KalVista Pharmaceuticals, Inc. is a biopharmaceutical company developing oral therapies for rare diseases, notably the FDA-approved EKTERLY® for hereditary angioedema.

# Company Overview of KalVista Pharmaceuticals, Inc.

## Business Focus
- **Industry:** Biopharmaceuticals
- **Core Mission:** Developing and delivering life-changing oral therapies for individuals with rare diseases with significant unmet needs.
- **Key Product:** EKTERLY® (sebetralstat)
  - **Approval Date:** July 3, 2025 (FDA)
  - **Indication:** Treatment of acute attacks of hereditary angioedema (HAE) in patients aged 12 and older.
  - **Administration:** Oral, small molecule plasma kallikrein inhibitor
  - **Significance:** First and only oral, on-demand therapy for HAE.

## Product and Clinical Data
- **Efficacy & Safety:** Established by the Phase 3 KONFIDENT trial, published in *The New England Journal of Medicine* in May 2024.
- **Trial Outcomes:**
  - Primary endpoint met: Symptom relief initiated faster than placebo (median 1.79 hours vs. 6.72 hours).
  - Safety profile: Well tolerated; no serious adverse events related to treatment.
  - Key secondary endpoints: Faster reduction in attack severity and attack resolution.
  
## Regulatory & Market Approvals
- **FDA:** Approved NDA for EKTERLY in July 2025.
- **EMA:** Validation of submission for marketing authorization application (MAA) in Europe (August 2024).
- **Other Markets:** Applications submitted or under review in the UK, Switzerland, Australia, Singapore, Japan, Canada, and other countries.
- **Designations:** Orphan drug and fast track in the U.S. and Japan, orphan status in Switzerland, and an Innovation Passport in the UK.
  
## Market Strategy
- **US Market:** Built internal commercial infrastructure; active promotional operations began post-FDA approval.
- **International Expansion:** Engaged partners in Japan (Kaken Pharmaceutical), Canada (Pendopharm), and plans for other regions.
- **Partnerships & Licensing:** 
  - Japan rights licensed to Kaken in April 2025.
  - Japan NDA submitted in January 2025.
  - Japan licensing deal includes milestone payments and royalties.

## Financial Data (as of June 25, 2025)
- **Outstanding Shares:** 49,953,739
- **Market Value of Shares Held by Non-Insiders:** approximately **$440,082,646** (based on last reported share price of $10.27 on October 31, 2024).
- **Cash & Equivalents:** $131.6 million (as of April 30, 2025)
- **Employees:** 270 full-time employees
  - U.S.: 171
  - U.K.: 65
  - Rest of World: 34
- **Revenue & Income:** No specific revenue or net income figures are provided, indicating the company is likely still in development and commercialization phases, not yet profitable.

KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies for hereditary angioedema and other diseases.

# KalVista Pharmaceuticals, Inc. Overview

**Business Focus:**
KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company that specializes in the discovery, development, and commercialization of drug therapies for diseases with significant unmet needs. 

**Key Product:**
- **Sebetralstat:** A novel, small molecule plasma kallikrein inhibitor targeting hereditary angioedema (HAE). It is designed to be the first oral, on-demand therapy for HAE, addressing a vital need in a market where existing therapies largely require injectable administration.

**Recent Developments:**
- In June 2024, the company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval of sebteralstat.
- Positive results from the Phase 3 KONFIDENT trial were announced in February 2024, with plans for further global regulatory applications in Q3 and Q4 2024 for European and Japanese markets, respectively. Potential product launches are targeted for 2025 and early 2026.

**Clinical Trials:**
- The KONFIDENT trial enrolled 136 patients across 66 clinical sites in 20 countries, marking it as the largest and most representative trial for HAE.
- The long-term safety and tolerability of sebetralstat are being assessed in the KONFIDENT-S trial, with an open-label extension study ongoing.
- A pediatric trial, KONFIDENT-KID, was initiated in June 2024 to assess the efficacy of a formulation designed for children aged 2 to 11.

**Market Opportunity:**
- HAE affects about 1 in 10,000 to 1 in 50,000 individuals, creating a niche market where sebteralstat could represent a significant advance, particularly among adolescents who currently rely on intravenously delivered therapies without adequate oral alternatives.

**Employee Count:**
- As of April 30, 2024, KalVista employs a total of **150 full-time employees** distributed as follows:
  - **81** in the U.S.
  - **55** in the U.K.
  - **14** in other international locations.

**Financials:**
- **Revenue & Income:** The company has incurred significant operating losses since its inception and does not currently generate substantial revenue. It expects to continue incurring losses for the foreseeable future due to ongoing clinical developments and operational costs.
- Future profitability hinges on the successful commercialization of its products, starting with sebetralstat.

**Regulatory Designations:**
- Sebetralstat has received **fast track** and **orphan drug designations** from the FDA, as well as orphan drug status in the E.U. and Switzerland.

**Strategic Goals:**
- The company aims to retain control over its product development and commercialization efforts for HAE while potentially seeking partners for products addressing larger markets or out-of-U.S. markets.

Through its innovative product candidates and strategic focus on addressing significant medical needs, KalVista endeavors to improve the management and treatment of hereditary angioedema and other diseases.

KalVista Pharmaceuticals, Inc.

10-K / July 10, 2025

10-K / July 11, 2024

10-K / July 10, 2025

Company Overview of KalVista Pharmaceuticals, Inc.

Business Focus

Product and Clinical Data

Regulatory & Market Approvals

Market Strategy

Financial Data (as of June 25, 2025)