Company

Won FierceBiotech’s 2011 Fierce 15 award
Completed PT005 Phase 2b study with results demonstrating comparability to marketed product Foradil, and dose ordering across the PT005 doses, providing dose guidance in support of Phase 3 program
Initiated a suite of four Phase 2b clinical trials to assess PT003 dose ranging and safety, including dose ranging and comparative assessment of the PT003 components PT001 and PT005 with marketed products, in over 500 patients with COPD
Presented results of a Phase 2b study (PT0031002) at the 2011 International Conference of American Thoracic Society at a late breaking session
Presented details of Pearl’s novel cosuspension metered dose inhaler platform at the Respiratory Drug Delivery Conference
Pearl’s first suite of US and PCT patent applications published
Appointed Charles (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

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.

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

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

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

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

Pearl Therapeutics