Kalvista Pharmaceuticals, Inc. · NASDAQ:KALV
Kalvista Pharmaceuticals — Investor Presentation (February 2024)
32 slides from Kalvista Pharmaceuticals's investor presentation, Feb 13, 2024
Slide 1: Corporate Overview February 2024
Exhibit 99.1 Corporate Overview February 2024
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. Forward-looking statements are inherently subject to risks and unc
Slide 3: Company Highlights
Company Highlights • Discovery, development, and commercialization of oral, small molecule protease inhibitors • Lead program Sebetralstat for on-demand treatment of rare disease hereditary angioedema (HAE) • Data from Phase 3 KONFIDENT trial announced February 2024; met all primary and secondary en
Slide 4: Program Portfolio
Program Portfolio Product Indication Preclinical Phase 1 Phase 2 Phase 3 Status Data reported; Sebetralstat On-Demand HAE KONFIDENT (trial completed) NDA mid-2024 Trial ongoing KONFIDENT-S (Open-Label Extension) Advancing to sNDA Orally Disintegrating Tablets as lifecycle extension Discovery and Ora
Slide 5: Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Slide 6: Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE) • Genetic condition causing painful and pronounced swelling in various parts of the body ‒ Primarily caused by defect in C1 inhibitor activity, which leads to uncontrolled plasma kallikrein activation and bradykinin release 1 • Orphan disease: incidence 1 in 10,000 to 1 i
Slide 7: On-Demand is $900 Million Market, With Growth Potential
On-Demand is $900 Million Market, With Growth Potential At branded prices, On-demand was $900 Million US on-demand market alone revenue market in 2022 would be $1+ billion Ruconest Global US units 2022 $206 On-demand Berinert Market Ruconest 29,200 Cinryze $288 $147 Berinert 35,400 Haegarda $436 Fir
Slide 8: Sebetralstat: HAE On-Demand Therapy
Sebetralstat: HAE On-Demand Therapy
Slide 9: Welcome to the New Era of HAE
Welcome to the New Era of HAE Positive topline results from the largest clinical trial conducted in HAE We believe SEBETRALSTAT offers the promise to be the foundational HAE treatment Adults and On-demand with or Any attack location adolescents without prophylaxis or severity 9
Slide 10: Unmet Need In HAE Is Underappreciated
Unmet Need In HAE Is Underappreciated The goal of treatment is to minimize compromises in lifestyle, but attacks still cause anxiety and impact quality of life 96% of people on People typically delay Anxiety and ~50% of people People living with HAE prophylaxis feel they injectable treatment depress
Slide 11: Patients on LTP Still Have Attacks
Patients on LTP Still Have Attacks Proportion of patients that experienced attacks on approved LTP in placebo-controlled trials 1 2 3 Treatment C1-INH (SC) 60 IU/kg Lanadelumab 300 mg Q2W Berotralstat 125 mg Randomized, double- Randomized, placebo- Randomized, double-blind, parallel-group, placebo-
Slide 12: The Sebetralstat Treatment Vision
The Sebetralstat Treatment Vision 100% ALL ATTACKS EASE OF USE EARLY • Patients empowered to treat • Patients able to treat all • Sebetralstat dosing is simple with early - at first recognition of attacks, since it is impossible easy-to-take tablets attack to predict which ones will • Patients can e
Slide 13: Topline Data from Phase 3 KONFIDENT Trial
Topline Data from Phase 3 KONFIDENT Trial
Slide 14: Sebetralstat Phase 3 Trial Design
Sebetralstat Phase 3 Trial Design • Double blind crossover trial assessing 300 mg and 600 mg sebetralstat versus placebo • Primary endpoint: Time to beginning of symptom relief using PGI-C • At least 90% powered to detect treatment differences vs placebo • Each patient treats up to 3 attacks anytime
Slide 15: Key Differences in Design Between Phase 2 and Phase 3 KONFIDENT Trials
Key Differences in Design Between the Sebetralstat Phase 2 and Phase 3 KONFIDENT Trials Phase 2 Trial Phase 3 KONFIDENT Trial PGI-C: TOSR defined as at least “a little better” Time to use of conventional attack treatment Primary endpoint (≥2 time points in a row) within 12 hours after study drug adm
Slide 16: Enrollment and Demographics
Enrollment and Demographics Total (N=110) Randomized Age (years) (N=136) Mean (SD) 37.7 (15.0) Median (min, max) 39.5 (13, 74) Age (category), n (%) Patients who treated 18+ 97 (88.2) ≥1 attack (N=110) 12-17 13 (11.8) Sex, n (%) Female 66 (60.0) 300 mg sebetralstat 600 mg sebetralstat Placebo (n=87
Slide 17: Comparable Attack Severity in Patients Using LTP
Comparable Attack Severity in Patients Using LTP 1 60 Attacks in patients using on-demand treatment only (n=206) 1 Attacks in patients using on-demand treatment + LTP (n=58) 50 46.6 41.7 Total 38.8 37.9 40 (N=110) Current treatment regimen, n (%) 30 On-demand only 86 (78.2) On-demand + LTP 24 (21.8)
Slide 18: Primary Endpoint: Time to Beginning of Symptom Relief
Primary Endpoint: Time to Beginning of Symptom Relief 100 • Time to beginning of symptom relief was statistically significantly faster vs placebo for 75 • 300 mg (p<0.0001) • 600 mg (p=0.0013) 50 • Median time (95% CI) to beginning of symptom relief was 25 • 1.61 h (1.28, 2.27) for 300 mg Sebetralst
Slide 19: Primary Endpoint: Consistent Treatment Effect Across Subgroups
Primary Endpoint: Consistent Treatment Effect Across Subgroups • Trial was not powered to statistically test treatment effect within subgroups • Treatment effect with sebetralstat was consistent across subgroups including ‒ Sex, race, age, geographic region, HAE subtype, time to treatment, attack lo
Slide 20: Key Secondary: Time to Reduction in Attack Severity
Key Secondary: Time to Reduction in Attack Severity 100 • Time to reduction in attack severity was statistically significantly faster vs placebo for 75 • 300 mg (p=0.0036) • 600 mg (p=0.0032) 50 • Median time (95% CI) to reduction in attack severity was: 25 • 9.27 h (4.08, >12) for 300 mg Sebetralst
Slide 21: Key Secondary: Time to Complete Attack Resolution
Key Secondary: Time to Complete Attack Resolution 100 • Time to complete attack resolution was statistically significantly faster vs placebo for 75 • 300 mg (p=0.0022) • 600 mg (p<0.0001) 50 • Proportion achieving complete attack resolution within 24 hours 25 was: Sebetralstat 300 mg Sebetralstat 60
Slide 22: On-treatment Related Adverse Events
On-treatment Related Adverse Events Sebetralstat Sebetralstat Placebo System organ class preferred term, n (%) E 300 mg 600 mg (n=86) (n=93) (n=83) Gastrointestinal disorders 1 (1.2) 1 1 (1.1) 1 1 (1.2) 1 Dyspepsia 1 (1.2) 1 0 0 Nausea 0 1 (1.1) 1 1 (1.2) 1 General disorders and administration site
Slide 23: Results in the Sebetralstat Phase 2 Trial and the Phase 3 KONFIDENT Trial
Results in the Sebetralstat Phase 2 Trial and the Phase 3 KONFIDENT Trial Phase 2 Trial Phase 3 KONFIDENT Trial Population Adults 100% | adolescents 0% Adults 88.2% | adolescents 11.8% On-demand only: 100% On-demand only: 78.2% LTP On-demand + LTP: Not allowed On-demand + LTP: 21.8% Attack Periphera
Slide 24: Update: KONFIDENT-S Open-Label Extension
Update: KONFIDENT-S Open-Label Extension • Trial to evaluate the long-term safety of sebetralstat • As of February 2, 2024 ‒ More than 110 patients enrolled ‒ More than 640 attacks treated • Median time to treatment: 10 minutes • All attack locations well represented, including 14 laryngeal attacks
Slide 25: Sebetralstat Halts the Attack When Today's Patients are Still Deciding Whether to Treat
Sebetralstat Halts the Attack When Today’s Patients are Still Deciding Whether to Treat Current on-demand 5+ HOURS 2 1 3.8 hours 2 to 2.3 hours Time to Treatment Halt the attack Attack Recognition 41-min 96 minutes Treatment Success Is Time to Halt the attack Measured in Minutes Treatment (KONFIDENT
Slide 26: Sebetralstat Can Become the Foundational HAE Therapy
Sebetralstat Can Become the Foundational HAE Therapy Low Patient HAE Disease Burden High Current treatment paradigm Injectable Injectable on-demand + on-demand prophylaxis Future with sebetralstat Oral on-demand Sebetralstat + with sebetralstat prophylaxis 26
Slide 27: Sebetralstat Can Become the Foundational HAE Therapy
Sebetralstat Can Become the Foundational HAE Therapy Prophy On-Demand Market Share Increased Treatment Future Indications ✓ Convert current on-✓ ~40% of attacks are ✓ Patients may switch ✓ Plasma kallikrein mediated normal C1- demand market, untreated, including for from prophylaxis to on- 1 includi
Slide 28: Orally Disintegrating Tablet (ODT): A Future Enhancement
Orally Disintegrating Tablet (ODT): A Future Enhancement • ODT increases ease of dosing for patients - in particular, pediatrics and those with difficulty swallowing • Phase 1 data shows similar pharmacokinetics to current film-coated tablets (FCT) • Regulatory plan agreed with FDA for sNDA filing 2
Slide 29: Factor XIIa
Factor XIIa
Slide 30: Factor XIIa is an Attractive Drug Target
Factor XIIa is an Attractive Drug Target FXII • Factor XIIa (FXIIa) activates the kallikrein kinin system HAE Attack Trigger ‒ Generates plasma kallikrein, leading to uncontrolled bradykinin release in HAE FXIIa ‒ FXIIa and plasma kallikrein inhibitors selectively block bradykinin generated by the p
Slide 31: KalVista Value Proposition
KalVista Value Proposition • Data from Phase 3 KONFIDENT trial announced February 2024; met all primary and secondary endpoints, with favorable safety profile; NDA expected H1 2024 • Sebetralstat would be first oral option in $900 million on-demand HAE market and has potential to transform treatment
Slide 32: NASDAQ: KALV
NASDAQ: KALV
KalVista Pharmaceuticals — Investor Presentation (February 2024) on 6ix