Endocyte, Inc. (ECYT) reported second quarter 2013 net loss per share of 23 cents, wider than the Zacks Consensus Estimate of a loss of 8 cents and the year-ago loss of 15 cents.
Second quarter 2013 revenues were $16.5 million compared with $7.8 million in the second quarter 2012. Revenues comprised solely of collaboration revenues. Revenues surpassed the Zacks Consensus Estimate of $15 million.
In the reported quarter, research and development expenses were $18.6 million, up 111.4%. Costs related to the PROCEED and TARGET trials were primarily responsible for the increase. In the reported quarter, general and administrative (G&A) expenses jumped 93.8% to $6.2 million. The increase was attributable to establishing commercial capability. An increase in compensation expenses was also responsible for pushing G&A costs up.
In 2012, Endocyte had submitted a marketing authorization application (MAA) seeking approval for vintafolide for platinum-resistant ovarian cancer. The company is also seeking EU approval for a folate-targeted molecular imaging agent, etarfolatide. Both candidates were granted orphan drug status in the EU in 2012. The company expects a decision from the European Commission on both candidates in the fourth quarter of 2013.
Endocyte completed enrollment in the phase IIb TARGET study of vintafolide in non-small cell lung cancer (:NSCLC) patients. Top-line data from the study is expected in the first quarter of 2014
Endocyte and its partner, Merck & Co. Inc. (MRK), will initiate a phase II randomized trial on vintafolide in folate receptor-positive triple negative breast cancer in the fourth quarter of 2013.
In the first half of 2014, Endocyte expects to complete enrollment in the phase III PROCEED study.
For its folate-targeted tubulysin therapeutic, Endocyte will file an investigational new drug application and initiate a study in the third quarter of 2013.
Endocyte maintained its cash, cash equivalents and investments guidance in the range of $145 - $160 million as provided on Dec 31, 2013.
Endocyte carries a Zacks Rank #3 (Hold). In the reported quarter, Endocyte completed the enrollment in the TARGET study ahead of schedule. The company is also working towards a strong foothold in the European market.
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