Aankondiging • Jun 05

Kalvista Pharmaceuticals Presents Data on Persisting Unmet Needs in Hereditary Angioedema At the European Academy of Allergy and Clinical Immunology (Eaaci) Congress 2024

KalVista Pharmaceuticals, Inc. announced that it presented real-world data from US patient surveys that assessed the experience of HAE patients using injectable on-demand treatments at the European Academy of Allergy and Clinical Immunology Congress 2024 that took place in Valencia, Spain. The following presentations occurred at EAACI 2024: Hereditary Angioedema (HAE) Patients Answer: Why Do Attacks Go Untreated? Cristine Radojicic, Division of Pulmonary, Allergy and Critical Care, Duke University Medical Center, Durham, North Carolina, USA. (Flash Talks Session) . For 50% of US survey respondents with HAE, their untreated attack progressed in severity while 25% of attacks migrated to other anatomic locations including the throat .Common reasons for not treating were desire to save injectable on-demand treatment for a severe attack, presumption the attack would stay mild, wanting to avoid needle pain or injection burning, stinging, or pain, and not having on-demand treatment with them .Delayed On-demand Treatment of Hereditary Angioedema Attacks: Patient Perceptions and Associated Barriers Rashmi Jain, Consultant in Clinical Immunology, Oxford University Hospital Trust, Oxford, UK. (Poster presentation) 63% of UK survey participants reported their perception of time to treatment for HAE attacks as “early” despite only 14% treating in less than one hour . Common barriers to early on-demand treatment included the belief that the attack was going to remain mild and wanting to save injectable on-demand treatment for a severe attack . Anxiety Associated with On-Demand Treatment for Hereditary Angioedema Attacks Patrick Yong, Frimley Health NHS Foundation Trust, Frimley, UK. (Poster presentation) . Almost half of UK survey participants reported moderate to extreme anxiety when anticipating use of injectable on-demand therapy to treat an attack . Top reasons for feeling anxious were desire not to ‘waste’ on-demand treatment, uncertainty about how long the treatment would take to begin working, and finding a vein for IV infusion .Patient-Reported Benefits of Early On-demand Treatment of HAE Attacks Hilary Longhurst, Auckland City Hospital, Te Toka Tumai, and University of Auckland, Auckland, New Zealand. (Poster presentation) .Results from this analysis highlight that survey respondents with HAE who treat their attacks early (<1 hour) are more likely to carry their on-demand treatment with them and treat more attacks overall compared with those who delay treatment (90.3% vs. 72.6%) .People living with HAE who treat their attacks early also recover more quickly from HAE attacks (1.4 hours vs 2.9 hours for those who waited =1 hour to treat), achieve full recovery earlier (1.3 vs 1.9 days), and feel less anxious when anticipating on-demand treatment .Treatment of HAE Attacks with Anticipated Future Oral On-demand Therapies as Reported by Patients Anna Valerieva, Medical University of Sofia, Sofia, Bulgaria. (Poster presentation) . Survey respondents reported that they anticipated carrying an oral on-demand treatment 95.1% of the time compared with 63.9% with parenteral on-demand treatment; they would treat 88.5% of their attacks with an oral on-demand treatment compared with 80.3% with parenteral on-demand treatment Of the respondents who thought they would treat attacks earlier with a pill vs. an injectable, 80% reported that they would have less anxiety when anticipating using an oral on-demand treatment .Attack Characteristics in Patients with Hereditary Angioedema Receiving Non-Androgen Long-term Prophylaxis William Lumry, Allergy and Asthma Research Associates, Dallas, Texas, United States. (Flash Talks session) . In patients using non-androgen LTP, 68% of patients reported their most recent attack as moderate to very severe; 19.6% of these attacks involved laryngeal swelling and 12% required an ER visit or hospitalization Only 55% of patients reported all their attacks to their physicians, which may have resulted in underestimation of attacks while receiving non-androgen LTP /Unmet Needs Associated with Non-androgen Long-term Prophylaxis (LTP) Therapies for HAE William Lumry, Allergy and Asthma Research Associates, Dallas, Texas, United States. (Poster presentation) /Despite the availability of non-androgen LTPs, their use is associated with a high treatment burden /Lack of efficacy and gastrointestinal issues were the most common issues reported by physicians for patients using oral LTP; route of administration, discomfort, and frequent dosing schedule were the most common issues reported by physicians for patients using injectable LTPs /A Sensitive and Specific Assay to Characterize Plasma Kallikrein Activity in Plasma from Hereditary Angioedema (HAE) Patients: Daniel Lee, KalVista Pharmaceuticals Inc., Cambridge, MA, USA. (Oral Abstract Session).Outlines substantial progress on a sensitive and specific PKa assay that could be useful to characterize the level of PKa activity in plasma samples from PKa-mediated diseases, including patients diagnosed with HAE with normal C1 esterase inhibitor (nC1-INH-HAE) .

Seeking Alpha • Oct 14

KalVista: Another Setback But The Key Value Driver Is Still In Place

Summary KalVista intends to provide best-in-class therapies, both for acute on-demand and prophylaxis treatment, to fundamentally change the way HAE is treated. Its lead drug Sebetralstat is currently being investigated in a Phase 3 study and top-line results are expected in the second half of 2023. Sebetralstat has a compelling drug profile for the on-demand treatment of HAE attacks and could become the new standard of care in a billion-dollar market opportunity. Although KalVista is funded beyond the next major milestones, the market does not attach value to the pipeline. KalVista once again shocks its shareholders with news regarding the termination of the KVD824 phase 2 trial. After its product candidate KVD001 failed to convince in a phase 2 study due to insufficient effectiveness a few years ago, safety concerns are the reason for the termination of the KVD824 trial. The news was very badly received by the market and, as a result, KalVista has lost more than 85% of its value since its peak following positive data on its product candidate Sebetralstat in 2021. Since Sebetralstat is apparently the main value driver of KalVista, and the developments in the pipeline do not allow any conclusions to be drawn about the latter, I wonder whether the high decline in the market capitalization of KalVista is justified. For me, the key value driver is still in place, meaning KalVista is significantly undervalued at current levels. In the following article, I want to introduce the company, explain my investment thesis and justify the potential of the value driver Sebetralstat. Business Of KalVista Pharmaceuticals KalVista (KALV) is a clinical-stage pharmaceutical company headquartered in Cambridge, Massachusetts, focused on developing oral therapies for the rare disease hereditary angioedema ((HAE)). KalVista intends to provide best-in-class therapies, both for acute on-demand and prophylaxis treatment, to fundamentally change the way HAE is treated. HAE is a rare and potentially life-threatening disease, and despite the fact that there are several approved therapies, there is a high unmet medical need to improve the quality of life and ease of disease control. KalVista went public in 2016 through a reverse merger with Carbylan Therapeutics and raised $78.2 million at $17 per share in its first public offering in 2018. The Pipeline Looks Bigger Than It Is The origin of KalVista's pipeline lies in the deep understanding of plasma kallikrein inhibitors. Prior to the change in strategy to focus on developing therapies for HAE, the molecules were also being investigated for diseases in diabetic macular edema ((DME)). In summary, however, KalVista's research efforts have not been very successful in the past. Investors should currently focus on KalVista's lead product candidate, Sebetralstat, formerly known as KVD900, which is currently being investigated in a placebo-controlled Phase 3 trial as an on-demand therapy for HAE attacks. The results of the study are expected to be published in the second half of 2023 which, if positive, will form the foundation for a regulatory submission in the first half of 2024. Since there is already very strong and meaningful data from the Phase 2 trial, I think it is very likely that the success can be duplicated in the Phase 3 trial. The Phase 2 study in 53 HAE patients demonstrated with statistical significance both the clinical efficacy across all primary and secondary endpoints and the overall safety profile of Sebetralstat. The factor XIIa program clearly has great potential, but is still in preclinical development and investors should not assign a value to it at this time. In 2023, KalVista plans to file an investigational new drug application ((IND)) to move the program into human clinical trials. The factor XIIa program has tremendous potential in the prophylactic treatment of HAE. It targets an enzyme that plays a key role in HAE and could block the underlying cause of HAE attacks. If successful in a proof-of-concept study, the program could be expanded in other large market opportunities in the area of inflammation and thrombosis. Overview of Kalvista's pipeline (Company Presentation) KVD824 was investigated in a Phase 2 study for the prophylactic treatment of HAE. However, KalVista has terminated the study due to safety concerns, which indicate that KVD824 will no longer meet the requirements for a best-in-class oral prophylactic therapy. In the beginning, the DME program with its product candidate KVD001 generated a great deal of interest and resulted in a collaboration with Merck (MRK). Following disappointing Phase 2 data in which the primary endpoint was missed, Merck did not extend the collaboration. However, as a dose-dependent clinical benefit on vision has been observed in certain patients, KalVista is still evaluating how to proceed with KVD001. Financial Situation Following the last capital raise following the publication of the Phase 2 data of Sebetralstat at a price of $36 per share, KalVista is currently in a good financial position. With $142 million in cash and a cash runaway until at least 2024, KalVista is funded across key milestones and significant value drivers. With the recently announced termination of the KVD824 Phase 2 trial, an additional $3 million in research and development costs can be saved on a quarterly basis. In my opinion, investors should not fear dilution, as current prices do not reflect the value of Sebetralstat in any way. Nevertheless, I would like to mention that KalVista has access to an ATM with Cantor Fitzgerald, and can issue shares in the amount of $100 million. However, I expect a funding effort with the publication of Phase 3 topline data in the second half of 2023. At current prices, KalVista has a negative pipeline value of approximately $18 million. Consequently, despite the good Phase 2 trial results and the independence to KVD824, investors do not believe that Sebetralstat will be successful. KalVista is currently very attractively valued (Author's Chart) Investment Thesis An investor should always be clear on the reasons for investing in a company. Therefore, I will present my reasons why I believe KalVista is an attractive investment at current prices. KalVista currently has a negative pipeline value even though its lead product candidate is being investigated in a Phase 3 trial in an attractive orphan indication with high unmet medical need. In my opinion, an investment in KalVista given a negative pipeline value is a good opportunity to speculate on a data run in the second half of 2023. The HAE market is very attractive and KalVista has the opportunity to take market share from the established players with a differentiated and more convenient mechanism of action. Personally, I expect KalVista to reach a positive pipeline value of at least $200 million before data readout, which equates to at least $10 per share. Although much higher prices are certainly possible with positive data, I would like to limit my investment thesis to the data run at this time and reduce risk prior to the data release. The release of the data represents a binary event and carries tremendous risk. Even though the peer comparison below does not allow a complete comparison, one can still conclude that KalVista is undervalued based on current share prices. BioCryst (BCRX), with its approved oral drug for the prophylactic treatment of HAE, is a good example of KalVista's potential pathway with positive data. Even Astria (ATXS), which still owes proof-of-concept, currently has a higher pipeline valuation than KalVista. However, it should be noted that Astria is about to publish Phase 2 data, while KalVista has no catalysts scheduled for the next 12 months. Comparison of companies with oral HAE therapies. (Author's Chart) Market Outlook In HAE And Potential of Sebetralstat Having made my investment thesis clear, I want to justify why I attribute substantial value to Sebetralstat. The current standard of care provides both on-demand and preventive treatments. Overall, 6000-8000 patients are affected in the US and up to 15,000 patients in Europe, which translates into up to 100,000 annual attacks in the US and 150,000 in Europe. According to forecasts, the HAE market will show tremendous growth in the coming years, reaching 4.5 billion in 2027. The market will focus more and more on the prophylactic treatment, nevertheless patients will always need a back-up solution in case of an attack. Global HAE Treatment Market is Substantial and Growing (Astria Company Presentation) Currently, there are a number of approved products for HAE patients. The largest player in the HAE market is Takeda (TAK) with its product Takhzyro, which is administered subcutaneously every two weeks for prophylactic treatment. For on-demand treatment of HAE, Takeda offers Firazyr and Kalbitor as subcutaneous injections, generating in total approximately 50% of sales in the HAE market. Overall, the HAE market is very competitive and new product candidates are attracting very high interest. For example, in 2015, Shire (now Takeda) bought Dyax and its product candidate Takhzyro for $5.9 billion after robust Phase 1b data. HAE is a Meaningful and Growing Global Market (Pharvaris Company Presentation) Despite the large number of approved therapies, the HAE market continues to have a high unmet medical need. Except for the oral prophyhlactic drug Orladeyo, all therapies are administered by injection, which is generally less convenient for patients and reduces patient compliance. Injections present a hurdle for patients because, despite their effectiveness, they can cause pain at the injection site, are time-consuming to administer, and are difficult to store. All approved on-demand options have significant shortcomings. Early treatment improves outcomes but undertreatment and late treatment are common. Source: KalVista The barrier of using injections is also shown by studies. These show that less than 40% of all treated attacks are dosed within the first hour, and up to 45% of attacks weren't treated at all. These numbers prove that patients want new medicines that deliver on all fronts. People Living with HAE Desire HAE Therapy that can Deliver on ALL Fronts (Pharvaris Company Presentation) KalVista believes that its oral product candidate, Sebetralstat, has the potential to change the treatment paradigm for this disease. People living with HAE actively seek new products that demonstrate improvements in efficacy, safety and tolerability, and convenience. In addition, research with patient physicians and payers indicate that the drug profile of Sebetralstat could meet these requirements in case of positive study results. As a result, 93% of all patients said they could imagine switching to the oral product candidate Sebetralstat if approved. The benefits of Sebetralstat arise mainly from the fact that the drug is taken earlier due to the lower barriers. Patients should take the drug at the first sign of symptoms. Combined with the rapid uptake of the drug, Sebetralstat has the potential to stop the development of an attack at an early stage while symptoms are still mild and swelling is not severe. Early treatment of attacks leads to better overall disease management and prevention of attacks reaching the critical stage of significant swelling and discomfort. We therefore believe that a safe, oral on-demand treatment has the potential to become a preferred alternative for patients currently using injectable treatments. Source: KalVista

Sneeuwvlok Score
Waardering	2/6
Toekomstige groei	5/6
Prestaties in het verleden	0/6
Financiële gezondheid	1/6
Dividenden	0/6

Historische aandelenkoersen
Huidige aandelenkoers	US$27.00
52 Week Hoogtepunt	US$27.00
52 Week Laag	US$9.83
Bèta	-0.11
1 maand verandering	0.75%
3 maanden verandering	59.39%
1 Jaar Verandering	108.33%
3 jaar verandering	179.79%
5 jaar verandering	-3.67%
Verandering sinds IPO	222.20%

	KALV	US Biotechs	US Markt
7D	0.2%	-4.4%	-0.2%
1Y	108.3%	39.9%	14.8%

KALV volatility
KALV Average Weekly Movement	12.8%
Biotechs Industry Average Movement	9.6%
Market Average Movement	6.9%
10% most volatile stocks in US Market	15.5%
10% least volatile stocks in US Market	2.9%

KALV fundamentele statistieken
Marktkapitalisatie	US$1.44b
Inkomsten(TTM)	-US$135.94m
Inkomsten(TTM)	US$114.48m

Belangrijkste winstgevendheidsstatistieken uit het laatste winstverslag (TTM)
KALV resultatenrekening (TTM)
Inkomsten	US$114.48m
Kosten van inkomsten	US$56.02m
Brutowinst	US$58.47m
Overige uitgaven	US$194.40m
Inkomsten	-US$135.94m

Winst per aandeel (EPS)	-2.55
Brutomarge	51.07%
Nettowinstmarge	-118.74%
Schuld/Eigen Vermogen Verhouding	-1,385.2%

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/06/12 09:36
Aandelenkoers aan het einde van de dag	2026/06/10 00:00
Inkomsten	2026/03/31
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

This company has been acquired

KalVista Pharmaceuticals (KALV) Aandelenoverzicht

Beloningen

Risicoanalyse

Analyst Price Targets

Oral Hereditary Angioedema Shift And Global Expansion Will Reshape This Undervalued Opportunity

Payer Restrictions And Slower Adoption Will Test Oral HAE Therapy But Long Term Potential Remains

Oral HAE Therapies Will Transform Global Treatment And Drive Long-Term Market Leadership

Top Analyst Narratives

Oral Hereditary Angioedema Shift And Global Expansion Will Reshape This Undervalued Opportunity

Payer Restrictions And Slower Adoption Will Test Oral HAE Therapy But Long Term Potential Remains

Oral HAE Therapies Will Transform Global Treatment And Drive Long-Term Market Leadership

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Prijsgeschiedenis en prestaties

Recent nieuws en updates

Chiesi Group Acquires KalVista Pharmaceuticals and EKTERLY Oral HAE Treatment

Kalvista Pharmaceuticals, Inc. Announces Management Changes

KalVista Pharmaceuticals, Inc.(NasdaqGM:KALV) dropped from NASDAQ Biotechnology Index

CEO & Director exercised options and sold US$293k worth of stock

Price target decreased by 15% to US$28.60

KalVista Pharmaceuticals Faces Board Investigation Following US$1.9b Chiesi Acquisition Deal

Recent updates

Chiesi Group Acquires KalVista Pharmaceuticals and EKTERLY Oral HAE Treatment

Kalvista Pharmaceuticals, Inc. Announces Management Changes

KalVista Pharmaceuticals, Inc.(NasdaqGM:KALV) dropped from NASDAQ Biotechnology Index

CEO & Director exercised options and sold US$293k worth of stock

Price target decreased by 15% to US$28.60

KalVista Pharmaceuticals Faces Board Investigation Following US$1.9b Chiesi Acquisition Deal

Chiesi Farmaceutici S.p.A. entered into a definitive agreement to acquire KalVista Pharmaceuticals, Inc. (NasdaqGM:KALV) for approximately $1.5 billion.

KalVista: 'Strong Buy' As Acquired By Chiesi And Positive KONFIDENT-KID Outcome

KalVista Pharmaceuticals Announces Positive Interim Phase 3 Data From KONFIDENT-KID Trial Of EKTERLY (Sebetralstat) For Children Aged 2-11 Years

KalVista Pharmaceuticals, Inc. to Report 8 Months 2025 Results on Mar 25, 2026

KalVista Pharmaceuticals, Inc. Presents New Data Highlighting High Patient Satisfaction and Evolving Treatment Trends with EKTERLY®? (sebetralstat)

KalVista Pharmaceuticals, Inc. Announces Inclusion of EKTERLY®? (sebetralstat) as a First-Line Therapy for Adolescents 12 and Older in International Pediatric HAE Guideline

Payer Restrictions And Slower Adoption Will Test Oral HAE Therapy But Long Term Potential Remains

Health Check: How Prudently Does KalVista Pharmaceuticals (NASDAQ:KALV) Use Debt?

Kalvista Pharmaceuticals Announces New Data Highlighting the Potential of Ekterly®? (Sebetralstat) to Transform On-Demand Hereditary Angioedema Treatment in Europe

KalVista Pharmaceuticals, Inc. Appoints Bilal Arif as Chief Operating Officer and Linea Aspesi as Chief People Officer, Effective October 6, 2025

KalVista Pharmaceuticals, Inc. Announces Board and Committee Changes

KalVista Pharmaceuticals, Inc. Announces European Commission and Swissmedic Approval of EKTERLY®? (sebetralstat), First and Only Oral On-Demand Treatment for Hereditary Angioedema

Is KalVista Pharmaceuticals (NASDAQ:KALV) A Risky Investment?

KalVista Pharmaceuticals, Inc., Annual General Meeting, Oct 01, 2025

KalVista Pharmaceuticals, Inc. Announces UK MHRA Approval of EKTERLY (Sebetralstat), First and Only Oral On-Demand Treatment for Hereditary Angioedema

KalVista Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

Here's Why We're Not Too Worried About KalVista Pharmaceuticals' (NASDAQ:KALV) Cash Burn Situation

Kalvista Pharmaceuticals Announces FDA Approval of Ekterly®? (Sebetralstat)

KalVista Pharmaceuticals, Inc. Announces FDA to Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints

KalVista Pharmaceuticals to Present New Sebetralstat Data at the European Academy of Allergy and Clinical Immunology Congress 2025

KalVista Pharmaceuticals Medical Congress Presentations Highlight Potential of Sebetralstat to Redefine Hereditary Angioedema Management

KalVista Pharmaceuticals to Present New Sebetralstat Data with 10 Abstracts Accepted At Upcoming Medical Meetings

Is KalVista Pharmaceuticals (NASDAQ:KALV) In A Good Position To Deliver On Growth Plans?

Kalvista Pharmaceuticals Announces Early Completion of Enrollment in KONFIDENT-KID Pediatric HAE Trial

KalVista: Potential First With Multiple Sebetralstat Regulatory Reviews In 2025

KalVista Pharmaceuticals, Inc. Appoints Jeb Ledell as Chief Operating Officer

KalVista Pharmaceuticals, Inc. Appoints Laurence Reid to Board of Directors

KalVista: Upcoming PDUFA, But Not Without Risks

KalVista Pharmaceuticals, Inc. announced that it expects to receive $5 million in funding from DRI Capital Inc.

KalVista Pharmaceuticals, Inc. Presents New Sebetralstat Data at the 2024 American College of Allergy Asthma and Immunology

KalVista Announces the Submission of Additional Marketing Authorization Applications for Sebetralstat for the Oral On-Demand Treatment of Hereditary Angioedema

Is KalVista Pharmaceuticals (NASDAQ:KALV) In A Good Position To Deliver On Growth Plans?

KalVista Pharmaceuticals: Looking To Be A Major Player In HAE

Kalvista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

KalVista Pharmaceuticals, Inc., Annual General Meeting, Oct 03, 2024

KalVista Pharmaceuticals, Inc. Announces Validation of Marketing Authorization Application by the European Medicines Agency for Sebetralstat for Hereditary Angioedema

KalVista Pharmaceuticals, Inc. Initiates KONFident-KID Trial for On-Demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Children Aged 2 to 11

Bullish On KalVista Pharmaceuticals: Sebetralstat Nears Approval, Aiming For 2025 Launch

KalVista Pharmaceuticals, Inc. Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary Angioedema

KalVista Pharmaceuticals, Inc. Presents Data At Eastern Allergy Conference 2024 and the Japanese Dermatological Association 2024

Kalvista Pharmaceuticals Presents Data on Persisting Unmet Needs in Hereditary Angioedema At the European Academy of Allergy and Clinical Immunology (Eaaci) Congress 2024

Kalvista Pharmaceuticals Announces New England Journal of Medicine Publishes Oral Sebetralstat Phase 3 Data Demonstrating Its Potential to Transform the Treatment Landscape for People with Hereditary Angioedema

CEO & Director exercised options and sold US$258k worth of stock

Forecast to breakeven in 2027

Kalvista Pharmaceuticals, Inc. Appoints William C. Fairey to the Board of Directors

KalVista Pharmaceuticals, Inc. to Present HAE Attack Journey Data at 2024 HAEi Regional Conference Americas

KalVista Pharmaceuticals, Inc. Announces Board Changes

New minor risk - Share price stability