Follow the Money to Bio/Pharmaceutical Opportunities
Spotlight on Clearside Biomedical, Inc.

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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.

Clearside Biomedical is a U.S. public bio/pharmaceutical company that develops and commercializes therapeutic products using an ocular microinjection platform to target the individual compartments of the eye. It plans to raise $36 million in a secondary public offering, as reported in the PharmSource Lead Sheet on December 15, 2016.

Corporate Highlights

  • Clearside Biomedical was incorporated in Delaware in 2011.
  • Corporate Headquarters: Alpharetta, GA – approximately 8,800 square feet of office space. In November 2016, the company signed a new office agreement for a 20,000 square foot office space in Alpharetta, GA and expects to relocate in the first half of 2017.
  • As of September 30, 2016, they had 23 employees
  • Stock Exchange: NASDAQ
  • Stock Symbol: CLSD

Sourcing Opportunities

  • Clearside Biomedical plans to use the proceeds to continue early-stage R&D and to complete a Phase I/II study with Zuprata:
    • Zuprata – To complete a Phase I/II study:
      • For treatment of diabetic macular edema
      • Dosage Form: Parenteral – Liquid
      • Nature of API: Chemical – Steroid
      • Therapeutic Area: Diabetes; Ophthalmology
  • The company contracts with contract research organizations (CROs) to conduct ongoing and planned clinical trials.
  • Clearside Biomedical 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.
  • Clearside Biomedical has no sales, marketing or distribution infrastructure and experience.

Business Relationships

  • In April 2015, Clearside Biomedical entered into a research and license agreement with Spark Therapeutics for the exclusive rights to develop gene therapies for the treatment of orphan diseases of the back of the eye using Clearside Biomedical’s SCS Microinjector intellectual property and technology. Under the terms of the agreement, Spark paid a $500,000 upfront payment, up to $6 million based on the agreement’s option period and up to $13.5 million in development and commercialization milestones.
  • In August 2014, Clearside Biomedical and NovaMedica entered into a license agreement for the use of Clearside Biomedical’s intellectual property to develop and commercialize products using TA as the primary ingredient in Russia and other surrounding territories. Under the terms of the agreement, NovaMedica paid a $200,000 upfront payment and up to $12.7 million in development and commercial milestones.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
CLS-1002 Wet age-related macular degeneration (AMD) Parenteral – Proprietary device Preclinical IND submission in H1 of 2017
Zuprata (CLS-1004) Diabetic Macular Edema (DME) Parenteral – Liquid Phase I/II Preliminary results expected in H2 of 2017
CLS-1003 Macular Edema associated with Retinal Vein Occlusion (RVO) Parenteral – Proprietary device Phase II Phase III trial expected to begin in H1 of 2017
CLS-1001 Macular Edema associated with Non-infectious Uveitis Parenteral – Proprietary device Phase III TBA

Finances

(In $ thousands) 2015 2014
Revenues
R&D Expenditures
10,762
6,692
General & Administrative Expenditures
6,555
3,131
Total Operating Expenses
17,317
9,823

1Clearside Biomedical, Inc. 11/30/16 S-1, SEC.gov

Contact Information

Clearside Biomedical, Inc. Key Officers
1220 Old Alpharetta Road, Suite 300 Daniel White, President & CEO
Alpharetta, GA 30005 USA Thomas Godfrey, Senior Director, Manufacturing
Phone: +1-678-270-3631 Glenn Noronha, PhD, CSO
Fax: +1-678-270-4033 Jennifer Kissner, PhD, VP, Clinical Development
Web: www.clearsidebio.com Ellie Smith, Director, Clinical Trial Management

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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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