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Sep 30, 2021
Krystal Biotech Q3 2021 Earnings Report
Reported financial results for the third quarter ended September 30, 2021.
Key Takeaways
Krystal Biotech reported a productive third quarter with progress in clinical trials, including the completion of the GEM-3 trial for B-VEC and advancements in other pipeline programs. The company's cash, cash equivalents, and investments totaled $362.3 million as of September 30, 2021.
Top-line results from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) are on track for 4Q21.
Enrollment in Phase 1 proof-of-concept study (PEARL-1 study) to treat aesthetic skin conditions is complete.
Krystal expects to initiate a Phase 1 clinical trial of inhaled KB407 in patients with CF in Australia in the fourth quarter of 2021.
Cash, cash equivalents, and investments totaled $362.3 million on September 30, 2021.
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech anticipates key milestones, including topline data from the GEM-3 trial, initiation of a Phase 1 clinical trial of KB407 for cystic fibrosis in Australia, and efficacy data for KB301 from Jeune Aesthetics in early 2022. The company also expects ASTRA, its second manufacturing facility, to come online in 2022.
Positive Outlook
- Topline data expected from the pivotal GEM-3 trial evaluating B-VEC this quarter.
- On track to open enrollment in Phase 1 study of KB407 for cystic fibrosis in Australia.
- Deliver Phase 1 proof-of-concept efficacy data for KB301 from Jeune Aesthetics in early 2022.
- Expanding manufacturing footprint with continued progress on ASTRA, expected to come online in 2022.
- Company continues to work towards an IND filing for KB104 for Netherton Syndrome, which is anticipated in 2022.
Challenges Ahead
- Uncertainties inherent in the initiation and conduct of clinical trials.
- Uncertainties associated with regulatory review of clinical trials and applications for marketing approvals.
- The availability or commercial potential of product candidates.
- The sufficiency of cash resources and need for additional financing.
- Actual results may differ materially from those indicated by forward-looking statements.