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KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company specializing in the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet medical needs. The company is primarily focused on developing treatments for hereditary angioedema (HAE), a rare genetic condition characterized by episodes of painful swelling. KalVista does not currently sell any products but is advancing its lead candidate, sebetralstat, through regulatory approval processes and conducting preclinical research on additional therapeutic programs.
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Sebetralstat - A novel, small molecule plasma kallikrein inhibitor being developed as the first oral, on-demand therapy for hereditary angioedema (HAE). The drug has completed the phase 3 KONFIDENT trial and is under regulatory review following the submission of a New Drug Application (NDA) in June 2024.
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Factor XIIa Inhibitor Program - A preclinical program focused on developing oral Factor XIIa inhibitors for next-generation HAE therapeutics. This program also explores potential applications in other diseases with high unmet medical needs.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Benjamin L. Palleiko Executive | Chief Executive Officer | None | Benjamin L. Palleiko is the CEO of KalVista Pharmaceuticals. He has also held roles as Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer. No external roles are listed. | View Report → |
Brian Piekos Executive | Chief Financial Officer | None | Brian Piekos joined KalVista as CFO in September 2024. He previously held CFO roles at Elicio Therapeutics and Gemini Therapeutics and has extensive experience in corporate finance and biopharma leadership. | |
Christopher M. Yea Executive | Chief Development Officer | None | Christopher M. Yea has been with KalVista since November 2015 as Chief Development Officer. He has extensive experience in drug development, previously serving as COO at Vantia, Ltd.. | |
Jeb Ledell Executive | Chief Operating Officer | None | Jeb Ledell became COO of KalVista in December 2024. He has over 20 years of experience in operational leadership, previously serving as COO at AVEO Pharmaceuticals and Enzyvant Therapeutics. | |
Paul K. Audhya Executive | Chief Medical Officer | None | Paul K. Audhya joined KalVista in May 2021 as CMO. He has held senior roles at Arena Pharmaceuticals, Vertex Pharmaceuticals, and Hospira, focusing on advancing KalVista's therapeutic programs. | |
Brian J. G. Pereira Board | Chairman of the Board | President & CEO of Visterra, Inc.; Board Member at ProKidney Corp., Visterra, Inc., and Africa Healthcare Network Ltd.; Director at America India Foundation; Adjunct Professor at Tufts University School of Medicine. | Brian J. G. Pereira has been Chairman of KalVista's Board since October 2022. He has extensive experience in biopharma leadership and academic roles, with a focus on rare diseases and healthcare innovation. | |
Edward W. Unkart Board | Director | None | Edward W. Unkart has been a director at KalVista since December 2014. He is a CPA with extensive experience in finance and accounting, having served on the boards of XTENT and VNUS Medical Technologies. | |
Laurence Reid Board | Director | Chair of the Board at Broken String Biosciences; Board Member at Garuda Therapeutics; Board Advisor to Life Science Cares and Mount Auburn Hospital. | Laurence Reid joined KalVista's Board in November 2024. He has over 30 years of experience in biopharma leadership, previously serving as CEO of Decibel Therapeutics and Warp Drive Bio. | |
Nancy Stuart Board | Director | Board Member at The Greater Boston YMCA. | Nancy Stuart has been a director at KalVista since March 2021. She has extensive experience in strategic planning and business operations, previously serving as COO at Concert Pharmaceuticals. | |
Patrick Treanor Board | Director | Board Member at XORTX Therapeutics. | Patrick Treanor joined KalVista's Board in May 2022. He has held senior commercial roles at Pathalys Pharma, Relypsa, and Insulet Corporation, focusing on operational leadership and commercialization. | |
William Fairey Board | Director | Board Member at Ascendis Pharma, Aileron Therapeutics, Mirum Pharmaceuticals, and Respira Therapeutics. | William Fairey joined KalVista's Board in April 2024. He has held senior commercial roles at MyoKardia, ChemoCentryx, and Actelion Pharmaceuticals, focusing on rare and specialty diseases. |
Recent press releases and 8-K filings for KALV.
- The FDA has pushed the sebetralstat review decision approximately four weeks past the original June 17, 2025 goal date due to resourcing constraints, without requesting additional data or raising safety concerns.
- Final label approval is expected to be the last regulatory step, and KalVista’s management remains optimistic about imminent approval.
- Wall Street analysts maintain an average one-year price target of $27.25, implying over 110% upside from the current stock price of $12.96.
- DRI Healthcare Trust, which holds royalty interests in sebetralstat, retains a Hold rating with a C$15.00 price target and is classified as Neutral amid profitability challenges.
- Upcoming FDA decision: The CEO confirmed the PDUFA date for sebetralstat is set for June 17, 2025, positioning it as the first oral on-demand treatment for acute HAE attacks.
- Robust commercialization readiness: The company has completed extensive physician profiling, final sales training, and established a patient support service with a quick start program for free initial drug shipments.
- Global expansion strategy: Kalvista plans independent launch efforts in Europe (with a focus on Germany and the UK) and a partnership in Japan to support international commercialization.
- Strong financial footing: The firm reported a balance sheet of approximately $250 million as of the last reported quarter, ensuring funding into the second half of 2027 and supporting rapid post-approval commercialization.
- KalVista Pharmaceuticals discussed sebetralstat, their first oral on-demand therapy for hereditary angioedema, with an anticipated PDUFA decision around June 17.
- The company highlighted robust Phase III data, noting innovative trial design that allowed early treatment of all attack types, including laryngeal attacks and use in adolescents.
- The oral formulation is expected to address ease‐of-use challenges associated with current injectable therapies, potentially improving treatment adherence and outcomes.
- There is strong regulatory engagement and payer confidence in sebetralstat’s differentiated value proposition in the HAE market.
- Licensing Agreement: KalVista Pharmaceuticals, Inc. has entered into a licensing agreement with Kaken Pharmaceutical to commercialize sebetralstat—an investigational, oral on-demand treatment for hereditary angioedema (HAE) in Japan.
- Financial Terms: The agreement includes an upfront payment of $11 million with potential additional milestone payments and royalties at mid-twenties percentages of sales.
- Strategic Focus: This collaboration supports KalVista’s global strategy to expand the reach of sebetralstat, which is also under regulatory review by multiple authorities.
- Sebetralstat, the first oral on-demand therapy for HAE, is positioned to transform the treatment paradigm by enabling early treatment across all attack types, based on an extensive clinical trial program including the record‐sized KONFIDENT Phase III study.
- The company detailed a comprehensive commercialization strategy that includes a QuickStart program, robust field engagement with over 1,000 key healthcare professionals, and plans for both U.S. and global launches in markets such as Germany, Japan, and the U.K..
- Q&A discussions provided clarity on dosing flexibility, label expectations, and competitive positioning versus other oral on-demand therapies, emphasizing the strong efficacy and safety profile of sebetralstat.
- Q3 2025 financial update: The company reported no revenue for the quarter, with research and development expenses of $12.6M and increased general and administrative expenses of $30.3M, leading to a net loss of $44.3M approximately.
- Regulatory and product milestones: KalVista secured orphan drug designation in Japan for its lead product sebetralstat, marking its seventh regulatory submission globally, with a U.S. PDUFA goal date set for June 17, 2025.
- Operational progress: The company has fully onboarded its field sales team in preparation for a U.S. commercial launch, appointed new senior leadership, and scheduled a virtual investor day on March 25, 2025 to detail its commercialization strategy.
- Sebetralstat is advancing as an on-demand treatment for hereditary angioedema, with robust clinical data showing rapid symptom relief and an excellent safety profile.
- The company has filed for marketing authorization in 7 territories and is targeting a key PDUFA date of June 17 in the U.S., with plans for subsequent launches in the EU, Germany, and other regions.
- A dedicated 32-person field team with HAE expertise has been established to support the commercial launch and enhance patient access globally.