KalVista Pharma Files 2024 10-K

TL;DR

KalVista's 2024 10-K is in. Financials and equity plan details are out.

AI Summary

KalVista Pharmaceuticals, Inc. filed its 2024 10-K report on July 11, 2024, detailing its fiscal year ending April 30, 2024. The company, formerly known as Carbylan Therapeutics, Inc., is focused on pharmaceutical preparations. The filing includes financial data such as Additional Paid-In Capital and Retained Earnings, and information on its equity incentive plans.

Why It Matters

This filing provides a comprehensive overview of KalVista Pharmaceuticals' financial health and operational status for the past fiscal year, crucial for investors and stakeholders to assess the company's performance and future prospects.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, KalVista faces inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• 2024-04-30 — Fiscal Year End (The end date of the reporting period.)
• 2024-07-11 — Filing Date (The date the 10-K was officially submitted to the SEC.)

Key Players & Entities

• KalVista Pharmaceuticals, Inc. (company) — Filer of the 10-K
• Carbylan Therapeutics, Inc. (company) — Former name of KalVista Pharmaceuticals
• 20240430 (date) — Fiscal year end date
• 20240711 (date) — Filing date
• 0000950170-24-082965 (filing_id) — Accession number for the filing

FAQ

Key Financial Figures

• $0.001 — nge on Which Registered Common Stock, $0.001 par value per share KALV The Nasdaq
• $8.49 — alculated based on the closing price of $8.49 of the registrant's common stock as rep

Filing Documents

• kalv-20240430.htm (10-K) — 2164KB
• kalv-ex10_17.htm (EX-10.17) — 166KB
• kalv-ex21_1.htm (EX-21.1) — 10KB
• kalv-ex23_1.htm (EX-23.1) — 3KB
• kalv-ex31_1.htm (EX-31.1) — 16KB
• kalv-ex32_1.htm (EX-32.1) — 7KB
• kalv-ex97_1.htm (EX-97.1) — 83KB
• 0000950170-24-082965.txt ( ) — 8707KB
• kalv-20240430.xsd (EX-101.SCH) — 1144KB
• kalv-20240430_htm.xml (XML) — 1375KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 18 Item 1B. Unresolved Staff Comments 49 Item 1C. Cybersecurity 50 Item 2.

Properties

Properties 51 Item 3.

Legal Proceedings

Legal Proceedings 51 Item 4. Mine Safety Disclosures 51 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 Item 6. Reserved 52 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 53 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 59 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 60 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 60 Item 9A.

Controls and Procedures

Controls and Procedures 60 Item 9B. Other Information 61 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 61 PART III Item 10. Directors, Executive Officers and Corporate Governance 62 Item 11.

Executive Compensation

Executive Compensation 62 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 62 Item 13. Certain Relationships and Related Transactions, and Director Independence 63 Item 14. Principal Accounting Fees and Services 63 PART IV Item 15. Exhibits, Financial Statement Schedules 64 Item 16. Form 10-K Summary 66

Signatures

Signatures 67 Index to Consolidated Financial Statements F- 1 i PAR T I SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical fact are "forward-looking statements" for purposes of this Annual Report on Form 10-K. These forward-looking statements may include, but are not limited to, statements regarding our current and future nonclinical, preclinical and clinical development activities, macroeconomic conditions, including rising inflation and fluctuating interest rates, labor shortages, supply chain issues, uncertainty with respect to the federal debt ceiling and budget and potential government shutdowns related thereto and global regional conflicts, our future results of operations and financial position, business strategy, market size, potential growth opportunities, the efficacy and safety profile of our product candidates, expected timing and results of our clinical trials, and receipt and timing of potential regulatory designations, approval and commercialization of product candidates. In some cases, forward-looking statements may be identified by terminology such as "believe," "may," "will," "should," "predict," "goal," "strategy," "potentially," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect," "seek" and similar expressions and variations thereof. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the "Risk Factors" section and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitiv

B usiness

Item 1. B usiness. Overview We are a clinical stage pharmaceutical company focused on the discovery, development and commercialization of drug therapies for diseases with significant unmet need. We have used our capabilities to develop sebetralstat, a novel, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema ("HAE"). In June 2024, we announced that we have filed a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") seeking marketing approval of sebetralstat as the first oral, on-demand therapy for HAE. We also are conducting preclinical development on a novel, oral, Factor XIIa inhibitor program. HAE is a rare and potentially life-threatening, genetically-driven disease that features episodes of debilitating and often painful swelling in the skin, gastrointestinal tract or airways. Although multiple therapies have been approved for the disease, we believe people living with HAE are in need of alternatives that better meet their objectives for quality of life and ease of disease control. Other than one oral therapy approved for prophylaxis, currently marketed therapies are all administered by injection, which patients find challenging despite their efficacy because they are painful, time consuming to prepare and administer, and difficult to transfer and store. As a result, many attacks are treated too late to prevent significant symptoms, and a large percentage aren't treated at all, leading to needless suffering. We anticipate that there will be strong interest in a safe and effective, orally delivered on-demand treatment, which would provide patients a new and compelling option with which to treat their disease. Our belief that there could be a fundamental shift in the manner in which HAE is managed is based upon extensive and continuing research we conduct with patients, physicians and payers. We have conducted research to further understand the process that people living with HAE follow when

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