Press Release
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Endocyte Reports Fourth Quarter and Year End 2011 Financial Results and Operations Update
"2011 was an important year in
"We have made important progress in recent weeks to clarify our clinical and regulatory path forward given the continued global shortage of Doxil®, the control drug used in the PROCEED trial," added
Upcoming Milestones
- Renewed enrollment in Phase 3 PROCEED trial in early Q2 2012
- First patient enrollment in Phase 2b/3 non-small cell lung cancer trial in early Q2 2012
- Submit EU marketing applications for conditional authorization of EC145 and EC20 for treatment of folate receptor positive, FR(++), platinum resistant ovarian cancer in Q3 2012
"Our current cash balance provides us with the financial resources to complete two important trials of EC145 and EC20 in folate-receptor positive patient populations - the Phase 3 PROCEED trial and a Phase 2b trial in second-line non small cell lung cancer. At the same time, we are in a position to bring an additional small molecule drug conjugate into the clinic," said
Fourth Quarter Financial Results
Revenues of
Research and development expenses for the fourth quarter of 2011 were
General and administrative expenses for the fourth quarter of 2011 were
Interest expense was
Cash, cash equivalents and short-term investments were
2011 Financing Highlights
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Stock offering proceeds of
$144.9 million : On Feb. 9, 2011, the company completed its initial public offering of 14,375,000 shares of common stock. Proceeds, net of underwriting discounts, commissions and other transaction costs were approximately$78.2 million . On Aug. 2, 2011, the company completed a public offering of 5,839,810 shares of common stock. Proceeds, net of underwriting discounts, commissions and other transaction costs were approximately$66.7 million .
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Modification to the loan arrangement with
Mid-Cap Financial (Mid-Cap) and Silicon Valley Bank (SVB): InSeptember 2011 ,Endocyte modified the loan agreement with Mid-Cap and SVB to revise the repayment terms. Under the amendment, the interest-only period has been extended.Endocyte is only required to make interest payments throughDecember 2012 and then interest and principal payments for three years beginning inJanuary 2013 . This modification provided additional working capital of$7.4 million .
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. 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 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) | ||||
For the Three Months Ended |
For the Years Ended |
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2010 | 2011 | 2010 | 2011 | |
(unaudited) | (unaudited) | (unaudited) | ||
Revenue: | ||||
License fees | $ — | $ 191 | $ — | $ 191 |
Total Revenue | — | 191 | — | 191 |
Costs and expenses: | ||||
Research and development | 3,290 | 7,753 | 14,561 | 28,828 |
General and administrative | 1,317 | 2,862 | 6,039 | 10,000 |
Total costs and expenses | 4,607 | 10,615 | 20,600 | 38,828 |
Loss from operations | (4,607) | (10,424) | (20,600) | (38,637) |
Interest income | 2 | 38 | 8 | 129 |
Interest expense | (395) | (351) | (1,065) | (1,988) |
Other income, net | 1,652 | (17) | 1,564 | (36) |
Net loss | $ (3,348) | $ (10,754) | $ (20,093) | $ (40,532) |
Net loss per share — basic and diluted | $ (3.57) | $ (0.30) | $ (21.77) | $ (1.40) |
Weighted average number of common shares used in net loss per share — basic and diluted | 937,088 | 35,745,364 | 923,007 | 29,003,991 |
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Balance Sheets | ||
(in thousands, except per share amount) | ||
As of |
As of |
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2010 | 2011 | |
(unaudited) | ||
Assets | ||
Cash, cash equivalents and short-term investments | $ 16,873 | $ 128,085 |
Other assets | 4,341 | 3,590 |
Total assets | $ 21,214 | $ 131,675 |
Liabilities, convertible preferred stock, and stockholders' equity (deficit) | ||
Current liabilities | $ 7,673 | $ 5,470 |
Long-term debt, net of current portion | 11,124 | 12,833 |
Subordinated notes | 9,529 | — |
Convertible preferred stock, no par value | 89,799 | — |
Total stockholders' equity (deficit) | (96,911) | 113,372 |
Total liabilities, convertible preferred stock and stockholders' equity | $ 21,214 | $ 131,675 |
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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