Endocyte Provides First Quarter 2018 Financial Results and Operational Update
-Recently Updated Phase 2 Data on 177Lu-PSMA-617 Published in The Lancet Oncology Favorable to Preliminary Data Presented at 2017
-Positive End of Phase 2 FDA Meeting Set Stage for Successful
Financing in First Quarter-
-Phase 3 VISION Trial on Track for First Patient Visit in Q2 2018-
-Conference Call Today at
“We made important progress during the first quarter in establishing the design of our phase 3 VISION trial of 177Lu-PSMA-617, securing clinical supply of no-carrier-added Lutetium, and raising sufficient capital to fund the company through expected completion of the trial,” said
Mr. Sherman continued, “In addition, we are encouraged by the updated 30 patient data from the ongoing phase 2 trial at
First Quarter and Recent Highlights
- Finalized the design for the phase 3 VISION trial evaluating 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) following a successful End-of-Phase 2 meeting with the
U.S. Food and Drug Administration.
- Announced an agreement with ITM Isotopen Technologien München AG to supply no-carrier-added Lutetium (177Lu) to support the phase 3 VISION trial.
- Presented data on the chimeric antigen receptor T-cell (CAR T) adaptor molecule (CAM) platform at the
American Association for Cancer ResearchAnnual Meeting 2018 confirming the anti-tumor activity of Endocyte’s folate-targeted EC17/CAR T-cell therapy.
- Completed an underwritten registered public offering of 20,535,714 shares of its common stock, including full exercise of the underwriters’ option to purchase additional shares of common stock, at a public offering price of
$4.20per share. Endocytereceived aggregate net proceeds from the offering of approximately $80.9 million.
- Hired additional experienced clinical trial professionals to ensure strong execution and support the success of its clinical programs.
Patrick Machado, J.D., co-founder and former chief business and financial officer of Medivation, and Dawn Svoronos, former president of Merck’s Europe/ Canadaregion, to serve on the Board of Directors, bringing significant commercial leadership and understanding of the prostate cancer market to the Board.
Expected 2018 Milestones
- First patient visit for phase 3 VISION trial of 177Lu-PSMA-617 in mCRPC (2Q 2018).
- 50-patient response rate data readout of investigator-initiated trial of 177Lu-PSMA-617 in mCRPC patients at
Peter MacCallum Cancer Centrein Melbourne, Australia, to be presented at the Annual Meeting of the American Society of Clinical Oncology( ASCO) ( June 2018).
- 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).
First Quarter 2018 Financial Results
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents and investments were
The company anticipates its cash, cash equivalents and investments balance at the end of 2018 to exceed
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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, future use of capital, sufficiency of cash, the timing of initiation, interim assessments and completion of clinical trials, the enrollment period for, and availability and reporting of data from, ongoing and future clinical trials, the occurrence and timing of actions by regulatory agencies, estimates of the potential market opportunity for the company’s product candidates, and the company's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials and future sources of supply of product candidates to support clinical and commercial activities. 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 or independent investigators may experience delays in the initiation or completion of clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that suppliers or other third party contractors may not fulfill their contractual obligations on a timely basis or at all; risks that data from prior 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'sability to capture value for thetechnology; 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
Ended March 31,
|Costs and expenses:|
|Research and development||7,994||5,255|
|General and administrative||3,745||3,778|
|Total costs and expenses||11,739||9,033|
|Loss from operations||(11,727||)||(9,017||)|
|Interest income, net||235||413|
|Other income, net||3||1|
|Net loss per share - basic and diluted||$||(0.27||)||$||(0.16||)|
|Weighted average number of common shares used in net loss per share – basic and diluted:||42,434,709||55,000,743|
|Cash, cash equivalents and investments||$||97,471||$||173,125|
|Liabilities and stockholders’ equity|
|Deferred revenue and other liabilities, net of current portion||732||363|
|Total stockholders’ equity||95,484||171,702|
|Total liabilities and stockholders’ equity||$||100,762||$||176,678|
Source: Endocyte, Inc.