On May 1, 2019 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the first quarter, 2019 (Press release, ArQule, MAY 1, 2019, View Source [SID1234535491]).
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For the quarter ended March 31, 2019, the Company reported a net loss of $10,267,000, or $0.09 per share, compared with net loss of $6,532,000, or $0.07 per share, for the quarter ended March 31, 2018.
As of March 31, 2019, the Company had a total of approximately $92,223,000 in cash, cash equivalents, and marketable securities.
Key Highlights from Q1, 2019
ARQ 531, our potent and reversible dual inhibitor of both wild-type and C481S-mutant BTK. Reported in March that the first evaluable CLL patient with a C481S mutation enrolled in cohort 7 (65 mg QD) of our phase 1 trial achieved a partial response that has since been confirmed with a subsequent scan. This is in addition to a previously reported follicular lymphoma patient who had also achieved a partial response and continues on therapy. Cohort 7 has been cleared for safety and we have begun enrolling patients in cohort 8 (75 mg QD). No additional DLTs have been observed at any dose. We plan to present detailed, updated data from this ongoing trial at the European Hematological Association meeting in June
Miransertib, our potent and selective first-generation AKT inhibitor. Concluded interactions with the FDA and defined the registrational trial designs for both Proteus syndrome and PIK3CA-Related Overgrowth Spectrum (PROS). We have finalized the protocol and received the first conditional IRB approvals
ARQ 751, our highly potent and selective next-generation AKT inhibitor. Signal generation work in genetically-defined solid tumors continues, and we plan to present the final data set at a major conference by year end
Derazantinib, our FGFR inhibitor, partnered with Basilea and Sinovant, in a registrational trial for intrahepatic cholangiocarcinoma. Substantially completed the timely recruitment and transfer of clinical and other responsibilities to Sinovant and Basilea
Paolo Pucci, Chief Executive Officer of ArQule, commented, "We have made tremendous progress across our pipeline in Q1, and we are particularly pleased with the safety and dose dependent clinical activity profile that is emerging with ARQ 531."
"We are busy collecting data for our ARQ 531 presentation at EHA (Free EHA Whitepaper), and we are confident that we will demonstrate meaningful incremental clinical activity in addition to the two PRs already announced", commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. "We are also pleased by the rapid review of the initial IRBs for our registrational trial with miransertib in Proteus syndrome and PROS."
Revenues and Expenses
Revenues for the first quarter, 2019, were $1,345,000 compared with revenues of $4,138,000 for the first quarter, 2018.
Research and development expenses in the first quarter, 2019 were $7,448,000 compared with $5,812,000 for the first quarter, 2018.
General and administrative expenses in the first quarter, 2019 were $4,300,000 compared with $2,351,000 for the first quarter, 2018.
2019 Financial Guidance
Our 2019 financial guidance has not changed. For 2019, ArQule expects revenue to range between $3 and $5 million. Net loss is expected to range between $40 and $43 million, and net loss per share to range between $(0.37) and $(0.39) for the year. ArQule expects to end 2019 with between $60 and $63 million in cash and marketable securities.
Conference Call and Webcast
ArQule will hold its first quarter financial results call today, May 1, 2019 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations."