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Krystal Biotech Reports First Quarter 2021 Financial Results and Provides Update on Operational Progress
Completed enrollment in pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) Strong balance sheet with March 31, 2021 cash, cash equivalents
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Completed enrollment in pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) Strong balance sheet with March 31, 2021 cash, cash equivalents and short-term investments of $403.4 million PITTSBURGH, May 10, 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 first quarter ending March 31, 2021. “This year has already been, and will continue to be, a busy period for Krystal and I would like to thank our employees for their commitment, passion and resiliency during a global pandemic,” said Krish Krishnan, Chairman and CEO of Krystal Biotech, Inc. “We look forward to continued progress across the organization, including initiating clinical testing of our first respiratory program, making headway on our 2nd GMP manufacturing facility, and announcing top line pivotal data for B-VEC later this year.” Program Highlights & Upcoming Events: B-VEC for DEB During the first quarter, the Company completed enrollment in the ongoing pivotal GEM-3 trial and finalized the statistical analysis plan (SAP) based on feedback from the FDA.Topline data from the study is anticipated in 4Q21.Details of the pivotal Phase 3 study can be found at www.clinicaltrials.gov under NCT identifier NCT04491604. KB105 for TGM1-ARCI The Company is on track to provide an update on this program in 1H21. The update will consist of safety, TGM1 expression level and efficacy data from the 4th patient enrolled. Data from this patient, together with the data from the three initial patients will help determine next steps.Details of the Phase 1/2 study can be found at www.clinicaltrials.gov under NCT identifier NCT04047732. KB407 for Cystic Fibrosis In April 2021, the Company announced data from the GLP toxicology and biodistribution study which demonstrated in vivo safety of repeat, nebulized doses of KB407 in nonhuman primates. More detailed data will be presented at a future scientific conference.The Company intends to initiate a Phase 1 study of KB407 in 3Q21. KB408 for Alpha-1 Antitrypsin Deficiency In April 2021, Krystal announced initial positive proof-of-concept data from preclinical studies of KB408 in mice. Additional preclinical studies are ongoing, and more detailed data will be presented at...