Endocyte Reports First Quarter Financial Results and Provides Clinical and Pipeline Update
"We look forward to providing safety and efficacy updates for our clinical trials of both EC1169 and EC1456 at the Annual Meeting of the
"Enrollment in the expansion phase of the EC1169 trial
in prostate cancer continues to progress well, and we recently completed our work with EC1456 exploring multiple dosing schedules," added Dr.
Lead SMDC Programs
EC1169 (PSMA-targeted tubulysin): Enrolling patients in the expansion phase of the EC1169 trial in up to 50 taxane-exposed metastatic castration-resistant prostate cancer (mCRPC) patients and up to 50 taxane-naïve mCRPC patients at a maximum clinical dose of 6.5 mg/m2 once per week. The primary endpoint of this expansion phase is radiographic progression-free survival (rPFS), with a target of 5 months for taxane-naïve mCRPC patients and 3 months for taxane-exposed mCRPC patients. Secondary endpoints, which will provide earlier insight into drug activity, include overall response rates as measured by response evaluation criteria in solid tumors (RECIST) 1.1 and prostate-specific antigen (PSA). Enrollment is not limited based on the results of the scan with EC0652, but primary endpoints of the trial are to be assessed on PSMA positive patients.
EC1456 (folate receptor-targeted tubulysin): Enrolling expansion cohort of up to 40 folate receptor-positive (FR-positive) non-small cell lung cancer (NSCLC) patients, as determined by an etarfolatide scan, to receive the maximum clinical dose of 6.0 mg/m2 twice per week. Patients included in this expansion phase of the trial
will have received first-line chemotherapy and may have also been treated with anti-programmed death-1 (anti-PD-1) therapy.
EC2629: Pre-clinical development currently underway with a potential Investigational New Drug (IND) filing in mid-2017. EC2629 leverages a proprietary warhead with a dual mechanism of action: targeting both TAMs and FR-positive cancer cells.
CAR T-Cell Development Program: Continued progress with next-generation CAR T-cell therapeutic platform, in collaboration with leading experts in the field at
First Quarter 2017 Financial Results
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents and investments were
The company anticipates its cash balance at the end of 2017 to be approximately
About EC1169 and EC0652
EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status is determined using the investigational companion imaging agent, EC0652.
About EC1456 and etarfolatide
EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status is determined using the investigational companion imaging agent, etarfolatide.
A live, listen-only webcast of the conference call may also be accessed by visiting the Investors & News section of the
The webcast will be recorded and available on the company's website for 90 days following the call.
Forward Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, the successful completion of current and future clinical trials, the enrollment period for, and availability and reporting, of data from ongoing and future clinical trials, and the company's future development plans including those
relating to the completion of pre-clinical development in preparation for possible future clinical trials. 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; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and
intellectual property landscape may impair the company's ability to capture value for the technology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company's product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by
Statements of Operations
(dollars in thousands, except per share amounts)
|For the Three Months|
|Costs and expenses:|
|Research and development||6,531||7,994|
|General and administrative||3,820||3,745|
|Total costs and expenses||10,351||11,739|
|Loss from operations||(10,339||)||(11,727||)|
|Interest income, net||189||235|
|Other income (expense), net||(3||)||3|
|Net loss per share - basic and diluted||$||(0.24||)||$||(0.27||)|
|Weighted average number of common shares used in net loss per share - basic and diluted:||42,109,828||42,434,709|
|As of||As of|
|Cash, cash equivalents and investments||$||138,207||$||127,562|
|Liabilities and stockholders' equity|
|Deferred revenue and other liabilities, net of current portion||785||770|
|Total stockholders' equity||137,147||126,702|
|Total liabilities and stockholders' equity||$||143,494||$||132,387|
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, firstname.lastname@example.org
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