On July 31, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported financial results for the second quarter ending June 30, 2018 and provided an operational update (Press release, Endocyte, JUL 31, 2018, View Source [SID1234527974]).
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"During the second quarter, we continued to execute rapidly on our strategy, initiating the phase 3 VISION study of 177Lu-PSMA-617 and securing a long-term commercial supply agreement for no-carrier added lutetium, which could support treatment of a potentially large patient population if approved," said Mike Sherman president and CEO of Endocyte. "Additionally, data from 177Lu-PSMA-617 were prominently featured at key medical meetings during the quarter, and we are pleased that data continue to suggest a favorable profile and improved PSA response rates. We also presented key preclinical data from our CAR-T platform and expect to file an IND for EC17/CAR T-cell therapy in patients with osteosarcoma in the fourth quarter this year."
Second Quarter and Recent Highlights
Enrolled the first patient in the phase 3 VISION study of 177Lu-PSMA-617 in patients with progressive prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Signed a long-term global supply agreement with ITG Isotope Technologies Garching GmbH (ITG), for highly purified, no-carrier-added Lutetium-177 to support both clinical and commercial supply of 177Lu-PSMA-617, through 2035.
Announced that multiple presentations related to Endocyte’s PSMA-617 radioligand therapy were presented at the 2018 Society of Nuclear Medicine and Molecular Imaging Annual Meeting.
Announced the publication of data in The Lancet Oncology from the original 30 patients in the phase 2 trial of 177Lu-PSMA-617 initiated by Professor Michael Hofman of the Peter MacCallum Cancer Centre (MacCallum study). Relative to previously presented data from this study, the updated data reflected longer median overall survival, longer median prostate specific antigen (PSA) progression-free survival, and higher RECIST soft tissue response rates. The safety profile of 177Lu-PSMA-617 was similar to that previously reported.
Announced the presentation of data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 50 patients in the MacCallum study, which included data from 20 additional patients and demonstrated higher PSA response rates than the initial 30 patients in the study, as well as consistency in activity regardless of prior therapies. Survival data from these additional 20 patients were not yet mature.
Presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, including a late-breaking poster, demonstrating that EC17/CAR T-cell therapy showed consistent antitumor activity in human xenografts, with multiple mechanisms for controlling immune response to potentially mitigate cytokine release syndrome.
Expected 2018 Milestones
Publications on additional ongoing investigator-initiated clinical trials of 177Lu-PSMA-617 in prostate cancer patients (2018).
IND for phase 1 trial of EC17/CAR T-cell therapy in patients with osteosarcoma (4Q 2018).
Second Quarter 2018 Financial Results
Endocyte reported a net loss of $11.6 million, or $0.17 per basic and diluted share, for the second quarter of 2018, compared to a net loss of $11.7 million, or $0.28 per basic and diluted share, for the same period in 2017.
Research and development expenses were $7.6 million for the second quarter of 2018, compared to $8.7 million for the same period in 2017. The decrease was primarily attributable to a strategic portfolio review announced in June 2017 which led to a reduction in workforce and the discontinuation of certain research and development activities, including, for the second quarter of 2018 compared to the second quarter of 2017: a decrease of $1.5 million in EC1456 trial expenses; a decrease of $1.3 million in expenses related to pre-clinical work and general research, including the development of EC2629; a decrease of $1.0 million in EC1169 trial expenses; a decrease of $0.5 million in compensation expense as a result of employee terminations since June 30, 2017; and a decrease of $0.2 million in manufacturing expense for EC1169 and EC1456. These decreases were partially offset by: an increase of $3.3 million in expenses related to development of PSMA-617; and an increase of $0.2 million related to our CAR T-cell therapy program.
General and administrative expenses were $4.6 million for the second quarter of 2018, compared to $3.3 million for the same period in 2017. The increase was primarily attributable to an increase of $0.5 million in compensation expense, of which $0.4 million related to stock-based compensation charges; an increase of $0.5 million in legal and professional fees; and an increase of $0.3 million in other general and administrative fees.
Cash, cash equivalents and investments were $166.8 million at June 30, 2018, compared to $118.4 million at June 30, 2017, and $97.5 million at Dec. 31, 2017. Cash, cash equivalents and investments of $166.8 million at June 30, 2018 included $80.9 million of net proceeds from our public offering of 20,535,714 shares of our common stock that closed in March 2018.
Financial Expectations
The company anticipates its cash, cash equivalents and investments balance at the end of 2018 to exceed $130 million. Based on current operational assumptions, Endocyte has sufficient cash to fund its activities through the expected end of the VISION trial and potential proof of concept of its EC17/CAR T-cell therapy.
Conference Call
Endocyte management will host a conference call today at 8:30 a.m. EDT.
U.S. and Canadian participants: (877) 845-0711
International: (760) 298-5081
A live, listen-only webcast of the conference call may be accessed by visiting the Investors & News section of the Endocyte website, www.endocyte.com.
The webcast will be recorded and available on the company’s website for 90 days following the call.
Website Information
Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document