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Jun 30, 2022
Krystal Biotech Q2 2022 Earnings Report
Reported financial results for Q2 2022 and provided operational progress updates.
Key Takeaways
Krystal Biotech reported a net loss of $28.1 million for the second quarter of 2022. The company's cash, cash equivalents, and investments totaled $438.5 million as of June 30, 2022. The B-VEC BLA was filed with the FDA on June 22, 2022, and the FDA accepted the IND on KB407 for the treatment of Cystic Fibrosis.
Filed Biologics License Application for B-VEC with the FDA on June 22, 2022.
FDA accepted IND on KB407 for the treatment of Cystic Fibrosis.
Closed the quarter with $438.5 million in cash, cash equivalents and investments.
Marketing Authorization Application for B-VEC is anticipated to be filed with the European Medical Agency (“EMA”) in 2H 2022.
Forward Guidance
Krystal Biotech anticipates a productive second half of the year as they advance the development of several of their pipeline candidates and prepare for the potential global launch of B-VEC.
Positive Outlook
- EMA filing for B-VEC is anticipated in 2H 2022
- Phase 1 clinical trial (CORAL-1/US study) in CF patients in the US is anticipated in 2H 2022
- Initiate dosing in the Phase 1 clinical study of inhaled KB407 (CORAL-1/AU study) in 2H 2022
- Dosing the next cohort in the ongoing Phase 1/2 clinical trial of KB105 for the treatment of TGM1-deficient ARCI is on track to resume in 2H 2022
- Commencing a Phase 2 study of KB301 in Q4 2022 or Q1 2023
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