KalVista Pharmaceuticals Announces Positive Interim Phase 3 Data From KONFIDENT-KID Trial of EKTERLY® (sebetralstat) for Children Aged 2-11 Years at the 2026 Global Angioedema Leadership Conference

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A rare inherited disorder that causes sudden, painful swelling under the skin or in internal tissues, including the airway, because a natural blood‑control protein is missing or not working. Attacks can be unpredictable and sometimes life‑threatening, so people often need ongoing medication or emergency treatment. For investors, hereditary angioedema represents a niche but stable market for specialized therapies, diagnostics, and emergency care solutions.

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Interim data show sebetralstat enables early, effective treatment of hereditary angioedema (HAE) attacks in children with favorable safety and tolerability

FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new interim results from its KONFIDENT-KID clinical trial evaluating EKTERLY® (sebetralstat) for the on-demand treatment of hereditary angioedema (HAE) attacks in children ages 2-11 presented at the 2026 Global Angioedema Leadership Conference. KONFIDENT-KID is the largest pediatric trial ever conducted in HAE. It features a proprietary oral disintegrating tablet (ODT) formulation of sebetralstat in a population that currently relies on burdensome injectable treatments. The study was designed to enable compliance with treatment guidelines, consistent with the recently published “International Guideline on the Diagnosis and Management of Pediatric Patients with Hereditary Angioedema,” which recommends ensuring on-demand treatment is available anytime, anywhere and prioritizes early intervention and rapid self-administration, regardless of attack severity or location.

On-demand Oral Sebetralstat for Hereditary Angioedema Attacks in Children Aged 2-11: Interim Analysis of KONFIDENT-KID was presented by Emel Aygören-Pürsün, MD, University Hospital Frankfurt.

• Among 172 HAE attacks in 33 pediatric participants treated using weight-based dosing of sebetralstat in a proprietary oral disintegrating tablet (ODT) formulation as of December 15, 2025:
  • Mean 0.7 attacks treated per patient per month
  • Median time to treatment of 25 minutes with 67% of attacks treated within the first hour; 88.9% were mild or moderate in severity
  • Median times to symptom relief and complete resolution (150 mg dose group, largest cohort) were 1.5 hours and 12 hours respectively
• Sebetralstat was well tolerated with no serious or treatment-related adverse events, and no reports of difficulty swallowing.

“Managing HAE attacks in children remains particularly challenging, as currently available on-demand treatments rely on injections or intravenous infusions that can be painful, anxiety-inducing, and difficult to administer promptly at symptom onset,” said Dr. Aygören-Pürsün. “These barriers can contribute to treatment delays or avoidance, which may worsen outcomes. The KONFIDENT-KID data demonstrate that children and caregivers were able to treat attacks early and achieve rapid symptom relief with sebetralstat. This is especially meaningful in pediatric patients, where timely treatment can help limit swelling progression and reduce the overall duration and impact of an attack. An effective oral on-demand option has the potential to transform the treatment experience for children and families, reducing fear and burden while enabling early treatment of attacks.”

Currently, the only on-demand HAE treatment approved in the US for patients aged 2-11 is administered intravenously, highlighting a critical need for new therapeutic options. KalVista completed enrollment in the Phase 3 KONFIDENT-KID trial a full year ahead of schedule and expects to file a new drug application in the US in the third quarter of 2026 with a launch anticipated in 2027. If approved, sebetralstat would be the first and only oral on-demand therapy for pediatric patients aged 2-11 years and only the second FDA-approved on-demand therapy of any type in this population.

“Each update from KONFIDENT-KID continues to build compelling evidence that sebetralstat has the potential to transform the treatment paradigm for children living with HAE,” said Ben Palleiko, Chief Executive Officer of KalVista. “The rapid pace of enrollment and high attack treatment rate may signal a meaningful shift in treatment behavior with an oral on-demand option. Efficacy and safety outcomes remain consistent with those observed across the broader sebetralstat program, including rapid symptom relief and a favorable safety profile. These findings reinforce our confidence that sebetralstat is well-positioned to significantly reduce the burden of HAE and redefine how children and their caregivers manage attacks, and we are committed to bringing it to the community as quickly as possible.”

A link to the presentation is available on the KalVista website under Publications.

About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity.

About KONFIDENT-KID
KONFIDENT-KID is an open label clinical trial of sebetralstat for on-demand treatment of HAE attacks in pediatric patients. Originally designed to enroll 24 pediatric patients, the trial was met with high demand and will ultimately enroll approximately 36 children aged 2-11 years across seven countries in North America, Europe and Asia. KONFIDENT-KID will collect safety, pharmacokinetic and efficacy data for each patient for up to one year and features a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat. If approved, sebetralstat would be the first oral on-demand therapy for this age group, and only the second FDA-approved on-demand therapy of any type for this population.

About EKTERLY® (sebetralstat)
EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With a US regulatory filing planned for 2026 to expand use to children aged 2–11, and additional filings anticipated in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full US Prescribing Information, visit EKTERLY.com.

About KalVista Pharmaceuticals, Inc.
KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "position," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-KID trial, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our transition report on Form 10-KT for the transition period from May 1, 2025 to December 31, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com



Molly Cameron

Senior Director, Corporate Affairs

(978) 339-3378

molly.cameron@kalvista.com

Source: KalVista Pharmaceuticals, Inc.