On May 3, 2017 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the first quarter of 2017 (Press release, ArQule, MAY 3, 2017, View Source [SID1234518795]). Schedule your 30 min Free 1stOncology Demo! For the quarter ended March 31, 2017, the Company reported a net loss of $7,576,000 or $0.11 per share, compared with net loss of $4,981,000 or $0.08 per share, for the quarter ended March 31, 2016.
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At March 31, 2017, the Company had a total of approximately $37,540,000 in cash and marketable securities.
Key Highlights
ARQ 087, our FGFR inhibitor, will be featured in a poster discussion session highlighting the phase 1/2 trial in second-line intrahepatic cholangiocarcinoma (iCCA) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 3, 2017. A registrational phase 3 trial in this patient population is planned to commence in the third quarter of 2017.
ARQ 092, our lead AKT inhibitor, phase 1/2 company-sponsored trial in Overgrowth Diseases with genetic alterations of the PI3K/AKT1 pathway is open and the first patient has been identified. The phase 1/2 trial will enroll patients ages six and older with a spectrum of Overgrowth Diseases driven by genetic alterations of the PI3K/AKT1 pathway such as PROS (PIK3CA-Related Overgrowth Spectrum) and Proteus syndrome.
ARQ 531, our orally bioavailable, potent and reversible BTK inhibitor, received Investigational New Drug (IND) clearance from the FDA. A phase 1 trial is planned to commence by the third quarter of 2017 in patients with B-cell malignancies who are refractory to other therapeutic options.
ARQ 531 was issued a U.S. Patent by the U.S. Patent and Trademark Office covering composition of matter. ArQule will be entitled to patent protection through December 2035 in the U.S. for the allowed claims.
"We achieved two important milestones already this year, the initiation of our company-sponsored trial in Overgrowth Diseases with ARQ 092 and the clearance of the IND for ARQ 531 in B-cell malignancies," said Paolo Pucci, Chief Executive Officer of ArQule. "These milestones enable ArQule to execute the next phase of its business plan. In addition, we are looking forward to presenting data from our iCCA trial with ARQ 087 at ASCO (Free ASCO Whitepaper) in June and initiating the registrational trial in this indication."
"The clearance of the IND for ARQ 531 keeps us on track to begin the phase 1 trial by the third quarter," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "The therapeutic need for a reversible, non-covalent BTK inhibitor that works in wild type and C481S-mutant BTK is significant and we have the potential to be best-in-class in this therapeutic area."
Revenues and Expenses
Revenues for the quarter ended March 31, 2017, were zero compared with revenues of $1,227,000 for the quarter ended March 31, 2016. Research and development revenue in 2016 includes revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement. No further revenue is anticipated from these agreements.
Research and development expenses in the first quarter of 2017 were $5,194,000, compared with $4,198,000 for the first quarter 2016.
Research and development expense increased $1.0 million in the first quarter of 2017 compared to the first quarter of 2016 primarily due to higher outsourced pre-clinical, clinical and product development costs.
General and administrative expenses in the first quarter of 2017 were $2,074,000, compared with $2,044,000 for the first quarter of 2016.