Company

2013



2012

  • US Patent and Trademark Office issued first co-suspension technology patent
  • Completed a $65 million Series D financing to prepare the Company for PT003 Phase 3 program start in 2013
  • Completed the last two studies in a rigorous nine-study Phase 2 program of PT003 and its components, identifying optimal doses of the combination and monotherapy candidates for use in Phase 3 (See summary on http://clinicaltrials.gov or press releases)
  • Presented evidence supporting morning and evening benefits of twice-daily PT003 in patients with COPD
  • Presented in vitro data demonstrating “triple” combination of two bronchodilators and an inhaled corticosteroid retains MDI stability and prevents co-formulation effect
  • Successfully formulated nanogram-dose MDIs to deliver doses as low as 300ng per actuation of PT001 (glycopyrrolate MDI) to complete characterization of PT001 and PT003 dose response
  • Won the TiE50 2012 award in Life Sciences from TiE, a global entrepreneurship organization ‘Recognizing World’s Most Enterprising Technology Startups’


2011

  • Initiated and completed four Phase 2 trials to assess dose ranging and comparative efficacy and safety of PT003 components, PT001 (glycopyrrolate MDI) and PT005 (formoterol fumarate MDI) with marketed products in over 500 patients with COPD (See summary on http://clinicaltrials.gov or press releases)
  • Won FierceBiotech’s 2011 Fierce 15 award
  • Presented results of a Phase 2b study (PT0031002) showing a 50% improvement in lung function with PT003 versus active comparators in patients with COPD
  • Presented details of the tunability, versatility and universality of Pearl’s co-suspension platform, whether formed with one, two or three drugs
  • Pearl’s first suite of US and PCT patent applications published
  • Appointed Chuck Bramlage as chief executive officer, substantially expanding Pearl’s Executive Management experience base, and adding deep expertise in area of respiratory product commercialization
  • Won FierceBiotech’s Top 15 Venture Capital Deals of 2010 award


2010

  • Preliminary results from the Phase 2b study of PT003 announced; complex eight arm study completed in less than 6 months.
  • Raised $69 million Series C Financing
  • 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
  • Presented additional findings on PT001 and PT005 clinical studies at the European Respiratory Society Annual Congress
  • Appointed Howard B. Rosen, as Interim Pearl CEO and President
  • Raised $15M in financing via convertible note to progress Pearl pipeline
  • Awarded $733 thousand in therapeutic discovery project grants under Section 48D of the IRS code.


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