Company

2010

  • Initiated Phase 2b study of PT003 (PT0031002) in the United States, Australia and New Zealand to evaluate safety and efficacy in patients with COPD
  • PT003 IND filed and in effect: third active IND in approximately three years since Pearl began operations
  • Presented results of three successful clinical studies on PT001, PT005 and PT003 at the 2010 International Conference of American Thoracic Society
  • Developed a triple combination - PT010 (Formoterol - Glycopyrrolate – Inhaled Corticosteroid) HFA-MDI formulation candidate suitable for clinical testing, without a change in drug delivery of each active relative to the mono-therapies and to the dual combinations
  • Winner of TiE50 2010 Top Startup award from TiE, the world’s largest organization for entrepreneurs
  • Former President and CEO, Perry Karsen, now Chief Operations Officer of Celgene Corporation, continues as member of Pearl Board of Directors
  • Appointed Howard B. Rosen, as Interim Pearl CEO and President
  • Raised $15M in financing via convertible note to progress Pearl pipeline


2009

  • Received clearance to proceed to Phase 2b trial of inhaled formoterol HFA-MDI (PT005) following submission of a U.S. Investigational New Drug (IND) application
  • Completed Phase 2a dose-ranging study to evaluate the safety and efficacy of inhaled glycopyrrolate HFA-MDI (PT001) in patients with chronic obstructive pulmonary disease (COPD)
  • Completed Phase 1 healthy volunteer safety and pharmacokinetics study with glycopyrrolate-formoterol combination HFA-MDI (PT003)
  • Completed Phase 2b enabling 14-day inhalation toxicology studies for formoterol HFA-MDI (PT005) and glycopyrrolate-formoterol combination HFA-MDI (PT003)
  • Completed Phase 2a dose-ranging study to evaluate the safety and efficacy of inhaled formoterol HFA-MDI (PT005) in patients with COPD
  • Filed patent application for new formulation platform
  • Received clearance to proceed to Phase 2a trial of glycopyrrolate HFA-MDI (PT001) in COPD following submission of U.S. IND application
  • Secured $8 million venture debt financing from Silicon Valley Bank and Oxford Finance
  • Appointed Perry Karsen as Chief Executive Officer


2008

  • Completed Phase 2b enabling 14-day inhalation tox study for glycopyrrolate HFA-MDI (PT001)
  • Initiated Phase 2a dose-ranging study to evaluate the safety and efficacy of inhaled formoterol HFA-MDI (PT005) in patients with COPD
  • Raised $18 million Series B2 financing to accelerate pipeline
  • Established manufacturing pilot plant for clinical production


2007

  • Initiated preclinical product development
  • Appointed Michael Golden as Vice President, Regulatory Affairs and Quality
  • Appointed Colin Reisner, M.D., as Chief Medical Officer
  • Transferred technology from Nektar
  • Established operations in California, North Carolina and New Jersey
  • Raised $15.5 million Series B1 financing
  • Obtained license to a fully developed pulmonary drug delivery platform from Nektar in exchange for Series A equity


2006

  • Pearl founded by Sarvajna Dwivedi, Ph.D., and Adrian Smith, industry veterans with experience in drug development, specifically novel pulmonary therapeutics, with a vision of developing unique respiratory therapeutics utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers