On May 04, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the first quarter ending March 31, 2016, and provided a clinical update (Press release, Endocyte, MAY 4, 2016, View Source [SID:1234511887]).
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 continue to be pleased with the progress of our two lead, clinical-stage assets, EC1456 and EC1169, in Phase 1 dose escalation studies. Both drugs are very well-tolerated and show evidence of anti-tumor activity. Maximum tolerated dose has not yet been reached with either drug," said Ron Ellis, Endocyte’s president and chief executive officer. "We look forward to providing more detailed updates on both of these dose escalation trials at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June."
Endocyte recently announced promising data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, highlighting its preclinical work in the area of immuno-oncology. In collaboration with Purdue University, the company announced a novel approach that makes possible the engineering of a single universal chimeric antigen receptor (CAR) T cell that can be targeted to multiple receptors on cancer cells through the use of unique, small molecule, bispecific adaptors. This approach has the potential to address major challenges faced by other CAR T cell technologies, by improving the management of safety, having a mechanism to address tumor heterogeneity, and lowering the cost of therapy.
Also at AACR (Free AACR Whitepaper), Endocyte announced data reflecting the promise of synergistic activity of its SMDCs in combination with immune modulating therapies. The combination of EC1456 with an anti-PD1 antibody demonstrated curative activity in models expressing PD-L1. It was further demonstrated that treated animals developed an immune response when tumors were re-introduced months after the cessation of therapy.
"These new developments, along with our new lead development candidate in oncology, which deploys a dual mechanism of cytotoxic tumor cell killing plus activity against tumor associated macrophages, demonstrates the range of applications of our SMDC platform," added Ron Ellis. "The ability to target receptors with high specificity and deeply penetrate the tumor microenvironment uniquely positions SMDCs to be effective not only as targeted cytotoxic agents, but also by engaging the immune system to participate in the fight against disease. We look forward to a deeper discussion of the data and the science behind these approaches at a research event later this year."
Upcoming Expected Milestones
Phase 1 dose escalation updates on EC1456 and EC1169 at ASCO (Free ASCO Whitepaper) annual meeting in June 2016
EC1456 single agent efficacy data (tumor response) in non-small cell lung cancer before year-end 2016
EC1169 single agent efficacy data in prostate cancer in late 2016 or 2017
Updates on plans for earlier stage programs
First Quarter 2016 Financial Results
Endocyte reported a net loss of $10.2 million, or $0.24 per basic and diluted share, for the first quarter of 2016, compared to a net loss of $10.9 million, or $0.26 per basic and diluted share, for the same period in 2015.
Research and development expenses were $6.5 million for the first quarter of 2016, compared to $6.6 million for the same period in 2015. The slight decrease was primarily attributable to a decrease in expenses related to the TARGET trial which is now complete and a decrease in discovery research expenses, which were partially offset by an increase in expenses relating to the EC1169 dose escalation trial as well as an increase in compensation expenses, primarily for noncash stock compensation.
General and administrative expenses were $3.8 million for the first quarter of 2016, compared to $4.4 million for the same period in 2015. The decrease in expenses was primarily attributable to a reduction in legal and professional fees in the first quarter of 2016 as compared to the same period in 2015, which was partially offset by an increase in compensation expenses, primarily for noncash stock compensation.
Cash, cash equivalents and investments were $163.3 million at March 31, 2016, compared to $196.8 million at March 31, 2015, and $173.6 million at December 31, 2015.
Financial Expectations
The Company reiterated guidance that it expects its cash balance at the end of 2016 to be between $125 and $130 million.