Follow the Money to Bio/Pharmaceutical Opportunities
Spotlight on Aldeyra Therapeutics, Inc.

by

Follow the Money to Bio/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.

Aldeyra Therapeutics is a U.S. public bio/pharmaceutical company that develops potent, small molecule, irreversible aldehyde traps for the treatment of diseases caused by inflammation and inborn errors of metabolism. It raised $10.5 million in a secondary public offering, as reported in the PharmSource Lead Sheet on February 16, 2017.

Corporate Highlights

  • Aldeyra Therapeutics was incorporated in Delaware on August 13, 2004 as Neuron Systems, Inc. and officially changed their name to Aldeyra Therapeutics on March 17, 2014
  • Corporate Headquarters: Lexington, MA – approximately 6,888 square feet of office space
  • As of December 31, 2015, they had 8 employees
  • Stock Exchange: NASDAQ
  • Stock Symbol: ALDX

Sourcing Opportunities

  • Aldeyra Therapeutics plans to use the proceeds to support R&D activities, including the development of its lead compound, ADX-102, for multiple indications.
    • ADX-102 – To complete the Discovery phase:
      • For treatment of Sjogren-Larsson syndrome and SSADH deficiency
      • Dosage Form: Topical; Semi-solid – Non-sterile
      • Nature of API: Unknown
      • Therapeutic Area: Dermatology; Metabolic
  • ADX-102 – To complete a Phase II study:
    • For treatment of noninfectious anterior uveitis
    • Dosage Form: Topical; Liquid – Sterile
    • Nature of API: Chemical – Normal potency
    • Therapeutic Area: Ophthalmology
  • The company contracts with contract research organizations (CROs) to conduct ongoing and planned clinical trials.
  • Aldeyra Therapeutics does not own or operate manufacturing facilities and currently has no plans to build their own. They currently rely on third party contract manufacturers for all required raw materials, API and finished product for preclinical studies and clinical trials.
  • Aldeyra Therapeutics has limited sales, marketing and distribution capabilities.
  • Business Relationships

    • In February 2010, Aldeyra Therapeutics and CyDex Pharmaceuticals entered into a license and supply agreement for the development and commercialization of aldehyde traps for the treatment of ocular disease. Under the terms of the agreement, Aldeyra Therapeutics will pay up to $2.15 million in milestone payments based on development and regulatory milestones and royalties based on commercialization of any products.1

    Drug Product Pipeline

    Product Candidate Indication Dosage Form Status Next Anticipated Step
    ADX-102 (Systemic) Sjögren-Larsson Syndrome & SSADH Deficiency Topical; Semi-solid – None-sterile Discovery TBA
    ADX-102 (Ocular) Dry Eye Syndrome Topical; Liquid – Sterile Phase I Initiate a Phase IIa trial in 2017
    ADX-102 (Ocular) Allergic Conjunctivitis Topical; Liquid – Sterile Phase II Initiate a Phase IIb in 2017
    ADX-102 (Ocular) Noninfectious Anterior Uveitis Topical; Liquid – Sterile Phase II Initiate a Phase III trial in Q2 2017
    ADX-102 (Dermatologic) Sjögren-Larsson Syndrome Topical; Semi-solid – None-sterile Phase II Initiate a Phase III trial in H2 of 2017

    Finances

    (In $ thousands) 2015 2014
    Revenues
    R&D Expenditures
    7,574,398
    3,707,544
    General & Administrative Expenditures
    4,414,709
    3,563,046
    Total Operating Expenses
    11,989,107
    7,270,590

    1Aldeyra Therapeutics, Inc. 3/30/16 10-K, SEC.gov

    Contact Information

    Aldeyra Therapeutics, Inc. Key Officers
    131 Hartwell Avenue Todd C. Brady, MD, PhD, President & CEO
    Lexington, MA, 02421 USA David Clark, MD, CMO
    Phone: +1-781-761-4904 Philip L. Piscitelli, Director, Clinical Operations
    Web: www.aldeyra.com Donna Keith, Director, CMC

    Related posts:
    Follow the Money to Pharmaceutical Opportunities – Spotlight on Zynerba Pharmaceuticals, Inc.
    Follow the Money to Pharmaceutical Opportunities – Spotlight on Clearside Biomedical, Inc.
    Follow the Money to Pharmaceutical Opportunities – Spotlight on Synthetic Biologics, Inc.

    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.

    More posts by Scotty Chung-Siu