Follow the Money: ArQule, Inc.

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Follow the Money highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

ArQule, Inc. is a U.S. public biopharmaceutical company that develops innovative therapeutics for the treatment of cancer and rare diseases. They plan to raise $15.6 million in a completion of a secondary public offering, as reported in the March 3, 2016 issue of the PharmSource Lead Sheet.

Corporate Highlights

  • ArQule was incorporated in Delaware in 1993.
  • Corporate Headquarters: Burlington, MA – approximately 15,000 square feet of office and laboratory space.
  • As of December 31, 2015, they had 36 employees, of whom 21 were engaged in R&D or manufacturing.

Sourcing Opportunities

  • ArQule plans to use the proceeds to support preclinical research and clinical trials of its pipeline, including:
    • ARQ 751 – complete Preclinical studies:
      • For the treatment of rare diseases – tumor inhibition and downstream AKT signaling
      • Dosage Form: Oral
      • Nature of API: Chemical – High Potency non-cyto
      • Therapeutic Area: Oncology – Other
    • ARQ 092 – complete Phase I study:
      • For the treatment of Proteus syndrome, also known as Wiedemann syndrome
      • Dosage Form: Oral
      • Nature of API: Chemical – High Potency non-cyto
      • Therapeutic Area: Oncology – Other
    • ARQ 197 (Tivantinib) – complete Phase III study:
      • For the treatment of hepatocellular carcinoma
      • Dosage Form: Tablet
      • Nature of API: Chemical – High Potency non-cyto
      • Therapeutic Area: Oncology
  • The company contracts with contract research organizations (CROs) to conduct clinical trials.
  • ArQule does not own or operate manufacturing facilities and has no plans to develop them. The company relies on third party contract manufacturers for all required raw materials, API, and finished product for preclinical studies and clinical trials.
  • ArQule has no sales, marketing or distribution experience.

Business Relationships

  • In May 2015, ArQule and Beryllium Discovery entered into a collaborative R&D agreement for the preclinical development of PD-1 and PDL-1 inhibitors. Each company was responsible for their own preclinical development costs and then jointly agreed on whether to advance compounds into clinical testing on a shared cost basis. Financial terms were not disclosed.
  • On December 18, 2008, ArQule and Daiichi Sankyo entered into a license, co-development, and co-commercialization agreement for tivantinib in the US, Europe, South America, and the rest of the world except Japan, China, South Korea and Taiwan. Under the terms of the agreement, ArQule received $60 million upfront payment with up to $560 million in milestone payments.
  • On April 27, 2007, ArQule and Kyowa Hakko Kirin entered into a license agreement for the development and commercialization of tivantinib in Japan, China, South Korea, and Taiwan. ArQule received a $30 million upfront payment with up to $123 million in licensing and sales milestone payments.
  • On April 02, 2004, ArQule and Roche entered into a strategic alliance for the discovery and development of drug candidates for the treatment of cancer. Under the terms of the agreement, Roche obtained an option to ArQule’s E2F programs for cancer therapy and provided $15 million in initial research funding, while ArQule was responsible for advancing drug candidates through Phase II clinical trials. To date, ArQule has received an undisclosed amount in payments and royalties.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
ARQ 751 Onoclogy/Rare Diseases Oral Preclinical TBA
ARQ 092 Other Rare Diseases Oral Preclinical TBA
ARQ 092 Proteus syndrome Oral Phase I TBA
ARQ 092 Solid Tumors/Lymphoma/Endometrial cancer Oral Phase I TBA
ARG 087 Solid Tumors Oral Phase I TBA
ARG 087 Intrahepatic Cholangiocarcinoma Oral Phase II TBA
ARQ 761 Solid Tumors/Pancreatic Cancer Unknown Phase II TBA
Tivantinib Hepatocellular Carcinoma Tablet Phase III TBA

Finances

(In $ thousands) 2015 2014 2013
Revenues
11,239
11,254
15,914
R&D Expenditures
15,561
22,271
27,555
General & Administrative Expenditures
9,830
12,154
12,836
Total Operating Expenses
25,391
35,524
41,041

1ArQule, Inc., 2/29/16 10-K, SEC.gov

Contact Information

ArQule, Inc. Key Officers
1 Wall Street Paolo Pucci, CEO
Burlington, MA 01803 USA Brian Schwartz, MD, CMO
Phone: +1-781-994-0300 Kathryn Davis, VP, Clinical Operations
Fax: +1-781-376-6019 Giovanni Abbadessa, VP, Clinical Development
Web: www.arqule.com Ron Savage, Director, Preclinical Development & Clinical Pharmacology

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

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