Loading...
•
Jan 31, 2021
KalVista Q3 2021 Earnings Report
KalVista reported third fiscal quarter results and recent KVD900 Phase 2 clinical trial results as statistically and clinically significant.
Key Takeaways
KalVista Pharmaceuticals reported no revenue for the third fiscal quarter ended January 31, 2021, compared to $1.6 million for the same period in the prior fiscal year. Research and development expenses were $9.1 million, compared to $11.2 million for the same period in the prior fiscal year. Net loss was $10.1 million, or $(0.56) per share, compared to a net loss of $9.3 million, or $(0.52) per share, for the same period in the prior fiscal year. Cash, cash equivalents and marketable securities were $50.3 million as of January 31, 2021, compared to $67.7 million as of April 30, 2020.
Reported positive results for KVD900 in a Phase 2 clinical trial demonstrating statistically and clinically significant responses across primary and secondary endpoints as an oral on-demand treatment for HAE attacks.
The trial met its primary endpoint comparing the time to use of conventional attack treatment within 12 hours on KVD900 versus placebo (p=0.0010) with rates of use at 12 hours of 15.1% following treatment with KVD900 versus 30.2% after placebo.
Closed an upsized public offering of common stock and full exercise of the underwriters’ options to purchase additional shares, resulting in gross proceeds of approximately $222.5 million.
Filed the IND for a Phase 2 clinical trial of KVD824 and expect to initiate that trial in the second quarter of 2021.
KalVista
KalVista
Forward Guidance
KalVista is focused on advancing its oral HAE franchise, including finalizing the Phase 3 program for KVD900 and initiating a Phase 2 clinical trial for KVD824.
Positive Outlook
- Positive Phase 2 clinical trial results for KVD900 as an oral on-demand therapy for HAE attacks.
- KVD900 demonstrated statistically and clinically significant responses across primary and secondary endpoints.
- IND submitted for Phase 2 clinical trial of KVD824 as an oral prophylactic treatment for HAE.
- Upsized public offering provides sufficient cash to reach KVD900 NDA filing.
- Advancing oral Factor XIIa inhibitor program for improved HAE treatment.
Challenges Ahead
- Potential impact of COVID-19 on clinical trials and operations.
- Risks and uncertainties associated with the safety and efficacy of product candidates.
- Dependence on successful commencement and completion of clinical studies.
- Uncertainty in obtaining regulatory approvals for KVD900, KVD824, and other candidates.
- Risks related to the future progress and potential success of the oral Factor XIIa program.