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Oct 31, 2022
KalVista Q2 2023 Earnings Report
KalVista reported second fiscal quarter results and completed Phase 1 clinical trial for orally disintegrating tablet formulation of sebetralstat.
Key Takeaways
KalVista Pharmaceuticals reported no revenue for the second fiscal quarter ended October 31, 2022. The company's net loss was $22.3 million, or $(0.90) per share. Research and development expenses were $18.1 million, and general and administrative expenses were $7.8 million. Cash, cash equivalents and marketable securities were $122.3 million as of October 31, 2022.
Terminated phase 2 KOMPLETE trial for KVD824 due to safety concerns.
Reported new patient-focused data at the American College of Allergy Asthma & Immunology (ACAAI) 2022 meeting.
Announced data from a Phase 1 study of an ODT formulation of sebetralstat.
Enrollment is proceeding as expected for the Phase 3 KONFIDENT trial for sebetralstat, with data expected in the second half of 2023.
Forward Guidance
KalVista is focused on developing oral treatments for hereditary angioedema (HAE) and expects Phase 3 KONFIDENT trial data in the second half of 2023, with an NDA filing planned for the first half of 2024.
Positive Outlook
- Phase 3 KONFIDENT trial for sebetralstat remains on track for data in the second half of 2023.
- Data from Phase 1 study of an ODT formulation of sebetralstat supports further development.
- New sebetralstat data published in the Journal of Medicinal Chemistry and Xenobiotica.
- Enrollment is proceeding as expected for the Phase 3 KONFIDENT trial for sebetralstat.
- NDA filing planned for the first half of 2024.
Challenges Ahead
- Terminated the Phase 2 KOMPLETE study for KVD824 due to elevations in liver enzymes observed in patients during the trial.
- Increase in operating expenses, primarily research and development.
- Net loss increased compared to the same period in the prior fiscal year.
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