KalVista Pharmaceuticals Updates Operations and Fiscal Year 2024 Financial Results

KalVista Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, and Salisbury, England, has announced significant advancements and financial outcomes for the fiscal year ending April 30, 2024. This period marked a pivotal moment for the company, highlighted by the submission of the New Drug Application (NDA) for sebetralstat to the U.S. Food and Drug Administration (FDA). Sebetralstat is a groundbreaking investigational oral plasma kallikrein inhibitor aimed at treating hereditary angioedema (HAE) attacks in both adults and children aged 12 and above.

The submission of the NDA in June 2024 was a significant milestone for KalVista. Sebetralstat, if approved, would become the first oral, on-demand treatment for HAE, potentially changing the treatment landscape for this condition. This submission was supported by positive results from the phase 3 KONFIDENT trial, which were published in The New England Journal of Medicine. The company is preparing to file additional marketing authorization applications to various international health authorities throughout 2024, with hopes for approval and launch in the U.S. by the first half of 2025.

In addition to the NDA submission, KalVista also initiated the KONFIDENT-KID trial ahead of schedule. This pediatric trial involves an orally disintegrating tablet formulation of sebetralstat, specifically designed for children aged 2 to 11. The trial will include approximately 24 participants across seven countries in North America, Europe, and Asia. With this initiative, KalVista aims to extend the benefits of sebetralstat to a younger demographic, potentially making it the first oral, on-demand treatment for pediatric HAE patients.

KalVista has continued to share its findings with the scientific community. Data from the phase 3 KONFIDENT trial were presented at notable medical conferences, including the European Academy of Allergy and Clinical Immunology Congress 2024 and the Eastern Allergy Conference. Furthermore, subgroup analyses were showcased, offering deeper insights into the drug’s efficacy across different populations.

The company is on track to submit Market Authorization Applications to the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Agency by the third quarter of 2024. A Japanese New Drug Application (JNDA) will also be submitted to the Pharmaceuticals and Medical Devices Agency in the fourth quarter of 2024.

In the realm of early-stage development, KalVista is exploring the potential of its preclinical Factor XIIa inhibitor program. This program could lead to the first orally delivered Factor XIIa inhibitor for various therapeutic uses. The company is currently conducting a strategic review to assess the prospects for further development.

Organizationally, KalVista has undergone leadership changes and financial maneuvers to strengthen its position. In March 2024, Benjamin L. Palleiko was promoted to Chief Executive Officer and appointed to the Board of Directors. In February, the company entered into an underwriting agreement for the sale of common stock and pre-funded warrants, netting approximately $150.1 million. This capital raise significantly bolstered KalVista's cash reserves, which stood at $210.4 million as of April 30, 2024.

Financially, KalVista reported no revenue for the fiscal year ending April 30, 2024. Research and development (R&D) expenses rose to $86.2 million, primarily due to the phase 3 KONFIDENT trial and increased personnel costs. General and administrative expenses also saw a significant increase, totaling $54.3 million, attributed mainly to higher employee-related expenses and commercial planning costs. The net loss for the fiscal year was $126.6 million, reflecting the increased investments in R&D and administrative functions.

Overall, KalVista Pharmaceuticals has made substantial progress in its quest to bring innovative treatments to the HAE community, with sebetralstat at the forefront of its efforts. The upcoming months and years will be crucial as the company seeks regulatory approvals and prepares for potential product launches in multiple markets.