On August 5, 2015 Endocyte Inc., a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the second quarter ending June 30, 2015, and provided a clinical update (Press release, Purdue Research Foundation, AUG 4, 2015, View Source [SID:1234507029]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are pleased with our continued success in escalating the dose of our folate and PSMA-targeted tubulysin SMDCs," said Ron Ellis, Endocyte’s president and chief executive officer. "Increasing the activity of our agents through higher doses and the use of a more potent drug payload were two key elements of our second generation SMDC strategy. We also continue to hone our patient selection process through refining our use of imaging agents to define targeted patients. We believe that all of these adjustments will increase the likelihood of success as we expand our trials for EC1456 and EC1169, once we determine the maximum tolerated dose."
"We were also pleased to announce today the appointment of Alison Armour, M.D. to the position of Chief Medical Officer," added Mr. Ellis. "Alison strengthens the team at Endocyte with her tremendous experience in both clinical practice and oncology drug development. Her leadership has been directly responsible for the regulatory approval of oncology therapies in the United States and international markets. We are very excited to engage her in the development of our pipeline of SMDCs and diagnostic imaging agents." Dr. Armour was most recently the VP of Oncology at Novartis and GSK.
The Company also announced that the final overall survival results from the Phase 2 TARGET trial of EC145 in NSCLC have been accepted for oral presentation at the IASLC World Conference on Lung Cancer to be held in Denver from September 6-9, 2015. While development efforts have focused on the second generation SMDCs, results of this trial provide insights into the effectiveness of the SMDC platform, particularly in targeting the folate receptor.
Second Quarter 2015 Financial Results
Endocyte reported a net loss of $10.6 million, or $0.25 per basic and diluted share, for the second quarter of 2015, compared to net income of $22.4 million, or $0.54 per basic share and $0.52 per diluted share, for the same period in 2014. The second quarter of 2014 included the recognition of the balance of deferred revenue related to the former collaboration with Merck.
Research and development expenses were $6.7 million for the second quarter of 2015, compared to $19.0 million for the same period in 2014. The decrease in research and development expense was primarily attributable to a decrease in expenses related to the TARGET trial, which is now completed, and the PROCEED trial, which was terminated in May 2014 and for which a termination charge of $4.7 million was recorded in the second quarter of 2014, along with a decrease in manufacturing expenses for vintafolide and etarfolatide related to pre-commercial activity.
General and administrative expenses were $4.1 million for the second quarter of 2015, compared to $8.0 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in headcount and ceasing all commercial activities during the second quarter of 2014 following the withdrawal of the marketing applications in Europe.
Cash, cash equivalents and investments were $188.6 million at June 30, 2015, compared to $219.2 million at June 30, 2014, and $206.8 million at December 31, 2014.
Financial Expectations
The Company reiterated its expectation that its 2015 year-end cash balance will exceed $155 million. Spending is expected to increase from current levels as the trials for EC1456 and EC1169 are expanded once the maximum tolerated doses are determined.