Endocyte, Inc. (Nasdaq:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, announced financial results for the fourth quarter ending December 31, 2014, and provided a clinical update.
“We continue to be pleased with the progress of the Phase 1 trials for EC1456, a folate-targeted tubulysin, and EC1169, a prostate-specific membrane antigen (PSMA)-targeted tubulysin,” said Ron Ellis, Endocyte’s president and chief executive officer. “Data to date have consistently shown the high level of potency of the tubulysin payload compared to the vinca payload in vintafolide and to other chemotherapies. We have confirmed that our proprietary SMDC technology is allowing us to deliver this drug safely at dose levels we had targeted. We are looking forward to expanding both trials, selecting patients who test positive for the targeted receptor, once we have determined the maximum tolerated dose (MTD) for each drug. For EC1456, we plan to explore both monotherapy and drug combinations in non-small cell lung cancer (NSCLC), triple-negative breast, ovarian and endometrial cancers. For EC1169, we plan to continue to focus on patients with recurrent prostate cancer.”
Mike Sherman, chief operating officer and chief financial officer of Endocyte, commented, “We have done extensive work to define the optimal indications for the next phase of development for EC1456 in order to maximize the likelihood of success. Our goal is to secure efficacy and safety data by mid-year 2016 for at least two indications for EC1456, and for the expanded trial of EC1169. With more than $200 million in cash, we are in a strong position to advance theses agents into the next phase of development.”
Upcoming Expected Milestones
- Final overall survival results from the TARGET trial of vintafolide in combination with docetaxel in NSCLC expected to be announced in the second or third quarter of 2015.
- Completion of Phase 1 dose escalation trials for both EC1456 and EC1169, identifying the MTD and preferred schedule for each agent. Safety and efficacy data expected to be announced at a medical conference in 2015.
- Expansion of the trial for EC1456, which will evaluate the safety and efficacy of EC1456 at the MTD as a monotherapy and in drug combinations in patients with all target lesions positive for the folate receptor in NSCLC, triple-negative breast, ovarian and endometrial cancers. We expect to initiate this portion of the trial in the second half of 2015, and to reach tumor response endpoints in some indications by mid-year 2016.
- Expansion of the trial for EC1169, which will evaluate the safety and efficacy of EC1169 at the MTD in recurrent prostate cancer patients. We also expect to initiate this portion of the trial on the second half of 2015 and to reach primary endpoints by mid-2016.
Fourth Quarter 2014 Financial Results
Endocyte reported a net loss of $8.1 million, or $0.19 per basic and diluted share, for the fourth quarter of 2014, compared to a net loss of $2.9 million, or $0.08 per basic and diluted share, for the same period in 2013.
Research and development expenses were $4.0 million for the fourth quarter of 2014, compared to $13.5 million for the same period in 2013. No expenses for the PROCEED trial of vintafolide in ovarian cancer were recorded during the fourth quarter of 2014 as all remaining expenses were recognized in the second quarter of 2014 when the trial was terminated. The remaining decrease in expenses was driven by a reduction in TARGET trial expenses as this trial is nearing completion, and a reduction in manufacturing expenses.
General and administrative expenses were $4.2 million for the fourth quarter of 2014, compared to $6.7 million for the same period in 2013. The decrease in expenses was attributable to ceasing all commercial activities following the withdrawal of the marketing applications in Europe.
Cash, cash equivalents and investments were $206.8 million at December 31, 2014, compared to $211.1 million at September 30, 2014, and $148.9 million at December 31, 2013. In April 2014 the company closed an equity offering yielding net proceeds of $101.9 million. Net cash outflow from operations for the fourth quarter of 2014 was $4.3 million compared to $8.1 million in the third quarter of 2014 and $10.3 million in the fourth quarter of 2013.
The Company expects that its cash balance at the end of 2015 will exceed $155 million. Spending is expected to increase from the first half of 2015 to the second half as the trials for EC1456 and EC1169 are expanded once the maximum tolerated doses are determined.
Endocyte management will host a conference call today at 8:30 a.m. EST.
|U.S. and Canadian participants:
A live, listen-only webcast of the conference call may also 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 two weeks following the call.
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 “Investor & 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.
Shares of Endocyte closed last Friday at $5.8 . ECYT has a 1-year high of $33.70 and a 1-year low of $5.01. The stock’s 50-day moving average is $5.40 and it’s 200-day moving average is $6.20.
On the ratings front, Endocyte has been the subject of a number of recent research reports. In a report issued on November 7, Brean Murray Carret analyst Jonathan Aschoff maintained a Hold rating on ECYT.
Endocyte, Inc. is a biopharmaceutical company developing targeted therapies for the treatment of cancer and inflammatory diseases.