Quarterly Report for Quarter Ending July 31, 2025 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OFFINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this report. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential" or "continue" or the negative of these terms or other comparable terminology. These forward-looking statements, include, but are not limited to, statements regarding the success, cost and timing of our product development activities and clinical trials as well as other activities we may undertake, macroeconomic conditions, including rising inflation and changing interest rates, labor shortages, supply chain issues, and global conflicts such as the war in Ukraine and conflicts in the Middle East, our business strategy, our ability to receive, maintain and recognize the benefits of certain designations received by product candidates and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates. Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under "Risk Factors" in our Annual Report on Form 10-K or described elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Unless the context indicates otherwise, in this Quarterly Report on Form 10-Q, the terms "KalVista," "Company," "we," "us" and "our" refer to KalVista Pharmaceuticals, Inc. and, where appropriate, its consolidated subsidiaries.

Management Overview

We are a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our product, EKTERLY®(sebetralstat), is a novel, orally delivered, small molecule plasma kallikrein inhibitor for the treatment of acute attacks of hereditary angioedema ("HAE") in adult and pediatric patients aged 12 years and older. EKTERLY (sebetralstat) is the first and only oral, on-demand therapy for HAE.

The efficacy and safety of EKTERLY (sebetralstat) was established by the results from the phase 3 KONFIDENT clinical trial, published in the New England Journal of Medicine in May 2024. The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. HAE attacks treated with 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p=0.0013 ) with a median time to beginning of symptom relief of 1.79 hours (CI 1.33, 2.27) as compared to 6.72 hours with placebo (CI 2.33, >12). Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo. There were no patient withdrawals due to any adverse event and no treatment-related serious adverse events (SAEs) were observed. Treatment-related adverse event rates were 2.2% for 600 mg sebetralstat as compared to 4.8% for placebo. Primary and key secondary endpoints were analyzed in a fixed, hierarchical sequence and adjusted for multiplicity. Key secondary endpoints showed:

Prior to the approval of EKTERLY, all on-demand treatment options approved in the U.S. for HAE required intravenous or subcutaneous administration, which carries a significant treatment burden. Even with the use of long-term prophylaxis as a preventative therapy, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication. We believe that EKTERLY has the potential to fundamentally shift the manner in which HAE is managed, based upon extensive and continuing research conducted with patients, physicians and payers. Sebetralstat is currently under review with regulatory authorities in the EU, Japan, Switzerland and other territories.

Key Updates

On July 3, 2025, the U.S. Food and Drug Administration (the "FDA") approved our NDA for EKTERLY, a novel, orally delivered, small molecule plasma kallikrein inhibitor, for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral, on-demand therapy for HAE.

In July 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) granted marketing authorization for EKTERLY (sebetralstat). EKTERLY (sebetralstat) also met the requirements of the MHRA Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 10 years of market exclusivity.

Also in July, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending market authorization for sebetralstat. The European Commission (EC) final decision is expected in October 2025.

Additionally, the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) confirmed maintenance of orphan designation for sebetralstat. The decision to maintain orphan designation was based on a finding of comparable efficacy of sebetralstat to injectable on-demand treatments while offering a major contribution to patient care by reducing the morbidity of HAE attacks. Maintenance of orphan designation provides several important regulatory and financial benefits, including 10 years of market exclusivity in the EU following approval. Sebetralstat is now one of only two HAE medicines to have maintained orphan designation in the EU, highlighting its distinctive position within the HAE treatment landscape.

In June 2025, KalVista Pharmaceuticals Limited granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Financial terms of the agreement were not disclosed.

Upon FDA approval of EKTERLY, KalVista Pharmaceuticals notified DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust ("DRI") that it elected to receive an optional payment of $22.0 million as part of the November 2024 royalty transaction. As a result of receiving this one-time payment from DRI, the royalty rate on the first sales tranche steps up from 5.00% to 6.00% on net sales up to and including $500.0 million and the sales-based milestone amount increases from $50.0 million to $57.0 million if annual worldwide net sales of EKTERLY meet or exceed $550.0 million in any calendar year before January 1, 2031.

Results of Operations

Refer to Note 2, Summary of Significant Accounting Policies, for a description of our significant accounting policies related to product revenue recognition and cost of revenue,

Comparison of the three months ended July 31, 2025 and 2024

The following table sets forth the key components of our results of operations for the three months ended July 31, 2025 and 2024 (in thousands):

Product revenue, net.Product revenue, net was $1.4 million for the three months ended July 31, 2025 compared to zero for the three months ended July 31, 2024, as a result of our commercial launch of EKTERLY in the United States in July 2025, following the FDA approval of EKTERLY on July 3, 2025.

Cost of revenue. Cost of revenue was $0.6 million for the three months ended July 31, 2025, compared to zero for the three months ended July 31, 2024, and primarily consisted of costs related to commercial revenue, including manufacturing costs and indirect costs associated with the manufacturing and distribution of EKTERLY following the FDA approval.

Research and Development Expenses.Research and development expenses decreased $11.5 million to $15.2 million for the three months ended July 31, 2025 compared to $26.6 million in the same period in the prior fiscal year due to decreases in spending on EKTERLY of $6.5 million, personnel costs of $1.1 million, and other R&D activities of $3.9 million. The impact of exchange rates on research and development expenses was immaterial for the three months ended July 31, 2025 compared to the same period in the prior fiscal year, which is reflected in the figures above.

Research and development expenses by major programs or categories were as follows (in thousands):

Other R&D costs decreased primarily due to recognizing expense associated with sebetralstat pre-commercial awareness within Selling, general and administrative expenses. We anticipate these expenses will remain approximately at current levels as the KONFIDENT-S and KONFIDENT-KID trials are ongoing and we continue preclinical research including the oral Factor XIIa inhibitor program.

Selling, General and Administrative Expenses.Selling, general and administrative expenses increased by $27.1 million primarily due to increases in personnel costs of $14.7 million, commercial expenses of $3.7 million, professional fees of $3.1 million, sebetralstat awareness of $1.8 million, and other administrative expenses of $3.8 million. We anticipate these expenses will continue at or above current levels to support the commercialization of EKTERLY.

Other Income.Other income decreased $2.7 million primarily due to an increase in interest expense and change in fair value of the derivative liability of $3.5 million and $1.1 million, respectively offset by the change foreign currency exchange rate gains of $1.4 million.

Liquidity and Capital Resources

The three months ended July 31, 2025 is the first period in which we have generated revenue from product sales, following the FDA approval of EKTERLY on July 3, 2025. Previously, we have funded operations primarily through the issuance of capital stock, pre-funded warrants, and royalty financing. Our working capital, primarily cash and marketable securities, is anticipated to fund our operations for at least the next twelve months from the date these unaudited interim condensed consolidated financial statements are issued.

Sources of Liquidity

In February 2024, we entered into an underwriting agreement with Jefferies LLC, Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated, and Cantor Fitzgerald & Co., as the representatives of several underwriters to sell an aggregate of 7,016,312 shares of our common stock at a price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of our common stock at a price of $15.249 per pre-funded warrant. The net proceeds from the offering, after deducting expenses, were approximately $150.1 million. As of July 31, 2025, no pre-funded warrants from the offering have been exercised.

In July 2024, we filed a registration statement on Form S-3 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC"), pursuant to which we may offer and sell securities having an aggregate public offering price of up to $300 million.

In November 2024, we entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC and Stifel Nicolaus & Company, Incorporated, as the representatives of several underwriters to sell an aggregate of 5,500,000 shares of our common stock at an offering price of $10.00 per share (the "November 2024 Offering") pursuant to the Registration Statement. The net proceeds from the November 2024 Offering, after deducting expenses, were approximately $51.3 million.

Also in November 2024, we entered into a securities purchase agreement with DRI to sell an aggregate of 500,000 shares of our common stock at a price of $10.00 per share in a private placement. The net proceeds from the private placement, after deducting placement agent fees and other expenses, were approximately $4.7 million.

Also, in November 2024, we entered into a royalty purchase agreement with DRI to monetize a portion of our future sebetralstat worldwide net sales. Under the terms of the agreement, we received an upfront payment of $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat, which is recorded as the Royalty Liability on our Consolidated Balance Sheet. In July 2025, we received the one-time cash payment of $22.0 million as a result of obtaining FDA approval of sebetralstat before October 1, 2025.

In April 2025, we entered into a License, Supply and Distribution Agreement (the "Kaken Agreement") with Kaken Pharmaceutical Co., Ltd. ("Kaken") pursuant to which we have licensed exclusive commercialization rights in Japan to Kaken for the Licensed Product (as defined under the Kaken Agreement) in exchange for a non-refundable upfront payment of $11.0 million, potential regulatory and sales milestone payments totaling approximately $13.0 million and effective royalty payments in the mid-twenties that shall be payable for each unit of revenue of Licensed Product (as defined in the Kaken Agreement) that we supply, which reflect a percentage of the Japanese National Health Insurance price of the Licensed Product. On June 20, 2025, we received the upfront payment of $11.0 million.

In July 2025, we entered into a sales agreement with TD Securities (USA) LLC ("TD Cowen") pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (the "ATM Shares"), under the prospectus supplement, dated July 10, 2025, to the Registration Statement, through TD Cowen as sales agent. During the three months ended July 31, 2025, we did not offer or sell any ATM Shares pursuant to the Registration Statement.

Cash Flows

The following table shows a summary of the net cash flow activity for the three months ended July 31, 2025 and 2024 (in thousands):

Net cash used in operating activities

Net cash used in operating activities was $54.5 million for the three months ended July 31, 2025 and primarily consisted of a net loss of $60.0 million adjusted for stock-based compensation of $5.4 million, interest expense and issuance cost amortization associated with the sale of future royalties of $3.5 million, realized gains from available for sale securities of $0.6 million, and other changes in net working capital. Net cash used in operating activities was $40.2 million for the three months ended July 31, 2024 and primarily consisted of a net loss of $40.4 million adjusted for stock-based compensation of $3.0 million, an increase in the research and development tax credit receivable of $1.3 million, an increase in prepaid expenses and other assets of $0.8 million, and other changes in net working capital.

Net cash provided by investing activities

Net cash provided by investing activities for the three months ended July 31, 2025 was $21.3 million and primarily consisted of the sales and maturities of marketable securities of $41.6 million offset by purchases of marketable securities of $20.0 million, as compared to $37.2 million provided by investing activities during the same period in the prior year primarily due to sales and maturities of marketable securities of $38.2 million offset by purchases of marketable securities of $1.0 million.

Net cash provided by financing activities

Net cash provided by financing activities during the three months ended July 31, 2025 was $23.2 million and primarily consisted of the increase of the royalty liability of $22.0 million related to our drawdown of the milestone payment from DRI after FDA approval of EKTERLY. Net cash provided by financing activities during the same period in the prior year was $3.0 million which consisted of the issuance of common stock from equity incentive plans.

Contractual Obligations and Commitments

We enter into contracts in the normal course of business with contract research organizations and clinical trial sites for the conduct of clinical trials, preclinical and clinical studies, professional consultants and other vendors for clinical supply manufacturing or other services. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the SEC on July 10, 2025. We are party to several operating leases for office and laboratory space as of July 31, 2025.

Critical Accounting Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP"). The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of our financial statements and the reported revenue and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience, known trends and events, contractual milestones and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. See Note 2 to the unaudited interim condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for a description of our significant accounting policies and assumptions used in applying those policies. The accounting policies and estimates that we deem to be critical are discussed in more detail in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the SEC on July 10, 2025. There have been no material changes to our critical accounting estimates in the three months ended July 31, 2025.

Recently Issued Accounting Pronouncements

See Note 2 in the Interim Financial Statements for a description of recent accounting pronouncements, including the expected dates of adoption and expected effects on results of operations and financial condition, if known.