Kalvista Pharmaceuticals, Inc. · NASDAQ:KALV
Kalvista Pharmaceuticals — Corporate Update (July 2025)
24 slides from Kalvista Pharmaceuticals's corporate update, Jul 7, 2025
Slide 1: U.S. FDA Approval of EKTERLY (sebetralstat)
U.S. FDA Approval of EKTERLY® (sebetralstat) July 7, 2025 Exhibit 99.2
Slide 2: Forward-looking statements
Forward-looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. For this purpose, any statements that are not statements of histor
Slide 3: EKTERLY now approved by U.S. FDA
EKTERLY® now approved by U.S. FDA What is EKTERLY? EKTERLY (sebetralstat) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Please see Prescribing Information at KalVista.com.
Slide 4: EKTERLY U.S. Prescribing Information & Clinical Data
EKTERLY U.S. Prescribing Information & Clinical Data
Slide 5: Hereditary angioedema: a rare disease defined by unpredictable swelling attacks
Hereditary angioedema: a rare disease defined by unpredictable swelling attacks 1 in 35,000 - 1 in 50,000 people worldwide1,2 Lifelong attacks of debilitating swelling in the face, extremities, abdomen and genitals2 Life threatening if the upper airway is involved3 Attack severity may increase rap
Slide 6: Management of HAE
All Patients Treatment goals: achieve total disease control and normalize patients' lives1,2 Management of HAE 1. Busse PJ, et al. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. 2. Maurer M, et al. Allergy. 2022;77(7):1961-1990 Long-term prophylaxis in appropriate patients: Effective On-Demand
Slide 7: Four key recommendations in global guidelines for treatment of HAE attacks
Four key recommendations in global guidelines for the treatment of HAE attacks1-3 Treat attacks as early as possible after recognition of onset Treatment should be considered for all attacks, regardless of anatomic location or severity Train all patients in the self-administration of on-demand treat
Slide 8: Management of HAE today
Management of HAE today Long-term prophylaxis in majority of patients Injectable or Intravenous On-demand treatment is underutilized Complex logistics and painful Delays and denial of treatment Inadequate control High treatment burden High cost Less benefit than anticipated in many cases Inadequate
Slide 9: Management of HAE with EKTERLY
Management of HAE with EKTERLY 1. Busse PJ, et al. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. 2. Maurer M, et al. Allergy. 2022;77(7):1961-1990. Long-term prophylaxis in appropriate patients1,2 EKTERLY On-Demand Treatment First and only oral on-demand HAE treatment Poised to Become the Foun
Slide 10: Prescribing information highlights
Prescribing information highlights Full prescribing information can be found at kalvista.com
Slide 11: Key label takeaways: dosing, contraindications, indications
Key label takeaways Dosing & Administration Only label to include "at the earliest recognition of an acute HAE attack" 600 mg with second dose in 3 hours up to 1200 mg max daily dose Contraindications, Warnings & Precautions No contraindications, warnings, or precautions Indications and Usage Adoles
Slide 12: Key label takeaways: pharmacokinetics, clinical studies
Key label takeaways Pharmacokinetics Clinical Studies Adverse Reactions Greater than 90% inhibition of plasma kallikrein maintained through 6 hours Effect of food: no clinically relevant differences The only label to include statistically significantly faster times to: Beginning of symptom relief Re
Slide 13: Time to beginning of symptom relief: primary endpoint
As shown in Figure 1, the median time to beginning of symptom relief within 12 hours of first dose was 2.0 hours (95% CI: 1.5, 2.8) in patients administered EKTERLY 600 mg. Patients who did not achieve the endpoint, received alternate on-demand therapy, or lacked at least 2 consecutive post-baseline
Slide 14: Open-label extension trial data
1. NCT05505916, EudraCT: 2021-001176-42. Note: Data cutoff date of September 14, 2024. 2. Reidl MA, et al. Presented at WSAAI Annual Meeting; Feb. 9-13, 2025, Manning ME, et al. Presented at WSAAI Annual Meeting; Feb. 9-13, 2025. 3. Lumry WR, et al. Presented at C1-INH Workshop; May 29-June 1, 2025
Slide 15: Commercial Strategy & Launch Plans
Commercial Strategy & Launch Plans
Slide 16: EKTERLY: The first and only oral on-demand HAE treatment
EKTERLY: The first and only oral on-demand HAE treatment Early Treatment Can be taken immediately upon attack recognition Injection-like Efficacy Proven to halt attack progression quickly and safely without any needles or pain All Attacks Effective against all types of HAE attacks, regardless of pro
Slide 17: We are selling EKTERLY today
We are selling EKTERLY today Team Sales leaders have extensive HAE launch experience Representatives have profiled 100% of tier 1 and 95% of tier 2 targets Reps in physician offices today Readiness Focus Emphasis on 1,000 allergists and immunologists that account for 90% of HAE claims Total call uni
Slide 18: Commercial launch underway
Prescriber Activation HCP appointments in place for next 2 months HCP speaker lunches at over 80 sites begin mid-July Patient Brand Awareness Email campaign to 2,900+ patients Patient speaker programs begin mid-July Engage with 1,200+ community members at HAEA Patient Summit July 10-13 Commercial la
Slide 19: Access and product support
Access and product support Patient Support Services Reimbursement support and insurance navigation Patient education and advocacy Work with the specialty pharmacy Navigate insurance coverage Each EKTERLY pack includes two doses (4 tablets) WAC price $16,720 per dose Comparable to current branded pro
Slide 20: Initial view into U.S. launch metrics
Initial view into U.S. launch metrics HCPs Patients Payers Start Forms from Top 1,000 HCPs Start Forms Payor Mix IMMEDIATE EARLY MID LAUNCH Formulary Initiation Engagement w/ Top 1,000 HCPs 1st Product Ship Paid Prescriptions Repeat Prescribers Refills
Slide 21: Pathway to becoming standard of care for HAE
Pathway to becoming standard of care for HAE GROW ATTACK TREATMENT RATE GROW MARKET SHARE EKTERLY Opportunity: US on-demand market grows from $650M to $1.2B Sources: Evaluate Pharma and Company Reports TODAY Drive early demand Focus on Firazyr and icatibant users Access via QuickStart and Medical Ex
Slide 22: EKTERLY poised for rapid global expansion
EKTERLY poised for rapid global expansion US launch underway Germany launch* Japan launch* Rest of world launches* UK launch* *Anticipated, subject to regulatory approval. 2H 2025 2026
Slide 23: Poised to become the foundational therapy for HAE
Poised to become the foundational therapy for HAE
Slide 24: Q&A
Q&A
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