ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the fourth quarter and full year of 2017.
For the quarter ended December 31, 2017, the Company reported a net loss of $7,760,000 or $0.09 per share, compared with net loss of $6,820,000 or $0.10 per share, for the quarter ended December 31, 2016. The Company reported a net loss of $29,203,000 or $0.39 per share, for the year ended December 31, 2017, compared with a net loss of $22,718,000 or $0.33 per share, for the year ended December 31, 2016.
At December 31, 2017, the Company had a total of approximately $48,036,000 in cash and marketable securities.
Key Highlights
- ARQ 531, orally bioavailable, potent and reversible BTK inhibitor, is recruiting on schedule in the phase 1a trial. Initial phase 1a data will be presented at American Association for Cancer Research (AACR) which will be held April 14 through April 18, 2018.
- Miransertib, lead proprietary AKT inhibitor, is recruiting at three sites for Overgrowth Diseases. The phase 1/2 trial for Overgrowth Diseases evaluating patients with PROS and Proteus syndrome, age two and older in the U.S. and EU, continues to dose.
- Data supporting miransertib in combination with the aromatase inhibitor, anastrozole, for the treatment of advanced endometrial cancer will be presented at AACR. Phase 1b trial conducted at Memorial Sloan Kettering presents potential clinical path forward in this hard to treat disease setting.
- Derazantinib, a pan-FGFR inhibitor, continues to enroll on schedule in a registrational trial for FGFR2 fusion driven intrahepatic cholangiocarcinoma (iCCA). The recruitment of patients needed to perform the interim analysis is expected to be completed by year-end.
- ArQule has granted a Roivant Sciences Ltd. subsidiary an exclusive license to develop and commercialize derazantinib in the People’s Republic of China, Hong Kong, S.A.R., China, Macau, S.A.R., China, and Taiwan, China. Deal terms include an upfront payment to ArQule of $3 million and an additional $2.5 million development milestone within the first year. ArQule is also eligible for regulatory and commercial milestones and royalties on future sales of derazantinib in Greater China.
2018 Goals
ARQ 531 – BTK Inhibitor
- Complete phase 1a trial in refractory B-cell malignancies
- Publish foundational pre-clinical paper including chemical and crystal structure
- Present initial phase 1a data at AACR and additional data later this year
Miransertib – AKT Inhibitor Rare Diseases
- Initiate registrational program in Proteus syndrome
- Publish NIH phase 1 trial findings and compassionate use case reports
Miransertib and ARQ 751 – AKT Inhibitors Oncology
- Present data from phase 1b in oncology for miransertib
- Present data from phase 1a in oncology for ARQ 751
Derazantinib – FGFR Inhibitor
- Complete dosing of patients needed to conduct interim analysis in registrational trial in 2nd line iCCA
- Explore opportunities in additional tumor types
"During 2017 we have worked diligently to advance all the assets in our proprietary pipeline, and we are now in the position to make 10 presentations at AACR in April demonstrating our commitment to precision medicine," said Paolo Pucci, Chief Executive Officer of ArQule. "2018 has the prospect of being a pivotal year for ArQule as we see a complete data set from the phase 1a trial of our BTK inhibitor, ARQ 531, launch a registrational program in Proteus syndrome, and explore emerging late-stage opportunities in oncology with our AKT program."
"For ArQule the scientific highlights of 2017 were achieving, in collaboration with the NIH, clinical proof of concept...
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