KalVista Pharmaceuticals Inc (KALV) Reports Second Fiscal Quarter Results
KalVista Pharmaceuticals Inc (NASDAQ:KALV) targets NDA filing for sebetralstat in H1 2024 following KONFIDENT trial completion.
R&D expenses rose to $19.1 million, contributing to a net loss of $27.7 million for the quarter.
Cash reserves decreased to $103.2 million as of October 31, 2023, from $149.4 million as of April 30, 2023.
On December 7, 2023, KalVista Pharmaceuticals Inc (NASDAQ:KALV) released its 8-K filing, announcing the completion of the KONFIDENT trial and detailing its financial results for the second fiscal quarter ended October 31, 2023. The company is preparing for a New Drug Application (NDA) submission for sebetralstat, an oral on-demand therapy for hereditary angioedema (HAE), in the first half of 2024.
Operational and Clinical Developments
KalVista highlighted several key operational updates, including the achievement of the required number of on-treatment attacks for the phase 3 KONFIDENT trial. The company anticipates a topline data readout in early 2024, with regulatory filings in the U.S., European Union, and Japan to follow. Additionally, KalVista received Orphan Drug Status approval from Switzerland for sebetralstat, which promises benefits such as shorter review times and extended market protection.
Financial Performance Overview
The company reported no revenue for the quarter, consistent with the same period in the previous year. Research and development expenses increased to $19.1 million, up from $18.1 million in the prior year, primarily due to ongoing clinical trials. General and administrative expenses also rose to $10.7 million, compared to $7.8 million in the previous year, driven by higher employee-related and commercial strategy expenses.
The net loss for the quarter was $27.7 million, or $(0.80) per weighted average basic and diluted share, an increase from a net loss of $22.3 million, or $(0.90) per weighted average basic and diluted share, in the same period of the prior fiscal year. This increase in net loss was primarily due to the rise in operating expenses, particularly in research and development.
Balance Sheet and Cash Flow
KalVista's cash reserves, including cash equivalents and marketable securities, stood at $103.2 million as of October 31, 2023, a decrease from $149.4 million as of April 30, 2023. The reduction in cash reserves was attributed to cash used in operating activities.
The balance sheet shows total current assets at $128.6 million, with a notable $19.9 million in research and development tax credit receivable. Total assets amounted to $138.7 million. On the liabilities side, current liabilities totaled $17.8 million, and stockholders' equity was reported at $114.4 million.
The condensed consolidated statements of cash flows reveal a net cash used in operating activities of $(46.6) million for the six months ended October 31, 2023. Investing activities provided a net cash inflow of $48.2 million, primarily from sales and maturities of marketable securities.
Looking Ahead
KalVista's focus remains on advancing sebetralstat towards regulatory approval and preparing for commercialization. The company's ongoing investment in research and development reflects its commitment to addressing unmet medical needs in the HAE space and beyond.
For more detailed information on KalVista Pharmaceuticals Inc (NASDAQ:KALV) and its latest financial results, readers are encouraged to review the full 8-K filing.
Explore the complete 8-K earnings release (here) from KalVista Pharmaceuticals Inc for further details.
This article first appeared on GuruFocus.
