Endocyte Reports Fourth Quarter and Year End 2013 Financial Results and Provides Business Update
- Key Data Readouts from TARGET Phase 2b Non-Small Cell Lung Cancer (NSCLC) Trial and PROCEED Phase 3 Trial in Platinum-Resistant Ovarian Cancer (PROC) in 1H 2014 -
- Launch of Clinical Trials in Solid Tumors, Prostate Cancer and Inflammation with Expanding SMDC Pipeline -
- Conference call today at
"We made significant progress during 2013 with our lead program, vintafolide, across multiple indications and advancing our proprietary pipeline of SMDCs into the clinic, setting the stage for several major milestones in the first half of 2014," said
"We expect to announce top-line results for our Phase 2b TARGET trial of vintafolide and etarfolatide in non-small cell lung cancer in March. Investigators completed enrollment for the TARGET trial ahead of schedule and it has achieved the targeted number of events. Patient enrollment remains on track for the Phase 3 PROCEED registration trial of vintafolide and etarfolatide in ovarian cancer, and we expect enrollment of the 250th patient in the targeted FR(100%) patient population in the second quarter; evaluation of interim results by the independent data and safety monitoring board (DSMB) will determine whether the final 100 patients are enrolled. If the progression free survival (PFS) hurdle is achieved, they will recommend the enrollment of the final 100 patients. Because the PFS hurdle at this interim analysis is similar to that required for a positive result at the end of the trial, achieving this hurdle will increase confidence in achieving the primary PFS endpoint. Additionally, we have made substantial progress with our pipeline of proprietary SMDCs and companion imaging agents, including the start of enrollment for a Phase 1 trial of our folate-tubulysin oncology agent EC1456 in the fourth quarter of last year and preparing the IND submission for PSMA-targeted tubulysin," Ellis continued.
Endocyteannounced the enrollment of the first patient in the Phase 1 trial of EC1456, the folate-targeted tubulysin SMDC, for the treatment of advanced solid tumors. Etarfolatide (EC20) is the companion imaging agent for EC1456.
Endocyteand Merck provided an oral explanation to the CHMPin support of the conditional marketing authorization applications for vintafolide and etarfolatide.
- The Phase 2b TARGET trial of vintafolide and etarfolatide in NSCLC has achieved its targeted number of events needed for analysis of the primary endpoint.
Vintafolide received orphan drug designation by the
U.S. Food and Drug Administration(FDA) for the treatment of ovarian cancer. The companion imaging agent etarfolatide also has orphan drug designation for the identification of folate receptor positive ovarian carcinomas.
Upcoming Expected Milestones
- Report top-line data from the Phase 2b TARGET trial in NSCLC in March. If the TARGET trial is successful, Merck will be responsible for execution and funding of the Phase 3 trial.
Receive opinion from
CHMPon pending EU conditional marketing authorization applications for vintafolide and etarfolatide at the March meeting to be held between March 17 and March 20.
- File IND for proprietary PSMA-targeted tubulysin SMDC for prostate cancer in March.
Endocyte'scollaboration with Merck, a Phase 2 randomized trial for vintafolide in folate receptor-positive triple negative breast cancer is expected to begin in second quarter. This is the third indication being studied in patients with folate-receptor positive tumors for the vintafolide program.
- Announce late in the second quarter the DSMB decision on whether to complete the enrollment of the final 100 FR(100%) patients in the Phase 3 PROCEED trial of vintafolide and etarfolatide in platinum resistant ovarian cancer.
- File IND and launch clinical trial for proprietary folate inflammation SMDC and companion imaging agent candidates in early 2015.
Fourth Quarter 2013 Financial Results
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents and investments were
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Note on Non-GAAP Financial Measures
As used in this press release, the term "adjusted research and development expenses" and "adjusted general and administrative expenses" are financial measures not expressly recognized by accounting principles generally accepted in the United States, or GAAP. These measures are net of the amounts reimbursable during a period by Merck pursuant to the collaboration agreement for vintafolide which for U.S. GAAP purposes are ultimately recorded as revenue. Endocyte provides these non-GAAP financial measures to enhance comparability with prior periods and uses it as a basis for guidance regarding future operations. A reconciliation of these non-GAAP measures to the most directly comparable measures computed in accordance with GAAP is included in the financial tables below.
Forward Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential regulatory approval and commercial launch of products, the success of the Merck collaboration, the initiation of future clinical trials, the enrollment period for and availability of data from ongoing and future clinical trials, and the company's timeline for seeking regulatory approval to initiate clinical trials for new compounds. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its
clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company's product candidates; the goals of its development activities; estimates of the potential markets for its product candidates; estimates of the capacity of manufacturing and other facilities required to support its product candidates; projected cash needs; and expected financial results. More information about the risks and uncertainties faced by
|Statements of Operations|
|(in thousands, except per share amounts)|
For the Three Months
For the Twelve Months
|Collaboration revenue||$ 14,454||$ 17,274||$ 34,682||$ 64,871|
|Costs and expenses:|
|Research and development||10,518||13,533||35,671||57,899|
|General and administrative||4,950||6,704||15,054||25,314|
|Total costs and expenses||15,468||20,237||50,725||83,213|
|Loss from operations||(1,014)||(2,963)||(16,043)||(18,342)|
|Other expense, net||(25)||(28)||(948)||(154)|
|Net loss||$ (849)||$ (2,902)||$ (17,292)||$ (18,032)|
|Net loss per share - basic and diluted||$ (0.02)||$ (0.08)||$ (0.48)||$ (0.50)|
|Comprehensive loss||$ (843)||$ (2,867)||$ (17,213)||$ (18,049)|
|Weighted average number of common shares used in net loss per share - basic and diluted||35,910,490||36,146,061||35,858,757||36,036,996|
|Cash, cash equivalents and investments||$ 201,378||$ 148,853|
|Total assets||$ 214,079||$ 162,858|
|Liabilities and stockholders' equity|
|Current liabilities||$ 10,478||$ 13,917|
|Deferred revenue, current portion||51,993||59,747|
|Deferred revenue, net of current portion||51,993||932|
|Other liabilities, net of current portion||42||33|
|Total stockholders' equity||99,573||88,229|
|Total liabilities and stockholders' equity||$ 214,079||$ 162,858|
|(in thousands, unaudited)|
For the Three Months
For the Twelve Months
|Research and development expenses||$10,518||$13,533||$35,671||$57,899|
|Amounts reimbursable by Merck||(4,098)||(4,219)||(11,861)||(19,665)|
|Adjusted research and development expenses||
||$ 23,810||$ 38,234|
|General and administrative||$4,950||$6,704||$15,054||$25,314|
|Amounts reimbursable by Merck||-||(171)||-||(879)|
|Adjusted general and administrative expenses||
||$ 15,054||$ 24,435|
Stephanie Ascher, Stern Investor Relations, Inc. (212) 362-1200, firstname.lastname@example.org Martina Schwarzkopf, Ph.D., Russo Partners(212) 845-4292, email@example.com Tony Russo, Ph.D., Russo Partners(212) 845-4251, firstname.lastname@example.org
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