Corporate Overview
May 2024
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 uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expect," "plan," anticipate," "believe," "estimate," "predict," "intend," "potential," "would," "continue," "ongoing" or the negative of these terms or other comparable terminology. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information business plans and objectives, timing and success of our planned nonclinical and clinical development activities, timing and results of nonclinical studies and clinical trials, efficacy and safety profiles of our product candidates, any expectations about safety, efficacy of sebetralstat and our ability to obtain regulatory approvals for sebetralstat and other candidates in development, the ability of sebetralstat to treat hereditary angioedema (HAE), the potential therapeutic benefits and economic value of our product candidates, potential growth opportunities, competitive position, industry environment and potential market opportunities, our ability to protect intellectual property and the impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, and geopolitical conflicts, including the conflicts in Ukraine and the Middle East, on our business and operations.
Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. These factors, together with those that are described under the heading "Risk Factors" contained in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") and other documents we file from time to time with the SEC, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements.
In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this presentation, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
2
KalVista Is Focused on Discovering, Developing and Commercializing Oral Protease Inhibitors
Lead program, sebetralstat, is an oral, on-demand treatment for HAE that
achieved positive results in a pivotal Phase 3 clinical trial
Sebetralstat would be first oral option in the $900mm on-demand HAE market with potential to transform treatment of HAE and the entire
$2.9bn market
Regulatory approval filings planned for US in June 2024, and
EU, UK and Japan later in 2024; expected first launches in 2025 if approved
Sebetralstat internally developed, with full rights and IP protection into the 2040s
Cash runway sufficient to fund operations into 2026
3
HAE = Hereditary Angioedema.
KalVista Pipeline
Building a pipeline of novel oral, small molecule protease inhibitors through preclinical and clinical development as potential best-in-class treatments for a range of diseases, beginning with HAE
Product | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 | Status | |
KONFIDENT (Trial Completed) | Data reported; | ||||||
NDA June 2024 | |||||||
KONFIDENT-S(Open-Label Extension) | Trial ongoing, | ||||||
supports approval | |||||||
Sebetralstat | On-Demand HAE | ||||||
sNDA enabling, | |||||||
Orally Disintegrating Tablets | commence Q4 2024 |
KONFIDENT-KID (Pediatric)
Oral Factor | Multiple |
XIIa | Indications |
Initiate Q3 2024
Will advance with partner
4
Hereditary Angioedema (HAE)
Hereditary Angioedema
Genetic condition causing painful and
pronounced swelling in various parts of the body
Orphan disease:
incidence 1 in 10,000 to 1 in 50,0001
High unmet need for efficacious and safe oral administration - approved on-demand therapies are injected or infused
- Primarily caused by defect in C1 inhibitor activity, which leads to uncontrolled plasma kallikrein activation and bradykinin release
- 6,500 - 8,000 patients in US; similar in EU
- Incidence consistent worldwide; patients have average of ~2 attacks per month
- On-demand+ prophylaxis is majority share in US, although burden of treatment remains high
- On-demandonly is majority share ex-US
1www.haei.org | 6 |
HAE Management
The goals of treatment are to achieve total control of the disease and to normalize patients' lives1,2:
Access to effective on- demand treatment in all patients with 3 main goals:
- Treat early
- Consider treatment of all attacks
- Carry enough on demand treatment at all times to treat 2 attacks1,2
Consideration of long-term prophylaxis (LTP) in addition to on-demand treatment in appropriate patients based on frequency and severity of attacks and impact on quality of life 1,2
References: 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):1061-1990. | 7 |
Unmet Need In HAE Is Underappreciated
Attacks still cause anxiety and impact quality of life
Anxiety and | ~50% of people taking | 96% of people on | People living with HAE | People typically delay |
depression are | prophylaxis continue to | prophylaxis feel they | prefer to treat at home | injectable treatment for |
common in people living | experience HAE | must change their | to avoid treating attacks | hours and studies show |
with HAE | attacks | plans for the day when | in public | more than 40% of attacks |
an attack occurs3 | aren't treated at all1,2,4 |
1Maurer M, et al. Hereditary Angioedema Attacks Resolve Faster and Are Shorter after Early Icatibant Treatment. PLoS ONE. 2013;8(2):e53773. 2Longhurst H J et al. Real- | |
world outcomes in hereditary angioedema: first experience from the Icatibant Outcome Survey in the United Kingdom Allergy Asthma Clin Immunol. 2018;14: 28. 3Remaining | |
Burden of Hereditary Angioedema (HAE) Attacks Despite Modern Long-term Prophylaxis Stephen Betschel, Sally van Kooten, Markus Heckmann, Sherry Danese, Ledia | 8 |
Goga,Teresa Caballero; EAACI 2023 Hybrid Congress. 4Banerji A, et al. Allergy Asthma Proc. 2015;36(3):213-7. doi: 10.2500/aap.2015.36.3824 |
Patients on Long-Term Prophylaxis Still Have Attacks
Although LTP reduces attack frequency, many patients continue to have attacks and require
ready access to effective on-demand treatment
Proportion of patients that experienced attacks on approved LTP in placebo-controlled trials
Treatment | C1-INH (SC) 60 IU/kg1 | Lanadelumab 300 mg Q2W2 | Berotralstat 125 mg3 | |
Randomized, placebo-controlled | Randomized, double-blind,parallel-group, placebo- | Randomized, double-blind, | ||
Trial design | crossover phase 3 trial (16 | parallel-group,dose-response | ||
controlled phase 3 trial (26 weeks) | ||||
weeks) | phase 2 trial4 (28 days) | |||
(N=45) | (N=27) | (N=14) | ||
Patients | 23% | |||
experiencing | ||||
attacks during | 60% | 56% | 57% | |
observed | ||||
period | ||||
Entire 16-week | Entire 26-week | Steady state | Entire 28-day | |
treatment period | treatment period | (days 70-182) | treatment period | |
References: 1. Longhurst H, et al. N Engl J Med. 2017;376(12):1131-1140. 2. Banerji A, et al. JAMA. 2018;320(20): 2108-2121. 3. Aygören-Pürsün E, et al. N Engl J Med. 2018;379:352-362. 4.Not reported in | 9 |
phase 3 trial. |
On-Demand Therapy for HAE Remains a Critical Need
Attacks Happen | Severity Remains | On-Demand Resilience |
~50% of patients on | KONFIDENT study | On-demand treatment total |
prophylaxis still have attacks1 | demonstrated LTP use does | volume remains unchanged |
not reduce attack severity2 | since 20183 |
1,See references on slide 11. 2. See slide 18. 3. IQVIA NSP Data (2018-2023). | 10 |
LTP = Long-Term Prophylaxis | |
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Kalvista Pharmaceuticals Inc. published this content on 01 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 10:07:45 UTC.