On October 30, 2019 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the third quarter of 2019 (Press release, ArQule, OCT 30, 2019, View Source [SID1234550016]).
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For the quarter ended September 30, 2019, the Company reported a net loss of $10.7 million, or $0.09 per basic share, compared with net loss of $5.6 million, or $0.05 per basic share, for the quarter ended September 30, 2018.
As of September 30, 2019, the Company had a total of approximately $174.1 million in cash, cash equivalents, and marketable securities.
Key Highlights from Q3, 2019
ARQ 531, our potent and reversible dual inhibitor of both wild-type and C481-mutant BTK:
Completed recruitment of the phase 1 dose escalation trial and determined a recommended phase 2 dose (RP2D) of 65 mg once a day
Submitted American Society of Hematology (ASH) (Free ASH Whitepaper) abstract in July, which is scheduled to be made public at 9:00 a.m. ET, November 6, 2019
Began dosing phase 2 expansion cohorts in multiple B cell malignancies at the RP2D
Requested and received a meeting date with the FDA to discuss registrational trial design
Miransertib, our potent and selective first-generation AKT inhibitor:
Initiated multiple additional sites in our previously described registrational trial, MOSAIC (Miransertib in Overgrowth Syndromes in Adults and Children), for both Proteus syndrome (PS) and PIK3CA-related Overgrowth Spectrum (PROS)
Recently announced the first patient dosed under the MOSAIC protocol at Texas Children’s Hospital (TCH) Vascular Anomalies Center
ARQ 751, our highly potent and selective next-generation AKT inhibitor:
Continued the signal generation work in genetically defined solid tumors
Derazantinib, our FGFR inhibitor, partnered with Basilea and Sinovant, in a registrational trial for intrahepatic cholangiocarcinoma:
Continued to interact with our partners, Basilea and Sinovant
Paolo Pucci, Chief Executive Officer of ArQule, commented, "We are very excited to present the final phase 1 data set for ARQ 531 at ASH (Free ASH Whitepaper) in December. These data will include meaningful updates on clinical activity and durability that provide a more complete picture of the potential of ARQ 531 and will reinforce its position as the leading reversible BTK inhibitor."
"The tremendous progress ARQ 531 has made in such a short period has allowed us to provide first ever proof of concept with a reversible BTK inhibitor in the emerging unmet medical need of C481-mutant CLL patients. We are now actively recruiting patients in the multi-arm phase 2 trial," commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. "It is also very gratifying to have begun patient enrollment in our registrational MOSAIC trial in Proteus syndrome and PROS."
Revenues and Expenses
Revenues for the third quarter, 2019, were $0.2 million compared with revenues of $5.0 million for the third quarter, 2018.
Research and development expenses in the third quarter, 2019 were $8.3 million compared with $7.3 million for the third quarter, 2018.
General and administrative expenses in the third quarter, 2019 were $3.2 million compared with $3.4 million for the third quarter, 2018.
2019 Financial Guidance
For 2019, ArQule expects revenue to range between $2 and $5 million. Net loss is expected to range between $40 and $43 million, and net loss per share to range between $(0.35) and $(0.37) for the year. ArQule expects to end 2019 with approximately $160 million in cash and marketable securities which will support the current business plan into 2022.
Conference Call and Webcast
ArQule will hold its second quarter financial results call today, October 30, 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 & 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. and entering the conference ID: 4289763. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."