Business
Krystal Biotech Reports Second Quarter 2020 Financial Results and Provides Update on Operational Progress
Initiated the pivotal GEM-3 clinical study evaluating B-VEC in DEB patients Today announced enrollment of 1st patient in Phase 2 clinical study evaluating
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Initiated the pivotal GEM-3 clinical study evaluating B-VEC in DEB patients\n Today announced enrollment of 1st patient in Phase 2 clinical study evaluating KB105 in ARCI patients On track to initiate Phase 1 trial of KB301 for an aesthetic indication in 2H 2020 Strong balance sheet with June 30, 2020 cash, cash equivalents and marketable securities of $297 million PITTSBURGH, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (Nasdaq: KRYS), a fully integrated gene therapy company driven by its proprietary, engineered herpes simplex virus type 1 vector (HSV-1) platform, today reported financial results and key operational progress updates for the second quarter ending June 30, 2020. “The future of Krystal shines brighter than ever. We enter the second half of the year with a Phase 3 trial in DEB, a Phase 2 trial in ARCI and expect to initiate a Phase 1 trial in aesthetic skin conditions in the near term, leading to multiple data readouts in the next 6 to 12 months,” said Krish Krishnan, chairman and chief executive officer of Krystal Biotech, Inc. He added, “With the completion of our recent stock offering, we have the financial strength to support our clinical programs, expand our pipeline to pulmonary indications and complete our second GMP facility to support growth in our pipeline demand. I look forward to updating you as the year progresses.” Program Highlights & Upcoming Events Beremagene Geperpavec (B-VEC) for DEB In July 2020, Krystal announced the initiation of the pivotal GEM-3 study. The trial is a randomized, double-blind, intra-patient, placebo controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for patients suffering from both recessive and dominant dystrophic forms of Epidermolysis Bullosa. Details of the pivotal study can be found at www.clinicaltrials.gov under NCT identifier NCT04491604.Top line data and Biologics License Application (BLA) filing are anticipated in 2021. Data from this trial will also form the basis of an Marketing Authorisation Application (MAA) filing in the EU which is anticipated to occur shortly after the BLA filing. In May 2020, at the Society for Investigative Dermatology (SID) annual meeting, Dr. Peter Marinkovich, M.D. (associate professor of dermatology and director of the Blistering Disease Clinic at Stanford University) presented an overview of d...