URLINGTON, Mass.--(BUSINESS WIRE)--ArQule, Inc. (Nasdaq: ARQL) today announced its financial results for the second quarter of 2019.

For the quarter ended June 30, 2019, the Company reported a net loss of $9.1 million, or $0.08 per basic share, compared with net income of $5.2 million, or $0.05 per diluted share, for the quarter ended June 30, 2018.

As of June 30, 2019, the Company had a total of approximately $182.8 million in cash, cash equivalents, and marketable securities.

Key Highlights from Q2, 2019

• In June 2019, the Company raised approximately $104 million of gross proceeds in a public offering of common stock. Net proceeds will be used to fund clinical programs and for general corporate purposes
• ARQ 531, our potent and reversible dual inhibitor of both wild-type and C481S-mutant BTK.
  • Presented first-of-its kind clinical proof-of-concept data at the 2019 European Hematology Association (EHA) Annual meeting from the ongoing phase 1 trial, including 4 Partial Responses (PRs) out of 6 evaluable CLL patients in the 65 mg QD dose cohort, a PR in a Richter’s transformation patient at the same dose and a PR in a follicular lymphoma patient on therapy for approximately two years. Subsequent to the EHA presentation an additional PR was observed in a DLBCL patient and was disclosed in the context of the recent public offering
  • Selected 65 mg QD as the recommended starting phase 2 dose (RP2D) after assessing incremental clinical activity and tolerability data from cohorts 7 (65 mg QD) and 8 (75 mg QD); no additional dose limiting toxicities have been observed and a maximum tolerated dose has not been reached
  • Commenced preparations for the next phase of development, including planned regulatory interactions and design of expansion cohorts at the RP2D in multiple B-Cell malignancies, including C481S mutant CLL
• Miransertib, our potent and selective first-generation AKT inhibitor.
  • Presented updated Proteus syndrome and PIK3CA-related Overgrowth Spectrum (PROS) data at the 2019 European Society of Human Genetics conference in Gothenburg, Sweden
  • Finalized the registrational protocol, received initial IRB approvals, nearing dosing of first patient
• 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.
  • Clinical activities ongoing with our partners, Basilea and Sinovant

Paolo Pucci, Chief Executive Officer of ArQule, commented, “Our second quarter was punctuated by the proof-of-concept data presented at EHA for ARQ 531, and we are gratified that our recent public offering will allow us to pursue the next phase of clinical development with ARQ 531.”

“Having observed substantial clinical activity with ARQ 531 at a well-tolerated dose in the target populations, we have been able to select a phase 2 dose and are aggressively taking the drug into the expansion phase,” commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. “We are also excited to have opened additional sites in our registrational MOSAIC study in Proteus syndrome and PROS.”

Revenues and Expenses

Revenues for the second quarter, 2019, were $0.3 million compared with revenues of $13.7 million for the second quarter, 2018.

Research and development expenses in the second quarter, 2019 were $6.3 million compared with $6.8 million for the second quarter, 2018.

General and administrative expenses in the second quarter, 2019 were $3.2 million compared with $2.2 million for the second quarter, 2018.

2019 Financial Guidance

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 $(0.35) and $(0.37) for the year. As a result of our common stock offering in June, we are updating our cash guidance. ArQule now expects to end 2019 with approximately $160 million in cash and marketable securities which will support the current business plan into 2022.

About ArQule 

ArQule is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. ArQule’s mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of our patients. Our clinical-stage pipeline consists of four drug candidates, all of which are in targeted, biomarker-defined patient populations, making ArQule a leader among companies our size in precision medicine. ArQule’s pipeline includes: ARQ 531, an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant BTK, in phase 1 for patients with B-cell malignancies refractory to other therapeutic options; miransertib (ARQ 092), a potent and selective inhibitor of the AKT serine/threonine kinase, in a planned registrational trial with cohorts in Proteus syndrome and PROS to initiate in 2019; ARQ 751, a next generation highly potent and selective AKT inhibitor, in phase 1 for patients with AKT1 and PI3K mutations; and derazantinib, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, in a registrational trial for iCCA in collaboration with Basilea and Sinovant. ArQule’s current discovery efforts are focused on the identification and development of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds.