ArQule, Inc. (Nasdaq: ARQL) today announced that eight presentations of clinical and pre-clinical data on three early clinical-stage product candidates will take place during the 26th EORTC-NCI-AACR Symposium to be held November 18-21, 2014 in Barcelona, Spain.

These product candidates include: ARQ 092, designed to inhibit the AKT serine/threonine kinase; ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family; and ARQ 761, a Beta lapachone analog being investigated as a promoter of NQ01-mediated programmed cancer cell necrosis.

Logistical information for these presentations follows below.

ARQ 092 data presentations

Abstract #320, Poster Board 100
First-in-human study with ARQ 092, a novel pan AKT-inhibitor, in subjects with advanced solid tumors or recurrent malignant lymphoma
Date: November 20, 2014
Location: Exhibition Hall
Authors: M. Saleh et al.

Abstract #531, Poster Board 103
In vitro and in vivo anti-tumor activity of ARQ 092, a potent and selective pan-AKT inhibitor
Date: November 21, 2014
Location: Exhibition Hall
Authors: Y. Yu et al.

ARQ 087 data presentations

Abstract #145, Poster Board 139
ARQ 087, a novel pan FGFR inhibitor crosses the BBB (blood-brain barrier) and distributes to the brain of rats
Date: November 19, 2014
Location: Exhibition Hall
Authors: R. Savage et al.

Abstract #389, Poster Board 169
A phase 1, dose-escalation, first-in-human study of ARQ 087, an oral pan-FGFR inhibitor, in adult subjects with advanced solid tumors
Date: November 20, 2014
Location: Exhibition Hall
Authors: K. Papadopoulos et al.

Combination of ARQ 092 and ARQ 087 data presentations

Abstract #475, Poster Board 047
The synergistic anti-proliferative effect of combining the FGFR inhibitor, ARQ 087 with the AKT inhibitor, ARQ 092 in human cancer cell lines and PDX models
Date: November 21, 2014
Location: Exhibition Hall
Authors: E. Marchlik et al.

Abstract #481, Poster Board 053
In vitro and vivo evaluation of the pan FGFR inhibitor ARQ 087 and selective pan AKT inhibitor ARQ 092 in endometrial cancer: potential for combination therapy
Date: November 21, 2014
Location: Exhibition Hall
Authors: J. Meade et al.

Abstract #513, Poster Board 085
Synergistic inhibition of ovarian and endometrial cancer cell lines using combined treatment of ARQ 092 and ARQ 087 in vitro and in vivo
Date: November 21, 2014
Location: Exhibition Hall
Authors: Y. Yu et al.

ARQ 761 data presentation

Abstract #253, Poster Board 033
Phase 1 correlative study of ARQ 761, a β-lapachone analogue that promotes NQ01-mediated programmed cancer cell necrosis
Date: November 20, 2014
Location: Exhibition Hall
Authors: D. Gerber et al.

About ArQule

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company’s pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase, and ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family. ArQule’s current discovery efforts are focused on the identification of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds.

This press release contains forward-looking statements regarding the Company’s clinical trials and planned clinical trials with ARQ 092, ARQ 087 and ARQ 761, as well as its ability to fund operations with current cash and marketable securities. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, ARQ 092, ARQ 087 or ARQ 761 may not demonstrate promising therapeutic effect; in addition, they may not demonstrate appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise prior to the initiation of planned clinical trials, during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or its partners and collaborators, to fail to initiate or to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for these products tivantinib is subject to the ability of the Company and its partners and collaborators to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials for which each of them is responsible. There is a risk that these issues may not be successfully resolved. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.