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Dec 31, 2020
Krystal Biotech Q4 2020 Earnings Report
Reported financial results and key operational progress updates for the fourth quarter ending December 31, 2020.
Key Takeaways
Krystal Biotech reported its Q4 2020 financial results, with a strong cash position of $271.3 million in cash, cash equivalents and short-term investments. The company is progressing with its clinical trials, including B-VEC for DEB, KB105 for TGM1-ARCI, KB407 for Cystic Fibrosis and KB301 for Aesthetic Indications.
Cash, cash equivalents and short-term investments totaled $271.3 million on December 31, 2020.
Research and development expenses for the fourth quarter ended December 31, 2020 were $5.7 million.
General and administrative expenses for the fourth quarter ended December 31, 2020 were $4.8 million.
Net losses for the quarter ended December 31, 2020 were $10.5 million, or $(0.53) per common share (basic and diluted).
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech anticipates completing enrollment in the GEM-3 study in Q1 2021 and expects top-line data in Q4 2021. They also plan to present updates on their KB105 and KB301 programs in the first half of 2021 and are working towards an IND filing for KB104 in the second half of 2021.
Positive Outlook
- Enrollment in the ongoing pivotal GEM-3 study is expected to complete in 1Q21.
- Top line data is anticipated in 4Q21 followed by BLA filing shortly after
- Clinical trial initiation of KB407 is anticipated in 1H21
- The Company plans to announce initial data from KB301 cohort, consisting of safety and COL3 expression levels, in 1Q21 and present more details at the upcoming SID Annual meeting
- The Company continues to work towards an IND filing for KB104, which is anticipated in 2H21
Challenges Ahead
- Uncertainties inherent in the initiation and conduct of clinical trials
- Availability and timing of data from clinical trials
- Uncertainties associated with regulatory review of clinical trials and applications for marketing approvals
- The availability or commercial potential of product candidates including B-VEC, KB105, KB104, KB301 and KB407
- The unanticipated impact of COVID-19 on Krystal’s business operations, pre-clinical activities and clinical trials