Business
Krystal Biotech Reports Second Quarter 2021 Financial Results and Provides Update on Operational Progress
Top-line data from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (“DEB”) on track for 4Q21Initiation of Phase 1 study of inhaled KB407
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Top-line data from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (“DEB”) on track for 4Q21Initiation of Phase 1 study of inhaled KB407 for the treatment of cystic fibrosis expected in 3Q21Our wholly-owned subsidiary Jeune Aesthetics, Inc. initiated dosing in the efficacy cohort of the PEARL-1 study of intradermal KB301 for aesthetic skin conditionsStrong balance sheet with June 30, 2021 cash, cash equivalents and marketable securities of $389.1 million PITTSBURGH, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today reported financial results and key operational progress updates for the second quarter ending June 30, 2021. “We are pleased with the progress we have made this quarter on multiple fronts. Not only has the Krystal team continued to advance three clinical stage programs including the pivotal GEM-3 trial, we have also grown the commercial side of our organization and made significant headway on the construction of our 2nd GMP manufacturing facility,” said Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech, Inc. “The remainder of 2021 promises to be even more exciting as we look forward to reporting pivotal data on B-VEC, Jeune announcing initial efficacy data for KB301 in aesthetic skin conditions, and initiating a Phase 1 trial to evaluate our first pulmonary candidate - KB407 for the treatment of cystic fibrosis.” Program Highlights & Upcoming Events: B-VEC for DEB The Company continued to advance the pivotal GEM-3 trial and is on track to announce top-line data in 4Q21. Details of the pivotal Phase 3 study can be found at www.clinicaltrials.gov under NCT identifier NCT04491604.During the second quarter the Company began enrolling patients into an open label extension (“OLE”) study, including patients who participated in the Phase 3 study and new patients who meet all enrollment criteria. Details of the OLE study can be found at www.clinicaltrials.gov under NCT identifier NCT04917874. KB407 for Cystic Fibrosis Following the initial announcement of data from the GLP toxicology and biodistribution study of repeat doses of KB407 in nonhuman primates in April 2021, the Company will present more detailed results from this study in a poster at the North American Cystic Fibrosis Confe...