KalVista Pharmaceuticals Reports $42.3 Million Net Loss for Q4 2024, Advances Product Pipeline

KalVista Pharmaceuticals, Inc. reported a net loss of $42.3 million for the three months ended October 31, 2024, compared to a net loss of $27.7 million for the same period in 2023. For the six months ended October 31, 2024, the company recorded a net loss of $82.7 million, up from $53.0 million in the prior year. Total operating expenses for the latest quarter reached $45.8 million, a significant increase from $29.7 million in the previous year, driven primarily by a rise in general and administrative expenses, which surged to $29.2 million from $10.7 million. Research and development expenses decreased slightly to $16.6 million from $19.1 million year-over-year.

The company's financial position showed a decline in total assets, which fell to $160.8 million as of October 31, 2024, down from $235.4 million at the end of April 2024. This decrease was largely attributed to a reduction in marketable securities, which dropped to $94.2 million from $178.6 million. KalVista's accumulated deficit also widened to $552.4 million, reflecting ongoing investment in research and development without any product sales revenue to date. The company had cash and cash equivalents of $41.6 million at the end of the reporting period, an increase from $31.8 million at the end of April 2024.

Strategically, KalVista has made significant advancements in its product pipeline, particularly with its lead candidate, sebetralstat, an oral therapy for hereditary angioedema (HAE). The company announced that it filed a New Drug Application (NDA) with the U.S. FDA in June 2024, which has been accepted for review, with a PDUFA date set for June 17, 2025. Additionally, the European Medicines Agency has validated the company's Marketing Authorization Application (MAA) for sebetralstat, which is currently under review. The company is also preparing submissions for regulatory approval in other international markets, including the UK, Switzerland, Australia, and Japan.

Operationally, KalVista has expanded its workforce and infrastructure in anticipation of future commercialization efforts. The company has entered into a new lease for a larger headquarters in Framingham, Massachusetts, set to commence in early 2025. As of October 31, 2024, the company had 43.3 million shares outstanding, reflecting an increase from 42.5 million shares at the end of April 2024. The company anticipates continued losses as it invests in the development of sebetralstat and other product candidates, with plans to finance future operations through equity offerings, debt financing, and potential partnerships.

Looking ahead, KalVista expects to continue incurring losses as it advances its clinical programs and seeks regulatory approvals. The company has sufficient funding to operate for at least the next twelve months, but it acknowledges the inherent risks in pharmaceutical development, including the potential for unforeseen expenses and delays. The successful commercialization of sebetralstat remains contingent on regulatory approvals, and the company is actively preparing for the potential launch of this product, which it believes could meet significant unmet needs in the treatment of HAE.