Business
Krystal Biotech Reports Third Quarter 2021 Financial Results and Provides Update on Operational Progress
– Top-line results from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) on track for 4Q21 – Enrollment in Phase 1 proof-of-concept
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"– Top-line results from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) on track for 4Q21 – Enrollment in Phase 1 proof-of-concept study (PEARL-1 study) to treat aesthetic skin conditions is complete – Strong balance sheet with September 30, 2021 cash, cash equivalents, and investments of $362.3 million PITTSBURGH, Nov. 08, 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 third quarter ending September 30, 2021. “We’ve had a productive third quarter and the momentum continues to build with topline data expected from the pivotal GEM-3 trial evaluating B-VEC this quarter,” said Krish Krishnan, Chairman and CEO of Krystal Biotech, Inc. “If positive, this will be a significant milestone for patients living with DEB and strong validation of our redosable gene therapy platform. Outside of the B-VEC program, we are on track to open enrollment in our Phase 1 study of KB407 for cystic fibrosis in Australia and deliver Phase 1 proof-of-concept efficacy data for KB301 from our wholly-owned subsidiary, Jeune Aesthetics in early 2022. As we continue to advance and grow our pipeline, we are also expanding our manufacturing footprint with continued progress on our second facility – ASTRA – which we expect will come online in 2022.” Program Highlights & Upcoming Events: B-VEC for DEB The Company recently announced completion of the pivotal GEM-3 trial of topical B-VEC for the treatment of DEB, and expects topline data in the fourth quarter of 2021. Details of the pivotal Phase 3 study can be found at www.clinicaltrials.gov under NCT identifier NCT04491604.Enrollment of DEB patients into the open label extension (“OLE”) study, including patients who participated in the Phase 3 study as well as new participants who were unable to participate in the Phase 3 study who meet all enrollment criteria, is ongoing. Details of the OLE study can be found at www.clinicaltrials.gov under NCT identifier NCT04917874. KB407 for Cystic Fibrosis More detailed results from the Good Laboratory Practice toxicology and biodistribution study were presented in a poster at the virtual 2021 North American Cystic Fibrosis (“CF”) Conference that took place November 2-5.Krystal expects t...