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Apr 30, 2021
KalVista Q4 2021 Earnings Report
KalVista reported financial results for the fourth quarter and fiscal year ended April 30, 2021, and provided an operational update.
Key Takeaways
KalVista Pharmaceuticals reported no revenue for Q4 2021, compared to $3.8 million for the same period in the prior fiscal year. Research and development expenses were $11.9 million, compared to $9.5 million for the same period in the prior fiscal year. Net loss was $15.0 million, or $(0.65) per share, compared to a net loss of $6.6 million, or $(0.37) per share for the same period in the prior fiscal year. Cash, cash equivalents and marketable securities were $248.9 million as of April 30, 2021, compared to $67.7 million as of April 30, 2020.
Reported positive results for KVD900 in a Phase 2 clinical trial as an oral on-demand treatment for hereditary angioedema (HAE) attacks.
Provided data on KVD824 as a twice-daily oral candidate for prophylactic treatment of HAE.
Announced a novel oral Factor XIIa inhibitor program as the next area of focus.
Submitted an IND for a Phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks.
KalVista
KalVista
Forward Guidance
KalVista is working with regulatory agencies to finalize the Phase 3 program for KVD900 and begin the Phase 2 clinical trial of KVD824 and looks forward to providing additional details on the trials later this year as they begin.
Positive Outlook
- FDA End-of-Phase 2 Meeting on KVD900 Oral HAE Phase 3 Program Scheduled for Late Q3 2021
- FDA Response Submission for KVD824 Phase 2 Clinical Hold Expected Q3 2021
- The Company intends to submit its response to the FDA during the third quarter of calendar year 2021.
- KalVista also continues to progress regulatory filings for other countries where it plans to initiate sites for the KVD824 Phase 2.
- IND-enabling studies for oral Factor XIIa inhibitor candidates are expected to commence in calendar year 2021.
Challenges Ahead
- The U.S. FDA notified the Company in a letter that it has placed a clinical hold on the proposed Phase 2 clinical trial of KVD824.
- The FDA letter requested further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2 trial, as well as refinements to the intended KVD824 Phase 2 study protocol.
- No revenue was recognized for the three months ended April 30, 2021, compared to $3.8 million for the same period in the prior fiscal year.
- Net loss was $15.0 million, or $(0.65) per weighted average basic and diluted share, for the three months ended April 30, 2021, compared to net loss of $6.6 million, or $(0.37) per weighted average basic and diluted share for the same period in the prior fiscal year.
- The increase in net loss and net loss per share primarily resulted from the absence of revenue in the current fiscal year due to the expiration of the Merck Option Agreement in February 2020, as well as increased spending on research and development activities in the current fiscal year.