KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. The company's lead candidate, sebetralstat, has recently demonstrated positive results in a pivotal Phase 3 clinical trial for the treatment of hereditary angioedema (HAE), a rare and potentially life-threatening genetic disorder.
Business Overview
KalVista is dedicated to advancing its pipeline of novel, small molecule protease inhibitors, with a primary focus on developing oral therapies for HAE. HAE is characterized by recurrent, debilitating swelling episodes in the skin, gastrointestinal tract, or airways, which can be painful and potentially life-threatening if the swelling occurs in the throat.The company's lead product candidate, sebetralstat, is a novel, oral plasma kallikrein inhibitor that has shown the potential to provide rapid relief for HAE attacks. In February 2024, KalVista announced positive topline results from the pivotal Phase 3 KONFIDENT trial, which evaluated the safety and efficacy of sebetralstat in 136 patients across 20 countries. The trial met all primary and key secondary endpoints, demonstrating that sebetralstat achieved a significantly faster time to beginning of symptom relief compared to placebo, as well as faster time to reduction in attack severity and complete attack resolution.
Sebetralstat has received several regulatory designations, including Fast Track and Orphan Drug status from the FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA). In June 2024, KalVista submitted a New Drug Application (NDA) to the FDA for the review of sebetralstat, and the company expects to file for approval in the European Union and Japan later this year.
Financials
For the fiscal year ended April 30, 2024, KalVista reported no revenue, a net loss of $126.6 million, and negative operating and free cash flows of $89.2 million and $89.7 million, respectively. These financial results reflect the company's continued investment in the development of sebetralstat and other pipeline candidates.During the fourth quarter of fiscal 2024, research and development expenses increased to $25.2 million, up from $24.0 million in the same period of the prior year, primarily due to the ongoing Phase 3 KONFIDENT and KONFIDENT-S trials for sebetralstat. General and administrative expenses also increased significantly to $23.2 million, compared to $7.8 million in the prior-year quarter, driven by higher employee-related costs and commercial planning expenses.
The company's cash position remains strong, with $210.4 million in cash, cash equivalents, and marketable securities as of April 30, 2024, up from $149.4 million a year earlier. This increase was primarily due to the net proceeds of $150.1 million from an underwritten offering of common stock and pre-funded warrants completed in February 2024.
Outlook
KalVista is well-positioned for the potential approval and commercialization of sebetralstat in the coming years. The company anticipates submitting additional marketing authorization applications for sebetralstat in the UK, European Union, and Japan throughout 2024, following the NDA submission to the FDA in June 2024. If approved, sebetralstat would be the first oral, on-demand treatment for HAE attacks in adults and pediatric patients aged 12 and older.In addition to the sebetralstat program, KalVista is also advancing a preclinical oral Factor XIIa inhibitor program, which the company believes may have the potential to yield the first orally delivered Factor XIIa inhibitor for a variety of therapeutic indications, including HAE. The company is currently evaluating the strategic options for this program.
Risks and Challenges
As a clinical-stage biopharmaceutical company, KalVista faces several risks and challenges common to the industry, including the inherent uncertainty of drug development, the potential for regulatory delays or setbacks, and the need for significant additional funding to support its operations and pipeline advancement.The success of KalVista's business is heavily dependent on the approval and commercialization of sebetralstat. Any delays or failures in the regulatory approval process or commercialization efforts could have a material adverse impact on the company's financial performance and future prospects.
Additionally, KalVista operates in a highly competitive environment, with other companies developing novel HAE treatments, both oral and injectable. The company's ability to maintain a competitive edge and capture market share will be crucial to its long-term success.