Loading...
•
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.
KalVista
KalVista
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.
- Decrease in cash and marketable securities position due to cash consumption from operating expenses.
- Uncertainty regarding the potential future development of KVD824.