ArQule, Inc. (NASDAQ: ARQL) stock surged 30.37% on June 16th, 2019 and continued its northward journey rising over 16^ (as of 12:18 pm GMT-4; Source: Google finance)
The company announced preliminary data from a Phase 1 trial of its investigational cancer drug ARQ 531. The study focused on using ARQ 531 to treat both wild type and C481S-mutant Bruton’s tyrosine kinase in patients with relapsed or refractory hematologic malignancies which are leukemias and lymphomas. The early-stage trial, which is still ongoing, looks at several different doses of the drug in 34 patients with advanced chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), Richter’s Transformation, Waldenström macroglobulinemia or other B-cell Non-Hodgkin lymphomas. The goal of such Phase 1 trials is to establish a recommended dose of a new drug for study in Phase 2 trials. Researchers looking at ARQ 531 said patients were fine at dosages up to 65 milligrams once a day. The drug demonstrated promising anti-tumor activity in some patients, according to the company. ARQL had presented the results at the 2019 European Hematology Association (EHA) Annual Meeting in Amsterdam, the Netherlands. ARQ 531 was selected and extensively tested preclinically to address the emerging therapeutic need for patients who have become resistant to covalent BTK inhibitors. The company is now focused on finalizing the recommended phase 2 dose and planning for the expansion of thw clinical efforts with ARQ 531 into later stage trials across multiple indications as a single agent and as a combination therapy.
Meanwhile, for the quarter ended March 31, 2019, the company reported a net loss of $10,267,000 compared with net loss of $6,532,000 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. 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.
For 2019, ArQule expects revenue to be in the range of $3 and $5 million. Net loss is expected to be in the range $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.