Follow the Money to Pharmaceutical Opportunities
Spotlight on Ignyta, Inc.

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Follow the Money to Pharmaceutical Opportunities 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.

Ignyta, Inc. is a U.S. public biopharmaceutical company that develops personalized medicine tests to improve the diagnosis and treatment of patients with autoimmune diseases such as rheumatoid arthritis and lupus. It plans to raise $50 million in a completion of a secondary public offering, as reported in the PharmSource Lead Sheet on May 5, 2016.

Corporate Highlights

  • Ignyta was incorporated in Delaware in 2011.
  • Corporate Headquarters: San Diego, CA – approximately 44,000 square feet of office and laboratory space
  • As of February 29, 2016, they had 116 employees, of whom 88 were engaged in R&D and product development
  • Stock Exchange: NASDAQ
  • Stock Symbol: RXDX

Sourcing Opportunities

  • Ignyta plans to use the proceeds to complete development activities related to its companion diagnostics for targeted therapeutics and to support R&D activities for its pipeline, including:
    • Entrectinib – complete Phase I/II study:
      • For the treatment of cancer
      • Dosage Form: Capsule
      • Nature of API: Chemical – High potency non-cyto
      • Therapeutic Area: Oncology – Other
    • Taladegib – complete Phase I/Ib study:
      • For the treatment of advanced solid tumors
      • Dosage Form: Capsule
      • Nature of API: Chemical – Normal potency
      • Therapeutic Area: Oncology – Other; Oncology – Chemotherapy
    • RXDX-105 – complete Phase Ib study:
      • For the treatment of RET and BRAF
      • Dosage Form: Oral
      • Nature of API: Chemical – High potency non-cyto
      • Therapeutic Area: Oncology – Other
  • The company contracts with contract research organizations (CROs) to conduct clinical trials both within and outside the US.
  • Ignyta does not own or operate manufacturing facilities and relies on third party contract manufacturers for all required raw materials, API, and finished product for preclinical studies and clinical trials, as well as commercial manufacture.
  • Ignyta has no sales, marketing or distribution experience.

Business Relationships

  • In November 2015, Ignyta and Moffitt Cancer Center entered into a research collaboration agreement for RXDX-106. The agreement consisted of the research and development of a diagnostic assay that assessed RXDX-106 in solid tumors. Financial terms were undisclosed.
  • In July 2015, Ignyta and the University of California, San Francisco (UCSF) entered into a collaboration agreement for a clinical trial with entrectinib in patients with metastatic melanoma. Ignyta paid $1 million and provided enough entrectinib to complete the clinical trial, while UCSF provided clinical data and samples.
  • In August 2014, Ignyta entered into a license agreement with Nerviano Medical Sciences for RXDX-103 and RXDX-104. Ignyta received exclusive development and commercialization rights for the two drug candidates while Nerviano received a $3.5 million upfront payment and regulatory and royalty payments.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
Spark Programs Tumorigenesis Unknown Discovery TBA
RXDX-106 TAM, cMET Unknown Preclinical TBA
RXDX-105 RET,BRAF Oral Phase I TBA
Taladegib Advanced solid tumors Oral Phase I TBA
Entrectinib NTRK, ROS1, ALK Capsule Phase I/II TBA

Finances

(In $ thousands) 2015 2014
Revenues
150
R&D Expenditures
73,511
30,505
General & Administrative Expenditures
17,069
9,506
Total Operating Expenses
90,580
40,011

1Ignyta, Inc. 3/14/16 10-K, SEC.gov

Contact Information

Ignyta, Inc. Key Officers
11111 Flintkote Avenue Jonathan E. Lim, MD, President & CEO
San Diego, CA 92121 USA Pratik S. Multani, MD, CMO
Phone: +1-858-255-5959 David Luo, Senior Director, Clinical Operations
Web: www.ignyta.com Peter Chua, Associate Director, Medicinal Chemistry

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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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