KalVista Pharmaceuticals, Inc., a clinical stage pharmaceutical company, discovers, develops, and commercializes small molecule protease inhibitors for diseases with unmet needs. The company's product portfolio comprises small molecule plasma kallikrein inhibitors targeting hereditary angioedema (HAE) and diabetic macular edema (DME); and oral plasma kallikrein inhibitors. Its products include KVD001, a plasma kallikrein inhibitor that completed a Phase II clinical trial for the treatment of DME; KVD900, which has completed Phase II clinical trial for an oral on-demand therapy for acute HAE attacks; and KVD824, an oral product candidate for the treatment of HAE. The company is headquartered in Cambridge, Massachusetts.
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Here are 1-3 brief analogies for KalVista Pharmaceuticals (KALV):
- A specialized pharmaceutical company, like a focused Eli Lilly, concentrating solely on developing treatments for rare diseases.
- A biotech company aspiring to be the next Vertex Pharmaceuticals, but focused on rare conditions like hereditary angioedema.
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KalVista Pharmaceuticals (KALV) major products are investigational oral therapies for hereditary angioedema (HAE):
- Sezaki (KVD824): An investigational oral kallikrein inhibitor being developed for the prophylactic (preventative) treatment of hereditary angioedema (HAE).
- KVD900: An investigational oral kallikrein inhibitor being developed for the acute (on-demand) treatment of hereditary angioedema (HAE).
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KalVista Pharmaceuticals (NASDAQ: KALV) is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of oral small molecule protease inhibitors. As such, it does not currently have approved products on the market generating significant sales to traditional end-customers (such as individuals, pharmacies, or hospitals).
Instead, its major financial relationships concerning the development and future commercialization of its product candidates are with collaboration partners. The most significant of these 'customer companies' in terms of current revenue derived from its drug programs is:
- Maruho Co., Ltd. (Private company, Japan) - KalVista has a licensing agreement with Maruho for the development and commercialization of its oral plasma kallikrein inhibitor programs, including sebetralstat, in Japan. Under this agreement, Maruho has provided upfront payments, and KalVista is eligible to receive additional milestone payments and royalties on future sales within Maruho's licensed territories.
If KalVista's lead product candidate, sebetralstat, receives regulatory approval in other regions (e.g., the United States and Europe), KalVista intends to commercialize it independently or with other partners. In such scenarios, its future 'customers' would primarily be pharmaceutical wholesalers and distributors, who then supply pharmacies and hospitals.
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Benjamin L. Palleiko Chief Executive Officer
Mr. Palleiko was appointed CEO of KalVista Pharmaceuticals in March 2024, having previously served as President, Chief Business Officer, and Chief Financial Officer at the company. He joined KalVista in August 2016 as CFO. Prior to KalVista, he co-founded and served as CEO of Cielo Therapeutics, Inc.. His background also includes a decade as an investment banker with firms such as Robertson Stephens and SunTrust Bank, and he held senior executive roles as SVP & CFO of Ore Pharmaceutical Holdings (Nasdaq: ORXE) and Penwest Pharmaceuticals Co. (Nasdaq: PPCO).
Brian Piekos Chief Financial Officer
Mr. Piekos joined KalVista Pharmaceuticals as Chief Financial Officer in September 2024. He brings over 25 years of financial and strategic planning experience in the biopharmaceutical industry. Before KalVista, he was CFO at Elicio Therapeutics, where he was responsible for launching it as a public company. His previous roles include CFO for Gemini Therapeutics and Executive Vice President, CFO, and Treasurer at AMAG Pharmaceuticals. Mr. Piekos also held leadership positions in corporate finance, tax, and treasury at Cubist Pharmaceuticals and began his career as a healthcare investment banker at Needham & Company and Leerink Partners.
Christopher M. Yea Chief Development Officer
Christopher M. Yea is the Chief Development Officer at KalVista Pharmaceuticals.
Edward P. Feener Chief Scientific Officer
Dr. Feener is a scientific co-founder of KalVista Pharmaceuticals and a recognized expert in plasma kallikrein. His laboratory at the Joslin Diabetes Center made significant discoveries regarding the role of plasma kallikrein in vascular disorders and was the first to identify it as a potential therapeutic target for diabetic macular edema. He has over 27 years of research experience in vascular biology and diabetic complications, with more than 80 scientific publications. Before joining KalVista, he was an Associate Professor of Medicine at Harvard Medical School and a Senior Investigator at the Joslin Diabetes Center.
Paul K. Audhya Chief Medical Officer
Paul K. Audhya serves as the Chief Medical Officer at KalVista Pharmaceuticals.
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The emergence of PTC Therapeutics' PTC518, an oral plasma kallikrein inhibitor in Phase 2 clinical development for the on-demand treatment of hereditary angioedema (HAE) attacks. This compound is a direct competitor to KalVista Pharmaceuticals' lead product candidate, sebetralstat, targeting the same patient population and treatment modality. While sebetralstat is further along in development (post-Phase 3 with planned NDA submission), PTC518 represents a clear emerging threat that could challenge KalVista's market share upon launch if it demonstrates comparable or superior efficacy, safety, or commercial viability.
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KalVista Pharmaceuticals' main products target Hereditary Angioedema (HAE) and Diabetic Macular Edema (DME).
Sebetralstat (formerly KVD900, marketed as EKTERLY®) for Hereditary Angioedema (HAE)
- The global market for hereditary angioedema therapeutics is projected to reach approximately $7.8 billion by 2033.
- The total HAE market was valued at around $3 billion in 2023.
- The U.S. market for HAE was estimated at approximately $2 billion in 2023, accounting for about 90% of the market share across the 7 major markets (U.S., EU4, UK, and Japan).
- Sebetralstat (EKTERLY®) is the first and only FDA-approved oral on-demand treatment for acute HAE attacks in the U.S. for patients aged 12 years and older.
- Analysts project global peak revenues for Sebetralstat (Ekterly) to be $651 million by 2032.
- Other analyses suggest that Sebetralstat could achieve over $750 million in peak sales.
- It is also estimated that Sebetralstat could unlock a $900 million on-demand market for acute HAE episodes and potentially expand its total addressable market to the entire $2.9 billion global HAE market.
- BofA Securities projects risk-adjusted peak sales for Sebetralstat in the U.S. market at $604 million by 2035.
- GlobalData's Expiry Model predicts Sebetralstat's annual global revenue to reach $517 million by 2034.
KVD001 for Diabetic Macular Edema (DME)
- KalVista completed a Phase 2 clinical trial for KVD001, an intravitreally administered plasma kallikrein inhibitor, in 2019.
- The global Diabetic Macular Edema market was valued at $3.95 billion in 2023 and is projected to reach $4.56 billion by 2031.
- Another estimate places the global DME market size at approximately $3 billion in 2023 across the 7 major markets (U.S., EU4, UK, and Japan), with expectations for significant growth.
- The U.S. represented approximately 60% of the total DME market size in 2023 within these 7 major markets.
- The global Diabetic Macular Edema market is projected to grow from $4.2 billion in 2025 to $4.7 billion by 2035.
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KalVista Pharmaceuticals (NASDAQ: KALV) is poised for significant revenue growth over the next two to three years, primarily driven by the commercialization and expansion of its lead product, EKTERLY (sebetralstat), for hereditary angioedema (HAE). The key drivers include:
- Commercialization and Uptake of EKTERLY in the United States: Following FDA approval in July 2025, KalVista launched EKTERLY, the first and only oral on-demand treatment for acute HAE attacks, in the U.S. Initial sales of $1.4 million were reported in Q1 2026 (ended July 31, 2025), with patient start forms exceeding management's expectations, indicating strong early adoption. The continued ramp-up of this product is expected to be a primary revenue generator.
- International Expansion of EKTERLY: KalVista is actively pursuing global market penetration for EKTERLY. The drug received marketing authorization in the UK in July 2025, and a European Commission decision was anticipated in October 2025. The company expects a staged European launch over the next 12-18 months, with Germany slated for Q4 2025 and the UK for the first half of 2026. Additionally, approval in Japan is anticipated by the end of 2025, with a launch through commercial partner Kaken Pharmaceutical in early 2026.
- Potential Label Expansion for EKTERLY with New Formulations and Indications: KalVista is working to expand the market opportunity for sebetralstat. This includes a pediatric trial (KONFIDENT-KID) commenced in Q3 2024 for an orally disintegrating tablet (ODT) formulation, which, if approved, would be the first oral therapy for HAE patients under 18. Furthermore, the conversion of adolescent and adult participants in the KONFIDENT-S study to an ODT formulation in Q4 2024 could lead to a potential sNDA approval in 2026, offering an additional oral on-demand treatment option.
- Strategic Partnerships and Milestone Payments: KalVista's licensing agreement with Kaken Pharmaceutical for the commercialization rights of sebetralstat in Japan is expected to contribute to revenue. This partnership includes an upfront payment, potential contingent regulatory milestone payments, and tiered royalties on net sales as the product successfully navigates the Japanese market.
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Share Issuance
- In February 2024, KalVista Pharmaceuticals completed a public offering that yielded $150.1 million in net proceeds.
- In September 2025, the company priced an upsized offering of $125.0 million in 3.250% Convertible Senior Notes due 2031, with estimated net proceeds of approximately $120.8 million.
- In November 2024, KalVista completed an underwritten public offering of 5,500,000 shares for $55 million in gross proceeds, alongside a concurrent private placement of 500,000 shares to DRI Healthcare Acquisitions LP for $5 million.
Inbound Investments
- In November 2024, DRI Healthcare Trust acquired a royalty interest in sebetralstat from KalVista for an aggregate purchase price of up to $179 million, including a $100 million upfront payment.
- Concurrently with the royalty deal, DRI Healthcare Trust also made a $5 million equity investment in KalVista's common stock through a private placement.
Outbound Investments
- KalVista Pharmaceuticals has not made any investments or acquisitions.
Capital Expenditures
- KalVista Pharmaceuticals' capital expenditures were approximately -$0.4 million by 2025.
- The company's capital expenditures to revenue ratio for the last 12 months is 0.0%.
- Capital lease obligations were reported as $6.02 million in 2024 and $4.33 million in 2025.