ArQule Announces Data Presentations with Tivantinib and ARQ 087 to Be Featured at ASCO 2015

ArQule, Inc. (Nasdaq: ARQL) today announced that tivantinib and ARQ 087 will be included in seven presentations during the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held from May 29-June 2, 2015 in Chicago, Illinois.

The presentations with tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase, will feature clinical trials across multiple diseases and therapeutic combinations. Data will relate to the safety and combinability of tivantinib with approved anticancer agents, supporting the ongoing development of this compound.

The most advanced ongoing clinical trial with tivantinib is a pivotal Phase 3 randomized, double-blind controlled study (the METIV-HCC trial) of the compound as single agent therapy in a biomarker-defined population of previously treated patients with MET-diagnostic-high, inoperable hepatocellular carcinoma (HCC).

Logistical information for the ASCO presentations featuring tivantinib follows below.

Abstract #2554
A phase I study of ARQ 197 in combination with temsirolimus in advanced solid tumors.
Saturday, May 30, 8:00 AM to 11:30 AM
S Hall A, Poster Board: #270
CE Kyriakopoulos, MD

Abstract #2549
Phase I trial of tivantinib (T) in combination with carboplatin (C) and pemetrexed (P) as first-line treatment in patients (pts) with advanced nonsquamous NSCLC or malignant pleural mesothelioma (MPM).
Saturday, May 30, 8:00 AM to 11:30 AM
S Hall A, Poster Board #265
PA Zucali, MD

Abstract #6060
A Randomized Phase II Trial of the MET inhibitor Tivantinib + Cetuximab Versus Cetuximab alone in Patients with Recurrent/Metastatic Head and Neck Cancer.
Saturday, May 30, 1:15 PM to 4:45 PM
S Hall A, Poster Board: #384
EE Vokes, MD

Abstract #4065
A phase II study of the c-Met inhibitor tivantinib (tiv) in combination with FOLFOX for the treatment of patients (pts) with previously untreated metastatic adenocarcinoma of the distal esophagus, gastroesophageal (GE) junction, or stomach.
Monday June 1, 8:00 AM to 11:30 AM
S Hall A, Poster Board #175
S Pant, MD

Abstract #7511
ARQ 197 (tivantinib) in patients (pts) with previously-treated malignant mesothelioma (MM):
A phase II trial from the University of Chicago Phase II Consortium.
Monday, June 1, 8:00 AM to 11:30 AM
S Hall A, Poster Board #258
S Maron, MD

Abstract #4523
SWOG 1107: Parallel Randomized Phase II Evaluation of Tivantinib (ARQ-197) and Tivantinib in Combination with Erlotinib in Patients (Pts) with Advanced Papillary Renal Cell Carcinoma (pRCC).
Monday June 1, 1:15 PM to 4:45 PM
S Hall A, Poster Board #193
P Twardowski, MD

ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, will be featured in the following presentation.

Abstract #2545
Phase 1, first-in-human study of ARQ 087, an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in patients (pts) with advanced solid tumors.
Saturday May 30, 8:00 AM to 11:30 AM
S Hall A, Poster Board #261
K P Papadopoulos, MD

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; 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 evaluated as a promoter of NQ01-mediated programmed cancer cell necrosis. 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 tivantinib (ARQ 197) and ARQ 087. 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, tivantinib and ARQ 087 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 tivantinib is subject to the ability of the Company as well as Daiichi Sankyo, Inc., our development partner for tivantinib, and Kyowa Hakko Kirin, a licensee of tivantinib, 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. In addition, we and our partners are utilizing a companion diagnostic to identify MET-high patients in the METIV-HCC and JET-HCC trials, and we expect to utilize diagnostic tools in our biomarker-guided clinical trials with ARQ 087; we may encounter difficulties in developing and obtaining approval for companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our collaborators or ourselves to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of our product candidates. 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. Moreover, with respect to partnered programs, even if certain compounds show initial promise, Daiichi Sankyo or Kyowa Hakko Kirin may decide not to license or continue to develop them, as the case may be. In addition, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate their agreements with ArQule. If either company were to do so, the Company might not be able to complete development and commercialization of the applicable licensed products on its own. 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.

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