's costs as well as the costs of all other development activities for vintafolide- Merck has committed to develop vintafolide in multiple additional indications
First Quarter Financial Results
Research and development expenses for the first quarter of 2012 were
General and administrative expenses for the first quarter of 2012 were
Interest expense was
Cash, cash equivalents and short-term investments were
Financial Guidance
With the anticipated achievement of development and regulatory milestones related to vintafolide, this cash position is expected to be sufficient to fund operations until the company becomes profitable. Endocyte anticipates operating expense growth for the full year 2012 compared to 2011 of no more than 12 percent.
"The agreement with Merck will relieve us of considerable expenses we would have otherwise incurred in the development of vintafolide," said
Upcoming Milestones
Conference Call
| U.S. and Canadian participants | (877) 263-3108 |
| International | (253) 237-1176 |
A live, listen-only webcast of the conference call may also be accessed by visiting the Investor Relations section of the
A replay of the call will be available beginning at
About
Forward Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's expectations for seeking regulatory approval and commercial launch of its products, including any conditional marketing authorization from the EMA, initiation of future clinical trials, future availability of Doxil, data availability from ongoing and future clinical trials, and the company's expectations for its 2012 financial outlook and sufficiency of its cash position. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, unavailability of Doxil, regulatory issues or other factors);
risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks associated with the receipt of milestone payments under the Merck collaboration, risks related to the safety and efficacy of the company's product candidates, the goals of its development activities, estimates of the potential markets for its product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected financial results. More information about the risks and uncertainties faced by
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| Statements of Operations | ||
| (in thousands, except per share amounts) | ||
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For the Three Months Ended |
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| 2011 | 2012 | |
| (unaudited) | (unaudited) | |
| Revenue: | ||
| License fees | $ — | $ — |
| Total Revenue | — | — |
| Costs and expenses: | ||
| Research and development | 4,439 | 6,417 |
| General and administrative | 2,074 | 3,094 |
| Total costs and expenses | 6,513 | 9,511 |
| Loss from operations | (6,513) | (9,511) |
| Interest income | 19 | 13 |
| Interest expense | (698) | (347) |
| Other income, net | 3 | 75 |
| Net loss | $ (7,189) | $ (9,770) |
| Net loss per share — basic and diluted | $ (0.43) | $ (0.27) |
| Weighted average number of common shares used in net loss per share — basic and diluted | 16,907,823 | 35,798,530 |
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| Balance Sheets | ||
| (in thousands, except per share amount) | ||
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As of |
As of |
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| 2011 | 2012 | |
| (unaudited) | ||
| Assets | ||
| Cash, cash equivalents and short-term investments | $ 128,085 | $ 117,887 |
| Other assets | 3,590 | 4,512 |
| Total assets | $ 131,675 | $ 122,399 |
| Liabilities and stockholders' equity (deficit) | ||
| Current liabilities | $ 5,470 | $ 6,072 |
| Long-term debt, net of current portion | 12,833 | 11,827 |
| Total stockholders' equity | 113,372 | 104,500 |
| Total liabilities, convertible preferred stock and stockholders' equity | $ 131,675 | $ 122,399 |
CONTACT:Source:Stephanie Ascher , Stern Investor Relations, Inc. (212) 362-1200, stephanie@sternir.comMartina Schwarzkopf , Ph.D.,Russo Partners (212) 845-4292, martina.schwarzkopf@russopartnersllc.comTony Russo , Ph.D.,Russo Partners (212) 845-4251, tony.russo@russopartnersllc.com
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